Dataset Information

Validation of a patient-reported outcome measure for giant cell arteritis.

ABSTRACT:

Objectives

GCA is systemic vasculitis manifesting as cranial, ocular or large vessel vasculitis. A prior qualitative study developed 40 candidate items to assess the impact of GCA on health-related quality of life (HRQoL). This study aimed to determine final scale structure and measurement properties of the GCA patient reported outcome (GCA-PRO) measure.

Methods

Cross-sectional study included UK patients with clinician-confirmed GCA. They completed 40 candidate items for the GCA-PRO at times 1 and 2 (3 days apart), EQ-5D-5L, ICECAP-A, CAT-PROM5 and self-report of disease activity. Rasch and exploratory factor analyses informed item reduction and established structural validity, reliability and unidimensionality of the final GCA-PRO. Evidence of validity was also established with hypothesis testing (GCA-PRO vs other PRO scores, and between participants with 'active disease' vs those 'in remission') and test-retest reliability.

Results

The study population consisted of 428 patients: mean (s.d.) age 74.2 (7.2), 285 (67%) female; 327 (76%) cranial GCA, 114 (26.6%) large vessel vasculitis and 142 (33.2%) ocular involvement. Rasch analysis eliminated 10 candidate GCA items and informed restructuring of response categories into four-point Likert scales. Factor analysis confirmed four domains: acute symptoms (eight items), activities of daily living (seven items), psychological (seven items) and participation (eight items). The overall scale had adequate Rasch model fit (χ2 = 25.219, degrees of freedom = 24, P = 0.394). Convergent validity with EQ5D-5L, ICECAP-A and Cat-PROM5 was confirmed through hypothesis testing. Internal consistency and test-retest reliability were excellent.

Conclusion

The final GCA-PRO is a 30-item, four-domain scale with robust evidence of validity and reliability in measuring HRQoL in people with GCA.

SUBMITTER: Ndosi M

PROVIDER: S-EPMC10765151 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

Validation of a patient-reported outcome measure for giant cell arteritis.

Ndosi Mwidimi M Almeida Celia C Dawson Jill J Dures Emma E Greenwood Rosemary R Bromhead Alison A Guly Catherine C Stern Steve S Hill Catherine C Mackie Sarah S Robson Joanna C JC

Rheumatology (Oxford, England) 20240101 1

<h4>Objectives</h4>GCA is systemic vasculitis manifesting as cranial, ocular or large vessel vasculitis. A prior qualitative study developed 40 candidate items to assess the impact of GCA on health-related quality of life (HRQoL). This study aimed to determine final scale structure and measurement properties of the GCA patient reported outcome (GCA-PRO) measure.<h4>Methods</h4>Cross-sectional study included UK patients with clinician-confirmed GCA. They completed 40 candidate items for the GCA-P ...[more]

PMID: 37144946

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Project description:BackgroundSurgical success of cochlear implantation is usually measured through speech perception and quality of life questionnaires. Although these questionnaires cover a broad spectrum of domains, they do not evaluate the consciousness of wearing a cochlear implant (CI) and how this impacts the daily life of patients. To evaluate this concept we aimed to develop and validate a standardized patient reported outcome measure (PROM) for use in cochlear implant users.MethodsDevelopment and evaluation of the COchlear iMPlant AwareneSS (COMPASS) questionnaire was realized following the COSMIN guidelines in three phases: (1) item generation, (2) qualitative pilot study to ensure relevance, comprehensiveness, comprehensibility, and face validity, and (3) quantitative survey study for the assessment of reliability (test-retest) with 54 participants.ResultsNine domains of CI awareness were identified through literature research and interviews with experts and patients. These resulted in the formulation of 18 items which were tested with a pilot study, after which 3 items were deleted. The final 15-item COMPASS questionnaire proved to have good validity and satisfactory reliability. The intraclass correlation coefficient calculated for items with continuous variables ranged from 0.66 to 0.89 with seven out of eight items scoring above the acceptable level of 0.7. The Cohen's kappa calculated for items with nominal variables ranged from -0.4 to 0.78 with 11 (sub)items out of 15 scoring above fair to good agreement. Measurement error analysis for items with continuous variables showed a mean difference of -2.18 to 0.22. The calculated 95% limits of agreement for these items revealed no statistically significant difference between the two administered questionnaires. For items with nominal variables, the percentages of agreement calculated, ranged between 0 and 95%, and 83.3 and 96.6% for positive and negative agreement, respectively.ConclusionThe COMPASS questionnaire is a valid and reliable PROM for evaluating the cochlear implant awareness, and it can be easily used in routine clinical practice.

Project description:BackgroundDue to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.MethodsAccording to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients' responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.ResultsThe final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach's alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.ConclusionsThe final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.

Dataset Information

Validation of a patient-reported outcome measure for giant cell arteritis.

Objectives

Methods

Results

Conclusion

Publications

Validation of a patient-reported outcome measure for giant cell arteritis.

Similar Datasets

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