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Introduction\ud Domiciliary care workers (DCWs) continued providing social care to adults in their own homes throughout the COVID-19 pandemic. Evidence of the impact of COVID-19 on health outcomes of DCWs is currently mixed, probably reflecting methodological limitations of existing studies. The risk of COVID-19 to workers providing care in people's homes remains unknown.\ud \ud \ud Objectives\ud To quantify the impact of COVID-19 upon health outcomes of DCWs in Wales, to explore causes of variation, and to extrapolate to the rest of the UK DCW population.\ud \ud \ud Methods\ud Mixed methods design comprising cohort study of DCWs and exploratory qualitative interviews. Data for all registered DCWs in Wales is available via the SAIL Databank using a secured, privacy-protecting encrypted anonymisation process. Occupational registration data for DCWs working during the pandemic will be combined with EHR outcome data within the SAIL Databank including clinical codes that identify suspected and confirmed COVID-19 cases. We will report rates of suspected and confirmed COVID-19 infections and key health outcomes including mortality and explore variation (by factors such as age, sex, ethnicity, deprivation quintile, rurality, employer, comorbidities) using regression modelling, adjusting for clustering of outcome within Health Board, region and employer. A maximum variation sample of Welsh DCWs will be approached for qualitative interview using a strategy to include participants that vary across factors such as sex, age, ethnicity and employer. The interviews will inform the quantitative analysis modelling. We will generalise the quantitative findings to other UK nations.\ud \ud \ud Discussion\ud Using anonymised linked occupational and EHR data and qualitative interviews, the OSCAR study will quantify the risk of COVID-19 on DCWs' health and explore sources of variation. This will provide a secure base for informing public health policy and occupational guidance.

Background: The ELCID (Early Lung Cancer Investigation and Diagnosis) 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 years 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. We integrated this within the feasibility trial to inform the design of any future definitive trial, particularly in view of the lack of research exploring symptomatic patients’ experiences of participating in diagnostic trials for possible/suspected lung cancer. Although previous studies contributed valuable information concerning screening for lung cancer and patient participation in trials, this paper is the first to explore issues relating to this specific patient group.\ud \ud \ud \ud Methods: Qualitative interviews were conducted with 21 patients, comprising 9 who had been randomised to receive an immediate chest x-ray, 10 who were randomised to receive the standard treatment according to the National Institute for Health and Care Excellence guidelines, and 2 who chose not to participate in the trial. Interviews were analysed using a framework approach.\ud \ud \ud \ud Results: The findings of this analysis showed that altruism, personal benefit and the reassurance of not having lung cancer were important factors in patient participation. However, patients largely believed that being in the intervention arm was more beneficial, highlighting a lack of understanding of clinical equipoise. Disincentives to participation in the trial included the stigmatisation of patients who smoked (given the inclusion criteria). Although the majority of patients reported that they were happy with the trial design, there was evidence of poor understanding. Last, for several patients, placing trust in health professionals was preferred to understanding the trial processes.\ud \ud \ud \ud Conclusions: The integration of a qualitative study focusing on participant experience as a secondary outcome of a feasibility trial enabled exploration of patient response to participation and recruitment. The study demonstrated that although it is feasible to recruit patients to the ELCID trial, more work needs to be done to ensure an understanding of study principles and also of smoking stigmatisation.\ud \ud \ud \ud Trial registration: ClinicalTrials.gov, NCT01344005. Registered on 27 April 2011.

BACKGROUND: Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation. METHODS: We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care. RESULTS: The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer. CONCLUSIONS: We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care.British Journal of Cancer advance online publication 10 January 2017; doi:10.1038/bjc.2016.414 www.bjcancer.com.

The previously reported Patients’ Experience of LIving with CANcer-associated thrombosis (PELICAN) identified several areas of unmet clinical and support need for cancer patients diagnosed with venous thromboembolism (VTE) in the UK. It is not known whether such experiences are restricted to one particular country’s healthcare system and culture. We therefore undertook an evaluation of patients’ experience of cancer-associated thrombosis (CAT) within a Spanish setting. Twenty consecutive Spanish patients with CAT were interviewed about their experiences of living with CAT as per the previous PELICAN study. Where possible, spouses were interviewed in conjunction. Semi-structured interviews were audio recorded, transcribed and translated into English. Transcripts were coded using Nvivo software and data were analysed using framework analysis. A pragmatic approach was undertaken to allow explication of the potential cultural and operational differences that were not apparent in the UK dataset. Several commonalities between the UK and Spanish patients were identified including the traumatic nature of the experience, the need for information and adaptive behaviors through ritualisation. Within the major themes lay new themes as follows. (1) The traumatic experience of CAT impacted on the family dynamic with respect to discussions within the family unit and support needs of individuals other than the patient. It also had a profound impact on the patient’s concept of self with increased awareness of their mortality and seriousness of the cancer. (2) The need for information extended to the family as well as the patients. This was needed at the point of CAT diagnosis as well as an opportunity to later address unanswered questions. (3) Adaptive behaviors were common with similar ritualisations seen in the UK patients. The distress experienced by patients with CAT is not isolated to the UK alone but is similar in Spanish patients as well. The patient information provided regarding LMWH injections is important, but there is a need to for patients and their families to be given additional information about CAT itself and future prognosis. CAT also has a profound impact on the patient’s family who has similar support needs. It appears that there are several commonalities between UK and Spanish patients, as well as specific local issues. This study justifies expansion of the sampling to other countries.

Background\ud Patients often do not get the information they require from doctors and nurses. To address this problem, interventions directed at patients to help them gather information in their healthcare consultations have been proposed and tested.\ud \ud \ud Objectives\ud To assess the effects on patients, clinicians and the healthcare system of interventions which are delivered before consultations, and which have been designed to help patients (and/or their representatives) address their information needs within consultations.\ud \ud \ud Search strategy\ud We searched: the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library (issue 3 2006); MEDLINE (1966 to September 2006); EMBASE (1980 to September 2006); PsycINFO (1985 to September 2006); and other databases, with no language restriction. We also searched reference lists of articles and related reviews, and handsearched Patient Education and Counseling (1986 to September 2006).\ud \ud \ud Selection criteria\ud Randomised controlled trials of interventions before consultations designed to encourage question asking and information gathering by the patient.\ud \ud \ud Data collection and analysis\ud Two researchers assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of five outcomes.\ud \ud \ud Main results\ud We identified 33 randomised controlled trials, from 6 countries and in a range of settings. A total of 8244 patients was randomised and entered into studies. The most common interventions were question checklists and patient coaching. Most interventions were delivered immediately before the consultations.\ud \ud Commonly-occurring outcomes were: question asking, patient participation, patient anxiety, knowledge, satisfaction and consultation length. A minority of studies showed positive effects for these outcomes. Meta-analyses, however, showed small and statistically significant increases for question asking (standardised mean difference (SMD) 0.27 (95% confidence interval (CI) 0.19 to 0.36)) and patient satisfaction (SMD 0.09 (95% CI 0.03 to 0.16)). There was a notable but not statistically significant decrease in patient anxiety before consultations (weighted mean difference (WMD) -1.56 (95% CI -7.10 to 3.97)). There were small and not statistically significant changes in patient anxiety after consultations (reduced) (SMD -0.08 (95%CI -0.22 to 0.06)), patient knowledge (reduced) (SMD -0.34 (95% CI -0.94 to 0.25)), and consultation length (increased) (SMD 0.10 (95% CI -0.05 to 0.25)). Further analyses showed that both coaching and written materials produced similar effects on question asking but that coaching produced a smaller increase in consultation length and a larger increase in patient satisfaction.\ud \ud Interventions immediately before consultations led to a small and statistically significant increase in consultation length, whereas those implemented some time before the consultation had no effect. Both interventions immediately before the consultation and those some time before it led to small increases in patient satisfaction, but this was only statistically significant for those immediately before the consultation. There appear to be no clear benefits from clinician training in addition to patient interventions, although the evidence is limited.\ud \ud \ud Authors' conclusions\ud Interventions before consultations designed to help patients address their information needs within consultations produce limited benefits to patients. Further research could explore whether the quality of questions is increased, whether anxiety before consultations is reduced, the effects on other outcomes and the impact of training and the timing of interventions. More studies need to consider the timing of interventions and possibly the type of training provided to clinicians.

Background\ud Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders’ views about the ethical and practical challenges associated with recruiting care home residents into research studies.\ud \ud Methods\ud Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes.\ud \ud Results\ud Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study.\ud \ud Conclusions\ud Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.

Background Upper respiratory tract infection in children is one of the most frequent reasons for visiting a family doctor, and antibiotics are often prescribed inappropriately. Sodium cromoglicate inhibits the ICAM-1 molecule, which is the receptor for human rhinoviruses. We aimed to investigate whether intranasal cromoglicate shortens duration of infection of the upper respiratory tract. Methods We randomly assigned 290 children diagnosed with suspected acute viral upper respiratory tract infection by their family doctor (137 boys, 153 girls; mean age 5.2 years [SD 3.39]) either intranasal 4% sodium cromoglicate spray or intranasal normal saline spray. Follow-up was by daily symptom diary for 2 weeks and by telephone. Canadian Acute Respiratory Illness and Flu Scale (CARIFS) score was the primary outcome measure. Findings 195 patients returned symptom diaries, and 20 of these could not be included in the main analysis. 246 patients completed the telephone interview at week 1. There was no difference in recovery rate over the first week between the two groups, with the estimated difference in slope of log (CARIFS) being −0.01 (95% CI −0.05 to 0.03). There were no differences between the two groups in sideeffects or re-consultation rates. 43 (17%) of 246 children with suspected acute viral upper respiratory tract infection went back to see their family doctor, and 220 (89%) of 246 were managed without prescription of antibiotics. Interpretation Intranasal sodium cromoglicate is not a useful additional treatment for this infection. Our results further clarify the role of prescribed drugs for children with these frequent illnesses.

Introduction The Patients’ Experiences of LIving with CANcer associated thrombosis (PELICAN) study has identified the experience of cancer-associated thrombosis (CAT) to be a distressing one, for which patients feel ill prepared for and receive insufficient support. However, such data was from a United Kingdom (UK) population and may not be representative of all nationalities, cultures and healthcare systems. Aim To explore the experience of cancer associated thrombosis amongst patients living in Spain. Materials and Methods Twenty consecutive patients with CAT were recruited from a Spanish University Hospital. Where possible spouses were interviews in conjunction. Semi-structured qualitative interviews were undertaken, assited by a pre-agreed promt list. Interviews were audio recorded and transcribed verbatim. Preliminary data analysis was undertaken using thematic analysis. Results Several commonalities between UK and Spanish patients were identified including the traumatic nature of the experience, need for information and adaptive behaviors through ritualization. Three new major themes also emerged: Communication needs: over emphasis on heparin injection training, additional need for explanation of cause, response and prognosis The impact of CAT on the concept of self: CAT was considered defining watershed moment, confirmation of seriousness of the cancer, The impact of CAT on the family dynamic: distressing diagnosis for loved ones, exaggerated desire to help which could disempower patient independence. Conclusions: The experience of CAT is a distressing one which brings with it additional information needs through effective communication. Within the Spanish population, the role of family is of particular importance as well as the impact of CAT on the patient’s feelings of worth and personal identity. Effective communication, support and access to information are essential in order to minimize distress and enhance treatment complicance.

BackgroundVenous thromboembolism is common in cancer patients and requires anticoagulation with low-molecular-weight heparin (LMWH). Current data recommend LMWH for anticoagulation as far as 6 months, yet guidelines recommend LMWH beyond 6 months in patients who have ongoing or active cancer. This recommendation, based on expert consensus, has not been evaluated in a clinical study.Objectives(1) To identify the most clinically and cost-effective length of anticoagulation with LMWH in the treatment of cancer-associated thrombosis (CAT); (2) to identify practicalities of conducting a full randomised controlled trial (RCT) with regard to recruitment, retention and outcome measurement; and (3) to explore the barriers for progressing to a full RCT.DesignThe Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT) trial is a randomised, multicentre, feasibility mixed-methods study with three components: (1) a RCT comparing ongoing LMWH treatment for CAT with cessation of LMWH at 6 months’ treatment (current licensed practice) in patients with locally advanced or metastatic cancer, consulted in three clinical settings (haematology outpatients, oncology outpatients and primary care); (2) a nested qualitative study, including focus groups with clinicians to investigate attitudes for recruiting to the study and identify the challenges of progressing to a full RCT, and semistructured interviews with patients and relatives to explore their attitudes towards participating in the study, and potential barriers and concerns to participation; and (3) a UK-wide survey exercise to develop a classification and enumeration system for the CAT models and pathways of care.SettingA haematology outpatients department, an oncology outpatients department and primary care.ParticipantsPatients with ongoing active or metastatic cancer who have received 6 months of LMWH for CAT.InterventionsOngoing LMWH treatment for CAT versus cessation of LMWH at 6 months’ treatment in patients with locally advanced or metastatic cancer.Main outcome measures(i) The number of eligible patients over 12 months; (ii) the number of recruited patients over 12 months (target recruitment rate of 30% of eligible patients); and (iii) the proportion of randomised participants with recurrent venous thromboembolisms (VTEs) during follow-up.ResultsFollowing several delays in setting up the RCT component of the study, 5 out of 32 eligible patients consented to be randomised to the RCT suggesting progression to a full RCT was not feasible. Reasons for non-consenting were primarily based on a fixed preference for continuing or discontinuing treatment after 6 months of anticoagulation, and a fear of randomisation to their non-preferred option. Views were largely influenced by patients’ initial experience of CAT. Focus groups with clinicians revealed that they would be reticent to recruit to such a study as they had fixed views of best management despite the lack of evidence. Patient pathway modelling suggested that there is a broad heterogeneity of practice with respect to CAT management and co-ordination, with no consensus on which specialty should best manage such cases.ConclusionsThe results of the RCT reflect recruitment from the oncology site only and provide no recruitment data from haematology centres. However, it is unlikely that these other sites would have access to more eligible patients. The management of cancer-associated thrombosis beyond 6 months will remain a clinical challenge. As it is unlikely that a prospective study will successfully recruit, other strategies to accrue relevant data are necessary. Currently the LONGHEVA (Long-term treatment for cancer patients with deep-venous thrombosis or pulmonary embolism) registry is in development to prospectively evaluate this important and common clinical scenario.Study registrationThis study is registered as clinical trials.gov number NCT01817257 and International Standard Randomised Controlled Trial Number (ISRCTN) 37913976.Funding detailsFunding for the ALICAT trial was provided by the Health Technology Assessment programme (10/145/01) in response to a themed funding call. The study was designed in accordance with the initial funding brief and feedback from the review process.

Simon Noble, Hayley Prout, Annmarie Nelson Marie Curie Palliative Care Research Centre, Cardiff University, Cardiff, Wales, UK Introduction: Thrombosis remains the most common preventable cause of mortality in cancer patients receiving chemotherapy. Whilst the prophylaxis and treatment of this condition is well understood, the patient experience and subsequent behavioral factors are not. Methods: Patients receiving treatment for cancer-associated thrombosis (CAT) were interviewed about their experiences of CAT within the context of their cancer journey. Twenty interviews were transcribed and analyzed using framework analysis. Results: Chemotherapy patients were well informed about the risks of febrile neutropenia, how to recognize it, and when to seek medical attention. However, they had limited knowledge about CAT and received no information about the condition. Red flag symptoms suggestive of CAT were attributed to chemotherapy or the underlying cancer, resulting in delayed presentation to hospital, and diagnosis. The CAT journey was considered a distressing one, with limited support or information, in complete juxtaposition with the treatment they received for their cancer. Patients felt there was little ownership for the management of CAT, which further added to their distress. Conclusion: CAT is a common occurrence and patients view their experiences of it within the context of their overall cancer journey. However, patients receive little information to help recognize CAT and access timely treatment on the development of symptoms. Whilst other cancer complications have clear treatment pathways, thrombosis does not appear to have been afforded the same priority. A proactive approach to increase patient awareness, coupled with established CAT pathways is likely to reduce mortality, morbidity, and long-term psychological distress. Keywords: venous thromboembolism, qualitative, patient journey, low-molecular-weight heparin, patient experience

Background. For findings of randomized controlled trials in primary care to be applicable, both the sample of clinicians implementing the trial and the recruited patients should be as representative as possible. The processes of conducting trials should be made ‘user-friendly’ to clinician investigators in order to maximize their participation in research. Formal evaluations of trial implementation are unusual. This study reports clinicians' perspectives on acting as a clinician investigator in a randomized controlled trial (the SAVIT study) in general practice. Objective. Our purpose was to explore clinicians' accounts of taking part in a randomized controlled trial in which subjects were recruited opportunistically during general practice consultations. Method. Individual semi-structured interviews were conducted with nine GPs and one practice nurse practising in the Bro Taf area of South Wales who recruited children into the SAVIT study. A structured interview guide was used and data were analysed using the qualitative method of pattern coding. Results. Major emerging themes included recruitment difficulties and concerns about the safety of the study medication. Participants also outlined positive aspects of the study (clarity and simplicity of the study, potential benefits to clinicians and patients and study team follow-up of recruited patients). Recommendations for possible improvements in study implementation included the simplification and reduction of patient reading materials and improved presentation of study materials. Conclusions. Difficulty in recruiting patients was the most frequently mentioned problem by clinician investigators. Insufficient time in the consultation was perceived as the main barrier. Ingredients of successful trial implementation include good organization, simple documentation and study procedures, and the ability to allay concerns about patient safety. Findings from this evaluation may assist researchers in the design and implementation of future community-based randomized controlled trials.

Item does not contain fulltext Antibiotics are often prescribed to patients with respiratory tract infections who are unlikely to benefit. Models of physician-patient interaction may help understanding of this problem and inform the design of communication skills interventions to enhance appropriate prescribing. The 'paternalistic model' of the consultation remains common in the setting of acute respiratory tract infections. However, the four assumptions that could support this model are not valid for most of these patients, because: best treatment is controversial; management is inconsistent; physicians are not in the best position to evaluate trade-offs between management options without understanding patients' perspectives; and many pressures (apart from patients' agendas) intrude into the consultation. One alternative is the 'informed model' of consulting, but this does not take society's interests into account. The 'shared decision-making model', however, provides a framework for addressing both clinicians' and patients' agendas, and could guide the development and evaluation of specific consultation strategies to promote more appropriate use of antibiotics in primary care.

Background In order to improve lung cancer survival in the UK, a greater proportion of resectable cancers must be diagnosed. It is likely that resectability rates would be increased by more timely diagnosis. Aside from screening, the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers. Currently, lung cancers are mainly diagnosed by general practitioners (GPs) using the National Institute for Health and Clinical Excellence (NICE) guidelines for urgent referral for chest X-ray, which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3 weeks. We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients. Methods/Design We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates. This trial would have to be large (and consequently resource-intensive) because most of these patients will not have lung cancer, making optimal design crucial. We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial. Discussion This trial will assess the feasibility and inform the design of a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer. It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods in order to fully assess feasibility. Trial registration Clinicaltrials.gov NCT01344005

Objectives Cancer-associated thrombosis (CAT) complex condition, which may present to any healthcare professional and at any point during the cancer journey. As such, patients may be managed by a number of specialties, resulting in inconsistent practice and suboptimal care. We describe the development of a dedicated CAT service and its evaluation.\ud \ud Setting Specialist cancer centre, district general hospital and primary care.\ud \ud Participants Patients with CAT and their referring clinicians.\ud \ud Intervention A cross specialty team developed a dedicated CAT service , including clear referral pathways, consistent access to medicines, patient's information and a specialist clinic.\ud \ud Primary and secondary outcome measures The service was evaluated using a mixed-methods evaluation , including audits of clinical practice, clinical outcomes, staff surveys and qualitative interviewing of patients and healthcare professionals.\ud \ud Results Data from 457 consecutive referrals over an 18-month period were evaluated. The CAT service has led to an 88% increase in safe and consistent community prescribing of low-molecular-weight heparin, with improved access to specialist advice and information. Patients reported improved understanding of their condition, enabling better self-management as well as better access to support and information. Referring clinicians reported better care standards for their patients with improved access to expertise and appropriate management.\ud \ud Conclusions A dedicated CAT service improves overall standards of care and is viewed positively by patients and clinicians alike. Further health economic evaluation would enhance the case for establishing this as the standard model of care.

Background: Venous thromboembolism is common in patients with cancer and the risk increases with advanced disease. Evidence-based treatment is administration of low-molecular-weight heparin daily by subcutaneous injection. Clinical uncertainty exists as to whether treating venous thromboembolism in advanced disease is in the patient’s best interests. Aim: To explore the barriers faced by doctors when diagnosing and treating patients with cancer-associated thrombosis. Design: Qualitative, in-depth interview study using framework analysis. Participants: Forty-five UK doctors across urban and rural settings, from three specialties, oncology, palliative medicine and general practice, with a mixture of senior and junior staff. Results: Organisational constraints served to act as barriers to the diagnosis and treatment of this patient group. Issues were identified around access to diagnostic testing. A cancer-associated thrombosis patient having to wait for a scan as an inpatient was sometimes deemed unnecessary. Patient ambulance transport (especially transportation of hospice patients) was often viewed as inflexible and bureaucratic. Low-molecular-weight heparin prescribing had sometimes led to tension between the acute, community and hospice sectors about whose prescribing responsibility this was, with different areas having divergent ‘rules’ and practices. Finally, the doctors interviewed discussed the role of nurses. Conclusions: Multiple logistical barriers are hindering best patient care for people with cancer-associated thrombosis. There is scope for some of these barriers to be reduced to improve service delivery and ultimately patient care. The research team proposes practical recommendations, which could yield direct benefit for patients and the health services.

Background Cancer patients are at risk of developing blood clots in their veins - venous thromboembolism (VTE) - which often takes the form of a pulmonary embolism or deep vein thrombosis. The risk increases with advanced disease. Evidence based treatment is low molecular weight heparin (LMWH) by daily subcutaneous injection. The aim of this research is to explore the barriers for doctors in the UK when diagnosing and treating advanced cancer patients with VTE. Method Qualitative, in-depth interview study with 45 doctors (30 across Yorkshire, England and 15 across South Wales). Doctors were from three specialties: oncology, palliative medicine and general practice, with a mixture of senior and junior staff. Framework analysis was used. Results Doctors opinions as to whether LMWH treatment was ethically appropriate for patients who were symptomatic from VTE but at end of life existed on a shifting continuum, largely influenced by patient prognosis. A lack of immediate benefit coupled with the discomfort of a daily injection had influenced some doctors not to prescribe LMWH. The point at which LMWH injections should be stopped in patients at the end of life was ambiguous. Some perceived ‘overcaution’ in their own and other clinicians’ treatment of patients. Viewpoints were divergent on whether dying of a PE was considered a “good way to go”. The interventionalism and ethos of palliative medicine was discussed. Conclusions Decisions are difficult for doctors to make regarding LMWH treatment for advanced cancer patients with VTE. Treatment for this patient group is bounded to the doctors own moral and ethical frameworks.

Background The PAAD Study (Probiotics for Antibiotic Associated Diarrhoea in care homes) involves 2 stages. The first stage is a prospective 12 month observational study to collect data on the amount and type of antibiotic prescribed episodes of Antibiotic Associated Diarrhoea and C.difficile Associated Diarrhoea and outcome in a randomly selected sample of 9 care homes. The second stage is currently being designed but will take the form of a RCT of probiotic vs. placebo administered alongside the antibiotic. These two studies are governed by separate laws and regulations in relation to mental capacity. PAAD stage 1 is covered by the Mental Capacity Act and, for those service users who lack capacity, personal consultees are able to give agreement to the service user’s participation. PAAD stage 2 is covered by the Medicines for Human Use (Clinical Trials) Regulations and consent is given by a personal legal representative or a professional legal representative of the participant. The PAAD study also presents novel challenges in relation to advanced consent. We propose to explore some of the ethical and practical challenges of conducting these studies (and others like it) within the care home setting using qualitative methods. Our purpose is to optimise the informed consent process in a vulnerable population in preparation for stage two of PAAD.

This paper reports on a study of the ways in which 54 older people in South Wales (UK) talk about the symptoms and causes of cold and influenza (flu). The study was designed to understand why older people might reject or accept the offer of seasonal flu vaccine, and in the course of the interviews respondents were also asked to express their views about the nature and causes of the two key illnesses. The latter are among the most common infections in human beings. In terms of the biomedical paradigm the common cold is caused by numerous respiratory viruses, whilst flu is caused by the influenza virus. Medical diagnosis is usually made on clinical grounds without laboratory confirmation. Symptoms of flu include sudden onset of fever and cough, and colds are characterized by sneezing, sore throat, and runny nose, but in practice the symptoms often overlap. In this study we examine the degree by which the views of lay people with respect to both diagnosis and epidemiology diverge with that which is evident in biomedical discourse. Our results indicate that whilst most of the identified symptoms are common to lay and professional people, the former integrate symptoms into a markedly different observational frame from the latter. And as far as causation is concerned it is clear that lay people emphasize the role of ‘resistance’ and ‘immunity’ at least as much as ‘infection’ in accounting for the onset of colds and flu. The data are analyzed using novel methods that focus on the co-occurrence of concepts and are displayed as semantic networks. As well as reporting on its findings the authors draw out some implications of the study for social scientific and policy discussions concerning lay diagnosis, lay expertise and the concept of an expert patient., Highlights ► Novel methods of qualitative data analysis that focus on co-occurrence relations in talk. ► Novel methods of data representation that focus on networks of concepts and ideas. ► Contribution to the lay understanding of common illnesses. ► Implications of lay understanding for public health policy.

Objective To assess the effects on patients, clinicians, and the healthcare system of interventions before consultations to help patients or their representatives gather information in consultations by question asking.\ud \ud Design Systematic review with meta-analysis.\ud \ud Data sources Electronic literature searches of seven databases and hand searching of one journal and bibliographies of relevant articles.\ud \ud Review methods Inclusion criteria included randomised controlled trials.\ud \ud Main outcome measures Primary outcomes were question asking; patients’ anxiety, knowledge, and satisfaction; and length of consultation.\ud \ud Results 33 randomised trials of variable quality involving 8244 patients were identified. A few studies showed positive effects. Meta-analyses showed small and statistically significantly increases in question asking (standardised mean difference 0.27, 95% confidence interval 0.19 to 0.36) and patients’ satisfaction (0.09, 0.03 to 0.16). Non-statistically significant changes occurred in patients’ anxiety before consultations (weighted mean difference −1.56, −7.10 to 3.97), patients’ anxiety after consultations (standardised mean difference −0.08, −0.22 to 0.06), patients’ knowledge (−0.34, −0.94 to 0.25), and length of consultation (0.10, −0.05 to 0.25). Interventions comprising written materials had similar effects on question asking, consultation length, and patients’ satisfaction as those comprising the coaching of patients. Interventions with additional training of clinicians had little further effect than those targeted at patients alone for patients’ satisfaction and consultation length.\ud \ud Conclusions Interventions for patients before consultations produce small benefits for patients. This may be because patients and clinicians have established behaviours in consultations that are difficult to change. Alternatively small increases in question asking may not be sufficient to make notable changes to other outcomes.

Introduction Within palliative and end-of-life research, qualitative research interviews are often undertaken in the home. Despite practical and ethical challenges, little attention has been given in the literature to the impact of the home setting on both participants and researchers. Aim(s) and method(s) We present the views and experiences of researchers from an academic palliative care research centre on conducting qualitative research with vulnerable populations in the home. Our researchers come from a range of backgrounds (including nursing, occupational therapy, social science, psychology and palliative medicine) with varying degrees of experience. Results We reflect on several important ethical and practical issues, including ways in which to build rapport in often singular encounters and applying sensitivity and flexibility in difficult circumstances. The research interview has the potential to become therapeutic for the participant. However, interviewers need to be aware of unintentional power relationships between the researcher and the patient, and the implications for data quality, as well as both patients’ and interviewers’ physical and emotional well-being. Conclusion(s) In this setting, and with this particular patient group, less attention should be paid to interviewers’ professional stance of neutrality and nondisclosure and more to allowing appropriate social contact, and humanity. However, care needs to be taken to avoid creating a false rapport and therapeutic environment. We offer a list of recommendations to address both practical and ethical concerns for researchers working in this field.

Promoting self care for children with acute viral illness is an opportunity for relieving pressure on primary care. Carers may return for a second consultation and expect antibiotic treatment if they are not given a clear idea of what to expect or if their child fails to recover as predicted.1 We therefore set out to describe the clinical course of suspected acute viral infection of the upper respiratory tract in children who consult their general practitioner. We wanted to help clinicians to better predict the course of the condition.

Background Studies have shown that long-term LMWH (low molecular weight heparin) is superior to warfarin for ambulant, good performance status cancer patients with venous thromboembolism (VTE) and is standard care. Patients with poor performance status are largely excluded from these studies. We explored the barriers for doctors in their investigation and treatment of advanced cancer patients with VTE. Method Qualitative in depth interview study conducted with 45 participants (oncologists, palliative medicine doctors and GPs) working across a range of grades in Yorkshire, England and South Wales. Results A strong theme emerged from the data about whether doctors considered it ethically appropriate to investigate and/or treat a patient with advanced cancer for VTE. The expected prognosis of the patient was a pivotal factor in decision making. Doctors were more willing to investigate and treat if the patient had a better prognosis. There was considerable debate whether LMWH should be used in patients likely to die within days/weeks and whether these patients should be moved for investigation, with concerns about inflexible ambulance transport and worries that hospital was not able to manage such unwell patients. Uncertainty existed about when LMWH injections should cease with some feeling a sense of over-caution in their own and others9 treatment of patients as a result. Participants diverged on whether dying of a PE was ‘a good way to go’ with a minority viewing LMWH treatment as ‘overmedicalisation’. The lack of evidence base in this patient group was observed. Illustrative quotations will be employed. Conclusion The personal ethical framework of doctors plays a large role in medical decisions. Acknowledging this via empirical research informs a scant evidence base about how decisions are made for VTE management.

Background The treatment of cancer associated thrombosis (CAT) is well established, with level 1A evidence to support the recommendation of a low molecular weight heparin (LMWH) by daily injection for 3–6 months. However, registry data suggest compliance to clinical guidelines is poor. Clinicians face particular challenges in treating CAT in advanced cancer patients due to shorter life expectancy, increased bleeding risk and concerns that self injection may be too burdensome. For these reasons decision making around the diagnosis and management of CAT in people with advanced cancer, can be complex, and should focus on its likely net benefit for the patient. We explored factors that influence doctors’ decision making in this situation and sought to gain an understanding of the barriers and facilitators to the application of best practice. Methods Think aloud exercises using standardised case scenarios, and individual in depth interviews were conducted. All were transcribed. The think aloud exercises were analysed using Protocol Analysis and the interviews using Framework Analysis. Participants: 46 participants took part in the think aloud exercises and 45 participants were interviewed in depth. Each group included oncologists, palliative physicians and general practitioners and included both senior doctors and those in training. Setting: Two Strategic Health Authority regions, one in the north of England and one in Wales. Results The following key issues arose from the data synthesis: the importance of patient prognosis; the concept of “appropriateness”; “benefits and burdens” of diagnosis and treatment; LMWH or warfarin for treatment and sources of information which changed practice. Although interlinked, they do describe distinct aspects of the factors that influence doctors in their decisions in this area. Conclusions The above factors are issues doctors take into account when deciding whether to send a patient to hospital for investigation or to anticoagulate a patient with confirmed or suspected VTE. Many factors interweave and are themselves influenced by and dependent on each other. It is only after all are taken into account that the doctor arrives at the point of referring the patient for investigation. Some factors including logistic and organisational issues appeared to influence whether a patient would be investigated or treated with LMWH for a confirmed VTE. It is important that services are optimised to ensure that these do not hinder the appropriate investigation and management of individual patients.

Background\ud The ELCID Trial is a feasibility randomised controlled\ud trial examining the effect on lung cancer diagnosis of\ud giving an urgent chest x-ray to smokers, and recent exsmokers,\ud aged over 60 with new chest symptoms.\ud Aims\ud The qualitative component explores the feasibility of\ud individually randomising patients to an urgent CXR or\ud not and investigates any barriers to patient participation.\ud Methods\ud To date we have conducted semi-structured interviews\ud with six primary care staff (practice managers, research\ud nurses), ten patients randomised to ‘extra-NICE’ guidelines\ud for referral for urgent chest x-ray, and six patients\ud randomised to ‘usual care’ (NICE guidelines)). We hope\ud to also interview patients who decline randomisation.\ud Interviews were analysed using a Framework approach.\ud Results\ud Initial analysis indicated that practices have struggled to\ud recruit patients, partly due to the eligibility criteria that\ud requires ex-smokers to have stopped smoking within the\ud last five years. Practices with a research nurse have\ud recruited the most patients. Patients indicated that they\ud are happy to take part in the trial and their anxiety\ud levels were not raised. Most patients hoped to be\ud randomised to urgent chest x-ray, although those who\ud were not did not go back to their GP to request one.\ud Conclusions\ud Eligibility criteria needed revision to include ex-smokers\ud of any duration. These preliminary findings suggest that\ud the trial appears to be feasible and patients are happy to\ud accept randomisation. The findings will inform the\ud design of the main trial in the future.