Stephanie Coward

Effect of oral capsule– vs colonoscopy-delivered fecal microbiota transplantation on recurrent Clostridium difficile infection: A randomized clinical trial

Importance Fecal microbiota transplantation (FMT) is effective in preventing recurrent Clostridium difficile infection (RCDI). However, it is not known whether clinical efficacy differs by route of delivery. Objective To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy. Design, Setting, and Participants Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada. A total of 116 adult patients with RCDI were enrolled between October 2014 and September 2016, with follow-up to December 2016. The noninferiority margin was 15%. Interventions Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio. Main Outcomes and Measures The primary outcome was the proportion of patients without RCDI 12 weeks after FMT. Secondary outcomes included (1) serious and minor adverse events, (2) changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst possible quality of life) to 100 (best quality of life), and (3) patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst). Results Among 116 patients randomized (mean [SD] age, 58 [19] years; 79 women [68%]), 105 (91%) completed the trial, with 57 patients randomized to the capsule group and 59 to the colonoscopy group. In per-protocol analysis, prevention of RCDI after a single treatment was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52) (difference, 0%; 1-sided 95% CI, −6.1% to infinity; P < .001), meeting the criterion for noninferiority. One patient in each group died of underlying cardiopulmonary illness unrelated to FMT. Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group. There was no significant between-group difference in improvement in quality of life. A significantly greater proportion of participants receiving capsules rated their experience as “not at all unpleasant” (66% vs 44%; difference, 22% [95% CI, 3%-40%]; P = .01). Conclusions and Relevance Among adults with RCDI, FMT via oral capsules was not inferior to delivery by colonoscopy for preventing recurrent infection over 12 weeks. Treatment with oral capsules may be an effective approach to treating RCDI. Trial Registration clinicaltrials.gov Identifier: NCT02254811

Funding a Smoking Cessation Program for Crohn’s Disease: An Economic Evaluation

OBJECTIVES:Patients with Crohn’s disease (CD) who smoke are at a higher risk of flaring and requiring surgery. Cost-effectiveness studies of funding smoking cessation programs are lacking. Thus, we performed a cost–utility analysis of funding smoking cessation programs for CD.METHODS:A cost–utility analysis was performed comparing five smoking cessation strategies: No Program, Counseling, Nicotine Replacement Therapy (NRT), NRT+Counseling, and Varenicline. The time horizon for the Markov model was 5 years. The health states included medical remission (azathioprine or antitumor necrosis factor (anti-TNF), dose escalation of an anti-TNF, second anti-TNF, surgery, and death. Probabilities were taken from peer-reviewed literature, and costs (CAN

Cost-effectiveness of screening for hepatitis C virus: a systematic review of economic evaluations

) for surgery, medications, and smoking cessation programs were estimated locally. The primary outcome was the cost per quality-adjusted life year (QALY) gained associated with each smoking cessation strategy. Threshold, three-way sensitivity, probabilistic sensitivity analysis (PSA), and budget impact analysis (BIA) were carried out.RESULTS:All strategies dominated No Program. Strategies from most to least cost effective were as follows: Varenicline (cost:

Intrapartum corticosteroid use significantly increases the risk of gestational diabetes in women with inflammatory bowel disease.

55,614, QALY: 3.70), NRT+Counseling (cost:

Comparative Effectiveness of Mesalamine, Sulfasalazine, Corticosteroids, and Budesonide for the Induction of Remission in Crohn's Disease: A Bayesian Network Meta-analysis.

58,878, QALY: 3.69), NRT (cost:

Hospital Volume and Other Risk Factors for In-Hospital Mortality among Diverticulitis Patients: A Nationwide Analysis

59,540, QALY: 3.69), Counseling (cost:

Colorectal cancer surveillance in patients with inflammatory bowel disease and primary sclerosing cholangitis: an economic evaluation.

61,029, QALY: 3.68), and No Program (cost:

The NOD2-Smoking Interaction in Crohn's Disease is likely Specific to the 1007 fs Mutation and may be Explained by Age at Diagnosis: A Meta-Analysis and Case-Only Study

63,601, QALY: 3.67). Three-way sensitivity analysis demonstrated that No Program was only more cost effective when every strategy’s cost exceeded approximately 10 times their estimated costs. The PSA showed that No Program was the most cost-effective <1% of the time. The BIA showed that any strategy saved the health-care system money over No Program.CONCLUSIONS:Health-care systems should consider funding smoking cessation programs for CD, as they improve health outcomes and reduce costs.

Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression in Adult and Youth Populations: A Systematic Literature Review and Meta-Analysis.

Objectives With the developments of near-cures for hepatitis C virus (HCV), who to screen has become a high-priority policy issue in many western countries. Cost-effectiveness of screening programmes should be one consideration when developing policy. The objective of this work is to synthesise the cost-effectiveness of HCV screening programmes. Setting A systematic review was completed. 5 databases were searched until May 2016 (NHSEED, MEDLINE, the HTA Health Technology Assessment Database, EMBASE, EconLit). Participants Any study reporting an economic evaluation (any type) of screening compared with opportunistic or no screening for HCV was included. Exclusion criteria were: (1) abstracts or commentaries, (2) economic evaluations of other interventions for HCV, including blood donors screening, diagnosis tests for HCV, screening for concurrent disease or medications for treatment. Primary and secondary outcome measures Data extraction included type of model, target population, perspective, comparators, time horizon, discount rate, clinical inputs, cost inputs and outcome. Quality was evaluated using the Consolidated Health Economic Evaluation Reporting Standards checklist. Data are summarised using narrative synthesis by population. Results 2305 abstracts were identified with 52 undergoing full-text review. 30 papers met inclusion criteria addressing 7 populations: drug users (n=6), high risk (n=5), pregnant (n=4), prison (n=3), birth cohort (n=8), general population (n=5) and other (n=6). The majority (77%) of the studies were high quality. Drug users, birth cohort and high-risk populations were associated with cost-effectiveness ratios of under £30 000 per quality-adjusted-life-year (QALY). The remaining populations were associated with cost-effectiveness ratios that exceeded £30 000 per QALY. Conclusions Economic evidence for screening populations is robust. If a cost per QALY of £30 000 is considered reasonable value for money, then screening birth cohorts, drug users and high-risk populations are policy options that should be considered.

Incidence of Appendicitis over Time: A Comparative Analysis of an Administrative Healthcare Database and a Pathology-Proven Appendicitis Registry.

BACKGROUND AND AIMS Women with inflammatory bowel disease (IBD) may be at higher risk of adverse pregnancy outcomes. This study compared perinatal outcomes in women with and without IBD. METHODS The population-based Data Integration, Measurement, and Reporting (DIMR) administrative discharge database was used to identify women (≥18 years of age) in Alberta, Canada, with IBD who delivered a baby between 2006 and 2009 inclusive. Women without IBD were randomly sampled and matched in a 3:1 ratio to IBD cases by age at conception (±1 year). Odds ratios of gestational diabetes, preterm birth, low birth weight, cesarean section, and neonatal intensive care unit admission were calculated. RESULTS One hundred and sixteen IBD patients were age-matched to 381 pregnant women without IBD. Gestational diabetes, preterm birth, and cesarean section were more common in women with IBD compared with controls (6.9 versus 1.8%, p = 0.03; 12.9 versus 0.3%, p < 0.0001; 43.1 versus 21.0%, p = 0.009, respectively). On multivariate analysis, women with IBD were independently more likely to have gestational diabetes (odds ratio [OR] = 4.3; 95% confidence interval [CI] 1.2-16.3), preterm birth (OR = 19.7, 95% CI 2.2-173.9), and to deliver by cesarean section (OR = 2.7, 95% CI 1.6-4.6) after adjusting for age and smoking status. CONCLUSION Intrapartum corticosteroid use significantly increases the risk of gestational diabetes in women with IBD. Furthermore, IBD patients are at higher risk of preterm delivery and are more likely to undergo cesarean section compared with a healthy age-matched population. The finding of a higher risk of gestational diabetes is a novel finding not previously reported in the IBD literature.