Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox Within an Orthopaedic Trauma Clinical Trials Consortium.
Ontology highlight
ABSTRACT: Level of evidence
Prognostic Level II.
SUBMITTER: Carlini AR
PROVIDER: S-EPMC8694658 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
Publications
Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox Within an Orthopaedic Trauma Clinical Trials Consortium.
Carlini Anthony R AR Collins Susan C SC Staguhn Elena D ED Frey Katherine P KP O'Toole Robert V RV Archer Kristin R KR Obremskey William T WT Agel Julie J Kleweno Conor P CP Morshed Saam S Weaver Michael J MJ Higgins Thomas F TF Bosse Michael J MJ Levy Joseph F JF Wu Albert W AW Castillo Renan C RC
Journal of orthopaedic trauma 20220101 Suppl 1
<h4>Level of evidence</h4>Prognostic Level II. ...[more]
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Project description:PurposeThe objectives of this study are to describe the outcome measures used in orthopaedic fracture care trials, with a particular focus on patient-reported outcome measures (PROMs), and to determine which study characteristics are associated with number of citations.MethodsWe retrieved randomized clinical trials on fracture care between 2012 and 2017 from Embase, Medline and CENTRAL databases. Data collected included study characteristics (e.g., region, design, setting, sample size) and outcome measures (e.g., primary variable, measurement perspective, use of PROMs, study results and number of citations).ResultsWe identified a total of 8,580 articles in the initial search. After title screening, abstract screening and full-text review, we included 416 articles for analysis. 58.4% (243) of the studies clearly defined a primary outcome measure and 56.3% (234) reported sample size justifications for outcome selection. The most common primary outcome reported was a visual analogue scale for pain; used in 21 of the 243 (8.6%) studies that defined a primary outcome. At least one PROM was used in 68.5% (285) of the papers included.ConclusionsA large proportion of studies reporting on PROMs for orthopaedic trauma patients do not provide key information on the outcome selection process; a step of utmost importance in and the designing and reporting of RCTs. There is substantial heterogeneity in the selection of PROMs for fracture care trials, which limits the ability to compare and summarize across studies. Future research in fracture care should strive towards improving the reporting of informative PROMs, with rationale that demonstrates understating of the injury, intervention and patient values.Supplementary informationThe online version contains supplementary material available at 10.1007/s43465-022-00667-8.
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Project description:IntroductionThe recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in "the big five" general medical journals. The quality of this research has, however, not yet been established.MethodsWe therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010-April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool.ResultsA total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias.ConclusionsThese findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted.Level of evidenceLevel 1.
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Project description:IntroductionThe Royal College of Surgeons of England (RCS) has issued guidance regarding the use of reoperation rates in the revalidation of UK-based orthopaedic surgeons. Currently, little has been published concerning acceptable rates of reoperation following primary surgical management of orthopaedic trauma, particularly with reference to revalidation.MethodsA retrospective review was conducted of patients undergoing clearly defined reoperations following primary surgical management of trauma between 1 January 2010 and 31 December 2011. A full case note review was undertaken to establish the demographics, clinical course and context of reoperation. A review of the imaging was performed to establish whether the procedure performed was in line with accepted trauma practice and whether the technical execution was acceptable.ResultsA total of 3,688 patients underwent primary procedures within the time period studied while 70 (1.90%, 99% CI: 1.39-2.55) required an unplanned reoperation. Thirty-nine (56%) of these patients were male. The mean age of patients was 56 years (range: 18-98 years) and there was a median time to reoperation of 50 days (IQR: 13-154 days). Potentially avoidable reoperations occurred in 41 patients (58.6%, 99% CI: 43.2-72.6). This was largely due to technical errors (40 patients, 57.1%, 99% CI: 41.8-71.3), representing 1.11% (99% CI: 0.73-1.64) of the total trauma workload. Within RCS guidelines, 28-day reoperation rates for hip, wrist and ankle fractures were 1.4% (99% CI: 0.5-3.3), 3.5% (99% CI: 0.8%-12.1) and 1.86% (99% CI: 0.4-6.6) respectively.ConclusionsWe present novel work that has established baseline reoperation rates for index procedures required for revalidation of orthopaedic surgeons.
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Project description:ObjectivesCharacterise the health status of patients newly consulting an orthopaedic specialist across eight clinical subspecialties.DesignRetrospective cohort.Setting18 orthopaedic clinics, including 8 subspecialties (14 ambulatory and 4 hospital based) within an academic health system.Participants14 910 patients consulting an orthopaedic specialist for a new patient consultation who completed baseline Patient-Reported Outcomes Measurement Information System (PROMIS) measures associated with their appointment from 17 November 2017 to 13 May 2019. Patients were aged 55.72±5.8 years old, and 61.3% were female and 79.3% were Caucasian and 13.4% were black or African American. Patients who did not complete PROMIS measures or cancelled their appointment were excluded from the study.Primary outcomePROMIS domains of physical function, pain interference, pain intensity, depression, anxiety, fatigue, sleep disturbance and the ability to participate in social roles.ResultsMean PROMIS scores for physical function were (38.1±9.2), pain interference (58.9±8.1), pain intensity (4.6±2.5), depression (47.9±8.9), anxiety (49.9±9.5), fatigue (50.5±10.3), sleep disturbance (51.1±9.8) and ability to participate in social roles (49.1±10.3) for the entire cohort. Across the clinical subspecialties, neurosurgery, spine and trauma patients were most profoundly affected across almost all domains and patients consulting with a hand specialist reported the least limitations or symptoms across domains. There was a moderate, negative correlation between pain interference and physical functioning (r=-0.59) and low correlations between pain interference with anxiety (r=0.36), depression (r=0.39) as well as physical function and anxiety (r=-0.32) and depression(r=-0.30) and sleep (r=-0.31).ConclusionsWe directly compared clinically meaningful PROMIS domains across eight orthopaedic subspecialties, which would not have been possible with legacy measures alone. These results support PROMIS's utility as a common metric to assess and compare patient health status across multiple orthopaedic subspecialties.
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