Table 1

Summary and background for three measures chosen for each of the four devices

Measure chosenDescription
Total hip/knee replacement
 Harris Hip Score/Knee Society Score
  • Harris Hip Score (HHS) is a clinician-administered survey based on a 100-point scale to assess hip pain and function after surgery.

  • Knee Society Score (KSS) is a validated 200-point scale to assess knee condition after surgical intervention.

 QoL
  • Patient-reported physical, social and mental functioning using the Short Form 12 (SF-12) and Short Form 36 (SF-36).

 Revision
  • A reoperation due to mechanical or biological failure.

  • Used as safety indicator registries.36–39

  • Widely accepted as a patient-centered outcome.

Endovascular aneurysm repair (EVAR)
 Endoleak
  • Continued perfusion and pressurization.

  • Considered as an effectiveness outcome.40 41

  • 20%–25% of EVAR procedures are complicated by endoleaks.42 43

  • Excluding type II, the cumulative endoleak rate is 5.67% at 2 years.26

 30-day all-cause mortality
  • Most frequently used primary outcome in major clinical trials such as EVAR 1, EVAR 2 and ACE.44–47

  • Mortality varies from 0.5% to 3.6%48 based on different studies and different EVAR grafts.40 41 49

 Secondary vascular intervention
  • Major indications: endoleak, graft migration, kinking of limb grafts, stenosis and occlusions, and landing site enlargement.50

  • Reintervention rates are 17% for intermediate follow-up (up to 4 years) and 23% for a longer term follow-up (beyond 4 years) with a median of 6 years.51

Surgical mesh for POP
 QoL
  • King’s College Pelvic Organ Prolapse Quality of Life (P-QoL)27–29 is the most commonly used validated questionnaire with nine domains.

 Total reoperation rate
  • Reoperation due to postoperative complications and prolapse recurrence.

  • Total 1-year reoperation rate is estimated to be 3%–4%.30–32

  • Estimates for longer term (1.5–5 years) vary between 8.5% and 13%.52 53

 Mesh erosion
  • One of the most frequently experienced safety issues related to vaginal mesh is the risk of vaginal-urethral erosion/extrusion.

  • Factors contributing to erosion include operative technique, implant size, and the specific properties of the material (size, stiffness, elasticity and basic tissue compatibility, and so on).54

  • 110 studies based on safety warning, issued by FDA in 2011: approximately 10% of women undergoing POP repair with mesh experienced mesh erosion within 1 year.17 55

  • FDA, Food and Drug Administration; POP, pelvic organ prolapse.