Capturing the impacts of end of life care on those close to the dying for use in economic evaluation

This thesis reports work to develop and score (value) a measure to capture the impact of end of life care (EoLC) on those people close to the dying. This work is conducted in response to the need to capture wider impacts of EoLC for economic evaluation where there is lack of appropriate measures. To develop the measure, twenty seven in-depth interviews were conducted with those who were recently bereaved or close to somebody receiving EoLC. Constant-comparative analysis was used to develop dimensions for the measure. Pictorial tools were used to explore who is close to those at the end-of-life and therefore could legitimately be included within the evaluation of EoLC interventions. The measure was valued using an exploratory deliberative methodology conducted with six focus groups comprising members of the public. The measure contains six dimensions: $communication$ $with$ $those$ $providing$ $care$ $services$, $practical$ $support$, $privacy$ $and$ $space$, $emotional$ $support$, $preparing$ $and$ $coping$ and $emotional$ $distress$. The communication and practical support attributes received the greatest weighting in the valuation process. On average, there were eight individuals close to those at EoL. This work significantly enhances the potential for including close-persons in economic evaluation of interventions at the end of life

“I’m just a long history of people rejecting referrals” experiences of young people who fell through the gap between child and adult mental health services

The paediatric-adult split in mental health care necessitates young people to make a transition between services when they reach the upper end of child and adolescent mental health services (CAMHS). However, we know that this transition is often poor, and not all young people who require ongoing support are able to continue care in adult mental health services (AMHS). These young people are said to have fallen through the gap between services. This research aimed to explore the reasons why young people fall through the gap between CAMHS and AMHS, and what effect his has had on them and their families. Narrative interviews were conducted with 15 young people and 15 parents, representing 19 unique transition stories. Themes were identified collaboatively using thematic analysis. Reasons for falling through the gap were grouped into systemic problems and problems with the quality of care received. Effects of alling through the gap were grouped into separate themes for young people (feeling abandoned; struggling to manage without continued care; problems with medication) and parents (emotional impact of care ending; parents taking an active role in the young person’s care). To our knowledge, this is the firt qualitative study that has focused only on the experiences of young people who have fallen through the gap between services. This research adds novel findings o existing literature regarding barriers to transition and the effectsof discontinuity of care

“It is not a scientific number it is just a feeling”:Populating a multi-dimensional end-of-life decision framework using deliberative methods

The capability approach is potentially valuable for economic evaluation at the end of life because of its conceptualisation of wellbeing as freedom and the potential for capturing outcomes for those at end of life and those close to persons at the end of life. For decision making, however, this information needs to be integrated into current evaluation paradigms. This research explored weights for an integrated economic evaluation framework using a deliberative approach. Twelve focus groups were held (38 members of the public, 29 ‘policy makers’, 7 hospice volunteers); budget pie tasks were completed to generate weights. Constant comparison was used to analyse qualitative data, exploring principles behind individuals’ weightings. Average weights elicited from members of the general population and policy makers for the importance that should be given to close persons (versus patients) were very similar, at around 30%. A ‘sliding scale’ of weights between health gain and the capability for a good death resulted from the policy maker and volunteer groups, with increasing weight given to the capability for a good death as the trajectory got closer to death. These weights can be used in developing a more comprehensive framework for economic evaluation at end of life

How does age affect the relationship between weight and health utility during the middle years of childhood?

Purpose: The limited literature examining weight status and preference-based health-related quality of life (HRQL) in young children is equivocal. This study aims to examine how the association between weight status and preference-based HRQL changes as children develop between the ages of 6 and 10 years old. Methods: The Child Health Utility 9D (CHU-9D) was used to determine preference-based HRQL. Height and weight data were also collected and used to calculate z-BMI adjusted for age and gender. 1467 children were recruited from 54 schools across the West Midlands. Data were collected at four time points over 5 years. Impact of weight on dimensions of HRQL was assessed via the distribution of responses to CHU-9D dimensions by weight status. Multi-level regression analysis controlling for ethnicity, deprivation and other relevant co-variates was conducted to examine the relationship between weight and HRQL. Results: There was no evidence to suggest that the weight status impacted upon the distribution of responses to CHU-9D dimensions. Correspondingly, the multi-level regression analysis found no statistically significant differences in CHU-9D scores between underweight, healthy weight, overweight and obese children. Conclusions: The evidence surrounding the link between preference-based HRQL and weight status in children is limited. This study found no association between weight status and HRQL as measured by the CHU-9D in children between the ages of 5 and 10 years in the UK. Given this, it is recommended that future studies aiming to prevent obesity in children in their middle years do not rely solely on preference-based measures for economic evaluation, and instead focus on capturing clinical or wellbeing outcomes

Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? : Results from a multicentre trial in Israel

Objective To assess the cost-effectiveness of an enhanced transtheoretical model of behaviour change in conjunction with physiotherapy compared with standard care (physiotherapy) in patients with chronic lower back pain (CLBP). Design Cost-utility and cost-effectiveness analyses alongside a multicentre controlled trial from a healthcare perspective with a 1-year time horizon. Setting The trial was conducted in eight centres within the Sharon district in Israel. Participants 220 participants aged between 25 and 55 years who suffered from CLBP for a minimum of 3 months were recruited. Interventions The intervention used a model of behaviour change that sought to increase the adherence and implementation of physical activity in conjunction with physiotherapy. The control arm received standard care in the form of physiotherapy. Primary and secondary measures The primary outcome was the incremental cost per quality-adjusted life year (QALY) of the intervention arm compared with standard care. The secondary outcome was the incremental cost per Roland-Morris Disability Questionnaire point. Results The cost per QALY point estimate was 10 645 New Israeli shekels (NIS) (£1737.11). There was an 88% chance the intervention was cost-effective at NIS50 000 per QALY threshold. Excluding training costs, the intervention dominated the control arm, resulting in fewer physiotherapy and physician visits while improving outcomes. Conclusions The enhanced transtheoretical model intervention appears to be a very cost-effective intervention leading to improved outcomes for low cost. Given limitations within this study, there is justification for examining the intervention within a larger, long-term randomised controlled trial

Realist evaluation of the use of patient experience data to improve the quality of inpatient mental health care (EURIPIDES) in England : study protocol

Introduction Inpatient mental healthcare continues to be an area of high risk and where patients report negative experiences. To ensure the patient voice is heard, National Health Service (NHS) Trusts are required to collect feedback from patients routinely. We do not know what kinds of feedback are most important or what management processes are needed to translate this into effective action plans. Further, we do not know if this makes any difference to the patients themselves. This study seeks to explore which of the many different approaches to collecting and using patient experience data are the most useful for supporting improvements in inpatient mental healthcare. The overarching aim of the study is to arrive at recommendations for best practice in the collection and use of patient experience data in NHS England adult inpatient mental health settings. We present the protocol for Realist Evaluation of the Use of Patient Experience Data to Improve the Quality of Inpatient Mental Health Care study (EURIPIDES). Methods and analysis The study is composed of five work packages (WPs), including a systematic review of patient experiences (WP1); a telephone survey to assist the selection of case sites (WP2); six in depth case studies involving interviews with service users, carers and staff to enable a realist evaluation of the use of patient experience to improve quality in adult inpatient mental health services (WP3); an economic evaluation of patient experience feedback activity (WP5); and a consensus conference (WP4). We discuss the methodological rationale for the five WPs. Ethics and dissemination This study has received approval from West Midlands/South Birmingham NHS Research Ethics Committee. The outcome of the consensus conference meeting (WP4) will form the basis of the outputs to be disseminated to NHS providers. Dissemination will also take place through publications and presentations at relevant conferences

Using patient experience data to support improvements in inpatient mental health care: the EURIPIDES multimethod study

Background All NHS providers collect data on patient experience, although there is limited evidence about what to measure or how to collect and use data to improve services. We studied inpatient mental health services, as these are important, costly and often unpopular services within which serious incidents occur. Aims To identify which approaches to collecting and using patient experience data are most useful for supporting improvements in inpatient mental health care. Design The study comprised five work packages: a systematic review to identify evidence-based patient experience themes relevant to inpatient mental health care (work package 1); a survey of patient experience leads in NHS mental health trusts in England to describe current approaches to collecting and using patient experience data in inpatient mental health services, and to populate the sampling frame for work package 3 (work package 2); in-depth case studies at sites selected using the work package 2 findings, analysed using a realist approach (work package 3); a consensus conference to agree on recommendations about best practice (work package 4); and health economic modelling to estimate resource requirements and potential benefits arising from the adoption of best practice (work package 5). Using a realist methodology, we analysed and presented our findings using a framework based on four stages of the patient experience data pathway, for which we coined the term CRAICh (collecting and giving, receiving and listening, analysing, and quality improvement and change). The project was supported by a patient and public involvement team that contributed to work package 1 and the development of programme theories (work package 3). Two employed survivor researchers worked on work packages 2, 3 and 4. Setting The study was conducted in 57 NHS providers of inpatient mental health care in England. Participants In work package 2, 47 NHS patient experience leads took part and, in work package 3, 62 service users, 19 carers and 101 NHS staff participated, across six trusts. Forty-four individuals attended the work package 4 consensus conference. Results The patient experience feedback cycle was rarely completed and, even when improvements were implemented, these tended to be environmental rather than cultural. There were few examples of triangulation with patient safety or outcomes data. We identified 18 rules for best practice in collecting and using inpatient mental health experience data, and 154 realist context–mechanism–outcome configurations that underpin and explain these. Limitations The study was cross-sectional in design and we relied on examples of historical service improvement. Our health economic models (in work package 5) were therefore limited in the estimation and modelling of prospective benefits associated with the collection and use of patient experience data. Conclusions Patient experience work is insufficiently embedded in most mental health trusts. More attention to analysis and interpretation of patient experience data is needed, particularly to ways of triangulating these with outcomes and safety data. Future work Further evaluative research is needed to develop and evaluate a locally adapted intervention based on the 18 rules for best practice. Study registration The systematic review (work package 1) is registered as PROSPERO CRD42016033556

Supervised pulmonary hypertension exercise rehabilitation (SPHERe):Study protocol for a multi-centre randomised controlled trial

Background Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting. Methods This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1–5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions. Discussion The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH

Exercise to prevent shoulder problems after breast cancer surgery : the PROSPER RCT

Background: Upper limb problems are common after breast cancer treatment. Objectives: To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. Design: This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). Setting: Breast cancer centres, secondary care. Participants: Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. Interventions: All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). Main outcome measures: The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound- related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. Results: Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants’ mean age was 58.1 years (standard deviation 12.1 years; range 28–88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of –7.81, 95% confidence interval –12.44 to –3.17; p = 0.001) and complier-average causal effect analyses (adjusted mean difference –8.74, 95% confidence interval –13.71 to –3.77; p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04; p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (–£387, 95% CI –£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. Limitations: Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. Conclusions: This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. Future work: Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. Trial registration: This trial is registered as ISRCTN35358984. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 15. See the NIHR Journals Library website for further project information