Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Abstract Background The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Results Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. Conclusions The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items

Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Abstract Background The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Results Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. Conclusions The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items

せん妄を呈した進行がん患者における苦悩の実態 : 多施設前向き観察研究

【目的】せん妄を呈した進行がん患者における苦悩の実態の検討．【方法】国内14施設の緩和ケア病棟に入院中または国内10施設の一般病棟に入院し精神腫瘍科が介入中の進行がん患者のうち，せん妄と診断され抗精神病薬の定期投与を受ける患者を前向きに連続サンプリングした．苦悩の有無を緩和ケア専門医が判断し，患者背景，DRS-R-98で評価したせん妄の重症度を比較した．【結果】対象患者818名のうち99名（12.1％）に苦悩を認めた．年齢，39歳以下，認知症の有無に有意差を認めた．治療前のDRS-R-98（15.3±8.1点 vs 17.3±7.8点，p<0.02）は苦悩を伴う群で有意に低く，情動の変容は有意に高かった．【考察】せん妄を呈した進行がん患者で苦悩を伴うものでは年齢が低く，認知症の併存が少なく，せん妄の重症度は低く，情動の変容が強いことが示された．Objective: This study aimed to reveal the prevalence and characteristics of anguish among delirious patients with advanced cancer receiving specialized palliative care services. Methods: We conducted a subanalysis of a multicenter, prospective, observational study at 14 inpatient palliative care units and 10 general wards that offered psycho-oncology consultation service in Japan. We consecutively enrolled the patients with advanced cancer who were diagnosed with delirium and prescribed antipsychotics. Palliative care specialists decided whether patients suffered from anguish or not. We assessed patients\u27 background and severity of delirium with the Delirium Rating Scale-Revised (DRS-R-98). Results: Of 818 enrolled patients, 99 (12.1%) suffered from anguish. We observed a significant difference in the mean age (68.9±12.6 vs. 72.1±11.2, p=0.009), prevalence of dementia (2% vs. 10.4%, p=0.005) between patients with anguish and those without anguish. Patients with anguish had lower DRS-R-98 total scores before medication than those without anguish (15.3±8.1 vs. 17.3±7.8, p=0.018), but higher severity score in lability of affect (1.2±0.8 vs 1.0±0.9, p=0.023). Conclusions: The results of this study suggested that patients with anguish tend to be younger, mostly do not have dementia, and have lower delirium severity score but higher score in lability of affect. Nevertheless, further research, investigating appropriate evaluations and medical interventions for patients with anguish is warranted