Evaluation of an Innovative Colon Capsule Endoscopy Service in Scotland From the Perspective of Patients: Mixed Methods Study.

BACKGROUND: Colonoscopy is the gold standard for lower gastrointestinal diagnostics. The procedure is invasive, and its demand is high, resulting in long waiting times. Colon capsule endoscopy (CCE) is a procedure that uses a video capsule to investigate the colon, meaning that it can be carried out in a person's own home. This type of "hospital-at-home" service could potentially reduce costs and waiting times, and increase patient satisfaction. Little is currently understood, however, about how CCE is actually experienced and accepted by patients. OBJECTIVE: The aim of this study was to capture and report patient experiences of the CCE technology (the capsule and associated belt and recorder) and of the new clinical pathway for the CCE service being rolled out as part of routine service in Scotland. METHODS: This was a mixed methods service evaluation of patient experiences of a real-world, deployed, managed service for CCE in Scotland. Two hundred and nine patients provided feedback via a survey about their experiences of the CCE service. Eighteen of these patients took part in a further telephone interview to capture more in-depth lived experiences to understand the barriers and opportunities for the further adoption and scaling up of the CCE service in a way that supports the patient experience and journey. RESULTS: Patients overall perceived the CCE service to be of significant value (eg, mentioning reduced travel times, reduced waiting times, and freedom to complete the procedure at home as perceived benefits). Our findings also highlighted the importance of clear and accessible information (eg, what to expect and how to undertake the bowel preparation) and the need for managing expectations of patients (eg, being clear about when results will be received and what happens if a further colonoscopy is required). CONCLUSIONS: The findings led to recommendations for future implementations of managed CCE services in National Health Service (NHS) Scotland that could also apply more widely (United Kingdom and beyond) and at a greater scale (with more patients in more contexts). These include promoting CCE with, for, and among clinical teams to ensure adoption and success; capturing and understanding reasons why patients do and do not opt for CCE; providing clear information in a variety of appropriate ways to patients (eg, around the importance of bowel preparation instructions); improving the bowel preparation (this is not specific to CCE alone); providing flexible options for issuing and returning the kit (eg, dropping off at a pharmacy); and embedding formative evaluation within the service itself (eg, capturing patient-reported experiences via surveys in the information pack when the equipment is returned).

Restarting gastrointestinal endoscopy in the deceleration and early recovery phases of COVID-19 pandemic: Guidance from the British Society of Gastroenterology.

Many non-emergency clinical services were suspended during COVID-19 pandemic peak. It is essential to develop a plan for restarting services following the peak. It is equally important to protect patients and staff and to use resources and personal protective equipment (PPE) efficiently. The British Society of Gastroenterology Endoscopy Committee and Quality Improvement Programme has produced guidance on how a restart can be safely delivered. Key recommendations include the following: all patients should have need for endoscopy assessed by senior clinicians and prioritised according to criteria we have outlined; once the need for endoscopy is confirmed, patients should undergo telephone screening for symptoms using systematic questionnaires; all outpatients should undergo RT-PCR testing for COVID-19 virus 1-3 days prior to endoscopy; and PPE should be determined by patient risk stratification, the nature of the procedure and the results of testing. While this guidance is tailored to endoscopy services, it could be adapted for any interventional medical discipline.

Simplify to improve in capsule endoscopy - TOP 100 is a swift and reliable evaluation tool for the small bowel inflammatory activity in Crohn's disease.

Background: Capsule endoscopy is a widely recognized method to study the small bowel, including in patients with Crohn's disease (CD). The Lewis score (LS) is a valuable tool in this setting, able to assess inflammatory activity. TOP100, a new software tool of the RAPID Reader®, emerged to assist in the time-consuming capsule reading process, by automatically selecting 100 images that will most likely contain abnormalities.Aim: Evaluate the agreement between TOP100 and classic reading (CR) in determining LS in the setting of CD.Methods: Retrospective study including consecutive patients undergoing small bowel capsule endoscopy (SBCE) for suspected or established CD. One experienced reader performed CR and calculated the LS. Another experienced reader, blinded to the CR results, reviewed all SBCE videos using TOP100 and calculated the LS.Results: One hundred and fifteen patients were included. SBCE detected significant inflammatory activity (LS ≥135) in 64 patients (55.7%). We verified a strong agreement between the two methods of capsule reading (Kappa = 0.83, p < .001), with an agreement on 89.6% of the cases. The agreement was superior in moderate-to-severe inflammatory activity (Kappa = 0.92, p < .001). All cases of moderate-to-severe activity detected by CR were identified by TOP100 as significant inflammatory activity. A good agreement was verified in all tertiles (p < .001).Conclusions: Although the classical review of the entire video remains the gold standard, the TOP100 has been shown to be a useful tool in assisting the reader in a prompt calculation of LS, in particular for identifying patients with moderate-to-severe inflammatory disease.

Video capsule endoscopy for upper gastrointestinal hemorrhage in the emergency department: A systematic review and meta-analysis.

OBJECTIVE: The assessment of the severity of upper gastrointestinal hemorrhage in emergency department (ED) patients is difficult to assess with commonly available diagnostic tools. Small studies have shown that video capsule endoscopy (VCE) is a promising risk-stratification method and may be better than current clinical decision rules such as the Rockall score and the Glasgow Blatchford score. This review aims to assess the accuracy of VCE to detect active upper gastrointestinal hemorrhage compared to a reference standard. METHODS: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology was used to perform a review of studies that have measured the diagnostic accuracy of VCE. Studies were included if they measured ED use of VCE for upper GI hemorrhage as compared to a reference standard of an esophagogastroduodenoscopy (EGD). A meta-analysis was performed on select patients using a fixed effects and random-effects model to determine the primary outcome of diagnostic test accuracy. RESULTS: 40 studies were screened for eligibility and five studies representing 193 patients met the inclusion and exclusion criteria. All patients received both a VCE and an EGD. The sensitivity and specificity of VCE were 0.724 and 0.748, respectively. The diagnostic odds ratio was 6.29 (95% CI: 3.23-12.25) and the summary receiver operating characteristic curve was 0.782. CONCLUSIONS: VCE demonstrated high accuracy for detecting upper GI hemorrhage in this meta-analysis of existing studies. In light of the potential advantages of VCE in the ED, further research is warranted to further establish its role.

Nomenclature and semantic descriptions of ulcerative and inflammatory lesions seen in Crohn's disease in small bowel capsule endoscopy: An international Delphi consensus statement.

BACKGROUND: In the medical literature, the nomenclature and descriptions (ND) of small bowel (SB) ulcerative and inflammatory (U-I) lesions in capsule endoscopy (CE) are scarce and inconsistent. Inter-observer variability in interpreting these findings remains a major limitation in the assessment of the severity of mucosal lesions, which can impact negatively on clinical care, training and research on SB-CE. OBJECTIVE: Focusing on SB-CE in Crohn's disease (CD), our aim is to establish a consensus on the ND of U-I lesions. METHODS: An international panel of experienced SB-CE readers was formed during the 2016 United European Gastroenterology Week meeting. A core group of five CE and inflammatory bowel disease (IBD) experts established an Internet-based, three-round Delphi consensus but did not participate in the voting process. The core group built illustrated questionnaires, including SB-CE still frames of U-I lesions from patients with documented CD. Twenty-seven other experts were asked to rate and comment on the different proposals for the ND of the most frequent SB U-I lesions. For each round, we used a 6-point rating scale (varying from 'strongly disagree' to 'strongly agree'). The consensus was reached when at least 80 % of the voting members scored the statement within the 'agree' or 'strongly agree' categories. RESULTS: A 100% participation rate was obtained for all the rounds. Consensual ND were reached for the following seven U-I lesions: aphthoid erosion, deep ulceration, superficial ulceration, stenosis, edema, hyperemia and denudation. CONCLUSION: Considering the most frequent SB U-I lesions seen in CE in CD, a consensual ND was reached by the international group of experts. These descriptions and names are useful not only for daily practice and medical education, but also for medical research.

Normative values for region-specific colonic and gastrointestinal transit times in 111 healthy volunteers using the 3D-Transit electromagnet tracking system: Influence of age, gender, and body mass index.

BACKGROUND: The 3D-Transit electromagnet tracking system (Motilis Medica, SA, Lausanne, Switzerland) is an emerging tool for the ambulatory assessment of gastrointestinal (GI) transit and motility. Using this tool, we aimed to derive normative values for region-specific colonic and GI transit times and to assess the influence of age, gender, and body mass index (BMI). METHODS: Regional and total colonic transit times (CTT), gastric emptying (GET), small intestinal (SITT), and whole gut (WGTT) transit times were extracted from 111 healthy volunteers from the United Kingdom and Denmark (58 female; median age: 40 years [range: 21-88]). The effects of age, gender, and BMI were assessed using standard statistical methods. KEY RESULTS: The ascending, transverse, descending, and rectosigmoid colon transit times accounted for 32%, 34%, 17%, and 17% of total CTT in females, and 33%, 25%, 14%, and 28% of total CTT in males. CTT and WGTT were seen to cluster at intervals separated by approximately 24 hours, providing further evidence of the non-continuous nature of these measurements. Increasing age was associated with longer CTT (P = .021), WGTT (P < .001) ascending (P = .004), transverse (P < .001), and total right (P < .001) colon transit times, but shorter rectosigmoid (P = .004) transit time. Female gender was significantly associated with longer transverse (P = .049) and descending (P < .001) colon transit times, but shorter rectosigmoid (P < .001) transit time. Increasing BMI was significantly associated with shorter WGTT (P = .012). CONCLUSIONS AND INFERENCES: For the first time, normative reference values for region-specific colonic transit have been presented. Age, gender, and BMI were seen to have an effect on transit times.

Comparison of Lewis Score and Capsule Endoscopy Crohn's Disease Activity Index in Patients with Crohn's Disease.

BACKGROUND/AIMS: Small bowel capsule endoscopy (SBCE) is used to visualize mucosal inflammatory changes in the small intestine of patients with Crohn's disease (CD). The Lewis score (LS) and Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) are used to evaluate the visualized images. We determined the score disagreement between LS and CECDAI in patients with CD. METHODS: We evaluated 184 SBCE procedures in 102 CD patients with small bowel lesions. Patients were classified according to the Montreal classification. LS and CECDAI were calculated, and cases with disagreement between the two scores were identified. We investigated the characteristics of disagreement, and analyzed the relationships with the Crohn's Disease Activity Index (CDAI) and C-reactive protein. RESULTS: LS (504 ± 1160) correlated strongly with CECDAI (6 ± 5.4) (Spearman's rank correlation coefficient ρ = 0.81, p < 0.0001). LS values of 135 and 790 were equivalent to CECDAI values of 4.9 and 6.9, respectively. The inflammatory changes by LS were significantly observed in several tertiles in the CECDAI discrepancy group (LS < 135, CECDAI ≥ 4.9) compared with the normal agreement group (LS < 135, CECDAI < 4.9) (p < 0.0001). In both groups, CDAI was also significantly different between Montreal L1 and L3 groups (p = 0.0232, p = 0.0196, respectively). LS inflammation score was 0 in six cases in the LS discrepancy group (LS ≥ 135, CECDAI ≤ 4.9, n = 10); the high LS scores were in patients with high stricture scores. CONCLUSIONS: Discrepancies between the LS and CECDAI scores were observed in some patients. Cases with high CECDAI alone exhibited extensive inflammation and high disease activity (clinical symptoms and biomarker levels). CECDAI seems to better reflect active intestinal inflammation than LS.

A systematic evaluation and optimization of automatic detection of ulcers in wireless capsule endoscopy on a large dataset using deep convolutional neural networks.

Compared with conventional gastroscopy which is invasive and painful, wireless capsule endoscopy (WCE) can provide noninvasive examination of gastrointestinal (GI) tract. The WCE video can effectively support physicians to reach a diagnostic decision while a huge number of images need to be analyzed (more than 50 000 frames per patient). In this paper, we propose a computer-aided diagnosis method called second glance (secG) detection framework for automatic detection of ulcers based on deep convolutional neural networks that provides both classification confidence and bounding box of lesion area. We evaluated its performance on a large dataset that consists of 1504 patient cases (the largest WCE ulcer dataset to our best knowledge, 1076 cases with ulcers, 428 normal cases). We use 15 781 ulcer frames from 753 ulcer cases and 17 138 normal frames from 300 normal cases for training. Validation dataset consists of 2040 ulcer frames from 108 cases and 2319 frames from 43 normal cases. For test, we use 4917 ulcer frames from 215 ulcer cases and 5007 frames from 85 normal cases. Test results demonstrate the 0.9469 ROC-AUC of the proposed secG detection framework outperforms state-of-the-art detection frameworks including Faster-RCNN (0.9014) and SSD-300 (0.8355), which implies the effectiveness of our method. From the ulcer size analysis, we find the detection of ulcers is highly related to the size. For ulcers with size larger than 1% of the full image size, the sensitivity exceeds 92.00%. For ulcers that are smaller than 1% of the full image size, the sensitivity is around 85.00%. The overall sensitivity, specificity and accuracy are 89.71%, 90.48% and 90.10%, at a threshold value of 0.6706, which implies the potential of the proposed method to suppress oversights and to reduce the burden of physicians.

Current Controversies Concerning Capsule Endoscopy.

Video capsule endoscopy became a reality in 2001. This device enabled us to directly view the mucosa of the small intestine for the first time. The main indications for the video capsule remain the detection of small intestinal bleeding and iron deficiency anemia, diagnosis and management of Crohn's disease, and detection of tumors. The device is extraordinarily safe and can be used in the very young to the very old. However, there remain several areas of controversy and difficulty. These are covered in this article and include details of indications and contraindications, whether to prepare patients, whether or not to use simethicone and prokinetics. Detection of location of the capsule remains a major engineering challenge. Reading the videos reliably and quickly remains challenging. However, artificial intelligence and machine learning are already on the horizon to provide assistance. New uses for capsule endoscopy promise more accurate diagnosis and hence improved management of acute gastrointestinal bleeding. The colon capsule may eventually help those who refuse conventional colonoscopy, and robotically controlled capsules may be helpful in screening for serious disease in patients with upper abdominal complaints. The advent of the broadening use of video capsule endoscopy is, though it will be controversial, embraced by some and derided by others; such is the nature of technological development. In the long run, if the use of the video capsule, based on sound evidence-based studies, can be shown to improve the care of our patients and reduce the cost of health care, its use will continue to expand.

Performance measures for small-bowel endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy (ESGE) together with the United European Gastroenterology (UEG) recently developed a short list of performance measures for small-bowel endoscopy (i.e. small-bowel capsule endoscopy and device-assisted enteroscopy) with the final goal of providing endoscopy services across Europe with a tool for quality improvement. Six key performance measures both for small-bowel capsule endoscopy and for device-assisted enteroscopy were selected for inclusion, with the intention being that practice at both a service and endoscopist level should be evaluated against them. Other performance measures were considered to be less relevant, based on an assessment of their overall importance, scientific acceptability, and feasibility. Unlike lower and upper gastrointestinal endoscopy, for which performance measures had already been identified, this is the first time small-bowel endoscopy quality measures have been proposed.

Automated diagnosis of celiac disease by video capsule endoscopy using DAISY Descriptors.

Celiac disease is a genetically determined disorder of the small intestine, occurring due to an immune response to ingested gluten-containing food. The resulting damage to the small intestinal mucosa hampers nutrient absorption, and is characterized by diarrhea, abdominal pain, and a variety of extra-intestinal manifestations. Invasive and costly methods such as endoscopic biopsy are currently used to diagnose celiac disease. Detection of the disease by histopathologic analysis of biopsies can be challenging due to suboptimal sampling. Video capsule images were obtained from celiac patients and controls for comparison and classification. This study exploits the use of DAISY descriptors to project two-dimensional images onto one-dimensional vectors. Shannon entropy is then used to extract features, after which a particle swarm optimization algorithm coupled with normalization is employed to select the 30 best features for classification. Statistical measures of this paradigm were tabulated. The accuracy, positive predictive value, sensitivity and specificity obtained in distinguishing celiac versus control video capsule images were 89.82%, 89.17%, 94.35% and 83.20% respectively, using the 10-fold cross-validation technique. When employing manual methods rather than the automated means described in this study, technical limitations and inconclusive results may hamper diagnosis. Our findings suggest that the computer-aided detection system presented herein can render diagnostic information, and thus may provide clinicians with an important tool to validate a diagnosis of celiac disease.

Adherence to European Society of Gastrointestinal Endoscopy recommendations of endoscopists performing small bowel capsule endoscopy in Italy.

BACKGROUND: The European Society of Gastrointestinal Endoscopy (ESGE) has recently issued a technical review focused on small bowel capsule endoscopy (SBCE). AIM: To compare SBCE current practice in Italy to ESGE technical recommendations. MATERIAL AND METHODS: A dedicated per-centre semi-quantitative questionnaire was prepared by a group of SBCE experts. One-hundred-fifty Centres were invited to participate in the data collection concerning SBCEs performed between June 2016 and June 2017. Data were compared with ESGE recommendations. RESULTS: 120 Centres participated in the data collection. Current practices agreed with ESGE recommendations in 56.3% (9/16) of the issues evaluated. Differences between ESGE recommendations and current practice concerned the management of patients with pacemakers or cardiac implantable defibrillators (which was in agreement with ESGE recommendations in 31.7% and 15.8% of Centres, respectively), the SBCE setting (only 51% of SBCEs were performed as outpatients procedures), the assessment of capsule excretion (timing and modality were in agreement with ESGE recommendation in 20.0% of Centres), and in the involvement of trained nurses or fellows in training as pre-readers (7/120; 5.8%). CONCLUSIONS: Although SBCE is widely used and largely available in Italy, there are still some technical, practical and organizational issues that can be modified to bridge the gap between current practice and ESGE guideline recommendations.

Predictive factors of an incomplete examination and inadequate small-bowel cleanliness during capsule endoscopy.

AIM: the aim of this study was to determine predictive factors for an incomplete capsule endoscopy and an inadequate small-bowel preparation in capsule endoscopy. METHODS: predictive factors for an incomplete capsule endoscopy were evaluated. Therefore, all patients with incomplete examinations performed between June 2009 and February 2016 were retrospectively included and compared with all patients with complete procedures performed between January 2014 and February 2016. Predictive factors of an inadequate small-bowel cleanliness were assessed. Therefore, the subset of patients that underwent capsule endoscopy between January 2014 and February 2016, including incomplete examinations, were evaluated. Small-bowel cleanliness was evaluated according to a quantitative index and a qualitative evaluation scale. Data with regard to patient and capsule endoscopy was analyzed. RESULTS: 31 incomplete and 122 complete capsule endoscopies were included in the analysis of predictive factors for an incomplete capsule endoscopy. The degree of dependency (OR = 4.67; p = 0.028), performance of a capsule endoscopy in hospitalized patients (OR = 4.04; p = 0.006) and prior abdominal surgery (OR = 3.45; p = 0.012) were independent predictive factors of an incomplete procedure. 130 patients were included in the analysis of predictive factors for an inadequate small-bowel cleanliness. The mean quantitative index value was 7.3 (s.d. ± 2.3); 41.6% and 58.5% of capsule endoscopies were classified as poor-fair and good/excellent respectively, according to the qualitative evaluation. Independent predictive factors for an inadequate preparation according to the quantitative index included male gender (Beta = -0.79; p = 0.028), small-bowel transit time (Beta = -0.007; p < 0.0001) and cardiac disease (Beta = -1.29; p = 0.001). Associated factors according to the qualitative evaluation included male gender (OR = 0.406; p = 0.027) and small-bowel transit time (SBTT) (OR = 0.993; p < 0.0001). CONCLUSION: inpatient status, higher degrees of dependency and abdominal surgery are predictive factors for an incomplete capsule endoscopy; male gender and higher small-bowel transit time are predictive factors for an inadequate cleanliness.

High concordance between trained nurses and gastroenterologists in evaluating recordings of small bowel video capsule endoscopy (VCE).

BACKGROUND AND AIMS: . The video capsule endoscopy (VCE) is an accurate and validated tool to investigate the entire small bowel mucosa, but VCE recordings interpretation by the gastroenterologist is time-consuming. A pre-reading of VCE recordings by an expert nurse could be accurate and cost saving. We assessed the concordance between nurses and gastroenterologists in detecting lesions on VCE examinations. METHODS: This was a prospective study enrolling consecutive patients who had undergone VCE in clinical practice. Two trained nurses and two expert gastroenterologists participated in the study. At VCE pre-reading the nurses selected any abnormalities, saved them as "thumbnails" and classified the detected lesions as a vascular abnormality, ulcerative lesion, polyp, tumor mass, and unclassified lesion. Then, the gastroenterologist evaluated and interpreted the selected lesions and, successively, reviewed the entire video for potential missed lesions. The time for VCE evaluation was recorded. RESULTS: A total of 95 VCE procedures performed on consecutive patients (M/F: 47/48; mean age: 63 +/- 12 years, range: 27-86 years) were evaluated. Overall, the nurses detected at least one lesion in 54 (56.8%) patients. There was total agreement between nurses and gastroenterologists, no missing lesions being discovered at a second look of the entire VCE recording by the physician. The pre-reading procedure by nurse allowed a time reduction of medical evaluation from 49 (33-69) to 10 (8-16) minutes (difference: -79.6%). CONCLUSIONS: Our data suggest that trained nurses can accurately identify and select relevant lesions in thumbnails that subsequently were faster reviewed by the gastroenterologist for a final diagnosis. This could significantly reduce the cost of VCE procedure.

Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

SMALL-BOWEL CAPSULE ENDOSCOPY (SBCE): 1: ESGE recommends that prior to SBCE patients ingest a purgative (2 L of polyethylene glycol [PEG]) for better visualization.Strong recommendation, high quality evidence.However, the optimal timing for taking purgatives is yet to be established. 2: ESGE recommends that SBCE should be performed as an outpatient procedure if possible, since completion rates are higher in outpatients than in inpatients.Strong recommendation, moderate quality evidence. 3: ESGE recommends that patients with pacemakers can safely undergo SBCE without special precautions.Strong recommendation, low quality evidence. 4: ESGE suggests that SBCE can also be safely performed in patients with implantable cardioverter defibrillators and left ventricular assist devices.Weak recommendation, low quality evidence. 5: ESGE recommends the acceptance of qualified nurses and trained technicians as prereaders of capsule endoscopy studies as their competency in identifying pathology is similar to that of medically qualified readers. The responsibility of establishing a diagnosis must however remain with the attending physician.Strong recommendation, moderate quality evidence. 6: ESGE recommends observation in cases of asymptomatic capsule retention.Strong recommendation, moderate quality evidence.In cases where capsule retrieval is indicated, ESGE recommends the use of device-assisted enteroscopy as the method of choice.Strong recommendation, moderate quality evidence. DEVICE-ASSISTED ENTEROSCOPY (DAE): 1: ESGE recommends performing diagnostic DAE as a day-case procedure in patients without significant underlying co-morbidities; in patients with co-morbidities and/or those undergoing a therapeutic procedure, an inpatient stay is recommended.Strong recommendation, low quality evidenceThe choice between different settings also depends on sedation protocols.Strong recommendation, low quality evidence. 2: ESGE suggests that conscious sedation, deep sedation, and general anesthesia are all acceptable alternatives: the choice between them should be governed by procedure complexity, clinical factors, and local organizational protocols.Weak recommendation, low quality evidence. 3: ESGE recommends that the findings of previous diagnostic investigations should guide the choice of insertion route.Strong recommendation, moderate quality evidence.If the location of the small-bowel lesion is unknown or uncertain, ESGE recommends that the antegrade route should be generally preferred.Strong recommendation, low quality evidence.In the setting of massive overt bleeding, ESGE recommends an initial antegrade approach.Strong recommendation, low quality evidence. 4: ESGE recommends that, for balloon-assisted enteroscopy (i. e., single-balloon enteroscopy [SBE] and double-balloon enteroscopy [DBE]), small-bowel insertion depth should be estimated by counting net advancement of the enteroscope during the insertion phase, with confirmation of this estimate during withdrawal.Strong recommendation, low quality evidence.ESGE recommends that, for spiral enteroscopy, insertion depth should be estimated during withdrawal.Strong recommendation, moderate quality evidence. Since the calculated insertion depth is only a rough estimate, ESGE recommends placing a tattoo to mark the identified lesion and/or the deepest point of insertion.Strong recommendation, low quality evidence. 5: ESGE recommends that all endoscopic therapeutic procedures can be undertaken at the time of DAE.Strong recommendation, moderate quality evidence.Moreover, when therapeutic interventions are performed, additional specific safety measures are needed to prevent complications.Strong recommendation, high quality evidence.

Validation of the computed assessment of cleansing score with the Mirocam® system

Background and aims: A computed assessment of cleansing (CAC) score was developed to objectively evaluate small-bowel cleansing in the PillCam capsule endoscopy (CE) system and to overcome the subjectivity and complexity of previous scoring systems. Our study aimed to adapt the CAC score to the Mirocam® ystem, evaluate its reliability with the Mirocam® CE system and compare it with three validated subjective grading scales. Patients and methods: Thirty CE were prospectively and independently reviewed by two authors who classified the degree of small-bowel cleanliness according to a quantitative index, a qualitative evaluation and an overall adequacy assessment. The authors were blinded for the CAC score of each CE, which was calculated as ([mean intensity of the red channel]/[mean intensity of the green channel] - 1) x 10. The mean intensities of the red and green channels of the small-bowel segment of the «Map View» bar in the Miroview Client® were determined using the histogram option of two photo-editing software. Results: There was a strong agreement between both CE readers for each of the three subjective scales used. The reproducibility of the CAC score was excellent and identical results were obtained with the two photo-editing software. Regarding the comparison between the CAC score and the subjective scales, there was a moderate-to-good agreement with the quantitative index, qualitative evaluation and overall adequacy assessment. Conclusions: CAC score represents an objective and feasible score in the assessment of small-bowel cleansing in the Mirocam® CE system, and could be used per se or as part of a more comprehensive score (AU)

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Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.

BACKGROUND: Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data. METHODS AND FINDINGS: Studies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies) from PubMed (MEDLINE), Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio) decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07-8.76] vs. postmarketing: 1.48 [0.81-2.69]). The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2) increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%). The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease. CONCLUSIONS: Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be useful to continuously monitor the effectiveness of medical device in clinical practices.

A Simple Evaluation Tool (ET-CET) Indicates Increase of Diagnostic Skills From Small Bowel Capsule Endoscopy Training Courses: A Prospective Observational European Multicenter Study.

Small bowel capsule endoscopy (SBCE) has become a first line diagnostic tool. Several training courses with a similar format have been established in Europe; however, data on learning curve and training in SBCE remain sparse.Between 2008 and 2011, different basic SBCE training courses were organized internationally in UK (n = 2), Italy (n = 2), Germany (n = 2), Finland (n = 1), and nationally in Germany (n = 10), applying similar 8-hour curricula with 50% lectures and 50% hands-on training. The Given PillCam System was used in 12 courses, the Olympus EndoCapsule system in 5, respectively. A simple evaluation tool for capsule endoscopy training (ET-CET) was developed using 10 short SBCE videos including relevant lesions and normal or irrelevant findings. For each video, delegates were required to record a diagnosis (achievable total score from 0 to 10) and the clinical relevance (achievable total score 0 to 10). ET-CET was performed at baseline before the course and repeated, with videos in altered order, after the course.Two hundred ninety-four delegates (79.3% physicians, 16.3% nurses, 4.4% others) were included for baseline analysis, 268 completed the final evaluation. Forty percent had no previous experience in SBCE, 33% had performed 10 or less procedures. Median scores for correct diagnosis improved from 4.0 (IQR 3) to 7.0 (IQR 3) during the courses (P < 0.001, Wilcoxon), and for correct classification of relevance of the lesions from 5.0 (IQR 3) to 7.0 (IQR 3) (P < 0.001), respectively. Improvement was not dependent on experience, profession, SBCE system, or course setting. Previous experience in SBCE was associated with higher baseline scores for correct diagnosis (P < 0.001; Kruskal-Wallis). Additionally, independent nonparametric partial correlation with experience in gastroscopy (rho 0.33) and colonoscopy (rho 0.27) was observed (P < 0.001).A simple ET-CET demonstrated significant improvement of diagnostic skills on completion of formal basic SBCE courses with hands-on training, regardless of preexisting experience, profession, and course setting. Baseline scores for correct diagnoses show a plateau after interpretation of 25 SBCE before courses, supporting this number as a compromise for credentialing. Experience in flexible endoscopy may be useful before attending an SBCE course.