[Show abstract][Hide abstract] ABSTRACT: Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.
A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45 %. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain 'number of deaths'.
The following outcome domains were included in this updated COS: 'physical functioning', 'pain intensity', 'health-related quality of life' and 'number of deaths'. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
European Spine Journal 04/2015; 24(6). DOI:10.1007/s00586-015-3892-3 · 2.47 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP were proposed in 1998 however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials.
An International Steering Committee including researchers, clinicians, and patient representatives from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed during the study. The patients' responses were isolated to assess whether there was substantial disagreement with the rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants' responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies between the two approaches emerged.
We present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to determine the smallest worthwhile effects of two treatments for nonspecific low back pain (LBP).
The benefit-harm trade-off method was used to estimate the smallest worthwhile effect of nonsteroidal anti-inflammatory drugs (NSAIDs) and physiotherapy for LBP. Patients seeking care for chronic LBP were interviewed by telephone before treatment commenced and 4 weeks later.
Patients need to see a median of 30% (interquartile range [IQR]: 10-40) more improvement in pain and 20% (IQR: 10-40) more improvement in disability than would occur without intervention to perceive the effect of NSAIDs are worthwhile. They would need to see 20% (IQR: 0-30) more improvement on pain and disability over natural recovery to perceive that the effect of physiotherapy was worthwhile. There was no difference in estimates of the smallest worthwhile effect elicited at baseline and 4 weeks later.
People with chronic back pain need to see larger effects on pain of NSAIDS than physiotherapy to consider the effects of these interventions worthwhile. These estimates of the smallest worthwhile effect can be used to interpret the findings of clinical trials and to design adequately powered clinical trials.
[Show abstract][Hide abstract] ABSTRACT: PURPOSE: To explore how patients with sciatica rate the 'bothersomeness' of paresthesia (tingling and numbness) and weakness as compared with leg pain during 2 years of follow-up. METHODS: Observational cohort study including 380 patients with sciatica and lumbar disc herniation referred to secondary care. Using the Sciatica Bothersomeness Index paresthesia, weakness and leg pain were rated on a scale from 0 to 6. A symptom score of 4-6 was defined as bothersome. RESULTS: Along with leg pain, the bothersomeness of paresthesia and weakness both improved during follow-up. Those who received surgery (n = 121) reported larger improvements in both symptoms than did those who were treated without surgery. At 2 years, 18.2 % of the patients reported bothersome paresthesia, 16.6 % reported bothersome leg pain, and 11.5 % reported bothersome weakness. Among patients with no or little leg pain, 6.7 % reported bothersome paresthesia and 5.1 % bothersome weakness. CONCLUSION: During 2 years of follow-up, patients considered paresthesia more bothersome than weakness. At 2 years, the percentage of patients who reported bothersome paresthesia was similar to the percentage who reported bothersome leg pain. Based on patients' self-report, paresthesia and weakness are relevant aspects of disc-related sciatica.
European Spine Journal 06/2013; 22(11). DOI:10.1007/s00586-013-2871-9 · 2.47 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The purpose of this study was to compare the predictive ability of the standardised screening tool Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) and the clinicians' prognostic assessment in identifying patients with low back pain (LBP) and neck pain at risk for persistent pain and disability at eight weeks follow-up. Patients seeking care for LBP or neck pain were recruited by 19 manual therapists in Norway. Patients completed the ÖMPQ and the low back- or neck specific Oswestry Disability Index/Neck Disability Index at baseline and 8 weeks after first consultation. The manual therapists filled in their assessment of patient's prognosis immediately after the first consultation, blinded for patient's answers to the questionnaire. A total of 157 patients (81with neck pain and 76 with LBP) were included. The best odds for predicting the outcome for LBP patients was found for the clinicians' assessment of prognosis (LR+ = 2.1 and LR- = 0.55), whereas the likelihood ratios were similar for the two tools in the neck group. For LBP patients, both the clinicians' assessment and the ÖMPQ contributed significantly in the separate regression models (p = 0.02 and p = 0.002, resp), whereas none of the tools where significant contributors for neck patients (p = 0.67 and 0.07). Neither of the two methods showed high precision in their predictions of follow-up at eight weeks. However, for LBP patients, the ÖMPQ and the clinicians' prognostic assessment contributed significantly in the prediction of functional outcome 8 weeks after the initial assessment of manual therapist, whereas the prediction for neck patients was unsure.
[Show abstract][Hide abstract] ABSTRACT: Introduction
Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition. The aim of this study was to evaluate whether a single treatment session with acupuncture can reduce time to recovery when applied in addition to standard LBP treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out.
Methods and analysis
In this randomised, controlled multicentre study in general practice in Southern Norway, 270 patients will be allocated into one of two treatment groups, using a web-based application based on block randomisation. Outcome assessor will be blinded for group allocation of the patients. The control group will receive standard treatment, while the intervention group will receive standard treatment plus acupuncture treatment. There will be different GPs treating the two groups, and both groups will just have one consultation. Adults who consult their GP because of acute LBP will be included. Patients with nerve root affection, ‘red flags’, pregnancy, previous sick leave more than 14 days and disability pension will be excluded. The primary outcome of the study is the median time to recovery (in days). The secondary outcomes are rated global improvement, back-specific functional status, sick leave, medication, GP visits and side effects. A pilot study will be conducted.
Ethics and dissemination
Participation is based on informed written consent. The authors will apply for an ethical approval from the Regional Committee for Medical and Health Research Ethics when the study protocol is published. Results from this study, positive or negative, will be disseminated in scientific medical journals.
Trial Registration Number
ClinicalTrials.gov Identifier: NCT01439412.
BMJ Open 05/2012; 2(3). DOI:10.1136/bmjopen-2012-001164 · 2.06 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To provide a thorough description of team rehabilitation care and compare the structure, process, and outcomes in two specialized arthritis rehabilitation settings.
Patients with inflammatory arthritis scheduled for inpatient rehabilitation in seven specialized rehabilitation centres and three rheumatology hospital departments in Norway were included consecutively in a prospective cohort study. Patients completed questionnaires at admission, at discharge, and at a 6-month follow-up, and kept a diary regarding structure and process variables during the rehabilitation stay.
Eighty patients in rehabilitation centres and 73 in hospital departments were included and 80% responded to the 6-month follow-up questionnaire. The two clinical settings differed significantly with regard to structure variables such as cost, referral of patients, length of stay, and number of health professionals involved, and most process variables reflecting treatment modalities. The most remarkable difference was in the amount of individual intervention compared with group intervention. Despite significant improvements in most outcomes at discharge, the scores deteriorated towards baseline level 6 months later. There was a trend towards more significant improvement during rehabilitation for patients at rehabilitation centres whereas patients at hospitals had more prolonged improvement.
Team rehabilitation for inflammatory arthritis in two different clinical settings differed across most variables for structure and process, but few significant differences in outcome were found. Considering the substantial differences in cost, there is an urgent need for consensus concerning which patients should receive rehabilitation in which setting. Future research on the development and evaluation of methods for prolonging the beneficial effects of rehabilitation is needed.
[Show abstract][Hide abstract] ABSTRACT: To compare the predictive ability of the Orebro Musculoskeletal Pain Questionnaire-a screening tool for psychosocial factors in patients with low back pain across 2 cultural settings (Norway and Australasia) and to establish whether the Orebro provides additional information about outcome than that provided by the baseline value of the prognostic outcome.
Prospective cohort studies with 12 month follow-up; 97 working patients were seeking primary care in Norway and 133 working individuals participated in a trial conducted in Australasia. A series of multiple regression analyses were conducted with pain and disability as outcomes, and the Orebro score and baseline values of the outcome as predictors.
The predictive ability of the Orebro was similar in Norway and Australasia in all the analyses except for disability at 12 months, in which the predictive ability was significantly stronger in Norway as compared to Australasia (P=0.011). The Orebro provided additional information about outcome than that provided by the baseline value of the prognostic outcome: for pain the R-square changes were from 2.4% to 4.0% with no statistically difference between the nationalities. For disability the R-square changes in the Australasian cohort ranged from 1.9% to 4.8% and in the Norwegian cohort from 4.5% to 6.5%.
The Orebro questionnaire had similar predictive ability in Norway and Australasia when pain was used as an outcome, whereas the Orebro tended to be a stronger predictor in Norway when disability was used as outcome.
The Clinical journal of pain 10/2009; 25(8):666-70. DOI:10.1097/AJP.0b013e3181a08732 · 2.70 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate health-care experiences of patients following inpatient rheumatology rehabilitation and to assess the association between these experiences and aspects of health-care delivery and patient characteristics.
Data were collected from 435 patients with a rehabilitation stay of >or= 1 week at 12 institutions in Norway in 2006. At discharge, patients completed the Rehabilitation Patient Experiences Questionnaire (Re-PEQ), which includes four important aspects of patient experiences. Multiple regression analysis was used to assess associations between Re-PEQ scores, health-care process, health and sociodemographic variables.
A total of 412 (94.7%) patients completed the Re-PEQ; scores ranged from 69 (social environment) to 83 (care/organization) on the 0-100 scale, where 100 represents the best possible experience. The social environment scale had the largest component of variation explained by the independent variables, which included number of doctor visits, amount of group education, and individual exercise (p < 0.01). The type of institution, number of doctor visits, mental health, and gender also explained significant components of variation in the other Re-PEQ scale scores.
Patients reported good experiences with rheumatology rehabilitation. Areas where poorer experiences emerged can help target areas for future initiatives aimed at improving the quality of care. Health and sociodemographic variables should be controlled for in studies of patient experiences.
[Show abstract][Hide abstract] ABSTRACT: Seven previous systematic reviews (SRs) have evaluated back schools, and one has evaluated brief education, with the latest SR including studies until November 2004. The effectiveness of fear-avoidance training has not been assessed.
To assess the effectiveness of back schools, brief education, and fear-avoidance training for chronic low back pain (CLBP).
We searched the MEDLINE database of randomized controlled trials (RCT) until August 2006 for relevant trials reported in English. Assessment of effectiveness was based on pain, disability, and sick leave. RCTs that reported back schools, or brief education as the main intervention, were included. For fear-avoidance training, evaluation of domain-specific outcome was required. Two reviewers independently reviewed the studies.
Eight RCTs including 1,002 patients evaluated back schools, three studies were of high quality. We found conflicting evidence for back schools compared with waiting list, placebo, usual care, and exercises, and a cognitive behavioral back school. Twelve trials including 3,583 patients evaluated brief education. Seven trials, six of high quality, evaluated brief education in the clinical setting. We found strong evidence of effectiveness on sick leave and short-term disability compared with usual care. We found conflicting or limited evidence for back book or Internet discussion (five trials, two of high quality) compared with waiting list, no intervention, massage, yoga, or exercises. Three RCTs of high quality, including 364 patients, evaluated fear-avoidance training. We found moderate evidence that there is no difference between rehabilitation including fear-avoidance training and spinal fusion.
Consistent recommendations are given for brief education in the clinical setting, and fear-avoidance training should be considered as an alternative to spinal fusion, and back schools may be considered in the occupational setting. The discordance between reviews can be attributed differences in inclusion criteria and application of evidence rules.
The Spine Journal 12/2007; 8(6):948-58. DOI:10.1016/j.spinee.2007.07.389 · 2.80 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate reliability and construct validity of the Norwegian versions of the Roland Morris Disability Questionnaire and the modified Oswestry Disability Index.
Translation of two functional status questionnaires and a cross-sectional study of measurement properties.
The questionnaires were translated and back-translated following the Guillemin criteria. The Norwegian versions were tested for 55 patients with acute low back pain and 50 patients with chronic low back pain. Test-retest with a 2-day interval was performed in a subsample of 28 patients from the chronic sample. Reliability was assessed by repeatability according to Bland and Altman, intraclass coefficient and coefficient of variation. Internal consistency was assessed by Cronbach's alpha. Concurrent construct validity was assessed with correlations between the questionnaires and the SF-36, Disability Rating Index and pain intensity.
Repeatability of the Roland Morris Disability Questionnaire was 4 points, coefficient of variation 15% and intraclass correlation coefficient 0.89, and of the modified Oswestry Disability Index 11, 12% and 0.88, respectively. Internal consistency was 0.94 for both questionnaires. The questionnaires correlated highly with the physical functioning scale of SF-36, moderately with pain, and low with mental scales of the SF-36.
The reliability and construct validity of the Norwegian versions of the Roland Morris Disability Questionnaire and the modified Oswestry Disability Index are acceptable for assessing functional status of Norwegian-speaking patients with low back pain.
Journal of Rehabilitation Medicine 10/2003; 35(5):241-7. DOI:10.1080/16501970306094 · 1.90 Impact Factor