title: Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC).
abstract: Patient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients' perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up.
  
  
  
  This study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups. The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia.
  
  
  
  This study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection.
  
  
  
  ACTRN12615001369516 (Registered on December 16, 2015).
authors.affiliation: Department of Epidemiology and Preventive Medicine (DEPM), School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, 3004, Australia. emdad.hoque@monash.edu.|International Centre for Diarrhoeal Diseases Research in Bangladesh (icddr,b), 68, Shahid Tajuddin Sarani, Mohakhali, Dhaka, 1212, Bangladesh. emdad.hoque@monash.edu.
authors.forename: Dewan Md Emdadul
authors.initials: DM
authors.lastname: Hoque
authors.affiliation: Department of Epidemiology and Preventive Medicine (DEPM), School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, 3004, Australia.
authors.forename: Fanny
authors.initials: F
authors.lastname: Sampurno
authors.affiliation: Department of Epidemiology and Preventive Medicine (DEPM), School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, 3004, Australia.
authors.forename: Rasa
authors.initials: R
authors.lastname: Ruseckaite
authors.affiliation: Centre for Health Economics, 15 Innovation Walk, Monash University, Clayton, VIC, 3168, Australia.|Office of Health Econimics (OHE), Southside, 7th Floor, 105 Victoria Street, London, SW1E 6QT, UK.
authors.forename: Paula
authors.initials: P
authors.lastname: Lorgelly
authors.affiliation: Department of Epidemiology and Preventive Medicine (DEPM), School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Road, Melbourne, VIC, 3004, Australia.
authors.forename: Sue M
authors.initials: SM
authors.lastname: Evans
mesh_terms: D003362:Cost-Benefit Analysis; D003625:Data Collection / Q000379:methods*; D057286:Electronic Health Records; D006801:Humans; D008297:Male; D008498:Medical Record Linkage; D000071066:Patient Reported Outcome Measures; D011471:Prostatic Neoplasms / Q000628:therapy*; D011788:Quality of Life; D012042:Registries; D014739:Victoria / Q000453:epidemiology
keywords: Cost-effectiveness; Data collection methods; Mixed-mode; Patient Reported Outcome Measures; Randomized Controlled Trial