Cost-effectiveness of taurolidine-citrate in a cohort of patients with intestinal failure receiving home parenteral nutrition.

BACKGROUND: Catheter-related bloodstream infections (CRBSIs) in patients receiving home parenteral nutrition (HPN) for chronic intestinal failure (CIF) are associated with significant morbidity and financial costs. Taurolidine is associated with a reduction in bloodstream infections, with limited information on the cost-effectiveness as the primary prevention. This study aimed to determine the cost-effectiveness of using taurolidine-citrate for the primary prevention of CRBSIs within a quaternary hospital. METHODS: All patients with CIF receiving HPN were identified between January 2015 and November 2022. Data were retrospectively collected regarding patient demographics, HPN use, CRBSI diagnosis, and use of taurolidine-citrate. The direct costs associated with CRBSI-associated admissions and taurolidine-citrate use were obtained from the coding department using a bottom-up approach. An incremental cost-effective analysis was performed, with a time horizon of 4 years, to compare the costs associated with primary and secondary prevention against the outcome of cost per infection avoided. RESULTS: Forty-four patients received HPN within this period. The CRBSI rates were 3.25 infections per 1000 catheter days before the use of taurolidine-citrate and 0.35 infections per 1000 catheter days after taurolidine-citrate use. The incremental cost-effectiveness ratio indicates primary prevention is the weakly dominant intervention, with the base case value of $27.04 per CRBSI avoided. This held with one-way sensitivity analysis. CONCLUSION: Taurolidine-citrate in the primary prevention of CRBSIs in patients with CIF receiving HPN is associated with reduced hospital costs and infection rates.

Validation of the Structured Assessment of Gastrointestinal Symptoms Scale to Support Standardized Evaluation and Follow-up.

OBJECTIVES: Patient-reported outcome measures facilitate evaluation of patients and allow to better assess treatment effects. Validated tools are lacking for pediatric gastroenterological patients. We thus aimed to adapt and validate for pediatric populations a self-administered Structured Assessment of Gastrointestinal Symptoms (SAGIS) tool that previously has been validated in adult cohorts. METHODS: Each item of the original SAGIS instrument was thoroughly reviewed for its relevance in the pediatric population. The resulting pediatric (p)SAGIS was utilized over a 35 months' period in consecutive patients in a pediatric outpatient GI clinic. Principal component analysis (PCA) followed by varimax rotation and confirmatory factor analysis (CFA) was performed in derivation and validation samples. Responsiveness to change was assessed in 32 children with inflammatory bowel disease (IBD) after 12 months of therapy. RESULTS: The final pediatric SAGIS (pSAGIS) consisted of 21 GI-related Likert-type questions, 8 dichotomous questions assessing extra-intestinal symptoms, and 2 most bothersome symptoms; 1153 children/adolescents completed a total of 2647 questionnaires. Cronbach alpha was 0.89, indicating good internal consistency. PCA supported a 5-factor model (symptom groups: abdominal pain, dyspepsia, diarrhea, constipation, dysphagia/nausea) and CFA showed good model fit (comparative fit index: 0.96, root-mean-square error of approximation: 0.075). The initial mean total GI symptom score in IBD patients (8.7 ± 10.3) decreased to 3.6 ± 7.7 after 1 year of therapy ( P < 0.01), and 4 of 5 symptom group scores decreased significantly upon treatment ( P < 0.05). CONCLUSIONS: The pSAGIS is a novel, easy to use, self-administered instrument for GI-symptom assessment in children/adolescents with excellent psychometric properties. It may standardize GI-symptom assessment and may enable uniform clinical analysis of treatment outcomes.

Risk-based decision-making related to preprocedural coronavirus disease 2019 testing in the setting of GI endoscopy: management of risks, evidence, and behavioral health economics.

BACKGROUND AND AIMS: Controversies exist regarding the benefits and most appropriate approach for preprocedural coronavirus disease 2019 (COVID-19) testing (eg, rapid antigen test, polymerase chain reaction, or real-time polymerase chain reaction) for outpatients undergoing diagnostic and therapeutic procedures, such as GI endoscopy, to prevent COVID-19 infections among staff. Guidelines for protecting healthcare workers (HCWs) from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from outpatient procedures varies across medical professional organizations. This study provides an evidence-based decision support tool for key decision-makers (eg, clinicians) to respond to COVID-19 transmission risks and reduce the effect of personal biases. METHODS: A scoping review was used to identify relevant factors influencing COVID-19 transmission risk relevant for GI endoscopy. From 12 relevant publications, 8 factors were applicable: test sensitivity, prevalence of SARS-CoV-2 in the population, age-adjusted SARS-CoV-2 prevalence in the patient cohort, proportion of asymptomatic patients, risk of transmission from asymptomatic carriers, risk reduction by personal protective equipment (PPE), vaccination rates of HCWs, and risk reduction of SAE by vaccination. The probability of a serious adverse event (SAE), such as workplace-acquired infection resulting in HCW death, under various scenarios with preprocedural testing was determined to inform decision-makers of expected costs of reductions in SAEs. RESULTS: In a setting of high community transmission, without testing and PPE, 117.5 SAEs per million procedures were estimated to occur, and this was reduced to between .079 and 2.35 SAEs per million procedures with the use of PPE and preprocedural testing. When these variables are used and a range of scenarios are tested, the probability of an SAE was low even without testing but was reduced by preprocedural testing. CONCLUSIONS: Under all scenarios tested, preprocedural testing reduced the SAE risk for HCWs regardless of the SARS-CoV-2 variant. Benefits of preprocedural testing are marginal when community transmission is low (eg, below 10 infections a day per 100,000 population). The proposed decision support tool can assist in developing rational preprocedural testing policies.

Physician Perceptions on the Use of Antibiotics and Probiotics in Adults: An International Survey in the Asia-Pacific Area.

Background and Aims: The over-prescription of antibiotics is thought to represent a major threat to public health worldwide and is more frequently observed in some low- and middle-income countries. In the Asia-Pacific region, economic development, health care organization and population demographics are very heterogenous. The objective of this survey was to investigate antibiotic use and probiotic co-prescription among adult patients in this area. Methods: An online survey of physicians from seven countries of the Asia-Pacific region (Australia, Japan, Indonesia, India, China, Singapore and South Korea) was performed in 2018. The questionnaire explored current practices of physicians concerning antibiotics and probiotics and factors related to prescribing decisions. Results: A total of 387 general practitioners and 350 gastroenterologists completed the questionnaire. Physicians in Australia, Japan and South-Korea were low prescribers of antibiotics (11% to 19% of visits resulted in an antibiotic prescription), while physicians in Indonesia, India, China and Singapore were high prescribers (41% to 61%). A large majority (85%) of physicians agreed that antibiotics disrupted intestinal microbiota. The rates of co-prescription of probiotics varied from 16% in Japan to 39% in Singapore (overall, 27%). Conditions considered by physicians to be prevented by probiotics were mostly antibiotic-associated diarrhea (62%) and Clostridium difficile colitis (43%). Conclusions: Rates of probiotic co-prescription remain low in many countries although the negative effects of antibiotics on the gut microbiota and the benefits of co-prescribing probiotics are generally known.

Structured oropharynx, hypopharynx and larynx assessment during routine esophagogastroduodenoscopy improves detection of pre- and early cancerous lesions: a multicenter, comparative study.

Background and study aims A structured assessment of the oropharynx, hypopharynx and larynx (OHL) may improve the diagnostic yield for the detection of precancerous and early cancerous lesions (PECLs) during routine esophagogastroduodenoscopy (EGD). Thus, we aimed to compare routine EGDs ± structured OHL assessment (SOHLA), including photo documentation with regard to the detection of PECLs. Patients and methods Consecutive patients with elective EGD were arbitrarily allocated to endoscopy lists with or without SOHLA. All detected OHL abnormalities were assessed by an otolaryngologist-head & neck surgeon (ORL-HNS) and the frequency of PECLS detected during SOHLA vs. standard cohort compared. Results Data from 1000 EGDs with and 1000 EGDs without SOHLA were analyzed. SOHLA was successful in 93.3 % of patients, with a median assessment time of 45 seconds (interquartile range: 40-50). SOHLA identified 46 potential PECLs, including two benign subepithelial lesions (4.6 %, 95 % CI: 3.4-6.1) while without SOHLA, no malignant and only one benign lesion was found ( P  < 0.05). ORL-HNS imaging review classified 23 lesions (2.3 %, 95 % CI: 1.5-3.4) as concerning and ORL-HNS clinic assessment was arranged. This identified six PECLs (0.6 %, 95 % CI: 0.2-1.3) including two pharyngeal squamous cell lesions (0.2 %) demonstrating high-grade dysplasia and carcinoma in situ (CIS) and four premalignant glottic lesions (0.4 %) demonstrating low-grade dysplasia and CIS. Conclusion In the routine setting of a gastrointestinal endoscopy practice precancerous and early cancerous lesions of the oropharynx, hypopharynx, and larynx are rare (< 1 %) but can be detected with a structured assessment of this region during routine upper gastrointestinal endoscopy.

Routine assessment of gastrointestinal symptom using a validated questionnaire in the clinical setting to assess the probability of organic or functional gastrointestinal diseases.

BACKGROUND: Patients presenting with gastrointestinal symptoms can be challenging in terms of determining etiology and management strategies. Identifying likely organic pathology is important since it can be treated and may result in further, long-term harm to the patient if not treated. Currently, organic pathology is often identified via invasive procedures such as endoscopy or referral to a medical imaging service. We report on an approach that offers a first step at identifying patients with an organic gastrointestinal disease based on the SAGIS, a validated symptom questionnaire. METHODS: 8,922 patients referred to a tertiary care hospital were classified as having either functional gastrointestinal disease or an organic gastrointestinal disease. A model was developed to distinguish organic from functional symptoms on one random split half of the sample and validated on the other half. The incremental benefit of including psychological conditions and extra-gastrointestinal conditions was also evaluated. KEY RESULTS: Functional gastrointestinal patients scored higher on average than organic patients on all dimensions of the SAGIS and reported higher rates of psychological and extra-gastrointestinal conditions. All five dimensions of the SAGIS provided statistically independent discrimination of organic from functional diagnoses with good overall discrimination (AUC = 0.75). However, there was no noticeable incremental benefit of adding either psychological or extra-gastrointestinal conditions. Model performance was highly reproducible. CONCLUSIONS AND INFERENCES: The proposed algorithm for identifying likely organic gastrointestinal disease applied to symptoms as recorded in the SAGIS questionnaire provides a useful tool for the clinician in deciding what or if further diagnostic testing is required.

Use of Evidence-Based Herbal Medicines for Patients with Functional Gastrointestinal Disorders: A Conceptional Framework for Risk-Benefit Assessment and Regulatory Approaches.

BACKGROUND: Herbal or complementary medicines are frequently used for the treatment of patients with functional gastrointestinal disorders (FGID). Regulatory requirements for herbal therapies are inconsistent and, in many jurisdictions, herbal therapies are either self-, minimally- or unregulated. AIM: To provide guidance for the appropriate and safe use of herbal medicines in patients with FGID patients with special consideration of the regulatory frameworks. METHODS: A PubMed search of the literature was performed; relevant articles were included. RESULTS: Similar to chemically defined therapies herbal medicines can cause adverse events. Thus, a risk-benefit appraisal should be undertaken for these therapies. While there is no disease specific mortality in FGID patients, patients with FGID who fail to respond to "empiric" chemically defined therapies undergo diagnostic and therapeutic measures that can be associated with appreciable morbidity and mortality. Thus, effective herbal treatments that subsequently reduce health-care utilization, reduce risks related to diagnostic or therapeutic measures that are initiated if no improvement of symptoms occurs. This "protective" effect of effective treatments for FGID needs to be taken in consideration when the risks and benefits of treatments are determined. In addition, standards that mirror regulations for chemically defined treatments should apply and the components of the respective preparations should undergo ongoing toxicological testing and rigorous quality assurance measures (including pharmacovigilance) applied. CONCLUSIONS: Some herbal therapies offer significant benefits for patients with FGID. To ensure the safety of these treatments, the regulatory requirements should mirror requirements for chemically defined treatments.

The use of modelling studies to inform planning of health services: case study of rapidly increasing endoscopy services in Australia.

BACKGROUND: Demand for gastrointestinal endoscopy in Australia is increasing as a result of the expanding national bowel cancer screening program and a growing, ageing population. More services are required to meet demand and ensure patients are seen within clinically recommended timeframes. METHODS: A discrete event simulation model was developed to project endoscopy waiting list outcomes for two large metropolitan health services encompassing 8 public hospitals in Australia. The model applied routinely collected health service data to forecast the impacts of future endoscopic demand over 5 years and to identify the level of service activity required to address patient waiting times and meet key policy targets. The approach incorporated evidence from the literature to produce estimates of cost-effectiveness by showing longer term costs and Quality Adjusted Life Years (QALYs) associated with service expansion. RESULTS: The modelling revealed that doing nothing would lead to the number of patients waiting longer than clinically recommended doubling across each health service within 5 years. A 38% overall increase in the number of monthly procedures available was required to meet and maintain a target of 95-98% of patients being seen within clinically recommended timeframes to the year 2021. This was projected to cost the funder approximately $140 million in additional activity over a 5 year period. Due to improved patient outcomes associated with timely intervention, it was estimated that the increased activity would generate over 22,000 additional QALYs across the two health services. This translated to an incremental cost-effectiveness ratio of $6467 and $5974 per QALY for each health service respectively. CONCLUSIONS: Discrete event simulation modelling provided a rational, data based approach that allowed decision makers to quantify the future demand for endoscopy services and identify cost-effective strategies to meet community needs.

The role of the microbiome and the use of probiotics in gastrointestinal disorders in adults in the Asia-Pacific region - background and recommendations of a regional consensus meeting.

The Asia-Pacific region is diverse, with regard to ethnicity, culture, and economic development incorporating some of the world's least and most developed nations. Gastrointestinal diseases are common in the Asia-Pacific region, and their prevalence, presentation, and management vary considerably within the region. There is growing evidence for an important role for the human gut microbiota in gastrointestinal health. As a consequence, geographic variations in the composition of the gut microbiota may contribute to variations in both the prevalence and response to therapy of specific diseases. Probiotics have been proposed as a valuable option in the prevention and treatment of a number of gastrointestinal illnesses, but the quality of available evidence to support their efficacy is variable. A meeting of international experts in adult and pediatric gastroenterology was held at the Sorbonne University, Paris, France, on April 11 and 12, 2016, to discuss current evidence supporting the use of probiotics in gastrointestinal disorders in the Asia-Pacific region. This article provides an overview of the discussions held at this meeting and recommends the formation of an Asia-Pacific Consortium on Gut Microbiota similar to those established in Europe and North America.

Non-physician endoscopists: A systematic review.

AIM: To examine the available evidence on safety, competency and cost-effectiveness of nursing staff providing gastrointestinal (GI) endoscopy services. METHODS: The literature was searched for publications reporting nurse endoscopy using several databases and specific search terms. Studies were screened against eligibility criteria and for relevance. Initial searches yielded 74 eligible and relevant articles; 26 of these studies were primary research articles using original datasets relating to the ability of non-physician endoscopists. These publications included a total of 28883 procedures performed by non-physician endoscopists. RESULTS: The number of publications in the field of non-specialist gastrointestinal endoscopy reached a peak between 1999 and 2001 and has decreased thereafter. 17/26 studies related to flexible sigmoidoscopies, 5 to upper GI endoscopy and 6 to colonoscopy. All studies were from metropolitan centres with nurses working under strict supervision and guidance by specialist gastroenterologists. Geographic distribution of publications showed the majority of research was conducted in the United States (43%), the United Kingdom (39%) and the Netherlands (7%). Most studies conclude that after appropriate training nurse endoscopists safely perform procedures. However, in relation to endoscopic competency, safety or patient satisfaction, all studies had major methodological limitations. Patients were often not randomized (21/26 studies) and not appropriately controlled. In relation to cost-efficiency, nurse endoscopists were less cost-effective per procedure at year 1 when compared to services provided by physicians, due largely to the increased need for subsequent endoscopies, specialist follow-up and primary care consultations. CONCLUSION: Contrary to general beliefs, endoscopic services provided by nurse endoscopists are not more cost effective compared to standard service models and evidence suggests the opposite. Overall significant shortcomings and biases limit the validity and generalizability of studies that have explored safety and quality of services delivered by non-medical endoscopists.

Cost and time savings from a rapid access model of care using transient elastography to screen and triage patients with chronic Hepatitis C infection.

BACKGROUND: Treatment uptake amongst patients with chronic Hepatitis C virus (HCV) in Australia is relatively low. New approaches to assessment have the potential to reduce public waiting lists, improve access to treatment, and to reduce healthcare costs. AIM: To describe the costs to the public hospital system and waiting time associated with a novel integrated rapid access to assessment and treatment (RAAT) model of care that utilizes Transient Elastography (TE) as a specialist outpatient-based approach for a streamlined assessment of patients with chronic HCV, compared to conventional outpatient management with liver biopsy (LB). METHODS: Time from first medical review to treatment plan and costs associated with detection of fibrosis were recorded for patients receiving RAAT during a 3-month period, and for a similar historical cohort managed conventionally with LB. Costs related to medical and multidisciplinary team reviews and the TE/LB test itself were included. RESULTS: Patients receiving RAAT had lower costs (n = 27, median AU$2716) and shorter time to treatment (median = 194 days) than for conventional management (n = 13, median $5005, 420 days; p < 0.01). Differences related to the lower TE test costs and the lower cost of consults between first medical review and establishment of a treatment plan. CONCLUSIONS: Based on real world audit data, this evaluation suggests TE, used as part of a new RAAT model of care, is cost saving to the health system in the short-term and reduces waiting times. The analysis reported here was intended to assess the costs related to detection of fibrosis, and is limited by the small sample size and potential selection bias. Future research should undertake a full economic evaluation at a whole of service level, to consider a more comprehensive and longer-term assessment of the costs and benefits associated with HCV management.

An integrated model of care for inflammatory bowel disease sufferers in Australia: development and the effects of its implementation.

BACKGROUND: Psychological comorbidities are associated with poor outcome and increased healthcare utilization in patients with inflammatory bowel disease (IBD). However, a model of care addressing the biopsychosocial dimension of disease is not routinely applied in IBD. This review describes the development of such a model and the effects of its implementation in a hospital-based cohort of patients with IBD. METHODS: Three different approaches were used: 1) collecting baseline epidemiological data on mental health comorbidities; 2) raising awareness of and targeting mental health problems; 3) examining the effects of the model implementation. RESULTS: High rates of anxiety and depressive symptoms (36% and 13%, respectively) that are maintained over time were identified in IBD patients presenting at a metropolitan teaching hospital. Patients with documented psychological comorbidities were more likely to be hospitalized than those without (odds ratio [OR] = 4.13, 95% confidence interval [CI]: 1.25, 13.61). Improvements in disease activity, anxiety, depression, quality of life, and coping have been noted when cognitive-behavioral therapy (CBT) was provided to patients. A drop in the use of opiates (P = 0.037) and hospitalization rates (from 48% to 30%) in IBD patients has been noted as a result of introduction of the changed model of care. In addition, the mean total cost of inpatient care was lower for IBD patients than controls (US$12,857.48 [US$15,236.79] vs. US$ 30,467.78 [US$ 53,760.20], P = 0.005). CONCLUSION: Our data to date suggest that an integrated model of care for patients with IBD may yield superior long-term outcomes in terms of medication use and hospitalization rates and reduce healthcare costs.

The burden of inpatient costs in inflammatory bowel disease and opportunities to optimize care: a single metropolitan Australian center experience.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) causes significant morbidity, frequently resulting in hospital admission and resection surgery. However, little is known about: 1. how IBD patients' inpatient healthcare utilisation compares to other inpatients and 2. whether there are potentially modifiable factors which may influence this. METHODS: Over five months a cohort of admitted IBD patients were acquired and each assigned five admitted, age and gender matched controls at a single tertiary center. Data compared over 15 months included: total cumulative length of stay (TLoS), number of admissions (index and subsequent re-admissions), inpatient costs, care complexity (defined by relative stay index [RSI]), and disease-specific factors amongst the IBD cohort. Data were confirmed by case notes review. RESULTS: There were 102 IBD patients and 510 controls (median age 44 years, 57% female). IBD patients had more re-admissions (mean 1.72 vs 1.55, p=0.002) and longer TLoS (median 6.8 vs 3.4 days, p<0.0001) than controls. Both median cumulative cost of inpatient healthcare and RSI were also higher in IBD compared to controls ($7052 vs $5470 and RSI 362% vs 293%, each p<0.008). IBD patients seen by a gastroenterologist prior to their index admission had fewer re-admissions (mean 1.37 vs 2.02, p=0.016,) and tended to have lower total cumulative inpatient costs than those without prior Gastroenterologist review (median $6439 vs $9479, p=0.069). CONCLUSIONS: IBD patients have significantly greater inpatient healthcare utilization, complexity and costs than age and gender matched, hospitalized controls. Prior gastroenterologist care in IBD may reduce subsequent admission rates, and inpatient-related costs.

Real-time high-resolution MRI for the assessment of gastric motility: pre- and postpharmacological stimuli.

PURPOSE: To determine the practicality of MRI using a new real-time sequence for the assessment of gastric motion, and quantify the effects of motility-modifying substances. MATERIALS AND METHODS: Six healthy volunteers ingested 400 mL of a high-calorie liquid nutrient. Two-dimensional real-time TrueFISP sequences were acquired for up to 30 minutes following the ingestion. The acquisition plane was chosen parallel to the axis of the gastric antrum. The examination was performed on three separate days with and without i.v. administration of 10 mg metoclopramide or 20 mg scopolamine. A motility index was calculated for each real-time data set. RESULTS: Delineation of the gastric lumen proved easy and robust. The intravenous application of motility-modifying agents resulted in significant changes in the motility index. The administration of metoclopramide resulted in an average increase of the index by a factor of 1.5, whereas the application of scopolamine led to a decrease of the index by a factor of 3.0. CONCLUSION: TrueFISP MRI performed well in depicting the gastric lumen and assessing gastric motility. Furthermore, we were able to evaluate and quantify the effect of motility-modifying agents. The noninvasive nature of MRI makes this imaging modality an attractive alternative to conventional invasive diagnostic tools for gastric motility disorders and monitoring of therapy.