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Design and analysis of pilot studies: recommendations for good practice.
A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs.
The COMET Handbook: version 1.0
A four-step process to develop a core outcome set is recommended, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.
Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes
- E. C. Davies, C. F. Green, Stephen Taylor, P. Williamson, D. Mottram, M. Pirmohamed
- MedicinePloS one
- 11 February 2009
It is concluded that approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode.
Developing core outcome sets for clinical trials: issues to consider
The need for general guidance on the development of core outcome sets, which should be measured and reported, as a minimum, in all trials for a specific clinical area, is identified.
Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies
Ian Sinha and colleagues advise that when using the Delphi process to develop core outcome sets for clinical trials, patients and clinicians be involved, researchers and facilitators avoid imposing…
The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial
Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias
There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.
The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial
How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline
This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS, which can be used by COS developers in defining how to measure core outcomes.
Adverse Drug Reactions in Children—A Systematic Review
A systematic review of observational studies in children in three settings: causing admission to hospital, occurring during hospital stay and occurring in the community, provides estimates of incidence in different settings and some indication of the therapeutic classes most frequently associated with ADRs.