Core outcome measurement instruments for clinical trials in nonspecific low back pain

Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A.; Buchbinder, Rachelle; Corbin, Terry P.; Costa, Leonardo Oliveira Pena; Foster, Nadine E; Grotle, Margreth; Koes, Bart W.; Kovacs, Francisco M.; Lin, Chung‐Wei Christine; Maher, Christopher G.; Pearson, Adam M.; Peul, Wilco C.; Schoene, Mark L.; Turk, Dennis C.; Tulder, Maurits W. van; Terwee, Caroline B.; Ostelo, Raymond

doi:10.1097/j.pain.0000000000001117

Cited by 280 publications

(264 citation statements)

References 105 publications

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“…Targeting self‐reported disability due to LBP with treatment may help reduce the need to seek professional advice (eg, physiotherapist, physical therapist, or exercise physiologist), improve the ability of the individual to complete ADLs, and subsequently reduce healthcare costs . Furthermore, clinical guidelines recommend that assessing disability should be the highest priority for clinicians . In addition to LBP disability measures, tools such as the Orebro Musculoskeletal Pain Questionnaire and the Keele STarT Back Tool may also be used as an initial screening tool to predict long‐term disability .…”

Section: Multidimensional Assessment Of Chronic Low Back Painmentioning

confidence: 99%

“…40 Furthermore, clinical guidelines recommend that assessing disability should be the highest priority for clinicians. 41 In addition to LBP disability measures, tools such as the Orebro Musculoskeletal Pain Questionnaire 42 and the Keele STarT Back Tool 43 may also be used as an initial screening tool to predict long-term disability. 42,43 Because LBP is a key component contributing to the global burden of disability, self-reported measures of LBP disability and long-term disability prognosis should be considered when assessing the efficacy of CLBP treatments.…”

Section: Biological and Functional Outcomesmentioning

confidence: 99%

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Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective

et al. 2019

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Nonspecific chronic low back pain (CLBP) is a common clinical condition that has impacts at both the individual and societal level. Pain intensity is a primary outcome used in clinical practice to quantify the severity of CLBP and the efficacy of its treatment; however, pain is a subjective experience that is impacted by a multitude of factors. Moreover, differences in effect sizes for pain intensity are not observed between common conservative treatments, such as spinal manipulative therapy, cognitive behavioral therapy, acupuncture, and exercise training. As pain science evolves, the biopsychosocial model is gaining interest in its application for CLBP management. The aim of this article is to discuss our current scientific understanding of pain and present why additional factors should be considered in conservative CLBP management. In addition to pain intensity, we recommend that clinicians should consider assessing the multidimensional nature of CLBP by including physical (disability, muscular strength and endurance, performance in activities of daily living, and body composition), psychological (kinesiophobia, fear‐avoidance, pain catastrophizing, pain self‐efficacy, depression, anxiety, and sleep quality), social (social functioning and work absenteeism), and health‐related quality‐of‐life measures, depending on what is deemed relevant for each individual. This review also provides practical recommendations to clinicians for the assessment of outcomes beyond pain intensity, including information on how large a change must be for it to be considered “real” in an individual patient. This information can guide treatment selection when working with an individual with CLBP.

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Section: Multidimensional Assessment Of Chronic Low Back Painmentioning

confidence: 99%

Section: Biological and Functional Outcomesmentioning

confidence: 99%

Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective

et al. 2019

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“…The other recommended outcomes are included as secondary parameters, i.e. pain intensity, health-related quality of life, psychological functioning and pain interference [43][44][45] (Table 2). All selected measurement instruments in the current study are determined to be valid and reliable in previous research.…”

Section: Primary Outcome Measurementioning

confidence: 99%

“…Physical functioning due to pain in LBP patients is assessed by the Oswestry Disability Index (ODI), version 2.1a [44][45][46].…”

Section: Primary Outcome Measurementioning

confidence: 99%

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Effectiveness and cost-effectiveness of stratified blended physiotherapy in patients with non-specific low back pain: study protocol of a cluster randomized controlled trial

Koppenaal

Arensman

Dongen³

et al. 2020

BMC Musculoskelet Disord

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Background: Patient education, advice on returning to normal activities and (home-based) exercise therapy are established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour. Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on patients' physical functioning. The aim of this study is to investigate the short-(3 months) and long-term (12 and 24 months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual primary care physiotherapy in patients with LBP.

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Outcome Measures for the Evaluation of Treatment Response in Hidradenitis Suppurativa for Clinical Practice

Mastacouris,

Tannenbaum,

Strunk

et al. 2023

JAMA Dermatol

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ImportanceAlthough several clinician- and patient-reported outcome measures have been developed for trials in hidradenitis suppurativa (HS), there is currently no consensus on which measures are best suited for use in clinical practice. Identifying validated and feasible measures applicable to the practice setting has the potential to optimize treatment strategies and generate generalizable evidence that may inform treatment guidelines.ObjectiveTo establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied.Evidence ReviewClinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice.FindingsAmong HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]).Conclusions and RelevanceAn international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.

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Core outcome measurement instruments for clinical trials in nonspecific low back pain

Abstract: Supplemental Digital Content is Available in the Text.Consensus-based recommendations are provided on outcome measurement instruments for physical functioning, pain intensity, and health-related quality of life in patients with nonspecific low back pain.

Cited by 280 publications

References 105 publications

Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective

Domains of Chronic Low Back Pain and Assessing Treatment Effectiveness: A Clinical Perspective

Effectiveness and cost-effectiveness of stratified blended physiotherapy in patients with non-specific low back pain: study protocol of a cluster randomized controlled trial

Outcome Measures for the Evaluation of Treatment Response in Hidradenitis Suppurativa for Clinical Practice

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