To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and ...health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.
Young adulthood is a sensitive period of life where development of musculoskeletal neck pain may be established and impact future health. The objective of this systematic review was to investigate ...risk factors for non-specific neck pain in young adults.
Systematic searches were conducted in six databases in September 2019. Prospective cohorts and registry studies including participants in whom the risk factor or the outcome (neck pain) was registered in the ages 18-29 years old were included. The Quality in Prognosis Studies tool was used for quality assessment. A modification of the Grading of Recommendations Assessments, Development and Evaluation was used to assess the overall quality of the evidence. Potential risk factors investigated in more than one study were summarised.
Searches yielded 4527 articles, of which six matched the eligibility criteria. Fifty-six potential risk factors were investigated in the six studies, covering a broad range of domains. Five risk factors were investigated in more than one study (female sex, body mass index (BMI), physical activity, duration of computer use and perceived stress). Physical activity and BMI showed no association with neck pain, and inconsistent results were found for female sex, duration of daily computer use and perceived stress. Risk of bias was moderate or high in all studies, and the overall quality of evidence was very low.
The studies included many potential risk factors, but none of them showed consistent associations with neck pain. There is a paucity of high-quality studies investigating risk factors for neck pain in young adults.
Pain catastrophizing has been found to be an important predictor of disability and days lost from work in patients with low back pain. The most commonly used outcome measure to identify pain ...catastrophizing is the Pain Catastrophizing Scale (PCS). To enable the use of the PCS in clinical settings and research in Norwegian speaking patients, the PCS had to be translated. The purpose of this study was therefore to translate and cross-culturally adapt the PCS into Norwegian and to test internal consistency, construct validity and reproducibility of the PCS.
The PCS was translated before it was tested for psychometric properties. Patients with subacute or chronic non-specific low back pain aged 18 years or more were recruited from primary and secondary care. Validity of the PCS was assessed by evaluating data quality (missing, floor and ceiling effects), principal components analysis, internal consistency (Cronbach's alpha), and construct validity (Spearman's rho). Reproducibility analyses included standard error of measurement, minimum detectable change, limits of agreement, and intraclass correlation coefficients.
A total of 38 men and 52 women (n = 90), with a mean (SD) age of 47.6 (11.7) years, were included for baseline testing. A subgroup of 61 patients was included for test-retest assessments. The Norwegian PCS was easy-to-comprehend. The principal components analysis supported a three-factor structure, internal consistency was satisfactory for the PCS total score (α 0.90) and the subscales rumination (α 0.83) and helplessness (α 0.86), but not for the subscale magnification (α 0.53). In total, 86% of the correlation analyses were in accordance with predefined hypothesis. The reliability analyses showed intraclass correlation coefficients of 0.74 - 0.87 for the PCS total score and subscales. The PCS total score (range 0-52 points) showed a standard error of measurement of 4.6 points and a 95% minimum detectable change estimate of 12.8 points.
The Norwegian PCS total score showed acceptable psychometric properties in terms of comprehensibility, consistency, construct validity, and reproducibility when applied to patients with subacute or chronic LBP from different clinical settings. Our study support the use of the PCS total score for clinical or research purposes identifying or evaluating pain catastrophizing.
Although many patients report clinical improvement after surgery due to degenerative cervical myelopathy, the aim of intervention is to stop progression of spinal cord dysfunction. We wanted to ...provide estimates and assess achievement rates of Minimal Clinically Important Difference (MCID) at 3- and 12-month follow-up for Neck Disability Index (NDI), Numeric Rating Scale for arm pain (NRS-AP) and neck pain (NRS-NP), Euro-Qol (EQ-5D-3L), and European Myelopathy Score (EMS).
614 degenerative cervical myelopathy patients undergoing surgery responded to Patient-Reported Outcome Measures (PROMs) prior to, 3 and 12 months after surgery. External criterion was the Global Perceived Effect Scale (1-7), defining MCID as "slightly better", "much better" and "completely recovered". MCID estimates with highest sensitivity and specificity were calculated by Receiver Operating Curves for change and percentage change scores in the whole sample and in anterior and posterior procedural groups.
The NDI and NRS-NP percentage change scores were the most accurate PROMs with a MCID of 16%. The change score for NDI and percentage change scores for NDI, NRS-AP and NRS-NP were slightly higher in the anterior procedure group compared to the posterior procedure group, while remaining PROM estimates were similar across procedure type. The MCID achievement rates at 12-month follow-up ranged from 51% in EMS to 62% in NRS-NP.
The NDI and NRS-NP percentage change scores were the most accurate PROMs to measure clinical improvement after surgery for degenerative cervical myelopathy. We recommend using different cut-off estimates for anterior and posterior approach procedures. A MCID achievement rate of 60% or less must be interpreted in the perspective that the main goal of surgery for degenerative cervical myelopathy is to prevent worsening of the condition.
Musculoskeletal conditions (MSCs) are widely prevalent in present-day society, with resultant high healthcare costs and substantial negative effects on patient health and quality of life. The main ...aim of this overview was to synthesize evidence from systematic reviews on the effects of exercise therapy (ET) on pain and physical function for patients with MSCs. In addition, the evidence for the effect of ET on disease pathogenesis, and whether particular components of exercise programs are associated with the size of the treatment effects, was also explored.
We included four common conditions: fibromyalgia (FM), low back pain (LBP), neck pain (NP), and shoulder pain (SP), and four specific musculoskeletal diseases: osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and osteoporosis (OP). We first included Cochrane reviews with the most recent update being January 2007 or later, and then searched for non-Cochrane reviews published after this date. Pain and physical functioning were selected as primary outcomes.
We identified 9 reviews, comprising a total of 224 trials and 24,059 patients. In addition, one review addressing the effect of exercise on pathogenesis was included. Overall, we found solid evidence supporting ET in the management of MSCs, but there were substantial differences in the level of research evidence between the included diagnostic groups. The standardized mean differences for knee OA, LBP, FM, and SP varied between 0.30 and 0.65 and were significantly in favor of exercise for both pain and function. For NP, hip OA, RA, and AS, the effect estimates were generally smaller and not always significant. There was little or no evidence that ET can influence disease pathogenesis. The only exception was for osteoporosis, where there was evidence that ET increases bone mineral density in postmenopausal women, but no significant effects were found for clinically relevant outcomes (fractures). For LBP and knee OA, there was evidence suggesting that the treatment effect increases with the number of exercise sessions.
There is empirical evidence that ET has beneficial clinical effects for most MSCs. Except for osteoporosis, there seems to be a gap in the understanding of the ways in which ET influences disease mechanisms.
The Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and the Patient-Specific Functional Scale (PSFS) are commonly used outcome instruments for measuring self-reported ...disability in patients with shoulder pain. To date, few studies have evaluated the responsiveness and estimated their minimal important change (MIC). Further assessment will expand the current knowledge and improve the interpretability of these instruments in clinical and research practice. The purpose of this prospective cohort study with 3 months follow-up was to evaluate the responsiveness of the QuickDASH and PSFS in patients with shoulder pain, and to estimate their MICs by using two different anchor-based methods.
Patients with shoulder pain recruited at a multidisciplinary hospital outpatient clinic completed the QuickDASH and PSFS at baseline and at 3 months follow-up. The responsiveness was evaluated by using a criterion approach with the area under the receiver operating characteristic curve (AUC) and a construct approach by testing 9 a-priori hypotheses. The MIC was assessed using two anchor-based MIC methods.
134 patients participated at baseline and 117 (87.3%) at 3 months follow-up. The AUC was acceptable for both QuickDASH (0.75) and PSFS (0.75). QuickDASH met 7 (77.8%) and PSFS 8 (88.9%) of the hypotheses. None of the instruments showed signs of floor and ceiling effects. The MIC estimates ranged from 10.8 to 13.6 for QuickDASH and from 1.9 to 2.0 for PSFS, depending on the method used.
This study demonstrates that both the QuickDASH and PSFS are responsive measures of disability in patients with shoulder pain. The estimated MIC values were presented.
Object
Although many patients report clinical improvement after surgery due to degenerative cervical myelopathy, the aim of intervention is to stop progression of spinal cord dysfunction. We wanted ...to provide estimates and assess achievement rates of Minimal Clinically Important Difference (MCID) at 3- and 12-month follow-up for Neck Disability Index (NDI), Numeric Rating Scale for arm pain (NRS-AP) and neck pain (NRS-NP), Euro-Qol (EQ-5D-3L), and European Myelopathy Score (EMS).
Methods
614 degenerative cervical myelopathy patients undergoing surgery responded to Patient-Reported Outcome Measures (PROMs) prior to, 3 and 12 months after surgery. External criterion was the Global Perceived Effect Scale (1–7), defining MCID as “slightly better”, “much better” and “completely recovered”. MCID estimates with highest sensitivity and specificity were calculated by Receiver Operating Curves for change and percentage change scores in the whole sample and in anterior and posterior procedural groups.
Results
The NDI and NRS-NP percentage change scores were the most accurate PROMs with a MCID of 16%. The change score for NDI and percentage change scores for NDI, NRS-AP and NRS-NP were slightly higher in the anterior procedure group compared to the posterior procedure group, while remaining PROM estimates were similar across procedure type. The MCID achievement rates at 12-month follow-up ranged from 51% in EMS to 62% in NRS-NP.
Conclusion
The NDI and NRS-NP percentage change scores were the most accurate PROMs to measure clinical improvement after surgery for degenerative cervical myelopathy. We recommend using different cut-off estimates for anterior and posterior approach procedures. A MCID achievement rate of 60% or less must be interpreted in the perspective that the main goal of surgery for degenerative cervical myelopathy is to prevent worsening of the condition.
Purpose
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.
Methods
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.
Results
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’.
Conclusions
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.
Assessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol ...(EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance.
The Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported 'completely recovered' or 'much improved' from those who reported 'slightly improved', unchanged', 'slightly worse', 'much worse', or 'worse than ever' were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score.
We analysed 3859 patients with Lumbar Spinal Stenosis (LSS); mean age 66; female gender 50% and 617 patients with Lumbar Degenerative Spondylolisthesis (LDS); mean age 67; 72% female gender. The accuracy of identifying 'completely recovered' and 'much better' patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline. The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS.
For estimating a 'success' rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.
Abstract
Background
Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for ...biopsychosocial interventions that incorporate several different components and methods of delivery.
Objective
The study objective was to examine the indirect effects of the Cognitive Patient Education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome.
Design
This study was a secondary analysis of the COPE randomized controlled trial.
Methods
Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline – posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis.
Results
Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect = 0.09 95% CI = 0.03 to 0.16; pain catastrophizing standardized indirect effect = 0.05 95% CI = 0.01 to 0.12). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant.
Limitations
This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects.
Conclusions
The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term.
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