Number of circumcised clients experiencing at least one moderate or severe adverse event (AE) during or following surgery, within the reporting period
Intra- and post-operative complications must be monitored to ensure maximization of the provision of safe, quality MC services, and in turn engender trust in communities and foster high demand for MC services.
3 randomized controlled clinical trials in sub-Saharan Africa demonstrated a 60% reduction in risk of female-to-male HIV transmission among men randomized to receive circumcision (compared to uncircumcised controls). This evidence is supported by long-standing ecologic and observational data. Elective surgical male circumcision confers a partially protective effect against HIV acquisition for HIV-negative men at risk for acquiring HIV from HIV-infected female sexual partners, and may be particularly beneficial in generalized HIV epidemics and where HIV prevalence is high and male circumcision prevalence is low. Like all surgeries, male circumcision is not without risk, and the performance and reporting of safe MC services depends in part upon skill and quality of surgery, effectiveness of post-operative instructions, willingness or ability of the patient to follow post-operative instructions, suitability of the surgical candidate, level of CD4 count if HIV-positive, and the judgment of the healthcare personnel assessing AEs.
Number of clients circumcised that experience (reporting back to the respective circumcising program) one or more moderate or severe AE(s) during the reporting period, according to the date of MC surgery, and disaggregated by severity (moderate and/or severe), timing of AE(s), and specific AE(s)
The numerator can be generated by summing the clients experiencing moderate and severe adverse events documented in Adverse Event Monitoring Logs or client medical records maintained by programs.
Explanation: Clients who have documentation in the facility record that they experienced one or more moderate or severe AEs (AEs would necessarily have to be reported back to the respective circumcising program) during or following MC surgery meet the definition for the numerator. It is the date of surgery, not the date of AE(s) that must fall within the reporting period. For instance, if the reporting period is October 1, 2009, through December 31, 2009, and a client was circumcised December 29, 2009 and had a moderate adverse event on January 2, 2010, then this client would meet the definition and be included in the numerator (since his surgery was performed within the reporting period, even though his adverse event occurred after the reporting period). Adverse events must be documented in a client’s clinic record or registry by the facility that performed the surgery. For this reason, it is anticipated that the indicator reporting may reflect fewer adverse events than actually occurred (as clients experiencing AE(s) may not return to the facility at all, seek care for AE(s) elsewhere, or the facility may fail to document occurrence of the AE(s) in the appropriate record). For reporting purposes, AEs include MC cases involving an occupational exposure to blood/body fluids. Occupational exposure to blood/body fluids (splash, sharps injuries) are based upon guidelines set forth in the WHO/ILO Post-exposure Prophylaxis to Prevent HIV Infection (http://www.who.int/hiv/pub/guidelines/PEP/en/index.html)
For the specific moderate/severe AEs listed in the disaggregation above, the following guidance for distinguishing between moderate and severe is offered. Routine reporting of moderate and severe AEs is all that is recommended. AEs of seriousness less than moderate should not be reported.
-Moderate: Reaction to anesthetic requiring medical treatment on site, but not transfer to another facility (Palpitations, vaso-vagal reactions, or emesis would not qualify as moderate AE(s) unless such reaction(s) were so serious as to require medical treatment).
-Severe: Anaphylaxis or other reaction requiring hospitalization or referral/transfer to another facility
-Moderate: Intra-operative bleeding that requires a pressure dressing to control; or post-operative bleeding that requires a special return to the clinic for medical attention (Intra-operative bleeding that is easily controlled or post-operative spotting of the bandage with blood would not qualify as a moderate AE).
-Severe: Intra-operative bleeding requiring blood transfusion, transfer to another facility, or hospitalization; or post-operative bleeding that requires surgical re-exploration, hospitalization, or transfer to another facility.
-Moderate: Purulent discharge from the wound (Erythema around the incision line, by itself, would not be serious enough to qualify as a moderate AE)
-Severe: Cellulitis or wound necrosis
PAIN (INTRA- AND POST-OPERATIVE):
-Moderate: Pain serious enough to result in disability (as evidenced by loss of work or cancellation of normal activities) that lasting for at least 4 days after surgery but not more than 7 days
-Severe: Pain serious enough to result in disability (as evidenced by loss of work or cancellation of normal activities) lasting for at least 8 days after surgery. Pain that is so extraordinary as to result in early termination of surgery or administration of general anesthesia (where possible) would also be considered a severe pain AE.
-Moderate: Surgical re-exploration is required, but hospitalization or referral to another facility is not necessary (Re-suturing, by itself, would not be considered serious enough to qualify as a moderate wound disruption AE)
-Severe: Referral/transfer to another facility or hospitalization is required.
SEXUAL DYSFUNCTION/UNDESIRABLE SENSORY CHANGES:
-Moderate: Post-operative changes that impair or preclude sexual function for between 3 and 6 months after the date of surgery (sexual dysfunction for a shorter period would not qualify as a moderate AE)
-Severe: Post-operative changes that impair or preclude sexual function for greater than 6 months after the date of surgery
SCARRING/DISFIGUREMENT/POOR COSMETIC RESULT; EXCESS SKIN REMOVAL; INJURY TO GLANS:
-Scarring/disfigurement/poor cosmetic result Moderate: Scarring/disfigurement is discernible but re-operation not required (absence of discernible scarring/disfigurement, despite a client’s complaint about the surgical outcome, would not be considered a moderate AE).
-Excess skin removal Moderate: Tightening of the skin is discernible but re-operation not required (absence of discernible tightening of skin, despite a client’s complaint about the surgical outcome, would not be considered a moderate AE).
-Injury to glans/shaft Moderate: Abrasion of the glans or shaft requiring pressure dressing or additional surgical intervention to stop bleeding
-Scarring/disfigurement/poor cosmetic result Severe: Requires re-operation or referral/transfer to another facility
-Excess skin removal Severe: Requires re-operation or referral/transfer to another facility
-Injury to glans/shaft Severe: Severing of the glans or shaft
-Moderate: All occupational exposures are moderate (none are mild or severe)
OTHER: EXCESS SWELLING OF PENIS/SCROTUM (INCLUDING HEMATOMA); DIFFICULTY URINATING; OTHER:
-Excess swelling of penis/scrotum (including hematoma) Moderate: Symptoms /signs so extraordinary as to cause disability (as evidenced by loss of work or cancellation of normal activities) lasting for at least 4 days after surgery but not more than 7 days.
-Difficulty urinating Moderate: Partial obstruction requiring a special return to the clinic but no additional treatment (transient difficulty urinating that resolves on its own would not be considered a moderate AE).
-Other Moderate: Other adverse events related to the surgery that result in disability (as evidenced by loss of work or cancellation of normal activities) lasting for at least 4 days after surgery but not more than 7 days.
-Excess swelling of penis/scrotum (including hematoma) Severe: Surgical re-exploration required or symptoms /signs so extraordinary as to cause disability (as evidenced by loss of work or cancellation of normal activities) lasting for at least 8 days after surgery
-Difficulty urinating Severe: Complete obstruction and/or requires referral for treatment or surgery to correct.
-Other Severe: Other AE(s) related to the surgery that result in disability (as evidenced by loss of work or cancellation of normal activities) lasting for at least 8 days after surgery, or result in hospitalization or referral/transfer to another facility.
Condom type: N/A
Geographic location: N/A
HIV status: N/A
Pregnancy status: N/A
Service Type: N/A
Time period: N/A
Type of orphan: N/A
Type/Timing of testing: N/A
Vulnerability status: N/A
Programs are recommended to report the number clients experiencing moderate or severe adverse events to allow for monitoring of safe, quality service provision. Frequency and frequency of severity, of AEs above ‘an acceptable level’ is an indication of the need for investigation into causes and possible interventions. Further, disaggregation by timing of adverse event may inform planning of post-operative care considerations, particularly from mobile/remote services that may have limited availability following surgery. Disaggregation by specific type of AE may help determine the need for additional training to prevent or manage certain complications.