Box 6.3.a: Cochrane definitions and criteria for randomized controlled trials (RCTs) and controlled clinical trials (CCTs)

Records identified for inclusion should meet the eligibility criteria devised and agreed in November 1992, which were first published, in 1994, in the first version of the Handbook (see Chapter 1, Section 1.4). According to these eligibility criteria:

A trial is eligible if, on the basis of the best available information (usually from one or more published reports), it is judged that:

  • the individuals (or other units) followed in the trial were definitely or possibly assigned prospectively to one of two (or more) alternative forms of health care using

  • random allocation or

  • some quasi-random method of allocation (such as alternation, date of birth, or case record number).

 

Trials eligible for inclusion are classified according to the reader’s degree of certainty that random allocation was used to form the comparison groups in the trial. If the author(s) state explicitly (usually by some variant of the term ‘random’ to describe the allocation procedure used) that the groups compared in the trial were established by random allocation, then the trial is classified as a RCT (randomized controlled trial). If the author(s) do not state explicitly that the trial was randomized, but randomization cannot be ruled out, the report is classified as a CCT (controlled clinical trial). The classification CCT is also applied to quasi-randomized studies, where the method of allocation is known but is not considered strictly random, and possibly quasi-randomized trials. Examples of quasi-random methods of assignment include alternation, date of birth, and medical record number.

 

The classification as RCT or CCT is based solely on what the author has written, not on the reader's interpretation; thus, it is not meant to reflect an assessment of the true nature or quality of the allocation procedure. For example, although ‘double-blind’ trials are nearly always randomized, many trial reports fail to mention random allocation explicitly and should therefore be classified as CCT.

 

Relevant reports are reports published in any year, of studies comparing at least two forms of health care (healthcare treatment, healthcare education, diagnostic tests or techniques, a preventive intervention, etc.) where the study is on either living humans or parts of their body or human parts that will be replaced in living humans (e.g., donor kidneys). Studies on cadavers, extracted teeth, cell lines, etc. are not relevant. Searchers should identify all controlled trials meeting these criteria regardless of relevance to the entity with which they are affiliated.

 

The highest possible proportion of all reports of controlled trials of health care should be included in CENTRAL. Thus, those searching the literature to identify trials should give reports the benefit of any doubts. Review authors will decide whether to include a particular report in a review.