Publications by authors named "Susan Connor"

72 Publications

Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: Does underlying inflammatory bowel disease impact tolerability and efficacy?

World J Gastroenterol 2021 Mar;27(11):1090-1100

Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.

Background: Colonoscopy remains the gold standard for detection of colonic disease. An optimal evaluation depends on adequate bowel cleansing. Patients with inflammatory bowel disease (IBD), require frequent endoscopic assessment for both activity and dysplasia assessment. Two commonly used bowel preparations in Australia are Prep Kit-C (Pc) and Moviprep (Mp). Little is known about tolerability, efficacy and safety of split protocols of Mp and Pc in both IBD and non-IBD patients.

Aim: To primary aim was to compare the tolerability, efficacy and safety of split protocols of Mp and Pc in patients having a colonoscopy. The secondary aim was to compare the efficacy, tolerability and safety of either preparation in patients with or without IBD.

Methods: Patients were randomized to Pc or Mp bowel preparation. Patients completed a questionnaire to assess tolerability. Efficacy was assessed using the Ottawa Bowel Preparation Score. Serum electrolytes and renal function were collected one week prior to colonoscopy and on the day of colonoscopy.

Results: Of 338 patients met the inclusion criteria. Of 168 patients randomized to Mp and 170 to Pc. The efficacy of bowel preparation (mean Ottawa Bowel Preparation Score) was similar between Mp (5.4 ± 2.4) and Pc (5.1 ± 2.1) ( = 0.3). Mean tolerability scores were similar in Mp (11.84 ± 5.4) and Pc (10.99 ± 5.2; = 0.17). 125 patients had IBD (73 had Crohn's Disease and 52 had Ulcerative colitis). Sixty-four IBD patients were allocated to Mp and 61 to Pc. In non-IBD patients, 104 were allocated to Mp and 109 to Pc. The mean tolerability score in the IBD group was lower than the non-IBD group (mean tolerability scores: IBD: 10.3 ± 5.1 and non-IBD: 12.0 ± 5.3; = 0.01). IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4 Pc: 3.6 ± 2.6, = 0.046). Serum magnesium level increased with Pc compared with Mp in all patients (mean increase in mmol/L: Mp: 0.03 ± 0.117 and Pc: 0.11 ± 0.106; < 0.0001).

Conclusion: In this study, the efficacy, tolerability and safety of Mp and Pc were similar in all patients. However, patients with IBD reported lower tolerability with both preparations. Specifically, IBD patients had more abdominal pain with Mp. These results should be considered when recommending bowel preparation especially to IBD patients.
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http://dx.doi.org/10.3748/wjg.v27.i11.1090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985733PMC
March 2021

Survey of barriers to adherence to international inflammatory bowel disease guidelines: Does gastroenterologists' confidence translate to high adherence?

Intern Med J 2021 Mar 23. Epub 2021 Mar 23.

South Western Sydney Clinical School, University of New South Wales, Australia.

Background & Aims: Despite the availability of evidence-based inflammatory bowel disease (IBD) guidelines, suboptimal care persists. There is little published research assessing barriers to IBD guideline adherence. This study aimed to identify barriers to IBD guideline adherence including gastroenterologists' knowledge and attitudes towards guidelines.

Methods: An online cross-sectional survey of 824 Australian gastroenterologists was conducted from April to August 2018, with 198 (24%) responses. A novel survey was developed which was informed by the theoretical domain's framework.

Results: Confidence in guideline recommendations was high, however referral to them was low. The European Crohn's and Colitis Organisation (ECCO) guidelines were the most commonly referred to (43.6%). In multivariate analysis, significant predictors of frequent versus infrequent guideline referral were: high confidence in the guideline (OR 7.70, 95% CI: 2.43-24.39, p = 0.001), and low (≤10 years) clinical experience (OR 3.62, 95% CI: 1.11-11.79, p = 0.03). The most common barriers to guideline adherence were not having time (62%) followed by guideline specifics being difficult to remember (61%). Low confidence was reported in managing pregnancy and IBD (34%) and loss of response to therapy (29%). High confidence was reported in managing immunomodulators, however only 43% answered the associated knowledge question correctly.

Conclusion: Although gastroenterologists' have high confidence in guidelines, they use them infrequently, primarily due to specifics being difficult to remember and lack of time. Self-reported confidence in an area of IBD management does not always reflect knowledge. An intervention targeting these barriers, for example computer-based clinical decision support tools, may improve adherence and standardise care. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/imj.15299DOI Listing
March 2021

Development and Feasibility of a Web-Based Decision Aid for Patients With Ulcerative Colitis: Qualitative Pilot Study.

J Med Internet Res 2021 02 25;23(2):e15946. Epub 2021 Feb 25.

Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.

Background: Shared decision making (SDM) is becoming an important part of ulcerative colitis (UC) management because of the increasing complexity of available treatment choices and their trade-offs. The use of decision aids (DA) may be effective in increasing patients' participation in UC management but their uptake has been limited due to high attrition rates and lack of a participatory approach to their design and implementation.

Objective: The primary aim of this study is to explore the perspectives of Australian patients and their clinicians regarding the feasibility and acceptability of myAID, a web-based DA, in informing treatment decisions in UC. The secondary aim is to use the findings of this pilot study to inform the design of a cluster randomized clinical trial (CRCT) to assess the efficacy of the DA compared with usual care.

Methods: myAID, a DA was designed and developed using a participatory approach by a multidisciplinary team of clinicians, patients, and nonmedical volunteers. A qualitative pilot study to evaluate the DA, involving patients with UC facing new treatment decisions and inflammatory bowel disease clinicians, was undertaken.

Results: A total of 11 patients with UC and 15 clinicians provided feedback on myAID. Themes explored included the following: Acceptability and usability of myAID-myAID was found to be acceptable by the majority of clinicians as a tool to facilitate SDM, uptake was thought to vary depending on clinicians' approaches to patient education and practice, potential to overcome time restrictions associated with outpatient clinics was identified, presentation of unbiased information enabling patients to digest information at their own pace was noted, and potential to provoke anxiety among patients with a new diagnosis or mild disease was raised; Perceived role and usefulness of myAID-discordance was observed between patients who prioritized voicing preferences and clinicians who prioritized treatment adherence, and myAID facilitated early discussion of medical versus surgical treatment options; Target population and timing of use-greatest benefit was perceived at the time of initiating or changing treatment and following commencement of immunosuppressive therapy; and Potential concerns and areas for improvement-some perceived that use of myAID may precipitate anxiety by increasing decisional conflict and impact the therapeutic relationship between patient and the clinician and may increase resource requirements.

Conclusions: These preliminary findings suggest that patients and clinicians consider myAID as a feasible and acceptable tool to facilitate SDM for UC management. These pilot data have informed a participatory approach to the design of a CRCT, which will evaluate the clinical efficacy of myAID compared with usual care.

Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001246370.
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http://dx.doi.org/10.2196/15946DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952232PMC
February 2021

Australia IBD Microbiome (AIM) Study: protocol for a multicentre longitudinal prospective cohort study.

BMJ Open 2021 02 16;11(2):e042493. Epub 2021 Feb 16.

Microbiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia

Introduction: Crohn's disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia's first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.

Methods: The AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.

Ethics And Dissemination: Ethical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.

Trial Registration Number: ACTRN12619000911190.
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http://dx.doi.org/10.1136/bmjopen-2020-042493DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7888320PMC
February 2021

Ulcerative Colitis Narrative Global Survey Findings: The Impact of Living With Ulcerative Colitis-Patients' and Physicians' View.

Inflamm Bowel Dis 2021 Feb 2. Epub 2021 Feb 2.

Liverpool Hospital, South Western Sydney Clinical School, University of New South Wales, Ingham Institute of Applied Medical Research, Liverpool, New South Wales, Australia.

Background: The Ulcerative Colitis (UC) Narrative is a global patient and physician survey aimed at identifying the impact of UC and comparing and contrasting perceptions of UC burden and management approaches.

Methods: Surveys of patients with UC (self-reported diagnosis; n = 2100) and physicians (n = 1254) were completed across 10 countries by The Harris Poll between August 2017 and February 2018. Questionnaires covered multiple aspects of UC, including diagnosis, treatment, and impact on patient quality of life, in addition to standard demographic information. Descriptive statistics are reported.

Results: The majority of patients (82%) had moderate to severe UC (based on medication history; those who had only ever taken 5-aminosalicylates were excluded); 67% described their UC as controlled with few to no symptoms. On average, patients experienced 4.3 flares (standard deviation, 7.4) in the past year. Diagnostic delay was on average 2.0 years (standard deviation, 5.4); 42% of patients waited ≥1 year. Most patients (65%) felt that UC controlled their life rather than them controlling their disease. Because of the fear of repercussions, many patients had not disclosed their UC to their employer. Discussion of the emotional impact of UC during routine appointments was less of a priority for physicians, compared with patients.

Conclusions: The data from this global survey highlight that patients with UC experience diagnostic delay, poor disease control, and adverse impact on their quality of life. Patients report UC to be a mentally exhausting condition; however, emotional and mental health issues are infrequently discussed at routine appointments.
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http://dx.doi.org/10.1093/ibd/izab016DOI Listing
February 2021

Crohn's Colitis Care (CCCare): bespoke cloud-based clinical management software for inflammatory bowel disease.

Scand J Gastroenterol 2020 Dec 8;55(12):1419-1426. Epub 2020 Nov 8.

Department of Gastroenterology, Royal Adelaide Hospital & University of Adelaide, Adelaide, Australia.

Background: Adherence to evidence-based management is variable in inflammatory bowel disease (IBD), which leads to worse patient outcomes and higher healthcare utilization. Solutions include electronic systems to enhance care, but these have often been limited by lack of clinician design input, poor usability, and low perceived value. A cloud-based IBD-specific clinical management software - 'Crohn's Colitis Care' (CCCare) was developed by Australia and New Zealand Inflammatory Bowel Disease Consortium clinicians and software developers to improve this.

Methods: CCCare captures patient-reported disease activity and medical assessment, medication monitoring, cancer screening, preventative health, and facilitates communication with the IBD team and referring doctor. De-identified longitudinal data are stored separately in a clinical quality registry for research. CCCare was tested for feasibility and usability in routine clinical settings at two large Australian hospitals. Users' experience was evaluated with System Usability Scale (SUS). Value to clinicians and patients was assessed by qualitative feedback. Security was assessed by penetration testing.

Results: Users ( = 13; doctors, nurses, patients) reported good usability and learnability (mean SUS score 75 (range 50-95), sub-scores were 77 (50-94) and 68 (38-100), respectively). Patients reported better communication with clinical team and greater ability to track disease. Clinicians highlighted structured management plans, medication adherence, and centralised data repository as positive features. Penetration testing was passed successfully.

Conclusions: Initial evaluation demonstrates CCCare is usable, secure, and valued in clinical use. It is designed to measure outcomes of clinical care, including efficacy, quality, cost, and complications for individuals, and to audit these at hospital and national level.
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http://dx.doi.org/10.1080/00365521.2020.1839960DOI Listing
December 2020

Clinical communication in inflammatory bowel disease: a systematic literature review protocol.

BMJ Open 2020 11 4;10(11):e039503. Epub 2020 Nov 4.

Faculty of Medicine, South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.

Introduction: Evidence regarding effective communication between clinicians and patients with inflammatory bowel disease (IBD) is limited. Studies that investigate clinical communication in IBD are much fewer in number than studies that investigate the perceptions of patients and clinicians about communication in clinical encounters. The current review aims to identify, organise and summarise systematically what is currently known about (1) the characteristics of interactions between clinicians who manage IBD and patients with IBD, and (2) how clinical discussion affects health outcomes in IBD.

Methods And Analysis: Scopus, PubMed, Embase, Communication Abstracts, Health & Society, Linguistics and Language Behavior Abstracts and PsycINFO will be systematically searched for studies that investigate the characteristics of IBD clinical interactions during recorded consultations, from earliest available dates within each database to May 2020. A specifically developed quality assessment tool, grounded in linguistic theory, will be used to critically assess the evidence. In addition, a data extraction template will be developed and utilised to provide a description of the characteristics of IBD clinical communication as well as an estimation of its effect on health outcomes in a narrative synthesis.

Ethics And Dissemination: Ethical review and approval is not required for this systematic review as no primary data will be collected. The results will be published in peer-reviewed journals and presented at academic conferences.

Prospero Registration Number: International Prospective Register of Systematic Reviews (PROSPERO) on 28 April 2020 (registration number: CRD42020169657).
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http://dx.doi.org/10.1136/bmjopen-2020-039503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643514PMC
November 2020

Comparative Evaluation of 4 Commercially Available ELISA Kits for Measuring Adalimumab and Anti-adalimumab Antibodies.

Ther Drug Monit 2020 12;42(6):821-828

Immunology Laboratory, Department of Haematology, NSW Health Pathology, Liverpool Hospital.

Background: Therapeutic drug monitoring of tumor necrosis factor inhibitors, such as adalimumab (ADM), is increasingly being performed for the management of autoimmune diseases. However, there can be significant variation in drug and antibody concentrations obtained by different assay methods. The aim of this study was to compare the performance of 4 enzyme-linked immunosorbent assay (ELISA) kits for measuring ADM and anti-ADM antibodies.

Method: Dilutions of ADM or anti-ADM spiked sera were assessed for recovery rate and precision using the following 4 kits: LISA-Tracker (Theradiag, Croissy-Beaubourg, France), Promonitor (Grifols, Barcelona, Spain), Ridascreen (R-Biopharm, Darmstadt, Germany), and Shikari (Matriks Biotek, Gölbaşi/Ankara Turkey). Interference samples were also assessed.

Results: At the therapeutic concentration, ADM detection was comparable among the 4 ELISA kits. Lisa-Tracker and Shikari kits produced low-range false positive results in normal sera. Infliximab and etanercept caused false positives in Lisa-Tracker and Shikari kits. Anti-ADM antibody ELISA kits performed differently with spiked samples because of different measuring units and ranges. Ridascreen and Shikari kits were dose responsive across the entire standard curve and correlated well with each other (r = 0.997). Cross reactivity was observed in rheumatoid factor positive sera tested on the Promonitor anti-ADM kit.

Conclusions: All ADM kits tested were dose responsive within the therapeutic range and correlated well. The significance of observed low-range false positives and cross reactivity with infliximab in LISA-Tracker and Shikari kits is dependent on the indications received for testing in the laboratory. Anti-ADM ELISA kits produced varied results for spiked sera; however, they showed good precision. Inter-kit variability suggested that anti-ADM levels should be compared only when using the same method.
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http://dx.doi.org/10.1097/FTD.0000000000000795DOI Listing
December 2020

Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford.

World J Gastroenterol 2020 Aug;26(30):4428-4441

Centre for Inflammatory Bowel Diseases, St John of God Hospital, Subiaco 6008, Western Australia, Australia.

Background: Vedolizumab (VDZ), a humanised monoclonal antibody that selectively inhibits integrins is approved for use in adult moderate to severe ulcerative colitis (UC) patients.

Aim: To assess the efficacy and safety of VDZ in the real-world management of UC in a large multicenter cohort involving two countries and to identify predictors of achieving remission.

Methods: A retrospective review of Australian and Oxford, United Kingdom data for UC patients. Clinical response at 3 mo, endoscopic remission at 6 mo and clinical remission at 3, 6 and 12 mo were assessed. Cox regression models and Kaplan Meier curves were performed to assess the time to remission, time to failure and the covariates influencing them. Safety outcomes were recorded.

Results: Three hundred and three UC patients from 14 centres in Australia and United Kingdom, [60% = 182, anti-TNF naïve] were included. The clinical response was 79% at 3 mo with more Australian patients achieving clinical response compared to Oxford (83% 70% = 0.01). Clinical remission for all patients was 56%, 62% and 60% at 3, 6 and 12 mo respectively. Anti-TNF naive patients were more likely to achieve remission than exposed patients at all the time points (3 mo 66% 40% < 0.001, 6 mo 73% 46% < 0.001, 12 mo 66% 51% = 0.03). More Australian patients achieved endoscopic remission at 6 mo compared to Oxford (69% 43% = 0.01). On multi-variate analysis, anti-TNF naïve patients were 1.8 (95%CI: 1.3-2.3) times more likely to achieve remission than anti-TNF exposed ( < 0.001). 32 patients (11%) had colectomy by 12 mo.

Conclusion: VDZ was safe and effective with 60% of UC patients achieving clinical remission at 12 mo and prior anti-TNF exposure influenced this outcome.
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http://dx.doi.org/10.3748/wjg.v26.i30.4428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7438197PMC
August 2020

A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial.

JMIR Res Protoc 2020 Jul 10;9(7):e15994. Epub 2020 Jul 10.

Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, The University of New South Wales, Sydney, Australia.

Background: Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice.

Objective: This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management.

Methods: The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only).

Results: Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021.

Conclusions: myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia.

Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370.

International Registered Report Identifier (irrid): DERR1-10.2196/15994.
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http://dx.doi.org/10.2196/15994DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7382012PMC
July 2020

Practical management of inflammatory bowel disease patients during the COVID-19 pandemic: expert commentary from the Gastroenterological Society of Australia Inflammatory Bowel Disease faculty.

Intern Med J 2020 07;50(7):798-804

Department of Gastroenterology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.

The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, has emerged as a public health emergency and challenged healthcare systems globally. In a minority of patients, SARS-CoV-2 manifests with a severe acute respiratory illness and currently there is insufficient data regarding the virulence of COVID-19 in inflammatory bowel disease patients taking immunosuppressive therapy. This review aims to summarise the current literature and provide guidance on the management of inflammatory bowel disease patients in the context of the COVID-19 pandemic in the Australasian setting.
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http://dx.doi.org/10.1111/imj.14889DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405147PMC
July 2020

Aeromedical retrievals for gastrointestinal disorders in rural and remote Australia: the need for improved access to specialist advice.

Intern Med J 2020 05;50(5):619-623

Department of Gastroenterology and Hepatology, RAH and University of Adelaide, Adelaide, Australia.

The Royal Flying Doctor Service (RFDS) provides medical care to populations without access to traditional health-care services. From 2014 to 2018 the RFDS conducted 6007 (≈1201/year) aeromedical retrievals for gastrointestinal (GI) disorders. More detailed research is needed to determine specific GI disorders that contributed to this caseload, and in particular inform whether the establishment of a GI specialist service is justified.
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http://dx.doi.org/10.1111/imj.14822DOI Listing
May 2020

Building Pre-Professional Students' Interprofessional Skills and Confidence: A Population Health Approach.

J Nurs Educ 2020 Mar;59(3):169-172

Background: Many graduates of health science programs lack the skills and confidence to incorporate multiple providers' perspectives when designing coordinated care outcomes.

Method: This longitudinal cross-sectional study used the Interprofessional Attitude Scale (IPAS) to study prelicensure nursing students' perceptions of interprofessional (IP) work. Between 2015 and 2018, IPAS scores and anecdotal data were collected for four consecutive semesters.

Results: Data suggest students' (n = 162) attitudes changed significantly toward teamwork, community centeredness, and biases with medium to large effect sizes (r = .33 to .51). Anecdotal findings echoed these shifts in student attitudes.

Conclusion: There is no one ideal approach to build IP practice into curricula that is content saturated. With the shared commitment of IP faculty and the use of creative educational approaches, weaving IP processes into population health curricula encourages students to engage in IP work and develop the skills and confidence needed for IP practice. [J Nurs Educ. 2020;59(3):169-172.].
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http://dx.doi.org/10.3928/01484834-20200220-10DOI Listing
March 2020

Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice.

Gut 2020 05 11;69(5):801-810. Epub 2020 Feb 11.

The University of Sydney, Sydney, New South Wales, Australia

Objective: Faecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent infection, and there is interest in its potential application in other gastrointestinal and systemic diseases. However, the recent death and episode of septicaemia following FMT highlights the need for further appraisal and guidelines on donor evaluation, production standards, treatment facilities and acceptable clinical indications.

Design: For these consensus statements, a 24-member multidisciplinary working group voted online and then convened in-person, using a modified Delphi approach to formulate and refine a series of recommendations based on best evidence and expert opinion. Invitations to participate were directed to Australian experts, with an international delegate assisting the development. The following issues regarding the use of FMT in clinical practice were addressed: donor selection and screening, clinical indications, requirements of FMT centres and future directions. Evidence was rated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

Results: Consensus was reached on 27 statements to provide guidance on best practice in FMT. These include: (1) minimum standards for donor screening with recommended clinical selection criteria, blood and stool testing; (2) accepted routes of administration; (3) clinical indications; (4) minimum standards for FMT production and requirements for treatment facilities acknowledging distinction between single-site centres (eg, hospital-based) and stool banks; and (5) recommendations on future research and product development.

Conclusions: These FMT consensus statements provide comprehensive recommendations around the production and use of FMT in clinical practice with relevance to clinicians, researchers and policy makers.
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http://dx.doi.org/10.1136/gutjnl-2019-320260DOI Listing
May 2020

Faecal calprotectin testing for identifying patients with organic gastrointestinal disease: systematic review and meta-analysis.

Med J Aust 2019 11 3;211(10):461-467. Epub 2019 Nov 3.

Mater Hospital Brisbane, Brisbane, QLD.

Objectives: To assess the clinical effectiveness of faecal calprotectin (FC) testing for distinguishing between organic gastrointestinal diseases (organic GID), such as inflammatory bowel disease (IBD), and functional gastrointestinal disorders (functional GIDs).

Study Design: Studies that assessed the accuracy of FC testing for differentiating between IBD or organic GID and functional GIDs were reviewed. Articles published in English during January 1998 - June 2018 that compared diagnostic FC testing in primary care and outpatient hospital settings with a reference test and employed the standard enzyme-linked immunosorbent FC assay method with a cut-off of 50 or 100 μg/g faeces were included. Study quality was assessed with QUADAS-2, an evidence-based quality assessment tool for diagnostic accuracy studies.

Data Sources: MEDLINE and EMBASE; reference lists of screened articles.

Data Synthesis: Eighteen relevant studies were identified. For distinguishing patients with organic GID (including IBD) from those with functional GIDs (16 studies), the estimated sensitivity of FC testing was 81% (95% CI, 74-86%), the specificity 81% (95% CI, 71-88%); area under the curve (AUC) was 0.87. For distinguishing IBD from functional GIDs (ten studies), sensitivity was 88% (95% CI, 80-93%), specificity 72% (95% CI, 59-82%), and AUC 0.89. Assuming a population prevalence of organic GID of 1%, the positive predictive value was 4.2%, the negative predictive value 100%. The difference in sensitivity and specificity between FC testing cut-offs of 50 μg/g and 100 μg/g faeces was not statistically significant (P = 0.77).

Conclusions: FC testing is clinically useful for distinguishing organic GID (including IBD) from functional GIDs, and its incorporation into clinical practice for evaluating patients with lower gastrointestinal symptoms could lead to fewer patients with functional GIDs undergoing colonoscopy, reducing costs for both patients and the health system.

Prospero Registration: CRD4201810507.
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http://dx.doi.org/10.5694/mja2.50384DOI Listing
November 2019

Therapeutic drug monitoring in inflammatory bowel disease reduces unnecessary use of infliximab with substantial associated cost-savings.

Intern Med J 2021 May;51(5):739-745

South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.

Background: Therapeutic drug monitoring (TDM) of infliximab (IFX) levels in inflammatory bowel disease (IBD) patients can help to guide dose adjustments or changes to therapy for selected patients in remission or with secondary loss of response (LOR).

Aims: To determine how IFX TDM is utilised in a real-life clinical setting and to quantify the potential for TDM to reduce the unnecessary use of IFX.

Methods: Data from all public IBD IFX level testing performed across Australia were prospectively collected from June 2016 to July 2017 to assess physician-reported for testing indications (induction, in remission or LOR) and associated results. The hypothetical influence of IFX TDM was based on an optimal therapeutic range of 6-10 mg/L for mucosal healing.

Results: Secondary LOR (reactive TDM) was the most common indication for TDM. These patients have consistently lower median IFX levels: 3.02 mg/L (IQR 1.14-6.67 mg/L) versus 5.22 mg/L (IQR 2.70-8.12 mg/L), P = 0.0001 compared with patients in remission (proactive TDM). TDM helped to identify unnecessary use of IFX in 30.6% of the TDM tests performed in luminal Crohn disease and ulcerative colitis patients, with an associated drug cost saving of $531.38 per IFX TDM test episode. Unnecessary IFX use was identified in 38.9% (96/247) of reactive IFX TDM tests performed and in 19.3% (35/181) of proactive testing.

Conclusion: Use of both reactive and proactive IFX TDM is cost-effective for IBD management as it informs the clinician where unnecessary use of IFX can be stopped.
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http://dx.doi.org/10.1111/imj.14644DOI Listing
May 2021

Anti-TNF Therapy in Pregnant Women With Inflammatory Bowel Disease: Effects of Therapeutic Strategies on Disease Behavior and Birth Outcomes.

Inflamm Bowel Dis 2020 01;26(1):93-102

Department of Gastroenterology, St Vincent's Hospital, and University of Melbourne, Melbourne, Australia.

Background: Active inflammatory bowel disease (IBD) adversely affects pregnancy outcomes. Little is known about the risk of relapse after stopping anti-tumor necrosis factor (anti-TNF) treatment during pregnancy. We assessed the risk of relapse before delivery in women who discontinued anti-TNF treatment before gestational week (GW) 30, predictors of reduced infant birth weight, a marker associated with long-term adverse outcomes, and rates and satisfaction with counseling.

Methods: Pregnant women with IBD receiving anti-TNF treatment were prospectively invited to participate in an electronic questionnaire carried out in 22 hospitals in Denmark, Australia, and New Zealand from 2011 to 2015. Risk estimates were calculated, and birth weight was investigated using t tests and linear regression.

Results: Of 175 women invited, 153 (87%) responded. In women in remission, the relapse rate did not differ significantly between those who discontinued anti-TNF before GW 30 (1/46, 2%) compared with those who continued treatment (8/74, 11%; relative risk, 0.20; 95% confidence interval [CI], 0.02 to 1.56; P = 0.08). Relapse (P = 0.001) and continuation of anti-TNF therapy after GW 30 (P = 0.007) were independently associated with reduced mean birth weight by 367 g (95% CI, 145 to 589 g; relapse) and 274 g (95% CI, 77 to 471 g; anti-TNF exposure after GW 30). Of 134 (88%) women who received counseling, 116 (87%) were satisfied with the information provided.

Conclusions: To minimize fetal exposure in women in remission, discontinuation of anti-TNF before GW 30 seems safe. Relapse and continuation of anti-TNF therapy after GW 30 were each independently associated with lower birth weight, although without an increased risk for birth weight <2500 g. Most women received and were satisfied with counseling.
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http://dx.doi.org/10.1093/ibd/izz110DOI Listing
January 2020

Comparison of Adalimumab Serum Drug Levels When Delivered by Pen Versus Syringe in Patients With Inflammatory Bowel Disease. An International, Multicentre Cohort Analysis.

J Crohns Colitis 2019 Dec;13(12):1527-1536

Department of Gastroenterology, Alfred Health and Monash University, Melbourne, VIC, Australia.

Background: Adalimumab is administered via a pre-filled syringe or spring-loaded pen. In a previous study in Crohn's disease, higher drug levels were observed in syringe users. The aim of this study was to evaluate the impact of delivery device on adalimumab drug levels in patients with Crohn's disease.

Methods: Consecutive Crohn's disease patients treated with maintenance adalimumab [40 mg fortnightly] were recruited from five centres. The first recorded drug level with matched clinical and biochemical markers of disease activity was compared between pen and syringe users.

Results: Of 218 patients, 64% used pen, with a median faecal calprotectin 110 μg/g and serum C-reactive protein 4 mg/L. In comparison to pen, syringe users had higher albumin [39 vs 42 g/L; p = 0.016], lower Harvey-Bradshaw Index [2 vs 1; p = 0.017], and higher rates of concomitant immunomodulation [54% vs 71%; p = 0.014]. Drug levels were equivalent between pen and syringe users [median 5.3 vs 5.2 μg/ml; p = 0.584], even after controlling for disease activity and immunomodulation. Syringe users at Alfred Health had higher drug levels than pen [6.1 vs 4.5 μg/ml; p = 0.039]; a greater proportion achieved therapeutic levels [75% vs 44%; p = 0.045]. A higher proportion of pen users from Saint-Étienne had therapeutic levels [79% vs 42%; p = 0.027], yet no significant difference in drug levels [7.9 vs 4.5 μg/ml; p = 0.119].

Conclusions: Delivery device does not appear to significantly affect adalimumab drug levels. Given differences between study sites, studies evaluating administration education and technique are warranted.
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http://dx.doi.org/10.1093/ecco-jcc/jjz103DOI Listing
December 2019

Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis.

Gastroenterology 2019 Apr 6;156(5):1440-1454.e2. Epub 2018 Dec 6.

University of New South Wales, Sydney, Australia. Electronic address:

Background & Aims: Fecal microbiota transplantation (FMT) can induce remission in patients with ulcerative colitis (UC). In a randomized controlled trial of FMT in patients with active UC, we aimed to identify bacterial taxonomic and functional factors associated with response to therapy.

Methods: We performed a double-blind trial of 81 patients with active UC randomly assigned to groups that received an initial colonoscopic infusion and then intensive multidonor FMT or placebo enemas, 5 d/wk for 8 weeks. Patients in the FMT group received blended homogenized stool from 3-7 unrelated donors. Patients in the placebo group were eligible to receive open-label FMT after the double-blind study period. We collected 314 fecal samples from the patients at screening, every 4 weeks during treatment, and 8 weeks after the blinded or open-label FMT therapy. We also collected 160 large-bowel biopsy samples from the patients at study entry, at completion of 8 weeks of blinded therapy, and at the end of open-label FMT, if applicable. We analyzed 105 fecal samples from the 14 individual donors (n = 55), who in turn contributed to 21 multidonor batches (n = 50). Bacteria in colonic and fecal samples were analyzed by both 16S ribosomal RNA gene and transcript amplicon sequencing; 285 fecal samples were analyzed by shotgun metagenomics, and 60 fecal samples were analyzed for metabolome features.

Results: FMT increased microbial diversity and altered composition, based on analyses of colon and fecal samples collected before vs after FMT. Diversity was greater in fecal and colon samples collected before and after FMT treatment from patients who achieved remission compared with patients who did not. Patients in remission after FMT had enrichment of Eubacterium hallii and Roseburia inulivorans compared with patients who did not achieve remission after FMT and had increased levels of short-chain fatty acid biosynthesis and secondary bile acids. Patients who did not achieve remission had enrichment of Fusobacterium gonidiaformans, Sutterella wadsworthensis, and Escherichia species and increased levels of heme and lipopolysaccharide biosynthesis. Bacteroides in donor stool were associated with remission in patients receiving FMT, and Streptococcus species in donor stool was associated with no response to FMT.

Conclusions: In an analysis of fecal and colonic mucosa samples from patients receiving FMT for active UC and stool samples from donors, we associated specific bacteria and metabolic pathways with induction of remission. These findings may be of value in the design of microbe-based therapies for UC. ClinicalTrials.gov, Number NCT01896635.
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http://dx.doi.org/10.1053/j.gastro.2018.12.001DOI Listing
April 2019

What can Australian Inflammatory Bowel Disease Association achieve in the next 3 to 5 years?

Authors:
Susan Connor

J Gastroenterol Hepatol 2018 Sep;33 Suppl 3:35

Department of Gastroenterology, Liverpool Hospital, South Western Sydney Local Health District and South Western Clinical School, University of NSW, Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.

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http://dx.doi.org/10.1111/jgh.14437DOI Listing
September 2018

Genomic analysis of oral Campylobacter concisus strains identified a potential bacterial molecular marker associated with active Crohn's disease.

Emerg Microbes Infect 2018 Apr 11;7(1):64. Epub 2018 Apr 11.

School of Biotechnology and Biomolecular Sciences, University of New South Wales, Sydney, NSW, Australia.

Campylobacter concisus is an oral bacterium that is associated with inflammatory bowel disease (IBD) including Crohn's disease (CD) and ulcerative colitis (UC). C. concisus consists of two genomospecies (GS) and diverse strains. This study aimed to identify molecular markers to differentiate commensal and IBD-associated C. concisus strains. The genomes of 63 oral C. concisus strains isolated from patients with IBD and healthy controls were examined, of which 38 genomes were sequenced in this study. We identified a novel secreted enterotoxin B homologue, Csep1. The csep1 gene was found in 56% of GS2 C. concisus strains, presented in the plasmid pICON or the chromosome. A six-nucleotide insertion at the position 654-659 bp in csep1 (csep1-6bpi) was found. The presence of csep1-6bpi in oral C. concisus strains isolated from patients with active CD (47%, 7/15) was significantly higher than that in strains from healthy controls (0/29, P = 0.0002), and the prevalence of csep1-6bpi positive C. concisus strains was significantly higher in patients with active CD (67%, 4/6) as compared to healthy controls (0/23, P = 0.0006). Proteomics analysis detected the Csep1 protein. A csep1 gene hot spot in the chromosome of different C. concisus strains was found. The pICON plasmid was only found in GS2 strains isolated from the two relapsed CD patients with small bowel complications. This study reports a C. concisus molecular marker (csep1-6bpi) that is associated with active CD.
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http://dx.doi.org/10.1038/s41426-018-0065-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5893538PMC
April 2018

Role of capsule endoscopy and fecal biomarkers in small-bowel Crohn's disease to assess remission and predict relapse.

Gastrointest Endosc 2017 Dec 22;86(6):1070-1078. Epub 2017 Sep 22.

Department of Gastroenterology and Hepatology, St. George Hospital and University of New South Wales, Sydney, Australia.

Background And Aims: Capsule endoscopy (CE) is the most sensitive test to diagnose small-bowel Crohn's disease (CD). Conventional parameters poorly assess CD remission, and although fecal biomarkers assess colonic activity, their role in assessing remission is uncertain. We report CE findings in small-bowel CD patients in clinical remission compared with fecal biomarkers and standard clinical tools to determine mucosal remission and predict relapses.

Methods: Forty-three adult small-bowel CD patients in clinical remission (Crohn's Disease Activity Index [CDAI] <150) were prospectively enrolled at 4 academic centers and followed clinically for 12 months. Baseline CE studies were scored using the Capsule Endoscopy Scoring Index (CESI or Lewis score). Baseline and endpoint fecal biomarkers were assayed.

Results: CE findings were normal in 17 patients (40%), mild inflammation in 19 (44%), and moderate to severe inflammation in 7 (16%). Of the 26 patients (60%) with mucosal inflammation on CE, 85% had elevated baseline fecal calprotectin and 77% elevated lactoferrin level. Calprotectin and lactoferrin were normal in all patients without inflammation and elevated in all with moderate to severe inflammation. CESI correlated significantly with calprotectin, lactoferrin, and S100A12 levels but not either CDAI or C-reactive protein. During follow-up, 14% of patients exhibited a clinical flare; all had mucosal inflammation at CE and 83% had elevated baseline calprotectin and lactoferrin levels.

Conclusions: In small-bowel CD patients in clinical remission, many had ongoing mucosal inflammation assessed by CE and fecal biomarkers. Only some developed a clinical flare during medium-term follow-up. These findings suggest CE and fecal biomarkers are useful in monitoring small-bowel CD progress.
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http://dx.doi.org/10.1016/j.gie.2017.09.011DOI Listing
December 2017

CE: Original Research: Exploring How Nursing Schools Handle Student Errors and Near Misses.

Am J Nurs 2017 Oct;117(10):24-31

Joanne Disch is professor ad honorem at the University of Minnesota School of Nursing in Minneapolis. Jane Barnsteiner is a professor emerita at the University of Pennsylvania School of Nursing in Philadelphia, and editor of translational research and quality improvement at AJN. Susan Connor is an associate professor at the College of St. Scholastica School of Nursing, Duluth, MN. Fabiana Brogren is an executive assistant at the University of Minnesota School of Nursing. Funding for this study was provided by the National Council of State Boards of Nursing (grant no. 41008). Contact author: Joanne Disch, The authors and planners have disclosed no potential conflicts of interest, financial or otherwise.

: Background: Little attention has been paid to how nursing students learn about quality and safety, and to the tools and policies that guide nursing schools in helping students respond to errors and near misses.

Purpose: This study sought to determine whether prelicensure nursing programs have a policy for reporting and following up on student clinical errors and near misses, a tool for such reporting, a tool or process (or both) for identifying trends, strategies for follow-up with students after errors and near misses, and strategies for follow-up with clinical agencies and individual faculty members.

Methods: A national electronic survey of 1,667 schools of nursing with a prelicensure registered nursing program was conducted. Data from 494 responding schools (30%) were analyzed.

Results: Of the responding schools, 245 (50%) reported having no policy for managing students following a clinical error or near miss, and 272 (55%) reported having no tool for reporting student errors or near misses.

Conclusions: Significant work is needed if the principles of a fair and just culture are to shape the response to nursing student errors and near misses. For nursing schools, some essential first steps are to understand the tools and policies a school has in place; the school's philosophy regarding errors and near misses; the resources needed to establish a fair and just culture; and how faculty can work together to create learning environments that eliminate or minimize the negative consequences of errors and near misses for patients, students, and faculty.
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http://dx.doi.org/10.1097/01.NAJ.0000525849.35536.74DOI Listing
October 2017

Performance of risk prediction for inflammatory bowel disease based on genotyping platform and genomic risk score method.

BMC Med Genet 2017 08 29;18(1):94. Epub 2017 Aug 29.

Queensland Brain Institute, The University of Queensland, Brisbane, Australia.

Background: Predicting risk of disease from genotypes is being increasingly proposed for a variety of diagnostic and prognostic purposes. Genome-wide association studies (GWAS) have identified a large number of genome-wide significant susceptibility loci for Crohn's disease (CD) and ulcerative colitis (UC), two subtypes of inflammatory bowel disease (IBD). Recent studies have demonstrated that including only loci that are significantly associated with disease in the prediction model has low predictive power and that power can substantially be improved using a polygenic approach.

Methods: We performed a comprehensive analysis of risk prediction models using large case-control cohorts genotyped for 909,763 GWAS SNPs or 123,437 SNPs on the custom designed Immunochip using four prediction methods (polygenic score, best linear genomic prediction, elastic-net regularization and a Bayesian mixture model). We used the area under the curve (AUC) to assess prediction performance for discovery populations with different sample sizes and number of SNPs within cross-validation.

Results: On average, the Bayesian mixture approach had the best prediction performance. Using cross-validation we found little differences in prediction performance between GWAS and Immunochip, despite the GWAS array providing a 10 times larger effective genome-wide coverage. The prediction performance using Immunochip is largely due to the power of the initial GWAS for its marker selection and its low cost that enabled larger sample sizes. The predictive ability of the genomic risk score based on Immunochip was replicated in external data, with AUC of 0.75 for CD and 0.70 for UC. CD patients with higher risk scores demonstrated clinical characteristics typically associated with a more severe disease course including ileal location and earlier age at diagnosis.

Conclusions: Our analyses demonstrate that the power of genomic risk prediction for IBD is mainly due to strongly associated SNPs with considerable effect sizes. Additional SNPs that are only tagged by high-density GWAS arrays and low or rare-variants over-represented in the high-density region on the Immunochip contribute little to prediction accuracy. Although a quantitative assessment of IBD risk for an individual is not currently possible, we show sufficient power of genomic risk scores to stratify IBD risk among individuals at diagnosis.
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http://dx.doi.org/10.1186/s12881-017-0451-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576242PMC
August 2017

Effectiveness of Interventions for Caregivers of People With Alzheimer's Disease and Related Major Neurocognitive Disorders: A Systematic Review.

Am J Occup Ther 2017 Sep/Oct;71(5):7105180020p1-7105180020p10

Suzanne Sager, MS, OTR/L, is Occupational Therapist, Exceptional Rehab, Lexington, KY. At the time of the systematic review, she was Student, Entry-Level BSMS Program in Occupational Therapy, Thomas Jefferson University, Philadelphia, PA.

Objective: The goal of the evidence review was to evaluate the effectiveness of interventions for caregivers of people with Alzheimer's disease and related major neurocognitive disorders that facilitate the ability to maintain participation in the caregiver role.

Method: Scientific literature published in English between January 2006 and April 2014 was reviewed. Databases included MEDLINE, PsycINFO, CINAHL, OTseeker, and the Cochrane Database of Systematic Reviews.

Results: Of 2,476 records screened, 43 studies met inclusion criteria. Strong evidence shows that multicomponent psychoeducational interventions improve caregiver quality of life (QOL), confidence, and self-efficacy and reduce burden; cognitive reframing reduces caregiver anxiety, depression, and stress; communication skills training improves caregiver skill and QOL in persons with dementia; mindfulness-based training improves caregiver mental health and reduces stress and burden; and professionally led support groups enhance caregiver QOL.

Conclusion: Strong evidence exists for a spectrum of caregiver interventions. Translation of effective interventions into practice and evaluation of sustainability is necessary.
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http://dx.doi.org/10.5014/ajot.2017.027581DOI Listing
November 2017

The need for better preventative strategies for inflammatory bowel disease patients at risk of herpes zoster virus.

Intern Med J 2017 Nov;47(11):1263-1269

Department of Gastroenterology and Hepatology, St Vincent's Hospital, Sydney, New South Wales, Australia.

Background: Immunosuppressed inflammatory bowel disease (IBD) patients have an increased risk of herpes zoster virus (HZV) infection. The existing live-attenuated HZV vaccine is contraindicated in some of these patients and can only be used with caution in others.

Aims: To describe characteristics of IBD patients suffering HZV to enable implementation of risk mitigation strategies for those at highest risk.

Methods: Gastroenterologists completed a proforma for IBD patients who experienced HZV infection: IBD phenotype, details of HZV infection, immunosuppression and any change to treatment upon diagnosis of HZV.

Results: A total of 30 cases was identified: Crohn disease (CD) (n = 25) and ulcerative colitis (n = 5). In total, 80% (20/25) of the CD patients had penetrating, stricturing or perianal disease. Time from commencement of immunosuppression to HZV infection was highly variable (range: 3 months to over 10 years). A total of 90% (27/30) of patients was on at least one immunosuppressive therapy; of those, one-third was on monotherapy (9/27) and two-thirds (18/27) on dual therapy. A total of 89% (24/27) of immunosupressed patients was on a thiopurine (monotherapy; 6/27) or in combination (18/27). Complications of HZV occurred in 27% (8/30) of patients.

Conclusion: Our series is consistent with existing epidemiological analysis that identified more severe IBD and the use of multiple immunosuppressive therapies as risk factors for HZV. If the promise of an investigational subunit HZV vaccine is realised in immunocompromised patients, better protection may be possible in the future. Thiopurine medications were the most commonly used immunosuppressant in this series. Age and duration of immunosuppressive therapy do not appear to predict HZV infection.
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http://dx.doi.org/10.1111/imj.13488DOI Listing
November 2017

Efficacy of Rectal Tacrolimus for Induction Therapy in Patients With Resistant Ulcerative Proctitis.

Clin Gastroenterol Hepatol 2017 Aug 7;15(8):1248-1255. Epub 2017 Mar 7.

Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, NSW, Australia; South Western Sydney Clinical School, University of NSW Medicine, Sydney, NSW, Australia; Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Australia, Sydney, NSW, Australia.

Background & Aims: Resistant ulcerative proctitis can be extremely difficult to manage. Topically administered tacrolimus, however, may be effective in difficult-to-treat proctitis. This was a randomized, double-blind, placebo-controlled induction trial of rectal tacrolimus in patients with active ulcerative colitis.

Methods: Eleven patients received rectal tacrolimus (0.5 mg/mL), and 10 placebo, for 8 weeks. The primary endpoint was clinical response by using the Mayo Clinic score.

Results: A planned interim analysis after 20 patients had completed the study demonstrated highly significant differences between the groups and the study was closed because of ethical considerations with patients already recruited allowed to complete the study. The primary endpoint was met in 8 of 11 patients receiving rectal tacrolimus and 1 of 10 patients receiving placebo (73% vs 10%; P = .004). Of the secondary endpoints, 5 patients with rectal tacrolimus achieved clinical remission compared with none receiving placebo (45% vs 0%; P = .015). Mucosal healing at Week 8 was achieved in 8 patients receiving rectal tacrolimus compared with 1 (73% vs 10%) receiving placebo (P = .004). The Inflammatory Bowel Disease Questionnaire increased ≥16 points over baseline in 5 of the tacrolimus and 2 (45% vs 20%) of the placebo patients (P = .36). Finally, the average partial Mayo score was numerically lower in the tacrolimus-treated group compared with placebo at Week 2 (4.3 ± 0.74 vs 5.8 ± 0.64; P = .15) and Week 4 (3.7 ± 0.96 vs 5.8 ± 0.6; P = .08) but was significantly lower at Week 8 (3.3 ± 1.2 vs 6.7 ± 0.62; P = .01). There were no safety issues identified with rectal tacrolimus use.

Conclusions: Rectal tacrolimus was more effective than placebo for induction of a clinical response, clinical remission, and mucosal healing in resistant ulcerative proctitis (Clinicaltrials.gov registration: NCT01418131).
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http://dx.doi.org/10.1016/j.cgh.2017.02.027DOI Listing
August 2017

Response to: Comparison of infliximab drug measurement across three commercially available ELISA kits: author reply.

Pathology 2017 04 6;49(3):334-335. Epub 2017 Mar 6.

Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, NSW, Australia.

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http://dx.doi.org/10.1016/j.pathol.2017.01.005DOI Listing
April 2017

Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.

Lancet 2017 03 15;389(10075):1218-1228. Epub 2017 Feb 15.

Centre for Digestive Diseases, Sydney, NSW, Australia.

Background: The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.

Methods: We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia. We randomly allocated patients with active ulcerative colitis (Mayo score 4-10) in a 1:1 ratio, using a pre-established randomisation list, to either faecal microbiota transplantation or placebo colonoscopic infusion, followed by enemas 5 days per week for 8 weeks. Patients, treating clinicians, and other study staff were unaware of the assigned treatment. Faecal microbiota transplantation enemas were each derived from between three and seven unrelated donors. The primary outcome was steroid-free clinical remission with endoscopic remission or response (Mayo score ≤2, all subscores ≤1, and ≥1 point reduction in endoscopy subscore) at week 8. Analysis was by modified intention-to-treat and included all patients receiving one study dose. We performed 16S rRNA stool analysis to assess associated microbial changes. This trial is registered with ClinicalTrials.gov, number NCT01896635. The trial has ended; this report presents the final analysis.

Findings: From November, 2013, to May, 2015, 85 patients were enrolled to our trial, of whom 42 were randomly assigned faecal microbiota transplantation and 43 were allocated placebo. One patient assigned faecal microbiota transplantation and three allocated placebo did not receive study treatment and were excluded from the analysis. The primary outcome was achieved in 11 (27%) of 41 patients allocated faecal microbiota transplantation versus three (8%) of 40 who were assigned placebo (risk ratio 3·6, 95% CI 1·1-11·9; p=0·021). Adverse events were reported by 32 (78%) of 41 patients allocated faecal microbiota transplantation and 33 (83%) of 40 who were assigned placebo; most were self-limiting gastrointestinal complaints, with no significant difference in number or type of adverse events between treatment groups. Serious adverse events occurred in two patients assigned faecal microbiota transplantation and in one allocated placebo. Microbial diversity increased with and persisted after faecal microbiota transplantation. Several bacterial taxa were associated with clinical outcome; in particular, the presence of Fusobacterium spp was associated with lack of remission.

Interpretation: Intensive-dosing, multidonor, faecal microbiota transplantation induces clinical remission and endoscopic improvement in active ulcerative colitis and is associated with distinct microbial changes that relate to outcome. Faecal microbiota transplantation is, thus, a promising new therapeutic option for ulcerative colitis. Future work should focus on precisely defining the optimum treatment intensity and the role of donor-recipient matching based on microbial profiles.

Funding: Broad Medical Research Program, Gastroenterological Society of Australia, Mount Sinai (New York) SUCCESS fund, University of New South Wales.
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http://dx.doi.org/10.1016/S0140-6736(17)30182-4DOI Listing
March 2017

Anemia and iron deficiency in gastrointestinal and liver conditions.

World J Gastroenterol 2016 Sep;22(35):7908-25

Jürgen Stein, Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt am Main, Department of Gastroenterology and Clinical Nutrition, DGD Clinics Sachsenhausen, Frankfurt am Main, 60594 Frankfurt, Germany.

Iron deficiency anemia (IDA) is associated with a number of pathological gastrointestinal conditions other than inflammatory bowel disease, and also with liver disorders. Different factors such as chronic bleeding, malabsorption and inflammation may contribute to IDA. Although patients with symptoms of anemia are frequently referred to gastroenterologists, the approach to diagnosis and selection of treatment as well as follow-up measures is not standardized and suboptimal. Iron deficiency, even without anemia, can substantially impact physical and cognitive function and reduce quality of life. Therefore, regular iron status assessment and awareness of the clinical consequences of impaired iron status are critical. While the range of options for treatment of IDA is increasing due to the availability of effective and well-tolerated parenteral iron preparations, a comprehensive overview of IDA and its therapy in patients with gastrointestinal conditions is currently lacking. Furthermore, definitions and assessment of iron status lack harmonization and there is a paucity of expert guidelines on this topic. This review summarizes current thinking concerning IDA as a common co-morbidity in specific gastrointestinal and liver disorders, and thus encourages a more unified treatment approach to anemia and iron deficiency, while offering gastroenterologists guidance on treatment options for IDA in everyday clinical practice.
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http://dx.doi.org/10.3748/wjg.v22.i35.7908DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5028806PMC
September 2016