Hietink, R. (Rebecca) (2021) Differences in monitoring and auditing between RCTs into Neglected Tropical Diseases and the Big Three in low/middle-income countries. thesis, Medicine.
Full text available on request.Abstract
Introduction The Neglected Tropical Diseases (NTDs) are poverty related diseases neglected in the field of research and can be distinguished from the Big Three diseases (HIV/AIDS, malaria, TB) that significantly receive more resources. Because of this, the quality of the research, and thus also the monitoring and auditing, can be different between the two groups of Randomised Controlled Trials (RCT). Therefore, this study investigates the monitoring and auditing process in the two groups of RCTs and the potential differences between them. Methods This research is a cohort study with published RCTs targeting NTDs and the Big Three as study objects. The information on the monitoring and auditing process that was included in the articles or study protocols of the RCTs was evaluated and statistically analysed. Questionnaires were sent out to the corresponding authors of the RCTs to determine the challenges they encountered regarding monitoring and auditing. Results In total, 215 RCTs were included. Monitoring was mentioned in 32.5% of the articles and/or protocols on NTDs and in 50.5% on the Big Three (RR 1.56; 95% CI: 1.12-2.16). Pharmaceutical funding proved to be a confounder when analysing this difference. Auditing was mentioned in 7.0% of the articles and/or protocols on NTDs and in 8.9% when focussing on the Big Three. Most corresponding authors replied to have encountered challenges during organizing monitoring and auditing, especially financial and logistical problems. Discussion The monitoring and auditing in the two groups of RCTs could be improved by addressing the described financial and logistical problems. Furthermore, an incentive to organize monitoring and auditing and make it more verifiable could be to implement relevant uniform guidelines in LMICs and to make monitoring and auditing an item on the submission checklist for medical journals.
| Item Type: | Thesis (UNSPECIFIED) |
|---|---|
| Supervisor name: | Stienstra, prof. Y. |
| Faculty: | Medical Sciences |
| Date Deposited: | 04 Jan 2022 10:10 |
| Last Modified: | 04 Jan 2022 10:10 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/2929 |
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