The psychometric properties of the PROMIS® profile CAT in people with stroke.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System® (PROMIS) Profile Computer Adaptive Testing (CAT) consists of seven CATs and one single item measuring most relevant aspects of health-related quality of life (HRQoL). The aim of our study was to determine construct validity and floor and ceiling effects of the PROMIS Profile CAT in Dutch people with stroke. METHODS: People with stroke receiving rehabilitation completed the PROMIS Profile CAT and the EuroQol-5 dimensions (EQ5D). Construct validity was evaluated with hypotheses testing based on expected correlations between the profile domains and the domains of the EQ5D. The proportion of participants with the lowest and highest scores were calculated for each profile domain to assess floor and ceiling effects. RESULTS: 160 participants were included (median age 61 years, 41.9% female). For the PROMIS Profile domains Physical Function, Anxiety, Depression, Sleep Disturbance, Pain Interference, and Pain Intensity > 75% of the results met our hypotheses. For Fatigue and Ability to Participate in Social Roles and Activities only 60% of hypotheses were met. No floor or ceiling effects were found, with the exception of a floor effect for Pain Intensity which probably indicates that many participants had no pain. CONCLUSION: Most domains of the PROMIS Profile CAT showed sufficient construct validity and no problematic floor or ceiling effects in people with stroke. These CATs and the single item Pain Intensity can be used to efficiently measure HRQoL in people with stroke.

Translation and cross-cultural adaptation of the ICHOM standard set for stroke: the Dutch version.

INTRODUCTION: The International Consortium for Health Outcomes Measurement (ICHOM) developed a standard set of patient-centered outcome measures for use in stroke patients. In addition to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, it is comprised of 25 questions that are not part of a specific questionnaire. This study aimed to translate these 25 single questions into Dutch. METHODS: Two native Dutch-speaking translators independently translated the original ICHOM questions into Dutch. A consensus translation was made by these translators and a third person. This translation was subsequently translated back to English independently by two native English-speaking translators. Afterwards a pre-final version was made by consensus of a committee. After field-testing among 30 stroke patients, a final version was made. RESULTS: The forward and backward translations led to eight cross-cultural adaptations. Based on the interviews with stroke patients, 12 questions were changed to enhance comprehensibility leading to a final Dutch translation of the 25 single questions. CONCLUSIONS: A Dutch translation of the 25 single questions of the ICHOM Standard Set for Stroke was developed. Now a complete ICHOM Standard Set for Stroke can be used in Dutch populations allowing comparison and improvement of stroke care.

Stratified exercise therapy does not improve outcomes compared with usual exercise therapy in people with knee osteoarthritis (OCTOPuS study): a cluster randomised trial.

QUESTION: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? DESIGN: Pragmatic cluster randomised controlled trial in a primary care setting. PARTICIPANTS: A total of 335 people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. INTERVENTION: Physiotherapy practices were randomised into an experimental arm providing stratified exercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. OUTCOME MEASURES: Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. RESULTS: Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI -0.4 to 0.7) and physical function (-0.8, 95% CI -4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. CONCLUSION: This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. REGISTRATION: Netherlands National Trial Register NL7463.

Pulmonary Rehabilitation Improves Self-Management Ability in Subjects With Obstructive Lung Disease.

BACKGROUND: Optimizing self-management is a key element in multidisciplinary pulmonary rehabilitation in patients with asthma or COPD. This observational study aimed to investigate the changes in self-management following pulmonary rehabilitation in subjects with chronic lung disease. METHODS: Data were prospectively and routinely gathered at initial assessment and discharge in subjects taking part in a 12-week multidisciplinary out-patient pulmonary rehabilitation program. Measures of self-management included the Patient Activation Measure (PAM), the Health Education Impact Questionnaire (HEIQ) (8 subscales), a Self-Efficacy Questionnaire (2 subscales), the Lung Information Needs Questionnaire (LINQ), and the Health Literacy Questionnaire (HLQ) (9 subscales). Mean differences with 95% CI and effect sizes were computed. RESULTS: A total of 70 subjects (62.9% women) were included, with a median age of 63.5 y; most of the subjects had been diagnosed with COPD (77%). Between admission and discharge, all measures of self-management increased significantly except for the HEIQ subscales of constructive attitudes and approaches, social integration and support, and health services navigation; and the HLQ subscale of social support for health. The largest improvements (effect size > 0.55) were seen for the PAM (0.57); the HEIQ subscales of health-directed behavior (0.71), self-monitoring and insight (0.62), and skill and technique acquisition (1.00); the HLQ subscales of having sufficient information to manage my health (1.21) and actively managing my health (0.66); and the LINQ (1.85). CONLCUSIONS: Self-management, including activation, improved significantly in subjects with asthma or COPD who took part in a multidisciplinary pulmonary rehabilitation program.

Hand-Use-at-Home Questionnaire: validity and reliability in children with neonatal brachial plexus palsy or unilateral cerebral palsy.

OBJECTIVE: To investigate construct validity and test-retest reliability of the parent-rated Hand-Use-at-Home questionnaire (HUH) in children with neonatal brachial plexus palsy or unilateral cerebral palsy. DESIGN AND SUBJECTS: For this cross-sectional study, children with neonatal brachial plexus palsy or unilateral cerebral palsy, aged 3-10 years, were eligible. MAIN MEASURES: The HUH, Pediatric Outcome Data Collection Instrument Upper Extremity Scale (neonatal brachial plexus palsy only), and Children's Hand-Use Experience Questionnaire (unilateral cerebral palsy only) were completed. The HUH was completed twice in subgroups of both diagnoses. Lesion-extent (indication of involved nerve rootlets in neonatal brachial plexus palsy as confirmed during clinical observation and/or nerve surgery) and Manual Ability Classification System levels (unilateral cerebral palsy) were obtained from the medical records. Spearman correlation coefficients between the HUH and all clinical variables, agreement, standard error of measurement, smallest detectable change and intra-class correlation were calculated. RESULTS: A total of 260 patients participated (neonatal brachial plexus palsy: 181), of which 56 completed the second HUH (neonatal brachial plexus palsy: 16). Median age was 6.9 years for children with neonatal brachial plexus palsy, 116 had C5-C6 lesions. Median age for children with unilateral cerebral palsy was 6.4 years, 33 had Manual Ability Classification System Level II. The HUH correlated moderately with lesion-extent ( rs =-0.5), Pediatric Outcome Data Collection Instrument Upper Extremity Scale ( rs = 0.6) and Children's Hand-Use Experience Questionnaire ( rs = 0.5) but weakly with Manual Ability Classification System levels ( rs = -0.4). Test-retest reliability was excellent (intra-class correlation2,1 = 0.89, standard error of measurement = 0.599 and smallest detectable change = 1.66 logits) and agreement was good (mean difference HUH1 - HUH2 = 0.06 logits). CONCLUSION: The HUH showed good construct validity and test-retest reliability in children with neonatal brachial plexus palsy or unilateral cerebral palsy.

Participation restrictions among adolescents and adults with neonatal brachial plexus palsy: the patient perspective.

PURPOSE: To examine the impact of neonatal brachial plexus palsy (NBPP) on societal participation of adolescents and adults. METHODS: This cross-sectional study was conducted among patients with NBPP, aged ≥16 years, who had visited our NBPP clinic. Patients completed questions on the influence of NBPP on their choices regarding education/work and their work-performance, the Impact on Participation/Autonomy questionnaire and the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). In addition, health-related quality of life (HRQoL) was assessed. RESULTS: Seventy-five patients participated (median age 20, inter quartile range 17-27). Twenty were full-time students, 28 students with a job, 21 employed, two unemployed, and four work-disabled. Sixty-six patients had had a job at some stage. Patients' overall HRQoL was comparable to the general population. 27/75 patients reported that NBPP had affected their choices regarding education and 26/75 those regarding work. 33/66 reported impact on their work performance. On the Impact on Participation/Autonomy questionnaire, 80% (49/61) reported restrictions in the work-and-education domain, 74% in social-relations and 67% in autonomy-outdoors. 37/61 reported participation restrictions on the USER-P. CONCLUSIONS: Although their overall HRQoL was not impaired, a substantial proportion of adolescent/adult patients reported that NBPP had an impact on choices regarding education and profession, as well as on work-performance. Restrictions in participation, especially in work and education were also reported. Guiding patients in making choices on education and work at an early stage and providing tailored physical as well as psychosocial care may prevent or address restrictions, which may improve participation. Implications for Rehabilitation Adolescent and adult patients with neonatal brachial plexus palsy perceive restrictions in societal participation, especially regarding the work-and-education domain. All patients with neonatal brachial plexus palsy may perceive restrictions in societal participation regardless of lesion severity, treatment history and side of the lesion. Adolescents and adults with neonatal brachial plexus palsy report that their choices regarding education and work, as well as their work-performance are influenced by their neonatal brachial plexus palsy. Patients with neonatal brachial plexus palsy should be followed throughout their life in order to provide them with appropriate information and treatment when health- or participation-related issues arise. Rehabilitation treatment is the best option to address all of the aforementioned issues, as surgical options in adolescents and adults are limited.

Role of rheumatology clinical nurse specialists in optimizing management of hand osteoarthritis during daily practice in secondary care: an observational study.

BACKGROUND: The purpose of this study was to describe the effectiveness of a single one-hour consultation by a clinical nurse specialist in patients with hand osteoarthritis during daily rheumatology practice in secondary care. METHODS: Consecutive patients diagnosed by rheumatologists to have primary hand osteoarthritis and referred to the clinical nurse specialist were eligible for entry into this study. The standardized 1-hour consultation consisted of assessments and education on hand osteoarthritis by a clinical nurse specialist. Before and 3 months after the consultation, assessments were done to evaluate treatment (use of assistive devices, acetaminophen), health-related quality of life (physical component summary [PCS] score of Short-Form 36), and hand pain/function (Australian/ Canadian Osteoarthritis Hand Index [AUSCAN]). Paired t-tests and McNemar tests were used to analyze differences between baseline and follow-up. Satisfaction was measured after consultation at follow-up using a multidimensional questionnaire comprising 13 items (rated on a four-point scale). RESULTS: A total of 439 patients were referred, with follow-up data available for 195 patients, comprising 177 (87%) females, and of mean age 59 ± 9.0 years. After consultation, the proportions of patients using assistive devices and/or acetaminophen increased significantly from 30% to 39% and from 35% to 49%, respectively. PCS improved significantly (P = 0.03) whereas AUSCAN hand pain/function showed no significant differences compared with baseline (P values 0.52 and 0.92, respectively). The proportions of patients reporting to be satisfied or fully satisfied ranged from 78% to 99% per item. CONCLUSION: A single, comprehensive, standardized assessment and education by a clinical nurse specialist improved the physical dimension of health-related quality of life in hand osteoarthritis. Most patients were satisfied with the consultation. Further controlled trials are needed to determine the added value of the clinical nurse specialist in care for hand osteoarthritis.

Dynamic exercise programs (aerobic capacity and/or muscle strength training) in patients with rheumatoid arthritis.

BACKGROUND: An up-to-date overview of the effectiveness and safety of dynamic exercise therapy (exercise therapy with a sufficient intensity, duration, and frequency to establish improvement in aerobic capacity and/or muscle strength) is lacking. OBJECTIVES: To assess the effectiveness and safety of short-term (< three months) and long-term (> three months) dynamic exercise therapy programs (aerobic capacity and/or muscle strength training), either land or water-based, for people with RA. To do this we updated a previous Cochrane review (van den Ende 1998) and made categories for the different forms of dynamic exercise programs. SEARCH STRATEGY: A literature search (to December 2008) within various databases was performed in order to identify randomised controlled trials (RCTs). SELECTION CRITERIA: RCTs that included an exercise program fulfilling the following criteria were selected: a) frequency at least twice weekly for > 20 minutes; b) duration > 6 weeks; c) aerobic exercise intensity > 55% of the maximum heart rate and/or muscle strengthening exercises starting at 30% to 50% of one repetition maximum; and d) performed under supervision. Moreover, the RCT included one or more of the following outcome measures: functional ability, aerobic capacity, muscle strength, pain, disease activity or radiological damage. DATA COLLECTION AND ANALYSIS: Two review authors independently selected eligible studies, rated the methodological quality, and extracted data. A qualitative analysis (best-evidence synthesis) was performed and, where appropriate, a quantitative data analysis (pooled effect sizes). MAIN RESULTS: In total, eight studies were included in this updated review (two additional studies). Four of the eight studies fulfilled at least 8/10 methodological criteria. In this updated review four different dynamic exercise programs were found: (1) short-term, land-based aerobic capacity training, which results show moderate evidence for a positive effect on aerobic capacity (pooled effect size 0.99 (95% CI 0.29 to 1.68). (2) short-term, land-based aerobic capacity and muscle strength training, which results show moderate evidence for a positive effect on aerobic capacity and muscle strength (pooled effect size 0.47 (95% CI 0.01 to 0.93). (3) short-term, water-based aerobic capacity training, which results show limited evidence for a positive effect on functional ability and aerobic capacity. (4) long-term, land-based aerobic capacity and muscle strength training, which results show moderate evidence for a positive effect on aerobic capacity and muscle strength. With respect to safety, no deleterious effects were found in any of the included studies. AUTHORS' CONCLUSIONS: Based on the evidence, aerobic capacity training combined with muscle strength training is recommended as routine practice in patients with RA.