Cargando…

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

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%; r...

Descripción completa

Detalles Bibliográficos
Autores principales: Marongwe, Phiona, Gonouya, Paidamoyo, Madoda, Thoko, Murenje, Vernon, Tshimanga, Mufuta, Balachandra, Shirish, Mandisarisa, John, Sidile-Chitimbire, Vuyelwa, Xaba, Sinokuthemba, Makunike-Chikwinya, Batsirai, Holec, Marrianne, Barnhart, Scott, Feldacker, Caryl
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557516/
https://www.ncbi.nlm.nih.gov/pubmed/31181096
http://dx.doi.org/10.1371/journal.pone.0218137
_version_ 1783425463546281984
author Marongwe, Phiona
Gonouya, Paidamoyo
Madoda, Thoko
Murenje, Vernon
Tshimanga, Mufuta
Balachandra, Shirish
Mandisarisa, John
Sidile-Chitimbire, Vuyelwa
Xaba, Sinokuthemba
Makunike-Chikwinya, Batsirai
Holec, Marrianne
Barnhart, Scott
Feldacker, Caryl
author_facet Marongwe, Phiona
Gonouya, Paidamoyo
Madoda, Thoko
Murenje, Vernon
Tshimanga, Mufuta
Balachandra, Shirish
Mandisarisa, John
Sidile-Chitimbire, Vuyelwa
Xaba, Sinokuthemba
Makunike-Chikwinya, Batsirai
Holec, Marrianne
Barnhart, Scott
Feldacker, Caryl
author_sort Marongwe, Phiona
collection PubMed
description 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.
format Online
Article
Text
id pubmed-6557516
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher Public Library of Science
record_format MEDLINE/PubMed
spelling pubmed-65575162019-06-17 Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program? Marongwe, Phiona Gonouya, Paidamoyo Madoda, Thoko Murenje, Vernon Tshimanga, Mufuta Balachandra, Shirish Mandisarisa, John Sidile-Chitimbire, Vuyelwa Xaba, Sinokuthemba Makunike-Chikwinya, Batsirai Holec, Marrianne Barnhart, Scott Feldacker, Caryl PLoS One Research Article 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. Public Library of Science 2019-06-10 /pmc/articles/PMC6557516/ /pubmed/31181096 http://dx.doi.org/10.1371/journal.pone.0218137 Text en https://creativecommons.org/publicdomain/zero/1.0/ This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication.
spellingShingle Research Article
Marongwe, Phiona
Gonouya, Paidamoyo
Madoda, Thoko
Murenje, Vernon
Tshimanga, Mufuta
Balachandra, Shirish
Mandisarisa, John
Sidile-Chitimbire, Vuyelwa
Xaba, Sinokuthemba
Makunike-Chikwinya, Batsirai
Holec, Marrianne
Barnhart, Scott
Feldacker, Caryl
Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?
title Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?
title_full Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?
title_fullStr Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?
title_full_unstemmed Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?
title_short Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?
title_sort trust but verify: is there a role for active surveillance in monitoring adverse events in zimbabwe’s large-scale male circumcision program?
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557516/
https://www.ncbi.nlm.nih.gov/pubmed/31181096
http://dx.doi.org/10.1371/journal.pone.0218137
work_keys_str_mv AT marongwephiona trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT gonouyapaidamoyo trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT madodathoko trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT murenjevernon trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT tshimangamufuta trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT balachandrashirish trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT mandisarisajohn trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT sidilechitimbirevuyelwa trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT xabasinokuthemba trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT makunikechikwinyabatsirai trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT holecmarrianne trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT barnhartscott trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram
AT feldackercaryl trustbutverifyistherearoleforactivesurveillanceinmonitoringadverseeventsinzimbabweslargescalemalecircumcisionprogram