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Index in paper (p-WOMAC®) and electronic (m-WOMAC®) format in random order. .... questionnaire in black pen, and time to completion was recorded manually. ..... Guidance for Industry Part 11, Electronic Records; Electronic Signatures ...
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This is the author version published as: This is the accepted version of this article. To be published as :

This is the author version published as: Bellamy, Nicholas and Wilson, Cecilia and Hendrikz, Joan and Whitehouse, Sarah L. and Patel, Bipin and Dennison, Simon and Davis, Tim (2010) Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive. Journal of Clinical Epidemiology.

Catalogue from Homo Faber 2007

Copyright 2010 Elsevier

FINAL DRAFT 30 JULY 2009 Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable and responsive

Corresponding Author: Nicholas Bellamy Postal Address: Centre of National Research on Disability and Rehabilitation Medicine (CONROD), Level 3, Mayne Medical School, The University of Queensland, Herston Rd, Brisbane, Queensland 4006, Australia e-mail: [email protected] Telephone: +61 7 3365 5560 Fax: +61 7 3346 4603 Nicholas Bellamy,1 Cecilia Wilson,1 Joan Hendrikz,1 Sarah L Whitehouse,2,3 Bipin Patel,4 Simon Dennison,4 Tim Davis,4 for the EDC Study Group2. 1Centre of National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland, Brisbane, Australia; 2 Departments of Orthopedic Surgery - Prince Charles Hospital, Royal Brisbane and Women’s Hospital and Mater Hospital, Brisbane, Australia. 3Institute of Health and Biomedical Innovation, Queensland University of Technology, The Prince Charles Hospital, Brisbane, Australia; 4Exco InTouch, Harlow, UK. Keywords: WOMAC, EDC, Osteoarthritis, Measurement, PRO Word Count: 2860

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FINAL DRAFT 30 JULY 2009

ABSTRACT Objectives: To evaluate the validity, reliability and responsiveness of EDC using the WOMAC® NRS 3.1 Index on Motorola V3 mobile phones. Methods: Patients with osteoarthritis (OA) undergoing primary unilateral hip or knee joint replacement surgery were assessed pre-operatively and 3-4 months post-operatively. Patients completed the WOMAC® Index in paper (p-WOMAC®) and electronic (m-WOMAC®) format in random order. Results: 24 men and 38 women with hip and knee OA participated and successfully completed the mWOMAC® questionnaire. Pearson correlations between the summated total index scores for the pWOMAC® and m-WOMAC® pre- and post-surgery were 0.98 and 0.99 (p