The DutchFlemish PROMIS Assessment Center Dr Caroline Terwee

The Dutch-Flemish PROMIS Assessment Center Dr. Caroline Terwee Dutch-Flemish PROMIS group VU University Medical Center Department of Epidemiology and Biostatistics

Conflict of interest statement § We received financial support from the Dutch Arthritis Association and the Dutch Physiotherapy Association.

Content § Dutch-Flemish PROMIS experiences, challenges and lessons learned § Different ways of using PROMIS in the Netherlands and Flanders

The Dutch-Flemish PROMIS experience Oct 2006: ISOQOL meeting Lisbon Leo and Caroline: “Dave, we want to translate PROMIS into Dutch” Dave: “OMG, please come back in 2 years!”

The Dutch-Flemish PROMIS experience Oct 2008: ISOQOL meeting Montevideo Leo and Caroline: “Dave, we still want to translate PROMIS into Dutch” Dave: “OK, let’s do it”

Dutch-Flemish PROMIS group Ø Caroline B Terwee, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, the Netherlands Ø Leo D Roorda, Reade, Center for Rehabilitation and Rheumatology, Amsterdam, the Netherlands Ø Henrica CW de Vet, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, the Netherlands Ø Joost Dekker, VU University Medical Center, Department of Rehabilitation Medicine and Department of Psychiatry, Amsterdam, the Netherlands Ø Rene Westhovens, Catholic University Leuven, Department of Rheumatology, Leuven, Belgium Ø Jaap van Leeuwen, CEO Leones Group bv, Amsterdam, the Netherlands Ø Maarten Boers, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, the Netherlands

Dutch-Flemish pediatric PROMIS group Ø Lotte Haverman, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands Ø Martha Grootenhuis, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands Ø Hein Raat, Department of Public Health, Erasmus MCUniversity Medical Center Rotterdam, The Netherlands Ø Marion van Rossum, Emma Children’s Hospital and Reade, Center for Rehabilitation and Rheumatology, Amsterdam, The Netherlands Ø Eline van Dulmer-den Broeder, VU University Medical Center, Department of Paediatrics, Amsterdam, the Netherlands Ø Karel Hoppenbrouwers, Youth Health Care, KU Leuven, Belgium

Translation Requirements: § Grant for translation: difficult to find € 100. 000 for translating 26 item banks (Dutch Arthritis Association) § Permission from PHO to translate PROMIS using approved translation methodology (FACIT trans) § Time: 1. 5 years for translating 26 item banks, including cognitive debriefing § Participate in the translation as reviewer !

Dutch-Flemish PROMIS item banks Volwassenen # items Anger Anxiety Depression Fatigue Pain Behavior Pain Interference Physical Function Sleep Disturbance Sleep-Related Impairment Ability to Participate in Social Roles and Activities Satisfaction with Social Roles and Activities Companionship Emiotional support Informational support Instrumental support Social Isolation Global health Total 22 29 28 95 39 40 121 27 16 35 44 6 16 10 11 14 10 563 Kinderen # items Anger Anxiety Asthma Impact Depressive Symptoms Fatigue Physical Function - Mobility 5 13 17 13 23 23 Physical Function – Upper extremity Function Pain Interference Peer Relationships 29 Total 13 15 151

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Validation PROMIS International group 2014: Minimum requirements for the release of PROMIS instruments after translation and recommendations for further psychometric evaluation Instrument Short form Item bank/CAT Minimum requirement BEFORE release Availability of good validation data previous to the translation and a good quality translation An evaluation of Differential Item Functioning (DIF) between language groups and within relevant sub-groups

Validation Instrument Item bank Recommendations for further psychometric evaluation AFTER release Calibration of item banks in relevant patient groups and the general population; Sample size Minimum 500 Optimal 10002000 Short form / item The collection of language- or country-specific At least 300 -400 bank reference scores in the general population; Short form / item An evaluation of the relevance and 4 -6 focus groups bank comprehensiveness of the items (content or 12 interviews validity) of the item bank and cultural adaptation; Short form / CAT Further psychometric evaluation (construct 200 subjects per validity, internal consistency, test-retest group for DIF reliability, measurement error, DIF among 50 -100 for other different patient groups) of PROMIS measurement instruments in specific patient populations; properties Short form / CAT Responsiveness and Minimal Important 50 -100 Change of PROMIS instruments in relevant patient populations.

Dutch-Flemish Validation § Each item bank should be calibrated in a relevant sample of at least 1000 patients § Collaborative effort § 15 validation studies § Cross-sectional studies, including full item banks and legacy instruments § Patient recruitment through hospital records § Reference scores for the Dutch general population for 11 item banks

Calibration analysis Need psychometric expertise Standardize analyses across item banks PROMIS class § 8 people each analyzed one item bank § 1 psychometrician prepared R codes § Normal (probit) Graded Response Model (LAVAAN) § WLS estimations on polychorical correlations § Scaled fit statistics (CFI, TLI, RMSEA) § Local dependence, monotonicity, DIF § T-scores, reliability § Meeting once a week to discuss output and answer questions

Dutch-Flemish validation studies Item bank items Population Pain behavior Pain Interference Pain Interference Physical Function 39 39 39 40 40 40 121 121 Chronic pain SMT General population Chronic pain RA (Dutch/Flemish) OA SMT General Population Chronic pain Physiotherapy General Population Anxiety 29 Depression 28 Fatigue 95 Sleep Disturbances 27 Sleep-Related Impairment-3 16 Sample size 1042 1631 1049 1085 2020 390 1631 1049 1247 753 1309 CFI RMSEA Item bank items Pop 0. 960 0. 814 0. 986 0. 997 0. 966 0. 901 0. 992 0. 976 0. 982 0. 991 0. 099 0. 094 0. 082 0. 159 0. 128 0. 107 0. 145 0. 146 0. 122 0. 091 0. 094 5 13 13 Common mental disorders and general population RA (Dutch/Flemish) Adolescents 2010 0. 990 0. 085 Anger Anxiety Depressive symptoms Fatigue Physical function – Mobility Physical Function – Upper Extremity Function Pain Interference Peer Relationships (pediatric) 2010 0. 995 0. 093 2020 1024 0. 994 0. 790 0. 116 0. 125 Adolescents 1024 0. 960 0. 125 CFI JIA JIA Sample size 196 195 0. 999 0. 991 0. 995 RMSE A 0. 072 0. 082 0. 076 23 23 JIA 196 199 0. 989 0. 991 0. 052 29 JIA 196 0. 994 0. 043 13 15 JIA 196 195 0. 982 0. 944 0. 120 0. 141

Implementation PHO recommends to set up one PROMIS National Center in each country Dutch-Flemish PROMIS Foundation MISSION: to improve the quality of health care and research by developing, translating, validating, improving, and stimulating the use of Dutch-Flemish PROMIS instruments and other innovative, top quality, measurement instruments in research and clinical practice

A PROMIS National Center will … §. . have the exclusive rights to distribute PROMIS materials in its country (PHO also retains the right) §. . be responsible for coordinating all translation efforts performed in its country to ensure one unique translation per language §. . be responsible that the most up to date versions of the PROMIS materials are distributed and synchronized with a central PHO library §. . encourage widespread use of PROMIS and educate people about the value of IRT, CATs and PROMIS, e. g. through workshops and symposia §. . set up a sustainable model to make PROMIS instruments available now and in the future at low costs (not only for profit) 17

Dutch-Flemish Assessment Center All PROMIS materials will be made available for use in the Netherlands and Flanders through a private not only for profit company: Dutch-Flemish Assessment Center (part of the Dutch. Flemish PROMIS foundation) § Dutch-Flemish Assessment Center § Instrument library (PROMIS and other instruments) § CAT engine– developed in R § Connections of CAT engine to other PRO data collection systems (e. g. Vital Health) § Research Data Management system to set up studies § Patient website for self-monitoring

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