1. The COSMIN study COnsensus-based Standards for the selection of health status Measurement INstruments Wieneke Mokkink, Caroline Terwee, Paul Stratford, Jordi Alonso, Donald Patrick, Dirk Knol, Lex Bouter, Riekie de Vet

2. Outline presentation Background –Methodological guidelines COSMIN Delphi Study –Purpose –Methods –Preliminary results

3. Why methodological guidelines? Importance of high-quality studies - Detection of potential bias that may influence the results - Better and more realistic estimates of results - Greater acceptance of results in health care community Moher et al. Controlled Clinical Trials 1995;16:62-73

4. Accepted guidelines RCT: Delphi List (Verhagen et al.) Diagnostic research: QUADAS

5. Why a new guideline? Several checklists for measurement properties exist (SAC MOS/Lohr, Bombardier & Tugwell, Andresen, Terwee) No consensus on terminilogy and defintions None is generally accepted and widely used Most chance of getting enough support is by developing a checklist in an international consensus study, i.e. a Delphi Study

6. Aim of the COSMIN study 1. Which measurements properties should be included in the assessment of evaluative HR- PROs, and how should they be defined? 2. How should these measurement properties be assessed in terms of study design and statistical analysis? (i.e. standards) Available as a checklist

7. Methods (1) International Delphi study Steering committee Background panel members: –clinical medicine –biostatistics –psychology (psychometrics) –epidemiology (clinimetrics)

8. Methods (2) Design delphi rounds: Four written rounds –which measurement properties (term and definitions) –how selected properties should be assessed (standards) –achieve consensus on complete checklist 5 point scale + arguments and comments –strongly disagree/disagree/no opinion/agree/strongly agree Consensus: ≥67% (strongly) agreed

9. Focus of COSMIN HR-PRO instruments used in an evaluative application PRO: endpoint derived from patient report HR: not adherence or satisfaction with care

10. Flow chart Invited: N=91 Agreed to participate: N=57

11. Flow chart Invited: N=91 Agreed to participate: N=57 Round 1: N=57 Round 2: N=54 Round 3: N=52 Round 4: N=51 Responses: N=42 (74%) Responses: N=31 (58%) Responses: N=25 (48%) Responses: N=27 (53%) Drop out: N=3 Drop out: N=2 Drop out: N=1

12. Products of COSMIN Taxonomy (consensus on terms and definitions) COSMIN checklist

15. Reliability

17. Content validity Construct validity Criterion validity face validity concurrent validity predictive validity cross-cultural validity † hypotheses testing, e.g. convergent validity, divergent validity, known group validity structural validity * * necessary for multi-item instruments, † necessary for cross-cultural comparison Validity

19. Responsiveness

20. Results (2) Structure COSMIN checklist 3 Sections: -Descriptive information about the HR-PRO instrument -Descriptive information about a study of a measurement property -Evaluation of methodological quality of studies of measurement properties, i.e. standards

21. Section 1 Descriptive information of the HR-PRO instrument Development process Format Translation process Interpretability

22. Example (1)

23. Section 2 Descriptive information of the study IRT study

24. Example (2)

25. Section 3 Evaluation of methodological quality of the studies Term Definition Standard –design requirement –statistical analysis

26. Standard for internal consistency

27. Future Selecting an HR-PRO instrument –Content –Practical issues –Measurement properties Standards Criteria of adequacy for good measurement properties Inter-rater reliability study of COSMIN checklist

28. Many thanks to … Neil Aaronson Linda Abetz Elena Andresen Dorcas Beaton Martijn Berger Giorgio Bertolotti Monika Bullinger David Cella Joost Dekker Dominique Dubois Anne Evers Diane Fairclough David Feeny Raymond Fitzpatrick Andrew Garratt Francis Guillemin Dennis Hart Graeme Hawthorne Ron Hays Elizabeth Juniper Robert Kane Donna Lamping Marissa Lassere Matthew Liang Kathleen Lohr Patrick Marquis Chris McCarthy Elaine McColl Ian McDowell Don Mellenbergh Mauro Niero Geoffrey Norman Manoj Pandey Luis Rajmil Bryce Reeve Dennis Revicki Margaret Rothman Mirjam Sprangers David Streiner Gerold Stucki Giulio Vidotto Sharon Wood-Dauphinee Albert Wu