A service-user digital intervention to collect real-time safety information on acute, adult mental health wards: the WardSonar mixed-methods study.

Background: Acute inpatient mental health services report high levels of safety incidents. The application of patient safety theory has been sparse, particularly concerning interventions that proactively seek patient perspectives. Objective(s): Develop and evaluate a theoretically based, digital monitoring tool to collect real-time information from patients on acute adult mental health wards about their perceptions of ward safety. Design: Theory-informed mixed-methods study. A prototype digital monitoring tool was developed from a co-design approach, implemented in hospital settings, and subjected to qualitative and quantitative evaluation. Setting and methods: Phase 1: scoping review of the literature on patient involvement in safety interventions in acute mental health care; evidence scan of digital technology in mental health contexts; qualitative interviews with mental health patients and staff about perspectives on ward safety. This, alongside stakeholder engagement with advisory groups, service users and health professionals, informed the development processes. Most data collection was virtual. Phase 1 resulted in the technical development of a theoretically based digital monitoring tool that collected patient feedback for proactive safety monitoring. Phase 2: implementation of the tool in six adult acute mental health wards across two UK NHS trusts; evaluation via focused ethnography and qualitative interviews. Statistical analysis of WardSonar data and routine ward data involving construction of an hour-by-hour data set per ward, permitting detailed analysis of the use of the WardSonar tool. Participants: A total of 8 patients and 13 mental health professionals participated in Phase 1 interviews; 33 staff and 34 patients participated in Phase 2 interviews. Interventions: Patients could use a web application (the WardSonar tool) to record real-time perceptions of ward safety. Staff could access aggregated, anonymous data to inform timely interventions. Results: Coronavirus disease 2019 restrictions greatly impacted the study. Stakeholder engagement permeated the project. Phase 1 delivered a theory-based, collaboratively designed digital tool for proactive patient safety monitoring. Phase 2 showed that the tool was user friendly and broadly acceptable to patients and staff. The aggregated safety data were infrequently used by staff. Feasibility depended on engaged staff and embedding use of the tool in ward routines. There is strong evidence that an incident leads to increased probability of further incidents within the next 4 hours. This puts a measure on the extent to which social/behavioural contagion persists. There is weak evidence to suggest that an incident leads to a greater use of the WardSonar tool in the following hour, but none to suggest that ward atmosphere predicts future incidents. Therefore, how often patients use the tool seems to send a stronger signal about potential incidents than patients' real-time reports about ward atmosphere. Limitations: Implementation was limited to two NHS trusts. Coronavirus disease 2019 impacted design processes including stakeholder engagement; implementation; and evaluation of the monitoring tool in routine clinical practice. Higher uptake could enhance validity of the results. Conclusions: WardSonar has the potential to provide a valuable route for patients to communicate safety concerns. The WardSonar monitoring tool has a strong patient perspective and uses proactive real-time safety monitoring rather than traditional retrospective data review. Future work: The WardSonar tool can be refined and tested further in a post Coronavirus disease 2019 context. Study registration: This study is registered as ISRCTN14470430. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128070) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 14. See the NIHR Funding and Awards website for further award information.

Mental health wards can feel unsafe. We know that patients and staff have different ideas about what makes a hospital ward safe or unsafe. Patients are often the first to know when the atmosphere on a ward becomes tense but, often, no one asks them for input or feedback at the time. We worked with service users and staff to develop new technology to make it easy for patients to tell staff about changes in the ward atmosphere. We put everyone's ideas together and some technical developers then built a digital safety tool to use on a tablet computer. Patients put in anonymous information about the ward atmosphere and staff can read it straight away. We tested it on six adult acute mental health wards for 10 weeks. We asked patients and staff what they thought about the tool and we looked at how it was being used. Patients and staff liked the look of the tool on the tablet computer. Some staff said they did not need it because they could tell how patients were feeling, but patients told us that staff did not talk with them much and did not always know when patients were feeling tense. Coronavirus disease 2019 made life difficult on the wards. Most ward managers said the tool could be helpful, but they had not had time to get used to it on the wards. Occasionally, the tablet computers were out of action. Many staff tried hard to use the tool. Most patient information was gathered when it was calm, perhaps because staff were not too busy to help them. We found that this tool could help staff know about tensions on the ward, but they need to get used to it and bring it into ward routines.

Long-term cost-utility analysis of family therapy vs. treatment as usual for young people seen after self-harm.

BACKGROUND: The joint evidence of the cost and the effectiveness of family-based therapies is modest. OBJECTIVE: To study the cost-effectiveness of family therapy (FT) versus treatment-as-usual (TAU) for young people seen after self-harm combining data from an 18-month trial and hospital records up to 60-month from randomisation. METHODS: We estimate the cost-effectiveness of FT compared to TAU over 5 years using a quasi-Markov state model based on self-harm hospitalisations where probabilities of belonging in a state are directly estimated from hospital data. The primary outcome is quality-adjusted life years (QALY). Cost perspective is NHS and PSS and includes treatment costs, health care use, and hospital attendances whether it is for self-harm or not. Incremental cost-effectiveness ratios are calculated and deterministic and probabilistic sensitivity analyses are conducted. RESULTS: Both trial arms show a significant decrease in hospitalisations over the 60-month follow-up. In the base case scenario, FT participants incur higher costs (mean +£1,693) and negative incremental QALYs (-0.01) than TAU patients. The associated ICER at 5 years is dominated and the incremental health benefit at the £30,000 per QALY threshold is -0.067. Probabilistic Sensitivity Analysis finds the probability that FT is cost-effective is around 3 - 2% up to a maximum willingness to pay of £50,000 per QALY. This suggest that the extension of the data to 60 months show no difference in effectiveness between treatments. CONCLUSION: Whilst extended trial follow-up from routinely collected statistics is useful to improve the modelling of longer-term cost-effectiveness, FT is not cost-effective relative to TAU and dominated in a cost-utility analysis.

Comparison of trueness and repeatability of facial prosthesis design using a 3D morphable model approach, traditional computer-aided design methods, and conventional manual sculpting techniques.

STATEMENT OF PROBLEM: Manually sculpting a wax pattern of a facial prosthesis is a time-, skill-, and resource-intensive process. Computer-aided design (CAD) methods have been proposed as a substitute for manual sculpting, but these techniques can still require high technical or artistic abilities. Three-dimensional morphable models (3DMMs) could semi-automate facial prosthesis CAD. Systematic comparisons of different design approaches are needed. PURPOSE: The purpose of this study was to compare the trueness and repeatability of replacing facial features with 3 methods of facial prosthesis design involving 3DMM, traditional CAD, and conventional manual sculpting techniques. MATERIAL AND METHODS: Fifteen participants without facial defects were scanned with a structured light scanner. The facial meshes were manipulated to generate artificial orbital, nasal, or combined defects. Three methods of facial prosthesis design were compared for the 15 participants and repeated to produce 5 of each design for 2 participants. For the 3DMM approach, the Leeds face model informed the designs in a statistically meaningful way. For the traditional CAD methods, designs were created by using mirroring techniques or from a nose model database. For the conventional manual sculpting techniques, wax patterns were manually created on 3D printed full face baseplates. For analysis, the unedited facial feature was the standard. The unsigned distance was calculated from each of the several thousand vertices on the unedited facial feature to the closest point on the external surface of the prosthesis prototype. The mean absolute error was calculated, and a Friedman test was performed (α=.05). RESULTS: The median mean absolute error was 1.13 mm for the 3DMM group, 1.54 mm for the traditional CAD group, and 1.49 mm for the manual sculpting group, with no statistically significant differences among groups (P=.549). Boxplots showed substantial differences in the distribution of mean absolute error among groups, with the 3DMM group showing the greatest consistency. The 3DMM approach produced repeat designs with the lowest coefficient of variation. CONCLUSIONS: The 3DMM approach shows potential as a semi-automated method of CAD. Further clinical research is planned to explore the 3DMM approach in a feasibility trial.

'Smart' BLE wearables for digital contact tracing in care homes during the COVID-19 pandemic-a process evaluation of the CONTACT feasibility study.

BACKGROUND: Rapid and mass transmission of the SARS-CoV-2 virus amongst vulnerable people led to devastating effects from COVID-19 in care homes. The CONTACT intervention introduced Bluetooth Low Energy 'smart' wearable devices (BLE wearables) as a basis for automated contact tracing in, and feedback on infection risks and patterns to, care homes to try and improve infection prevention and control (IPC). We planned a cluster randomised controlled trial (RCT) of CONTACT. To be feasible, homes had to adopt CONTACT's technology and new ways of working. This paper reports on the process evaluation conducted alongside CONTACT's feasibility study and explains why it lacked the feasibility and acceptability for a definitive RCT. METHODS: This mixed method process evaluation used Normalisation Process Theory (NPT) qualitative (interviews, field notes, study case report forms and documents, and observation) and quantitative (survey instruments, counts of activity) data to plan, implement, and analyse the mechanisms, effects, and contextual factors that shaped the feasibility and acceptability of the CONTACT intervention. RESULTS: Thirteen themes within four core NPT constructs explained CONTACT's lack of feasibility. Coherence: the home's varied in the scale and extent of commitment and understanding of the technology and study procedures. Leadership credibility was important but compromised by competing priorities. Management and direct care staff saw CONTACT differently. Work to promote (cognitive participation) and enact (collective action) CONTACT was burdensome and failed to be prioritised over competing COVID-19-related demands on time and scarce human and cognitive resources. Ultimately, staff appraisal of the value of CONTACT-generated information and study procedures (reflexivity) was that any utility for IPC was insufficient to outweigh the perceived burden and complexity involved. CONCLUSIONS: Despite implementation failure, dismissing BLE wearables' potential for contact tracing is premature. In non-pandemic conditions, with more time, better co-design and integration of theory-driven implementation strategies tailored to care homes' unique contexts, researchers could enhance normalisation in readiness for future pandemic challenges. TRIAL REGISTRATION: ISRCTN registration: 11,204,126 registered 17/02/2021.

Worth a try or a last resort: Healthcare professionals' experiences and opinions of above cuff vocalisation.

BACKGROUND: Above cuff vocalisation (ACV) involves the application of an external flow of air via the subglottic port of a tracheostomy. ACV can facilitate vocalisation and may improve swallowing and quality of life for patients with a tracheostomy. A recent systematic review highlighted the limited evidence available for the acceptability, effectiveness, safety or optimal implementation of ACV. AIMS: To explore the experience of healthcare professionals (HCPs) using ACV and their perceptions of best practice. METHODS AND PROCEDURES: Semi-structured interviews were conducted with a range of HCPs with experience using ACV. Topics included: experiences with ACV, management of ACV, opinions about ACV, impact of COVID-19, future directions for ACV and impact on length of stay. Interviews were conducted online from December 2020 to March 2022. Data were analysed using reflexive thematic analysis. OUTCOMES AND RESULTS: Twenty-four HCPs were interviewed from seven countries and five professional groups. Four interconnected themes were developed: (1) moral distress amplifying the need to fix patients; (2) subjectivity and uncertainty leading to variations in practice and purpose; (3) knowledge and experience leading to control and caution; and (4) worth a try or a last resort. Theme four contained three sub-themes: (a) part of the toolbox; (b) useful but limited tool; and (c) following the patient's lead. The moral distress experienced by HCPs and their essential 'need to fix' patients seems to underpin the varied opinions of ACV. These opinions appear to be formed primarily on the basis of experience, because of the underlying subjectivities and uncertainties. As knowledge and experience with ACV increased, and adverse events were experienced, most HCPs became more cautious in their approach to ACV. CONCLUSIONS AND IMPLICATIONS: More research is needed to reduce the subjectivities and uncertainties surrounding ACV. The implementation of standardised procedures, processes, and competencies may help to reduce the frequency of adverse events and support a more controlled approach. Widening the focus of the purpose of ACV to include swallowing may help to maximise the potential benefits. WHAT THIS PAPER ADDS: What is already known on the subject There is limited and low-quality evidence for above cuff vocalisation (ACV) and clinical application and practice varies substantially. However, the reasons for this variation in practice and healthcare professionals' (HCPs') opinions of ACV were unclear. What this study adds HCPs' experiences and opinions of ACV vary as a result of the uncertainty and subjectivity surrounding ACV compounded by their personal experiences with it. A need for caution also appears to emerge as HCPs become more familiar and experienced with using ACV. What are the clinical implications of this work? Implementing standardised procedures, safety processes and competencies may help to compensate for the uncertainty and subjectivity surrounding ACV and may reduce the frequency of adverse events. Widening the focus of purpose of ACV, including swallowing in addition to communication, may increase the number of potential candidates and increase the potential benefits of ACV. Using multidisciplinary team (MDT) simulation training for ACV competency development might help to improve MDT working and ACV implementation.

Association between weight loss and health care resource utilization in adults living with obesity: Evidence from a UK primary care database.

AIMS: We investigated the impact of intentional weight loss on health care resource utilization (HCRU) and costs among people with obesity. MATERIALS AND METHODS: This retrospective, observational cohort study used data from the Clinical Practice Research Datalink (CPRD) GOLD database. Adults >18 years at index date [first recorded body mass index (BMI) of 30-50 kg/m2 between 2006 and 2015 with a further BMI record 4 years later] were assigned to an intentional weight loss cohort (-25% to -10% BMI change) or a stable weight cohort (-3% to +3%), based on their BMI change during a 4-year baseline period from index date. Evidence of intention to lose weight during the baseline period was required. Linked Hospital Episode Statistics datasets captured HCRU and costs over an 8-year follow-up period. Mixed effects models adjusted for demographics, total costs during baseline and baseline comorbidities were used. RESULTS: Baseline characteristics were similar between cohorts with weight loss (n = 8676) and stable weight (n = 44 519). Over follow-up, the weight loss cohort experienced a significantly lower mean annual increase in total costs [2.1% (95% confidence interval: 1.3-2.8)] than the stable weight cohort [4.3% (95% confidence interval: 4.0-4.6); p < .0001]. Weight loss was associated with a lower mean annual increase in multiple HCRU and cost components compared with maintaining a stable high weight. CONCLUSIONS: Our findings suggest that intentional weight loss of 10-25% is associated with lower HCRU and costs in the long term among individuals living with obesity, relative to stable weight.

IMproving facial PRosthesis construction with contactlESs Scanning and Digital workflow (IMPRESSeD): study protocol for a feasibility crossover randomised controlled trial of digital versus conventional manufacture of facial prostheses in patients with orbital or nasal facial defects.

BACKGROUND: Facial prostheses can have a profound impact on patients' appearance, function and quality of life. There has been increasing interest in the digital manufacturing of facial prostheses which may offer many benefits to patients and healthcare services compared with conventional manufacturing processes. Most facial prosthesis research has adopted observational study designs with very few randomised controlled trials (RCTs) documented. There is a clear need for a well-designed RCT to compare the clinical and cost-effectiveness of digitally manufactured facial prostheses versus conventionally manufactured facial prostheses. This study protocol describes the planned conduct of a feasibility RCT which aims to address this knowledge gap and determine whether it is feasible to conduct a future definitive RCT. METHODS: The IMPRESSeD study is a multi-centre, 2-arm, crossover, feasibility RCT with early health technology assessment and qualitative research. Up to 30 participants with acquired orbital or nasal defects will be recruited from the Maxillofacial Prosthetic Departments of participating NHS hospitals. All trial participants will receive 2 new facial prostheses manufactured using digital and conventional manufacturing methods. The order of receiving the facial prostheses will be allocated centrally using minimisation. The 2 prostheses will be made in tandem and marked with a colour label to mask the manufacturing method to the participants. Participants will be reviewed 4 weeks following the delivery of the first prosthesis and 4 weeks following the delivery of the second prosthesis. Primary feasibility outcomes include eligibility, recruitment, conversion, and attrition rates. Data will also be collected on patient preference, quality of life and resource use from the healthcare perspective. A qualitative sub-study will evaluate patients' perception, lived experience and preference of the different manufacturing methods. DISCUSSION: There is uncertainty regarding the best method of manufacturing facial prostheses in terms of clinical effectiveness, cost-effectiveness and patient acceptability. There is a need for a well-designed RCT to compare digital and conventional manufacturing of facial prostheses to better inform clinical practice. The feasibility study will evaluate key parameters needed to design a definitive trial and will incorporate early health technology assessment and a qualitative sub-study to identify the potential benefits of further research. TRIAL REGISTRATION: ISRCTN ISRCTN10516986). Prospectively registered on 08 June 2021,  https://www.isrctn.com/ISRCTN10516986 .

Digital database for nasal prosthesis design with a 3D morphable face model approach.

Designing nasal prostheses can be challenging because of the unpaired nature of the facial feature, especially in patients lacking preoperative information. Various nose model databases have been developed as a helpful starting point for the computer-aided design of nasal prostheses, but these do not appear to be readily accessible. Therefore, an open-access digital database of nose models has been generated based on a 3-dimensional (3D) morphable face model approach. This article describes the generation of the database, highlights steps for designing a nasal prosthesis, and points readers to the database for future clinical application and research.

Cost-Effectiveness of PHMB & betaine wound bed preparation compared with standard care in venous leg ulcers: A cost-utility analysis in the United Kingdom.

BACKGROUND: Wounds cost £8.3 billion per year in the United Kingdom (UK) annually. Venous leg ulcers (VLUs) account for 15% of wounds and can be complicated to heal, increasing nurse visits and resource costs. Recent wound bed preparation consensus recommends wound cleansing and biofilm disrupting agents. However, inert cleansers such as tap water or saline are inexpensive, an evaluation of evidence is required to justify the higher upfront costs of treatment with active cleansers. We undertook a cost-effectiveness analysis of the use of a biofilm disrupting and cleansing solution and gel, Prontosan® Solution and Gel X, (PSGX) (B Braun Medical), as compared to the standard practice of using saline solution, for treating VLUs. METHODS: A Markov model was parameterised to one-year costs and health-related quality of life consequences of treating chronic VLUs with PSGX versus saline solution. Costs are viewed from a UK healthcare payer perspective, include routine care and management of complications. A systematic literature search was performed to inform the clinical parameters of the economic model. Deterministic univariate sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were undertaken. RESULTS: For PSGX an Incremental Net Monetary Benefit (INMB) of £1,129.65 to £1,042.39 per patient (with a Maximum Willingness to Pay of £30k and £20k per QALY respectively), of which cost savings are £867.87 and 0.0087 quality-adjusted life years (QALYs) gain per patient. PSA indicates a 99.3% probability of PSGX being cost-effective over saline. CONCLUSIONS: PSGX for the treatment of VLUs is dominant compared with saline solution in the UK with expected cost-savings within a year and improved patient outcomes.

Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot.

INTRODUCTION: Heart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients. METHODS AND ANALYSIS: ISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and planned discharge to the geographical area of the cluster will be recruited. The MaTI consists of training for staff, a toolkit for participants, transfer of discharge information to community pharmacies and a medicines reconciliation/review. Treatment as usual is determined by local policy and practices. The primary outcome is a composite of all-cause mortality and heart failure-related hospitalisation at 12 months postregistration obtained from national electronic health records. The key secondary outcome is continued prescription of guideline-indicated therapies at 12 months measured via patient-reported data and Hospital Episode Statistics. The trial contains a parallel mixed-methods process evaluation and an embedded health economics study. ETHICS AND DISSEMINATION: The study obtained approval from the Yorkshire and the Humber-Bradford Leeds Research Ethics Committee; REC reference 18/YH/0017. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. Amendments to the protocol are disseminated to all relevant parties as required. TRIAL REGISTRATION NUMBER: ISRCTN66212970; Pre-results.

Collection of cancer Patient Reported Outcome Measures (PROMS) to link with primary and secondary electronic care records to understand and improve long term cancer outcomes: A protocol paper.

INTRODUCTION: More people are living with and beyond a cancer diagnosis. There is limited understanding of the long-term effects of cancer and cancer treatment on quality of life and personal and household finances when compared to people without cancer. In a separate protocol we have proposed to link de-identified data from electronic primary care and hospital records for a large population of cancer survivors and matched controls. In this current protocol, we propose the linkage of Patient Reported Outcomes Measures data to the above data for a subset of this population. The aim of this study is to investigate the full impact of living with and beyond a cancer diagnosis compared to age and gender matched controls. A secondary aim is to test the feasibility of the collection of Patient Reported Outcomes Measures (PROMS) data and the linkage procedures of the PROMs data to electronic health records data. MATERIALS AND METHODS: This is a cross-sectional study, aiming to recruit participants treated at the Leeds Teaching Hospitals National Health Service Trust. Eligible patients will be cancer survivors at around 5 years post-diagnosis (breast, colorectal and ovarian cancer) and non-cancer patient matched controls attending dermatology out-patient clinics. They will be identified by running a query on the Leeds Teaching Hospitals Trust patient records system. Approximately 6000 patients (2000 cases and 4000 controls) will be invited to participate via post. Participants will be invited to complete PROMs assessing factors such as quality of life and finances, which can be completed on paper or online (surveys includes established instruments, and bespoke instruments (demographics, financial costs). This PROMs data will then be linked to routinely collected de-identified data from patient's electronic primary care and hospital records. DISCUSSION: This innovative work aims to create a truly 'comprehensive patient record' to provide a broad picture of what happens to cancer patients across their cancer pathway, and the long-term impact of cancer treatment. Comparisons can be made between the cases and controls, to identify the aspects of life that has had the greatest impact following a cancer diagnosis. The feasibility of linking PROMs data to electronic health records can also be assessed. This work can inform future support offered to people living with and beyond a cancer diagnosis, clinical practice, and future research methodologies.

Evidence for Above Cuff Vocalization in Patients With a Tracheostomy: A Systematic Review.

OBJECTIVES/HYPOTHESIS: To determine how above cuff vocalization (ACV) is implemented in clinical practice, to identify what evidence exists on the effectiveness and safety of ACV, and to evaluate the acceptability of ACV. STUDY DESIGN: Systematic review. METHODS: A literature search was conducted in eight databases (MEDLINE, Embase, AMED, CINAHL, Cochrane Library, PsycINFO, Scopus, and Web of Science) in May 2019 and updated in June 2020. Two reviewers independently screened, selected, and extracted data. Study quality was appraised using the Joanna Briggs Institute Critical Appraisal Tools and a narrative synthesis was conducted. Systematic review registration number: CRD42019133942. RESULTS: The searches identified 1327 records. The 13 eligible studies included four case studies, three case series, four observational studies without a control group, one quasi-experimental study, and one randomized controlled trial. Study quality was low, with most studies having high risk of bias. There was a high level of heterogeneity in study design and outcome measures used. Detailed information on ACV application and dose-delivered was lacking in 12 studies. Positive effects were reported for communication (n = 7), swallowing (n = 4), cough response (n = 2), and quality-of-life (n = 2), but with inconsistent use of objective outcome measures. There is limited quantitative or qualitative evidence for acceptability. Adverse events and complications were reported in nine studies, and four highlighted the importance of involving an experienced speech and language therapist. CONCLUSIONS: There is limited evidence for the acceptability, effectiveness, safety, or optimal implementation of ACV. The evidence is insufficient to provide recommendations regarding optimal intervention delivery. Future research should ensure detailed recording of ACV delivery and utilize a core outcome set. Laryngoscope, 132:600-611, 2022.

Determining the Prevalence, Implementation Approaches, and Opinions of Above Cuff Vocalization: A Survey of Health Care Professionals.

OBJECTIVE: To conduct an international survey to investigate the use of above cuff vocalization (ACV) and how practice and opinion differs. DESIGN: Observational, cross-sectional online survey. SETTING: Critical care, acute, rehabilitation, long-term care, and community. PARTICIPANTS: Health care professionals involved in tracheostomy care or weaning (N=243). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Tracheostomy management, prevalence, personal experiences and opinions, and barriers to use. Quantitative data were reported descriptively, and content analysis was conducted with qualitative data. RESULTS: The survey was completed by 243 health care professionals from 9 professional groups and 25 countries, with most responses from the United Kingdom (54%) and speech and language therapists (55%). ACV was used in 39% of services (n=93). Sixty percent (n=50/83) of health care professionals with direct experience of ACV had used it with <10 people. Implementation of ACV varied widely concerning procedures, contraindications, safety processes, professionals involved, competencies, staff training, delivery, and outcome measures. The top benefits were communication (n=76/93; 82%), mood (n=62/93; 67%), and laryngeal sensation (n=49/93; 53%). Complications included discomfort (n=54/93; 58%) and strained vocal quality (n=39/93; 42%). Barriers to ACV implementation included lack of knowledgeable staff (n=92/238; 39%) and lack of access to training (n=73/238; 31%). CONCLUSIONS: ACV uptake varies internationally with no standardized approach to ACV delivery. Diversity of opinions on approaches and benefits exist. Serious complications are infrequent, but minor complications are common. Future research is needed to establish optimal ACV implementation to maximize benefits and minimize risks.

Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT.

BACKGROUND: Falls and fractures are a major problem. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions. DESIGN: Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice. SETTING: Primary care. PARTICIPANTS: People aged ≥ 70 years. INTERVENTIONS: All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling. MAIN OUTCOME MEASURES: The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit. RESULTS: Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported. LIMITATIONS: The rate of fractures was lower than anticipated. CONCLUSIONS: Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective. FUTURE WORK: Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71002650. 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. 25, No. 34. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Falls are a major problem for older people. Current practice is to give people advice leaflets. Another approach is exercise, especially balance and strength training. A third alternative is to invite older people to attend a falls assessment with a health-care professional, either a doctor or a trained nurse. This usually involves a careful check of prescribed tablets, blood pressure, eyesight and other problems that might cause falls. WHAT DID WE DO?: We compared three strategies. We recruited 9803 people aged 70­101 years from 63 general practices across England. We randomly allocated practices in clusters into three treatment groups. The participants in one group were given a Staying Steady advice leaflet (Age UK. Staying Steady. London: Age UK; 2009). Participants in the second group received the same leaflet and were assessed to see if they were at higher risk of falling. Those participants identified as being at higher risk (about 1000 people) were invited to take part in an exercise programme, supported by an exercise therapist. These people did balance and strength training at home for up to 6 months. In the third group, we again identified participants who were at higher risk of falling (about 1000 people) and invited them for a detailed falls assessment with a trained nurse or doctor. This last group of participants were referred for other treatments if any health problems were found. In all groups we counted fractures and falls and measured changes in quality of life, frailty and the cost of the treatments over 18 months of follow-up. WHAT DID WE FIND OUT?: We found no difference in the number of fractures over 18 months between the different treatments. The exercise programme reduced falls in the short term but not over the longer term. The exercise programme was cheaper and led to a slightly better overall quality of life.

Outcome measures in facial prosthesis research: A systematic review.

STATEMENT OF PROBLEM: Facial prosthesis research uses a wide variety of outcome measures, which results in challenges when comparing the effectiveness of interventions among studies. Consensus is lacking regarding the most appropriate and meaningful outcome measures to use in facial prosthesis research to capture important perspectives. PURPOSE: The purpose of the systematic review was to identify and synthesize outcome measures used in facial prosthesis research. MATERIAL AND METHODS: Electronic searches were performed in 11 databases (including nonpeer-reviewed literature). The citations were searched, and expert societies were contacted to identify additional studies. Inclusion criteria comprised studies of participants with facial defects who required or had received prosthetic rehabilitation with an external facial prosthesis. Exclusion criteria comprised participants with ocular prostheses, case reports, case series with fewer than 5 participants, laboratory-based studies, and studies published before 1980. Study selection was performed independently by 2 reviewers. Discrepancies were resolved through discussion or by a third reviewer. Outcome measures were synthesized with a categorization approach based on the perspective, theme, and subtheme of the outcome measures. Quality assessment was performed with an appraisal tool that enabled evaluation of studies with diverse designs. RESULTS: Database searching identified 13 058 records, and 7406 remained after duplications were removed. After initial screening, 189 potentially relevant records remained, and 186 full texts were located (98% retrieval rate). After full-text screening, 124 records were excluded. Citation searches and contact with expert societies identified 4 further records. In total, 69 articles (grouped into 65 studies) were included. Studies were categorized as per the perspective of their outcome measures, with the following findings: patient-reported (74% of studies), clinical indicators (34%), clinician-reported (8%), multiple viewpoints (6%), and independent observer-reported (3%). Patient-reported outcome measures included tools to assess satisfaction, quality of life, and psychologic health. Variability in the choice of outcome measures was evident among the studies, with many self-designed, unvalidated, condition-specific questionnaires reported. A greater number of outcome measure themes emerged over time; themes such as service delivery and health state utility have recently been evaluated. CONCLUSIONS: Over the past 40 years, facial prosthesis research has focused on patient-reported outcome measures. Outcome measures relating to other perspectives have been used less frequently, although new themes appear to be emerging in the literature. Future research should use outcome measures with appropriate measurement properties for use with facial prosthetics.

Copula Models for Addressing Sample Selection in the Evaluation of Public Health Programmes: An Application to the Leeds Let's Get Active Study.

Sample selectivity is a recurrent problem in public health programmes and poses serious challenges to their evaluation. Traditional approaches to handle sample selection tend to rely on restrictive assumptions. The aim of this paper is to illustrate a copula-based selection model to handle sample selection in the evaluation of public health programmes. Motivated by a public health programme to promote physical activity in Leeds (England), we describe the assumptions underlying the copula selection, and its relative advantages compared with commonly used approaches to handle sample selection, such as inverse probability weighting and Heckman's selection model. We illustrate the methods in the Leeds Let's Get Active programme and show the implications of method choice for estimating the effect on individual's physical activity. The programme was associated with increased physical activity overall, but the magnitude of its effect differed according to adjustment method. The copula selection model led to a similar effect to the Heckman's approach but with relatively narrower 95% confidence intervals. These results remained relatively similar when different model specifications and alternative distributional assumptions were considered. The copula selection model can address important limitations of traditional approaches to address sample selection, such as the Heckman model, and should be considered in the evaluation of public health programmes, where sample selection is likely to be present.

Screening and Intervention to Prevent Falls and Fractures in Older People.

BACKGROUND: Community screening and therapeutic prevention strategies may reduce the incidence of falls in older people. The effects of these measures on the incidence of fractures, the use of health resources, and health-related quality of life are unknown. METHODS: In a pragmatic, three-group, cluster-randomized, controlled trial, we estimated the effect of advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise for people at increased risk for falls) as compared with advice by mail only. The primary outcome was the rate of fractures per 100 person-years over 18 months. Secondary outcomes were falls, health-related quality of life, frailty, and a parallel economic evaluation. RESULTS: We randomly selected 9803 persons 70 years of age or older from 63 general practices across England: 3223 were assigned to advice by mail alone, 3279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail. A falls-risk screening questionnaire was sent to persons assigned to the exercise and multifactorial fall-prevention groups. Completed screening questionnaires were returned by 2925 of the 3279 participants (89%) in the exercise group and by 2854 of the 3301 participants (87%) in the multifactorial fall-prevention group. Of the 5779 participants from both these groups who returned questionnaires, 2153 (37%) were considered to be at increased risk for falls and were invited to receive the intervention. Fracture data were available for 9802 of the 9803 participants. Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71). The exercise strategy was associated with small gains in health-related quality of life and the lowest overall costs. There were three adverse events (one episode of angina, one fall during a multifactorial fall-prevention assessment, and one hip fracture) during the trial period. CONCLUSIONS: Advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls did not result in fewer fractures than advice by mail alone. (Funded by the National Institute of Health Research; ISRCTN number, ISRCTN71002650.).

Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial.

INTRODUCTION: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence. METHODS AND ANALYSIS: A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks. ETHICS AND DISSEMINATION: Ethics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN64926597; registered on 6 June 2017.

Does regulation increase the rate at which doctors leave practice? Analysis of routine hospital data in the English NHS following the introduction of medical revalidation.

BACKGROUND: In 2012, the UK introduced medical revalidation, whereby to retain their licence all doctors are required to show periodically that they are up to date and fit to practise medicine. Early reports suggested that some doctors found the process overly onerous and chose to leave practice. This study investigates the effect of medical revalidation on the rate at which consultants (senior hospital doctors) leave NHS practice, and assesses any differences between the performance of consultants who left or remained in practice before and after the introduction of revalidation. METHODS: We used a retrospective cohort of administrative data from the Hospital Episode Statistics database on all consultants who were working in English NHS hospitals between April 2008 and March 2009 (n = 19,334), followed to March 2015. Proportional hazard models were used to identify the effect of medical revalidation on the time to exit from the NHS workforce, as implied by ceasing NHS clinical activity. The main exposure variable was consultants' time-varying revalidation status, which differentiates between periods when consultants were (a) not subject to revalidation-before the policy was introduced, (b) awaiting a revalidation recommendation and (c) had received a positive recommendation to be revalidated. Difference-in-differences analysis was used to compare the performance of those who left practice with those who remained in practice before and after the introduction of revalidation, as proxied by case-mix-adjusted 30-day mortality rates. RESULTS: After 2012, consultants who had not yet revalidated were at an increased hazard of ceasing NHS clinical practice (HR 2.33, 95% CI 2.12 to 2.57) compared with pre-policy levels. This higher risk remained after a positive recommendation (HR 1.85, 95% CI 1.65 to 2.06) but was statistically significantly reduced (p < 0.001). We found no statistically significant differences in mortality rates between those consultants who ceased practice and those who remained, after adjustment for multiple testing. CONCLUSION: Revalidation appears to have led to greater numbers of doctors ceasing clinical practice, over and above other contemporaneous influences. Those ceasing clinical practice do not appear to have provided lower quality care, as approximated by mortality rates, when compared with those remaining in practice.

How health policy shapes healthcare sector productivity? Evidence from Italy and UK.

The English (NHS) and the Italian (SSN) healthcare systems share many similar features: basic founding principles, financing, organization, management, and size. Yet the two systems have faced diverging policy objectives since 2000, which may have affected differently healthcare sector productivity in the two countries. In order to understand how different healthcare policies shape the productivity of the systems, we assess, using the same methodology, the productivity growth of the English and Italian healthcare systems over the period from 2004 to 2011. Productivity growth is measured as the rate of change in outputs over the rate of change in inputs. We find that the overall NHS productivity growth index increased by 10% over the whole period, at an average of 1.39% per year, while SSN productivity increased overall by 5%, at an average of 0.73% per year. Our results suggest that different policy objectives are reflected in differential growth rates for the two countries. In England, the NHS focused on increasing activity, reducing waiting times and improving quality. Italy focused more on cost containment and rationalized provision, in the hope that this would reduce unjustified and inappropriate provision of services.