Alison Foote

How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews

In the past, several authors have attempted to review randomized clinical trials (RCT) evaluating the impact of Patient Information Leaflets (PILs) used during a consultation and draw some general conclusions. However, this proved difficult because the clinical situations, size and quality of RCTs were too heterogeneous to pool relevant data.

A scale assessing doctor-patient communication in a context of acute conditions based on a systematic review

Background There is no validated generic tool to measure Doctor-Patient-Communication (DPC) in a context of acute conditions. Objective To create and validate such a scale in a real population. Materials and method We performed a systematic review of validated DPC scales available in English. From these, using a theoretical model based on a multidisciplinary approach, we selected pertinent items that met the inclusion criteria and included them in a simple questionnaire. This tool based on a synthesis of the literature was then validated in a prospective study in two hospital emergency departments. Results We found 22 pertinent questionnaires and scoring systems. From these, we extracted items and built a scale based on 15 questions with graded responses (Likert from 1 to 4). The mean time for questionnaire completion was 3 minutes. We included 189 adults and adolescents in the study and analyzed complete responses to the questionnaire by 149 patients, gathered over the phone one week after their consultation. The scale had high internal consistency (Cronbach’s alpha = 0.89) and good external validity. Two questions were removed due to redundancy giving a scale based on 13 questions. Conclusions We have created an easy-to-use and validated generic questionnaire to assess DPC in a context of acute conditions, usable both in clinical research and in routine practice.

Combination of obstructive sleep apnoea and insomnia treated by continuous positive airway pressure with the SensAwake pressure relief technology to assist sleep: a randomised cross-over trial protocol

Introduction Obstructive sleep apnoea (OSA) is a common sleep breathing disorder affecting up to 17% of the middle-aged population. Continuous positive airway pressure (CPAP) is the primary treatment for patients with OSA, but acceptance and adherence to therapy is suboptimal in specific subgroups particularly those with insomnia or poor sleep quality (40%–80% of patients with OSA). Pressure intolerance, particularly during periods of wakefulness, inhibiting sleep onset or return to sleep, is one reason for poor CPAP adherence. AutoCPAPs continually monitor airflow changes and only increase the pressure when the upper airway requires it. Reducing the pressure during wakefulness-sleep transition and wakefulness-after-sleep-onset (WASO) may improve therapy comfort and potentially adherence without compromising therapy efficacy. We hypothesise that SensAwake, a pressure relief function that reduces CPAP pressure on the transition from sleep to wakefulness and on WASO, may improve objective sleep quality. Methods and analysis This is a multicentre, randomised double-blind crossover clinical trial on patients with both OSA and insomnia. Insomnia is defined as Insomnia Severity Index >15 at screening. Baseline data, including actigraphy, are collected for 1 week before randomisation (1:1) to either conventional AutoCPAP or AutoCPAP with SensAwake for 4 weeks. After an evaluation visit, patients are switched to the other treatment arm for a further 4 weeks. Allowing for 20% dropout, 48 patients are required. If applicable, repeated measures analysis of variance will be used to assess differences in WASO measured by actigraphy (primary outcome), other actigraphy measures, AutoCPAP compliance, subjective questionnaire scores (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Short-Form 12 Health Survey) and 24 hours blood pressure (secondary outcomes). Ethics and dissemination The protocol was approved by the regional Ethics Committee (CPP Sud-Est–V, IRB N°6705) on 9 December 2015, is registered on ClincalTrials.gov (NCT02721329) and started in June 2016 with expected publication of primary outcome results in 2018. Trial registration number NCT0272132; Pre-results.

010 Plateau for occurrence of very late stent thrombosis beyond 3-years after implantation of the Sirolimus-eluting stent: long term follow-up of the EVASTENT patients

Gilles Barone-Rochette [Orateur] (1), Gérald Vanzetto (1), Pascal Motreff (2), Alison Foote (3), Jean-Louis Quesada (3), Nicolas Danchin (4), Jacques Machecourt (5) (1) CHU Grenoble, USIC, Grenoble, France – (2) CHU ClermontFerrand, Cardiologie, Clermont-Ferrand, France – (3) CHU Grenoble, Centre d’Investigation Clinique, Grenoble, France – (4) AP-HP, Hôpital Européen Goerges-Pompidou, Cardiologie, Paris, France – (5) CHU Grenoble, Cardiologie, Grenoble, France