Dataset Information

Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

ABSTRACT: BACKGROUND:Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. METHODS:In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. RESULTS:Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care. CONCLUSION:There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.

SUBMITTER: Das D

PROVIDER: S-EPMC4055798 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

Das Debashish D Cheah Phaik Yeong PY Akter Fateha F Paul Dulal D Islam Akhterul A Sayeed Abdullah A AA Samad Rasheda R Rahman Ridwanur R Hossain Amir A Dondorp Arjen A Day Nicholas P NP White Nicholas J NJ Hasan Mahtabuddin M Ghose Aniruddha A Ashley Elizabeth A EA Faiz Abul A

Malaria journal 20140604

<h4>Background</h4>Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial.<h4>Methods</h4>In this study s ...[more]

PMID: 24893933

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Project description:BackgroundInflammatory bowel disease (IBD), comprising Crohn disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of this study, telemedicine for patients with IBD (TELE-IBD), was to compare disease activity and quality of life (QoL) in a 1-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL, but there were no significant differences between groups. Study adherence to the text-based intervention was less than 80%, the targeted goal.ObjectiveTo understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants' perceptions, including their recommendations for future monitoring.MethodsIn this study, patients attending 3 tertiary referral centers with worsening IBD symptoms in the previous 2 years were eligible for randomization to remote monitoring via SMS text messages (short message service, SMS) every other week, weekly, or standard care. Participants (n=348) were evenly enrolled in the treatment groups, and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and nonadherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% (278/348) or more of the weekly or every other week self-assessments. Semistructured interviews conducted by phone surveyed (1) the strengths and benefits of TELE-IBD, (2) challenges associated with using TELE-IBD, and (3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti, version.7 qualitative data analysis software.ResultsParticipants' discussions centered on 3 elements of the intervention: (1) self-assessment questions, (2) action plans, and (3) educational messages. Participants also commented on text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and nonadherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive the intervention as effective in facilitating IBD self-management.ConclusionsParticipants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD.

Project description:Bats are known reservoirs of Nipah virus (NiV) and some filoviruses and also appear likely to harbor the evolutionary progenitors of severe acute respiratory syndrome coronavirus (SARS-CoV), severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and Middle East respiratory syndrome coronavirus (MERS-CoV). While bats are considered a reservoir of deadly viruses, little is known about people's knowledge, attitudes, and perceptions of bat conservation and ecology. The current study aimed to assess community people's knowledge, attitudes, and perceptions of bat ecology, myths, and the role of bats in transmitting NiV in Bangladesh. Since 2001, NiV has been a continuous threat to public health with a mortality rate of approximately 70% in Bangladesh. Over the years, many public health interventions have been implemented to raise awareness about bats and the spreading of NiV among the community peoples of Nipah outbreak areas (NOAs) and Nipah non-outbreak areas (NNOAs). We hypothesized that people from both areas might have similar knowledge of bat ecology and myths about bats but different knowledge regarding their role in the spreading of NiV. Using a four-point Likert scale-based questionnaire, our analysis showed that most people lack adequate knowledge regarding the role of bats in maintaining the ecological balance and instead trust their beliefs in different myths about bats. Factor score analysis showed that respondents' gender (p = 0.01), the outbreak status of the area (p = 0.03), and their occupation (p = 0.04) were significant factors influencing their knowledge of bat ecology and myths. A regression analysis showed that farmers had 0.34 times the odds of having correct or positive knowledge of bat ecology and myths than businesspersons (odds ratio (OR) = 0.34, 95% confidence interval (95% CI) = 0.15-0.78, p = 0.01). Regarding the spreading of NiV via bats, people had a lower level of knowledge. In NOAs, age (p = 0.00), occupation (p = 0.00), and level of education (p = 0.00) were found to be factors contributing to the amount of knowledge regarding the transmission of NiV, whereas in NNOAs, the contributing factors were occupation (p = 0.00) and level of education (p = 0.01). Regression analysis revealed that respondents who were engaged in services (OR = 3.02, 95% CI = 1.07-8.54, p = 0.04) and who had completed primary education (OR = 3.06, 95% CI = 1.02-9.17, p < 0.05) were likely to have correct knowledge regarding the spreading of NiV. Based on the study results, we recommend educational interventions for targeted groups in the community, highlighting the ecosystem services and conservation of bats so as to improve people's current knowledge and subsequent behavior regarding the role of bats in ecology and the spreading of NiV in Bangladesh.

Project description:Background: The range and amount of volunteer infection studies, known as Controlled Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is increasing with rapid technological advancement, world-class laboratory facilities and increasing capacity development initiatives. However, the ethical issues these studies present in LMICs have not been empirically studied. We present findings of a descriptive social science study nested within a malaria volunteer infection study, on-going at the time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the Kenyan Coast. Methods: The study included non-participant observations, five group discussions with more than half of the CHMI study participants, two in-depth interviews with study team members, and an exit questionnaire administered to the participants. Results: Participants understood the key elements of the study, including that they would be deliberately infected with malaria parasites and may get malaria as a result, there would be regular blood draws, and they would spend up to 24 days in a residence facility away from their homes. The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay. Also appreciated were the health screening tests prior to enrolment and the positive relations with the study team. Concerns raised included the amount and regularity of blood draws experienced, and concerns that this type of research may feed into on-going rumours about research generally. Conclusion: With the increasing range and number of CHMI studies being conducted in LMICs, current ethical guidance are inadequate. This study highlights some of the ethical issues that could emerge in these settings, emphasizing the heavy responsibility placed on research review and regulatory systems, researchers and funders, as well as the importance of carefully tailored community engagement and consent processes.

Dataset Information

Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

Publications

Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

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