Understanding how shared decision-making approaches and patient aids influence patients with advanced cancer when deciding on palliative treatments and care: A realist review.

BACKGROUND: Patients with advanced incurable cancer face difficult decisions about palliative treatment options towards their end of life. However, they are often not provided with the appropriate information and support that is needed to make informed decisions. This review aimed to identify contexts and mechanisms associated with communication tools, patient decision-aids and shared decision-making (SDM) approaches that influence patient outcomes. METHODS: We used a realist review method to search for published studies of patients (adults > 18) with advanced cancer who were expected to make a decision about palliative treatment and/or supportive care in consultation with healthcare practitioners. We appraised and synthesised literature describing the contexts of (when and how) decision aids and SDM approaches are used, and how these contexts interact with mechanisms (resources and reasoning) which impact patient outcomes. Stakeholders including academics, palliative healthcare professionals (HCPs) and people with lived experience of supporting people with advanced incurable cancer contributed to identifying explanatory accounts. These accounts were documented, analysed and consolidated to contribute to the development of a programme theory. RESULTS: From the 33 included papers, we consolidated findings into 20 explanatory accounts to develop a programme theory that explains key contexts and mechanisms that influence patient and SDM. Contexts include underlying patients' and HCPs' attitudes and approaches. These need to be understood in relation to key mechanisms, including presenting information in multiple formats and providing adequate time and opportunities to prepare for and revisit decisions. Contexts influenced mechanisms which then influence the levels of patient decisional satisfaction, conflict and regret. CONCLUSIONS: Our programme theory highlights mechanisms that are important in supporting shared treatment decisions for advanced noncurative cancer. The findings are informative for developing and evaluating interventions to improve understanding and involvement in SDM for patients with advanced incurable cancer. PATIENT AND PUBLIC CONTRIBUTION: We included patient and public involvement (PPI) representatives in four stakeholder meetings. PPI helped to define the scope of the review, identify their unique experiences and perspectives, synthesise their perspectives with our review findings, make decisions about which theories we included in our programme theory and develop recommendations for policy and practice and future research.

Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)-protocol for an individually randomised parallel-group trial.

BACKGROUND: Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given by paramedics, but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes. We completed a feasibility study of paramedic-provided fascia iliaca compartment block (FICB), testing the intervention, trial methods and data collection. The study (RAPID) demonstrated that a full trial was feasible. In this subsequent study, we aim to test safety, clinical and cost-effectiveness of paramedic-provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment. METHODS: We will conduct a pragmatic multi-centre individually randomised parallel-group trial, with a 1:1 allocation between usual care (control) and FICB (intervention). Hospital clinicians in five sites (paired ambulance services and receiving hospitals) in England and Wales will train 220 paramedics to administer FICB. The primary outcome is change in pain score from pre-randomisation to arrival at the emergency department. One thousand four hundred patients are required to find a clinically important difference between trial arms in the primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). We will use NHS Digital (England) and the SAIL (Secure Anonymised Information Linkage) databank (Wales) to follow up patient outcomes using routine anonymised linked data in an efficient study design, and questionnaires to capture patient-reported outcomes at 1 and 4 months. Secondary outcomes include mortality, length of hospital stay, job cycle time, prehospital medications including morphine, presence of hip fracture, satisfaction, mobility, and NHS costs. We will assess safety by monitoring serious adverse events (SAEs). DISCUSSION: The trial will help to determine whether paramedic administered FICB is a safe, clinically and cost-effective treatment for suspected hip fracture in the pre-hospital setting. Impact will be shown if and when clinical guidelines either recommend or reject the use of FICB in routine practice in this context. TRIAL REGISTRATION: ISRCTN15831813 . Registered on 22 September 2021.

Chemotherapy decision-making in advanced lung cancer: a prospective qualitative study.

OBJECTIVE: To study how treatment decisions are made alongside the lung cancer clinical pathway. METHODS: A prospective, multicentre, multimethods, five-stage, qualitative study. Mediated discourse, thematic, framework and narrative analysis were used to analyse the transcripts. RESULTS: 51 health professionals, 15 patients with advanced lung cancer, 15 family members and 18 expert stakeholders were recruited from three UK NHS trusts. Multidisciplinary team (MDT) members constructed treatment recommendations around patient performance status, pathology, clinical information and imaging. Information around patients' social context, needs and preferences were limited. The provisional nature of MDTs treatment recommendations was not always linked to future discussions with the patient along the pathway, that is, patients' interpretation of their prognosis, treatment discussions occurring prior to seeing the oncologist. This together with the rapid disease trajectory placed additional stress on the oncologist, who had to introduce a different treatment option from that recommended by the MDT or patient's expectations. Palliative treatment was not referred to explicitly as such, due to its potential for confusion. Patients were unaware of the purpose of each consultation and did not fully understand the non-curative intent of treatment pathways. Patients' priorities were framed around social and family needs, such as being able to attend a family event. CONCLUSION: Missed opportunities for information giving, affect both clinicians and patients; the pathway for patients with non-small cell lung cancer focuses on clinical management at the expense of patient-centred care. Treatment decisions are a complex process and patients draw conclusions from healthcare interactions prior to the oncology clinic, which prioritises aggressive treatment and influences decisions.

The impacts and effectiveness of support for people bereaved through advanced illness: A systematic review and thematic synthesis.

BACKGROUND: Bereavement support is a key component of palliative care, with different types of support recommended according to need. Previous reviews have typically focused on specialised interventions and have not considered more generic forms of support, drawing on different research methodologies. AIM: To review the quantitative and qualitative evidence on the effectiveness and impact of interventions and services providing support for adults bereaved through advanced illness. DESIGN: A mixed-methods systematic review was conducted, with narrative synthesis of quantitative results and thematic synthesis of qualitative results. The review protocol is published in PROSPERO ( www.crd.york.ac.uk/prospero , CRD42016043530). DATA SOURCES: The databases MEDLINE, Embase, PsycINFO, CINAHL and Social Policy and Practice were searched from 1990 to March 2019. Studies were included which reported evaluation results of bereavement interventions, following screening by two independent researchers. Study quality was assessed using GATE checklists. RESULTS: A total of 31 studies were included, reporting on bereavement support groups, psychological and counselling interventions and a mix of other forms of support. Improvements in study outcomes were commonly reported, but the quality of the quantitative evidence was generally poor or mixed. Three main impacts were identified in the qualitative evidence, which also varied in quality: 'loss and grief resolution', 'sense of mastery and moving ahead' and 'social support'. CONCLUSION: Conclusions on effectiveness are limited by small sample sizes and heterogeneity in study populations, models of care and outcomes. The qualitative evidence suggests several cross-cutting benefits and helps explain the impact mechanisms and contextual factors that are integral to the support.

Coping and wellbeing in bereavement: two core outcomes for evaluating bereavement support in palliative care.

BACKGROUND: Bereavement support is a core part of palliative care. However, the evidence base is limited by a lack of consistency in the outcomes used to evaluate services and models of support, which makes it difficult to compare approaches. Core Outcome Sets (COS) represent the minimum that should be measured in research into specific conditions or services. The aim of this study was to use a stakeholders' perspective to develop a COS for evaluating bereavement support for adults in adult palliative care settings. METHODS: A list of outcomes relevant to bereavement support was created following a systematic review of the quantitative and qualitative literature. At an expert workshop 21 stakeholders discussed their views on the most important outcomes and compared these to and critiqued the lists constructed from the review. These lists and discussions informed a two round international DELPHI survey (n = 240) designed to reach consensus on which outcomes/outcome dimensions should be included in the COS. To prioritise and validate the items emerging from the survey, participants at a subsequent consensus day ranked the relative importance of these items (n = 23). A final feedback exercise with these consensus day participants was conducted to confirm the selection of outcomes and dimensions. RESULTS: 'Ability to cope with grief' and 'Quality of life and mental wellbeing' were selected as two core outcomes. Twenty-one different dimensions to explore when assessing these outcomes were also identified. The coping related dimensions have been categorised as: Negative and overwhelming grief; Communication and connectedness; Understanding, accepting and finding meaning in grief; Finding balance between grief and life going forwards; Accessing appropriate support. Those relating to quality of life and wellbeing have been categorised as; Participation in work and/or regular activities; Relationships and social functioning; Positive mental wellbeing and Negative mental and emotional state. CONCLUSION: This COS outlines a more consistent way forward for bereavement researchers and practitioners, whilst also orientating towards public health and resilience-based approaches to bereavement care. Further work is planned to identify and develop measures which are specific to this core outcome set, and which will facilitate the future comparability of bereavement services and interventions.

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study.

OBJECTIVE: To explore patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury. DESIGN: Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture. SETTING: Patients treated by paramedics in the catchment area of one emergency department in South Wales. PARTICIPANTS: Six patients and one carer of a patient who received fascia iliaca compartment block (FICB). INTERVENTION: FICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB-a local anaesthetic injection directly into the hip region-or usual care-most commonly morphine-using audited scratch cards. OUTCOMES: Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants' consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member. RESULTS: Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury. CONCLUSIONS: This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting. TRIAL REGISTRATION NUMBER: ISRCTN60065373.

Development of an intervention to support patients and clinicians with advanced lung cancer when considering systematic anticancer therapy: protocol for the PACT study.

INTRODUCTION: Patient-centred care is essential to the delivery of healthcare; however, this necessitates direct patient involvement in clinical decision-making and can be challenging for patients diagnosed with advanced non-small cell lung cancer where there may be misunderstanding of the extent of disease, prognosis and aims of treatment. In this context, decisions are complex and there is a need to balance the risks and benefits, including treatment with palliative intent. The aim of the PACT study is to identify the information and decision support needs of patients, leading to the development of an intervention to support patients with advanced lung cancer when considering treatment options. METHODS AND ANALYSIS: PACT is a five-stage, multimethod and multicentre study. Participants: Patients and health professionals will be recruited from three health boards. Methods: Non-participant observation of multidisciplinary team meetings (n=12) will be used to determine patients' allocation to treatment pathways (stage I). Non-participant observation of patient-clinician consultations (n=20-30) will be used to explore communication of treatment options and decision-making. Extent of participation in decision-making will be assessed using the Observing Patient Involvement in Shared Decision-Making tool. Interviews with patients (stage III) and their clinicians (stage IV) will explore the perception of treatment options and involvement in decision-making. Based on stages I-IV, an expert consensus meeting will finalise the content and format of the intervention. Cognitive interviews with patients will then determine the face validity of the intervention (stage V). Analysis: analysis will be according to data type and research question and will include mediated discourse analysis, thematic analysis, framework analysis and interpretative phenomenological analysis. ETHICS AND DISSEMINATION: Ethical approval has been granted. The study findings will contribute to and promote shared and informed decision-making in the best interest of patients and prudent healthcare. We therefore aim to disseminate results via relevant respiratory, oncology and palliative care journals and conferences.

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT).

BACKGROUND: The efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC. METHOD: Between May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn's and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1-3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years. RESULTS: The 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) -0.0088 to 0.0682; p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI -0.032 to 0.096; p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI -0.0250 to 0.0353; p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188; p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493; p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546; p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917; p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114; p = 0.998); deaths (all three who died received infliximab; p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference -£5632, 95% CI -£8305 to -£2773; p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin. CONCLUSIONS: Total cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1-3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22663589. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.

Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial.

PURPOSE: Venous thromboembolism (VTE) is common in cancer patients. Evidence has suggested that low molecular weight heparin (LMWH) might improve survival in patients with cancer by preventing both VTE and the progression of metastases. No trial in a single cancer type has been powered to demonstrate a clinically significant survival difference. The aim of this trial was to investigate this question in patients with lung cancer. PATIENTS AND METHODS: We conducted a multicenter, open-label, randomized trial to evaluate the addition of a primary prophylactic dose of LMWH for 24 weeks to standard treatment in patients with newly diagnosed lung cancer of any stage and histology. The primary outcome was 1-year survival. Secondary outcomes included metastasis-free survival, VTE-free survival, toxicity, and quality of life. RESULTS: For this trial, 2,202 patients were randomly assigned to the two treatment arms over 4 years. The trial did not reach its intended number of events for the primary analysis (2,047 deaths), and data were analyzed after 2,013 deaths after discussion with the independent data monitoring committee. There was no evidence of a difference in overall or metastasis-free survival between the two arms (hazard ratio [HR], 1.01; 95% CI, 0.93 to 1.10; P = .814; and HR, 0.99; 95% CI, 0.91 to 1.08; P = .864, respectively). There was a reduction in the risk of VTE from 9.7% to 5.5% (HR, 0.57; 95% CI, 0.42 to 0.79; P = .001) in the LMWH arm and no difference in major bleeding events but evidence of an increase in the composite of major and clinically relevant nonmajor bleeding in the LMWH arm. CONCLUSION: LMWH did not improve overall survival in the patients with lung cancer in this trial. A significant reduction in VTE is associated with an increase in clinically relevant nonmajor bleeding. Strategies to target those at greatest risk of VTE are warranted.

Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy.

BACKGROUND: Approximately 1 in 5 pregnant women in the United Kingdom are obese. In addition to being associated generally with poor health, obesity is known to be a contributing factor to pregnancy and birth complications and the retention of gestational weight can lead to long term obesity.This paper describes the protocol for a cluster randomised trial to evaluate whether a weight management intervention for obese pregnant women is effective in reducing women's Body Mass Index at 12 months following birth. METHODS/DESIGN: The study is a cluster randomised controlled trial involving 20 maternity units across England and Wales. The units will be randomised, 10 to the intervention group and 10 to the control group. 570 pregnant women aged 18 years or over, with a Body Mass Index of +/=30 (kg/m2) and between 12 and 20 weeks gestation will be recruited. Women allocated to the control group will receive usual care and two leaflets giving advice on diet and physical activity. In addition to their usual care and the leaflets, women allocated to the intervention group will be offered to attend a weekly 1.5 hour weight management group, which combines expertise from Slimming World with clinical advice and supervision from National Health Service midwives, until 6 weeks postpartum.Participants will be followed up at 36 weeks gestation and at 6 weeks, 6 months and 12 months postpartum. Body Mass Index at 12 months postpartum is the primary outcome. Secondary outcomes include pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity levels, pregnancy and birth complications, social support, self-regulation and self-efficacy. A cost effectiveness analysis and process evaluation will also be conducted. DISCUSSION: This study will evaluate the effectiveness of a theory-based intervention developed for obese pregnant women. If successful the intervention will equip women with the necessary knowledge and skills to enable them to make healthier choices for themselves and their unborn child. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN25260464 Date of registration: 16th April 2010.