Theories, models and frameworks to understand barriers to the provision of mobility-assistive technologies: a scoping review.

OBJECTIVES: There is strong evidence that mobility-assistive technologies improve occupational performance, social participation, educational and employment access and overall quality of life in people with disabilities. However, people with disabilities still face barriers in accessing mobility products and related services. This review aims to summarise and synthesise: (1) theories, models and frameworks that have been used to understand mobility-assistive technology access, (2) determinants of access and (3) gaps in knowledge. DESIGN: A scoping review using the five-step framework by Arksey and O'Malley. DATA SOURCES: We searched the MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and SCOPUS databases for publications published between 2000 and 2024. We searched for articles published up to 20 March 2024. ELIGIBILITY CRITERIA: We included English-published literature in peer-reviewed journals that reported (a) barriers to the provision of mobility-assistive technologies, (b) including at least one theory, model or framework and (c) between 2000 and 2024. DATA EXTRACTION AND SYNTHESIS: We extracted the study characteristics, theories, models, framework usage, research recommendations, key findings on mobility-assistive technology barriers and theoretical propositions. We conduct a theoretical synthesis guided by Turner's approach. RESULTS: We included 18 articles that used 8 theories, models and frameworks, synthesised into 9 propositions. The synthesised theory emphasises that mobility is essential for human flourishing, and that certain health conditions may impose restrictions on mobility. This impact can be alleviated by two direct determinants: (1) the provision of suitable services and (2) their comprehensive provision. Policies and costs influence these services indirectly. Environmental and personal factors also affect the use of these services. Ineffectively addressing these determinants can limit access to mobility-assistive technologies and subsequent disabilities. CONCLUSION: Our synthetic model describes the logic of providing evidence-based mobility-assistive technologies, and we identify the determinants of access that can act as targets for future work to improve the provision of mobility-assistive technologies.

"Reality is frequently inaccurate" A case study examining the whens and whys of post-live database changes in a UK clinical trials unit *Douglas Adams.

INTRODUCTION: Accurately estimating the costs of clinical trials is challenging. There is currently no reference class data to allow researchers to understand the potential costs associated with database change management in clinical trials. METHODS: We used a case-based approach, summarising post-live changes in eleven clinical trial databases managed by Sheffield Clinical Trials Research Unit. We reviewed the database specifications for each trial and summarised the number of changes, change type, change category, and timing of changes. We pooled our experiences and made observations in relation to key themes. RESULTS: Median total number of changes across the eleven trials was 71 (range 40-155) and median number of changes per study week was 0.48 (range 0.32-1.34). The most common change type was modification (median 39, range 20-90), followed by additions (median 32, range 18-55), then deletions (median 7, range 1-12). In our sample, changes were more common in the first half of the trial's lifespan, regardless of its overall duration. Trials which saw continuous changes seemed more likely to be external pilots or trials in areas where the trial team was either less experienced overall or within the particular therapeutic area. CONCLUSIONS: Researchers should plan trials with the expectation that clinical trial databases will require changes within the life of the trial, particularly in the early stages or with a less experienced trial team. More research is required to understand potential differences between clinical trial units and database types.

Classification and stratification in pilonidal sinus disease: findings from the PITSTOP cohort.

AIM: Research in pilonidal disease faces several challenges, one of which is consistent and useful disease classification. The International Pilonidal Society (IPS) proposed a four-part classification in 2017. The aim of this work was to assess the validity and reliability of this tool using data from the PITSTOP cohort study. METHOD: Face validity was assessed by mapping the items/domains in the IPS tool against tools identified through a systematic review. Key concepts were defined as those appearing in more than two-thirds of published tools. Concurrent and predictive validity were assessed by comparing key patient-reported outcome measures between groups at baseline and at clinic visit. The outcomes of interest were health utility, Cardiff Wound Impact Questionnaire (CWIQ) and pain score between groups. Significance was set at p = 0.05 a priori. Interrater reliability was assessed using images captured during the PITSTOP cohort. Ninety images were assessed by six raters (two experts, two general surgeons and two trainees), and classified into IPS type. Interrater reliability was assessed using the unweighted kappa and unweighted Gwet's AC1 statistics. RESULTS: For face validity items represented in the IPS were common to other classification systems. Concurrent and predictive validity assessment showed differences in health utility and pain between groups at baseline, and for some treatment groups at follow-up. Assessors agreed the same classification in 38% of participants [chance-corrected kappa 0.52 (95% CI 0.42-0.61), Gwet's AC1 0.63 (95% CI 0.56-0.69)]. CONCLUSION: The IPS classification demonstrates key aspects of reliability and validity that would support its implementation.

Inequalities in Healthcare Access, Experience and Outcomes in Adults With Inflammatory Bowel Disease: A Scoping Review.

BACKGROUND: Inflammatory bowel diseases (IBDs) are incurable diseases that require lifelong access to health services. Accumulating evidence of inequalities in health care access, experience, and outcomes for individuals with IBD is apparent. This review aimed to describe the inequalities in healthcare access, experiences, and outcomes of care for adults with IBD, to identify research gaps, and to identify future research priorities in this area. METHODS: A scoping review was conducted to retrieve quantitative, qualitative, and mixed methods evidence from 3 databases (EMBASE, Medline, and CINAHL) published between January 1, 2000, and September 27, 2023. RESULTS: Fifty-one studies met the criteria for inclusion. The majority (42 of 51) focused on IBD health outcomes, followed by healthcare access (24 of 51). Significantly fewer investigated patient experiences of IBD healthcare (8 of 51). Most available studies reported on race/ethnic disparities of healthcare (33 of 51), followed by inequalities driven by socioeconomic differences (12 of 51), rurality (7 of 51), gender and sex (3 of 51), age (2 of 51), culture (2 of 51), literacy (1 of 51), and sexuality (1 of 51). Inflammatory bowel disease patients from Black, Asian, and Hispanic ethnic groups had significantly poorer health outcomes. A lack of research was found in the sexual and gender minority community (1 of 51). No research was found to investigate inequalities in IBD patients with learning disabilities or autism. CONCLUSIONS: Further research, particularly utilizing qualitative methods, is needed to understand health experiences of underserved patient populations with IBD. Cultural humility in IBD care is required to better serve individuals with IBD of Black and Asian race/ethnicity. The lack of research amongst sexual and gender minority groups with IBD, and with learning disabilities, poses a risk of creating inequalities within inequalities.

Inequalities in inflammatory bowel disease healthcare access, experiences, and outcomes exist. However, it is unclear what populations and social determinants of health have been investigated in this area. This review synthesizes empirical evidence across a range of inequalities in IBD healthcare.

A service mapping exercise of four health and social care staff mental health and wellbeing services, Resilience Hubs, to describe health service provision and interventions.

BACKGROUND: NHS England funded 40 Mental Health and Wellbeing Hubs to support health and social care staff affected by the COVID-19 pandemic. We aimed to document variations in how national guidance was adapted to the local contexts of four Hubs in the North of England. METHODS: We used a modified version of Price's (2019) service mapping methodology. Service level data were used to inform the analysis. A mapping template was adapted from a range of tools, including the European Service Mapping Schedule, and reviewed by Hub leads. Key data included service model; staffing; and interventions. Data were collected between March 2021 - March 2022 by site research assistants. Findings were accuracy-checked by Hub leads, and a logic model developed to theorise how the Hubs may effect change. RESULTS: Hub goals and service models closely reflected guidance; offering: proactive outreach; team-based support; clinical assessment; onward referral, and rapid access to mental health support (in-house and external). Implementation reflected a service context of a client group with high mental health need, and high waiting times at external mental health services. Hubs were predominantly staffed by experienced clinicians, to manage these mental health presentations and organisational working. Formulation-based psychological assessment and the provision of direct therapy were not core functions of the NHS England model, however all Hubs incorporated these adaptations into their service models in response to local contexts, such as extensive waiting lists within external services, and/or client presentations falling between gaps in existing service provision. Finally, a standalone clinical records system was seen as important to reassure Hub users of confidentiality. Other more nuanced variation depended on localised contexts. CONCLUSION: This study provides a map for setting up services, emphasising early understandings of how new services will integrate within existing systems. Local and regional contexts led to variation in service configuration. Whilst additional Hub functions are supported by available literature, further research is needed to determine whether these functions should comprise essential components of staff wellbeing services moving forward. Future research should also determine the comparative effectiveness of service components, and the limits of permissible variation. STUDY REGISTRATION: researchregistry6303.

Evaluation of venous thromboembolism risk assessment models for hospital inpatients: the VTEAM evidence synthesis.

Background: Pharmacological prophylaxis during hospital admission can reduce the risk of acquired blood clots (venous thromboembolism) but may cause complications, such as bleeding. Using a risk assessment model to predict the risk of blood clots could facilitate selection of patients for prophylaxis and optimise the balance of benefits, risks and costs. Objectives: We aimed to identify validated risk assessment models and estimate their prognostic accuracy, evaluate the cost-effectiveness of different strategies for selecting hospitalised patients for prophylaxis, assess the feasibility of using efficient research methods and estimate key parameters for future research. Design: We undertook a systematic review, decision-analytic modelling and observational cohort study conducted in accordance with Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines. Setting: NHS hospitals, with primary data collection at four sites. Participants: Medical and surgical hospital inpatients, excluding paediatric, critical care and pregnancy-related admissions. Interventions: Prophylaxis for all patients, none and according to selected risk assessment models. Main outcome measures: Model accuracy for predicting blood clots, lifetime costs and quality-adjusted life-years associated with alternative strategies, accuracy of efficient methods for identifying key outcomes and proportion of inpatients recommended prophylaxis using different models. Results: We identified 24 validated risk assessment models, but low-quality heterogeneous data suggested weak accuracy for prediction of blood clots and generally high risk of bias in all studies. Decision-analytic modelling showed that pharmacological prophylaxis for all eligible is generally more cost-effective than model-based strategies for both medical and surgical inpatients, when valuing a quality-adjusted life-year at £20,000. The findings were more sensitive to uncertainties in the surgical population; strategies using risk assessment models were more cost-effective if the model was assumed to have a very high sensitivity, or the long-term risks of post-thrombotic complications were lower. Efficient methods using routine data did not accurately identify blood clots or bleeding events and several pre-specified feasibility criteria were not met. Theoretical prophylaxis rates across an inpatient cohort based on existing risk assessment models ranged from 13% to 91%. Limitations: Existing studies may underestimate the accuracy of risk assessment models, leading to underestimation of their cost-effectiveness. The cost-effectiveness findings do not apply to patients with an increased risk of bleeding. Mechanical thromboprophylaxis options were excluded from the modelling. Primary data collection was predominately retrospective, risking case ascertainment bias. Conclusions: Thromboprophylaxis for all patients appears to be generally more cost-effective than using a risk assessment model, in hospitalised patients at low risk of bleeding. To be cost-effective, any risk assessment model would need to be highly sensitive. Current evidence on risk assessment models is at high risk of bias and our findings should be interpreted in this context. We were unable to demonstrate the feasibility of using efficient methods to accurately detect relevant outcomes for future research. Future work: Further research should evaluate routine prophylaxis strategies for all eligible hospitalised patients. Models that could accurately identify individuals at very low risk of blood clots (who could discontinue prophylaxis) warrant further evaluation. Study registration: This study is registered as PROSPERO CRD42020165778 and Researchregistry5216. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127454) and will be published in full in Health Technology Assessment; Vol. 28, No. 20. See the NIHR Funding and Awards website for further award information.

People who are admitted to hospital are at risk of blood clots that can cause serious illness or death. Patients are often given low doses of blood-thinning drugs to reduce this risk. However, these drugs can cause side effects, such as bleeding. Hospitals currently use complex risk assessment models (risk scores, which usually include patient, disease, mobility and intervention factors) to determine the individual risk of blood clots and identify people most likely to benefit from blood-thinning drugs. There are a lot of different risk scores and we do not know which one is best. We also do not know how these scores compare to each other or whether using scores to decide who should get blood-thinning drugs provides good value for money to the NHS. We reviewed all previous studies of risk scores. We found that they did not predict blood clots very well and we could not recommend one score over another. We then created a mathematical model to simulate the use of blood-thinning drugs in people admitted to hospital. The model suggested that giving blood-thinning drugs to everyone who could have them would probably provide the best value for money, in medical patients. Our findings were the same, but less certain, for surgical patients. We also collected information from four NHS hospitals to explore possibilities for future research. Our work showed that routinely collected electronic data on blood clots and bleeding events is not very accurate and that using different scores could result in variable use of blood-thinning medications. Our findings suggest that it may be better value to the NHS and better for patients if we were to offer blood-thinning medications to everyone on admission to hospital, without using any risk score. However, this approach needs further research to ensure it is safe and effective. Such research would not be able to rely on routine electronic data to identify blood clots or bleeding events, in isolation.

Research and practice priorities in pilonidal sinus disease: a consensus from the PITSTOP study.

AIM: Pilonidal sinus disease is a common condition treated by colorectal surgeons. There is a lack of literature in the field to guide optimal management of this condition. As part of the PITSTOP study, we aimed to identify policy and research priorities to provide direction to the field. METHOD: Patients and surgeons were invited to participate. A 'So what, now what' exercise was conducted, informed by data from PITSTOP. This generated statements for research and practice priorities. A three-round online Delphi study was conducted, ranking statements based on policy and research separately. Statements were rated 1 (not important) to 9 (important). Statements that were rated 7-9 by more than 70% of participants were entered into the consensus meeting. Personalized voting feedback was shown between rounds. A face-to-face meeting was held to discuss statements, and participants were asked to rank statements using a weighted choice vote. RESULTS: Twenty-two people participated in the focus group, generating 14 research and 19 policy statements. Statements were voted on by 56 participants in round 1, 53 in round 2 and 51 in round 3. A total of 15 policy statements and 19 research statements were discussed in the consensus round. Key policy statements addressed treatment strategies and intensity, surgeon training opportunities, need for classification and the impact of treatment on return to work. Research recommendations included design of future trials, methodology considerations and research questions. CONCLUSION: This study has identified research and policy priorities in pilonidal sinus disease which are relevant to patients and clinicians. These should inform practice and future research.

Prehospital early warning scores for adults with suspected sepsis: the PHEWS observational cohort and decision-analytic modelling study.

Background: Guidelines for sepsis recommend treating those at highest risk within 1 hour. The emergency care system can only achieve this if sepsis is recognised and prioritised. Ambulance services can use prehospital early warning scores alongside paramedic diagnostic impression to prioritise patients for treatment or early assessment in the emergency department. Objectives: To determine the accuracy, impact and cost-effectiveness of using early warning scores alongside paramedic diagnostic impression to identify sepsis requiring urgent treatment. Design: Retrospective diagnostic cohort study and decision-analytic modelling of operational consequences and cost-effectiveness. Setting: Two ambulance services and four acute hospitals in England. Participants: Adults transported to hospital by emergency ambulance, excluding episodes with injury, mental health problems, cardiac arrest, direct transfer to specialist services, or no vital signs recorded. Interventions: Twenty-one early warning scores used alongside paramedic diagnostic impression, categorised as sepsis, infection, non-specific presentation, or other specific presentation. Main outcome measures: Proportion of cases prioritised at the four hospitals; diagnostic accuracy for the sepsis-3 definition of sepsis and receiving urgent treatment (primary reference standard); daily number of cases with and without sepsis prioritised at a large and a small hospital; the minimum treatment effect associated with prioritisation at which each strategy would be cost-effective, compared to no prioritisation, assuming willingness to pay £20,000 per quality-adjusted life-year gained. Results: Data from 95,022 episodes involving 71,204 patients across four hospitals showed that most early warning scores operating at their pre-specified thresholds would prioritise more than 10% of cases when applied to non-specific attendances or all attendances. Data from 12,870 episodes at one hospital identified 348 (2.7%) with the primary reference standard. The National Early Warning Score, version 2 (NEWS2), had the highest area under the receiver operating characteristic curve when applied only to patients with a paramedic diagnostic impression of sepsis or infection (0.756, 95% confidence interval 0.729 to 0.783) or sepsis alone (0.655, 95% confidence interval 0.63 to 0.68). None of the strategies provided high sensitivity (> 0.8) with acceptable positive predictive value (> 0.15). NEWS2 provided combinations of sensitivity and specificity that were similar or superior to all other early warning scores. Applying NEWS2 to paramedic diagnostic impression of sepsis or infection with thresholds of > 4, > 6 and > 8 respectively provided sensitivities and positive predictive values (95% confidence interval) of 0.522 (0.469 to 0.574) and 0.216 (0.189 to 0.245), 0.447 (0.395 to 0.499) and 0.274 (0.239 to 0.313), and 0.314 (0.268 to 0.365) and 0.333 (confidence interval 0.284 to 0.386). The mortality relative risk reduction from prioritisation at which each strategy would be cost-effective exceeded 0.975 for all strategies analysed. Limitations: We estimated accuracy using a sample of older patients at one hospital. Reliable evidence was not available to estimate the effectiveness of prioritisation in the decision-analytic modelling. Conclusions: No strategy is ideal but using NEWS2, in patients with a paramedic diagnostic impression of infection or sepsis could identify one-third to half of sepsis cases without prioritising unmanageable numbers. No other score provided clearly superior accuracy to NEWS2. Research is needed to develop better definition, diagnosis and treatments for sepsis. Study registration: This study is registered as Research Registry (reference: researchregistry5268). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/136/10) and is published in full in Health Technology Assessment; Vol. 28, No. 16. See the NIHR Funding and Awards website for further award information.

Sepsis is a life-threatening condition in which an abnormal response to infection causes heart, lung or kidney failure. People with sepsis need urgent treatment. They need to be prioritised at the emergency department rather than waiting in the queue. Paramedics attempt to identify people with possible sepsis using an early warning score (based on simple measurements, such as blood pressure and heart rate) alongside their impression of the patient's diagnosis. They can then alert the hospital to assess the patient quickly. However, an inaccurate early warning score might miss cases of sepsis or unnecessarily prioritise people without sepsis. We aimed to measure how accurately early warning scores identified people with sepsis when used alongside paramedic diagnostic impression. We collected data from 71,204 people that two ambulance services transported to four different hospitals in 2019. We recorded paramedic diagnostic impressions and calculated early warning scores for each patient. At one hospital, we linked ambulance records to hospital records and identified who had sepsis. We then calculated the accuracy of using the scores alongside diagnostic impression to diagnose sepsis. Finally, we used modelling to predict how many patients (with and without sepsis) paramedics would prioritise using different strategies based on early warning scores and diagnostic impression. We found that none of the currently available early warning scores were ideal. When they were applied to all patients, they prioritised too many people. When they were only applied to patients whom the paramedics thought had infection, they missed many cases of sepsis. The NEWS2, score, which ambulance services already use, was as good as or better than all the other scores we studied. We found that using the NEWS2, score in people with a paramedic impression of infection could achieve a reasonable balance between prioritising too many patients and avoiding missing patients with sepsis.

Patient and public involvement in the development of health services: Engagement of underserved populations in a quality improvement programme for inflammatory bowel disease using a community-based participatory approach.

INTRODUCTION: Involving people with lived experience is fundamental to healthcare development and delivery. This is especially true for inflammatory bowel disease (IBD) services, where holistic and personalised models of care are becoming increasingly important. There is, however, a significant lack of representation of underserved and diverse groups in IBD research, and there are significant barriers to healthcare access and utilisation among minority groups in IBD. IBD centres need to be aware of these experiences to address barriers via service changes, improve interactions with local communities and promote meaningful engagement for improved health outcomes. METHODS: A pragmatic community-based approach was taken to engage with leaders and members of underserved groups across 11 workshops representing Roma, Afro-Caribbean, people of African descent and the wider black, Asian and minority ethnic (BAME) communities, Muslim women, refugee community members, deprived areas of South Yorkshire, LGBTQ+ and deaf populations. Thematic analysis of field notes identified patterns of attention across the community groups and where improvements to services were most frequently suggested. RESULTS: Findings demonstrated several barriers experienced to healthcare access and utilisation, including language accessibility, staff attitudes and awareness, mental health and stigma, continuity of support, and practical factors such as ease of service use and safe spaces. These barriers acted as a lever to co-producing service changes that are responsive to the health and social care needs of these groups. CONCLUSIONS: Engaging with people from a range of communities is imperative for ensuring that service improvements in IBD are accessible and representative of individual needs and values. PATIENT OR PUBLIC CONTRIBUTION: Local community leaders and members of community groups actively participated in the co-design and development of improvements to the IBD service for a local hospital. Their contributions further informed a pilot process for quality improvement programmes in IBD centres.

Delivering relational continuity of care in UK general practice: a scoping review.

BACKGROUND: Relational continuity of care (patients seeing the same GP) is associated with better outcomes for patients, but it has been declining in general practice in the UK. AIM: To understand what interventions have been tried to improve relational continuity of care in general practice in the UK. DESIGN & SETTING: Scoping review METHOD: An electronic search of MEDLINE, Embase and Scopus from 2002 to the present day was undertaken. Sources of grey literature were also searched. Studies that detailed service-level methods of achieving relational continuity of care with a GP in the UK were eligible for inclusion. Interventions were described narratively in relation to the elements listed in the Template for Intervention Description and Replication (TIDieR). A logic model describing the rationale behind interventions was constructed. RESULTS: 17 unique interventions were identified. The interventions used a wide variety of strategies to try to improve relational continuity. This included personal lists, amended booking processes, regular reviews, digital technology, facilitated follow ups, altered appointment times, and use of acute hubs. 12 of the interventions targeted specific patient groups for increased continuity whilst others focused on increasing continuity for all patients. Changes in continuity levels were measured inconsistently using several different methods. CONCLUSION: Several different strategies have been used in UK general practices in an attempt to improve relational continuity of care. Whilst there is a similar underlying logic to these interventions, their scope, aims and methods vary considerably. Furthermore, due to a weak evidence base, comparing their efficacy remains challenging.

Real-world practice and outcomes in pilonidal surgery: Pilonidal Sinus Treatment Studying The Options (PITSTOP) cohort.

BACKGROUND: Numerous surgical approaches exist for the treatment of pilonidal disease. Current literature on treatment is of poor quality, limiting the ability to define optimal intervention. The aim of this study was to provide real-world data on current surgical practice and report patient and risk-adjusted outcomes, informing future trial design. METHODS: This UK-wide multicentre prospective cohort study, including patients (aged over 16 years) who had definitive treatment for symptomatic pilonidal disease, was conducted between May 2019 and March 2022. Patient and disease characteristics, and intervention details were analysed. Data on patient-reported outcomes, including pain, complications, treatment failure, wound issues, and quality of life, were gathered at various time points up to 6 months after surgery. Strategies were implemented to adjust for risk influencing different treatment choices and outcomes. RESULTS: Of the 667 participants consenting, 574 (86.1%) were followed up to the study end. Twelve interventions were observed. Broadly, 59.5% underwent major excisional surgery and 40.5% minimally invasive surgery. Complications occurred in 45.1% of the cohort. Those who had minimally invasive procedures had better quality of life and, after risk adjustment, less pain (score on day 1: mean difference 1.58, 95% c.i. 1.14 to 2.01), fewer complications (difference 17.5 (95% c.i. 9.1 to 25.9)%), more rapid return to normal activities (mean difference 25.9 (18.4 to 33.4) days) but a rate of higher treatment failure (difference 9.6 (95% c.i. 17.3 to 1.9)%). At study end, 25% reported an unhealed wound and 10% had not returned to normal activities. CONCLUSION: The burden after surgery for pilonidal disease is high and treatment failure is common. Minimally invasive techniques may improve outcomes at the expense of a 10% higher risk of treatment failure.

Quality improvement exercises in Inflammatory Bowel Disease (IBD) services: A scoping review.

OBJECTIVE: Quality Improvement initiatives aim to improve care in Inflammatory Bowel Disease (IBD). These address a range of aspects of care including adherence to published guidelines. The objectives of this review were to document the scope and quality of published quality improvement initiatives in IBD, highlight successful interventions and the outcomes achieved. DESIGN/METHOD: We searched MEDLINE, EMBASE, CINAHL and Web of Science. Two reviewers independently screened and extracted data. We included peer reviewed articles or conference proceedings reporting initiatives intended to improve the quality of IBD care, with both baseline and prospectively collected follow-up data. Initiatives were categorised based on problems, interventions and outcomes. We used the Quality Improvement Minimum Quality Criteria Set instrument to appraise articles. We mapped the focus of the articles to the six domains of the IBD standards. RESULTS: 100 studies were identified (35 full text; 65 conference abstracts). Many focused on vaccination, medication, screening, or meeting multiple quality measures. Common interventions included provider education, the development of new service protocols, or enhancements to the electronic medical records. Studies principally focused on areas covered by the IBD standards 'ongoing care' and 'the IBD service', with less focus on standards 'pre-diagnosis', 'newly diagnosed', 'flare management', 'surgery' or 'inpatient care'. CONCLUSION: Good quality evidence exists on approaches to improve the quality of a narrow range of IBD service functions, but there are many topic areas with little or no published quality improvement initiatives. We highlight successful quality improvement interventions and offer recommendations to improve reporting of future studies.

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

BACKGROUND: Without surgical repair, flexor tendon injuries do not heal and patients' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap. METHODS: FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants' preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness. DISCUSSION: FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes. TRIAL REGISTRATION: ISRCTN: 10236011.

Safety and efficacy of autologous haematopoietic stem-cell transplantation with low-dose cyclophosphamide mobilisation and reduced intensity conditioning versus standard of care in refractory Crohn's disease (ASTIClite): an open-label, multicentre, randomised controlled trial.

BACKGROUND: A previous controlled trial of autologous haematopoietic stem-cell transplantation (HSCT) in patients with refractory Crohn's disease did not meet its primary endpoint and reported high toxicity. We aimed to assess the safety and efficacy of HSCT with an immune-ablative regimen of reduced intensity versus standard of care in this patient population. METHODS: This open-label, multicentre, randomised controlled trial was conducted in nine National Health Service hospital trusts across the UK. Adults (aged 18-60 years) with active Crohn's disease on endoscopy (Simplified Endoscopic Score for Crohn's Disease [SES-CD] ulcer sub-score of ≥2) refractory to two or more classes of biological therapy, with no perianal or intra-abdominal sepsis or clinically significant comorbidity, were recruited. Participants were centrally randomly assigned (2:1) to either HSCT with a reduced dose of cyclophosphamide (intervention group) or standard care (control group). Randomisation was stratified by trial site by use of random permuted blocks of size 3 and 6. Patients in the intervention group underwent stem-cell mobilisation (cyclophosphamide 1 g/m2 with granulocyte colony-stimulating factor (G-CSF) 5 µg/kg) and stem-cell harvest (minimum 2·0 × 106 CD34+ cells per kg), before conditioning (fludarabine 125 mg/m2, cyclophosphamide 120 mg/kg, and rabbit anti-thymocyte globulin [thymoglobulin] 7·5 mg/kg in total) and subsequent stem-cell reinfusion supported by G-CSF. Patients in the control group continued any available conventional, biological, or nutritional therapy. The primary outcome was absence of endoscopic ulceration (SES-CD ulcer sub-score of 0) without surgery or death at week 48, analysed in the intention-to-treat population by central reading. This trial is registered with the ISRCTN registry, 17160440. FINDINGS: Between Oct 18, 2018, and Nov 8, 2019, 49 patients were screened for eligibility, of whom 23 (47%) were randomly assigned: 13 (57%) to the intervention group and ten (43%) to the control group. In the intervention group, ten (77%) participants underwent HSCT and nine (69%) reached 48-week follow-up; in the control group, nine (90%) reached 48-week follow-up. The trial was halted in response to nine reported suspected unexpected serious adverse reactions in six (46%) patients in the intervention group, including renal failure due to proven thrombotic microangiopathy in three participants and one death due to pulmonary veno-occlusive disease. At week 48, absence of endoscopic ulceration without surgery or death was reported in three (43%) of seven participants in the intervention group and in none of six participants in the control group with available data. Serious adverse events were more frequent in the intervention group (38 in 13 [100%] patients) than in the control group (16 in four [40%] patients). A second patient in the intervention group died after week 48 of respiratory and renal failure. INTERPRETATION: Although HSCT with an immune-ablative regimen of reduced intensity decreased endoscopic disease activity, significant adverse events deem this regimen unsuitable for future clinical use in patients with refractory Crohn's disease. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.

Bracing Adolescent Idiopathic Scoliosis (BASIS) study - night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial.

Aims: Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of 'full-time bracing' versus 'night-time bracing' in adolescent idiopathic scoliosis (AIS). Methods: UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion: The primary outcome is 'treatment failure' (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or 'treatment success' (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry.

Prehospital early warning scores for adults with suspected sepsis: retrospective diagnostic cohort study.

BACKGROUND: Ambulance services need to identify and prioritise patients with sepsis for early hospital assessment. We aimed to determine the accuracy of early warning scores alongside paramedic diagnostic impression to identify sepsis that required urgent treatment. METHODS: We undertook a retrospective diagnostic cohort study involving adult emergency medical cases transported to Sheffield Teaching Hospitals ED by Yorkshire Ambulance Service in 2019. We used routine ambulance service data to calculate 21 early warning scores and categorise paramedic diagnostic impressions as sepsis, infection, non-specific presentation or other presentation. We linked cases to hospital records and identified those meeting the sepsis-3 definition who received urgent hospital treatment for sepsis (reference standard). Analysis determined the accuracy of strategies that combined early warning scores at varying thresholds for positivity with paramedic diagnostic impression. RESULTS: We linked 12 870/24 955 (51.6%) cases and identified 348/12 870 (2.7%) with a positive reference standard. None of the strategies provided sensitivity greater than 0.80 with positive predictive value greater than 0.15. The area under the receiver operating characteristic curve for the National Early Warning Score, version 2 (NEWS2) applied to patients with a diagnostic impression of sepsis or infection was 0.756 (95% CI 0.729, 0.783). No other early warning score provided clearly superior accuracy to NEWS2. Paramedic impression of sepsis or infection had sensitivity of 0.572 (0.519, 0.623) and positive predictive value of 0.156 (0.137, 0.176). NEWS2 thresholds of >4, >6 and >8 applied to patients with a diagnostic impression of sepsis or infection, respectively, provided sensitivities and positive predictive values of 0.522 (0.469, 0.574) and 0.216 (0.189, 0.245), 0.447 (0.395, 0.499) and 0.274 (0.239, 0.313), and 0.314 (0.268, 0.365) and 0.333 (0.284, 0.386). CONCLUSION: No strategy is ideal but using NEWS2 alongside paramedic diagnostic impression of infection or sepsis could identify one-third to half of sepsis cases without prioritising unmanageable numbers. No other score provided clearly superior accuracy to NEWS2. TRIAL REGISTRATION NUMBER: researchregistry5268, https://www.researchregistry.com/browse-the-registry%23home/registrationdetails/5de7bbd97ca5b50015041c33/.

Implementing psychological support for health and social care staff affected by the COVID-19 pandemic: a qualitative exploration of staff well-being hubs ('Resilience Hubs') using normalisation process theory.

OBJECTIVES: Evaluate the implementation of Hubs providing access to psychological support for health and social care keyworkers affected by the COVID-19 pandemic. DESIGN: Qualitative interviews informed by normalisation process theory to understand how the Hub model became embedded into normal practice, and factors that disrupted normalisation of this approach. SETTING: Three Resilience Hubs in the North of England. PARTICIPANTS: Hub staff, keyworkers who accessed Hub support (Hub clients), keyworkers who had not accessed a Hub, and wider stakeholders involved in the provision of staff support within the health and care system (N=63). RESULTS: Hubs were generally seen as an effective way of supporting keyworkers, and Hub clients typically described very positive experiences. Flexibility and adaptability to local needs were strongly valued. Keyworkers accessed support when they understood the offer, valuing a confidential service that was separate from their organisation. Confusion about how Hubs differed from other support prevented some from enrolling. Beliefs about job roles, unsupportive managers, negative workplace cultures and systemic issues prevented keyworkers from valuing mental health support. Lack of support from managers discouraged keyworker engagement with Hubs. Black, Asian and minority ethnic keyworkers impacted by racism felt that the Hubs did not always meet their needs. CONCLUSIONS: Hubs were seen as a valuable, responsive and distinct part of the health and care system. Findings highlight the importance of improving promotion and accessibility of Hubs, and continuation of confidential Hub support. Policy implications for the wider health and care sector include the central importance of genuine promotion of and value placed on mental health support by health and social care management, and the creation of psychologically safe work environments. Diversity and cultural competency training is needed to better reach under-represented communities. Findings are consistent with the international literature, therefore, likely to have applicability outside of the current context.

Personalising airway clearance in chronic suppurative lung diseases: a scoping review.

Background: Personalised airway clearance techniques are commonly recommended to augment mucus clearance in chronic suppurative lung diseases. It is unclear what current literature tells us about how airway clearance regimens should be personalised. This scoping review explores current research on airway clearance technique in chronic suppurative lung diseases, to establish the extent and type of guidance in this area, identify knowledge gaps and determine the factors which physiotherapists should consider when personalising airway clearance regimens. Methods: Systematic searching of online databases (MEDLINE, EMBASE, CINAHL, PEDro, Cochrane, Web of Science) was used to identify full-text publications in the last 25 years that described methods of personalising airway clearance techniques in chronic suppurative lung diseases. Items from the TIDieR framework provided a priori categories which were modified based on the initial data to develop a "Best-fit" framework for data charting. The findings were subsequently transformed into a personalisation model. Results: A broad range of publications were identified, most commonly general review papers (44%). The items identified were grouped into seven personalisation factors: physical, psychosocial, airway clearance technique (ACT) type, procedures, dosage, response and provider. As only two divergent models of ACT personalisation were found, the personalisation factors identified were then used to develop a model for physiotherapists. Conclusions: The personalisation of airway clearance regimens is widely discussed in the current literature, which provides a range of factors that should be considered. This review summarises the current literature, organising findings into a proposed airway clearance personalisation model, to provide clarity in this field.

Patient preferences for pilonidal sinus treatments: a discrete choice experiment survey.

BACKGROUND: A range of treatments are available for pilonidal sinus disease (PSD), each of which has a different risk/benefit profile. The aim of this study was to collect patient views on which interventions they would rather avoid and which outcomes they most value for PSD. METHOD: We conducted an online survey using the discrete choice experiment (DCE) method. DCE task involved participants choosing the best treatment option when presented with a set of competing hypothetical treatment profiles. Participants with symptomatic PSD, referred for elective surgery were recruited from 33 NHS trusts between 2020 and 2022. Collected DCE data were analysed using regression analyses. RESULTS: One hundred and eleven participants completed the survey. In the overall group, low risk of infection/persistence was the most important characteristic when making a treatment decision (attribute importance score of 70%), followed by treatments with shorter recovery time with an attribute importance score of 30%. The results demonstrated that patients are willing to accept trade-offs between treatment recovery time and risk of infection/persistence. Patients above 30 years old are willing to accept a higher chance of treatment failure in exchange for rapid treatment recovery (risk tolerance between 22.35 - 34.67 percentage points). Conversely, patients in the younger age groups, were risk averse, and were only willing to accept a small risk 1.51-2.15 in exchange for a treatment with faster recovery time. All patient groups appear to the reject the excision and leave open technique due to the need for protracted nursing care. CONCLUSION: This study highlights the need for shared decision making when it comes to surgery for PSD.