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.     

Clinical trials and SCID row: the ethics of phase 1 trials in the developing world

Relatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer's most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations' health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short-course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations.     

Integrating evidence-based treatments for common mental disorders in routine primary care: feasibility and acceptability of the MANAS intervention in Goa,India

Common mental disorders, such as depression and anxiety, pose a major public health burden in developing countries. Although these disorders are thought to be best managed in primary care settings, there is a dearth of evidence about how this can be achieved in low resource settings. The MANAS project is an attempt to integrate an evidence based package of treatments into routine public and private primary care settings in Goa, India. Before initiating the trial, we carried out extensive preparatory work, over a period of 15 months, to examine the feasibility and acceptability of the planned intervention. This paper describes the systematic development and evaluation of the intervention through this preparatory phase. The preparatory stage, which was implemented in three phases, utilized quantitative and qualitative methods to inform our understanding of the potential problems and possible solutions in implementing the trial and led to critical modifications of the original intervention plan. Investing in systematic formative work prior to conducting expensive trials of the effectiveness of complex interventions is a useful exercise which potentially improves the likelihood of a positive result of such trials.     

The use of research evidence in public health decision making processes: systematic review

Background

The use of research evidence to underpin public health policy is strongly promoted. However, its implementation has not been straightforward. The objectives of this systematic review were to synthesise empirical evidence on the use of research evidence by public health decision makers in settings with universal health care systems.

Methods

To locate eligible studies, 13 bibliographic databases were screened, organisational websites were scanned, key informants were contacted and bibliographies of included studies were scrutinised. Two reviewers independently assessed studies for inclusion, extracted data and assessed methodological quality. Data were synthesised as a narrative review.

Findings

18 studies were included: 15 qualitative studies, and three surveys. Their methodological quality was mixed. They were set in a range of country and decision making settings. Study participants included 1063 public health decision makers, 72 researchers, and 174 with overlapping roles. Decision making processes varied widely between settings, and were viewed differently by key players. A range of research evidence was accessed. However, there was no reliable evidence on the extent of its use. Its impact was often indirect, competing with other influences. Barriers to the use of research evidence included: decision makers'' perceptions of research evidence; the gulf between researchers and decision makers; the culture of decision making; competing influences on decision making; and practical constraints. Suggested (but largely untested) ways of overcoming these barriers included: research targeted at the needs of decision makers; research clearly highlighting key messages; and capacity building. There was little evidence on the role of research evidence in decision making to reduce inequalities.

Conclusions

To more effectively implement research informed public health policy, action is required by decision makers and researchers to address the barriers identified in this systematic review. There is an urgent need for evidence to support the use of research evidence to inform public health decision making to reduce inequalities.     

Public preferences for health care: prioritisation in the United Kingdom

The Government in the UK is encouraging consumerism within health care and is requiring Health Authorities to consult with the public on prioritisation of resources. Public consultation within the National Health Service (NHS) has had limited success in the past. Many of the techniques used are flawed. Despite the limited scope of the public surveys conducted so far, a number of themes have emerged: a willingness to pay for experimental, 'high-tech' life-saving treatments rather than more cost-effective treatments which will improve quality of life, which are more likely to maximise utility from the scarce resources available; preference for treating the young rather than the old; preference for treating patients with dependents (e.g. spouse, children) rather than those who have none; a willingness to discriminate against those patients who were partially responsible for their illness due to choice of 'unhealthy' lifestyle (e.g. smoking cigarettes, drinking excess alcohol). These public preferences raise ethical problems. For example, is it just to spend more on heroic treatments which are likely to fail? Is there a right to health care irrespective of whether you have had 'a fair innings' or whether a patient is in part responsible for their illness due to an unhealthy lifestyle? If there are ethical concerns about these preferences, should health authorities consult with the public at all? Is human life and suffering incommensurable, and hence is it impossible to prioritise anyway? Some of the ethical consequences of using empirical data on public preferences are discussed.     

Considerations for community engagement when conducting clinical trials during infectious disease emergencies in West Africa

Community engagement in research, including public health related research, is acknowledged as an ethical imperative. While medical care and public health action take priority over research during infectious disease outbreaks, research is still required in order to learn from epidemic responses. The World Health Organisation developed a guide for community engagement during infectious disease epidemics called the Good Participatory Practice for Trials of Emerging (and Re‐emerging) Pathogens that are Likely to Cause Severe Outbreaks in the Near Future and for which Few or No Medical Counter‐Measures Exist (GPP‐EP). This paper identified priorities for community engagement for research conducted during infectious disease outbreaks drawing on discussions held with a purposive sample of bioethicists, social scientists, researchers, policy makers and laypersons who work with ethics committees in West Africa. These perspectives were considered in the light of the GPP‐EP, which adds further depth and dimension to discussions on community engagement frameworks. It concludes that there is no presumptive justification for the exclusion of communities in the design, implementation and monitoring of clinical trials conducted during an infectious disease outbreak. Engagement that facilitates collaboration rather than partnership between researchers and the community during epidemics is acceptable.     

Public Preferences for Health Care: Prioritisation in the United Kingdom

The Government in the UK is encouraging consumerism within health care and is requiring Health Authorities to consult with the public on prioritisation of resources. Public consultation within the National Health Service (NHS) has had limited success in the past. Many of the techniques used are flawed. Despite the limited scope of the public surveys conducted so far, a number of themes have emerged:
— a willingness to pay for experimental, 'high-tech' life-saving treatments rather than more cost-effective treatments which will improve quality of life, which are more likely to maximise utility from the scarce resources available;
— preference for treating the young rather than the old;
— preference for treating patients with dependants (e.g. spouse, children) rather than those who have none;
— a willingness to discriminate against those patients who were partially responsible for their illness due to choice of `unhealthy' lifestyle (e.g. smoking cigarettes, drinking excess alcohol).
These public preferences raise ethical problems. For example, is it just to spend more on heroic treatments which are likely to fail? Is there a right to health care irrespective of whether you have had 'a fair innings' or whether a patient is in part responsible for their illness due to an unhealthy lifestyle? If there are ethical concerns about these preferences, should health authorities consult with the public at all? Is human life and suffering incommensurable, and hence is it impossible to prioritise anyway? Some of the ethical consequences of using empirical data on public preferences are discussed.     

The role of herbs and spices in cancer prevention

Historically, herbs and spices have enjoyed a rich tradition of use for their flavor enhancement characteristics and for their medicinal properties. The rising prevalence of chronic diseases worldwide and the corresponding rise in health care costs is propelling interest among researchers and the public for multiple health benefits related to these food items, including a reduction in cancer risk and modification of tumor behavior. A growing body of epidemiological and preclinical evidence points to culinary herbs and spices as minor dietary constituents with multiple anticancer characteristics. This review focuses on the antimicrobial, antioxidant, and antitumorigenic properties of herbs and spices; their ability to influence carcinogen bioactivation; and likely anticancer contributions. While culinary herbs and spices present intriguing possibilities for health promotion, more complete information is needed about the actual exposures to dietary components that are needed to bring about a response and the molecular target(s) for specific herbs and spices. Only after this information is obtained will it be possible to define appropriate intervention strategies to achieve maximum benefits from herbs and spices without eliciting ill consequences.     

Suicide prevention in Nepal: a comparison to Australia-a personal view

Suicide is a crisis of unknown proportions in much of the developing world. The majority of research into suicide has been done in high-resource countries such as Australia, and most intervention protocols have been drawn up using Western models. There appear to be a number of differences in the aetiology, presentation and treatment options for mental health problems between high-resource and low-resource countries. This review compares suicide in a high-resource country, Australia, and low-resource country, Nepal.Many low-resource countries such as Nepal struggle to address barriers to mental health care due to limited mental health resources and issues such as stigma, workforce and mental health literacy. Issues relating to suicide prevention are raised, contrasting a low-resource country, Nepal, with a high-resource country, Australia.     

Recent Advances in Behavioral Research in Geriatric Dentistry1

This paper examines recent studies in behavioral science and health services aspects of geriatric dentistry. With the increased focus on special needs of older patients, researchers have become concerned with psychological and sociocultural factors that influence older people's oral health status, behavior, and attitudes. Studies of dental service utilization patterns among subgroups of the elderly, including those in long-term care settings, will be reviewed. Research on methods to improve oral health care behaviors will be discussed, with their implications for developing oral health promotion and service delivery programs. The special oral health needs of cognitively impaired and frail elderly will be reviewed. Studies of clinical decision-making in geriatric dentistry have been conducted. These studies have revealed significant gaps in dental professionals' knowledge and attention to the special needs of older patients. This and other aspects of behavioral research suggest the need for better methods to disseminate research findings in geriatric dentistry to clinical practice in this field. The presentation will discuss ways of improving dissemination and transfer of research findings to the clinical management of aged patients.     

Lessons from the field--health care experiences and preferences in a Latino community

As part of Midwest Bioethics Center's PATHWAYS to Improve End-of-Life Care project, we conducted an exploratory study in the Latino community of Kansas City to understand health beliefs, practices, and values, particularly as they relate to end-of-life care. We conducted ten focus groups and interviewed more than seventeen individuals who serve the Latino community in a social service, ministry, or health care capacity. We found that people were very concerned with "barriers to health care" (our term), and very willing to reveal their preferences for health care decision making and end-of-life care treatment options. We believe that bioethicists should conduct other, similar projects because they can improve our engagement with the Latino population and help Latinos find a greater voice in health care settings.     

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study

Objectives

Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations.

Methods

From 2008–2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement.

Results

Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of “community”; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted.

Conclusions

This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making.     

Facilitating the Recruitment of Minority Ethnic People into Research: Qualitative Case Study of South Asians and Asthma

Background

There is international interest in enhancing recruitment of minority ethnic people into research, particularly in disease areas with substantial ethnic inequalities. A recent systematic review and meta-analysis found that UK South Asians are at three times increased risk of hospitalisation for asthma when compared to white Europeans. US asthma trials are far more likely to report enrolling minority ethnic people into studies than those conducted in Europe. We investigated approaches to bolster recruitment of South Asians into UK asthma studies through qualitative research with US and UK researchers, and UK community leaders.

Methods and Findings

Interviews were conducted with 36 researchers (19 UK and 17 US) from diverse disciplinary backgrounds and ten community leaders from a range of ethnic, religious, and linguistic backgrounds, followed by self-completion questionnaires. Interviews were digitally recorded, translated where necessary, and transcribed. The Framework approach was used for analysis. Barriers to ethnic minority participation revolved around five key themes: (i) researchers'' own attitudes, which ranged from empathy to antipathy to (in a minority of cases) misgivings about the scientific importance of the question under study; (ii) stereotypes and prejudices about the difficulties in engaging with minority ethnic populations; (iii) the logistical challenges posed by language, cultural differences, and research costs set against the need to demonstrate value for money; (iv) the unique contexts of the two countries; and (v) poorly developed understanding amongst some minority ethnic leaders of what research entails and aims to achieve. US researchers were considerably more positive than their UK counterparts about the importance and logistics of including ethnic minorities, which appeared to a large extent to reflect the longer-term impact of the National Institutes of Health''s requirement to include minority ethnic people.

Conclusions

Most researchers and community leaders view the broadening of participation in research as important and are reasonably optimistic about the feasibility of recruiting South Asians into asthma studies provided that the barriers can be overcome. Suggested strategies for improving recruitment in the UK included a considerably improved support structure to provide academics with essential contextual information (e.g., languages of particular importance and contact with local gatekeepers), and the need to ensure that care is taken to engage with the minority ethnic communities in ways that are both culturally appropriate and sustainable; ensuring reciprocal benefits was seen as one key way of avoiding gatekeeper fatigue. Although voluntary measures to encourage researchers may have some impact, greater impact might be achieved if UK funding bodies followed the lead of the US National Institutes of Health requiring recruitment of ethnic minorities. Such a move is, however, likely in the short- to medium-term, to prove unpopular with many UK academics because of the added “hassle” factor in engaging with more diverse populations than many have hitherto been accustomed to. Please see later in the article for the Editors'' Summary     

A systems approach to improving rural care in Ethiopia

Background

Multiple interventions have been launched to improve the quality, access, and utilization of primary health care in rural, low-income settings; however, the success of these interventions varies substantially, even within single studies where the measured impact of interventions differs across sites, centers, and regions. Accordingly, we sought to examine the variation in impact of a health systems strengthening intervention and understand factors that might explain the variation in impact across primary health care units.

Methodology/Principal Findings

We conducted a mixed methods positive deviance study of 20 Primary Health Care Units (PHCUs) in rural Ethiopia. Using longitudinal data from the Ethiopia Millennium Rural Initiative (EMRI), we identified PHCUs with consistently higher performance (n = 2), most improved performance (n = 3), or consistently lower performance (n = 2) in the provision of antenatal care, HIV testing in antenatal care, and skilled birth attendance rates. Using data from site visits and in-depth interviews (n = 51), we applied the constant comparative method of qualitative data analysis to identify key themes that distinguished PHCUs with different performance trajectories. Key themes that distinguished PHCUs were 1) managerial problem solving capacity, 2) relationship with the woreda (district) health office, and 3) community engagement. In higher performing PHCUs and those with the greatest improvement after the EMRI intervention, health center and health post staff were more able to solve day-to-day problems, staff had better relationships with the woreda health official, and PHCU communities'' leadership, particularly religious leadership, were strongly engaged with the health improvement effort. Distance from the nearest city, quality of roads and transportation, and cultural norms did not differ substantially among PHCUs.

Conclusions/Significance

Effective health strengthening efforts may require intensive development of managerial problem solving skills, strong relationships with government offices that oversee front-line providers, and committed community leadership to succeed.     

Conducting Research with Human Subjects in International Settings: Ethical Considerations

Biomedical research in international settings is undergoing expansive growth and may potentially result in far-reaching benefits, such as direction of research resources toward solving basic health care needs of world populations. However, key ethical concerns surround this expansion and must be carefully considered by international researchers. International research is impacted by differences in language, culture, regulatory structures, financial resources, and possibly ethical standards. Local community leadership involvement in the planning stages of research is imperative. Especially in resource-poor countries, the research agenda must be designed to address local needs and provide local benefit. Capacity strengthening efforts, aimed at improving institutional support for ethical conduct of human subjects research, must continue to be supported by wealthier nations.     

Patient satisfaction and quality in home health care of elderly islanders

Patient satisfaction has been a widely investigated subject in health care research. Quality of care from the patient perspective, especially in home health care, however has been investigated only very recently. Home health care is a system of care provided by skilled practitioners to patients in their homes under the direction of a physician. Multidisciplinary nature of home health care services present challenges to quality measurement that differ from those found in a more traditional hospital settings. The aim of the study was to investigate the satisfaction of elderly patients living on islands with home health care. Participants receiving skilled nursing care in their homes, for any diagnosis, who met selection criteria, were surveyed about their perception of the quality of health care. The research was conducted during the year 2010 among the residents of Kvarnerian islands (Krk, Cres and Mali Losinj) under the authority of Croatian Institute for Health Insurance that approved the protocols employed in the investigation. Most older patients (96.2%) reported high levels of satisfaction with health services delivery. Common leading diagnosis among home health care patient include diseases of circulatory system (28.9% of patients), nutritional and metabolic disease (14.5%), malignant diseases (13.2%), musculoskeletal and connective tissue disease (11.8%), diseases of the nervous system (9.2%), followed by injury and poisoning (7.9%). Provision of home health care was well received by elderly patients. Home health care providers seek to provide high quality, safe care in ways that honour patient autonomy and accommodate the individual characteristics of each patients home and family. The demographics of an aging society will sustain the trend towards home-based care. Therefore, research on effective practices, conducted in home health care settings, is necessary to support excellent and evidence-based care.     

Medical Researchers' Ancillary Care Obligations: The Relationship‐Based Approach

In this article, I provide a new account of the basis of medical researchers' ancillary care obligations. Ancillary care in medical research, or medical care that research participants need but that is not required for the validity or safety of a study or to redress research injuries, is a topic that has drawn increasing attention in research ethics over the last ten years. My view, the relationship‐based approach, improves on the main existing theory, Richardson and Belsky's ‘partial‐entrustment model’, by avoiding its problematic restriction on the scope of health needs for which researchers could be obligated to provide ancillary care. Instead, it grounds ancillary care obligations in a wide range of morally relevant features of the researcher‐participant relationship, including the level of engagement between researchers and participants, and weighs these factors against each other. I argue that the level of engagement, that is, the duration and intensity of interactions, between researchers and participants matters for ancillary care because of its connection to the meaningfulness of a relationship, and I suggest that other morally relevant features can be grounded in researchers' role obligations.     

Engaging the Public to Identify Opportunities to Improve Critical Care: A Qualitative Analysis of an Open Community Forum

Objective

To engage the public to understand how to improve the care of critically ill patients.

Design

A qualitative content analysis of an open community forum (Café Scientifique).

Setting

Public venue in Calgary, Alberta, Canada.

Participants

Members of the general public including patients, families of patients, health care providers, and members of the community at large.

Methods

A panel of researchers, decision-makers, and a family member led a Café Scientifique, an informal dialogue between the populace and experts, over three-hours to engage the public to understand how to improve the care of critically ill patients. Conventional qualitative content analysis was used to analyze the data. The inductive analysis occurred in three phases: coding, categorizing, and developing themes.

Results

Thirty-eight members of the public (former ICU patients, family members of patients, providers, community members) attended. Participants focused the discussion and provided concrete suggestions for improvement around communication (family as surrogate voice, timing of conversations, decision tools) and provider well-being and engagement, as opposed to medical interventions in critical care.

Conclusions

Café participants believe patient and family centered care is important to ensure high-quality care in the ICU. A Café Scientifique is a valuable forum to engage the public to contribute to priority setting areas for research in critical care, as well as a platform to share lived experience. Research stakeholders including health care organizations, governments, and funding organizations should provide more opportunities for the public to engage in meaningful conversations about how to best improve healthcare.     

Effects of residency training in family medicine v. internship training on professional attitudes and practice patterns.

OBJECTIVES: To determine whether the professional attitudes and practice patterns of physicians with residency training in family medicine differ from those of generalists with internship training. DESIGN: Mail survey conducted in 1985-86. SETTING: Province of Quebec. PARTICIPANTS: A stratified random sample of French-speaking family and general practitioners who graduated after 1972 (325 physicians with residency training and 304 with internship training) (response rate 82%). MAIN RESULTS: Physicians with residency training were 3 years younger on average than those with internship training, were more likely to be female (38% v. 18%, p less than 0.001) and were more likely to work on a salaried basis in CLSCs (public community health centres) (36% v. 14%, p less than 0.001). Even after these confounding factors were controlled for, physicians with residency training seemed to be more sensitive to the psychosocial aspects of patient care and tended to attach more importance to informing patients about useful materials and resources concerning their health problems. They were not, however, more likely to value health counselling or integrate it in medical practice. CONCLUSION: Our findings provide some evidence that the new requirement that physicians complete a residency in family medicine to obtain medical licensure in general practice in Quebec may foster a more patient-centred approach to health care.