Dataset Information

Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour.

ABSTRACT:

Background

The success of any randomized clinical trial relies on the willingness of people to be recruited in the trial. However, 90% of all clinical trials worldwide have been reported to have failed to recruit the required number of trial participants within the scheduled time. This study aimed to qualitatively explore the motivations and barriers for healthy participants to participate in herbal remedy clinical trials in Tanzania.

Materials and methods

This study used a qualitative descriptive research design based on the theory of planned behaviour. A total of five Focus Group Discussions (FGD) were conducted at Bagamoyo Clinical Trial Facility from 29 to 30 May 2021. Each group consisted of 5 to 10 participants. The participants of the study were 30 healthy males aged 18 to 45 male who participated in the clinical trial that evaluated the safety, tolerability, and efficacy of Maytenus Senegalensis. The focus group discussions were recorded audio-recorded. Verbatim transcription and thematic analysis were performed on the data.

Results

The prominent motivations mentioned were the opportunity for self-development, altruism, flexible study visit schedule, and financial compensation. Furthermore, the Participants' mothers and friends were reported as those most likely to approve of participation in an herbal remedy. The most mentioned barriers were inconvenience related to time commitment requirements, possible side effects, inflexible study visit schedule, and having other commitments. Moreover, the participants' father was reported to be more likely to disapprove of participation in a clinical trial of herbal remedy clinical trial.

Conclusions

The results of this study showed that the motivations and barriers of healthy participants to participate in clinical trials of herbal remedies are varied and that participants are motivated by more than financial gains. The identified motivations and barriers can be used as a guideline to improve the design of recruitment and retention strategies for herbal remedy clinical trials.

SUBMITTER: Kassimu KR

PROVIDER: S-EPMC9302811 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour.

Kassimu Kamaka R KR Milando Florence A FA Omolo Justin J JJ Nyaulingo Gloria G Mbarak Hussein H Mohamed Latipha L Rashid Ramla R Ahmed Saumu S Rashid Mohammed M Abdallah Gumi G Mbaga Thabit T Issa Fatuma F Lweno Omar O Balige Neema N Mwalimu Bakari B Hamad Ali A Olotu Ally A Jongo Said S Ngasala Billy B Abdulla Salim S

PloS one 20220721 7

<h4>Background</h4>The success of any randomized clinical trial relies on the willingness of people to be recruited in the trial. However, 90% of all clinical trials worldwide have been reported to have failed to recruit the required number of trial participants within the scheduled time. This study aimed to qualitatively explore the motivations and barriers for healthy participants to participate in herbal remedy clinical trials in Tanzania.<h4>Materials and methods</h4>This study used a qualit ...[more]

PMID: 35862395

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Project description:BACKGROUND:Clinical treatment trials are increasingly being designed in primary mitochondrial disease (PMD), a phenotypically and genetically heterogeneous collection of inherited multi- system energy deficiency disorders that lack effective therapy. We sought to identify motivating factors and barriers to clinical trial participation in PMD. METHODS:A survey study was conducted in two independent mitochondrial disease subject cohorts. A discovery cohort invited subjects with well-defined biochemical or molecularly- confirmed PMD followed at a single medical center (CHOP, n = 30/67 (45%) respondents). A replication cohort included self-identified PMD subjects in the Rare Disease Clinical Research Network (RDCRN) national contact registry (n = 290/1119 (26%) respondents). Five-point Likert scale responses were analyzed using descriptive and quantitative statistics. Experienced and prioritized symptoms for trial participation, and patient attitudes toward detailed aspects of clinical trial drug features and study design. RESULTS:PMD subjects experienced an average of 16 symptoms. Muscle weakness, chronic fatigue, and exercise intolerance were the lead symptoms encouraging trial participation. Motivating trial design factors included a self-administered study drug; vitamin, antioxidant, natural or plant-derivative; pills; daily treatment; guaranteed treatment access during and after study; short travel distances; and late-stage (phase 3) participation. Relative trial participation barriers included a new study drug; discontinuation of current medications; disease progression; daily phlebotomy; and requiring participant payment. Treatment trial type or design preferences were not influenced by population age (pediatric versus adult), prior research trial experience, or disease severity. CONCLUSIONS:These data are the first to convey clear PMD subject preferences and priorities to enable improved clinical treatment trial design that cuts across the complex diversity of disease. Partnering with rare disease patient communities is essential to effectively design robust clinical trials that engage patients and enable meaningful evaluation of emerging treatment interventions.

Project description:BackgroundMedical regulators worldwide have implemented programmes of maintenance of professional competence (MPC) to ensure that doctors, throughout their careers, are up to date and fit to practice. The introduction of MPC required doctors to adopt a range of new behaviours. Despite high enrolment rates on these programmes, it remains uncertain whether doctors engage in the process because they perceive benefits like improvements in their practice and professional development or if they solely meet the requirements to retain medical registration. In this study, we aimed to explore the relationship between doctors' beliefs, intention and behaviour regarding MPC through the lens of the Theory of Planned Behaviour (TPB) to make explicit the factors that drive meaningful engagement with the process.MethodsWe conducted a qualitative study using semi-structured interviews. From a pool of 1258 potential participants, we purposively selected doctors from multiple specialities, age groups, and locations across Ireland. We used thematic analysis, and the TPB informed the analytic coding process.ResultsForty-one doctors participated in the study. The data analysis revealed doctors' intention and behaviour and the factors that shape their engagement with MPC. We found that attitudes and beliefs about the benefits and impact of MPC mediated the nature of doctors' engagement with the process. Some participants perceived positive changes in practice and other gains from participating in MPC, which facilitated committed engagement with the process. Others believed MPC was unfair, unnecessary, and lacking any benefit, which negatively influenced their intention and behaviour, and that was demonstrated by formalistic engagement with the process. Although participants with positive and negative attitudes shared perceptions about barriers to participation, such perceptions did not over-ride strongly positive beliefs about the benefits of MPC. While the requirements of the regulator strongly motivated doctors to participate in MPC, beliefs about patient expectations appear to have had less impact on intention and behaviour.ConclusionsThe findings of this study broaden our understanding of the determinants of doctors' intention and behaviour regarding MPC, which offers a basis for designing targeted interventions. While the barriers to engagement with MPC resonate with previous research findings, our findings challenge critical assumptions about enhancing doctors' engagement with the process. Overall, our results suggest that focused policy initiatives aimed at strengthening the factors that underpin the intention and behaviour related to committed engagement with MPC are warranted.

Project description:BackgroundFinnish clinical guidelines are evolving toward integration of knowledge modules into the electronic health record in the Evidence-Based Medicine electronic Decision Support project. It therefore became important to study which factors affect professionals' intention to use clinical guidelines generally in their decision-making on patient care. A theory-based approach is a possible solution to explore determinants of professionals' behaviour. The study's aim was to produce baseline information for developers and implementers by using the theory of planned behaviour.MethodsA cross-sectional internet-based survey was carried out in Finnish healthcare organisations within three hospital districts. The target population (n = 2,252) included physicians, nurses, and other professionals, of whom 806 participated. Indicators of the intention to use clinical guidelines were observed by using a theory-based questionnaire. The main data analysis was done by means of multiple linear regressions.ResultsThe results indicated that all theory-based variables--the attitude toward the behaviour, the subjective norm, and the perceived behaviour control--were important factors associated with the professionals' intention to use clinical practice guidelines for their area of specialisation in the decisions they would make on the care of patients in the next three months. In addition, both the nurse and the physician factors had positive (p < 0.01) effects on this intention in comparison to other professionals. In the similar models for all professions, the strongest factor for the physicians was the perceived behaviour control, while the key factor for the nurses and the other professionals was the subjective norm. This means that context- and guideline-based factors either facilitate or hinder the intention to use clinical guidelines among physicians and, correspondingly, normative beliefs related to social pressures do so for nurses and other healthcare professionals.ConclusionsThe results confirm suggestions that the theory of planned behaviour is a suitable theoretical basis for implementing clinical guidelines in healthcare practices. Our new finding was that, in general, profession had an effect on intention to use clinical guidelines in patient care. Therefore, the study reaffirms the general contention that different strategies need to be in place when clinical guidelines are targeted at different professional groups.

Dataset Information

Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour.

Background

Materials and methods

Results

Conclusions

Publications

Motivations and barriers for healthy participants to participate in herbal remedy clinical trial in Tanzania: A qualitative study based on the theory of planned behaviour.

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