In Patients With Inflammatory Bowel Disease, Racial Disparities Exist in Burden of Vaccine-preventable Disease Hospitalizations and Outcomes.

OBJECTIVE: Patients with inflammatory bowel disease (IBD) are at increased risk of vaccine-preventable diseases (VPDs). Despite the increasing prevalence of IBD in non-white populations, little is known regarding racial disparities in VPD burden. METHODS: Retrospectively analyzing the 2016 to 2020 National Inpatient Sample, we identified adults with IBD hospitalized for a principal diagnosis of VPD. The primary outcome investigated was hospitalization for VPD stratified by patient-reported race. Secondary outcomes were in-hospital morbidity, mortality, length of stay, and health care utilization. Multivariable regression analysis was performed to adjust for patient and hospital characteristics. RESULTS: The search identified 554,114 hospitalizations for VPD, including 4170 hospitalizations in patients with IBD. Patients with IBD had significantly greater odds of hospitalization from herpes zoster virus (adjusted odds ratio [aOR]: 1.73) and varicella zoster virus (aOR: 2.31). Comparing white and non-white patients with IBD, significant racial disparities were noted. Non-white patients were at greater odds of hospitalization from influenza (aOR: 1.74), herpes zoster virus (aOR: 1.77), and varicella zoster virus (aOR: 1.62). In-hospital morbidity was greater in non-white patients, including greater odds of requiring intensive care unit stay (aOR: 1.18). Morbidity was elevated in African Americans, with greater odds of acute kidney injury (aOR: 1.25), venous thromboembolism (aOR: 1.17), respiratory failure (aOR: 1.16), and intensive care unit stay (aOR: 1.18). No differences were found in mortality, length of stay, and health care utilization. CONCLUSIONS: Significant racial disparities in VPD hospitalization and in-hospital morbidity were found among adults with IBD in the United States. With the increasing prevalence of IBD in non-white populations, targeted efforts are needed to improve health equity.

Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases.

Recent evidence points to a plausible role of diet and the microbiome in the pathogenesis of both Crohn's disease (CD) and Ulcerative Colitis (UC). Dietary therapies based on exclusion of table foods and replacement with nutritional formulas and/or a combination of nutritional formulas and specific table foods may induce remission in CD. In UC, specific dietary components have also been associated with flare of disease. While evidence of varying quality has identified potential harmful or beneficial dietary components, physicians and patients at the present time do not have guidance as to which foods are safe, may be protective or deleterious for these diseases. The current document has been compiled by the nutrition cluster of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) based on the best current evidence to provide expert opinion regarding specific dietary components, food groups and food additives that may be prudent to increase or decrease in the diet of patients with inflammatory bowel diseases to control and prevent relapse of inflammatory bowel diseases.

Men With Inflammatory Bowel Disease: Sexual Function, Fertility, Medication Safety, and Prostate Cancer.

Half of patients with inflammatory bowel disease (IBD) are men, yet less attention has been focused on their sexual issues despite higher rates of sexual dysfunction and infertility than the general population. Depression and IBD disease activity are the most consistently reported risk factor for sexual dysfunction among men with IBD. Methotrexate and sulfasalazine have been rarely associated with impotence. Sulfasalazine reversibly reduces male fertility. No other medications used in IBD significantly affect fertility in humans. There is no increase in adverse fetal outcomes among offspring of fathers with IBD. Patients with IBD seem to be at a higher risk for prostate cancer; therefore, screening as recommended for high-risk patients should be considered.

Prediction of life-story narrative for end-of-life surrogate's decision-making is inadequate: a Q-methodology study.

BACKGROUND: Substituted judgment assumes adequate knowledge of patient's mind-set. However, surrogates' prediction of individual healthcare decisions is often inadequate and may be based on shared background rather than patient-specific knowledge. It is not known whether surrogate's prediction of patient's integrative life-story narrative is better. METHODS: Respondents in 90 family pairs (30 husband-wife, 30 parent-child, 30 sibling-sibling) rank-ordered 47 end-of-life statements as life-story narrative measure (Q-sort) and completed instruments on decision-control preference and healthcare-outcomes acceptability as control measures, from respondent's view (respondent-personal) and predicted pair's view (respondent-surrogate). They also scored their confidence in surrogate's decision-making (0 to 4 = maximum) and familiarity with pair's healthcare-preferences (1 to 4 = maximum). Life-story narratives' prediction was examined by calculating correlation of statements' ranking scores between respondent-personal and respondent-surrogate Q-sorts (projection) and between respondent-surrogate and pair-personal Q-sorts before (simulation) and after controlling for correlation with respondent-personal scores (adjusted-simulation), and by comparing percentages of respondent-surrogate Q-sorts co-loading with pair-personal vs. respondent-personal Q-sorts. Accuracy in predicting decision-control preference and healthcare-outcomes acceptability was determined by percent concordance. Results were compared among subgroups defined by intra-pair relationship, surrogate's decision-making confidence, and healthcare-preferences familiarity. RESULTS: Mean (SD) age was 35.4 (10.3) years, 69% were females, and 73 and 80% reported ≥ very good health and life-quality, respectively. Mean surrogate's decision-making confidence score was 3.35 (0.58) and 75% were ≥ familiar with pair's healthcare-preferences. Mean (95% confidence interval) projection, simulation, and adjusted-simulation correlations were 0.68 (0.67-0.69), 0.42 (0.40-0.44), and 0.26 (0.24-0.28), respectively. Out of 180 respondent-surrogate Q-sorts, 24, 9, and 32% co-loaded with respondent-personal, pair-personal, or both Q-sorts, respectively. Accuracy in predicting decision-control preference and healthcare-outcomes acceptability was 47 and 52%, respectively. Surrogate's decision-making confidence score correlated with adjusted-simulation's correlation score (rho = 0.18, p = 0.01). There were significant differences among the husband-wife, parent-child, and sibling-sibling subgroups in percentage of respondent-surrogate Q-sorts co-loading with pair-personal Q-sorts (38, 32, 55%, respectively, p = 0.03) and percent agreement on healthcare-outcomes acceptability (55, 35, and 67%, respectively, p = 0.002). CONCLUSIONS: Despite high self-reported surrogate's decision-making confidence and healthcare-preferences familiarity, family surrogates are variably inadequate in simulating life-story narratives. Simulation accuracy may not follow the next-of-kin concept and is 38% based on shared background.

Eluxadoline-Associated Pancreatitis in a Post-Cholecystectomy Patient: A Case Report.

Eluxadoline has emerged as an effective treatment option for patients with diarrhea- predominant irritable bowel syndrome (IBS-D). It was approved by the Food and Drug Administration (FDA) in May 2015 for treatment of IBS-D. It is a p-opioid receptor agonist and 6-receptor antagonist that acts locally in the gastrointestinal (GI) tract. In recently published phase IlIl IBS-3001 and IBS- 3002 trials, eight patients experienced abdominal pain due to sphincter of Oddi dysfunction (SOD), and one patient had acute pancreatitis, thought to be related to eluxadoline. Here, we describe a patient with eluxadoline- induced pancreatitis, the first case we know of to be reported outside of phase Ill clinical trials. Interestingly, only patients with prior cholecystectomy developed SOD and acute pancreatitis in the IBS 3001/3002 trials which also stands true with our patient. The enthusiasm with the efficacy of this drug should not have clinicians disregard the potential adverse effects, particularly serious ones, such as acute pancreatitis. We expect more cases of eluxadoline-induced pancreatitis and SOD to be reported, and future studies should focus on better understanding this association so as to guide treatment recommendations.

Immunomodulatory Therapy and an Insidious Presentation of a Large Intra-Abdominal Abscess.

Crohn's disease is a disorder characterized by transmural inflammation which can potentially affect any part of the gastrointestinal tract from the mouth to the perianal area. Cohn's disease is a systemic disease characterized by a relapsing remitting course, with variable intestinal and extra-intestinal complications. Abdominal and pelvic abscesses are not an uncommon complication of Crohn's disease occurring in 10-30 percent of all patients. We present the case of a 21-year-old male with Crohn's disease presenting with a massive abdominal abscess, whose diagnosis was delayed given lack of typical symptoms. Shortly after initiating therapy with Prednisone and Adalimumab he presented with worsening abdominal distention. Cross sectional imaging of the abdomen with IV contrast (Figure 1) demonstrated a 34cm x 23 cm x 11 cm rim-enhancing fluid collections in the abdomen and pelvis consistent with a large intra-abdominal abscess. He underwent an exploratory laparotomy, abdominal washout, and wound vacuum placement. Five liters of purulent fluid were aspirated and cultures grew citrobacter, veillonella and candida glabrata. A bowel perforation was suspected as the etiology for abscess formation; however magnetic resonance heterography (Figure2) was unremarkable. He was treated with appropriate antibiotics, antifungal agents, and was started on Aprisa. His course was complicated with recurrence of intra-abdominal abscesses and a colocutaneous fistula for which he underwent an open sigmoidectomy with a diverting loop colostomy. After condirmation of healing with repeat imaging, he was an uneventful postoperative course. He followed as an outpatient and continues to do well on Infliximab. Most abscesses are picked up in their early stages given characteristic symptoms; however in presence of immunosuppressive therapy the host immune system can be suppressed leading to delayed diagnosis. The presence of a massive intra-abdominal purulent fluid collection of this size has not been described on our review of the literature. Furthermore, despite the abscess taking up most of the abdominal cavity, the fairly limited symptom burden highlights the importance of having high degree of clinical suspicion for infectious compications in Crohn's disease patients even when classical symptoms are not present.

Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

BACKGROUND: The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. METHODS: We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. RESULTS: Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). CONCLUSIONS: 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

Patients' perceived purpose of clinical informed consent: Mill's individual autonomy model is preferred.

BACKGROUND: Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients' perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient's self decision-making. Different purposes require different processes. METHODS: We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: "meaningless routine", "courtesy gesture" "litigation protection", "take away compensation rights", "inform patient', "make sure patient understand", "document patient's decision", "discover patient's preferences", "have shared decision", and "help patient decide". RESULTS: Respondents' mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was "meaningless routine" (ranked 1-3 by 2.6% of respondents) and the most reflective statements were "help patient decide", "make sure patient understand", and "inform patient" (ranked 1-3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked "help patient decide" better, whereas females and post-procedure respondents ranked "inform patient" better (p = 0.007 to p < 0.001). Age was associated with better ranking of "help patient decide" and "make sure patient understand" statements (p < 0.001 and p = 0.002, respectively), which were ranked 1-3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). CONCLUSIONS: 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients' self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill's individual autonomy model may be suitable for most patients.

RAD-140 Drug-Induced Liver Injury.

Background: RAD-140, one of the novel selective androgen receptor modulators (SARMs), has potent anabolic effects on bones and muscles with little androgenic effect. Despite the lack of approval for its clinical use, RAD-140 is readily accessible on the consumer market. Hepatotoxicity associated with the use of SARMs has only rarely been reported in the literature. Case Report: A 24-year-old male presented with a 2-week history of diffuse abdominal pain, scleral icterus, pruritus, and jaundice. Prior to presentation, he had been taking the health supplement RAD-140 for muscle growth for 5 weeks. He had a cholestatic pattern of liver injury, with a peak total bilirubin of 38.5 mg/dL. Liver biopsy was supportive of a diagnosis of RAD-140-associated liver injury characterized pathologically by intracytoplasmic and canalicular cholestasis with minimal portal inflammation. Symptoms and liver injury resolved after cessation of the offending agent. Conclusion: To date, only select descriptions of the potential hepatoxicity associated with the use of SARMs, including RAD-140, have been published. Given their potential hepatoxicity and ready availability on the consumer market, RAD-140 and other SARMs should be used judiciously and under close clinical supervision until further hepatic safety data become available.

Clostridioides difficile toxin is infrequently detected in inflammatory bowel disease and does not associate with clinical outcomes.

INTRODUCTION: Clostridioides difficile infection (CDI) rates and outcomes can vary based on differences in testing strategy. Our aim was to assess the prevalence of toxin detection in inflammatory bowel disease (IBD) when compared to those without IBD. Secondly, the clinical outcomes of CDI in IBD were assessed using two-step testing strategies. METHODS: We included patients undergoing CDI testing from four academic centers in the United States between January 1, 2018 and June 30, 2020. First the prevalence of toxin detection was compared between individuals with IBD and those without IBD. Secondly, among patients with IBD a primary composite outcome of abdominal colectomy, admission to an intensive care unit (ICU) or death within 30 days of C. difficile testing was assessed across the three categorical groups (screen positive/toxin positive, screen positive/toxin negative and screen negative assay) resulting from the two-step testing strategy. RESULTS: When comparing individuals with a positive screening assay, patients with IBD were less likely to have toxin detected by enzyme immunoassay (EIA) as compared to the non-IBD population (22/145 (15.2%) vs. 413/1144 (36.1%), p < 0.0001). Among all patients with IBD (n = 300), twenty-five (8.3%) had a screen positive assay/toxin positive assay, 136 (45.3%) had a screen positive/toxin negative assay and 139 (46.3%) had a negative screening assay. No significant difference in the primary composite outcome was detected across the three groups (p = 0.566). CONCLUSION: When compared to those without IBD, patients with IBD have a reduced proportion of cases of C. difficile with toxin positivity. Differences in clinical outcomes among patients with IBD were not detected and limited by the infrequent detection of expressed toxin.

Case Report: Nivolumab-Induced Autoimmune Pancreatitis.

Nivolumab is an anti-programmed cell death protein 1 monoclonal antibody. While an effective treatment for a variety of tumors, immune checkpoint inhibitors (ICI) can cause immune-related adverse events such as ICI-pancreatic injury (ICI-PI). Here we present a case of a 60-year-old man with metastatic acral melanoma treated with nivolumab and ipilimumab who developed ICI-PI. Changes in positron emission tomography images preceded symptom onset. However, this case is unique in that the patient presented with cholestatic liver disease. Magnetic resonance cholangiopancreatography showed a dilated extrahepatic bile duct that resolved with steroid therapy, similar to the clinical course of autoimmune pancreatitis. ICI-PI has variable presentations including obstructive jaundice with a clinical course mimicking autoimmune pancreatitis and prompt awareness and treatment of ICI-PI is clinically significant given increasing use of ICIs.

Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites.

Background Bacterial translocation plays a pivotal role in the natural course of cirrhosis and its complications. Serum-derived bovine immunoglobulin (SBI) is an oral medical food that has been shown to both reduce inflammation in the intestines and neutralize bacteria. It represents a unique intervention that has not been studied in this population. Methodology We conducted a prospective open-label trial with an eight-week treatment phase of SBI. Individuals were assessed using lactulose breath testing, serum markers for enterocyte damage and bacterial translocation, and the Chronic Liver Disease Questionnaire (CLDQ) prior to and after completion of the treatment phase. Results We evaluated nine patients with a diagnosis of decompensated cirrhosis with ascites. Subjects had a mean Model for End-Stage Liver Disease (MELD) score of 11.6 ± 3.0 and were not taking lactulose or antibiotics. All subjects tolerated SBI well with no significant adverse events or changes to any of the six domains of the CLDQ. Laboratory tests including liver tests and MELD score remained stable over the course of treatment. There were no significant changes in the rates of small intestinal bacterial overgrowth (55.6% vs 55.6%, p = 1.00) or serum levels of lipopolysaccharide-binding protein, intestinal fatty acid-binding protein, or soluble CD14 (p-values 0.883, 0.765, and 0.748, respectively) when comparing values prior to and immediately after treatment. Conclusions No adverse events or significant changes to the quality of life were detected while on treatment. There were no statistically significant differences in our outcomes when comparing individuals before and after treatment in this small prospective proof-of-concept pilot study. Further prospective randomized studies could be beneficial.

Modeling Lay People's Ethical Attitudes to Organ Donation: A Q-Methodology Study.

BACKGROUND: Organ donation is commonly evaluated by biomedical ethicists based largely on principlism with autonomy at the top of the "moral mountain." Lay people may differ in the way they invoke and balance the various ethical interests. We explored lay people's ethical attitudes to organ donation. METHODS: Respondents (n=196) ranked 42 opinion-statements on organ donation according to a 9-category symmetrical distribution. Statements' scores were analyzed by averaging-analysis and Q-methodology. RESULTS: Respondents' mean (SD) age was 34.5 (10.6) years, 53% were women, 69% Muslims (30% Christians), 29% Saudis (26% Filipinos), and 38% healthcare-related. The most-agreeable statements were "Acceptable if benefit to recipient large," "Explicit donor consent and family approval for live donation," "Acceptable if directed to family member," and "Explicit donor consent and family approval for postmortem donation." The most-disagreeable statements were "Donor consent and family approval not required for postmortem donation," "Acceptable with purely materialistic motivation," and "Only donor no-known objection for postmortem donation." Women, Christians, and healthcare respondents gave higher rank to "Explicit donor consent and family approval for live donation," "Only donor family consent required for postmortem donation," and "Acceptable if organ distribution equitable," respectively, and Muslims gave more weight to donor/family harm (p ≤0.001). Q-methodology identified various ethical resolution models that were associated with religious affiliation and included relatively "motives-concerned," "family-benefit-concerned," "familism-oriented," and "religious or non-religious altruism-concerned" models. Of 23 neutral statements on averaging-analysis, 48% and 65% received extreme ranks in ≥1 women and men Q-methodology models, respectively. CONCLUSION: 1) On average, recipient benefit, requirement of both explicit donor consent and family approval, donor-recipient relationship, and motives were predominant considerations; 2) ranking of some statements was associated with respondents' demographics; 3) Q-methodology identified various ethical resolution models that were partially masked by averaging-analysis; and 4) strong virtue and familism approaches in our respondents provide some empirical evidence against principlism adequacy.

Role of Octreotide in Menetrier's Disease: Case Report and Review of Literature.

Menetrier's disease (MD) is a rare disease characterized macroscopically by gastric rugae thickening and microscopically by foveolar hyperplasia with glandular atrophy, resulting in luminal protein loss. Different treatment strategies, including antibiotics, prednisone, octreotide, and monoclonal antibodies, have yielded varying degrees of success. Here, we present a rare complication of MD with a gastric outlet obstruction from a large adenoma. However, prior to this complication, dramatic clinical and laboratory improvements were observed after 12 months of treatment with subcutaneous octreotide. We also present a review of the literature for the role of octreotide in the treatment of MD.

Cervical Cancer Screening in Inflammatory Bowel Disease: Who Should Be Screening?

BACKGROUND: Immunosuppressed women with inflammatory bowel disease (IBD) are at elevated risk of cervical cancer yet have lower screening rates. The objective of this study was to assess the familiarity with cervical cancer screening recommendations, and the perceived responsibility for implementing screening among three physician groups involved in the clinical care of women with IBD: primary care physicians (PCP), gastroenterologists (GI) and gynecologists (GYN). METHODS: We anonymously surveyed a sample of 117 PCP, 52 GYN and 35 GI physicians affiliated with Saint Louis University, Saint Louis, MO, USA, from April 2018 to January 2019. The physicians completed a questionnaire adressing essential aspects of cervical cancer screening such as screening age, screening frequency, human papillomavirus (HPV) vaccination, comfort level in performing Papanicolaou (Pap) smears, perception of physician responsibility in terms of which physicians should perform Pap smears. RESULTS: A total of 2.6% of PCPs, 37% of GIs and 29% of GYNs reported familiarity with cervical cancer screening recommendations. In addition, PCP and GI had no definite opinions regarding which physicians should be in charge of cervical cancer screening and performing Pap smears. However, 94% of GYNs felt that they should be in charge of cervical cancer screening and performing Pap smears. CONCLUSIONS: An apparent lack of familiarity exists among all three physician groups regarding cervical cancer screening recommendations in immunosuppressed patients with IBD. Similarly, there is no consensus regarding which specialty should be responsible for cervical cancer screening in this patient population.