The utility of international studies that examine adverse events of therapy might be improved by going beyond the simple translation of terminology from English. The terminology used in validated questionnaires for patient-reported outcomes should account for the social and cultural contexts of the countries involved. This is one of the conclusions of a study by an Italian group led by Francesco Perrone, MD, director of the Clinical Trial Unit of the National Cancer Institute in Naples.
“It is well recognized that if patient-reported outcome measures are to be used in different countries and cultures, they must demonstrate cultural acceptability, as well as linguistic and conceptual equivalence to the source measure,” the investigators wrote in a recent article in Tumori Journal. “The aim of this study was to develop an Italian language version of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE] and examine its content validity and test-retest reliability in a diverse sample of Italian-speaking patients undergoing cancer treatment.”
Their study was published June 8 in Tumori Journal.
PRO-CTCAE, a set of 124 self-report items reflecting 78 symptomatic adverse events, was developed at the US National Cancer Institutes. It is increasingly being used in cancer research and in clinician reporting. The items proved useful in improving precision and reliability in the reporting of symptomatic adverse events that traditionally have been underestimated and underreported.
“Clinicians tend to ask proactively about adverse events they see as more relevant and those about which they can do something. They ask much less about the ones they think they have no solution for, even when they have the best intentions,” Perrone told Medscape Medical News. Perrone is president elect of the Italian Association of Medical Oncology and participated in the group that developed the guidelines of the European Society of Medical Oncology on the use of these tools in clinical practice earlier this year.
“This is particularly true for adverse events affecting the sexual sphere, which can have a dramatic impact on their quality of life and for many reasons are not always adequately investigated by the clinicians, nor spontaneously reported by the patients themselves,” study author Lucia Del Mastro, MD, professor of medical oncology at Università di Genova, told Medscape.
The research group recruited 96 patients with cancer who were being treated in 15 cancer centers throughout Italy, where different local dialects can affect the common meaning of various expressions. “Approximately half of all PRO-CTCAE symptom terms posed comprehension difficulties for at least one respondent, and four items presented difficulties in more than 10% of participants,” Perrone explained. As a result, two of the PRO-CTCAE symptom terms were revised.
“Results of the cognitive testing confirm the comprehensibility, clarity, and ease of judgment of the Italian PRO-CTCAE and support its conceptual equivalence to the English source,” Perrone explained. He noted that a more precise estimate of side effects is not only important for clinicians’ decision-making but also can affect the quality of life of patients, who accept adverse events more easily when they are warned in advance.
Commenting on the study for Medscape, Salvatore Siena, MD, director of the Niguarda Cancer Center and professor of medical oncology at Università Statale in Milan, said, “So far, we have been using translations lacking this kind of scrupulous validation. This Italian version obtained with a rigorous methodology is welcome.” Siena was not involved in the study.
The next step is the creation of much shorter, simplified versions of the Italian questionnaire tailored for specific cancers. It should be much quicker to create these versions. Achieving this task might also favor the adoption of this tool in the clinical context, where it could help in monitoring adverse events and adjusting long-term therapies.
Perrone focused on another kind of toxicity in which the need for a context-dependent approach is even more evident: financial toxicity. This term refers to the significant effects on important clinical outcomes, including mortality, caused by the financial hardship experienced after a cancer diagnosis. The questionnaire for patients that was proposed in the United States inevitably reflected that country’s healthcare system. Eight of the 11 questions focused on patients’ psychological reactions.
“American patients assume that a cancer diagnosis will bring ruinous expenses, while patients in Italy are surprised and angry to discover that they also have an economic burden, because they expect to be entitled to free universal healthcare,” Perrone said. This difference pushed the group to rethink the questionnaire from scratch. Their decision was based on findings from focus groups involving patients. Patients appeared to be much more interested in discussing the causes of financial hardship, namely, transportation (including the need for a family member to take days off), complementary therapies, and diagnostics not covered by the National Health Service (because of a lack of evidence of effectiveness or because they are deemed inessential), and lack of coordination between hospital doctors and family physicians.
The patient-reported outcome for fighting financial toxicity (PROFFIT, published in 2021) is undergoing cultural adaptation in the United Kingdom, since the British National Health Service is more like that of Italy than that of the US.
The study was supported by an unrestricted grant of the Fondazione Smith-Kline. Perrone has received payments or honoraria from Incyte, GSK, Eli Lilly, Ipsen, Astellas, Astra Zeneca, Roche, BMS, Bayer, Clovis, and Pierre Fabre. His institution received grants from Roche, Astra Zeneca, Pfizer, MSD, Bayer, Incyte Taiho, Janssen, Exelixis, Aileron, and Daiichi Sankyo. Del Mastro has received payments or honoraria from Roche, Novartis, Eli Lilly, MSD, Pfizer, Ipsen, Celgene, Genomic Helath, Pierre Fabre, Daiichi Sankyo, Seagen, AstraZeneca, and Eisai. Siena has disclosed no relevant financial relationships.
Tumori. Published online June 8, 2022. Full text
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