Create a COVID-19 commission.

We need a definitive public reference for the history of events.

Forming and implementing community advisory boards in low- and middle-income countries: a scoping review.

BACKGROUND: Community advisory boards (CABs) have expanded beyond high-income countries (HICs) and play an increasing role in low- and middle-income country (LMIC) research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. METHODS: We searched five databases (PubMed, Embase, Global Health, Scopus, and Google Scholar) for publications describing or evaluating CABs in LMICs. Two researchers independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. RESULTS: Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies (65) were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa (17), China (8), and Thailand (7) having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs (53/88, 60%) focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. CONCLUSIONS: Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs.

Reflections on the ISPOR Special Task Force on U.S. Value Frameworks: Implications of a Health Economics Approach for Managed Care Pharmacy.

In 2016, The Professional Society for Health Economics and Outcomes Research (ISPOR) formed a special task force (STF) to review approaches and methods to support the definition and use of high-quality U.S. value frameworks. As the leadership group of that initiative, we present our perspective, focusing on implications for the managed care pharmacy community. Our reflections are organized by 9 key observations and conclude with a summary recommendation. We begin by emphasizing the importance of distinguishing among "perspectives" and "decision contexts." Possible perspectives include patient, payer, provider, health care sector, and societal. Decision contexts range from formulary inclusion to guideline development to clinical shared decision making, and multiple perspectives can be taken on each of these decisions. The STF focused on value in the context of including a new medicine in a formulary and, thus, health plan, using a health economics approach that compares marginal benefit (gross value) and marginal (opportunity) cost, yielding the net value. Health care is unique compared with other markets. While economists often use market purchases as indicators of value, they also recognize that this does not work well in health care, since most patent-protected drugs are covered by insurance. To assess the likely health and economic impact, health economists often employ cost-effectiveness analysis, using the quality-adjusted life-year (QALY), a metric that combines mortality and morbidity into a single preference-based index. We strongly endorse the STF's recommendation that payers should use the cost-per-QALY metric as a starting point. However, like the STF, and many of those stakeholders who provided input, we recognize that this metric has some limitations in theory and in practice. Nonetheless, the cost-per-QALY metric is a pragmatic tool that can be augmented to address some of its limitations by integrating other elements of value, particularly those related to uncertainty, such as financial risk protection, health risk protection, the value of hope, real option value, and the value of knowing. The resulting adjusted ratio can be compared with a willingness-to-pay threshold or combined in a measure of net monetary benefit. Alternatively, the array of elements can be valued using multi-criteria decision analysis. We end with the key recommendation that further development and testing of these promising approaches is needed to improve the deliberative process of health technology assessment. DISCLOSURES: No outside funding supported the writing of this article. The authors are leaders of the ISPOR Special Task Force on U.S. Value Frameworks. Willke is employed by ISPOR. Garrison and Neumann have nothing to disclose. The opinions expressed in this article should be considered as belonging only to the authors.

Conflicts of interest and the (in)dependence of experts advising government on immunization policies.

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts' degree of (in)dependence with commercial interests. We analyzed COI disclosures of members of Québec's immunization EAC (in Canada) using (In)DepScale, a tool we developed for assessing experts' level of (in)dependence. We found great variability of independence with industry and that companies with the highest vaccine sales were predominantly associated with disclosed COIs. We argue that EACs can use the (In)DepScale to better assess and disclose the COIs that affect their experts. Going forward our scale could help manage risk and select members who are less conflicted to foster a culture of transparency and trust in advisors and policy-makers.

Economic evaluation of the impact of physician-hospital integration and physician boards on hospital expenditure per patient: A 5-year longitudinal study.

BACKGROUND: This study aims to contribute to the ongoing policy and scholarly debate on physician-hospital integration (INT) and health care cost by providing evidence for the role of physician boards in mitigating hospital expenditure associated with INT. METHODS: We conducted our study of the relationship between INT, physician boards, and hospital expenditure using data on hospitals in California. We obtained data from the Centers for Medicare and Medicaid Services, American Hospital Association, and California Office of Statewide Health Planning and Development from 2002 to 2006. A hospital fixed-effect ordinary least square (OLS) regression analysis was used. RESULTS: Hospital expenditure was higher in a hospital with an integrated arrangement (e.g., a hospital that adopted an integrated salary model) than under other independent arrangements between physicians and hospitals, and the proportion of physician members on hospital boards negatively moderated the effect of integration on hospital expenditure. CONCLUSIONS: Physician boards may provide a context that affords benefits that can reduce hospital expenditures under INT. This finding highlights the importance to having a supportive organizational design when implementing INT.

Economic Analysis of Vaccination Programs: An ISPOR Good Practices for Outcomes Research Task Force Report.

This report provides recommendations for budget holders and decision makers in high-, middle, and low-income countries requiring economic analyses of new vaccination programs to allocate scarce resources given budget constraints. ISPOR's Economic Evaluation of Vaccines Designed to Prevent Infectious Disease: Good Practices Task Force wrote guidelines for three analytic methods and solicited comments on them from external reviewers. Cost-effectiveness analyses use decision-analytic models to estimate cumulative changes in resource use, costs, and changes in quality- or disability-adjusted life-years attributable to changes in disease outcomes. Constrained optimization modeling uses a mathematical objective function to be optimized (e.g. disease cases avoided) for a target population for a set of interventions including vaccination programs within established constraints. Fiscal health modeling estimates changes in net present value of government revenues and expenditures attributable to changes in disease outcomes. The task force recommends that those designing economic analyses for new vaccination programs take into account the decision maker's policy objectives and country-specific decision context when estimating: uptake rate in the target population; vaccination program's impact on disease cases in the population over time using a dynamic transmission epidemiologic model; vaccination program implementation and operating costs; and the changes in costs and health outcomes of the target disease(s). The three approaches to economic analysis are complementary and can be used alone or together to estimate a vaccination program's economic value for national, regional, or subregional decision makers in high-, middle-, and low-income countries.

Fiscal transfers based on inputs or outcomes? Lessons from the Twelfth and Thirteenth Finance Commission in India.

BACKGROUND: There is limited empirical evidence about the efficacy of fiscal transfers for a specific purpose, including for health which represents an important source of funds for the delivery of public services especially in large populous countries such as India. OBJECTIVE: To examine two distinct methodologies for allocating specific-purpose centre-to-state transfers, one using an input-based formula focused on equity and the other using an outcome-based formula focused on performance. MATERIALS AND METHODS: We examine the Twelfth Finance Commission (12FC)'s use of Equalization Grants for Health (EGH) as an input-based formula and the Thirteenth Finance Commission (13FC)'s use of Incentive Grants for Health (IGH) as an outcome-based formula. We simulate and replicate the allocation of these two transfer methodologies and examine the consequences of these fiscal transfer mechanisms. RESULTS: The EGH placed conditions for releasing funds, but states varied in their ability to meet those conditions, and hence their allocations varied, eg, Madhya Pradesh received 100% and Odisha 67% of its expected allocation. Due to the design of the IGH formula, IGH allocations were unequally distributed and highly concentrated in 4 states (Manipur, Sikkim, Tamil Nadu, Nagaland), which received over half the national IGH allocation. DISCUSSION: The EGH had limited impact in achieving equalization, whereas the IGH rewards were concentrated in states which were already doing better. Greater transparency and accountability of centre-to-state allocations and specifically their methodologies are needed to ensure that allocation objectives are aligned to performance.

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis.

OBJECTIVES: Investigate if the recommendations by the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) to provincial, territorial and federal drug plans about whether to list non-oncology and oncology drug-indication combinations on their formularies are associated with whether the drug-indication combination was approved via the standard evidence pathway or the Notice of Compliance with conditions (NOC/c-limited evidence) pathway. DESIGN: Cohort study. DATA SOURCES: Websites of the CDR and pCODR up to the end of 31 March 2017; journal articles evaluating drugs approved through the NOC/c pathway, the NOC database, the NOC/c website and the Summary Basis of Decision website. INTERVENTIONS: Recommendations by the CDR and pCODR. PRIMARY AND SECONDARY OUTCOME MEASURES: Analysis of the percent of drugs receiving positive listing recommendations from CDR and pCODR depending on the pathway used to approve the drug. RESULTS: There were 310 recommendations for drug-indication combinations from the CDR and 79 from the pCODR. There was a statistically significant difference in the number of drug-indication combinations that received a list versus do not list recommendation from the CDR for those approved through the standard pathway compared with those approved through the NOC/c pathway (p=0.0407). A similar analysis for recommendations from the pCODR was not statistically significant. CONCLUSION: For non-oncology drug-indication combinations, the type of review appears to influence the recommendation regarding listing on public formularies. This difference may reflect the level of evidence about the efficacy and safety of the drug indication at the time the recommendation was made.

Supporting Implementation Research to Improve Coverage and Uptake of HIV Related Interventions.

In 2015, Global Affairs Canada joined other members of the United Nations to establish the Sustainable Development Goals, which include the elimination of AIDS by 2030. Innovation is an important part of accelerating the response against HIV and ensuring success in eliminating AIDS by 2030. This is the reason Global Affairs Canada decided to partner with the World Health Organization, to support the INtegration and Scaling Up PMTCT through Implementation REsearch (INSPIRE) initiative, to learn how HIV interventions can be successfully integrated with other essential health services for mothers and children, especially among the most vulnerable populations. Canada also believes that the empowerment of women and girls will be critical to eliminating AIDS. INSPIRE is the evidence that providing women with the knowledge and skills necessary to prevent, treat, and manage HIV enables them to become experts and agents of change in their families and communities. We know that when women are empowered with critical information regarding their health, there is greater retention in care which leads to improved treatment adherence and ultimately helps to reduce the rate of new infections. Global Affairs Canada is proud to have supported the World Health Organization in this effort.

Improving Retention in Care Among Pregnant Women and Mothers Living With HIV: Lessons From INSPIRE and Implications for Future WHO Guidance and Monitoring.

Identifying women living with HIV, initiating them on lifelong antiretroviral treatment (ART), and retaining them in care are among the important challenges facing this generation of health care managers and public health researchers. Implementation research attempts to solve a wide range of implementation problems by trying to understand and work within real-world conditions to find solutions that have a measureable impact on the outcomes of interest. Implementation research is distinct from clinical research in many ways yet demands similar standards of conceptual thinking and discipline to generate robust evidence that can be, to some extent, generalized to inform policy and service delivery. In 2011, the World Health Organization (WHO), with funding from Global Affairs Canada, began support to 6 implementation research projects in Malawi, Nigeria, and Zimbabwe. All focused on evaluating approaches for improving rates of retention in care among pregnant women and mothers living with HIV and ensuring their continuation of ART. This reflected the priority given by ministries of health, program implementers, and researchers in each country to the importance of women living with HIV returning to health facilities for routine care, adherence to ART, and improved health outcomes. Five of the studies were cluster randomized controlled trials, and 1 adopted a matched cohort design. Here, we summarize some of the main findings and key lessons learned. We also consider some of the broader implications, remaining knowledge gaps, and how implementation research is integral to, and essential for, global guideline development and to inform HIV/AIDS strategies.

Complexity in the new NHS: longitudinal case studies of CCGs in England.

OBJECTIVE: The reform in the English National Health Services (NHS) under the Health and Social Care Act 2012 is unlike previous NHS reorganisations. The establishment of clinical commissioning groups (CCGs) was intended to be 'bottom up' with no central blueprint. This paper sets out to offer evidence about how this process has played out in practice and examines the implications of the complexity and variation which emerged. DESIGN: Detailed case studies in CCGs across England, using interviews, observation and documentary analysis. Using realist framework, we unpacked the complexity of CCG structures. SETTING/PARTICIPANTS: In phase 1 of the study (January 2011 to September 2012), we conducted 96 interviews, 439 h of observation in a wide variety of meetings, 2 online surveys and 38 follow-up telephone interviews. In phase 2 (April 2013 to March 2015), we conducted 42 interviews with general practitioners (GPs) and managers and observation of 48 different types of meetings. RESULTS: Our study has highlighted the complexity inherent in CCGs, arising out of the relatively permissive environment in which they developed. Not only are they very different from one another in size, but also in structure, functions between different bodies and the roles played by GPs. CONCLUSIONS: The complexity and lack of uniformity of CCGs is important as it makes it difficult for those who must engage with CCGs to know who to approach at what level. This is of increasing importance as CCGs are moving towards greater integration across health and social care. Our study also suggests that there is little consensus as to what being a 'membership' organisation means and how it should operate. The lack of uniformity in CCG structure and lack of clarity over the meaning of 'membership' raises questions over accountability, which becomes of greater importance as CCG is taking over responsibility for primary care co-commissioning.

Exploring the role and function of trial steering committees: results of an expert panel meeting.

BACKGROUND: The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC makes recommendations. The detailed roles and function of this executive committee, known as the Trial Steering Committee (TSC), have not previously been studied or reviewed since those originally proposed by the MRC in 1998. METHODS: An expert panel (n = 7) was convened comprising statisticians, clinicians and trial methodologists with prior TSC experience. Twelve questions about the role and responsibilities of the TSC were discussed by the panel at two full-day meetings. Each meeting was transcribed in full and the discussions were summarised. RESULTS: The expert panel reached agreement on the role of the TSC, to which it was accountable, the membership, the definition of independence, and the experience and training needed. The management of ethical issues, difficult/complex situations and issues the TSC should not ask the DMC to make recommendations on were more difficult to discuss without specific examples, but support existed for further work to help share issues and to provide appropriate training for TSC members. Additional topics discussed, which had not been identified by previous work relating to the DMCs but were pertinent to the role of the TSC, included the following: review of data sharing requests, indemnity, lifespan of the TSC, general TSC administration, and the roles of both the Funder and the Sponsor. CONCLUSIONS: This paper presents recommendations that will contribute to the revision and update of the MRC TSC terms of reference. Uncertainty remains in some areas due to the absence of real-life examples; future guidance on these issues would benefit from a repository of case studies. Notably, the role of a patient and public involvement (PPI) contributor was not discussed, and further work is warranted to explore the role of a PPI contributor in independent trial oversight.