Virtual consultations: the experience of oncology and palliative care healthcare professionals.

OBJECTIVES: To maintain continuity of care during the Covid-19 pandemic, virtual consultations (VC) became the mainstay of patient-healthcare practitioner interactions. The aim of this study was to explore the views of oncology and palliative care healthcare professionals (HCPs) regarding the medium of VC. METHOD: A cross sectional mixed methodology observational study of oncology and palliative care HCPs, analysed via an inductive thematic approach. This was undertaken in accordance with relevant guidelines and regulations. RESULTS: 87 surveys were completed. Three master themes were identified. Personal, professional, and familial factors including patient age, illness and VC skillset all influenced practitioner's experience of VC. Relationships and connection were highlighted by survey respondents as important influences, with a perception that VC could reduce usual relationships with patients, compared to previous face-to-face consults. There was a perceived loss in these domains with VC. Sharing bad news and having challenging conversations was seen as particularly difficult via VC. Many survey respondents emphasized that they preferred to have first time consultations face-to-face, and not virtually. Within the domain of logistical and practical implications reduced travel and increased accessibility were seen as a significant benefit of VC. The inability to examine patients and concerns regarding missing clinical signs was emphasised as a significant worry, alongside the challenges faced with occasionally failing technology. CONCLUSION: VC were felt to have a role for those patients who are already known to professionals, where there was an established relationship. VC for difficult discussions and for unstable patients were felt to be inadequate. Triaging patient suitability prior to offering VC, with emphasis on the importance of patient choice, was seen as a priority in this new era of VC.

Barriers and facilitators to engaging in smoking cessation support among lung screening participants.

INTRODUCTION: Embedded smoking cessation support within lung cancer screening is recommended in the UK; however, little is known about why individuals decline smoking cessation support in this setting. This study identified psychosocial factors that influence smoking cessation and quit motivation among those who declined support for quitting smoking alongside lung cancer screening. METHODS: Qualitative interviews conducted between August 2019 - April 2021 with thirty adults with a smoking history, recruited from the Yorkshire Lung Screening Trial. Participants had declined smoking cessation support. Verbatim interview transcripts were thematically analysed. RESULTS: Fifty percent of participants were male and the majority were from the most deprived groups. Participants reported low motivation and a variety of barriers to stopping smoking. Participants described modifiable behavioural factors that influenced their quit motivation including self-efficacy, perceived effectiveness of stop-smoking services including smoking cessation aids, risk-minimising beliefs, lack of social support, absence of positive influences on smoking and beliefs about smoking/smoking cessation. Broader contextual factors included social isolation and stigma, COVID-19 and comorbid mental and physical health conditions that deterred smoking cessation. CONCLUSIONS: To encourage engagement in smoking cessation support during lung cancer screening, interventions should seek to encourage positive beliefs about the effectiveness of smoking cessation aids and increase confidence in quitting as part of supportive, person-centred care. Interventions should also acknowledge the wider social determinants of health among the lung screening-eligible population. IMPLICATIONS: This study provides an in-depth understanding of the beliefs surrounding smoking and smoking cessation and further potential psychosocial factors that influence those attending lung cancer screening. Many of the barriers to smoking cessation found in the present study are similar to those outside of a lung screening setting however this work offers an understanding of potential facilitators that should be considered in future lung screening programmes.

Development of a core outcome set for use in adult primary glioma phase III interventional trials: A mixed methods study.

Background: Glioma interventional studies should collect data aligned with patient priorities, enabling treatment benefit assessment and informed decision-making. This requires effective data synthesis and meta-analyses, underpinned by consistent trial outcome measurement, analysis, and reporting. Development of a core outcome set (COS) may contribute to a solution. Methods: A 5-stage process was used to develop a COS for glioma trials from the UK perspective. Outcome lists were generated in stages 1: a trial registry review and systematic review of qualitative studies and 2: interviews with glioma patients and caregivers. In stage 3, the outcome lists were de-duplicated with accessible terminology, in stage 4 outcomes were rated via a 2-round Delphi process, and stage 5 comprised a consensus meeting to finalize the COS. Patient-reportable COS outcomes were identified. Results: In Delphi round 1, 96 participants rated 35 outcomes identified in stages 1 and 2, to which a further 10 were added. Participants (77/96) rated the resulting 45 outcomes in round 2. Of these, 22 outcomes met a priori threshold for inclusion in the COS. After further review, a COS consisting of 19 outcomes grouped into 7 outcome domains (survival, adverse events, activities of daily living, health-related quality of life, seizure activity, cognitive function, and physical function) was finalized by 13 participants at the consensus meeting. Conclusions: A COS for glioma trials was developed, comprising 7 outcome domains. Additional research will identify appropriate measurement tools and further validate this COS.

Development of a Core Outcome Set for the research and assessment of inoperable malignant bowel obstruction.

BACKGROUND: Malignant bowel obstruction is experienced by 15% of people with advanced cancer, preventing them from eating and drinking and causing pain, nausea and vomiting. Surgery is not always appropriate. Management options include tube or stent drainage of intestinal contents and symptom control using medication. Published literature describing palliative interventions uses a broad range of outcome measures, few of which are patient-relevant. This hinders evidence synthesis, and fails to consider the perspectives of people undergoing treatment. AIMS: To develop a Core Outcome Set for the assessment of inoperable malignant bowel obstruction with clinician, patient and caregiver involvement, using COMET methodology (Core Outcome Measures in Effectiveness Trials). METHODS: A systematic review of clinical trials and observational studies, a rapid review of the qualitative literature and in-depth patient and clinician interviews were conducted to identify a comprehensive list of outcomes. Outcomes were compared and consolidated by the study Steering Group and Patient and Public Involvement contributors, and presented to an international clinical Expert Panel for review. Outcomes from the finalised list were rated for importance in a three-round international Delphi process: results of two survey rounds were circulated to respondents, and two separate consensus meetings were conducted with clinicians and with patients and caregivers via virtual conferencing, using live polling to reach agreement on a Core Outcome Set. RESULTS: 130 unique outcomes were identified. Following the independent Expert Panel review, 82 outcomes were taken into round 1 of the Delphi survey; 24 outcomes reached criteria for critical importance across all stakeholder groups and none reached criteria for dropping. All outcomes rated critically important were taken forward for re-rating in round 2 and all other outcomes dropped. In round 2, all outcomes were voted critically important by at least one stakeholder group. Round 2 outcomes were presented again at online consensus meetings, categorised as high ranking (n = 9), middle ranking (n = 7) or low ranking (n = 8). Stakeholders reached agreement on 16 core outcomes across four key domains: Symptom control, Life impact, Treatment outcomes, and Communication and patient preferences. CONCLUSION: Use of this Core Outcome Set can help to address current challenges in making sense of the evidence around treatment for inoperable malignant bowel obstruction to date, and underpin a more robust future approach. Clearer communication and an honest understanding between all stakeholders will help to provide a basis for responsible decision-making in this distressing situation in clinical practice.

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.

"I don't want to hear statistics, I want real life stories": Systematic review and thematic synthesis of patient and caregiver experiences of Proton Beam Therapy.

PROBLEM IDENTIFICATION: Proton Beam Therapy (PBT) is an advanced form of radiotherapy, yet little evidence exists on patient experience to inform decision making and improve future care. We thematically synthesized the qualitative evidence of patient and caregivers' perceptions and experiences of PBT. LITERATURE SEARCH: Five electronic databases were systematically searched, using Medical Subject Headings (MeSH) terms and keywords. Two reviewers independently screened search results for qualitative studies relating to patients' and caregivers' experiences of PBT. The search generated 4,020 records, of which nine were eligible. Study quality (assessed by CASP checklist) varied. DATA SYNTHESIS: Qualitative results were analyzed using thematic synthesis. Three main themes were generated: decision making and perceptions, living in the PBT "bubble," and coping with the cancer treatment journey. CONCLUSIONS: PBT is not yet widely accessible worldwide, which uniquely influences the patient experience. Our review uncovers areas PBT providers could target to improve patient-centered care; however, additional primary qualitative research is recommended.

Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study.

INTRODUCTION: Primary brain tumours, specifically gliomas, are a rare disease group. The disease and treatment negatively impacts on patients and those close to them. The high rates of physical and cognitive morbidity differ from other cancers causing reduced health-related quality of life. Glioma trials using outcomes that allow holistic analysis of treatment benefits and risks enable informed care decisions. Currently, outcome assessment in glioma trials is inconsistent, hindering evidence synthesis. A core outcome set (COS) - an agreed minimum set of outcomes to be measured and reported - may address this. International initiatives focus on defining core outcomes assessments across brain tumour types. This protocol describes the development of a COS involving UK stakeholders for use in glioma trials, applicable across glioma types, with provision to identify subsets as required. Due to stakeholder interest in data reported from the patient perspective, outcomes from the COS that can be patient-reported will be identified. METHODS AND ANALYSIS: Stage I: (1) trial registry review to identify outcomes collected in glioma trials and (2) systematic review of qualitative literature exploring glioma patient and key stakeholder research priorities. Stage II: semi-structured interviews with glioma patients and caregivers. Outcome lists will be generated from stages I and II. Stage III: study team will remove duplicate items from the outcome lists and ensure accessible terminology for inclusion in the Delphi survey. Stage IV: a two-round Delphi process whereby the outcomes will be rated by key stakeholders. Stage V: a consensus meeting where participants will finalise the COS. The study team will identify the COS outcomes that can be patient-reported. Further research is needed to match patient-reported outcomes to available measures. ETHICS AND DISSEMINATION: Ethical approval was obtained (REF SMREC 21/59, Cardiff University School of Medicine Research Ethics Committee). Study findings will be disseminated widely through conferences and journal publication. The final COS will be adopted and promoted by patient and carer groups and its use by funders encouraged. PROSPERO REGISTRATION NUMBER: CRD42021236979.

The range and suitability of outcome measures used in the assessment of palliative treatment for inoperable malignant bowel obstruction: A systematic review.

BACKGROUND: Malignant bowel obstruction, a complication of certain advanced cancers, causes severe symptoms which profoundly affect quality of life. Clinical management remains complex, and outcome assessment is inconsistent. AIM: To identify outcomes evaluating palliative treatment for inoperable malignant bowel obstruction, as part of a four-phase study developing a core outcome set. DESIGN: The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA); PROSPERO (ID: CRD42019150648). Eligible studies included at least one subgroup with obstruction below the ligament of Treitz undergoing palliative treatment for inoperable malignant bowel obstruction. Study quality was not assessed because the review does not evaluate efficacy. DATA SOURCES: Medline, Embase, the Cochrane Database, CINAHL, PSYCinfo Caresearch, Open Grey and BASE were searched for trials and observational studies in October 2021. RESULTS: A total of 4769 studies were screened, 290 full texts retrieved and 80 (13,898 participants) included in a narrative synthesis; 343 outcomes were extracted verbatim and pooled into 90 unique terms across six domains: physiological, nutrition, life impact, resource use, mortality and survival. Prevalent outcomes included adverse events (78% of studies), survival (54%), symptom control (39%) and mortality (31%). Key individual symptoms assessed were vomiting (41% of studies), nausea (34%) and pain (33%); 19% of studies assessed quality of life. CONCLUSIONS: Assessment focuses on survival, complications and overall symptom control. There is a need for definitions of treatment 'success' that are meaningful to patients, a more consistent approach to symptom assessment, and greater consideration of how to measure wellbeing in this population.

Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences.

BACKGROUND: Phase 1 drug trials are popular treatment options for patients with advanced disease, despite the greater levels of uncertainty associated with them. However, their meaning and consequences for patient-participants remains under-explored. This review synthesises the qualitative evidence of patients' experiences of participating in phase 1 oncology trials, exploring their decisions to take part and the impacts of these trials on patient wellbeing. METHODS: A comprehensive literature search involving medical subject headings (MeSH) and keywords was undertaken in the following databases: MEDLINE, EMBASE, PsycINFO, Scopus, CINAHL, and Cochrane CENTRAL, with supplementary searches also conducted. Studies were independently screened for inclusion by two researchers. Included studies were critically appraised and data extracted using standardised forms. Qualitative results were analysed using thematic synthesis. RESULTS: Three main themes were identified across 13 studies: decision-making and joining the trial; experiences of taking part in the trial and hope and coping. Patients primarily joined trials hoping for therapeutic benefits, sentiments which prevailed and shaped their experiences across their trial journey. Rather than indicate therapeutic misconception based on poor understanding, patient perspectives more commonly pointed to differences between hope and expectation and cultural narratives of staying positive, trying everything and trusting in experts. CONCLUSIONS: These findings challenge information-based models of consent, favouring coping frameworks which account for the role of hope and meaning-making during serious illness. Personalised consideration of existential and quality-of-life matters before and during trials is recommended, including palliative and supportive care alternatives to active treatment. REVIEW REGISTRATION: The review was registered with PROSPERO international prospective register of systematic reviews (CRD 42020163250).

Symptom burden and lived experiences of patients, caregivers and healthcare professionals on the management of malignant bowel obstruction: A qualitative systematic review.

BACKGROUND: Malignant bowel obstruction occurs in up to 50% of people with advanced ovarian and 15% of people with gastrointestinal cancers. Evaluation and comparison of interventions to manage symptoms are hampered by inconsistent evaluations of efficacy and lack of agreed core outcomes. The patient perspective is rarely incorporated. AIM: To synthesise the qualitative data regarding patient, caregiver and healthcare professionals' views and experience of malignant bowel obstruction to inform the development of a core outcome set for the evaluation of malignant bowel obstruction. DESIGN: A qualitative systematic review was conducted, with narrative synthesis. The review protocol was registered prospectively (https://www.crd.york.ac.uk/prospero, CRD42020176393). DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsycINFO and Scopus databases were searched for studies published between 2010 and 2021. Reference lists were screened for further relevant publications, and citation tracking was performed. RESULTS: Nine papers were included, reporting on seven studies which described the views and experiences of malignant bowel obstruction through the perspectives of 75 patients, 13 caregivers and 62 healthcare professionals. Themes across the papers included symptom burden, diverse experiences of interventions, impact on patient quality of life, implications and trajectory of malignant bowel obstruction, mixed experience of communication and the importance of realistic goals of care. CONCLUSION: Some of the most devastating sequelae of malignant bowel obstruction, such as pain and psychological distress, are not included routinely in its clinical or research evaluation. These data will contribute to a wider body of work to ensure the patient and caregiver perspective is recognised in the development of a core outcome set.

Maximising recruitment of research participants into a general practice based randomised controlled trial concerning lung diagnosis-staff insights from an embedded qualitative study.

BACKGROUND: The ELCID Trial was a feasibility randomised controlled trial examining the effect on lung cancer diagnosis of lowering the threshold for referral for urgent chest X-ray for smokers and recent ex-smokers, aged over 60 with new chest symptoms. The qualitative component aimed to explore the feasibility of individually randomising patients to an urgent chest X-ray or not and to investigate any barriers to patient recruitment and participation. This would inform the design of any future definitive trial. This paper explores general practice staff insights into participating in and recruiting to diagnostic trials for possible/suspected lung cancer. METHODS: Qualitative interviews were conducted with 11 general practice staff which included general practitioners, a nurse practitioner, research nurses and practice managers. Interviews were analysed using a framework approach. RESULTS: Findings highlight general practice staff motivators to participate in the trial as recruiters, practice staff interactions with patients recruited onto the study, methods of organisation staff used to undertake the trial, the general impact of the trial on practice staff, how the trial research team supported the practices and lastly practice staff suggestions for trial delivery improvement. CONCLUSIONS: The integration of a qualitative component focused on staff experiences participating in a lung diagnostic trial has demonstrated the feasibility to recruit for similar future studies within general practice. Although recruitment into trials can be difficult, results from our study offer suggestions on maximising patient recruitment not just to trials in general but also specifically for a lung diagnosis study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01344005. Registered on 27 April 2011.

Early palliative interventions for improving outcomes in people with a primary malignant brain tumour and their carers.

BACKGROUND: Primary malignant brain tumours can have an unpredictable course, but high-grade gliomas typically have a relentlessly progressive disease trajectory. They can cause profound symptom burden, affecting physical, neurocognitive, and social functioning from an early stage in the illness. This can significantly impact on role function and on the experiences and needs of informal caregivers. Access to specialist palliative and supportive care early in the disease trajectory, for those with high-grade tumours in particular, has the potential to improve patients' and caregivers' quality of life. However, provision of palliative and supportive care for people with primary brain tumours - and their informal caregivers - is historically ill-defined and ad hoc, and the benefits of early palliative interventions have not been confirmed. It is therefore important to define the role and effectiveness of early referral to specialist palliative care services and/or the effectiveness of other interventions focused on palliating disease impact on people and their informal caregivers. This would help guide improvement to service provision, by defining those interventions which are effective across a range of domains, and developing an evidence-based model of integrated supportive and palliative care for this population. OBJECTIVES: To assess the evidence base for early palliative care interventions, including referral to specialist palliative care services compared to usual care, for improving outcomes in adults diagnosed with a primary brain tumour and their carers. SEARCH METHODS: We conducted searches of electronic databases, CENTRAL, MEDLINE, CINAHL, Web of Science, and PsycINFO (last searched 16 November 2021). We conducted searches to incorporate both qualitative and quantitative search terms. In addition to this, we searched for any currently recruiting trials in ClinicalTrials.gov and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, and undertook citation tracking via Scopus. We also handsearched reference lists of potentially eligible systematic review articles to identify any other relevant studies, contacted experts in the field and searched key authors via Web of Science and searched SIGLE (System of Information on Grey Literature in Europe). SELECTION CRITERIA: We included studies looking at early referral to specialist palliative care services - or early targeted palliative interventions by other healthcare professionals - for improving quality of life, symptom control, psychological outcomes, or overall survival as a primary or secondary outcome measure. Studies included randomised controlled trials (RCTs), non-randomised studies (NRS), as well as qualitative and mixed-methods studies where both qualitative and quantitative data were included. Participants were adults with a confirmed radiological and/or histological diagnosis of a primary malignant brain tumour, and/or informal adult carers (either at individual or family level) of people with a primary malignant brain tumour. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodological procedures for data extraction, management, and analysis. We used GRADE to assess the certainty of the evidence for symptom control, i.e. cognitive function. MAIN RESULTS: We identified 9748 references from the searches, with 8337 remaining after duplicates were removed. After full-text review, we included one trial. There were no studies of early specialist palliative care interventions or of early, co-ordinated generalist palliative care approaches. The included randomised trial addressed a single symptom area, focusing on early cognitive rehabilitation, administered within two weeks of surgery in a mixed brain tumour population, of whom approximately half had a high-grade glioma. The intervention was administered individually as therapist-led computerised exercises over 16 one-hour sessions, four times/week for four weeks. Sessions addressed several cognitive domains including time orientation, spatial orientation, visual attention, logical reasoning, memory, and executive function. There were no between-group differences in outcome for tests of logical-executive function, but differences were observed in the domains of visual attention and verbal memory. Risk of bias was assessed and stated as high for performance bias and attrition bias but for selective reporting it was unclear whether all outcomes were reported. We considered the certainty of the evidence, as assessed by GRADE, to be very low. AUTHORS' CONCLUSIONS: Currently there is a lack of research focusing on the introduction of early palliative interventions specifically for people with primary brain tumours, either as co-ordinated specialist palliative care approaches or interventions focusing on a specific aspect of palliation. Future research should address the methodological shortcomings described in early palliative intervention studies in other cancers and chronic conditions. In particular, the specific population under investigation, the timing and the setting of the intervention should be clearly described and the standardised palliative care-specific components of the intervention should be defined in detail.

'Hospice inpatient deep vein thrombosis detection (HIDDen) in advanced non-malignant diseases': a longitudinal pilot study.

OBJECTIVES: To gain preliminary data regarding the prevalence of proximal deep vein thrombosis (DVT) in those with non-malignant conditions admitted to specialist palliative care units (SPCUs). METHODS: Data were collected as part of a prospective longitudinal observational study in five SPCUs in England, Wales and Northern Ireland (Registration: ISRCTN97567719) to estimate the prevalence of proximal femoral vein DVT in people admitted to SPCUs. The primary outcome for this exploratory substudy was the prevalence of DVT in patients with non-malignant palliative conditions. Consecutive consenting adults underwent bilateral femoral vein ultrasonography within 48 hours of admission. Data were collected on symptoms associated with venous thromboembolism. Patients were ineligible if the estimated prognosis was <5 days. Cross-sectional descriptive analysis was conducted on baseline data and prevalence estimates presented with 95% CIs. RESULTS: 1390 patients were screened, 28 patients had non-malignant disease and all were recruited. The mean age 68·8 (SD 12·0), range 43-86 years; men 61%; survival mean 86 (SD 108.5) range 1-345 days. No patient had a history of venous thromboembolism. Four (14%) were receiving thromboprophylaxis. Of 22 evaluable scans, 8 (36%, 95% CI: 17% to 59%) showed femoral vein DVT. The level of reported relevant symptoms (leg oedema, leg pain, chest pain and breathlessness) was high irrespective of the presence of DVT. CONCLUSIONS: Our exploratory data indicate one in three people admitted to an SPCU with non-malignant disease had a femoral vein DVT. Although definitive conclusions cannot be drawn, these data justify a larger prospective survey.

A mixed-methods study to evaluate a patient-designed tool to reduce harm from cancer-associated thrombosis: The EMPOWER study.

INTRODUCTION: Venous thromboembolism (VTE) is a common and serious complication of systemic anticancer therapies. Delays in presentation increase risk of death or long-term morbidity. BACKGROUND: A patient charity developed an information video for patients receiving systemic anticancer therapy including what to do if they developed symptoms of VTE. This was introduced into clinical practice in a regional cancer center and its impact compared with a district general hospital where the video was not used. METHODS: A mixed-methods approach was used, comprising clinical audit data, patient surveys, and key informant interviews. The time between development of VTE symptoms and seeking medical evaluation was routinely recorded on patients attending a regional cancer-associated thrombosis service with systemic anticancer therapy-provoked VTE. The video was then embedded into clinical practice at the regional cancer center for 3 months. The primary outcome was the difference in time to presentation with VTE symptoms, between patients attending the regional cancer center and the district general hospital (which acted as control). Other outcomes included impact on radiology resources, patient knowledge, and perspectives of chemotherapy nurses. RESULTS: Addition of the video was associated with a lower mean time to presentation from 8.9 to 2.9 days (0.33 hazard ratio; 95% confidence interval, 4.5-7.4; P < .0001). This may reflect greater awareness of VTE, resulting in earlier clinical presentation when they developed attributable symptoms. CONCLUSION: The video was associated with reduced delays in diagnosis of systemic anticancer therapy-associated VTE by 6 days, thereby reducing long-term complications.

Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT.

BACKGROUND: Most patients with oesophageal cancer present with incurable disease. For those with advanced disease, the mean survival is 3-5 months. Treatment emphasis is therefore on effective palliation, with the majority of patients requiring intervention for dysphagia. Insertion of a self-expanding metal stent provides rapid relief but dysphagia may recur within 3 months owing to tumour progression. Evidence reviews have called for trials of interventions combined with stenting to better maintain the ability to swallow. OBJECTIVES: The Radiotherapy after Oesophageal Cancer Stenting (ROCS) study examined the effectiveness of palliative radiotherapy, combined with insertion of a stent, in maintaining the ability to swallow. The trial also examined the impact that the ability to swallow had on quality of life, bleeding events, survival and cost-effectiveness. DESIGN: A pragmatic, multicentre, randomised controlled trial with follow-up every 4 weeks for 12 months. An embedded qualitative study examined trial experiences in a participant subgroup. SETTING: Participants were recruited in secondary care, with all planned follow-up at home. PARTICIPANTS: Patients who were referred for stent insertion as the primary management of dysphagia related to incurable oesophageal cancer. INTERVENTIONS: Following stent insertion, the external beam radiotherapy arm received palliative oesophageal radiotherapy at a dose of 20 Gy in five fractions or 30 Gy in 10 fractions. MAIN OUTCOME MEASURES: The primary outcome was the difference in the proportion of participants with recurrent dysphagia, or death, at 12 weeks. Recurrent dysphagia was defined as deterioration of ≥ 11 points on the dysphagia scale of the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire oesophago-gastric module questionnaire. Secondary outcomes included quality of life, bleeding risk and survival. RESULTS: The study recruited 220 patients: 112 were randomised to the usual-care arm and 108 were randomised to the external beam radiotherapy arm. There was no evidence that radiotherapy reduced recurrence of dysphagia at 12 weeks (48.6% in the usual-care arm compared with 45.3% in the external beam radiotherapy arm; adjusted odds ratio 0.82, 95% confidence interval 0.40 to 1.68; p = 0.587) and it was less cost-effective than stent insertion alone. There was no difference in median survival or key quality-of-life outcomes. There were fewer bleeding events in the external beam radiotherapy arm. Exploration of patient experience prompted changes to trial processes. Participants in both trial arms experienced difficulty in managing the physical and psychosocial aspects of eating restriction and uncertainties of living with advanced oesophageal cancer. LIMITATIONS: Change in timing of the primary outcome to 12 weeks may affect the ability to detect a true intervention effect. However, consistency of results across sensitivity analyses is robust, including secondary analysis of dysphagia deterioration-free survival. CONCLUSIONS: Widely accessible palliative external beam radiotherapy in combination with stent insertion does not reduce the risk of dysphagia recurrence at 12 weeks, does not have an impact on survival and is less cost-effective than inserting a stent alone. Reductions in bleeding events should be considered in the context of patient-described trade-offs of fatigue and burdens of attending hospital. Trial design elements including at-home data capture, regular multicentre nurse meetings and qualitative enquiry improved recruitment/data capture, and should be considered for future studies. FUTURE WORK: Further studies are required to identify interventions that improve stent efficacy and to address the multidimensional challenges of eating and nutrition in this patient population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12376468 and Clinicaltrials.gov NCT01915693. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 31. See the NIHR Journals Library website for further project information.

Most people are diagnosed with oesophageal (gullet) cancer when it is already at an advanced stage. Losing the ability to swallow food and even fluids is very common when patients are approaching the last months of life. Placing a flexible metal tube, or stent, in the gullet opens it up and improves the ability to swallow quickly. Unfortunately this can fail after around 3 months because the cancer grows and presses on the stent. We designed this trial to see if giving a small dose of radiotherapy alongside insertion of the stent would allow more people to remain swallowing well after 3 months. This could then improve their quality of life and reduce hospitalisation towards the end of life. It may also reduce bleeding from the gullet, as well as other symptoms. We recruited 220 people across the UK, randomly assigning them to have the stent as usual or the stent and a low dose of radiotherapy. We collected a lot of information from the participants at home on how the cancer, the stent and the radiotherapy affected their ability to swallow and their quality of life. Overall, the study showed that the radiotherapy did not improve the ability to swallow 3 months following stent insertion and was less cost-effective than stent insertion alone. It seemed to reduce the risk of bleeding from the tumour itself, but patients found that radiotherapy made them tired and attending extra hospital visits could be troublesome. We also learned that, even after a stent was inserted, patients still struggled with food and needed more support with managing daily life with the stent. The trial results are important. They show that, to answer questions such as these, studies should use different ways of assessing what works, particularly focusing on patients' and families' viewpoints. The results will guide doctors to not routinely give radiotherapy in this situation. The results also suggest that, after the insertion of a stent, patients need extra help in managing their diet, their worries about the stent and their worries about the future.

Psychosocial determinants of quit motivation in older smokers from deprived backgrounds: a cross-sectional survey.

OBJECTIVES: To identify psychosocial determinants of quit motivation in older deprived smokers. The evidence may be used to optimise smoking cessation interventions for the target population. DESIGN: Cross-sectional survey using online recruitment methods including Facebook-targeted advertising. SETTING: UK, 2019. PARTICIPANTS: Current smokers aged 50 years or older and from a socioeconomically deprived background. MAIN OUTCOME MEASURES: Measures included motivation to stop smoking, smoking history, perceived social support, self-efficacy for quitting, self-exempting beliefs and lung cancer risk perception. Multivariable regression was used to analyse factors associated with quit motivation. RESULTS: Of a total 578 individuals who consented to take part, 278 (48.1%) did not meet the inclusion criteria. Of the 300 eligible participants, most were recruited using Facebook (94.0%), were aged 50-64 years (83.7%) and women (85.7%). Most participants were renting from a housing association (72.0%) and had low education (61.0%). Higher motivation to quit was statistically significantly associated with a higher intensity of previous quit attempts (p=0.03), higher quit confidence (p=0.01), higher smoking self-efficacy (p=0.01), a lower risk-minimising beliefs score (p=0.01) and using traditional nicotine replacement therapy (NRT) when trying to stop smoking or cut down (p<0.001). CONCLUSION: Older smokers from deprived backgrounds face complex barriers to quitting smoking. Interventions are needed to increase self-efficacy for quitting, modify risk-minimising beliefs and target elements of previous quit attempts (ie, the use of NRT) that are associated with motivation to stop smoking.

Using the United Kingdom standards for public involvement to evaluate the impact of public involvement in a multinational clinical study.

BACKGROUND: The publication of the United Kingdom (UK) Standards for Public Involvement (PI) (UK Standards) in research drew a clear line in the sand regarding the importance of utilising the unique experience, skills and expertise that lay people may offer to the development, conduct and dissemination of clinical research. The UK Standards provide a benchmark which researchers should aim to achieve, yet its implementation continues to be a step wise iterative process of change management. A recent evaluation by a regional research group has suggested that our understanding of PI is enhanced through reflection on the UK Standards. We report on the utility of PI in the design, conduct and dissemination of the HIDDen study, a national, multicentre clinical study based across three UK centres. METHODS: A retrospective review of PI within the HIDDen study was conducted using field notes taken by the lead author from interactions throughout their involvement as a lay representative on the study. Key members of the HIDDen study were interviewed and data analysed to explore adherence to the UK Standards. RESULTS: There was universal support for PI across the study management group with genuine inclusivity of lay members of the committee. All six of the UK Standards were met to varying degrees. The greatest opportunities lay in 'working together' and 'support and learning'. There were challenges meeting 'governance' with evidence of participation in decision making but less evidence of opportunities in management, regulation, leadership. CONCLUSION: This study concurs with previous research supporting the utility of the Standards in the conduct and evaluation of PI in clinical research. To our knowledge this is the first multi-national study to be evaluated against the UK Standards.

The past decade has seen a genuine increase in patient and public involvement (PI) in clinical research, far beyond a symbolic presence on a trial management committee or inclusion on a grant application. The United Kingdom (UK) Standards for Public Involvement provide a useful structure to support PI throughout a study as well as defining a benchmark that can be used to improve the involvement of patients and the public in studies.The importance of reflecting on and reporting on PI in specific studies has been recognised since it contributes to a stepwise change process which will eventually lead to PI becoming normal practice for clinical research. A recent review identified a myriad of frameworks by which PI may be evaluated, risking an inconsistent approach to PI evaluation and consequently slowing down its progression.The Hospice Inpatient Deep vein thrombosis Detection study (HIDDen) was a national multicentre study to explore the prevalence and associated variables of blood clots in patients with advanced cancer when they were admitted to the specialist palliative care unit.In this paper we will be considering the HIDDen research in terms of the UK Standards for Public Involvement.

Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial.

BACKGROUND: Patients with advanced oesophageal cancer have a median survival of 3-6 months, and most require intervention for dysphagia. Self-expanding metal stent (SEMS) insertion is the most typical form of palliation in these patients, but dysphagia deterioration and re-intervention are common. This study examined the efficacy of adjuvant external beam radiotherapy (EBRT) compared with usual care alone in preventing dysphagia deterioration and reducing service use after SEMS insertion. METHODS: This was a multicentre, open-label, phase 3 randomised controlled trial based at cancer centres and acute care hospitals in England, Scotland, and Wales. Patients (aged ≥16 years) with incurable oesophageal carcinoma receiving stent insertion for primary management of dysphagia were randomly assigned (1:1) to receive usual care alone or EBRT (20 Gy in five fractions or 30 Gy in ten fractions) plus usual care after stent insertion. Usual care was implemented according to need as identified by the local multidisciplinary team (MDT). Randomisation was via the method of minimisation stratified by treating centre, stage at diagnosis (I-III vs IV), histology (squamous or non-squamous), and MDT intent to give chemotherapy (yes vs no). The primary outcome was difference in proportions of participants with dysphagia deterioration (>11 point decrease on patient-reported European Organisation for Research and Treatment of Cancer quality of life questionnaire-oesophagogastric module [QLQ-OG25], or a dysphagia-related event consistent with such a deterioration) or death by 12 weeks in a modified intention-to-treat (ITT) population, which excluded patients who did not have a stent inserted and those without a baseline QLQ-OG25 assessment. Secondary outcomes included survival, quality of life (QoL), morbidities (including time to first bleeding event or hospital admission for bleeding event and first dysphagia-related stent complications or re-intervention), and cost-effectiveness. Safety analysis was undertaken in the modified ITT population. The study is registered with the International Standard Randomised Controlled Trial registry, ISRCTN12376468, and ClinicalTrials.gov, NCT01915693, and is completed. FINDINGS: 220 patients were randomly assigned between Dec 16, 2013, and Aug 24, 2018, from 23 UK centres. The modified ITT population (n=199) comprised 102 patients in the usual care group and 97 patients in the EBRT group. Radiotherapy did not reduce dysphagia deterioration, which was reported in 36 (49%) of 74 patients receiving usual care versus 34 (45%) of 75 receiving EBRT (adjusted odds ratio 0·82 [95% CI 0·40-1·68], p=0·59) in those with complete data for the primary endpoint. No significant difference was observed in overall survival: median overall survival was 19·7 weeks (95% CI 14·4-27·7) with usual care and 18·9 weeks (14·7-25·6) with EBRT (adjusted hazard ratio 1·06 [95% CI 0·78-1·45], p=0·70; n=199). Median time to first bleeding event or hospital admission for a bleeding event was 49·0 weeks (95% CI 33·3-not reached) with usual care versus 65·9 weeks (52·7-not reached) with EBRT (adjusted subhazard ratio 0·52 [95% CI 0·28-0·97], p=0·038; n=199). No time versus treatment interaction was observed for prespecified QoL outcomes. We found no evidence of differences between trial group in time to first stent complication or re-intervention event. The most common (grade 3-4) adverse event was fatigue, reported in 19 (19%) of 102 patients receiving usual care alone and 22 (23%) of 97 receiving EBRT. On cost-utility analysis, EBRT was more expensive and less efficacious than usual care. INTERPRETATION: Patients with advanced oesophageal cancer having SEMS insertion for the primary management of their dysphagia did not gain additional benefit from concurrent palliative radiotherapy and it should not be routinely offered. For a minority of patients clinically considered to be at high risk of tumour bleeding, concurrent palliative radiotherapy might reduce bleeding risk and the need for associated interventions. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

The development of a scheme of Public & Patient Involvement (PPI) in the Wales Cancer Research Centre (WCRC) and reflections on the process.

The Wales Cancer Research Centre (WCRC) was established in 2015. It made an early and strong commitment to Public and Patient Involvement (PPI) in all its work. That commitment was made manifest through the immediate appointment of Lay and Researcher Leads and an administrator to develop and implement a scheme of PPI. At the core of the scheme was the allocation to each of the centre's four themes two Research Partners (RPs), who were to offer routine and strategic support to researchers but also to have a wider ambassadorial role, acting as champions for PPI. The RPs were appointed through a full recruitment process and supported financially, with a 'budget' of 10 half days per annum, with training where needed and supported by a mentor. Their core tasks were defined through an audit of then current practice in PPI within the themes. Monitoring of progress was undertaken at regular group PPI meetings, reports to the centre's funders against key performance indicators and against a rerun of the initial audit. A library of documents was produced to support this work, including a centre policy statement, procedures for the recruitment, training and support of RPs, a partnership agreement between RPs and researchers and a mentorship agreement. Most recently procedures have been drafted to assess the impact on research of PPI. The scheme has been regarded as largely successful by researchers, RPs and the Centre's External Advisory Board. However there remains much to do to ensure consistently high quality involvement of RPs in the centre's research. A significant stumbling block to making progress has been the lack of time given to researchers by funders to become involved in PPI. A reflection on progress against the UK Standards for PPI has identified a number of key actions for the future. They include the roll out of a scheme to assess the impact of PPI and to increase diversity in the centre's pool of RPs.

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.