Rates of adverse events associated with male circumcision in U.S. medical settings, 2001 to 2010.
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ABSTRACT:
SUBMITTER: El Bcheraoui C
PROVIDER: S-EPMC4578797 | biostudies-literature | 2014 Jul
REPOSITORIES: biostudies-literature
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]
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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.
| S-EPMC6868762 | biostudies-literature
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.
| S-EPMC6128519 | biostudies-literature
Project description:BackgroundClinical trials showed strong evidence that voluntary medical male circumcision (VMMC) reduces the acquisition of HIV among heterosexual men by up to 60%. However, VMMC uptake in East and Southern Africa remains suboptimal, with safety concerns identified as a barrier to uptake. We investigated the occurrence and severity of adverse events (AEs) in a routine VMMC programme implemented in Gauteng and North West provinces of South Africa.MethodsWe describe the frequency and characteristics of AEs using routinely collected data from a VMMC programme implemented between 01 May 2013 and 31 December 2014. The surgical procedure was provided at fixed clinics and mobile units in three districts. Adult men undertaking the procedure were referred for follow-up appointments where AEs were monitored.ResultsA total of 7,963 adult men were offered the VMMC service with 7,864 (98.8%) met the age and consent requirements for inclusion in a research follow-up after the surgical procedure and were followed-up for potential AEs. In total, 37 (0.5%) patients reported AEs post-surgery with infection [11 (29.7%)] and excessive bleeding [11 (29.7%)] commonly reported AEs. In terms of severity, 14 (37.8%) were classified as mild, 13 (35.1%) as moderate, and 10 (27.0%) as severe. Further, 32 (86.5%) of the AEs were classified as definitely related to the surgical procedure, with 36 (97.5%) of all AEs resolving without sequelae.ConclusionThe VMMC programme was able to reach adult men at high risk of HIV acquisition. Reported AEs in the programme were minimal, with the observed safety profile comparable to clinical trial settings, suggesting that VMMC can be safely administered in a programmatic setting.
| S-EPMC8370616 | biostudies-literature
Project description:ObjectiveTo estimate the incidence of adverse drug events (ADEs) associated with health care visits among U.S. adults across all ambulatory settings.Data sourceWe analyzed data from two nationally representative probability sample surveys: the National Ambulatory Medical Care Survey and the National Hospital and Ambulatory Medical Care Survey. From 2005 to 2007, the presence of an ADE was specifically defined, requested, and recorded in these surveys.Study designSecondary data analysis.Principal findingsAn estimated 13.5 million ADE-related visits occurred between 2005 and 2007 (0.5 percent of all visits), the large majority (72 percent) occurring in outpatient practice settings, and the remaining in emergency departments. Older patients (age ≥65 years) had the highest age-specific ADE rate, 3.8 ADEs per 10,000 persons per year. In adjusted analyses of outpatient visits, there was an increased odds of an ADE-related visit with increased medication burden (odds ratio [OR] for six to eight medications compared with no medications, OR 3.83 [2.20, 6.65]), and increased odds of ADEs associated with primary care visits compared with specialty visits (OR 2.22 [1.70, 2.89]).ConclusionsApproximately 4.5 million ambulatory visits related to ADEs occur each year, the majority of these in outpatient office practices. A greater focus on ADE prevention and detection is warranted among patients receiving multiple medications in primary care practices.
| S-EPMC3168717 | biostudies-literature
Project description:BackgroundVoluntary Medical Male Circumcision (VMMC) is a key intervention in HIV/AIDS. Improving VMMC program uptake in Zambia requires careful monitoring of adverse events (AE) to inform program quality and safety. We investigate the prevalence of VMMC AE and their associated factors among adult males in Ndola, Copperbelt Province, Zambia.MethodsWe performed a cross-sectional study using secondary clinical data collected in 2015 using two validated World Health Organisation/Ministry of Health reporting forms. We reviewed demographics and VMMC surgical details from 391 randomly sampled adult males aged ≥18 years at Ndola Teaching Hospital, a specialised VMMC fixed site in Zambia. Non-parametric tests (Fisher's exact test or Chi-square depending on assumptions being met) and logistic regression were conducted to determine the relationships between associated factors and VMMC AE.ResultsThe overall VMMC AE prevalence was 3.1% (95% CI 1.60%- 5.30%) and most AEs occurred postoperatively. In decreasing order, the commonly reported VMMC AE included; bleeding (47.1%), swelling (29.4%), haematoma (17.6%), and delayed wound healing (5.9%). There was an inversely proportional relationship between VMMC volume (as measured by the number of surgeries conducted per VMMC provider) and AEs. Compared to the highest VMMC volume of 63.2% (247/391) as reference, as VMMC volume reduced to 35.0% (137/391) and then 1.8% (7/391), the likelihood of AEs increased by five times (aOR 5.08; 95% CI 1.33-19.49; p = 0.018) and then sixteen times (aOR 16.13; 95% CI 1.42-183.30; p = 0.025) respectively.ConclusionsOur study found a low prevalence of VMMC AEs in Ndola city, Copperbelt Province of Zambia guaranteeing the safety of the VMMC program. We recommend more surgically proficient staff to continue rendering this service. There is a need to explore other high priority national/regional areas of VMMC program safety/quality, such as adherence to follow-up visits.
| S-EPMC8415607 | biostudies-literature
Project description:BACKGROUND: Safe Male Circumcision is a proven approach for partial HIV prevention. Several sub Saharan African countries have plans to reach a prevalence of 80% of their adult males circumcised by 2015. These targets require out of ordinary organization, demand creation, timely execution and perhaps the use of SMC devices. OBJECTIVE: To profile Adverse Events rate and acceptance of PrePex, a non surgical device for adult male circumcision. METHODS: A prospective study, conducted at International Hospital Kampala, Uganda, between August and October 2012. Ethical approval was obtained from Uganda National Council of Science and Technology. RESULTS: Of 1,040 men received to undergo SMC, 678 opted for PrePex, 36 were excluded at an initial physical examination screening. 642 were enrolled and consented, and another 17 were excluded before device placement. 625 underwent the procedure. Average age was 24 years (± 7). Twelve moderate AEs occurred among 10 participants 12/625, (1.9%). These were all reversible. Five had device displacement, one had an everted foreskin; five had bleeding after the device was removed and one had voiding difficulties. The majority (279 out of 300) of men interviewed complained of some pain within the week of placement. Mean pain score at device placement (using visual analogue scale) was 0.5, at device removal 4.5 and within 2 min of removal the pain score was 1.4. Over 70% of the devices were placed and removed by non-physician clinicians. Presented with a choice, 60% of men chose PrePex over surgical SMC. Close to 90% would recommend the device to their friends. Odour from the necrotic skin was a concern. Removals done 1-2 days earlier than day 7 were beneficial and conferred no extra risk. CONCLUSION: AEs of a moderate or severe nature associated with PrePex were low and reversible. PrePex is feasible for mass safe male circumcision scaling up.
| S-EPMC3904949 | biostudies-other
Project description:BackgroundSocioeconomic inequalities in death rates from all causes combined widened from 1960 until 1990 in the U.S., largely because cardiovascular death rates decreased more slowly in lower than in higher socioeconomic groups. However, no studies have examined trends in inequalities using recent US national data.Methodology/principal findingsWe calculated annual age-standardized death rates from 1993-2001 for 25-64 year old non-Hispanic whites and blacks by level of education for all causes and for the seven most common causes of death using death certificate information from 43 states and Washington, D.C. Regression analysis was used to estimate annual percent change. The inequalities in all cause death rates between Americans with less than high school education and college graduates increased rapidly from 1993 to 2001 due to both significant decreases in mortality from all causes, heart disease, cancer, stroke, and other conditions in the most educated and lack of change or increases among the least educated. For white women, the all cause death rate increased significantly by 3.2 percent per year in the least educated and by 0.7 percent per year in high school graduates. The rate ratio (RR) comparing the least versus most educated increased from 2.9 (95% CI, 2.8-3.1) in 1993 to 4.4 (4.1-4.6) in 2001 among white men, from 2.1 (1.8-2.5) to 3.4 (2.9-3-9) in black men, and from 2.6 (2.4-2.7) to 3.8 (3.6-4.0) in white women.ConclusionSocioeconomic inequalities in mortality are increasing rapidly due to continued progress by educated white and black men and white women, and stable or worsening trends among the least educated.
| S-EPMC2367434 | biostudies-literature
Project description:The PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal.To assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants.A multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics.Of 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001).Reported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.
| S-EPMC5868790 | biostudies-literature
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.
| S-EPMC4222873 | biostudies-literature
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.
| S-EPMC8528325 | biostudies-literature