Experiences of delivering and receiving mental healthcare in the acute hospital setting: a qualitative study.

BACKGROUND: Recent investment in UK liaison psychiatry services has focused on expanding provision for acute and emergency referrals. Little is known about the experiences of users and providers of these services. The aim of this study was to explore the experiences of users of acute liaison mental health services (LMHS) and those of NHS staff working within LMHS or referring to LMHS. A secondary aim was to explore the potential impact of a one-hour service access target on service delivery. METHODS: Cross-sectional qualitative study. Individual interviews were audio-recorded, transcribed verbatim and interpreted using framework analysis. RESULTS: Service users reported mixed experiences of LMHS, with some reporting positive experiences and some reporting poor care. Most service users described the emergency department (ED) environment as extremely stressful and wished to be seen as quickly as possible. Staff described positive benefits of the one-hour access target but identified unintended consequences and trade-offs that affected other parts of the liaison service. CONCLUSIONS: The assessment and treatment of people who attend ED with mental health problems needs to improve and particular attention should be given to the stressful nature of the ED environment for those who are extremely agitated or distressed.

Temporary treatment cessation versus continuation of first-line tyrosine kinase inhibitor in patients with advanced clear cell renal cell carcinoma (STAR): an open-label, non-inferiority, randomised, controlled, phase 2/3 trial.

BACKGROUND: Temporary drug treatment cessation might alleviate toxicity without substantially compromising efficacy in patients with cancer. We aimed to determine if a tyrosine kinase inhibitor drug-free interval strategy was non-inferior to a conventional continuation strategy for first-line treatment of advanced clear cell renal cell carcinoma. METHODS: This open-label, non-inferiority, randomised, controlled, phase 2/3 trial was done at 60 hospital sites in the UK. Eligible patients (aged ≥18 years) had histologically confirmed clear cell renal cell carcinoma, inoperable loco-regional or metastatic disease, no previous systemic therapy for advanced disease, uni-dimensionally assessed Response Evaluation Criteria in Solid Tumours-defined measurable disease, and an Eastern Cooperative Oncology Group performance status of 0-1. Patients were randomly assigned (1:1) at baseline to a conventional continuation strategy or drug-free interval strategy using a central computer-generated minimisation programme incorporating a random element. Stratification factors were Memorial Sloan Kettering Cancer Center prognostic group risk factor, sex, trial site, age, disease status, tyrosine kinase inhibitor, and previous nephrectomy. All patients received standard dosing schedules of oral sunitinib (50 mg per day) or oral pazopanib (800 mg per day) for 24 weeks before moving into their randomly allocated group. Patients allocated to the drug-free interval strategy group then had a treatment break until disease progression, when treatment was re-instated. Patients in the conventional continuation strategy group continued treatment. Patients, treating clinicians, and the study team were aware of treatment allocation. The co-primary endpoints were overall survival and quality-adjusted life-years (QALYs); non-inferiority was shown if the lower limit of the two-sided 95% CI for the overall survival hazard ratio (HR) was 0·812 or higher and if the lower limit of the two-sided 95% CI of the marginal difference in mean QALYs was -0·156 or higher. The co-primary endpoints were assessed in the intention-to-treat (ITT) population, which included all randomly assigned patients, and the per-protocol population, which excluded patients in the ITT population with major protocol violations and who did not begin their randomisation allocation as per the protocol. Non-inferiority was to be concluded if it was met for both endpoints in both analysis populations. Safety was assessed in all participants who received a tyrosine kinase inhibitor. The trial was registered with ISRCTN, 06473203, and EudraCT, 2011-001098-16. FINDINGS: Between Jan 13, 2012, and Sept 12, 2017, 2197 patients were screened for eligibility, of whom 920 were randomly assigned to the conventional continuation strategy (n=461) or the drug-free interval strategy (n=459; 668 [73%] male and 251 [27%] female; 885 [96%] White and 23 [3%] non-White). The median follow-up time was 58 months (IQR 46-73 months) in the ITT population and 58 months (46-72) in the per-protocol population. 488 patients continued on the trial after week 24. For overall survival, non-inferiority was demonstrated in the ITT population only (adjusted HR 0·97 [95% CI 0·83 to 1·12] in the ITT population; 0·94 [0·80 to 1·09] in the per-protocol population). Non-inferiority was demonstrated for QALYs in the ITT population (n=919) and per-protocol (n=871) population (marginal effect difference 0·06 [95% CI -0·11 to 0·23] for the ITT population; 0·04 [-0·14 to 0·21] for the per-protocol population). The most common grade 3 or worse adverse events were hypertension (124 [26%] of 485 patients in the conventional continuation strategy group vs 127 [29%] of 431 patients in the drug-free interval strategy group); hepatotoxicity (55 [11%] vs 48 [11%]); and fatigue (39 [8%] vs 63 [15%]). 192 (21%) of 920 participants had a serious adverse reaction. 12 treatment-related deaths were reported (three patients in the conventional continuation strategy group; nine patients in the drug-free interval strategy group) due to vascular (n=3), cardiac (n=3), hepatobiliary (n=3), gastrointestinal (n=1), or nervous system (n=1) disorders, and from infections and infestations (n=1). INTERPRETATION: Overall, non-inferiority between groups could not be concluded. However, there seemed to be no clinically meaningful reduction in life expectancy between the drug-free interval strategy and conventional continuation strategy groups and treatment breaks might be a feasible and cost-effective option with lifestyle benefits for patients during tyrosine kinase inhibitor therapy in patients with renal cell carcinoma. FUNDING: UK National Institute for Health and Care Research.

Women's attitudes, beliefs and values about tests, and management for hypertensive disorders of pregnancy.

BACKGROUND: Advances in research suggest the possibility of improving routine clinical care for preeclampsia using screening (predictive) and diagnostic tests. The views of women should be incorporated into the way in which such tests are used. Therefore, we explored the views of women with experience of preeclampsia and other hypertensive disorders in pregnancy (HDPs) about predictive and diagnostic tests, treatment risks, and expectant management. METHOD: Eight hundred and seven women with experience of preeclampsia or other HDPs completed an online questionnaire. These women were participants in the Preeclampsia Registry (USA). The questionnaire contained 22 items to elicit women's views about predictive tests (n = 8); diagnostic tests (n = 5); treatment risks (n = 7), and expectant management (n = 2). An optional text box allowed participants to add qualitative open-ended comments. Levels of agreement with the statements were reported descriptively for the sample as a whole, and a preliminary investigation of the role of lived experience in shaping women's views was conducted by comparing subgroups within the sample based on time of HDP delivery (preterm/term). The qualitative data provided in the optional text box was analysed using inductive thematic analysis to examine participants' responses. RESULTS: Women generally favored predictive and diagnostic testing, although not because they would opt for termination of pregnancy. Participants generally disagreed that taking daily low-dose aspirin (LDA) would make them nervous, with disagreement significantly higher in the preterm delivery subgroup. A high proportion of participants, especially in the preterm delivery subgroup, would take LDA throughout pregnancy. The majority of participants would be more worried about the possibility of preeclampsia than about the risks of treatments to their health (60%), and that proportion was significantly higher in the preterm delivery subgroup. There were no differences between subgroups in the views expressed about expectant management, although opinion was divided in both groups. Overall, most participants opted to put the baby's interests first. CONCLUSION: Women with experience of hypertensive disorders were enthusiastic about improved predictive and diagnostic tests. However, varied views about treatment options and expectant management suggest the need for a shared decision-making tool to enable healthcare professionals to support pregnant women's decision-making to maximize the utility of these tests and interventions.

Experiences of people seen in an acute hospital setting by a liaison mental health service: responses from an online survey.

BACKGROUND: In recent years the UK has expanded the provision of liaison mental health services (LMHS). Little work has been undertaken to explore first-hand experiences of them. AIMS: The aim of this study was to gain insights into the experiences of users of LMHS in both emergency departments and acute inpatient wards in the UK. METHODS: This cross-sectional internet survey was initially advertised from May-July 2017 using the social media platform Facebook. Due to a paucity of male respondents, it was re-run from November 2017-February 2018, specifically targeting male respondents. The survey featured a structured questionnaire divided into three categories: the profile of the respondent, perceived professionalism of LMHS and overall opinion of the service. ANALYSIS: Responses to the structured questionnaire were analysed using descriptive statistics and latent class analysis. Free-text responses were transcribed verbatim and interpreted using thematic analysis. RESULTS: 184 people responded to the survey. 147 were service users and 37 were partners, friends or family members of service users. Only 31% of service users and 27% of close others found their overall contact helpful. Latent class analysis identified three clusters - 46% of service users generally disliked their contact, 36% had an overall positive experience, and 18% did not answer most questions about helpfulness or usefulness. Features most frequently identified as important were the provision of a 24/7 service, assessment by a variety of healthcare professionals and national standardisation of services. Respondents indicated that the least important feature was the provision of a separate service for older people. They desired faster assessments following referral from the parent team, clearer communication about next steps and greater knowledge of local services and third sector organisations. CONCLUSIONS: This survey identified mixed responses, but overall experiences were more negative than indicated in the limited previous research. The evaluation and adaptation of LMHS along the lines suggested in our survey should be prioritised to enhance their inherent therapeutic value and to improve engagement with treatment and future psychiatric care.

SABRTooth: a randomised controlled feasibility study of stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I nonsmall cell lung cancer considered to be at higher risk of complications from surgical resection.

OBJECTIVES: Stereotactic ablative radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I nonsmall cell lung cancer (NSCLC). Previous nonrandomised evidence supports SABR as an alternative to surgery, but high-quality randomised controlled trial (RCT) evidence is lacking. The SABRTooth study aimed to establish whether a UK phase III RCT was feasible. DESIGN AND METHODS: SABRTooth was a UK multicentre randomised controlled feasibility study targeting patients with peripheral stage I NSCLC considered to be at higher risk of surgical complications. 54 patients were planned to be randomised 1:1 to SABR or surgery. The primary outcome was monthly average recruitment rates. RESULTS: Between July 2015 and January 2017, 318 patients were considered for the study and 205 (64.5%) were deemed ineligible. Out of 106 (33.3%) assessed as eligible, 24 (22.6%) patients were randomised to SABR (n=14) or surgery (n=10). A key theme for nonparticipation was treatment preference, with 43 (41%) preferring nonsurgical treatment and 19 (18%) preferring surgery. The average monthly recruitment rate was 1.7 patients against a target of three. 15 patients underwent their allocated treatment: SABR n=12, surgery n=3. CONCLUSIONS: We conclude that a phase III RCT randomising higher risk patients between SABR and surgery is not feasible in the National Health Service. Patients have pre-existing treatment preferences, which was a barrier to recruitment. A significant proportion of patients randomised to the surgical group declined and chose SABR. SABR remains an alternative to surgery and novel study approaches are needed to define which patients benefit from a nonsurgical approach.

The nature and activity of liaison mental services in acute hospital settings: a multi-site cross sectional study.

BACKGROUND: To describe the clinical activity patterns and nature of interventions of hospital-based liaison psychiatry services in England. METHODS: Multi-site, cross-sectional survey. 18 acute hospitals across England with a liaison psychiatry service. All liaison staff members, at each hospital site, recorded data on each patient they had face to face contact with, over a 7 day period. Data included location of referral, source of referral, main clinical problem, type of liaison intervention employed, staff professional group and grade, referral onto other services, and standard assessment measures. RESULTS: A total of 1475 face to face contacts from 18 hospitals were included in the analysis, of which approximately half were follow-up reviews. There was considerable variation across sites, related to the volume of Emergency Department (ED) attendances, number of hospital admissions, and work hours of the team but not to the size of the hospital (number of beds). The most common clinical problems were co-morbid physical and psychiatric symptoms, self-harm and cognitive impairment. The main types of intervention delivered were diagnosis/formulation, risk management and advice. There were differences in the type of clinical problems seen by the services between EDs and wards, and also differences between the work conducted by doctors and nurses. Almost half of the contacts were for continuing care, rather than assessment. Eight per cent of all referrals were offered follow up with the LP team, and approximately 37% were referred to community or other services. CONCLUSIONS: The activity of LP services is related to the flow of patients through an acute hospital. In addition to initial assessments, services provide a wide range of differing interventions, with nurses and doctors carrying out distinctly different roles within the team. The results show the volume and diversity of LP work. While much clinical contact is acute and confined to the inpatient episode, the LP service is not defined solely by an assessment and discharge function; cases are often complex and nearly half were referred for follow up including liaison team follow up.

Patient preferences for prenatal testing and termination of pregnancy for congenital anomalies and genetic diseases in Ethiopia.

OBJECTIVE: As prenatal diagnostic services expand throughout low-income countries, an important consideration is the appropriateness of these services for patients. In these countries, services now include prenatal ultrasound and occasionally genetic testing. To assess patient interest, we surveyed pregnant patients at a hospital in Addis Ababa, Ethiopia, on their preferences for prenatal testing and termination of affected pregnancies for congenital anomalies and genetic diseases. METHOD: One hundred one pregnant patients were surveyed on their preferences for prenatal testing and termination of affected pregnancies using a survey covering various congenital anomalies and genetic diseases. RESULTS: Eighty-nine percent of patients reported interest in testing for all conditions. Three percent of patients were not interested in any testing. Over 60% of patients reported interest in termination for anencephaly, early infant death, severe intellectual disability, hemoglobinopathy, and amelia. Patients were more likely to express interest in prenatal testing and termination for conditions associated with a shortened lifespan. CONCLUSION: Ethiopian patients were interested in prenatal testing and termination of pregnancy for many conditions. Advancing prenatal diagnostic capacities is a potential strategy for addressing the incidence of congenital anomalies and genetic disease in Ethiopia. Importantly, there exist many factors and technological limitations to consider before implementation.

Integrated liaison psychiatry services in England: a qualitative study of the views of liaison practitioners and acute hospital staffs from four distinctly different kinds of liaison service.

BACKGROUND: Liaison psychiatry services provide mental health care for patients in physical healthcare (usually acute hospital) settings including emergency departments. Liaison work involves close collaboration with acute hospital staff so that high quality care can be provided. Services however are patchy, relatively underfunded, heterogeneous and poorly integrated into acute hospital care pathways. METHODS: We carried out in-depth semi-structured interviews with 73 liaison psychiatry and acute hospital staff from 11 different acute hospitals in England. The 11 hospitals were purposively sample to represent hospitals in which four different types of liaison services operated. Staff were identified to ensure diversity according to professional background, sub-specialism within the team, and whether they had a clinical or managerial focus. All interviews were audio-recorded and transcribed. The data were analysed using a best-fit framework analysis. RESULTS: Several key themes emerged in relation to facilitators and barriers to the effective delivery of integrated services. There were problems with continuity of care across the secondary-primary interface; a lack of mental health resources in primary care to support discharge; a lack of shared information systems; a disproportionate length of time spent recording information as opposed to face to face patient contact; and a lack of a shared vision of care. Relatively few facilitators were identified although interviewees reported a focus on patient care. Similar problems were identified across different liaison service types. CONCLUSIONS: The problems that we have identified need to be addressed by both liaison and acute hospital teams, managers and funders, if high quality integrated physical and mental health care is to be provided in the acute hospital setting.

Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID): a randomised controlled trial in systemic cancer treatment.

BACKGROUND: eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation. METHODS: The trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients. Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504. The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff. DISCUSSION: The pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88520246 . Registered 11 September 2014.

Patient attitudes towards prenatal diagnostic testing for inherited retinal disease.

OBJECTIVE: To explore factors that influence decision-making in relation to prenatal diagnostic testing (PDT) for inherited retinal disease (IRD). METHOD: Semi-structured interviews were conducted with 50 adults with IRD, selected from a larger sample to provide a diversity of backgrounds and opinions on genetic testing. Interviews were transcribed verbatim and analysed using thematic analysis. RESULTS: Mostly participants supported PDT, believing that it would provide information to help them prepare for and plan the future care of the child and the potential for early access to emerging therapies. Opposition to PDT stemmed from its use to justify termination of pregnancy, with participants feeling that it was not justified as they retained a good quality of life despite their visual impairment. Participants raised concerns about the risk of PDT and the accuracy of the results. However, most suggested that it should be available as an option for others, but for specific reasons and not as a part of routine care. CONCLUSION: The variation in attitudes towards PDT and uncertainty about the risk and accuracy of results suggest that individuals at risk of having a child with IRD should have access to genetic counselling to support decision making.

Presenting life with cystic fibrosis: a Q-methodological approach to developing balanced, experience-based prenatal screening information.

BACKGROUND: Cystic fibrosis (CF) is one of the most common life-threatening genetically inherited conditions and prenatal screening for CF is available in many countries. Genetic counsellors and other health professionals are expected to provide information about the condition in a way that facilitates personal decision making. Knowing what information to deliver about complex genetic conditions to support informed screening decisions can be challenging for health professionals. OBJECTIVE: To solicit views from those with personal experience with CF on which aspects of the condition they consider most important to include in prenatal screening materials. METHODS: Q-methodology; an approach to systematically explore variations in viewpoint that combines factor analytic techniques with qualitative approaches to pattern interpretation. SETTING AND PARTICIPANTS: Twelve adults with CF and 18 parents of affected children were recruited from a regional centre in the UK. RESULTS: Five distinct viewpoints on the items most and least important to include in screening information were identified: Factor 1 the normality of life with CF and increasing life expectancy; Factor 2 the hardships and reduced lifespan. Factor 3 medical interventions and the importance of societal support. Factor 4 longer-term consequences of CF. Factor 5 the ability to adjust to the condition. DISCUSSION: The identification of five different views on what represented the most and least important information to include about CF highlights the challenge of portraying a complex genetic condition in a balanced and accurate manner. Novel ways in which Q-methodology findings can be used to meet this challenge are presented.

Psychological aspects of individualized choice and reproductive autonomy in prenatal screening.

Probably the main purpose of reproductive technologies is to enable people who choose to do so to avoid the birth of a baby with a disabling condition. However the conditions women want information about and the 'price' they are willing to pay for obtaining that information vary enormously. Individual women have to arrive at their own prenatal testing choices by 'trading off' means and ends in order to resolve the dilemmas facing them. We know very little about how individuals make these trade-offs, so it is difficult to predict how new technologies will affect their choices and preferences. Uptake decisions can be expected to change, especially in the group of women who now are put off by some aspect of the current screening approach, where the avoidance of miscarriage risk may have provided a kind of 'psychological shelter', protecting a lot of people from having to make other decisions. Technologies such as Pre-implantation Genetic Diagnosis may remove a second 'psychological shelter' because they offer the means of avoiding the birth of an affected child without terminating a pregnancy. Even if new technologies will make some decisions easier in terms of their cognitive demands, they will also create new dilemmas and decision making will not necessarily become less stressful in emotional terms. Key challenges concern information and decision-making.

Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis.

BACKGROUND: There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. METHODS: Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. RESULTS: 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. CONCLUSIONS: Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for doing the qualitative research and important methodological details. Acknowledging the space restrictions faced by researchers writing grant proposals, we suggest a starting point for providing practical guidance to help researchers write proposals and research commissioners assess proposals of qualitative research with trials.

Antenatal telephone support intervention with and without uterine artery Doppler screening for low risk nulliparous women: a randomised controlled trial.

BACKGROUND: The number of routine antenatal visits provided to low risk nulliparous women has been reduced in the UK, acknowledging this change in care may result in women being less satisfied with their care and having poorer psychosocial outcomes. The primary aim of the study was to investigate whether the provision of proactive telephone support intervention (TSI) with and without uterine artery Doppler screening (UADS) would reduce the total number of antenatal visits required. A secondary aim was to investigate whether the interventions affected psychological outcomes. METHODS: A three-arm randomised controlled trial involving 840 low risk nulliparous women was conducted at a large maternity unit in North East England. All women received antenatal care in line with current UK guidance. Women in the TSI group (T) received calls from a midwife at 28, 33 and 36 weeks and women in the telephone and Doppler group (T + D) received the TSI and additional UADS at 20 weeks' gestation. The main outcome measure was the total number of scheduled and unscheduled antenatal visits received after 20 weeks' gestation. RESULTS: The median number of unscheduled (n = 2.0), scheduled visits (n = 7.0) and mean number of total visits (n = 8.8) were similar in the three groups. The majority (67%) of additional antenatal visits were made to a Maternity Assessment Unit because of commonly occurring pregnancy complications. Additional TSI+/-UADS was not associated with differences in clinical outcomes, levels of anxiety, social support or satisfaction with care. There were challenges to the successful delivery of the telephone support intervention; 59% of women were contacted at 29 and 33 weeks gestation reducing to 52% of women at 37 weeks. CONCLUSIONS: Provision of additional telephone support (with or without UADS) in low risk nulliparous women did not reduce the number of unscheduled antenatal visits or reduce anxiety. This study provides a useful insight into the reasons why this client group attend for unscheduled visits. TRIAL REGISTRATION: ISRCTN62354584.

Do people really know what makes a family history of cancer?

BACKGROUND: Family history is often referred to as a family tree in casual everyday conservations, but it carries a different connotation in medicine. This study is the first to investigate people's understanding of 'family medical history' and the concept of 'family' in the context of inherited cancer. METHODS: Three hundred and nine staff at the Faculty of Medicine and Health, University of Leeds completed an online web survey. RESULTS: Not all respondents understood or knew what makes a family history of cancer. Only 54% knew exactly the type of information required to make a family history. Apart from blood relatives, adopted and step-siblings, step parents, in-laws, spouses, friends and colleagues were also named as 'family' for family history taking. Personal experience of living with cancer and academic qualification were not significant in influencing knowledge of family history. CONCLUSIONS: There is misunderstanding and poor knowledge of family history of cancer and the type of information required to make a family history even in a sample of people teaching and researching medicine and health issues. Public understanding of the value of family medical history in cancer prevention and management is important if informed clinical decisions and appropriate health care are to be delivered.

Measuring patient-perceived continuity of care for patients with long-term conditions in primary care.

BACKGROUND: Continuity of care is widely acknowledged as important for patients with multi-morbidity but simple, service-orientated indices cannot capture the full impact of continuity in complex care delivery systems. The patient's perspective is important to assess outcomes fully and this is challenging because generic measures of patient-perceived continuity are lacking. We investigate the Chao Perception of Continuity (Chao PC) scale to determine its suitability as a measure of continuity of care for patients with a long-term condition (stroke), and co-morbidity, in a primary care setting. DESIGN AND SETTING: A questionnaire study embedded in a prospective observational cohort study of outcomes for patients following acute stroke. PARTICIPANTS: 168 community dwelling patients (58% male) mean age 68 years a minimum one year post-stroke. Functional status: Barthel Index mean =16. INTERVENTION: A 23-item questionnaire, the Chao Perception of Continuity (Chao PC) scale, sent by post to their place of residence or administered face to face as part of the final cohort study assessment. RESULTS: 310 patients were invited to participate; 168 (54%) completed a questionnaire. All 23 questionnaire items were entered into a Principal Component Analysis. Emergent factors from the exploratory analysis were (1) inter-personal trust (relational continuity); (2) interpersonal knowledge and information (informational and relational continuity) and (3) the process of care (managerial continuity). The strongest of these was inter-personal trust. CONCLUSION: The context-specific items in the Chao PC scale are difficult for respondents to interpret in a United Kingdom Primary Care setting resulting in missing data and low response rates. The Chao-PC therefore cannot be recommended for wider application as a general measure of continuity of care without significant modification. Our findings reflect the acknowledged dimensions of continuity and support the concept of continuity of care as a multi-dimensional construct. We demonstrate the overlapping boundaries across the dimensions in the factor structure derived. Trust and interpersonal knowledge are clearly identified as valuable components of any patient-perceived measure of continuity of care.

Linkage of routinely collected NHS data to evaluate liaison mental health services: challenges and lessons learned.

Background: Liaison mental health services provide mental health care to patients in acute hospital settings. Evaluation of liaison services is challenging due to their heterogeneous organisation and delivery, high case throughput and varied patient case mix. We aimed to link routinely collected National Health Service data from secondary care settings, chosen for their service characteristics, to data from primary care to evaluate hospital-based liaison mental health services in England. Methods: We planned to compare patients referred to hospital-based liaison services with comparable patients in the same hospital not referred to liaison services and comparable patients in hospitals without any liaison services. We designed and enacted a methodology to link data from: (1) Hospital Episode Statistics, a database controlled by the National Health Service Digital and (2) ResearchOne, a primary care database controlled by The Phoenix Partnership. Results: Obtaining approvals for the steps prespecified in the methodological protocol took 907 days. Enactment following approvals took 385 days. Data supplied from Hospital Episode Statistics contained 181,063 patients from 6 hospitals (mean = 30,177, standard deviation = 28,875.86) who matched the inclusion and exclusion criteria. Data supplied from ResearchOne contained 33,666 (18.6%) of these patients from the 6 hospitals (mean = 5611, standard deviation = 5206.59). Discussion: Time required for approvals and enactment was attributable to slowness of data handling processes within each data holder and to resolution of technical and organisational queries between them. Variation in number of patients for which data was supplied between databases and between hospitals was attributable to coding inconsistencies and to the limited intersection of patient populations between databases and variation in recording practices between hospitals. Conclusion: Although it is technically feasible to link primary and secondary care data, the current system is challenging, complicated, unnecessarily bureaucratic, time consuming and costly. This limits the number of studies that could be conducted with these rich data sources. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 13/58/08.

Liaison mental health services are based in acute general hospitals and provide assessment and treatment for people who have both physical and mental health problems. Our aim was to use routinely collected National Health Service data to find out whether general hospital patients referred to liaison mental health services have improved outcomes, compared with patients not referred to liaison services, and comparable patients in hospitals where there are no liaison services. The main outcomes were less time spent in hospital and fewer re-admissions to hospital following discharge. We tried to link data from routine National Health Service sources for hospital and primary care, to compare patients referred to liaison mental health services with similar people in each hospital who had not been referred, and similar people in hospitals without any liaison services at all. We planned to find out how long these people stayed in hospital, whether they were re-admitted and how much was their healthcare cost was. We experienced significant difficulties in being able to link the National Health Service data from the different organisations we approached. The whole process was extremely complex, and a delay in one part of the process resulted delays in other parts. We eventually had to abandon the research without obtaining any meaningful data, although the lessons we learnt will be useful for other researchers, so they can avoid experiencing similar problems. Routinely collected National Health Service data from primary care and secondary care can be linked using the approaches we tried, but we were unable to complete the process within the time frame of the research programme, even with time extensions. Current processes need to be streamlined and standardised with designated clear response times for the different organisations.

The Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) protocol to explore the feasibility of embedding behavioural modifications into the clinical pathway for patients undergoing radical radiotherapy for lung cancer.

Patients with curable non-surgical lung cancer are often current smokers, have co-existing medical comorbidities and are treated with curative radiotherapy. To maximise the benefits of modern radiotherapy, there is an urgent need to optimise the patient's health to improve survival and quality of life. METHODS AND ANALYSIS: The Yorkshire Cancer Research-funded Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) (L426) is a single-centre prospective feasibility study to assess embedding behavioural changes into the radical radiotherapy pathway of patients with lung cancer. Feasibility will be assessed by measuring acceptability, demand and implementation. The duration of the study is 24 months. PREHABS has two workstreams: the intervention study and the theory of change (ToC) study.Intervention study: PREHABS will commence at the R-IDEAL phase 2 trial (exploratory) based on existing evidence and includes support for smoking cessation, increasing activity and dietary well-being. Patients undergoing radical radiotherapy for lung cancer will be recruited from the oncology department at Leeds Teaching Hospitals NHS Trust (LTHT). ToC study: to maximise the acceptability and adherence to the PREHABS, we will use a ToC approach to qualitatively explore the key barriers and enablers of implementing a tailored programme of 'prehabilitation'. The PREHABS ToC study participants will be recruited from patients with lung cancer undergoing radical radiotherapy and staff from the LTHT oncology department. ANALYSIS: The primary endpoint analysis will report the number of participants and adherence to the study interventions. Secondary endpoints include continued engagement with study interventions post-treatment. The analysis will focus on descriptive statistics. Thematic analysis of the qualitative data from the ToC study will identify consensus on intervention optimisation and delivery. ETHICS AND DISSEMINATION: On 12 May 2021, the Cambridge East Ethics Committee granted ethical approval (21/EE/0048). The study is registered in the National Institute for Health and Care Research (NIHR) portfolio. The results will be disseminated through publication in peer-reviewed scientific journals and presented at conferences. TRIAL REGISTRATION NUMBER: NIHR portfolio 48420.

Cost-Effectiveness of eRAPID eHealth Intervention for Symptom Management During Chemotherapy.

PURPOSE: A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self-efficacy, without increasing hospital admissions and visits. The aim of this study was to evaluate the cost-effectiveness of the eRAPID eHealth intervention compared with usual care for patients receiving systemic treatment for colorectal, breast, or gynecologic cancers in the United Kingdom. METHODS: An embedded economic evaluation was conducted alongside the trial evaluating the effectiveness of eRAPID from health care provider and societal perspectives. Costs and quality-adjusted life-years (QALYs) of patients were compared over 18 weeks of the trial. Incremental cost-effectiveness ratios (ICERs) were estimated and compared with the National Institute for Health and Care Excellence cost-effectiveness threshold. Uncertainty around the ICER was explored using nonparametric bootstrapping and sensitivity analyses. Follow-up data were collected 12-months after random assignment for a subset of the study sample to conduct exploratory analysis of potential longer-term effects. RESULTS: Patients in the eRAPID group had the highest QALY gain and lowest costs over 18 weeks. Although differences were small and not statistically significant, eRAPID had a 55%-58% probability of being more cost-effective than usual care. Patient out-of-pocket costs were lower in the eRAPID group, indicating eRAPID may help patients access support needed within the National Health Service. Exploratory 12-months analysis showed small differences in costs and QALYs, with higher QALY gains in the eRAPID group but also higher costs. Exploratory subgroup analysis by disease status indicated that the eRAPID intervention was cost-effective for patients with early-stage cancers but not for patients with metastatic disease. CONCLUSION: Despite small differences in QALYs and costs, the analyses show potential cost-effectiveness of online symptom monitoring, when added to usual care, particularly during adjuvant systemic treatment for early-stage cancers.

Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation.

BACKGROUND: UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS. METHODS: Men with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a 'safety to exercise' check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences. DISCUSSION: The STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services. TRIAL REGISTRATION: ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.