Quality indicators for GI endoscopic procedures

Quality indicators common to all GI endoscopic procedures

Endoscopic procedures are frequently performed in Canada but can be associated with potential complications and medicolegal implications. This study aimed to identify potential medicolegal cases in Canada relating to upper and lower endoscopies as well as advanced endoscopic procedures.

Westlaw Canada was searched for any cases regarding upper and lower endoscopies and advanced endoscopic procedures from inception to December 31, 2020. Cases were classified by type of case, procedure performed, patient and defendant demographics, outcome, and alleged reason for litigation/complaint.

Twenty-nine civil cases and 9 board and tribunal decisions for upper and lower endoscopies and 3 advanced endoscopic procedure cases were analyzed. The most frequent defendant specialties were family physician, general surgery, and gastroenterology. The plaintiff was successful in 12 cases involving upper or lower endoscopy with an average award of $243,934 (2021 CDN). The most alleged reasons for litigation were procedural error or negligence (n = 19). The plaintiff was successful in 1 advanced endoscopic procedure case with an award of $153,032.

Medicolegal cases regarding gastrointestinal endoscopy in Canada occur infrequently. Endoscopy should be performed by skilled providers with appropriate informed consent from the patient, and careful consideration of whether procedures are indicated are key for endoscopic providers.

Colonoscopy remains one of the most common procedures performed by gastroenterologists and is critical for early detection and management of precursors to colorectal cancer (CRC). Although CRC remains one of the deadliest malignancies, earlier detection of precancerous polyps is directly associated with increased patient survival. As such, quality metrics for colonoscopy, such as polyp detection and mucosal visualization, are key parameters that are directly tied to patient outcomes. Over the past 2 decades, artificial intelligence and machine learning (AI/ML) tools have been tested and developed to augment colonoscopy performance and in 2021 resulted in the first-ever FDA-approved computer-aided detection (CADe) tool. This narrative review begins by reviewing the evidence behind the use of CADe that led to FDA approval. Next, the review discusses the current evidence and technological approaches for computer-aided diagnosis for optical in situ histopathological differentiation of colorectal polyps, including narrow-band imaging, blue light imaging, and endocytoscopy. Studies are ongoing to develop systems to predict the depth of submucosal invasion and to assess endoscopic disease activity among patients with inflammatory bowel disease. The applications of AI/ML to quality improvement are explored, including real-time assessment of bowel preparation, detection of cecal intubation, and automated polyp reporting and surveillance recommendations using natural language processing. Despite initial cost concerns, models have suggested that CADe systems could result in long-term cost savings and are generally accepted by patients and gastroenterologists. There is some reservation in adopting computer-aided diagnosis systems among gastroenterologists due to medico-legal concerns. Future directions for AI/ML in colonoscopy include health system improvements, such as automating note writing, optimizing procedural scheduling, and predicting sedation needs.

Capsule endoscopy (CE) and deep enteroscopy (DE) can be useful for diagnosing and treating suspected small-bowel disease. Guidelines and detailed recommendations exist for the use of CE/DE, but comprehensive quality indicators are lacking. The goal of this task force was to develop quality indicators for appropriate use of CE/DE by using a modified RAND/UCLA Appropriateness Method.

An expert panel of 7 gastroenterologists with diverse practice experience was assembled to identify quality indicators. A literature review was conducted to develop a list of proposed quality indicators applicable to preprocedure, intraprocedure, and postprocedure periods. The panelists reviewed the literature; identified and modified proposed quality indicators; rated them on the basis of scientific evidence, validity, and necessity; and determined proposed performance targets. Agreement and consensus with the proposed indicators were verified using the RAND/UCLA Appropriateness Method.

The voting procedure to prioritize metrics emphasized selecting measures to improve quality and overall patient care. Panelists rated indicators on the perceived appropriateness and necessity for clinical practice. After voting and discussion, 2 quality indicators ranked as inappropriate or uncertain were excluded. Each quality indicator was categorized by measure type, performance target, and summary of evidence. The task force identified 13 quality indicators for CE and DE.

Comprehensive quality indicators have not existed for CE or DE. The task force identified quality indicators that can be incorporated into clinical practice. The panel also addressed existing knowledge gaps and posed research questions to better inform future research and quality guidelines for these procedures.

Current endoscopy quality guidelines largely focus on cancer screening–related metrics that are not applicable to pediatric populations. Through an international Pediatric Endoscopy Quality Improvement Network (PEnQuIN), quality standards and indicators for pediatric endoscopic procedures were developed and endorsed by the American Society for Gastrointestinal Endoscopy (ASGE).

The Appraisal of Guidelines for REsearch and Evaluation II instrument guided PEnQuIN members, from 31 centers representing 11 countries, in generating and refining proposed quality standards and indicators. Quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development, and Evaluation approach. Consensus on reporting elements was sought with an iterative online Delphi process.

Forty-nine quality standards and 47 indicators, encompassing pediatric endoscopy facilities, procedures, and endoscopists, as well as 30 reporting elements essential for inclusion within a pediatric endoscopy report reached consensus. Minimal acceptable standards were defined for 3 key indicators related to pediatric lower endoscopy: terminal ileal intubation rate ≥85%, cecal intubation rate ≥90%, and rate of adequate bowel preparation ≥80%. There was strong consensus that terminal ileal intubation, rather than cecal intubation, is integral to ensuring high-quality endoscopic care in children.

The PEnQuIN guidelines establish international agreement on clinically meaningful metrics tailored to pediatric endoscopy that can be used to promote safe, high-quality, patient- and family-centered endoscopic care. Moving forward, it is recommended that all providers and facilities involved in endoscopy service for children adopt the PEnQuIN standards, indicators, and key reporting elements outlined in these ASGE-endorsed guidelines.