Medicine (St Vincent's) - Research Publications

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    Long-Term Outcome of Multidisciplinary Versus Standard Gastroenterologist Care for Functional Gastrointestinal Disorders: A Randomized Trial
    Basnayake, C ; Kamm, MA ; Stanley, A ; Wilson-O'Brien, A ; Burrell, K ; Lees-Trinca, I ; Khera, A ; Kantidakis, J ; Wong, O ; Fox, K ; Talley, NJ ; Liew, D ; Salzberg, MR ; Thompson, AJ (ELSEVIER SCIENCE INC, 2022-09)
    BACKGROUND & AIMS: Functional gastrointestinal disorders are common and costly to the healthcare system. In the Multidisciplinary Treatment of Functional Gastrointestinal Disorders study, we demonstrated that multidisciplinary care resulted in superior clinical and cost outcomes, when compared with standard gastroenterologist-only care at end of treatment. In this study we evaluate the longer-term outcomes. METHODS: In a single-center, pragmatic trial patients with Rome IV criteria-defined functional gastrointestinal disorders were randomized 1:2 to a gastroenterologist-only standard care vs a multidisciplinary clinic comprising gastroenterologists, dietitians, gut hypnotherapists, psychiatrists, and biofeedback physiotherapists. Outcomes in this study were assessed 12 months after the end of treatment. Global symptom improvement was assessed by using a 5-point Likert scale. Symptoms, specific disorder status, psychological state, quality of life, and cost were additional outcomes. A modified intention-to-treat analysis was performed. RESULTS: Of 188 randomized patients, 143 (46 standard care, 97 multidisciplinary) formed the longer-term modified intention-to-treat analysis. Sixty-two percent of multidisciplinary clinic patients saw allied clinicians. Sixty-five percent (30/46) standard care versus 76% (74/97) multidisciplinary clinic patients achieved global symptom improvement 12 months after end of treatment (P = .17), whereas 20% (9/46) versus 37% (36/97) rated their symptoms as "5/5 much better" (P = .04). A ≥50-point reduction in Irritable Bowel Syndrome Severity Scoring System occurred in 38% versus 66% (P = .02), respectively, for irritable bowel syndrome patients. Anxiety and depression were greater in the standard care than multidisciplinary clinic (12 vs 10, P = .19), and quality of life was lower in standard care than the multidisciplinary clinic (0.75 vs 0.77, P =·.03). An incremental cost-effectivness ratio found that for every additional 3555AUD spent in the multidisciplinary clinic, a further quality-adjusted life year was gained. CONCLUSIONS: Twelve months after the completion of treatment, integrated multidisciplinary clinical care achieved a greater proportion of patients with improvement of symptoms, psychological state, quality of life, and cost, compared with gastroenterologist-only care. CLINICAL TRIALS: gov: number NCT03078634.
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    Maternal thiopurine metabolism during pregnancy in inflammatory bowel disease and clearance of thiopurine metabolites and outcomes in exposed neonates
    Flanagan, E ; Wright, EK ; Hardikar, W ; Sparrow, MP ; Connell, WR ; Kamm, MA ; De Cruz, P ; Brown, SJ ; Thompson, A ; Greenway, A ; Westley, I ; Barclay, M ; Ross, AL ; Kiburg, KV ; Bell, SJ (WILEY, 2021-04)
    BACKGROUND: Azathioprine and mercaptopurine are considered safe during pregnancy. However, the pharmacokinetic effects of pregnancy on thiopurine metabolism are undefined. AIMS: To characterise thiopurine metabolism in pregnancy and measure infant metabolite levels and outcomes. METHODS: Women with IBD who were taking a thiopurine and pregnant or trying to conceive were recruited. Maternal thiopurine metabolites were measured pre-conception, in each trimester, at delivery and post-partum. Infant metabolite levels, full blood examination and liver function testing were performed at birth, and repeated until levels undetectable and haematological and biochemical abnormalities resolved. RESULTS: Forty patients were included with measurements on at least two occasions, and two with only mother-baby levels at delivery. The median maternal 6-TGN level dropped in the second trimester compared with post-partum (179.0 vs 323.5 pmol/8 × 108 RBCs, P < 0.001) and the median 6-MMP level increased in the second trimester compared with post-partum (1103.0 vs 329.5 pmol/8 × 108 RBCs, P < 0.01). At delivery, the median 6-TGN level was lower in infants (n = 20) than mothers (78.5 vs 217 pmol/8 × 108 RBCs) (P < 0.001). Metabolites were not detected at 6 weeks in any infants. Anaemia was not seen, but thrombocytosis and abnormal liver biochemistry were detected in 80% of infants from 6 weeks, which gradually improved. CONCLUSIONS: 6-TGN levels decrease and 6-MMP levels increase in the second trimester of pregnancy. Infants are exposed to thiopurine metabolites at low levels with clearance by 6 weeks and no anaemia. The cause of infant thrombocytosis and abnormal liver biochemistry in the absence of metabolites is unclear.
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    Low failure to attend rates and increased clinic capacity with Telehealth: A highly effective outpatient model that should continue beyond the COVID-19 pandemic
    Tambakis, G ; Lee, T ; Shah, R ; Wright, E ; Connell, W ; Miller, A ; Demediuk, B ; Ryan, M ; Howell, J ; Tsoi, E ; Lust, M ; Basnayake, C ; Ding, N ; Croagh, C ; Hong, T ; Kamm, M ; Farrell, A ; Papaluca, T ; MacIsaac, M ; Iser, D ; Mahady, S ; Holt, B ; Thompson, A ; Holmes, J (WILEY, 2021-04)
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    Telehealth model of care for outpatient inflammatory bowel disease care in the setting of the COVID-19 pandemic
    Shah, R ; Wright, E ; Tambakis, G ; Holmes, J ; Thompson, A ; Connell, W ; Lust, M ; Niewiadomski, O ; Kamm, M ; Basnayake, C ; Ding, J (WILEY, 2021-07)
    BACKGROUND: Advances in inflammatory bowel disease (IBD) monitoring, greater number of available treatments and a shift towards tight disease control, IBD care has become more dynamic with regular follow ups. AIMS: We assessed the impacts of the COVID-19 pandemic on outpatient IBD patient care at a tertiary centre in Melbourne. More specifically, we assessed patient satisfaction with a telehealth model of care, failure to attend rates at IBD clinics and work absenteeism prior to and during the pandemic. METHODS: We conducted a retrospective, qualitative analysis to assess our aims through an online survey. We invited patients who attended an IBD outpatient clinic from April to June 2020 to participate. This study was conducted at a single, tertiary referral hospital in Melbourne. The key data points that we analysed were patient satisfaction with a telehealth model of care and the effect of telehealth clinics on work absenteeism. RESULTS: One hundred and nineteen (88.1%) patients were 'satisfied' or 'very satisfied' with the care received in the telehealth clinic. Eighty-four (60.4%) patients reported needing to take time off work to attend a face-to-face appointment, compared to 29 (20.9%) patients who needed to take time off work to attend telehealth appointments (P < 0.001). Clinic non-attendance rates were similar prior to and during the pandemic with rates of 11.4% and 10.4% respectively (P = 0.840). CONCLUSIONS: Patients report high levels of satisfaction with a telehealth model of care during the COVID-19 pandemic, with clinic attendance rates not being affected. Telehealth appointments significantly reduced work absenteeism when compared to traditional face-to-face clinics.
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    Delivery of care for functional gastrointestinal disorders: A systematic review
    Basnayake, C ; Kamm, MA ; Salzberg, MR ; Wilson-O'Brien, A ; Stanley, A ; Thompson, AJ (WILEY, 2020-02)
    BACKGROUND: A diverse range of treatments are available for the treatment of functional gastrointestinal disorders (FGIDs). Individual treatments, including drug therapies, behavioral therapy ("biofeedback"), psychological therapies, and dietary therapies, have been well validated in controlled, randomized trials and real-life case series. However, few studies have evaluated models of delivery of care for the whole population of referred patients with an FGID. This review evaluates models of specialist outpatient care for the management of FGIDs. METHODS: A systematic review was performed of full-text articles published until October 2018 in Pubmed/Medline and Embase. Studies were included if they evaluated a model of outpatient care in a specialist setting for the treatment of adult patients with an FGID and included patient-reported outcomes comprising symptoms, quality of life, or psychological well-being. RESULTS: Few studies have evaluated the delivery of care for the whole population of referred patients with an FGID, and there was one randomized comparison of different models of care. Two studies that evaluated the outcome of gastroenterologist-only clinics suggested poor long-term results. Two non-comparative case series reported the outcome of multidisciplinary care, including gastroenterologists and psychological therapists, suggesting improved patient quality of life and psychological well-being. CONCLUSIONS: Despite the high prevalence and cost of treating FGIDs, and the availability of effective treatments, there are few data and limited randomized comparisons reporting the outcome of different types of specialist care. The few data available suggest that multidisciplinary care is superior to gastroenterologist-only care, but this needs to be validated in prospective comparative studies.
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    Accuracy of point-of-care intestinal ultrasound for Crohn's disease.
    Wright, EK ; Wang, I ; Wong, D ; Bell, SJ ; Connell, WR ; Thompson, AJ ; Novak, KL ; Kamm, MA (Wiley, 2020-08)
    BACKGROUND: Point-of-care ultrasound (POCUS), performed by a gastroenterologist, provides safe and convenient imaging allowing for immediate clinical decision in Crohn's disease. The minimum training required to gain competency, its accuracy and clinical utility requires evaluation. METHODS: In this pilot study, Crohn's disease activity and extent were assessed using POCUS (performed by a single gastroenterologist following the completion of 200 supervised scans), magnetic resonance enterography (MRE) and ileo-colonoscopy. The presence of complications was assessed by POCUS and MRE. Accuracy of POCUS was analysed with respect to MRE and ileo-colonoscopy. Agreement between modalities was assessed using kappa coefficient. RESULTS: Forty-two patients had a POCUS paired with MRE. Thirty-eight patients had a POCUS paired with ileo-colonoscopy. When compared to MRE, POCUS was accurate in the assessment of disease activity (sensitivity 87.5%, specificity 61.1%, ROC 0.74), extent (sensitivity 77.8%, specificity 83.3%, ROC 0.81) and complications (sensitivity 85.7%, specificity 94.3%, ROC 0.90). Agreement between POCUS and MRE was moderate (kappa estimates 0.50, P < 0.001, 0.61, P < 0.001 and 0.76, P < 0.001) for disease activity, extent and complications, respectively. When compared to ileo-colonoscopy, POCUS was accurate in the assessment of disease activity (sensitivity 72%, specificity 86%, ROC 0.79) and extent (sensitivity 85.7%, specificity 86%, ROC 0.86). For POCUS and ileo-colonoscopy, kappa estimates were 0.55, P < 0.001 for disease activity and 0.62, P < 0.001 for disease extent. CONCLUSION: POCUS performed by a gastroenterologist after completion of limited training is accurate for assessing Crohn's disease activity, extent and the presence of complications.
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    Long-term outcomes of perianal fistulizing Crohn's disease in the biologic era
    Lee, T ; Kamm, MA ; Bell, S ; Lust, M ; Brown, S ; Niewiadomski, O ; Basnayake, C ; Wright, E ; D'Souza, B ; Woods, R ; Wei, SC ; Connell, W ; Thompson, A ; Yong, E ; Ding, NS (WILEY, 2020-12-20)
    While the advent of biologic therapy has led to improved outcomes in perianal fistulizing Crohn's disease (pfCD), loss of response is common. Previous studies suggest that patients who achieve radiological healing (with healing of underlying tracts on magnetic resonance imaging [MRI]) have a longer duration of response. The aim of this study was to characterize MRI outcomes of pfCD at a specialist inflammatory bowel disease (IBD) unit and compare the long‐term clinical outcomes between patients achieving MRI and clinical healing.
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    Determinants of long-term function and general well-being in patients with an ileoanal pouch
    Khera, AJ ; Chase, JW ; Salzberg, M ; Thompson, AJ ; Woods, RJ ; Wilson-O'Brien, A ; Kamm, MA (WILEY, 2021-01-01)
    BACKGROUND AND AIM: Fecal incontinence and/or evacuation difficulty are common after ileoanal pouch surgery. This study aimed to determine whether the development of these symptoms can be predicted so that preventive measures might be instituted. METHODS: A consecutive series of 46 patients with ulcerative colitis (median age at surgery, 41 years; 50% female) and a functioning pouch for a duration ≥12 months was included. Assessment utilized medical record review and questionnaires on pre- and postoperative bowel function, quality of life, and psychological well-being. Pouch function was assessed by the Colorectal Functional Outcome score (0 = no impairment, 100 = worst impairment). Good pouch function was defined as a score ≤24. RESULTS: Fecal incontinence occurred in 67% preoperatively and 54% postoperatively; evacuation difficulty occurred in 65% and preoperatively and 85% postoperatively. The postoperative median Colorectal Functional Outcome score was 20 (range 2-74), with 44% of patients >24 (poor pouch function). Preoperative nocturnal fecal incontinence (odds ratio [OR] 4.92, 95% confidence interval [CI] 1.2-19.4, P = 0.02) and pouchitis (OR 5.41, 95% CI 1.2-23.7, P = 0.02) were associated with poor pouch function after multivariable regression analysis. Postoperative satisfaction, psychological well-being, and quality of life were significantly better in those with good pouch function, while poor sleep, impaired work, and sexual dysfunction were independently associated with poor pouch function. CONCLUSIONS: Functional bowel symptoms are common before and after pouch surgery and are associated with the impairment of patient-reported outcomes. Preoperative nocturnal fecal incontinence predicts poor pouch function. Therapeutic focus on continence, bowel evacuation, psychological well-being, and quality of life should begin before surgery.
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    Systematic review: efficacy of escalated maintenance anti-tumour necrosis factor therapy in Crohn's disease
    Mattoo, VY ; Basnayake, C ; Connell, WR ; Ding, N ; Kamm, MA ; Lust, M ; Niewiadomski, O ; Thompson, A ; Wright, EK (WILEY, 2021-08)
    BACKGROUND: Loss of response to anti-TNF agents is a common clinical problem. Dose escalation may be effective for reestablishing clinical response in Crohn's disease (CD). AIMS: To perform a systematic review assessing the efficacy of escalated maintenance anti-TNF therapy in CD. METHODS: EMBASE, MEDLINE, Web of Science, and CENTRAL databases were searched for English language publications through to April 25, 2021. Full-text articles evaluating escalated maintenance treatment (infliximab or adalimumab) in adult CD patients were included. RESULTS: A total of 4733 records were identified, and 68 articles met eligibility criteria. Rates of clinical response (33%-100%) and remission (15%-83%) after empiric dose escalation for loss of response to standard anti-TNF therapy were high but varied across studies. Dose intensification strategies (doubling the dose versus shortening the therapeutic interval) were similarly efficacious. Dose-escalated patients tended to have higher serum drug levels compared to those on standard dosing. An exposure-response relationship following dose escalation was found in a number of observational studies. Randomised controlled trials comparing therapeutic drug monitoring (TDM) to empiric treatment intensification have failed to reach their primary end-points. Strategies including Bayesian dashboard-dosing and early treatment escalation targeting biomarker normalisation were found to be associated with improved long-term outcomes. CONCLUSIONS: Empiric escalation of maintenance anti-TNF therapy can recapture clinical response in a majority of patients with secondary loss of response to standard maintenance doses. Proactive optimisation of maintenance dosing might prolong time to loss of response in some patients.