Socioeconomic and cultural factors associated with pap smear screening among French women living in Réunion Island.

BACKGROUND: Réunion Island is a French overseas territory located in the southern Indian Ocean, with a challenging socioeconomic and multicultural context. Compared to mainland France, Réunion has an overincidence and overmortality of cervical cancer. In order to investigate these two issues, it is important to evaluate the barriers and potential levers to Pap smear screening among female inhabitants of the island. We aimed to identify the specific socio-demographic factors, cultural factors, and living conditions associated with Pap smear screening in Réunion, with a view to increasing uptake. METHODS: We conducted a Knowledge Attitude Behavior and Practices (KABP) survey on cervical cancer screening practices among women aged between 25 and 65 years old living in Réunion Island, selected using random digit dialing sampling. Data were collected using Computer Assistant Telephone Interviews. Weighted chi-squared tests and Student's t-tests were used to compare women who had up-to-date Pap smear screening with women who did not. Weighted logistic models were used to identify the factors associated with not having up-to-date screening. RESULTS: A total of 1000 women were included in the study. Of these, 88.1% had a Pap smear test during the previous three years. Factors independently associated with not being up to date were as follows: aged over 55 (AOR 2.3 [1.2-4.3]), no children (AOR 2.5 [1.4-4.3]), having free universal health coverage (AOR 1.7 [1.1-2.7]), an income per unit consumption lower than 1500€ per month (AOR 2.0 [1.1-3.7]), low health literacy (AOR 2.7 [1.7-4.1]), not consulting a general practitioner in the prior 12 months (AOR 3.6 [2.0-6.5]), and a BMI > 30 (AOR 2.6 [1.5-4.4]). CONCLUSIONS: This is the first large-scale survey focusing on recommended Pap smear screening uptake in Réunion Island. Although self-reported screening incidence was higher than in mainland France, national screening policies must take into account the island's diverse social and cultural characteristics (e.g., an ageing population, low health literacy), while implementing actions to fight against poverty and increase general access to healthcare.

Machine learning for predicting neurodegenerative diseases in the general older population: a cohort study.

BACKGROUND: In the older general population, neurodegenerative diseases (NDs) are associated with increased disability, decreased physical and cognitive function. Detecting risk factors can help implement prevention measures. Using deep neural networks (DNNs), a machine-learning algorithm could be an alternative to Cox regression in tabular datasets with many predictive features. We aimed to compare the performance of different types of DNNs with regularized Cox proportional hazards models to predict NDs in the older general population. METHODS: We performed a longitudinal analysis with participants of the English Longitudinal Study of Ageing. We included men and women with no NDs at baseline, aged 60 years and older, assessed every 2 years from 2004 to 2005 (wave2) to 2016-2017 (wave 8). The features were a set of 91 epidemiological and clinical baseline variables. The outcome was new events of Parkinson's, Alzheimer or dementia. After applying multiple imputations, we trained three DNN algorithms: Feedforward, TabTransformer, and Dense Convolutional (Densenet). In addition, we trained two algorithms based on Cox models: Elastic Net regularization (CoxEn) and selected features (CoxSf). RESULTS: 5433 participants were included in wave 2. During follow-up, 12.7% participants developed NDs. Although the five models predicted NDs events, the discriminative ability was superior using TabTransformer (Uno's C-statistic (coefficient (95% confidence intervals)) 0.757 (0.702, 0.805). TabTransformer showed superior time-dependent balanced accuracy (0.834 (0.779, 0.889)) and specificity (0.855 (0.0.773, 0.909)) than the other models. With the CoxSf (hazard ratio (95% confidence intervals)), age (10.0 (6.9, 14.7)), poor hearing (1.3 (1.1, 1.5)) and weight loss 1.3 (1.1, 1.6)) were associated with a higher DNN risk. In contrast, executive function (0.3 (0.2, 0.6)), memory (0, 0, 0.1)), increased gait speed (0.2, (0.1, 0.4)), vigorous physical activity (0.7, 0.6, 0.9)) and higher BMI (0.4 (0.2, 0.8)) were associated with a lower DNN risk. CONCLUSION: TabTransformer is promising for prediction of NDs with heterogeneous tabular datasets with numerous features. Moreover, it can handle censored data. However, Cox models perform well and are easier to interpret than DNNs. Therefore, they are still a good choice for NDs.

Age-specific associations between underlying health conditions and hospitalisation, death and in-hospital death among confirmed COVID-19 cases: a multi-country study based on surveillance data, June to December 2020.

BackgroundUnderlying conditions are risk factors for severe COVID-19 outcomes but evidence is limited about how risks differ with age.AimWe sought to estimate age-specific associations between underlying conditions and hospitalisation, death and in-hospital death among COVID-19 cases.MethodsWe analysed case-based COVID-19 data submitted to The European Surveillance System between 2 June and 13 December 2020 by nine European countries. Eleven underlying conditions among cases with only one condition and the number of underlying conditions among multimorbid cases were used as exposures. Adjusted odds ratios (aOR) were estimated using 39 different age-adjusted and age-interaction multivariable logistic regression models, with marginal means from the latter used to estimate probabilities of severe outcome for each condition-age group combination.ResultsCancer, cardiac disorder, diabetes, immunodeficiency, kidney, liver and lung disease, neurological disorders and obesity were associated with elevated risk (aOR: 1.5-5.6) of hospitalisation and death, after controlling for age, sex, reporting period and country. As age increased, age-specific aOR were lower and predicted probabilities higher. However, for some conditions, predicted probabilities were at least as high in younger individuals with the condition as in older cases without it. In multimorbid patients, the aOR for severe disease increased with number of conditions for all outcomes and in all age groups.ConclusionWhile supporting age-based vaccine roll-out, our findings could inform a more nuanced, age- and condition-specific approach to vaccine prioritisation. This is relevant as countries consider vaccination of younger people, boosters and dosing intervals in response to vaccine escape variants.

SARS-CoV-2 transmission in educational settings during an early summer epidemic wave in Luxembourg, 2020.

BACKGROUND: Following a first wave in spring and gradual easing of lockdown, Luxembourg experienced an early second epidemic wave of SARS-CoV-2 before the start of summer school holidays on 15th July. This provided the opportunity to investigate the role of school-age children and school settings for transmission. METHODS: We compared the incidence of SARS-CoV-2 in school-age children, teachers and the general working population in Luxembourg during two epidemic waves: a spring wave from March-April 2020 corresponding to general lockdown with schools being closed and May-July 2020 corresponding to schools being open. We assessed the number of secondary transmissions occurring in schools between May and July 2020 using routine contact tracing data. RESULTS: During the first wave in March-April 2020 when schools were closed, the incidence in pupils peaked at 28 per 100,000, while during the second wave in May-July 2020 when schools were open, incidence peaked 100 per 100,000. While incidence of SARS-CoV-2 was higher in adults than in children during the first spring wave, no significant difference was observed during the second wave in early summer. Between May and July 2020, we identified a total of 390 and 34 confirmed COVID-19 cases among 90,150 school-age children and 11,667 teachers, respectively. We further estimate that 179 primary cases caused 49 secondary cases in schools. While some small clusters of mainly student-to-student transmission within the same class were identified, we did not observe any large outbreaks with multiple generations of infection. CONCLUSIONS: Transmission of SARS-CoV-2 within Luxembourg schools was limited during an early summer epidemic wave in 2020. Precautionary measures including physical distancing as well as easy access to testing, systematic contact tracing appears to have been successful in mitigating transmission within educational settings.

Methods to Generate Innovative Research Ideas and Improve Patient and Public Involvement in Modern Epidemiological Research: Review, Patient Viewpoint, and Guidelines for Implementation of a Digital Cohort Study.

BACKGROUND: Patient and public involvement (PPI) in research aims to increase the quality and relevance of research by incorporating the perspective of those ultimately affected by the research. Despite these potential benefits, PPI is rarely included in epidemiology protocols. OBJECTIVE: The aim of this study is to provide an overview of methods used for PPI and offer practical recommendations for its efficient implementation in epidemiological research. METHODS: We conducted a review on PPI methods. We mirrored it with a patient advocate's viewpoint about PPI. We then identified key steps to optimize PPI in epidemiological research based on our review and the viewpoint of the patient advocate, taking into account the identification of barriers to, and facilitators of, PPI. From these, we provided practical recommendations to launch a patient-centered cohort study. We used the implementation of a new digital cohort study as an exemplary use case. RESULTS: We analyzed data from 97 studies, of which 58 (60%) were performed in the United Kingdom. The most common methods were workshops (47/97, 48%); surveys (33/97, 34%); meetings, events, or conferences (28/97, 29%); focus groups (25/97, 26%); interviews (23/97, 24%); consensus techniques (8/97, 8%); James Lind Alliance consensus technique (7/97, 7%); social media analysis (6/97, 6%); and experience-based co-design (3/97, 3%). The viewpoint of a patient advocate showed a strong interest in participating in research. The most usual PPI modalities were research ideas (60/97, 62%), co-design (42/97, 43%), defining priorities (31/97, 32%), and participation in data analysis (25/97, 26%). We identified 9 general recommendations and 32 key PPI-related steps that can serve as guidelines to increase the relevance of epidemiological studies. CONCLUSIONS: PPI is a project within a project that contributes to improving knowledge and increasing the relevance of research. PPI methods are mainly used for idea generation. On the basis of our review and case study, we recommend that PPI be included at an early stage and throughout the research cycle and that methods be combined for generation of new ideas. For e-cohorts, the use of digital tools is essential to scale up PPI. We encourage investigators to rely on our practical recommendations to extend PPI in future epidemiological studies.

Adherence trajectories of adjuvant endocrine therapy in the five years after its initiation among women with non-metastatic breast cancer: a cohort study using administrative databases.

PURPOSE: Despite the benefits of adjuvant endocrine therapy (AET) for reducing recurrence and mortality risks after hormone-sensitive breast cancer, AET adherence is sub-optimal for a high proportion of women. However, little is known about long-term patterns of AET adherence over the minimally recommended 5 years. Our objectives were to: (1) identify 5-year AET adherence trajectory groups; (2) describe trajectory groups according to adherence measures traditionally used (i.e., Proportion of Days Covered); and (3) explore factors associated with trajectories. METHODS: We conducted a 5-year cohort study using data from a French national study that included AET dispensing data. Women diagnosed with first non-metastatic breast cancer and having at least 1 AET dispensing in the 12 months after diagnosis were included. Group-based trajectory modeling was used to identify adherence trajectory groups by clustering similar patterns of monthly AET dispensing. Multinomial logistic regressions were used to identify factors associated with trajectories. RESULTS: Among 674 women, five AET adherence trajectory groups were identified: (1) quick decline and stop (5.2% of women); (2) moderate decline and stop (6.4%); (3) slow decline (17.2%); (4) high adherence (30.0%); and (5) maintenance of very high adherence (41.2%). Mean 5-year Proportion of Days Covered varied from 10 to 97% according to trajectories. Women who did not receive chemotherapy or a personalized care plan were more likely to belong to trajectories where AET adherence declined and stopped. CONCLUSION: Our results provide information on the diversity of longitudinal AET adherence patterns, the timing of decline and discontinuation and associated factors that could inform healthcare professionals.

Relationship of oxidative stress to visceral adiposity in youth and role played by vitamin D.

BACKGROUND: Visceral adipose tissue (VAT) accumulation is a major cardiometabolic risk factor, associated with increased inflammation. Oxidative stress (OS) is also associated with inflammation and cardiometabolic issues, yet mainly through general obesity. Both OS and obesity were linked to vitamin D deficiency. OBJECTIVES: To investigate whether OS increase is associated with VAT accumulation in youth, and whether in the presence of VAT accumulation, a higher vitamin D status is associated with lower OS. METHODS: One hundred and fifty-eight youth with overweight/obesity, 7 to 17 years old, were recruited (Pediatric Clinic, Luxembourg). We assessed visceral and subcutaneous abdominal adipose tissues by magnetic resonance imaging, OS by DNA/RNA oxidative damage with ELISA and vitamin D by high-performance liquid chromatography. RESULTS: VAT was the body fat compartment the most strongly associated with OS (RPearson : 0.298; P < 10-4 ). The general linear (GLM) models assessing the relationship between OS, VAT and vitamin D concentrations showed that "Log10 OS = (0.003 × VAT) + 3.911 (R2adjusted : 0.083; P-value < 10-4 )"; "Log10 OS = (0.003 × VAT) - (0.156 × log10 vitamin D) + 4.110 (R2adjusted : 0.101; P-value < 10-4 )". After back-transformation of the log-values into normal values, the GLM showed that, for a person with an average value of VAT (40.7 cm2 ), a 10 cm2 increase in VAT would increase OS by approx. 771.833 pg/mL, after age, gender, Tanner stage and physical activity adjustment. An approximate increase of 9 ng/mL of vitamin D would counterbalance this negative effect of increased VAT. CONCLUSION: Dietary strategies improving vitamin D status should be investigated to tackle VAT and OS increase.

Digital Health Strategies to Fight COVID-19 Worldwide: Challenges, Recommendations, and a Call for Papers.

The coronavirus disease (COVID-19) pandemic has created an urgent need for coordinated mechanisms to respond to the outbreak across health sectors, and digital health solutions have been identified as promising approaches to address this challenge. This editorial discusses the current situation regarding digital health solutions to fight COVID-19 as well as the challenges and ethical hurdles to broad and long-term implementation of these solutions. To decrease the risk of infection, telemedicine has been used as a successful health care model in both emergency and primary care. Official communication plans should promote facile and diverse channels to inform people about the pandemic and to avoid rumors and reduce threats to public health. Social media platforms such as Twitter and Google Trends analyses are highly beneficial to model pandemic trends as well as to monitor the evolution of patients' symptoms or public reaction to the pandemic over time. However, acceptability of digital solutions may face challenges due to potential conflicts with users' cultural, moral, and religious backgrounds. Digital tools can provide collective public health benefits; however, they may be intrusive and can erode individual freedoms or leave vulnerable populations behind. The COVID-19 pandemic has demonstrated the strong potential of various digital health solutions that have been tested during the crisis. More concerted measures should be implemented to ensure that future digital health initiatives will have a greater impact on the epidemic and meet the most strategic needs to ease the life of people who are at the forefront of the crisis.

Early assessment of the impact of mitigation measures to control COVID-19 in 22 French metropolitan areas, October to November 2020.

In France, measures including curfew and lockdown were implemented to control the COVID-19 pandemic second wave in 2020. This study descriptively assesses their possible effects, also relative to their timing. A considerable decrease in incidence of COVID-19 cases and hospital admissions was observed 7 to 10 days after mitigation measures were put in place, occurring earlier in metropolitan areas which had implemented these first. This temporal coincidence suggests the measures' positive impact, consistent with international experiences.

Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial.

Importance: Rocuronium and succinylcholine are often used for rapid sequence intubation, although the comparative efficacy of these paralytic agents for achieving successful intubation in an emergency setting has not been evaluated in clinical trials. Succinylcholine use has been associated with several adverse events not reported with rocuronium. Objective: To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations. Design, Setting and Participants: Multicenter, single-blind, noninferiority randomized clinical trial comparing rocuronium (1.2 mg/kg) with succinylcholine (1 mg/kg) for rapid sequence intubation in 1248 adult patients needing out-of-hospital tracheal intubation. Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units. The date of final follow-up was August 31, 2016. Interventions: Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624). Main Outcomes and Measures: The primary outcome was the intubation success rate on first attempt. A noninferiority margin of 7% was chosen. A per-protocol analysis was prespecified as the primary analysis. Results: Among 1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis. The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine group, with a between-group difference of -4.8% (1-sided 97.5% CI, -9% to ∞), which did not meet criteria for noninferiority. The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group. Conclusions and Relevance: Among patients undergoing endotracheal intubation in an out-of-hospital emergency setting, rocuronium, compared with succinylcholine, failed to demonstrate noninferiority with regard to first-attempt intubation success rate. Trial Registration: ClinicalTrials.gov Identifier: NCT02000674.

Trends in the prescription of novel oral anticoagulants in UK primary care.

AIMS: Novel oral anticoagulants (NOACs) are alternatives to vitamin-K antagonists (VKAs) for the prevention of thromboembolism. It is unclear how NOACs have been adopted in the UK since first introduced in 2008. The present study was conducted to describe the trends in the prescription of NOACs in the UK, including dabigatran, rivaroxaban and apixaban. METHODS: Using the UK's Clinical Practice Research Datalink, the rates of new use of NOACs and VKAs from 2009 to 2015 were calculated using Poisson regression. Patient characteristics associated with NOAC initiation were identified using multivariate logistic regression. RESULTS: The overall rate of oral anticoagulant initiation increased by 58% over the study period [rate ratio (RR) 1.58; 95% confidence interval (CI) 1.23, 2.03], even as the rate of new VKA use decreased by 31% (RR 0.69; 95% CI 0.52, 0.93). By contrast, the rate of initiation of NOAC increased, particularly from 2012 onwards, with a 17-fold increase from 2012 to 2015 (RR 17.68; 95% CI 12.16, 25.71). In 2015, NOACs accounted for 56.5% of oral anticoagulant prescriptions, with rivaroxaban prescribed most frequently, followed by apixaban and then dabigatran. Compared to VKAs, new NOAC users were less likely to have congestive heart failure, coronary artery disease and peripheral vascular disease, and more likely to have a history of ischaemic stroke. CONCLUSIONS: In the UK, the rate of initiation of NOACs has increased substantially since 2009, and these agents have now surpassed VKAs as the anticoagulant of choice. Moreover, the characteristics of patients initiated on NOACs have changed over time, and this should be accounted for in future studies comparing NOACs and VKAs.

Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information.

BACKGROUND: Improvement of coordination of all health and social care actors in the patient pathways is an important issue in many countries. Health Information (HI) technology has been considered as a potentially effective answer to this issue. The French Health Ministry first funded the development of five TSN ("Territoire de Soins Numérique"/Digital health territories) projects, aiming at improving healthcare coordination and access to information for healthcare providers, patients and the population, and at improving healthcare professionals work organization. The French Health Ministry then launched a call for grant to fund one research project consisting in evaluating the TSN projects implementation and impact and in developing a model for HI technology evaluation. METHODS: EvaTSN is mainly based on a controlled before-after study design. Data collection covers three periods: before TSN program implementation, during early TSN program implementation and at late TSN program implementation, in the five TSN projects' territories and in five comparison territories. Three populations will be considered: "TSN-targeted people" (healthcare system users and people having characteristics targeted by the TSN projects), "TSN patient users" (people included in TSN experimentations or using particular services) and "TSN professional users" (healthcare professionals involved in TSN projects). Several samples will be made in each population depending on the objective, axis and stage of the study. Four types of data sources are considered: 1) extractions from the French National Heath Insurance Database (SNIIRAM) and the French Autonomy Personalized Allowance database, 2) Ad hoc surveys collecting information on knowledge of TSN projects, TSN program use, ease of use, satisfaction and understanding, TSN pathway experience and appropriateness of hospital admissions, 3) qualitative analyses using semi-directive interviews and focus groups and document analyses and 4) extractions of TSN implementation indicators from TSN program database. DISCUSSION: EvaTSN is a challenging French national project for the production of evidenced-based information on HI technologies impact and on the context and conditions of their effectiveness and efficiency. We will be able to support health care management in order to implement HI technologies. We will also be able to produce an evaluation toolkit for HI technology evaluation. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02837406 , 08/18/2016.

[Self-employed and small business owners diagnosed with cancer: effect on entrepreneurial survival]. / Travailleurs indépendants et dirigeants de très petites entreprises atteints d'un cancer: effet sur la survie entrepreneuriale.

AIM: When self-employed andsmall business owners are diagnosed with cancer what is the effect on their small-firm survival duration? METHODS: Data Sources: secondary data for 3,587 subjects, 18-65 years, working when diagnosed with cancer in 1995-2009 and a comparison group of 27,688 subjects matched for gender, age and occupation. Study design: a comprehensive population-based longitudinal study. A Cox model described time to failures of small businesses and terminations ofself-employment. Data Collection Methods: extraction from the statutory mandatory self-employed social security scheme database. RESULTS: Findings were that age, cancer prognosis and very intense physical workload occupation were independent predictors of enterprise failure for cancer-exposed subjects. Compared with unexposed subjects, their global hazard ratio was 1.59 (95% CI = 1.50 - 1.70). However, the difference atfiveyears after cancer diagnosis became non-significant: hazard ratio 1.11 (95% CI = 0.95 - 1.30). CONCLUSION: These findings demonstrate that beyond 5 years of maintenance of activity, the economic cost of cancer supported by very small businesses and self-employed is not important. However, support is required to pass through these first 5 years. The authors describe the various possible aids that could be implemented.

Measuring persistence to hormonal therapy in patients with breast cancer: accounting for temporary treatment discontinuation.

PURPOSE: Several studies have been conducted to estimate persistence to hormonal therapy among women with breast cancer (BC). Most studies focus on first treatment discontinuation. Patients, however, can have numerous periods of treatment discontinuation or treatment exposure. Our objective is to estimate persistence to tamoxifen in patients with BC while accounting for temporary treatment discontinuations and this by using multi-state (MS) models. METHODS: A cohort of 10,806 women with BC having received at least one prescription of tamoxifen between 1998 and 2008 was constituted from the UK General Practice Research Database. We fitted a semi-Markov model with three states to estimate the probability of being off treatment over a 5-year period while accounting for temporary treatment discontinuations (transition between on treatment and off treatment) and competing risks (recurrence of BC or death). RESULTS: Non-persistence, as estimated from the MS model, ranged from 12.1% (95% confidence interval [95%CI]: 9.2-15.1) at 1 year to 14.9% (95%CI: 11.7-18.1) at 5 years. Estimations of non-persistence based on the Kaplan-Meier model were higher, i.e., 29.3% (95%CI: 28.1-30.6) at 5 years, as well as those obtained from a competing risk model, i.e., 24.0% (95%CI: 22.9-25.1). Most temporary discontinuations (94.7%) lasted less than 6 months. Temporary treatment discontinuations are frequent and should be accounted for when measuring adherence to treatment. MS models can provide a useful framework for this sort of analysis insofar as they help describe patients' complex behavior. This may help tailor interventions that improve persistence to hormonal therapy among women with BC.

Prediction of BRCA1 germ-line mutation status in patients with breast cancer using histoprognosis grade, MS110, Lys27H3, vimentin, and KI67.

Family structure, lack of reliable information, cost, and delay are usual concerns when deciding to perform BRCA analyses. Testing breast cancer tissues with four antibodies (MS110, lys27H3, vimentin, and KI67) in addition to grade evaluation enabled us to rapidly select patients for genetic testing identification. We constituted an initial breast cancer tissue microarray, considered as a learning set, comprising 27 BRCA1 and 81 sporadic tumors. A second independent validation set of 28 BRCA1 tumors was matched to 28 sporadic tumors using the same original conditions. We investigated morphological parameters and 21 markers by immunohistochemistry. A logistic regression model was used to select the minimal number of markers providing the best model to predict BRCA1 status. The model was applied to the validation set to estimate specificity and sensibility. In the initial set, univariate analyses identified 11 markers significantly associated with BRCA1 status. Then, the best multivariate model comprised only grade 3, MS110, Lys27H3, vimentin, and KI67. When applied to the validation set, BRCA1 tumors were correctly classified with a sensitivity of 83% and a specificity of 81%. The performance of this model was superior when compared to other profiles. This study offers a new rapid and cost-effective method for the prescreening of patients at high risk of being BRCA1 mutation carriers, to guide genetic testing, and finally to provide appropriate preventive measures, advice, and treatments including targeted therapy to patients and their families.

Quality of life assessment in diabetic patients: validity of the creole version of the EQ-5D-5L in Reunion Island.

Introduction: Due to the high prevalence of diabetes and its complications, evaluating the patient's quality of life is critical. EQ-5D-5L is a valid tool for assessing health-related quality of life (HRQOL) in chronic diseases, including diabetes. However, no psychometric measures have been validated in a Creole-speaking population. Therefore, this study aimed for the first time to validate and cross-culturally adapt Creole and French versions of EQ-5D-5L on Type II diabetes patients in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation process were based on the EUROQOL methods. Internal consistency and construct validity were determined using confirmatory factor analysis (CFA) of EQ-5D-5L for both versions. CFA model for HRQOL and global fit measures were calculated based on the EQ-5D-5L items using the maximum likelihood (ML) method. Results: From November 2016 to October 2017, 148 patients were included in the Creole group and 152 in the French group. EQ-5D-5L measures were unidimensional for both versions. Cronbach's coefficient alpha was 0.76 for the Creole version and 0.81 for the French version in CFA models. The root mean square error of approximation (RMSEA) was 0.06 for the Creole version and 0.02 for the French version. The Comparative Fit Index (CFI) was closer to 1 for both versions. CFA models for both the Creole and French versions fit the data adequately. Discussion: Overall, our findings provided evidence that both the Creole and French versions of EQ-5D-5L are suitable for assessing HRQOL in diabetes patients in Reunion Island. However, further research could be done to investigate French-Creole differences concerning the perception of health status, and a cultural adaptation of the French version will be considered.

Psychometric properties of a Creole version of Medical Outcome Study - Short Form 36 among type II diabetes patients on Reunion Island.

Introduction: Health quality of life assessment is particularly important to measure the impact of chronic diseases. The aims of this study were to provide a cross-culturally adapted Creole-translation of the Medical Outcome Study Short-Form 36 (SF-36) and to assess psychometric performance of the Creole and French versions of the SF-36 among patients with type II diabetes in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation processes were based on the International Quality Of Life Assessment (IQOLA) methods. Internal consistency, test-retest reliability, convergent and discriminant validity using Multi-Trait-Multi-Method analysis and structural validity using exploratory factor analysis of the SF-36 for both versions were performed. Results: In the Creole version of the SF-36, Cronbach's alpha exceeded 0.70 for all subscales except general health. In the French SF-36, Cronbach's alpha exceeded 0.70 on all subscales except general health and bodily pain. In the Creole SF-36, intraclass correlation coefficient (ICC) for reproducibility was suboptimal. Multi-trait multi-method analysis showed that item-scale correlation exceeded 0.4 for all items except two general health items of the Creole SF-36 and one of the French SF-36. Factor analysis of 2 versions showed that the physical functioning, vitality, and mental health were each divided into two subscales. Discussion: Overall, our findings provided evidence that the SF-36 is adapted to Reunion Island in both Creole and French versions. However, further research could be conducted to investigate French-Creole differences in perceived health status and a cultural adaptation of the French version will be considered.

Financial and relational impact of having a boy with posterior urethral valves.

Introduction: Childhood chronic diseases affect family functioning and well-being. The aim of this study was to measure the impact of caring for a child with PUV, and the factors that most impact the burden of care. Patients and method: We gave a questionnaire on the familial impact of having a child with posterior urethral valves to all parents of a child included in the CIRCUP trial from 2015 onwards. The questionnaire included questions about the parents' demographics, health, professional, financial and marital status and how these evolved since the child's birth as well as the "impact on family scale" (IOFS), which gives a total score ranging from 15 (no impact) to 60 (maximum impact). We then analyzed both the results of the specific demographic questions as well as the factors which influenced the IOFS score. Results: We retrieved answers for 38/51 families (74.5% response rate). The average IOFS score was 23.7 (15-51). We observed that the child's creatinine level had an effect on the IOFS score (p = 0.02), as did the parent's gender (p = 0.008), health status (p = 0.015), being limited in activity since the birth of the child (p = 0.020), being penalized in one's job (p = 0.009), being supported in one's job (p = 0.002), and decreased income (p = 0.004). Out of 38 mother/father binomials, 8/33 (24.2%) declared that they were no longer in the same relationship afterwards. Conclusion: In conclusion, having a boy with PUV significantly impacts families. The risk of parental separation and decrease in revenue is significant. Strategies aiming to decrease these factors should be put in place as soon as possible.