scholarly journals The conundrum of clinical trials and standard of care in sub-Saharan Africa – the research nurse perspective

2019 ◽  
Vol 24 (8) ◽  
pp. 649-660 ◽  
Author(s):  
Jane Frances Ndyetukira ◽  
Richard Kwizera ◽  
Florence Kugonza ◽  
Cynthia Ahimbisibwe ◽  
Carol Namujju ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Research Nurse ◽  
Loss To Follow Up ◽  
Resource Limited ◽  
Research Nurses ◽  
Sub Saharan

Background Nurses form a very important part of the health workforce in sub-Saharan Africa. Research nurses are critical to the implementation of clinical trials. The duties and responsibilities of a research nurse are complex and continue to evolve as new practices and guidelines are formulated. Aims In this paper, we have highlighted the major contributions of research nurses in HIV clinical trials in sub-Saharan Africa from the unique perspective of Ugandan nurses. Methods The requirements and challenges of two multi-site, randomised cryptococcal meningitis clinical trials in Uganda were assessed from the perspective of research nurses conducting complex research in resource-limited settings. Results Over the course of 8 years, approximately 1739 participants were screened and 934 people were enrolled into the two trials. The nurses found that patient education and engagement were among the most important predictors of success in minimising loss to follow-up. Conclusions Research nurses played a key role in communicating clinical research goals to patients, obtaining informed consent, minimising loss to follow-up, and ensuring that research practices are translated and implemented into standard of care. However, there remains a need to integrate the same level of care provided in clinical research studies to non-study patients.

scholarly journals SLE clinical trials: impact of missing data on estimating treatment effects

2019 ◽  
Vol 6 (1) ◽  
pp. e000348 ◽  
Author(s):  
Mimi Kim ◽  
Joan T Merrill ◽  
Cuiling Wang ◽  
Shankar Viswanathan ◽  
Ken Kalunian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Missing Data ◽  
Multiple Imputation ◽  
Treatment Effects ◽  
Standard Of Care ◽  
Response Rates ◽  
Alternative Methods ◽  
Loss To Follow Up ◽  
Collective Data

ObjectiveA common problem in clinical trials is missing data due to participant dropout and loss to follow-up, an issue which continues to receive considerable attention in the clinical research community. Our objective was to examine and compare current and alternative methods for handling missing data in SLE trials with a particular focus on multiple imputation, a flexible technique that has been applied in different disease settings but not to address missing data in the primary outcome of an SLE trial.MethodsData on 279 patients with SLE randomised to standard of care (SoC) and also receiving mycophenolate mofetil (MMF), azathioprine or methotrexate were obtained from the Lupus Foundation of America-Collective Data Analysis Initiative Database. Complete case analysis (CC), last observation carried forward (LOCF), non-responder imputation (NRI) and multiple imputation (MI) were applied to handle missing data in an analysis to assess differences in SLE Responder Index-5 (SRI-5) response rates at 52 weeks between patients on SoC treated with MMF versus other immunosuppressants (non-MMF).ResultsThe rates of missing data were 32% in the MMF and 23% in the non-MMF groups. As expected, the NRI missing data approach yielded the lowest estimated response rates. The smallest and least significant estimates of differences between groups were observed with LOCF, and precision was lowest with the CC method. Estimated between-group differences were magnified with the MI approach, and imputing SRI-5 directly versus deriving SRI-5 after separately imputing its individual components yielded similar results.ConclusionThe potential advantages of applying MI to address missing data in an SLE trial include reduced bias when estimating treatment effects, and measures of precision that properly reflect uncertainty in the imputations. However, results can vary depending on the imputation model used, and the underlying assumptions should be plausible. Sensitivity analysis should be conducted to demonstrate robustness of results, especially when missing data proportions are high.

scholarly journals International epidemiology databases to evaluate AIDS (IeDEA) in sub-Saharan Africa, 2012–2019

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035246 ◽  
Author(s):  
Frédérique Chammartin ◽  
Cam Ha Dao Ostinelli ◽  
Kathryn Anastos ◽  
Antoine Jaquet ◽  
Ellen Brazier ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Clinical Stage ◽  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Loss To Follow Up ◽  
Sub Saharan ◽  
Treat All ◽  
The Impact ◽  
International Epidemiology

PurposeThe objectives of the International epidemiology databases to evaluate AIDS (IeDEA) are to (i) evaluate the delivery of combination antiretroviral therapy (ART) in children, adolescents and adults in sub-Saharan Africa, (ii) to describe ART regimen effectiveness, durability and tolerability, (iii) to examine HIV-related comorbidities and coinfections and (iv) to examine the pregnancy-related and HIV-related outcomes of women on ART and their infants exposed to HIV or ART in utero or via breast milk.ParticipantsIeDEA is organised in four regions (Central, East, Southern and West Africa), with 240 treatment and care sites, six data centres at African, European and US universities, and almost 1.4 million children, adolescents and adult people living with HIV (PLWHIV) enrolled.Findings to dateThe data include socio-demographic characteristics, clinical outcomes, opportunistic events, treatment regimens, clinic visits and laboratory measurements. They have been used to analyse outcomes in PLWHIV-1 or PLWHIV-2 who initiate ART, including determinants of mortality, of switching to second-line and third-line ART, drug resistance, loss to follow-up and the immunological and virological response to different ART regimens. Programme-level estimates of mortality have been corrected for loss to follow-up. We examined the impact of coinfection with hepatitis B and C, and the epidemiology of different cancers and of (multidrug resistant) tuberculosis, renal disease and of mental illness. The adoption of ‘Treat All’, making ART available to all PLWHIV regardless of CD4+ cell count or clinical stage was another important research topic.Future plansIeDEA has formulated several research priorities for the ‘Treat All’ era in sub-Saharan Africa. It recently obtained funding to set up sentinel sites where additional data are prospectively collected on cardiometabolic risks factors as well as mental health and liver diseases, and is planning to create a drug resistance database.

scholarly journals PO 8564 WHAT IS CLINICAL TRIAL QUALITY? A QUALITATIVE STUDY BASED ON INTERVIEWS WITH DIFFERENT STAKEHOLDERS CONDUCTING CLINICAL TRIALS IN SUB-SAHARAN AFRICA

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A54.1-A54
Author(s):  
Angela Lazarova ◽  
Claudia Fuchs ◽  
Christian Burri
Keyword(s):  
Clinical Trials ◽  
Qualitative Study ◽  
Web Search ◽  
Sub Saharan Africa ◽  
Quality Factors ◽  
Structured Interviews ◽  
Trial Quality ◽  
Resource Limited ◽  
Quality Aspects ◽  
Sub Saharan

BackgroundThere is no unified, broad definition for quality in clinical trials (CTs). Besides the explicit quality requirements in international guidelines and national legislation, however, there are broader factors to consider, including specific setting-related aspects influencing quality needs, quality perception and local implementation of guidelines. Our objective was to identify these factors from a resource-limited settings perspective (in this case, sub-Saharan Africa).MethodsIn March-April 2018, we conducted a qualitative study based on semi-structured interviews with participants from three stakeholder groups (monitors, sponsors, and investigators) conducting CTs in sub-Saharan Africa. We identified the interviewees either through CT registry platforms, a web search or by reference. We aimed to include 10–20 participants per stakeholder group. After consent, the interviews were held in person (via Skype or telephone), recorded, and transcribed verbatim. The interview questionnaire addressed a CT quality definition and quality factors during the CT process. We performed the analysis using the framework method.ResultsSo far, we included 21 participants (17 investigators, two sponsors, two monitors). Eight (8) (from sub-Saharan Africa) and 13 (not from sub-Saharan Africa) who contributed to CTs in 19 different countries in sub-Saharan Africa. Quality definitions mentioned so far were variable. A repeated statement was that the quality definition should be broad and include a system of multiple aspects and layers. We will interview more experts with sponsor and monitor experience in May 2018 and elaborate these quality aspects and layers. We will discuss these results with regards to a comprehensive quality framework for CTs currently under development for Northern countries by another Swiss research team.ConclusionCT quality was perceived in variable ways, as was the relevance of the aspects across different CT steps. Structuring the multifaceted layers of CT quality will facilitate appropriate and efficient CT quality management in sub-Saharan Africa.

scholarly journals Correcting Mortality for Loss to Follow-Up: A Nomogram Applied to Antiretroviral Treatment Programmes in Sub-Saharan Africa

PLoS Medicine ◽  
2011 ◽  
Vol 8 (1) ◽  
pp. e1000390 ◽  
Author(s):  
Matthias Egger ◽  
Ben D. Spycher ◽  
John Sidle ◽  
Ralf Weigel ◽  
Elvin H. Geng ◽  
...  
Keyword(s):  
Antiretroviral Treatment ◽  
Sub Saharan Africa ◽  
Loss To Follow Up ◽  
Sub Saharan

scholarly journals PO 8538 STRENGTHENING SOCIAL STRATEGIES TO ENGAGE SUB-SAHARAN AFRICAN SOCIETIES TO VALUE CLINICAL RESEARCH: THE EXPERIENCE IN CONDUCTING CLINICAL TRIALS IN LAMBARéNé

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A51.1-A51
Author(s):  
Pamela C Angoissa Minsoko ◽  
Selidji T Agnandji
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Community Engagement ◽  
Sub Saharan Africa ◽  
Social Meaning ◽  
Willingness To Participate ◽  
The Social ◽  
Social Meanings ◽  
Sub Saharan ◽  
Social Components

BackgroundOver the last two decades, clinical research activities have increased significantly in sub-Saharan Africa but societal engagement to make research socially and economically valuable is limited. Thus, engaging communities when designing clinical research and promoting social impacts of research are becoming key objectives among stakeholders involved in clinical research in sub-Saharan Africa. However, there is a need to define concepts and indicators to assess the strength of community engagement as well as the social impacts of clinical research.Here, we hypothesised that the social meanings of willingness to participate and compliance to clinical trial procedures are relevant indicators to assess community engagement.MethodsWe conducted a retrospective, prospective case study of clinical trials conducted in CERMEL between 1995 and 2017. We performed a social meaning framework analysis of the following processes: protocol design, ethical and regulatory clearance, informed consent and medical study procedures. We identified the social meanings of each procedure according to the involvement of social components (actors, ideas, communication strategies).ResultsA total of 42 clinical trials were identified in the ClinicalTrials.gov and Pan-African Clinical Trials Registry databases and confirmed by the top management of CERMEL. Between 1995 and 2004, there was little social meaning connected to trial procedures. This period was associated with poor compliance to study procedures. Between 2005 and 2017, compliance to study procedures improved. Detailed results will be presented during the meeting.ConclusionThe rise in willingness to participate in clinical research and improved compliance with study procedures were associated with the introduction of social components to medical procedures. Both indicators may be relevant to assess the strength of community engagement.

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