Table 3 Steps for identification of discontinued trials and data extraction; REC, regional ethics committee
Steps | Actions |
|---|---|
1 | Identification of protocols of RCTs submitted 2000 to 2002 with the help of REC staff members |
2 | Extraction of trial characteristics from eligible protocols and attempt to clarify completion of trials through filed correspondence between the REC and applicants |
3 | Electronic search for publications (e.g. MEDLINE, EMBASE, Google Scholar) of eligible trials using filed information such as key words from protocol title/intervention or names of investigators |
4 | REC in charge will contact the applicants using a standardized questionnaire to ask about reasons of discontinuation and the availability of any formal publications, unpublished reports or other information from eligible trials (only in case trial completion and publication status remain unknown after searching filed correspondence and comprehensive publication search) |
5 | The REC in charge may send several reminders or contact applicants by phone if necessary |
6 | After receiving responses from applicants the data collection process will be finalized |
7 | The analysis database will contain only anonymous data with trial identification numbers |