Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis

Kosinski, Mark; Zhao, Sean Z.; Dedhiya, Seema D.; Osterhaus, Jane T.; Ware, John E.

doi:10.1002/1529-0131(200007)43:7<1478::aid-anr10>3.0.co;2-m

Cited by 429 publications

(263 citation statements)

References 21 publications

(16 reference statements)

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“…Self-efficacy has been correlated with SLE outcome in several studies (8)(9)(10)(11)(12)(13)(14)(15) and has been found to consistently predict health-related outcomes in prospective studies (60). In this trial, we demonstrated that self-efficacy could be enhanced by our intervention and that it was a key predictor of mental health status and fatigue outcomes.…”

Section: Discussionmentioning

confidence: 52%

A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus

Karlson¹,

Liang²,

Eaton³

et al. 2004

Arthritis & Rheumatism

160

157

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Objective. In a cross-sectional study, we previously identified 2 potentially modifiable risk factors for adverse outcomes in systemic lupus erythematosus (SLE): self-efficacy and social support. The goal of this study was to evaluate in a randomized controlled trial a theory-based intervention to improve patient selfefficacy and partner support to manage SLE.Methods. Patients with SLE ages 18 years and older who met the American College of Rheumatology criteria and were able to identify a partner (spouse or family member) were recruited from 2 academic medical centers and randomized into an experimental group or a control group. Patients in the experimental group and their partners received an intervention designed to enhance self-efficacy, couples communication about lupus, social support, and problem solving, in the form of a 1-hour session with a nurse educator followed by monthly telephone counseling for 6 months. Patients in the control group and their partners received an attention placebo, including a 45-minute video presentation about lupus, and monthly telephone calls. Measures of physical and mental health status, disease activity, and psychosocial factors were collected at baseline, 6 months, and 12 months. The effect of the intervention on physical and mental health and disease activity at 6 and at 12 months was modeled with linear regression and adjusted for baseline health status, disease activity, sociodemographic factors, treatment change, and psychosocial factors.Results. One hundred twenty-two patients (plus their partners) were enrolled and randomized as follows: 64 to the experimental intervention and 58 to the attention control group. The participants were predominantly white, approximately half were college educated, and the groups were balanced for sociodemographic factors. At 6 months, significantly higher scores for couples communication (P ‫؍‬ 0.01) and problem-focused coping (P ‫؍‬ 0.03) were seen in the experimental group compared with the control group. At 12 months (6 months after the intervention ended), social support was higher (4.4 versus 4.1; P ‫؍‬ 0.03), self-efficacy was higher (7.2 versus 6.2; P ‫؍‬ 0.02), couples communication was higher (3.5 versus 3.1; P ‫؍‬ 0.03), and fatigue was lower (5.1 versus 6.3; P ‫؍‬ 0.02) in the experimental group compared with the control group. Global mental health status at 12 months, as measured by the Short Form 36 survey, was 69 points in the experimental group compared with 58 points in the control group (P ‫؍‬ 0.04). In multivariate models, adjusting for baseline covariates, scores for couple communication (P ‫؍‬ 0.01) were significantly higher at 6 months, and scores for self-efficacy (P ‫؍‬ 0.004) and global mental health status (P ‫؍‬ 0.03) were significantly higher at 12 months in the experimental group compared with the control group, and the mean score for global physical function was higher by 7 points, which was a clinically meaningful

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Section: Discussionmentioning

confidence: 52%

A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus

Karlson¹,

Liang²,

Eaton³

et al. 2004

Arthritis & Rheumatism

160

157

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“…The comparison of patients on ERT and patients naïve to ERT revealed that bodily pain was the only domain whose score had a statistically significant difference between groups (p ¼ 0.036), and the higher scores were found to be for the ERT group. According to the criteria established by Kosinski et al (2000), this change may also be classified as clinically significant. The physical functioning, role-physical, general health, social functioning, and role-emotional domains also showed clinically significant changes that favored the ERT subgroup (Table 3).…”

Section: Resultsmentioning

confidence: 99%

“…Changes in domain scores were classified as clinically significant according to the study conducted by Kosinski et al (2000), who evaluated patients with rheumatoid arthritis in the USA. The minimally significant changes defined by those authors were as follows: physical functioning -8.4; role-physical -21.0; bodily pain -14.7; general health -4.2; vitality -11.1; social functioning -11.7; roleemotional -17.9; and mental health domain -7.3.…”

Section: Definition Of Clinically Significant Changementioning

confidence: 99%

Quality of Life of Brazilian Patients with Gaucher Disease and Fabry Disease

et al. 2012

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Summary Objective: To evaluate QoL in a sample of Brazilian patients with Gaucher (GD) and Fabry (FD) disease using the SF-36 survey.Method: Observational cross-sectional study. The SF-36 survey was administered to cognitively able patients 12 years or older, who were seen in the Medical Genetics Service of Hospital de Clínicas de Porto Alegre, Brazil.Results: Thirty-five patients were included in the study (GD ¼ 21, FD ¼ 14), mean age was 29.8 AE 14. Discussion and Conclusion: Although limited because of the small number of patients included, findings suggest that patients with GD receiving ERT have a better QoL than patients with FD or with GD not receiving ERT. Imiglucerase has a beneficial effect against pain for patients with GD. Further studies should be conducted to confirm our findings.

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“…At baseline, median Sharp/van der Heijde scores were already larger in PROAR cohort patients than in SERAP cohort patients, and the progression rate was double in the nonintervention group (Table 1). The median TSS (25th percentile, 75th percentile) of PROAR cohort patients worsened from 12 (6,20) at baseline to 21 (11,28) after 2 years (P Ͻ 0.001). The same happened in the SERAP cohort, with the median TSS (25th percentile, 75th percentile) worsening from 7 (3,18) to 13 (5, 25) after 2 years (P ϭ 0.033).…”

Section: Resultsmentioning

confidence: 99%

Effectiveness of a clinical practice intervention in early rheumatoid arthritis

Descalzo¹,

Carbonell²,

González‐Álvaro³

et al. 2012

Arthritis Care & Research

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Objective. To compare the outcome of early rheumatoid arthritis (RA) patients in a country where early clinics were established versus the outcome of patients in nonprotocolized clinics. Methods. We compared 2 multicenter cohorts: an RA cohort derived from an early arthritis registry set in 36 reference hospitals in which a specific intervention was established (Evaluation of a Model for Arthritis Care in Spain [SERAP]), and a historical control cohort of patients with early RA attending 34 rheumatology departments (Prognosis in Rheumatoid Arthritis [PROAR] cohort). Effectiveness was tested by comparing the change in the Disease Activity Score in 28 joints (DAS28), the change in the Health Assessment Questionnaire (HAQ), and the change in the Sharp/van der Heijde radiologic score using marginal structural models. Results. A total of 161 early RA patients were recruited in the PROAR cohort and 447 in the SERAP cohort. Being a SERAP patient was inversely correlated with activity, resulting in a decrease of ؊0.24 (95% confidence interval [95% CI] ؊0.39, ؊0.08) units in the population average of the DAS28 after adjustment was made. Moreover, intervention may be seen as a protective factor of radiologic damage, with a decrease of ؊0.05 (95% CI ؊0.09, ؊0.01) units in the logarithm of the total Sharp/van der Heijde score. On the other hand, a decrease in functional impairment was detected, but intervention was not statistically associated with HAQ changes. Conclusion. Preventing major radiographic progression in a 2-year term inside structured and organized special programs for the management of disease, such as early arthritis clinics, are effective compared to nonprotocolized referrals, treatment, and followup.

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Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis

Abstract: Based on these results, minimally important changes in the SF-36 scales and HAQ disability scores were determined, which will be useful in interpreting HQL results in clinical trials.

Cited by 429 publications

References 21 publications

A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus

A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus

Quality of Life of Brazilian Patients with Gaucher Disease and Fabry Disease

Effectiveness of a clinical practice intervention in early rheumatoid arthritis

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