Dataset Information

Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review.

ABSTRACT:

Introduction

Low back pain can lead to substantial decline in physical functioning. For disabling pain not responsive to conservative management, surgical intervention can enhance physical functioning. Measurements of physical functioning include patient-reported outcome measures and physical outcome measures using evaluations of impairments, performance on a standardised task or activity in a natural environment. Selecting outcome measures with adequate measurement properties is fundamental to evaluating effectiveness of interventions. The purpose of this systematic review is to identify outcome measures (patient reported and physical) used to evaluate physical functioning (stage 1) and assess the measurement properties of physical outcome measures of physical functioning (stage 2) in the lumbar spinal surgery population.

Methods and analysis

This protocol aligns with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Using a two-staged approach, searches will be performed in MEDLINE, EMBASE, Health and Psychosocial Instruments, CINAHL, Web of Science, Scopus, PEDro and the grey literature from inception until 15 December 2021. Stage 1 will identify studies evaluating physical functioning with patient-reported or physical outcome measures in the lumbar spinal surgery population. Stage 2 will search for studies evaluating measurement properties (validity, reliability, responsiveness) of the physical outcome measures identified in stage 1 in the lumbar spinal surgery population. Two independent reviewers will evaluate studies for inclusion, extract data, assess risk of bias (COSMIN risk of bias tool and checklist) and quality of evidence (modified Grading of Recommendations Assessment, Development and Evaluation approach). Results for each measurement property per physical outcome measure will be quantitatively pooled if there is adequate clinical and methodological homogeneity or qualitatively synthesised if there is high heterogeneity in studies.

Ethics and dissemination

Ethics approval is not required. Results will be disseminated through peer-reviewed journal publication and conference presentation.

Prospero registration number

CRD42021293880.

SUBMITTER: Kowalski KL

PROVIDER: S-EPMC9171219 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review.

Kowalski Katie L KL Lukacs Michael J MJ Mistry Jai J Goodman Maren M Rushton Alison B AB

BMJ open 20220606 6

<h4>Introduction</h4>Low back pain can lead to substantial decline in physical functioning. For disabling pain not responsive to conservative management, surgical intervention can enhance physical functioning. Measurements of physical functioning include patient-reported outcome measures and physical outcome measures using evaluations of impairments, performance on a standardised task or activity in a natural environment. Selecting outcome measures with adequate measurement properties is fundame ...[more]

PMID: 35667717

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Project description:BackgroundInternational agreement supports physical functioning as a key domain to measure interventions effectiveness for low back pain. Patient reported outcome measures (PROMs) are commonly used in the lumbar spinal surgery population but physical functioning is multidimensional and necessitates evaluation also with physical measures.Objective1) To identify outcome measures (PROMs and physical) used to evaluate physical functioning in the lumbar spinal surgery population. 2) To assess measurement properties and describe the feasibility and interpretability of physical measures of physical functioning in this population.Study designTwo-staged systematic review and narrative synthesis.MethodsThis systematic review was conducted according to a registered and published protocol. Two stages of searching were conducted in MEDLINE, EMBASE, Health & Psychosocial Instruments, CINAHL, Web of Science, PEDro and ProQuest Dissertations & Theses. Stage one included studies to identify physical functioning outcome measures (PROMs and physical) in the lumbar spinal surgery population. Stage two (inception to 10 July 2023) included studies assessing measurement properties of stage one physical measures. Two independent reviewers determined study eligibility, extracted data and assessed risk of bias (RoB) according to COSMIN guidelines. Measurement properties were rated according to COSMIN criteria. Level of evidence was determined using a modified GRADE approach.ResultsStage one included 1,101 reports using PROMs (n = 70 established in literature, n = 67 developed by study authors) and physical measures (n = 134). Stage two included 43 articles assessing measurement properties of 34 physical measures. Moderate-level evidence supported sufficient responsiveness of 1-minute stair climb and 50-foot walk tests, insufficient responsiveness of 5-minute walk and sufficient reliability of distance walked during the 6-minute walk. Very low/low-level evidence limits further understanding.ConclusionsMany physical measures of physical functioning are used in lumbar spinal surgery populations. Few have investigations of measurement properties. Strongest evidence supports responsiveness of 1-minute stair climb and 50-foot walk tests and reliability of distance walked during the 6-minute walk. Further recommendations cannot be made because of very low/low-level evidence. Results highlight promise for a range of measures, but prospective, low RoB studies are required.

Project description:IntroductionPhysical functioning (PF) is the ability to carry out the physical activity of daily living. It is an important outcome that provides a meaningful evaluation of individuals' life. PF can be assessed using patient-reported outcome measures, performance-based outcome measures or body structure and function measure. Measures need to be valid, reliable and responsive to change to evaluate the effects of an intervention. Adolescent idiopathic scoliosis (AIS) is the most common deformity among the paediatric population and impacts on individuals' lives. This systematic review will appraise evidence on the measurement properties of PF tools in individuals with AIS.Methods/analysisA protocol for systematic review and meta-analysis informed by Cochrane guidelines is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis-P. MEDLINE, PsycINFO, EMBASE, CINAHL, SPORTdiscus, Web of Science and PubMed will be searched in two stages, from inception until December 2019. Search 1 will inventory all studies that assessed PF in participants with AIS, without any limitations. The search terms will be scoliosis, adolescent and PF-related terms. Search 2 will include studies which investigated instrument measurement properties in the same population for measures identified in search one. Two reviewers will independently perform study selection, data extraction, risk of bias and overall quality assessment. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias and a modified Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines will be used. A meta-analysis will be conducted if possible, or the evidence will be synthesised and summarised per measurement property per outcome measure per measurement type.Ethics and disseminationThis review will provide recommendations for practice and future research, considering psychometric properties of outcome measures of PF in AIS. The results of this study will be disseminated through a peer-reviewed publication and conference presentation.Prospero registration numberCRD42019142335.

Project description:Several measurement tools commonly used in face-to-face neurological rehabilitation have been used in telerehabilitation. However, it is not known whether these tools have adequate measurement properties and clinical utility. This systematic review aims to investigate the measurement properties and the clinical utility of measurement tools used in telerehabilitation in individuals with neurological diseases. A systematic review to investigate the measurement properties and clinical utility of measurement tools used in telerehabilitation in individuals with neurological conditions will be conducted. This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. this systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) on 28 May 2021 (registration number: CRD42021257662). Electronic searches will be performed in following databases: Medical Literature Analysis and Retrieval System Online (MEDLINE Ovid), Excerpta Medica Database (Embase Classic + Embase Ovid), Physiotherapy Evidence Database (PEDro), Scientific Electronic Library Online (Scielo), and Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS). Two trained independent reviewers will select the studies according to the inclusion criteria, and will also extract the data, evaluate the clinical utility and methodological quality. The relevant data such as design, participants, settings, and mode of administration, measurement properties, and clinical utility will be summarized. Disagreements between reviewers will be resolved by consensus or by the decision of a third independent reviewer. Hand searches of other relevant studies will be employed. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist and the clinical utility scale will be used to assess the methodological quality and clinical utility of these tools, respectively. This systematic review will provide information regarding the measurement properties and the clinical utility of the measurement tools used in neurological telerehabilitation. This information will be useful to assist health professionals in choosing adequate measurement tools and planning new research studies.

Project description:BackgroundHyperhidrosis is a chronic skin condition that impairs the patient's quality of life (QoL). There are several patient-reported outcome measures (PROMs) for patients affected by hyperhidrosis available; however an evidence-based assessment of their quality has not been undertaken so far.ObjectiveIn our systematic review, we aim to identify all existing PROMs that were developed and/or validated for measuring patient-reported outcomes in patients with hyperhidrosis and assess their measurement properties in a transparent and structured way to give a recommendation for future clinical research.Methods/designOur systematic review aims to contain all PROMs developed and/or validated for patients with hyperhidrosis. We will perform a highly sensitive, systematic literature search including the databases MEDLINE (Ovid), EMBASE (Ovid), and Science Citation Index Expanded and Social Sciences Citation Index (Web of Science). Especially studies which evaluate, describe, or compare measurement properties of PROMs for patients with hyperhidrosis will be considered as eligible. Two independent reviewers will judge the eligibility of the studies found in the literature search. The study and PROM characteristics will be summarized in evidence tables. The methodological quality of each study will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. We will apply predefined and consensus-based quality criteria for good measurement properties. Subsequently, the quality of the evidence will be graded. Furthermore, aspects on interpretability and feasibility will be described. A final recommendation will be given.DiscussionIn our systematic review, we aim to provide a comprehensive description of the quality of all existing PROMs for patients with hyperhidrosis. The assessment of measurement properties, interpretability, and feasibility will serve as a guidance regarding the selection of PROMs for future clinical hyperhidrosis trials.Systematic review registrationPROSPERO CRD42020170247.

Project description:IntroductionOutcome assessments after surgery for degenerative lumbar disorders (DLDs) rely on subjective patient-reported outcomes (PROMs). New objective functional capacity tests, like the smartphone-based 6-min walking test (6WT), have been introduced but presumably also do not reflect the patient's real-life functional performance.Research questionPilot study to analyze changes in smartphone-based real-life activity data for physical performance outcome in patients undergoing surgery for DLD.Material and methodsProspective observational study of DLD patients. Objective functional capacity and subjective outcomes were measured using 6WT and PROMs. Real-life physical performance data were acquired retrospectively using Apple iPhone Health data and compared against objective capacity and subjective outcomes.ResultsEight patients (mean 46 years, 62% male) provided 286.858 smartphone mile counts. PROMs and physical capacity (6WT) significantly improved postoperatively. 6WT results increased from 352m pre-to 555/567m at 6/12 weeks postoperatively (p = 0.03). For physical performance a linear mixed effect models showed an increase in daily distance in the first 4 months after surgery (slope +0.178; p < 0.001). However, those increases reversed from 4 until 12 months postoperatively (negative slope estimate of -0.076; p < 0.001). Smartphone-derived physical performance measures showed a positive correlation with corresponding physical capacity in the 6WT (R = 0.57,p = 0.004) and negative correlations with PROMs (COMI: R = -0.62p = 0.001; ZCQ-Physical-Function: R = -0.68,p < 0.001; ZCQ-Symptom-Severity: R = -0.52,p = 0.009).Discussion and conclusionSmartphone-based real-life activity data allows for longitudinal physical performance assessment. Physical performance correlated with physical capacity and patient's subjective perception of disability. However, physical performance may be more resistant to postoperative longtime change which should consult a more cautious use as objective outcome measure.

Project description:BackgroundThe management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients' functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs.ObjectiveOur aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed.MethodsThis study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines.ResultsA total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ≥5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a "sufficient (+)" rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use.ConclusionsThis study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978.

Project description:IntroductionOver the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures.Methods and analysisThe following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored.Ethics and disseminationEthical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for reviewers of papers and grants to determine the psychometric quality of the measures used in implementation research.Trial registration numberInternational Prospective Register of Systematic Reviews (PROSPERO): CRD42017065348.

Project description:IntroductionThe Health of the Nation Outcome Scales (HoNOS) for adults, and equivalent measures for children and adolescents and older people, are widely used in clinical practice and research contexts to measure mental health and functional outcomes. Additional HoNOS measures have been developed for special populations and applications. Stakeholders require synthesised information about the measurement properties of these measures to assess whether they are fit for use with intended service settings and populations and to establish performance benchmarks. This planned systematic review will critically appraise evidence on the measurement properties of the HoNOS family of measures.Methods and analysisJournal articles meeting inclusion criteria will be identified via a search of seven electronic databases: MEDLINE via EBSCOhost, PsycINFO via APA PsycNET, Embase via Elsevier, Cumulative Index to Nursing and Allied Health Literature via EBSCOhost, Web of Science via Thomson Reuters, Google Scholar and the Cochrane Library. Variants of 'Health of the Nation Outcome Scales' or 'HoNOS' will be searched as text words. No restrictions will be placed on setting or language of publication. Reference lists of relevant studies and reviews will be scanned for additional eligible studies. Appraisal of reliability, validity, responsiveness and interpretability will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Feasibility/utility will be appraised using definitions and criteria derived from previous reviews. For reliability studies, we will also apply the Guidelines for Reporting Reliability and Agreement Studies to assess quality of reporting. Results will be synthesised narratively, separately for each measure, and by subgroup (eg, treatment setting, rater profession/experience or training) where possible. Meta-analyses will be undertaken where data are adequate.Ethics and disseminationEthics approval is not required as no primary data will be collected. Outcomes will be disseminated to stakeholders via reports, journal articles and presentations at meetings and conferences.Prospero registration numberCRD42017057871.

Project description:Background: Patient centred healthcare is the corner stone to many healthcare strategies. Patient specific health needs should be at the fore of healthcare improvements and quality measurements. Patient reported outcome measures (PROM) that support real world clinical effectiveness assessments are increasingly being used to highlight domains where there is the greatest scope for change. Objectives: This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines. Methods: Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day. Two reviewers independently will judge eligibility, conduct data extraction and assess the methodological quality of each study as per COSMIN guidelines. Inclusion criteria: studies should concern PROM with an aim to evaluate measurement properties in the development or the evaluation of a PROM of interest. Included PROM will focus upon postpartum women assessing morbidity and quality of care. All peer reviewed studies with an assessment tool designed for patient completion will be considered. Exclusion criteria; abstract, letters and non-peer reviewed publications. Studies will be graded on measurement properties and quality of evidence as laid out by COSMIN. All studies and characteristics eligible for inclusion will be summarised and a recommendation to the most suitable measurement tool(s) will be given. Discussion: We will provide a comprehensive description of all available patient reported assessment tools available for childbirth and postpartum quality of life and recommend based on COSMIN guidelines the most suitable instrument(s) available for use.

Project description:BackgroundSuccess rates for lumbar discectomy are estimated as 78-95% patients at 1-2 years post-surgery, supporting its effectiveness. However, ongoing pain and disability is an issue for some patients, and recurrence contributing to reoperation is reported. It is important to identify prognostic factors predicting outcome to inform decision-making for surgery and rehabilitation following surgery. The objective was to determine whether pre-operative physical factors are associated with post-operative outcomes in adult patients [≥16 years old] undergoing lumbar discectomy or microdiscectomy.MethodsA systematic review was conducted according to a registered protocol [PROSPERO CRD42015024168]. Key electronic databases were searched [PubMed, CINAHL, EMBASE, MEDLINE, PEDro and ZETOC] using pre-defined terms [e.g. radicular pain] to 31/3/2017; with additional searching of journals, reference lists and unpublished literature. Prospective cohort studies with ≥1-year follow-up, evaluating candidate physical prognostic factors [e.g. leg pain intensity and straight leg raise test], in adult patients undergoing lumbar discectomy/microdiscectomy were included. Two reviewers independently searched information sources, evaluated studies for inclusion, extracted data, and assessed risk of bias [QUIPS]. GRADE determined the overall quality of evidence.Results1189 title and abstracts and 45 full texts were assessed, to include 6 studies; 1 low and 5 high risk of bias. Meta-analysis was not possible [risk of bias, clinical heterogeneity]. A narrative synthesis was performed. There is low level evidence that higher severity of pre-operative leg pain predicts better Core Outcome Measures Index at 12 months and better post-operative leg pain at 2 and 7 years. There is very low level evidence that a lower pre-operative EQ-5D predicts better EQ-5D at 2 years. Low level evidence supports duration of leg pain pre-operatively not being associated with outcome, and very low-quality evidence supports other factors [pre-operative ODI, duration back pain, severity back pain, ipsilateral SLR and forward bend] not being associated with outcome [range of outcome measures used].ConclusionAn adequately powered low risk of bias prospective observational study is required to further investigate candidate physical prognostic factors owing to existing low/very-low level of evidence.

Dataset Information

Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review.

Introduction

Methods and analysis

Ethics and dissemination

Prospero registration number

Publications

Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review.

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