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Aksel Paulsen, M.D., Ph.D. Fellow Department of Orthopaedics and Traumatology ,

Feasibility and validity of four patient reported outcome measures in the Danish Hip Arthroplasty Registry. A. Paulsen, A. B. Pedersen, S. Overgaard, E. M. Roos. Aksel Paulsen, M.D., Ph.D. Fellow Department of Orthopaedics and Traumatology , Odense University Hospital

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Aksel Paulsen, M.D., Ph.D. Fellow Department of Orthopaedics and Traumatology ,

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  1. Feasibility and validity of four patient reported outcome measures in the Danish Hip Arthroplasty Registry A. Paulsen, A. B. Pedersen, S. Overgaard, E. M. Roos Aksel Paulsen, M.D., Ph.D. Fellow Department of Orthopaedics and Traumatology, Odense University Hospital Institute of Clinical Research, University of Southern Denmark Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  2. A cross-sectional study of 6000 patients September 9th 2010 9th Domestic Meeting of the European Hip Society Athens, Greece Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  3. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Background Total hip arthroplasty (THA) in Denmark: 10 years implant survival (all primary THA): 91.9% (Annual report 2009, http://www.dhr.dk) Implant survival do not give information on clinical outcome! Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  4. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Background Are we reducing pain? Are we improving the patients physical function? Are we giving the patients a better quality of life? Ask the patients! Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  5. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Background Patient reported outcome (PRO) instruments can give us a way to measure these clinical outcomes PROs are therefore warranted in the different national hip arthroplasty registries Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  6. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Aim To test two generic PROs; SF‐12 Health Survey (SF-12) EuroQOL-5D (EQ-5D ) And to test two disease- or site-specific PROs; Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Oxford 12‐item Hip Score (OHS) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  7. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Aim To assess the different PROs relevant to THA patients in a registry setting, in relation to: Response rate Floor- and ceiling effect Percentage of missing items Cost Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  8. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Criteria Response rate: > 80% Floor- and ceiling effect: < 15% Percentage of missing items: < 15% Cost: Proportion of items needing manual validation: < 5% Economic cost: <2,000.00 USD Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  9. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Methods - DHR Patients from the Danish Hip Arthroplasty Registry (DHR) DHR is a nation-wide, clinical database of primary THA, and revisions performed in Denmark All public and private orthopedic departments performing THA in Denmark report to DHR Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  10. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Methods - DHR Since 1995, 85.075 primary THA and 14.083 revisions have been recorded (Annual Report 2009, http://www.dhr.dk/) The registry was validated in 2003, and completeness of primary THAs and/or revisions was found to be 94% (Pedersen 2004) In 2008, the completeness of primary THAs was found to be 96% (Annual Report 2009, http://www.dhr.dk) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  11. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Methods - Patients 5747 primary THA patients were contacted All patients were operated; 1‐2 years ago (Approximately 1900 patients) 5‐6 years ago (Approximately 1900 patients) 10‐11 years ago (Approximately 1900 patients) To get a sample of both short-, middle-, and longtime follow up Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  12. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Methods - PROs EQ-5D HOOS OHS SF-12 Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  13. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Methods - Automated forms processing • Automated forms processing • (data scanning of the PROs instead of double-key manual data entry) • Benefits using automated forms processing: • Efficient data entry • Acceptable level of data entry error (Jinks et al., 2003) • Paper forms and postal administration • (age of patient population/ variable familiarity to computers) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  14. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results 5747 patients were sent invitations and included (100%) 541 patients did not reply (9%) 5206 patients answered the invitation (91%) 422 patients declined study participation (7%) 4784 patients accepted participation and answered the PROs (83%) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  15. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results – Response rate • Response rates for the PROs: • HOOS: 82.4%   (95% CI: 81.0-83.8) • OHS: 84.1% (95% CI: 82.7-85.4) • SF-12: 82.6% (95% CI: 81.2-84.0) • EQ-5D: 83.9% (95% CI: 82.6-85.2) • No statistically significant difference (P=0.22) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  16. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results – Floor effect • Floor effect: PROs with lowest possible sum score • The floor effect was <0.5% for all PROs • Statistically significant difference (P<0.001) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  17. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results – Ceiling effect • Statistically significant difference (P<0.001) • Ceiling effect: PROs with highest possible sum score • HOOS Subscale; Pain: 36.6%   • Physical Function: 31.2% • Quality of Life: 30.5% • OHS: 20.2% • SF-12 Subscale; PCS: 6.1% • MCS: 6.1% • EQ-5D Subscale; VAS: 12.1% • Index: 45.8% PCS and MCS low ceiling effect is due to computation of these subscales with a norm based value set Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  18. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results – Missing items • Statistically significant difference (P<0.001) • When applying PRO specific rules for missing items, a score could not be calculated for 1-6% of the PROs Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  19. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results - Cost Assessed as; license requirements fees need for manual validation The proportion of items needing manual validation ranged from 1% (SF-12, HOOS) to 4% (EQ-5D) OHS and HOOS is free of charge and do not have any license or registration procedure SF-12 and EQ-5D requires licence SF-12; administrative fee, survey reference kit, and scoring software cost altogether 1,569.90 USD EQ-5D; Academic and clinical use is free of charge only if patient numbers is less than 5000 Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  20. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Discussion All PROs had excellent response rates The low floor effects and high ceiling effects can largely be explained by the overall good outcome from THA. A ceiling effect of less than 15% is a suboptimal criteria on postoperative THA patients A score could be calculated for 94-99% of patients, indicating the items and format of the four PROs being appropriate for administration within a hip registry Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  21. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Conclusion We conclude that all four PROs; Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Oxford 12‐item Hip Score (OHS) SF‐12 Health Survey (SF-12) EQ-5D …are all appropriate for administration in a hip registry Thank you for your attention Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  22. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results – Response rate • Response rates for the PROs: • HOOS: 82.4%   (95% CI: 81.0-83.8) • OHS: 84.1% (95% CI: 82.7-85.4) • SF-12: 82.6% (95% CI: 81.2-84.0) • EQ-5D: 83.9% (95% CI: 82.6-85.2) • No statistically significant difference (P=0.22) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  23. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results – Missing items • When applying questionnaire specific rules for missing items, a score could not be calculated for 1-6% of the PROs • HOOS Subscale; Pain: 14.6%   • Physical Function: 9.0% • Quality of Life: 3.2% • OHS: 5.4% • SF-12 Subscale; PCS: 9.9% • MCS: 9.9% • EQ-5D Subscale; VAS: 3.2% • Index: 5.5% • Statistically significant difference (P<0.001) Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

  24. Feasibility of four patient reported outcome measures in the Danish Hip Arthroplasty Registry Results Orthopaedic Research Unit – Department of Orthopaedics and Traumatology Odense University Hospital – Institute of Clinical Research – University of Southern Denmark DENMARK – www.sdu.dk/ki/ortopaedkirurgi

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