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2016 ; 14
(ä): 33
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Patient Uncertainty Questionnaire-Rheumatology (PUQ-R): development and
validation of a new patient-reported outcome instrument for systemic lupus
erythematosus (SLE) and rheumatoid arthritis (RA) in a mixed methods study
#MMPMID26927364
Cleanthous S
; Isenberg DA
; Newman SP
; Cano SJ
Health Qual Life Outcomes
2016[Mar]; 14
(ä): 33
PMID26927364
show ga
BACKGROUND: An in-depth qualitative exploration of uncertainty in systemic lupus
erythematosus (SLE) and rheumatoid arthritis (RA) led to the development of a
five-domain conceptual framework of patient uncertainty in these two conditions.
The purpose of this study was to develop and evaluate a new patient-reported
outcome (PRO) instrument for patient uncertainty in SLE and RA on the basis of
this empirically developed conceptual framework. METHODS: Cognitive debriefing
interviews were conducted to pre-test the initial items generated on the basis of
the preliminary qualitative exploration of patient uncertainty in SLE and RA. Two
separate field tests were conducted in five hospital sites to evaluate the
measurement properties of the new instrument; the first to identify and form
scales, and the second to assess measurement properties of the final version in
an independent sample. Psychometric evaluation was conducted in line with the
Rasch Measurement Theory (RMT), examining the extent to which sample to scale
targeting was satisfactory, measurement scales were constructed effectively and
the sample was measured successfully. Traditional psychometric techniques were
also used to provide complementary analyses best understood by clinicians.
RESULTS: Pre-testing supported the relevance, acceptability and comprehensibility
of the initial items. Findings indicated that the Patient Uncertainty
Questionnaire for Rheumatology PUQ-R instrument fulfilled the expectations of RMT
to a large extent (including person separation index 0.73 - 0.91). The PUQ-R
comprises 49 items across five scales; symptoms and flares (14 items), medication
(11 items), trust in doctor (8 items), self-management (6 items) and impact (10
items) which further displayed excellent measurement properties as assessed
against the traditional psychometric criteria (including Cronbach's alpha 0.82 -
0.93). CONCLUSION: The PUQ-R has been developed and evaluated specifically for
patients with SLE and RA. By quantifying uncertainty, the PUQ-R has the potential
to support evidence-based management programmes and research.