BMJ open
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Randomized Controlled Trial
Effectiveness of a pragmatic school-based universal resilience intervention in reducing tobacco, alcohol and illicit substance use in a population of adolescents: cluster-randomised controlled trial.
Initiation of tobacco, alcohol and illicit substance use typically occurs during adolescence, with the school setting recommended to reduce adolescent substance use. Strengthening individual (eg, problem solving) and environmental (eg, caring relationships at school) resilience protective factors of adolescents has been suggested as a strategy for reducing substance use by adolescents; however, few studies have examined this potential. A study was conducted to investigate the effectiveness of a pragmatic school-based universal 'resilience' intervention in reducing the prevalence of tobacco, alcohol and illicit substance use, and increasing the individual and environmental protective factors of students. ⋯ The universally implemented pragmatic school-based intervention was not effective in reducing the prevalence of tobacco, alcohol or illicit substance use, or in increasing the protective factors of students.
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Randomized Controlled Trial Multicenter Study Comparative Study
The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing.
To investigate, prior to an oncology consultation, the use of a pre-prepared list of evidence based questions, Question Prompt Sheet (QPS), compared with a Question List (QL), a patient self-generated list of questions. ⋯ Both interventions have similar impact on patients' participation in terms of question asking during the consultation. Future research is needed in order to explore which components of the interventions are really useful and efficacious.
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Randomized Controlled Trial Multicenter Study
Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol.
Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients. ⋯ This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.
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Randomized Controlled Trial
Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.
Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. ⋯ This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository.
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Randomized Controlled Trial
The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy.
Indigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general. We developed a behaviour change intervention aimed to improve health professionals' management of smoking in Indigenous pregnant women-the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy. This intervention includes webinar training for health professionals, an educational resources package for health professionals and pregnant women, free oral nicotine replacement therapy (NRT) for pregnant women, and audit and feedback on health professionals' performance.The aim of this study is to test the feasibility and acceptability of the ICAN QUIT in Pregnancy intervention to improve health professionals' provision of evidence-based culturally responsive smoking cessation care to Australian Indigenous pregnant smokers. ⋯ This protocol (version 4, 14 October 2016) is registered with the Australian and New Zealand Clinical Trials Registry (Ref #: ACTRN12616001603404).