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Continuous research monitoring improves the quality of research conduct and compliance among research trainees: internal evaluation of a monitoring programme.

ABSTRACT: Background: Research site monitoring (RSM) is an effective way to ensure compliance with Good Clinical Practice (GCP). However, RSM is not offered to trainees (investigators) at African Institutions routinely. The Makerere University/Uganda Virus Research Institute Centre of Excellence in Infection and Immunity Research and Training (MUII-Plus) introduced internal monitoring to promote the quality of trainees' research projects. Here, we share our monitoring model, experiences and achievements, and challenges encountered. Methods: We analysed investigators' project reports from monitoring visits undertaken from April 2017 to December 2019. Monitors followed a standard checklist to review investigator site files and record forms, and toured site facilities. We planned four monitoring visits for each trainee: one at site initiation, two interim, and a closeout monitoring visit. A team of two monitors conducted the visits. Results: We monitored 25 out of the 26 research projects in progress between April 2017 and December 2019. Compliance with protocols, standard operating procedures, GCP, and GCLP improved with each monitoring visit. Median (IQR) compliance rate was 43% (31%, 44%) at site initiation visit for different monitoring items, 70% (54%, 90%) at the 1st interim monitoring visit, 100% (92%, 100%) at 2nd interim monitoring visit and all projects achieved 100% compliance at site closeout. All investigators had good work ethics and practice, and appropriate facilities. Initially, some investigators' files lacked essential documents, and informed consent processes needed to be improved. We realized that non-compliant investigators had not received prior training in GCP/GCLP, so we offered them this training. Conclusions: Routine monitoring helps identify non-compliance early and improves the quality of research. We recommend continuous internal monitoring for all research studies. Investigators conducting research involving human subjects should receive GCP/GCLP training before commencing their projects. Institutional higher degrees and research ethics committees should enforce this as a requirement for project approvals.

SUBMITTER: Akello M

PROVIDER: S-EPMC8170533 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRecent studies in the Sub-Saharan countries in Africa have indicated gaps and challenges for voluntary medical male circumcision (VMMC) quality of service. Less has focused on the changes in quality of service after implementation of continuous quality improvement (CQI) action plans. This study aimed to evaluate the impact of coaching, provision of standard operating procedures (SOPS) and guidelines, mentoring and on-site in-service training in improving quality of VMMC services across four Right to Care (RTC) supported provinces in South Africa.MethodThis was a pre- and post-interventional study on RTC supported VMMC sites from July 2018 to October 2019. All RTC-supported sites that were assessed at baseline and post-intervention were included in the study. Data for baseline CQI assessment and re-assessments was collected using a standardized National Department of Health (NDoH) CQI assessment tool for VMMC services from routine RTC facility level VMMC programme data. Quality improvement support was provided through a combination of coaching, provision of standard operating procedures and guidelines, mentoring and on-site in-service training on quality improvement planning and implementation. The main outcome measure was quality of service. A paired sample t-test was used to compare the difference in mean quality of service scores before and after CQI implementation by quality standard.ResultsA total of 40 health facilities were assessed at both baseline and after CQI support visits. Results showed significant increases for the overall changes in quality of service after CQI support intervention of 12% for infection prevention (95%CI: 7-17; p<0.001) and 8% for male circumcision surgical procedure, (95%CI: 3-13; p<0.01). Similarly, individual counselling, and HIV testing increased by 14%, (95%CI: 7-20; p<0.001), group counselling, registration and communication by 8%, (95%CI: 3-14; p<0.001), and 35% for monitoring and evaluation, (95%CI: 28-42; p<0.001). In addition, there were significant increases for management systems of 29%, (95%CI: 22-35; p<0.001), leadership and planning 23%, (95%CI: 13-34; p<0.001%) and supplies, equipment, environment and emergency 5%, (95%CI: 1-9; p<0.01). The overall quality of service performance across provinces increased by 18% (95%CI: 14-21; p<0.001).ConclusionThe overall quality of service performance across provinces was significantly improved after implementation of CQI support intervention program. Regular visits and intensive CQI support are required for sites that will be performing below quality standards.

Project description:BackgroundLaparoscopic appendectomy is a common procedure and introduced early in general surgical training. How internal (i.e. surgeon's experience) or external (i.e. disease severity) may affect procedure performance is not well-studied. The aim of this study was to evaluate factors that may have an influence on the performance scores for surgical trainees.MethodsA prospective, observational cohort study of laparoscopic appendectomies performed by surgical trainees (experience < 4 years) operating under supervision. Trainers evaluated trainees' overall performance on a 6-point scale for proficiency. Perioperative data were recorded, including appendicitis severity, operating time and the overall difficulty of the procedure as assessed by the trainer. A "Challenging" procedure was defined as a combination of either/or "perforation" and "difficult". Trainees who had performed > 30 appendectomies were defined as "experienced". The trainees were asked if they had used simulation or web-based tools the week prior to surgery.Results142 procedure evaluation forms were included of which 19 (13%) were "perforated", 14 (10%) "difficult" and 24 (17%) "Challenging". Perforated appendicitis was strongly associated with procedure difficulty (OR 21.2, 95% CI 6.0-75.6). Experienced trainees performed "proficient" more often than non-experienced (OR 34.5, 95% CI 6.8-176.5). "Difficult" procedures were inversely associated with proficiency (OR 0.1, 95% CI 0.0-0.9). In "Challenging" procedures, identifying the appendix had lowest proficiency (OR 0.4, 95% CI 0.1-0.9). The procedures assessed as "difficult" had significantly longer operating time with a median (IQR) of 90 (75-100) min compared to 59 (25-120) min for the non-difficult (p < 0.001).ConclusionBoth internal and external factors contribute to the performance score. Perforated appendicitis, technical difficult procedures and trainee experience all play a role, but a "difficult" procedure had most overall impact on proficiency evaluation.

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Continuous research monitoring improves the quality of research conduct and compliance among research trainees: internal evaluation of a monitoring programme.

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