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Background Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes. Objective To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback. Design Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control. Setting UK primary care (141 group general practices in England and Wales). Inclusion criteria Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations. Exclusions Current depression treatment, dementia, psychosis, substance misuse and risk of suicide. Intervention Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10–35 days later, compared with usual care. Primary outcome Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks. Secondary outcomes Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events. Sample size The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure. Randomisation Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location. Blinding Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation. Analysis Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks. Qualitative interviews Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework. Results Three hundred and two patients were recruited in intervention arm practices and 227 patients were recruited in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%), respectively. No significant difference in Beck Depression Inventory, 2nd edition, score was found at 12 weeks (adjusted mean difference –0.46, 95% confidence interval –2.16 to 1.26). Nor were significant differences found in Beck Depression Inventory, 2nd Edition, score at 26 weeks, social functioning, patient satisfaction or adverse events. EuroQol-5 Dimensions, five-level version, quality-of-life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053, 95% confidence interval 0.013 to 0.093). However, quality-adjusted life-years over 26 weeks were not significantly greater (difference 0.0013, 95% confidence interval –0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (–£163, 95% confidence interval –£349 to £28). Cost-effectiveness and cost–utility analyses, therefore, suggested that the intervention was dominant over usual care, but with considerable uncertainty around the point estimates. Patients valued using the Patient Health Questionnaire-9 to compare scores at baseline and follow-up, whereas practitioner views were more mixed, with some considering it too time-consuming. Conclusions We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients’ quality of life was better at 26 weeks, perhaps because feedback of Patient Health Questionnaire-9 scores increased their awareness of improvement in their depression and reduced their anxiety. Further research in primary care should evaluate patient-reported outcome measures including anxiety symptoms, administered remotely, with algorithms delivering clear recommendations for changes in treatment. Study registration This study is registered as IRAS250225 and ISRCTN17299295. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information. Plain language summary Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too. In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a ‘randomised controlled trial’ in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or ‘PHQ-9’, patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them. We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower. Using the Patient Health Questionnaire-9 can improve patients’ quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression. Scientific summary Some text in this chapter has been adapted from the study protocol published as: Kendrick T, Moore M, Leydon G, et al. Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial. Trials 2020;21:441. https://doi.org/10.1186/s13063-020-04344-9. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article unless otherwise stated. Background Depression is common and costly. It can lead to chronic disability, poor quality of life, suicide, and high service use and costs. National Institute for Health and Care Excellence guidelines recommend different treatments for more severe and less severe depression, but general practitioners, who treat more the majority of people with depression in primary care, are often inaccurate in their global clinical assessments of depression severity, and treatment is not targeted to patients most likely to benefit. The National Institute for Health and Care Excellence recommends that practitioners consider using validated patient-reported outcome measures to inform treatment at diagnosis and follow-up of people with depression, but there is insufficient evidence that these measures improve depression management and outcomes for patients in primary care. Aim and objectives The aim of the study was to answer the research question: What is the effectiveness and cost-effectiveness of assessing primary care patients with depression or low mood soon after diagnosis and again at follow-up 10–35 days later, using the Patient Health Questionnaire-9 combined with patient feedback and practitioner guidance on treatment? The objectives were to (1) carry out a cluster-randomised controlled trial to compare the intervention with usual care; (2) provide intervention arm patients with written feedback on their Patient Health Questionnaire-9 scores, indicating evidence-based treatments relevant to the level of severity of depression to discuss with practitioners; (3) train practitioners to interpret Patient Health Questionnaire-9 scores and their implications for choice of treatment, taking into account contextual factors; (4) follow up participants for 26 weeks, with research assessments at 12 and 26 weeks; (5) determine the primary outcome of depressive symptoms on the Beck Depression Inventory, 2nd edition, at 12-week follow-up; (6) examine secondary outcomes, including depressive symptoms on the Beck Depression Inventory, 2nd edition, at 26 weeks, and social functioning and quality of life at both 12- and 26-week follow-ups; (7) measure patient satisfaction, adverse events, antidepressant treatment, secondary care contacts, service use, and costs over 26 weeks’ follow-up, and perform cost-effectiveness and cost–utility analyses; and (8) carry out a qualitative process analysis to explore participants’ reflections on the use of the Patient Health Questionnaire-9 and the potential for implementing it in practice. Methods The study design was a parallel-group, cluster-randomised superiority trial with 1 : 1 allocation to intervention and control arms. The setting was UK primary care (141 group general practices in England and Wales). Inclusion criteria were age ≥ 18 years with a new episode of depressive disorder or symptoms. Patients were recruited mainly through regular medical records searches but also opportunistically at consultations for new episodes of depression. Exclusion criteria were current treatment for depression; dementia; psychosis; substance misuse; or a significant risk of suicide. The intervention was administration of the Patient Health Questionnaire-9 questionnaire as a PROM soon after diagnosis and at follow-up 10–35 days later. Patients were given written feedback on their Patient Health Questionnaire-9 scores and potential treatments to discuss with their general practitioners. Practitioners were trained in interpreting Patient Health Questionnaire-9 scores and taking them into account in treatment decisions. The primary outcome was depressive symptoms on the Beck Depression Inventory, 2nd edition, at 12 weeks. Secondary outcomes were Beck Depression Inventory, 2nd edition, scores at 26 weeks; social functioning (on the Work and Social Adjustment Scale) and quality of life (on the EuroQol-5 Dimensions, five-level) at 12 and 26 weeks; service use including antidepressant treatment and primary and secondary care contacts over 26 weeks to calculate NHS costs; and patient satisfaction at 26 weeks (on the Medical Informant Satisfaction Scale). For our sample size calculation, we assumed a baseline mean Beck Depression Inventory, 2nd edition, score of 24.0 with a standard deviation of 10.0 (derived from a feasibility study), and mean scores at 12-week follow-up of 14.0 in the intervention arm and 17.0 in the control arm. The anticipated difference of 3.0 points (effect size of 0.3) represented the minimum clinically important difference on the Beck Depression Inventory, 2nd edition. At the 5% level of significance, to have 90% power to detect that difference we calculated we needed 235 patients analysed per arm. We aimed to recruit a mean of six patients per practice and assumed an intracluster correlation coefficient of 0.03 (from the feasibility study), which gave a cluster design effect of 1.15, meaning we needed 270 per arm. We assumed a 20% loss to follow-up at 12 weeks, so the total sample size needed was 270 × 2/0.8 and our original target sample size was a total of 676 patients recruited, from 113 practices, by three recruitment centres (the University of Southampton, the University of Liverpool and University College London). We subsequently revised the target sample size on finding a significant correlation coefficient of > 0.5 between baseline and follow-up values for the primary outcome, which meant that we needed only 222 patients analysed per arm and, therefore, a target sample size of 554 patients recruited (revised 10 June 2021). Cluster randomisation of practices to intervention and control arms was carried out remotely by a Clinical Trials Unit statistician using computerised sequence generation, with minimisation by recruiting centre, size of practice and urban or rural location. Blinding of participating practitioners and patients to allocation was impossible given the nature of the intervention and the cluster-randomised design, but self-report outcome measures were used to prevent researcher rating bias, and statistical analysis was blind to allocation. Differences between intervention and control arms in the outcomes of depressive symptoms, social functioning and quality of life measured at 12- and 26-week follow-up were analysed using linear mixed models, adjusting for baseline depression; duration of depression; history of depression; baseline anxiety; sociodemographic factors (gender, age, socioeconomic position, housing, education, marital status and dependants), and clustering including a random effect for practice. Patient satisfaction, quality of life (quality-adjusted life-years) and costs were compared between the arms over the 26 weeks’ study follow-up period. Differences between the arms in the process of care for depression were also analysed, including patients’ self-reported use of antidepressants at the 12- and 26-week follow-up points, and medication and contacts with mental health services (community mental health nurses, counsellors, psychologists, psychiatrists, other therapists and social workers) recorded in practice medical records over the 26 weeks’ follow-up. A health economic evaluation was undertaken from an NHS and Personal Social Services perspective. The outcomes were expressed as incremental cost per point improvement in the Beck Depression Inventory, 2nd edition, clinical outcome (cost-effectiveness analysis), and incremental cost per quality-adjusted life-year gained (cost–utility analysis). The primary analysis at 26 weeks used a generalised linear mixed model to estimate the differences in costs and quality-adjusted life-years (using the EuroQol-5 Dimensions, five-level to calculate patient utilities), adjusted for baseline quality of life; baseline anxiety; sociodemographic factors; and practice as a random effect. Incremental cost-effectiveness ratios and a cost-effectiveness acceptability curve were generated using non-parametric bootstrapping. Qualitative interviews with participating practitioners and patients in both arms were conducted to reflect on their involvement in the trial and analysed using reflexive thematic analysis. Intervention arm participants were asked about barriers, facilitators, benefits and problems related to using the Patient Health Questionnaire-9, including questions derived from the normalisation process theory framework. Results Practices and patients As the number of patients recruited per practice was smaller than anticipated, we recruited significantly more than our target of 113 practices, eventually reaching a total of 189, but 48 practices subsequently withdrew (24 in each arm), so the final number of active practices was 141: 72 intervention and 69 control (28 above our original target). Practice characteristics were well balanced by arm. Of 11,468 patients approached in consultations or through mailed invitations, 1058 (9.2%) returned reply slips about the study: 574 (10.6% of those approached) in the intervention arm and 484 (8.0% of those approached) in the control arm. After the exclusion of patients declining to participate, ineligible at screening or uncontactable, 529 patients were assessed at baseline: 302 (5.5% of those approached) in the intervention arm and 227 (3.8% of those approached) in the control arm. The ratio of intervention to control arm patients recruited was, therefore, 1.3 to 1, which may have reflected lower motivation to take part among control arm practices. Of 529 patients recruited, 453 (85.6%) were followed up at 12 weeks: 254 intervention arm (84.1%) and 199 control arm (87.7%) patients. At the 26-week point, 414 patients (78.3%) were followed up: 230 intervention arm (76.2%) and 184 control arm (81.1%). Medical records data were collected for 259 intervention arm patients (85.8%) and 201 control arm patients (88.5%). The mean BDI-II score for depressive symptoms at baseline was higher in the intervention arm, at 24.1 (standard deviation 8.89) than in the control arm, at 22.4 (standard deviation 9.52). Baseline anxiety and quality-of-life scores were also worse in the intervention arm. Control arm patients were more likely to have had two or more previous depressive episodes. Demographic characteristics were relatively well balanced. Clinical outcomes At the 12-week follow-up, the mean Beck Depression Inventory, 2nd edition, score was 18.5 (standard deviation 10.2) in the intervention arm and 16.9 (standard deviation 10.3) in the control arm. The adjusted mean score was slightly lower in the intervention arm, but this was not statistically significant (mean adjusted difference –0.46, 95% confidence interval –2.16 to 1.26; p = 0.60). At 26 weeks, the mean Beck Depression Inventory, 2nd edition, scores were 15.1 (standard deviation 10.8) in the intervention arm and 14.7 (standard deviation 10.6) in the control arm (mean adjusted difference –1.63, 95% confidence interval –3.48 to 0.21; p = 0.08). Social functioning on the Work and Social Adjustment Scale and Medical Informant Satisfaction Scale satisfaction with care scores favoured the intervention, but the differences found were not statistically significant. A post hoc analysis at 26 weeks showed similar proportions improving by ≥ 50% on the Beck Depression Inventory, 2nd edition, in the intervention and control arms (45.1% vs. 37.3%), but the proportion remitting to a score of

Introduction Coronavirus disease (Covid-19) has led to a global pandemic since its emergence in December 2019. The majority of research into Covid-19 has focused on transmission, and mortality and morbidity associated with the virus. However, less attention has been given to its impact on health-related quality of life (HRQoL) of patients with Covid-19. Methods We searched for original studies published between December 2019 and Jan 2021 in PubMed, Scopus and Medline databases using a specific search strategy. We also explored literature on websites of distinguished public health organisations and hand-searched reference lists of eligible studies. The studies were screened by two reviewers according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) flowchart using pre-determined eligibility criteria. Data were synthesised, analysed descriptively and reported in line with PRISMA guidelines. Results In total, 1276 studies were identified through the search strategy. Of these, 77 studies were selected for full-text reading after screening the studies. After reading full-text, 12 eligible studies were included in this review. The majority of the studies used a generic HRQoL assessment tool; five studies used SF-36, five studies used EQ-5D-5L, and three used pulmonary disease-specific HRQoL tools (two studies used two tools each). The impact of Covid-19 on HRQoL was found to be considerable in both Acute Covid and Long Covid patients. Higher impact on HRQoL was reported in Acute Covid, females, older ages, patients with more severe disease and patients from low-income countries. Conclusion The impact of Covid-19 on HRQoL of Acute and Long Covid patients is substantial. There was disproportional impact on patients by gender, age, severity of illness and study country. The long-term impact of Covid-19 is still in its initial stage. The findings of the review may be useful to researchers, policymakers, and clinicians caring for people following Covid-19 infection.

Introduction Falls are a major health problem for older people; 35% of people aged 65+ years fall every year, leading to fractures in 10%–15%. Upper limb fractures are often the first sign of osteoporosis and routine screening for osteoporosis is recommended by the National Institute for Health and Care Excellence to prevent subsequent hip fractures. However, both frailty and sarcopenia (muscle weakness) are associated with increased risk of falling and fracture but are not routinely identified in this group. The aim of this study is to evaluate the feasibility of assessing and managing frailty and sarcopenia among people aged 65+ years with an upper limb fracture.Methods and analysis This study will be conducted in three fracture clinics in one acute trust in England. 100 people aged 65+ years with an upper arm fracture will be recruited and assessed using six validated frailty measures and two sarcopenia tools. The prevalence of the two conditions and the best tools to use will be determined. Those with either condition will be referred to geriatric clinical teams for comprehensive geriatric assessment (CGA). We will document the proportion who are referred for CGA and those who receive CGA. Other outcome measures including falls, fractures and healthcare resource use over 6 months will be collected. In-depth interviews with a purposive sample of patients who undergo the frailty and sarcopenia assessments and healthcare professionals in fracture clinics and geriatric services will be carried out to their acceptability of assessing frailty and sarcopenia in a busy environment.Ethics and dissemination The study was given the relevant ethical approvals from NHS Research Ethics Committee (REC No: 18/NE/0377), the University Hospital Southampton NHS Foundation Trust, and the University of Southampton, Faculty of Medicine Ethics Committee and Research Governance Office. Findings will be published in scientific journals and presented to local, national and international conferences.Trial registration number ISRCTN13848445

Background: Conservative kidney management (CKM) is recognised as an alternative to dialysis for a significant number of older adults with multimorbid stage 5 chronic kidney disease (CKD5). However, little is known about the way CKM is delivered or how it is perceived. Aim: To determine the practice patterns for the CKM of older patients with CKD5, to inform service development and future research. Objectives: (1) To describe the differences between renal units in the extent and nature of CKM, (2) to explore how decisions are made about treatment options for older patients with CKD5, (3) to explore clinicians’ willingness to randomise patients with CKD5 to CKM versus dialysis, (4) to describe the interface between renal units and primary care in managing CKD5 and (5) to identify the resources involved and potential costs of CKM. Methods: Mixed-methods study. Interviews with 42 patients aged > 75 years with CKD5 and 60 renal unit staff in a purposive sample of nine UK renal units. Interviews informed the design of a survey to assess CKM practice, sent to all 71 UK units. Nineteen general practitioners (GPs) were interviewed concerning the referral of CKD patients to secondary care. We sought laboratory data on new CKD5 patients aged > 75 years to link with the nine renal units’ records to assess referral patterns. Results: Sixty-seven of 71 renal units completed the survey. Although terminology varied, there was general acceptance of the role of CKM. Only 52% of units were able to quantify the number of CKM patients. A wide range reflected varied interpretation of the designation ‘CKM’ by both staff and patients. It is used to characterise a future treatment option as well as non-dialysis care for end-stage kidney failure (i.e. a disease state equivalent to being on dialysis). The number of patients in the latter group on CKM was relatively small (median 8, interquartile range 4.5–22). Patients’ expectations of CKM and dialysis were strongly influenced by renal staff. In a minority of units, CKM was not discussed. When discussed, often only limited information about illness progression was provided. Staff wanted more research into the relative benefits of CKM versus dialysis. There was almost universal support for an observational methodology and a quarter would definitely be willing to participate in a randomised clinical trial, indicating that clinicians placed value on high-quality evidence to inform decision-making. Linked data indicated that most CKD5 patients were known to renal units. GPs expressed a need for guidance on when to refer older multimorbid patients with CKD5 to nephrology care. There was large variation in the scale and model of CKM delivery. In most, the CKM service was integrated within the service for all non-renal replacement therapy CKD5 patients. A few units provided dedicated CKM clinics and some had dedicated, modest funding for CKM. Conclusions: Conservative kidney management is accepted across UK renal units but there is much variation in the way it is described and delivered. For best practice, and for CKM to be developed and systematised across all renal units in the UK, we recommend (1) a standard definition and terminology for CKM, (2) research to measure the relative benefits of CKM and dialysis and (3) development of evidence-based staff training and patient education interventions. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Guidelines indicate eligibility for lipid lowering drugs, but it is not known to what extent GPs' follow guidelines in routine clinical practice or whether additional clinical factors systematically influence their prescribing decisions.A retrospective cohort analysis was undertaken using electronic primary care records from 421 UK general practices. At baseline (May 2008) patients were aged 30 to 74 years, free from cardiovascular disease and not taking lipid lowering drugs. The outcome was prescription of a lipid lowering drug within the next two years. The proportions of eligible and ineligible patients prescribed lipid lowering drugs were reported and multivariable logistic regression models were used to investigate associations between age, sex, cardiovascular risk factors and prescribing.Of 365,718 patients with complete data, 13.8% (50,558) were prescribed lipid lowering drugs: 28.5% (21,101/74,137) of those eligible and 10.1% (29,457/291,581) of those ineligible. Only 41.7% (21,101/50,558) of those prescribed lipid lowering drugs were eligible. In multivariable analysis prescribing was most strongly associated with increasing age (OR for age ≥ 65 years 4.21; 95% CI 4.05-4.39); diabetes (OR 4.49; 95% CI 4.35-4.64); total cholesterol level ≥ 7 mmol/L (OR 2.20; 95% CI 2.12-2.29); and ≥ 4 blood pressure measurements in the past year (OR 4.24; 95% CI 4.06-4.42). The predictors were similar in eligible and ineligible patients.Most lipid lowering drugs for primary prevention are prescribed to ineligible patients. There is underuse of lipid lowering drugs in eligible patients.

To establish the relative weighting given by patients and healthcare professionals to gains in diagnostic sensitivity versus loss of specificity when using CT colonography (CTC) for colorectal cancer screening.Following ethical approval and informed consent, 75 patients and 50 healthcare professionals undertook a discrete choice experiment in which they chose between "standard" CTC and "enhanced" CTC that raised diagnostic sensitivity 10% for either cancer or polyps in exchange for varying levels of specificity. We established the relative increase in false-positive diagnoses participants traded for an increase in true-positive diagnoses.Data from 122 participants were analysed. There were 30 (25%) non-traders for the cancer scenario and 20 (16%) for the polyp scenario. For cancer, the 10% gain in sensitivity was traded up to a median 45% (IQR 25 to >85) drop in specificity, equating to 2250 (IQR 1250 to >4250) additional false-positives per additional true-positive cancer, at 0.2% prevalence. For polyps, the figure was 15% (IQR 7.5 to 55), equating to 6 (IQR 3 to 22) additional false-positives per additional true-positive polyp, at 25% prevalence. Tipping points were significantly higher for patients than professionals for both cancer (85 vs 25, p

Introduction: Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. Methods and analysis: The HOME BP trial will be a randomised controlled trial comparing BP selfmanagement-- consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration--with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. Ethics and dissemination: This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. [ABSTRACT FROM AUTHOR]

Objectives: CT colonography (CTC) may be an acceptable test for colorectal cancer screening but bowel preparation can be a barrier to uptake. This study tested the hypothesis that prospective screening invitees would prefer full-laxative preparation with higher sensitivity and specificity for polyps, despite greater burden, over less burdensome reduced-laxative or non-laxative alternatives with lower sensitivity and specificity. Design: Discrete choice experiment. Setting: Online, web-based survey. Participants: 2819 adults (45-54 years) from the UK responded to an online invitation to take part in a cancer screening study. Quota sampling ensured that the sample reflected key demographics of the target population and had no relevant bowel disease or medical qualifications. The analysis comprised 607 participants. Interventions: After receiving information about screening and CTC, participants completed 3-4 choice scenarios. Scenarios showed two hypothetical forms of CTC with different permutations of three attributes: preparation, sensitivity and specificity for polyps. Primary outcome measures: Participants considered the trade-offs in each scenario and stated their preferred test (or chose neither). Results: Preparation and sensitivity for polyps were both significant predictors of preferences (coefficients: -3.834 to -6.346 for preparation, 0.207-0.257 for sensitivity; p<0.0005). These attributes predicted preferences to a similar extent. Realistic specificity values were non-significant (-0.002 to 0.025; p=0.953). Contrary to our hypothesis, probabilities of selecting tests were similar for realistic forms of full-laxative, reduced-laxative and non-laxative preparations (0.362-0.421). However, they were substantially higher for hypothetical improved forms of reduced-laxative or non-laxative preparations with better sensitivity for polyps (0.584-0.837). Conclusions: Uptake of CTC following non-laxative or reduced-laxative preparations is unlikely to be greater than following full-laxative preparation as perceived gains from reduced burden may be diminished by reduced sensitivity. However, both attributes are important so a more sensitive form of reduced-laxative or non-laxative preparation might improve uptake substantially. [ABSTRACT FROM AUTHOR]

Background: We developed a method to estimate the expected cost-effectiveness of a service intervention at the design stage and 'road-tested' the method on an intervention to improve patient handover of care between hospital and community. Method: The development of a nine-step evaluation framework: 1. Identification of multiple endpoints and arranging them into manageable groups; 2. Estimation of baseline overall and preventable risk; 3. Bayesian elicitation of expected effectiveness of the planned intervention; 4. Assigning utilities to groups of endpoints; 5. Costing the intervention; 6. Estimating health service costs associated with preventable adverse events; 7. Calculating health benefits; 8. Cost-effectiveness calculation; 9. Sensitivity and headroom analysis. Results: Literature review suggested that adverse events follow 19% of patient discharges, and that one-third are preventable by improved handover (ie, 6.3% of all discharges). The intervention to improve handover would reduce the incidence of adverse events by 21% (ie, from 6.3% to 4.7%) according to the elicitation exercise. Potentially preventable adverse events were classified by severity and duration. Utilities were assigned to each category of adverse event. The costs associated with each category of event were obtained from the literature. The unit cost of the intervention was €16.6, which would yield a Quality Adjusted Life Year (QALY) gain per discharge of 0.010. The resulting cost saving was €14.3 per discharge. The intervention is costeffective at approximately €214 per QALY under the base case, and remains cost-effective while the effectiveness is greater than 1.6%. Conclusions: We offer a usable framework to assist in ex ante health economic evaluations of health service interventions. [ABSTRACT FROM AUTHOR]