As part of the Crohn’s & Colitis Foundation’s IBD Plexus, a novel prospective, longitudinal multicenter surgical inception cohort was implemented. In this first report from the first 100 patients enrolled, we aimed to assess patient reported outcomes before and after IBD surgery. We hypothesized surgery is associated with improved patient reported outcomes.
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SHORT NONCODING RNAS AS PREDICTIVE BIOMARKERS FOR THE DEVELOPMENT FROM INFLAMMATORY BOWEL DISEASE UNCLASSIFIED TO CROHN’S DISEASE OR ULCERATIVE COLITIS
Numerous pathogenic processes are mediated by short noncoding RNAs (ncRNA). Twenty percent of inflammatory bowel disease (IBD) patients are labelled as IBD unclassified (IBDU) at disease onset. Most IBDU patients are reclassified as Crohn’s disease (CD) or ulcerative colitis (UC) within few years. Since the therapeutic methods for CD and UC differ, biomarkers that can forecast the categorization of IBDU into CD or UC are highly desired. Here, we investigated whether short ncRNAs can predict CD or UC among IBDU patients.
Effective Treatments for Opioid Use Disorder — Finding Recovery and Staying Safe
New England Journal of Medicine, Volume 390, Issue 4, January 2024.
Bladder sparing by short-course radiotherapy combined with toripalimab in high-risk/extremely high-risk non-muscle invasive bladder cancer (HOPE-04): study protocol for a single-arm, prospective, phase II trial
Introduction
Radical cystectomy remains the standard treatment for intravesical Bacille Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) because potential bladder-preserving therapies are not well established. Combination of radiotherapy with programmed death-1 (PD-1) antibody may offer an optional bladder preservation treatment for high-risk/extremely high risk NMIBC. Hence, the current study aims to investigate the safety and efficacy of short-course radiotherapy (5×5 Gy) and toripalimab (PD-1 antibody) as a novel bladder sparing treatment in this population.
Methods and analysis
HOPE-04 is an open-label, single-arm, phase II study, designed to evaluate the safety and efficacy of short-course radiotherapy and toripalimab in patients with high-risk/extremely high risk NMIBC. Fifty-five patients with pathological and imaging diagnosed NMIBC with or without BCG treatment will be recruited. Radiotherapy of 5×5 Gy will be given to the whole bladder followed by a focal tumour bed boost and concomitant administration of toripalimab of 240 mg intravenous infusion every 21 days for 12 cycles (about 1 year). The primary endpoints are disease-free survival and safety. The secondary endpoint is overall survival. Additional indicators include implementation rate of salvage surgery and quality of life.
Ethics and dissemination
This trial has been approved by the Ethics Committee of West China Hospital, Sichuan University. Trial findings will be disseminated via peer reviewed journals and conference presentations.
Trial registration number
Chinese Ethics Committee of Registering Clinical Trials (ChiCTR2200059970).
Intranasal Naloxone for Opioid Overdose
This JAMA Insights describes indications for naloxone use in preventing opioid overdoses and benefits vs barriers to its availability following FDA approval of its availability without a prescription.
Treating Opioid Use Disorder in General Practice — Diagnosis, Harm Reduction, and Medications
New England Journal of Medicine, Volume 390, Issue 2, January 2024.
Effect of rapid colonic transit on stool microbiome and short-chain fatty acids in diarrhoea-predominant irritable bowel syndrome
In a recent article in GUT,1 we showed that, among 194 patients with diarrhoea-predominant irritable bowel syndrome (IBS-D), 43 had altered bile acid (BA) metabolism (ABAM) (serum 7αC4 >52 ng/mL). Patients with ABAM, had faster colonic transit (CT), lower α diversity and a different microbial compositional profile based on β diversity compared with IBS-D without ABAM. There were no significant differences in the stool short-chain fatty acid (SCFA) concentrations between the two groups.1 There is evidence that transit impacts gut microbiome composition and diversity.2 We wish to extend the previous analysis to compare the microbiome composition and SCFA in the same cohort of patients with IBS-D (total 181) with and without rapid CT, before and after adjusting for presence of ABAM. Patient selection, CT measurement, microbiome and SCFA analysis have been previously described.1 CT was measured as geometric centre (GC) by scintigraphy (range…
Shorter-acting glucagon-like peptide-1 receptor agonists are associated with increased development of gastro-oesophageal reflux disease and its complications in patients with type 2 diabetes mellitus: a population-level retrospective matched cohort study
Background
Shorter half-life glucagon-like peptide-1 receptor agonists (GLP-1 RAs) delay gastric emptying (DGE) more than GLP-1 RAs with longer half-lives. DGE is a known risk factor for gastro-oesophageal reflux disease (GERD) and its complications.
Aim
To determine whether short-acting or long-acting GLP-1 RAs are associated with an increased risk of new GERD or GERD-related complications
Design
We used the TriNetX global database to identify adult patients with type 2 diabetes mellitus and generated two cohorts totalling 1 543 351 patients on (1) GLP-1 RA or (2) other second-line diabetes medication. Using propensity-score matching, Kaplan-Meier Analysis and Cox-proportional hazards ratio (HR), we analysed outcomes and separately examined outcomes in patients starting short-acting (≤1 day) and long-acting (≥5 days) GLP-1 RAs.
Results
177 666 patients were in each propensity-matched cohort. GLP-1 RA exposure was associated with an increased risk (HR 1.15; 95% CI 1.09 to 1.22) of erosive reflux disease (ERD). However, this was solely due to short-acting (HR 1.215; 95% CI 1.111 to 1.328), but not long-acting (HR 0.994; 95% CI 0.924 to 1.069) GLP-1 RA exposure. Short-acting GLP-1 RAs were also associated with increased risk of oesophageal stricture (HR 1.284; 95% CI 1.135 to 1.453), Barrett’s without dysplasia (HR 1.372; 95% CI 1.217 to 1.546) and Barrett’s with dysplasia (HR 1.505; 95% CI 1.164 to 1.946) whereas long-acting GLP-1 RAs were not. This association persisted in sensitivity analyses, and when individually examining the short-acting GLP-1 RAs liraglutide, lixisenatide and exenatide.
Conclusion
Starting shorter-acting GLP-1 RAs is associated with increased risks of GERD and its complications.
Distribution of intranasal naloxone to potential opioid overdose bystanders in Sweden: effects on overdose mortality in a full region-wide study
Objectives
Distribution of take-home naloxone is suggested to reduce opioid-related fatalities, but few studies have examined the effects on overdose deaths in the general population of an entire community. This study aimed to assess the effects on overdose deaths of a large-scale take-home naloxone programme starting in June 2018, using an observational design with a historic control period.
Design
From the national causes of death register, deaths diagnosed as X42 or Y12 (International Classification of Diseases, 10th revision, ICD-10) were registered as overdoses. Numbers of overdoses were calculated per 100 000 inhabitants in the general population, and controlled for data including only individuals with a prior substance use disorder in national patient registers, to focus on effects within the primary target population of the programme. The full intervention period (2019–2021) was compared with a historic control period (2013–2017).
Setting
Skåne county, Sweden.
Participants
General population.
Interventions
Large-scale take-home naloxone distribution to individuals at risk of overdose.
Primary and secondary outcome measures
Decrease in overdose deaths per 100 000 inhabitants, in total and within the population with substance use disorder diagnosis.
Results
Annual average number of overdose deaths decreased significantly from 3.9 to 2.8 per 100 000 inhabitants from the control period to the intervention period (a significant decrease in men, from 6.7 to 4.3, but not in women, from 1.2 to 1.3). Significant changes remained when examining only prior substance use disorder patients, and decreases in overdose deaths could not be attributed to a change in treatment needs for opioid use disorders in healthcare and social services.
Conclusions
The present study, involving 3 years of take-home naloxone distribution, demonstrated a decreased overdose mortality in the population, however, only in men. The findings call for further implementation of naloxone programmes, and for further studies of potential effects and barriers in women.
Trial registration number
NCT03570099.
Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study
Objectives
Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.
Design
Prospective observational cohort study.
Setting
12 National Health Service centres in England.
Participants
Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.
Primary and secondary outcome measures
Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.
Results
In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p
Risk Prediction of Return to Use During Opioid Use Disorder Treatment
This decision analytical model uses a harmonized data set to develop an individual-level prediction tool to assess the risk of return to use in patients treated for opioid use disorder.
Short birth interval prevalence, determinants and effects on maternal and child health outcomes in Asia-Pacific region: a systematic review and meta-analysis protocol
Background
Short birth interval (SBI) has been linked to an increased risk of adverse maternal, perinatal, infant and child health outcomes. However, the prevalence and maternal and child health impacts of SBI in the Asia-Pacific region have not been well understood. This study aims to identify and summarise the existing evidence on SBI including its definition, measurement prevalence, determinants and association with adverse maternal and child health outcomes in the Asia-Pacific region.
Methods
Five databases (MEDLINE, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Maternity and Infant Care, and Web of Science (WoS)) will be systematically searched from September 2000 up to May 2023. Data will be extracted, charted, synthesised and summarised based on the outcomes measured, and where appropriate, meta-analysis will be performed. The risk of bias will be assessed using Joanna Briggs Institute quality appraisal. Grading of Recommendation Assessment, Development and Evaluation framework will be used to evaluate the quality of cumulative evidence from the included studies.
Ethics and dissemination
This review does not require ethics approval. Findings will be disseminated through peer-reviewed publications, policy briefs and conference presentations.
PROSPERO registration number
A protocol will be registered on PROSPERO for each separate outcome before performing the review.
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Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery – a randomised control trial
Introduction
Perioperative rehabilitation (PORT) has shown a positive effect on patients undergoing cardiac surgery. However, there are minimal data on the impact of short-term PORT in cardiac surgery, which is associated with higher postoperative morbidity and mortality. The trial will assess the efficacy of short-term PORT in reducing in-hospital mortality, postoperative pulmonary complications and length of stay, compared with the usual care in cardiac surgical patients.
Methods and analysis
This is a single-centre prospective, randomised, open, controlled trial with a 1:1 ratio. Consecutive 800 adult patients undergoing elective valve surgery will be randomised to either usual care or in-hospital short-term PORT that consists of education, inspiratory muscle training, active cycle of breathing techniques and early mobilisation. The primary outcome of this study will be a composite of in-hospital all-cause mortality, incidence of postoperative pulmonary complications and the ratio of postoperative hospitalisation >7 days.
Ethics and dissemination
The PORT study was granted by the Medical Research Ethics Committee of Guangdong Provincial People’s Hospital in August 2018. Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.
Trial registration number
NCT03709511.
Esophageal Symptoms Can Be Associated with Chronic Opioid Use
Chronic opioid use can cause distal esophageal spasm and esophagogastric outflow obstruction.
Trends in Before Medically Advised Discharges for Patients With Opioid Use Disorder
This study examines discharge trends for opioid-related admissions from 2016-2020 with a focus on admissions with opioid use disorder and an injection-related infection.
Non-high-density lipoprotein cholesterol levels as a risk factor for short-term mortality in elderly Chinese: a large-scale, population-based cohort study
Objectives
To explore the association between non-high-density lipoprotein (non-HDL) and mortality risk, both short-term and long-term, in Chinese people.
Design
A prospective cohort study.
Setting
The National Basic Public Health Service (BPHS) in China.
Participants
Including 621 164 elderly individuals around Hunan Province who underwent healthcare management receiving check-ups in China BPHS from 2010 to 2020. Exclusion criteria: (1) missing information on gender; (2) missing records of lipid screening; (3) missing information on key covariates; and (4) missing records of comorbidities (cardiovascular disease, hypertension, diabetes, cancer.)
Primary and secondary outcome measures
The study’s primary endpoint was all-cause and cause-specific mortality, sourced from Hunan’s CDC(Center for Disease Control and Prevention)-operated National Mortality Surveillance System, tracking participants until 24 February 2021.
Results
26 758 (4.3%) deaths were recorded, with a median follow-up of 0.83 years. Association between non-HDL and mortality was non-linear after multivariable adjustment, with the optimum concentration (OC) being 3.29 and 4.85 mmol/L. Compared with OC, the risk increased by 1.12-fold for non-HDL