Comparative Responsiveness of Pain Outcome Measures Among Primary Care Patients With Musculoskeletal Pain (original) (raw)

Assessing Dimensionality and Responsiveness of Outcomes Measures for Patients with Low Back Pain

Pain Practice, 2011

Objective: To provide a systematic literature review of the responsiveness of patient-reported health outcomes measures for the evaluation of low back pain (LBP). Methods and Design: Searches of MEDLINE and EMBASE were performed for articles published in English through June 29, 2009 using the search terms "back pain" or "low back pain" and "questionnaires" or "instrument" or "survey" or "measure" or "patient report outcome." Information on responsiveness was gathered through additional measurespecific searches that included the measure name, first author of the original paper, and "respons*" or "sensit*." Responsiveness was determined based on use of a receiver operating characteristics curve or effect size statistics. Results: Of 43 identified measures, 31 were reported as being responsive to treatment or clinical change, 25 of which were evaluated for responsiveness using methods considered adequate. When considering both the responsiveness evaluation and the underlying factor structure, 13 measures were identified as being adequately validated for use in evaluating responsiveness in the research or clinical practice setting. The majority of the LBP outcome assessment studies were comprised of patients undergoing physical and interventional therapies from clinical practice and clinical trials. The Roland Morris Disability Questionnaire and the Oswestry Disability Index were the most comprehensively validated measures with respect to responsiveness. Conclusions: We identified 13 measures of LBP that can be used to evaluate responsiveness to change. Choice of a measure warrants careful evaluation of its construct and responsiveness properties in order to maximize the observed impact on pain and functional improvement in subjects with LBP.

A Systematic Review of Measures Used to Assess Chronic Musculoskeletal Pain in Clinical and Randomized Controlled Clinical Trials

The Journal of Pain, 2007

There are many types of pain assessments available to researchers conducting clinical trials, ranging from simple, single-item Visual Analog Scale (VAS) questions through extensive, multidimensional inventories. The primary question addressed in this survey of top-tier medical journals was: Which pain assessments are most commonly used in trials? Articles addressing chronic musculoskeletal pain in clinical trials were identified in seven major medical journals for the year 2003. A total of 50 studies (total original research articles reviewed: 1,476) met selection criteria, and from these we identified 28 types of pain assessments. Selected studies were classified according to the dimensions of pain assessed, the type of scale and descriptors/anchors used, and the reporting period specified. The most frequently used assessments were the single-item VAS scale and the Numeric Rating Scale (NRS); multidimensional inventories were used infrequently. There was considerable variability in the instructions patients received about the period to consider when evaluating their pain, and many studies provided only cursory information about their assessments in the methods. Overall, it appears that clinical trials utilize simple measures of pain and that there is no widely accepted standard for clinical pain assessment that would facilitate comparison of outcomes across trials.

Measurement properties of patient-reported outcome measures used in rehabilitation of adults with chronic musculoskeletal pain: A mapping review

Journal of Back and Musculoskeletal Rehabilitation, 2022

BACKGROUND: Choosing measurement tools for diagnostic, prognostic, or evaluative purposes in a chronic musculoskeletal pain (CMP) population is challenging for rehabilitation practice. Implementation of measurement tools for clinical practice is impaired by gaps in knowledge about measurement properties. OBJECTIVE: Identifying evidence about the measurement properties of tools frequently used in Dutch pain rehabilitation practice. METHODS: A mapping review was conducted of eligible studies that investigated reliability, validity, or responsiveness, and interpretability, as defined by the COSMIN taxonomy, of original versions or Dutch translations of predefined Patient-Reported Outcome Measures (PROMs) in a CMP population. MEDLINE, PsycINFO, EMBASE, and CINAHL were searched in March 2021. Results were visually mapped. RESULTS: Thirty-five studies were included. The results show many knowledge gaps in both original and translated versions. In general, aspects of validity were most frequently reported. The Pain Disability Index, Pain Catastrophizing Scale, and the 12-Item Short Form Health Survey were the most studied measurement tools. No results were found for the Checklist Individual Strength, Illness Perception Questionnaire, and Utrecht Coping List. CONCLUSION: Little evidence of the measurement properties of PROMs used in rehabilitation of patients with CMP in the Netherlands was found. PROMs need to be used and interpreted with caution in daily practice.

Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients

BMC musculoskeletal disorders, 2006

The choice of an evaluative instrument has been hampered by the lack of head-to-head comparisons of responsiveness and the minimal clinically important difference (MCID) in subpopulations of low back pain (LBP). The objective of this study was to concurrently compare responsiveness and MCID for commonly used pain scales and functional instruments in four subpopulations of LBP patients. The Danish versions of the Oswestry Disability Index (ODI), the 23-item Roland Morris Disability Questionnaire (RMQ), the physical function and bodily pain subscales of the SF36, the Low Back Pain Rating Scale (LBPRS) and a numerical rating scale for pain (0-10) were completed by 191 patients from the primary and secondary sectors of the Danish health care system. Clinical change was estimated using a 7-point transition question and a numeric rating scale for importance. Responsiveness was operationalized using standardized response mean (SRM), area under the receiver operating characteristic curve (R...

Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain

Pain medicine (Malden, Mass.), 2017

To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims. Literature review of existing PRO measures. Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes. Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris...

Refinement and validation of a tool for stratifying patients with musculoskeletal pain

European Journal of Pain, 2021

BackgroundPatients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost‐effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients.MethodsTool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF‐36 Physical Component Score [PCS]) and pain intensity were assessed at 2‐ and 6‐month cohort follow‐up; pain intensity was measured at 6‐month trial follow‐up.ResultsThe to...

Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 1—the Patient Assessment for Low Back Pain - Symptoms (PAL-S)

Pain, 2018

We describe the mixed-methods (qualitative and quantitative) development and preliminary validation of the Patient Assessment for Low Back Pain-Symptoms (PAL-S), a patient-reported outcome measure for use in chronic low back pain (cLBP) clinical trials. Qualitative methods (concept elicitation and cognitive interviews) were used to identify and refine symptom concepts and quantitative methods (classical test theory and Rasch measurement theory) were used to evaluate item-and scale-level performance of the measure using an iterative approach. Patients with cLBP participated in concept elicitation interviews (N 5 43), cognitive interviews (N 5 38), and interviewbased assessment of paper-to-electronic mode equivalence (N 5 8). A web-based sample of patients with self-reported cLBP participated in quantitative studies to evaluate preliminary (N 5 598) and revised (n 5 401) drafts and a physician-diagnosed cohort of patients with cLBP (N 5 45) participated in preliminary validation of the measure. The PALS contained 14 items describing symptoms (overall pain, sharp, prickling, sensitive, tender, radiating, shocking, shooting, burning, squeezing, muscle spasms, throbbing, aching, and stiffness). Item-level performance, scale structure, and scoring seemed to be appropriate. One-week test-retest reproducibility was acceptable (intraclass correlation coefficient 0.81 [95% confidence interval, 0.61-0.91]). Convergent validity was demonstrated with total score and MOS-36 Bodily Pain (Pearson correlation 20.79), Neuropathic Pain Symptom Inventory (0.73), Roland-Morris Disability Questionnaire (0.67), and MOS-36 Physical Functioning (20.65). Individual item scores and total score discriminated between numeric rating scale tertile groups and painDETECT categories. Respondent interpretation of paper and electronic administration modes was equivalent. The PALS has demonstrated content validity and is potentially useful to assess treatment benefit in cLBP clinical trials.