作者: Yokoyama, Hisayuki ; Cheung, Matthew C. ; Casanova, María ; Snauwaert, Sylvia ; Gyan, Emmanuel ; Fornecker, Luc-Matthieu ; Robu, Daniela ; Johnson, Nathalie A. ; Deconinck, Eric ; Van Den Neste, Eric ; Choudhary, Yuvraj ; Marjanovic, Zora ; Mace, Joseph Ronald ; Dorvaux, Veronique ; Yamamoto, Go ; Guidez, Stephanie ; Quick, Donald P. ; Foucher, Yohann ; Fabbro, Michel ; Morschhauser, Franck ; Terui, Yasuhito ; Glaisner, Sylvie

Background: The effectiveness of treatments in follicular lymphoma is evaluated by the reduction in the rate of recurrence. One of the methodological difficulties is related to the presence of competitive events such as death or second primary malignancies. The related cumulative incidence functions (CIF) are always estimated by using the non-parametric Aalen-Johansen estimator and the associated predictors by using the Fine and Gray approach or by considering a cause-specific Cox model. In the present study, we investigated if the use of a parametric mixture model would provide additional information on the interpretation of the impact of treatments in the management of follicular lymphoma.Methods: We used the RELEVANCE study database (Morschhauser et al.NEJM 2018, JCO 2022) because of the prolonged follow-up of patients treated for follicular lymphoma. RELEVANCE study is a multicenter, phase 3 randomized clinical trial that evaluates rituximab lenalidomide (R 2) as compared to rituximab plus chemotherapy (R-chemo), in patients with previously untreated follicular lymphoma. All 1030 patients received a rituximab maintenance.Results: With a median follow up of 72 months, median progression-free survival (PFS) was not reached in both groups (Kaplan-Meier estimator): the 6-years PFS was 60% and 59% for R 2 and R-chemo, respectively (Cox model, HR = 1.03 [IC95% CI, 0.84 to 1.27]). The CIF of relapse at 72 months was 41% and 39% in the R 2 and R-chemo, respectively (Aalen-Johansen estimator, Figure 1). We did not highlight any significant difference between the treatments in terms of the CIF of relapse (Fine and Gray model, HR = 0.938 [IC95% CI, 0.754 to 1.17], for the same prognostic time, the CIF of death was 2,5% and 2,9% in the R 2 and R-chemo, respectively).We then performed the test with the mixture model, and confirmed there was no significant differences across groups at 72 months. Indeed, 64% and 96% of patients have not relapsed and died respectively.However the mixture model approach allows for extrapolation, and thus we predicted the long-term CIF of relapse to be 67% if patients were followed-up 20 years across groups. The mixture model extrapolation calculated that 60% of relapse would occurr between 72 months and 240 months (20 years).Conclusion: There was no difference at 72 months for survival across tests; but the mixture model, that allow extrapolation, suggested that a difference could be revealed with a greater follow-up.We concluded that future studies of survival in FL will require longer follow-up. This comment appears of particular importance in the context of the forthcoming immunotherapies such as bispecific and CAR-T cells.We can also propose for hematologic malignancies with a chronic evolution, FL, alternative primary outcomes not based on survival, allowing a shorter read out, such as the disability-adjusted life years (DALYs) or quality-adjusted life years (QALYs).

2023-04-01·Allergology International

Longitudinal changes in the prevalence of adult asthma: An epidemiological survey among Japanese salaried employees and their dependents using healthcare insurance claim from 1999 to 2019

Article

作者: Fukutomi, Yuma ; Watai, Kentaro ; Irie, Mari ; Tomita, Yasuhiro ; Fujisawa, Takao ; Nakamura, Yoichi ; Taniguchi, Masami ; Nagao, Mizuho ; Sekiya, Kiyoshi ; Shimoda, Terufumi ; Okada, Chiharu ; Kamide, Yosuke ; Hamada, Yuto ; Azekawa, Kazuhiro ; Nagayama, Kisako ; Nakatani, Eiji

BACKGROUNDInformation on changes in asthma prevalence and the treatment status for asthma is used as basic information for taking medical and administrative measures against asthma. However, this information among adults is relatively limited.METHODSTo elucidate changes in the prevalence of asthma and treatment status over time among Japanese adults, health insurance claim data from some health insurance societies covering salaried employees and their dependents were studied longitudinally. Claim data from FY1999 to 2007 were obtained from two health insurance societies, and data from FY 2011 to 2019 were obtained from three different health insurance societies, and changes in standardized asthma prevalence among subjects aged 20-59 years, proportion of asthma patients prescribed ICS, leukotriene receptor antagonist (LTRA), and LABA, and the mean number of acute asthma exacerbations per year were analyzed.RESULTSThe prevalence of asthma increased from 1.6% in 1999 to 3.0% in 2007 and 2.9% in 2011 to 4.6% in 2019. Increased trends in asthma prevalence from 2011 to 2019 were more noticeable in subjects in their 50s than those in their 20s for both sexes. The number of emergency visits related to asthma was 1.5 per year in 1999, which decreased to 0.8 per year in 2019. The proportion of people prescribed all anti-asthma medications (ICS, LTRA, and LABA) increased over time.CONCLUSIONSThe prevalence of adult asthma among Japanese salaried employees and their dependents has increased over the last 20 years, suggesting more attention should be paid to the prevention of this disease in adults.

2023-01-04·Journal of Occupational Health

Reliability and validity of the Japanese version of the Professional Fulfillment Index among healthcare professionals: A validation study

Article

作者: Ikeda, Miki ; Nishi, Daisuke ; Koido, Yuichi ; Sasaki, Natsu ; Kawashima, Yuzuru ; Miyamoto, Yuki ; Asaoka, Hiroki

AbstractObjectivesTranslation of the Professional Fulfillment Index (PFI) into Japanese would be more useful than the currently developed scales for appropriately measuring burnout and professional fulfillment in healthcare professionals. This study aimed to develop the Japanese version of the PFI and examine its internal consistency, structural validity, and convergent validity in healthcare professionals.MethodsHealthcare professionals in Japan were recruited online. The survey was conducted from October to November 2022. Internal consistency was tested using Cronbach’s α. Structural validity was tested using confirmatory factor analysis (CFA) and exploratory factor analysis (EFA). Convergent validity was tested using Pearson’s correlation coefficients, which were calculated between each score of the PFI scale and burnout (the Japanese Burnout Scale: JBS), depressive symptoms (the Patient Health Questionnaire-9), and QOL (the General Health Questionnaire-12).ResultsThe Cronbach’s alpha was .91 in professional fulfillment, .80 in burnout: work exhaustion, .90 in burnout: interpersonal disengagement, and .89 in burnout: total score. Confirmatory factor analysis demonstrated a modest fit, and EFA yielded a three-factor structure the same as the original PFI. The all three subscales and total score of burnout were significantly correlated with the scores of all the scales (p < .001; e.g., burnout: work exhaustion correlated emotional exhaustion in JBS, r = .71).ConclusionsThe Japanese version of the PFI demonstrated acceptable high internal consistency, structural validity, and convergent validity of the scale with a three-factor structure the same as in the original PFI. The Japanese version of PFI proved to be reliable and valid for use in healthcare professionals.

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