Reliability of intestinal ultrasound for evaluating Crohn's disease activity using point-of-care and central reading.

BACKGROUND & AIMS: Intestinal ultrasound (IUS) is increasingly used to assess Crohn's disease (CD) activity in clinical practice. However, application in clinical trials has been limited by heterogeneous scoring methods and concerns about reliability. We aimed to determine the inter- and intra-rater reliability of locally- and centrally-read IUS parameters for evaluating CD using prospectively performed scans. METHODS: Twenty-four participants with CD and 6 gastroenterologists participated in a 2-day workshop where each participant underwent 6 IUS scans in total. Eight IUS parameters (bowel wall thickness [BWT], bowel wall stratification [BWS], color Doppler signal [CDS], inflammatory mesenteric fat [i-fat], submucosal prominence, submucosal layer thickness, haustra coli/peristalsis, and affected segment length) and an overall measure of sonographic disease activity were blindly assessed by the 6 local readers and 4 central gastroenterologist-sonographers. Reliability was quantified using intraclass correlation coefficients (ICCs). Institutional review board approval was granted for this study (12938). RESULTS: Five IUS parameters demonstrated at least moderate (ICC >0.41) inter- and intra-rater reliability when local and central reading was performed (BWT, CDS, i-fat, submucosal prominence, and affected segment length). Reliability was generally better with central, in distinction to local, reading. ICCs for BWS and i-fat were highest when evaluated as binary outcomes. Sensitivity analyses demonstrated that IUS parameters are most reliable when evaluated in the worst affected segment. Fair reliability was observed when local readers identified the worst affected segment. CONCLUSIONS: Local and central reading of IUS demonstrated at least moderate inter- and intra-rater reliability for several parameters. This study supports refining existing activity indices and incorporating IUS central reading into clinical trials.

Latent profiles of fatigue in inflammatory bowel disease.

INTRODUCTION: Fatigue is prevalent in people with inflammatory bowel disease (IBD) and has been associated with IBD activity, sleep quality, depression, and anxiety. This study aimed to identify fatigue profiles or clusters through latent profile analysis. METHODS: An online questionnaire was administered through three tertiary IBD centres, social media and through Crohn's Colitis Australia. Fatigue was assessed via the Functional assessment of chronic illness measurement system fatigue subscale (FACIT-F), a validated assessment of fatigue and its severity. Validated measures of anxiety, depression, IBD activity and sleep quality were also included. Latent profile analysis was performed including fatigue, sleep quality, active IBD, and depression and anxiety. The relationships between profiles and IBD and demographic data were investigated. RESULTS: In a cohort of 535 respondents, 77% were female, the median age was 41 years (range 32-52 years), and the majority had Crohn's disease (62%). Severe fatigue was seen in 62%. Latent profile analysis identified four distinct profiles differing by fatigue score - low fatigue, at-risk profile, active IBD, and a poor mental health profile. Female gender, obesity and opioid usage were associated with higher risk of being in the active IBD and poor mental health profile. Age over 40 was associated with lower risk of being in the poor mental health profile. CONCLUSION: Latent profile analysis identifies four classes of fatigue in an IBD cohort with associations with specific risk factors for fatigue along with specific IBD and demographic attributes. This has implications for the classification of fatigue in IBD and treatment algorithms.

Active Inflammatory Bowel Disease Is Associated with Short Sleep Duration via Objective Measures.

INTRODUCTION: Poor sleep quality has been associated with inflammatory bowel disease (IBD) activity, although studies incorporating actigraphy suggest that the perception of sleep differs rather than objective difference in sleep quality. Short sleep duration has been associated with increased pro-inflammatory cytokines that have been implicated in the pathogenesis of IBD. METHODS: An observational study incorporated home-based polysomnography that was conducted within twelve weeks of an objective assessment of IBD activity such as calprotectin, colonoscopy, or MRI. Participants completed a survey on subjective measures of sleep quality, clinical IBD activity, depression, and anxiety. Polysomnography results were normalized by standardized results for a healthy population matched by gender and age. RESULTS: Twenty participants were included in the final analysis. Those with objective evidence of active IBD had shorter stage 2 sleep duration, leading to shorter NREM sleep and total sleep time. Sleep latency was also longer in those with active IBD, leading to worse sleep efficiency-despite no difference in time available for sleep between the two groups. These changes persisted after normalization of polysomnography results by health population age and gender matched norms. Depression scores correlated with sleep latency and stage 2 sleep duration and were associated with objectively active IBD. CONCLUSIONS: Objectively confirmed active IBD was associated with shorter sleep duration. Observed sleep changes may, in part, relate to coexistent depression. Further research should consider the utility of changes in sleep duration and quality as a means of longitudinally assessing objective IBD activity.

Psychological Care for People with Inflammatory Bowel Diseases: Exploring Consumers' Perspectives to Inform Future Service Co-design.

BACKGROUND: There is a need to improve psychological care for people with Inflammatory Bowel Diseases (IBD), noting the high psychosocial burden of disease. AIMS: This study qualitatively explored the views of people living with IBD to help inform future co-design of services that better meet the psychological needs of consumers. METHODS: Adults with IBD were recruited to attend virtual focus groups to discuss what they want most in an IBD-specific psychological service. The discussions were recorded and transcribed, and data were analyzed using conventional qualitative content analysis. Draft results were summarized midway and reviewed by remaining focus groups and a final expert consumer. A quantitative dataset was created of comment frequencies. RESULTS: Thirty-one participants took part in the study: 10 focus groups were held with an average of three participants per group. The analysis identified 254 codes, 38 sub-categories and six categories. Five main categories were identified for an IBD-specific psychological service: People-Centered Healthcare (commented on by 90% of participants), Education and Preparation (83%), Social Connection (83%), Psychological Input (93%), and Accessible Services (97%). Results were summarized in a set of proposed clinical guidelines. CONCLUSIONS: The findings of this study identify important insights from people living with IBD regarding priorities for psychological services. IBD services should focus on improving education, addressing social connection, and integrating psychological input, as well as becoming more people-centered and accessible. It is hoped that IBD services consult the proposed clinical guidelines to inform co-designed service improvements.

Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study.

BACKGROUND & AIMS: Guselkumab, a selective p19 interleukin-23 antagonist, is approved for the treatment of plaque psoriasis and psoriatic arthritis. This study evaluated the efficacy and safety of guselkumab in patients with moderately to severely active Crohn's disease with inadequate response or intolerance to conventional or biologic therapy. METHODS: GALAXI-1, a phase 2, double-blind, placebo-controlled study, randomized patients 1:1:1:1:1 to intravenous guselkumab 200 mg, 600 mg, or 1200 mg at weeks 0, 4, and 8; intravenous ustekinumab approximately 6 mg/kg at week 0 and 90 mg subcutaneously at week 8; or placebo. Change from baseline in Crohn's Disease Activity Index score (primary end point), clinical remission, clinical response, Patient Reported Outcomes-2 remission, clinical-biomarker response, endoscopic response (major secondary end points), and safety in guselkumab-treated patients vs placebo were evaluated through week 12. Ustekinumab was a reference arm. RESULTS: Of 309 patients evaluated, approximately 50% had disease refractory to prior biologic therapy. At week 12, significantly greater reductions in Crohn's Disease Activity Index from baseline (least squares means: 200 mg: -160.4, 600 mg: -138.9, and 1200 mg: -144.9 vs placebo: -36.2; all, P < .05) and significantly greater proportions of patients achieved clinical remission in each guselkumab group vs placebo (Crohn's Disease Activity Index <150; 57.4%, 55.6%, and 45.9% vs 16.4%; all, P < .05). Greater proportions of patients receiving guselkumab achieved clinical response, Patient Reported Outcomes-2 remission, clinical-biomarker response, and endoscopic response at week 12 vs placebo. Efficacy of ustekinumab vs placebo was also demonstrated. Safety event rates were generally similar across treatment groups. CONCLUSIONS: At week 12, all 3 dose regimens of guselkumab induced greater clinical and endoscopic improvements vs placebo, with a favorable safety profile. CLINICALTRIALS: gov, Number: NCT03466411.

Management of iron-deficiency anemia following acute gastrointestinal hemorrhage: A narrative analysis and review.

Many patients experiencing acute gastrointestinal bleeding (GIB) require iron supplementation to treat subsequent iron deficiency (ID) or iron-deficiency anemia (IDA). Guidelines regarding management of these patients are lacking. We aimed to identify areas of unmet need in patients with ID/IDA following acute GIB in terms of patient management and physician guidance. We formed an international working group of gastroenterologists to conduct a narrative review based on PubMed and EMBASE database searches (from January 2000 to February 2021), integrated with observations from our own clinical experience. Published data on this subject are limited and disparate, and those relating to post-discharge outcomes, such as persistent anemia and re-hospitalization, are particularly lacking. Often, there is no post-discharge follow-up of these patients by a gastroenterologist. Acute GIB-related ID/IDA, however, is a prevalent condition both at the time of hospital admission and at hospital discharge and is likely underdiagnosed and undertreated. Despite limited data, there appears to be notable variation in the prescribing of intravenous (IV)/oral iron regimens. There is also some evidence suggesting that, compared with oral iron, IV iron may restore iron levels faster following acute GIB, have a better tolerability profile, and be more beneficial in terms of quality of life. Gaps in patient care exist in the management of acute GIB-related ID/IDA, yet further data from large population-based studies are needed to confirm this. We advocate the formulation of evidence-based guidance on the use of iron therapies in these patients, aiding a more standardized best-practice approach to patient care.

Co-design and Consultation Ensure Consumer Needs Are Met: Building an eHealth Platform for Children with Inflammatory Bowel Disease.

BACKGROUND: Crohn's Colitis Care is an adult inflammatory bowel disease eHealth system. Crohn's Colitis Care required additional pediatric functionality to enable life-long records and mitigate transition inadequacies. AIM: This study describes and evaluates a consensus method developed to ensure consumer needs were met. METHODS: Pediatric-specific functionality and associated resources considered important for inclusion were developed by a clinician consensus group. This group was divided into thematic subgroups and underwent two voting rounds. The content validity index was used to determine items reaching consensus. Children with inflammatory bowel disease and their parents were later shown a descriptive list of non-clinical inclusion topics proposed by the consensus group, and asked to vote on whether topic-related functionality and resources should be included. RESULTS: The consensus process consulted 189 people in total (38 clinicians, 32 children with inflammatory bowel disease and 119 parents). There was agreement across all groups to incorporate functionality and resources pertaining to quality of life, mental health, self-management, and transition readiness; however, divergence was seen for general inflammatory bowel disease facts, your inflammatory bowel disease history, and satisfaction. Cost saw the greatest disparity, being less supported by consumers compared to clinicians. Over 75% of consumers agreed it would be okay for appointments to take longer for survey completion, and > 90% thought Crohn's Colitis Care should allow consumers to ask their treating team questions. CONCLUSIONS: Widespread consumer co-design and consultation were important in unveiling differing perspectives to ensure Crohn's Colitis Care was built to support both consumer and clinician perspectives. Consumers collaborate to create a list of functionality and resources to be included in software (left), influencing the final product build (right).

Proactive Metabolite Testing in Patients on Thiopurine May Yield Long-Term Clinical Benefits in Inflammatory Bowel Disease.

BACKGROUND: The thiopurine medications are well established in the treatment of inflammatory bowel disease (IBD). There is significant variation in levels of toxic and therapeutic metabolites. Current data from small or short-term studies support therapeutic drug monitoring (TDM) in assessing azathioprine (AZA) and 6-mercaptopurine (6MP). TDM of thiopurines involves measurement and interpretation of metabolites 6-TGN and 6-MMPR. AIMS: This study aimed to assess long-cterm outcomes of patients on thiopurines following therapeutic drug monitoring. METHODS: A multicenter retrospective observational study of outcomes post thiopurine TDM was conducted. Demographics, disease characteristics, physician global assessment, IBD therapy at baseline TDM and again at 12 months were collected. Clinical outcomes were analyzed according to TDM result, and indication for TDM including proactive and other indications. RESULTS: The study included 541 patients. Only 39% of patients had appropriate dosing of thiopurines. AZA/6MP TDM informed a management change in 61.9%, and enabled 88.8% of the cohort to continue AZA/6MP following TDM. At 12 months following TDM the majority (74.1%) of the cohort remained on AZA/6MP. Clinical remission was higher at 12-months following thiopurines TDM (68%) compared to baseline (37%), including proactive TDM. Post TDM, 13.0% of patients were identified as shunters and commenced on thiopurine-allopurinol co-therapy. CONCLUSION: Thiopurine TDM resulted in a change in management for the majority of patients. Post TDM significantly more patients were in remission. TDM allowed the identification of non-adherence and shunters who, without intervention, would not reach therapeutic drug levels. Proactive TDM allowed identification and management of inappropriate dosing, and was associated with increased levels of clinical remission.

Poor engagement and adherence predict neoplasia in inflammatory bowel disease: a case-control study.

BACKGROUND: Colorectal adenocarcinoma is an important and preventable complication of inflammatory bowel disease (IBD). A previous case series suggested mental health issues and poor engagement in care as novel risk factors. AIMS: To confirm the role of patient engagement in care in the development of neoplasia using a case-control methodology. METHODS: Patients in a single referral centre from 2007 to 2017 with colorectal adenocarcinoma, high-grade dysplasia or multifocal low-grade dysplasia were included as neoplasia cases. Each case was assigned up to three matched controls (matched for age, gender, underlying disease, IBD type and phenotype and disease duration). Novel and known risk factors were compared between groups. RESULTS: Thirty-two cases with 88 matched controls were included. Patients with neoplasia were more likely to have poor adherence to, or engagement with, care (odds ratio (OR) 4.79). They were also more likely to have chronic use of opioids (OR 3.86) and long-term prednisolone (OR 2.97). Of note, no difference was found in measures of socioeconomic disadvantage, reflecting equitable access to healthcare in the public institution where the care was studied. As previously shown, patients with neoplasia had multiple markers of increased cumulative burden of inflammation, including more IBD-related hospital admissions, elevated inflammatory markers and severe inflammation at colonoscopy. CONCLUSIONS: This study confirms poor adherence or engagement with care as a new risk factor for colorectal adenocarcinoma in patients with IBD; identifying a vulnerable group whom clinicians should endeavour to engage in order to avoid this catastrophic complication.

Integration of mental health and quality of life screening tools in an inflammatory bowel disease-specific electronic medical record (Crohn Colitis Care): process and early outcomes.

Psychological problems are prevalent in people with inflammatory bowel diseases but are not routinely addressed. To improve recognition, three psychological screening tools were integrated into clinical management software (Crohn Colitis Care). In the first 6 months, completion rates varied between participating sites, and approximately 23-34% of respondents scored in moderate or higher ranges for psychological distress. Evaluation of the clinical utility of the module to improve patient outcomes is recommended.

Therapeutic Potential of the 4 Strategies to SUlfide-REduction (4-SURE) Diet in Adults with Mild to Moderately Active Ulcerative Colitis: An Open-Label Feasibility Study.

BACKGROUND: Diet therapy may bridge the therapeutic gap in ulcerative colitis (UC). OBJECTIVES: The novel 4-SURE diet (4-strategies-to-SUlfide-REduction), designed to modulate colonic fermentation and influence production of excess hydrogen sulfide, was examined in a feasibility study for tolerability, clinical efficacy, and effects on microbial endpoints. METHODS: Adults aged ≥18 y old with mild to moderately active UC were advised to increase intake of fermentable fibers, restrict total and sulfur-containing proteins, and avoid specific food additives for 8 wk. The primary outcome was tolerability of diet [100-mm visual analogue scale (VAS) with 100-mm being intolerable]. Secondary exploratory outcomes were self-reported adherence (always adherent ≥76-100%), clinical and endoscopic response (reduction in partial Mayo ≥2 and Mayo endoscopic subscore ≥1), modulation of fecal characteristics including markers of protein and carbohydrate fermentation, and food-related quality of life (IBD-FRQoL-29). Primary analysis was by intention to treat, performed using paired t and Wilcoxon signed-rank statistical tests. RESULTS: Twenty-eight adults with UC [mean (range) age: 42 (22-72) y, 15 females, 3 proctitis, 14 left-sided, and 11 extensive] were studied. Prescribed dietary targets were achieved overall. The diet was well tolerated (VAS: 19 mm; 95% CI: 7, 31 mm) with 95% frequently or always adherent. Clinical response occurred in 13 of 28 (46%) and endoscopic improvement in 10 of 28 participants (36%). Two participants (7%) worsened. Fecal excretion of SCFAs increased by 69% (P < 0.0001), whereas the proportion of branched-chain fatty acids to SCFAs was suppressed by 27% (-1.34%; 95% CI: -2.28%, -0.40%; P = 0.007). The FRQoL improved by 10 points (95% CI: 4, 16; P < 0.001). CONCLUSIONS: The 4-SURE dietary strategy is considered tolerable and an acceptable diet by adults with mild to moderately active UC. The dietary teachings achieved the prescribed dietary and fecal targets. Given signals of therapeutic efficacy, further evaluation of this diet is warranted in a placebo-controlled trial. This trial was registered at https://www.anzctr.org.au (Australian New Zealand Clinical Trials Registry) as ACTRN12619000063112.

Attitudes towards COVID-19 vaccination in patients with inflammatory bowel disease.

The majority of the Australian public are willing to have a Coronavirus disease 2019 (COVID-19) vaccination. It is unclear whether people with inflammatory bowel disease (IBD) have the same attitude towards COVID-19 vaccination. A survey was performed to assess the attitude of patients with IBD towards COVID-19 vaccination in South Australia. Two-thirds of surveyed patients with IBD were willing to accept COVID-19 vaccine. Females and younger patients were less likely to accept the COVID-19 vaccine, as were those who had never had a discussion around vaccines.

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.

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.

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

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%; X2(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.

Gender bias in resident evaluations: Natural language processing and competency evaluation.

BACKGROUND: Research shows that female trainees experience evaluation penalties for gender non-conforming behaviour during medical training. Studies of medical education evaluations and performance scores do reflect a gender bias, though studies are of varying methodology and results have not been consistent. OBJECTIVE: We sought to examine the differences in word use, competency themes and length within written evaluations of internal medicine residents at scale, considering the impact of both faculty and resident gender. We hypothesised that female internal medicine residents receive more negative feedback, and different thematic feedback than male residents. METHODS: This study utilised a corpus of 3864 individual responses to positive and negative questions over the course of six years (2012-2018) within Yale University School of Medicine's internal medicine residency. Researchers developed a sentiment model to assess the valence of evaluation responses. We then used natural language processing (NLP) to evaluate whether female versus male residents received more positive or negative feedback and if that feedback focussed on different Accreditation Council for Graduate Medical Education (ACGME) core competencies based on their gender. Evaluator-evaluatee gender dyad was analysed to see how it impacted quantity and quality of feedback. RESULTS: We found that female and male residents did not have substantively different numbers of positive or negative comments. While certain competencies were discussed more than others, gender did not seem to influence which competencies were discussed. Neither gender trainee received more written feedback, though female evaluators tended to write longer evaluations. CONCLUSIONS: We conclude that when examined at scale, quantitative gender differences are not as prevalent as has been seen in qualitative work. We suggest that further investigation of linguistic phenomena (such as context) is warranted to reconcile this finding with prior work.

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

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.

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

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.

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

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.

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

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 (n = 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.

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

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.