COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

BACKGROUND: Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs. METHODS: An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings. RESULTS: Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM. DISCUSSION: The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.

Does pain medication influence outcomes in elderly people seeking care for back pain? BACE cohort study.

BACKGROUND: Back pain is common among older adults resulting in the high societal and economic burden of persistent pain and disability. Pain medications are frequently prescribed for back pain, especially among older patients, but the efficacy of analgesics on back pain in this patient population remains under debate. In the present study, we investigated the outcomes (i.e. pain intensity and disability) of pain medication use in older people with back pain participating in a prospective cohort study. METHODS: A total of 669 patients aged >55 years consulting a general practitioner for a new episode of back complaints were included in this study. The association between pain medication use and outcomes (pain intensity and disability) was assessed at 3-month follow-up. RESULTS: Pain medication users were observed to experience more pain and disability at baseline compared with non-users. At 3-month follow-up, patients from all subgroups (e.g. pain medication users versus non-users) improved over time. Yet medication users had higher pain intensity and poorer disability scores compared with non-users. Patients who de-escalated or stopped pain medication had lower pain and disability than non-users. When comparing different types of medications (i.e. paracetamol, non-steroidal anti-inflammatory drugs, opioids), none of the groups showed better scores regarding pain and disability in users compared with non-users. Opioid users displayed the highest levels of pain and disability. CONCLUSIONS: In the present study, although patients who de-escalated or stopped analgesics had less pain and disability, pain medication overall does not result in better outcomes in older people with back pain. SIGNIFICANCE: Older patients taking pain medication did not report better outcomes than the ones who did not, except for those who de-escalated or stopped pain medication. Caution should be taken in prescribing pain medication for older patients with back pain in primary care.

Predictors of outcome following a short multimodal rehabilitation program for patients with whiplash associated disorders.

BACKGROUND: Patients with whiplash associated disorders (WAD) may present with physical and psychological symptoms which persist long after the initial onset of pain. Several studies have shown that therapeutic exercise for motor and sensorimotor control combined with manual therapy in a multimodal rehabilitation (MMR) program is effective at improving pain and disability in patients with neck disorders. To date, no studies have investigated which self-reported physical or psychological symptoms are predictive of response to this MMR program. AIM: To determine which baseline features can predict outcome following a 3-week MMR program in patients with WAD. DESIGN: Observational prospective cohort study. SETTING: Outpatient rehabilitation clinic. POPULATION: Thirty-seven patients aged >18 years with a diagnosis of WAD grade II or III. METHODS: The MMR program included manual therapy, motor control and sensorimotor control training according to the clinical impairments of each patient. Patients were assessed before and after treatment for their physical and psychological symptoms by means of self-reported questionnaires. Regression models were estimated with pain intensity, disability and post-traumatic stress symptoms (PTSS) as outcomes. RESULTS: After treatment, patients exhibited significant improvements in all evaluated outcomes (all P<0.01). Regression models accounting for 35% and 36% of the variance in pain intensity outcomes included average pain intensity over the previous week and pain catastrophizing as significant predictors. Disability and pain catastrophizing were predictors of changes in disability following the MMR program explaining 49% of the variance in the model. Furthermore, higher PTSS at baseline was a significant predictor of PTSS after treatment, explaining 55% of the variance in the model. CONCLUSION: Improved outcomes on pain intensity, disability and PTSS following a MMR program could be partially predicted based on the patient's initial presentation. CLINICAL REHABILITATION IMPACT: This knowledge may assist clinicians in predicting outcome following a MMR program inclusive of specific exercise therapy and manual therapy in patients with WAD.

Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis.

OBJECTIVE: To assess the long term effects of multidisciplinary biopsychosocial rehabilitation for patients with chronic low back pain. DESIGN: Systematic review and random effects meta-analysis of randomised controlled trials. DATA SOURCES: Electronic searches of Cochrane Back Review Group Trials Register, CENTRAL, Medline, Embase, PsycINFO, and CINAHL databases up to February 2014, supplemented by hand searching of reference lists and forward citation tracking of included trials. STUDY SELECTION CRITERIA: Trials published in full; participants with low back pain for more than three months; multidisciplinary rehabilitation involved a physical component and one or both of a psychological component or a social or work targeted component; multidisciplinary rehabilitation was delivered by healthcare professionals from at least two different professional backgrounds; multidisciplinary rehabilitation was compared with a non- multidisciplinary intervention. RESULTS: Forty one trials included a total of 6858 participants with a mean duration of pain of more than one year who often had failed previous treatment. Sixteen trials provided moderate quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.21, 95% confidence interval 0.04 to 0.37; equivalent to 0.5 points in a 10 point pain scale) and disability (0.23, 0.06 to 0.40; equivalent to 1.5 points in a 24 point Roland-Morris index) compared with usual care. Nineteen trials provided low quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.51, -0.01 to 1.04) and disability (0.68, 0.16 to 1.19) compared with physical treatments, but significant statistical heterogeneity across trials was present. Eight trials provided moderate quality evidence that multidisciplinary rehabilitation improves the odds of being at work one year after intervention (odds ratio 1.87, 95% confidence interval 1.39 to 2.53) compared with physical treatments. Seven trials provided moderate quality evidence that multidisciplinary rehabilitation does not improve the odds of being at work (odds ratio 1.04, 0.73 to 1.47) compared with usual care. Two trials that compared multidisciplinary rehabilitation with surgery found little difference in outcomes and an increased risk of adverse events with surgery. CONCLUSIONS: Multidisciplinary biopsychosocial rehabilitation interventions were more effective than usual care (moderate quality evidence) and physical treatments (low quality evidence) in decreasing pain and disability in people with chronic low back pain. For work outcomes, multidisciplinary rehabilitation seems to be more effective than physical treatment but not more effective than usual care.