Natural language processing to automate a web-based model of care and modernize skin cancer multidisciplinary team meetings.

BACKGROUND: Cancer multidisciplinary team (MDT) meetings are under intense pressure to reform given the rapidly rising incidence of cancer and national mandates for protocolized streaming of cases. The aim of this study was to validate a natural language processing (NLP)-based web platform to automate evidence-based MDT decisions for skin cancer with basal cell carcinoma as a use case. METHODS: A novel and validated NLP information extraction model was used to extract perioperative tumour and surgical factors from histopathology reports. A web application with a bespoke application programming interface used data from this model to provide an automated clinical decision support system, mapped to national guidelines and generating a patient letter to communicate ongoing management. Performance was assessed against retrospectively derived recommendations by two independent and blinded expert clinicians. RESULTS: There were 893 patients (1045 lesions) used to internally validate the model. High accuracy was observed when compared against human predictions, with an overall value of 0.92. Across all classifiers the virtual skin MDT was highly specific (0.96), while sensitivity was lower (0.72). CONCLUSION: This study demonstrates the feasibility of a fully automated, virtual, web-based service model to host the skin MDT with good system performance. This platform could be used to support clinical decision-making during MDTs as 'human in the loop' approach to aid protocolized streaming. Future prospective studies are needed to validate the model in tumour types where guidelines are more complex.

The epidemiology, healthcare and societal burden of basal cell carcinoma in Wales 2000-2018: a retrospective nationwide analysis.

BACKGROUND: Basal cell carcinoma (BCC) represents the most commonly occurring cancer worldwide within the white population. Reports predict 298 308 cases of BCC in the UK by 2025, at a cost of £265-366 million to the National Health Service (NHS). Despite the morbidity, societal and healthcare pressures brought about by BCC, routinely collected healthcare data and global registration remain limited. OBJECTIVES: To calculate the incidence of BCC in Wales between 2000 and 2018 and to establish the related healthcare utilization and estimated cost of care. METHODS: The Secure Anonymised Information Linkage (SAIL) databank is one of the largest and most robust health and social care data repositories in the UK. Cancer registry data were linked to routinely collected healthcare databases between 2000 and 2018. Pathological data from Swansea Bay University Health Board (SBUHB) were used for internal validation. RESULTS: A total of 61 404 histologically proven BCCs were identified within the SAIL Databank during the study period. The European age-standardized incidence for BCC in 2018 was 224.6 per 100 000 person-years. Based on validated regional data, a 45% greater incidence was noted within SBUHB pathology vs. matched regions within SAIL between 2016 and 2018. A negative association between deprivation and incidence was noted with a higher incidence in the least socially deprived and rural dwellers. Approximately 2% travelled 25-50 miles for dermatological services compared with 37% for plastic surgery. Estimated NHS costs of surgically managed lesions for 2002-2019 equated to £119.2-164.4 million. CONCLUSIONS: Robust epidemiological data that are internationally comparable and representative are scarce for nonmelanoma skin cancer. The rising global incidence coupled with struggling healthcare systems in the post-COVID-19 recovery period serve to intensify the societal and healthcare impact. This study is the first to demonstrate the incidence of BCC in Wales and is one of a small number in the UK using internally validated large cohort datasets. Furthermore, our findings demonstrate one of the highest published incidences within the UK and Europe.

Infliximab versus ciclosporin in steroid resistant acute severe ulcerative colitis: a model-based cost-utility analysis of data from CONSTRUCT pragmatic trial.

BACKGROUND: There is limited evidence in the literature on the long-term effectiveness and cost-effectiveness of treatments for Acute Severe Ulcerative Colitis (ASUC). The study aimed to perform decision analytic model-based long-term cost-utility analysis (CUA) of infliximab versus ciclosporin for steroid-resistant ASUC investigated in CONSTRUCT pragmatic trial. METHODS: A decision tree (DT) model was developed using two-year health effect, resource use and costs data from CONSTRUCT trial to estimate relative cost-effectiveness of two competing drugs from the United Kingdom (UK) National Health Services (NHS) perspective. Using short-term trial data, a Markov model (MM) was then developed and evaluated over further 18 years. Both DT and MM were combined to investigate cost-effectiveness of infliximab versus ciclosporin for ASUC patients over 20-year time horizon, with a rigorous multiple deterministic and probabilistic sensitivity analyses to address uncertainty in results. RESULTS: The decision tree mirrored trial-based results. Beyond 2-year trial follow-up, Markov model predicted a decrease in colectomy rate, but it remained slightly higher for ciclosporin. NHS costs and quality adjusted life years (QALYs) over base-case 20 year time horizon were £26,793 and 9.816 for ciclosporin and £34,185 and 9.106 for infliximab, suggesting ciclosporin dominates infliximab. Ciclosporin had 95% probability of being cost-effective at a willingness-to-pay (WTP) threshold value up to £20,000. CONCLUSION: Using data from a pragmatic RCT, the cost-effectiveness models produced incremental net health benefit in favour of ciclosporin relative to infliximab. Results from long-term modelling indicated that ciclosporin remains dominant compared with infliximab for the treatment of NHS ASUC patients, however, these need to be interpreted cautiously. TRIAL REGISTRATION: CONSTRUCT Trial registration number ISRCTN22663589; EudraCT number: 2008- 001968-36 (Date 27/08/2008).

Risk factors that predict mortality in patients with blunt chest wall trauma: an updated systematic review and meta-analysis.

BACKGROUND: Over the last 10 years, research has highlighted emerging potential risk factors for poor outcomes following blunt chest wall trauma. The aim was to update a previous systematic review and meta-analysis of the risk factors for mortality in blunt chest wall trauma patients. METHODS: A systematic review of English and non-English articles using MEDLINE, Embase and Cochrane Library from January 2010 to March 2022 was completed. Broad search terms and inclusion criteria were used. All observational studies were included if they investigated estimates of association between a risk factor and mortality for blunt chest wall trauma patients. Where sufficient data were available, ORs with 95% CIs were calculated using a Mantel-Haenszel method. Heterogeneity was assessed using the I2 statistic. RESULTS: 73 studies were identified which were of variable quality (including 29 from original review). Identified risk factors for mortality following blunt chest wall trauma were: age 65 years or more (OR: 2.11; 95% CI 1.85 to 2.41), three or more rib fractures (OR: 1.96; 95% CI 1.69 to 2.26) and presence of pre-existing disease (OR: 2.86; 95% CI 1.34 to 6.09). Other new risk factors identified were: increasing Injury Severity Score, need for mechanical ventilation, extremes of body mass index and smoking status. Meta-analysis was not possible for these variables due to insufficient studies and high levels of heterogeneity. CONCLUSIONS: The results of this updated review suggest that despite a change in demographics of trauma patients and subsequent emerging evidence over the last 10 years, the main risk factors for mortality in patients sustaining blunt chest wall trauma remained largely unchanged. A number of new risk factors however have been reported that need consideration when updating current risk prediction models used in the ED. PROSPERO REGISTRATION NUMBER: CRD42021242063. Date registered: 29 March 2021. https://www.crd.york.ac.uk/PROSPERO/%23recordDetails.

Exploring facilitators of the implementation of electronic health records in Saudi Arabia.

INTRODUCTION: The introduction of information technology was one of the key priorities for policy-makers in health care organisations over the last two decades due to the potential benefits of this technology to improve health care services and quality. However, approximately 50% of those projects failed to achieve their intended aims. This was a result of several factors, including the cost of these projects. The Saudi Ministry of Health (MoH) planned to implement an electronic health record system (EHRS) in approximately 2100 primary health care centres nationwide. It was acknowledged that this project may face hurdles, which might result in the failure of the project if implementation facilitators were not first determined. According to the Saudi MoH, previous electronic health record system implementation in primary health care centres failed as a consequence of several barriers, such as poor infrastructure, lack of connectivity and lack of interoperability. However, the facilitators of successful electronic health record system implementation in Saudi primary health care centres are not understood. AIM: To determine the facilitators that enhance the success of the implementation of an EHRS in public primary health care centres in SA. METHOD: A mixed methods approach was used with both qualitative and quantitative methods (qualitative using semistructured interviews and quantitative with a closed survey). The purpose of the utilisation of exploratory mixed methods was to identify a wide range of facilitators that may influence EHRS implementation. The data were obtained from two different perspectives, primary health care centre practitioners and project team members. A total of 351 practitioners from 21 primary health care centres participated in the online survey, and 14 key informants at the Saudi Ministry of Health who were directly involved in the electronic health record system implementation in the primary health care centres agreed to be interviewed face to face. RESULTS: The findings from both studies revealed several facilitators. Among these facilitators, financial resources were found to be the most influential factor that assisted in overcoming some barriers, such as software selection. The size of the primary health care centres was the second facilitator of successful implementation, despite the scale of the project. Perceived usefulness was another facilitator identified in both the interviews and the survey. More than 90% of the participants thought that the electronic health record system was useful and could contribute to improving the quality of health care services. While a high level of satisfaction was expressed towards the electronic health record system's usability and efficiency, low levels of satisfaction were recorded for organisational factors such as user involvement, training and support. Hence, system usability and efficiency were documented to be other facilitators of successful electronic health record system implementation in Saudi primary health care centres. CONCLUSION: The findings of the present study suggest that sufficient financial support is essential to enhance the success of electronic health record system implementation despite the scale of the project. Additionally, effective leadership and project management are core factors to overcome many obstacles and ensure the success of large-scale projects.

Rasch Analysis of the Listening Effort Questionnaire-Cochlear Implant.

OBJECTIVES: Listening effort may be defined as the attentional and cognitive resources needed to understand an auditory message, modulated by motivation. Despite the use of hearing devices such as hearing aids or cochlear implants (CIs), the requirement for high listening effort remains a challenge for individuals with hearing loss. The Listening Effort Questionnaire-Cochlear Implant (LEQ-CI) is a hearing-specific patient-reported outcome measure (PROM), which has been designed for use in the CI candidacy and rehabilitation process to assess perceived listening effort in everyday life in adults with severe-profound hearing loss. The LEQ-CI has been developed in line with international consensus-based standards for best practice in PROM construction. The aim of this study was to improve the measurement precision of the LEQ-CI and to assess its psychometric measurement properties. DESIGN: A field test was undertaken with 330 CI patients from five National Health Service auditory implant centers in the United Kingdom. Participants were adults (≥18 years of age), had a severe-profound hearing loss, and met the UK candidacy criteria for cochlear implantation specified by the National Institute for Health and Care Excellence (NICE). Participants completed and returned an anonymized 29-item (each with a 5- or 7-point response option), draft version of the LEQ-CI (LEQ-CI29) and a demographic questionnaire. Rasch analysis was undertaken using Winsteps software and the partial credit model to assess rating scale function and item fit. Results informed refinements to produce a 21-item version (LEQ-CI21), which underwent a further Rasch analysis. RESULTS: The sample was predominantly female: 60.3% (n = 191). Median age of participants was 66 (range 21 to 89) years, with 7.3% (n = 24) of respondents being CI candidates and 92.7% (n = 306) being CI recipients. Mean duration of implantation was 3.8 (SD = 4.8) years. Initial Rasch analysis of the LEQ-CI29 revealed poor rating scale functioning. Collapsing the 5- and 7-point rating scales to 3- and 4-point scales and removing eight items produced a 21-item PROM (LEQ-CI21). Rasch analysis of the LEQ-CI21 showed good fit to the Rasch measurement model. No items showed misfit and dimensionality analysis supported the existence of a single Rasch dimension, defined as perceived listening effort in daily life. Person reliability was 0.91 and the person separation index was 3.28, establishing four levels of person ability. The item separation index was 9.69, confirming the item hierarchy. No items showed differential item functioning for gender or age. The item difficulty range was -0.81 to 1.05, the person ability range for nonextreme persons was -3.54 to 2.49, and the mean person ability was -0.31. CONCLUSIONS: Overall, the LEQ-CI21 was found to meet the Rasch model criteria for interval-level measurement. The LEQ-CI21 is the first PROM to be developed specifically for the measurement of perceived listening effort and one of the first patient-reported outcome measures for use with CI patients to be developed using Rasch analysis. The LEQ-CI21 has the potential to be used as a research tool and in clinical practice to evaluate perceived listening effort in daily life. Further psychometric evaluation of the LEQ-CI21 is planned.

Making the Most of Big Data in Plastic Surgery: Improving Outcomes, Protecting Patients, Informing Service Providers.

ABSTRACT: In medicine, "big data" refers to the interdisciplinary analysis of high-volume, diverse clinical and lifestyle information on large patient populations. Recent advancements in data storage and electronic record keeping have enabled the expansion of research in this field. In the United Kingdom, Big data has been highlighted as one of the government's "8 Great Technologies," and the Medical Research Council has invested more than £100 million since 2012 in developing the Health Data Research UK infrastructure. The recent Royal College of Surgeons Commission of the Future of Surgery concluded that analysis of big data is one of the 4 most likely avenues to bring some of the most innovative changes to surgical practice in the 21st century.In this article, we provide an overview of the nascent field of big data analytics in plastic and highlight how it has the potential to improve outcomes, increase safety, and aid service planning.We outline the current resources available, the emerging role of big data within the subspecialties of burns, microsurgery, skin and breast cancer, and how these data can be used. We critically review the limitations and considerations raised with big data, offer suggestions regarding database optimization, and suggest future directions for research in this exciting field.

EarLy Exercise in blunt Chest wall Trauma: a feasibility trial (ELECT Trial).

BACKGROUND: The aim was to complete a feasibility study that would test the methods of the main trial, that will investigate whether early thoracic and shoulder girdle exercises reduce chronic pain in patients with blunt chest wall trauma, when compared with normal care. METHODS: A single centre, parallel, feasibility randomised controlled trial was completed at a University Teaching Hospital in Wales between June and September 2019. Adult patients with blunt chest wall trauma, admitted to hospital for greater than 24 hours, with no concurrent, immediately life-threatening injuries, were included. The intervention was a simple physiotherapy programme comprising thoracic and shoulder girdle exercises. Feasibility outcome measures included: primary outcomes: (1) 80% or more of identified eligible patients were approached for potential recruitment to the trial (2) 30% or less of approached, eligible patients dissented to participate in the trial; secondary outcomes: (3) follow-up data for patient secondary outcomes can be collected for 80% or more of patients, (4) there should be no greater than 10% increase in serious adverse events in the intervention group compared with the control group. RESULTS: A total of 19/19 (100%) patients were deemed eligible for the trial and were approached for participation, 5/19 (26%) eligible patients declined to participate in the trial, follow-up data were collected for n=10/14 (71%) patients and there were no serious adverse events reported in either group. CONCLUSIONS: We have demonstrated that a fully powered randomised clinical trial of the EarLy Exercise in blunt Chest wall Trauma Trial is feasible. TRIAL REGISTRATION NUMBER: ISRCTN16197429.

Prognostic prediction tools and clinician communication: a qualitative study of the effect of the STUMBL tool on clinical practice.

BACKGROUND: In recent years, researchers and clinicians have been developing prognostic prediction tools (PPTs) as a way of identifying patients at risk of deterioration. The use of PPTs in the clinical environment not only impacts the risk of adverse outcomes for patients, but the use of these tools also effect clinical practice. Much attention has been paid to the clinical performance of PPTs. But more insight is needed on how the use of PPTs impacts clinical practice. The objective of this study was to map some of the ways in which PPTs effect clinical practice. The STUMBL (STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients) feasibility trial evaluated the use of a new prognostic prediction tool (PPT) to guide the management blunt chest wall trauma patients in the emergency departments (ED). The trial was undertaken between October 2016 and September 2018 and conducted at four sites in England and Wales. Nested within the feasibility trial was a qualitative study aimed at understanding how ED clinicians experienced and used the PPT. The qualitative methods included a focus group and telephone interviews with 9 ED clinicians. This study focused on participant perceptions of the feasibility and use of the STUMBL tool on clinical practice in the ED. RESULTS: Clinical practice is reshaped as a result of the introduction of the STUMBL PPT into the clinical environment. The PPT enhanced reflexive awareness of prognostic practice; facilitated communication between patients and professionals; helps to guide patient outcomes; and provides a common ground for clinician discussion on prognostication. CONCLUSIONS: The qualitative data collected offered useful insights into the ways in which the tool changes clinical practice. This was a small study of the effect of one kind of PPT on clinical practice. Nevertheless, this study maps areas in which clinical practice is affected by the introduction of a PPT into the clinical environment. More research is needed to better understand these effects, and to understand how these tools become embedded in clinical practice over the longer term.

Effect of the COVID-19 pandemic on the mental health of carers of people with intellectual disabilities.

INTRODUCTION: The measures implemented to manage the COVID-19 pandemic have been shown to impair mental health. This problem is likely to be exacerbated for carers. METHOD: Informal carers (mainly parents) of children and adults with intellectual disabilities, and a comparison group of parents of children without disabilities, completed an online questionnaire. Almost all the data were collected while strict lockdown conditions were in place. RESULTS: Relative to carers of children without intellectual disability, carers of both children and adults with intellectual disability had significantly greater levels of a wish fulfilment coping style, defeat/entrapment, anxiety, and depression. Differences were 2-3 times greater than reported in earlier pre-pandemic studies. Positive correlations were found between objective stress scores and all mental health outcomes. Despite their greater mental health needs, carers of those with intellectual disability received less social support from a variety of sources. CONCLUSIONS: The greater mental health needs of carers in the context of lesser social support raises serious concerns. We consider the policy implications of these findings.

Patient views about the impact of ulcerative colitis and its management with drug treatment and surgery: a nested qualitative study within the CONSTRUCT trial.

BACKGROUND: A nested qualitative interview study within the CONSTRUCT trial was conducted to explore experiences and perceptions of patients with acute severe ulcerative colitis following treatment with infliximab or ciclosporin, surgery, or other medication. METHODS: Two hundred seventy patients with steroid-resistant ulcerative colitis were randomised to either infliximab or ciclosporin. Interviews were conducted with 20 trial participants. Thirty-five data capture events took place in total, 20 interviews conducted 3 months after treatment and a further 15 interviews with the same cohort as second interviews at 12 months. RESULTS: Disease duration varied but similar stories emerged about how people adjusted to living with ulcerative colitis. Issues raised by patients included; the debilitating effect of the disease on quality of life, living with the unpredictability of symptoms and treatment, dealing with embarrassment and stigma and the desire to share knowledge of the disease with others to combat the private nature of this debilitating illness and bring greater visibility to patient experience of symptoms and outcomes. CONCLUSION: Patients were more positive about treatment with infliximab than ciclosporin, mainly due to the cumbersome intravenous regimen required for ciclosporin. Prompt diagnosis is required and early reporting of changes in symptoms is encouraged to ensure appropriate treatment. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry; number ISRCTN22663589 . The date of registration was 16/05/2008.

Social Connectedness and Perceived Listening Effort in Adult Cochlear Implant Users: A Grounded Theory to Establish Content Validity for a New Patient-Reported Outcome Measure.

OBJECTIVES: Individuals with hearing loss often report a need for increased effort when listening, particularly in challenging acoustic environments. Despite audiologists' recognition of the impact of listening effort on individuals' quality of life, there are currently no standardized clinical measures of listening effort, including patient-reported outcome measures (PROMs). To generate items and content for a new PROM, this qualitative study explored the perceptions, understanding, and experiences of listening effort in adults with severe-profound sensorineural hearing loss before and after cochlear implantation. DESIGN: Three focus groups (1 to 3) were conducted. Purposive sampling was used to recruit 17 participants from a cochlear implant (CI) center in the United Kingdom. The participants included adults (n = 15, mean age = 64.1 years, range 42 to 84 years) with acquired severe-profound sensorineural hearing loss who satisfied the UK's national candidacy criteria for cochlear implantation and their normal-hearing significant others (n = 2). Participants were CI candidates who used hearing aids (HAs) and were awaiting CI surgery or CI recipients who used a unilateral CI or a CI and contralateral HA (CI + HA). Data from a pilot focus group conducted with 2 CI recipients were included in the analysis. The data, verbatim transcripts of the focus group proceedings, were analyzed qualitatively using constructivist grounded theory (GT) methodology. RESULTS: A GT of listening effort in cochlear implantation was developed from participants' accounts. The participants provided rich, nuanced descriptions of the complex and multidimensional nature of their listening effort. Interpreting and integrating these descriptions through GT methodology, listening effort was described as the mental energy required to attend to and process the auditory signal, as well as the effort required to adapt to, and compensate for, a hearing loss. Analyses also suggested that listening effort for most participants was motivated by a need to maintain a sense of social connectedness (i.e., the subjective awareness of being in touch with one's social world). Before implantation, low social connectedness in the presence of high listening effort encouraged self-alienating behaviors and resulted in social isolation with adverse effects for participant's well-being and quality of life. A CI moderated but did not remove the requirement for listening effort. Listening effort, in combination with the improved auditory signal supplied by the CI, enabled most participants to listen and communicate more effectively. These participants reported a restored sense of social connectedness and an acceptance of the continued need for listening effort. CONCLUSIONS: Social connectedness, effort-reward balance, and listening effort as a multidimensional phenomenon were the core constructs identified as important to participants' experiences and understanding of listening effort. The study's findings suggest: (1) perceived listening effort is related to social and psychological factors and (2) these factors may influence how individuals with hearing loss report on the actual cognitive processing demands of listening. These findings provide evidence in support of the Framework for Understanding Effortful Listening a heuristic that describes listening effort as a function of both motivation and demands on cognitive capacity. This GT will inform item development and establish the content validity for a new PROM for measuring listening effort.

Women's Perceptions of Journeying Toward an Unknown Future With Breast Cancer: The "Lives at Risk Study".

Breast cancer risk classifications are useful for prognosis, yet little is known of their effect on patients. This study clarified women's understandings of risk as they "journeyed" through the health care system. Breast cancer patients and women undergoing genetic investigation were recruited ( N = 25) from a large UK Health Board, 2014-2015, completing a "Book of Experience," and Bio-photographic elicitation interviews. Stakeholder and Participant Feedback Forums were undertaken with key stakeholders, including patients, oncologists, funders, and policy developers, to inform team understanding. Thematic and visual frameworks from multidisciplinary analysis workshops uncovered two themes: "Subjective Understandings of Risk" and "Journeying Toward an Unknown Future." Breast cancer patients and women undergoing investigation experienced risk intuitively. Statistical formulations were often perplexing, diverting attention away from concrete life-and-death facts. Following risk classification, care must be co-defined to reduce patients' foreboding about an unknown future, taking into consideration personal risk management strategies and aspirations for a cancer-free future.

It could be a 'Golden Goose': a qualitative study of views in primary care on an emergency admission risk prediction tool prior to implementation.

BACKGROUND: Rising demand for health care has prompted interest in new technologies to support a shift of care from hospital to community and primary care, which may require clinicians to undertake new working practices. A predictive risk stratification tool (Prism) was developed for use in primary care to estimate patients' risk of an emergency hospital admission. As part of an evaluation of Prism, we aimed to understand what might be needed to bring Prism into effective use by exploring clinicians and practice managers' attitudes and expectations about using it. We were informed by Normalisation Process Theory (NPT) which examines the work needed to bring an innovation into use. METHODS: We conducted 4 focus groups and 10 interviews with a total of 43 primary care doctors and colleagues from 32 general practices. All were recorded and transcribed. Analysis focussed in particular on the construct of 'coherence' within NPT, which examines how people understand an innovation and its purpose. RESULTS: Respondents were in agreement that Prism was a technological formalisation of existing practice, and that it would function as a support to clinical judgment, rather than replacing it. There was broad consensus about the role it might have in delivering new models of care based on active management, but there were doubts about the scope for making a difference to some patients and about whether Prism could identify at-risk patients not already known to the clinical team. Respondents did not expect using the tool to be onerous, but were concerned about the work which might follow in delivering care. Any potential value would not be of the tool in isolation, but would depend on the availability of support services. CONCLUSIONS: Policy imperatives and the pressure of rising demand meant respondents were open to trying out Prism, despite underlying uncertainty about what difference it could make. TRIAL REGISTRATION: Controlled Clinical Trials no. ISRCTN55538212 .

Development and validation of the Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ).

BACKGROUND AND STUDY AIMS: Patient satisfaction is a key indicator of the quality of gastrointestinal (GI) endoscopy. The aim of this study was to develop and validate a specific patient satisfaction questionnaire for patients undergoing GI endoscopy--the Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ). PATIENTS AND METHODS: We developed and validated the GESQ within the context of a national multi-institution nurse endoscopy trial, based in secondary care, in three stages: (1) item generation with a panel of patients and professionals following a detailed literature review to identify the most relevant items from existing scales; (2) development and piloting of a draft questionnaire on a sample of patients referred for GI endoscopy; and (3) testing of the questionnaire within a large multicenter pragmatic randomized trial. We undertook psychometric analysis of the questionnaire to identify the underlying dimensions and assessed the questionnaire for reliability and validity. RESULTS: The final version of the GESQ contains 21 items. Principal components analysis revealed four subscales with high internal consistency: skills and hospital (seven items; Cronbach's alpha 0.83), pain and discomfort during and after endoscopy (four items; Cronbach's alpha 0.84), information before endoscopy (five items; Cronbach's alpha 0.80), and information after endoscopy (five items; Cronbach's alpha 0.76). CONCLUSIONS: The four identified subscales are clinically relevant and correspond to domains of patient satisfaction identified in previous studies. Our development and validation of the GESQ confirmed that it is a valid, reliable, interpretable, and acceptable tool to measure satisfaction in patients who have undergone a GI endoscopy.

Qualitative research and its methods in epilepsy: Contributing to an understanding of patients' lived experiences of the disease.

This review paper makes the case for the usefulness of qualitative research methods in the context of epilepsy research. It begins with an assessment of the current state of epilepsy literature and identifies gaps especially in the following: research in 'developing' countries and research around surgery for adults with epilepsy. It makes the case that disclosure of people's behaviors, actions, and reactions in different, often complex health-care situations can indicate how they bring meaning to their disease experiences and support needs. It shows the value of encouraging work that clarifies how patients manage their illness and how they understand changes in their health and well-being over the life course of their illness and how health-care professionals and other stakeholder groups care for those with epilepsy. The paper suggests a range of methods for addressing gaps in the literature and highlights a range of data collection, data analysis, and data interpretation and synthesis techniques that are appropriate in this context. It pays particular attention to the strengths of qualitative applications in mixed-methods research using an example from a recent ulcerative colitis drug trial that indicates how they can be integrated into study findings, add rich description, and enhance study outcomes. Ethnographic methodology is also presented, as a way of offering rare access to the 'lived experience' dimension, before the paper concludes with an assessment of the qualitative criteria of credibility, dependability, transferability, and confirmability for judging a study's 'trustworthiness'. The criteria evidence not only the trustworthiness of data and findings but also the ways in which a study has approached any challenges inherent in its research design.

Lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea and Clostridium difficile diarrhoea in older inpatients (PLACIDE): a randomised, double-blind, placebo-controlled, multicentre trial.

BACKGROUND: Antibiotic-associated diarrhoea (AAD) occurs most frequently in older (≥65 years) inpatients exposed to broad-spectrum antibiotics. When caused by Clostridium difficile, AAD can result in life-threatening illness. Although underlying disease mechanisms are not well understood, microbial preparations have been assessed in the prevention of AAD. However, studies have been mostly small single-centre trials with varying quality, providing insufficient data to reliably assess effectiveness. We aimed to do a pragmatic efficacy trial in older inpatients who would be representative of those admitted to National Health Service (NHS) and similar secondary care institutions and to recruit a sufficient number of patients to generate a definitive result. METHODS: We did a multicentre, randomised, double-blind, placebo-controlled, pragmatic, efficacy trial of inpatients aged 65 years and older and exposed to one or more oral or parenteral antibiotics. A computer-generated randomisation scheme was used to allocate participants (in a 1:1 ratio) to receive either a multistrain preparation of lactobacilli and bifidobacteria, with a total of 6 × 10(10) organisms, one per day for 21 days, or an identical placebo. Patients, study staff, and specimen and data analysts were masked to assignment. The primary outcomes were occurrence of AAD within 8 weeks and C difficile diarrhoea (CDD) within 12 weeks of recruitment. Analysis was by modified intention-to-treat. This trial is registered, number ISRCTN70017204. FINDINGS: Of 17,420 patients screened, 1493 were randomly assigned to the microbial preparation group and 1488 to the placebo group. 1470 and 1471, respectively, were included in the analyses of the primary endpoints. AAD (including CDD) occurred in 159 (10·8%) participants in the microbial preparation group and 153 (10·4%) participants in the placebo group (relative risk [RR] 1·04; 95% CI 0·84-1·28; p=0·71). CDD was an uncommon cause of AAD and occurred in 12 (0·8%) participants in the microbial preparation group and 17 (1·2%) participants in the placebo group (RR 0·71; 95% CI 0·34-1·47; p=0·35). 578 (19·7%) participants had one or more serious adverse event; the frequency of serious adverse events was much the same in the two study groups and none was attributed to participation in the trial. INTERPRETATION: We identified no evidence that a multistrain preparation of lactobacilli and bifidobacteria was effective in prevention of AAD or CDD. An improved understanding of the pathophysiology of AAD is needed to guide future studies. FUNDING: Health Technology Assessment programme; National Institute for Health Research, UK.

Predicting outcomes after blunt chest wall trauma: development and external validation of a new prognostic model.

INTRODUCTION: Blunt chest wall trauma accounts for over 15% of all trauma admissions to Emergency Departments worldwide. Reported mortality rates vary between 4 and 60%. Management of this patient group is challenging as a result of the delayed on-set of complications. The aim of this study was to develop and validate a prognostic model that can be used to assist in the management of blunt chest wall trauma. METHODS: There were two distinct phases to the overall study; the development and the validation phases. In the first study phase, the prognostic model was developed through the retrospective analysis of all blunt chest wall trauma patients (n = 274) presenting to the Emergency Department of a regional trauma centre in Wales (2009 to 2011). Multivariable logistic regression was used to develop the model and identify the significant predictors for the development of complications. The model's accuracy and predictive capabilities were assessed. In the second study phase, external validation of the model was completed in a multi-centre prospective study (n = 237) in 2012. The model's accuracy and predictive capabilities were re-assessed for the validation sample. A risk score was developed for use in the clinical setting. RESULTS: Significant predictors of the development of complications were age, number of rib fractures, chronic lung disease, use of pre-injury anticoagulants and oxygen saturation levels. The final model demonstrated an excellent c-index of 0.96 (95% confidence intervals: 0.93 to 0.98). CONCLUSIONS: In our two phase study, we have developed and validated a prognostic model that can be used to assist in the management of blunt chest wall trauma patients. The final risk score provides the clinician with the probability of the development of complications for each individual patient.

Study to evaluate the readability and visual appearance of online resources for blunt chest trauma: an evaluation of online resources using mixed methods.

OBJECTIVES: Blunt chest trauma (BCT) is characterised by forceful and non-penetrative impact to the chest region. Increased access to the internet has led to online healthcare resources becoming used by the public to educate themselves about medical conditions. This study aimed to determine whether online resources for BCT are at an appropriate readability level and visual appearance for the public. DESIGN: We undertook a (1) a narrative overview assessment of the website; (2) a visual assessment of the identified website material content using an adapted framework of predetermined key criteria based on the Centers for Medicare and Medicaid Services toolkit and (3) a readability assessment using five readability scores and the Flesch reading ease score using Readable software. DATA SOURCES: Using a range of key search terms, we searched Google, Bing and Yahoo websites on 9 October 2023 for online resources about BCT. RESULTS: We identified and assessed 85 websites. The median visual assessment score for the identified websites was 22, with a range of -14 to 37. The median readability score generated was 9 (14-15 years), with a range of 4.9-15.8. There was a significant association between the visual assessment and readability scores with a tendency for websites with lower readability scores having higher scores for the visual assessment (Spearman's r=-0.485; p<0.01). The median score for Flesch reading ease was 63.9 (plain English) with a range of 21.1-85.3. CONCLUSIONS: Although the readability levels and visual appearance were acceptable for the public for many websites, many of the resources had much higher readability scores than the recommended level (8-10) and visually were poor.Better use of images would improve the appearance of websites further. Less medical terminology and shorter word and sentence length would also allow the public to comprehend the contained information more easily.