Longer-term quality of care, effectiveness, and cost-effectiveness of implementing a model of care for osteoarthritis: A cluster-randomized controlled trial.

OBJECTIVE: To assess the quality of care, effectiveness, and cost-effectiveness over 12 months after implementing a structured model of care for hip and knee osteoarthritis (OA) in primary healthcare as compared to usual care. DESIGN: In this pragmatic cluster-randomized, controlled trial with a stepped-wedge cohort design, we recruited 40 general practitioners (GPs), 37 physiotherapists (PTs), and 393 patients with symptomatic hip or knee OA from six municipalities (clusters) in Norway. The model included the delivery of a 3-hour patient education and 8-12 weeks individually tailored exercise programs, and interactive workshops for GPs and PTs. At 12 months, the patient-reported quality of care was assessed by the OsteoArthritis Quality Indicator questionnaire (16 items, pass rate 0-100%, 100%=best). Costs were obtained from patient-reported and national register data. Cost-effectiveness at the healthcare perspective was evaluated using incremental net monetary benefit (INMB). RESULTS: Of 393 patients, 109 were recruited during the control periods (control group) and 284 were recruited during interventions periods (intervention group). At 12 months the intervention group reported statistically significant higher quality of care compared to the control group (59% vs. 40%; mean difference: 17.6 (95% confidence interval [CI] 11.1, 24.0)). Cost-effectiveness analyses showed that the model of care resulted in quality-adjusted life-years gained and cost-savings compared to usual care with mean INMB €2020 (95% CI 611, 3492) over 12 months. CONCLUSIONS: This study showed that implementing the model of care for OA in primary healthcare, improved quality of care and showed cost-effectiveness over 12 months compared to usual care. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02333656.

Trajectories of change in symptom severity in patients with fibromyalgia: exploratory analyses of a randomised controlled trial.

The clinical picture of fibromyalgia (FM) symptoms fluctuates, and the symptom severity varies within and between patients. The current study aimed to identify groups of PDS trajectories and to explore differences in baseline characteristics between the potential groups of trajectories. We included patients from a completed randomised controlled trial, in total 170 patients diagnosed with FM according to the ACR 2010 criteria. The mean age was 40 years, and 94% were women. Symptom severity was assessed by the Polysymptomatic distress scale (PDS) [range 0 (no symptoms) to 31] at four timepoints over 13-18 months. Latent class growth analysis was used to identify patient trajectories based on their response pattern on the PDS. Potential differences in baseline characteristics between the trajectories were compared using appropriate statistical tests. Two distinct PDS trajectories were identified with 110 patients (65%) classified as the "no improvement" group and 60 (35%) as the "some improvement" group. Mean PDS scores at pre-baseline were ≥ 20 in both groups. At 12 months, the groups diverged, mean (SD) PDS score was 14 (3.82) in the "some improvement" group and 21 (4.12) in the "no improvement" group. There were no significant differences in baseline characteristics between the groups of PDS trajectories. We identified one group of FM patients that improved slightly during the study period and one group that not improved. There were no differences in baseline characteristics between the two groups.

Criterion validity of The International Physical Activity Questionnaire-Short Form (IPAQ-SF) for use in clinical practice in patients with osteoarthritis.

BACKGROUND: To tailor physical activity treatment programs for patients with osteoarthritis, clinicians need valid and feasible measurement tools to evaluate habitual physical activity. The widely used International Physical Activity Questionnaire-Short Form (IPAQ-SF) is not previously validated in patients with osteoarthritis. PURPOSE: To assess the concurrent criterion validity of the IPAQ-SF in patients with osteoarthritis, using an accelerometer as a criterion-method. METHOD: Patients with osteoarthritis (n = 115) were recruited at The Division of Rheumatology and Research at Diakonhjemmet Hospital (Oslo, Norway). Physical activity was measured by patients wearing an accelerometer (ActiGraph wGT3X-BT) for seven consecutive days, followed by reporting their physical activity for the past 7 days using the IPAQ-SF. Comparison of proportions that fulfilled physical activity recommendations as measured by the two methods were tested by Pearson Chi-Square analysis. Differences in physical activity levels between the IPAQ-SF and the accelerometer were analyzed with Wilcoxon Signed-Rank Test and Spearman rank correlation test. Bland-Altman plots were used to visualize the concurrent criterion validity for total- and intensity-specific physical activity levels. RESULTS: In total, 93 patients provided complete physical activity data, mean (SD) age was 65 (8.7) years, 87% were women. According to the IPAQ-SF, 57% of the patients fulfilled the minimum physical activity recommendations compared to 31% according to the accelerometer (p = 0.043). When comparing the IPAQ-SF to the accelerometer we found significant under-reporting of total physical activity MET-minutes (p = < 0.001), sitting (p = < 0.001) and walking (p < 0.001), and significant over-reporting of moderate-to-vigorous physical activity (p < 0.001). For the different physical activity levels, correlations between the IPAQ-SF and the accelerometer ranged from rho 0.106 to 0.462. The Bland-Altman plots indicated an increased divergence between the two methods with increasing time spent on moderate-to-vigorous intensity physical activity. CONCLUSION: Physical activity is a core treatment of osteoarthritis. Our finding that patients tend to over-report activity of higher intensity and under-report low-intensity activity and sitting-time is of clinical importance. We conclude that the concurrent criterion validity of the IPAQ-SF was weak in patients with osteoarthritis.

Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated osteoarthritis care model: secondary analyses from a cluster-randomised stepped-wedge trial.

BACKGROUND: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. METHODS: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. RESULTS: Two hundred eighty-four intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (ORadjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. CONCLUSIONS: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02333656. Registered 7. January 2015.

High intensity exercise for 3 months reduces disease activity in axial spondyloarthritis (axSpA): a multicentre randomised trial of 100 patients.

BACKGROUND: Exercise is considered important in the management of patients with rheumatic diseases, but the effect of high intensity exercises on disease activity is unknown. OBJECTIVE: To investigate the effectiveness of high intensity exercises on disease activity in patients with axial spondyloarthritis (axSpA). METHOD: Assessor blinded multicentre randomised controlled trial. 100 patients (aged from their 20s to their 60s) with axSpA were randomly assigned to an exercise group or to a no-intervention control group. The exercise group performed cardiorespiratory and muscular strength exercises at high intensity over 3 months. The control group received standard care and was instructed to maintain their usual physical activity level. Primary outcome was disease activity measured with the Ankylosing Spondylitis (AS) Disease Activity Scale (ASDAS, higher score=worst) and the Bath AS Disease Activity Index (BASDAI, 0-10, 10=worst). Secondary outcomes were inflammatory markers, physical function and cardiovascular (CV)-health. There was patient involvement in the design and reporting of this study. RESULTS: 97 of the 100 (97%) randomised patients completed the measurements after the intervention. There was a significant treatment effect of the intervention on the primary outcome (ASDAS: -0.6 [-0.8 to -0.3], p<0.001 and BASDAI: -1.2 [-1.8 to -0.7], p<0.001). Significant treatment effects were also seen for inflammation, physical function and CV-health. CONCLUSION: High intensity exercises reduced disease symptoms (pain, fatigue, stiffness) and also inflammation in patients with axSpA. It improves patients' function and CV health. This debunks concerns that high intensity exercise might exacerbate disease activity in patients with axSpA. TRIAL REGISTRATION NUMBER: NCT02356874.

Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002949.].

Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial.

BACKGROUND: To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international recommendations. The objective of this study was to assess the effectiveness of this model in primary care. METHODS AND FINDINGS: We conducted a cluster-randomised controlled trial with stepped-wedge cohort design in 6 Norwegian municipalities (clusters) between January 2015 and October 2017. The randomised order was concealed to the clusters until the time of crossover from the control to the intervention phase. The intervention was implementation of the SAMBA model, facilitated by interactive workshops for general practitioners and physiotherapists with an update on OA treatment recommendations. Patients in the intervention group attended a physiotherapist-led OA education and individually tailored exercise programme for 8-12 weeks. The primary outcome was patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire; 0-100, 100 = optimal quality) at 6 months. Secondary outcomes included patient-reported referrals to physiotherapy, magnetic resonance imaging (MRI), and orthopaedic surgeon consultation; patients' satisfaction with care; physical activity level; and proportion of patients who were overweight or obese (body mass index ≥ 25 kg/m2). In all, 40 of 80 general practitioners (mean age [SD] 50 [12] years, 42% females) and 37 of 64 physiotherapists (mean age [SD] 42 [8] years, 65% females) participated. They identified 531 patients, of which 393 patients (mean age [SD] 64 [10] years, 71% females) with symptomatic hip or knee OA were included. Among these, 109 patients were recruited during the control periods (control group), and 284 patients were recruited during interventions periods (intervention group). The patients in the intervention group reported significantly higher quality of care (score of 60 versus 41, mean difference 18.9; 95% CI 12.7, 25.1; p < 0.001) and higher satisfaction with OA care (odds ratio [OR] 12.1; 95% CI 6.44, 22.72; p < 0.001) compared to patients in the control group. The increase in quality of care was close to, but below, the pre-specified minimal important change. In the intervention group, a higher proportion was referred to physiotherapy (OR 2.5; 95% CI 1.08, 5.73; p = 0.03), a higher proportion fulfilled physical activity recommendations (OR 9.3; 95% CI 2.87, 30.37; p < 0.001), and a lower proportion was referred to an orthopaedic surgeon (OR 0.3; 95% CI 0.08, 0.80; p = 0.02), as compared to the control group. There were no significant group differences regarding referral to MRI (OR 0.6; 95% CI 0.13, 2.38; p = 0.42) and proportion of patients who were overweight or obese (OR 1.3; 95% CI 0.70, 2.51; p = 0.34). Study limitations include the imbalance in patient group size, which may have been due to an increased attention to OA patients among the health professionals during the intervention phase, and a potential recruitment bias as the patient participants were identified by their health professionals. CONCLUSIONS: In this study, a structured model in primary care resulted in higher quality of OA care as compared to usual care. Future studies should explore ways to implement the structured model for integrated OA care on a larger scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT02333656.

Is the Association Between Obesity and Hip Osteoarthritis Surgery Explained by Familial Confounding?

BACKGROUND: Familial confounding is confounding due to genetics or environmental exposures shared by family members. We aimed to study whether familial confounding explains the association between body mass index (BMI) and severe hip osteoarthritis (OA). METHODS: We linked data from the Norwegian Arthroplasty Registry with the Norwegian Twin Registry on the National ID-number in 2014, generating a population-based prospective cohort study of same-sex twins born between 1915 and 1960 (53.4% females). BMI was calculated from self-reported height/weight. The outcome was incident hip arthroplasty due to OA (follow-up time, 1987-2014; 424 914 person-years). We performed sex-specific co-twin control analyses of dizygotic (N = 5,226) and monozygotic (MZ, N = 3,803) twin pairs using Cox regression models and explored reasons for any familial confounding using bivariate twin models. RESULTS: The mean (SD) BMI was 22.6 (2.96), peak lifetime BMI 25.6 (2.61), and N = 614 had hip surgery due to OA. In cohort analyses, BMI was associated with hip OA for women and men (hazard ratio [HR] = 1.09, 95% confidence intervals [CIs] = 1.06 to 1.11 and HR = 1.08, 95% CI = 1.04 to 1.12, respectively). When adjusting for familial confounding within MZ twins, the association got stronger for women (HR = 1.19; 95% CI = 1.05 to 1.36) but weaker for men (HR = 0.93; 95% CI = 0.75 to 1.16). There was no genetic overlap between BMI and hip OA, yet the familial confounding in men provides suggestive evidence that the association could be explained by shared environmental factors. CONCLUSION: The association between BMI and hip OA may be explained by familial confounding for men. For women, there was no evidence for familial confounding, consistent with a causal association. See video abstract at, http://links.lww.com/EDE/B336.

Exercise for hand osteoarthritis.

BACKGROUND: Hand osteoarthritis (OA) is a prevalent joint disease that may lead to pain, stiffness and problems in performing hand-related activities of daily living. Currently, no cure for OA is known, and non-pharmacological modalities are recommended as first-line care. A positive effect of exercise in hip and knee OA has been documented, but the effect of exercise on hand OA remains uncertain. OBJECTIVES: To assess the benefits and harms of exercise compared with other interventions, including placebo or no intervention, in people with hand OA. Main outcomes are hand pain and hand function. SEARCH METHODS: We searched six electronic databases up until September 2015. SELECTION CRITERIA: All randomised and controlled clinical trials comparing therapeutic exercise versus no exercise or comparing different exercise programmes. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data, assessed risk of bias and assessed the quality of the body of evidence using the GRADE approach. Outcomes consisted of both continuous (hand pain, physical function, finger joint stiffness and quality of life) and dichotomous outcomes (proportions of adverse events and withdrawals). MAIN RESULTS: We included seven studies in the review. Most studies were free from selection and reporting bias, but one study was available only as a congress abstract. It was not possible to blind participants to treatment allocation, and although most studies reported blinded outcome assessors, some outcomes (pain, function, stiffness and quality of life) were self-reported. The results may be vulnerable to performance and detection bias owing to unblinded participants and self-reported outcomes. Two studies with high drop-out rates may be vulnerable to attrition bias. We downgraded the overall quality of the body of evidence to low owing to potential detection bias (lack of blinding of participants on self-reported outcomes) and imprecision (studies were few, the number of participants was limited and confidence intervals were wide for the outcomes pain, function and joint stiffness). For quality of life, adverse events and withdrawals due to adverse events, we further downgraded the overall quality of the body of evidence to very low because studies were very few and confidence intervals were very wide.Low-quality evidence from five trials (381 participants) indicated that exercise reduced hand pain (standardised mean difference (SMD) -0.27, 95% confidence interval (CI) -0.47 to -0.07) post intervention. The absolute reduction in pain for the exercise group, compared with the control group, was 5% (1% to 9%) on a 0 to 10 point scale. Pain was estimated to be 3.9 points on this scale (0 = no pain) in the control group, and exercise reduced pain by 0.5 points (95% CI 0.1 to 0.9; number needed to treat for an additional beneficial outcome (NNTB) 9).Four studies (369 participants) indicated that exercise improved hand function (SMD -0.28, 95% CI -0.58 to 0.02) post intervention. The absolute improvement in function noted in the exercise group, compared with the control group, was 6% (0.4% worsening to 13% improvement). Function was estimated at 14.5 points on a 0 to 36 point scale (0 = no physical disability) in the control group, and exercise improved function by 2.2 points (95% CI -0.2 to 4.6; NNTB 9).One study (113 participants) evaluated quality of life, and the effect of exercise on quality of life is currently uncertain (mean difference (MD) 0.30, 95% CI -3.72 to 4.32). The absolute improvement in quality of life for the exercise group, compared with the control group, was 0.3% (4% worsening to 4% improvement). Quality of life was 50.4 points on a 0 to 100 point scale (100 = maximum quality of life) in the control group, and the mean score in the exercise group was 0.3 points higher (3.5 points lower to 4.1 points higher).Four studies (369 participants) indicated that exercise reduced finger joint stiffness (SMD -0.36, 95% CI -0.58 to -0.15) post intervention. The absolute reduction in finger joint stiffness for the exercise group, compared with the control group, was 7% (3% to 10%). Finger joint stiffness was estimated at 4.5 points on a 0 to 10 point scale (0 = no stiffness) in the control group, and exercise improved stiffness by 0.7 points (95% CI 0.3 to 1.0; NNTB 7).Three studies reported intervention-related adverse events and withdrawals due to adverse events. The few reported adverse events consisted of increased finger joint inflammation and hand pain. Low-quality evidence from the three studies showed an increased likelihood of adverse events (risk ratio (RR) 4.55, 95% CI 0.53 to 39.31) and of withdrawals due to adverse events in the exercise group compared with the control group (RR 2.88, 95% CI 0.30 to 27.18), but the effect is uncertain and further research may change the estimates.Included studies did not measure radiographic joint structure changes. Two studies provided six-month follow-up data (220 participants), and one (102 participants) provided 12-month follow-up data. The positive effect of exercise on pain, function and joint stiffness was not sustained at medium- and long-term follow-up.The exercise intervention varied largely in terms of dosage, content and number of supervised sessions. Participants were instructed to exercise two to three times a week in four studies, daily in two studies and three to four times daily in another study. Exercise interventions in all seven studies aimed to improve muscle strength and joint stability or function, but the numbers and types of exercises varied largely across studies. Four studies reported adherence to the exercise programme; in three studies, this was self-reported. Self-reported adherence to the recommended frequency of exercise sessions ranged between 78% and 94%. In the fourth study, 67% fulfilled at least 16 of the 18 scheduled exercise sessions. AUTHORS' CONCLUSIONS: When we pooled results from five studies, we found low-quality evidence showing small beneficial effects of exercise on hand pain, function and finger joint stiffness. Estimated effect sizes were small, and whether they represent a clinically important change may be debated. One study reported quality of life, and the effect is uncertain. Three studies reported on adverse events, which were very few and were not severe.

Distribution of osteoarthritis in a Norwegian population-based cohort: associations to risk factor profiles and health-related quality of life.

The objective of the study was to examine the hand-, knee- and hip osteoarthritis (OA) distribution, risk factor profiles and health-related quality of life (HRQoL) in a population-based OA cohort. Persons with self-reported OA responded to questionnaires and attended a clinical examination (N = 606). We analyzed cross-sectional associations to risk factor profiles and HRQoL dimensions (Short Form 36) in four mutually exclusive groups based on fulfillment of The American College of Rheumatology criteria: no OA (NOA), monoarticular upper extremity (hand) OA (MOAupper-ex.), monoarticular lower extremity (hip or knee) OA (MOAlower-ex.) and polyarticular OA (POA). Multivariate regression analyses and correspondence analysis were performed. The distribution of NOA, MOAupper-ex. MOAlower-ex. and POA was 21.1, 25.4, 22.4 and 31.0%, respectively. Compared to NOA, minor differences were found in risk factor profile in MOAupper-ex., whereas POA was significantly associated with sociodemographic, metabolic and mechanical features. The correspondence analysis identified different risk factor profiles between the four OA phenotypes, but the differences were not statistically significant (p = 0.13). Regarding HRQoL, neither OA groups were associated with poorer mental functioning. MOAlower-ex. and POA were associated with, among other things, poorer physical functioning (ß = -6.2, 95% CI -11.2 to -1.2 and ß = -12.5, 95% CI -17.4 to -7.9, respectively) and more pain (ß = -5.4, 95% CI -10.4 to -0.3 and ß = -10.5, 95% CI -15.3 to -5.8, respectively). In this cohort of persons with self-reported OA, POA was the most prevalent phenotype and was associated with an unfortunate risk factor profile and several diminished HRQoL dimensions. POA needs further attention in research and clinical care.

Effect of cardiorespiratory and strength exercises on disease activity in patients with inflammatory rheumatic diseases: a systematic review and meta-analysis.

OBJECTIVE: To investigate the effects of cardiorespiratory and strength exercises on disease activity for patients with inflammatory rheumatic diseases (IRDs). DESIGN: A systematic review with meta-analysis registered at PROSPERO (CRD42015020004). PARTICIPANTS: Patients with IRDs. DATA SOURCES: The databases MEDLINE, AMED, Embase and CINAHL were searched from inception up to April 2016. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Trials were included if they were randomised controlled trials of adults with IRDs, comparing the effect of cardiorespiratory and strength exercises with usual care on disease activity and followed the American College of Sports Medicine's exercise recommendations. The primary outcome was disease activity in terms of inflammation, joint damage and symptoms. DATA SYNTHESIS: Data were pooled in a random-effect model for all outcomes, and standardised mean differences (SMDs) were calculated. The quality of evidence was evaluated according to the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: Twenty-six trials with a total of 1286 participants were included. There was high to moderate quality evidence, for a small beneficial effect on disease activity scores (0.19 (95% CI 0.05 to 0.33), p<0.01) and joint damage (SMD 0.27 (95% CI 0.07 to 0.46), p<0.01). Furthermore, moderate quality evidence for a small beneficial effect on erythrocyte sedimentation rate (SMD 0.20 (95% CI 0.0 to 0.39), p=0.04) and for no effect on C reactive protein (SMD -0.14 (95% CI -0.37 to 0.08), p=0.21). Beneficial effects were also seen for symptoms. CONCLUSIONS: The results of this review suggest beneficial effects of exercises on inflammation, joint damage and symptoms in patients with IRDs.

Aquatic exercise for the treatment of knee and hip osteoarthritis.

BACKGROUND: Osteoarthritis is a chronic disease characterized by joint pain, tenderness, and limitation of movement. At present, no cure is available. Thus only treatment of the person's symptoms and treatment to prevent further development of the disease are possible. Clinical trials indicate that aquatic exercise may have advantages for people with osteoarthritis. This is an update of a published Cochrane review. OBJECTIVES: To evaluate the effects of aquatic exercise for people with knee or hip osteoarthritis, or both, compared to no intervention. SEARCH METHODS: We searched the following databases up to 28 April 2015: the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library Issue 1, 2014), MEDLINE (from 1949), EMBASE (from 1980), CINAHL (from 1982), PEDro (Physiotherapy Evidence Database), and Web of Science (from 1945). There was no language restriction. SELECTION CRITERIA: Randomized controlled clinical trials of aquatic exercise compared to a control group (e.g. usual care, education, social attention, telephone call, waiting list for surgery) of participants with knee or hip osteoarthritis. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data and assessed risk of bias of the included trials. We analysed the pooled results using standardized mean difference (SMD) values. MAIN RESULTS: Nine new trials met the inclusion criteria and we excluded two earlier included trials. Thus the number of participants increased from 800 to 1190 and the number of included trials increased from six to 13. Most participants were female (75%), with an average age of 68 years and a body mass index (BMI) of 29.4. Osteoarthritis duration was 6.7 years, with a great variation of the included participants. The mean aquatic exercise duration was 12 weeks. We found 12 trials at low to unclear risk of bias for all domains except blinding of participants and personnel. They showed that aquatic exercise caused a small short term improvement compared to control in pain (SMD -0.31, 95% CI -0.47 to -0.15; 12 trials, 1076 participants) and disability (SMD -0.32, 95% CI -0.47 to -0.17; 12 trials, 1059 participants). Ten trials showed a small effect on quality of life (QoL) (SMD -0.25, 95% CI -0.49 to -0.01; 10 trials, 971 participants). These effects on pain and disability correspond to a five point lower (95% CI three to eight points lower) score on mean pain and mean disability compared to the control group (scale 0 to 100), and a seven point higher (95% CI 0 to 13 points higher) score on mean QoL compared with control group (scale 0 to 100). No included trials performed a radiographic evaluation. No serious adverse events were reported in the included trials with relation to aquatic exercise. AUTHORS' CONCLUSIONS: There is moderate quality evidence that aquatic exercise may have small, short-term, and clinically relevant effects on patient-reported pain, disability, and QoL in people with knee and hip OA. The conclusions of this review update does not change those of the previous published version of this Cochrane review.

Variation in fatigue may be poorly explained by pain: results from a longitudinal, exploratory study.

It is frequently claimed that fatigue reflects pain and that strategies for alleviating fatigue in patients with ankylosing spondylitis (AS) should focus on pain management. The aim of this study was twofold: to investigate the correlation between fatigue and pain over time and to investigate the temporal relationship between fatigue and pain in patients with AS. Fatigue and pain were assessed twice a week for 35 weeks in 23 patients with AS. Data were reported with text messages on mobile phones, constituting around 70 repeated measurements per patient. To estimate correlation over time, the correlation coefficient within individuals was estimated. When estimating the temporal relationship, we lagged the independent variable and performed individual linear regression. In 16 (70 %) of the patients, ≤ 36 % of the variance in fatigue was explained by pain. The association between fatigue and pain was synchronous in time in 13 (57 %) patients, while 5 (22 %) patients reported that fatigue precedes pain by 1 week and 5 (22 %) that pain precedes fatigue by 1 week. Fatigue and pain may be two separate and independent symptoms in some patients with AS. The clinical implication is that the two symptoms should be targeted separately because it cannot always be expected that an improvement in one is followed by an improvement in the other.

Collection of patient-reported outcomes;--text messages on mobile phones provide valid scores and high response rates.

BACKGROUND: Patients with inflammatory rheumatic diseases have expressed a need for more frequent measurement of relevant outcomes, due to the variations in their symptoms during the day and from day to day. At present, patient-reported outcomes are extensively collected with questionnaires completed with pen and paper. However, as a measurement tool in frequent data collection the questionnaires are impractical. In contrast, text messages on mobile phones are suitable for frequent data collection. The aim of this study was two-fold; to compare daily registrations of patient-reported outcomes assessed with text-messages on mobile phones (SMS) or with questionnaires completed with pen and paper (P&P), with regard to scores and variation of scores, and to examine feasibility of the SMS method in a multicentre clinical study. METHODS: To compare scores, 21 patients with an inflammatory, rheumatic disease performed daily assessments of pain, fatigue, stiffness and ability to carry out daily activities on a numeric rating scale (NRS). The patients were asked to assess the variables every other day with the SMS method and every other day with the P&P method for 28 consecutive days. In total each participant had to answer 14 P&P forms and 14 SMS messages. Mean scores and variation, expressed as the pooled standard deviation or as the average range between the maximum and minimum scores for the two methods, were compared using paired sample t-tests or Wilcoxon Signed Rank Test. To examine feasibility, 36 patients with an inflammatory, rheumatic disease assessed the same four variables with SMS twice a week for 35 weeks. Feasibility of the SMS method was expressed as mean response-rate (%) in the total group and per centre. RESULTS: Mean scores, standard deviation of mean scores and mean range scores did not differ significantly between the two methods (p > 0.05). Response-rate with the SMS method was 97.9% for the whole group and for the three centres 97.1%, 98.3% and 98.4%, respectively. CONCLUSION: Outcomes assessed on numeric rating scales and reported with text-messages on mobile phones or with questionnaires completed with pen and paper provide comparable scores. Further, the SMS method provided high response rates (> 97%) in a multicentre setting. Our results encourage the use of text messages on mobile phones in studies requiring frequent data collection and real-time assessment, as in fluctuating diseases such inflammatory, rheumatic diseases.

Effects of controlled breathing exercises and respiratory muscle training in people with chronic obstructive pulmonary disease: results from evaluating the quality of evidence in systematic reviews.

BACKGROUND: This paper reviews evidence and quality of Systematic Reviews (SRs) on the effects of breathing control exercises (BCEs) and respiratory muscle training (RMT) on breathlessness/dyspnea and other symptoms, and quality of life (QOL) for individuals with chronic obstructive pulmonary disease (COPD). METHODS: A search for BCE and RMT literature in COPD published between January 1, 2002 and December 31, 2013 was performed in the following databases: PubMed, Ovid, CINAHL, PsycINFO, AMED, Cochrane and PEDro. The AMSTAR criteria were used to evaluate quality. RESULTS: After reviewing 642 reports, seven SRs were identified on RMT and BCEs. Three SRs were of high quality, three were of moderate quality, and one was of low quality. Two high-quality SRs reported significantly beneficial effects of RMT on dyspnea, and one reported significant effects on disease-specific QOL and fatigue. In these SRs, pooled data analyses were performed with three to fourteen single randomised control trials (RCTs) included in the analysis. In one of the SRs the quality of the single RCTs were rated by the authors to be between 5-7 (with10 best) and in the other one the quality of the single RCTs were rated to be between 30-83% of the maximum score.One high-quality SR found a significant positive effect of BCE based on pooled data analysis with two single RCTs in regard to pursed-lip breathing (PLB) on breathlessness. In this SR, one single RCT on diaphragmatic breathing (DB) and another one on yoga breathing (YB) showed effect on disease-specific QOL. The single RCTs included in the SR were rated by the authors in the SRs to be of low and moderate quality. CONCLUSIONS: Based on three high-quality SRs performing pooled data analyses, there is evidence that RMT has effect on breathlessness, fatigue and disease-specific QOL and PLB on breathlessness. There is also evidence that single studies on DB and YB has effect on disease-specific QOL. Few RCTs are available and the variable quality of the single RCTs in the SRs, seem to require more RCTs in particular for BCEs, but also RMT before conclusions regarding effects and high quality SRs can be written.

Quality of hip and knee osteoarthritis management in primary health care in a Norwegian county: a cross-sectional survey.

BACKGROUND: Osteoarthritis (OA) is one of the most common causes of pain and disability in the adult population. Several studies have documented discordance between general practioners (GP) practice and management recommendations, but there is limited published information about patient reported experience of quality of care. The primary aim of this study was to assess the patient perceived quality of OA management in primary health care. Secondly, we wanted to explore the factors associated with the perceived quality of OA care. METHODS: A cross-sectional survey in six general practices in the county of Nord-Trøndelag in Norway, patients with radiologically diagnosed OA, according to ICPC codes L89, L90 or L91 or clinical signs and symptoms corresponding to OA in the hip or knee and patient-reported quality of OA care on the 17-item OsteoArthritis Quality Indicator questionnaire (OA-QI). OA-QI summary pass rates were calculated, in which the numerator represents the number with indicators passed and the denominator represents the total number of eligible persons. Associations with summary pass rates were explored with demographic, disease related and health care related factors as independent variables. RESULTS: A total of 119 patients were included (response rate 42%). The median summary QI pass rate for all 17 QIs was 47% (Inter Quartile Range 33-65%), but there were large variation between the different items. The referral for weight reduction had the lowest pass rate (8%), whereas the highest pass rate was having received information about the importance of physical activity and exercise (84%). The median summary QI pass rates for both non-pharmacological- (QIs 1-11) and pharmacological (QIs 13-16) treatments were 50% (IQR 25-75). In bivariate regression analyses, only overall treatment satisfaction was significantly associated with QI pass rate (p = 0.001), with unstandardized beta = 6.1 (95% CI 2.7 to 9.5), i.e. a one-point increase on the five-point satisfaction scale was associated with a 6% increase in pass rate. CONCLUSION: Considering that the median summary QI pass rate was 47%, there might be room for improvement in OA care. Advice and the referral of OA patients in need of weight reduction seem to have the greatest potential for improvement.

Exercise programme with telephone follow-up for people with hand osteoarthritis - protocol for a randomised controlled trial.

BACKGROUND: Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual's functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA. METHODS: Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based "Musculoskeletal pain in Ullensaker Study" (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives "usual care", whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted. DISCUSSION: This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.

The validity of self-reported body mass index in a population-based osteoarthritis study.

BACKGROUND: Obesity is a well-known risk factor for osteoarthritis (OA). The majority of obesity research in OA is performed using self-reported BMI-data, however, its validity in persons with OA is unknown. The aim of this study was to compare the validity of self-reported body mass index (BMI) in persons with and without clinical osteoarthritis (OA) in a population-based survey. METHODS: Height and weight were self-reported, and thereafter measured in 600 persons with and without clinical OA according to the American College of Rheumatology-criteria (knees, hips and/or hands). We compared the differences between measured and self-reported heights, weights and BMIs (kg/m2) for the two groups and explored whether demographic/clinical factors were associated with inaccurate reporting in the OA patients using multivariate linear regression analyses. RESULTS: Mean (SD) age was 64 (8.7) years and 412 (69%) were women. Participants with clinical OA (n = 449) underreported their BMI to a greater extent than participants without clinical OA (n = 151) [mean (SD) difference 1.34 (1.68) kg/m2 and 0.78 (1.40) kg/m2 (p = 0.000), respectively]. There was a strong dose-dependent association between higher measured BMI and greater underreporting of BMI in multivariate analyses (BMI 25-29.99 kg/m2: B = 0.40, 95% CI, 0.06, 0.77), BMI ≥ 30 kg/m2: B = 1.30, 95% CI, 0.86, 1.75) in the clinical OA patients. A higher age as well as the time interval from self-reported to measured BMI-data were associated with inaccurate reporting. CONCLUSIONS: Researchers using self-reported height and weight data should be aware of limited agreement with actual height and weight in overweight and obese individuals with clinical OA.

Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial.

BACKGROUND: Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge. METHODS/DESIGN: To evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index.The main analysis will be on an intention to treat basis and will assess the clinical- and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases. DISCUSSION: The findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases. TRIAL REGISTRATION: ISRCTN91433175.