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We then discuss aspects of trial implementation, including recruitment, randomization, and data management.
This article highlights the scientific aspects of trial design for this pivotal clinical trial.
Educational interventions can help dyadic exchanges with different aspects of trial recruitment but less work has focussed on team interventions.
Blinding of evaluators of subjective measures and randomization of subjects are also critical aspects of trial performance.
In conclusion, analysis of the methodology showed several aspects of trial design that can be improved in future studies.
During a meeting organised on behalf of the European Organisation for Research and Treatment of Cancer (EORTC), methodological aspects of trial design in BM were discussed.
We highlight aspects of trial design, conduct, and reporting that should be taken into account to minimise bias and improve quality.
There is no agreement yet on several aspects of trial design, but the situation should become clearer once the results of these trials are reported.
Investigators should refer to the forthcoming SPIRIT-PRO Extension [23] to develop PRO aspects of trial protocols with clear strategies to minimise the missing data, as well as the CONSORT-PRO guidance for reporting [20].
We systematically reviewed RCTs of anxiety interventions in acquired brain injury (ABI) conditions including stroke and traumatic brain injury (TBI) in order to summarize efficacy and key aspects of trial design to help guide future RCTs.
Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials.
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