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Trd-Draft.Pdf Technology Assessment Program Definition of Treatment-Resistant Depression in the Medicare Population Draft Technology Assessment Project ID: PSYT0816 Date: August 23, 2017 1 Technology Assessment Program–Draft Technical Assessment Project ID: PSYT0816 Definition of Treatment-Resistant Depression in the Medicare Population Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov This information is distributed solely for the purposes of predissemination peer review. It has not been formally disseminated by the Agency for Healthcare Research and Quality. The findings are subject to change based on the literature identified in the interim and peer-review/public comments and should not be referenced as definitive. It does not represent and should not be construed to represent an Agency for Healthcare Research and Quality or Department of Health and Human Services (AHRQ) determination or policy. Contract No.: __ Publication Date: August 23, 2017 Purpose and Key Messages: Purpose • To review the current definitions of treatment-resistant depression (TRD), to assess how closely current TRD treatment studies fit the most common definition, and to suggest how to improve TRD treatment research. Key Messages • TRD is commonly defined as a failure of patients to respond or go into remission after two or more treatment attempts of adequate dose and duration, but no clear consensus exists about this definition. • TRD definitions in treatment studies do not closely match the definition above; only 17 percent of studies do so. • To improve TRD treatment research, experts should standardize the number of prior treatment failures and specify the adequacy of both dose and duration. In addition, they should identify the core outcome measures to be used in such research. Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The Centers for Medicare and Medicaid Services requested this report from the Evidence-based Practice Center (EPC) Program at the Agency for Healthcare Research and Quality (AHRQ). AHRQ assigned this report to the following EPC: (To be inserted in final report) Evidence-based Practice Center (Contract Number: To be inserted in final report). The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new health care technologies and strategies. They also identify research gaps in the selected scientific area, identify methodological and scientific weaknesses, suggest research needs, and move the field forward through an unbiased, evidence- based assessment of the available literature. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review and public comment prior to their release as a final report. AHRQ expects that the EPC evidence reports and technology assessments, when appropriate, will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. If you have comments on this evidence report, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected] Gopal Khanna, M.B.A. Agency for Healthcare Research and Quality Director Arlene Bierman, M.D., M.S. Agency for Healthcare Research and Quality Director Center for Evidence and Practice Improvement Stephanie Chang, M.D., M.P.H. Agency for Healthcare Research and Quality Director Evidence-based Practice Center Program Aysegul Gozu, M.D., M.P.H. Center for Evidence and Practice Improvement Task Order Officer Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Elise Berliner, Ph.D. Director, Technology Assessment Program Center for Evidence and Practice Improvement This draft technology assessment is distributed solely for the purpose of public and peer review and/or discussion at the MedCAC meeting. It has not been otherwise disseminated by AHRQ. It does not represent and should not be construed to represent an AHRQ determination or policy. This report is based on research conducted by the (to be inserted in final report) Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. to be inserted in final report). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services. None of the investigators has any affiliations or financial involvement related to the material presented in this report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected] ii Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: <To be added to final> Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report does not necessarily represent the views of individual reviewers. Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential non-financial conflicts may be retained. The Task Order Officer and the EPC work to balance, manage, or mitigate any potential non-financial conflicts of interest identified. The list of Peer Reviewers will be added to the final report. iii Definition of Treatment-Resistant Depression in the Medicare Population Structured Abstract Objectives. To inform future discussions and decisions about how to define treatment-resistant depression (TRD) and specify the important outcomes measured in research studies, and to clarify how trials or observational studies might best be designed and conducted to inform clinical practice and health policy. Data sources. To provide a comprehensive understanding of how experts and investigators have defined and studied TRD, we first performed a narrative review of relevant literature. We considered consensus statements, practice guidelines, government materials, and other literature published from 1/1/1995 through 3/31/2017, except for systematic reviews (limited to start 1/1/2005). Next, we performed a systematic review of published studies of TRD interventions (1/1/2005 through 3/31/2017) indexed in MEDLINE®, EMBASE, PsycINFO, and Cochrane Library. Review methods. Trained personnel dually reviewed all titles and abstracts for eligibility. Studies marked for possible inclusion by either reviewer and those with inadequate abstracts underwent dual full-text review. Disagreements were resolved by consensus discussion. One member of the research team abstracted data; a senior investigator reviewed abstractions for accuracy and completeness. Results. Our narrative review indicated that no consensus definition existed for TRD. We identified four basic definitions for TRD (3 for major depressive disorder [MDD]; 1 for bipolar disorder). Based on frequency of reporting in the literature, the most common TRD definition for MDD required a minimum of two prior treatment failures and confirmation of prior adequate dose and duration. The most common TRD definition for bipolar disorder required one prior treatment failure. For all TRD definitions, no clear consensus emerged on defining adequacy of either dose or duration. Little agreement exists about the best approach to diagnose TRD or the preferred outcome measure, although the Hamilton Depression Rating Scale was the most used. We found some agreement about minimizing bias by using randomization; studies have not focused on minimizing placebo effects. Evidence to address risk factors (e.g., age, sex, number of prior failed treatments, and length of current depressive episode) for TRD and data to assess potential prognostic factors were limited. Only 17 percent of intervention studies enrolled populations that met frequently specified criteria for TRD. Most studies were randomized controlled trials; all studies applied some exclusion criteria to limit potential confounders. Depressive
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