Cochrane Summaries

Trusted evidence. Informed decisions. Better health.
Language:
English

Methods that might help to keep people in randomised trials

Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G
Published Online: 
3 December 2013

Background

Most trials follow people up to collect data through personal contact after they have been recruited. Some trials get data from other sources, such as routine collected data or disease registers. There are many ways to collect data from people in trials, and these include using letters, the internet, telephone calls, text messaging, face-to-face meetings or the return of medical test kits. Most trials have missing data, for example, because people are too busy to reply, are unable to attend a clinic, have moved or no longer want to participate. Sometimes data has not been recorded at study sites, or are not sent to the trial co-ordinating centre. Researchers call this 'loss to follow-up', 'drop out' or 'attrition' and it can affect the trial's results. For example, if the people with the most or least severe symptoms do not return questionnaires or attend a follow-up visit, this will bias the findings of the trial. Many methods are used by researchers to keep people in trials. These encourage people to send back data by questionnaire, return to a clinic or hospital for trial-related tests, or be seen by a health or community care worker.

Study characteristics

This review identified methods that encouraged people to stay in trials. We searched scientific databases for randomised studies (where people are allocated to one of two or more possible treatments in a random manner) or quasi-randomised studies (where allocation is not really random, e.g. based on date of birth, order in which they attended clinic) that compared methods of increasing retention in trials. We included trials of participants from any age, gender, ethnic, cultural, language and geographic groups.

Key results

The methods that appeared to work were offering or giving a small amount of money for return of a completed questionnaire and enclosing a small amount of money with a questionnaire with the promise of a further small amount of money for return of a filled in questionnaire. The effect of other ways to keep people in trials is still not clear and more research is needed to see if these really do work. Such methods are shorter questionnaires, sending questionnaires by recorded delivery, using a trial design where people know which treatment they will receive, sending specially designed letters with a reply self addressed stamped envelope followed by a number of reminders, offering a donation to charity or entry into a prize draw, sending a reminder to the study site about participants to follow-up, sending questionnaires close to the time the patient was last followed-up, managing peoples' follow-up, conducting follow-up by telephone and changing the order of questionnaire questions.

Quality of evidence

The methods that we identified were tested in trials run in many different disease areas and settings and, in some cases, were tested in only one trial. Therefore, more studies are needed to help decide whether our findings could be used in other research fields.

This record should be cited as: 
Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G. Strategies to improve retention in randomised trials. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: MR000032. DOI: 10.1002/14651858.MR000032.pub2
Assessed as up to date: 
13 June 2013
Health topics: