Trials
-
Some patients will experience more or less benefit from treatment than the averages reported from clinical trials; such variation in therapeutic outcome is termed heterogeneity of treatment effects (HTE). Identifying HTE is necessary to individualize treatment. The degree to which heterogeneity is sought and analyzed correctly in the general medical literature is unknown. We undertook this literature sample to track the use of HTE analyses over time, examine the appropriateness of the statistical methods used, and explore the predictors of such analyses. ⋯ HTE is frequently ignored or incorrectly analyzed. An iterative process of exploratory analysis followed by confirmatory HTE analysis will generate the data needed to facilitate an individualized approach to evidence-based medicine.
-
Randomized Controlled Trial Comparative Study
The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury.
Cerebral oedema is associated with significant neurological damage in patients with traumatic brain injury. Bradykinin is an inflammatory mediator that may contribute to cerebral oedema by increasing the permeability of the blood-brain barrier. We evaluated the safety and effectiveness of the non-peptide bradykinin B2 receptor antagonist Anatibant in the treatment of patients with traumatic brain injury. During the course of the trial, funding was withdrawn by the sponsor. ⋯ This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness.
-
Inadequate reporting of randomized controlled trials (RCTs) is associated with biased estimates of treatment effects. The reporting quality of RCTs involving patients with polycystic ovary syndrome (PCOS) is unknown. The purpose of this study was to assess the reporting quality of RCTs involving patients with PCOS using a standardized tool based on the Consolidated Standards of Reporting Trials (CONSORT) statement. ⋯ There is empirical evidence of suboptimal reporting quality of RCTs in PCOS. Endorsement of the CONSORT statement may optimize the reporting quality and enhance the validity of research.
-
Comparing the effectiveness of interventions is now a requirement for regulatory approval in several countries. It also aids in clinical and public health decision-making. However, in the absence of head-to-head randomized trials (RCTs), determining the relative effectiveness of interventions is challenging. Several methodological options are now available. We aimed to determine the comparative validity of the adjusted indirect comparisons of RCTs with the mixed treatment comparison approach. ⋯ In most analyses, the adjusted indirect comparison yields estimates of relative effectiveness equal to the mixed treatment comparison. In less complex indirect comparisons, where all studies share a mutual comparator, both approaches yield similar benefits. As comparisons become more complex, the mixed treatment comparison may be favoured.
-
Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae Sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient. ⋯ The PORTAS 2 - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Center of Clinical Trials at the Department of Surgery, University Hospital Heidelberg is responsible for design and conduct of the trial including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI), University of Heidelberg.