Patients' Experience of Living with Cancer-associated thrombosis in Spain (PELICANOS).

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial.

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.

Trust, openness and continuity of care influence acceptance of antibiotics for children with respiratory tract infections: a four country qualitative study.

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. OBJECTIVE: To achieve a deeper understanding of parents' acceptance, or otherwise, of clinicians' antibiotic prescribing decisions for children with RTIs. 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). 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. 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.

Long-term risk prediction after major lower limb amputation: 1-year results of the PERCEIVE study.

BACKGROUND: Decision-making when considering major lower limb amputation is complex and requires individualized outcome estimation. It is unknown how accurate healthcare professionals or relevant outcome prediction tools are at predicting outcomes at 1-year after major lower limb amputation. METHODS: An international, multicentre prospective observational study evaluating healthcare professional accuracy in predicting outcomes 1 year after major lower limb amputation and evaluation of relevant outcome prediction tools identified in a systematic search of the literature was undertaken. Observed outcomes at 1 year were compared with: healthcare professionals' preoperative predictions of death (surgeons and anaesthetists), major lower limb amputation revision (surgeons) and ambulation (surgeons, specialist physiotherapists and vascular nurse practitioners); and probabilities calculated from relevant outcome prediction tools. RESULTS: A total of 537 patients and 2244 healthcare professional predictions of outcomes were included. Surgeons and anaesthetists had acceptable discrimination (C-statistic = 0.715), calibration and overall performance (Brier score = 0.200) when predicting 1-year death, but performed worse when predicting major lower limb amputation revision and ambulation (C-statistics = 0.627 and 0.662 respectively). Healthcare professionals overestimated the death and major lower limb amputation revision risks. Consultants outperformed trainees, especially when predicting ambulation. Allied healthcare professionals marginally outperformed surgeons in predicting ambulation. Two outcome prediction tools (C-statistics = 0.755 and 0.717, Brier scores = 0.158 and 0.178) outperformed healthcare professionals' discrimination, calibration and overall performance in predicting death. Two outcome prediction tools for ambulation (C-statistics = 0.688 and 0.667) marginally outperformed healthcare professionals. CONCLUSION: There is uncertainty in predicting 1-year outcomes following major lower limb amputation. Different professional groups performed comparably in this study. Two outcome prediction tools for death and two for ambulation outperformed healthcare professionals and may support shared decision-making.

Barriers to the diagnosis and treatment of venous thromboembolism in advanced cancer patients: a qualitative study.

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.

Impact of the COVID-19 pandemic on domiciliary care workers in Wales, UK: a data linkage cohort study using the SAIL Databank.

OBJECTIVES: To quantify population health risks for domiciliary care workers (DCWs) in Wales, UK, working during the COVID-19 pandemic. DESIGN: A population-level retrospective study linking occupational registration data to anonymised electronic health records maintained by the Secure Anonymised Information Linkage Databank in a privacy-protecting trusted research environment. SETTING: Registered DCW population in Wales. PARTICIPANTS: Records for all linked DCWs from 1 March 2020 to 30 November 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome was confirmed COVID-19 infection; secondary outcomes included contacts for suspected COVID-19, mental health including self-harm, fit notes, respiratory infections not necessarily recorded as COVID-19, deaths involving COVID-19 and all-cause mortality. RESULTS: Confirmed and suspected COVID-19 infection rates increased over the study period to 24% by 30 November 2021. Confirmed COVID-19 varied by sex (males: 19% vs females: 24%) and age (>55 years: 19% vs <35 years: 26%) and were higher for care workers employed by local authority social services departments compared with the private sector (27% and 23%, respectively). 34% of DCWs required support for a mental health condition, with mental health-related prescribing increasing in frequency when compared with the prepandemic period. Events for self-harm increased from 0.2% to 0.4% over the study period as did the issuing of fit notes. There was no evidence to suggest a miscoding of COVID-19 infection with non-COVID-19 respiratory conditions. COVID-19-related and all-cause mortality were no greater than for the general population aged 15-64 years in Wales (0.1% and 0.034%, respectively). A comparable DCW workforce in Scotland and England would result in a comparable rate of COVID-19 infection, while the younger workforce in Northern Ireland may result in a greater infection rate. CONCLUSIONS: While initial concerns about excess mortality are alleviated, the substantial pre-existing and increased mental health burden for DCWs will require investment to provide long-term support to the sector's workforce.

The ethical decisions UK doctors make regarding advanced cancer patients at the end of life--the perceived (in) appropriateness of anticoagulation for venous thromboembolism: a qualitative study.

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.

Diagnosis and management of people with venous thromboembolism and advanced cancer: how do doctors decide? A qualitative study.

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.

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

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

"I don't mean to be rude, but could you put a mask on while I'm here?" A qualitative study of risks experienced by domiciliary care workers in Wales during the COVID-19 pandemic.

Domiciliary care workers (DCWs) continued to provide care to adults in their own homes throughout the COVID-19 pandemic. The evidence of the impact of COVID-19 on health outcomes of DCWs is currently mixed. The OSCAR study will quantify the impact of COVID-19 upon health outcomes of DCWs in Wales, explore causes of variation and extrapolate to the rest of the UK DCW population. An embedded qualitative study aimed to explore DCW experiences during the pandemic, including factors that may have varied risk of exposure to COVID-19 and adverse health and wellbeing outcomes. Registered DCWs working throughout Wales were invited to participate in a semi-structured telephone interview. 24 DCWs were interviewed between February and July 2021. Themes were identified through inductive analysis using thematic coding. Several themes emerged relating to risk of exposure to COVID-19. First, general changes to the role of the DCW during the pandemic were identified. Second, practical challenges for DCWs in the workplace were reported, including staff shortages, clients and families not following safety procedures, initial shortages of personal protective equipment (PPE), DCW criticism of standard use PPE, client difficulty with PPE and management of rapid antigen testing. Third, lack of government/employer preparation for a pandemic was described, including the reorganisation of staff clients and services, inadequate or confusing information for many DCWs, COVID-19 training and the need for improved practical instruction and limited official standard risk assessments for DCWs. Pressure to attend work and perceptions of COVID-19 risk and vaccination was also reported. In summary, this paper describes the risk factors associated with working during the pandemic. We have mapped recommendations for each problem using these qualitative findings including tailored training and better support for isolated team members and identified the required changes at several socio-ecological levels.

Nobody ever questions-Polypharmacy in care homes: A mixed methods evaluation of a multidisciplinary medicines optimisation initiative.

BACKGROUND: Nurse-led monitoring of patients for signs and symptoms associated with documented 'undesirable effects' of medicines has potential to prevent avoidable harm, and optimise prescribing. INTERVENTION: The Adverse Drug Reaction Profile for polypharmacy (ADRe-p) identifies and documents putative adverse effects of medicines commonly prescribed in primary care. Nurses address some problems, before passing ADRe-p to pharmacists and prescribers for review, in conjunction with prescriptions. OBJECTIVES: We investigated changes in: the number and nature of residents' problems as recorded on ADRe-p; prescription regimens; medicines optimisation: and healthcare costs. We explored aetiologies of problems identified and stakeholders' perspectives. SETTING AND PARTICIPANTS: In three UK care homes, 19 residents completed the study, December 2018 to May 2019. Two service users, three pharmacists, six nurses gave interviews. METHODS: This mixed-method process evaluation integrated data from residents' ADRe-ps and medicines charts, at the study's start and 5-10 weeks later. RESULTS: We recruited three of 27 homes approached and 26 of 45 eligible residents; 19 completed ADRe-p at least twice. Clinical gains were identified for 17/19 residents (mean number of symptoms 3 SD 1.67, range 0-7). Examples included management of: pain (six residents), seizures (three), dyspnoea (one), diarrhoea (laxatives reduced, two), falls (two of five able to stand). One or more medicine was de-prescribed or dose reduced for 12/19 residents. ADRe administration and review cost ~£30 in staff time. ADRe-p helped carers and nurses bring residents' problems to the attention of prescribers. IMPLICATIONS: ADRe-p relieved unnecessary suffering. It supported carers and nurses by providing a tool to engage with pharmacists and prescribers, and was the only observable strategy for multidisciplinary team working around medicines optimisation. ADRe-p improved care by: a) regular systematic checks and problem documentation; b) information transfer from care home staff to prescribers and pharmacists; c) recording changes. REGISTRATION: NLM Identifier NCT03955133; ClinicalTrials.gov.

A question of balance: a qualitative study of mothers' interpretations of dietary recommendations.

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 official definitions. 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.

Establishing the impact of COVID-19 on the health outcomes of domiciliary care workers in Wales using routine data: a protocol for the OSCAR study.

INTRODUCTION: 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. OBJECTIVES: 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. METHODS: 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. DISCUSSION: 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.

Evaluation of different delivery modes of an interactive e-learning programme for teaching cultural diversity.

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.

Considerations and recommendations for conducting qualitative research interviews with palliative and end-of-life care patients in the home setting: a consensus paper.

OBJECTIVES: To present and discuss the views of researchers at an academic palliative care research centre on research encounters with terminally ill patients in the home setting and to generate a list of recommendations for qualitative researchers working in palliative and end-of-life care. METHODS: Eight researchers took part in a consensus meeting to discuss their experiences of undertaking qualitative interviews. The researchers were of varying backgrounds and all reported having experience in interviewing terminally ill patients, and all but one had experience of interviewing patients in their home environment. RESULTS: The main areas discussed by researchers included: whether participation in end-of-life research unintentionally becomes a therapeutic experience or an ethical concern; power relationships between terminally ill patients and researchers; researcher reflexivity and reciprocity; researchers' training needs. Qualitative methods can complement the home environment; however, it can raise ethical and practical challenges, which can be more acute in the case of research undertaken with palliative and patients at the end-of-life. CONCLUSIONS: The ethical and practical challenges researchers face in this context has the potential to place both participant and researcher at risk for their physical and psychological well-being. We present a set of recommendations for researchers to consider prior to embarking on qualitative research in this context and advocate researchers in this field carefully consider the issues presented on a study-by-study basis.

Palliative care research centre's move into social media: constructing a framework for ethical research, a consensus paper.

BACKGROUND: Social media (SM) have altered the way we live and, for many, the way we die. The information available on even the rarest conditions is vast. Free from restrictions of mobility, time and distance, SM provides a space for people to share experiences of illness, death and dying, and potentially benefit from the emotional and practical support of others n similar positions. The communications that take place in these spaces also create large amounts of 'data' which, for any research centre, cannot be ignored. However, for a palliative care research centre the use of this 'data' comes with specific ethical dilemmas. METHODS: This paper details the process that we, as a research, went through in constructing a set of ethical guidelines by which to work. This involved conducting two consensus days; one with researchers from within the centre, and one with the inclusion of external researchers with a specific interest in SM. RESULTS: The primary themes that emerged from the consensus meetings includes; SM as a public or private space; the status of open and closed groups; the use of historical data; recruiting participants and obtaining informed consent and problems of anonymity associated with dissemination. CONCLUSIONS: These are the themes that this paper will focus on prior to setting out the guidelines that we subsequently constructed.

Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study.

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. 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. 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. 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01344005 . Registered on 27 April 2011.

A qualitative study of lay beliefs about influenza immunisation in older people.

BACKGROUND: Although influenza immunisation is now recommended for all people aged 65 years and over in the UK, many people in that age group still remain unimmunised. AIM: To investigate lay beliefs about influenza and influenza vaccine in older people to identify appropriate ways of promoting vaccine uptake. DESIGN: Qualitative study using narrative interviews. SETTING: Urban and rural communities in South Wales. METHOD: Participants were 54 people aged 65 years and over who were interviewed in their own home. Of these, 11 were regularly immunised, 18 had consistently refused immunisation (refusers), 15 had defaulted (defaulters), five had never been offered immunisation, and five had recently been immunised for the first time. RESULTS: There was an overwhelming consensus among immunised and unimmunised individuals that they were not at risk from influenza. Even if they did catch influenza, they would not suffer from any serious consequences. Refusers and defaulters were more likely to believe that the influenza vaccine had serious side-effects, while the regularly immunised group were more likely to perceive the vaccine as effective. Multiple prompts from family, friends, or primary care staff were important triggers for receiving immunisation. CONCLUSION: Many older people did not feel vulnerable to influenza, regardless of their age, and this influenced their views on the need for immunisation. Both refusers and defaulters overstated adverse effects from influenza vaccine so this is a potential target for an intervention. Individual prompts, particularly from GPs, seemed to be the most significant motivators to attend for immunisation.

A case-control study of presentations in general practice before diagnosis of coeliac disease.

BACKGROUND: Delay in the diagnosis of coeliac disease prolongs morbidity and may increase mortality. Little is known about presentations in general practice that may predict a subsequent diagnosis of coeliac disease. AIM: To examine presentations in general practice during the 5 years prior to diagnosis of coeliac disease. DESIGN OF STUDY: A case-control study with each biopsy-proven coeliac disease case matched by age, sex, and general practice to an average of two controls. SETTING: Thirty-seven general practices in south-east Wales. METHOD: Cases were identified via a secondary care clinic and controls recruited from the general practices of cases. General practice clinical records of both cases and controls were analysed to determine frequency of consultations, presenting symptoms, diagnoses, referrals, and investigations during the 5 years prior to diagnosis. RESULTS: Cases (n = 68) had an increased number of consultations compared with controls (n = 160) during the 5 years prior to diagnosis (mean difference five consultations, P = 0.001). Three clinical features were independently associated with subsequent diagnosis of coeliac disease: depression and/or anxiety (odds ratio [OR] = 2.5, 95% confidence interval [CI] = 1.1 to 5.7, P = 0.031); diarrhoea (OR = 4.5, 95% CI = 2.0 to 10.0, P <0.001); and anaemia (OR = 26.3, 95% CI = 5.7 to 120.6, P <0.001). Both diarrhoea and anaemia remained associated even when data for the year prior to diagnosis was excluded from the analysis. CONCLUSION: [corrected] GPs should consider testing for coeliac disease when patients present often, especially with diarrhoea and/or who are discovered to be anaemic. Further research is required to clarify the role of depression and/or anxiety in the diagnosis of coeliac disease.

Impact of a dedicated cancer-associated thrombosis service on clinical outcomes: a mixed-methods evaluation of a clinical improvement exercise.

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. SETTING: Specialist cancer centre, district general hospital and primary care. PARTICIPANTS: Patients with CAT and their referring clinicians. 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. 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. 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. 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.