Those not randomised to website access received standard patient information and were offered website access at the end of the trial.
In addition to up-to-date information on risks based on the results of randomised clinical trials, a website offers five methods for prediction of the risk of treatment-related toxicity based on individual factors relevant to each patient.
Secondly, the sample was restricted to that community subgroup of participants who was prepared to participate in a randomised controlled trial of Internet websites.
We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care.
In addition to documenting each allocation on the randomisation schedule, so as to generate a unique username and password to enable each randomised participant access to their allocated website program, the independent staff member will be required to assign the allocated program to the user's profile in the trial website.
12 Medline, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, and Embase databases and www.tctmd.com, www.clinicaltrials.gov, www.clinicaltrialresults.org, and www.cardiosource.com websites were searched until 15 May 2013 for relevant randomised controlled trials; documents accessible through the FDA website were also scrutinised.
Data sources Medline, Embase, the pharmaceutical company clinical trials register, the US Food and Drug Administration website, and ClinicalTrials.gov for randomised controlled trials from inception to July 2010.
The site has been adapted from the www.DownYourDrink.org.uk (DYD) website developed for the DYD-randomised controlled trial (RCT) trial.
The clinicaltrials.gov and the Cochrane Library website will be also searched for randomised trials that were registered as completed but not yet published.
A two-group randomised trial will be applied to compare a website using the novel Web 2.0 features with a traditional Web 1.0 intervention, and investigate the effectiveness of both interventions in a 'real-world' setting.
