Publications by authors named "Jane M Andrews"

131 Publications

Assessing effectiveness and patient perceptions of a novel electronic medical record for the management of inflammatory bowel disease.

JGH Open 2021 Sep 7;5(9):1063-1070. Epub 2021 Aug 7.

Department of Gastroenterology and Hepatology Royal Adelaide Hospital Adelaide South Australia Australia.

Background And Aim: There is an increasing prevalence of chronic disease worldwide, resulting in multiple management challenges. Inflammatory bowel disease (IBD) is an exemplar chronic disease requiring coordinated longitudinal care. We propose that Crohn's Colitis Care (CCCare), a novel IBD-specific, structured electronic medical record is effective at improving data capture and is acceptable to patients.

Methods: A comparison was made between IBD-data completeness in usual records and CCCare. CCCare's acceptability to patients was assessed in two independent IBD patient cohorts and included:• Overall ratings of acceptability.• Factors associated with pre-exposure acceptability ratings.• Whether exposure and security concerns influenced acceptability ratings.• Direct patient feedback through CCCare's patient portal.

Results: In all cases reviewed, there was data gain using structured CCCare fields compared with IBD documentation in usual medical records. The overall acceptability in the combined cohort ( = 310) was very high. More than three-quarters of patients rated acceptability as >7 of 10. Self-reported information technology (IT) literacy positively associated with acceptability. Exposure had a small positive affect on acceptability, whereas security concerns had little impact on acceptability. Patient portal feedback revealed that most patients are very likely to recommend CCCare to others (8.56 ± 2.2 [out of 10]).

Conclusion: CCCare is effective in supporting more complete IBD-specific data capture compared with usual medical records. It is highly acceptable to patients, especially those with reasonable IT literacy. Patient concerns about privacy and security of electronic medical records (EMRs) did not significantly affect acceptability.
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http://dx.doi.org/10.1002/jgh3.12631DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8454479PMC
September 2021

Food avoidance, restrictive eating behaviour and association with quality of life in adults with inflammatory bowel disease: A systematic scoping review.

Appetite 2021 Dec 12;167:105650. Epub 2021 Aug 12.

Inflammatory Bowel Disease Services, The Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia, Australia; School of Medicine, Faculty of Health Sciences, University of Adelaide, Frome Road, Adelaide, 5000, South Australia, Australia. Electronic address:

Background: Dietary misconceptions and behaviours may worsen outcomes of inflammatory bowel disease (IBD). This scoping review aims to examine the dietary beliefs and behaviours of individuals with IBD and identify evidence of food avoidance, dietary restriction or disordered eating and any association with quality of life (QoL).

Methodology: A systematic search of CINAL, EMBASE, MEDLINE was conducted. Primary, peer-reviewed studies in English examining dietary beliefs and dietary behaviours or diet and quality of life in adults with inflammatory bowel disease were included. Key dietary terminology was pre-defined.

Results: Twenty-nine studies met inclusion criteria. A range of quantitative self-reported questionnaires (16/29), qualitative interviews (1/29) and mixed methods (7/29) were used to measure dietary beliefs and dietary behaviours. A high prevalence of food avoidance (28-89%) and restrictive dietary behaviours (41-93%) were identified. Factors associated with these behaviours included a diagnosis of CD, perceived active disease, female sex, dietary misinformation, and fears of adverse bowel symptoms. Diet and QoL remains largely unexplored in IBD beyond two recent studies demonstrating impairment of food-related quality of life in IBD.

Conclusion: A high prevalence of self-reported food avoidance and restrictive dietary behaviour exists in people with IBD. The psychosocial impact of IBD-related dietary behaviour is poorly understood. Validated tools with predefined diet terminology and objective markers of disease activity are required to measure dietary behaviour in future prospective studies, using food-related quality of life as an outcome measure.
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http://dx.doi.org/10.1016/j.appet.2021.105650DOI Listing
December 2021

Prospective randomised controlled trial of adults with perianal fistulising Crohn's disease and optimised therapeutic infliximab levels: PROACTIVE trial study protocol.

BMJ Open 2021 07 1;11(7):e043921. Epub 2021 Jul 1.

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

Introduction: Perianal fistulising Crohn's disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy.

Methods And Analysis: Patients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18-80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate.

Ethics And Dissemination: Results will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia.

Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN12621000023853); Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-043921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252869PMC
July 2021

Food-related quality of life in adults with inflammatory bowel disease is associated with restrictive eating behaviour, disease activity and surgery: A prospective multicentre observational study.

J Hum Nutr Diet 2021 May 18. Epub 2021 May 18.

Inflammatory Bowel Disease Services, The Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, Woodville South, SA, Australia.

Background: Measuring food-related quality of life (FRQoL) quantifies the psychosocial impact of eating and drinking. FRQoL and associated factors are not well explored in people with inflammatory bowel disease (IBD), despite IBD being a chronic disease affecting the digestive tract. The present study aimed to characterise and identify any patient or disease-related predictors of FRQoL in individuals with IBD.

Methods: Adults with a formal diagnosis of IBD were recruited to a prospective multicentre cross-sectional study between April 2018 and December 2019. Participants completed questionnaires measuring FRQoL (FRQoL-29), clinical disease activity (Harvey Bradshaw Index and Simple Clinical Colitis Activity Index), restrictive eating behaviour (Nine-Item Avoidant/Restrictive Food Intake Disorder Screen), mental health (Depression Anxiety Stress Scale-21) and other patient and disease-related variables. A multivariable regression was performed to identify factors associated with FRQoL.

Results: One hundred and eight participants completed the questionnaires (n = 39, Crohn's disease; n = 69, ulcerative colitis). The mean FRQoL was 79 (95% confidence interval = 75-84) (poor, 0; superior, 145). Poorer FRQoL was observed in those with restrictive eating behaviour associated with fear of a negative consequence from eating (p < 0.0001) and reduced appetite (p < 0.030). Greater FRQoL was observed in those with lower disease activity (p < 0.0001) and previous IBD surgery (p = 0.024). FRQoL was not associated either way by IBD phenotype, duration, or gender. The majority of participants obtained their dietary information from the internet (60%) or gastroenterologist (46%).

Conclusions: FRQoL in people with IBD is poorer in those with restrictive eating behaviours and clinically active disease. Interestingly, it was greater in those with previous IBD surgery. Further research is required to validate these associations and explore longitudinal effects of poor FRQoL on patient outcomes and potential strategies for prevention or management of impaired FRQoL in IBD.
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http://dx.doi.org/10.1111/jhn.12920DOI Listing
May 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

Clearing a colonoscopy waiting list: how we did it.

ANZ J Surg 2021 01;91(1-2):10-12

Gastrointestinal Investigation Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

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http://dx.doi.org/10.1111/ans.15942DOI Listing
January 2021

The Adequacy of Habitual Dietary Fiber Intake in Individuals With Inflammatory Bowel Disease: A Systematic Review.

J Acad Nutr Diet 2021 04 20;121(4):688-708.e3. Epub 2021 Jan 20.

Background: Dietary fiber may influence disease course in individuals with inflammatory bowel disease (IBD), yet there is a paucity of understanding of habitual fiber intakes.

Objectives: To identify studies measuring fiber intakes of individuals with IBD, compare the adequacy of fiber intakes with that of control groups or respective national dietary guidelines, and examine factors associated with fiber consumption.

Methods: Five electronic databases-MEDLINE, CINAHL, SCOPUS, PROQUEST, and COCHRANE LIBRARY-were systematically searched, using search terms inflammatory bowel disease, Crohn's disease, ulcerative colitis, dietary intake, and fiber, until December 2019, with hand searching of reference lists. Primary studies were included if fiber intakes were measured in participants 18 years of age or older, with confirmed IBD, with or without comparison to a control.

Results: A total of 2105 publications were identified, and 26 met inclusion criteria. Total fiber intake of 4164 participants with IBD ranged broadly (9.9 ± 7.8 g/day to 21.0 ± 10.5 g/day). Most (18/26) used cross-sectional study design, with a large degree of heterogeneity in tools measuring fiber intake. Sixty-six percent of studies comparing participants with IBD with control groups found that participants with IBD consumed significantly less fiber than control subjects. Four studies reported that less than 10% to 21% of IBD participants met their national fiber recommendations. Data conflicted regarding an association between disease type, disease activity, or rate of relapse and fiber intake.

Conclusions: Individuals with IBD consume less fiber than healthy populations. Fiber intakes are inadequate compared with respective national fiber guidelines. Interpretation of factors associated with fiber intakes were limited by data quality and conflicting results. Future research is required into factors associated with fiber intake and whether increasing fiber intakes can influence disease course and behavior.
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http://dx.doi.org/10.1016/j.jand.2020.12.001DOI Listing
April 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

Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure.

Aliment Pharmacol Ther 2020 11 27;52(10):1551-1562. Epub 2020 Sep 27.

Fitzroy, VIC, Australia.

Background: The impact of pregnancy on levels of biologic agents in patients with IBD is undefined and time to elimination in vedolizumab-exposed infants is unknown.

Aims: To determine the effect of pregnancy on infliximab, adalimumab and vedolizumab levels and to study infant vedolizumab clearance METHODS: In a prospective observational study, maternal drug levels were measured pre-conception, in each trimester, at delivery and postpartum. The association between drug levels and gestation in weeks was assessed using generalised estimating equation modelling. Infant vedolizumab levels were performed at birth (cord blood), 6 weeks and 3 months or until undetectable.

Results: We included 50 IBD patients (23 on infliximab, 15 on adalimumab and 12 on vedolizumab) with at least two intrapartum observations, plus 5 patients on vedolizumab with only mother and baby samples at delivery. Modelling showed no change in adalimumab levels, an increase in infliximab levels of 0.16 (95% CI 0.08-0.24) µg/L/week (P < 0.001) and a decrease of 0.18 (95% CI: -0.33 to -0.02) µg/L/week (P = 0.03) for vedolizumab. In 17 mother-baby pairs, median infant vedolizumab levels at birth were lower than maternal levels (P < 0.05) with an infant:maternal ratio of 0.7 (IQR 0.5-0.9). Vedolizumab was undetectable between 15 and 16 weeks of age in all 12 infants completing follow-up testing.

Conclusions: During pregnancy, adalimumab levels remain stable, while infliximab levels increase and vedolizumab levels decrease. However, the increments were small suggesting that intrapartum therapeutic drug monitoring and dose adjustment are not indicated. Unlike infliximab and adalimumab, infant vedolizumab levels are lower in cord blood than in mothers and appear to clear rapidly.
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http://dx.doi.org/10.1111/apt.16102DOI Listing
November 2020

Infliximab-related weight gain in inflammatory bowel disease: associations and financial impacts.

Intern Med J 2020 09;50(9):1134-1138

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

Association between tumour necrosis alpha inhibitors and weight gain has been reported. We examined weight change in our cohort of inflammatory bowel disease patients treated with infliximab (IFX) for over 12 months, its associations and financial implications. Two-thirds of patients gained weight during the course of therapy. The mean change in weight after 12 months of IFX therapy was 3.3 (±6.5) kg.
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http://dx.doi.org/10.1111/imj.14987DOI Listing
September 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

Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease.

J Crohns Colitis 2021 Jan;15(1):125-142

Department of Gastroenterology, Queen Elizabeth Hospital, Adelaide, SA, Australia.

Background And Aims: Serial measurements of luminal disease activity may facilitate inflammatory bowel disease management. Gastrointestinal ultrasound is an easily performed, non-invasive alternative to other assessment modes. However, its widespread use is limited by concerns regarding validity, reliability, and responsiveness. We systematically identified ultrasound scoring indices used to evaluate inflammatory bowel disease activity and examine their operating characteristics.

Methods: Electronic databases were searched from inception to June 14, 2019 using pre-defined terms. Studies that reported on gastrointestinal ultrasound index operating properties in an inflammatory bowel disease population were eligible for inclusion. Study characteristics, index components, and operating property data [ie, validity, reliability, responsiveness, sensitivity, specificity, accuracy, positive predictive value, and negative predictive value] were extracted. The QUADAS-2 tool was used to examine study-level risk of bias.

Results: Of the 2610 studies identified, 26 studies reporting on 21 ultrasound indices were included. The most common index components included bowel wall thickness, colour Doppler imaging, and bowel wall stratification. The correlation between ultrasound indices and references standards ranged r = 0.62-0.95 and k = 0.40-0.96. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive values ranged 39-100%, 63-100%, 73-100%, 57-100%, and 40-100%, respectively. Reliability and responsiveness data were limited. Most [92%, 24/26] studies received at least one unclear or high risk of bias rating.

Conclusions: Several gastrointestinal ultrasound indices for use in inflammatory bowel disease have been developed. Future research should focus on fully validating existing or novel gastrointestinal ultrasound scoring instruments for assessment of Crohn's disease and ulcerative colitis.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa129DOI Listing
January 2021

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

Psychological distress is highly prevalent in inflammatory bowel disease: A survey of psychological needs and attitudes.

JGH Open 2020 Apr 2;4(2):166-171. Epub 2019 Aug 2.

IBD Service, Department of Gastroenterology and Hepatology Royal Adelaide Hospital Adelaide South Australia Australia.

Background And Aim: Data on patient needs and access to psychological services in inflammatory bowel disease (IBD) are scarce. This study aimed to describe the levels of distress and the needs, attitudes, and access to psychological services for people within Australia against established Australian IBD Standards.

Methods: An online cross-sectional survey was conducted with Australians ≥16 years old recruited via Crohn's & Colitis Australia membership, public and private clinics, and the Royal Flying Doctor Service. K10 was used to measure psychological distress. The Chi-square test was used to compare those with and without distress on key variables.

Results: Overall, 731 respondents provided complete data (71.5% female, mean age 46.5 years). Overall, 50% of respondents reported distress; only 15.2% were currently seeing a mental health practitioner; only 16.1% were asked about their mental health by their IBD specialist or IBD nurse; and only 12.2% reported access to a mental health practitioner as part of their IBD service. Those with psychological distress were significantly less satisfied with their IBD care; more commonly hospitalized; had an active disease, fistula or perianal disease, pain, or fatigue; and were receiving steroids, opioids, or antidepressants (all  < 0.05). As many as 68.2% of those with severe distress were not seeing a mental health practitioner.

Conclusions: The integrated biopsychosocial model of health care, with regular mental health screening and good access to mental health professionals, is requested by people living with IBD to improve their outcomes.
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http://dx.doi.org/10.1002/jgh3.12236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144796PMC
April 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

Integrated Psychological Care Reduces Health Care Costs at a Hospital-Based Inflammatory Bowel Disease Service.

Clin Gastroenterol Hepatol 2021 01 31;19(1):96-103.e3. Epub 2020 Jan 31.

Inflammatory Bowel Disease Service, Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia; School of Medicine, Faculty of Health & Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.

Background & Aims: Inflammatory bowel diseases (IBD) are associated with high psychosocial burden and economic cost. Integrating psychological care into routine management might lead to savings. We performed a 2-year investigation of the effects of integrated psychological care in reducing healthcare use and costs.

Methods: We performed a prospective study of 335 adult patients treated at a hospital-based IBD service in Australia. Participants were recruited between September 2015 and August 2016 and completed screening instruments to evaluate mental health and quality of life. Data on healthcare use and costs for the previous 12 months were also collected. Patients found to be at risk for mental health issues were offered psychological intervention. Patients were followed up 12 months after screening (between September 2016 and August 2017).

Results: A significantly higher proportion of subjects at risk for mental health issues had presented to an emergency department in the 12 months before screening (51/182; 28%) compared to psychologically healthy subjects (28/152; 18%; X(1) = 4.23; P = .040). Higher levels of depression and general distress (but not anxiety) were related to increased odds of hospital admission (adjusted odds ratios, 1.07 and 1.05, respectively). Among the patients who accepted psychological intervention, the number who presented to emergency departments was reduced significantly in the 12 months after screening (follow-up) compared to the 12 months before screening (P = .047), resulting in a cost saving of AU$30,140 ($20,816 USD). A cost-benefit analysis of the integrated psychological care model revealed a net saving of AU$84,905 ($58,647 USD) over a 2-year period.

Conclusions: Risk for mental health issues is associated with higher healthcare costs in people with IBD. Providing integrated psychological care to individuals at risk for mental health issues can reduce costs, particularly by decreasing visits to emergency departments. Further studies are required to determine the best care to provide to reduce costs.
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http://dx.doi.org/10.1016/j.cgh.2020.01.030DOI Listing
January 2021

The Potential of Integrated Nurse-Led Models to Improve Care for People With Functional Gastrointestinal Disorders: A Systematic Review.

Gastroenterol Nurs 2020 Jan/Feb;43(1):53-64

Ecushla C. Linedale, PhD, The University of Adelaide, Adelaide, South Australia; and The South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.

Functional gastrointestinal disorders such as irritable bowel syndrome and functional dyspepsia are extremely common, debilitating, and costly. Although diagnostic guidelines and effective management options exist, management is suboptimal, with long waiting lists, delayed diagnosis, and poor patient outcomes. The aim of this systematic review was to explore and evaluate evidence for existing models of care for functional gastrointestinal disorders. Thirty-eight studies pertaining to the diagnosis or management of functional gastrointestinal disorders were found; however, only 6 investigated a full model of care. Five studies assessed a nurse-led model and 1 a structured gastroenterologist consultation. Nurse-led models were cheaper to current treatments and resulted in symptomatic improvement, high patient satisfaction, reduced healthcare usage, and improved psychosocial functioning and quality of life, whereas standard gastroenterological care did not alleviate pain or improve quality of life. There is minimal research trialing integrated models of care for the diagnosis and management of functional gastrointestinal disorders. This represents a lost opportunity for timely and effective healthcare provision to a large patient group. Although low in quality, preliminary data suggest that integrated nurse-led models of care are economically viable and may facilitate timely diagnosis and management and improve patient outcomes. Furthermore, studies to robustly evaluate the efficacy, safety, and acceptability of such models are needed.
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http://dx.doi.org/10.1097/SGA.0000000000000379DOI Listing
December 2020

Quality of care in inflammatory bowel disease: actual health service experiences fall short of the standards.

Intern Med J 2020 Oct;50(10):1216-1225

IBD Service, Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

Background: Quality of care in inflammatory bowel disease (IBD) has received much attention internationally; however, the available surveys focus on health professionals rather than patients.

Aims: To assess the experiences of healthcare for people living with IBD against established Australian IBD Standards.

Methods: An online cross-sectional survey was conducted with Australians ≥16 years old recruited via Crohn's & Colitis Australia membership, public and private clinics and the Royal Flying Doctor Service. Participants completed a questionnaire incorporating items addressing the Australian IBD Standards 2016, the Picker Patient Experience Questionnaire, IBD Control Survey and the Manitoba Index.

Results: Complete data were provided by 731 respondents (71.5% female, median age 46 years, ranging from 16 to 84 years). While the majority (74.8%) were satisfied with their IBD healthcare, the care reported did not meet the Australian IBD Standards. Overall, 32.4% had access to IBD nurses, 30.9% to a dietician and 12% to a psychologist in their treating team. Participants managed by public IBD clinics were most likely to have access to an IBD nurse (83.7%), helpline (80.7%) and research trials (37%). One third of respondents reported waiting >14 days to see a specialist when their IBD flared. Participants received enough information, mostly from medical specialists (88.8%) and IBD nurses (79.4%). However, 51% wanted to be more involved in their healthcare.

Conclusions: These data show discordance between expectations of patients and national standards with current levels of service provision, which fail to deliver equitable and comprehensive IBD care.
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http://dx.doi.org/10.1111/imj.14683DOI Listing
October 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

Fecal Microbiota Transplantation for Ulcerative Colitis-Reply.

JAMA 2019 06;321(22):2240-2241

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia.

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http://dx.doi.org/10.1001/jama.2019.3950DOI Listing
June 2019

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

Adjuvant therapy with antidepressants for the management of inflammatory bowel disease.

Cochrane Database Syst Rev 2019 Apr 12;4:CD012680. Epub 2019 Apr 12.

School of Psychology, Deakin University Geelong, 221 Burwood Highway, Burwood, VIC, Victoria, Australia, 3025.

Background: Symptoms of anxiety and depression are common in inflammatory bowel disease (IBD). Antidepressants are taken by approximately 30% of people with IBD. However, there are no current guidelines on treating co-morbid anxiety and depression in people with IBD with antidepressants, nor are there clear data on the role of antidepressants in managing physical symptoms of IBD.

Objectives: The objectives were to assess the efficacy and safety of antidepressants for treating anxiety and depression in IBD, and to assess the effects of antidepressants on quality of life (QoL) and managing disease activity in IBD.

Search Methods: We searched MEDLINE; Embase, CINAHL, PsycINFO, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 23 August 2018. Reference lists, trials registers, conference proceedings and grey literature were also searched.

Selection Criteria: Randomised controlled trials (RCTs) and observational studies comparing any type of antidepressant to placebo, no treatment or an active therapy for IBD were included.

Data Collection And Analysis: Two authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. We used the Newcastle-Ottawa Scale to assess quality of observational studies. GRADE was used to evaluate the certainty of the evidence supporting the outcomes. Primary outcomes included anxiety and depression. Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS) or the Hamilton Anxiety Rating Scale (HARS). Depression was assessed using HADS or the Beck Depression Inventory. Secondary outcomes included adverse events (AEs), serious AEs, withdrawal due to AEs, quality of life (QoL), clinical remission, relapse, pain, hospital admissions, surgery, and need for steroid treatment. QoL was assessed using the WHO-QOL-BREF questionnaire. We calculated the risk ratio (RR) and corresponding 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) with 95% CI. A fixed-effect model was used for analysis.

Main Results: We included four studies (188 participants). Two studies were double-blind RCTs, one was a non-randomised controlled trial, and one was an observational retrospective case-matched study. The age of participants ranged from 27 to 37.8 years. In three studies participants had quiescent IBD and in one study participants had active or quiescent IBD. Participants in one study had co-morbid anxiety or depression. One study used duloxetine (60 mg daily), one study used fluoxetine (20 mg daily), one study used tianeptine (36 mg daily), and one study used various antidepressants in clinical ranges. Three studies had placebo controls and one study had a no treatment control group. One RCT was rated as low risk of bias and the other was rated as high risk of bias (incomplete outcome data). The non-randomised controlled trial was rated as high risk of bias (random sequence generation, allocation concealment, blinding). The observational study was rated as high methodological quality, but is still considered to be at high risk of bias given its observational design.The effect of antidepressants on anxiety and depression is uncertain. At 12 weeks, the mean anxiety score in antidepressant participants was 6.11 + 3 compared to 8.5 + 3.45 in placebo participants (MD -2.39, 95% -4.30 to -0.48, 44 participants, low certainty evidence). At 12 months, the mean anxiety score in antidepressant participants was 3.8 + 2.5 compared to 4.2 + 4.9 in placebo participants (MD -0.40, 95% -3.47 to 2.67, 26 participants; low certainty evidence). At 12 weeks, the mean depression score in antidepressant participants was 7.47 + 2.42 compared to 10.5 + 3.57 in placebo participants (MD -3.03, 95% CI -4.83 to -1.23, 44 participants; low certainty evidence). At 12 months, the mean depression score in antidepressant participants was 2.9 + 2.8 compared to 3.1 + 3.4 in placebo participants (MD -0.20, 95% -2.62 to 2.22, 26 participants; low certainty evidence).The effect of antidepressants on AEs is uncertain. Fifty-seven per cent (8/14) of antidepressant participants group reported AEs versus 25% (3/12) of placebo participants (RR 2.29, 95% CI 0.78 to 6.73, low certainty evidence). Commonly reported AEs include nausea, headache, dizziness, drowsiness, sexual problems, insomnia, fatigue, low mood/anxiety, dry mouth, muscle spasms and hot flushes. None of the included studies reported any serious AEs. None of the included studies reported on pain.One study (44 participants) reported on QoL at 12 weeks and another study (26 participants) reported on QoL at 12 months. Physical, Psychological, Social and Environmental QoL were improved at 12 weeks compared to placebo (all low certainty evidence). There were no group differences in QoL at 12 months (all low certainty evidence). The effect of antidepressants on maintenance of clinical remission and endoscopic relapse is uncertain. At 12 months, 64% (9/14) of participants in the antidepressant group maintained clinical remission compared to 67% (8/12) of placebo participants (RR 0.96, 95% CI 0.55 to 1.69; low certainty evidence). At 12 months, none (0/30) of participants in the antidepressant group had endoscopic relapse compared to 10% (3/30) of placebo participants (RR 0.14, 95% CI 0.01 to 2.65; very low certainty evidence).

Authors' Conclusions: The results for the outcomes assessed in this review are uncertain and no firm conclusions regarding the efficacy and safety of antidepressants in IBD can be drawn. Future studies should employ RCT designs, with a longer follow-up and develop solutions to address attrition. Inclusion of objective markers of disease activity is strongly recommended as is testing antidepressants from different classes, as at present it is unclear if any antidepressant (or class thereof) has differential efficacy.
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http://dx.doi.org/10.1002/14651858.CD012680.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6459769PMC
April 2019

Systematic review of rectal stump management during and after emergency total colectomy for acute severe ulcerative colitis.

ANZ J Surg 2019 12 28;89(12):1556-1560. Epub 2019 Mar 28.

Faculty of Health and Medical Science, School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia.

Background: There is no consensus about the optimal management of the rectal stump after an emergency subtotal colectomy in patients with acute severe ulcerative colitis (ASUC). The aim was to perform a systematic review of the published literature on the surgical and medical management of the rectal stump after an emergency (sub) total colectomy in patients with ASUC.

Methods: The following databases were searched, MEDLINE (PubMed), EMBASE and OVID SP, from January 1993 to March 2018. Studies that reported post-operative outcomes after surgical and/or medical management of the rectal stump after emergency (sub) total colectomy in adults with ASUC were included. Two independent assessors reviewed eligible articles.

Results: A total of 11 studies met the inclusion criteria. All were case series and included 476 patients. Regarding surgical management, five studies reported on closed subcutaneous placement of the rectal stump, seven on intraperitoneal placement and two on the formation of a formal mucous fistula. The lowest reported pelvic sepsis rate was in patients with subcutaneous closure of the rectal stump (n = 144, 2%) and lowest wound infection rate was reported after intraperitoneal closure (n = 268, 7.8%). The highest rate of mortality was reported after intraperitoneal placement of the rectal stump (n = 268, 1.5%). There were insufficient data reported on medical management for any comparison.

Conclusion: Subcutaneous placement of the rectal stump was associated with the lowest morbidity and mortality rate, although data are of limited quality and insufficient to guide practice recommendations.
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http://dx.doi.org/10.1111/ans.15075DOI Listing
December 2019

Integrated Psychological Care is Needed, Welcomed and Effective in Ambulatory Inflammatory Bowel Disease Management: Evaluation of a New Initiative.

J Crohns Colitis 2019 Jul;13(7):819-827

IBD Service, Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, Australia.

Background And Aims: Inflammatory bowel disease is associated with psychosocial issues which reduce quality of life and impair medical management. However, these issues are rarely addressed in routine care. A model of integrated psychological screening and intervention was trialled to measure prevalence, patient participation, and potential benefits to mental health and/or quality of life.

Methods: During a 12-month period, 490 adult patients at an established hospital-based service were approached to complete screening instruments for anxiety, depression, general distress, quality of life and medication adherence. Disease-specific and demographic data were also collected. Patients who scored highly on screening questionnaires were offered psychological intervention (in-service or externally referred). Participants were reassessed after 12 months.

Results: Psychological screening was well accepted with 68% (N = 335) participating. Psychological care was 'needed', with 55% (N = 183) scoring highly for anxiety, depression and/or general distress. Half of those 'in need' (N = 91) accepted intervention. In those who accepted, levels of anxiety (mean at intake [M1] = 12.11 vs mean at follow-up [M2] = 9.59, p < 0.001), depression (M1 = 8.38 vs M2 = 6.42, p < 0.001), general distress (M1 = 17.99 vs M2 = 13.96, p < 0.001), mental health quality of life (M1 = 54.64 vs M2 = 59.70, p < 0.001) and overall quality of life (M1 = 57.60 vs M2 = 64.10, p < 0.001) each improved between intake and follow-up. Engagement in psychological intervention was six times greater for those treated in-service vs externally referred (χ2[1] = 13.06, p < 0.001, odds ratio = 6.47).

Conclusions: Mental health issues are highly prevalent in people with inflammatory bowel disease. Patients are open to psychological screening and treatment. Psychological care can improve patient mental health and quality of life, and works best when integrated into routine management.
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http://dx.doi.org/10.1093/ecco-jcc/jjz026DOI Listing
July 2019

Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial.

JAMA 2019 01;321(2):156-164

Centre for Nutrition and Gastrointestinal Disease, Adelaide Medical School, University of Adelaide and South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.

Importance: High-intensity, aerobically prepared fecal microbiota transplantation (FMT) has demonstrated efficacy in treating active ulcerative colitis (UC). FMT protocols involving anaerobic stool processing methods may enhance microbial viability and allow efficacy with a lower treatment intensity.

Objective: To assess the efficacy of a short duration of FMT therapy to induce remission in UC using anaerobically prepared stool.

Design, Setting, And Participants: A total of 73 adults with mild to moderately active UC were enrolled in a multicenter, randomized, double-blind clinical trial in 3 Australian tertiary referral centers between June 2013 and June 2016, with 12-month follow-up until June 2017.

Interventions: Patients were randomized to receive either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35) via colonoscopy followed by 2 enemas over 7 days. Open-label therapy was offered to autologous FMT participants at 8 weeks and they were followed up for 12 months.

Main Outcomes And Measures: The primary outcome was steroid-free remission of UC, defined as a total Mayo score of ≤2 with an endoscopic Mayo score of 1 or less at week 8. Total Mayo score ranges from 0 to 12 (0 = no disease and 12 = most severe disease). Steroid-free remission of UC was reassessed at 12 months. Secondary clinical outcomes included adverse events.

Results: Among 73 patients who were randomized (mean age, 39 years; women, 33 [45%]), 69 (95%) completed the trial. The primary outcome was achieved in 12 of the 38 participants (32%) receiving pooled donor FMT compared with 3 of the 35 (9%) receiving autologous FMT (difference, 23% [95% CI, 4%-42%]; odds ratio, 5.0 [95% CI, 1.2-20.1]; P = .03). Five of the 12 participants (42%) who achieved the primary end point at week 8 following donor FMT maintained remission at 12 months. There were 3 serious adverse events in the donor FMT group and 2 in the autologous FMT group.

Conclusions And Relevance: In this preliminary study of adults with mild to moderate UC, 1-week treatment with anaerobically prepared donor FMT compared with autologous FMT resulted in a higher likelihood of remission at 8 weeks. Further research is needed to assess longer-term maintenance of remission and safety.

Trial Registration: anzctr.org.au Identifier: ACTRN12613000236796.
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http://dx.doi.org/10.1001/jama.2018.20046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439766PMC
January 2019

Crohn's & Colitis Australia inflammatory bowel disease audit: measuring the quality of care in Australia.

Intern Med J 2019 07;49(7):859-866

Gastroenterology and Hepatology Unit, The Canberra Hospital, Canberra, Australian Capital Territory, Australia.

Background: Australia has among the highest prevalence of Crohn disease and ulcerative colitis in the world. Management of the chronic gastrointestinal disorders results in significant societal costs and the standard of care is inconsistent across Australia.

Aim: To audit the quality of care received by patients admitted for inflammatory bowel disease (IBD) across Australia against national IBD standards.

Methods: A retrospective cross-sectional survey and clinical audit was undertaken assessing organisational resources, clinical processes and outcome measures. This study was conducted in Australian hospitals that care for inpatients with Crohn disease or ulcerative colitis. The main outcome measures were adherence to national IBD standards and comparison of quality of care between hospitals with and without multidisciplinary IBD services.

Results: A total of 71 hospitals completed the organisational survey. Only one hospital had a complete multidisciplinary IBD service and 17 had a partial IBD service (IBD nurse, helpline and clinical lead). A total of 1440 inpatient records was reviewed from 52 hospitals (mean age 37 years; 51% female, 53% Crohn disease), approximately 26% of IBD inpatient episodes over a 12-month period in Australia. These patients were chronically unwell with high rates of anaemia (30%) and frequent readmissions (40% within 2 years). In general, care was inconsistent, and documentation was poor. Hospitals with a partial IBD service performed better in many processes and outcome measures: for example, 22% reduction in admissions through emergency departments and greater adherence to standards for safety monitoring of biological (89% vs 59%) and immunosuppressive drugs (79% vs 55%) in those hospitals than those without.

Conclusion: Patients admitted to hospital suffering from IBD are young, chronically unwell and are subject to substantial variations in clinical documentation and quality of care. Only one hospital met accepted standards for multidisciplinary care; hospitals with even a minimal IBD service provided improved care.
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http://dx.doi.org/10.1111/imj.14187DOI Listing
July 2019

Letter: vedolizumab drug concentrations in neonates following intrauterine exposure.

Aliment Pharmacol Ther 2018 12;48(11-12):1328-1330

St Vincent's Hospital, Melbourne, Victoria, Australia.

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http://dx.doi.org/10.1111/apt.15027DOI Listing
December 2018

Referrals to a tertiary hospital: A window into clinical management issues in functional gastrointestinal disorders.

JGH Open 2017 Nov 31;1(3):84-91. Epub 2017 Oct 31.

Department of Medicine, The University of Adelaide Adelaide South Australia Australia.

Background And Aim: To investigate the quality of and reasons for referrals of patients with likely functional gastrointestinal disorders (FGID) and explore patients' experience of clinical management.

Methods: A cross sectional, mixed-methods study was undertaken. Referrals (July 2013-2015) to one gastroenterology outpatient department triaged as "likely FGID", the referred patients and their referring primary healthcare providers were examined.

Results: A total of 69% of patients reported not yet receiving an initial diagnosis, 52% reported persistent/distressing symptoms or reduced quality of life, 24% feared missed or worsening pathology, and 35% were seeking repeat specialist consultation. Most patients were dissatisfied (40%) or only partially satisfied (36%) with current management. Dissatisfaction was significantly related to the lack of provision of a diagnosis and effective treatment options ( < 0.001). Referral quality was poor and with the reason for referral clearly communicated in only 25%. Common referral reasons included repeat presentations ( = 32), diagnostic uncertainty ( = 19), to ensure nothing is missed ( = 19), patient request ( = 17), no response to treatment ( = 16), and to allay patient fears ( = 14). A total of 28/60 primary healthcare providers were confident that their patient had a FGID, yet sought confirmation ( = 16), second opinion ( = 8), or advice ( = 4).

Conclusion: Current management of FGID in usual care is suboptimal, as evidenced by the tertiary referral load, patient dissatisfaction, and the lack of provision of diagnoses and effective treatment options. Some clinicians lack confidence in effectively identifying and managing these conditions. Resources and supports to equip and assist clinicians to identify and manage FGID successfully may enhance patient care.
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http://dx.doi.org/10.1002/jgh3.12015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207011PMC
November 2017

Nonsynonymous Polymorphism in Guanine Monophosphate Synthetase Is a Risk Factor for Unfavorable Thiopurine Metabolite Ratios in Patients With Inflammatory Bowel Disease.

Inflamm Bowel Dis 2018 11;24(12):2606-2612

Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand.

Background: Up to 20% of patients with inflammatory bowel disease (IBD) who are refractory to thiopurine therapy preferentially produce 6-methylmercaptopurine (6-MMP) at the expense of 6-thioguanine nucleotides (6-TGN), resulting in a high 6-MMP:6-TGN ratio (>20). The objective of this study was to evaluate whether genetic variability in guanine monophosphate synthetase (GMPS) contributes to preferential 6-MMP metabolizer phenotype.

Methods: Exome sequencing was performed in a cohort of IBD patients with 6-MMP:6-TGN ratios of >100 to identify nonsynonymous single nucleotide polymorphisms (nsSNPs). In vitro assays were performed to measure GMPS activity associated with these nsSNPs. Frequency of the nsSNPs was measured in a cohort of 530 Caucasian IBD patients.

Results: Two nsSNPs in GMPS (rs747629729, rs61750370) were detected in 11 patients with very high 6-MMP:6-TGN ratios. The 2 nsSNPs were predicted to be damaging by in silico analysis. In vitro assays demonstrated that both nsSNPs resulted in a significant reduction in GMPS activity (P < 0.05). The SNP rs61750370 was significantly associated with 6-MMP:6-TGN ratios ≥100 (odds ratio, 5.64; 95% confidence interval, 1.01-25.12; P < 0.031) in a subset of 264 Caucasian IBD patients.

Conclusions: The GMPS SNP rs61750370 may be a reliable risk factor for extreme 6MMP preferential metabolism.
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http://dx.doi.org/10.1093/ibd/izy163DOI Listing
November 2018
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