Unit10:临床实践指南 主讲教师：王艺助理教师：张赟健 一、教学目的：掌握和熟悉临床实践指南的应用原则和方法 二、教学内容： 1,掌握临床实践指南的基本概念、推荐意见的证据级别、评价原则和应用原则 2.熟悉临床实践指南的检索方法 3.了解临床实践指南的制定步骤 三、教学重点：实践指南的推荐意见的证据级别 四、教学难点：实践指南的评价原则 五、中文和英文关健词 临床实践指南Clinical Practice Guidelines 推荐意见Recommendations 证据等级Levels of evidence 六、阅读文献：见附后文献 七、讨论思考题： 1,获得临床指南的主要途径： 2.临床指南的基本格式和特点： 3.比较几篇参考文献的特点和异同： 4.EBM在临床指南制定中的作用
Unit 10：临床实践指南 主讲教师：王艺 助理教师：张赟健 一、教学目的：掌握和熟悉临床实践指南的应用原则和方法 二、教学内容： 1. 掌握临床实践指南的基本概念、推荐意见的证据级别、评价原则和应用原则 2. 熟悉临床实践指南的检索方法 3. 了解临床实践指南的制定步骤 三、教学重点：实践指南的推荐意见的证据级别 四、教学难点：实践指南的评价原则 五、中文和英文关键词 临床实践指南 Clinical Practice Guidelines 推荐意见 Recommendations 证据等级 Levels of evidence 六、阅读文献：见附后文献 七、讨论思考题： 1. 获得临床指南的主要途径； 2. 临床指南的基本格式和特点； 3. 比较几篇参考文献的特点和异同； 4. EBM 在临床指南制定中的作用
R68光9 Evidence Report:Genetic and Metabolic Testing on Children with Global Developmental Delay CcPreialheiobouehto arding his unremarkable and that concern about his development first arose because he was not speaking at 2 years of age.The pediatrician had ordered an audiological examination,basic laboratory uding the M mages.and you interpret ther The child's past medical history is negative for any chronic illnesses,prior hospitalizations, surgeries,or episodes of head trauma.I he parents deny consanguinity,prior miscarrages,or any rly childhood death or ne going ba three generanon a gm than that hes oleterand stratiht On examination his awake anda a 二 La ha cssHsooemirewih es desires or me mildly decrease tone,and at least engt y exam appea His deep accurately for obiects without tremor.though he uses a raking sp and chews an offered pen rather than writing with it.He is able to sit,stand,and walk independently but runs slowly and clumsily,with his hands held above his waist. ental delav ent that ence of m half his age.You further explain that his examination and family history do not clearly indicate a more specific diagnosis,but that you suspect a problem with brain function that may be genetic in nature.You review their options with them,and they express interest in further diagno tic testing ns long-term prognosis and r ons.on s of t in ended in counsen and coordination of care
Evidence Report: Genetic and Metabolic Testing on Children with Global Developmental Delay Case Presentation A 3-year-old boy is brought to your child neurology clinic due to concerns regarding his development. The parents state that the pregnancy, delivery, and early postnatal period were unremarkable and that concern about his development first arose because he was not speaking at 2 years of age. The pediatrician had ordered an audiological examination; basic laboratory evaluations for anemia, lead toxicity, and hypothyroidism; a karyotype; and a non-contrast head MRI. You are able to review these test results, including the MRI images, and you interpret them as normal. The child’s past medical history is negative for any chronic illnesses, prior hospitalizations, surgeries, or episodes of head trauma. The parents deny consanguinity, prior miscarriages, or any family history of early childhood death or neurologic disease, going back three generations. They have three older children, two boys and a girl, who are healthy and developing normally. On 10- topic review of systems, the parents deny any concerns other than that he is often constipated, is not toilet trained, is easily frustrated and prone to aggression, and sleeps poorly at night. On examination his vital signs and growth parameters are within normal limits for age. He is awake and alert and shows no signs of acute distress, though he is fearful and uncooperative with the examination. He has no obvious dysmorphism or signs of a phakomatosis. His general physical examination is normal. He makes contact with you and his parents and expresses desires to leave and for snacks through sounds and gestures but does not say any words. He turns when his name is spoken but does not follow any commands. His cranial nerve examination is normal. His motor examination reveals normal bulk, mildly decreased limb tone, and at least 4/5 strength. His sensory exam appears grossly intact, with withdrawal of all limbs from light touch. His deep tendon reflexes are normal and symmetric, and Babinski signs are not elicited. He reaches accurately for objects without tremor, though he uses a raking grasp and chews an offered pen rather than writing with it. He is able to sit, stand, and walk independently but runs slowly and clumsily, with his hands held above his waist. You explain to the parents that their son shows evidence of moderate to severe global developmental delay (GDD), with development that is generally below that expected for children half his age. You further explain that his examination and family history do not clearly indicate a more specific diagnosis, but that you suspect a problem with brain function that may be genetic in nature. You review their options with them, and they express interest in further diagnostic testing to better understand his long-term prognosis and risk of complications. On the basis of the recent evidence review, you order a genomic microarray study. The total time spent in this evaluation is 1 hour, 30 minutes of which was expended in counseling and coordination of care
ons A Th ara ka n be considered for this patient because ofGDD B Both if follow-up testing is needed to int ret an ambiguous result C.The child has no dysmorphic features to suggest a specific syndromic diagnosis D.The child has no family history to suggest an X-linked inheritance pattern E.All of the above The correct ar y ailable evidence sum microarray studies have th 2 What additional histo nLsnrs i esting this patient for muatio A.The parents discover that they are second cousins B.The mother learns that her older sister has just given birth to a son with Down syndrome The father adds that he and his brothers all struggled in school and were in spectal cducation mo er reveals that her older brother and a sister's son both have unexplained intellectual The correct answer is D.A family history that fits possible or definite X-linked inheritance of ID greatly increases the likelihood that testing XLID genes will be diagnostic (Class IlI studies). 3.Which of these inborn errors of metabolism(IEM)is not inherited in an X-linked recessive manner? sport deficiency due to mutation of the gene C Sm ndr D.Ornithine nscarbamylase deficiency E.Hunter syndrome (MPS The correct answer is C.Smith-Lemli-Opitz syndrome is inherited in an autosomal recessive manner,wit h mu isted are i of 30 persons of European descent.The other IEMs manner an are us mos for ren with GD nd th ependin (Class ID.Testing for cong ital disorders of glyc svlation has a vield of up to 14%,and testing for creatine synthesis and transport disorders has a yield of up to 2.8%(Class II). Diagnosis Coding nprovides the diagnosis Global developmental delay(GDD).I ode in ICD-9 less specific code that best fits GDD captures the concept without attributing undiagnosed defici 783.42 Delayed milestones If after the evaluation(or with time)more specific developmental delays or specific disease states are found,it is very important that the appropriate codes for those conditions be used instead of the above nonspecific code.Codes for several specific developmental delays are found in Chapter ch as of October 1,2011,has been renamed "Me es Ior t h the cause and type of delay should be used whe
Questions 1. Microarray can be considered for this patient because: A. The normal karyotype does not exclude a genetic cause of GDD B. Both parents are available if follow-up testing is needed to interpret an ambiguous result C. The child has no dysmorphic features to suggest a specific syndromic diagnosis D. The child has no family history to suggest an X-linked inheritance pattern E. All of the above The correct answer is E. Available evidence suggests that genomic microarray studies have the highest diagnostic yield in this clinical scenario (Class III studies). 2. What additional history would most increase your interest in testing this patient for mutations in X-linked intellectual disability (XLID) genes? A. The parents discover that they are second cousins B. The mother learns that her older sister has just given birth to a son with Down syndrome C. The father adds that he and his brothers all struggled in school and were in special education D. The mother reveals that her older brother and a sister’s son both have unexplained intellectual disability (ID) E. The child has a 9-year-old sister who has been diagnosed with dyslexia The correct answer is D. A family history that fits possible or definite X-linked inheritance of ID greatly increases the likelihood that testing XLID genes will be diagnostic (Class III studies). 3. Which of these inborn errors of metabolism (IEM) is not inherited in an X-linked recessive manner? A. Creatine transport deficiency due to mutation of the SLC6A8 gene B. Menkes kinky hair disease C. Smith-Lemli-Opitz syndrome D. Ornithine transcarbamylase deficiency E. Hunter syndrome (MPS II) The correct answer is C. Smith-Lemli-Opitz syndrome is inherited in an autosomal recessive manner, with mutations carried by 1 out of 30 persons of European descent. The other IEMs listed are inherited in an X-linked recessive manner and are thus most often found in males. Screening for IEMs in children with GDD/ID has a yield of between 0.2% and 4.6%, depending on the presence of clinical indicators (such as family history) and the range of testing performed (Class III). Testing for congenital disorders of glycosylation has a yield of up to 1.4%, and testing for creatine synthesis and transport disorders has a yield of up to 2.8% (Class III). Diagnosis Coding The documentation provides the diagnosis Global developmental delay (GDD). There is no index entry or specific numerical code in ICD-9-CM for GDD.1 A less specific code that best fits GDD and captures the concept without attributing undiagnosed deficits is: 783.42 Delayed milestones If after the evaluation (or with time) more specific developmental delays or specific disease states are found, it is very important that the appropriate codes for those conditions be used instead of the above nonspecific code. Codes for several specific developmental delays are found in Chapter 5 of ICD-9-CM, which as of October 1, 2011, has been renamed “Mental, Behavioral and Neurodevelopmental Disorders.” Codes for both the cause and type of delay should be used when
available,with the cause being listed first. ng th of a formal con de for ocument the expending of 60 minutes with the patient and 30 minutes in counseling and coordination of care.This would permit the use of code99205,which is a level 5 new-patient visitThe coding is based on time and requires that 50%or more of time is spent counseling and coordinating care during a 60-minute visit. Practice Management Information Corporation.International Classification of Diseases. 9th revision;clinical modification,6th edition.Los Angeles,CA:Practice Management Information Corporation;2006. PCenters for Medicare and Medicaid Services.Evaluation and Management Services Guide.Baltimore.MD:Centers for Medicare and Medicaid Services:December 2010 Disclaimer This oren nneme It is based on an asse all possible proper methods of care for a particular neurologic problem or all legitimate criteria for choosing to use a specific procedure.Neither is it intended to exclude any reasonable alternative methodologies.The AAN recognizes that specific patient care decisions are the r and the physictan caning for the patient,bascd on all of the 2011 American Academy of Neurology
available, with the cause being listed first. Evaluation and Management Coding Since there is no reference in the history of a formal consultation request, the pediatric neurologist would code for a new patient. The comment at the end of the evaluation documents the expending of 60 minutes with the patient and 30 minutes in counseling and coordination of care. This would permit the use of code 99205, which is a level 5 new-patient visit.2 The coding is based on time and requires that 50% or more of time is spent counseling and coordinating care during a 60-minute visit. 1 Practice Management Information Corporation. International Classification of Diseases, 9th revision; clinical modification, 6th edition. Los Angeles, CA: Practice Management Information Corporation; 2006. 2 Centers for Medicare and Medicaid Services. Evaluation and Management Services Guide. Baltimore, MD: Centers for Medicare and Medicaid Services; December 2010. Disclaimer This statement is provided as an educational service of the American Academy of Neurology. It is based on an assessment of current scientific and clinical information. It is not intended to include all possible proper methods of care for a particular neurologic problem or all legitimate criteria for choosing to use a specific procedure. Neither is it intended to exclude any reasonable alternative methodologies. The AAN recognizes that specific patient care decisions are the prerogative of the patient and the physician caring for the patient, based on all of the circumstances involved. © 2011 American Academy of Neurology
NGC benner Guideline Summary NGC-5791 Guideline Title d dinical interventions for children and young people with autism spectrum disorders.A Bibliographic Source(s) ren and 间 Guideline Status This is the current release of the quideline This guideline was issued in 2007 and will be considered for review in three years.Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN)Web site Scope Disease/Condition(s) Autism spectrum disorders (ASDs)including autism,atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Lanquage Pathologists Guideline Objective(s) Yomand cinica ntevnor chdrenand Target Population Children and young people with autism spectrum disorders(ASD)
Guideline Summary NGC-5791 NGC banner Guideline Title Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Scope Disease/Condition(s) Autism spectrum disorders (ASDs) including autism, atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Language Pathologists Guideline Objective(s) To provide evidence-based recommendations on the assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders (ASD) Target Population Children and young people with autism spectrum disorders (ASD) Interventions and Practices Considered Diagnosis/Evaluation 1. Clinical assessment according to diagnostic criteria from the International Classification of Diseases of the World Health Organisation, 10th edition (ICD-10) and the Diagnostic and Statistical Manual, 4th edition (DSM-IV) 2. Surveillance 3. Identification of children of high risk (use of structured instrument) 4. Timing of diagnosis 5. Autism spectrum disorder-specific diagnostic history from parent/carer 6. Direct observation and assessment of social, and communication skills and behaviour 7. Evaluation of speech, language and communication skills 8. Assessment of intellectual, neuropsychological and adaptive functioning 9. Biomedical investigations l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Other investigations to rule out recognised aetiologies of autism spectrum disorders (ASD) (e.g., tuberous sclerosis) 10. Assessment of comorbid conditions Management/Treatment 1. Support for early communication skills 2. Interventions for social communication and interaction 3. Intensive behavioural programmes 4. Behavioural interventions 5. Pharmacologic therapy l Risperidone l Methylphenidate l Melatonin 6. Service provision l Training of healthcare personnel l Provision of information for parents/carers l Education and skills interventions for parents of pre-school children with ASD Major Outcomes Considered l Accuracy of diagnostic tests l Communication and social functioning l Symptom relief l Quality of life l Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A systematic review of the literature was carried out using a search strategy devised by a Scottish Intercollegiate Guidelines Network (SIGN) Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. For most searches, the year range covered was 1996-2006. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NeLH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports. The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigor and practicality of use. The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion (e.g., an acceptable level of loss to follow up) and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimize any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment Evidence Tables Evidence tables are compiled by SIGN executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder (ASD) in the Literature When reviewing the literature the guideline development group found that the definitions of ASD used for diagnosis varied considerably when reported and were often not reported at all. To allow for consistency within the guideline the group agreed that three elements – assessment process, classification system and diagnostic instrument - were important in the accurate diagnosis of ASD. If a paper did not record diagnosis in this way it was downgraded. Additional information can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site . A. Components of diagnostic assessment 1. A recognised process of obtaining information in necessary domains, usually by multidisciplinary or multiagency personnel 2. Mapping of the resulting information into a recognised classification system such as DSM–IV or ICD–10 (see section 2.2) 3. Assessment using a recognised and published diagnostic instrument B. Components of a reliable diagnosis Increasing accuracy and reliability Use of a process, and a diagnostic classification system, and an instrument (i.e. 1, 2, and 3, from A) 1. Use of a process and a diagnostic classification system OR 2. Use of an instrument and a diagnostic classification system The use of a process, a diagnostic classification system or an instrument, used singly Diagnosis simply stated Note: Each component of the assessment should be explicitly stated in the study/report under consideration Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable. It is important to emphasize that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved. Considered Judgment It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, SIGN has introduced the concept of considered judgment. Under the heading of considered judgment, guideline development groups summarize their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects: l Quantity, quality, and consistency of evidence l Generalisability of study findings l Directness of application to the target population for the guideline l Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them.) l Implementability (i.e., how practical it would be for the NHS in Scotland to implement the recommendation.) Guideline development groups are provided with a pro forma in which to record the main points from their considered judgment. Once they have considered these issues, the group is asked to summarize their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site . Rating Scheme for the Strength of the Recommendations Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development. Peer Review All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to a lay reviewer in order to obtain comments from the patient's perspective. The comments received from peer reviewers and others are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication. Recommendations Major Recommendations Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document. The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field. Diagnostic Criteria C- All professionals involved in diagnosing Autism Spectrum Disorders (ASD) in children and young people should consider using either International Classification of Diseases (ICD)-10 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. Recognition, Assessment, and Diagnosis Recognition in Primary Care Screening C - Population screening for ASD is not recommended. Surveillance D - As part of the core program of child health surveillance, healthcare professionals can contribute to the early identification of children requiring further assessment for ASD, and other developmental disorders: l Clinical assessment should incorporate a high level of vigilance for features suggestive of ASD, in the domains of social interaction and play, speech and language development and behavior l The Checklist for Autism in Toddlers (CHAT) or modified CHAT (M-CHAT) can be used in young children to identify clinical features indicative of an increased risk of ASD but should not be used to rule out ASD Screening of High Risk Groups C - The use of an appropriate structured instrument may be a useful supplement to the clinical process to identify children and young people at high risk of ASD. Timing of Diagnosis D - ASD should be part of the differential diagnosis for very young (preschool) children displaying absence of normal developmental features, as typical ASD behaviors may not be obvious in this age group. Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D - Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C - ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) D - Healthcare professionals should directly observe and assess the child or young person's social and communication skills and behavior. C - Healthcare professionals should consider using ASD-specific observational instruments, as a means of improving the reliability of ASD diagnosis. Individual Profiling D - All children and young people with ASD should have a comprehensive evaluation of their speech and language and communication skills, which should inform intervention. D - Children and young people with ASD should be considered for assessment of intellectual, neuropsychological and adaptive functioning. Biomedical Investigations D - Where clinically relevant, the need for the following should be reviewed for all children and young people with ASD: l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Investigations to rule out recognised aetiologies of ASD (e.g., tuberous sclerosis, see Annex 3 in the original guideline document) Conditions Associated with ASD C - Healthcare professionals should be aware of the need to routinely check for comorbid problems in children and young people with ASD. Where necessary, detailed assessment should be carried out to accurately identify and manage comorbid problems. Non-Pharmacological Interventions Communication Interventions Support for Early Communication Skills D - Interventions to support communication in ASD are indicated, such as the use of visual augmentation (e.g., in the form of pictures of objects). Interventions for Social Communication and Interaction D - Interventions to support social communication should be considered for children and young people with ASD, with the most appropriate intervention being assessed on an individual basis. Behavior/Psychological Interventions Intensive Behavioral Programmes A - The Lovaas programme should not be presented as an intervention that will lead to normal functioning. Interventions for Specific Behaviors B - Behavioral interventions should be considered to address a wide range of specific behaviors in children and young people with ASD, both to reduce symptom frequency and severity and to increase the development of adaptive skills. Auditory Integration Training A - Auditory integration training is not recommended. Facilitated Communication A - Facilitated communication should not be used as a means to communicate with children and young people with ASD. Pharmacological Interventions Risperidone B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism B - Weight should be monitored regularly in children and young people who are taking risperidone. Methylphenidate B - Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD. Secretin A - Secretin is not recommended for use in children and young people with ASD. Melatonin D - Melatonin may be considered for treatment of sleep problems which have persisted despite behavioral interventions. Service Provision ASD Training D - All professions and service providers working in the ASD field should review their training arrangements to ensure staff has up-to-date knowledge and adequate skill levels. Training and Support for Parents Information Provision D - Professionals should offer parents good quality written information and an opportunity to ask questions when disclosing information about their child with ASD D - Parents should be provided with information in an accessible and absorbable form. Meeting Support Needs B - Education and skills interventions for parents of pre-school children with ASD should be offered. Definitions: Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Clinical Algorithm(s) None provided Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate early diagnosis and management of children and young people with autism spectrum disorders may help a child to maximize his or her potential. Potential Harms l Adverse effects associated with risperidone include tiredness/sedation early in treatment and increased appetite and weight gain l Methylphenidate adverse effects may include difficulty falling asleep, appetite decrease, irritability and emotional outbursts. l Melatonin is not a licensed medication, which limits the information that is available about effectiveness and safety Qualifying Statements Qualifying Statements This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken. Implementation of the Guideline Description of Implementation Strategy Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit. Key points for audit are identified in the original guideline document. Implementation Tools Audit Criteria/Indicators Chart Documentation/Checklists/Forms Quick Reference Guides/Physician Guides For information about availability, see the Availability of Companion Documents and Patient Resources fields below. Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Living with Illness IOM Domain Effectiveness Patient-centeredness Identifying Information and Availability Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2007 Jul Guideline Developer(s) Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.] Source(s) of Funding Scottish Executive Health Department Guideline Committee Not stated Composition of Group That Authored the Guideline Guideline Development Group: Dr Iain McClure* (Chair) Consultant Child and Adolescent Psychiatrist, Murray Royal Hospital, Perth; Mrs Jennifer Beattie, Principal Teacher in Special Needs, Kenmay Academy, Aberdeenshire; Mrs Sheila Boyd, Occupational Therapist, Scottish Centre for Autism, Glasgow; Ms Margo Cattanach, Community Charge Nurse - Learning Disabilities, Larbert; Dr Sally Cheseldine, Consultant Clinical Psychologist, Child and Adolescent Mental Health Services, Edinburgh; Mr Paul Dickinson, Clinical Psychologist, NHS Highland, Inverness; Mrs Penny Ellingham, Social Worker, Royal Hospital for Sick Children, Edinburgh; Dr David Fitzpatrick, Clinical Paediatric Geneticist, MRC Human Genetics Unit, Edinburgh; Mrs Bette Francis, Vulnerable Adults Unit, Scottish Executive Health Department, Edinburgh; Dr Anne Gilchrist*, Consultant Adolescent Psychiatrist, Royal Cornhill Hospital, Aberdeen; Dr Rob Henderson, Specialist Registrar in Public Health Medicine, Highland NHS Board, Inverness; Mrs Alison Leask*, Project Manager, NHS Education for Scotland and Chair, Autism Argyll; Dr Tommy MacKay, Consultant Psychologist, Psychology Consultancy Services, Dunbartonshire; Ms Marjory Macleod, Senior Dietitian, Sighthill Health Centre, Edinburgh; Mrs Roslyn McCaughey, Senior Speech and Language Therapist, Renton Primary (Secretary) School, Renton; Dr John March, Research Scientist, Moredun Research Institute, Penicuik; Dr Craig Melville*, Senior Lecturer in Learning Disabilities Psychiatry, University of Glasgow, Gartnavel Royal Hospital; Mrs Rona Membury, Lay Representative, Inverness; Dr Elise Merry, Consultant Paediatrician, Armitstead Child Development Centre, Dundee; Professor Anne O'Hare*, Consultant Paediatrician, Royal Hospital for Sick Children, (Vice-chair) Edinburgh; Dr Safia Qureshi, SIGN Programme Director; Ms Marion Rutherford, Speech and Language Therapist, Royal Hospital for Sick Children, Edinburgh; Ms Chris Simmonds, Health Visitor, Aberdeen; Dr Georgina Soulby, Consultant Community Paediatrician - Children Services, Raigmore Hospital, Inverness; Ms Janis Toy, Residential Services Manager, Daldorch House School, East Ayrshire; Ms Diane Waugh, Lay Representative, Sense Scotland, Glasgow; Ms Joanna Welsh, SIGN Information Officer *Member of the writing group Financial Disclosures/Conflicts of Interest Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive. Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . Availability of Companion Documents The following are available: l Quick reference guide: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. Scottish Intercollegiate Guidelines Network, 2007 Jun. 2 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . l SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site . l Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network, 2001. Available from the SIGN Web site . Also, chart documentation of suggested screening instruments in high risk groups is provided in Annex 4 of the original guideline document . Patient Resources None available NGC Status This summary was completed by ECRI Institute on August 31, 2007. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. Copyright Statement Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit. Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net. Additional copyright information is available on the SIGN Web site . Disclaimer NGC Disclaimer The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer
Interventions and Practices Considered Diagnosis/Evaluation 2 Surveillance 3.Identification of children of high risk (use of structured instrument) 4.Timing of diagnosis 5.Autism spectrum disorder-specific diagnostic history from parent/carer 6.Direct observation and assessment of social,and communication skills and behaviour 7.Evaluation of speech.language and communication skills 8.Assessment of intellectual.neuropsychological and adaptive functioning 9.Biomedical investigations .Examination of physical status,with particular attention to neurological and dysmorphic features Karyotyping and Fragile X DNA analysis Examination of audiological status investigations to rule out recognised aetiologies of autism spectrum disorders(ASD)(e.g.tuberous 10.Assessment of comorbid conditions Management/Treatment 1.Support for early communication skills 2.Interventions for social communication and interaction 3.Intensive behavioural programmes 4.Behavioural interventions 5.Pharmacologic therapy Risperidone Methylphenidate Melatonin sonnel carer Education or parents of pre-school children with ASD stic teste Communication and social functioning 。Symntom relief 。Quality of life Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature(Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence E ng the ew Ze LH GUI Nation umber of Source Documents
Guideline Summary NGC-5791 NGC banner Guideline Title Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Scope Disease/Condition(s) Autism spectrum disorders (ASDs) including autism, atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Language Pathologists Guideline Objective(s) To provide evidence-based recommendations on the assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders (ASD) Target Population Children and young people with autism spectrum disorders (ASD) Interventions and Practices Considered Diagnosis/Evaluation 1. Clinical assessment according to diagnostic criteria from the International Classification of Diseases of the World Health Organisation, 10th edition (ICD-10) and the Diagnostic and Statistical Manual, 4th edition (DSM-IV) 2. Surveillance 3. Identification of children of high risk (use of structured instrument) 4. Timing of diagnosis 5. Autism spectrum disorder-specific diagnostic history from parent/carer 6. Direct observation and assessment of social, and communication skills and behaviour 7. Evaluation of speech, language and communication skills 8. Assessment of intellectual, neuropsychological and adaptive functioning 9. Biomedical investigations l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Other investigations to rule out recognised aetiologies of autism spectrum disorders (ASD) (e.g., tuberous sclerosis) 10. Assessment of comorbid conditions Management/Treatment 1. Support for early communication skills 2. Interventions for social communication and interaction 3. Intensive behavioural programmes 4. Behavioural interventions 5. Pharmacologic therapy l Risperidone l Methylphenidate l Melatonin 6. Service provision l Training of healthcare personnel l Provision of information for parents/carers l Education and skills interventions for parents of pre-school children with ASD Major Outcomes Considered l Accuracy of diagnostic tests l Communication and social functioning l Symptom relief l Quality of life l Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A systematic review of the literature was carried out using a search strategy devised by a Scottish Intercollegiate Guidelines Network (SIGN) Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. For most searches, the year range covered was 1996-2006. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NeLH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports. The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigor and practicality of use. The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion (e.g., an acceptable level of loss to follow up) and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimize any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment Evidence Tables Evidence tables are compiled by SIGN executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder (ASD) in the Literature When reviewing the literature the guideline development group found that the definitions of ASD used for diagnosis varied considerably when reported and were often not reported at all. To allow for consistency within the guideline the group agreed that three elements – assessment process, classification system and diagnostic instrument - were important in the accurate diagnosis of ASD. If a paper did not record diagnosis in this way it was downgraded. Additional information can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site . A. Components of diagnostic assessment 1. A recognised process of obtaining information in necessary domains, usually by multidisciplinary or multiagency personnel 2. Mapping of the resulting information into a recognised classification system such as DSM–IV or ICD–10 (see section 2.2) 3. Assessment using a recognised and published diagnostic instrument B. Components of a reliable diagnosis Increasing accuracy and reliability Use of a process, and a diagnostic classification system, and an instrument (i.e. 1, 2, and 3, from A) 1. Use of a process and a diagnostic classification system OR 2. Use of an instrument and a diagnostic classification system The use of a process, a diagnostic classification system or an instrument, used singly Diagnosis simply stated Note: Each component of the assessment should be explicitly stated in the study/report under consideration Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable. It is important to emphasize that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved. Considered Judgment It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, SIGN has introduced the concept of considered judgment. Under the heading of considered judgment, guideline development groups summarize their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects: l Quantity, quality, and consistency of evidence l Generalisability of study findings l Directness of application to the target population for the guideline l Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them.) l Implementability (i.e., how practical it would be for the NHS in Scotland to implement the recommendation.) Guideline development groups are provided with a pro forma in which to record the main points from their considered judgment. Once they have considered these issues, the group is asked to summarize their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site . Rating Scheme for the Strength of the Recommendations Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development. Peer Review All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to a lay reviewer in order to obtain comments from the patient's perspective. The comments received from peer reviewers and others are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication. Recommendations Major Recommendations Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document. The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field. Diagnostic Criteria C- All professionals involved in diagnosing Autism Spectrum Disorders (ASD) in children and young people should consider using either International Classification of Diseases (ICD)-10 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. Recognition, Assessment, and Diagnosis Recognition in Primary Care Screening C - Population screening for ASD is not recommended. Surveillance D - As part of the core program of child health surveillance, healthcare professionals can contribute to the early identification of children requiring further assessment for ASD, and other developmental disorders: l Clinical assessment should incorporate a high level of vigilance for features suggestive of ASD, in the domains of social interaction and play, speech and language development and behavior l The Checklist for Autism in Toddlers (CHAT) or modified CHAT (M-CHAT) can be used in young children to identify clinical features indicative of an increased risk of ASD but should not be used to rule out ASD Screening of High Risk Groups C - The use of an appropriate structured instrument may be a useful supplement to the clinical process to identify children and young people at high risk of ASD. Timing of Diagnosis D - ASD should be part of the differential diagnosis for very young (preschool) children displaying absence of normal developmental features, as typical ASD behaviors may not be obvious in this age group. Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D - Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C - ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) D - Healthcare professionals should directly observe and assess the child or young person's social and communication skills and behavior. C - Healthcare professionals should consider using ASD-specific observational instruments, as a means of improving the reliability of ASD diagnosis. Individual Profiling D - All children and young people with ASD should have a comprehensive evaluation of their speech and language and communication skills, which should inform intervention. D - Children and young people with ASD should be considered for assessment of intellectual, neuropsychological and adaptive functioning. Biomedical Investigations D - Where clinically relevant, the need for the following should be reviewed for all children and young people with ASD: l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Investigations to rule out recognised aetiologies of ASD (e.g., tuberous sclerosis, see Annex 3 in the original guideline document) Conditions Associated with ASD C - Healthcare professionals should be aware of the need to routinely check for comorbid problems in children and young people with ASD. Where necessary, detailed assessment should be carried out to accurately identify and manage comorbid problems. Non-Pharmacological Interventions Communication Interventions Support for Early Communication Skills D - Interventions to support communication in ASD are indicated, such as the use of visual augmentation (e.g., in the form of pictures of objects). Interventions for Social Communication and Interaction D - Interventions to support social communication should be considered for children and young people with ASD, with the most appropriate intervention being assessed on an individual basis. Behavior/Psychological Interventions Intensive Behavioral Programmes A - The Lovaas programme should not be presented as an intervention that will lead to normal functioning. Interventions for Specific Behaviors B - Behavioral interventions should be considered to address a wide range of specific behaviors in children and young people with ASD, both to reduce symptom frequency and severity and to increase the development of adaptive skills. Auditory Integration Training A - Auditory integration training is not recommended. Facilitated Communication A - Facilitated communication should not be used as a means to communicate with children and young people with ASD. Pharmacological Interventions Risperidone B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism B - Weight should be monitored regularly in children and young people who are taking risperidone. Methylphenidate B - Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD. Secretin A - Secretin is not recommended for use in children and young people with ASD. Melatonin D - Melatonin may be considered for treatment of sleep problems which have persisted despite behavioral interventions. Service Provision ASD Training D - All professions and service providers working in the ASD field should review their training arrangements to ensure staff has up-to-date knowledge and adequate skill levels. Training and Support for Parents Information Provision D - Professionals should offer parents good quality written information and an opportunity to ask questions when disclosing information about their child with ASD D - Parents should be provided with information in an accessible and absorbable form. Meeting Support Needs B - Education and skills interventions for parents of pre-school children with ASD should be offered. Definitions: Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Clinical Algorithm(s) None provided Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate early diagnosis and management of children and young people with autism spectrum disorders may help a child to maximize his or her potential. Potential Harms l Adverse effects associated with risperidone include tiredness/sedation early in treatment and increased appetite and weight gain l Methylphenidate adverse effects may include difficulty falling asleep, appetite decrease, irritability and emotional outbursts. l Melatonin is not a licensed medication, which limits the information that is available about effectiveness and safety Qualifying Statements Qualifying Statements This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken. Implementation of the Guideline Description of Implementation Strategy Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit. Key points for audit are identified in the original guideline document. Implementation Tools Audit Criteria/Indicators Chart Documentation/Checklists/Forms Quick Reference Guides/Physician Guides For information about availability, see the Availability of Companion Documents and Patient Resources fields below. Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Living with Illness IOM Domain Effectiveness Patient-centeredness Identifying Information and Availability Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2007 Jul Guideline Developer(s) Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.] Source(s) of Funding Scottish Executive Health Department Guideline Committee Not stated Composition of Group That Authored the Guideline Guideline Development Group: Dr Iain McClure* (Chair) Consultant Child and Adolescent Psychiatrist, Murray Royal Hospital, Perth; Mrs Jennifer Beattie, Principal Teacher in Special Needs, Kenmay Academy, Aberdeenshire; Mrs Sheila Boyd, Occupational Therapist, Scottish Centre for Autism, Glasgow; Ms Margo Cattanach, Community Charge Nurse - Learning Disabilities, Larbert; Dr Sally Cheseldine, Consultant Clinical Psychologist, Child and Adolescent Mental Health Services, Edinburgh; Mr Paul Dickinson, Clinical Psychologist, NHS Highland, Inverness; Mrs Penny Ellingham, Social Worker, Royal Hospital for Sick Children, Edinburgh; Dr David Fitzpatrick, Clinical Paediatric Geneticist, MRC Human Genetics Unit, Edinburgh; Mrs Bette Francis, Vulnerable Adults Unit, Scottish Executive Health Department, Edinburgh; Dr Anne Gilchrist*, Consultant Adolescent Psychiatrist, Royal Cornhill Hospital, Aberdeen; Dr Rob Henderson, Specialist Registrar in Public Health Medicine, Highland NHS Board, Inverness; Mrs Alison Leask*, Project Manager, NHS Education for Scotland and Chair, Autism Argyll; Dr Tommy MacKay, Consultant Psychologist, Psychology Consultancy Services, Dunbartonshire; Ms Marjory Macleod, Senior Dietitian, Sighthill Health Centre, Edinburgh; Mrs Roslyn McCaughey, Senior Speech and Language Therapist, Renton Primary (Secretary) School, Renton; Dr John March, Research Scientist, Moredun Research Institute, Penicuik; Dr Craig Melville*, Senior Lecturer in Learning Disabilities Psychiatry, University of Glasgow, Gartnavel Royal Hospital; Mrs Rona Membury, Lay Representative, Inverness; Dr Elise Merry, Consultant Paediatrician, Armitstead Child Development Centre, Dundee; Professor Anne O'Hare*, Consultant Paediatrician, Royal Hospital for Sick Children, (Vice-chair) Edinburgh; Dr Safia Qureshi, SIGN Programme Director; Ms Marion Rutherford, Speech and Language Therapist, Royal Hospital for Sick Children, Edinburgh; Ms Chris Simmonds, Health Visitor, Aberdeen; Dr Georgina Soulby, Consultant Community Paediatrician - Children Services, Raigmore Hospital, Inverness; Ms Janis Toy, Residential Services Manager, Daldorch House School, East Ayrshire; Ms Diane Waugh, Lay Representative, Sense Scotland, Glasgow; Ms Joanna Welsh, SIGN Information Officer *Member of the writing group Financial Disclosures/Conflicts of Interest Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive. Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . Availability of Companion Documents The following are available: l Quick reference guide: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. Scottish Intercollegiate Guidelines Network, 2007 Jun. 2 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . l SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site . l Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network, 2001. Available from the SIGN Web site . Also, chart documentation of suggested screening instruments in high risk groups is provided in Annex 4 of the original guideline document . Patient Resources None available NGC Status This summary was completed by ECRI Institute on August 31, 2007. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. Copyright Statement Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit. Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net. Additional copyright information is available on the SIGN Web site . Disclaimer NGC Disclaimer The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer
Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme(Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence quality meta-analyses,systematic reviews of randomised controlled trials(RCTs)or RCTs with a very low 1+:Well-conducted meta-analyses,systematic reviews of RCTs,or RCTs with a low risk of bias 1-:Meta-analyses,systematic reviews of RCTs,or RCTs with a high risk of bias 2++High quality systematic reviews of case control or cohort studies onoor cohor studies with a very low risk of confoundngor bias and a high probability that the 3:Non-analytic studies(e.g.case reports,case series) 4:Expert opinior Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence en sele e arade of recomr endation that it sur a ra ment Scottis N GN) the South w ich h The e etho oiogIcaf and pra involves a degree from the s the y DY Evidence Tables the pasis of the quidene development aroup's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder(ASD)in the Literature A.Components of diagr ment A recognised p ation in necessary domains,usually by multidisciplinary or multiagency personne oing of the into a ed c ion system such as DSM-IV or ICD-10 (see section 2.2 3.Assessment using a recognised and pub ished diagnostic instrument B.Components of a rellable diagnosis Use of a pro pent (Le.1.2.and 3.from A 1.use of a process and a diagnostic classification system OR creasing accuracy and rellabilit 2.Use of an instrument and a diagnostic classification system
Guideline Summary NGC-5791 NGC banner Guideline Title Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Scope Disease/Condition(s) Autism spectrum disorders (ASDs) including autism, atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Language Pathologists Guideline Objective(s) To provide evidence-based recommendations on the assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders (ASD) Target Population Children and young people with autism spectrum disorders (ASD) Interventions and Practices Considered Diagnosis/Evaluation 1. Clinical assessment according to diagnostic criteria from the International Classification of Diseases of the World Health Organisation, 10th edition (ICD-10) and the Diagnostic and Statistical Manual, 4th edition (DSM-IV) 2. Surveillance 3. Identification of children of high risk (use of structured instrument) 4. Timing of diagnosis 5. Autism spectrum disorder-specific diagnostic history from parent/carer 6. Direct observation and assessment of social, and communication skills and behaviour 7. Evaluation of speech, language and communication skills 8. Assessment of intellectual, neuropsychological and adaptive functioning 9. Biomedical investigations l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Other investigations to rule out recognised aetiologies of autism spectrum disorders (ASD) (e.g., tuberous sclerosis) 10. Assessment of comorbid conditions Management/Treatment 1. Support for early communication skills 2. Interventions for social communication and interaction 3. Intensive behavioural programmes 4. Behavioural interventions 5. Pharmacologic therapy l Risperidone l Methylphenidate l Melatonin 6. Service provision l Training of healthcare personnel l Provision of information for parents/carers l Education and skills interventions for parents of pre-school children with ASD Major Outcomes Considered l Accuracy of diagnostic tests l Communication and social functioning l Symptom relief l Quality of life l Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A systematic review of the literature was carried out using a search strategy devised by a Scottish Intercollegiate Guidelines Network (SIGN) Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. For most searches, the year range covered was 1996-2006. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NeLH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports. The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigor and practicality of use. The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion (e.g., an acceptable level of loss to follow up) and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimize any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment Evidence Tables Evidence tables are compiled by SIGN executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder (ASD) in the Literature When reviewing the literature the guideline development group found that the definitions of ASD used for diagnosis varied considerably when reported and were often not reported at all. To allow for consistency within the guideline the group agreed that three elements – assessment process, classification system and diagnostic instrument - were important in the accurate diagnosis of ASD. If a paper did not record diagnosis in this way it was downgraded. Additional information can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site . A. Components of diagnostic assessment 1. A recognised process of obtaining information in necessary domains, usually by multidisciplinary or multiagency personnel 2. Mapping of the resulting information into a recognised classification system such as DSM–IV or ICD–10 (see section 2.2) 3. Assessment using a recognised and published diagnostic instrument B. Components of a reliable diagnosis Increasing accuracy and reliability Use of a process, and a diagnostic classification system, and an instrument (i.e. 1, 2, and 3, from A) 1. Use of a process and a diagnostic classification system OR 2. Use of an instrument and a diagnostic classification system The use of a process, a diagnostic classification system or an instrument, used singly Diagnosis simply stated Note: Each component of the assessment should be explicitly stated in the study/report under consideration Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable. It is important to emphasize that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved. Considered Judgment It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, SIGN has introduced the concept of considered judgment. Under the heading of considered judgment, guideline development groups summarize their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects: l Quantity, quality, and consistency of evidence l Generalisability of study findings l Directness of application to the target population for the guideline l Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them.) l Implementability (i.e., how practical it would be for the NHS in Scotland to implement the recommendation.) Guideline development groups are provided with a pro forma in which to record the main points from their considered judgment. Once they have considered these issues, the group is asked to summarize their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site . Rating Scheme for the Strength of the Recommendations Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development. Peer Review All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to a lay reviewer in order to obtain comments from the patient's perspective. The comments received from peer reviewers and others are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication. Recommendations Major Recommendations Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document. The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field. Diagnostic Criteria C- All professionals involved in diagnosing Autism Spectrum Disorders (ASD) in children and young people should consider using either International Classification of Diseases (ICD)-10 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. Recognition, Assessment, and Diagnosis Recognition in Primary Care Screening C - Population screening for ASD is not recommended. Surveillance D - As part of the core program of child health surveillance, healthcare professionals can contribute to the early identification of children requiring further assessment for ASD, and other developmental disorders: l Clinical assessment should incorporate a high level of vigilance for features suggestive of ASD, in the domains of social interaction and play, speech and language development and behavior l The Checklist for Autism in Toddlers (CHAT) or modified CHAT (M-CHAT) can be used in young children to identify clinical features indicative of an increased risk of ASD but should not be used to rule out ASD Screening of High Risk Groups C - The use of an appropriate structured instrument may be a useful supplement to the clinical process to identify children and young people at high risk of ASD. Timing of Diagnosis D - ASD should be part of the differential diagnosis for very young (preschool) children displaying absence of normal developmental features, as typical ASD behaviors may not be obvious in this age group. Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D - Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C - ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) D - Healthcare professionals should directly observe and assess the child or young person's social and communication skills and behavior. C - Healthcare professionals should consider using ASD-specific observational instruments, as a means of improving the reliability of ASD diagnosis. Individual Profiling D - All children and young people with ASD should have a comprehensive evaluation of their speech and language and communication skills, which should inform intervention. D - Children and young people with ASD should be considered for assessment of intellectual, neuropsychological and adaptive functioning. Biomedical Investigations D - Where clinically relevant, the need for the following should be reviewed for all children and young people with ASD: l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Investigations to rule out recognised aetiologies of ASD (e.g., tuberous sclerosis, see Annex 3 in the original guideline document) Conditions Associated with ASD C - Healthcare professionals should be aware of the need to routinely check for comorbid problems in children and young people with ASD. Where necessary, detailed assessment should be carried out to accurately identify and manage comorbid problems. Non-Pharmacological Interventions Communication Interventions Support for Early Communication Skills D - Interventions to support communication in ASD are indicated, such as the use of visual augmentation (e.g., in the form of pictures of objects). Interventions for Social Communication and Interaction D - Interventions to support social communication should be considered for children and young people with ASD, with the most appropriate intervention being assessed on an individual basis. Behavior/Psychological Interventions Intensive Behavioral Programmes A - The Lovaas programme should not be presented as an intervention that will lead to normal functioning. Interventions for Specific Behaviors B - Behavioral interventions should be considered to address a wide range of specific behaviors in children and young people with ASD, both to reduce symptom frequency and severity and to increase the development of adaptive skills. Auditory Integration Training A - Auditory integration training is not recommended. Facilitated Communication A - Facilitated communication should not be used as a means to communicate with children and young people with ASD. Pharmacological Interventions Risperidone B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism B - Weight should be monitored regularly in children and young people who are taking risperidone. Methylphenidate B - Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD. Secretin A - Secretin is not recommended for use in children and young people with ASD. Melatonin D - Melatonin may be considered for treatment of sleep problems which have persisted despite behavioral interventions. Service Provision ASD Training D - All professions and service providers working in the ASD field should review their training arrangements to ensure staff has up-to-date knowledge and adequate skill levels. Training and Support for Parents Information Provision D - Professionals should offer parents good quality written information and an opportunity to ask questions when disclosing information about their child with ASD D - Parents should be provided with information in an accessible and absorbable form. Meeting Support Needs B - Education and skills interventions for parents of pre-school children with ASD should be offered. Definitions: Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Clinical Algorithm(s) None provided Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate early diagnosis and management of children and young people with autism spectrum disorders may help a child to maximize his or her potential. Potential Harms l Adverse effects associated with risperidone include tiredness/sedation early in treatment and increased appetite and weight gain l Methylphenidate adverse effects may include difficulty falling asleep, appetite decrease, irritability and emotional outbursts. l Melatonin is not a licensed medication, which limits the information that is available about effectiveness and safety Qualifying Statements Qualifying Statements This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken. Implementation of the Guideline Description of Implementation Strategy Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit. Key points for audit are identified in the original guideline document. Implementation Tools Audit Criteria/Indicators Chart Documentation/Checklists/Forms Quick Reference Guides/Physician Guides For information about availability, see the Availability of Companion Documents and Patient Resources fields below. Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Living with Illness IOM Domain Effectiveness Patient-centeredness Identifying Information and Availability Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2007 Jul Guideline Developer(s) Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.] Source(s) of Funding Scottish Executive Health Department Guideline Committee Not stated Composition of Group That Authored the Guideline Guideline Development Group: Dr Iain McClure* (Chair) Consultant Child and Adolescent Psychiatrist, Murray Royal Hospital, Perth; Mrs Jennifer Beattie, Principal Teacher in Special Needs, Kenmay Academy, Aberdeenshire; Mrs Sheila Boyd, Occupational Therapist, Scottish Centre for Autism, Glasgow; Ms Margo Cattanach, Community Charge Nurse - Learning Disabilities, Larbert; Dr Sally Cheseldine, Consultant Clinical Psychologist, Child and Adolescent Mental Health Services, Edinburgh; Mr Paul Dickinson, Clinical Psychologist, NHS Highland, Inverness; Mrs Penny Ellingham, Social Worker, Royal Hospital for Sick Children, Edinburgh; Dr David Fitzpatrick, Clinical Paediatric Geneticist, MRC Human Genetics Unit, Edinburgh; Mrs Bette Francis, Vulnerable Adults Unit, Scottish Executive Health Department, Edinburgh; Dr Anne Gilchrist*, Consultant Adolescent Psychiatrist, Royal Cornhill Hospital, Aberdeen; Dr Rob Henderson, Specialist Registrar in Public Health Medicine, Highland NHS Board, Inverness; Mrs Alison Leask*, Project Manager, NHS Education for Scotland and Chair, Autism Argyll; Dr Tommy MacKay, Consultant Psychologist, Psychology Consultancy Services, Dunbartonshire; Ms Marjory Macleod, Senior Dietitian, Sighthill Health Centre, Edinburgh; Mrs Roslyn McCaughey, Senior Speech and Language Therapist, Renton Primary (Secretary) School, Renton; Dr John March, Research Scientist, Moredun Research Institute, Penicuik; Dr Craig Melville*, Senior Lecturer in Learning Disabilities Psychiatry, University of Glasgow, Gartnavel Royal Hospital; Mrs Rona Membury, Lay Representative, Inverness; Dr Elise Merry, Consultant Paediatrician, Armitstead Child Development Centre, Dundee; Professor Anne O'Hare*, Consultant Paediatrician, Royal Hospital for Sick Children, (Vice-chair) Edinburgh; Dr Safia Qureshi, SIGN Programme Director; Ms Marion Rutherford, Speech and Language Therapist, Royal Hospital for Sick Children, Edinburgh; Ms Chris Simmonds, Health Visitor, Aberdeen; Dr Georgina Soulby, Consultant Community Paediatrician - Children Services, Raigmore Hospital, Inverness; Ms Janis Toy, Residential Services Manager, Daldorch House School, East Ayrshire; Ms Diane Waugh, Lay Representative, Sense Scotland, Glasgow; Ms Joanna Welsh, SIGN Information Officer *Member of the writing group Financial Disclosures/Conflicts of Interest Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive. Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . Availability of Companion Documents The following are available: l Quick reference guide: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. Scottish Intercollegiate Guidelines Network, 2007 Jun. 2 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . l SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site . l Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network, 2001. Available from the SIGN Web site . Also, chart documentation of suggested screening instruments in high risk groups is provided in Annex 4 of the original guideline document . Patient Resources None available NGC Status This summary was completed by ECRI Institute on August 31, 2007. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. Copyright Statement Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit. Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net. Additional copyright information is available on the SIGN Web site . Disclaimer NGC Disclaimer The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer
ote:Each component of the a xnlicitly stated in the under consideratin the SIGN Web site Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence ed.Thus lered Judgm et population for the gudelin (ie the exte impact on the target patient population,and the resources needed to trea Implementability (.how practical it would be for the NHS in Scotland to implement the recommendation.) Guidelines Network.(IGN from the GN Rating Scheme for the Strength of the Recommendations Grades of recor nmendation a8gte886r8aTmgeaee8eoaeshen2t8ithevdenceonwhichtherecommendatonsbased.r evreateireciabetothepuiand studies rated asdirectly applicable to the targepopulaioand demonsrating apolated nce from studies rated as2++ D:Ev dence level 3 or 4:o studies rated as 2+ CostAnalysis
Guideline Summary NGC-5791 NGC banner Guideline Title Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Scope Disease/Condition(s) Autism spectrum disorders (ASDs) including autism, atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Language Pathologists Guideline Objective(s) To provide evidence-based recommendations on the assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders (ASD) Target Population Children and young people with autism spectrum disorders (ASD) Interventions and Practices Considered Diagnosis/Evaluation 1. Clinical assessment according to diagnostic criteria from the International Classification of Diseases of the World Health Organisation, 10th edition (ICD-10) and the Diagnostic and Statistical Manual, 4th edition (DSM-IV) 2. Surveillance 3. Identification of children of high risk (use of structured instrument) 4. Timing of diagnosis 5. Autism spectrum disorder-specific diagnostic history from parent/carer 6. Direct observation and assessment of social, and communication skills and behaviour 7. Evaluation of speech, language and communication skills 8. Assessment of intellectual, neuropsychological and adaptive functioning 9. Biomedical investigations l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Other investigations to rule out recognised aetiologies of autism spectrum disorders (ASD) (e.g., tuberous sclerosis) 10. Assessment of comorbid conditions Management/Treatment 1. Support for early communication skills 2. Interventions for social communication and interaction 3. Intensive behavioural programmes 4. Behavioural interventions 5. Pharmacologic therapy l Risperidone l Methylphenidate l Melatonin 6. Service provision l Training of healthcare personnel l Provision of information for parents/carers l Education and skills interventions for parents of pre-school children with ASD Major Outcomes Considered l Accuracy of diagnostic tests l Communication and social functioning l Symptom relief l Quality of life l Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A systematic review of the literature was carried out using a search strategy devised by a Scottish Intercollegiate Guidelines Network (SIGN) Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. For most searches, the year range covered was 1996-2006. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NeLH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports. The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigor and practicality of use. The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion (e.g., an acceptable level of loss to follow up) and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimize any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment Evidence Tables Evidence tables are compiled by SIGN executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder (ASD) in the Literature When reviewing the literature the guideline development group found that the definitions of ASD used for diagnosis varied considerably when reported and were often not reported at all. To allow for consistency within the guideline the group agreed that three elements – assessment process, classification system and diagnostic instrument - were important in the accurate diagnosis of ASD. If a paper did not record diagnosis in this way it was downgraded. Additional information can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site . A. Components of diagnostic assessment 1. A recognised process of obtaining information in necessary domains, usually by multidisciplinary or multiagency personnel 2. Mapping of the resulting information into a recognised classification system such as DSM–IV or ICD–10 (see section 2.2) 3. Assessment using a recognised and published diagnostic instrument B. Components of a reliable diagnosis Increasing accuracy and reliability Use of a process, and a diagnostic classification system, and an instrument (i.e. 1, 2, and 3, from A) 1. Use of a process and a diagnostic classification system OR 2. Use of an instrument and a diagnostic classification system The use of a process, a diagnostic classification system or an instrument, used singly Diagnosis simply stated Note: Each component of the assessment should be explicitly stated in the study/report under consideration Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable. It is important to emphasize that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved. Considered Judgment It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, SIGN has introduced the concept of considered judgment. Under the heading of considered judgment, guideline development groups summarize their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects: l Quantity, quality, and consistency of evidence l Generalisability of study findings l Directness of application to the target population for the guideline l Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them.) l Implementability (i.e., how practical it would be for the NHS in Scotland to implement the recommendation.) Guideline development groups are provided with a pro forma in which to record the main points from their considered judgment. Once they have considered these issues, the group is asked to summarize their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site . Rating Scheme for the Strength of the Recommendations Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development. Peer Review All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to a lay reviewer in order to obtain comments from the patient's perspective. The comments received from peer reviewers and others are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication. Recommendations Major Recommendations Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document. The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field. Diagnostic Criteria C- All professionals involved in diagnosing Autism Spectrum Disorders (ASD) in children and young people should consider using either International Classification of Diseases (ICD)-10 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. Recognition, Assessment, and Diagnosis Recognition in Primary Care Screening C - Population screening for ASD is not recommended. Surveillance D - As part of the core program of child health surveillance, healthcare professionals can contribute to the early identification of children requiring further assessment for ASD, and other developmental disorders: l Clinical assessment should incorporate a high level of vigilance for features suggestive of ASD, in the domains of social interaction and play, speech and language development and behavior l The Checklist for Autism in Toddlers (CHAT) or modified CHAT (M-CHAT) can be used in young children to identify clinical features indicative of an increased risk of ASD but should not be used to rule out ASD Screening of High Risk Groups C - The use of an appropriate structured instrument may be a useful supplement to the clinical process to identify children and young people at high risk of ASD. Timing of Diagnosis D - ASD should be part of the differential diagnosis for very young (preschool) children displaying absence of normal developmental features, as typical ASD behaviors may not be obvious in this age group. Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D - Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C - ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) D - Healthcare professionals should directly observe and assess the child or young person's social and communication skills and behavior. C - Healthcare professionals should consider using ASD-specific observational instruments, as a means of improving the reliability of ASD diagnosis. Individual Profiling D - All children and young people with ASD should have a comprehensive evaluation of their speech and language and communication skills, which should inform intervention. D - Children and young people with ASD should be considered for assessment of intellectual, neuropsychological and adaptive functioning. Biomedical Investigations D - Where clinically relevant, the need for the following should be reviewed for all children and young people with ASD: l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Investigations to rule out recognised aetiologies of ASD (e.g., tuberous sclerosis, see Annex 3 in the original guideline document) Conditions Associated with ASD C - Healthcare professionals should be aware of the need to routinely check for comorbid problems in children and young people with ASD. Where necessary, detailed assessment should be carried out to accurately identify and manage comorbid problems. Non-Pharmacological Interventions Communication Interventions Support for Early Communication Skills D - Interventions to support communication in ASD are indicated, such as the use of visual augmentation (e.g., in the form of pictures of objects). Interventions for Social Communication and Interaction D - Interventions to support social communication should be considered for children and young people with ASD, with the most appropriate intervention being assessed on an individual basis. Behavior/Psychological Interventions Intensive Behavioral Programmes A - The Lovaas programme should not be presented as an intervention that will lead to normal functioning. Interventions for Specific Behaviors B - Behavioral interventions should be considered to address a wide range of specific behaviors in children and young people with ASD, both to reduce symptom frequency and severity and to increase the development of adaptive skills. Auditory Integration Training A - Auditory integration training is not recommended. Facilitated Communication A - Facilitated communication should not be used as a means to communicate with children and young people with ASD. Pharmacological Interventions Risperidone B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism B - Weight should be monitored regularly in children and young people who are taking risperidone. Methylphenidate B - Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD. Secretin A - Secretin is not recommended for use in children and young people with ASD. Melatonin D - Melatonin may be considered for treatment of sleep problems which have persisted despite behavioral interventions. Service Provision ASD Training D - All professions and service providers working in the ASD field should review their training arrangements to ensure staff has up-to-date knowledge and adequate skill levels. Training and Support for Parents Information Provision D - Professionals should offer parents good quality written information and an opportunity to ask questions when disclosing information about their child with ASD D - Parents should be provided with information in an accessible and absorbable form. Meeting Support Needs B - Education and skills interventions for parents of pre-school children with ASD should be offered. Definitions: Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Clinical Algorithm(s) None provided Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate early diagnosis and management of children and young people with autism spectrum disorders may help a child to maximize his or her potential. Potential Harms l Adverse effects associated with risperidone include tiredness/sedation early in treatment and increased appetite and weight gain l Methylphenidate adverse effects may include difficulty falling asleep, appetite decrease, irritability and emotional outbursts. l Melatonin is not a licensed medication, which limits the information that is available about effectiveness and safety Qualifying Statements Qualifying Statements This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken. Implementation of the Guideline Description of Implementation Strategy Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit. Key points for audit are identified in the original guideline document. Implementation Tools Audit Criteria/Indicators Chart Documentation/Checklists/Forms Quick Reference Guides/Physician Guides For information about availability, see the Availability of Companion Documents and Patient Resources fields below. Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Living with Illness IOM Domain Effectiveness Patient-centeredness Identifying Information and Availability Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2007 Jul Guideline Developer(s) Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.] Source(s) of Funding Scottish Executive Health Department Guideline Committee Not stated Composition of Group That Authored the Guideline Guideline Development Group: Dr Iain McClure* (Chair) Consultant Child and Adolescent Psychiatrist, Murray Royal Hospital, Perth; Mrs Jennifer Beattie, Principal Teacher in Special Needs, Kenmay Academy, Aberdeenshire; Mrs Sheila Boyd, Occupational Therapist, Scottish Centre for Autism, Glasgow; Ms Margo Cattanach, Community Charge Nurse - Learning Disabilities, Larbert; Dr Sally Cheseldine, Consultant Clinical Psychologist, Child and Adolescent Mental Health Services, Edinburgh; Mr Paul Dickinson, Clinical Psychologist, NHS Highland, Inverness; Mrs Penny Ellingham, Social Worker, Royal Hospital for Sick Children, Edinburgh; Dr David Fitzpatrick, Clinical Paediatric Geneticist, MRC Human Genetics Unit, Edinburgh; Mrs Bette Francis, Vulnerable Adults Unit, Scottish Executive Health Department, Edinburgh; Dr Anne Gilchrist*, Consultant Adolescent Psychiatrist, Royal Cornhill Hospital, Aberdeen; Dr Rob Henderson, Specialist Registrar in Public Health Medicine, Highland NHS Board, Inverness; Mrs Alison Leask*, Project Manager, NHS Education for Scotland and Chair, Autism Argyll; Dr Tommy MacKay, Consultant Psychologist, Psychology Consultancy Services, Dunbartonshire; Ms Marjory Macleod, Senior Dietitian, Sighthill Health Centre, Edinburgh; Mrs Roslyn McCaughey, Senior Speech and Language Therapist, Renton Primary (Secretary) School, Renton; Dr John March, Research Scientist, Moredun Research Institute, Penicuik; Dr Craig Melville*, Senior Lecturer in Learning Disabilities Psychiatry, University of Glasgow, Gartnavel Royal Hospital; Mrs Rona Membury, Lay Representative, Inverness; Dr Elise Merry, Consultant Paediatrician, Armitstead Child Development Centre, Dundee; Professor Anne O'Hare*, Consultant Paediatrician, Royal Hospital for Sick Children, (Vice-chair) Edinburgh; Dr Safia Qureshi, SIGN Programme Director; Ms Marion Rutherford, Speech and Language Therapist, Royal Hospital for Sick Children, Edinburgh; Ms Chris Simmonds, Health Visitor, Aberdeen; Dr Georgina Soulby, Consultant Community Paediatrician - Children Services, Raigmore Hospital, Inverness; Ms Janis Toy, Residential Services Manager, Daldorch House School, East Ayrshire; Ms Diane Waugh, Lay Representative, Sense Scotland, Glasgow; Ms Joanna Welsh, SIGN Information Officer *Member of the writing group Financial Disclosures/Conflicts of Interest Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive. Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . Availability of Companion Documents The following are available: l Quick reference guide: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. Scottish Intercollegiate Guidelines Network, 2007 Jun. 2 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . l SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site . l Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network, 2001. Available from the SIGN Web site . Also, chart documentation of suggested screening instruments in high risk groups is provided in Annex 4 of the original guideline document . Patient Resources None available NGC Status This summary was completed by ECRI Institute on August 31, 2007. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. Copyright Statement Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit. Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net. Additional copyright information is available on the SIGN Web site . Disclaimer NGC Disclaimer The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer
A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Reviev Description of Method of Guideline validation r Review AII SIGN who are ask eral pract (GPs)and other prin provide co en y care the ha w sen Recommendations Major Recommendations te Gu 二高尚品器物光 Recognition,Asse ment,and Diagnosis Recognition in Primary Care Screening C-Population screening for ASD is not recommended. Surveillance 8eneat6aons8rnreaamngfer8e地smeitr是ebeataie29esopmtng8gabstetotheeary eveotures sugestive of ASD,in the domains of chidren to iming of Diagnosis 8e860a9ai98saso89rR35le89ae5smgy8oe89.Cgmteag0lgsnispayngabsenceofnoma Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D-Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C-ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) should directly observeand assess the child or young pers'social and communication
Guideline Summary NGC-5791 NGC banner Guideline Title Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Scope Disease/Condition(s) Autism spectrum disorders (ASDs) including autism, atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Language Pathologists Guideline Objective(s) To provide evidence-based recommendations on the assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders (ASD) Target Population Children and young people with autism spectrum disorders (ASD) Interventions and Practices Considered Diagnosis/Evaluation 1. Clinical assessment according to diagnostic criteria from the International Classification of Diseases of the World Health Organisation, 10th edition (ICD-10) and the Diagnostic and Statistical Manual, 4th edition (DSM-IV) 2. Surveillance 3. Identification of children of high risk (use of structured instrument) 4. Timing of diagnosis 5. Autism spectrum disorder-specific diagnostic history from parent/carer 6. Direct observation and assessment of social, and communication skills and behaviour 7. Evaluation of speech, language and communication skills 8. Assessment of intellectual, neuropsychological and adaptive functioning 9. Biomedical investigations l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Other investigations to rule out recognised aetiologies of autism spectrum disorders (ASD) (e.g., tuberous sclerosis) 10. Assessment of comorbid conditions Management/Treatment 1. Support for early communication skills 2. Interventions for social communication and interaction 3. Intensive behavioural programmes 4. Behavioural interventions 5. Pharmacologic therapy l Risperidone l Methylphenidate l Melatonin 6. Service provision l Training of healthcare personnel l Provision of information for parents/carers l Education and skills interventions for parents of pre-school children with ASD Major Outcomes Considered l Accuracy of diagnostic tests l Communication and social functioning l Symptom relief l Quality of life l Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A systematic review of the literature was carried out using a search strategy devised by a Scottish Intercollegiate Guidelines Network (SIGN) Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. For most searches, the year range covered was 1996-2006. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NeLH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports. The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigor and practicality of use. The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion (e.g., an acceptable level of loss to follow up) and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimize any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment Evidence Tables Evidence tables are compiled by SIGN executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder (ASD) in the Literature When reviewing the literature the guideline development group found that the definitions of ASD used for diagnosis varied considerably when reported and were often not reported at all. To allow for consistency within the guideline the group agreed that three elements – assessment process, classification system and diagnostic instrument - were important in the accurate diagnosis of ASD. If a paper did not record diagnosis in this way it was downgraded. Additional information can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site . A. Components of diagnostic assessment 1. A recognised process of obtaining information in necessary domains, usually by multidisciplinary or multiagency personnel 2. Mapping of the resulting information into a recognised classification system such as DSM–IV or ICD–10 (see section 2.2) 3. Assessment using a recognised and published diagnostic instrument B. Components of a reliable diagnosis Increasing accuracy and reliability Use of a process, and a diagnostic classification system, and an instrument (i.e. 1, 2, and 3, from A) 1. Use of a process and a diagnostic classification system OR 2. Use of an instrument and a diagnostic classification system The use of a process, a diagnostic classification system or an instrument, used singly Diagnosis simply stated Note: Each component of the assessment should be explicitly stated in the study/report under consideration Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable. It is important to emphasize that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved. Considered Judgment It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, SIGN has introduced the concept of considered judgment. Under the heading of considered judgment, guideline development groups summarize their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects: l Quantity, quality, and consistency of evidence l Generalisability of study findings l Directness of application to the target population for the guideline l Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them.) l Implementability (i.e., how practical it would be for the NHS in Scotland to implement the recommendation.) Guideline development groups are provided with a pro forma in which to record the main points from their considered judgment. Once they have considered these issues, the group is asked to summarize their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site . Rating Scheme for the Strength of the Recommendations Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development. Peer Review All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to a lay reviewer in order to obtain comments from the patient's perspective. The comments received from peer reviewers and others are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication. Recommendations Major Recommendations Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document. The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field. Diagnostic Criteria C- All professionals involved in diagnosing Autism Spectrum Disorders (ASD) in children and young people should consider using either International Classification of Diseases (ICD)-10 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. Recognition, Assessment, and Diagnosis Recognition in Primary Care Screening C - Population screening for ASD is not recommended. Surveillance D - As part of the core program of child health surveillance, healthcare professionals can contribute to the early identification of children requiring further assessment for ASD, and other developmental disorders: l Clinical assessment should incorporate a high level of vigilance for features suggestive of ASD, in the domains of social interaction and play, speech and language development and behavior l The Checklist for Autism in Toddlers (CHAT) or modified CHAT (M-CHAT) can be used in young children to identify clinical features indicative of an increased risk of ASD but should not be used to rule out ASD Screening of High Risk Groups C - The use of an appropriate structured instrument may be a useful supplement to the clinical process to identify children and young people at high risk of ASD. Timing of Diagnosis D - ASD should be part of the differential diagnosis for very young (preschool) children displaying absence of normal developmental features, as typical ASD behaviors may not be obvious in this age group. Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D - Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C - ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) D - Healthcare professionals should directly observe and assess the child or young person's social and communication skills and behavior. C - Healthcare professionals should consider using ASD-specific observational instruments, as a means of improving the reliability of ASD diagnosis. Individual Profiling D - All children and young people with ASD should have a comprehensive evaluation of their speech and language and communication skills, which should inform intervention. D - Children and young people with ASD should be considered for assessment of intellectual, neuropsychological and adaptive functioning. Biomedical Investigations D - Where clinically relevant, the need for the following should be reviewed for all children and young people with ASD: l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Investigations to rule out recognised aetiologies of ASD (e.g., tuberous sclerosis, see Annex 3 in the original guideline document) Conditions Associated with ASD C - Healthcare professionals should be aware of the need to routinely check for comorbid problems in children and young people with ASD. Where necessary, detailed assessment should be carried out to accurately identify and manage comorbid problems. Non-Pharmacological Interventions Communication Interventions Support for Early Communication Skills D - Interventions to support communication in ASD are indicated, such as the use of visual augmentation (e.g., in the form of pictures of objects). Interventions for Social Communication and Interaction D - Interventions to support social communication should be considered for children and young people with ASD, with the most appropriate intervention being assessed on an individual basis. Behavior/Psychological Interventions Intensive Behavioral Programmes A - The Lovaas programme should not be presented as an intervention that will lead to normal functioning. Interventions for Specific Behaviors B - Behavioral interventions should be considered to address a wide range of specific behaviors in children and young people with ASD, both to reduce symptom frequency and severity and to increase the development of adaptive skills. Auditory Integration Training A - Auditory integration training is not recommended. Facilitated Communication A - Facilitated communication should not be used as a means to communicate with children and young people with ASD. Pharmacological Interventions Risperidone B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism B - Weight should be monitored regularly in children and young people who are taking risperidone. Methylphenidate B - Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD. Secretin A - Secretin is not recommended for use in children and young people with ASD. Melatonin D - Melatonin may be considered for treatment of sleep problems which have persisted despite behavioral interventions. Service Provision ASD Training D - All professions and service providers working in the ASD field should review their training arrangements to ensure staff has up-to-date knowledge and adequate skill levels. Training and Support for Parents Information Provision D - Professionals should offer parents good quality written information and an opportunity to ask questions when disclosing information about their child with ASD D - Parents should be provided with information in an accessible and absorbable form. Meeting Support Needs B - Education and skills interventions for parents of pre-school children with ASD should be offered. Definitions: Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Clinical Algorithm(s) None provided Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate early diagnosis and management of children and young people with autism spectrum disorders may help a child to maximize his or her potential. Potential Harms l Adverse effects associated with risperidone include tiredness/sedation early in treatment and increased appetite and weight gain l Methylphenidate adverse effects may include difficulty falling asleep, appetite decrease, irritability and emotional outbursts. l Melatonin is not a licensed medication, which limits the information that is available about effectiveness and safety Qualifying Statements Qualifying Statements This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken. Implementation of the Guideline Description of Implementation Strategy Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit. Key points for audit are identified in the original guideline document. Implementation Tools Audit Criteria/Indicators Chart Documentation/Checklists/Forms Quick Reference Guides/Physician Guides For information about availability, see the Availability of Companion Documents and Patient Resources fields below. Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Living with Illness IOM Domain Effectiveness Patient-centeredness Identifying Information and Availability Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2007 Jul Guideline Developer(s) Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.] Source(s) of Funding Scottish Executive Health Department Guideline Committee Not stated Composition of Group That Authored the Guideline Guideline Development Group: Dr Iain McClure* (Chair) Consultant Child and Adolescent Psychiatrist, Murray Royal Hospital, Perth; Mrs Jennifer Beattie, Principal Teacher in Special Needs, Kenmay Academy, Aberdeenshire; Mrs Sheila Boyd, Occupational Therapist, Scottish Centre for Autism, Glasgow; Ms Margo Cattanach, Community Charge Nurse - Learning Disabilities, Larbert; Dr Sally Cheseldine, Consultant Clinical Psychologist, Child and Adolescent Mental Health Services, Edinburgh; Mr Paul Dickinson, Clinical Psychologist, NHS Highland, Inverness; Mrs Penny Ellingham, Social Worker, Royal Hospital for Sick Children, Edinburgh; Dr David Fitzpatrick, Clinical Paediatric Geneticist, MRC Human Genetics Unit, Edinburgh; Mrs Bette Francis, Vulnerable Adults Unit, Scottish Executive Health Department, Edinburgh; Dr Anne Gilchrist*, Consultant Adolescent Psychiatrist, Royal Cornhill Hospital, Aberdeen; Dr Rob Henderson, Specialist Registrar in Public Health Medicine, Highland NHS Board, Inverness; Mrs Alison Leask*, Project Manager, NHS Education for Scotland and Chair, Autism Argyll; Dr Tommy MacKay, Consultant Psychologist, Psychology Consultancy Services, Dunbartonshire; Ms Marjory Macleod, Senior Dietitian, Sighthill Health Centre, Edinburgh; Mrs Roslyn McCaughey, Senior Speech and Language Therapist, Renton Primary (Secretary) School, Renton; Dr John March, Research Scientist, Moredun Research Institute, Penicuik; Dr Craig Melville*, Senior Lecturer in Learning Disabilities Psychiatry, University of Glasgow, Gartnavel Royal Hospital; Mrs Rona Membury, Lay Representative, Inverness; Dr Elise Merry, Consultant Paediatrician, Armitstead Child Development Centre, Dundee; Professor Anne O'Hare*, Consultant Paediatrician, Royal Hospital for Sick Children, (Vice-chair) Edinburgh; Dr Safia Qureshi, SIGN Programme Director; Ms Marion Rutherford, Speech and Language Therapist, Royal Hospital for Sick Children, Edinburgh; Ms Chris Simmonds, Health Visitor, Aberdeen; Dr Georgina Soulby, Consultant Community Paediatrician - Children Services, Raigmore Hospital, Inverness; Ms Janis Toy, Residential Services Manager, Daldorch House School, East Ayrshire; Ms Diane Waugh, Lay Representative, Sense Scotland, Glasgow; Ms Joanna Welsh, SIGN Information Officer *Member of the writing group Financial Disclosures/Conflicts of Interest Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive. Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . Availability of Companion Documents The following are available: l Quick reference guide: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. Scottish Intercollegiate Guidelines Network, 2007 Jun. 2 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . l SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site . l Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network, 2001. Available from the SIGN Web site . Also, chart documentation of suggested screening instruments in high risk groups is provided in Annex 4 of the original guideline document . Patient Resources None available NGC Status This summary was completed by ECRI Institute on August 31, 2007. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. Copyright Statement Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit. Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net. Additional copyright information is available on the SIGN Web site . Disclaimer NGC Disclaimer The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer
a comprehensive evaluation of their speech and language and Biomedical Investigations D-Where clinically relevant,the need for the following should be reviewed for all children and young people with ASD: Examination of physical status,with particular attention to neurological and dysmorphic features Karyotyping and Fragile X DNA analysis Examination of audiological status Conditions Associated with ASD S85ae0r7ene68awssn88ee8Casaehgnnage Non-ph ventions cation skill B-epiegi85tcommu cation in ASD are indicated,such as the use of visual augmentation(e.g.in the nterventions for Beeg'gpgeiRetR2etoea'SemgmagategheaabeetsteegorchlidrenandyoungpeoplewithAso,wth l Interventions Benavioral Programmes The Lovaas prograr e should not be presented as an intervention that will lead to normal functioning. terventions for Specific Behavio Auditory Integration Training A-Auditory integration training is not recommended sFaclitated communication should not be used as a means to communicate with children and young people with Pharmacological Interventions Risperidone oeisusefulor term treatment otantrumsr nrynchildrenwith B-Weight should be monitored regularly in children and young people who are taking risperidone. Methvlphenidate Mthylphenidate may be considered for treamnof tteifficues/yperactivity in chldrenor young people A-Secretin is not re mended for use in children and young people with ASD Melatonin Melaton may be considered for of sleep problems which have persisted despite behaviora ASD Training ning and Support for Parents
Guideline Summary NGC-5791 NGC banner Guideline Title Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Scope Disease/Condition(s) Autism spectrum disorders (ASDs) including autism, atypical autism and Asperger's syndrome Guideline Category Diagnosis Evaluation Management Treatment Clinical Specialty Family Practice Ophthalmology Pediatrics Psychiatry Psychology Intended Users Allied Health Personnel Dietitians Health Care Providers Nurses Occupational Therapists Physicians Psychologists/Non-physician Behavioral Health Clinicians Public Health Departments Social Workers Speech-Language Pathologists Guideline Objective(s) To provide evidence-based recommendations on the assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders (ASD) Target Population Children and young people with autism spectrum disorders (ASD) Interventions and Practices Considered Diagnosis/Evaluation 1. Clinical assessment according to diagnostic criteria from the International Classification of Diseases of the World Health Organisation, 10th edition (ICD-10) and the Diagnostic and Statistical Manual, 4th edition (DSM-IV) 2. Surveillance 3. Identification of children of high risk (use of structured instrument) 4. Timing of diagnosis 5. Autism spectrum disorder-specific diagnostic history from parent/carer 6. Direct observation and assessment of social, and communication skills and behaviour 7. Evaluation of speech, language and communication skills 8. Assessment of intellectual, neuropsychological and adaptive functioning 9. Biomedical investigations l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Other investigations to rule out recognised aetiologies of autism spectrum disorders (ASD) (e.g., tuberous sclerosis) 10. Assessment of comorbid conditions Management/Treatment 1. Support for early communication skills 2. Interventions for social communication and interaction 3. Intensive behavioural programmes 4. Behavioural interventions 5. Pharmacologic therapy l Risperidone l Methylphenidate l Melatonin 6. Service provision l Training of healthcare personnel l Provision of information for parents/carers l Education and skills interventions for parents of pre-school children with ASD Major Outcomes Considered l Accuracy of diagnostic tests l Communication and social functioning l Symptom relief l Quality of life l Adverse effects of treatment Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A systematic review of the literature was carried out using a search strategy devised by a Scottish Intercollegiate Guidelines Network (SIGN) Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. For most searches, the year range covered was 1996-2006. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NeLH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Weighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Methods Used to Analyze the Evidence Systematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Once papers have been selected as potential sources of evidence, the methodology used in each study is assessed to ensure its validity. The result of this assessment will affect the level of evidence allocated to the paper, which will in turn influence the grade of recommendation that it supports. The methodological assessment is based on a number of key questions that focus on those aspects of the study design that research has shown to have a significant influence on the validity of the results reported and conclusions drawn. These key questions differ between study types, and a range of checklists is used to bring a degree of consistency to the assessment process. Scottish Intercollegiate Guidelines Network (SIGN) has based its assessments on the MERGE (Method for Evaluating Research and Guideline Evidence) checklists developed by the New South Wales Department of Health, which have been subjected to wide consultation and evaluation. These checklists were subjected to detailed evaluation and adaptation to meet SIGN's requirements for a balance between methodological rigor and practicality of use. The assessment process inevitably involves a degree of subjective judgment. The extent to which a study meets a particular criterion (e.g., an acceptable level of loss to follow up) and, more importantly, the likely impact of this on the reported results from the study will depend on the clinical context. To minimize any potential bias resulting from this, each study must be evaluated independently by at least two group members. Any differences in assessment should then be discussed by the full group. Where differences cannot be resolved, an independent reviewer or an experienced member of SIGN Executive staff will arbitrate to reach an agreed quality assessment Evidence Tables Evidence tables are compiled by SIGN executive staff based on the quality assessments of individual studies provided by guideline development group members. The tables summarise all the validated studies identified from the systematic literature review relating to each key question. They are presented in a standard format to make it easier to compare results across studies, and will present separately the evidence for each outcome measure used in the published studies. These evidence tables form an essential part of the guideline development record and ensure that the basis of the guideline development group's recommendations is transparent. Criteria for Assessing the Reporting of the Diagnosis of Autism Spectrum Disorder (ASD) in the Literature When reviewing the literature the guideline development group found that the definitions of ASD used for diagnosis varied considerably when reported and were often not reported at all. To allow for consistency within the guideline the group agreed that three elements – assessment process, classification system and diagnostic instrument - were important in the accurate diagnosis of ASD. If a paper did not record diagnosis in this way it was downgraded. Additional information can be found in the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50]), available from the SIGN Web site . A. Components of diagnostic assessment 1. A recognised process of obtaining information in necessary domains, usually by multidisciplinary or multiagency personnel 2. Mapping of the resulting information into a recognised classification system such as DSM–IV or ICD–10 (see section 2.2) 3. Assessment using a recognised and published diagnostic instrument B. Components of a reliable diagnosis Increasing accuracy and reliability Use of a process, and a diagnostic classification system, and an instrument (i.e. 1, 2, and 3, from A) 1. Use of a process and a diagnostic classification system OR 2. Use of an instrument and a diagnostic classification system The use of a process, a diagnostic classification system or an instrument, used singly Diagnosis simply stated Note: Each component of the assessment should be explicitly stated in the study/report under consideration Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Synthesizing the Evidence Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered in Scotland and is therefore implementable. It is important to emphasize that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved. Considered Judgment It is rare for the evidence to show clearly and unambiguously what course of action should be recommended for any given question. Consequently, it is not always clear to those who were not involved in the decision making process how guideline developers were able to arrive at their recommendations, given the evidence they had to base them on. In order to address this problem, SIGN has introduced the concept of considered judgment. Under the heading of considered judgment, guideline development groups summarize their view of the total body of evidence covered by each evidence table. This summary view is expected to cover the following aspects: l Quantity, quality, and consistency of evidence l Generalisability of study findings l Directness of application to the target population for the guideline l Clinical impact (i.e., the extent of the impact on the target patient population, and the resources needed to treat them.) l Implementability (i.e., how practical it would be for the NHS in Scotland to implement the recommendation.) Guideline development groups are provided with a pro forma in which to record the main points from their considered judgment. Once they have considered these issues, the group is asked to summarize their view of the evidence and assign a level of evidence to it, before going on to derive a graded recommendation. Additional detail about SIGN's process for formulating guideline recommendations is provided in Section 6 of the companion document titled "SIGN 50: A Guideline Developers' Handbook." (Edinburgh [UK]: Scottish Intercollegiate Guidelines Network. [SIGN publication; no. 50], available from the SIGN Web site . Rating Scheme for the Strength of the Recommendations Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Cost Analysis A formal cost analysis was not performed and published cost analyses were not reviewed. Method of Guideline Validation External Peer Review Internal Peer Review Description of Method of Guideline Validation The national open meeting is the main consultative phase of Scottish Intercollegiate Guidelines Network (SIGN) guideline development. Peer Review All SIGN guidelines are reviewed in draft form by independent expert referees, who are asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline. A number of general practitioners (GPs) and other primary care practitioners also provide comments on the guideline from the primary care perspective, concentrating particularly on the clarity of the recommendations and their assessment of the usefulness of the guideline as a working tool for the primary care team. The draft is also sent to a lay reviewer in order to obtain comments from the patient's perspective. The comments received from peer reviewers and others are carefully tabulated and discussed with the chairman and with the guideline development group. Each point must be addressed and any changes to the guideline as a result noted or, if no change is made, the reasons for this recorded. As a final quality control check prior to publication, the guideline and the summary of peer reviewers' comments are reviewed by the SIGN Editorial Group for that guideline to ensure that each point has been addressed adequately and that any risk of bias in the guideline development process as a whole has been minimised. Each member of the guideline development group is then asked formally to approve the final guideline for publication. Recommendations Major Recommendations Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document. The grades of recommendations (A–D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field. Diagnostic Criteria C- All professionals involved in diagnosing Autism Spectrum Disorders (ASD) in children and young people should consider using either International Classification of Diseases (ICD)-10 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV. Recognition, Assessment, and Diagnosis Recognition in Primary Care Screening C - Population screening for ASD is not recommended. Surveillance D - As part of the core program of child health surveillance, healthcare professionals can contribute to the early identification of children requiring further assessment for ASD, and other developmental disorders: l Clinical assessment should incorporate a high level of vigilance for features suggestive of ASD, in the domains of social interaction and play, speech and language development and behavior l The Checklist for Autism in Toddlers (CHAT) or modified CHAT (M-CHAT) can be used in young children to identify clinical features indicative of an increased risk of ASD but should not be used to rule out ASD Screening of High Risk Groups C - The use of an appropriate structured instrument may be a useful supplement to the clinical process to identify children and young people at high risk of ASD. Timing of Diagnosis D - ASD should be part of the differential diagnosis for very young (preschool) children displaying absence of normal developmental features, as typical ASD behaviors may not be obvious in this age group. Methods of Assessment Components of Specialist Assessment History Taking (Parent/Carer Interview) D - Healthcare professionals involved in specialist assessment should take an ASD specific diagnostic history C - ASD specific history taking instruments may be considered as a means of improving the reliability of ASD diagnosis Clinical Observation/Assessment (Child/Young Person Assessment/Interview) D - Healthcare professionals should directly observe and assess the child or young person's social and communication skills and behavior. C - Healthcare professionals should consider using ASD-specific observational instruments, as a means of improving the reliability of ASD diagnosis. Individual Profiling D - All children and young people with ASD should have a comprehensive evaluation of their speech and language and communication skills, which should inform intervention. D - Children and young people with ASD should be considered for assessment of intellectual, neuropsychological and adaptive functioning. Biomedical Investigations D - Where clinically relevant, the need for the following should be reviewed for all children and young people with ASD: l Examination of physical status, with particular attention to neurological and dysmorphic features l Karyotyping and Fragile X DNA analysis l Examination of audiological status l Investigations to rule out recognised aetiologies of ASD (e.g., tuberous sclerosis, see Annex 3 in the original guideline document) Conditions Associated with ASD C - Healthcare professionals should be aware of the need to routinely check for comorbid problems in children and young people with ASD. Where necessary, detailed assessment should be carried out to accurately identify and manage comorbid problems. Non-Pharmacological Interventions Communication Interventions Support for Early Communication Skills D - Interventions to support communication in ASD are indicated, such as the use of visual augmentation (e.g., in the form of pictures of objects). Interventions for Social Communication and Interaction D - Interventions to support social communication should be considered for children and young people with ASD, with the most appropriate intervention being assessed on an individual basis. Behavior/Psychological Interventions Intensive Behavioral Programmes A - The Lovaas programme should not be presented as an intervention that will lead to normal functioning. Interventions for Specific Behaviors B - Behavioral interventions should be considered to address a wide range of specific behaviors in children and young people with ASD, both to reduce symptom frequency and severity and to increase the development of adaptive skills. Auditory Integration Training A - Auditory integration training is not recommended. Facilitated Communication A - Facilitated communication should not be used as a means to communicate with children and young people with ASD. Pharmacological Interventions Risperidone B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism B - Weight should be monitored regularly in children and young people who are taking risperidone. Methylphenidate B - Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD. Secretin A - Secretin is not recommended for use in children and young people with ASD. Melatonin D - Melatonin may be considered for treatment of sleep problems which have persisted despite behavioral interventions. Service Provision ASD Training D - All professions and service providers working in the ASD field should review their training arrangements to ensure staff has up-to-date knowledge and adequate skill levels. Training and Support for Parents Information Provision D - Professionals should offer parents good quality written information and an opportunity to ask questions when disclosing information about their child with ASD D - Parents should be provided with information in an accessible and absorbable form. Meeting Support Needs B - Education and skills interventions for parents of pre-school children with ASD should be offered. Definitions: Grades of Recommendation Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group Levels of Evidence 1++: High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or RCTs with a very low risk of bias 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++: High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3: Non-analytic studies (e.g. case reports, case series) 4: Expert opinion Clinical Algorithm(s) None provided Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate early diagnosis and management of children and young people with autism spectrum disorders may help a child to maximize his or her potential. Potential Harms l Adverse effects associated with risperidone include tiredness/sedation early in treatment and increased appetite and weight gain l Methylphenidate adverse effects may include difficulty falling asleep, appetite decrease, irritability and emotional outbursts. l Melatonin is not a licensed medication, which limits the information that is available about effectiveness and safety Qualifying Statements Qualifying Statements This guideline is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, covering the diagnostic and treatment choices available. It is, however, advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken. Implementation of the Guideline Description of Implementation Strategy Implementation of national clinical guidelines is the responsibility of each National Health Service (NHS) Board and is an essential part of clinical governance. It is acknowledged that every Board cannot implement every guideline immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit. Key points for audit are identified in the original guideline document. Implementation Tools Audit Criteria/Indicators Chart Documentation/Checklists/Forms Quick Reference Guides/Physician Guides For information about availability, see the Availability of Companion Documents and Patient Resources fields below. Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Living with Illness IOM Domain Effectiveness Patient-centeredness Identifying Information and Availability Bibliographic Source(s) Scottish Intercollegiate Guidelines Network (SIGN). Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2007 Jul. 65 p. (SIGN publication; no. 98). [232 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2007 Jul Guideline Developer(s) Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.] Source(s) of Funding Scottish Executive Health Department Guideline Committee Not stated Composition of Group That Authored the Guideline Guideline Development Group: Dr Iain McClure* (Chair) Consultant Child and Adolescent Psychiatrist, Murray Royal Hospital, Perth; Mrs Jennifer Beattie, Principal Teacher in Special Needs, Kenmay Academy, Aberdeenshire; Mrs Sheila Boyd, Occupational Therapist, Scottish Centre for Autism, Glasgow; Ms Margo Cattanach, Community Charge Nurse - Learning Disabilities, Larbert; Dr Sally Cheseldine, Consultant Clinical Psychologist, Child and Adolescent Mental Health Services, Edinburgh; Mr Paul Dickinson, Clinical Psychologist, NHS Highland, Inverness; Mrs Penny Ellingham, Social Worker, Royal Hospital for Sick Children, Edinburgh; Dr David Fitzpatrick, Clinical Paediatric Geneticist, MRC Human Genetics Unit, Edinburgh; Mrs Bette Francis, Vulnerable Adults Unit, Scottish Executive Health Department, Edinburgh; Dr Anne Gilchrist*, Consultant Adolescent Psychiatrist, Royal Cornhill Hospital, Aberdeen; Dr Rob Henderson, Specialist Registrar in Public Health Medicine, Highland NHS Board, Inverness; Mrs Alison Leask*, Project Manager, NHS Education for Scotland and Chair, Autism Argyll; Dr Tommy MacKay, Consultant Psychologist, Psychology Consultancy Services, Dunbartonshire; Ms Marjory Macleod, Senior Dietitian, Sighthill Health Centre, Edinburgh; Mrs Roslyn McCaughey, Senior Speech and Language Therapist, Renton Primary (Secretary) School, Renton; Dr John March, Research Scientist, Moredun Research Institute, Penicuik; Dr Craig Melville*, Senior Lecturer in Learning Disabilities Psychiatry, University of Glasgow, Gartnavel Royal Hospital; Mrs Rona Membury, Lay Representative, Inverness; Dr Elise Merry, Consultant Paediatrician, Armitstead Child Development Centre, Dundee; Professor Anne O'Hare*, Consultant Paediatrician, Royal Hospital for Sick Children, (Vice-chair) Edinburgh; Dr Safia Qureshi, SIGN Programme Director; Ms Marion Rutherford, Speech and Language Therapist, Royal Hospital for Sick Children, Edinburgh; Ms Chris Simmonds, Health Visitor, Aberdeen; Dr Georgina Soulby, Consultant Community Paediatrician - Children Services, Raigmore Hospital, Inverness; Ms Janis Toy, Residential Services Manager, Daldorch House School, East Ayrshire; Ms Diane Waugh, Lay Representative, Sense Scotland, Glasgow; Ms Joanna Welsh, SIGN Information Officer *Member of the writing group Financial Disclosures/Conflicts of Interest Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive. Guideline Status This is the current release of the guideline. This guideline was issued in 2007 and will be considered for review in three years. Any amendments to the guideline in the interim period will be noted on Scottish Intercollegiate Guidelines Network (SIGN) Web site . Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . Availability of Companion Documents The following are available: l Quick reference guide: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders. Scottish Intercollegiate Guidelines Network, 2007 Jun. 2 p. Available in Portable Document Format (PDF) from the Scottish Intercollegiate Guidelines Network (SIGN) Web site . l SIGN 50: A guideline developer's handbook. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network. (SIGN publication; no. 50). Available from the SIGN Web site . l Appraising the quality of clinical guidelines. The SIGN guide to the AGREE (Appraisal of Guidelines Research & Evaluation) guideline appraisal instrument. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network, 2001. Available from the SIGN Web site . Also, chart documentation of suggested screening instruments in high risk groups is provided in Annex 4 of the original guideline document . Patient Resources None available NGC Status This summary was completed by ECRI Institute on August 31, 2007. This summary was updated by ECRI Institute on May 20, 2011 following the U.S. Food and Drug Administration advisory on antipsychotic drugs. Copyright Statement Scottish Intercollegiate Guidelines Network (SIGN) guidelines are subject to copyright; however, SIGN encourages the downloading and use of its guidelines for the purposes of implementation, education, and audit. Users wishing to use, reproduce, or republish SIGN material for commercial purposes must seek prior approval for reproduction in any medium. To do this, please contact sara.twaddle@nhs.net. Additional copyright information is available on the SIGN Web site . Disclaimer NGC Disclaimer The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusioncriteria.aspx. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer