Methods

3. Participants Specification of eligibility criteria allows readers to assess the extent to which the trial population may represent the population they are interested in. You should describe the rationale for any inclusions/exclusions, which might be considered unusual and in particular justify any limits imposed on continuous criteria such as age. The method of recruitment - for example by referral or self-selection - may also be relevant.

Settings and locations; this will define whether or not it is a multi-centre study, whether it was carried out in specialist centres, generally give further information necessary to help a reader determine whether the results are relevant to their own setting.

4. Interventions As well as the basic interventions (including placebos), you should include planned treatment modifications in response to events such as toxicity; rightly or wrongly, this report maybe used as a guideline for treating future patients. If applicable, describe who (or the type of person who) was responsible for administering the interventions.

5. Objectives Specific objectives and hypotheses. Objectives are the questions the trial was designed to answer. They often relate to the efficacy of a particular therapeutic or preventative intervention. Hypotheses are specific, prespecified questions being tested to help meet the objectives.

6. Outcomes The outcome measures should have been clearly defined in the protocol, but should be described in equal detail here. In addition, where an outcome measure may be assessed at several timepoints, indicate which is of primary interest. Where applicable, specify who assessed the outcome, any guidelines they followed, whether they were blind to treatment allocation and whether there was more than one assessor.

7. Sample size The basis of the sample size should be given in sufficient detail that the reader could reproduce it. It is particularly important to justify the effect size the trial was powered to detect (see Chapter 5). Pre-defined stopping rules/guidelines and/or procedures for interim monitoring of results should be described including the use of an independent data monitoring and ethics committee. Even if no formal rules were followed, the extent to which results were monitored should be described. If the actual trial size differs from that planned originally, whether larger or smaller, this should be explained.

0 0

Post a comment