REPORT-UK (Real-time Electronic Patient Outcome ReporTing of adverse events in UK cancer trials) – a feasibility pilot study in a UK oncology setting


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Fiona Kennedy1,Beverly Clayton1,Kate Absolom1,Elaine O’Connell Francischetto2,Louise Flintoff3,Kathryn Gordon1,Will Crocombe1,Victoria Hiley1,Julia Brown1,Jane M Blazeby4,Galina Velikova5
1University of Leeds,2University of Birmingham,3University Hospitals Bristol NHS Foundation Trust,4University of Bristol / University Hospitals Bristol NHS Foundation Trust,5University of Leeds / Leeds Teaching Hospitals NHS Trust

Abstract

Background

Adverse events (AEs) reporting is essential in clinical trials. The current system for reporting (Common Toxicity Criteria and Adverse Events, CTCAE) relies on clinicians’ interpretation of symptoms. The value of patient self-reports of AEs and Patient Reported Outcome Measures (PROMs) is recognised but robust data collection methods are needed. REPORT-UK was a proof-of-principle study to develop and evaluate an electronic (internet/telephone) system for self-reporting AEs and PROMs during trials. A feasibility pilot study to assess compliance with the systems in a general oncology setting ran between August 2014 and October 2015.

Method

249 varied diagnosis cancer patients undergoing treatment (chemotherapy/targeted agents/hormone therapy/radiotherapy/surgery, and an ECOG group with performance status ≥2) were recruited. For 12 weeks patients were reminded (text/email) to complete weekly AEs (NCI PRO-CTCAE) and monthly PROMs questionnaires (EORTC QLQ-C30) on their preferred system. Acceptability was measured by recruitment rates, attrition, compliance, and patient and staff feedback at end-of-study (EOS).

Results

Overall, the consent rate was 48%. System preference was 82% internet/17% IVR.  Only 13 participants withdrew and 6 died whilst on study.  192 returned EOS questionnaires.  Overall patient compliance was good for both weekly AE and monthly PROMs reporting, but differed between treatment groups, and dropped over time, but comparable to clinical trials. Both systems were perceived as easy-to-use. Time to complete was perceived by patients to be acceptable, although actual times show the internet is quicker (median time 9 minutes vs. 21.5 minutes). Baseline comparisons between patient vs. clinician-reporting of some AEs differed substantially.

Conclusion

The study demonstrates a user-friendly electronic data collection system, which provides information on patient compliance in a general oncology setting but we recognise this is different to a real trial setting. The system could be implemented in practice in clinical trials alongside traditional approaches to improve data quality and safety.