Participation and Successful Patient Recruitment in a Randomized Clinical Trial of Dyspepsia Treatment in Primary Care

,

Original Research

Participation and Successful Patient Recruitment in a Randomized Clinical Trial of Dyspepsia Treatment in Primary Care

J Fam Pract. 2001 November;50(11):976

By

Niek J. De Wit, MD, PhD

References

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OBJECTIVES: The demand for family physicians (FPs) to participate in research is growing. The balance between research participation and the daily practice routine might explain the often disappointing number of patients recruited. We analyzed practice and physician characteristics associated with successful patient recruitment.

STUDY DESIGN: A survey was used.

POPULATION: A total of 165 FPs participated in a combined randomized clinical trial/cohort study on drug treatment of dyspepsia in the Netherlands.

OUTCOMES MEASURED: We surveyed FPs about personal and practice characteristics and their motivation for participation in the project. These data were then related to the number of patients recruited. Univariate associations were calculated; relevant factors were entered into a logistic model that predicted patient recruitment.

RESULTS: Data on 128 FPs could be analyzed (80% response rate); these FPs recruited 793 patients in the cohort study (mean = 6.3 per FP) and 527 in the clinical trial (mean = 4.2 per FP). The main reasons for participation were the research topic (59%) and the participation of an academic research group in the study (63%). Many FPs felt that participation was a professional obligation (39%); the financial incentive played a minor role (15%). The number of recruited patients was only independently associated with the participation of an academic research group.

CONCLUSIONS: Successful patient recruitment in primary care research is determined more by motivation driven by the research group than by financial incentives, the research topic, or research experience.

Research in primary care is a growing field; the need for research on new diagnostic and therapeutic methods, the prognostic value of clinical signs and symptoms, and the effectiveness of clinical strategies in the population where these clinical contributions will be applied is well recognized.^1-5 The number and scale of research projects in primary care is expanding continuously, and research networks are being established.^6-8 This development, however, is putting increasing pressure on family physicians (FP) to actively participate in research. From an FP’s perspective there is a delicate balance between active research participation and efficient clinical practice.⁹ Proper planning to minimize paperwork and the delegation of research logistics to practice assistants can avoid many practical obstacles.^7,10,11

Motivating and recruiting FPs to participate is an essential step in conducting primary care research. Factors such as the clinical relevance of the research subject, personal interest in the topic, ownership, personal contact with the research group, and the required time investment have been shown to influence the participation of FPs.^5,11-15

Earlier studies have shown that higher-qualified physicians (with more continuing medical education training or a degree in research), physicians involved in under-or postgraduate training, FPs with research experience, and physicians working in well-organized practices (with more practice assistants and management protocols) are more interested in participating in research. Sex, the number of physicians per practice, and wages do not influence participation.¹⁵ The actual impact of financial incentives, however, is unclear. One study reported that incentives raised participation,¹⁶ while others could not confirm this.^12,15 Some have also drawn attention to the ethical and methodologic aspects of payment for research.^5,17

After successfully contracting with FPs to recruit patients for the study, the next task for a research group is to attain the maximal recruitment of patients. Unfortunately, less than half of the participating physicians actually recruit patients in the research project,^9,12,18 and often only a minority (20%)¹⁸ of the eligible patients are actually included. Our objective in this study was to identify practice and physician characteristics determining successful patient recruitment among FPs participating in a combined randomized clinical trial/cohort study on drug treatment of dyspepsia in the Netherlands.

Methods

Setting

Our data were compiled from a practice-based research network (PBRN) used for a primary care study of dyspepsia, the CIRANO study (Cisapride or Ranitidine in NonOrganic dyspepsia), which was conducted from 1996-1998 in the Netherlands. The CIRANO project consisted of 2 parts: a cohort study, in which dyspeptic patients were included and followed up for 1 year, and a randomized clinical trial in which patients selected from the cohort were treated with either an H2 blocker or a prokinetic drug.¹⁹ It was designed by the dyspepsia group of the Julius Centre, a group of primary care researchers who have been involved in gastrointestinal research and guideline development in the Netherlands for a number of years. Janssen Cilag Inc. was the sole sponsor of the project. The protocol was approved by the academic ethical committee, and data monitoring was done in accordance with the GCP guidelines (good clinical practice, a government protocol for conducting drug trials).

In the cohort study the workload for the participating physicians was small. After identification and inclusion by the FP, patients had to complete a validated dyspepsia symptom score, a quality of life questionnaire (COOP/WONCA chart), and a mental health state check list (GHQ 12). Also, the practice assistant performed a Helicobacter pylori whole- blood test. Follow-up of the patient was done by the research group. The FP workload in the clinical trial was heavier. After inclusion, the patients were randomized to one of the treatment arms, treated for 4 weeks, and followed up for 3 months. Patients were seen by the FP at inclusion and after 1 and 3 months.