Motivation of patients with inflammatory bowel disease to participate in a clinical trial

Abstract

Background: Clinical trials are designed to investigate innovative diagnostic and therapeutic strategies for patients. However, factors that influence patients with inflammatory bowel disease (IBD) and willingness to participate in a clinical trial are unknown.

Methods: We developed a questionnaire and asked IBD patients about their willingness to hypothetically participate in a clinical trial and their current health-related quality of life by using the IBDQ.

Results: Of 201 distributed questionnaires, 166 were returned and included in the analysis. One-hundred-one (61 %) patients declared their willingness to participate in a clinical trial hypothetically offered in their current situation, whereas 65 (39 %) declined. Among all patients, a trustful relationship between patient and doctor was most important for trial participation. The willingness to help others and to support medical progress were other key issues mentioned. In contrast, those patients inclined to refuse trial participation feared impairment of their current health status, potential side effects, medical examinations, and the expenditure of time and effort.

Conclusion: In our cohort of IBD patients, approximately two-thirds were willing to participate in a clinical trial. We were able to identify a number of factors that should help physicians to directly address fears and break down barriers in order to increase the number of patients willing to participate in clinical trials.

Zusammenfassung

Hintergrund: Klinische Studien dienen der Entwicklung und Überprüfung innovativer diagnostischer und therapeutischer Strategien. Einflussfaktoren auf die Motivation zur Teilnahme an klinischen Studien sind für Patienten mit chro-nisch-entzündlichen Darmerkankungen (CED-Patienten) unzureichend untersucht.

Methoden: Wir befragten CED-Patienten anhand eines dafür entwickelten Fragebogens und unter Verwendung des IBDQ zur potentiellen Bereitschaft in ihrer aktuellen Situation an einer klinischen Studie teilzunehmen, sowie zu Faktoren welche diese Entscheidung in die eine oder andere Richtung beeinflussen.

Ergebnisse: Von 201 Fragebögen wurden 166 korrekt beantwortet und konnten in die Auswertung eingehen. 101 (61 %) Patienten zeigten sich in ihrer aktuellen Situation mit der potentiellen Teilnahme an einer klinischen Studie einverstanden, während 65 (39 %) Patienten dies ablehnten. Als Gründe für eine mögliche Studienteilnahme wurde eine vertrauensvolle Arzt-Patienten-Beziehung genannt, der Wunsch anderen Patienten zu helfen und den medizinischen Fortschritt zu unterstützen. Patienten, die einer Studienteilnahme ablehnend gegenüber stehen, befürchten eine Verschlechterung ihres aktuellen Gesundheitszustands, mögliche Nebenwirkungen, sowie zusätzliche Untersuchungen und den damit verbundenen zeitlichen Aufwand.

Diskussion: Die vorliegende Untersuchung zeigt eine sehr große Bereitschaft zur potentiellen Teilnahme an einer klinischen Studie bei den befragten CED-Patienten. Zusätzlich konnten Faktoren identifiziert werden, deren Kenntnis es dem Arzt erleichtern kann auf mögliche Ängste und Hindernisse in der Rekrutierung von Patienten für klinische Studien einzugehen.

Schlüsselwörter

Chronisch-entzündliche Darmerkrankungen - Motivation - Klinische Studien - Gesundheitsbezogene Lebensqualität

Key words

inflammatory bowel disease - motivation - clinical trials - health-related quality of life

• References

• 1 Böcker U, Bokemeyer B, Kucharzik T. Ätiopathogenese chronisch entzündlicher Darmerkrankungen. In: Böcker U, Bokemeyer B, Kucharzik T. Hrsg. Chronisch entzündliche Darmerkrankungen – Grundlagen, Behandlungskonzepte und Compliance. Bremen: Uni-Med; 2007: 16-23
• 2 Folsch UR, Grebe J, Schreiber S. Chronic inflammatory bowel diseases competence network. Der Internist 2004; 45: 402-408
• 3 McDonald AM, Knight RC, Campbell MK et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006; 7
• 4 Drennan KB. Patient recruitment: the costly and growing bottleneck in drug development. Drug Discovery Today 2002; 7: 167-170
• 5 Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a Grounded Theory approach. Journal of Medical Ethics 2007; 33: 234-240
• 6 Madsen SM, Mirza MR, Holm S et al. Attitudes towards clinical research amongst participants and nonparticipants. Journal of Internal Medicine 2002; 251: 156-168
• 7 Ellis PM. Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Annals of Oncology 2000; 11: 939-945
• 8 Slevin M, Mossman J, Bowling A et al. Volunteers or victims: patients' views of randomised cancer clinical trials. British Joumal of Cancer 1995; 71: 1270-1274
• 9 Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. British Journal of Cancer 2000; 82: 1783-1788
• 10 Nurgat ZA, Craig W, Campbell NC et al. Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. British Journal of Cancer 2005; 92: 1001-1005
• 11 Solomon MJ, Pager CK, Young JM et al. Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation. Surgery 2003; 133: 608-613
• 12 Tannock IF. The recruitment of patients into clinical trials. British Joumal of Cancer 1995; 71: 1134-1135
• 13 Gaul C, Malcherczyk A, Schmidt T et al. Motivation of patients to participate in clinical trials. An explorative survey. Medizinische Klinik 2010; 105: 73-79
• 14 Guyatt G, Mitchell A, Irvine EJ et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989; 96: 804-810
• 15 Hauser W, Dietz N, Grandt D et al. Validation of the inflammatory bowel disease questionnaire IBDQ-D, German version, for patients with ileal pouch anal anastomosis for ulcerative colitis. Zeitschrift fur Gastroenterologie 2004; 42: 131-139
• 16 Janke KH, Steder-Neukamm U, Bauer M et al. Quality of life assessment in Inflammatory Bowel Disease (IBD): German version of the Inflammatory Bowel Disease Questionnaire (IBDQ-D; disease-specific instrument for quality of life assessment) -- first application and comparison with international investigations. Gesundheitswesen 2005; 67: 656-664
• 17 Moder K, Rasch D, Kubinger KD. Zur Legende der Voraussetzungen des Tests für unabhängige Stichproben. Psychologische Rundschau 2009; 60: 26-27
• 18 Langhorst J, Mueller T, Luedtke R et al. Effects of a comprehensive lifestyle modification program on quality-of-life in patients with ulcerative colitis: a twelve-month follow-up. Scandinavian Journal of Gastroenterology 2007; 42: 734-745
• 19 [Anonym]. www.clinicaltrials.gov [database online] In. Bethesda, MD: U. S. National Institutes of Health.
• 20 Bevan EG, Chee LC, McGhee SM et al. Patients' attitudes to participation in clinical trials. British Journal of Clinical Pharmacology 1993; 35: 204-207
• 21 Udrea G, Dumitrescu B, Purcarea M et al. Patients’ perspectives and motivators to participate in clinical trials with novel therapies for rheumatoid arthritis. Journal of Medicine and Life 2009; 2: 227-231
• 22 McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials 2010; 11
• 23 Madsen SM, Holm S, Davidsen B et al. Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. Journal of Internal Medicine 2000; 248: 463-474
• 24 Zammar G, Meister H, Shah J et al. So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians. Plos One 2010; 5: e14368
• 25 Böcker U, Bokemeyer B, Kucharzik T. Psychosoziale Probleme bei chronisch entzündlichen Darmerkrankungen. In: Böcker U, Bokemeyer B, Kucharzik T. Hrsg. Chronisch entzündliche Darmerkrankungen – Grundlagen, Behandlungskonzepte und Compliance. Bremen: Uni-Med; 2007: 77-82
• 26 Gaul C, Schmidt T, Helm J et al. Motivation and barriers to participation in clinical trials. Medizinische Klinik 2006; 101: 873-879
• 27 Coulter A. Paternalism or partnership? Patients have grown up—and there’s no going back. BMJ 1999; 319: 719-720
• 28 Elwyn G, Laitner S, Coulter A et al. Implementing shared decision making in the NHS. BMJ 2010; 341: c5146
• 29 Coulter A. When should you involve patients in treatment decisions?. British Journal of General Practice 2007; 57: 771-772
• 30 Sood A, Prasad K, Chhatwani L et al. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clinic Proceedings 2009; 84: 243-247
• 31 Partridge A, Wong J, Knudsen K et al. Offering participants results of a clinical trial: sharing results of a negative study. The Lancet 2005; 365: 963-964
• 32 Fernandez CV, Kodish E, Weijler C. Informing study participants of research results: an ethical imperative. IRB: Ethics & Human Research 2003; 25: 12-19
• 33 Fallowfield LJ, Jenkins V, Brennan C et al. Attitudes of patients to randomised clinical trials of Cancer therapy. European Journal of Cancer 1998; 34: 1554-1559
• 34 Welton AJ, Vickers MR, Cooper JA et al. Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study. BMJ 1999; 318: 1114-1117
• 35 Russell ML, Moralejo DG, Burgess ED. Paying research subjects: participants’ perspectives. Journal of Medical Ethics 2000; 26: 126-130
• 36 Ackerman TF. An ethical framework for the practice of paying research subjects. IRB: Ethics and Human Research 1989; 11: 1-4