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.

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.

Assessment of the Quality of the Clinical Evidence in Submissions to the Australian Pharmaceutical Benefits Advisory Committee: Fit for Purpose?

BACKGROUND: Assessments of the comparative clinical (and cost) effectiveness of new medicines are increasingly being used to inform decisions on their reimbursement. Assessments of added clinical benefit are invariably based on evidence generated to support registration. OBJECTIVE: Our objective was to identify and characterize significant problems relating to the quality of the clinical evidence in submissions to the Australian Pharmaceutical Benefits Advisory Committee (PBAC) seeking subsidy on the Pharmaceutical Benefits Scheme and thus determine whether the evidence presented to the committee was "fit for purpose." METHODS: We conducted a retrospective analysis of submissions considered by the PBAC between 2005 and 2012 using a published evaluation framework. We developed an additional framework to categorize significant problems in more detail. Significant problems related to the choice of comparator, the unavailability of randomized clinical trial evidence, poor-quality data, a claim of clinical superiority, and a claim of clinical noninferiority. RESULTS: We identified 261 significant problems in 479 major submissions. There was a significant problem with the sponsor's choice of comparator in 11% of the submissions. The most common significant problem (29%) was the determination of a medicine's comparative performance in the target patient population. CONCLUSIONS: The supporting clinical evidence is the foundation of a PBAC submission. We found a poor fit for purpose; on average, one in every two major submissions had a significant problem with the supporting evidence. The findings from our study, if confirmed in other jurisdictions, raise important questions regarding what clinical evidence should be generated to support the reimbursement of new medicines.

Applying dynamic simulation modeling methods in health care delivery research-the SIMULATE checklist: report of the ISPOR simulation modeling emerging good practices task force.

Health care delivery systems are inherently complex, consisting of multiple tiers of interdependent subsystems and processes that are adaptive to changes in the environment and behave in a nonlinear fashion. Traditional health technology assessment and modeling methods often neglect the wider health system impacts that can be critical for achieving desired health system goals and are often of limited usefulness when applied to complex health systems. Researchers and health care decision makers can either underestimate or fail to consider the interactions among the people, processes, technology, and facility designs. Health care delivery system interventions need to incorporate the dynamics and complexities of the health care system context in which the intervention is delivered. This report provides an overview of common dynamic simulation modeling methods and examples of health care system interventions in which such methods could be useful. Three dynamic simulation modeling methods are presented to evaluate system interventions for health care delivery: system dynamics, discrete event simulation, and agent-based modeling. In contrast to conventional evaluations, a dynamic systems approach incorporates the complexity of the system and anticipates the upstream and downstream consequences of changes in complex health care delivery systems. This report assists researchers and decision makers in deciding whether these simulation methods are appropriate to address specific health system problems through an eight-point checklist referred to as the SIMULATE (System, Interactions, Multilevel, Understanding, Loops, Agents, Time, Emergence) tool. It is a primer for researchers and decision makers working in health care delivery and implementation sciences who face complex challenges in delivering effective and efficient care that can be addressed with system interventions. On reviewing this report, the readers should be able to identify whether these simulation modeling methods are appropriate to answer the problem they are addressing and to recognize the differences of these methods from other modeling approaches used typically in health technology assessment applications.

Revisiting financial conflicts of interest in FDA advisory committees.

CONTEXT: The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests. METHODS: The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior. FINDINGS: Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005). CONCLUSIONS: There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.

Create a COVID-19 commission.

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

Economic evaluation of the decisions of the Israeli Public Committee for updating the National List of Health Services in 2006/2007.

OBJECTIVE: The Public Committee (PC), which decides on the inclusion and ranking of new technologies in the Israeli List of Health Services facing a given budget, does not explicitly consider the results of economic evaluations of the technologies discussed. The present article includes an ex post economic examination of the PC's 2006/2007 decisions. METHODS: The cost per quality-adjusted life-year (QALY) (CPQ) values of the technologies approved and rejected were retrieved from national health technologies assessments and the professional literature. RESULTS: CPQ values were found for 40 technologies out of the 52 that were approved by the PC, and for 26 out of 42 randomly sampled among those rejected. The technologies approved for inclusion produce QALYs in a cheaper way, in general, than those rejected. A CPQ of about 50,000 new Israeli shekels (NIS) (15,500 USDPPP [purchasing power parity adjusted U.S. dollars]) is identified as the best discriminating value between approved and rejected technologies. The agreement between the PC's ranking of the approved technologies and the ranking by CPQ is low, and the only significant determinant of the Committee's ranking is the number of patients expected to benefit from the technology. CONCLUSIONS: Although not considering CPQ data explicitly, the PC tends, in fact, to approve technologies with relatively low CPQ. In ranking the approved technologies, however, the PC tries to maximize the number of persons expected to benefit from the additional budget even at the expense of possibly giving up cheaper QALYs. The size of the budget should be determined in accordance with an Israeli value of QALY and Israeli values of the CPQ of the technologies submitted for inclusion.

The Pharmaceutical Benefits Scheme and implications for paediatric prescribing.

AIMS: To evaluate the impact of the Pharmaceutical Benefits Advisory Committee (PBAC) decisions on access to medicines listed on the Pharmaceutical Benefits Scheme (PBS) for children. METHODS: We analysed all public summary documents from PBAC meetings from July 2005 to November 2006 and compared these with the Therapeutic Goods Administration (TGA) recommendations for children for the same medicine. Main outcome measures stratified by age, the total number of medicines for specific indications (accepted and rejected) by therapeutic class; estimated cost to the PBS per annum for each medicine recommended for listing; comparison of TGA-approved product information and PBS listing for recommended medicines. RESULTS: Of the 102 medicines for specific indications considered by the PBAC, 7% (7/102) of submissions were for new paediatric indications. Most submissions (60%, 61/102) did not specify age for the PBS recommendation and were for conditions which only affect adults. Listings which specifically included children were more likely to have a positive PBAC recommendation. Of the six recommended medicines for children, four were estimated to cost between $10-30 million per year. There was fair concordance between PBS- and TGA-approved product information for age (kappa 0.21) but in 46%, PBAC recommendations were for age-unrestricted listing compared with adults-only use in the TGA-approved product information. CONCLUSION: Access to new subsidised medicines for children in Australia lags behind adults because most applications to the PBAC for new medicines are for conditions which only affect adults. PBS processes facilitate access for children to new medicines by avoiding age restrictions.