TRANSLATING RESEARCH INTO PRACTICE Release Date: January 8, 1999 RFA: HS-99-003 P.T. Agency for Health Care Policy and Research Letter of Intent Receipt Date: February 5, 1999 Application Receipt Date: April 22, 1999 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research related to implementing evidence-based tools and information in diverse health care settings among practitioners caring for diverse populations. Applications are sought for studies that apply innovative strategies for implementing evidence-based tools and information and demonstrate improved clinical practice and sustained practitioner behavior change. Evidence-based tools and information include findings from rigorously conducted research and from clinical practice guidelines, algorithms, treatment protocols, practice parameters, quality indicators, and continuous quality improvement initiatives that are developed using a systematic approach to evidence synthesis. This Request for Applications (RFA) is one in a series of RFAs to support research on quality of health care being issued by AHCPR over the next several weeks. These initiatives respond to the report, Quality First, The President"s Commission on Consumer Protection and Quality in the Health Care Industry (Commission), which called for a significant investment in the further development of research, tools, and information for patients, practitioners, purchasers, and payers. The three RFAs are: 1) Translating Research into Practice- to generate new knowledge about approaches, both innovative and established, which are effective and cost-effective in promoting the use of rigorously derived evidence in clinical settings and lead to improved health care practice and sustained practitioner behavior change (with particular interest in studies that implement AHCPR-supported evidence-based tools and information), 2) Quality Measurement for Vulnerable Populations- to develop and test new quality measures which can be used in the purchase or improvement of health care services for populations identified as vulnerable in the Commission report, and 3) Assessment of Quality Improvement Strategies in Health Care- to rigorously evaluate strategies for improving health care quality which are currently in widespread use by organized quality improvement systems (projects that would expand the conceptual and methodological basis for improving clinical quality and analyze the relative utility and costs of various approaches to quality improvement). In addition to their common context and theme, these three initiatives are also designed to help build capacity in the field of health services research. This is accomplished through the inclusion of specific incentives to attract applications from qualified minority and junior faculty health services researchers. AHCPR is especially interested in studies that implement AHCPR-supported evidence-based tools and information, including Patient Outcome Research Team (PORT) and other research findings, AHCPR-supported clinical practice guideline recommendations, and evidence reports and technology assessments produced by the AHCPR Evidence-based Practice Centers. The goal of this RFA is to improve the translation and use of research findings and evidence-based tools and information into practice by developing and validating innovative principles, methods, and tools that work in diverse settings, populations, and payment systems. Applicants are encouraged to form public-private partnerships or consortia, such as between academic and other research organizations and health plans and purchasers, to perform this research. Such partnerships may help to more quickly translate research findings into actual practice settings. Applicants may also seek collaborative funding for projects funded under this RFA. Roles of collaborators should be clearly defined in the application. AHCPR encourages minority institutions to apply for funding under this solicitation, and encourages collaboration on projects between minority institutions and majority institutions. Minority institutions have had a significant role in delivering health care to underserved communities and represent a valuable resource to facilitate collaboration with those communities. AHCPR is committed to achieving the goals of the President"s Race and Health Disparities Initiative: Eliminating by the year 2000 the differences in outcomes and health status for racial and ethnic minority populations in six clinical areas (infant mortality, cancer screening and management, cardiovascular disease, diabetes, HIV infection, and child and adult immunization). Many of these disparities are not due to gaps in knowledge regarding disease processes, but are largely the result of provider factors, patient factors, and organizational factors which impair the implementation of existing knowledge. AHCPR seeks research projects which will advance the implementation of existing research findings in order to assist in achieving this ambitious goal. For further information on this Initiative, see: http://raceandhealth.hhs.gov. HEALTHY PEOPLE 2000 The Public Health Serviced (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a printed copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402- 9325, telephone: 202/512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by public or private non-profit organizations, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. For-profit organizations may participate as members of consortia or subcontractors if the applicant is non-profit. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHCPR encourages women, members of minority groups and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed three years. The anticipated award date is September 30, 1999. This RFA is a one-time solicitation. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures. FUNDS AVAILABLE AHCPR expects to award up to $2 million in fiscal year 1999 to support the first year of up to 4 to 6 projects under this RFA. AHCPR will set-aside approximately $500,000 of the $2 million to support projects which address one or more of the six clinical areas identified in the President"s Race and Health Disparities Initiative (infant mortality, cancer screening and management, cardiovascular disease, diabetes, HIV infection, and child and adult immunization) with regard to racial and ethnic minority population groups. Funding beyond the initial budget period will depend on annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background A continuing challenge in health services research is to improve the translation and use of research findings for practitioners, patients, consumers and other decisionmakers to effect needed health care changes. Evidence-based decision making, the use of current best evidence in making decisions about individual patients, is an effective method for translating research into practice in order to effect sustained practitioner, patient, and organizational behavior change. This approach requires that research results be compiled in a systematic manner and made available to decision makers. But the evidence base is rapidly expanding, with more than 3800 biomedical journals indexed in MEDLINE and approximate 7300 citations added weekly. Health care practitioners are besieged with information, some of it evidence- based such as findings from clinical trials, but some irrelevant to clinical care. The lag period between publication of research findings demonstrating clinical effectiveness and the subsequent implementation in clinical practice is well recognized, and practitioners continue to base clinical decisions on outdated training and on experience with individual patients. Determining the best strategies for implementing evidence-based tools and information is crucial for translating evidence into practice. A wide range of strategies for implementing evidence into practice to accomplish behavior change has been proposed. These strategies include continuing medical education (CME), self-instructed learning, academic detailing, audit and feedback, provider reminder systems, incentives, local opinion leaders, outreach visits, continuous quality improvement initiatives, clinical information systems, and computer decision support systems. Some of these strategies have been the focus of research. In a systematic review of trials of interventions to improve medical practice, outreach visits and local opinion leaders were found to be effective.(Oxman, 1995) Soumerai and colleagues demonstrated the benefit of combining local opinion leaders with performance feedback to improve adoption of effective treatments in practice. (Soumerai, 1998) A systematic review of trials of CME pointed out educational strategies that may be effective and Soumerai and Avorn showed that academic detailing could be effective in some cases.(Davis, 1995, Soumerai, 1990) Taken together, these and other studies do not suggest a single superior strategy but show that different strategies may be effective in achieving behavior change depending on the target group, health care setting, desired behavior change, and identified barriers to implementation. For example, conducting audits and providing feedback may be effective in improving prescribing habits and diagnostic test ordering but not another behavior. Computer decision support systems enhance clinical performance for drug dosing and preventive care, but have been tested in a limited range of settings.(Hunt, 1998) Generally, academic detailing, reminders, and multifaceted approaches seem to be more successful, opinion leaders and audit and feedback to be variably effective, and didactic educational sessions and written educational materials are largely ineffective.(Bero, 1998) As pointed out by Greco and Eisenberg, the impact of implementation strategies depends on the context in which they are applied, and is influenced by health care settings, practitioner perceptions, and the desired behavior change.(Greco, 1993) Too little is known about which combinations of implementation strategies are effective in which clinical contexts and for which clinical conditions. Barriers to successful implementation of evidence-based information have been proposed, but research that includes identification of barriers and demonstration of effective strategies to overcome these barriers has generally not been conducted. Applications are encouraged to address these issues. Important to the design of implementation research studies is consideration of a conceptual framework for behavior change. For example, the "Precede/Proceed" model specifies three categories of factors that support behavior change.(Green,1991) Predisposing factors are the skills, knowledge, attitudes, and beliefs of individual practitioners. Enabling factors are practice setting and organization factors that make change possible, such as reminders, checklists, and clinical information systems. Reinforcing factors are those that reward and strengthen behavior change and include rewards, incentives, and feedback. Applications are strongly encouraged to describe a conceptual framework supporting the proposed implementation project and include multifaceted implementation strategies that address factors important to effect behavior change. Methodological Considerations The effect of implementation of evidence-based tools and information on the health status of patients may be difficult to measure directly. Focus on intermediate health outcomes in addition to provider knowledge and behavior, service delivery, resource use and cost, quality, and patient satisfaction is appropriate. Studies that compare the cost and/or cost- effectiveness of implementation strategies are encouraged. Methods can include rigorous qualitative studies, quantitative research, and empirical work. In order to monitor and account for secular changes in practice patterns, studies employing control group designs are strongly encouraged. Research Questions A broad array of research questions is relevant to implementation of evidence- based tools and information. The following questions are AHCPR priorities: o What are effective approaches that apply multifaceted strategies to implementation of evidence-based tools and information? o How does the structure of health care organizations affect implementation of evidence-based tools and information? o What strategy or combination of strategies consistently demonstrates improved behavior change and can be generalized to a range of providers, health care systems and settings, and geographic areas? o What is the effect of implementation of evidence-based tools and information on health care organizations in terms of resource use and cost? o What are the effects of implementation of evidence-based tools and information on health outcomes, cost, and quality of life? o What are strategies for identifying, validating, and addressing barriers to implementation of evidence-based tools and information? o What are the effects of evidence-based clinical information on patient and consumer quality of life, satisfaction with care, behavior, knowledge, and attitudes? o What is the comparative cost-effectiveness of various strategies for implementing evidence-based tools and information? o Is the effective implementation of evidence-based tools and information specific to racial/ethnic minority populations? For which populations? To what degree? o Is there a measurable difference in the effectiveness of evidence-based tools and information depending on the match of the race/ethnicity of providers and patients? o Are the existing racial/ethnic categories meaningful in identifying the effectiveness of evidence-based tools and information? Is the identification of sub-populations necessary? Is culture a more valid variable than race/ethnicity? SPECIAL REQUIREMENTS Research applications submitted in response to this RFA should describe how the proposed project will build on current implementation research findings. Projects should describe the evidence-based tools or information that will be implemented and the implementation strategies to be studied. Strategies for implementing evidence into practice that may be studied include: o continuing medical education (CME) o self-instructed learning o academic detailing o audit and feedback o provider reminder systems o incentives o local opinion leaders and outreach visits o continuous quality improvement initiatives o clinical information and computer decision support systems Projects should also describe the health care settings in which care is provided (such as provider networks, ambulatory clinics, managed care organizations, and other health care delivery systems) and the patient populations served, the target audience for implementation, behaviors to be changed, and the specific processes and outcomes being measured (e.g., practitioner knowledge and behavior, health outcomes, service delivery, resource use and cost, patient satisfaction, and quality). Applications should clearly identify the unit of analysis, which can be patients, individual providers (physicians, nurses, nurse practitioners, physician assistants, and others), provider groups, or health care systems. Applications are encouraged that propose taking evidence-based implementation interventions studied and shown effective in one setting and studying them in other settings or with other types of health care providers. CONDITIONS OF AWARD In addition to other applicable grants policies and requirements, the following conditions apply to all AHCPR grant awards. Applicants should also be familiar with the agency"s grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. Data Privacy Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers will be safeguarded. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses that are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal government license to use and permit others to use these products and materials for AHCPR purposes. In accordance with its legislative dissemination mandate, AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers, and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publicizes research findings but relies on grantees to publish in peer-reviewed journals and to market grant-supported products. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE of March 18, 1994. AHCPR follows the NIH Guidelines, as applicable. Investigators may obtain copies from these sources or from the AHCPR contractor, Equals Three Communications, Inc., listed under INQUIRIES. AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide of May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through the AHCPR web site http://www.ahcpr.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES). AHCPR program staff may also provide information concerning these policies (see INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by February 5, 1999, a letter of intent that includes the names, addresses, and telephone numbers, of the proposed Principal Investigator and other key personnel, a descriptive title of the application, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. Letters of intent are to be addressed to: Francis D. Chesley, Jr., M.D. Center for Practice and Technology Assessment Agency for Health Care Policy and Research 6010 Executive Boulevard, Suite 300 Rockville, MD 20852 Email: firstname.lastname@example.org APPLICATION PROCEDURES Applicants should use the research grant application form PHS 398 (rev. 4/98) in applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research. Also they may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda MD 20892-7910, telephone 301/710-0267, E-mail/Internet: grantsInfo@nih.gov. AHCPR applicants can also obtain application materials from the AHCPR contractor: Equals Three Communications, Inc. (see INQUIRIES) The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The PHS 398 type size requirements (p.6) will be enforced rigorously and non- compliant applications returned. Submit a signed, typewritten original of the application, including the Checklist, and four signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, one additional copy, labeled "Advanced Copy," must also be sent to: Francis D. Chesley, Jr., M.D. Center for Practice and Technology Assessment Agency for Health Care Policy and Research 6010 Executive Boulevard, Suite 300 Rockville, MD 20852 Applications submitted under this RFA must be received in the Center for Scientific Review, NIH, by April 22, 1999. If an application is received after that date, it will be returned to the applicant without review. For research proposals over $500,000 in direct costs for any year, investigators must have received written agreement from AHCPR that it will accept the applications (NIH Guide, August 22, 1997). This RFA is available through the AHCPR Web site http://www.ahcpr.gov (Funding Opportunities) and from the AHCPR contractor Equals Three Communications, Inc. Application Preparation (for Using HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the "Research Design and Methods" section of the Research Plan (for PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with HCFA, AHCPR will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with OMB circular a-130, Appendix III - "Security of Federal Automated Information Systems." The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA, or certify that the data has been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with AHCPR peer review procedures. If the application is not responsive to the RFA, Referral staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint, adequacy of the method(s), availability of data or proposed plans to collect data required for the project, adequacy of the plan for organizing and carrying out the project, qualification and experience of the Principal Investigator and proposed staff, reasonableness of the proposed budget and duration, adequacy of the proposed facilities and resources available to the applicant, the extent to which women, minorities and children (as appropriate), are adequately represented in study population, and when applicable, the adequacy of the proposed means for protecting human subjects. Special Review Criteria In addition to the review criteria above, to determine eligibility for minority set-aside funds, applications will be evaluated on the following criteria: 1. The significance of the project in addressing one or more of the six conditions identified in the President"s Race and Health Disparities Initiative (infant mortality, cancer screening and management, cardiovascular disease, diabetes, HIV infection, and child and adult immunization) in one or more of the four identified racial/ethnic minority population groups (Black, Hispanic, American Indian and Alaska Native, Asian American and Pacific Islander). 2. The degree to which the project demonstrates a meaningful collaboration between a minority institution and a majority institution. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. Applications deemed eligible for set-aside funds will compete with all other eligible applications for set-aside funds, and if not funded, will compete with all other applications under this RFA. The following will be considered when making the funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. Special preference will be accorded to applications from principal investigators who are not recent (within 2 years) or current AHCPR-funded principal investigators of an AHCPR grant for research in quality. The anticipated award date is September 30, 1999. INQUIRIES Copies of this RFA are available from: Equals Three Communications, Inc. 7910 Woodmont Avenue, Suite 200 Bethesda, MD 20814-3015 Telephone: 301/656-3100 FAX: 301/652-5264 The RFA is also available on AHCPR"s Web site, http://www.ahcpr.gov (Funding Opportunities) and through AHCPR InstantFAX at 301/594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompts to obtain a copy of the InstantFAX table of contents, which has the document number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call Judy Wilcox, Office of Health Care Information, at 301/594-1364, ext. 1389. AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries are encouraged. Direct inquiries regarding programmatic issues including information on the inclusion of women, minorities, and children in study populations, as well as additional information about AHCPR supported work pertaining to evidence-based practice and translating research into practice to: Francis D. Chesley, Jr., M.D. Center for Practice and Technology Assessment Agency for Health Care Policy and Research 6010 Executive Boulevard, Suite 300 Rockville, MD 20852 Telephone: 301/594-4021 Email: email@example.com The National Institute of Mental Health also supports research on the dissemination of evidence-based knowledge designed to promote the adoption of research-based change in clinical practice and policy dealing with mental health and behavioral issues. Studies range from psychological and social factors influencing decision-making by practitioners and consumers, to investigations targeting large-scale service systems and funding sources. Emphasis is placed upon the testing of interventions and strategies that will change practice and policy dealing with mental health and behavioral issues. Programmatic inquiries may be direct to: Harold Goldstein, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7146, MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3747 FAX: (301) 443-4045 Email: firstname.lastname@example.org Direct inquiries regarding fiscal matters to: Joan Metcalfe Grants Management Specialist Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: 301/594-1841 FAX: 301/594-3210 Email: email@example.com AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6) and section 1142 of the Social Security Act (42 U.S.C. 1320b-12) as applicable. Awards are administered under PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early child development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thompson MA, 1998. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. BMJ, 317:465- 68. Davis DA, Thomson MA, Oxman AD, Haynes RB, 1995. Changing physician performance: a systematic review of the effect of continuing medical education strategies. JAMA, 274:700-05. Greco PJ, Eisenberg JM, 1993. Changing physicians" practice. N Engl J Med, 329:1271-73. Green L, Kreuter M, 1991. Application of PRECEDE/PROCEED in Community Settings: Health Promotion Planning: An Educational and Environmental Approach. Mountain View, Calif: Mayfield. Hunt DL, Haynes RB, Hanna SE, Smith K, 1998. Effects of computer- based decision support systems on physician performance and patient outcomes. JAMA, 280:1339-46. Oxman AD, Thomson MA, Davis DA, Haynes RB, 1995. No magic bullet: a systematic review of 102 trials of interventions to improve professional practice. Can Med Assoc J, 153:1423-1431. Soumerai SB, Avorn JA, 1990. Principles of education outreach ("academic detailing") to improve clinical decision making. JAMA, 263:549-56. Soumerai SB, McLaughlin TJ, Gurwitz JH, Guadagnoli E, Hauptman PJ, Borbas C, Morris N, McLaughlin B, Gao X, Willison DJ, Asinger R, Gobel F, 1998. Effect of local medical opinion leaders on quality of care for acute myocardial infarction: a randomized controlled. JAMA 279:358-63.
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