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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

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. 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\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.

PURPOSE Poor nutrition is an increasing problem for economically deprived families, and mothers play a key role in establishing children’s diets. We explored mothers’ understanding of health-promotion recommendations for healthy eating. METHODS We conducted qualitative semistructured interviews of 46 mothers within a relatively socioeconomically deprived community. Data were subject to framework analysis. RESULTS The basic slogans of health promotion were known by mothers and had been adopted into everyday language. Television was the main source of information on dietary advice. Barriers to making changes were due to practical constraints (time, money, family preferences) and a desire to enhance quality of life through enjoyment of food. Although the headline messages of the importance of a healthy diet and what constitutes a healthy diet had reached mothers, misunderstandings were common and led to inappropriate actions. Many descriptions of what mothers reported as a balanced diet would not satisfy offi cial defi - nitions. Some women willfully adapted their understanding of advice to suit their preferences and the reality of their lives and family circumstances. CONCLUSIONS To provide effective advice and guidance, health professionals need a deeper understanding of how families interpret messages about healthy eating. In addition, they should provide advice based on more individual understandings of diet and take into account patient preferences and life circumstances.

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.

BACKGROUND: This study examined the processes of thinking and learning undertaken by general practitioners (GPs, family physicians) brought about by the presence of undergraduate medical students. METHOD: A qualitative study was undertaken using critical incident templates (a novel approach in this context) and focus groups. Data were analysed thematically, with iterative discussion between members of the study team after independent analysis. RESULTS: Thirty-eight critical incident templates were returned (40%), of which 27 (28%) were completed. Three themes were identified: challenges to the GP's thinking or learning behaviour (these included having to justify actions and answer questions); changes to the dynamic between doctor and patient (listening to discussion of their condition between doctor and student was reported to change the patient's experience); and additions to the GP's workload. Teaching made GPs' day longer and sometimes caused friction with colleagues. CONCLUSIONS: Our data elucidate a range of thinking and learning activities that are brought about by the presence of a student in a GP's consulting room. They show that there are a number of challenges that stimulate these activities. We recommend that undergraduate teaching in general practice be given greater recognition for the stimulus it provides for continuing professional development.

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.

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.

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.