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

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.

SUBMITTER: May K

PROVIDER: S-EPMC7189543 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

May Katherine K Lee Martin M Jefford Monica M Ribeiro Ana A Macdonald Alison A Morgan Veronica V Usher Marianne M de Souza Nandita M NM

Research involvement and engagement 20200428

<h4>Background</h4>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 impro ...[more]

PMID: 32368349

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Project description:ImportanceMany randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle-income countries (LMICs) and upper middle-income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which countries participate in RCTs and how this participation may contribute to global research.ObjectiveTo describe which UMICs and LMICs participate in RCTs led by HICs.Design, setting, and participantsA cross-sectional study of all oncology RCTs published globally during January 1, 2014, to December 31, 2017, was conducted. The study cohort was restricted to RCTs led by HICs that enrolled participants from LMICs and UMICs. Study analyses were conducted in November 1, 2021, to May 31, 2022.Main outcomes and measuresA bibliometric approach (Web of Science 2007-2017) was used to explore whether RCT participation was proportional to other measures of cancer research activity. Participation in RCTs (ie, percentage of RCTs in the cohort in which each LMIC and UMIC participated) was compared with country-level cancer research bibliometric output (ie, percentage of total cancer research bibliometric output from the same group of countries that came from a specific LMIC and UMIC).ResultsAmong the 636 HIC-led RCTs, 186 trials (29%) enrolled patients in LMICs (n = 84 trials involving 11 LMICs) and/or UMICs (n = 181 trials involving 26 UMICs). The most common participating LMICs were India (42 [50%]), Ukraine (39 [46%]), Philippines (23 [27%]), and Egypt (12 [14%]). The most common participating UMICs were Russia (115 [64%]), Brazil (94 [52%]), Romania (62 [34%]), China (56 [31%]), Mexico (56 [31%]), and South Africa (54 [30%]). Several LMICs are overrepresented in the cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (27% RCTs, 1% output), and Georgia (8% RCTs, 0.2% output). Overrepresented UMICs include Russia (64% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output), and South Africa (30% RCTs, 1% output).Conclusions and relevanceIn this cross-sectional study, a substantial proportion of RCTs led by HICs enrolled patients in LMICs and UMICs. The LMICs and UMICs that participated in these trials did not match overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity-strengthening activities require further study.

Project description:BackgroundThe aim of this study was to develop, together with the Lung Foundation Netherlands and Dutch Kidney Patients Association, patients and clinicians, a measure to evaluate patient experiences with the orphan drugs pirfenidone (for idiopathic pulmonary fibrosis [IPF]) and eculizumab (for atypical haemolytic uraemic syndrome [aHUS]), as well as a generic measure of patient experiences and satisfaction with medications.MethodsDevelopment of the Patient Experiences and Satisfaction with Medications (PESaM) questionnaire consisted of four phases: literature review (phase I); focus groups and individual patient interviews (phase II); item generation (phase III); and face and content validity testing (phase IV). Literature review aimed to identify existing disease-specific and generic patient experience measures to provide guidance on the domains of medication use relevant to patients, the number of items and type of response categories, and to generate an initial pool of items. Subsequent focus groups and patient interviews were conducted to gain insight into the perceived effectiveness of the therapies, the burden of side effects, and how the medication impacted on a patient's daily life. Focus groups and interviews were recorded and transcribed verbatim. Coding was carried out by highlighting passages in the text and assigning each passage a code representing the following predefined categories: (1) perceived effectiveness; (2) side effects; (3) ease of use; and (4) impact of medication. Using data from phase I and II, a panel of experts selected items relevant for inclusion in the questionnaire. Individual patient interviews with IPF and aHUS patients (n = 18), using a retrospective verbal probing technique, were conducted to assess face validity, time needed to fill out the questionnaire, and content validity.ResultsThe PESaM questionnaire that was developed consisted of two disease-specific modules that assessed patient experiences with pirfenidone for the treatment of IPF, and eculizumab for the treatment of aHUS, a generic module, applicable to any medication, and a module to assess patient expectations. Review of the literature identified multiple disease- or medication-specific questionnaires and two generic patient satisfaction questionnaires. Common domains across most questionnaires were effectiveness, side effects, ease of use and overall satisfaction. Patient interviews revealed the social impact (e.g. unable to go outside) of side effects such as photosensitivity associated with pirfenidone and the risk of infection associated with eculizumab. Each PESaM module focuses on patients' perceived effectiveness of the medication, side effects, and ease of use, and the impact these aspects have on physical and emotional health and daily life. The generic module additionally includes items related to satisfaction with the medication. Individual interviews with patients in phase IV confirmed, in general, that questions and response options of the modules were clear and content validity was good. The mean time to complete the modules ranged from 6 min for the disease-specific (aHUS) module to 9 min for the generic module.ConclusionsWe developed the PESaM questionnaire to quantitatively assess patient experiences and satisfaction with medications. A validation study is currently underway to examine the psychometric properties of the PESaM questionnaire.

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

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

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