CONSORT Extension for Within-Person Randomized Clinical Trials

CONSORT 2010 statement: extension checklist for reporting within person randomised trials

s for within person RCTs should indicate the paired or within person nature of the trial. Table 1⇓ shows the minimum information that should be included in the abstract of a within person trial, in addition to the items recommended for all trials. We were not able to find examples of good reporting that tackled all the items required. We therefore developed an example abstract by enhancing a pu...

Registering randomized clinical trials and the case for CONSORT.

Recent controversies in medical research and the increasing reliance on randomized clinical trials to inform evidence-based practice have prompted coordinated attempts to standardize reporting and register information about trials for consistency and transparency. The Consolidated Standards of Reporting Trials guidelines (D. G. Altman et al., 2001) and trial registry are described in this artic...

CONSORT statement: extension to cluster randomised trials.

Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials

BACKGROUND Feasibility and pilot studies are essential components of planning or preparing for a larger randomized controlled trial (RCT). They are intended to provide useful information about the feasibility of the main RCT-with the goal of reducing uncertainty and thereby increasing the chance of successfully conducting the main RCT. However, research has shown that there are serious inadequa...

Within-person variation in serum lipids: implications for clinical trials.

BACKGROUND Little is known about the degree to which behavioural, biological, and genetic traits contribute to within-person variation in serum cholesterol. Materials and Methods The authors studied within-person variation in serum total and high density lipoprotein (HDL) cholesterol in 458 participants of 27 dietary intervention studies in Wageningen, The Netherlands, from 1976 to 1995. RESU...