Imaging in clinical trials: a patient-led questionnaire study to assess impact of imaging regimes on patient participation

Katherine May; Martin Lee; Monica Jefford; Ana Ribeiro; Alison Macdonald; Veronica Morgan; Marianne Usher; Nandita M de Souza

doi:10.1186/s40900-020-00195-5

Imaging in clinical trials: a patient-led questionnaire study to assess impact of imaging regimes on patient participation

Res Involv Engagem. 2020 Apr 28:6:15. doi: 10.1186/s40900-020-00195-5. eCollection 2020.

Authors

Katherine May^{1

2

3}, Martin Lee⁴, Monica Jefford⁴, Ana Ribeiro², Alison Macdonald¹, Veronica Morgan¹, Marianne Usher¹, Nandita M de Souza^{1

5}

Affiliations

¹ 1Department of Radiology, The Royal Marsden NHS Foundation Trust, Sutton, Surrey UK.
² 2Nuclear Medicine, The Royal Marsden NHS Foundation Trust, Sutton, Surrey UK.
³ 3NIHR Royal Marsden Clinical Research Facility, The Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT UK.
⁴ 4Patient and Carer Research Review Panel, The Royal Marsden NHS Foundation Trust, Sutton, Surrey UK.
⁵ 5The Institute of Cancer Research, Sutton, Surrey UK.

Abstract

Background: Cancer trials often incorporate intensive imaging with Magnetic Resonance Imaging (MRI) and Positron Emission Tomography with Computerised Tomography (PET/CT), which can be physically and mentally exhausting for patients. This questionnaire study aimed to determine the aspects of imaging that affect a patient's decision to participate in clinical trials in order to inform the design of future trials that utilise imaging. This should achieve greater patient compliance and improve the patient experience.

Method: A detailed questionnaire assessing patient expectation and acceptability of imaging within clinical trials was developed in collaboration with two patient representatives. The questionnaire addressed the influence of scan type, length, frequency, scheduling, invasiveness and staff support on acceptability of imaging. It was applied to three patient groups. Group 1 consisted of patients newly recruited to studies with imaging, Group 2 consisted of previous participants in studies with imaging and Group 3 consisted of patients having imaging for clinical care.

Results: One hundred ninety six patients completed the questionnaires (Group 1:47; Group 2: 50 and Group 3: 99). The use of ionising radiation and number of scans required were identified as negative influences on decision to participate by 25% of Group 3 but only by 6% of Groups 1 and 2. Scan duration >30mins was perceived as a negative factor for decision to participate by all Groups (12-22%). Good communication provided by researchers in terms of discussing the study before and after reading study materials was a key factor in influencing decision to participate (> 50% in Groups 1 and 2 and > 20% in Group 3).

Conclusion: Factors relating to imaging procedures within clinical trials that affect participation have been identified with communication around study materials as the key determinant. These data will be used to influence the development of future research protocols. Modification of imaging requirements within clinical trials will improve patient tolerance and acceptability and is likely to raise recruitment.

Keywords: Clinical trials; Imaging; Magnetic resonance imaging (MRI); Patient participation; Positron emission tomography with computerised tomography (PET/CT).