1. 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

2. 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…)

3. 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

4. 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.

5. 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.

6. 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)

7. Differences in PRO administration

8. 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

9. 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

10. 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.

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

12. PRO-specific challenges for site coordinators

13. 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

14. PRO-specific training

15. 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

16. 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)

17. 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

18. 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.

19. Thank you
Photo by Ethan Rolhoff