Adapting CONSORT criteria to establish databases and flowcharts for the effective running of an RCT

Publishing research findings in scientific literature is the most common method for disseminating research findings. To interpret research findings and their implications for practice, readers need to be able to assess the strengths and limitations of randomised controlled trials (RCTs) and assess their methodological quality. Hence, sufficient detail about the conduct of RCTs needs to be reported. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to help authors improve on the reporting of RCTs through a checklist and flowchart. Many journals now require RCT papers submitted for publication to adhere to the CONSORT criteria. The checklist contains 22 items that are deemed essential to the reliability or relevance of the findings. To ensure that our trials adhere to the CONSORT criteria, we have used the statement to guide the development of recruitment protocols and databases in order to monitor recruitment for several RCTs that we are conducting. The databases also assist in the production of flowcharts, which depict the flow of participants through the study. An advantage of having the databases and flowcharts adapted from CONSORT is that it provides a systematic mechanism for monitoring sources of bias in the study and thus improves the overall quality of the RCT. For example, during the recruitment phase of the study any problems related to recruitment can be identified easily, interventions can be monitored, follow ups can be tracked to ensure that they are completed on time and differences between control and intervention recruitment rates can be observed.