Self-Reports on Adverse Effects From Younger Patients Are Reliable, Accurate

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Although younger patients experience multiple subjective adverse events, they can go underreported.
Although younger patients experience multiple subjective adverse events, they can go underreported.
The following article features coverage from the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. Click here to read more of Oncology Nurse Advisor's conference coverage. 

DENVER — Children and adolescent patients with cancer are able to accurately report subjective adverse events (AEs) they experience during their cancer treatment, and they are willing to do so, a presentation at the 2017 Oncology Nursing Society Annual Congress has shown.

Children experience multiple subjective adverse events such as fatigue, pain, and sadness; however, children are not routinely asked about these events, resulting in adverse events being underreported and undermanaged in this patient population thereby the total impact of treatment is not fully treated or documented, explained Pamela Hinds, PhD, RN, FAAN, of the Children's National Medical Center, Washington DC. Assessment of treatment-related adverse events in pediatric patients is limited to objective indicators graded by clinicians. “Adding the child's voice means that true risk and benefit of treatment in pediatric oncology become known,” said Dr Hinds. A more complete and accurate assessment would lead to better informed clinical management of adverse events.

Therefore, Dr Hinds and colleagues sought to create and validate a self-report measure of subjective adverse events for use with patients aged 7 years to 20 years undergoing cancer treatment.

For the study, 4 pediatric oncology clinicians reviewed all 790 common terminology criteria for adverse events (CTCAE) items and achieved consensus on 262 items. Using a Delphi approach, a panel of 187 experts identified which items could be accurately reported by patients aged 7 years to 20 years. Semi-structured interviews were conducted with 96 children and their guardians regarding the patients' adverse event experiences. In addition, cognitive interviews were conducted with 81 children and their guardians regarding child-friendly terminology for adverse events, directions, and time period for a self-report AE measure in pediatric patients.

Cognitive interviews were conducted twice because agreement on 12 of the terms was not achieved in the first interviews, and 62 terms were translated from medical jargon to child and adolescent friendly terms. Lastly, the measure was constructed and field tested.

Results revealed that most children were able to understand the 7-day recall period used for AE interviewing. Although younger children preferred that the AEs were read to them, patients aged 7 years and older and their guardians were generally able to understand and willing to report on cancer treatment AEs they experienced using the 7-day recall period.

A longitudinal assessment of the measure is currently underway at the 8 sites that participated in the development of the self-report AE measure. This is the first time that Patient-Report Outcomes (PRO)-CTCAE ratings from children's self-reports will be included in treatment toxicity reporting for oncology clinical trials. 

Subjective self-report of cancer treatment AEs from pediatric and adolescent patients could become a new trial end point, noted the researchers. Pediatric PRO-CCTCAE is being translated into different languages by study teams in China, Brazil, and Italy. 

Read more of Oncology Nurse Advisor's coverage of the 2017 American Society of Clinical Oncology Annual Meeting by visiting the conference page.

Reference

1. Hinds P, Reeve B, Jaobs S, Baker J, Mack J, Withycom J. Eliciting the child's voice in adverse event reporting in oncology clinical trials. Oral presentation at: 2017 Oncology Nursing Society Annual Congress; May 4-7, 2017; Denver, CO.


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