Motivation and frustration in cardiology trial participation: The patient perspective

Abstract

OBJECTIVE:The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration.METHODS:Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period.RESULTS:Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment.CONCLUSIONS:Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.

Factors affecting patient participation in clinical trials in Ireland: A narrative review

“…However patients participating in clinical trials may not always fully appreciate that such protocols are required to protect patient safety. Protocols that require regular and stringent monitoring of participants necessitating frequent hospital visits are cited as a reason to decline participation [24] as are the frequency of medical consultations [30] , the time spent within hospital [9] and the duration of the trial [6] , [9] . Other trial requirements including the randomisation process, including the risk of being randomised to the control arm of the study and receiving placebo [5] , [9] , [14] , [26] , [29] , having to complete questionnaires [7] , [28] and keeping a diary log [28] are also noted as research process barriers to participation.…”

Assessing Communication during Remote Follow-Up of Users with Pacemakers in Norway: The NORDLAND Study, a Randomized Trial

“…Measuring a patient’s communication experience includes feedback biases from intentionally answering the questionnaires to accomplish positive outcomes. Our overall positive communication experiences could have been influenced by the phenomenon called the “Hawthorne effect” [ 47 ], which states that patients tend to change their behavior when they are targets of interest and attention, irrespective of the specific nature of an intervention, which could be a limitation of our results. In such situations, patients may become eager to please their clinicians and make them feel successful.…”

Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial

“…Finally, it must be considered the phenomenon known as the Hawthorne effect [ 40 , 41 ]. The fact that people tend to change their behavior when they are the targets of interest and attention, regardless of the specific nature of an intervention could be a limitation of our results.…”

“…In such situations, patients become eager to please their physicians and make them feel successful. Additionally, patients wish to participate so that “good” results can be achieved in the study [ 40 , 41 ].…”