STROBE-GEMA: a STROBE extension for reporting of geographically explicit ecological momentary assessment studies.

CONTEXT: While a growing body of research has been demonstrating how exposure to social and built environments relate to various health outcomes, specific pathways generally remain poorly understood. But recent technological advancements have enabled new study designs through continuous monitoring using mobile sensors and repeated questionnaires. Such geographically explicit momentary assessments (GEMA) make it possible to link momentary subjective states, behaviors, and physiological parameters to momentary environmental conditions, and can help uncover the pathways linking place to health. Despite its potential, there is currently no review of GEMA studies detailing how location data is used to measure environmental exposure, and how this in turn is linked to momentary outcomes of interest. Moreover, a lack of standard reporting of such studies hampers comparability and reproducibility. AIMS: The objectives of this research were twofold: 1) conduct a systematic review of GEMA studies that link momentary measurement with environmental data obtained from geolocation data, and 2) develop a STROBE extension guideline for GEMA studies. METHOD: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria consisted of a combination of repeated momentary measurements of a health state or behavior with GPS coordinate collection, and use of these location data to derive momentary environmental exposures. To develop the guideline, the variables extracted for the systematic review were compared to elements of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and CREMAS (CRedibility of Evidence from Multiple Analyses of the Same data) checklists, to provide a new guideline for GEMA studies. An international panel of experts participated in a consultation procedure to collectively develop the proposed checklist items. RESULTS AND DEVELOPED TOOLS: A total of 20 original GEMA studies were included in the review. Overall, several key pieces of information regarding the GEMA methods were either missing or reported heterogeneously. Our guideline provides a total of 27 categories (plus 4 subcategories), combining a total of 70 items. The 22 categories and 32 items from the original STROBE guideline have been integrated in our GEMA guideline. Eight categories and 6 items from the CREMAS guideline have been included to our guideline. We created one new category (namely "Consent") and added 32 new items specific to GEMA studies. CONCLUSIONS AND RECOMMENDATIONS: This study offers a systematic review and a STROBE extension guideline for the reporting of GEMA studies. The latter will serve to standardize the reporting of GEMA studies, as well as facilitate the interpretation of results and their generalizability. In short, this work will help researchers and public health professionals to make the most of this method to advance our understanding of how environments influence health.

Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial.

BACKGROUND: Intention-to-treat analyses of POINCARE-2 trial led to inconclusive results regarding the effect of a conservative fluid balance strategy on mortality in critically ill patients. The present as-treated analysis aimed to assess the effectiveness of actual exposure to POINCARE-2 strategy on 60-day mortality in critically ill patients. METHODS: POINCARE­2 was a stepped wedge randomized controlled trial. Eligible patients were ≥ 18 years old, under mechanical ventilation and had an expected length of stay in ICU > 24 h. POINCARE-2 strategy consisted of daily weighing over 14 days, and subsequent restriction of fluid intake, administration of diuretics, and/or ultrafiltration. We computed a score of exposure to the strategy based on deviations from the strategy algorithm. We considered patients with a score ≥ 75 as exposed to the strategy. We used logistic regression adjusted for confounders (ALR) or for an instrumental variable (IVLR). We handled missing data using multiple imputations. RESULTS: A total of 1361 patients were included. Overall, 24.8% of patients in the control group and 69.4% of patients in the strategy group had a score of exposure ≥ 75. Exposure to the POINCARE-2 strategy was not associated with 60-day all-cause mortality (ALR: OR 1.2, 95% CI 0.85-1.55; IVLR: OR 1.0, 95% CI 0.76-1.33). CONCLUSION: Actual exposure to POINCARE-2 conservative strategy was not associated with reduced mortality in critically ill patients. Trial registration POINCARE-2 trial is registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.

Patient Satisfaction and Perspectives on Self-Management Education Programs: A Qualitative Study.

Purpose: According to the Centre for Disease Control and Prevention, "Self-management education (SME) refers to programs that help people who have ongoing health conditions learn how to live life to the fullest". Most studies to date have focused on SME outcomes, such as the acquisition of predefined knowledge or skills or quality of life. However, no study has yet investigated patients' satisfaction with SMEs. The aim of the present study was therefore to explore participants' subjective appreciation of SME programs using qualitative methods and formulate propositions based on patients' preferences to improve ultimately clinical outcomes. Patients and Methods: Twenty-five participants from five French SME programs to conduct focus groups were recruited. An inductive approach using grounded theory as an overall methodology orientation for the thematic analysis process has been followed. The study was reported in compliance with the consolidated criteria for reporting qualitative research criteria (COREQ). Results: Patients expressed great satisfaction concerning the effective delivery of SME sessions. They appreciated the considerations for their concerns and needs, the adaptation of sessions' content to their interests and questions, and learning to take care of themselves. Moreover, patients had a positive opinion on the quality of their relationship with health care providers. However, the major point of improvement of SMEs was the opportunity to repeat the program if needed, as this opportunity was not offered. This consideration was particularly salient when patients did not consider themselves autonomous for disease management at the end of the program, ie, when they had low levels of perceived self-efficacy. Conclusion: While patients expressed great satisfaction regarding SME programs, our results suggest that some changes might be needed to make the endpoint of SME interventions coincide with the patient's perception of self-efficacy in disease self-management and ultimately improve clinical outcomes.

Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial.

BACKGROUND: In critically ill patients, positive fluid balance is associated with excessive mortality. The POINCARE-2 trial aimed to assess the effectiveness of a fluid balance control strategy on mortality in critically ill patients. METHODS: POINCARE-2 was a stepped wedge cluster open-label randomized controlled trial. We recruited critically ill patients in twelve volunteering intensive care units from nine French hospitals. Eligible patients were ≥ 18 years old, under mechanical ventilation, admitted to one of the 12 recruiting units for > 48 and ≤ 72 h, and had an expected length of stay after inclusion > 24 h. Recruitment started on May 2016 and ended on May 2019. Of 10,272 patients screened, 1361 met the inclusion criteria and 1353 completed follow-up. The POINCARE-2 strategy consisted of a daily weight-driven restriction of fluid intake, diuretics administration, and ultrafiltration in case of renal replacement therapy between Day 2 and Day 14 after admission. The primary outcome was 60-day all-cause mortality. We considered intention-to-treat analyses in cluster-randomized analyses (CRA) and in randomized before-and-after analyses (RBAA). RESULTS: A total of 433 (643) patients in the strategy group and 472 (718) in the control group were included in the CRA (RBAA). In the CRA, mean (SD) age was 63.7 (14.1) versus 65.7 (14.3) years, and mean (SD) weight at admission was 78.5 (20.0) versus 79.4 (23.5) kg. A total of 129 (160) patients died in the strategy (control) group. Sixty-day mortality did not differ between groups [30.5%, 95% confidence interval (CI) 26.2-34.8 vs. 33.9%, 95% CI 29.6-38.2, p = 0.26]. Among safety outcomes, only hypernatremia was more frequent in the strategy group (5.3% vs. 2.3%, p = 0.01). The RBAA led to similar results. CONCLUSION: The POINCARE-2 conservative strategy did not reduce mortality in critically ill patients. However, due to open-label and stepped wedge design, intention-to-treat analyses might not reflect actual exposure to this strategy, and further analyses might be required before completely discarding it. Trial registration POINCARE-2 trial was registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.

Creation and validation of the pictorial ecological momentary well-being instrument (EMOWI) for adolescents.

PURPOSE: Adolescence is characterized by the ongoing maturation of emotion-regulation skills and increased emotional reactivity. There is a need for a measurement tool suitable to the Ecological Momentary Assessment methodology, to better capture within-day variations in well-being, and provide fine-grained data that can help understand how environments, behaviors, and health intersect. This paper presents the development and evaluation of the Ecological MOmentary Well-Being Instrument for adolescents, designed for use in EMA. METHODS: A mixed-methods study was conducted, using both qualitative and quantitative approaches, to develop and assess the EMOWI. A literature review, pictorial production by graphic designers, and qualitative interviews with French and Canadian professionals and adolescents helped design and evaluate the scale face validity. Quantitative evaluation of dimensionality, reliability, and validity was conducted in two samples of French 8th graders. RESULTS: The resulting 8-item EMOWI showed excellent face validity. Confirmatory factor analysis supported a single factor hypothesis (RMSEA = 0.072). Internal consistency (Cronbach's alpha = 0.85) and intraday test-retest reliability (ICC = 0.83) were high. Correlations with existing scales were consistent with preset hypotheses. Ceiling effects were evidenced for all items, yet not on the global score. Quantitative estimations were similar for the verbal and pictorial versions, but qualitative findings argued in favor of the pictorial version. CONCLUSION: The 8-item pictorial EMOWI is a short and innovative instrument to measure momentary well-being in adolescents aged 12 to 17 years. Its strong psychometric properties and its acceptability among adolescents make it an excellent candidate instrument for the Ecological Momentary Assessment of well-being in this population.

Prevalence and Distribution of HPV Genotypes in Immunosuppressed Patients in Lorraine Region.

BACKGROUND: The primary objective of this work was to assess the prevalence and distribution of HPV genotypes in immunosuppressed patients, and to compare them with the French Monsonego cohort. Secondary objectives were to evaluate whether the risk of HPV infection was correlated with HIV viral load, CD4 cell count in HIV-infected patients and the type, number of immunosuppressive therapies or type of pathology (transplant vs. autoimmune diseases) in patients undergoing long-term immunosuppressive therapy. METHODS: An observational, monocentric and historical study was conducted including all immunosuppressed patients having received an HPV testing, in the Laboratory of Virology, Nancy Regional Teaching Hospital Center, between 2014 and 2020. Immunosuppressed patients were either HIV-infected or received long-term immunosuppressive therapy. RESULTS: In our cohort, the prevalence of HPV infection (75.6% vs. 16.1% p < 0.05), the proportion of patients with high-risk HPV infection (48.9% vs. 15.1% p < 0.05) and with multiple HPV infection (41.1% vs. 5.7% p < 0.05) were significantly higher than in the Monsonego cohort. HPV 52 (13%), 53 (13%) and 16 (10%) were the most common in the immunosuppressed population, while it was HPV 16, 42 and 51 in the Monsonego cohort. CONCLUSIONS: This study supports that a particular attention must be given to all the immunosuppressed patients for the screening and care of HPV-related diseases because of major modifications of HPV epidemiology compared with the overall population.

[Description of trajectories of patients with end-stage renal disease from the REIN registry]. / Description synthétique des trajectoires des patients insuffisants rénaux chroniques terminaux à partir du registre REIN.

CONTEXT AND OBJECTIVES: Since 2001, the aim of the REIN registry has been to identify patients suffering from end-stage renal disease and benefiting from replacement therapy in France. The analysis of trajectories aims to evaluate the flow of patients between the different types of treatment in order to better understand and predict patient pathways. The objective of this study was to analyse the incoming and outgoing flows at 1 year of patients prevalent in the REIN registry on 12/31/2017. METHODS: Flow analysis was carried out on patients prevalent on 12/31/2017 in the REIN registry by studying the before and after treatment modalities on 12/31/2016 and 12/31/2018. This analysis was initially carried out on all patients, then in sub-groups for each of the 5 treatment modalities. RESULTS: The analyses covered 85,472 patients prevalent on 12/31/2017. The overall analysis showed that more than 20% of patients had been diagnosed with end-stage renal disease the year before. Regarding inflow, there was a relative stability for patients treated with self-care hemodialysis, in-center haemodialysis, peritoneal dialysis, and graft, in contrast to patients treated with hemodialysis in a medical unit. Regarding outgoing flows, proportion of deaths at one year was 9%. Peritoneal dialysis was the modality with the highest outflow proportion at one year. CONCLUSION: Analysis of patients' trajectories shows variable evolution profiles according to treatment modality and thus could be a valuable tool in the evaluation and improvement of management and care in the field of end-stage renal disease.

Endorsement of the domains of knee and hip osteoarthritis (OA) flare: A report from the OMERACT 2020 inaugural virtual consensus vote from the flares in OA working group.

OBJECTIVE: Towards developing an instrument to measure knee and hip osteoarthritis (KHOA) flare, the Outcome Measures in Rheumatology (OMERACT) Flares in OA Working Group first sought to identify and define relevant domains of flare in KHOA. METHODS: Guided by OMERACT Filter 2.1, candidate domains were identified from data generated in interviews, in English or French, with persons with KHOA and health professionals (HPs) who treat OA. The first and second rounds of an online Delphi process with patients and HPs, including researchers, selected relevant domains. The third round provided agreement on the selected domains and their definitions. At the virtual OMERACT 2020 workshop, the proposed domains and their definitions were discussed in facilitated breakout groups with patients and HPs. Participants then voted, with consensus set at ≥70%. RESULTS: Qualitative interviews characterizing OA flare were completed with 29 persons with KHOA and 16 HPs. Content was analyzed and grouped into nine clusters. These candidate domains were included in two Delphi rounds, completed by 91 patients and 165 HPs then 50 patients and 116 HPs, per round, respectively. This resulted in selecting five relevant domains. A final Delphi round, completed by 38 patients and 89 HPs, provided agreement on these domains and their definitions. The OMERACT virtual vote included 27 patients and 106 HPs. The domains and their definitions were endorsed with ≥98% agreement. Domains include: Pain, Swelling, Stiffness, Psychological aspects, and Impact of symptoms, all defined "during flare". CONCLUSION: Using OMERACT methodology, we have developed five domains of KHOA flare that were highly endorsed by patients and HPs.