Abstract
PurposesStudies investigating self-reported long-term morbidity in childhood cancer survivors (CCS) are using heterogeneous outcome definitions, which compromises comparability and include (un)treated asymptomatic and symptomatic outcomes. We generated a Dutch LATER core set of clinically relevant physical outcomes, based on self-reported data. Clinically relevant outcomes were defined as outcomes associated with clinical symptoms or requiring medical treatment.MethodsFirst, we generated a draft outcome set based on existing questionnaires embedded in the Childhood Cancer Survivor Study, British Childhood Cancer Survivor Study, and Dutch LATER study. We added specific outcomes reported by survivors in the Dutch LATER questionnaire. Second, we selected a list of clinical relevant outcomes by agreement among a Dutch LATER experts team. Third, we compared the proposed clinically relevant outcomes to the severity grading of the Common Terminology Criteria for Adverse Events (CTCAE).ResultsA core set of 74 self-reported long-term clinically relevant physical morbidity outcomes was established. Comparison to the CTCAE showed that 36% of these clinically relevant outcomes were missing in the CTCAE.Implications for Cancer SurvivorsThis proposed core outcome set of clinical relevant outcomes for self-reported data will be used to investigate the self-reported morbidity in the Dutch LATER study. Furthermore, this Dutch LATER outcome set can be used as a starting point for international harmonization for long-term outcomes in survivors of childhood cancer.
Highlights
The vast majority of children diagnosed with cancer nowadays will achieve long-term survival [1, 2]
Childhood cancer-directed surgeries impacting cancer survivors (CCS) in later life, for example, limb amputation which results in a lifelong disability or removal of an eye which results in lifelong complications, were added to the draft outcome list
In long-term morbidity research, the Childhood Cancer Survivor Study questionnaire was used either in its original form [6–8, 10, 12–15, 18, 20, 22, The draft outcome set was reviewed in detail by the Dutch LATER experts team, which comprised a multidisciplinary team of late effects clinicians, late effects researchers, a pediatric endocrinologist, and a survivor representative, all of whom are involved in the late effects research
Summary
The vast majority of children diagnosed with cancer nowadays will achieve long-term survival [1, 2]. While many authors do not grade the severity of the reported long-term morbidity in CCS, others use the Common Terminology Criteria for Adverse Events (CTCAE) [40], either in its original form or an adapted version incorporating specific additional outcomes that authors considered missing [41,42,43]. This lack of uniformity in types of outcomes, outcome definitions, and outcome grading—even among studies that use similar data ascertainment methods—limits interpretation, comparability, and generalizability of studies investigating the burden of long-term morbidity in CCS. To get a better insight in the overall burden for survivors, the Dutch LATER questionnaire study would like to evaluate only outcomes that are symptomatic and/or requiring medical treatment
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