Evaluation of the Cost-Effectiveness of Iron Formulations for the Treatment of Iron Deficiency Anaemia in Patients with Inflammatory Bowel Disease in the UK.

INTRODUCTION: In patients with inflammatory bowel disease (IBD), iron deficiency anaemia (IDA) can impair quality of life and increase healthcare costs. Treatment options for IDA-associated IBD include oral iron and intravenous iron formulations (such as ferric carboxymaltose [FCM], ferric derisomaltose [FD, previously known as iron isomaltoside 1000], and iron sucrose [IS]). The present analysis compared the cost-effectiveness of FCM versus FD, IS, and oral iron sulfate in terms of additional cost per additional responder in the UK setting. METHODS: Cost-effectiveness was calculated for FCM versus FD, IS, and oral iron individually in terms of the additional cost per additional responder, defined as haemoglobin normalisation or an increase of ≥2 g/dL in haemoglobin levels, in a model developed in Microsoft Excel. Relative efficacy inputs were taken from a previously published network meta-analysis, since there is currently no single head-to-head trial evidence comparing all therapy options. Costs were calculated in 2020 pounds sterling (GBP) capturing the costs of iron preparations, healthcare professional time, and consumables. RESULTS: The analysis suggested that FCM may be the most effective intervention, with 81% of patients achieving a response. Response rates with FD, IS, and oral iron were 74%, 75%, and 69%, respectively. Total costs with FCM, FD, IS, and oral iron were GBP 296, GBP 312, GBP 503, and GBP 56, respectively. FCM was found to be more effective and less costly than both FD and IS, and therefore was considered dominant. Compared with oral iron, FCM was associated with an incremental cost-effectiveness ratio of GBP 2045 per additional responder. CONCLUSIONS: FCM is likely to be the least costly and most effective IV iron therapy in the UK setting. Compared with oral iron, healthcare payers must decide whether the superior treatment efficacy of FCM is worth the additional cost.

Correction to: Direct observation of procedural skills (DOPS) assessment in diagnostic gastroscopy: nationwide evidence of validity and competency development during training.

The citation for Reference 22 should be replaced with: Kumar NL, Kugener G, Perencevich ML, et al (2018) The SAFE-T assessment tool: derivation and validation of a web-based application for point-of-care evaluation of gastroenterology fellow performance in colonoscopy. Gastrointest Endosc 87(1):262-269.

Direct observation of procedural skills (DOPS) assessment in diagnostic gastroscopy: nationwide evidence of validity and competency development during training.

BACKGROUND: Validated competency assessment tools and the data supporting milestone development during gastroscopy training are lacking. We aimed to assess the validity of the formative direct observation of procedural skills (DOPS) assessment tool in diagnostic gastroscopy and study competency development using DOPS. METHODS: This was a prospective multicentre (N = 275) analysis of formative gastroscopy DOPS assessments. Internal structure validity was tested using exploratory factor analysis and reliability estimated using generalisability theory. Item and global DOPS scores were stratified by lifetime procedure count to define learning curves, using a threshold determined from receiver operator characteristics (ROC) analysis. Multivariable binary logistic regression analysis was performed to identify independent predictors of DOPS competence. RESULTS: In total, 10086 DOPS were submitted for 987 trainees. Exploratory factor analysis identified three distinct item groupings, representing 'pre-procedure', 'technical', and 'post-procedure non-technical' skills. From generalisability analyses, sources of variance in overall DOPS scores included trainee ability (31%), assessor stringency (8%), assessor subjectivity (18%), and trainee case-to-case variation (43%). The combination of three assessments from three assessors was sufficient to achieve the reliability threshold of 0.70. On ROC analysis, a mean score of 3.9 provided optimal sensitivity and specificity for determining competency. This threshold was attained in the order of 'pre-procedure' (100-124 procedures), 'technical' (150-174 procedures), 'post-procedure non-technical' skills (200-224 procedures), and global competency (225-249 procedures). Higher lifetime procedure count, DOPS count, surgical trainees and assessors, higher trainee seniority, and lower case difficulty were significant multivariable predictors of DOPS competence. CONCLUSION: This study establishes milestones for competency acquisition during gastroscopy training and provides validity and reliability evidence to support gastroscopy DOPS as a competency assessment tool.

Changes in scoring of Direct Observation of Procedural Skills (DOPS) forms and the impact on competence assessment.

BACKGROUND: Direct Observation of Procedural Skills (DOPS) is an established competence assessment tool in endoscopy. In July 2016, the DOPS scoring format changed from a performance-based scale to a supervision-based scale. We aimed to evaluate the impact of changes to the DOPS scale format on the distribution of scores in novice trainees and on competence assessment. METHODS: We performed a prospective, multicenter (n = 276), observational study of formative DOPS assessments in endoscopy trainees with ≤ 100 lifetime procedures. DOPS were submitted in the 6-months before July 2016 (old scale) and after (new scale) for gastroscopy (n = 2998), sigmoidoscopy (n = 1310), colonoscopy (n = 3280), and polypectomy (n = 631). Scores for old and new DOPS were aligned to a 4-point scale and compared. RESULTS: 8219 DOPS (43 % new and 57 % old) submitted for 1300 trainees were analyzed. Compared with old DOPS, the use of the new DOPS was associated with greater utilization of the lowest score (2.4 % vs. 0.9 %; P < 0.001), broader range of scores, and a reduction in competent scores (60.8 % vs. 86.9 %; P < 0.001). The reduction in competent scores was evident on subgroup analysis across all procedure types (P < 0.001) and for each quartile of endoscopy experience. The new DOPS was superior in characterizing the endoscopy learning curve by demonstrating progression of competent scores across quartiles of procedural experience. CONCLUSIONS: Endoscopy assessors applied a greater range of scores using the new DOPS scale based on degree of supervision in two cohorts of trainees matched for experience. Our study provides construct validity evidence in support of the new scale format.