Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial.

BACKGROUND: Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers. METHODS/DESIGN: The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson's disease, Alzheimer's disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken. DISCUSSION: Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support adapted to caregivers, and provide an impulse for new health care policies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02626377 . Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.

Stroke impact scale version 2: validation of the French version.

BACKGROUND: Almost 1 person in 1,000 experiences a stroke annually in France. Health-related quality-of-life (HRQoL) measurement with specific questionnaires is useful to study the consequences of stroke on patients' daily lives. OBJECTIVE: The purpose of this study was to validate the French version of the Stroke Impact Scale (SIS) questionnaire, as no disease-specific questionnaire was validated in French heretofore. METHODS: Two hundred eighty-eight patients with stroke were classified into 2 groups (158 acute, 130 chronic). Rate of item completion, test-retest reliability, sensitivity to change, and construct validity, convergent validity, and discriminant validity of the questionnaire were assessed. Acute group patients were recruited during the first month poststroke and followed for 3 months. Chronic group patients (stroke dating from 1 year) were recruited from outpatient consultations. The first 100 patients in the chronic group were called back 15 days after inclusion for test-retest measurements. The Barthel Index, Hospital Anxiety and Depression Scale (HADS), and Duke Health Profile questionnaires were administered. RESULTS: The French version of the SIS was well accepted by all participants. It had good reproducibility. Cronbach alpha was 89% for all scales. A ceiling effect was noted in the majority of scales. Physical domains were significantly correlated to other measures of physical capacity (Barthel Index and Duke Health Profile; Spearman coefficients were between .5 and .73), and the emotional and social domains were significantly correlated to almost all domains of the Duke Health Profile. Psychometric properties were similar to those of the US version. Responsiveness was good for physical and emotional domains. LIMITATIONS: Validation was conducted only on people who were able to answer the questionnaire. CONCLUSIONS: The French SIS version presents good psychometric properties, except for ceiling effect. This is the first stroke-specific questionnaire evaluating perceived health after stroke to be validated in France and could be useful for further investigations of HRQoL after stroke.

Prevalence and risk factors of human papillomavirus infection types 16/18/45 in a cohort of French females aged 15-23 years.

Investigation of the prevalence and risk factors of human papillomavirus (HPV) infection is the basis for developing prophylactic strategies against cervical cancer, especially for young women. This study aimed to assess the prevalence and risk factors of HPV infection among a cohort of sexually active young French women eligible for catch-up vaccination. Between 1997 and 2007, 2163 women aged 15-23 years attending consultations at the department of gynecology in the Hospital of Besançon (France) were screened for high risk HPV (HR HPV) infection. Risk factors were investigated through a questionnaire sent to all participants in 2010. HPV DNA was detected by HC2 and Probe Set assays. The overall prevalence for HR HPV and HPV16, 18 and/or HPV45 was 44.6% (95% CI, 42.5-46.7%) and 19% (95% CI, 17.3-20.7%), respectively. The response rate to the questionnaire was 22.6%. The prevalence of independent risk factors (age older than 19, smoking, and oral contraception) for HPV 16/18/45 infection in this population was less than 20%. Based on this study, HPV vaccination should be offered not only to teenage girls, but also to young women, regardless of their sexual activity.