Table 100. Evaluation of applicability for individual observational studies

Author,
Year / Effectiveness Study Designation and Composite Score / Effectiveness Study Criteria Met / Applicability Limitation Category / Specific Factors Limiting Applicability
Bozic, 2010
/ Study Designation:
Effectiveness Study
Composite Score:
5 of 7 /
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Assessed final health outcomes
  4. Assessed adverse outcomes
  5. Adequate sample size
/ Population, Outcomes /
  • Only patients undergoing TKR
  • Only primary surgery (100%)
  • Did not use intention-to-treat analysis
  • Duration of followup for final health outcome (30d)

Gerkens, 2010 / Study Designation:
Effectiveness Study
Compostie Score:
5 of 7
/
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Assessed final heatlh outcomes
  4. Assessed adverse outcomes
  5. Adequate sample size
/ Population, Outcomes, Setting /
  • Primary versus revision surgery not reported
  • Duration of followup for all outcomes (during hospital stay)
  • Did not use intention-to-treat analysis
  • Conducted in Belgium

Cusick, 2009
/ Study Designation:
Effectiveness Study
Composite Score:
5 of 7 /
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Assessed final health outcomes
  4. Adequate sample size
  5. Adequate study duration with clinically relevant treatment
/ Population, Outcomes, Setting /
  • Only primary surgery (100%)
  • Gender not reported
  • Did not assess adverse outcomes
  • Did not use intention-to-treat analysis
  • Duration of followup for mortality (90d)
  • Conducted in Ireland

Froimson, 2009
/ Study Designation:
Efficacy Study
Composite Score:
4 of 7 /
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Assessed final health outcomes
  4. Adequate sample size
/ Population, Outcomes /
  • Only primary surgery (100%)
  • Gender not reported
  • Did not assess adverse outcomes
  • Did not use intention-to-treat analysis
  • Duration of followup for final health outcomes (30d)

Gandhi, 2009 / Study Designation:
Efficacy Study
Composite Score:
4 of 7 /
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Adequate study duration
  4. Adequate sample size
/ Population, Outcomes, Setting /
  • Only primary surgery
  • Did not assess final health outcomes
  • Did not assess adverse outcomes
  • Conducted in Canada
  • Did not use intention- to-treat analysis

McNamara, 2009 / Study Designation:
Efficacy Study
Composite Score:
4 of 7 /
  1. Less stringent eligibility criteria
  2. Adequate study duration
  3. Assessed final health outcomes
  4. Adequate sample size
/ Population, Outcomes, Setting /
  • High female to male ratio (F=78.5%: M=21.5% )
  • Did no report primary or secondary surgery
  • Did not assess adverse outcomes
  • Conducted in UK
  • Did not use intention-to- treat analysis

Dorr, 2007 / Study Designation:
Effectiveness Study
Composite Score:
5 of 7 /
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Adequate study duration
  4. Assessed final health outcomes
  5. Adequate sample size
/ Population, Outcomes /
  • Only primary surgery
  • Did not assess adverse outcomes
  • Did not use intention-to-treat analysis

Shorr, 2007
/ Study Designation:
Efficacy Study
Composite Score:
4 of 7 /
  1. Enrolled primary care population
  2. Assessed final health outcomes
  3. Assessed adverse outcomes
  4. Adequate sample size
/ Population, Outcomes /
  • Primary or secondary surgery not reported
  • Duration of followup for final health outcomes (in-hospital)
  • Did not use intention-to-treat analysis

Leirozovicz, 2004 / Study Designation:
Efficacy Study
Composite Score:
3 of 7 /
  1. Less stringent eligibility criteria
  2. Assessed final health outcomes
  3. Adequate sample size
/ Population, Outcomes, Setting /
  • Only primary surgery
  • Did not assess adverse outcomes
  • Duration of followup for final health outcomes (30d)
  • Conducted in Asia
  • Did not use intention-to-treat analysis

Sachs, 2003
/ Study Designation:
Effectiveness Study
Composite Score:
6 of 7 /
  1. Enrolled primary care population
  2. Less stringent eligibility criteria
  3. Assessed final health outcomes
  4. Assessed adverse outcomes
  5. Adequate sample size
  6. Adequate study duration with clinically relevant treatments
/ Population, Outcomes /
  • Only patients undergoing TKA
  • Only primary surgery (100%)
  • Duration of followup for mortality (90d)
  • Did not use intention-to-treat analysis

Ryan, 1998 / Study Designation:
Efficacy Study
Composite Score:
3 of 7 /
  1. Enrolled primary care population
  2. Assessed adverse outcomes
  3. Adequate sample size
/ Population, Outcomes, Setting /
  • Did not report primary or secondary surgery
  • Did not assess final health outcomes
  • Duration of followup for intermediate and adverse health outcomes (postoperative)
  • Conducted in USA and Canada
  • Did not use intention-to-treat analysis

Lemos, 1991 / Study Designation:
Efficacy Study
Composite Score:
2 of 7 /
  1. Less stringent eligibility criteria
  2. Assessed final health outcomes
/ Population, Outcomes, Setting /
  • Did not report male or female percentage
  • Did not report primary or secondary surgery
  • Did not assess adverse outcomes
  • Duration of followup for final health outcomes (postoperative)
  • Small sample size (240)
  • Did not use intention-to-treat analysis

Abbreviations: TKR=total knee replacement; THR=total hip replacement; TKA=total knee replacement