Rasch analysis of the 23-item version of the Roland Morris Disability Questionnaire

Objective: To determine the psychometric properties of the 23-item version of the Roland Morris Disability Questionnaire (RMDQ-23) and to quantify their stability across 2 cultures/languages and 2 types of care-settings. Methods: Rasch analysis of data from 1,000 patients with low back pain from primary care (UK and Denmark) and secondary care (Denmark). Results: The RMDQ-23 is unidimensional if local item dependency issues are accommodated, but contains several misfitting or overdiscriminating items, some poor targeting of items, and the scoring of 4-5 items is differentially affected by common clinical characteristics (such as age, gender, pain intensity, pain duration and care setting), depending on the country. Conclusion: As similar results have been found for the RMDQ-24, we believe it is timely to reconsider whether: (i) the RMDQ should be reconstructed using an item-response theory-based approach that includes consideration of new items and response options; or (ii) the use of alternative questionnaires should be recommended, such as the Oswestry Disability Index, that have shown evidence of fitting the Rasch model; or (iii) a completely new condition-specific questionnaire should be developed, perhaps utilizing a computerized adaptive testing platform

Individualized quality of life in patients with low back pain: reliability and validity of the Patient Generated Index

Objective: To evaluate the reliability and validity of the improved version of the Patient Generated Index (PGI) in patients with low back pain. Methods: The PGI was administered to 90 patients attending care in 1 of 6 institutions in Norway and evaluated for reliability and validity. The questionnaire was given out to 61 patients for re-test purposes. Results: The PGI was completed correctly by 80 (88.9%) patients and, of the 61 patients responding to the re-test, 50 (82.0%) completed both surveys correctly. PGI scores were approximately normally distributed, with a median of 40 (range 80), where 100 is the best possible quality of life. There were no floor or ceiling effects. The 5 most frequently listed areas affecting quality of life were pain, sleep, stiffness, socializing and housework. The test-retest intraclass correlation coefficient was 0.73. The smallest detectable changes for individual and group purposes were 32.8 and 4.6, respectively. The correlations between PGI scores and other instrument scores followed a priori hypotheses of low to moderate correlations. Discussion: The PGI has evidence for reliability and validity in Norwegian patients with low back pain at the group level and may be considered for application in intervention studies when a comprehensive evaluation of quality of life is important. However, the smallest detectable change, of approximately 30 points, may be considered too large for individual purposes in clinical application

Responsiveness and Minimal Important Change for Pain and Disability Outcome Measures in Pregnancy-Related Low Back and Pelvic Girdle Pain.

BACKGROUND: Pregnancy-related low back pain and pelvic girdle pain (LBP/PGP) are common and negatively impact the lives of many pregnant women. Several patient-based outcome instruments measure treatment effect but there is no consensus about which measure to use with women who have these pain presentations. OBJECTIVE: The objective was to compare the responsiveness of 3 outcome measures in LBP/PGP: Oswestry Disability Index-version 2.0 (ODI), Pelvic Girdle Questionnaire (PGQ), and 0-10 numerical rating scale for pain severity (NRS); and to estimate a minimal important change (MIC) for these measures in pregnancy-related LBP/PGP. DESIGN: This was a methodology study using data from a pilot randomised trial (RCT). METHODS: Women (n = 124) with pregnancy-related LBP/PGP were recruited to a pilot RCT evaluating the benefit of adding acupuncture to standard care and 90 completed 8-weeks follow-up. Responsiveness was evaluated by examining correlation between change score and the external anchor (6-point global perceived effect scale) and by using receiver operating characteristic (ROC) curve analysis. MIC was estimated using anchor-based methods. RESULTS: All measures showed good responsiveness, with areas under ROC curve ranging from 0.77 to 0.90. The estimated MICs were 3.1, 11.0, 9.4, 13.3, and 1.3 for ODI, PGQ-total, PGQ-activity, PGQ-symptoms, and NRS, respectively. All the measures, apart from ODI, had MICs larger than the measurement error. LIMITATIONS: Lack of optimal "gold standard" or external criterion for assessing responsiveness and MIC was a limitation of this study. CONCLUSION: All 3 outcome measures demonstrated good responsiveness. MICs were derived for each instrument. The PGQ at 8 weeks post-randomisation was identified as an appropriate outcome measure for pregnancy-related LBP/PGP since it is specific to these pain presentations and assesses both activity limitations and symptoms. The NRS is an efficient, shorter alternative

The COPE LBP trial: Cognitive Patient Education for Low Back Pain - a cluster randomized controlled trial in primary care

<p>Abstract</p> <p>Background</p> <p>Non-specific low back pain (LBP) is usually self-limiting within 4-6 weeks. Longstanding pain and disability are not predictable from clinical signs or pathoanatomical findings. Pain cognition and physical performance have been shown to improve patients with chronic LBP following neurophysiological education. The primary aim of this study is to evaluate whether a specific cognitive based education programme for patients with LBP in primary care is more effective than normal care in terms of increased function. The secondary aims of the study are to evaluate whether this intervention also results in earlier return to work, decreased pain, increased patient satisfaction, increased quality-of-life, and cost utility.</p> <p>Methods/Design</p> <p>Cluster randomised controlled trial with 20 general practitioners and 20 physiotherapists in primary care as the unit of randomisation. Each practitioner will recruit up to 10 patients, aged 20 to 55 years, with non-specific sub-acute/chronic LBP of more than four weeks but less than 1 year's duration. Practitioners in the intervention arm will provide cognitive patient education intervention in up to four weekly sessions, each lasting 30 minutes. Practitioners in the control arm will provide normal treatment, but have to make four appointments for the patients. Patients, outcome assessors, and study statistician will be blinded to group allocation.</p> <p>Discussion</p> <p>We present the rationale and design of an ongoing RCT study that potentially offers an easily implemented treatment strategy for LBP patients in primary care. The results will be available in 2012.</p> <p>Trial registration</p> <p>ISRCTN04323845</p

Obesity and osteoarthritis in knee, hip and/or hand: An epidemiological study in the general population with 10 years follow-up

<p>Abstract</p> <p>Background</p> <p>Obesity is one of the most important risk factors for osteoarthritis (OA) in knee(s). However, the relationship between obesity and OA in hand(s) and hip(s) remains controversial and needs further investigation. The purpose of this study was to investigate the impact of obesity on incident osteoarthritis (OA) in hip, knee, and hand in a general population followed in 10 years.</p> <p>Methods</p> <p>A total of 1854 people aged 24–76 years in 1994 participated in a Norwegian study on musculoskeletal pain in both 1994 and 2004. Participants with OA or rheumatoid arthritis in 1994 and those above 74 years in 1994 were excluded, leaving n = 1675 for the analyses. The main outcome measure was OA diagnosis at follow-up based on self-report. Obesity was defined by a body mass index (BMI) of 30 and above.</p> <p>Results</p> <p>At 10-years follow-up the incidence rates were 5.8% (CI 4.3–7.3) for hip OA, 7.3% (CI 5.7–9.0) for knee OA, and 5.6% (CI 4.2–7.1) for hand OA. When adjusting for age, gender, work status and leisure time activities, a high BMI (> 30) was significantly associated with knee OA (OR 2.81; 95%CI 1.32–5.96), and a dose-response relationship was found for this association. Obesity was also significantly associated with hand OA (OR 2.59; 1.08–6.19), but not with hip OA (OR 1.11; 0.41–2.97). There was no statistically significant interaction effect between BMI and gender, age or any of the other confounding variables.</p> <p>Conclusion</p> <p>A high BMI was significantly associated with knee OA and hand OA, but not with hip OA.</p

Validity and reliability of the Norwegian version of the Musculoskeletal Health Questionnaire in people on sick leave.

BACKGROUND: The Musculoskeletal Health Questionnaire (MSK-HQ) is a recently developed generic questionnaire that consists of 14 items assessing health status in people with musculoskeletal disorders. The objective was to translate and cross-culturally adapt the MSK-HQ into Norwegian and to examine its construct validity and reliability in people on sick leave with musculoskeletal disorders. METHODS: A prospective cohort study was carried out in Norway on people between 18 and 67 years of age and sick leave due to a musculoskeletal disorder. The participants were recruited through the Norwegian Labour and Welfare Administration during November 2018-January 2019 and responded to the MSK-HQ at inclusion and after four weeks. Internal consistency was assessed by Cronbach's alpha, and structural validity with a factor analysis. Construct validity was assessed by eight "a priori" defined hypotheses regarding correlations between the MSK-HQ and other reference scales. Correlations were analyzed by Spearman's- or Pearson's correlation coefficient and interpreted as high with values ≥ 0.50, moderate between 0.30-0.49, and low < 0.29. Reliability was tested with test-retest, standard error of measurement (SEM) and smallest detectable change (SDC). RESULTS: A total of 549 patients, mean age (SD) 48.6 (10.7), 309 women (56.3%), were included. The mean (SD) MSK-HQ sum scores (min-max 3-56) were 27.7 (8.2). Internal consistency was 0.86 and a three-factor structure was determined by factor analysis. Construct validity was supported by the confirmation of all hypotheses; high correlation with HRQOL, psychosocial risk profile, and self-perceived health; moderate correlation with physical activity, self-perceived work ability, and work presenteeism; and low correlation with the number of sick days. The test-retest reliability was good with an intraclass correlation coefficient of 0.83 (95% CI, 0.74-0.89), SEM was 2.3 and SDC 6.5. CONCLUSIONS: The Norwegian version of the MSK-HQ demonstrated high internal consistency, a three-factor structure, good construct validity and good test-retest reliability when used among people on sick leave due to musculoskeletal disorders

Fear of movement and emotional distress as prognostic factors for disability in patients with shoulder pain: a prospective cohort study

Background: Shoulder pain is a prevalent and often long-lasting musculoskeletal disorder. The overall prognosis of shoulder pain is highly variable with 40-50% of patients reporting persistent pain 6-12 months after consulting a clinician. The evidence for psychological prognostic factors for patients with shoulder pain is inconsistent. Therefore, the objective of this study was to investigate the association between fear of movement and emotional distress at presentation and self-reported disability over one year of follow-up. Methods: This is a prospective cohort study of consecutive patients referred to secondary outpatient care due to shoulder pain. Consenting patients underwent a physical examination and completed a comprehensive questionnaire at baseline, three months-, and one-year follow-up. Associations between baseline fear of movement (0-10) or emotional distress (1-4), respectively, and patient reported disability measured using Quick Disability of the Arm and Shoulder (QuickDASH, 0-100) over one year were analyzed with linear mixed-effects models (LMM) for repeated measures (baseline, 3 months and 1 year), adjusting for established prognostic factors. Results: A total of 138 patients were recruited between March 2015 and January 2018, with response rates of 84.7% (n = 117) and 79.7% (n = 1 00) at three months and one year, respectively. Adjusted associations revealed that for every point increase in baseline fear of movement, the QuickDASH score increased (worsened) by 1.10 points (95% CI 0.2-2.0) over the follow-up year. For every point increase in baseline emotional distress, the QuickDASH score increased by 19.9 points (95% CI 13.9-25.9) from baseline over the follow-up year. Conclusion: Higher fear of movement and emotional distress scores at baseline were significantly associated with higher disability over one year in patients with shoulder pain referred to secondary care. Our study indicates that these psychological factors affect prognosis and should be considered by clinicians and researchers working with ipatients with shoulder pain

Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term. Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration: ISRCTN: ISRCTN5871969

Prognosis of chronic low back pain: design of an inception cohort study

BACKGROUND: Although clinical guidelines generally portray chronic low back pain as a condition with a poor prognosis this portrayal is based on studies of potentially unrepresentative survival cohorts. The aim of this study is to describe the prognosis of an inception cohort of people with chronic low back pain presenting for primary care. METHODS/DESIGN: The study will be an inception cohort study with one year follow-up. Participants are drawn from a cohort of consecutive patients presenting with acute low back pain (less than 2 weeks duration) to primary care clinics in Sydney, Australia. Those patients who continue to experience pain at three months, and are therefore classified as having chronic back pain, are invited to participate in the current study. The cohort will be followed up by telephone at baseline, 9 months and 12 months after being diagnosed with chronic low back pain. Recovery from low back pain will be measured by sampling three different outcomes: pain intensity, interference with function due to pain, and work status. Life tables will be generated to determine the one year prognosis of chronic low back pain. Prognostic factors will be assessed using Cox regression. DISCUSSION: This study will determine the prognosis of chronic non-specific low back pain in a representative cohort of patients sourced from primary care. The results of this study will improve understanding of chronic low back pain, allowing clinicians to provide more accurate prognostic information to their patients

Negative beliefs about low back pain are associated with high pain intensity and high level disability in community-based women

Background Although previous studies have investigated beliefs about back pain in clinical and employed populations, there is a paucity of data examining the beliefs of the broader community. We aimed to characterize the beliefs that community-dwelling women have about back pain and its consequences, and to determine whether those with varying levels of pain intensity and disability differ in their beliefs. Methods 542 community-dwelling women, aged 24 to 80 years, were recruited from a research database. Participants completed a self-administered questionnaire that included detailed demographic information, the Chronic Pain Grade Questionnaire (CPG) and the Back Beliefs Questionnaire (BBQ). The CPG examined individuals\u27 levels of pain intensity and disability, and the BBQ investigated their beliefs about back pain and its consequences. Results 506 (93.4%) women returned the study questionnaire. The mean (SD) BBQ score for the cohort was 30.7 (6.0), indicating generally positive beliefs about back pain. However, those women with high intensity pain and high level disability had a mean (SD) score of 28.5 (5.7) and 24.8 (5.7) respectively, which reflects greater negativity about back pain and its consequences. There was an association between negative beliefs and high pain intensity (OR = 0.94 (95% CI: 0.90, 0.99), p = 0.01) and high level disability (OR = 0.93 (95% CI: 0.89, 0.97), p = 0.001), after adjusting for confounders. Conclusion This study highlights that although women living in the community were generally positive about back pain, subgroups of women with high pain intensity and high level disability were identified who had more pessimistic views. While a causal relationship cannot be inferred from these cross-sectional data, the results suggest that negative beliefs individuals have about back pain may be predictive of chronic, disabling spinal pain.<br /