Monitoring, data recording, and verification were performed by a clinical research organization under supervision of the research group. Data were stored and analyzed by the group.
FPs were given a financial incentive for each patient they included. It comprised a reimbursement for the extra practice time spent completing the research protocol. The estimated overall time investment for FPs was 2 hours with an additional 5 minutes for each patient included in the cohort and 1 additional hour for each patient included in the randomized clinical trial. Since the workload differed significantly, the reimbursement was higher for the patients included in the clinical trial ($25 per patient in the cohort, $70 for each patient in the randomized clinical trial). Also, project bulletins were distributed regularly during the course of the project.
All FPs in the academic network of the Utrecht University (2000 FPs, one third of all Dutch FPs) were invited by the academic research group to participate in the CIRANO study. Two hundred of them expressed interest in the study and asked for documentation. A total of 165 FPs finally signed the research contract.
Questionnaire
Five months after the CIRANO project was completed, all the participating physicians were sent an anonymous questionnaire containing 4 sections: (1) demographic and practice data, (2) initial motivation to participate, (3) evaluation of the logistics of the project, and (4) motivation to participate in future projects. The evaluation questions were Likert-type (a scale of 4 answer categories); motivation was analyzed by asking respondents to indicate the 3 most important reasons from a list of 8 Table 1. A reminder was sent 1 month after the first mailing. Data from the questionnaire, as well as the number of patients included in the study, were entered in SPSS for Windows software version 8.5 for analysis (SPSS, Inc; Chicago, Ill). Questionnaires that were not fully completed were excluded.
Analysis
To calculate odds ratios the number of recruited patients per FP was dichotomized, with cut-off points at the 25th percentile of inclusion: 0 to 4 versus 5 or more patients for inclusion in the cohort study, and 0 or 1 patient versus 2 or more for inclusion in the clinical trial. The association between demographic data, motivating factors and the number of recruited patients was calculated and expressed as an odds ratio (with 95% confidence interval [CI]). Factors that were thus associated with recruitment at a P level of less than 0.25 (so as not to exclude potentially important variables), together with 7 factors known from the literature to be relevant (sex, list size, years in practice, practice location, research experience, high specialization, and financial incentive-driven motivation) were entered in a logistic regression model.
Using a stepwise-backward procedure, determinants of maximal inclusion were analyzed and reported as adjusted odds ratio (with 95% CI). As the workload and the financial incentive for the clinical trial and cohort study differed significantly, we analyzed inclusion in the 2 parts of the research project separately.
Results
Of the 165 participating FPs, 132 returned the questionnaire; the response rate was 80%. Since 4 of the questionnaires were incomplete, data from 128 family physicians could be used for analysis. Most responders were men (87%), and half had been in practice for more than 5 years, primarily in semi-urban areas of the Netherlands (68%). Most (77%) were involved in other professional activities, such as vocational training, continuing medical education (CME), or activities of the College of Family Physicians (CFP) at the district level. Half the responders worked in a group practice, and more than 60% of the practices were “specialized” (defined as performing at least 4 of the following clinical activities in routine daily practice: minor surgery, Doppler studies, electrocardiography, cervical screening, intrauterine device insertion, diabetes protocol, or spirometry). Also, 57% of the participants had previous research experience.
The initial motivation for participation in the project varied Table 1. For the majority of the participants, the research topic and the participation of our academic research group were the most important factors. One third of the respondents considered participation a professional obligation, were attracted by the personal appeal by the research group, or were intrigued by the presentation of the project. The involvement of the sponsor and the financial incentive were important for only a minority in their decision to participate.
In general, the project was well evaluated; 80% of the respondents stated that the project had met their expectations (56% fully, 24% partially), and 60% noted that they would consider participation in a similar research project in the future. More specifically, the participants were satisfied with the quality of the correspondence, the newsletter, and the monitoring of the project Table 2. However, 47% of the participating FPs thought that the overall time investment in the project was too burdensome, and one third mentioned the negative impact the application of the GCP guidelines had on the workload of the project.