Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial.

BACKGROUND: Patients undergoing gynaecological surgery are known to experience anxiety. While the use of music selected by patients based on their personal taste has hardly been evaluated, a recent study suggests that musical preferences significantly alter the anxiolytic and relaxing effects of music. Our study aims to determine whether self-selected music decreases patient anxiety prior to gynaecological surgery, as compared with predetermined music from a software programme such as MUSIC CARE®. METHODS: The study will consist of a clinical trial comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery. A minimum of 170 patients will be randomised in a 1:1 ratio. Inclusion criteria will be: women aged 18-55 years, awaiting scheduled gynaecological surgery under general/local anaesthesia or under sedation; having created a personal 20-min playlist; and not having received anxiolytic drugs prior to surgery. The primary outcome will be the difference between the preoperative anxiety score taken 15 to 20 min before the music-listening session and the preoperative anxiety score taken shortly after the session, as measured with the STAI for state anxiety. DISCUSSION: This study should help to identify more effective non-medical treatments for preoperative anxiety, as well as to adapt music therapy to the cultural context of patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03226834 . Registered on 24 July 2017.

Trends in the prescription of novel oral anticoagulants in UK primary care.

AIMS: Novel oral anticoagulants (NOACs) are alternatives to vitamin-K antagonists (VKAs) for the prevention of thromboembolism. It is unclear how NOACs have been adopted in the UK since first introduced in 2008. The present study was conducted to describe the trends in the prescription of NOACs in the UK, including dabigatran, rivaroxaban and apixaban. METHODS: Using the UK's Clinical Practice Research Datalink, the rates of new use of NOACs and VKAs from 2009 to 2015 were calculated using Poisson regression. Patient characteristics associated with NOAC initiation were identified using multivariate logistic regression. RESULTS: The overall rate of oral anticoagulant initiation increased by 58% over the study period [rate ratio (RR) 1.58; 95% confidence interval (CI) 1.23, 2.03], even as the rate of new VKA use decreased by 31% (RR 0.69; 95% CI 0.52, 0.93). By contrast, the rate of initiation of NOAC increased, particularly from 2012 onwards, with a 17-fold increase from 2012 to 2015 (RR 17.68; 95% CI 12.16, 25.71). In 2015, NOACs accounted for 56.5% of oral anticoagulant prescriptions, with rivaroxaban prescribed most frequently, followed by apixaban and then dabigatran. Compared to VKAs, new NOAC users were less likely to have congestive heart failure, coronary artery disease and peripheral vascular disease, and more likely to have a history of ischaemic stroke. CONCLUSIONS: In the UK, the rate of initiation of NOACs has increased substantially since 2009, and these agents have now surpassed VKAs as the anticoagulant of choice. Moreover, the characteristics of patients initiated on NOACs have changed over time, and this should be accounted for in future studies comparing NOACs and VKAs.

Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information.

BACKGROUND: Improvement of coordination of all health and social care actors in the patient pathways is an important issue in many countries. Health Information (HI) technology has been considered as a potentially effective answer to this issue. The French Health Ministry first funded the development of five TSN ("Territoire de Soins Numérique"/Digital health territories) projects, aiming at improving healthcare coordination and access to information for healthcare providers, patients and the population, and at improving healthcare professionals work organization. The French Health Ministry then launched a call for grant to fund one research project consisting in evaluating the TSN projects implementation and impact and in developing a model for HI technology evaluation. METHODS: EvaTSN is mainly based on a controlled before-after study design. Data collection covers three periods: before TSN program implementation, during early TSN program implementation and at late TSN program implementation, in the five TSN projects' territories and in five comparison territories. Three populations will be considered: "TSN-targeted people" (healthcare system users and people having characteristics targeted by the TSN projects), "TSN patient users" (people included in TSN experimentations or using particular services) and "TSN professional users" (healthcare professionals involved in TSN projects). Several samples will be made in each population depending on the objective, axis and stage of the study. Four types of data sources are considered: 1) extractions from the French National Heath Insurance Database (SNIIRAM) and the French Autonomy Personalized Allowance database, 2) Ad hoc surveys collecting information on knowledge of TSN projects, TSN program use, ease of use, satisfaction and understanding, TSN pathway experience and appropriateness of hospital admissions, 3) qualitative analyses using semi-directive interviews and focus groups and document analyses and 4) extractions of TSN implementation indicators from TSN program database. DISCUSSION: EvaTSN is a challenging French national project for the production of evidenced-based information on HI technologies impact and on the context and conditions of their effectiveness and efficiency. We will be able to support health care management in order to implement HI technologies. We will also be able to produce an evaluation toolkit for HI technology evaluation. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02837406 , 08/18/2016.

Use of non-conventional medicine two years after cancer diagnosis in France: evidence from the VICAN survey.

PURPOSE: The purpose of this study was to assess the use of non-conventional medicine (NCM) in a representative sample of French patients 2 years after cancer diagnosis. METHODS: The study was based on data obtained in the VICAN survey (2012) on a representative sample of 4349 patients 2 years after cancer diagnosis. Self-reported data were collected at telephone interviews with patients. The questionnaire addressed the various types of non-conventional treatments used at the time of the survey. RESULTS: Among the participants, 16.4% reported that they used NCM, and 45.3% of this group had not used NCM before cancer diagnosis (new NCM users). Commonly, NCMs used were homeopathy (64.0%), acupuncture (22.1%), osteopathy (15.1%), herbal medicine (8.1%), diets (7.3%) and energy therapies (5.8%). NCM use was found to be significantly associated with younger age, female gender and a higher education level. Previous NCM use was significantly associated with having a managerial occupation and an expected 5-year survival rate ≥80% at diagnosis; recent NCM use was associated with cancer progression since diagnosis, impaired quality of life and higher pain reports. CONCLUSION: This is the first study on NCM use 2 years after cancer diagnosis in France. In nearly half of the NCM users, cancer diagnosis was one of the main factors which incited patients to use NCM. Apart from the NCM users' socioeconomic profile, the present results show that impaired health was a decisive factor: opting for unconventional approaches was therefore a pragmatic response to needs which conventional medicine fails to meet during the course of the disease. IMPLICATIONS FOR CANCER SURVIVORS: Better information of patients and caregivers is needed to allow access to these therapies to a larger population of survivors.

Complementary or alternative medicine as possible determinant of decreased persistence to aromatase inhibitor therapy among older women with non-metastatic breast cancer.

PURPOSE: Aromatase inhibitor therapy (AI) significantly improves survival in breast cancer patients. Little is known about adherence and persistence to aromatase inhibitors and about the causes of treatment discontinuation among older women. METHODS: We constituted a cohort of women over 65 receiving a first AI therapy for breast cancer between 2006 and 2008, and followed them until June 2011. Women were selected in the population-based French National Health Insurance databases, and data was collected on the basis of pharmacy refills, medical records and face-to-face interviews. Non-persistence to treatment was defined as the first treatment discontinuation lasting more than 3 consecutive months. Time to treatment discontinuation was studied using survival analysis techniques. RESULTS: Overall among the 382 selected women, non-persistence to treatment went from 8.7% (95%CI: 6.2-12.1) at 1 year, to 15.6% (95%CI: 12.2-19.8) at 2 years, 20.8% (95%CI: 16.7-25.6) at 3 years, and 24.7% (95%CI: 19.5-31.0) at 4 years. In the multivariate analysis on a sub-sample of 233 women with available data, women using complementary or alternative medicine (CAM) (HR = 3.2; 95%CI: 1.5-6.9) or suffering from comorbidities (HR = 2.2; 95%CI: 1.0-4.8) were more likely to discontinue their treatment, whereas women with polypharmacy (HR = 0.4; 95%CI: 0.2-0.91) were less likely to discontinue. In addition, 13% of the women with positive hormonal receptor status did not fill any prescription for anti-hormonal therapy. CONCLUSION: AI therapy is discontinued prematurely in a substantial portion of older patients. Some patients may use CAM not as a complementary treatment, but as an alternative to conventional medicine. Improving patient-physician communication on the use of CAM may improve hormonal therapy adherence.