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24-09-2018 | Patient-reported outcomes | News

Remote capture of patient-reported AEs feasible in clinical research

medwireNews: An internet- and telephone-based system that allows cancer patients participating in clinical trials to report symptomatic adverse events (AEs) from home is a viable option, suggests research reported in the Journal of Clinical Oncology.

In a comment to medwireNews, lead author Ethan Basch (University of North Carolina, Chapel Hill, USA) said that “[t]his study provides a roadmap for integrating patient-reported AEs into oncology clinical trials, and demonstrates that this approach is highly feasible.”

He continued: “Many symptomatic AEs experienced by patients are missed by investigators. Similarly, many symptoms patients had before trial enrollment are misattributed by investigators as adverse events. The PRO-CTCAE [Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events] approach improves capture of AEs, and prevents misattribution.

“For example, in this trial, many patients had gastrointestinal symptoms at baseline that investigators would have attributed to study treatment, whereas with the PRO-CTCAE we detect these at baseline and remove them from AE tabulations.”

The researchers previously showed that trial participants were “willing and able” to report AEs using the PRO-CTCAE during clinic visits. But noting the difficulties involved in implementing such an approach with patient populations who do not visit clinics frequently, as well as the need for on-site support and infrastructure, the team trialed a remote system as part of the multicenter PROSPECT study comparing neoadjuvant chemotherapy with chemoradiotherapy in patients with locally advanced rectal cancer.

Of the 557 PROSPECT participants enrolled at North American centers, 500 agreed to complete the PRO-CTCAE survey – comprising 30 items for this trial – weekly while receiving neoadjuvant treatment and every 6 months after surgery. Participants received email or automated telephone reminders if they did not complete a scheduled survey, followed by a telephone call from the central coordinator to administer the survey if the reminders failed.

The majority (63.2%) chose to complete the surveys online, with the remaining (36.8%) patients opting for the automated telephone system.

Compliance with the system during preoperative therapy was high, report the researchers, with 92.0% of the possible 4882 surveys completed. Of these, 77.2% were completed by the participants themselves and 14.7% were collected by the central coordinator.

The completion rate dropped to 71.2% at the 6-month postoperative follow-up, with 45.1% self-reported and 26.1% recovered by the back-up calls. The researchers plan to report on compliance at later timepoints once the primary analysis is undertaken.

The reasons for not completing the surveys are not clear “because many patients who did not self-report also did not respond to calls from study staff to elicit reasons for missing information,” say the authors, who believe that identifying this information in future evaluations could be useful “to determine the effects of missing data on bias and the generalizability of study conclusions.”

On a positive note, the administrative requirements associated with the system generally appeared to be low – site research associates needed a median of 15 minutes to teach a patient how to provide the PRO-CTCAE data and spent a median of 10 minutes at clinic visits to communicate with patients about problems with completing surveys. The central coordinator’s work of training and supporting site staff and collecting missing surveys from patients amounted to 50% of a full-time role.

Given that the investigators choose which of the 124 PRO-CTCAE items to include for a particular clinical trial, Basch admitted that there is a chance that AEs that are relevant to patients might be missed if they are not expected to occur, but added that “a ‘write-in’ can be included to enable patients to add any additional unsolicited AEs.”

Moreover, “one needs to recognize that currently there is no patient reporting of AEs in trials at all,” he emphasized, “and we don’t want the [need for the] perfect approach to stall progress – so a static form is a substantial improvement over the status quo, and adding a write-in makes it even better.”

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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