ReviewBMJ (Clinical research ed.)2000
Size and quality of randomised controlled trials in head injury: review of published studies.
Review in BMJ (Clinical research ed.), 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 152 citations in OpenAlex.
- Systematic review of prognostic models in traumatic brain injury.BMC medical informatics and decision making · 2006Pooled it
- Excitatory amino acid inhibitors for traumatic brain injury.The Cochrane database of systematic reviews · 2004Pooled it
- Intensive versus conventional glucose control in critically ill patients with traumatic brain injury: long-term follow-up of a subgroup of patients from the NICE-SUGAR study.Intensive care medicine · 2015Trial
- Covariate adjustment increased power in randomized controlled trials: an example in traumatic brain injury.Journal of clinical epidemiology · 2012Trial
- Trial
- Use of the Oxford Handicap Scale at hospital discharge to predict Glasgow Outcome Scale at 6 months in patients with traumatic brain injury.BMC medical research methodology · 2008Trial
- Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial.BMJ (Clinical research ed.) · 2006Trial
- The MRC CRASH Trial: study design, baseline data, and outcome in 1000 randomised patients in the pilot phase.Emergency medicine journal : EMJ · 2002Trial
- A review of 17 years of application of partnership care model on the consequences of chronic diseases: Describing and assessing the quality of the methodology of papers.Medical journal of the Islamic Republic of Iran · 2020Review
- Causes and outcomes of traumatic brain injuries in Uganda: analysis from a pilot hospital registry.Trauma surgery & acute care open · 2019Article
- Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey.Pilot and feasibility studies · 2018Article
- Observational
- Poor adherence of randomised trials in surgery to CONSORT guidelines for non-pharmacological treatments (NPT): a cross-sectional study.BMJ open · 2013Article
- Assessment and implication of prognostic imbalance in randomized controlled trials with a binary outcome--a simulation study.PloS one · 2012Article
- Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.The Angle orthodontist · 2010Article
- Severe head injury and the risk of early death.Journal of neurology, neurosurgery, and psychiatry · 2006Article
- [CONSORT statement. Revised findings on quality improvement based on reports from randomized studies in parallel design].Schmerz (Berlin, Germany) · 2005Review
- War on the roads: two years on.BMJ (Clinical research ed.) · 2004Article
- Sample size estimation in research with dependent measures and dichotomous outcomes.American journal of public health · 2004Review
- Prospective validation of a proposal for diagnosis and management of patients attending the emergency department for mild head injury.Journal of neurology, neurosurgery, and psychiatry · 2004Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess whether trials in head injury are large enough to avoid moderate random errors and designed to avoid moderate biases.
designAll randomised controlled trials on the treatment and rehabilitation of patients with head injury published before December 1998 were surveyed. Trials were identified from electronic databases, by hand searching journals and conference proceedings, and by contacting researchers. Data were extracted on the number of participants, quality of concealment of allocation, use of blinding, loss to follow up, and types of participants, interventions, and outcome measures.
results279 reports were identified, containing information on 208 separate trials. The average number of participants per trial was 82, with no evidence of increasing size over time. The total number of randomised participants in the 203 trials in which size was reported was 16 613. No trials were large enough to detect reliably a 5% absolute reduction in the risk of death or disability, and only 4% were large enough to detect an absolute reduction of 10%. Concealment of allocation was adequate in 22 and inadequate or unclear in 25 of the 47 (23%) in which it was reported. Of 126 trials assessing disability, 111 reported the number of patients followed up, and average loss to follow up was 19%. Of trials measuring disability, 26 (21%) reported that outcome assessors were blinded.
conclusionsRandomised trials in head injury are too small and poorly designed to detect or refute reliably moderate but clinically important benefits or hazards of treatment. Limited funding for injury research and unfamiliarity with issues of consent may have been important obstacles.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.