PERSPECTIVE RISKS(AND BENEFITS)IN CER TRIALS ment of the risks and benefits of reflect consideration and com- proposed changes to US federal regulations he study as a whole. This ap- munication about these potential governing research: JAMA2012 307:589.90 proach often requires analysts to risks and benefits both separate- vices. Notice of a Department of Health and make judgments when compar- ly and as a whole. Human Services public meeting Fed Regist ng one sort of risk to another. Disclosure forms provided by the authors 013:78(123):38343-5(http://www.gpo.gov/ The communication of informa- are available with the full text of this article fdsys/pkg/FR-2013-06-26/pdf/2013-15160 tion on these various forms of at NEJM. org 3. Feudtner C. Ethics in the midst of thera risks and benefits to potential From the ment of medical Ethics utic evolution. Arch pediatr Adolesc med 2008:1628547 study participants requires a bal- (C F)and the committees for the Protec. 4. Vist GE, Bryant D, somerville L, B ancing act. Detailed explanation of dren's Hospital of Philadelphia, Philadel. hem T, Oxman AD. Outcomes of( each separate risk may be over- phia; and the Children's Mercy Bioethics who participate in randomized whelming and confusing. Sum- Center, Children's Mercy Hospital, Kansa atients rec similar interventions who do not partic maries of the risks may ove ersi- hrane Database Syst Rev 2008 3 risks. 5 Evaluation of the accept. 20us article was published on August 21, 5. Schreiner MS. Can we keep it simple plify or underemphasize particular Th ability of studies and of the ad 1. Kass N, Faden R, Tunis S Addressing low. DOL: 10.1056/NEJMp1309322 equacy of consent forms must risk comparative effectiveness research in Copright o 2013 Massachusetts Medical Society Community Health Workers-A Local Solution to a global Problem Prabhjot Singh, M.D., Ph. D, and Dave A Chokshi, M D n the face of persistently lack- United States could improve health advocates, social activists, health luster job creation, the U.S. outcomes, reduce health care promoters, and patient navigators, health sector is paradoxically costs, and create jobs among other roles. In California seen as both a contributor to tor- In many countries, CHWs are and other border states, promotoras id macroeconomic growth and becoming paid, full-time members and promotors de salud address re- a source of local employment op- of community health systems. In productive health, diabetes, ar portunities. Labor costs account sub-Saharan Africa, the One Mil- cardiovascular health. In Arkan- for more than half of U.S. health lion Community Health Workers sas, CHWs have been shown care spending, but as payment Campaign is training, deploying, reduce Medicaid spending by structures shift from volume- and integrating CHWs into the reaching out to people with long- based reimbursement to the re- health system. 1 In India, 600,000 term care needs; in Alaska, they're warding of value in improving CHWs are paid through a fee-for- part of an effective primary care health, the locus of health care service system to perform a spe- extension system. multiple states delivery will expand from facili- cific set of primary care func- have created formal accreditation ties to communities. Ideally, pa- tions, such as immunization. In programs for CHWs, and in 2009, tient care will take place not just Brazil, community health agents the Department of Labor recog- in episodic encounters but also are part of family health teams nized CHWs' jobs as a distinct through continuous, community- that now care for 110 million category of employment. Yet de- based partnerships that include people And growing evidence re- spite these gains and in part new entities and workers. Else- veals the effectiveness of inter- because of the organic way in where in the world, such care ventions by CHWs in multiple which CHWs have emerged has involved the use of commu- health arenas, such as maternal there is little standardization nity health workers(CHWs)- and child health and chronic- across health systems in terms of ay community members with disease management.2 gaining access to CHWS, integrat focused health care training. We CHWs have been part of the ing them into health care pro- believe that scaling up the com- U.S. health care landscape for cesses, and compensating them. munity health workforce in the decades, serving as communi There are three models for N ENGL J MED 369; 10 NEJM.ORG SEPTEMBER 5, 2013PERSPECTIVE 894 n engl j med 369;10 nejm.org september 5, 2013 Risks (and Benefits) in CER Trials Community Health Workers — A Local Solution to a Global Problem Prabhjot Singh, M.D., Ph.D., and Dave A. Chokshi, M.D. I n the face of persistently lack￾luster job creation, the U.S. health sector is paradoxically seen as both a contributor to tor￾pid macroeconomic growth and a source of local employment op￾portunities. Labor costs account for more than half of U.S. health care spending, but as payment structures shift from volume￾based reimbursement to the re￾warding of value in improving health, the locus of health care delivery will expand from facili￾ties to communities. Ideally, pa￾tient care will take place not just in episodic encounters but also through continuous, community￾based partnerships that include new entities and workers. Else￾where in the world, such care has involved the use of commu￾nity health workers (CHWs) — lay community members with focused health care training. We believe that scaling up the com￾munity health workforce in the United States could improve health outcomes, reduce health care costs, and create jobs. In many countries, CHWs are becoming paid, full-time members of community health systems. In sub-Saharan Africa, the One Mil￾lion Community Health Workers Campaign is training, deploying, and integrating CHWs into the health system.1 In India, 600,000 CHWs are paid through a fee-for￾service system to perform a spe￾cific set of primary care func￾tions, such as immunization. In Brazil, community health agents are part of family health teams that now care for 110 million people. And growing evidence re￾veals the effectiveness of inter￾ventions by CHWs in multiple health arenas, such as maternal and child health and chronic￾disease management.2 CHWs have been part of the U.S. health care landscape for decades, serving as community advocates, social activists, health promoters, and patient navigators, among other roles. In California and other border states, promotoras and promotores de salud address re￾productive health, diabetes, and cardiovascular health. In Arkan￾sas, CHWs have been shown to reduce Medicaid spending by reaching out to people with long￾term care needs; in Alaska, they’re part of an effective primary care extension system. Multiple states have created formal accreditation programs for CHWs, and in 2009, the Department of Labor recog￾nized CHWs’ jobs as a distinct category of employment. Yet de￾spite these gains — and in part because of the organic way in which CHWs have emerged — there is little standardization across health systems in terms of gaining access to CHWs, integrat￾ing them into health care pro￾cesses, and compensating them. There are three models for or￾ment of the risks and benefits of the study as a whole. This ap￾proach often requires analysts to make judgments when compar￾ing one sort of risk to another. The communication of informa￾tion on these various forms of risks and benefits to potential study participants requires a bal￾ancing act. Detailed explanation of each separate risk may be over￾whelming and confusing. Sum￾maries of the risks may oversim￾plify or underemphasize particular risks.5 Evaluation of the accept￾ability of studies and of the ad￾equacy of consent forms must reflect consideration and com￾munication about these potential risks and benefits both separate￾ly and as a whole. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. From the Department of Medical Ethics (C.F.) and the Committees for the Protec￾tion of Human Subjects (M.S.), the Chil￾dren’s Hospital of Philadelphia, Philadel￾phia; and the Children’s Mercy Bioethics Center, Children’s Mercy Hospital, Kansas City, MO (J.D.L.). This article was published on August 21, 2013, at NEJM.org. 1. Kass N, Faden R, Tunis S. Addressing low￾risk comparative effectiveness research in proposed changes to US federal regulations governing research. JAMA 2012;307:1589-90. 2. Department of Health and Human Ser￾vices. Notice of a Department of Health and Human Services public meeting. Fed Regist 2013;78(123):38343-5 (http://www.gpo.gov/ fdsys/pkg/FR-2013-06-26/pdf/2013-15160 .pdf). 3. Feudtner C. Ethics in the midst of thera￾peutic evolution. Arch Pediatr Adolesc Med 2008;162:854-7. 4. Vist GE, Bryant D, Somerville L, Birming￾hem T, Oxman AD. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not partici￾pate. Cochrane Database Syst Rev 2008;3: MR000009. 5. Schreiner MS. Can we keep it simple? JAMA Pediatr 2013;167:603-5. DOI: 10.1056/NEJMp1309322 Copyright © 2013 Massachusetts Medical Society