Optimizing the Utility of Anorectal Manometry for Diagnosis and Therapy: A Roundtable Review and Recommendations.

BACKGROUND & AIMS: Anorectal manometry (ARM) is a comprehensive diagnostic tool for evaluating patients with constipation, fecal incontinence, or anorectal pain; however, it is not widely utilized for reasons that remain unclear. The aim of this roundtable discussion was to critically examine the current clinical practices of ARM and biofeedback therapy by physicians and surgeons in both academic and community settings. METHODS: Leaders in medical and surgical gastroenterology and physical therapy with interest in anorectal disorders were surveyed regarding practice patterns and utilization of these technologies. Subsequently, a roundtable was held to discuss survey results, explore current diagnostic and therapeutic challenges with these technologies, review the literature, and generate consensus-based recommendations. RESULTS: ARM identifies key pathophysiological abnormalities such as dyssynergic defecation, anal sphincter weakness, or rectal sensory dysfunction, and is a critical component of biofeedback therapy, an evidence-based treatment for patients with dyssynergic defecation and fecal incontinence. Additionally, ARM has the potential to enhance health-related quality of life and reduce healthcare costs. However, it has significant barriers that include a lack of education and training of healthcare providers regarding the utility and availability of ARM and biofeedback procedures, as well as challenges with condition-specific testing protocols and interpretation. Additional barriers include understanding when to perform, where to refer, and how to use these technologies, and confusion over billing practices. CONCLUSIONS: Overcoming these challenges with appropriate education, training, collaborative research, and evidence-based guidelines for ARM testing and biofeedback therapy could significantly enhance patient care of anorectal disorders.

Minimum false-positive risk of primary outcomes and impact of reducing nominal P-value threshold from 0.05 to 0.005 in anaesthesiology randomised clinical trials: a cross-sectional study.

BACKGROUND: Reproducibility of research is poor; this may be because many articles report statistically significant findings that are false positives. Two potential solutions are to lower the P-value for statistical significance testing from 0.05 to 0.005 and to report the minimum false-positive risk (minFPR). This study determined these metrics for randomised controlled trials (RCTs) in general anaesthesiology journals. METHODS: We identified superiority RCTs published between January 1, 2019 and March 15, 2021 from seven leading anaesthesia journals. P-values for primary outcomes were collected, and minFPRs for these outcomes were calculated using a formula assuming a 50% prior probability of an intervention being effective (minFPR50). The primary outcomes were the percentage of RCTs maintaining statistical significance at P<0.005 and minFPR50. RESULTS: We included 318 RCTs. P-values below 0.05 were reported in 205/318 (64%) of RCTs. Of these 205 RCTs, 119/205 (58%) maintained statistical significance at the P<0.005 threshold. The mean (standard deviation) minFPR50 was 22% (20). At P=0.005, the minFPR50 was approximately 5%. CONCLUSIONS: These proposed metrics aimed at mitigating reproducibility concerns would call a significant portion of the anaesthesiology literature into question. We found a minFPR of 22% and determined that 42% of primary outcomes would not maintain statistical significance if the P-value threshold changed from 0.05 to 0.005. These findings could partially explain the lack of reproducibility of research findings.

Utilization of Free Soft Tissue Grafts in Otoplasty: A Simple Yet Effective Way to Avoid Suture Extrusion.

BACKGROUND: Prominent ear deformity occurs in 5% of the general population and has been treated by otoplasty for many years to address the psychosocial challenges of having such a deformity. There is extensive literature but no consensus on the best method to address potential surgical complications, including suture extrusion. OBJECTIVES: The aim of this article was to describe a surgical technique designed to reduce suture extrusion following otoplasty surgery by placing free soft tissue grafts between Mustardé sutures and postauricular skin. METHODS: Two hundred and eleven patients who underwent otoplasties with soft tissue grafts between January 2017 and January 2020 were included in this study. All surgeries were performed by 2 facial plastic surgeons with more than 20 years of experience each, practicing in Toronto, Canada. Patients were followed up to assess for suture extrusion between 12 and 36 months (median, 21 months) postoperatively. The rates of suture complications and extrusion were compared with those previously reported in the literature. RESULTS: Only 2 patients out of 211 (0.47%) had unilateral suture extrusion and were treated with suture removal. This is dramatically lower than the upper values reported in the literature, which average 5.55% (range, 0%-22.2%). CONCLUSIONS: A soft tissue graft separating the Mustardé sutures and postauricular skin acts as a barrier, and can be used in conjunction with traditional surgical techniques. By adding this graft in the proposed manner, there is additional tissue reinforcing the suture repair, thereby reducing the rates of suture complications and extrusion without increasing the operative time.

Risk for Post-Colonoscopy Irritable Bowel Syndrome in Patients With and Without Antibiotic Exposure: A Retrospective Cohort Study.

BACKGROUND & AIMS: Laboratory studies have demonstrated that antibiotic use in conjunction with bowel purgatives causes alterations to the gut microbiota. Because gut microbiota changes may be a trigger for the development of irritable bowel syndrome (IBS), we sought to assess whether individuals who undergo bowel cleansing for colonoscopy and have concurrent antibiotic exposure develop IBS at higher rates than individuals who undergo colonoscopy without antibiotic exposure. METHODS: We used data from Optum's de-identified Clinformatics Data Mart Database in the United States to study a cohort of 50- to 55-year-olds who underwent screening colonoscopy. Individuals exposed to antibiotics within 14 days of colonoscopy were propensity-score matched to individuals who were not exposed to antibiotics around colonoscopy. The primary outcome was a new IBS diagnosis, and the composite outcome was a new claim for IBS, IBS medications, or IBS symptoms. The association of antibiotic exposure and the outcomes was calculated using Cox proportional hazards regression. RESULTS: There were 408,714 individuals who met criteria for the screening colonoscopy cohort. Of these, 24,617 (6.0%) were exposed to antibiotics around the time of colonoscopy, and they were propensity-score matched to 24,617 individuals not exposed to antibiotics. There was no statistically significant association between antibiotic use and IBS (hazard ratio, 1.11; 95% confidence interval, 0.89-1.39), but there was a weak association between antibiotic use and the composite outcome (hazard ratio, 1.12; 95% confidence interval, 1.02-1.24; number needed to harm, 94). CONCLUSIONS: Individuals concurrently exposed to antibiotics and bowel purgative had slightly higher rates of surrogate IBS outcomes compared with matched controls who did not receive antibiotics concurrently with bowel purgative.

Complementary and Alternative Medicine Therapies for Irritable Bowel Syndrome.

Complementary and alternative medicine (CAM) is a term used to define a broad range of therapies, most commonly grouped into natural products, mind-body medicine, and traditional systems of medicine. Patients with irritable bowel syndrome (IBS) commonly use CAM therapies, although there are many barriers that may keep patients and providers from talking about a patient's CAM use. Despite limited quantity and quality of evidence of CAM for IBS, providers can better counsel patients on CAM use by understanding pitfalls related to CAM use and by learning what is known about CAM.

Probiotic VSL#3 Treatment Reduces Colonic Permeability and Abdominal Pain Symptoms in Patients With Irritable Bowel Syndrome.

Background: Little is known regarding the clinical impact of treatment and treatment duration of probiotic VSL#3 on gut and microbiome function in irritable bowel syndrome (IBS). As part of a safety trial, we assessed the effect of VSL#3 treatment duration on abdominal pain, stooling, gut permeability, microbiome composition and function. Methods: Adults with IBS were randomized into an open label trial to receive the probiotic VSL#3 for 4 or 8 weeks. Adverse events, abdominal pain, and stooling patterns were recorded daily. Gut permeability, fecal bile acid levels, and microbiome composition were profiled at baseline and after treatment. Results: Fifteen subjects completed the trial (4-week: n = 8; 8-week: n = 7). Number of pain episodes decreased in both groups (P = 0.049 and P = 0.034; 4- vs. 8-week, respectively). Probiotic organisms contained in VSL#3 were detected in feces by whole shotgun metagenomic sequencing analysis and relative abundances of Streptococcus thermophilus, Bifidobacterium animalis, Lactobacillus plantarum, and Lactobacillus casei subsp. paraccasei correlated significantly with improved abdominal pain symptoms and colonic permeability at study completion. Although abdominal pain correlated significantly with the detection of probiotic species at study completion, a composite view of gut microbiome structure showed no changes in community diversity or composition after VSL#3 treatment. Conclusions: Probiotic organisms identified in stool correlated significantly with improvement in colonic permeability and clinical symptoms, prompting future studies to investigate the mechanistic role of VSL#3 and colonic permeability in IBS pathophysiology in a larger randomized controlled trial. Clinical Trial Registration: www.clinicaltrials.gov, Identifier: NCT00971711.

A multidisciplinary approach to improving transition readiness in pediatric liver transplant recipients.

The Six Core Elements of Transition have been advocated to guide transition, but little is published about their use with liver transplant patients. We started a liver transplant transition program in August 2015 using quality improvement (QI) methods and by linking the Six Core Elements of Transition to process measures. Eligible patients completed baseline transition readiness assessments (Readiness for Transition Questionnaire, RTQ), interviews with a psychologist, received focused education, and completed follow-up RTQs before transfer to adult care. Our QI goal was to improve RTQ scores by 20% prior to transfer to adult care. We also assessed continuity of care, tacrolimus levels, rejection, and retransplantation as balancing measures. Of the 24 patients who completed the transition program and were transferred to adult care, RTQ scores were available for 11 patients. Overall RTQ scores improved from 23.7 to 30.5 (+28.7%, P = .009) prior to transfer. Nearly two-thirds (63%) of patients were seen by adult transplant hepatology within 6 months, and one patient was lost to follow-up after the first adult visit. Tacrolimus-level standard deviations were <2.0 in 45% of patients in pediatric care and 72% of patients in adult care. Three patients had undergone immunosuppression withdrawal in pediatric care, with one restarted on immunosuppression prior to transfer to adult care due to late acute rejection. The Six Core Elements of Transition can be translated into patient- and system-level transition milestones to serve as potential quality metrics in the implementation of transition programs.

Recommendations for Successful Transition of Adolescents With Inflammatory Bowel Diseases to Adult Care.

Adolescents and young adults diagnosed with inflammatory bowel diseases (IBDs) in pediatric care are vulnerable during their transition to adult care. There are 6 core elements of transition from pediatric to adult IBD care. We identified gaps in this transition and make recommendations for clinical practice and research. There have been few studies of transition policy (core element 1) or studies that tracked and monitored patients through the transition (core element 2). Several studies have assessed transition readiness (core element 3), but instruments for assessment were not validated using important outcomes such as disease control, health care use, adherence, quality of life, or continuity of care. There have been no studies of best practices for transition planning (core element 4), including how to best educate patients and facilitate gradual shifts in responsibility. A small number of longitudinal studies have investigated transfer of care (core element 5), but these were conducted outside of the United States; these studies found mixed results in short- and intermediate-term outcomes after transition completion (core element 6). We discuss what is known about the transition from pediatric to adult care for IBD, make recommendations to improve this process, and identify areas for additional research.

Clinical Guideline Highlights for the Hospitalist: Initial Management of Acute Pancreatitis in the Hospitalized Adult.

GUIDELINE TITLE: 2018 American Gastroenterological Association (AGA) Institute Guideline on Initial Management of Acute Pancreatitis RELEASE DATE: March 2018 PRIOR VERSION: Not applicable DEVELOPER: AGA Clinical Practice Guideline Committee FUNDING SOURCE: AGA Institute TARGET POPULATION: Patients within first 48-72 hours of admission with acute pancreatitis (AP).

Risk of Bias Analysis of Systematic Reviews of Probiotics for Treatment of Irritable Bowel Syndrome.

Global prevalence of irritable bowel syndrome (IBS) is between 7% and 21%.1 Pathogenesis of IBS symptoms such as pain, altered bowel habits, and bloating is multifactorial, with central and peripheral mechanisms serving as targets for treatments.2 Probiotics have been studied for the treatment of IBS and are well tolerated and safe.3.

A Systematic Review of the Effectiveness of Psychological Treatments for IBS in Gastroenterology Settings: Promising but in Need of Further Study.

BACKGROUND: Psychological treatments are efficacious for irritable bowel syndrome (IBS) in clinical trials; however, their effectiveness when conducted in gastroenterology practice settings is unclear. AIM: To perform a systematic review of the types and effects of psychological treatments for IBS conducted in gastroenterology clinics. METHODS: We searched PubMed, EMBASE, and Cochrane central register. Studies conducted in gastroenterology clinic settings with IBS patients who were clinically referred from gastroenterology were included. RESULTS: We identified 3078 citations, of which only eight studies were eligible. Seven studies compared psychological treatments (average n = 25.7; range 12-43) to controls (average n = 25.4 patients; range 12-47), whereas one study compared two active "bonafide" interventions. Psychological treatments varied (cognitive-behavioral therapy, guided affective imagery, mindfulness, hypnosis, biofeedback, emotional awareness training). However, across approaches, short-term benefits were seen. IBS symptoms improved significantly among patients in cognitive and behavioral therapies, mindfulness-based stress reduction, guided affective imagery, and emotional awareness training compared with controls; there was a similar trend for gut-directed hypnotherapy. Similarly, IBS symptoms improved in a study of two active biofeedback and hypnosis treatments. CONCLUSIONS: Evidence for the effectiveness of psychological treatment in gastroenterology practice is promising but limited. Study designs that involve a blending of efficacy and effectiveness components are needed.

Improving symptom management for people with amyotrophic lateral sclerosis.

INTRODUCTION: Symptomatic management is the main focus of ALS clinical care. We aim to report the prevalence of ALS-related symptoms and characterize self-reported symptomatic management. METHODS: A symptom management survey developed by the Muscular Dystrophy Association Clinical Research Network was completed by ALS registrants. Logistic regression identified potential predictors of symptom prevalence, severity, and treatment. RESULTS: A total of 567 ALS participants reported fatigue (90%), muscle stiffness (84%), and muscle cramps (74%) as most prevalent symptoms. Fatigue (18%), muscle stiffness (14%), and shortness of breath (12%) were most bothersome. Although fatigue was the most prevalent symptom, it was also least treated (10%). Neither location of care nor disease duration was associated with symptom prevalence, severity, or probability of receiving treatment. DISCUSSION: This large patient-reported symptom survey suggests that fatigue is the most prevalent, bothersome, and undertreated ALS symptom. Improving ALS symptom management is an unmet medical need and clinical trials of symptomatic treatments are needed. Muscle Nerve 57: 20-24, 2018.

Residency as a Social Network: Burnout, Loneliness, and Social Network Centrality.

BACKGROUND: Burnout is typically viewed as an individual condition, and no link has been identified between burnout and loneliness. OBJECTIVE: To investigate the association of burnout with loneliness and social network degree and centrality. METHODS: A survey containing the Maslach Burnout Inventory (MBI), a 3-question loneliness scale, and a social connectivity component was sent to residents in a large urban academic medical center internal medicine residency program. RESULTS: The response rate was 77% (95 of 124 residents). We defined significant burnout as MBI subscores of ≥ 27 for emotional exhaustion (EE), ≥ 10 for depersonalization (DP), or both. This was met by 43 (45%), 47 (49%), and 31 (33%) out of 95 respondents, respectively. Those with significant burnout had higher loneliness scores: 5.6 versus 4.5 for EE (P = .002; OR = 1.50; 95% CI 1.15-1.95); 5.4 versus 4.6 for DP (P = .024; OR = 1.33; 95% CI 1.03-1.71); and 5.8 versus 4.6 for both EE and DP (P = .001; OR = 1.54; 95% CI 1.17-2.02). Rating a larger number of coresidents as closer connections on a 5-point Likert scale was not associated with lower burnout scores. No measures of centrality were associated with burnout scores for EE and/or DP. High personal accomplishment subscores on the MBI did correlate significantly with several measures of centrality. CONCLUSIONS: Burnout was associated with loneliness in a dose-dependent fashion. Greater sense of personal accomplishment was associated with greater network centrality.

Analysis of start-up, retention, and adherence in ALS clinical trials.

OBJECTIVE: To investigate predictors of trial start-up times, high attrition, and poor protocol adherence in amyotrophic lateral sclerosis (ALS) trials. METHODS: Retrospective analysis of start-up times, retention, and protocol adherence was performed on 5 clinical studies conducted by the Northeast ALS Consortium and 50 ALS clinical trials identified by PubMed search. Predictors of start-up times were estimated by accelerated failure time models with random effects. Predictors of retention and protocol deviations were estimated by mixed-model logistic regression. RESULTS: Median times for contract execution and institutional review board (IRB) approval were 105 days and 125 days, respectively. Contract execution was faster at sites with more ongoing trials (p = 0.005), and more full-time (p = 0.006) and experienced (p < 0.001) coordinators. IRB approval was faster at sites with more ongoing trials (p = 0.010) and larger ALS clinics (p = 0.038). Site activation after IRB approval was faster at sites with more full-time (p = 0.038) and experienced (p < 0.001) coordinators. Twenty-two percent of surviving participants withdrew before completing the trial. Better participant functional score at baseline was an independent predictor of trial completion (odds ratio 1.29, p = 0.002) and fewer protocol deviations (odds ratio 0.86, p = 0.030). CONCLUSION: Delays in IRB review contribute the most to prolonged trial start-up times, and these timelines are faster in sites with more experienced staff. Strategies to improve protocol adherence and participants' retention may include enrolling people at early disease stages.