Colonoscope retraction technique and predicting adenoma detection rate: a multicenter study.

BACKGROUND AND AIMS: The success of preventing colorectal cancer relies on the expertise of the colonoscopists. Studies suggest that the retraction technique is a powerful indicator of expertise in distinguishing endoscopists with various adenoma detection rates (ADRs). We aimed to develop a retraction technique score and explore the correlation between endoscopists' retraction technique and their ADRs. METHODS: In a prospective, multicenter study, 8 colonoscopist nurses and physicians with various ADRs were included. Data from patients admitted for a colonoscopy, as part of the Danish nationwide screening program, were gathered directly from the Olympus ScopeGuide system (UPD-3; Olympus Optical, Tokyo, Japan) providing XYZ-coordinates from the coils along the length of the colonoscope. Motor skill measures were developed based on tip retraction, retraction efficiency, and retraction distance. The principal component analysis was used to study the association among the 3 measures and the historical ADR to create a combined score, the colonoscopy retraction score (CoRS). RESULTS: Three hundred thirty-three recordings were analyzed. We demonstrated a significant and strong correlation between CoRS and ADR (.90, P < .01). Conversely, withdrawal time did not correlate significantly with ADR (.33, P = .42). In procedures without polypectomies or biopsy sampling, a significant and strong correlation was found between CoRS and ADR (.88, P < .01) and between withdrawal time and ADR (.75, P = .03). CONCLUSIONS: This study presents a novel, real-time computerized and unbiased assessment tool for colonoscopy withdrawal. CoRS strongly correlated with ADR with and without therapeutic interventions during withdrawal and could be used to ensure quality instead of minimal withdrawal time. (Clinical trial registration number: NCT03587935.).

The optimal cut-off value in fit-based colorectal cancer screening: An observational study.

BACKGROUND: Colorectal cancer (CRC) screening programs using fecal immunochemical test (FIT) have to choose a cut-off value to decide which citizens to recall for colonoscopy. The evidence on the optimal cut-off value is sparse and based on studies with a low number of cancer cases. METHODS: This observational study used data from the Danish Colorectal Cancer Screening Database. Sensitivity and specificity were estimated for various cut-off values based on a large number of cancers. Traditionally optimal cut-off values are found by weighting sensitivity and specificity equally. As this might result in too many unnecessary colonoscopies we also provide optimal cut-off values for different weighting of sensitivity and specificity/number of needed colonoscopies to detect one cancer. RESULTS: Weighting sensitivity and specificity equally gives an optimal cut-off value of 45 ng Hb/ml. This, however, means making 24 colonoscopies to detect one cancer. Weighting sensitivity lower and for example, aiming at making about 16 colonoscopies to detect one cancer, gives an optimal cut-off value of 125 ng Hb/ml. CONCLUSIONS: The optimal cut-off value in an FIT population-based screening program is 45 ng Hb/ml, when as traditionally sensitivity and specificity are weighted equally. If, however, 24 colonoscopies needed to detect one cancer is too huge a burden on the health care system and the participants, 80, 125, 175, and 350 ng Hb/ml are optimal cut-off values when only 19/16/14/10 colonoscopies are accepted to find one cancer.

Using computerized assessment in simulated colonoscopy: a validation study.

Background and study aims Patient safety during a colonoscopy highly depends on endoscopist competence. Endoscopic societies have been calling for an objective and regular assessment of the endoscopists, but existing assessment tools are time-consuming and prone to bias. We aimed to develop and gather evidence of validity for a computerized assessment tool delivering automatic and unbiased assessment of colonoscopy based on 3 dimensional coordinates from the colonoscope. Methods Twenty-four participants were recruited and divided into two groups based on experience: 12 experienced and 12 novices. Participants performed twice on a physical phantom model with a standardized alpha loop in the sigmoid colon. Data was gathered directly from the Olympus ScopeGuide system providing XYZ-coordinates along the length of the colonoscope. Five different motor skill measures were developed based on the data, named: Travel Length, Tip Progression, Chase Efficiency, Shaft movement without tip progression, and Looping. Results The experinced had a lower travel length ( P  < 0.001), tip progression ( P  < 0.001), chase efficiency ( P  = 0.001) and looping ( P  = 0.006), and a higher shaft movement without tip progression ( P  < 0.001) reaching the cecum compared with the novices. A composite score was developed based on the five measurements to create a combined score of progression, the 3D-Colonoscopy-Progression-Score (3D-CoPS). The 3D-CoPS revealed a significant difference between groups (experienced: 0.495 (SD 0.303) and novices -0.454 (SD 0.707), P  < 0.001). Conclusion This study presents a novel, real-time computerized assessment tool for colonoscopy, and strong evidence of validity was gathered in a simulation-based setting. The system shows promising opportunities for automatic, unbiased and continuous assessment of colonoscopy performance.

Three years of colorectal cancer screening in Denmark.

BACKGROUND: The Danish National Colorectal Cancer Screening Programme was implemented in March 2014 and is offered free of charge to all residents aged 50-74 years. The aim of this study is to compare performance indicators from the Danish National Colorectal Cancer Screening Programme to the recommendations from European Guidelines in order to assure the quality of the programme and to provide findings relevant to other population-based colorectal cancer screening programmes. METHODS: Based on data from the Danish Colorectal Cancer Screening Database, we evaluated all performance indicators for which the European Guidelines provided acceptable level, desirable level or the level from first screening rounds in population-based studies using FIT. RESULTS: All performance indicators were above the acceptable level and/or in line with the level from the first screening round in population-based studies using FIT. Whenever the European Guidelines provided a desirable level for a performance indicator, the Danish National Colorectal Cancer Screening Programme was close to or above this desirable level. CONCLUSIONS: Compared to the European Guidelines, all performance indicators were above the acceptable level and close to the desirable level. Based on these findings, the implementation of the National Danish Colorectal Cancer Screening Programme is considered a success and the programme is hopefully in the process of reducing colorectal cancer morbidity and mortality in Denmark. This study provides relevant information for comparisons to other population-based public service colorectal cancer screening programmes as well as for future revisions of guidelines.

Automatic and unbiased assessment of competence in colonoscopy: exploring validity of the Colonoscopy Progression Score (CoPS).

Background and aims: Colonoscopy is a difficult procedure to master. Increasing demands for colonoscopy, due to screening and surveillance programs, have highlighted the need for competent performers. Valid methods for assessing technical skills are pivotal for training and assessment. This study is the first clinical descriptive report of a novel colonoscopy assessment tool based on Magnetic Endoscopic Imaging (MEI) data and the aim was to gather validity evidence based on the data collected using the "Colonoscopy Progression Score" (CoPS). Methods: We recorded 137 colonoscopy procedures performed by 31 endoscopists at three university hospitals. The participants performed more than two procedures each (range 2 - 12) and had an experience of 0 - 10 000 colonoscopies. The CoPS was calculated for each recording and validity was explored using a widely accepted contemporary framework. The following sources of validity evidence were explored: response process (data collection), internal structure (reliability), relationship to other variables (i. e. operator experience), and consequences of testing (pass/fail). Results: Identical set-ups at all three locations ensured uniform data collection. The Generalizability coefficient (G-coefficient) was 0.80, and a Decision-study (D-study) revealed that four recordings were sufficient to ensure a G-coefficient above 0.80. We showed a positive correlation between CoPS and experience with Pearson's r of 0.61 (P < 0.001). A pass/fail standard of 107 points was established using the contrasting group method to explore the consequences of testing. Conclusion: This study provides evidence supporting the validity of the CoPS for use in assessing technical colonoscopy performance in the clinical setting. STUDY REGISTRATION: NCT01997177.

Effects of probiotic fermented milk on symptoms and intestinal flora in patients with irritable bowel syndrome: a randomized, placebo-controlled trial.

OBJECTIVE: The effect of probiotics on IBS symptoms has been mixed, but remains an intriguing treatment option with appeal to the patient. MATERIAL AND METHODS: Patients fulfilling the Rome II criteria were randomized double-blind to a daily intake of 500 ml of fermented milk containing at least 5 × 10(7) CFU/ml of Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or an equal volume of acidified milk for 8 weeks. Symptoms were assessed at baseline and weekly using a disease-specific validated symptom rating scale (IBS-SSI). The predefined primary outcome measure was patient reported adequate symptom relief. Adherence to study protocol were assessed by performing stool samples at the of the treatment period. RESULTS: Eight-one patients were screened. Sixty-four patients were randomized; 18 patients did not complete the study due to protocol violations or withdrew due to lack of effect. Fifty-two patients (13 males) completed the study as per protocol; mean age was 51.3 years (range 29-67). The proportion of patients reporting adequate symptom relief increased in both patient groups, but there was not any statistical difference between the groups. IBS-SSI scores did not differ statistically between the groups at the end of the treatment period, but improved during the study period in both groups. CONCLUSIONS: During this 8-week trial gastrointestinal symptoms improved. However, there was no difference between treatment with fermented milk containing probiotics or acidified milk. The effect of probiotics on IBS symptoms remains uncertain and further studies are warranted.

Proton-pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy.

BACKGROUND & AIMS: Rebound acid hypersecretion (RAHS) has been demonstrated after 8 weeks of treatment with a proton-pump inhibitor (PPI). If RAHS induces acid-related symptoms, this might lead to PPI dependency and thus have important implications. METHODS: A randomized, double-blind, placebo-controlled trial with 120 healthy volunteers was conducted. Participants were randomized to 12 weeks of placebo or 8 weeks of esomeprazole 40 mg/d followed by 4 weeks with placebo. The Gastrointestinal Symptom Rating Scale (GSRS) was filled out weekly. A score of >2 on 1 of the questions regarding heartburn, acid regurgitation, or dyspepsia was defined as a clinically relevant acid-related symptom. RESULTS: There were no significant differences between groups in GSRS scores at baseline. GSRS scores for acid-related symptoms were significantly higher in the PPI group at week 10 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .023), week 11 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .009), and week 12 (1.3 +/- 1.2 vs 1.0 +/- 0.3; P = .001). Forty-four percent (26/59) of those randomized to PPI reported > or = 1 relevant, acid-related symptom in weeks 9-12 compared with 15% (9/59; P < .001) in the placebo group. The proportion reporting dyspepsia, heartburn, or acid regurgitation in the PPI group was 13 of 59 (22%) at week 10, 13 of 59 (22%) at week 11, and 12 of 58 (21%) at week 12. Corresponding figures in the placebo group were 7% at week 10 (P = .034), 5% at week 11 (P = .013), and 2% at week 12 (P = .001). CONCLUSIONS: PPI therapy for 8 weeks induces acid-related symptoms in healthy volunteers after withdrawal. This study indicates unrecognized aspects of PPI withdrawal and supports the hypothesis that RAHS has clinical implications.