Did the COVID-19 pandemic affect levels of burnout, anxiety and depression among doctors and nurses in Bangladesh? A cross-sectional survey study.

INTRODUCTION: COVID-19 has caused severe disruption to clinical services in Bangladesh but the extent of this, and the impact on healthcare professionals is unclear. We aimed to assess the perceived levels of anxiety, depression and burnout among doctors and nurses during COVID-19 pandemic. METHODS: We undertook an online survey using RedCap, directed at doctors and nurses across four institutions in Bangladesh (The Sheikh Russel Gastro Liver Institute & Hospital (SRNGIH), Dhaka Medical College Hospital (DMCH), Mugda Medical College Hospital (MMCH) and M Abdur Rahim Medical College (MARMC) Hospital). We collected information on demographics, awareness of well-being services, COVID-19-related workload, as well as anxiety, depression and burnout using two validated questionnaires: the Hospital Anxiety and Depression Scale (HADS) and the Maslach Burnout Inventory (MBI). RESULTS: Of the 3000 participants approached, we received responses from 2705 (90.2%). There was a statistically significant difference in anxiety, depression and burnout scores across institutions (p<0.01). Anxiety, depression and burnout scores were statistically worse in COVID-19 active staff compared with those not working on COVID-19 activities (p<0.01 for HADS anxiety and depression and MBI emotional exhaustion (EE), depersonalisation (DP) and personal accomplishment (PA)). Over half of the participants exhibited some level of anxiety (SRNGIH: 52.2%; DMCH: 53.9%; MMCH: 61.3%; MARMC: 68%) with a high proportion experiencing depression (SRNGIH: 39.5%; DMCH: 38.7%; MMCH: 53.7%; MARMC: 41.1%). Although mean burnout scores were within the normal range for each institution, a high proportion of staff (almost 20% in some instances) were shown to be classified as experiencing burnout by their EE, DP and PA scores. CONCLUSION: We identified a high prevalence of perceived anxiety, depression and burnout among doctors and nurses during the COVID-19 pandemic. This was worse in staff engaged in COVID-19-related activities. These findings could help healthcare organisations to plan for future similar events.

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.

Can we collect health-related quality of life information from anticoagulated atrial fibrillation participants who have recently experienced a bleed? An observational feasibility study in primary and secondary care in Wales and through a UK online forum.

OBJECTIVE: To evaluate the feasibility of recruiting participants diagnosed with atrial fibrillation (AF) taking oral anticoagulation therapies (OATs) and recently experiencing a bleed to collect health-related quality of life (HRQoL) information. DESIGN: Observational feasibility study. The study aimed to determine the feasibility of recruiting participants with minor and major bleeds, the most appropriate route for recruitment and the appropriateness of the patient-reported outcome measures (PROMs) selected for collecting HRQoL information in AF patients, and the preferred format of the surveys. SETTING: Primary care, secondary care and via an online patient forum. PARTICIPANTS: The study population was adult patients (≥18) with AF taking OATs who had experienced a recent major or minor bleed within the last 4 weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes - PROMs: EuroQol 5 Dimensions-5 Levels, Perception of Anticoagulant Treatment Questionnaire, part 2 only (part 2), atrial fibrillation effect on quality of life. Secondary outcomes - Location of bleed, bleed severity, current treatment, patient perceptions of HRQoL in relation to bleeding events. RESULTS: We received initial expressions of interest from 103 participants. We subsequently recruited 32 participants to the study-14 from primary care and 18 through the AF forum. No participants were recruited through secondary care. Despite 32 participants consenting, only 26 initial surveys were completed. We received follow-up surveys from 11 participants (8 primary care and 3 AF forum). COVID-19 had a major impact on the study. CONCLUSIONS: Primary care was the most successful route for recruitment. Most participants recruited to the study experienced a minor bleed. Further ways to recruit in secondary care should be explored, especially to capture more serious bleeds. TRIAL REGISTRATION NUMBER: The study is registered in the Clinicaltrials.gov database, NCT04921176.

An evaluation of the readability and visual appearance of online patient resources for fibroadenoma.

INTRODUCTION: Fibroadenomas are benign lesions found in the breast tissue. Widespread access to and use of the internet has resulted in more individuals using online resources to better understand health conditions, their prognosis and treatment. The aim of this study was to investigate the readability and visual appearance of online patient resources for fibroadenoma. METHODS: We searched GoogleTM, BingTM and YahooTM on 6 July 2022 using the search terms "fibroadenoma", "breast lumps", "non-cancerous breast lumps", "benign breast lumps" and "benign breast lesions" to identify the top ten websites that appeared on each of the search engines. We excluded advertised websites, links to individual pdf documents and links to blogs/chats. We compiled a complete list of websites identified using the three search engines and the search terms and analysed the content. We only selected pages that were relevant to fibroadenoma. We excluded pages which only contained contact details and no narrative information relating to the condition. We did not assess information where links were directed to alternative websites. We undertook a qualitative visual assessment of each of the websites using a framework of pre-determined key criteria based on the Centers for Medicare and Medicaid Services toolkit. This involved assessing characteristics such as overall design, page layout, font size and colour. Each criterion was scored as: +1- criterion achieved; -1- criterion not achieved; and 0- no evidence, unclear or not applicable (maximum total score 43). We then assessed the readability of each website to determine the UK and US reading age using five different readability tests: Flesch Kincaid, Gunning Fog, Coleman Liau, SMOG, and the Automated Readability Index. We compared the readability scores to determine if there were any significant differences across the websites identified. We also generated scores for the Flesh Reading Ease as well as information about sentence structure (number of syllables per sentence and proportion of words with a high number of syllables) and proportion of people the text was readable to. RESULTS: We identified 39 websites for readability and visual assessment. The visual assessment scores for the 39 websites identified ranged from -19 to 31 points out of a possible score of 43. The median readability score for the identified websites was 8.58 (age 14-15), with a range of 6.69-12.22 (age 12-13 to university level). There was a statistically significant difference between the readability scores obtained across websites (p<0.001). Almost half of the websites (18/39; 46.2%) were classified as very difficult by the Flesch Reading Ease score, with only 13/39 (33.33%) classified as being fairly easy or plain English. CONCLUSION: We found wide differences in the general appearance, layout and focus of the fibroadenoma websites identified. The readability of most of the websites was also much higher than the recommended level for the public to understand. Fibroadenoma website information needs to be simplified to reduce the use of jargon and specificity to the condition for individuals to better comprehend it. In addition, their visual appearance could be improved by changing the layout and including images and diagrams.

Further Validation of the Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) to Measure the Quality of Life in Patients Treated with Biologics Therapy.

Background: Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) is a validated questionnaire to measure the quality of life (QoL) in Inflammatory Bowel Disease (IBD). However, it does not have stoma-specific questions and can be lengthy. This study aimed to validate a subset of the CUCQ-32 that would be suitable for patients with a stoma. Methods: Baseline data were collected from a cohort of patients with acute ulcerative colitis who were participating in the CONSTRUCT multicentre clinical trial. A subset of the CUCQ-32 questions was selected by stepwise regression. Further validation was examined using data from the UK IBD biological therapies audit. Construct validity was carried out using the EuroQol 5 dimensions (EQ5D) questionnaire, Simple Clinical Colitis Activity Index (SCCAI), and the Harvey−Bradshaw Index (HBI). Results: Using the data from 124 patients, a short-version questionnaire (CUCQ-12) was developed. Data from 484 patients with IBD (382 patients with Crohn's disease, 76 patients with ulcerative colitis, and 26 patients with IBD-Unclassified) and 61 patients with stoma provided further validation of the CUCQ-12. A literature review and an expert focus group identified supplementary stoma-specific questions for the CUCQ-12+. The CUCQ-12+ demonstrated excellent internal consistency (Cronbach's α = 0.86); established effective reproducibility (intra-class correlation coefficient = 0.74); correlated well with the EQ5D (r= −0.48), HBI (r = 0.45), and SCCAI (r = 0.43); and represented good responsiveness statistics (>0.5). Conclusions: CUCQ-12+ is a valid and reliable QoL measure used for all patients with IBD in clinical practice, including patients with a stoma.

Designing and evaluating a patient decision aid for patients with locally advanced or locally recurrent rectal cancer: a national multicentre mixed methods study protocol.

INTRODUCTION: Approximately 5%-10% of new rectal cancers are locally advanced (locally advanced rectal cancer (LARC)) at presentation with 4%-8% recurring (locally recurrent rectal cancer (LRRC)) after initial treatment. Patients with potentially curable disease have to consider many trade-offs when considering major exenterative surgery. There are no decision tools for these patients and current resources have found to not meet minimum international standards. The overall aim of this study is to produce a validated patient decision aid (PtDA) to assist patients considering radical pelvic exenteration for LARC and LRRC created in line with international minimum standards. METHODS AND ANALYSIS: This study is a national, multicentre mixed methods project and has been designed in keeping with guidance from the International Patient Decision Aids Standard.This study is in four stages. In stage 1, we will develop the PtDA and its content using agile developmental methodology. In stage 2, we will assess the content and face validity of the PtDA using mixed-methods with key stakeholders. In stage 3, we will assess the feasibility and efficacy of the PtDA. In stage 4, we will establish the barriers and facilitators to the use of a PtDA in the outpatient setting. Questionnaires including the QQ-10, EORTC PATSAT-C33, Preparation for Decision-Making Scale and the NoMAD survey will be analysed during the study. Interviews will be analysed using thematic analysis. ETHICS AND DISSEMINATION: Research ethics approval from North of Scotland Research Ethics Service 19/NS/0056 (IRAS 257890) has been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through bowel research UK charity. External endorsement will be sought from the International Patient Decision Standards Collaboration inventory of PtDAs. PROSPERO REGISTRATION NUMBER: CRD42019122933.

Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial).

INTRODUCTION: Chronic pain and disability are now well-recognised long-term complications of blunt chest wall trauma. Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definitive trial. This protocol describes the proposed definitive trial, the aim of which is to investigate the impact of an early exercise programme on chronic pain and disability in patients with blunt chest wall trauma. METHODS/ANALYSIS: This mixed-methods, multicentre, parallel randomised controlled trial will run in four hospitals in Wales and one in England over 12-month recruitment period. Patients will be randomised to either the control group (routine physiotherapy input) or the intervention group (routine physiotherapy input plus a simple exercise programme completed individually by the patient). Baseline measurements including completion of two surveys (Brief Pain Inventory and EuroQol 5-dimensions, 5-Levels) will be obtained on initial assessment. These measures and a client services receipt inventory will be repeated at 3-month postinjury. Analysis of outcomes will focus on rate and severity of chronic pain and disability, cost-effectiveness and acceptability of the programme by patients and clinicians. Qualitative feedback regarding acceptability will be obtained through patient and clinician focus groups. ETHICS/DISSEMINATION: London Riverside Research Ethics Committee (Reference number: 21/LO/0782) and the Health Research Authority granted approval for the trial in December 2021. Patient recruitment will commence in February 2022. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. TRIAL REGISTRATION NUMBER: ISRCTN65829737; Pre-results.

Phase II multicentre, double-blind, randomised trial of ustekinumab in adolescents with new-onset type 1 diabetes (USTEK1D): trial protocol.

INTRODUCTION: Most individuals newly diagnosed with type 1 diabetes (T1D) have 10%-20% of beta-cell function remaining at the time of diagnosis. Preservation of residual beta-cell function at diagnosis may improve glycaemic control and reduce longer-term complications.Immunotherapy has the potential to preserve endogenous beta-cell function and thereby improve metabolic control even in poorly compliant individuals. We propose to test ustekinumab (STELARA), a targeted and well-tolerated therapy that may halt T-cell and cytokine-mediated destruction of beta-cells in the pancreas at the time of diagnosis. METHODS AND ANALYSIS: This is a double-blind phase II study to assess the safety and efficacy of ustekinumab in 72 children and adolescents aged 12-18 with new-onset T1D.Participants should have evidence of residual functioning beta-cells (serum C-peptide level >0.2nmol/L in the mixed-meal tolerance test (MMTT) and be positive for at least one islet autoantibody (GAD, IA-2, ZnT8) to be eligible.Participants will be given ustekinumab/placebo subcutaneously at weeks 0, 4 and 12, 20, 28, 36 and 44 in a dose depending on the body weight and will be followed for 12 months after dose 1.MMTTs will be used to measure the efficacy of ustekinumab for preserving C-peptide area under the curve at week 52 compared with placebo. Secondary objectives include further investigations into the efficacy and safety of ustekinumab, patient and parent questionnaires, alternative methods for measuring insulin production and exploratory mechanistic work. ETHICS AND DISSEMINATION: This trial received research ethics approval from the Wales Research Ethics Committee 3 in September 2018 and began recruiting in December 2018.The results will be disseminated using highly accessed, peer-reviewed medical journals and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN14274380.

Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials.

It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

Systematic Review of the Clinical Disease Severity Indices for Inflammatory Bowel Disease.

BACKGROUND: Clinical disease severity indices are increasingly being used in choosing treatment and monitoring the response of patients with inflammatory bowel disease (IBD). The aim of this study was to systematically review the clinical disease severity indices in IBD and to appraise their measurement properties and methodological quality. METHODS: We searched the MEDLINE, Embase, and PsycINFO databases for original articles describing the development and/or evaluation of one or more of the measurement properties of clinical disease severity indices used in IBD. We assessed these properties (e.g., internal consistency, reliability, validity, responsiveness) using a standardized checklist. RESULTS: We examined the full text of 142 articles that we deemed potentially eligible and identified 22 clinical disease severity indices in IBD. No clinical disease index has met all the required measurement properties. All of the validation studies were not descriptive enough to allow assessment of their methodology. CONCLUSIONS: Although commonly used in multiple clinical trials, none of the clinical disease severity indices in IBD had all the required measurement properties. Further validation studies are required.

Systematic review of health-related quality of life measures for inflammatory bowel disease.

BACKGROUND AND AIM: Several measures have been developed to assess the health-related quality of life [HRQoL] of patients with inflammatory bowel disease [IBD]. Our aim is to systematically review the HRQoL measures specific for patients with IBD and to appraise their measurement properties and methodological quality. METHODS: We searched the PubMed, Embase, and PsycINFO databases for original articles describing the development and/or evaluation of one or more of the measurement properties [e.g. internal consistency, reliability, validity, responsiveness] of HRQoL measures specific for IBD. We assessed the measurement properties and examined the methodological quality of the measurement properties of each instrument using a standardized checklist. RESULTS: We examined the full text of 75 articles that we deemed potentially eligible and identified 10 disease-specific HRQoL measures in IBD that covered different aspects of patients' lives. Internal consistency, construct validity, and content validity were the commonly evaluated measurement properties. Seven HRQoL measures scored positive for at least four of eight measurement properties. The majority of studies were rated as 'fair' to 'poor' when assessing their methodology quality. The most established HRQoL measure in the literature was the Inflammatory Bowel Disease Questionnaire [IBDQ]. CONCLUSIONS: Most of the included HRQoL measures did not include all the required measurement properties or had a problem with their methodological quality. The most widely used and validated measure was the IBDQ. Further validation studies are required to support the use of other HRQoL measures.

Development of a short questionnaire to assess the quality of life in Crohn's disease and ulcerative colitis.

BACKGROUND AND AIMS: Most of the disease-specific quality of life (QoL) measures for inflammatory bowel disease (IBD) are lengthy and time consuming. None have been established for routine use in clinical practice. We designed this study to develop a short QoL measure in IBD. METHODS: A 32-item questionnaire, the Crohn's and ulcerative colitis questionnaire (CUCQ)-32 was developed by reviewing the literature of the previously validated questionnaires and by consultation with patients and experts. Construct validity was carried out using the Short Form 12 and the EuroQol 5 dimensions questionnaires and two disease severity measures (the Simple Clinical Colitis Activity Index and the Harvey-Bradshaw Index). Test-retest analysis was done by asking patients to complete the CUCQ questionnaire twice within a period of two weeks. RESULTS: Data were obtained from 205 patients with IBD who completed the CUCQ-32. Psychometric analysis showed that Cronbach's α was 0.88, item-total correlations were good, and there were no ceiling or flooring effects. Stepwise regression identified eight items that accounted for >95% of the variance in the CUCQ-32. The resulting CUCQ-8 demonstrated good internal consistency (Cronbach's α = 0.84), had good reproducibility (intraclass correlation coefficient = 0.94), was well correlated with the EuroQol 5 dimensions questionnaire (r = 0.58) and the Short Form-12 (r = 0.65 for physical component and r = 0.63 for mental component), and was responsive to change (responsiveness ratio was 0.64, p-value < 0.05). CONCLUSIONS: CUCQ-8 is a short questionnaire that has the potential to be an efficient tool for assessing the QoL of all patients with IBD in clinical practice.

Development and validation of a new disease severity index: the Inflammatory Bowel Disease Index (IBDEX).

OBJECTIVE: To develop, validate and apply a generic clinical severity index applicable to all adult patients with inflammatory bowel disease (IBD). DESIGN: A review of the literature and an expert focus group consultation were carried out in order to draw out relevant items from existing literature. The new index was called the IBD Index (IBDEX). Standard psychometric analysis was carried out. The construct validity was assessed against biochemical markers, clinical and endoscopic indices. The new index was completed again within 6 weeks to check responsiveness and reproducibility. RESULTS: IBDEX was used to assess 255 adult patients with IBD (125 with Crohn's disease and 130 with ulcerative colitis), and 64 patients were re-evaluated within 6 weeks. It had good internal consistency (Cronbach's α=0.79) and correlated very well with the Harvey Bradshaw Index (r=0.94), the Simple Clinical Colitis Activity Index (r=0.92), the Mayo Clinic Index (r=0.87) and the Simple Endoscopic Score (r=0.76), all with p values <0.05. IBDEX had a moderate but positive correlation with C reactive protein (r=0.51) and erythrocyte sedimentation rate (r=0.36) p values both <0.05. The test-retest reliability was good (intraclass correlation coefficient 0.97) and responsiveness ratio was 2.27. CONCLUSIONS: IBDEX is the first properly validated Clinical Disease Severity Index in IBD. Our results showed that it is valid, reliable and reproducible and has the potential to be used in clinical practice.