When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results?such as results with unknown validity?and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders?investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants?and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations. Table of Contents Front Matter Summary 1 Introduction 2 Principles for the Return of Individual Research Results: Ethical and Societal Considerations 3 Laboratory Quality Systems for Research Testing of Human Biospecimens 4 Processes to Enable Appropriate Decision Making Regarding the Return of Individual Research Results 5 Advancing Practices for Returning Individual Research Results 6 Reshaping the Legal and Regulatory Landscape to Support Return of Individual Research Results Appendix A: Study Approach and Methods Appendix B: Public Agendas Appendix C: Analysis of Legal and Regulatory Landscape Relevant to Return of Individual Results Generated from Biospecimens in Research Appendix D: The Return of Individual-Specific Research Results from Laboratories: Perspectives and Ethical Underpinnings Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff

The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already exist?like evidence-based medications?are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed. Table of Contents Front Matter Summary 1 Introduction 2 The Effectiveness of Medication-Based Treatment for Opioid Use Disorder 3 Treatment with Medications for Opioid Use Disorder in Different Populations 4 Medications for Opioid Use Disorder in Various Treatment Settings 5 Barriers to Broader Use of Medications to Treat Opioid Use Disorder Appendix A: Study Approach and Methods Appendix B: Public Workshop Agenda Appendix C: Biographical Sketches of Committee Members

The 2014?2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014?2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014?2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events. Table of Contents Front Matter Summary 1 Introduction 2 Conducting Clinical Research During an Epidemic 3 Assessment of Therapeutic Trials 4 Assessment of Vaccine Trials 5 Strengthening Capacity for Response and Research 6 Engaging Communities in Research and Response 7 Facilitating International Coordination and Collaboration Appendix A: Study Approach and Methods Appendix B: Clinical Trial Designs Appendix C: Ethical Principles for Research with Human Subjects Appendix D: Biographical Sketches of Committee Members and Staff

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes.
Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest; systematic review--guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating.
Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Health care in the United States is more expensive than in other developed countries, costing $2.7 trillion in 2011, or 17.9 percent of the national gross domestic product. Increasing costs strain budgets at all levels of government and threaten the solvency of Medicare, the nation's largest health insurer. At the same time, despite advances in biomedical science, medicine, and public health, health care quality remains inconsistent. In fact, underuse, misuse, and overuse of various services often put patients in danger. Many efforts to improve this situation are focused on Medicare, which mainly pays practitioners on a fee-for-service basis and hospitals on a diagnoses-related group basis, which is a fee for a group of services related to a particular diagnosis. Research has long shown that Medicare spending varies greatly in different regions of the country even when expenditures are adjusted for variation in the costs of doing business, meaning that certain regions have much higher volume and/or intensity of services than others. Further, regions that deliver more services do not appear to achieve better health outcomes than those that deliver less. Variation in Health Care Spending investigates geographic variation in health care spending and quality for Medicare beneficiaries as well as other populations, and analyzes Medicare payment policies that could encourage high-value care. This report concludes that regional differences in Medicare and commercial health care spending and use are real and persist over time. Furthermore, there is much variation within geographic areas, no matter how broadly or narrowly these areas are defined. The report recommends against adoption of a geographically based value index for Medicare payments, because the majority of health care decisions are made at the provider or health care organization level, not by geographic units. Rather, to promote high value services from all providers, Medicare and Medicaid Services should continue to test payment reforms that offer incentives to providers to share clinical data, coordinate patient care, and assume some financial risk for the care of their patients. Medicare covers more than 47 million Americans, including 39 million people age 65 and older and 8 million people with disabilities. Medicare payment reform has the potential to improve health, promote efficiency in the U.S. health care system, and reorient competition in the health care market around the value of services rather than the volume of services provided. The recommendations of Variation in Health Care Spending are designed to help Medicare and Medicaid Services encourage providers to efficiently manage the full range of care for their patients, thereby increasing the value of health care in the United States.

Interim Report of the Committee on Geographic Variation in Health Care Spending and Promotion of High-Value Health Care: Preliminary Committee Observations is designed to provide the committee's preliminary observations for the 113th Congress as it considers further Medicare reform. This report contains only key preliminary observations related primarily to the committee's commissioned analyses of Medicare Parts A (Hospital Insurance program), B (Supplementary Medical Insurance program) and D (outpatient prescription drug benefit), complemented by other empirical investigations. It does not contain any observations related to the committee's commissioned analyses of the commercial insurer population, Medicare Advantage, or Medicaid, which will be presented in the committee's final report after completion of quality-control activities. This interim report excludes conclusions or recommendations related to the committee's consideration of the geographic value index or other payment reforms designed to promote highvalue care. Additional analyses are forthcoming, which will influence the committee's deliberations. These analyses include an exploration of how Medicare Part C (Medicare Advantage) and commercial spending, utilization, and quality vary compared with, and possibly are influenced by, Medicare Parts A and B spending, utilization, and quality. The committee also is assessing potential biases that may be inherent to Medicare and commercial claims-based measures of health status. Based on this new evidence and continued review of the literature, the committee will confirm the accuracy of the observations presented in this interim report and develop final conclusions and recommendations, which will be published in the committee's final report. Table of Contents Front Matter Interim Report REFERENCES Appendix A: Glossary Appendix B: Statement of Task