A pilot study of the Mistletoe and Breast Cancer (MAB) trial:a protocol for a randomised double-blind controlled trial

BACKGROUND: A Cochrane review of mistletoe therapy concludes that there is some evidence that mistletoe extracts may offer benefits on measures of quality of life during chemotherapy for breast cancer, but these results need replication. Our aim is to add to this evidence base by initially testing the feasibility of a UK pilot placebo-controlled, double-blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. METHODS/DESIGN: A mixed phase pilot placebo-controlled, double-blind randomised controlled trial of mistletoe therapy in patients with breast cancer (EudraCT number: 2018-000279-34). There will be three arms (groups) in the trial: Iscador M, Iscador P, with physiological saline as the placebo. The aim is to recruit 45 adult patients with a new diagnosis of early or locally advanced breast cancer, up to 12 weeks following definitive breast surgery whose standard treatment plan includes chemotherapy with or without radiotherapy. They will be taught to administer the mistletoe and breast cancer (MAB) therapies subcutaneously. MAB therapy will continue throughout their standard chemotherapy and radiotherapy and 1 month beyond. The main outcome of the MAB study is the feasibility of conducting such a trial within the NHS in order to inform a future fully powered investigative trial. Feasibility will be measured through recruitment, retention and patient experience using clinical research forms, patient diaries, cancer-related questionnaires and qualitative interviews conducted with both patients and oncology staff. DISCUSSION: This trial is the first of its kind in the UK. Currently, mistletoe therapy is mostly available through private practice in the UK. Completion of this feasibility study will support applications for further funding for a fully powered randomised controlled trial which will measure effectiveness and cost-effectiveness of this herbal therapy

Determining when a hospital admission of an older person can be avoided in a subacute setting: a systematic review and concept analysis

Objective To conduct a systematic review of the evidence for when a hospital admission for an older person can be avoided in subacute settings. We examined the definition of admission avoidance and the evidence for the factors that are required to avoid admission to hospital in this setting. Methods Using defined PICOD criteria, we conducted searches in three databases (Medline, Embase and Cinahl) from January 2006 to February 2018. References were screened by title and abstract followed by full paper screening by two reviewers. Additional studies were searched from the grey literature, experts in the field and forward and backward referencing. Data were narratively described, and concept analysis was used to investigate the definition of admission avoidance. Results A total of 17 studies were considered eligible for review; eight provided a definition of admission avoidance and 10 described admission avoidance criteria. We identified three factors which play a key role in admission avoidance in the subacute setting: (1) ambulatory care sensitive conditions and common medical scenarios for the older person, which included respiratory infections or pneumonia, urinary tract infections and catheter care, dehydration and associated symptoms, falls and behavioural management, and managing ongoing chronic conditions; (2) criteria/tools, referring to interventions that have used clinical expertise in conjunction with a range of general and geriatric triage tools; in condition-specific interventions, the decision whether to admit or not was based on level of risk determined by defined clinical tools; and (3) personnel and resources, referring to the need for experts to make the initial decision to avoid an admission. Supervision by nurses or physicians was still needed at subacute level, requiring resources such as short-stay beds, intravenous antibiotic treatment or fluids for rehydration and rapid access to laboratory tests. Conclusion<jats:p/> The review identified a set of criteria for ambulatory care sensitive conditions and common medical scenarios for the older person that can be treated in the subacute setting with appropriate tools and resources. This information can help commissioners and care providers to take on these important elements and deliver them in a locally designed way

Development of a model of medication review for use in clinical practice:Bristol Medication Review Model

Abstract Background Medication review is a core aspect of medicine optimisation, yet existing models of review vary substantially in structure and content and are not necessarily easy to implement in clinical practice. This study aimed to use evidence from the existing literature to identify key medication review components and use this to inform the design of an improved review model. Methods A systematic review was conducted (PROSPERO: CRD42018109788) to identify randomised control trials of stand-alone medication review in adults (18+ years). The review updated that by Huiskes et al. (BMC Fam Pract. 18:5, 2017), using the same search strategy implemented in MEDLINE and Embase. Studies were assessed using the Cochrane risk of bias tool. Key review components were identified, alongside relevant clinical and health service outcomes. A working group (patients, doctors and pharmacists) developed the model through an iterative consensus process (appraisal of documents plus group discussions), working from the systematic review findings, brief evidence summaries for core review components and examples of previous models, to agree on the main purpose of the review model, overarching model structure, review components and supporting material. Results We identified 28 unique studies, with moderate bias overall. Consistent medication review components included reconciliation (26 studies), safety assessment (22), suboptimal treatment (19), patient knowledge/preferences (18), adherence (14), over-the-counter therapy (13) and drug monitoring (10). There was limited evidence from studies for improvement in key clinical outcomes. The review structure was underpinned by patient values and preferences, with parallel information gathering and evaluation stages, feeding into the final decision-making and implementation. Most key components identified in the literature were included. The final model was considered to benefit from a patient-centred, holistic approach, which captured both patient-orientated and medication-focused problems, and aligned with traditional consultation methods thus facilitating implementation in practice. Conclusions The Bristol Medication Review Model provides a framework for standardised delivery of structured reviews. The model has the potential for use by all healthcare professionals with relevant clinical experience and is designed to offer flexibility of implementation not limited to a particular healthcare setting

Законодательные барьеры для многоцелевого лесопользования

© 2017 Article author(s) (or their employer(s) unless otherwise stated in the text of the article). Background/objectives There are some older patients who are at the decision margin' of admission. This systematic review sought to explore this issue with the following objective: What admission alternatives are there for older patients and are they safe, effective and cost-effective? A secondary objective was to identify the characteristics of those older patients for whom the decision to admit to hospital may be unclear. Design Systematic review of controlled studies (April 2005-December 2016) with searches in Medline, Embase, Cinahl and CENTRAL databases. The protocol is registered at PROSPERO (CRD42015020371). Studies were assessed using Cochrane risk of bias criteria, and relevant reviews were assessed with the AMSTAR tool. The results are presented narratively and discussed. Setting Primary and secondary healthcare interface. Participants People aged over 65 years at risk of an unplanned admission. Interventions Any community-based intervention offered as an alternative to admission to an acute hospital. Primary and secondary outcomes measures Reduction in secondary care use, patient-related outcomes, safety and costs. Results Nineteen studies and seven systematic reviews were identified. These recruited patients with both specific conditions and mixed chronic and acute conditions. The interventions involved paramedic/emergency care practitioners (n=3), emergency department-based interventions (n=3), community hospitals (n=2) and hospital-at-home services (n=11). Data suggest that alternatives to admission appear safe with potential to reduce secondary care use and length of time receiving care. There is a lack of patient-related outcomes and cost data. The important features of older patients for whom the decision to admit is uncertain are: Age over 75 years, comorbidities/multi-morbidities, dementia, home situation, social support and individual coping abilities. Conclusions This systematic review describes and assesses evidence on alternatives to acute care for older patients and shows that many of the options available are safe and appear to reduce resource use. However, cost analyses and patient preference data are lacking

Supportive care for men with prostate cancer:why are the trials not working? A systematic review and recommendations for future trials

Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception––July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5–10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented