Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?

Abstract

Introduction Ensuring quality service provision is fundamental to ZAZIC’s voluntary medical male circumcision (MC) program in Zimbabwe. From October, 2014 to September, 2017, ZAZIC conducted 205,847 MCs. Passive surveillance recorded a combined moderate and severe adverse event (AE) rate of 0.3%; reported adherence to follow-up was 95%, suggesting program safety. Despite encouraging passive surveillance data, verification of data quality and accuracy would increase confidence in AE identification. Methods From May to August, 2017, ZAZIC implemented a focused quality assurance (QA) study on AE ascertainment and documentation at 6 purposively-selected, high-volume MC sites. ZAZIC Gold-Standard (GS) clinicians prospectively observed 100 post-MC follow-ups per site in tandem with facility-based MC providers to confirm and characterize AEs, providing mentoring in AE management when needed. GS clinicians also retrospectively reviewed site-based, routine MC data, comparing recorded to reported AEs, and held brief qualitative interviews with site leadership on AE-related issues. Results Observed AE rates varied from 1–8%, potentially translating to thousands of unidentified AEs if observed AE rates were applied to previous MC performance. Most observed AEs were infections among younger clients. Retrospective review found discrepancies in AE documentation and reporting. Interviews suggest human resource and transport issues challenge MC follow-up visit attendance. Post-operative self-care appears to produce generally good results for adults; however, younger clients and guardians need additional attention to ensure quality care. There was no evidence of missed severe AEs resulting in permanent impairment or morbidity. Conclusions Although results cannot be generalized, active surveillance suggests that AEs may be higher and follow-up lower than reported. In response, ZAZIC’s Quality Assurance Task Force will replicate this QA study in other sites; increase training in AE identification, management, and documentation for clinical and data teams; and improve post-operative counseling for younger clients. Additional nurses and vehicles, especially in rural health clinics, could be beneficial.

Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe

“…MC is safe and major complications are rare; thus, most follow-up visits are unnecessary [26,27]. Adverse events (AEs) from gold-standard active surveillance [25,28,29] report 5-7% AEs [4,[30][31][32] while routine passive surveillance reports below the commonly-accepted 2% AE rate [33][34][35][36][37]. To ensure client safety, current global standards for high quality MC services nevertheless require at least one follow-up within 14 days [38,39].…”

Balancing competing priorities: Quantity versus quality within a routine, voluntary medical male circumcision program operating at scale in Zimbabwe

“…First, despite low AE rates in the ZAZIC program that suggest overall patient safety [ 27 – 29 ], our results indicate that the drive for target achievement leaves quality gaps throughout the cascade of VMMC service delivery. Most KIs noted weaknesses in counseling sessions: both pre-and post-operative counseling may be shortened or group and individual sessions may be combined.…”

“…Reported adherence to follow-up visits, another indicator of program quality [21], was good with routine data indicating 90% of men attending at least one review visit within 14 days of procedure. However, ZAZIC investigation focused on active surveillance of AEs and found higher AE rates (~4%; range 1-8%) and, as part of the study, observed lower follow-up than reported [22]. As ZAZIC strives to achieve high VMMC productivity targets, early signs of weakness in quality service delivery require immediate action to maintain its dedication to both patient safety and program performance.…”

“…To fill the gap left from decreased attention to in-person follow-up, a recent mobile health (mHealth) study in Zimbabwe found that men were capable of healing safely at home when accompanied by daily, twoway texting with providers to ensure swift identification of, and review for, potential AEs [39]. Additional study of alternative follow-up methods (texting or incentives for attendance) and expansion of follow-up review capacity at rural health centers is warranted to safeguard Lastly, pervasive AE underreporting distorts perception of the simplicity and speed of the VMMC procedure and curtails resources needed to provide quality care [29]. This study illuminated additional reasons for AE underreporting: providers feared shouldering blame for AEs, perceived the AE paperwork and reporting burden as formidable, and were confronted by negative responses from supervisors when AEs were reported.…”

“…Third, VMMC teams enhanced client safety by prioritizing follow up of adolescent boys and providing postoperative care in the presence of parents or guardians. This effort was in direct response to ZAZIC [ 27 – 29 ] and previous research [ 34 – 36 ] indicating that adolescent boys are at higher risk for infections due to poor post-operative care. However, added attention on younger clients may diminish focus on adult men.…”