Non-invasive Fibrosis Markers for Predicting Esophageal Varices: A Potential Alternative to Endoscopic Screening.

BACKGROUND: Chronic liver infections and diseases lead to chronic liver injury, which results in fibrosis. Due to this continuous scarring and regeneration, cirrhosis occurs, which is also responsible for several adverse sequelae, including but not limited to esophageal varices. Cirrhosis has resulted in patients' increased morbidity and mortality, especially in low socioeconomic settings such as Pakistan. Endoscopy is the gold standard for measuring the presence or absence of esophageal varices, along with their grade. Currently, some non-invasive markers (aspartate aminotransferase-to-alanine aminotransferase ratio (AAR), fibrosis 4 (FIB-4), AAR to platelet ratio index (AARPRI), aspartate aminotransferase-to-platelet ratio index (APRI), S-index, King's score) are being established that make use of laboratory tests, such as a complete blood profile, liver function profile, and coagulation profile, to estimate the extent of hepatic fibrosis. OBJECTIVES: The objective of this study is to establish a correlation between non-invasive markers of fibrosis and the presence of esophageal varices and to assess their potential as a substitute for gastrointestinal endoscopy screening. Additionally, the study aims to compare these six scores, thereby generating data on their individual and relative accuracy. METHODOLOGY: This was a cross-sectional study conducted at the Shalamar Institute of Health Sciences, Lahore, Pakistan. Outpatient (OPD) data were obtained from the Shalamar online portal system from June 2022 to December 2022. Laboratory tests, abdominal ultrasounds, and endoscopy results were accessed and recorded in the questionnaire. The patient's medical records and contact numbers were also noted in case further questions arose. Data were then compiled into a Microsoft Excel spreadsheet (Microsoft Corp., Redmond, WA) and analyzed after computing the non-invasive procedure formulas. It was analyzed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY). P-values were calculated, and conclusions were drawn. RESULTS: Of the sample size of 100 patients with liver damage and injury, 60% were male and 40% were female. Among males, 15% had a milder (grade 1) degree of esophageal varices, and 45% had a moderate to advanced degree (grades 2-3) of esophageal varices. Among females, 19% had mild (grade 1) varices, while 21% had severe (grade 3) varices. The most common cause of varices in patients who had developed fibrosis and/or cirrhosis was hepatitis C, with a wide margin of other causes. The p-values obtained showed that from the selected list of non-invasive markers of fibrosis, only FIB-4 and AARPRI were statistically significant with p-values of 0.036 and 0.022, respectively. PRACTICAL IMPLICATIONS: Though endoscopy is currently the gold-standard procedure for detecting the presence or absence and grade of esophageal varices, it is invasive, which makes the patients extremely uncomfortable and apprehensive. It can also lead to post-procedure infection, internal hemorrhages, and trauma due to instrument use. Due to its invasive nature, some patients also tend to refuse this procedure. Non-invasive fibrosis markers can help make a diagnosis without undergoing an endoscopy, which in turn will improve patient compliance and satisfaction. CONCLUSION: It was observed that FIB-4 and AARPRI can be used together as reliable markers to assess the presence or absence of esophageal varices.

Restraint Practices in Incapable Wandering Patients During COVID-19: Ethics and Best Practice Recommendations.

Patients who wander as one of their psychological and behavioural symptoms of dementia are often unable to follow or recall Infection Prevention and Control precautions, putting them at risk of contracting or spreading COVID-19. Physical and chemical restraints have been used to limit the risk of transmission to wandering patients and their care providers, but restraints are not the standard of care for wandering behaviour in non-pandemic scenarios. Although provincial policies on restraint use are available, their guidance may not provide the context-dependent information necessary for individual patient decisions. To address this knowledge gap, we reviewed the medical, ethical, and legal considerations through an interdisciplinary approach including nurses, physicians, ethicists, hospital leadership, risk management, and legal counsel. We present an ethical framework that front-line health-care workers can use to create a balanced patient-centred care plan for incapable wandering patients who are at risk of contracting or spreading COVID-19.

High-Dose Thiamine Supplementation in Older Patients With Heart Failure: A Pilot Randomized Controlled Crossover Trial (THIAMINE-HF).

Background: Thiamine supplementation may improve cardiac function in older adults with heart failure (HF). Our objectives were to determine the following: (i) the feasibility of conducting a large trial of thiamine supplementation in HF; and (ii) the effects of thiamine on clinical outcomes. Methods: We conducted a double-blinded randomized placebo-controlled 2-period crossover feasibility study from June 2018 to April 2021. Adults aged ≥ 60 years with symptomatic HF and reduced ejection fraction (≤ 45%) were included. Participants were randomized to thiamine mononitrate 500 mg, or placebo, for 90 days and were switched to the opposite treatment for 90 days after a 6-week washout period. The primary feasibility outcome was recruitment of 24 participants in 11 months. Results: We screened 330 patients over 21 months to recruit 24 patients. Participants' mean age was 73.4 years. The targets for refusal rate, retention rate, and adherence rate were met. Nonsignificant improvements occurred in left ventricular ejection fraction and N-terminal pro-brain natriuretic peptide (NT-proBNP) level with thiamine. A total of 13 serious adverse events occurred in 7 patients; none were related to the study drug. Conclusions: Although we did not reach our recruitment target, we found high-dose thiamine supplementation to be well tolerated, with potential improvements in biomarker outcomes. A larger trial of thiamine supplementation is warranted.

Introduction: La supplémentation en thiamine peut améliorer la fonction cardiaque chez les personnes âgées atteintes d'insuffisance cardiaque (IC). Nos objectifs visaient à déterminer : (i) la faisabilité d'un essai de grande envergure sur la supplémentation en thiamine lors d'IC ; (ii) les effets de la thiamine sur les résultats cliniques. Méthodes: Nous avons réalisé une étude de faisabilité croisée à double insu et à répartition aléatoire contre placebo sur deux périodes de juin 2018 à avril 2021. Nous avons retenu les adultes de ≥ 60 ans qui avaient une IC symptomatique et une fraction d'éjection réduite (≤ 45 %). Nous avons réparti les participants de façon aléatoire pour recevoir 500 mg de mononitrate de thiamine ou le placebo durant 90 jours, et avons inversé le traitement durant 90 jours après une période de lavage de 6 semaines. Le principal critère de faisabilité était le recrutement de 24 participants en 11 mois. Résultats: Nous avons recruté 24 patients sur les 330 patients sélectionnés durant 21 mois. L'âge moyen des participants était de 73,4 ans. Les cibles des taux de refus, des taux de rétention et des taux d'adhésion ont été atteintes. Avec la thiamine, nous avons observé des améliorations non significatives de la fraction d'éjection ventriculaire gauche et de la concentration de propeptide natriurétique de type B N-terminal (NT-proBNP). Parmi les 13 événements indésirables sérieux qu'ont subis sept patients, aucun n'a été associé au médicament étudié. Conclusions: Bien que nous n'ayons pas atteint notre cible de recrutement, nous avons observé que la supplémentation en thiamine à dose élevée était bien tolérée et qu'il y avait des améliorations potentielles des résultats des biomarqueurs. Un essai de plus grande envergure sur la supplémentation en thiamine est justifié.

Thiamine versus placebo in older heart failure patients: study protocol for a randomized controlled crossover feasibility trial (THIAMINE-HF).

BACKGROUND: Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency occurs in 33% of patients with HF. However, the effectiveness of thiamine supplementation in HF is not known. METHODS: In a placebo-controlled randomized two-period crossover feasibility trial, patients age ≥ 60 years with HF and reduced ejection fraction (HFrEF, EF ≤ 45%) will be randomized to thiamine 500 mg oral capsule once daily or placebo for 3 months, then crossed over to the other intervention after a 6-week washout period. The primary outcome is recruitment rate. Secondary outcomes include feasibility and clinical measures. Feasibility outcomes include refusal rate, retention rate, and compliance rate. Secondary clinical outcomes include left ventricular ejection fraction, peak global longitudinal strain measured by echocardiography, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score, and clinical outcomes (all-cause mortality, HF hospitalizations, and HF emergency room visits). DISCUSSION: Thiamine is potentially a safe and low-cost treatment for older patients with HFrEF. Results from this study will inform the feasibility of a large clinical trial with clinical endpoints. The findings will be published in a peer review journal and presented at a relevant conference. This study has received full approval from the Hamilton Integrated Research Ethics Board (18-4537) and Health Canada (210603). This trial is funded by the Hamilton Health Sciences New Investigator Grant (15-387) and the McMaster/St. Peter's Hospital Chair of Aging. TRIAL REGISTRATION: NCT03228030 (ClinicalTrials.gov), registered July 24, 2017.

Impact of type 2 diabetes mellitus on quality of life in people with diabetespresenting to a specialist diabetes clinic.

BACKGROUND/AIM: Quality of life is an important health-related factor that has an impact on all health interventions. The aim of the study was to assess psychosocial outcomes in people with diabetes. MATERIALS AND METHODS: A total of 142 people with type 2 diabetes were recruited from a specialist diabetes center. The validated Urdu version of the WHO-5 Well-Being Index was administered for easy understanding of the quality of life of the regional population. RESULTS: The 142 adult participants with diabetes were recruited from a specialist diabetes clinic. The rate of likely depression (WHO-5 score of <28) was 16.9%. Neuropathy was found to have a negative impact on the quality of life in people with diabetes (P < 0.001). CONCLUSION: People with complications of diabetes like neuropathy may experience worsening quality of life. It is advised to incorporate the WHO-5 into annual patient reviews as a measure of emotional well-being to drive changes that improve outcomes for people with diabetes.