The roles, experiences, challenges & training needs of site coordinators who administer PRO questionnaires in Australian cancer trials Rebecca Mercieca-Bebber, Derek Kyte, Melanie Calvert, Martin Stockler, Madeleine King

Patient-reported outcomes (PROs) “A PRO is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else” FDA, 2009, p2 Responsible person: site coordinators (aka clinical research associate, research nurse…)

Rationale for this study Possible problems with PRO methodology: Suboptimal coverage of PROs in trial protocols Kyte PLOS One 2014; Mercieca-Bebber QOLR 2016 Persistent problems w/ missing data & non-reporting Bernhard SiM 1998, Schandelmaier Annals of Onc 2015 As PROs are increasingly being valued in the interpretation of cancer trials, the need to scrutinise current practice has become ever more important

Aims To explore the PRO-specific responsibilities, procedures, challenges of site coordinators. To determine what PRO-specific training had been received by site coordinators & their training needs.

Methods Approval from USYD, RPAH, RBWH Eligibility: coordinators at approved sites 12+ months PRO experience in cancer trials Semi-structured interviews Processes Training Audio-recorded and transcribed verbatim Content analysis The study team agreed on the final code structure.

Results 20 interviews (19 female), mean 46 minutes Professional training: nursing (n=12) science/research (n=4) e.g. B Appl Sci, Health Informatics both (n=4) Department: medical oncology (n=10) haematology (n=5) radiotherapy (n=4) endocrinology (n=1)

Differences in PRO administration

Differences regarding how PROs were discussed with patients Whether PRO addressed at consent stage Whether/when the purpose of PROs was explained to patients Potential impact? Patients unaware of the extent of trial participation when providing consent - Unethical! Patients may misunderstand purpose May alter responses, believing PROs impact their care May be less committed if unaware of importance, leading to missing data

Checking completed questionnaires Checking for missing items: immediately + following up VS too late VS no checking Checking for clinical reasons (not per protocol) “… I’ll discuss that with the patient and say, “You know I really think the doctor needs to know about this”.” Participant 19. “I’ll flick through and just follow up anything that’s really obvious, like that they’ve got, they didn’t sleep or that they’ve had really bad nausea” Participant 11. Potential impact? Co-intervention bias: Administering unstandardized, off-protocol interventions which may impact patient outcomes

Non-English patients Request validated questionnaire translation from sponsor: “When you meet them the first time for screening or stuff, so you identify whether they’d be comfortable doing it in English or, like, Mandarin or Cantonese so… I try to identify before we start, so I …can ask for a translated questionnaire from the sponsor.” Participant 08. SC provides assistance: “They speak English, they can understand English, but when they’re reading something and some of the questions, the way they’re worded, it trips them up a little bit, they don’t quite understand what that word means, and so I’ll go and I’ll explain, you know, I’ll sit and explain to them what, what that word is, in the context of the question.” Participant 13. Use human translators: “We use interpreters and would get interpreter service” Participant 09.

Potential impact of these differences? Use of human translators is bad practice! Unstandardized Unverifiable Selection bias: Differences in access to translators

PRO-specific challenges for site coordinators

Challenges Patient-related: non-English-speaking patients, dealing with patients’ relatives who inappropriately attempted to complete questionnaires, patient unwillingness to complete questionnaires. Design/implementation- related: e-PRO Double-side forms, photocopying Unclear guidance regarding concerning PRO data Fill-in/back-up staff when SC is absent

PRO-specific training

PRO Training PRO-specific training received varied considerably Dedicated PRO training (n=2) Study-specific (n=9) Informal on-the-job training from colleagues (n=6) Other sources (CCTG, GCP, nursing; n=9) No PRO training at all (n=2). Complementary (non-PRO) training: communication skills, nursing degree

Key PRO training needs Self-reported training needs: 9 had training needs: theory of PROs (n=4), concerning PRO data (n=2); assistance (n=1); communication (n=1), non-English patients (n=1). 11 said NO further training was needed. A barrier to improve practice? Needs evident from interviews: Importance of standardised practices: Assistance to patients Use of validated translations, not translators Following up missed assessments uniformly Checking completed questionnaires Missing data If appropriate: Concerning data (& procedures to address, e.g. referral)

Key PRO training needs, cont… Communication skills Dealing with family members attempting to complete PROs for patients Explaining purpose/importance of PRO assessment Missing data – why is it a problem? Role of coordinator in preventing or minimising the problem e-PROs

Conclusion Between-trial differences in PRO administration are expected BUT the administrative differences described regarding communication, patient assistance and checking are concerning as they may lead to various forms of bias and/or poor data quality. PRO training received varied considerably may explain these differences. Are we confusing SCs with our training approaches? Our findings highlight the importance of providing clear, PRO-specific guidance to coordinators, and providing access to training.

Thank you rebecca.mercieca@sydney.edu.au Photo by Ethan Rolhoff