Background and study aims Overcoming logistical obstacles for the implementation of colorectal endoscopic submucosal dissection (ESD) requires accurate prediction of procedure times. We aimed to... Show moreBackground and study aims Overcoming logistical obstacles for the implementation of colorectal endoscopic submucosal dissection (ESD) requires accurate prediction of procedure times. We aimed to evaluate existing and new prediction models for ESD duration.Patients and methods Records of all consecutive patients who underwent single, non-hybrid colorectal ESDs before 2020 at three Dutch centers were reviewed. The performance of an Eastern prediction model [GIE 2021;94(1):133-144] was assessed in the Dutch cohort. A prediction model for procedure duration was built using multivariable linear regression. The model's performance was validated using internal validation by bootstrap resampling, internal-external cross-validation and external validation in an independent Swedish ESD cohort.Results A total of 435 colorectal ESDs were analyzed (92% en bloc resections, mean duration 139 minutes, mean tumor size 39 mm). The performance of current unstandardized time scheduling practice was suboptimal (explained variance: R-2 =27%). We successfully validated the Eastern prediction model for colorectal ESD duration <60 minutes (c-statistic 0.70, 95% CI 0.62-0.77), but this model was limited due to dichotomization of the outcome and a relatively low frequency (14%) of ESDs completed <60 minutes in the Dutch centers. The model was more useful with a dichotomization cut-off of 120 minutes (c-statistic: 0.75; 88% and 17% of "easy" and "very difficult" ESDs completed <120 minutes, respectively). To predict ESD duration as continuous outcome, we developed and validated the six-variable cESD-TIME formula ( https://cesdtimeformula.shinyapps.io/calculator/ ; optimism-corrected R-2 =61%; R-2 =66% after recalibration of the slope).Conclusions We provided two useful tools for predicting colorectal ESD duration at Western centers. Further improvements and validations are encouraged with potential local adaptation to optimize time planning. Show less
Aseptic handling is the procedure to enable sterile products to be made ready to administer using closed systems (EU Resolution CM/Res(2016)2). Microbiological monitoring (MM) and media fills are... Show moreAseptic handling is the procedure to enable sterile products to be made ready to administer using closed systems (EU Resolution CM/Res(2016)2). Microbiological monitoring (MM) and media fills are used for environmental and process control.In this study, the application of MM methods during aseptic handling inside, or related to working in, a laminar airflow cabinet or safety cabinet in hospital pharmacies is described and evaluated. Results are expressed as colony forming units (cfu) and Contamination Recovery Rate (CRR; the rate at which MM samples contain any level of contamination -USP < 1116 >-). For trend analysis, a rolling CRR is developed (a rolling CRR calculates a CRR using a predetermined number of most recent samples).Of all MM methods, glove print is the most informative. The added value of air sampling is doubtful. Because of microbiological as well as statistical considerations, the use of CRR for assessing MM results is advised. Glove prints, in general, give the highest CRR. A CRR < 10% is a realistic limit for MM during aseptic handling in hospital pharmacies. A rolling CRR, calculated using the last 100 samples, is a good compromise between reliability of the CRR value and timely prediction of process changes. Show less
Claassen, A.A.O.M.; Schers, H.J.; Busch, V.J.J.F.; Heesterbeek, P.J.C.; Hoogen, F.H.J. van den; Vlieland, T.P.M.V.; Ende, C.H.M. van den 2020
Background To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip... Show moreBackground To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip or knee osteoarthritis (OA) on patients' satisfaction. Methods A two-armed randomized controlled trial involving 286 patients with (suspicion of) hip or knee OA, randomly allocated to either receiving an educational eHealth tool to prepare their upcoming consultation (n = 144) or usual care (n = 142). Satisfaction with the consultation on three subscales (range 1-4) of the Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0-22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1-5), assessment of patient's involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale), were assessed. Results No differences between groups were observed on the 3 subscales of the CQI (group difference (95% CI): communication 0.009 (- 0.10, 0.12), conduct - 0.02 (- 0.12, 0.07) and information provision 0.02 (- 0.18, 0.21)). Between group differences (95% CI) were in favor of the intervention group for knowledge (1.4 (0.6, 2.2)), negative beliefs regarding physical activities (- 0.19 (- 0.37, - 0.002) and pain medication (- 0.30 (- 0.49, - 0.01)). We found no differences on other secondary outcomes. Conclusions An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis. Show less
