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Z Gastroenterol 2016; 54(10): 1123-1129
DOI: 10.1055/s-0042-105749
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

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

Motivation von Patienten mit chronisch-entzündlichen Darmerkankungen zur Teilnahme an klinischen Studien
U. Gehrmann
1   Klinik für Innere Medizin IV, Universitätsklinikum Jena, Friedrich-Schiller-Universität Jena, Germany
,
U. Berger
2   Institut für Psychosoziale Medizin und Psychotherapie, Universitätsklinikum Jena, Friedrich-Schiller-Universität Jena, Germany
,
N. Teich
3   Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten, Leipzig, Germany
,
T. Bruns
4   Gastroenterology, Hepatology and Infectology, Friedrich Schiller University, Jena, Germany
,
A. Stallmach
4   Gastroenterology, Hepatology and Infectology, Friedrich Schiller University, Jena, Germany
,
M. Weber
4   Gastroenterology, Hepatology and Infectology, Friedrich Schiller University, Jena, Germany
› Author Affiliations
Further Information

Publication History

04 January 2016

23 March 2016

Publication Date:
10 October 2016 (online)

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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
 

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