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      Health Providers’ Perceptions of Clinical Trials: Lessons from Ghana, Kenya and Burkina Faso

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          Abstract

          Background

          Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso.

          Methods

          We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99) and health managers (n=14); and group discussions with fieldworkers (n=9 discussions). Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach.

          Results

          Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed.

          Conclusion

          Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising benefits requires careful planning and engagement of key actors at the outset of trials, throughout the trial and on its’ completion.

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          Most cited references43

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          Health worker motivation in Africa: the role of non-financial incentives and human resource management tools

          Background There is a serious human resource crisis in the health sector in developing countries, particularly in Africa. One of the challenges is the low motivation of health workers. Experience and the evidence suggest that any comprehensive strategy to maximize health worker motivation in a developing country context has to involve a mix of financial and non-financial incentives. This study assesses the role of non-financial incentives for motivation in two cases, in Benin and Kenya. Methods The study design entailed semi-structured qualitative interviews with doctors and nurses from public, private and NGO facilities in rural areas. The selection of health professionals was the result of a layered sampling process. In Benin 62 interviews with health professionals were carried out; in Kenya 37 were obtained. Results from individual interviews were backed up with information from focus group discussions. For further contextual information, interviews with civil servants in the Ministry of Health and at the district level were carried out. The interview material was coded and quantitative data was analysed with SPSS software. Results and discussion The study shows that health workers overall are strongly guided by their professional conscience and similar aspects related to professional ethos. In fact, many health workers are demotivated and frustrated precisely because they are unable to satisfy their professional conscience and impeded in pursuing their vocation due to lack of means and supplies and due to inadequate or inappropriately applied human resources management (HRM) tools. The paper also indicates that even some HRM tools that are applied may adversely affect the motivation of health workers. Conclusion The findings confirm the starting hypothesis that non-financial incentives and HRM tools play an important role with respect to increasing motivation of health professionals. Adequate HRM tools can uphold and strengthen the professional ethos of doctors and nurses. This entails acknowledging their professionalism and addressing professional goals such as recognition, career development and further qualification. It must be the aim of human resources management/quality management (HRM/QM) to develop the work environment so that health workers are enabled to meet their personal and the organizational goals.
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            Guidelines and mindlines: why do clinical staff over-diagnose malaria in Tanzania? A qualitative study

            Background Malaria over-diagnosis in Africa is widespread and costly both financially and in terms of morbidity and mortality from missed diagnoses. An understanding of the reasons behind malaria over-diagnosis is urgently needed to inform strategies for better targeting of antimalarials. Methods In an ethnographic study of clinical practice in two hospitals in Tanzania, 2,082 patient consultations with 34 clinicians were observed over a period of three months at each hospital. All clinicians were also interviewed individually as well as being observed during routine working activities with colleagues. Interviews with five tutors and 10 clinical officer students at a nearby clinical officer training college were subsequently conducted. Results Four, primarily social, spheres of influence on malaria over-diagnosis were identified. Firstly, the influence of initial training within a context where the importance of malaria is strongly promoted. Secondly, the influence of peers, conforming to perceived expectations from colleagues. Thirdly, pressure to conform with perceived patient preferences. Lastly, quality of diagnostic support, involving resource management, motivation and supervision. Rather than following national guidelines for the diagnosis of febrile illness, clinician behaviour appeared to follow 'mindlines': shared rationales constructed from these different spheres of influence. Three mindlines were identified in this setting: malaria is easier to diagnose than alternative diseases; malaria is a more acceptable diagnosis; and missing malaria is indefensible. These mindlines were apparent during the training stages as well as throughout clinical careers. Conclusion Clinicians were found to follow mindlines as well as or rather than guidelines, which incorporated multiple social influences operating in the immediate and the wider context of decision making. Interventions to move mindlines closer to guidelines need to take the variety of social influences into account.
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              Treatment-seeking behaviour, cost burdens and coping strategies among rural and urban households in Coastal Kenya: an equity analysis.

              Ill-health can inflict costs on households directly through spending on treatment and indirectly through impacting on labour productivity. The financial burden can be high and, for poor households, contributes significantly to declining welfare. We investigated socio-economic inequities in self-reported illnesses, treatment-seeking behaviour, cost burdens and coping strategies in a rural and urban setting along the Kenyan coast. We conducted a survey of 294 rural and 576 urban households, 9 FGDs and 9 in-depth interviews in each setting. Key findings were significantly higher levels of reported chronic and acute conditions in the rural setting, differences in treatment-seeking patterns by socio-economic status (SES) and by setting, and regressive cost burdens in both areas. These data suggest the need for greater governmental and non-governmental efforts towards protecting the poor from catastrophic illness cost burdens. Promising health sector options are elimination of user fees, at least in targeted hardship areas, developing more flexible charging systems, and improving quality of care in all facilities. The data also strongly support the need for a multi-sectoral approach to protecting households. Potential interventions beyond the health sector include supporting the social networks that are key to household livelihood strategies and promoting micro-finance schemes that enable small amounts of credit to be accessed with minimal interest rates.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                1 May 2015
                2015
                : 10
                : 5
                : e0124554
                Affiliations
                [1 ]Department of Public Health Research, KEMRI/Wellcome Trust Research Programme (KWTRP), P.O. Box, 230–80108, Kilifi, Kenya
                [2 ]Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana
                [3 ]Centre National de Recherche et de Formation sur le Paludisme (CNRFP), 01 BP 2208, Ouagadougou 01, Burkina Faso
                [4 ]European Vaccine Initiative (EVI),Universitäts Klinikum Heidelberg, Im Neuenheimer Feld 326, 69120, Heidelberg, Germany
                [5 ]Disease Control Department, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, WC1E 7HT, London, United Kingdom
                [6 ]The Ethox Centre, Department of Public Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom
                [7 ]The Centre for Clinical Vaccinology and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom
                Pennsylvania State University College of Medicine, UNITED STATES
                Author notes

                Competing Interests: All authors have declared no competing interests exist. Sassy Molyneux (SM) is a PLOS ONE Editorial Board member, and SM confirms that this does not alter the authors' adherence to PLOS ONE editorial policies and criteria.

                Conceived and designed the experiments: CJ SM KPA SOA AT SBS EBI DC JW VA. Performed the experiments: VA KPA AT LGF CT AK AO SM CJ. Analyzed the data: VA KPA AT LGF CT AK AO SM CJ. Contributed reagents/materials/analysis tools: VA KPA AT LGF CT AK AO SBS SOA EBI JW DC SM CJ. Wrote the paper: VA KPA AT LGF CT AK AO SBS SOA EBI JW DC SM CJ. Overall project coordinator: KPA.

                Article
                PONE-D-14-46746
                10.1371/journal.pone.0124554
                4416706
                25933429
                18b6bc39-08b5-4c35-aa66-d881e7e19b56
                Copyright @ 2015

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                History
                : 21 October 2014
                : 15 March 2015
                Page count
                Figures: 0, Tables: 6, Pages: 21
                Funding
                European and Developing Countries Clinical Trials Partnership (grant number JC.2010.10300.009) supported our networking activities that has resulted in this manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Custom metadata
                Some access restrictions apply to the data underlying the findings. The authors are unable to make the data more freely available because of terms for data sharing included in the consent forms for this study. Additional approvals will be required from the national/local ethical review committees and data governance committees to re-use the data: Ghana Health Service and Kintampo Health Research Center Ethics Committees in Ghana; KEMRI National Ethical Review Committee and Data Governance Committee of the KEMRI/Wellcome Trust Research Programme in Kenya; Comité de Bioéthique Institutionnel du CNRFP in Burkina Faso.

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