A randomised controlled trial comparing completeness of responses of three methods of collecting patient-reported outcome measures in men diagnosed with prostate cancer
The purpose of the study was to compare completeness, timeliness and cost of patient-reported outcome measures (PROMs) collection using telephone, email and post in men with prostate cancer.
A parallel, three-arm randomised controlled equivalence trial. 1168 patients were randomised to telephone (n = 295), postal (n = 388) and email (n = 385) arms. Participants were asked to provide self-reported responses for 26 items of Expanded Prostate Cancer Index Composite. Cost and resource data were collected from a provider perspective.
Equivalence tests showed no difference in completeness in the three arms within a 10% equivalence margin. Men diagnosed in public hospitals were less likely to complete the survey compared to those in private hospitals, OR = 0.19 (95% CI 0.04–0.89) (p = 0.035). The email survey required significantly less time to complete than telephone and postal methods [median time of 2 min (IQR 1,8) vs. 7 min (IQR 6,9) vs. 10 min (IQR 9,12), respectively (p < 0.001)]. The incremental cost effectiveness ratio for email compared to telephone was AUD$1.90, cost-effective if users valued an additional 1% improvement in survey completion greater than AUD$1.90.
Email method took less time and cost and should be used as the primary PROMs collection, with telephone if men without email or do not respond to email.
KeywordsPatient-reported outcomes Randomised controlled trial Data collection methods Intention to treat Telephone Postal Email
We would like to acknowledge the willingness and support provided by the respondents and their family members. We would also like to thank our all the data collectors for their hard work and ensuring quality data.
Funding for this project has been provided to SME by a Monash Partners Academic Health Science Centre Clinical Fellowship Grant. DEH has received Monash International Postgraduate Research Scholarship (MIPRS) for tuition fees and Monash Graduate Scholarship (MGS) for living costs and Monash ID: 25762931 for the PhD program. Data involved in this publication have been obtained from the Prostate Cancer Outcome Registry-Victoria, which is funded by Movember Foundation.
Compliance with ethical standards
Conflict of interest
None declared except Sue Evans is coordinator of the Prostate Cancer Outcome Registry—Australia and New Zealand (PCOR-ANZ).
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was built on an existing project, which received Ethical approval, by the Monash University Human Research Ethics Committee for enrolment of prostate cancer patients in PCOR VIC (Approval Number CF09/0931–2,009,000,436). We obtained separate approval for our study from the Monash University Human Research Ethics Committee (Approval Number CF15/4157-2015001762).
Men who participated in this study were part of the Prostate Cancer Outcomes Registry which has an opt out consent process. Men are sent an explanatory statement, which details the process for opting out and use of data for research purposes. As men are being contacted as part of the registry a waiver of consent for this study was provided to enable men to be randomised to one of the three arms, verbal consent for this was obtained at initial contact with the patient.
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