Randomized Controlled Trials in Adult Traumatic Brain Injury: A Systematic Review on the Use and Reporting of Clinical Outcome Assessments

Horton, Lindsay; Rhodes, Jonathan R.; Wilson, Lindsay

doi:10.1089/neu.2018.5648

Cited by 30 publications

(23 citation statements)

References 43 publications

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“…Questionnaires are perceived as easy for researchers and less expensive than reviewing a patient in person. Unfortunately, techniques related to outcome assessment after TBI are highly variable in both the assessment tool used and also the method of assessment, 30 and consensus is required to minimize the potential bias that varying techniques could introduce.…”

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confidence: 99%

Study Design Features Associated with Patient Attrition in Studies of Traumatic Brain Injury: A Systematic Review

Richter

Stevenson

Newman

et al. 2020

Journal of Neurotrauma

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Loss to follow-up or patient attrition is common in longitudinal studies of traumatic brain injury (TBI). Lack of understanding exists between the relation of study design and patient attrition. This review aimed to identify features of study design that are associated with attrition. We extended the analysis of a previous systematic review on missing data in 195 TBI studies using the Glasgow Outcome Scale Extended (GOSE) as an outcome measure. Studies that did not report attrition or had heterogeneous methodology were excluded, leaving 148 studies. Logistic regression found seven of the 14 design features studied to be associated with patient attrition. Four features were associated with an increase in attrition: greater follow-up frequency (odds ratio [OR]: 1.2, 95% confidence interval [CI]: 1.0-1.3), single rather than multi-center design (OR: 1.6, 95% CI: 1.2-2.2), enrollment of exclusively mild TBI patients (OR: 2.8, 95% CI: 1.6-4.9), and collection of the GOS by post or telephone without face-to-face contact (OR: 1.6, 95% CI:1.1-2.4). Conversely, two features were associated with a reduction in attrition: recruitment in an acute care setting defined as the ward or intensive care unit (OR: 0.58, 95% CI: 0.47-0.72) and a greater duration of time between injury and follow-up (OR: 0.93, 95% CI: 0.88-0.99). This review highlights design features that are associated with attrition and could be considered when planning for patient retention. Further work is needed to establish the mechanisms between the observed associations and potential remedies.

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confidence: 99%

Study Design Features Associated with Patient Attrition in Studies of Traumatic Brain Injury: A Systematic Review

Richter

Stevenson

Newman

et al. 2020

Journal of Neurotrauma

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“…We will search systematic reviews using the Cochrane Library, Excerpta Medica Database (Embase), Epistemonikos,31 PubMed and the International Prospective Register of Systematic Reviews32 from 1990 to up to 6 months prior to submission for publication. Using a snowball approach, we will screen the references of included studies in addition to previous reviews on this subject 7 21–23 33…”

Section: Methods and Analysismentioning

confidence: 99%

Low-value clinical practices in adult traumatic brain injury: an umbrella review protocol

et al. 2019

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IntroductionTraumatic brain injury (TBI) leads to 50 000 deaths, 85 000 disabilities and costs $60 billion each year in the USA. Despite numerous interventions and treatment options, the outcomes of TBI have improved little over the last three decades. In a previous scoping review and expert consultation survey, we identified 13 potentially low-value clinical practices in acute TBI. The objective of this umbrella review is to synthesise the evidence on potentially low-value clinical practices in the care of acute TBI.Methods and analysisUsing umbrella review methodology, we will search Cochrane Central Register of Controlled Trials, Embase, Epistemonikos, International Prospective Register of Systematic Reviews (PROSPERO) and PubMed to identify systematic reviews evaluating the effect of potential intrahospital low-value practices using tailored population, intervention, comparator, outcome and study design questions based on the results of a previous scoping review. We will present data on the methodological quality of these reviews (Assessing the Methodological Quality of Systematic Reviews-2), reported effect sizes and strength of evidence (Grading of Recommendations, Assessment, Development and Evaluation).Ethics and disseminationEthics approval is not required as original data will not be collected. Knowledge users from five healthcare quality organisations and clinical associations are involved in the design and conduct of the study. Results will be disseminated in a peer-reviewed journal, at international scientific meetings and to clinical, healthcare quality and patient–partner associations. This work will support the development of metrics to measure the use of low-value practices, inform policy makers on potential targets for deimplementation and in the long term reduce the use of low-value clinical practices in acute TBI care.PROSPERO registration numberCRD42019132428.

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“…Using a snowball approach, we then screened the references of included studies in addition to previous reviews on this subject. [7,[32][33][34][35]…”

Section: Epistemonikos[30] Medical Literature Analysis and Retrievalmentioning

confidence: 99%

Low-Value Clinical Practices in Adult Traumatic Brain Injury: An Umbrella Review

Moore

Tardif

Lauzier

et al. 2020

Journal of Neurotrauma

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Background Despite numerous interventions and treatment options, the outcomes of traumatic brain injury (TBI) have improved little over the last three decades, which raises concern about the value of care in this patient population. We aimed to synthesize the evidence on 14 potentially low-value clinical practices in TBI care. Methods Using umbrella review methodology, we identified systematic reviews evaluating the effectiveness of 14 potentially low-value practices in adults with acute TBI. We present data on methodological quality (AMSTAR-2), reported effect sizes and credibility of evidence (I to IV). Results The only clinical practice with evidence of benefit was therapeutic hypothermia (credibility of evidence II to IV). However, the most recent meta-analysis on hypothermia based on high-quality trials suggested harm (credibility of evidence IV). Meta-analyses on platelet transfusion for patients on antiplatelet therapy were all consistent with harm but were statistically non-significant. For the following practices, effect estimates were consistently close to the null: CT in adults with mild TBI who are low-risk on a validated clinical decision rule; repeat CT in adults with mild TBI on anticoagulant therapy with no clinical deterioration; antibiotic prophylaxis for external ventricular drain placement; and decompressive craniectomy for refractory intracranial hypertension. Conclusions We identified five clinical practices with evidence of lack of benefit or harm. However, evidence could not be considered to be strong for any clinical practice as effect measures were imprecise and heterogeneous, systematic reviews were often of low quality and most included studies had a high risk of bias. Protocol registration PROSPERO: CRD42019132428

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Randomized Controlled Trials in Adult Traumatic Brain Injury: A Systematic Review on the Use and Reporting of Clinical Outcome Assessments

Cited by 30 publications

References 43 publications

Study Design Features Associated with Patient Attrition in Studies of Traumatic Brain Injury: A Systematic Review

Study Design Features Associated with Patient Attrition in Studies of Traumatic Brain Injury: A Systematic Review

Low-value clinical practices in adult traumatic brain injury: an umbrella review protocol

Low-Value Clinical Practices in Adult Traumatic Brain Injury: An Umbrella Review

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