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63 result(s) for "Alrubaiy, Laith"
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Colorectal Cancer Screening in the Middle East and North Africa: Current Practices, Challenges, and Insights from the British Society of Gastroenterology (BSG) International Section
Colorectal cancer (CRC) is a significant public health issue, representing one of the greatest causes of both cancer diagnosis and mortality globally. While the incidence is highest in high-income countries, it is rising across the world, including in the Middle East and North Africa (MENA) region. Many countries have implemented national screening programmes to reduce the burden of CRC, utilising mostly stool tests and colonoscopy, but this has yet to occur across most MENA countries. Uptake of screening opportunities is generally poor. System-level barriers to establishing screening programmes include cost constraints and limited screening infrastructure. Patient-level barriers include embarrassment, fear of a cancer diagnosis, and limited awareness/education. Screening programmes across the MENA region would likely reduce the CRC incidence. These barriers must be overcome through patient education and government action to ensure appropriate patient uptake. This study aims to examine CRC screening practices across MENA, identify key barriers, and propose solutions for sustainable CRC management in the region, through a narrative review and expert input from the Middle East and North Africa Colorectal Cancer (MENA-CRC) Screening and Prevention collaborators.
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
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. 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. 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.
Using Information Videos to Improve Patient Satisfaction in Endoscopy: A Prospective Service Improvement Project
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. 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). 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. 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.
Utilisation and real-world effectiveness of advanced therapies for inflammatory bowel disease in Middle Eastern populations: a systematic review
ObjectivesWe aimed to systematically review the real-world evidence (RWE) on the effectiveness and utilisation of advanced therapies for inflammatory bowel disease (IBD) in Middle Eastern populations.DesignSystematic review.Data sourcesPubMed/MEDLINE, Embase, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials were searched up to May 2025.Eligibility criteriaObservational RWE studies investigating biologics or small molecules in Middle Eastern IBD patients (adult and paediatric) were included. Randomised controlled trials and case series with fewer than 10 patients were excluded. No language restrictions were applied.Data extraction and synthesisData were independently extracted by two reviewers. Due to significant heterogeneity in study design, populations and outcome reporting, a narrative synthesis was performed.ResultsFrom 884 records, 23 studies were included, originating primarily from Saudi Arabia (n=8) and Iran (n=4). For anti-tumour necrosis factor (TNF) therapy, a Kuwaiti study of biologic-naive patients found 12-month endoscopic remission rates with infliximab of 56% for ulcerative colitis (UC) and 53% for Crohn’s disease (CD), while a Saudi study reported higher odds of treatment failure with adalimumab versus infliximab (OR=26.91). Ustekinumab demonstrated strong efficacy, achieving 76.9% clinical remission at 52 weeks in a Saudi paediatric anti-TNF refractory IBD cohort and showing higher probability of effectiveness than vedolizumab in another Saudi study. In contrast, vedolizumab remission rates in advanced therapy-experienced UC patients were 89.3% with intensified dosing. Newer agents also showed promise; risankizumab induction led to 43.2% clinical remission in an Emirati CD cohort, while tofacitinib achieved clinical remission rates of 56.4% and 61.1% at 52 weeks in Lebanese and Iranian UC cohorts, respectively.ConclusionsAdvanced therapies for IBD appear to be effective in Middle Eastern cohorts; however, the available evidence is methodologically diverse, with substantial heterogeneity in study design, population characteristics and outcome reporting, which limits the ability to draw strong conclusions and highlights the need for further robust evaluation. Prospective, collaborative regional registries are imperative to address these gaps and inform local guidelines.PROSPERO registration numberCRD420251083256.
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.
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 ɑ (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.
FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial
IntroductionPrimary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). The strong association between gut and liver inflammation has driven several pathogenic hypotheses to which the intestinal microbiome is proposed to contribute. Pilot studies of faecal microbiota transplantation (FMT) in PSC and IBD are demonstrated to be safe and associated with increased gut bacterial diversity. However, the longevity of such changes and the impact on markers of disease activity and disease progression have not been studied. The aim of this clinical trial is to determine the effects of repeated FMT as a treatment for PSC-IBD.Methods and analysisFAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO) is a phase IIa randomised placebo-controlled trial to assess the efficacy and safety of repeated colonic administration of FMT in patients with non-cirrhotic PSC-IBD. Fifty-eight patients will be recruited from six sites across England and randomised in a 1:1 ratio between active FMT or FMT placebo arms. FMT will be manufactured by the University of Birmingham Microbiome Treatment Centre, using stool collected from rigorously screened healthy donors. A total of 8 weekly treatments will be delivered; the first through colonoscopic administration (week 1) and the remaining seven via once-weekly enema (up to week 8). Participants will then be followed on a 12-weekly basis until week 48 from the first treatment visit. The primary efficacy outcome will be to determine the effect of FMT on serum alkaline phosphatase values over time (end of study at 48 weeks). Key secondary outcomes will be to evaluate the impact of FMT on other liver biochemical parameters, PSC risk scores, circulating and imaging markers of liver fibrosis, health-related quality of life measures, IBD activity and the incidence of PSC-related clinical events. Key translational objectives will be to identify mucosal metagenomic, metatranscriptomic, metabolomic and immunological pathways associated with the administration of FMT.Ethics and disseminationThe protocol was approved by the South Central—Hampshire B Research Ethics Committee (REC 23/SC/0147). Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.Trial registration numberThe trial was registered at ClinicalTrials.gov on 23 February 2024 (NCT06286709). Weblink: Study Details | FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis | ClinicalTrials.gov.
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.
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).
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.