Main Article Content
IBS, recruitment, observational studies, patient retention, Canada
Longitudinal Outcomes of GastroIntestinal symptoms in Canada (LOGIC) is an ongoing study on irritable bowel syndrome (IBS) treatment patterns and health outcomes in routine Canadian clinical practice. Advancements in understanding IBS, a chronic multifaceted GI disorder, may be possible through methodical observational studies. The objective of this paper is to describe site recruitment techniques and extensive subject follow-up methodology used to facilitate a high return rate of questionnaires from this population-based study of subjects with IBS.
Invitation letters along with protocol synopses and preliminary site assessment questionnaires were faxed to potential sites across Canada. There were 1,556 subjects enrolled in this study from general practitioner sites (GP) and specialist sites (SP) in Canada. Subjects were compensated for the return of questionnaires reporting symptoms, quality of life, productivity, healthcare and resource utilization at baseline, Month 1, 3, 6, 9, and 12. Upon the return of questionnaires, subjects received thank you cards which included a reminder of the next questionnaire’s due date. If subject questionnaires were not received within 2 weeks after the due date, the subjects received a reminder letter in the mail.
The methodology in the LOGIC study allowed for a high patient questionnaire return rate (89%) through extensive subject reminders and follow-up. Subject participation throughout the study was not found to be linked to study site size or type (GP or SP).
Questionnaire based observational studies may benefit from focusing resources on increasing questionnaire return rates to effectively maintain data reliability and also reduce non-response bias
2. Martin R, Barron JJ, Zacker C. Irritable bowel syndrome: toward a cost-effective management approach. Am J Manag Care 2001;7(8 Suppl):S268-275.
3. Gunn MC, Cavin AA, Mansfield JC. Management of irritable bowel syndrome. Postgrad Med J 2003;79(929):154-158.
4. Drossman DA, Whitehead WE, Toner BB, et al. What determines severity among patients with painful functional bowel disorders? Am J Gastroenterol 2000;95(4):974-980.
5. Smith RC, Greenbaum DS, Vancouver JB, et al. Psychosocial factors are associated with health care seeking rather than diagnosis in irritable bowel syndrome. Gastroenterology 1990;98(2):293-301.
6. Longstreth GF, Hawkey CJ, Mayer EA, et al. Characteristics of patients with irritable bowel syndrome recruited from three sources: implications for clinical trials. Aliment Pharmacol Ther 2001;15(7):959-964.
7. Camilleri M, Heading RC, Thompson WG. Clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome. Aliment Pharmacol Ther 2002;16(8):1407-1430.
8. Longstreth GF, Wolde-Tsadik G. Irritable bowel-type symptoms in HMO examinees. Prevalence, demographics, and clinical correlates. Dig Dis Sci 1993;38(9):1581-1589.
9. Mitchell CM, Drossman DA. Survey of the AGA membership relating to patients with functional gastrointestinal disorders. Gastroenterology 1987;92(5 Pt 1):1282-1284.
10. Thompson WG. The treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2002;16(8):1395-1406.
11. Thompson WG, Irvine EJ, Pare P, Ferrazzi S, Rance L. Functional gastrointestinal disorders in Canada: first population-based survey using Rome II criteria with suggestions for improving the questionnaire. Dig Dis Sci 2002;47(1):225235.
12. Drossman DA, Thompson WG. The irritable bowel syndrome: review and a graduated multicomponent treatment approach. Ann Intern Med 1992;116(12 Pt 1):1009-1016.
13. American, Gastroenterologist, Association. The Burden of Gastrointestinal Diseases. American Gastroenterological Association 2001:1-86.
14. Camilleri M, Williams DE. Economic burden of irritable bowel syndrome. Proposed strategies to control expenditures. Pharmacoeconomics 2000;17(4):331-338.
15. Drennan KB. Patient recruitment: the costly and growing bottleneck in drug development. Drug Discov Today 2002;7(3):167-170.
16. Butterfield PG, Yates SM, Rogers B, Healow JM. Overcoming subject recruitment challenges: strategies for successful collaboration with novice research agencies. Appl Nurs Res 2003;16(1):46-52.
17. Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE. Appendix B. The Rome II Modular Questionnaire. In the Functional Gastrointestinal Disorders. Drossman DA, Corazziari, J Talley, WG Thompson, WE Whitehead, ed. McLean Virginia; Degnon. 2000:670-688.
18. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4(5):353-365.
19. Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci 1998;43(2):400-411.
20. The EuroQoL Group. Health Policy 1990;16:199-208.
21. Fuller RK, Mattson ME, Allen JP, Randall CL, Anton RF, Babor TF. Multisite clinical trials in alcoholism treatment research: organizational, methodological and management issues. J Stud Alcohol Suppl 1994;12:30-37.
22. Siemiatycki J. A comparison of mail, telephone, and home interview strategies for household health surveys. Am J Public Health 1979;69(3):238-245.
23. Edwards P, Roberts I, Clarke M, et al. Increasing response rates to postal questionnaires: systematic review. BMJ 2002;324(7347):1183.