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Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):184-192. Epub 2017 May 2.

Patient participation in patient-reported outcome instrument development in systemic sclerosis.

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Royal National Hospital for Rheumatic Diseases, Bath; and Department of Pharmacy and Pharmacology, University of Bath, UK.
University of Utah and Salt Lake Regional Veterans Affair Medical Center, Salt Lake City, UT, USA.
University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Jewish General Hospital, Lady Davis Institute and McGill University, Montreal, Canada.



The patient perspective captured using Patient-Reported Outcome (PRO) instruments provide insight into the patient condition not always captured by physician-derived assessment tools. Target patient population involvement is an essential component of PRO instrument development. We have reviewed the level of patient involvement in the development of PRO instruments used in the assessment of systemic sclerosis (SSc).


A comprehensive literature review was undertaken to identify studies reporting PRO instruments in SSc. Studies were assessed to establish whether the PRO instruments had been developed specifically for SSc or adopted from other disease areas. Studies reporting PRO instruments specific for SSc were scrutinised for evidence of target patient population involvement in the development of the instrument.


A total of 58 PRO instruments that have been used in SSc research were identified. Twelve (21%) of these were developed specifically for outcome assessment within SSc populations. Of these, 5 (42%) had not reported any patient involvement in the development phase of the instrument. Five SSc PRO instruments (42%) involved target patient population in the domain/item generation stage. Four (33%) of SSc PRO instruments had undertaken cognitive interviewing to ensure item wording adequately captured the intended conceptual framework.


The majority of PRO instruments used to assess SSc have not involved significant target patient involvement in their development. By involving patients in the development of novel PRO instruments in SSc, we can ensure such instruments adequately capture the experiences most relevant to our patients.

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