Number/percent of circumcised males experiencing at least one moderate or severe adverse event during or following surgery, during the reporting period

Number/percent of circumcised males experiencing at least one moderate or severe adverse event during or following surgery, during the reporting period

Number/percent of circumcised males experiencing at least one moderate or severe adverse event during or following surgery, during the reporting period

The number or percent of circumcised males who experience one or more adverse events, defined as either moderate or severe, intraoperatively (during surgery) or postoperatively (following surgery), during the reporting period. Data should be collected continuously at the facility and aggregated periodically, but the reporting period can be monthly, quarterly, or annually.

Clinical staff must routinely assess and record the presence of adverse events.  See Male Circumcision Services Quality Assessment Toolkit and Manual for Male Circumcision under Local Anaesthesia for general guidance. For specific data recording, Tool 23 (Adverse event descriptions and management) in the former and Appendix 9.3 (Sample male circumcision adverse event form) in the latter should be consulted.

Adverse events are defined as follows.

Intraoperative:

  • Pain
  • Excessive bleeding
  • Anaesthesia-related
  • Excessive skin removal
  • Damage to the penis
  • Sharps injury to personnel (not in Tool 23 or Appendix 9.3)

Postoperative:

  • Abnormal pain
  • Excessive swelling
  • Infection
  • Haematoma
  • Bleeding
  • Difficulty urinating
  • Wound disruption
  • Delay in healing
  • Problem with appearance (including scar or disfigurement)
  • Injury to the glans
  • Excessive skin removal

As a percent, this indicator is calculated as:

(Number of males circumcised who experience at least one moderate or severe adverse event / Total number of males circumcised) x 100

Data Requirement(s):

Number of males circumcised during the reporting period and number reporting one or more adverse events

Health facility records; a specific register of adverse events might be maintained for ease of recording

Evaluators should disaggregate data by age, health care facility, adverse event type, and timing of adverse event:

  • intraoperative
  • postoperative ( disaggregated by day 0, 1, 2, 3, 4, 5, 6, 7 or >7), based on the day the adverse event began

Surgery of any type occasionally leads to adverse events, determined in part by the skill and quality of the surgery, the effectiveness of postoperative instructions, the willingness or ability of the patient to follow postoperative instructions, the suitability of the surgical candidate (e.g. for male circumcision), the level of the CD4 count if HIV-positive men are circumcised, and the judgment of the health-care personnel assessing adverse events. The frequency, or frequency of severity, of adverse events above an acceptable level is an indication of the need for investigation into causes and possible interventions. Operational research may provide further information about specific causes and possible solutions. Therefore, disaggregating by type of adverse event will help to determine the need for additional training to prevent or manage certain complications; disaggregation by timing of adverse event may inform the planning of postoperative care considerations, particularly as regards mobile services that may not be available many days following surgery; disaggregation by age may inform the need for age-specific investigation into causes; and disaggregation by type of facility may indicate institutional type-specific needs.

A similar indicator has been added under a new Prevention sub-area on male circumcision in the PEPFAR Next Generation Indicators Reference Guide (2009), “Number of clients circumcised who experienced one or more moderate or severe adverse event(s) within the reporting period”.

Clients receiving surgery at one location but follow-up at another pose a challenge to data linkage. No single successful approach to linking these data has been devised. Furthermore, determining adverse events among men who do not return for follow-up presents a challenge, for which various approaches, e.g. text messages or mail-in forms, are being tried in order to obtain post-surgery data from all men.

male circumcision, HIV/AIDS

WHO & UNAIDS. A guide to indicators for male circumcision programmes in the formal health care system. 2009.  http://www.who.int/hiv/pub/malecircumcision/hiv_mc_me.pdf

WHO. Male Circumcision Services: Quality Assessment Toolkit. 2009.  http://www.who.int/hiv/pub/malecircumcision/qa_toolkit/en/

WHO, UNAIDS and JHPIEGO.  Male Circumcision under Local Anaesthesia. 2008. http://www.who.int/hiv/pub/malecircumcision/who_mc_local_anaesthesia.pdf

PEPFAR, 2009, The President’s Emergency Plan for AIDS Relief: Next Generation Indicators Reference Guide, Washington, DC: USAID/PEPFAR.  http://pdf.usaid.gov/pdf_docs/Pcaac330.pdf

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