P059 Impact of PHQ-9 Screen on Early Identification of Depression in IBD Clinic.

BACKGROUND: Over the past two decades there has been significant research linking inflammatory bowel disease (IBD) to depression. The chronicity of symptoms coupled with the financial burden of treatment costs, missed days of work/school and interpersonal relationship stress are contributing factors in the diagnosis of depression. The prevalence of depression within the IBD community is 15% and depressive symptoms are noted in 20% of patients. Furthermore, IBD patients with severe uncontrolled disease have higher rates of depression (40.7%) than those in remission (16.5%). The association between IBD and depression is linked to lower quality of life, poor medication compliance, worse disease outcomes, increased hospitalization, and higher suicidal risk. Early diagnosis and treatment of depression in IBD patients is paramount in achieving and maintaining IBD disease remission. While the association between IBD and depression is well-known, identifying depression can be a challenge. Review of recent literature shows that depression is under screened in IBD clinics. We present a prospective quality improvement study at a robust IBD center evaluating the impact of a validated depression screen (PHQ-9) on identifying depression compared to standard of care. METHODS: We compared the prevalence of depression in the IBD clinic in the control group using the history and diagnosis of depression and compared it against the intervention group after HQ-9 screening. Control group patient data was collected from June 2020 to July 2020 via virtual and in person visits. Intervention group PHQ-9 data was collected in person visits from January - March 2020 and post-intervention data collection was placed on hold until November 2020 due to the COVID pandemic. One randomly selected patient from each clinic session was asked to participate in the study at the time of visit. The primary end point was to compare the rates of depression and identify any barriers in providing early treatment for depression. The secondary endpoint was to identify high risk patients that are prone to depression. Categorical variables were analyzed by chi square analysis or fischer exact tests. Numerical data were analyzed using T-test. RESULTS: A total of 111 patients were screened. 60 patients were randomized to the control group (i.e. EMR based review for depression) and 51 patients were screened via survey during in person clinic visit. The identified depression rate from control vs intervention group is 20% vs. 35% (p = 0.071). Rates of depression were 15% in non-fistulizing Crohn's disease vs. 41.4% in fistulizing Crohn's disease (p = 0.003). Multivariate model for predicting depression noted to be significant for extra-intestinal manifestations OR of 3.06 (1.03, 9.12) p = 0.045 and age OR of 0.97 (0.94, 1.00) p = 0.042. Control vs. intervention identification of depression in patients with extra-intestinal manifestations is notable for OR of 3.31 (1.15, 9.52) p = 0.026 in the univariate model and OR of 3.30 (1.07, 10.16) p = 0.038 in the multivariate model. CONCLUSION: Key findings including identification of depression is higher in the intervention group compared to the control group. Though the data is not statistically significant, this is likely secondary to the small sample size in the setting of the pandemic. In addition, univariate analysis revealed a statistically significant finding that the older the age of the patient, the less likely they are to have depression. Our data showed that the mean age of depressed patients was 38.3 compared to nondepressed patients whose mean age is 47.1. Further analysis can help elucidate this finding, for example identifying if older patients are being treated for depression or more likely to seek out therapists compared to younger patients. Univariate analysis also revealed that intestinal Crohn's disease was a risk factor for depression. This is possibly secondary to the severity of disease in these individuals, especially if their IBD is causing an impact on their quality of life. Looking into the number of hospitalizations, days off from work or school, and coexisting medical diagnoses can allow us to further understand if depression stems from their disease. Given preliminary findings, we plan to continue this study for a larger sample size and further determine if there is a significant delay in identifying depression with the current standard of care.

Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience.

Fecal microbiota transplant (FMT) is recommended for Clostridium difficile infection (CDI) treatment; however, use in solid organ transplantation (SOT) patients has theoretical safety concerns. This multicenter, retrospective study evaluated FMT safety, effectiveness, and risk factors for failure in SOT patients. Primary cure and overall cure were defined as resolution of diarrhea or negative C difficile stool test after a single FMT or after subsequent FMT(s) ± anti-CDI antibiotics, respectively. Ninety-four SOT patients underwent FMT, 78% for recurrent CDI and 22% for severe or fulminant CDI. FMT-related adverse events (AE) occurred in 22.3% of cases, mainly comprising self-limiting conditions including nausea, abdominal pain, and FMT-related diarrhea. Severe AEs occurred in 3.2% of cases, with no FMT-related bacteremia. After FMT, 25% of patients with underlying inflammatory bowel disease had worsening disease activity, while 14% of cytomegalovirus-seropositive patients had reactivation. At 3 months, primary cure was 58.7%, while overall cure was 91.3%. Predictors of failing a single FMT included inpatient status, severe and fulminant CDI, presence of pseudomembranous colitis, and use of non-CDI antibiotics at the time of FMT. These data suggest FMT is safe in SOT patients. However, repeated FMT(s) or additional antibiotics may be needed to optimize rates of cure with FMT.

Private troubles to public issue: empowering communities to reduce alcohol-related harm in Sabah, Malaysia.

Summary: Alcohol is the number three contributor to the burden of disease worldwide so must remain a priority health promotion issue internationally. Malaysia is a Muslim country and alcohol-related harm was not seen as a priority until recently, because it only affects a minority of the population. Sabah has more than 30 different ethnic groups, and alcohol has a traditional role in the cultural practices of many of these groups. In 2009, the Intervention Group for Alcohol Misuse (IGAM) was formed, under the umbrella of Mercy Malaysia by a group of healthcare workers, academics, members of the Clergy and people who were previously alcohol-dependent concerned about the harmful effects of excessive alcohol consumption. IGAM in collaboration with other bodies have organized public seminars, visited villages and schools, encouraged the formation of a support group and trained healthcare professionals in health promotion intervention. The focus later changed to empowering communities to find solutions to alcohol-related harm in their community in a way which is sensitive to their culture. A standard tool-kit was developed using WHO materials as a guide. Village committees were formed and adapted the toolkit according to their needs. This strategy has been shown to be effective, in that 90% of the 20 committees formed are actively and successfully involved in health promotion to reduce alcohol-related harm in their communities.

Predictors of Thiopurine Treatment Failure in Biologic-Naïve Ulcerative Colitis Patients.

INTRODUCTION: Thiopurines (azathioprine and 6-mercaptopurine) have been used in the management of UC patients for over three decades. Nearly half of patients with UC treated with thiopurines fail to achieve remission or lose remission during treatment. Factors associated with thiopurine failure are poorly understood. The primary aim of our study was to investigate patient-related factors which are associated with thiopurine failure. METHODS: TNF-alpha antagonist-naïve patients with histological diagnosis of UC, receiving thiopurine therapy, with follow-up data from 1 to 3 years were included in the study. Data regarding demographics, laboratory results, and disease characteristics were collected. The primary endpoint was failure of thiopurine therapy, defined as treatment with steroids, therapeutic escalation to TNF-alpha antagonist therapy, or need for surgery. RESULTS: Of the 563 patients identified using ICD-9 codes, 78 TNF-alpha antagonist-naïve patients with a histological diagnosis of UC, receiving thiopurine treatment, were identified. Over the three-year follow-up period, 38 patients failed thiopurine treatment. On adjusted Cox regression, BMI < 25 kg/m(2) (HR 3, 95 % CI 1.55-5.83; p value = 0.001) was significantly associated with thiopurine failure. Furthermore, although not statistically significant, there was a strong trend toward thiopurine failure among patients with serum albumin level < 4 g/dL (HR 1.98, 95 % CI 0.97-4; p value = 0.06), non-smoking status (HR 2.2, 95 % CI 0.96-5.06; p value = 0.06), and higher degree of colon inflammation (HR 1.49, 95 % CI 0.96-2.32; p value = 0.08). DISCUSSION: Our results show that low body mass index is associated with increased risk of failure of thiopurine treatment. Furthermore, there was a strong trend toward thiopurine failure among patients with low serum albumin level (<4gm/dL). These factors should be considered as markers of non-response to thiopurine monotherapy for patients with moderately severe ulcerative colitis.

Translation, Cross-Cultural Adaptation to Malay, and psychometric evaluation of the AIM-IAM-FIM questionnaire: Measuring the implementation outcome of a community-based intervention programme.

BACKGROUND: The implementation outcomes determine the success and progress of a community-based intervention programme. The community is an important stakeholder whose effects should be assessed. Nevertheless, Malaysia has limited instruments for determining outcome measurements. This research aimed to develop Malay versions of the Acceptability, Appropriateness, and Feasibility Intervention Measures (AIM-IAM-FIM) questionnaire, which evaluates the implementation outcome of the programme. METHODS: A methodological study of the translation and validation of the implementation outcome measures was conducted from March 2022 until December 2022. Three key analyses were conducted: (1) translation and validation; (2) factor investigation and extraction (n = 170); and (3) scale evaluation (n = 235). RESULT: The Malay version measuring the implementation outcome measures of a community-based intervention programme was produced after extensive translation and modification, and it consisted of a single dimension with seven items. The content validity index was 0.9, the exploratory factor analysis showed that the KMO measure of sample adequacy was 0.9277, and Bartlett's sphericity test was statistically significant. Cronbach's alpha was good, with a level of 0.938. The single factor structure fitted the data satisfactorily [χ2 (p-value of 0.002), SRMR = 0.030, CFI = 0.999, RMSEA = 0.079, TLI = 0.998]. Factor loading for all items was > 0.7. CONCLUSION: The 7-item Malay version of the AIM-IAM-FIM survey instrument is valid and reliable for assessing the acceptability of a community-based intervention study and is applicable to other fields. Future studies in psychometric evaluation are recommended in other states due to the variety of Malay dialects spoken across Asia. The scale may also benefit other areas where the language is spoken.

Correction: Diabetic retinopathy among type 2 diabetes mellitus patients in Sabah primary health clinics-Addressing the underlying factors.

[This corrects the article DOI: 10.1371/journal.pone.0261249.].

Study on the Development of a Conceptual Framework to Identify the Risk Factors of Diabetic Retinopathy among Diabetic Patients: A Concept Paper.

The most common complication of diabetes mellitus (DM) is diabetic retinopathy (DR). The control of DR risk factors is essential for the effective prevention of DR. There is currently a lack of research to guide DR-related research in Malaysia. This concept paper aimed to review published studies and propose a conceptual framework (CF) as a guide for future research to determine the prevalence of DR and its risk factors across DM patients. After a review of prior research, this study has presented a CF that takes into account these four key elements: the patient's sociodemographic characteristics, comorbidities, complications, and diabetes conditions, namely, the length of the disease and glycaemic control. In the suggested CF, ethnicity was highlighted as a crucial risk factor for DR across lower- to middle-income countries (LMIC) and multiracial countries. In order to guide future studies, scientific guidance is essential. The proposed CF would help future research to conduct scientific research related to DR. Also, the proposed CF was tailored to suit research across LMIC and multiracial countries.

Diabetic retinopathy among type 2 diabetes mellitus patients in Sabah primary health clinics-Addressing the underlying factors.

Every person diagnosed with diabetes mellitus (T2DM) is at risk of developing Diabetic retinopathy (DR). Thus, DR is one of the major chronic microvascular complications of T2DM. However, in Malaysia, research about DR is still scarce. This study aimed to determine the prevalence of DR among diabetic patients across 46 primary healthcare clinics in Sabah, Malaysia. Secondly, it purported to identify the factors influencing the development of DR. This cross-sectional study involved a total of 22,345 Type 2 diabetes mellitus (T2DM) patients in the Sabah Diabetic Registry from 2008 to 2015. Of the 22,345 T2DM patients, 13.5% (n = 3,029) of them were diagnosed with DR. Multiple logistic regression revealed seven major risk factors of DR, i.e. patients with diabetic foot ulcer [aOR: 95% CI 3.08 (1.96-4.85)], patients with diabetic nephropathy [aOR: 95% CI 2.47 (2.13-2.86)], hypertension [aOR: 95% CI 1.63 (1.43-1.87)], dyslipidaemia [aOR: 95% CI 1.30 (1.17-1.44)], glycated haemoglobin [(HbA1c) > 6.5 (aOR: 95% CI 1.25 (1.14-1.38)], duration of diabetes mellitus (T2DM) [aOR: 95% CI 1.06 (1.05-1.07)] and age of patient [aOR: 95% CI 1.01 (1.00-1.02)] respectively. DR is a preventable complication. The effective glycaemic control is crucial in preventing DR. In minimizing the prevalence of DR, the healthcare authorities should institute programmes to induce awareness on the management of DR's risk factors among patient and practitioner.

Is There a Role for Therapeutic Drug Monitoring in Patients with Hidradenitis Suppurativa on Tumor Necrosis Factor-α Inhibitors?

Tumor necrosis factor-α inhibitors, adalimumab and infliximab, are at the forefront of biologic therapy for the management of moderate-to-severe hidradenitis suppurativa, with adalimumab as currently the only approved medication for this condition. In treating patients, primary or secondary lack of response (also termed suboptimal response) is a major burden for both patients and healthcare systems and is a challenge with biologics in part owing to the development of anti-drug antibodies following treatment. To overcome this, therapeutic drug monitoring may be conducted proactively or reactively to a patient's suboptimal response guided by measurements of trough serum drug concentrations and levels of anti-drug antibodies. While strong evidence to support the utility of therapeutic drug monitoring exists in patients with inflammatory bowel disease, current information is limited in the context of hidradenitis suppurativa. We sought to summarize the available evidence and to present the role of therapeutic drug monitoring and other dose optimization strategies in improving clinical response in patients with hidradenitis suppurativa treated with tumor necrosis factor-α inhibitors.

Post-Myocardial Infarction Complications During the COVID-19 Pandemic - A Case Series.

We report 4 cases of post myocardial infarction complications due to the delay in presentation during COVID-19 era. We highlighted the need for auscultating the chest for early diagnosis. Through this case series, we urge to raise awareness among cardiac patients to access healthcare despite the fear of COVID-19.

Forme Fruste in Recurring Mid-Ventricular Variant of Takotsubo Cardiomyopathy.

BACKGROUND Takotsubo cardiomyopathy (TC) is characterized as acute left ventricular dysfunction precipitated by intense emotional or physiological stress. The mid-ventricular variant of TC usually has akinesis, with or without ballooning of the mid-ventricular segment, and a hyperdynamic base and apex. Recurrence of the typical and atypical (reversed and mid-ventricular type) forms has been reported in only a very small number of cases. We report a forme fruste presentation of mid-ventricular variant of TC. CASE REPORT A 69-year-old woman with a prior history of stress-induced cardiomyopathy presented with complaint of moderate intensity, persistent, sub-sternal chest discomfort. She reported that her symptoms were similar to those she had during a previous hospitalization in 2015, and this time cited the death of her mother as an inciting stressor. No significant obstructive flow-limiting coronary artery disease was found on cardiac catheterization. However, the left ventriculogram was suggestive of mid-ventricular pattern of TC. Her first symptomatic episode of apparent TC did not reveal completion of the mid-ventricular pattern of the TC variant. The subsequent episode, during this hospitalization, manifested as a completed version of her initial apparent forme fruste of mid-ventricular variant of TC. CONCLUSIONS TC may present in a myriad of clinical forms that must be considered in the evaluation of patients with suspected acute coronary syndromes or cardiomyopathy. Treatment is mainly supportive, and recurrence rates range from 7.7% to 11.4%. To the best of our knowledge, this forme fruste presentation has not been previously reported in recurrent variants of TC.

Tumor Necrosis Factor Alpha Inhibition for Inflammatory Bowel Disease after Liver Transplant for Primary Sclerosing Cholangitis.

BACKGROUND: Outcome data regarding the use of tumor necrosis factor alpha inhibitors (anti-TNFα) in patients with inflammatory bowel disease (IBD) after liver transplant (LT) for primary sclerosing cholangitis (PSC) are scant. METHODS: We performed a retrospective chart review to investigate outcomes among a series of post-liver-transplant PSC/IBD patients receiving anti-TNFα therapy at Henry Ford Health System ((HFHS), Detroit, MI). RESULTS: A total of five patients were treated with anti-TNFα agents for IBD after LT for PSC from 1993 through 2015. Two patients were treated with adalimumab, and three were treated with infliximab. Three patients were hospitalized with severe posttransplant infections. Two patients developed posttransplant lymphoproliferative disease (PTLD); one of these patients died due to complications of PTLD. CONCLUSION: Anti-TNFα treatment following LT worsened the disease course in our patients with concurrent PSC/IBD and led to serious complications and surgical intervention. Larger studies are needed to evaluate the side effects and outcomes of the use of such agents in this patient population. Until then, clinicians should have a high threshold to use anti-TNFα therapy in this setting.

Ticagrelor-induced Angioedema After Percutaneous Coronary Intervention in a Patient with a History of Ischemic Stroke and Low Response to Clopidogrel: A Rare Dilemma.

Dual antiplatelet therapy (DAPT) is widely recognized as the mainstay of treatment after percutaneous coronary intervention (PCI). Premature discontinuation may pose a risk of in-stent thrombosis, acute myocardial infarction, and death. With the increased usage of antiplatelet agents, increased attention has been drawn to their potential allergic reactions. A 66-year-old male with a history of coronary artery disease and ischemic stroke was admitted with worsening severity angina for cardiac catheterization. He was on dual antiplatelet agents, clopidogrel, and aspirin prior to admission. He had PCI and a drug-eluting stent deployment to the culprit vessel. Due to low responsiveness to clopidogrel, he was started on ticagrelor, as prasugrel was contraindicated due to the history of ischemic stroke. A few hours after ticagrelor initiation, he developed shortness of breath, swelling of the throat and tongue, and was diagnosed with angioedema. He didn't have any prior reported history of allergy to any medications to the contrast medium or heparin. The offending medication, ticagrelor, was discontinued. He was managed with intravenous steroids and antihistamines. After the resolution of angioedema, he was discharged with double the dose of clopidogrel in addition to aspirin. The patient did not have any ischemic symptoms or coronary events for the following six-month period of follow-up. The case highlights a relatively rare side effect of ticagrelor. Health care providers should be vigilant about the angioedema following ticagrelor administration. In our patient, it was effectively managed by discontinuing the offending medication and the administration of steroids and histamine blockers. The recovery was prompt, without any serious untoward effects. The DAPT was changed to clopidogrel, double the conventional dose, in addition to aspirin.

Surveillance Evaluation of the National Cancer Registry in Sabah, Malaysia.

BACKGROUND: Cancer is the fourth leading cause of death in Sabah Malaysia with a reported agestandardized incidence rate was 104.9 per 100,000 in 2007. The incidence rate depends on nonmandatory notification in the registry. Underreporting will provide the false picture of cancer control program effectiveness. The present study was to evaluate the performance of the cancer registry system in terms of representativeness, data quality, simplicity, acceptability and timeliness and provision of recommendations for improvement. MATERIALS AND METHODS: The evaluation was conducted among key informants in the National Cancer Registry (NCR) and reporting facilities from FebMay 2012 and was based on US CDC guidelines. Representativeness was assessed by matching cancer case in the Health Information System (HIS) and state pathology records with those in NCR. Data quality was measured through case finding and reabstracting of medical records by independent auditors. The reabstracting portion comprised 15 data items. Selfadministered questionnaires were used to assess simplicity and acceptability. Timeliness was measured from date of diagnosis to date of notification received and data dissemination. RESULTS: Of 4613 cancer cases reported in HIS, 83.3% were matched with cancer registry. In the state pathology centre, 99.8% was notified to registry. Duplication of notification was 3%. Data completeness calculated for 104 samples was 63.4%. Registrars perceived simplicity in coding diagnosis as moderate. Notification process was moderately acceptable. Median duration of interval 1 was 5.7 months. CONCLUSIONS: The performances of registry's attributes are fairly positive in terms of simplicity, case reporting sensitivity, and predictive value positive. It is moderately acceptable, data completeness and inflexible. The usefulness of registry is the area of concern to achieve registry objectives. Timeliness of reporting is within international standard, whereas timeliness to data dissemination was longer up to 4 years. Integration between existing HIS and national registration department will improve data quality.

Fecal Microbiota Transplantation is Safe and Efficacious for Recurrent or Refractory Clostridium difficile Infection in Patients with Inflammatory Bowel Disease.

BACKGROUND: New treatments are needed as Clostridium difficile infection (CDI) is becoming increasingly formidable. Fecal microbiota transplantation (FMT) has a 90% success rate in the treatment of recurrent CDI. However, evidence regarding its safety, efficacy, and effect on disease activity in patients with inflammatory bowel disease (IBD) is lacking. METHODS: This cohort study used data from 8 national and international academic centers. Patients with established IBD who underwent FMT for recurrent CDI were followed for a minimum of 3 months. The primary outcome was CDI recurrence at 3 months after FMT. The secondary outcomes were (1) IBD activity and severity at 3 months based on the judgment of the treating physician, endoscopic findings, and clinical disease activity scores; and (2) safety. RESULTS: Sixty-seven patients were included in the analysis. Thirty-five (52%) had Crohn's disease, 31 (46%) ulcerative colitis, and one indeterminate colitis with 43 (64%) patients on an immunosuppressive agent at the time of FMT. The initial FMT was successful in 53 (79%) patients. After the FMT, IBD disease activity was reported as improved in 25 (37%), no change in 20 (30%), and worse in 9 (13%) patients. Serious adverse events included colectomy (1.4%), hospitalization for CDI (2.9%), hospitalization for IBD flare (2.9%), small bowel obstruction (1.4%), CMV colitis (1.4%), and pancreatitis (1.4%). DISCUSSION: The overall CDI cure rates were high, with a large percentage of patients experiencing clinical improvement of their IBD after FMT. A minority of patients developed an IBD flare. No severe adverse events directly attributable to FMT were found in this largest reported series of recurrent or refractory CDI patients with concurrent IBD.

Liver Injury Secondary to Anti-TNF-Alpha Therapy in Inflammatory Bowel Disease: A Case Series and Review of the Literature.

Background. Biologic therapy to inhibit tumor necrosis factor-alpha (TNF- α ) is an effective, safe treatment for patients with inflammatory bowel disease (IBD). All TNF- α inhibitors have been associated with liver toxicity, but many of these cases have been reported in patients receiving therapy for rheumatologic disease. Herein we report the first single-center case series of TNF- α antagonist related liver injury in patients with IBD. Methods. A retrospective case series was performed at the Henry Ford Inflammatory Bowel Diseases Center. IRB approval was obtained. Results. 2 patients were treated with infliximab, whereas the 3rd patient was treated with adalimumab for IBD. All 3 patients had negative viral markers, normal autoimmune serologies, and normal biliary imaging studies. Liver biopsy was performed in all 3 patients, and evidence of portal inflammation was seen. Liver enzymes normalized after discontinuation of therapy in all patients, and no long term effects have been observed. One patient was successfully transitioned from infliximab to adalimumab without relapse of either IBD or liver injury. Conclusion. Liver injury secondary to TNF- α antagonist is an underrecognized, important clinical entity with potentially serious consequences. The mechanism of drug-induced injury is idiosyncratic. Larger cohort studies are needed to establish risk factors and injury patterns related to hepatotoxicity in these patients.