The Minimally Important Difference for Patient Reported Outcomes in Systemic Lupus Erythematosus Including the HAQ-DI, Pain, Fatigue, and SF-36

Colangelo, Kim; Pope, Janet; Peschken, Christine A.

doi:10.3899/jrheum.090193

Cited by 60 publications

(51 citation statements)

References 19 publications

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“…Encouragingly, the scores obtained for the anchor-based estimates were similar in value to those obtained from the distribution-based estimates. Previous research has suggested that there may be differences in RD values depending on whether individuals improve or deteriorate [45-47]. In the present study there was no bi-directional difference in anchor-based RD values for individuals who improved or deteriorated for the PRIMUS Activities and QoL scales.…”

Section: Discussioncontrasting

confidence: 47%

Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)

Twiss

Doward

McKenna

et al. 2010

Health Qual Life Outcomes

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BackgroundThe PRIMUS is a Multiple Sclerosis (MS)-specific suite of outcome measures including assessments of QoL (PRIMUS QoL, scored 0-22) and activity limitations (PRIMUS Activities, scored 0-30). The U-FIS is a measure of fatigue impact (scored 0-66). These measures have been fully validated previously using an MS sample with mixed diagnoses. The aim of the present study was to validate the measures further in a specifically Relapse Remitting MS (RRMS) sample and to provide preliminary evidence of the responder definitions (RD; also known as minimal important difference) for these instruments.MethodsData were derived from a multi-country efficacy trial of MS patients with assessments at baseline and 12 months. Baseline data were used to assess the internal reliability and validity of the measures. Both anchor-based and distribution-based approaches were employed for estimating RD. Anchor-based estimates were based on published RD values for the EQ-5D and were assessed for those improving and deteriorating separately. Distribution-based estimates were based on standard error of measurement (SEM), change score equivalent to 0.30, and change score equivalent to 0.50, effect sizes (ES).ResultsThe sample included 911 RRMS patients (67.3% female, age mean (SD) 36.2 (8.4) years, duration of MS mean (SD) 4.8 (5.2) years). Results showed that the PRIMUS and U-FIS had good internal consistency. Appropriate correlations were observed with comparator instruments and both measures were able to distinguish between participants based on Expanded Disability Status Scale scores and time since diagnosis. The anchor-based and distribution-based RD estimates were: PRIMUS Activities range = 1.2-2.3, PRIMUS QoL range = 1.0-2.2, and U-FIS range = 2.4-7.0.ConclusionsThe results show that the PRIMUS and U-FIS are valid instruments for use with RRMS patients. The analyses provide preliminary information on how to interpret scores on the scales. These data will be useful for assessing treatment efficacy and for powering clinical studies.Trial Reference NumberClinicalTrials.gov Identifier NCT00340834.

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Section: Discussioncontrasting

confidence: 47%

Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)

Twiss

Doward

McKenna

et al. 2010

Health Qual Life Outcomes

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“…Sex-specific population means for satisfaction are 51 ± 9 and 49 ± 11 for males and females, respectively. We considered a difference in score of 2–4 as a clinically meaningful difference similar to other PROMIS measures [26–28]. …”

Section: Methodsmentioning

confidence: 99%

Inflammatory Bowel Diseases Can Adversely Impact Domains of Sexual Function Such as Satisfaction with Sex Life

et al. 2018

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“…Finally, MCIDs have been suggested to differ for patients with other conditions. (27, 28). Thus, we caution applying these MCID values for change in CDAI for early RA disease activity improvement and worsening to assume that they are the same in other settings, such as for RA patients with more established disease…”

Section: Discussionmentioning

confidence: 99%

Determining the Minimally Important Difference in the Clinical Disease Activity Index for Improvement and Worsening in Early Rheumatoid Arthritis Patients

Curtis

Yang

Chen

et al. 2015

Arthritis Care & Research

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Background Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasingly used. The minimally clinically important differences (MCID) for some measures, such as the clinical disease activity index (CDAI), have not been well-defined in real-world clinic settings, especially for early RA patients with low/moderate disease activity. Methods Data from Canadian Early Arthritis Cohort patients were used to examine absolute change in CDAI in the first year after enrollment, stratified by disease activity. MCID cutpoints were derived to optimize the sum of sensitivity and specificity versus the gold standard of patient self-reported improvement or worsening. Specificity, positive predictive value and negative predictive values were calculated against patient self-reported improvement (gold standard) and for change in pain, HAQ and DAS28 improvement. Discrimination was examined using area under receiver operator curves (ROC). Similar methods were used to evaluate MCIDs for worsening for patients who achieved low disease activity. Results A total of 578 patients (mean (SD) age 54.1 (15.3) years; 75% women, median (IQR) disease duration 5.3 (3.3, 8.0) months) contributed 1169 visit pairs to the improvement analysis. The MCID cutpoints for improvement were 12 (patients starting in high disease activity, CDAI>22), 6 (moderate, CDAI 10–22), and 1 (low disease activity, CDAI <10). Performance characteristics were acceptable using these cutpoints for pain, HAQ, and DAS28. The MCID for CDAI worsening among patients who achieved low disease activity was 2 units. Conclusions These minimally important absolute differences in CDAI can be used to evaluate improvement and worsening and increase the utility of CDAI in clinical practice.

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The Minimally Important Difference for Patient Reported Outcomes in Systemic Lupus Erythematosus Including the HAQ-DI, Pain, Fatigue, and SF-36

Cited by 60 publications

References 19 publications

Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)

Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)

Inflammatory Bowel Diseases Can Adversely Impact Domains of Sexual Function Such as Satisfaction with Sex Life

Determining the Minimally Important Difference in the Clinical Disease Activity Index for Improvement and Worsening in Early Rheumatoid Arthritis Patients

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