Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials

MacQueen, Kathleen M.; Eley, Natalie T.; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia Y; Seidel, Stephanie; Hannah, Stacey; Hamilton, Carol

doi:10.1177/1556264616657452

Cited by 7 publications

(11 citation statements)

References 20 publications

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“… 14 Implementing PCE can promote ethical and legal conduct on how interventions can be implemented successfully in local context including retention and adherence. 18 …”

Section: Resultsmentioning

confidence: 99%

“…It is critical to note that vaccine hesitancy determinants (determinants in delay acceptance or refusal of vaccination despite availability of vaccination services) like education and socio-economic status do not influence hesitancy in only one direction, 18 unlike the social determinants of health within which education is driven in one direction leading to better health outcomes. As previously demonstrated the individuals with higher level of education may be associated with both lower and higher levels of vaccine acceptance.…”

Section: Resultsmentioning

confidence: 99%

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Impact of telemonitoring approaches on integrated HIV and TB diagnosis and treatment interventions in sub-Saharan Africa: a scoping review

Yah

Tambo²,

Khayeka–Wandabwa³

et al. 2017

Health Promot Perspect

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Background: This paper explores telemonitoring/mhealth approaches as a promising real time and contextual strategy in overhauling HIV and TB interventions quality access and uptake, retention,adherence and coverage impact in endemic and prone-epidemic prevention and control in sub-Sahara Africa. Methods: The scoping review method was applied in acknowledged journals indexing platforms including Medline, Embase, Global Health, PubMed, MeSH PsycInfo, Scopus and Google Scholar to identify relevant articles pertaining to telemonitoring as a proxy surrogate method in reinforcing sustainability of HIV/TB prevention/treatment interventions in sub-Saharan Africa. Full papers were assessed and those selected that fosters evidence on telemonitoring/mhealth diagnosis, treatment approaches and strategies in HIV and TB prevention and control were synthesized and analyzed. Results: We found telemonitoring/mhealth approach as a more efficient and sustained proxy in HIV and TB risk reduction strategies for early diagnosis and prompt quality clinical outcomes. It can significantly contribute to decreasing health systems/patients cost, long waiting time in clinics, hospital visits, travels and time off/on from work. Improved integrated HIV and TB telemonitoring systems sustainability hold great promise in health systems strengthening including patient centered early diagnosis and care delivery systems, uptake and retention to medications/services and improving patients’ survival and quality of life. Conclusion: Telemonitoring/mhealth (electronic phone text/video/materials messaging)acceptability, access and uptake are crucial in monitoring and improving uptake, retention,adherence and coverage in both local and national integrated HIV and TB programs and interventions. Moreover, telemonitoring is crucial in patient-providers-health professional partnership, real-time quality care and service delivery, antiretroviral and anti-tuberculous drugs improvement, susceptibility monitoring and prescription choice, reinforcing cost effective HIV and TB integrated therapy model and survival rate.

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“… 14 Implementing PCE can promote ethical and legal conduct on how interventions can be implemented successfully in local context including retention and adherence. 18 …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Impact of telemonitoring approaches on integrated HIV and TB diagnosis and treatment interventions in sub-Saharan Africa: a scoping review

Yah

Tambo²,

Khayeka–Wandabwa³

et al. 2017

Health Promot Perspect

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“…A growing body of evidence examines use of ToCs for health interventions, international development and research uptake 13 , 14 , 17 , 18 . However, there is little documented experience of using ToC for evaluating community engagement in research (we found only one detailed report 20 ). Given the attention to evaluating community engagement and the potential advantages of a ToC approach, examples of using ToCs have value for informing their future use.…”

Section: Introductionmentioning

confidence: 99%

Using theories of change to design monitoring and evaluation of community engagement in research: experiences from a research institute in Malawi

et al. 2018

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Background: Evaluation of community and public engagement in research is important to deepen understanding of how engagement works and to enhance its effectiveness. Theories of change have been recommended for evaluating community engagement, for their ability to make explicit intended outcomes and understandings of how engagement activities contribute to these outcomes. However, there are few documented examples of using theories of change for evaluation of engagement. This article reports experience of using theories of change to develop a framework for evaluating community engagement in research at a clinical research organisation in Malawi. We describe the steps used to develop theories of change, and the way theories of change were used to design data collection plans. Based on our experience, we reflect on the advantages and challenges of the theory of change approach. Methods: The theories of change and evaluation framework were developed through a series of workshops and meetings between engagement practitioners, monitoring and evaluation staff, and researchers. We first identified goals for engagement, then used ‘so that’ chains to clarify pathways and intermediate outcomes between engagement activities and goals. Further meetings were held to refine initial theories of change, identify priority information needs, and define feasible evaluation methods. Results: The theory of change approach had several benefits. In particular, it helped to construct an evaluation framework focused on relevant outcomes and not just activities. The process of reflecting on intended goals and pathways also helped staff to review the design of engagement activities. Challenges included practical considerations around time to consider evaluation plans among practitioners (a challenge for evaluation more generally regardless of method), and more fundamental difficulties related to identifying feasible and agreed outcomes. Conclusions: These experiences from Malawi provide lessons for other research organisations considering use of theories of change to support evaluation of community engagement.

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“…Following the meeting, the evaluation framework was refined through ongoing discussion with members of the project advisory board. The full model is briefly outlined in Figure ; a comprehensive description of the framework is provided elsewhere .…”

Section: Introductionmentioning

confidence: 99%

“…A set of powerful strategies, each comprised of a range of potential practices, are hypothesized to lead to short‐term, intermediate and long‐term outcomes that cumulatively result in achieving the elements outlined in the Good Participatory Practice‐TB ethical goal. To qualify as powerful, a convincing argument or causal hypothesis had to be made for how a proposed strategy would lead to outcomes that in turn would lead to achieving the ethical goal .…”

Section: Introductionmentioning

confidence: 99%

Using theory of change frameworks to develop evaluation strategies for research engagement: results of a pre‐pilot study

et al. 2018

Self Cite

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IntroductionInadequate community and stakeholder engagement can lead to accusations that research is unethical and can delay or slow research or translation of results to practice. Such experiences have led major funders as well as regulatory and advisory bodies to establish minimal requirements for community and stakeholder engagement in HIV and other clinical research. However, systematic efforts to formally evaluate the contributions and impact of particular practices are lacking.MethodsA theory of change framework aligned with Good Participatory Practice for TB clinical trials was used to develop a set of measures for use in a minimally burdensome survey of trial implementing sites. The survey was pre‐piloted with three TB trial sites in North America, South America and Asia to assess the feasibility of surveying global research sites in a systematic way, and to see if the measures captured informative variation in the use of engagement strategies and desired outcomes. Surveys were conducted at baseline and six months. In‐depth interviews were conducted with site staff prior to the baseline survey to understand how sites conceptualized the concepts underlying the framework and the extent to which they viewed their work as aligned with the framework.ResultsSurvey measures captured considerable variability in the intensity and variety of engagement strategies, both across sites and within sites over time, and moderate variability in outcomes. Interviews indicated that underlying concepts were often unfamiliar to staff at baseline, but the goals of engagement aligned well with existing values.ConclusionsBrief, targeted surveys of trial sites to characterize use of broad strategies, specific practices and some outcomes are a feasible option for evaluating good participatory practice. Additional testing is warranted to assess and enhance validity, reliability and predictive value of indicators. Options for collecting outcome measures through additional objective means should be explored.

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Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials

Cited by 7 publications

References 20 publications

Impact of telemonitoring approaches on integrated HIV and TB diagnosis and treatment interventions in sub-Saharan Africa: a scoping review

Impact of telemonitoring approaches on integrated HIV and TB diagnosis and treatment interventions in sub-Saharan Africa: a scoping review

Using theories of change to design monitoring and evaluation of community engagement in research: experiences from a research institute in Malawi

Using theory of change frameworks to develop evaluation strategies for research engagement: results of a pre‐pilot study

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