Showing papers by "Jane M. Andrews published in 2020"

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

Abstract: Objective Faecal microbiota transplantation (FMT) has proved to be an extremely effective treatment for recurrent Clostridioides difficile 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.

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

Abstract: 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 (i.e., validity, reliability, responsiveness, sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) data 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 from r=0.62-0.95 and k=0.40-0.96. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive values ranged from 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.

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

Abstract: 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.

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

Abstract: 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 P < 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.

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

Abstract: 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.

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

Abstract: 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.

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

Abstract: BACKGROUND Vedolizumab (VDZ), a humanised monoclonal antibody that selectively inhibits alpha4-beta7 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% n = 182, anti-TNF naive] were included. The clinical response was 79% at 3 mo with more Australian patients achieving clinical response compared to Oxford (83% vs 70% P = 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% vs 40% P < 0.001, 6 mo 73% vs 46% P < 0.001, 12 mo 66% vs 51% P = 0.03). More Australian patients achieved endoscopic remission at 6 mo compared to Oxford (69% vs 43% P = 0.01). On multi-variate analysis, anti-TNF naive patients were 1.8 (95%CI: 1.3-2.3) times more likely to achieve remission than anti-TNF exposed (P < 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.

The potential of integrated nurse-led models to improve care for people with functional gastrointestinal disorders: A systematic review

Abstract: 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.

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

Abstract: 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...

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.

Abstract: 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

Development and Feasibility of a Web-based Decision Aid for Patients with Ulcerative Colitis: a Qualitative Pilot Study

Abstract: 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.

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

Abstract: 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.

Transfusion strategies in upper gastrointestinal bleeding management: a review of South Australian hospital practice.

Abstract: BACKGROUND Upper gastrointestinal bleeding (UGIB) is a common cause of hospital admission and red cell transfusion is frequently required. A large single-centre randomised study from 2013 showed that a restrictive transfusion strategy in UGIB management was associated with better outcomes compared to a liberal strategy. Subsequently multiple international guidelines favour a restrictive transfusion strategy. However, given the multiple exclusion criteria in the study, generalisation to everyday practice was unclear. AIMS To assess applicability of the data to a non-trial UGIB population and determine how often restrictive thresholds are used in clinical practice. METHODS A retrospective case note review of patients with an UGIB admission during 2014 in three tertiary hospitals was undertaken. Information collected included demographics, comorbidities and factors associated with transfusion, such as apparent haemoglobin triggers and units transfused. The proportion of patients who would have met inclusion criteria of the study was calculated. RESULTS Of 89 UGIB admissions reviewed, up to 70% would be suitable for a restrictive approach. Use of this approach was evident in only 26% of transfusion episodes in patients meeting inclusion criteria. However, assessment was, limited by rapidly changing clinical status and potential for overestimation of true haemoglobin level with fluid resuscitation and equilibration. CONCLUSION A restrictive transfusion strategy may be suitable for many patients presenting with UGIB; however, important exclusions were not uncommon. Opportunities for increased uptake of restrictive thresholds were identified. Ongoing improvement initiatives should address the risks of both over and under-transfusion.

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

Abstract: 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.

Rectal Stump Management After Subtotal Colectomy for Severe Colitis, In or Out? A Retrospective Cohort Study

Abstract: There is little evidence to guide optimal medical and surgical management of the rectal stump in patients undergoing subtotal colectomy (STC) for severe colitis (SC) and acute severe ulcerative colitis (ASUC). All patients undergoing an STC for SC and ASUC at the Royal Adelaide Hospital (RAH), Australia, between 1993 and 2018 were identified and included from the RAH inflammatory bowel disease database and hospital records. Patient demographics, postoperative medical and surgical outcomes, and second-stage procedures were analyzed. Sixty-one patients underwent an STC for SC including ASUC. In 21 patients, the rectal stump was left in situ, whereas in 40, the rectal stump was extra-fascial. Thirty-five of the 61 patients underwent surgery for ASUC, of whom 10 were in the in situ group and 25 in the extra-fascial group. Baseline patient characteristics were similar, except for a significantly higher American Society of Anaesthesiologists score (P 0.024) in the extra-fascial ASUC group. There were no statistically significant differences in the postoperative outcomes between the extra-fascial group and the in situ group for SC and ASUC. There was, however, a trend toward lower rates of systemic sepsis (1 (4%) vs 3 (30%), P 0.061) and pelvic sepsis (1 (4%) vs 2 (20%), P 0.190) in the extra-fascial compared with the in situ group in the ASUC subset. In our experience, exteriorization of the rectal stump after STC for ASUC may confer a lower systemic and pelvic sepsis rate compared with the in situ group; however, better powered prospective studies with larger numbers are required to confirm this.