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Purpose To measure the rate of recall of study participation and study attrition in survivors of acute respiratory distress syndrome(ARDS). Materials/Methods In this ancillary study of the Re-evaluation of Systemic Early neuromuscular blockade(ROSE) trial, we measured the rate of study participation recall 3 months following discharge and subsequent study attrition at 6 months. We compared patient and hospital characteristics, and long-term outcomes by recall. As surrogate decision-makers provided initial consent, we measured the rate of patient reconsent and its association with study recall. Results Of 487 patients evaluated, recall status was determined in 386(82.7%). Among these, 287(74.4%) patients recalled participation in the ROSE trial, while 99(25.6%) did not. There was no significant difference in 6-month attrition among patients who recalled study participation (9.1%) and those who did not (12.1%) (p = 0.38). Patient characteristics were similar between groups, except SOFA scores, ventilator-free days, and length of stay. 330(68%) were reconsented. Compared to those not reconsented, significantly more patients who were reconsented recalled study participation(78% vs. 66%;p = 0.01). Conclusions One in 4 ARDS survivors do not recall their participation in a clinical trial during hospitalization 3 months following hospital discharge, which did not influence 6-month attrition. However, more patients recall study participation if reconsent is obtained.

Background The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information on site-level facilitators of and barriers to optimal use of EHR systems with respect to trial recruitment. Methods We conducted qualitative focus groups and quantitative surveys as part of the EHR Ancillary Study, which is being conducted alongside the multicenter, global, Harmony Outcomes Trial comparing albiglutide to standard care for the prevention of cardiovascular events in type 2 diabetes. Subject matter experts used findings from focus groups to draft a 20-question survey examining the use of the EHR for participant identification, common site recruitment strategies, and variation in perceived barriers to optimal use of the EHR. The final survey was fielded with 446 site investigators actively enrolling participants in the main trial. Results Nearly two-thirds of respondents were study coordinators (63.2%), 23.1% were principal investigators, and 13.7% held other research roles. Approximately half of the respondents reported using the EHR to find potential trial participants. Of these, 79.4% reported using EHR searches in conjunction with other recruitment methods, including reviewing of upcoming clinic schedules (75.3%) and contacting past trial participants (71.2%). Important barriers to optimal use of the EHR included the lack of availability of certain research-focused EHR modules and limitations on the ability to contact patients cared for by other providers. Of survey respondents who did not use the EHR to find potential participants, one-quarter reported that the EHR was not accessible in their country; this finding varied from 2.6% of respondents in North America to 50% of respondents in the Asia Pacific. Conclusions While EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist. Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification. Trial registration ClinicalTrials.gov NCT02465515. Registered on 8 June 2015

Background Many patients confront physical, cognitive, and emotional problems after acute respiratory distress syndrome (ARDS). No proven therapies for these problems exist, and many patients manage new disability and recovery with little formal support. Eliciting patients’ adaptations to these problems after hospitalization may identify opportunities to improve recovery. Objectives To explore how patients adapt to physical, cognitive, and emotional changes related to hospitalization for ARDS. Methods Semistructured interviews were conducted after hospitalization in patients with ARDS who had received mechanical ventilation. This was an ancillary study to a multicenter randomized controlled trial. Consecutive surviving patients who spoke English, consented to follow-up, and had been randomized between November 12, 2017, and April 5, 2018 were interviewed 9 to 16 months after that. Results Forty-six of 79 eligible patients (58%) participated (mean [range] age, 55 [20-84] years). All patients reported using strategies to address physical, emotional, or cognitive problems after hospitalization. For physical and cognitive problems, patients reported accommodative strategies for adapting to new disabilities and recuperative strategies for recovering previous ability. For emotional issues, no clear distinction between accommodative and recuperative strategies emerged. Social support and previous familiarity with the health care system helped patients generate and use many strategies. Thirty-one of 46 patients reported at least 1 persistent problem for which they had no acceptable adaptation. Conclusions Patients employed various strategies to manage problems after ARDS. More work is needed to identify and disseminate effective strategies to patients and their families.

Introduction: In a legal context focused on the right and autonomy of the patient, some women wish to be able to choose their mode of childbirth. As midwives are primary care-givers for pregnant women with a physiological pregnancy, we wanted to find out whether it was ethically acceptable for them to accompany a woman in her decision to have a caesarean section.Purpose of research: This survey is an ancillary study of the CESARIA research program validated by the Comite de Protection des Personnes Sud Mediterranee IV and declared to the CNIL. Thirty-seven semi-directive interviews were conducted with midwives and women.Results: The majority of women and midwives share a vision of childbirth as “natural” and consider the request for caesarean section as a pathology. When formulated, this request places midwives in a situation of ethical tension. On the one hand, midwives wish to refer women to vaginal birth as the norm, and this choice embodies the ethical principles of beneficence and non-maleficence. On the other hand, midwives express a desire to respect patient choice and freedom, illustrating the ethical principle of respect for autonomy.Conclusions: The ethical issue of caesarean section on demand lies not so much in the decision to accept or not to accept a caesarean section but rather in listening to the request. Taking into consideration a medical indication more broadly than the simple obstetrical indication makes it possible to ethically support these requests while respecting the pregnant woman’s autonomy.

OBJECTIVE: To examine the association of social support with dental caries experience in Hispanics/Latinos living in the United States (US) and to assess whether the relationship is modified by nativity status. METHODS: This cross-sectional study analyzed data for 4,459 dentate men and women aged 18 to 74 years in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) Sociocultural Ancillary Study. At baseline (2008 to 2011), dentists quantified dental caries experience as the number of decayed, missing, and filled permanent tooth surfaces (DMFS) for all teeth excluding third molars. Social support was assessed according to measures of structural support (Social Network Index) and functional support (Interpersonal Support Evaluation List). Covariate adjusted multiple linear regression estimated the relationship between social support and dental caries experience and tested whether the association was modified by nativity status (born within the 50 US states, foreign-born less than 10 years in the US, foreign-born greater than 10 years or more in the US). RESULTS: In covariate-adjusted models, each additional role in the social network was associated with 1.39 fewer DMF tooth surfaces (95% CI: −2.21, −0.58) among foreign-born Hispanics/Latinos with fewer than 10 years lived in the US. For foreign-born Hispanics/Latinos with ten years or more in the US, each additional social network role was associated with 0.57 fewer DMF tooth surfaces (95% CI: −1.19, 0.04). No association was observed between functional social support and dental caries experience regardless of nativity status. DISCUSSION: Our findings suggest that structural social support is protective against dental caries experience among recent immigrants of Hispanic/Latino background. This association may reflect the importance of social support to integration into the medical and dental infrastructure and thus receipt of dental care. Future research that examines the behavioral and cultural factors that moderate the relationship between social support and dental caries experience will inform development of culturally sensitive dental caries prevention programs for Hispanics/Latinos in the United States.

Objectives Tumor mutation screening is standard of care for patients with stage IV NSCLC. Since a couple of years, widespread NGS approaches used in routine diagnostics to detect driver mutations such as EGFR, KRAS, BRAF or MET allows the identification of other alterations that could modulated the intensity or duration of response to targeted therapies. The prevalence of co-occurring alterations that could affect response or prognosis as not been largely analyzed in clinical settings and large cohorts of patients. Thanks to the IFCT program “Biomarkers France“, a collection of samples and data at a nation-wide level was available to test the impact of co-mutations on first line EGFR TKI in patients with EGFR mutated cancers. Materials and methods Targeted NGS was assessed on available (n = 208) samples using the Ion AmpliSeq™ Cancer Hotspot Panel v2 to screen for mutations in 50 different cancer genes. Results This study showed that PTEN inactivating mutations, ATM alterations, IDH1 mutations and complex EGFR mutations were predictors of short PFS in patients with a stage 4 lung adenocarcinoma receiving first line EGFR TKI and that PTEN, ATM, IDH1 and KRAS mutations as well as alterations in the MAPK pathway were related to shorter OS. Conclusion These findings may lead to new treatment options in patients with unfavorable genotypes to optimize first line responses.

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