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Introduction: GRADE and other Evidence to Decision (EtD) frameworks are widely used by guideline development groups (GDG) and other decision-makers. When GDGs judge the magnitude of desirable and undesirable health outcomes on EtDs, they typically categorize them as trivial, small, moderate or large. However, generic judgment or decision thresholds (DTs) that could guide the user about such estimates of effect size or serve as references for interpretation of findings are not yet available. The objective of this study was to empirically derive DTs for EtD judgments about the magnitude of dichotomously assessed health benefits and harms., Methods: We conducted a methodological randomised controlled trial to derive empirical DTs across conditions and health outcomes. We invited stakeholders including clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of GDGs, patient representatives, and the public to participate in the trial. We employed randomly assigned case scenarios to elicit ranges of absolute risk differences (ARD) judged as small and moderate effects from study participants. We then used the collected data to derive empirical decision thresholds. We also investigated the validity of our DTs by measuring the agreement between judgments that were made by GDGs in the past and the judgments that our DTs approach would suggest if applied to the same guideline data., Results: A total of 445 stakeholders accessed the survey of which 409 were randomised and 288 rated at least one case scenario. Based on these participants, the study findings support our a priori hypothesis of a difference in the DTs for trivial, small, moderate, and large effects and are suggestive of a relation between raters' judgments and the joint measure of absolute effects and outcome values. The results permit the use and calculation of DTs for a variety of scenarios and we present three ways of how to use the results practically., Conclusions: In this trial we confirmed that empirically derived DTs discriminate between judgments on the EtDs. These DTs can be used for judgments about desirable and undesirable health effects in systematic reviews or to initiate and inform a discussion with a GDG. This ensures consistency in judgments across different guideline questions and promotes transparency in judgments., (Copyright © 2024. Published by Elsevier Inc.)

An evidence-based approach is considered the gold standard for health decision-making. Sometimes, a guideline panel might judge the certainty that the desirable effects of an intervention clearly outweigh its undesirable effects as high, but the body of supportive evidence is indirect. In such cases, the application of the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach for grading the strength of recommendations is inappropriate. Instead, the GRADE Working Group has recommended developing ungraded best or good practice statement (GPS) and developed guidance under which circumsances they would be appropriate.Through an evaluation of COVID-1- related recommendations on the eCOVID Recommendation Map (COVID-19.recmap.org), we found that recommendations qualifying a GPS were widespread. However, guideline developers failed to label them as GPS or transparently report justifications for their development. We identified ways to improve and facilitate the operationalisation and implementation of the GRADE guidance for GPS.Herein, we propose a structured process for the development of GPSs that includes applying a sequential order for the GRADE guidance for developing GPS. This operationalisation considers relevant evidence-to-decision criteria when assessing the net consequences of implementing the statement, and reporting information supporting judgments for each criterion. We also propose a standardised table to facilitate the identification of GPS and reporting of their development. This operationalised guidance, if endorsed by guideline developers, may palliate some of the shortcomings identified. Our proposal may also inform future updates of the GRADE guidance for GPS., Competing Interests: Competing interests: This work was supported by grants from Canadian Institutes of Health (FRN VR4-172741 and GA3-177732) and WHO during the conduct of the study. EA, HJS and PA-C report contribution to the development of the original five criteria for assessing the appropriateness of issuing good practice statements. The remaining authors have nothing else to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The importance of quality indicators has become increasingly recognized in gastrointestinal endoscopy. Patient safety requires the identification and monitoring of occurrences associated with harm or the potential for harm. The identification of relevant indicators of safety compromise is, therefore, a critical element that is key to the effective implementation of endoscopy quality improvement programs., Objective: To identify key indicators of safety compromise in gastrointestinal endoscopy., Methods: The Canadian Association of Gastroenterology Safety and Quality Indicators in Endoscopy Consensus Group was formed to address issues of quality in endoscopy. A subcommittee was formed to identify key safety indicators. A systematic literature review was undertaken, and articles pertinent to safety in endoscopy were identified and reviewed. All complications and measures used to document safety were recorded. From this, a preliminary list of 16 indicators was compiled and presented to the 35-person consensus group during a three-day meeting. A revised list of 20 items was subsequently put to the consensus group for vote for inclusion on the final list of safety indicators. Items were retained only if the consensus group highly agreed on their importance., Results: A total of 19 indicators of safety compromise were retained and grouped into the three following categories: medication-related - the need for CPR, use of reversal agents, hypoxia, hypotension, hypertension, sedation doses in patients older than 70 years of age, allergic reactions and laryngospasm⁄bronchospasm; procedure-related early - perforation, immediate postpolypectomy bleeding, need for hospital admission or transfer to emergency department from the gastroenterology unit, instrument impaction, severe persistent abdominal pain requiring evaluation proven to not be perforation; and procedure-related delayed - death within 30 days of procedure, 14-day unplanned hospitalization, 14-day unplanned contact with a health provider, gastrointestinal bleeding within 14 days of procedure, infection or symptomatic metabolic complications., Conclusions: The 19 indicators of safety compromise in endoscopy, identified by a rigorous, evidence-based consensus process, provide clear outcomes to be recorded by all facilities as part of their continuing quality improvement programs.

Background: Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality, highlight the need for clearly defined, evidence-based processes to support quality improvement in endoscopy., Objective: To identify processes and indicators of quality and safety relevant to high-quality endoscopy service delivery., Methods: A multidisciplinary group of 35 voting participants developed recommendation statements and performance indicators. Systematic literature searches generated 50 initial statements that were revised iteratively following a modified Delphi approach using a web-based evaluation and voting tool. Statement development and evidence evaluation followed the AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidelines. At the consensus conference, participants voted anonymously on all statements using a 6-point scale. Subsequent web-based voting evaluated recommendations for specific, individual quality indicators, safety indicators and mandatory endoscopy reporting fields. Consensus was defined a priori as agreement by 80% of participants., Results: Consensus was reached on 23 recommendation statements addressing the following: ethics (statement 1: agreement 100%), facility standards and policies (statements 2 to 9: 90% to 100%), quality assurance (statements 10 to 13: 94% to 100%), training, education, competency and privileges (statements 14 to 19: 97% to 100%), endoscopy reporting standards (statements 20 and 21: 97% to 100%) and patient perceptions (statements 22 and 23: 100%). Additionally, 18 quality indicators (agreement 83% to 100%), 20 safety indicators (agreement 77% to 100%) and 23 recommended endoscopy-reporting elements (agreement 91% to 100%) were identified., Discussion: The consensus process identified a clear need for high-quality clinical and outcomes research to support quality improvement in the delivery of endoscopy services., Conclusions: The guidelines support quality improvement in endoscopy by providing explicit recommendations on systematic monitoring, assessment and modification of endoscopy service delivery to yield benefits for all patients affected by the practice of gastrointestinal endoscopy.

Background: Management of peptic ulcer disease has improved over the past few decades. However, the widespread use of nonsteroidal anti-inflammatory drugs and low-dose acetylsalicylic acid means that the burden of peptic ulcer disease remains a relevant issue., Methods: We systematically searched PubMed and EMBASE for articles published 1966-2007 that reported symptoms, impairment of well-being or health-related quality of life, and costs associated with peptic ulcer disease., Results: Thirty studies reported the prevalence of patient-reported gastrointestinal symptoms in individuals with endoscopically diagnosed symptomatic peptic ulcer disease. Average prevalence estimates, weighted by sample size, were 81% (95% confidence interval [CI], 77%-85%) for abdominal pain (11 studies), 81% (95% CI, 76%-85%) for pain specifically of epigastric origin (14 studies), and 46% (95% CI, 42%-50%) for heartburn or acid regurgitation (11 studies). On average, 29% (95% CI, 25%-34%) of patients with peptic ulcer disease presented with bleeding, often as the initial symptom (11 studies). Patients with peptic ulcer disease had significantly lower health-related quality of life than the general population, as measured by the Psychological General Well-Being index (P <.05; 7 studies) and the Short-Form-36 questionnaire (P <.05; 2 studies). Direct medical costs of peptic ulcer disease based on national estimates from several countries were USD163-866 per patient. The most costly aspects of peptic ulcer disease management were hospitalization and medication. Complicated peptic ulcer disease is particularly costly, estimated to be USD1883-25,444 per patient., Conclusion: Peptic ulcer disease significantly impairs well-being and aspects of health-related quality of life, and is associated with high costs for employers and health care systems.