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

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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

References

1. Gray DP. Research in general practice: law of inverse opportunity. BMJ 1991;302:1380-82.

2. Mold JW, Green AL. Primary care research: revisiting its definition and rationale. J Fam Pract 2000;49:206-08

3. Wallace P, Drage S, Jackson N. Linking education, research and service in general practice. BMJ 1998;316:323.-

4. Olesen F. Research in general practice is needed to develop family medicine, not get embroiled in defining it. BMJ 1998;316:324-

5. Foy R, Parry J, McAvoy B. Clinical trials in primary care. BMJ 1998;317:1168-69.

6. Smith LFP, Carter YH, Cox J. Accrediting research practices. Br J Gen Pract 1998;48(433):1464-65.

7. Bell Seyer SEM, Klaber Moffett JA. Recruiting patients to randomized trials in primary care; principles and case study. Fam Pract 2000;17:187-91.

8. Smith LFP. Research in general practice: what, who and why? Br J Gen Pract 1997;47:83-86.

9. Tognoni G, Alli C, Avanzini F, et al. Randomized clinical trials in general practice: lessons from a failure. BMJ 1991;303:969-71.

10. Murphy E, Spiegal N, Kinmonth A. Will you help me with my research? Gaining access to primary care settings and subjects. Br J Gen Pract 1992;42:162-65.

11. Ward J. General practitioners’ experience of research. Fam Pract 1994;11:418-23.

12. Kuyvenhoven MM, Dagnelie CF, de Melker RA. Recruitment of general practitioners in a sore throat study. Br J Gen Pract 1997;47:126-27.

13. Kocken RJJ, Prenger-Duchateau A, Smeets-Rinkens PELM, Knottnerus JA. Het oordeel van huisartsen over deelname aan wetenschappelijk onderzoek. Huisarts Wet 1992;35:32-34.

14. Borgiel AEM, Dunn EV, Lamont CT, et al. Recruiting family physicians as participants in research. Fam Pract 1989;6:168-72.

15. Silagy SA, Carson NE. Factors affecting the level of interest and activity in primary care research among general practitioners. Fam Pract 1989;6:173-76.

16. Deehan A, Templeton L, Taylor C, Drummond C, Strang J. The effect of cash and other financial inducements on the response rate of general practitioners in a national postal survey. Br J Gen Pract 1997;46:87-90.

17. Ferguson C. Payment of financial incentives to GP’s may invalidate informed consent process. BMJ 1998;316:75-76.

18. Peto V, Coulter A, Bond A. Factors affecting general practitioners’ recruitment of patients into a prospective study. Fam Pract 1993;10:207-11.

19. Quartero AO, Numans ME, de Melker RA, Hoes AW, de Wit NJ. Dyspepsia in primary care; prokinetic therapy or acid suppression, a randomized clinical trial. Scand J Gastroenterol 2001. In press.

From September 1996 until January 1998 these 128 physicians recruited 793 patients in the cohort phase of the study (average = 6.3 per FP; standard deviation [SD]=6.6) and 527 in the clinical trial (average = 4.2 per FP; SD=4.9). A total of 15% of the FPs recruited no patients in the cohort study, while 59% recruited 4 or more patients. In comparison, 21% of the FPs did not recruit any patients in the clinical trial, and 65% recruited 2 or more patients.

In the univariate analysis only the factors “active in CME/CFP” and “motivation by the academic research group” were associated with the number of recruited patients. These associations occurred in both the cohort study and the randomized clinical trial Table 3. After entering these 2 factors were entered in a logistic model, together with 7 factors earlier reported relevant in the literature, multivariate analysis indicated that only the factor “motivation by the participation of the academic research group” predicted the number of patients recruited in cohort study (adjusted odds ratio [OR] = 3.5; 95% CI, 1.4-9.0) and clinical trial (adjusted OR = 2.9; 95% CI, 1.2-6.9).

Discussion

The combination of participation in research and daily clinical practice requires a major time investment. Even though FPs consider their participation thoroughly before a research project commences, the actual numbers of patients they recruit are often disappointing.

In this large randomized trial on dyspepsia in primary care we showed that those FPs whose motivation was driven by the participation of an academic department of family medicine in the research group recruited the most patients. They were 3 times more likely than their colleagues to recruit at least 2 patients for the clinical trial or 5 patients for the cohort. Other factors such as list (practice) size, involvement in professional CME/CFP activities, research experience, and financial incentive may have played a role in the FPs’ decision to participate in the research project but were not associated with the actual number of patients they recruited.

As in most projects, a minority of the participating physicians did not manage to recruit any patients. These colleagues either underestimated the time investment required, had second thoughts about the acceptability for their patients, or were disappointed by the planning and paperwork of the project.

Factors determining patient recruitment in primary care research have hardly been studied. Busy schedules, forgetfulness, poor patient compliance, and FP involvement in too many projects are a few of the reasons given to explain poor recruitment.^18,9

One third of all Dutch FPs were invited to participate in the dyspepsia study. Even though bias might have been caused by either the subject (dyspepsia physicians), the fact that half of the FPs had experience in research, or the fact that the participants were generally very active in numerous professional activities (active physicians), we think the results of our study can be generalized to the primary care setting in the Netherlands. Our conclusions may, however, require modification in other countries because of differences in practice organization and research climate in primary care.

Although there were various reasons for participation in the CIRANO study, they are consistent with earlier reports. FPs who participated in our dyspepsia project were mainly motivated by the subject and by the fact that the project was affiliated with our academic primary care research group. The motivation was not a matter of personal acquaintance, since most of the participants were not known to the members of the research group.

A substantial number of the participating colleagues also felt that participation was a professional obligation. This perception might have been induced by the fact that during the introduction of the project, special emphasis was put on the evidence missing from certain paragraphs of the Dutch guidelines on dyspepsia and on the need for primary care-based research to fill this gap. Although the research group felt that this was an important aspect of motivation, the evaluation showed that while it was an important reason to participate, it was not independently associated with patient recruitment. Only 10% of the participants stated that the financial incentive was a major reason to participate. Although this could be an unrealistic subjective statement, multivariate analysis confirmed that incentive-driven motivation was not related to the number of patients recruited. The fact that the results were the same for both the cohort study and the clinical trial might also be an indication that the amount of the incentive played a minor role in patient recruitment. This confirms earlier reports^12,13 that FPs probably do not participate in research for the money, although they do want a proper reimbursement for the time invested.