Long-term fatigue in survivors of non-Hodgkin lymphoma: The Lymphoma Study Association SIMONAL cross-sectional study.

BACKGROUND: Long-term survivors of non-Hodgkin lymphoma (NHL) must cope with treatment complications and late toxicities that affect their health-related quality of life. Little is known about the risk-to-benefit ratio of new agents like rituximab. The impact of treatment regimens and health disorders on long-term fatigue levels was investigated in a cross-sectional study. METHODS: Two self-administered questionnaires, the 20-item Multidimensional Fatigue Inventory (MFI-20) and a Life Situation Questionnaire, were mailed in 2015 to NHL survivors enrolled onto 12 successive clinical studies (1993-2010) conducted by the Lymphoma Study Association. Private addresses were obtained for 3317 survivors, of whom 1671 (50%) returned the questionnaires. Severe fatigue was defined as MFI-20 scores ≥60 on dimension scales scored from 0 to 100. Linear regression models were used to assess factors that were linked to increased fatigue levels. RESULTS: The study population included 906 men and 765 women, and the median age was 64 years (age range, 24-95 years). Overall, 811 survivors had received cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-like chemotherapy, 518 had received high-dose CHOP, and 342 had undergone upfront autologous stem cell transplantation; 829 survivors also had received rituximab. In total, 1100 survivors (66%) reported 1 or more late health disorders. Severe fatigue was reported by 602 survivors (37%). Increased fatigue levels were associated (P < .001) with increased age, obesity, and the presence of health disorders, but not with initial treatment or rituximab. CONCLUSIONS: The survey confirms that high proportions long-term NHL survivors have severe fatigue. The results suggest that initial treatment and the receipt of rituximab have no influence on the development of long-term fatigue.

The French National Alzheimer database: a fast growing database for researchers and clinicians.

BACKGROUND: Alzheimer's disease (AD) is a major public health issue. The French National Alzheimer database (BNA) registers all medical acts performed by memory units and independent specialists throughout France. This article describes the national coverage, the registered patient characteristics and illustrates research possibilities. METHODS: All data transmitted up to December 2012 were analyzed. The following patient characteristics were studied: age, sex, educational level, place of living, diagnosis, Mini-Mental State Examination score and existence of pharmacological or psychosocial interventions. RESULTS: At the end of 2012, the BNA included 84% (n = 357) of all French memory units, contained 341,498 patients and more than 800,000 medical acts. AD accounted for 26.4% of all registered diagnoses, related disorders for 21.7% and mild cognitive impairment for 8.7%. CONCLUSION: The BNA offers a multitude of research possibilities. In the coming years, the BNA will play a major role in monitoring trends and related risk factors in AD.

Validation of the NVSCA registry for common oral clefts: study design and first results.

OBJECTIVE: Since 1997 the Dutch Association for Cleft Palate and Craniofacial Anomalies (NVSCA) has maintained a national registry of congenital craniofacial anomalies. This study validates data on three common oral cleft categories (cleft lip/alveolus = CL/A; cleft lip/alveolus and palate = CL/AP; and cleft palate = CP) and general items. DESIGN: Retrospective observational study. SETTING: All 15 Dutch cleft palate teams registered presurgery patients with common oral clefts (n = 2553) from 1997 to 2003. PATIENTS: A random sample of 250 cases was used; 13 cases were excluded. MAIN OUTCOME MEASURES: The corresponding medical data were reviewed; these medical data served to validate the NVSCA registry data. Prevalence comparisons, 2 x 2 tables and validity measures were performed. RESULTS: The cleft categories most accurately recorded were CL/A and CP. Both categories had an observed agreement of 98%, kappa of 0.94, and a sensitivity and specificity of 97%. Cleft lip/alveolus and palate had an observed agreement of 95%, kappa of 0.89, a sensitivity of 90%, and a specificity of 99%. Regarding the general items, observed agreement and kappa were highest for adoption/foster child (99%; 0.76) and lowest for remarks about pregnancy (63%; 0.20). Sensitivity ranged from 25% (consanguinity) to 97% (white mother) and specificity was high for all items (>93%) except for white father and mother (approximately 35%). CONCLUSIONS: The NVSCA registry is a valuable tool for quality improvement and research because validity on all three common oral cleft categories is very good. Validity on the general items is reasonable to satisfying and appears to be related to the type of information.

Do differences in maternal age, parity and multiple births explain variations in fetal and neonatal mortality rates in Europe?--Results from the EURO-PERISTAT project.

Perinatal mortality rates differ markedly between countries in Europe. If population characteristics, such as maternal age, parity or multiple births, contribute to these differences, standardised rates may be useful for international comparisons of health status and especially quality of care. This analysis used aggregated population-based data on fetal and neonatal mortality stratified by maternal age, parity and multiple birth from 12 countries participating in the EURO-PERISTAT project to explore this question. Adjusted odds ratios were computed for fetal and neonatal mortality and tested for inter-country heterogeneity; standardised mortality rates were calculated using a direct standardisation method. There were wide variations in fetal and neonatal mortality rates, from 3.3 to 7.1 and 2.0 to 6.0 per 1000 total and livebirths, respectively, and in the prevalence of mothers over 35 (7-22%), primiparae (41-50%) and multiple births (2-4%). These population characteristics had a significant association with mortality, although results were less consistent for primiparity. Odds ratios for older mothers and primiparae showed significant inter-country heterogeneity. The association between maternal age and fetal mortality declined as the prevalence of older mothers in the population increased. Standardised rates did not substantially change inter-country rankings and demographic characteristics did not explain the higher mortality observed in some countries. Our results do not support the use of mortality rates standardised for age, parity and multiple births for international comparisons of quality of care. Further research should explore why the negative effects of older maternal age decrease as delayed childbearing becomes more common and, in particular, whether this is due to changes in the social characteristics of older mothers or in health care provision.

[Conduct of epidemiologic studies in French cancer survivors: Methods, difficulties encountered and solutions provided. Lessons learned from the SIMONAL study on long-term toxicities after non-Hodgkin lymphoma treatment]. / Conduire des études épidémiologiques après cancer en France : modalités, difficultés et propositions de solutions. Les enseignements de l'étude SIMONAL sur les toxicités tardives des traitements du lymphome non Hodgkinien.

INTRODUCTION: Since the introduction of targeted therapies, specific lymphoma mortality has decreased. Possible long-term toxicities, however, are not known yet. This article describes the implementation of the SIMONAL study that investigates the hypothesis of an overconsumption of care after lymphoma treatment with a 10-year follow-up. METHODS: After the mandatory regulatory steps (CCTIRS and CNIL) the vital status and address of 5247 patients treated in 131 French centers were retrieved using a secure web portal, in order to send a quality of life after lymphoma questionnaire. After an additional vital status validation request at the center for epidemiologic research and population health (CESP), the questionnaires were sent. Double data entry was performed on the collected data and a request to access data from France's public health insurance scheme information system (SNIIRAM) was formulated. RESULTS: Retrieval of the addresses via the portal has been slow and multiple reminders were needed. The CESP identified 9.4 % additional deaths not known by the treatment centers. Of the 3391 questionnaires sent, the response rate was 50%. A comparison between the responders and non-responders revealed no demographic differences but showed that the responders were more often treated with targeted drugs as they were included in more recent trials. DISCUSSION: Logistic and information technology (IT) aspects rendered the implementation of the SIMONAL study more complex, time consuming and costly. However, using the collected data, many future research questions will be addressed.

Changes in perinatal care and survival in very preterm and extremely preterm infants in The Netherlands between 1983 and 1995.

OBJECTIVE: To evaluate changes in obstetrical and neonatal care for very preterm and extremely preterm infants between 1983 and 1995 in The Netherlands and to evaluate the effect of those changes. STUDY DESIGN: Data on all very preterm or VLBW infants from the linked national obstetrical and neonatal databases of 1995 (N=2066) were compared to data on similar infants from a nation-wide study of very preterm infants born in 1983 (N=1338). RESULTS: Obstetrical and neonatal management changed over time, with an increased number of deliveries in tertiary centres (35.7-60.7%), an increase in C-sections (43.7-56.8%) and prolonged artificial ventilation (3.4-9.5%). Survival until discharge increased from 75 to 90% and neonatal morbidity decreased in relative terms. CONCLUSIONS: The short-term outcome for these very preterm and extremely preterm infants has improved. Long-term follow-up through to school age and adulthood of preterm infants is needed to investigate the changes in the sequelae of intensive obstetrical and neonatal care.

The mini mental state examination at the time of Alzheimer's disease and related disorders diagnosis, according to age, education, gender and place of residence: a cross-sectional study among the French National Alzheimer database.

THE AIM OF THIS STUDY: was firstly to describe the MMSE (Mini-Mental State Examination) score upon initial diagnosis of Alzheimer's disease and related disorders among the French population, according to age. Secondly, education, gender and place of residence were studied as factors potentially associated with delayed Alzheimer's disease diagnosis. DESIGN: we conducted a cross sectional analysis of the French National Alzheimer database (BNA). Data from 2008 to 2012 were extracted. Patients were selected at the moment of their first diagnosis of AD (n = 39,451). RESULTS: The MMSE score at initial diagnosis dropped significantly with increasing age. The test score increased with the degree of educational background regardless of age. Gender and place of residence were significantly related to the MMSE score, women and persons living in medical institutions having lower MMSE scores under the age of 90 years and at all educational levels. CONCLUSIONS: Health care professionals should be aware of these risk factors in order to maximize chances of earliest possible diagnosis of Alzheimer's disease and related disorders.