Article type
Year
Abstract
Introduction: Systematic reviews depend on a comprehensive data collection of the primary studies. Since multiple reviews in the same field may use data from similar sets of trials, a computerized database of trial summaries would minimize duplication of effort and facilitate timely reviews and future updates.
Objective: To develop an electronic data repository of randomized controlled trials (RCTs) addressing newer pharmacotherapies for depressive disorders.
Methods: A relational database was created using Microsoft Access to store data summaries from individual trials. The data summary for each record (trial) includes four broad categories: trial methodology, participants, interventions (pharmacotherapy and psychosocial) and study results. User-friendly interfaces with integrated help menus were developed to enable the user with little computer experience to collect data electronically and access pre-defined queries and evidence tables. Trials were identified using the CCDAN registry, which yielded 1,277 publications. Randomized controlled trials that were at least 6 weeks in duration and compared a newer antidepressant to another intervention (older agent or psychotherapy) were included in the database. Two persons independently abstracted data from each trial and a third independent reviewer further assessed the accuracy of the outcome and drop-outs data.
Results: The database contains data summaries for 301 randomized controlled trials. For each record, nine fields assess trial methodology, 36 fields characterize the studied population and 20 fields describe phannacotherapy and psychosocial interventions. Customized queries (search strategies) are available to access the data of trials done in particular settings (e.g.: primary care versus mental health care setting), special populations (e.g.: depressive trials conducted in post-stroke, HIV+, adolescents, alcoholics or elderly) or on specific drug therapies. More than 90% of the trials evaluate treatment in patients with major depression. Out of the 10 classes of newer agents studied, the SSRIs are the most widely tested. Seventy-three percent of the trials evaluate drug therapy for 6 to 7 weeks only (range 6-104 weeks). The majority of the studies do not report details on the study participants' education level, socioeconomic status or ethnicity or methods of concealment allocation. More than 7,000 outcome results on more than 30 depressive scales are stored in the database. A demonstration of the database will be available at the poster session.
Discussion: The information collected for each trial is comprehensive, accurate, easily accessible and retrievable by all reviewers and can be updated as new trials are published. The electronic data repository of RCTs represents a rich source for the CCDAN reviewers to access and use for future systematic reviews.
Objective: To develop an electronic data repository of randomized controlled trials (RCTs) addressing newer pharmacotherapies for depressive disorders.
Methods: A relational database was created using Microsoft Access to store data summaries from individual trials. The data summary for each record (trial) includes four broad categories: trial methodology, participants, interventions (pharmacotherapy and psychosocial) and study results. User-friendly interfaces with integrated help menus were developed to enable the user with little computer experience to collect data electronically and access pre-defined queries and evidence tables. Trials were identified using the CCDAN registry, which yielded 1,277 publications. Randomized controlled trials that were at least 6 weeks in duration and compared a newer antidepressant to another intervention (older agent or psychotherapy) were included in the database. Two persons independently abstracted data from each trial and a third independent reviewer further assessed the accuracy of the outcome and drop-outs data.
Results: The database contains data summaries for 301 randomized controlled trials. For each record, nine fields assess trial methodology, 36 fields characterize the studied population and 20 fields describe phannacotherapy and psychosocial interventions. Customized queries (search strategies) are available to access the data of trials done in particular settings (e.g.: primary care versus mental health care setting), special populations (e.g.: depressive trials conducted in post-stroke, HIV+, adolescents, alcoholics or elderly) or on specific drug therapies. More than 90% of the trials evaluate treatment in patients with major depression. Out of the 10 classes of newer agents studied, the SSRIs are the most widely tested. Seventy-three percent of the trials evaluate drug therapy for 6 to 7 weeks only (range 6-104 weeks). The majority of the studies do not report details on the study participants' education level, socioeconomic status or ethnicity or methods of concealment allocation. More than 7,000 outcome results on more than 30 depressive scales are stored in the database. A demonstration of the database will be available at the poster session.
Discussion: The information collected for each trial is comprehensive, accurate, easily accessible and retrievable by all reviewers and can be updated as new trials are published. The electronic data repository of RCTs represents a rich source for the CCDAN reviewers to access and use for future systematic reviews.