Dataset Information

Rates of adverse events associated with male circumcision in U.S. medical settings, 2001 to 2010.

ABSTRACT:

Importance

Approximately 1.4 million male circumcisions (MCs) are performed annually in US medical settings. However, population-based estimates of MC-associated adverse events (AEs) are lacking.

Objectives

To estimate the incidence rate of MC-associated AEs and to assess whether AE rates differed by age at circumcision.

Design

We selected 41 possible MC AEs based on a literature review and on medical billing codes. We estimated a likely risk window for the incidence calculation for each MC AE based on pathogenesis. We used 2001 to 2010 data from SDI Health, a large administrative claims data set, to conduct a retrospective cohort study.

Setting and participants

SDI Health provided administrative claims data from inpatient and outpatient US medical settings.

Main outcomes and measures

For each AE, we calculated the incidence per million MCs. We compared the incidence risk ratio and the incidence rate difference for circumcised vs uncircumcised newborn males and for males circumcised at younger than 1 year, age 1 to 9 years, or 10 years or older. An AE was considered probably related to MC if the incidence risk ratio significantly exceeded 1 at P < .05 or occurred only in circumcised males.

Results

Records were available for 1,400,920 circumcised males, 93.3% as newborns. Of 41 possible MC AEs, 16 (39.0%) were probable. The incidence of total MC AEs was slightly less than 0.5%. Rates of potentially serious MC AEs ranged from 0.76 (95% CI, 0.10-5.43) per million MCs for stricture of male genital organs to 703.23 (95% CI, 659.22-750.18) per million MCs for repair of incomplete circumcision. Compared with boys circumcised at younger than 1 year, the incidences of probable AEs were approximately 20-fold and 10-fold greater for males circumcised at age 1 to 9 years and at 10 years or older, respectively.

Conclusions and relevance

Male circumcision had a low incidence of AEs overall, especially if the procedure was performed during the first year of life, but rose 10-fold to 20-fold when performed after infancy.

SUBMITTER: El Bcheraoui C

PROVIDER: S-EPMC4578797 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Rates of adverse events associated with male circumcision in U.S. medical settings, 2001 to 2010.

El Bcheraoui Charbel C Zhang Xinjian X Cooper Christopher S CS Rose Charles E CE Kilmarx Peter H PH Chen Robert T RT

JAMA pediatrics 20140701 7

<h4>Importance</h4>Approximately 1.4 million male circumcisions (MCs) are performed annually in US medical settings. However, population-based estimates of MC-associated adverse events (AEs) are lacking.<h4>Objectives</h4>To estimate the incidence rate of MC-associated AEs and to assess whether AE rates differed by age at circumcision.<h4>Design</h4>We selected 41 possible MC AEs based on a literature review and on medical billing codes. We estimated a likely risk window for the incidence calcul ...[more]

PMID: 24820907

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Project description:BACKGROUND:Adverse events (AE) resulting from voluntary medical male circumcision (VMMC) are commonly used to measure program quality. Mozambique's VMMC program data reports a combined moderate and severe AE rate of 0.2% through passive surveillance. With active surveillance, similar programs report AE rates ranging from 1.0 to 17.0%. The objective of this activity was to assess potential underreporting of AEs via the passive surveillance system in Mozambique. METHODS:This mixed-methods assessment randomly selected one third (16) of all 46 VMMC clinics through stratified sampling, based on volume. A retrospective record review was conducted including patient clinical files, stock records of Amoxicillin/Clavulanic Acid (the choice antibiotic for VMMC-related infections), and clinic-level AE rates from the national database. Records from the month of April 21 to May 20, 2017 were analyzed to identify both reported and potentially unreported AEs. In addition, external, expert clinicians observed post-operative visits (n = 167). Descriptive statistics were calculated, including difference between reported and identified AEs, an adjusted retrospective AE rate, and an observed prospective AE rate in each clinic. RESULTS:A total of 5352 circumcisions were performed in the 16 clinics: 8 (0.15%) AEs were reported. Retrospective clinical record reviews identified 36 AEs (0.67%); AE severity or type was unknown. Using Amoxicillin/Clavulanic Acid dispensation as a proxy for VMMC-related infections, 39 additional AEs infections were identified, resulting in an adjusted AE rate of 1.4%, an 8.3 fold increase from the reported AE rate. Prospective, post-operative visit observations of 167 clients found 10 AEs (5.9%); infection was common and boys 10-14 years old represented 80% of AE clients. CONCLUSIONS:Evidence suggests underreporting of AEs in the Mozambican VMMC program. Quality improvement efforts should be implemented in all VMMC sites to improve AE identification, documentation and prevention efforts.

Project description:BackgroundTiming of routine follow-up visits after adult male circumcision (MC) differs by country and method. Most men do not attend all routine follow-up visits. This cross-sectional study aimed to further understanding of AE timing within a large-scale, routine, MC program to improve patient safety.MethodsFrom 2013-2017, ZAZIC consortium performed 192,575 MCs in Zimbabwe; the reported adverse event (AE) rate was 0.3%. Three scheduled, routine, follow-up visits intend to identify AEs. For surgical MC, visits were days 2, 7 and 42 post-procedure. For PrePex (device-based), visits were days 7, 14 and 49. Descriptive statistics explored characteristics of those patients with AEs. For each MC method, chi-square tests were used to evaluate associations between AE timing (days from MC to AE diagnosis) and factors of interest (age, AE type, severity).ResultsOf 421 AEs, 290 (69%) were surgical clients: 55 (19%) AEs were ≤2 days post-MC; 169 (58%) between 3-7 days; 47 (16%) between days 8-14; and 19 (7%) were ≥15 post-MC. Among surgical clients, bleeding was most common AE on/before Day 2 while infections predominated in other follow-up periods (p<0.001). Younger surgical MC patients with AEs experienced AEs later than older clients (p<0.001). Among 131 (31%) PrePex clients with AEs, 46 (35%) were ≤2 days post-MC; 59 (45%) between 3-7 days; 16 (12%) between days 8-14; and 10 (7%) ≥15 post-MC. For PrePex clients, device displacements were more likely to occur early while late AEs were most commonly infections (p<0.001).ConclusionAlmost 23% of surgical and 8% of PrePex AEs occurred after Visit 2. Later AEs were likely infections. Clinicians, clients, and caregivers should be more effectively counseled that complications may arise after initial visits. Messages emphasizing attention to wound care until complete healing could help ensure client safety. Younger boys, ages 10-14, and their caregivers would benefit from improved, targeted, post-operative counseling.

Project description:As an HIV prevention strategy, the scale-up of voluntary medical male circumcision (VMMC) is underway in 14 countries in Africa. For prevention impact, these countries must perform millions of circumcisions in adolescent and adult men before 2015. Although acceptability of VMMC in the region is well documented and service delivery efforts have proven successful, countries remain behind in meeting circumcision targets. A better understanding of men's VMMC-seeking behaviors and experiences is needed to improve communication and interventions to accelerate uptake. To this end, we conducted semi-structured interviews with 40 clients waiting for surgical circumcision at clinics in Zambia. Based on Stages of Change behavioral theory, men were asked to recount how they learned about adult circumcision, why they decided it was right for them, what they feared most, how they overcame their fears, and the steps they took to make it to the clinic that day. Thematic analysis across all cases allowed us to identify key behavior change triggers while within-case analysis elucidated variants of one predominant behavior change pattern. Major stages included: awareness and critical belief adjustment, norming pressures and personalization of advantages, a period of fear management and finally VMMC-seeking. Qualitative comparative analysis of ever-married and never-married men revealed important similarities and differences between the two groups. Unprompted, 17 of the men described one to four failed prior attempts to become circumcised. Experienced more frequently by older men, failed VMMC attempts were often due to service-side barriers. Findings highlight intervention opportunities to increase VMMC uptake. Reaching uncircumcised men via close male friends and female sex partners and tailoring messages to stage-specific concerns and needs would help accelerate men's movement through the behavior change process. Expanding service access is also needed to meet current demand. Improving clinic efficiencies and introducing time-saving procedures and advance scheduling options should be considered.

Project description:IntroductionMonitoring clinical safety of voluntary medical male circumcision (VMMC) is critical to minimize risk as VMMC programs for HIV prevention are scaled. This cross-sectional analysis describes the adverse event (AE) profile of a large-scale, routine VMMC program and identifies factors associated with the development, severity, and timing of AEs to provide recommendations for program quality improvement.Materials and methodsFrom 2015-2018 there were 28,990 circumcisions performed in International Training and Education Center for Health (I-TECH) supported regions of Namibia in collaboration with the Ministry of Health and Social Services. Two routine follow-up visits after VMMC were scheduled to identify clients with AEs. Summary statistics were used to describe characteristics of all VMMC clients and the subset who experienced an AE. We used chi-square tests to evaluate associations between AE timing, patient age, and other patient and AE characteristics. We used a logistic regression model to explore associations between patient characteristics and AE severity.ResultsOf the 498 clients with AEs (AE rate of 1.7%), 40 (8%) occurred ≤2 days, 262 (53%) occurred 3-7 days, 161 (32%) between day 8 and 14, and 35 (7%) were ≥15 days post-VMMC. Early AEs (on or before day 2) tended to be severe and categorized as bleeding, while infections were the most common AEs occurring later (p<0.001). Younger clients (aged 10-14 years) experienced more infections, whereas older clients experienced more bleeding (p<0.001).ConclusionsAlmost 40% of AEs occurred after the second follow-up visit, of which 179 (91%) were infections. Improvements in pre-surgical and post-surgical counselling and post-operative educational materials encouraging clients to seek care at any time, adoption of alternative follow-up methods, and the addition of a third follow-up visit may improve outcomes for patients. Enhancing post-surgical counselling and emphasizing wound care for younger VMMC clients and their caregivers could help mitigate elevated risk of infection.

Dataset Information

Rates of adverse events associated with male circumcision in U.S. medical settings, 2001 to 2010.

Importance

Objectives

Design

Setting and participants

Main outcomes and measures

Results

Conclusions and relevance

Publications

Rates of adverse events associated with male circumcision in U.S. medical settings, 2001 to 2010.

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