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Challenges and barriers to physician decision-making for prescribing and deprescribing among patients with multimorbidity in eastern China's primary care settings: A qualitative study
Objectives Patients with multimorbidity have an increased risk of medication-related problems. Physicians face the dilemmas of multimorbidity management with multiple medications in primary care settings. We aimed to investigate the experiences and perceptions of primary care physicians (PCPs) regarding their decision-making processes in prescribing and deprescribing medications for patients with multimorbidity, and identify the challenges and barriers they face. Design From 5 October 2023 to 27 January 2024, this qualitative study was conducted through semi-structured interviews that encouraged in-depth exploration of the participants' experiences and perspectives. The interviews were audio-recorded, transcribed verbatim, and independently coded by two investigators. Themes were developed using a conventional content analysis approach. Setting 12 community health centers and 8 township health centers across four regions in eastern China were included. Participants 26 PCPs from 20 primary care institutions in eastern China were interviewed through purposive sampling, representing a mix of urban and rural healthcare settings. Results Of the 26 participants in this study, 14 (53.8%) were women, and the mean age was 36.3 years old. When prescribing and stopping medications for patients with multimorbidity, they often encounter complex challenges. These challenges stemmed from three key areas: (1) difficulties in identifying drug-disease and drug-drug interactions; (2) cognitive biases in medication benefit-risk evaluation and (3) heavy treatment burden. The challenges were further compounded by multiple barriers, including clinical inertia among physicians, patient resistance to medication changes, inadequate decision support and training, and time constraints in clinical consultation. Conclusions The complexity of prescribing and deprescribing decisions faced by PCPs in treating patients with multimorbidity in China is influenced by interconnected factors related to physicians, patients, technology and working environment. Future research could develop and evaluate implementation strategies to address specific challenges and barriers to allow PCPs to make effective medication decisions for patients with multimorbidity.
European expert consensus recommendations on the primary care use of direct oral anticoagulants in patients with venous thromboembolism.
BACKGROUND: Direct oral anticoagulants for the treatment of venous thromboembolism are supported by robust clinical trial evidence. Despite published guidance, general practitioners are faced with increasingly complex decisions and implementation remains sub-optimal in certain real-world scenarios. METHODS: A two stage formal consensus exercise was performed to formulate consensus statements and a summary guide, facilitating optimal management of direct oral anticoagulants in venous thromboembolism patients by generalist physicians across Europe. An online questionnaire distributed to a broad panel (Phase 1), followed by a virtual panel discussion by an expert group (Phase 2) were conducted. Phase 1 statements covered nine management domains, and were developed via a literature review and expert steering committee. Participants rated statements by their level of agreement. Phase 1 responses were collated and analysed prior to discussion and iterative refinement in Phase 2. RESULTS: In total 56 participants from across Europe responded to Phase 1. The majority had experience working as general practitioners. Consensus indicated that direct oral anticoagulants are the treatment of choice for managing patients with venous thromboembolism, at initiation and for extended treatment, with a review at three to six months to re-assess treatment effect and risk profile. Direct oral anticoagulant choice should be based on individual patient factors and include shared treatment choice between clinicians and patients; the only sub-group of patients requiring specific guidance are those with cancer. CONCLUSION: Results demonstrate an appreciation of best practices, but highlight challenges in clinical practice. The patient pathway and consensus recommendations provided, aim to highlight key considerations for general practice decision making, and aid optimal venous thromboembolism treatment.
Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial)
Introduction Insomnia is a prevalent sleep disorder that negatively impacts daytime functioning and quality of life. Breast cancer patients report higher rates of insomnia and more circadian disruption than other cancer groups. Approximately 50% of patients experience acute insomnia following breast cancer diagnosis, which often persists during cancer treatment and rehabilitation. Sleep Restriction Therapy (SRT) is a clinically effective and tolerable treatment for persistent insomnia in breast cancer survivors. However, SRT has never been tested on patients with early signs of sleep disturbance who are undergoing cancer treatment. The aim of this pilot randomised controlled trial is to explore the feasibility and preliminary effectiveness of nurse delivered SRT for newly diagnosed breast cancer patients with acute insomnia. The trial has been registered on ClinicalTrials.gov (identifier: NCT06294041). Methods The INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health. Dissemination Our dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023. Strengths and limitations of this study 1. This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients. 2. This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness. 3. An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care. 4. Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.
Efficacy of multicomponent CBT-I and its single components
This chapter provides an overview of contemporary evidence (as of 2021) for the efficacy of CBT-I and its components. The scientific support for the clinical use of CBT-I has emerged over the last 40 years and now comprises over 100 randomised controlled trials (RCTs). These trials have informed numerous meta-analyses that have, as a consequence, shaped the treatment guidelines we use today. The evidence considered in this chapter focuses on the most recent meta-analyses that report on the effects of CBT-I and its components on insomnia symptoms and measures of sleep continuity. The overarching conclusion from meta-analyses is that CBT-I is effective in improving night-time insomnia symptoms in both the short term and the long term. In addition, CBT-I improves daytime functioning and its efficacy seems to be independent of co-morbid conditions, age and use of medication. The efficacy of CBT-I components as standalone therapies has been examined to a lesser extent but shows promising results, especially for behavioural components.
A scoping review of the evidence for the impact of pharmacological and non-pharmacological interventions on shift work related sleep disturbance in an occupational setting.
Background: Shift work is essential in society but can be detrimental to health and quality of life and is associated with decreased productivity and increased risk of accidents. Interventions to reduce these consequences are needed, but the extent and range of trial evidence for interventions for those most affected by their shift-work schedules is unclear. We therefore carried out a scoping review to assess the availability of evidence to inform the development and evaluation of future interventions. Methods: We aimed to identify clinical trials of any intervention for shift work-related sleep disturbance that included a comparator group, where the intervention was delivered in an occupational setting. We searched Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL, EMBASE, Medline and Science Citation Index from inception to 30 th March 2020 for relevant citations. Citations were screened by two independent reviewers, a third reviewer resolved disagreements. Data were extracted by two independent reviewers. Results: From 1250 unique citations, 14 studies met inclusion criteria for comparative trials of treatment in an occupational setting. There were five trials of hypnotics, five trials of stimulants, and four trials of non-pharmacological therapies (cognitive behavioural therapy, light therapy, aromatherapy and herbal medicine). Outcomes included sleep parameters, day-time sleepiness, and quality of life. There were no consistently reported outcomes across trials. Conclusions: Interventions fell into three distinct groups investigated in distinct time periods without progression from efficacy trials to wider-scale interventions. The lack of consistent patient-reported outcome measures limits synthesising findings. Some trials focussed on optimising sleep, others on reducing wake-time sleepiness. Adequately powered trials of existing interventions are needed, with the development and testing of novel combination treatments in patients with well-defined shift work sleep disorder. A core set of clinically relevant outcomes will develop and standardise the evidence-base for shift work sleep disorder.