Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials.

INTRODUCTION: Current hospital-based care pathways are generally single-disease centred. As a result, coexisting morbidities are often suboptimally evaluated and managed, a deficiency becoming increasingly apparent among older patients who exhibit heterogeneity in health status, functional abilities, frailty, and other geriatric impairments. To address this issue, our study aims to assess a newly developed patient-centred care pathway for older patients with multimorbidity and cancer. The new care pathway was based on currently available evidence and co-designed by end-users including health care professionals, patients, and informal caregivers. Within this care pathway, all healthcare professionals involved in the care of older patients with multimorbidity and cancer will form a Health Professional Consortium (HPC). The role of the HPC will be to centralise oncologic and non-oncologic treatment recommendations in accordance with the patient's priorities. Moreover, an Advanced Practice Nurse will act as case-manager by being the primary point of contact for the patient, thus improving coordination between specialists, and by organising and leading the consortium. Patient monitoring and the HPC collaboration will be facilitated by digital communication tools designed specifically for this purpose, with the added benefit of being customisable for each patient. MATERIALS AND METHODS: The GERONTE study is a prospective international, multicentric study consisting of two stepped-wedge trials performed at 16 clinical sites across three European countries. Each trial will include 720 patients aged 70 years and over with a new or progressive cancer (breast, lung, colorectal, prostate) and at least one moderate or severe multimorbidity. The patients in the intervention group will receive the new care pathway whereas patients in the control group will receive usual oncologic care. DISCUSSION: GERONTE will evaluate whether this kind of holistic, patient-oriented healthcare management can improve quality of life (primary outcome) and other valuable endpoints in older patients with multimorbidity and cancer. An ancillary study will assess in depth the socio-economic impact of the intervention and deliver concrete implementation guidelines for the GERONTE intervention care pathway. TRIAL REGISTRATION: FRONE: NCT05720910 TWOBE: NCT05423808.

Self-compassion and relationship status moderate the relationship between sexual minority status and body image concerns.

A growing body of research suggests that sexual minority men (SMM) experience greater body image concerns including body shame, body surveillance, drive for muscularity and drive for thinness than heterosexual men. However, little is known regarding the potential factors that can buffer these relationships. The aim of the present study was to examine the role that both self-compassion and relationship status may play in decreasing the strength of the relationship between sexual minority status and body image concerns. A sample of n = 106 SMM and n = 145 heterosexual men completed an online survey assessing body image concerns, self-compassion, and relationship status. Findings revealed that SMM reported higher levels of body image concerns (on all measures, except drive for muscularity) as compared to heterosexual men. Self-compassion moderated the link between sexual orientation and drive for muscularity: in men with higher levels of self-compassion, sexual orientation was no longer associated with drive for muscularity. But, among men with less self-compassion, SMM reported higher drive for muscularity than heterosexual men. Moreover, relationship status moderated the relationship between sexual orientation and body shame and drive for thinness, such that, among SMM only, being in a relationship was associated with lower levels of these concerns.

Factors related to increased alcohol misuse by students compared to non-students during the first Covid-19 lockdown in France: the Confins study.

BACKGROUND: The closure of bars and lockdowns related to the Covid-19 pandemic changed alcohol use levels in France during the spring of 2020. We wondered whether this sudden cessation of social interactions impacted students more than non-students and what factors specific to students would explain the increase in alcohol misuse. The aims of this study were to compare self-reported changes in alcohol misuse (alcohol intake and binge-drinking frequency) during the first Covid-19 lockdown from March 17 to May 10, 2020, between French students and non-students and describe factors associated with this alcohol misuse in each subgroup. METHODS: Data collected in the Confins study from April 8 to May 10, 2020, were used in cross-sectional analyses stratified by student status. Multiple logistic regression was performed to estimate the association between self-reported increase in alcohol intake or binge-drinking frequency (at least six drinks of alcohol on one occasion) and demographic, socioeconomic, and clinical factors, as well as conditions associated with the Covid-19 pandemic. The population-attributable fraction was then used to estimate the contribution of identified risk factors to increased alcohol misuse in students and non-students. RESULTS: Among both students and non-students, a self-reported decrease or no change in alcohol intake or binge-drinking was more common than an increase. However, the risk factors explaining an increase in alcohol intake differed among students (≥ 25 years old, not working or studying in the health field, and having suicidal ideation during the last 7 days) and non-students (having a medical diagnosis of mental disorders). The risk factors explaining an increase in binge-drinking frequency were similar in the two subgroups (being a tobacco smoker before lockdown and not practicing any physical activity during the last 7 days), except suicidal thoughts, which was a risk factor for alcohol misuse specific to students. CONCLUSIONS: These results highlight the vulnerability of certain French students to alcohol misuse and the necessity of combining both mental health and substance use-related screening in the student population.

Adverse Childhood Experiences and Illegal Drug Use Among College Students: Findings from a French Sample.

BACKGROUND: While studies have demonstrated the negative impact of adverse childhood experiences (ACEs) on lifelong health, less is known about the relationship between ACEs and illegal drug use. Thus, the objective of the study was to examine the relationship between ACEs and illegal drug use among college students. METHODS: French college students between 18 and 30 years enrolled in a university cohort study were eligible for inclusion. Multivariate logistic regression models were conducted for each drug. RESULTS: Among the sample (n = 1,157), 30.6% had no ACE exposure, 29.6%, 19.2%, and 20.7% had 1, 2 and ≥ 3 ACEs, respectively. Students with ACEs had a higher likelihood of using illegal drugs (p = 0.0067). After controlling for potential confounders, having ≥ 3 ACEs increased the risk of lifetime use of multiple drugs (aOR:10.9; 95% CI: 4.6-26.0), stimulants (aOR: 3.6; 95% CI:1.7-7.7), hallucinogens (aOR: 2.0; 95% CI: 1.1-3.5), cannabis (aOR: 4.7; 95% CI: 2.7-8.0), and risky illegal drugs (e.g., higher lifetime frequency drug use) (aOR: 2.9; 95% CI: 1.5-5.8). Estimates for illegal drug use were highest with parental substance use (aOR: 2.6; 95% CI; 1.5-4.4), sexual abuse (aOR: 2.3; 95% CI; 1.4-3.8), and divorce (aOR: 1.9; 95% CI: 1.3-2.7). CONCLUSIONS: ACEs increase the risk for lifetime illegal drug use and risky drug use in a dose-respondent fashion. These findings suggest that university students with higher levels of ACEs may benefit from additional support and services from clinical practitioners and university administrators.

Mental health condition of college students compared to non-students during COVID-19 lockdown: the CONFINS study.

OBJECTIVES: To estimate the effect of student status on mental health condition during COVID-19 general lockdown in France. DESIGN: Cross-sectional analysis comparing students and non-students recruited in the same study. SETTING: Participants of the web-based CONFINS study implemented during the general lockdown in France in spring 2020. PARTICIPANTS: 2260 participants (78% women) including 1335 students (59%). PRIMARY AND SECONDARY OUTCOME MEASURES: Through an online questionnaire, participants declared if they have experienced suicidal thoughts, coded their perceived stress on a 10-points scale and completed validated mental health scales (Patient Health Questionnaire-9 for depressive symptoms, Generalised Anxiety Disorder-7 for anxiety symptoms) during the last 7 days. The effect of college student status on each mental health condition was estimated using multivariate logistic regression analyses. Stratified models for students and non-students were performed to identify population-specific factors. RESULTS: Student status was associated with a higher frequency of depressive symptoms (adjusted OR (aOR)=1.58; 95% CI 1.17 to 2.14), anxiety symptoms (aOR=1.51; 95% CI 1.10 to 2.07), perceived stress (n=1919, aOR=1.70, 95% CI 1.26 to 2.29) and suicidal thoughts (n=1919, aOR=1.57, 95% CI 0.97 to 2.53). Lockdown conditions that could be potentially aggravating on mental health like isolation had a higher impact on students than on non-students. CONCLUSIONS: College students were at higher risk of mental health disturbances during lockdown than non-students, even after taking into account several potential confounding factors. A close follow-up and monitoring of students' mental health status is warranted during lockdown periods in this vulnerable population.

The association of self-esteem and psychosocial outcomes in young adults: a 10-year prospective study.

BACKGROUND: This study investigates the association between self-esteem assessed either in adolescence or in adulthood with adult academic and psychosocial outcomes. METHOD: One hundred and thirty-one junior high school students were selected based on their experience of academic difficulty or success, and both groups were selected equally from regular or low-performing schools. Ten years later, 100 of these individuals participated in a follow-up assessment of academic, socioprofessional, and health-related outcomes. Logistic and linear regression models were performed to estimate the association of self-esteem (measured by the Rosenberg Self-Esteem Scale) at baseline and at follow-up, as well as change in self-esteem categories (high vs. low) on all outcomes. RESULTS: Fifty-four percent of adolescents were consistently high in self-esteem over the 10-year period, 17% experienced an improvement, 21% a decrease, and 8% stayed at a low level. Outcomes at follow-up were more consistently associated with young adult self-esteem than adolescent self-esteem. Self-esteem was associated with several outcomes (i.e., personal goals, life satisfaction, alcohol, and health outcomes) and its effects were different depending on the period considered and categories of self-esteem change. CONCLUSIONS: The self-esteem difficulties which are common in adolescence raise concerns about their potential impact on important outcomes later in life. However, self-esteem difficulties in young adulthood were more associated with negative outcomes at this phase of life (whether low self-esteem persisted into adulthood, or emerged only during adulthood). Relative to outcomes in young adulthood, the period of greatest interest for improving well-being may be concentrated in the years immediately surrounding the studied outcomes. KEY PRACTITIONER MESSAGE: Self-esteem change from adolescent to adulthood is associated with a large diversity of outcomes. Less is known concerning the extent to which adolescent self-esteem may independently determine outcomes in young adulthood as compared to more temporally proximal self-esteem levels. Only self-esteem difficulties in young adulthood were associated with negative outcomes at this phase of life (whether they persisted from adolescence into adulthood, or emerged for the first time during adulthood). Targeting self-esteem difficulties that are temporally proximal to the period of interest may improve mental health and well-being.

Pathways From ADHD Symptoms to Suicidal Ideation During College Years: A Longitudinal Study on the i-Share Cohort.

Objective: To estimate the association between ADHD symptoms and suicidal ideation in college students, and to test mediation by depressive symptoms or self-esteem. Method: Based on the i-Share cohort (prospective cohort of 2,331 college students in France). Self-reported measures included ADHD symptoms at baseline, self-esteem and depressive symptoms at 3 months, and suicidal ideation at 1-year follow-up. We conducted path analysis to estimate total, direct, and indirect effect. Results: Participants with high ADHD symptoms were more likely to report suicidal ideation 1 year later (p < .0001). Indirect effects through depressive symptoms (p < .0001) and self-esteem (p < .0001) explained 44% and 25% of this association, respectively. An indirect pathway via a combination of self-esteem, then depressive symptoms, was also identified (p < .0001), explaining 19% of the total effect. The direct effect was not significant (p = .524). Conclusion: ADHD symptoms seem to have no direct but indirect effect through both self-esteem and depressive symptoms on suicidal ideation.

Perceived stress partially accounts for the association between Attention Deficit Hyperactivity Disorder (ADHD) symptoms and suicidal ideation among students.

The association between Attention Deficit Hyperactivity Disorder (ADHD) and suicidal ideation has been the focus of recent research interest among youths and young adults. However, the role perceived stress plays in this association is unclear. We investigated whether perceived stress accounts for the association between ADHD and subsequent suicidal ideation among French students enrolled in the i-Share cohort. The associations between ADHD symptoms, perceived stress at baseline, and suicidal ideation during follow-up were investigated using logistic regression models, and Structural Equation Modeling was used to estimate the indirect effect via perceived stress. In total 4333 participants (median age: 20.3 years; [interquartile range: 18.7-21.8]) were included in the main analyses. ADHD was associated with suicidal ideation (adjusted Odds Ratio = 1.15 [95% Confidence Interval: 1.04-1.26]). Perceived stress partially accounts for the association between ADHD and suicidal ideation (proportion explained 49%). Our study suggests that ADHD and perceived stress represent mental health targets for suicide prevention programs.

Health Risk Behaviors and Self-Esteem Among College Students: Systematic Review of Quantitative Studies.

BACKGROUND: Due to their impact on premature mortality and long-term disabilities, a better understanding of health risk behavior (HRB) determinants among college students is crucial in order to build the most appropriate prevention tools. Although self-esteem appears to be a relevant candidate, a clear picture summarizing its multiple links with HRB is lacking to guide clinicians and researchers. This study aims to provide a systematic review of the associations between health risk behavior and self-esteem among college students. METHODS: This search was performed in several databases on 02/02/17. Study eligibility criteria were original articles in peer-reviewed journals, in English; observational quantitative studies; among college students; and investigated the association between self-esteem and HRB. The PRISMA statements were complied with. RESULTS: One hundred fifteen articles were included: 46 on substance use, 35 on sexual behavior, 11 on nutritional habits, 27 on physical activity, and 5 on other HRB. Most studies reported an association between higher self-esteem and healthier behavior. For alcohol consumption and number of sexual partners, both negative and positive associations have been reported. Directionality was investigated in a few studies suggesting potential bidirectional effects. CONCLUSIONS: This review points out the need for consensus for the definition of self-esteem and HRB. There was high heterogeneity in (1) the measurement of self-esteem either in the concept measured (global vs. domain) or in the way to implement validated tools; and (2) the definition of HRB. Self-esteem seems to be a relevant target to intervene on HRB, especially alcohol abuse and physical activity. TRIAL REGISTRATION: Registration number: PROSPERO (ID = CRD42017056599).

Is self-esteem associated with self-rated health among French college students? A longitudinal epidemiological study: the i-Share cohort.

OBJECTIVES: The aim of the study was to estimate the association between self-esteem and subsequent self-rated health during college years, taking into account a wide range of potential confounders. DESIGN: Prospective longitudinal study. SETTING: The French i-Share cohort. PARTICIPANTS: The sample consisted of 1011 college students. PRIMARY AND SECONDARY OUTCOME MEASURES: The association between self-esteem and later self-rated health was evaluated using multivariate modelling.Data regarding self-rated health, global self-esteem and demographic, educational, social, behavioural, environmental and financial characteristics were collected through an internet-based questionnaire. RESULTS: The 1011 participants had a median age of 21.9 years and 79% (795/1011) were females. Self-rated health was assessed a median of 8 months after the self-esteem measurement. Twenty per cent of the students declared average to very poor health (203/1011). Students with higher levels of self-esteem were more likely to declare good or very good self-rated health (adjusted OR=1.40, 95% CI 1.15 to 1.72, p value=0.001). Other factors associated with good or very good self-rated health were low body mass index, a comfortable financial situation during childhood and three personality traits (low persistence and harm avoidance and high cooperativeness). CONCLUSIONS: This study offers novel findings on the impact of self-esteem on self-rated health among college students. Interventions targeting self-esteem should be experimented during university years in order to improve health outcomes.

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial.

BACKGROUND: Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV. METHODS: The ANRS 144 Inter-ACTIV randomised, parallel, double-blind, multicentre, placebo-controlled phase 3 trial was done at 30 clinical hospital sites in France. People living with HIV who had smoked at least ten cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempt were eligible. Using a computer-generated randomisation sequence, we allocated (1:1) the patients to receive either varenicline titrated to two 0·5 mg doses twice daily or placebo twice daily for 12 weeks, plus face-to-face counselling. Patients and investigators were masked to treatment group allocation. Patients who were not abstinent at week 24 were offered open-label varenicline for 12 additional weeks. The primary outcome was the proportion of smokers continuously abstinent from week 9 to week 48. Smoking status was confirmed by carbon monoxide in exhaled air. Primary analyses were done in both the intention-to-treat (ITT) population and modified ITT (mITT) population, which comprised all patients who took at least one tablet of their assigned study treatment. The safety analyses were done in the mITT population. The trial is registered at ClinicalTrials.gov, number NCT00918307. The trial status is complete. FINDINGS: From Oct 26, 2009, to Dec 20, 2012, of 303 patients assessed for eligibility, 248 patients were randomly assigned to the varenicline group (n=123) or the placebo group (n=125). After randomisation, one participant initially assigned to the placebo group was excluded from the ITT analysis for a regulatory reason (no French health-care coverage). 102 patients in the varenicline group and 111 patients in the placebo group received at least one dose of their assigned treatment and were included in the mITT analysis. In the ITT analysis, varenicline was associated with a higher proportion of patients achieving continuous abstinence over the study period (week 9-48): 18 (15%, 95% CI 8-21) of 123 in the varenicline group versus eight (6%, 2-11) of 124 in the placebo group, adjusted odds ratio (OR) 2·5 (95% CI 1·0-6·1; p=0·041). In the mITT analysis, varenicline was also associated with higher continuous abstinence: 18 (18%, 95% CI 10-25) of 102 versus eight (7%, 2-12) of 111 in the placebo group (adjusted OR 2·7, 95% CI 1·1-6·5; p=0·029). The incidence of depression was 2·4 per 100 person-years (95% CI 0·6-9·5; two [2%] of 102) in the varenicline group and 12·4 per 100 person-years (95% CI 6·9-22·5; 11 [10%] of 111) in the placebo group. 14 (7%) of 213 participants had 18 cardiovascular events: six (6%) of 102 people in the varenicline group and eight (7%) of 111 people in the placebo group. INTERPRETATION: Varenicline is safe and efficacious for smoking cessation in people living with HIV and should be recommended as the standard of care. FUNDING: The French National Institute for Health and Medical Research (INSERM)-French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Pfizer.

CD4 cell count response to first-line combination ART in HIV-2+ patients compared with HIV-1+ patients: a multinational, multicohort European study.

Background: CD4 cell recovery following first-line combination ART (cART) is poorer in HIV-2+ than in HIV-1+ patients. Only large comparisons may allow adjustments for demographic and pretreatment plasma viral load (pVL). Methods: ART-naive HIV+ adults from two European multicohort collaborations, COHERE (HIV-1 alone) and ACHIeV2e (HIV-2 alone), were included, if they started first-line cART (without NNRTIs or fusion inhibitors) between 1997 and 2011. Patients without at least one CD4 cell count before start of cART, without a pretreatment pVL and with missing a priori-defined covariables were excluded. Evolution of CD4 cell count was studied using adjusted linear mixed models. Results: We included 185 HIV-2+ and 30321 HIV-1+ patients with median age of 46 years (IQR 36-52) and 37 years (IQR 31-44), respectively. Median observed pretreatment CD4 cell counts/mm3 were 203 (95% CI 100-290) in HIV-2+ patients and 223 (95% CI 100-353) in HIV-1+ patients. Mean observed CD4 cell count changes from start of cART to 12 months were +105 (95% CI 77-134) in HIV-2+ patients and +202 (95% CI 199-205) in HIV-1+ patients, an observed difference of 97 cells/mm3 in 1 year. In adjusted analysis, the mean CD4 cell increase was overall 25 CD4 cells/mm3/year lower (95% CI 5-44; P = 0.0127) in HIV-2+ patients compared with HIV-1+ patients. Conclusions: A poorer CD4 cell increase during first-line cART was observed in HIV-2+ patients, even after adjusting for pretreatment pVL and other potential confounders. Our results underline the need to identify more potent therapeutic regimens or strategies against HIV-2.