Responsiveness of self‐report and therapist‐rated upper extremity structural impairment and functional outcome measures in early rheumatoid arthritis

Adams, Jo; Mullee, Mark; Burridge, Jane; Hammond, Alison; Cooper, Cyrus

doi:10.1002/acr.20078

Cited by 17 publications

(8 citation statements)

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“…The difference in scores between the groups was between 4-5 points on the MHQ overall hand function scale in favour of the exercise group. Although the responsiveness to change of the MHQ has been reported elsewhere, 41 the minimum clinically important difference for the MHQ has not been established in a conservatively treated RA population. Previous work has investigated this property of the MHQ following MCP joint arthroplasty with the minimum clinically important difference of the hand function subscale reported at 13 points.…”

Section: Interpretation and Implications For Clinical Practice And Pomentioning

confidence: 99%

Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation

Williams

Williamson

Heine

et al. 2015

Health Technology Assessment

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BackgroundThe effectiveness of exercise for improving hand and wrist function in people with rheumatoid arthritis (RA) is uncertain.ObjectivesThe study aims were (1) to estimate the clinical effectiveness and cost-effectiveness of adding an optimised exercise programme for hands and upper limbs to standard care for patients with RA; and (2) to qualitatively describe the experience of participants in the trial with a particular emphasis on acceptability of the intervention, exercise behaviours and reasons for adherence/non-adherence.DesignA pragmatic, multicentred, individually randomised controlled trial with an embedded qualitative study. Outcome assessors were blind to group assignment and independent of treatment delivery.SettingSeventeen NHS trusts in England comprising 21 rheumatology and therapy departments.ParticipantsAdults with RA who had pain and dysfunction of the hands and/or wrists and had been on stable medication for at least 3 months. Patients were excluded if they were under 18 years old, had undergone upper limb surgery/fracture in the last 6 months, were on a waiting list for upper limb surgery or were pregnant.InterventionsUsual care or usual care plus an individualised exercise programme. Usual care consisted of joint protection education, general exercise advice and functional splinting if required. The exercise programme consisted of six sessions of strengthening and stretching exercises with a hand therapist, daily home exercises and strategies to maximise adherence.Main outcome measuresThe primary outcome was the Michigan Hand Outcome Questionnaire (MHQ) overall hand function subscale score at 12 months. Secondary outcome measures included the full MHQ, pain, health-related quality of life (Short Form questionnaire-12 items), impairment (grip strength, dexterity and range of motion) and self-efficacy. European Quality of Life-5 Dimensions, medication and health-care use were collected for the health economics evaluation. Follow-up was at 4 and 12 months post randomisation. Analysis was performed on an intention-to-treat basis.ResultsWe randomised 490 patients (244 to usual care, 246 to exercise programme). Compliance with the treatments was very good (93% of usual care participants and 75% of exercise programme participants completed treatment). Outcomes were obtained for 89% of participants at 12 months (222 for usual care, 216 for exercise programme). There was a statistically significant difference in favour of the exercise programme for the primary outcome at 4 and 12 months [mean difference 4.6 points, 95% confidence interval (CI) 2.2 to 7.0 points; and mean difference 4.4 points, 95% CI 1.6 to 7.1 points, respectively]. There were no significant differences in pain scores or adverse events. The estimated difference in mean quality-adjusted life-years (QALYs) accrued over 12 months was 0.01 greater (95% CI –0.03 to 0.05) in the exercise programme group. Imputed analysis produced incremental cost-effectiveness ratio estimates of £17,941 (0.59 probability of cost-effectiveness at willingness-to-pay threshold of £30,000 per QALY). The qualitative study found the exercise programme to be acceptable and highlighted the importance of the therapist in enabling patients to establish a routine and incorporate the exercises into their lives.ConclusionsThe results of the Strengthening And stretching for Rheumatoid Arthritis of the Hand trial suggest that the addition of an exercise programme for RA hands/wrists to usual care is clinically effective and cost-effective when compared with usual care alone. No adverse effects were associated with the exercise programme. The economic analysis suggests that the intervention is likely to be cost-effective.Study registrationCurrent Controlled Trials ISRCTN 89936343.Funding detailsThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 19. See the NIHR Journals Library website for further project information. This report has been developed in association with the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford and the NIHR Biomedical Research Unit Funding Scheme. This project benefited from facilities funded through Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands.

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Section: Interpretation and Implications For Clinical Practice And Pomentioning

confidence: 99%

Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation

Williams

Williamson

Heine

et al. 2015

Health Technology Assessment

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“…The Michigan Hand Outcome Questionnaire (MHQ) is a well-established measure for patients with RA and widely used in clinical trials [10]. It has previously been compared to the Health Assessment Questionnaire (HAQ) in patients with RA [11] and also compared to the SF-12 in a study including patients with thumb osteoarthritis [12]. However, no studies have, to our knowledge, have so far investigated the performance of the MHQ in relation to preference-based measures..…”

Section: Introductionmentioning

confidence: 99%

An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand

Dritsaki

Petrou

Williams

et al. 2017

Health Qual Life Outcomes

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BackgroundThe aim of this study was to assess the psychometric properties, namely acceptability, validity, reliability, interpretability and responsiveness of the EuroQol EQ-5D (EQ-5D visual analogue (VAS) and EQ-5D (utility)), Short Form 12 Dimensions (SF-12), SF-6D and Michigan Hand Outcome Questionnaire (MHQ) in patients with rheumatoid arthritis (RA) of the hand.MethodsThe empirical investigation was based upon data from a randomised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the hands and/or wrists. Participants completed the EQ-5D, SF-12 and MHQ at baseline and at 4 and 12 months follow up. Acceptability was measured using completion rates over time; construct validity using the “known groups” approach, based on pain troublesomeness; convergent validity using spearman’s rho correlation (ρ); reliability using internal consistency (Cronbach’s alpha); interpretability using minimal important differences (MID); and responsiveness using effect sizes and standardised response means (SRM) stratified by level of self-rated improvement in hand and wrist function or level of self-rated benefit and satisfaction from trial treatments.ResultsAt baseline, the study population had a mean age of 62.4 years, a mean MHQ score of 52.1 and included 76% women. The EQ-5D (utility) had the highest completion rates across time points. All instruments discriminated between pre-specified groups based on pain troublesomeness. Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D (ρ = 0.65) and SF-6D (ρ = 0.63) utility scores. The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months, whilst minimal important differences varied considerably across PROMs.ConclusionsThe instruments evaluated in this study displayed varying psychometric properties in the context of RA of the hand. The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.

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“…The baseline measures are summarised in Table 1. A Research Clinic Questionnaire will record demographic details (age, sex, date of RA diagnosis, ethnicity, marital status, hand dominance) and the Michigan Hand outcomes Questionnaire (MHQ) [17], The MHQ has shown to be a reliable, valid and responsive measure for an RA population [18-20] and contains six domains (1) overall hand function, (2) Activities of Daily Living (ADL), (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction. Scores range from 0 to 100, with higher scores indicating better performance, except for the pain scale.…”

Section: Methodsmentioning

confidence: 99%

Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

Adams

Bridle

Dosanjh

et al. 2012

BMC Musculoskelet Disord

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BackgroundRheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA.Methods/design480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel.DiscussionThis paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.Trial registrationCurrent Controlled Trials ISRCTN89936343

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Responsiveness of self‐report and therapist‐rated upper extremity structural impairment and functional outcome measures in early rheumatoid arthritis

Cited by 17 publications

References 12 publications

Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation

Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation

An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand

Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

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