The development of a cryptoglandular anal fistula quality of life scale (AF-QoL).

AIM: Quality of life (QoL) is a crucial and core outcome in assessing the effectiveness of treatments for cryptoglandular anal fistula. Despite its extensive impact, there is a lack of patient-centred, disease-specific QoL measurement instruments of adequate quality. The aim of this study is to develop a disease-specific measurement instrument that can accurately measure QoL for patients with cryptoglandular anal fistula. METHOD: Semi-structured qualitative patient interviews and a systematic review of current instruments were used to generate items for the draft instrument. This underwent successive rounds of cognitive interviews to refine its wording and structure. Individual item and overall scale content validity were determined by asking experts to rate the relevance of each item and those deemed irrelevant were removed. The final instrument then underwent psychometric testing and test-retest analysis to determine its sensitivity and stability. RESULTS: A total of 148 patients were involved in item generation, scale development and psychometric testing. A 22-item measurement instrument has been developed; it is scored on a scale of 0-100, where 0 indicates the worst QoL and 100 demonstrates perfect QoL. The scale demonstrates excellent internal consistency (Cronbach-α = 0.927), strong content and construct validity [correlation with Perianal Disease Activity Index = -0.713, Hospital Anxiety and Depression Anxiety (-0.659) and Depression (-0.673) subscales and Short Form-12 physical (0.609) and mental (0.589) component scales] and strong reliability and responsiveness. CONCLUSION: We have developed a cryptoglandular Anal Fistula Quality of Life scale (AF-QoL), a comprehensive, disease-specific patient reported outcome measure assessing QoL in patients with cryptoglandular anal fistula.

Validation of the ACE [Albumin, CRP, and Endoscopy] Index in Acute Colitis: Analysis of the CONSTRUCT dataset.

BACKGROUND AND AIMS: In 2020 we reported the ACE Index in acute colitis which used biochemical and endoscopic parameters to predict steroid non-response on admission in patients with acute ulcerative colitis [UC]. We aimed to validate the ACE Index in an independent cohort. METHODS: The validation cohort comprised patients screened as eligible for inclusion in the CONSTRUCT study, a prospective, randomized, placebo-controlled trial which compared the effectiveness of treatment with infliximab vs ciclosporin in patients admitted with acute UC. The CONSTRUCT cohort database was reviewed at The Edinburgh IBD Unit and the same biochemical and endoscopic variables and cut-off values as those in the derivation cohort were applied to the validation cohort. RESULTS: In total, 800 patients were identified; 62.5% [55/88] of patients with a maximum ACE Index of 3 did not respond to intravenous [IV] steroids (positive predictive value [PPV] 62.5%, negative predictive value [NPV] 79.8%). Furthermore, 79.8% [158/198] of patients with an ACE Index of 0 responded to IV steroids [PPV 79.8%, NPV 62.5%]. Receiver operator characteristic [ROC] curve analysis produced an area under the curve [AUC] of 0.663 [p < 0.001]. CONCLUSIONS: We have now reported and externally validated the ACE Index in acute colitis in a combined cohort of over 1000 patients from across the UK. The ACE Index may be used in conjunction with clinical judgement to help identify patients admitted with active UC who are at high risk of not responding to IV steroids. Further studies are required to improve objectivity and accuracy of assessment.

Critical shortfalls in the management of PBC: Results of a UK-wide, population-based evaluation of care delivery.

Background & Aims: Guidelines for the management of primary biliary cholangitis (PBC) were published by the British Society of Gastroenterology in 2018. In this study, we assessed adherence to these guidelines in the UK National Health Service (NHS). Methods: All NHS acute trusts were invited to contribute data between 1 January 2021 and 31 March 2022, assessing clinical care delivered to patients with PBC in the UK. Results: We obtained data for 8,968 patients with PBC and identified substantial gaps in care across all guideline domains. Ursodeoxycholic acid (UDCA) was used as first-line treatment in 88% of patients (n = 7,864) but was under-dosed in one-third (n = 1,964). Twenty percent of patients who were UDCA-untreated (202/998) and 50% of patients with inadequate UDCA response (1,074/2,102) received second-line treatment. More than one-third of patients were not assessed for fatigue (43%; n = 3,885) or pruritus (38%; n = 3,415) in the previous 2 years. Fifty percent of all patients with evidence of hepatic decompensation were discussed with a liver transplant centre (222/443). Appropriate use of second-line treatment and referral for liver transplantation was significantly better in specialist PBC treatment centres compared with non-specialist centres (p <0.001). Conclusions: Poor adherence to guidelines exists across all domains of PBC care in the NHS. Although specialist PBC treatment centres had greater adherence to guidelines, no single centre met all quality standards. Nationwide improvement in the delivery of PBC-related healthcare is required. Impact and implications: This population-based evaluation of primary biliary cholangitis, spanning four nations of the UK, highlights critical shortfalls in care delivery when measured across all guideline domains. These include the use of liver biopsy in diagnosis; referral practice for second-line treatment and/or liver transplant assessment; and the evaluation of symptoms, extrahepatic manifestations, and complications of cirrhosis. The authors therefore propose implementation of a dedicated primary biliary cholangitis care bundle that aims to minimise heterogeneity in clinical practice and maximise adherence to key guideline standards.

The adoption of artificial intelligence assisted endoscopy in the Middle East: challenges and future potential.

The use of artificial intelligence (AI) in endoscopy has shown immense potential to enhance diagnostic accuracy, streamline procedures, and improve patient outcomes. There are potential uses in every field of endoscopy, from improving adenoma detection rate (ADR) in colonoscopy to reducing read time in capsule endoscopy or minimizing blind spots in gastroscopy. Indeed, some of these systems are already licensed and in commercial use across the world. In the Middle East, where healthcare systems are rapidly evolving, there is a growing interest in adopting AI technologies to revolutionise endoscopic practices. This article provides an overview of the advancements, potential opportunities and challenges associated with the implementation of AI in endoscopy within the Middle East region. Our aim is to contribute to the ongoing dialogue surrounding the implementation of AI in endoscopy and consider some of the factors that are particularly relevant in the Middle Eastern context, including the need to train the models for local populations, cost and training, as well as trying to ensure equity of access for patients. It provides valuable insights for healthcare professionals, policymakers, and researchers interested in leveraging AI to enhance endoscopic procedures, improve patient care, and address the unique healthcare needs of the Middle East population.

The Usefulness of Mayo End-stage Liver Disease (MELD) and MELD-Sodium (MELD-Na) Scores for Predicting Mortality in Cirrhotic Patients With Spontaneous Bacterial Peritonitis.

BACKGROUND: Spontaneous bacterial peritonitis (SBP) is a common infection in patients with cirrhosis and ascites. Currently, the accuracy of the model for end-stage liver disease (MELD) and MELD-sodium (MELD-Na) as prognostic scores in this cohort is unclear. This study aimed to evaluate and compare the accuracy of MELD and MELD-Na for predicting 90-day mortality and determine whether the mortality risk estimates they provide accurately reflect the poor prognosis of patients with SBP Methods: Patients with cirrhosis and SBP were retrospectively identified from ascitic fluid samples sent for microscopy, culture and sensitivity analysis (1/1/18-31/12/20) and a previous audit. MELD and MELD-Na scores at diagnosis were calculated and associations with 90-day mortality were assessed using univariate analysis. Receiver operator characteristic curves were compared, and standardised mortality ratios (SMRs) were calculated by comparing the number of deaths observed to the number predicted by MELD and MELD-Na. RESULTS: Of the 567 patients identified, 15 patients with cirrhosis and SBP were included. The 90-day mortality rate was 66.7% (10/15). Only concurrent hyponatremia (<135mmol/L) was associated with mortality (6/10 non-survivors vs 0/5 survivors, p=0.04). The difference in MELD and MELD-Na's C-statistic was not significant: 0.66 (95% Cl:0.35-0.98) vs 0.74 (95% Cl:0.47-1.0) respectively (p=0.72). Patients with a MELD-Na >18.5 had significantly higher 90-day mortality than patients with MELD-Na ≤18.5 (88.9% (8/9) vs. 33.3% (2/6), p=0.05). The SMR (95% Cl) for each MELD decile evaluated was 33.3 (0-79.5), 11.1 (0.2-22.0) and 3.4 (0-7.0) for scores ≤9,10-19 and 20-29 respectively. For each MELD-Na tertile, these were: 25 (0-59.6), 5.2 (0.1-10.3) and 2.7 (0.1-8.1) for scores <17,17-26, ≥27 respectively. CONCLUSION: In a small cohort of patients with cirrhosis and SBP, the MELD's accuracy in predicting 90-day mortality was limited. MELD-Na's accuracy was higher but not significantly. Both scores consistently underestimated participants' mortality, therefore future studies could evaluate the accuracy of alternative prognostic scores in this patient group.

The Efficacy of Currently Licensed Biologics for Treatment of Ulcerative Colitis: A Literature Review.

Biologics have been emerging as promising therapies in ulcerative colitis (UC) patients who are refractory to conventional medical treatment. This literature review aims to appraise the existing evidence on the efficacy and safety of NICE approved biological therapies, of which there are currently five licensed drugs, available for the treatment of UC in adults. An initial search was performed using National Institute of Clinical Excellence (NICE) guidelines. A further literature search of EMBASE, MEDLINE, Science Direct and Cochrane Library databases was done, resulting in a total of 62 studies being included in this review. Recent and seminal papers were included. Inclusion criteria for this review were adult participants and English papers only. In most studies, anti-tumour necrosis factor É‘ (TNFɑ) naïve patients were found to have improved clinical outcomes. Infliximab was found to be highly effective in inducing short-term clinical response, clinical remission as well as mucosal healing. However, loss of response was common and dose escalation was often required for achievement of long-term efficacy. Adalimumab was found to have both short-term and long-term efficacy which was also supported by real-world data. Golimumab was shown to have comparable efficacy and safety profiles to other biologics, although lack of therapeutic dose monitoring and loss of response is a barrier to optimising golimumab treatment efficacy. Vedolizumab was shown to have higher clinical remission rates when compared to adalimumab in a head-to-head trial, and the most cost-effective biologic when calculating quality-adjusted life years. Ustekinumab was found to significantly improve clinical remission rates in UC patients who were previously unresponsive to other biological treatments. However, as this is a newly licensed drug, there is limited literature currently available. Further, head-to-head studies are required to help determine the optimal treatment for patients with UC. With patents expiring, the development of biosimilars will help to reduce costs and increase the availability of these drugs to patients.

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).

Colonoscopy Colorectal Cancer Screening Programme in Southern Iraq: Challenges, Knowledge Gaps and Future Potential.

Data on current colorectal cancer screening practices in Iraq are limited. This study aimed to better understand the current colorectal cancer screening practice and perceived barriers. The project also aimed to use UK expertise to introduce Bowel Cancer Screening Programme (BCSP) in Basra, Iraq. The study consisted of two parts: A pre-visit online survey of clinicians to test the project's feasibility. A public survey was conducted to understand and gauge the general knowledge and perceived barriers to having colorectal cancer screening. The second phase included a short visit to Basra and the delivery of a multidisciplinary meeting for bowel screening colonoscopists. Fifty healthcare providers completed the survey. Basra has no established bowel cancer screening programme, let alone the country. Opportunistic colonoscopy surveillance is done on an ad hoc base. A total of 350 individuals completed the public survey. The survey showed that more than 50% of participants were not familiar with the concept of a BCSP and less than 25% were aware of "red flag" symptoms of bowel cancer. The short visit to Basra included a roundtable discussion and delivered a training workshop for screening colonoscopists using UK training materials in conjunction with the Iraqi Medical Association. Feedback from the course was extremely positive. Several potential barriers were identified to participate in BCSP. The study highlighted potential barriers, including a lack of public awareness and insufficient training resources to be addressed in future screening programmes. The study has identified several potential areas for future collaboration to support the development of a BCSP centre in Basra.

Quality of Life in Patients with Acute Severe Ulcerative Colitis: Long-Term Follow-Up Results from the CONSTRUCT Trial.

BACKGROUND: there is currently limited research examining the QoL of patients with Ulcerative colitis (UC) following treatment of acute severe colitis (ASUC). OBJECTIVE: to examine the long-term QoL of ASUC patients enrolled in the CONSTRUCT trial following treatment of UC with infliximab or ciclosporin and to compare the differences in the QoL between the two drug treatments over time. METHODS: The CONSTRUCT trial examined the cost and clinical effectiveness of infliximab and ciclosporin treatments for acute severe UC. We collected QoL questionnaire data from patients during the active trial period up to 36 months. Following trial completion, we contacted patients postannually for up to a maximum of 84 months. We collected QoL data using a disease-specific (CUCQ, or CUCQ+ for patients who had colectomy surgery) or generic (EQ5D-3L) questionnaire. We analysed QoL scores to determine if there was any difference over time and between treatments in generic or disease-specific QoL. RESULTS: Following initial treatment with infliximab and ciclosporin, patients experienced a statistically significant improvement in both the generic and disease-specific QoL at three months. Generic scores remained fairly static for the whole follow-up period, reducing only slightly up to 84 months. Disease-specific scores showed a much sharper improvement up to 2 years with a gradual reduction in QoL up to 84 months. Generic and disease-specific QoL remained higher than baseline values. There was no significant difference between treatments in any of the QoL scores. CONCLUSIONS: Both infliximab and ciclosporin improve QoL following initial treatment for ASUC. QoL scores remain higher than at admission up to 84 months post-treatment.

Do Patient-Reported Quality-of-Life (QoL) Scales Provide an Adequate Assessment of Patients with Cryptoglandular Anal Fistulae? A Systematic Review of Measurement Instruments and Their Content Validity.

BACKGROUND: Cryptoglandular anal fistulae can significantly affect patient quality of life (QoL), making it essential to ensure that any study of fistula treatment assesses the impact on QoL. The aim of this systematic review was to evaluate the content validity of Patient-Reported Outcome Measures (PROMs) that assess QoL in patients with a fistula. METHODS: MEDLINE, EMBASE, PsycINFO, and Scopus were searched and studies assessing the content validity of patient-reported QoL measurement instruments, or PROM development studies in patients with cryptoglandular anal fistulae, were included. Data were extracted from eligible studies to determine the instruments' relevance, comprehensiveness, and comprehensibility, and their quality was assessed according to COnsensus-based Standards for the Selection of health Measurement Instruments (COSMIN). RESULTS: Two PROM development studies were identified, both of which described the development of a disease-specific QoL measurement instrument for patients with cryptoglandular anal fistulae. The overall content validity of these instruments was inconsistent and supported by very low-quality evidence. There were no studies assessing the content validity of established QoL measurement instruments in patients with fistulae. CONCLUSIONS: This systematic review could not establish the content validity of the available QoL PROMs for patients with anal fistulae, due either to the absence of designated content validity studies or a lack of comprehensiveness of the available PROMs. This highlights an important gap in the literature that needs to be addressed to ensure high-quality outcome assessment in patients with fistulae.

The National Audit of Primary Biliary Cholangitis (PBC) in the United Kingdom: Defining the Audit Dataset and Data Collection System.

Primary biliary cholangitis (PBC) is a debilitating chronic liver disease that progresses to cirrhosis with attendant complications in a substantial proportion of patients. It is a major cause of liver-related morbidity and mortality in the United Kingdom (UK). The British Society of Gastroenterology (BSG) published guidelines on PBC management, which included key audit standards. Therefore, we propose the first UK-wide audit of the management of PBC, sanctioned by the BSG and the British Association for Study of the Liver (BASL), to benchmark NHS trusts and health boards against these audit standards as a guide to targeted improvement in the delivery of PBC-related health care.

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.

Saving time and effort: Best practice for adapting existing patient-reported outcome measures in hepatology.

It is increasingly recognised that collecting patient reported outcome measures (PROMs) data is an important part of healthcare and should be considered alongside traditional clinical assessments. As part of a more holistic view of healthcare provision, there has been an increased drive to implement PROM collection as part of routine clinical care in hepatology. This drive has resulted in an increase in the number of PROMs currently developed to be used in various liver conditions. However, the development and validation of a new PROM is time-consuming and costly. Therefore, before deciding to develop a new PROM, researchers should consider identifying existing PROMs to assess their appropriateness and, if necessary, make adaptations to existing PROMs to ensure their rigour when used with the target population. Little is written in the literature on how to identify and adapt the existing PROMs in hepatology. This article aims to provide a summary of the current literature and guidance regarding identifying and adapting existing PROMs in clinical practice.

Setting Up a Local Registry to Improve the Care of Patients With Primary Biliary Cholangitis.

Primary biliary cholangitis (PBC) is a rare but progressive chronic disease of the liver. The national guidelines aim to standardise the care of patients with PBC across the UK. The guidelines also recommend routine screening for the presence of symptoms in patients with PBC, although none suggest how such screening should be achieved in clinical practice. We aim to develop a sustainable and comprehensive local registry for patients with PBC to examine current practice and help define long-term complications and survival. Setting up the registry involves working with several workstreams to identify the data required for the registry, technical IT infrastructure to support the data collection, and a steering committee to oversee the work of the PBC registry. This registry will involve patients aged ≥18 years from the London North West University Health Trust hospitals with a diagnosis of PBC as defined by the British Society of Gastroenterology (BSG) and the European Association for the Study of the Liver (EASL) criteria. Patients will not be subjected to any additional treatments or investigations as the registry will be part of routine clinical practice.

Whether Screening for Non-alcoholic Fatty Liver Disease in Patients With Psoriasis Is Necessary: A Pilot Quality Improvement Project.

Background Psoriasis is a chronic inflammatory skin disease that is strongly associated with non-alcoholic fatty liver disease (NAFLD). Both conditions are associated with excess cardiovascular and liver-related morbidity and mortality. The severity of psoriasis correlates with the degree of liver inflammation and scarring, which can be further exacerbated by systemic immunomodulators such as methotrexate. Currently, no clinical pathway exists to screen psoriasis patients for NAFLD in our Trust. We aimed to develop a shared clinical pathway between our hepatology and dermatology departments to allow early identification and management of NAFLD in this patient group. Methods A multidisciplinary team was assembled to identify patient priorities, management goals, and screening criteria. We identified gaps in our service and reviewed current clinical best practice guidelines. A clinical pathway was developed using a process map and revised according to feedback received. We piloted this pathway on a prospective cohort of psoriasis patients identified by our dermatology department. Patients were invited for transient elastography if fatty liver was identified on an ultrasound scan. Baseline demographics, biochemistry and imaging results were collected and analysed. Results Of 57 psoriasis patients, 30 (52.6%) had sonographic evidence of hepatic steatosis. The median age was comparable between groups with 56 and 55 years in the psoriasis-NAFLD (Ps-NAFLD) and no-NAFLD groups respectively. There were more males in the Ps-NAFLDgroup (56.7%) compared to the no-NAFLD group (37%). Fifteen out of 30 patients were eligible for transient elastography (two were excluded due to body habitus). Seven (53.8%) patients had no-to-mild fibrosis indicated by liver stiffness measurement (LSM) ≤7kPa, while six (46.1%) had moderate-to-severe fibrosis. Three (23.0%) patients had scores suggestive of cirrhosis (LSM>13kPa). Conclusions The introduction of a new shared-care pathway at our Trust has resulted in a streamlined way in which psoriasis patients can be screened and treated for NAFLD.

Using Information Videos to Improve Patient Satisfaction in Endoscopy: A Prospective Service Improvement Project.

BACKGROUND: Endoscopy is a rapidly developing discipline with new techniques and procedures being introduced each year. The consenting process is central to patient perception; using information videos as additional tools to aid consent and improve the quality of care in endoscopy is not well established. Our aim was to develop, implement and validate the use of patient educational videos to improve patients' satisfaction and experience in endoscopy. METHODS AND ANALYSIS: This was a prospective service quality improvement study. Eligible patients were invited to watch the educational videos in addition to standard practice. We compared this group with a matched cohort of patients who were receiving standard care of postal information leaflets. Patient satisfaction was measured through the validated Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ). RESULTS: Patients in the intervention group scored four questions relating to pre-procedural information significantly higher than the control (p=0.038). The total mean GESQ score was also higher in the intervention group compared to the control, however this was not statistically significant (p=0.397). The intervention group had significantly lower cancellation rate (4%) compared to the control group (20%), p=0.023. CONCLUSIONS: Patients who watched educational videos were more satisfied with pre-procedural information in the consenting period than those who did not. Further research is still needed to determine if they reduce patient anxiety. Meanwhile, it would be appropriate to implement these videos into routine practice as a cost-effective method of improving patient satisfaction.

Living with cryptoglandular anal fistula: a qualitative investigation of the patient's experience through semi-structured patient interviews.

PURPOSE: Cryptoglandular anal fistula continues to be a subject of extensive surgical research due to the lack of effective and enduring treatments, some of which incur risks to continence and quality of life. However, the patient experience of disease has seldom been reported. The aims of this study are to understand the impact of living with a fistula and the treatment outcomes that are valued by patients. METHODS: Patients with cryptoglandular anal fistula were recruited using purposive sampling from two tertiary referral centres in the UK and the Netherlands. Patients underwent semi-structured interviews that were audio-recorded and transcribed verbatim. Dutch transcripts were translated into English and underwent independent, thematic analysis using open coding by two study team members to identify common themes and sub-themes. RESULTS: Twenty interviews were conducted before saturation was reached (11 male, median age 49, Interquartile range 39-55 years). Four broad themes emerged, covering the physical symptoms of fistula, the patient journey towards understanding the condition, life impact, and treatment. Several inter-related sub-themes were found, reflecting the extensive impact and adjustment that the disease entails. CONCLUSION: The impact of cryptoglandular anal fistula extends beyond the physical symptoms of pain and discharge, requires significant readjustment, and often negatively impacts psycho-social wellbeing. These aspects of disease should receive greater attention in future assessment of treatment and quality of life.

Widespread gaps in the quality of care for primary biliary cholangitis in UK.

OBJECTIVE: Primary biliary cholangitis (PBC) is a progressive, autoimmune, cholestatic liver disease affecting approximately 15 000 individuals in the UK. Updated guidelines for the management of PBC were published by The European Association for the Study of the Liver (EASL) in 2017. We report on the first national, pilot audit that assesses the quality of care and adherence to guidelines. DESIGN: Data were collected from 11 National Health Service hospitals in England, Wales and Scotland between 2017 and 2020. Data on patient demographics, ursodeoxycholic acid (UDCA) dosing and key guideline recommendations were captured from medical records. Results from each hospital were evaluated for target achievement and underwent χ2 analysis for variation in performance between trusts. RESULTS: 790 patients' medical records were reviewed. The data demonstrated that the majority of hospitals did not meet all of the recommended EASL standards. Standards with the lowest likelihood of being met were identified as optimal UDCA dosing, assessment of bone density and assessment of clinical symptoms (pruritus and fatigue). Significant variations in meeting these three standards were observed across UK, in addition to assessment of biochemical response to UDCA (all p<0.0001) and assessment of transplant eligibility in high-risk patients (p=0.0297). CONCLUSION: Our findings identify a broad-based deficiency in 'real-world' PBC care, suggesting the need for an intervention to improve guideline adherence, ultimately improving patient outcomes. We developed the PBC Review tool and recommend its incorporation into clinical practice. As the first audit of its kind, it will be used to inform a future wide-scale reaudit.