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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. Clinician–parent interaction and health system influences on parental acceptance of prescribing decisions for children with respiratory tract infections (RTIs) may be important determinants of antibiotic use. \ud \ud \ud Objective. To achieve a deeper understanding of parents’ acceptance, or otherwise, of clinicians’ antibiotic prescribing decisions for children with RTIs. \ud \ud \ud Methods. Qualitative interviews with parents of child patients who had recently consulted in primary care with a RTI in four European countries, with a five-stage analytic framework approach (familiarization, developing a thematic framework from interview questions and emerging themes, indexing, charting and interpretation). \ud \ud \ud Results. Fifty of 63 parents accepted clinicians’ management decisions, irrespective of antibiotic prescription. There were no notable differences between networks. Parents ascribed their acceptance to a trusting and open clinician–patient relationship, enhanced through continuity of care, in which parents felt able to express their views. There was a lack of congruence about antibiotics between parents and clinicians in 13 instances, mostly when parents disagreed about clinicians’ decision to prescribe (10 accounts) rather than objecting to withholding antibiotics (three accounts). All but one parent adhered to the prescribing decision, although some modified how the antibiotic was administered. \ud \ud \ud Conclusions. Parents from contrasting countries indicated that continuity of care, open communication in consultations and clinician–patient trust was important in acceptance of management of RTI in their children and in motivating adherence. Interventions to promote appropriate antibiotic use in children should consider a focus on eliciting parents’ perspectives and promoting and building on continuity of care within a trusting clinician–patient relationship.

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.

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.

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.

OBJECTIVE: UK medical schools find it challenging to provide standardised teaching to expanding year intakes. In addition, developing and implementing diversity training can cause difficulties. This paper describes the evaluation of an interactive e-learning programme to raise awareness and understanding of communication difficulties in diversity consultations. METHODS: The programme was part of an undergraduate portfolio-based community module. Three hundred and two students were assigned to one of three delivery methods--a large group setting, small groups with a facilitator, and as part of distance learning while on community placement. The evaluation included analysis of their coursework marks, a self-completed evaluation questionnaire, and small group discussions. RESULTS: Two hundred and twenty-three students took part in the evaluation. They were able to apply the concepts they learnt to clinical examples from their own experiences. Type of delivery did not affect coursework marks, but students tended to prefer the e-learning as part of a distance learning package. They offered helpful suggestions to improve its complexity and range. CONCLUSION: The acceptability and utility of this e-learning module both in face to face teaching and remote placement has been demonstrated, and evaluation by the students has provided valuable information for its further development. PRACTICE IMPLICATIONS: All medical schools should include some diversity training, and further research should concentrate on the effects of this type of learning on longer term outcomes such as attitude and performance tests. Such tools could reduce demands on staff time in facilitation of small groupwork, and their cost effectiveness could be increased by making them available to other medical schools.

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 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.