Group-based trajectory models of integrated vaccine delivery and equity in low- and middle-income countries.

BACKGROUND: Integrated vaccine delivery - the linkage of routine vaccination with provision of other essential health services - is a hallmark of robust primary care systems that has been linked to equitable improvements in population health outcomes. METHODS: We gathered longitudinal data relating to routine immunization coverage and vaccination equity in 78 low- and middle-income countries that have ever received support from Gavi, the Vaccine Alliance, using multiple imputation to handle missing values. We then estimated several group-based trajectory models to describe the relationship between integrated vaccine delivery and vaccination equity in these countries. Finally, we used multinomial logistic regression to identify predictors of group membership. RESULTS: We identified five distinct trajectories of geographic vaccination equity across both the imputed and non-imputed datasets, along with two and four trajectories of socioeconomic vaccination equity in the imputed and non-imputed datasets, respectively. Integration was associated with reductions in the slope index of inequality of measles vaccination in the countries analyzed. Integration was also associated with an increase in the percentage of districts reporting high measles vaccination coverage. CONCLUSIONS: Integrated vaccine delivery is most strongly associated with improvements in vaccination equity in settings with high baseline levels of inequity. Continued scholarship is needed to further characterize the relationship between integration and health equity, as well as to improve measurement of vaccination coverage and integration.

Capacity for wonder among medical students: Assessment and educational implications.

OBJECTIVE: The capacity for wonder (CfW) is a personal disposition related to lifelong learning and moral character development, two highly valued characteristics of health professionals. We previously developed and validated a CfW measure among college students. Here we describe how the scale performs among medical students. METHODS: We invited all students at a top-tier U.S. medical school (N = 477) to participate in an online survey including the CfW measure, year in medical school, and demographics. We performed confirmatory factor analysis on the CfW measure and reassessed its reliability. RESULTS: 276 students completed the survey for an overall response rate of 58%. Factor analysis resulted in a 10-item scale with an alpha of 0.79 and an eigen value of 3.57. Factor loadings ranged from 0.43 to 0.77. The mean total score was 39.3 (SD = 8.9) out of a possible high score of 60. Total scores varied by year in school with significantly lower scores among 2nd year students (32.9 vs. 41.5; p < 0.001). CONCLUSION: We confirmed the reliability of a 10-item CfW scale in 4 cohorts of medical students. Results suggest that the 2nd year of medical school poses the greatest risk to students' capacity for wonder. Efforts should be made to understand this phenomenon and develop interventions to mitigate it. Future research should explore the validity of the CfW scale, its utility in evaluating interventions designed to cultivate the capacity for wonder, its applicability to other groups of health professionals, and its association with ethical decision-making and practice.

Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach.

OBJECTIVES: While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The "South African Values and Ethics for Universal Health Coverage" (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. METHODS: The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five. RESULTS: The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context. CONCLUSIONS: The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

Implementing post-trial access plans for HIV prevention research.

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA.

Exploring Meaning and Types of Trust in Maternity Care in Peri-Urban Kenya: A Qualitative Cross-Perspective Analysis.

Trust offers a distinctive lens on facility responsiveness during labor and birth. Though acknowledged in prior literature, limited work exists linking conceptual and empirical spheres. This study explores trust in the maternity setting in Kenya through a theoretically driven qualitative approach. Focus groups ( n = 8, N = 70) with women who recently gave birth (WRB), pregnant women, and male partners, and in-depth-interviews ( n = 33) with WRB, frontline providers, and management, were conducted in and around a peri-urban public hospital. Combined coding and memo-writing showed that trust in maternity care is nested within understandings of institutional and societal trust. Content areas of trust include confidence, communication, integrity, mutual respect, competence, fairness, confidentiality, and systems trust. Trust is relevant, multidimensional, and dynamic. Examining trust provides a basis for developing quantitative measures and reveals structural underpinnings, repercussions for trust in other health areas, and health systems inequities, which have implications for maternal health policy, programming, and service utilization.

Action Guide for Addressing Ethical Challenges of Resource Allocation Within Community-Based Healthcare Organizations.

This article proposes an action guide to making decisions regarding the ethical allocation of resources that affect access to healthcare services offered by community-based healthcare organizations. Using the filter of empirical data from a study of decision making in two community-based healthcare organizations, we identify potentially relevant conceptual guidance from a review of frameworks and action guides in the public health, health policy, and organizational ethics literature. We describe the development of this action guide. We used data from a prior empirical study of the values that influence decision making about the allocation of resources in particular types of community-based healthcare organizations. We evaluated, organized, and specified the conceptual guidance we found in 14 frameworks for ethical decision making. The result is an action guide that includes four domains that are relevant to the context of the decision to be made, eight domains that are relevant to the process of the decision to be made, and 15 domains that are relevant to the criteria of the decision to be made. We demonstrate the potential use of this action guide by walking through an illustrative resource allocation decision. The action guide provides community-based healthcare organizations with a conceptually grounded, empirically informed framework for ethical decision making.

Which strings attached: ethical considerations for selecting appropriate conditionalities in conditional cash transfer programmes.

Conditional cash transfers (CCTs) present a promising approach to simultaneously tackle chronic poverty and poor health. While these programmes clearly embody beneficent aims, questions remain regarding the ethical design of CCTs. Limited guidance exists for the ethical evaluation of the defining feature of these programmes: the conditionalities. Drawing upon prominent public health ethics frameworks and social justice theories, this paper outlines five categories of morally relevant considerations that CCT programme designers should consider when assessing which behaviours or outcomes they select as conditionalities for payment: (1) likelihood of yielding desired health outcomes, (2) risks and burdens, (3) receptivity, (4) attainability and (5) indirect impacts and externalities. When evaluating potential conditionalities across these five categories of considerations, it is important to recognise that not all beneficiaries or subgroups of beneficiaries will fare equally on each. Given that most CCTs aim to reduce inequities and promote long-term health and prosperity for the most disadvantaged, it is critical to apply these considerations with due attention to how different segments of the beneficiary population will be differentially affected. Taken on balance, with due reflection on distributional effects, these five categories represent a comprehensive set of considerations for the moral analysis of specific conditionalities and will help ensure that CCT designers structure programmes in a way that is both morally sound and effective in achieving their goals.

Investing in justice: ethics, evidence, and the eradication investment cases for lymphatic filariasis and onchocerciasis.

It has been suggested that initiatives to eradicate specific communicable diseases need to be informed by eradication investment cases to assess the feasibility, costs, and consequences of eradication compared with elimination or control. A methodological challenge of eradication investment cases is how to account for the ethical importance of the benefits, burdens, and distributions thereof that are salient in people's experiences of the diseases and related interventions but are not assessed in traditional approaches to health and economic evaluation. We have offered a method of ethical analysis grounded in theories of social justice. We have described the method and its philosophical rationale and illustrated its use in application to eradication investment cases for lymphatic filariasis and onchocerciasis, 2 neglected tropical diseases that are candidates for eradication.

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the design, planning, and conduct of a pragmatic clinical trial and offer insights regarding the best way to communicate the trial's results to their constituencies.

Community engagement and the human infrastructure of global health research.

BACKGROUND: Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement (CE) has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed. DISCUSSION: In this paper, we propose an ethical framework for CE. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement. These relationships create an essential "human infrastructure" - a web of relationships between researchers and the stakeholder community-i.e., the diverse stakeholders who have interests in the conduct and/or outcomes of the research. Through these relationships, researchers are able to address three core ethical responsibilities: (1) identifying and managing non-obvious risks and benefits; (2) expanding respect beyond the individual to the stakeholder community; and (3) building legitimacy for the research project. SUMMARY: By recognizing the social and political context of biomedical research, CE offers a promising solution to many seemingly intractable challenges in global health research; however there are increasing concerns about what makes engagement meaningful. We have responded to those concerns by presenting an ethical framework for CE. This framework reflects our belief that the value of CE is realized through relationships between researchers and stakeholders, thereby advancing three distinct ethical goals. Clarity about the aims of researcher-stakeholder relationships helps to make engagement programs more meaningful, and contributes to greater clarity about when CE should be recommended or required.

Post-epidemic health system recovery: A comparative case study analysis of routine immunization programs in the Republics of Haiti and Liberia.

Large-scale epidemics in resource-constrained settings disrupt delivery of core health services, such as routine immunization. Rebuilding and strengthening routine immunization programs following epidemics is an essential step toward improving vaccine equity and averting future outbreaks. We performed a comparative case study analysis of routine immunization program recovery in Liberia and Haiti following the 2014-16 West Africa Ebola epidemic and 2010s cholera epidemic, respectively. First, we triangulated data between the peer-reviewed and grey literature; in-depth key informant interviews with subject matter experts; and quantitative metrics of population health and health system functioning. We used these data to construct thick descriptive narratives for each case. Finally, we performed a cross-case comparison by applying a thematic matrix based on the Essential Public Health Services framework to each case narrative. In Liberia, post-Ebola routine immunization coverage surpassed pre-epidemic levels, a feat attributable to investments in surveillance, comprehensive risk communication, robust political support for and leadership around immunization, and strong public-sector recovery planning. Recovery efforts in Haiti were fragmented across a broad range of non-governmental agencies. Limitations in funding, workforce development, and community engagement further impeded vaccine uptake. Consequently, Haiti reported significant disparities in subnational immunization coverage following the epidemic. This study suggests that embedding in-country expertise within outbreak response structures, respecting governmental autonomy, aligning post-epidemic recovery plans and policies, and integrating outbreak response assets into robust systems of primary care contribute to higher, more equitable levels of routine immunization coverage in resource-constrained settings recovering from epidemics.

The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa.

OBJECTIVES: This article explores the perceived value, including associated strengths and challenges, of using a context-specified ethics framework to guide deliberative health technology appraisals. METHODS: The South African Values and Ethics for Universal Health Coverage (SAVE-UHC) approach, piloted in South Africa, consisted of 2 phases: (1) convening a national multistakeholder working group to develop a provisional ethics framework and (2) testing the provisional ethics framework through simulated health technology assessment appraisal committee meetings (SACs). Three SACs each reviewed 2 case studies of sample health interventions using the framework. Participants completed postappraisal questionnaires and engaged in focus group discussions. RESULTS: The SACs involved 27 participants across 3 provinces. Findings from the postappraisal questionnaires demonstrated general support for the SAVE-UHC approach and content of the framework, high levels of satisfaction with the recommendations produced, and general sentiment that participants were able to actively contribute to appraisals. Qualitative data showed participants perceived using a context-specified ethics framework in deliberative decision making: (1) supported wider consideration of and deliberation about morally relevant features of the health coverage decisions, thereby contributing to quality of appraisals; (2) could improve transparency; and (3) offered benefits to those directly involved in the priority-setting process. Participants also identified some challenges and concerns associated with the approach. CONCLUSIONS: The SAVE-UHC approach presents a novel way to develop and pilot a locally contextualized, explicit ethics framework for health priority setting. This work highlights how the combination of a context-specified ethics framework and structured deliberative appraisals can contribute to the quality of health technology appraisals and transparency of health priority setting.

The ethics of testing a test: randomized trials of the health impact of diagnostic tests for infectious diseases.

In the last decade, many new rapid diagnostic tests for infectious diseases have been developed. In general, these new tests are developed with the intent to optimize feasibility and population health, not accuracy alone. However, unlike drugs or vaccines, diagnostic tests are evaluated and licensed on the basis of accuracy, not health impact (eg, reduced morbidity or mortality). Thus, these tests are sometimes recommended or scaled up for purposes of improving population health without randomized evidence that they do so. We highlight the importance of randomized trials to evaluate the health impact of novel diagnostics and note that such trials raise distinctive ethical challenges of equipoise, equity, and informed consent. We discuss the distinction between equipoise for patient-important outcomes versus diagnostic accuracy, the equity implications of evaluating health impact of diagnostics under routine conditions, and the importance of offering reasonable choices for informed consent in diagnostic trials.

Responsibilities to plan for ancillary care pose ethical challenges for nutrition research in the community setting.

Investigators who conduct nutrition research in the community setting, particularly among underserved populations, face the ethical question of whether and how to respond to participants' unmet health needs. The research ethics literature conceptualizes this question as one of ancillary care (AC): what is the nature and extent of researchers' ethical responsibilities, if any, to provide or facilitate health care that research participants need but that is not necessary to ensure the safety or scientific validity of the research? In this paper, we highlight 3 ethical challenges involved in the planning of AC responses for nutrition research conducted in the community setting: influence of provision of AC on primary study outcomes as an issue of trial design; whether to extend the provision of AC beyond research participants to nonparticipants with the same health needs; and how best to train field workers who may be the most likely members of the study team to encounter the health needs anticipated among participants. Although the global ethical discussion of AC is gaining in depth, breadth, and practical influence, it remains relatively uninformed by perspectives specific to nutrition research. Our objective is to encourage nutrition researchers to engage proactively in the emerging ethical discussion of AC, so that their relevant experiences and concerns can be taken into account in the eventual formation of ethical guidelines and policies.

Provision of community-wide benefits in public health intervention research: the experience of investigators conducting research in the community setting in South Asia.

BACKGROUND: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. METHODS: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? FINDINGS: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance.

Determining a Trusting Environment for Maternity Care: A Framework Based on Perspectives of Women, Communities, Service Providers, and Managers in Peri-Urban Kenya.

Trust in health service providers and facilities is integral to health systems accountability. Understanding determinants of trust, a relational construct, in maternity settings necessitates exploring hierarchical perspectives of users, providers, and influencers in the care environment. We used a theoretically driven qualitative approach to explore trust determinants in a maternity setting across patient-provider, inter-provider, and community-policymaker interactions and relationships in peri-urban Kenya. Focus groups (n = 8, N = 70) with women who recently gave birth (WRB), pregnant women, and male partners, and in-depth-interviews (n = 33) with WRB, health care providers and managers, and community health workers (CHWs) were conducted in 2013, soon after the national government's March 2013 introduction of a policy mandate for "Free Maternity Care." We used thematic coding, memo writing, and cross-perspective triangulation to develop a multi-faceted trust determinants framework. We found that determinants of trust in a maternity setting can be broadly classified into six types of factors, where each type of factor represents a cluster of determinants that may each positively or negatively influence trust: patient, provider, health facility, community, accountability, and structural. Patient factors are prior experiences, perceived risks and harms, childbirth outcomes, and maternal health literacy. Provider factors are empathy and respect, responsiveness, and perceived capability of providers. Health facility factors are "good services" as perceived by patients, physical environment, process navigability, provider collaboration and oversight, discrimination, and corruption. Community factors are facility reputation and history, information channels, and maternal health literacy. Accountability factors are alignment of actions with expectations, adaptations to policy changes, and voice and feedback. Structural factors are institutional hierarchies and policies in the form of professional codes. Trust determinants are complex, nuanced and reflect power dynamics across relationships. Findings offer insight into socio-political maternity norms and demand a more equitable care interface between users and providers.

Health researchers' ancillary care obligations in low-resource settings: how can we tell what is morally required?

Health researchers working in low-resource settings often encounter serious unmet health needs among participants. What is the nature and extent of researchers' obligations to respond to such needs? Competing accounts have been proposed, but there is no independent standard by which to assess them or to guide future inquiry. I propose an independent standard and demonstrate its use. In conclusion I recommend two areas of focus for future inquiry: what makes an account of researchers' obligations reasonable from the standpoint of both participants and researchers and how general duties of rescue apply to researchers' resource-allocation decision making in low-resource settings.

Ancillary care in community-based public health intervention research.

Community-based public health intervention research in developing countries typically takes place not in clinics but in people's homes and other living spaces. Research subjects and their communities may lack adequate nutrition, clean water, sanitation, and basic preventive and therapeutic services. Researchers often encounter unmet health needs in their interactions with individual subjects and need ethical guidelines to help them decide how to respond. To what extent do researchers have an ethical obligation to provide ancillary care-health care beyond what is necessary to ensure scientific validity and subjects' safety? We discuss a case example from Nepal and propose a simple 2-step sequence of questions to aid decision making.

Measuring Stigma to Assess the Social Justice Implications of Health-Related Policy Decisions: Application to Novel Treatment Regimens for Multidrug-Resistant Tuberculosis.

In making policy decisions with constrained resources, an important consideration is the impact of alternative policy options on social justice. Social justice considers interactions between individuals and society and can be conceptualized across domains of agency, association, and respect. Despite its importance, social justice is rarely considered formally in health policy decision making, partially reflecting challenges in its measurement. We define three criteria for considering social justice in health-related policy decisions: 1) linkage of social justice to a measurable construct; 2) ability to reproducibly and feasibly estimate the impacts of a policy decision on the selected construct; and 3) appropriate presentation to decision makers of the expected social justice implications using that construct. We use preliminary data from qualitative interviews from three groups of respondents in South Africa and Uganda to demonstrate that stigma meets the first of these criteria. We then use the example of policy addressing novel treatment regimens for multidrug-resistant tuberculosis and a validated tuberculosis stigma scale to illustrate how policy effects on stigma could be estimated (criterion 2) and presented to decision makers in the form of justice-enhanced cost-effectiveness analysis (criterion 3). Finally, we provide a point-by-point guide for conducting similar assessments to facilitate consideration of social justice in health-related policy decisions. Our case study and guide for how to make social justice impacts more apparent to decision makers also illustrates the importance of local data and local capacity. Performing social justice assessments alongside more traditional evaluations of cost-effectiveness, budget impact, and burden of disease could help represent data-informed considerations of social justice in health care decision making more broadly.