Continuous monitoring of colonoscopy performance in the Netherlands: first results of a nationwide registry.

BACKGROUND: To optimize colonoscopy quality, several performance measures have been developed. These are usually assessed without distinction between the indications for colonoscopy. This study aimed to assess the feasibility of linking two national registries (one for colonoscopy and one for adverse events of gastrointestinal endoscopies in the Netherlands), and to describe the results of colonoscopy quality per indication. METHODS: This retrospective study was conducted with prospectively collected data of the Dutch Gastrointestinal Endoscopy Audit (DGEA) and the Dutch Registration of Complications in Endoscopy (DRCE). Data between 01-01-2016 and 01-01-2019 were analyzed. To calculate adverse event rates, data were linked at the level of endoscopy service. RESULTS: During the 3-year study period, 266 981 colonoscopies were recorded in DGEA. Of all indications, cecal intubation rate was highest in fecal immunochemical test (FIT)-positive screening colonoscopies (97.1 %), followed by surveillance (93.2 %), diagnostic (90.7 %), and therapeutic colonoscopies (83.1 %). The highest rate of adequate bowel preparation was observed in FIT-positive screening colonoscopies (97.1 %). A total of 1540 colonoscopy-related adverse events occurred (0.58 % of all colonoscopies). Bleeding and perforation and rates were highest for therapeutic (1.56 % and 0.51 %, respectively) and FIT-positive screening (0.72 % and 0.06 %, respectively) colonoscopies. The colonoscopy-related mortality was 0.006 %. CONCLUSION: This study describes the first results of the Dutch national colonoscopy registry, which was successfully linked to data from the national registry for adverse events of gastrointestinal endoscopies. In this large dataset, performance varied between indications. Our results emphasize the importance of defining benchmarks per indication in future guidelines.

Dutch Gastrointestinal Endoscopy Audit: automated extraction of colonoscopy data for quality assessment and improvement.

BACKGROUND AND AIMS: The importance of having quality assessment, assurance, and improvement tools in health care is increasingly recognized. However, the additional associated administration burden progressively interferes with the structural implementation and adoption of such tools, especially when it concerns high-volume procedures such as colonoscopies. The development of the Dutch Gastrointestinal Endoscopy Audit (DGEA), a registry with automated extraction of colonoscopy quality data, and its first results are described. METHODS: In close cooperation with commercial endoscopy reporting systems and a national histopathology database, healthcare professionals performing colonoscopies initiated a quality registry that extracts data from its core hospital resource or histology database without manual interference of the healthcare providers. Data extracted consisted of patient age, gender, indication of the colonoscopy, American Society of Anesthesiologists score, Boston Bowel Preparation Score, and cecal intubation; for the colonoscopy after a positive fecal immunochemical test in the colorectal cancer screening program, other data were polyp detection rate, which was available for all 48 hospitals or endoscopy centers, and adenoma detection rate, which was available for 26 hospitals or endoscopy centers. RESULTS: Between January 1, 2016 and March 31, 2019, 48 hospitals or endoscopy centers voluntarily participated in the DGEA, and 275,017 unique patients with 313,511 colonoscopies were registered. Overall missing values were limited to <1%. CONCLUSIONS: The results of this study demonstrate that it is feasible to deploy a quality registry collecting uniform data without additional administration burden for healthcare professionals.

Electromagnetic-guided placement of nasoduodenal feeding tubes versus endoscopic placement: a randomized, multicenter trial.

BACKGROUND AND AIMS: Electromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and EGDP in outpatients, ward patients, and critically ill patients with normal upper GI anatomy. METHODS: In 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle. RESULTS: In total, 160 patients were randomized to EGDP (N = 76) or EMP (N = 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; P = .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis N = 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP: $519.09 versus $622.49, respectively (P = .04). CONCLUSIONS: Success rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.).

A novel ingestible electronic drug delivery and monitoring device.

BACKGROUND: We developed an ingestible electronic drug delivery and monitoring system. This system includes an electronic capsule comprising a drug reservoir, a pH and temperature sensor, a microprocessor and wireless transceiver, a stepper motor, and batteries. The location of the capsule in the gut derived from pH data can be monitored in real time. The stepper motor can be remotely actuated to expel the contents of the drug reservoir. OBJECTIVES: First human study. DESIGN: Two consecutive observational studies. SETTING: University medical center. SUBJECTS: Twenty healthy volunteers. INTERVENTIONS: Study I: Ingestion and passage of the capsule. Study II: Ingestion and passage of the capsule, loaded with (99m)technetium-pertechnetate ((99m)Tc); remotely actuated expulsion of (99m)Tc in the gut. MAIN OUTCOME MEASUREMENTS: Study I: Safety, tolerability, and functionality (wireless pH and temperature recording). Study II: Tracing of the capsule and expulsion and distribution of (99m)Tc from the drug reservoir by scintigraphy. Correlating location pH with scintigraphy. RESULTS: Study I: Ingestion and passage of the capsule was safe and well tolerated. Transmitted pH and temperature data were received by the recorder in 96.5% ± 3%. Study II: pH-determined passage of the esophagogastric, gastroduodenal, and ileocolonic junction correlated well with scintigraphy. Expulsion of (99m)Tc from the capsule was successful in 9 of 10 subjects. LIMITATIONS: Subjects with relatively low body mass index. CONCLUSIONS: This electronic drug delivery and monitoring system may be a promising tool for targeted delivery of substances to well-defined areas of the GI tract.

Validation study of automatically generated codes in colonoscopy using the endoscopic report system Endobase.

OBJECTIVE: Gastrointestinal endoscopy databases are important for surveillance, epidemiology, quality control and research. A good quality of automatically generated databases to enable drawing justified conclusions based on the data is of key importance. The aim of this study is to validate the correctness of coding of a national automatically generated anonymous endoscopy database. MATERIAL AND METHODS: We evaluated a total of 500 colonoscopies performed in five larger hospitals of the TRANS.IT project focusing on endoscopy reporting. Randomly 500 examinations were selected from a total of 5,000 examinations and their generated endoscopic terminology codes as well as complete reports were analysed. Indications for the examination and described findings were scored for correctness and clinical relevance of the coding that would be exported to the anonymous database. RESULTS: Indications were correctly coded in 92% of all examinations (range 76-100%) per hospital. Correct coding of findings ranged from 42% to 93% per hospital (mean 77%). Different correct coding proportions were seen varying with the diagnosis, with the highest correct coding rates in polyps, carcinoma and diverticular disease. Incorrect coded examinations were scored for clinical relevance. Overall 11% of the investigated examinations were incorrectly coded with clinical relevance. CONCLUSIONS: Accuracy of clinically relevant endoscopy data recorded in the TRANS.IT anonymous central database is high. Further improvement is desirable, which may be achieved by education of individual endoscopists and enhancement of the program.

No beneficial effects of amantadine in treatment of chronic hepatitis C patients.

BACKGROUND: Benefit of adding amantadine to antiviral therapy for hepatitis C is controversial. AIMS: We aimed to examine whether such policy enhances sustained viral response in treatment-naïve patients. METHODS: 297 naïve hepatitis C patients were randomized for treatment with amantadine 200mg or placebo, combined with weight-based ribavirin and 12-day high-dose interferon alpha-2b induction therapy, followed by PEG-interferon alpha-2b (1.5 microg/kg/week up to 26 weeks and thereafter, 1.0 microg/kg/week until week 52). Treatment was discontinued if hepatitis C virus (HCV) RNA was positive at week 24. RESULTS: 49% of patients were (former) drug users. Genotype 1 occurred in 45%, high viral load in 70% and severe fibrosis/cirrhosis in 32%, without differences between amantadine or placebo groups. 90 patients prematurely discontinued treatment, mainly because of grade 3 or 4 toxicity. Intention-to-treat analysis revealed sustained viral response in 47% and 51% of amantadine and placebo groups (p=0.49). Amantadine did not enhance sustained viral response in patients with genotype 1 or high viral load nor did it improve primary non-response, breakthrough or relapse rates. Genotype non-1 and lower pre-treatment gamma GT levels were independent predictors for sustained viral response. CONCLUSION: Adding amantadine to antiviral therapy of previously untreated chronic hepatitis C patients has no beneficial effects.