Consensus Recommendations for Managing Patients with Nonvariceal Upper Gastrointestinal Bleeding

Upper gastrointestinal (GI) bleeding represents a substantial clinical and economic burden. It has a prevalence of approximately 170 cases per 100 000 adults per year (1), at an estimated total cost of $750 million in U.S. dollars (2). Peptic ulcer disease accounts for 50% to 70% of cases of acute nonvariceal upper GI bleeding (3, 4). Despite recent advances in therapy, mortality rates have remained essentially unchanged at 6% to 8% (1, 2, 5). This could be explained by the fact that patients are older and have more concurrent illnesses; it may also be due to underuse of endoscopic hemostatic techniques. The Canadian Registry in Upper Gastrointestinal Bleeding and Endoscopy (RUGBE) initiative and international data have demonstrated wide variations in the utilization and timing of different diagnostic and therapeutic technologies, as well as disparate management approaches (4-10). In this context, it is surprising that, except for the recent British Society of Gastroenterology guidelines (9), the last widely disseminated consensus conference and publication of practice guidelines occurred more than 10 years ago (11, 12). Since publication of the British Society of Gastroenterology guidelines, new data have become available and are strengthened by a series of evidence-based systematic reviews and meta-analyses performed for this consensus (13, 14). The current guidelines are a consensus paper with multisociety representation. Methods The recommendation statements were developed according to generally accepted standards (15, 16). A 7-step approach addressing most of 37 pertinent criteria of validity was followed (16-20). The process of guideline development is described in the Figure. Figure. The adopted process of guideline development . Determination of Need for Guidelines The need for clinical practice guidelines on the management of patients with nonvariceal upper GI bleeding was identified by an initial review of the existing literature, current recommendations, and the timing of previously published guidelines. Recommendations are directed primarily to the management of nonvariceal bleeding largely due to peptic ulcers. Membership of the Consensus Group An organizing committee selected a multidisciplinary group of 25 voting participants for their expertise in the management of patients with acute nonvariceal upper GI bleeding, evidence-based medicine, and continuing medical education. The group included Canadian and international gastroenterologists, endoscopists, surgeons, family physicians, emergency medicine physicians, pharmacologists, epidemiologists (with methodologic and health economic expertise), and a hospital pharmacist. The attendees represented 11 national societies (Appendix). A representative from the Canadian Association of General Surgeons reviewed the consensus guidelines a posteriori. Nonvoting observers included representatives from government (Health Canada), the pharmaceutical industry, and distributors and manufacturers of endoscopic equipment (Appendix). Determination of Clinically Relevant Issues The issues were determined according to perceived clinical importance, likelihood of being resolved with the existing knowledge base, applicability to current practice, and perceived need for change (16). The RUGBE data were critical to this process (4). The conference organizer and a small working group generated a list of topics and circulated it electronically in advance (21, 22). For each topic, a statement was proposed to the consensus conference participants for discussion, revision, and voting. Nature and Extent of Background Preparation Literature review methods for relevant articles included MEDLINE searches and manual searches of bibliographies of key articles published in English between 1966 and June 2002. Search terms included upper GI bleeding, non-variceal, guidelines, meta-analysis, naso-gastric tube, risk stratification, re-bleeding, mortality, surgery, endoscopy, second-look, clot, stigmata, injection, thermal coaptive, laser, hemostatic clips, proton pump inhibitor, histamine-receptor antagonist, somatostatin, and octreotide. We referred to past reviews, meta-analyses, and published consensus conferences to summarize data up to 1992. New systematic reviews were conducted on data from the past 10 years on the prevalence and natural history of nonvariceal GI bleeding, risk stratification, and various management strategies. Economic considerations were recognized, but the country-specific nature of most cost data limited the review. Data were formally reviewed, including previous consensus opinions (for recommendations 1, 2, 3, and 18), narrative reviews (for recommendations 4, 11, 12, 13, 14, and 19), systematic reviews (for recommendations 5.1, 5.2, 6, and 20), and meta-analyses (for recommendations 7, 8, 9, 10, 15, 16, and 17). Data available only in abstract form were not considered, with the exception of results from 2 meta-analyses by Bardou and colleagues from McGill University (13, 14) and the RUGBE initiative (4), which had been submitted for publication at the time of writing of this manuscript. In addition, for recommendations 7 and 10, data from pivotal abstracts were discussed in detail and were published within 3 months following the conference (23, 24). Consequently, a postconference Delphi process was carried out and results from this final vote were included. More than 875 articles were initially reviewed, and the Delphi process identified 20 issues for discussion. A series of original meta-analyses, including 71 articles and nearly 9000 patients, were performed (13, 14). The key results of specific meta-analyses follow individual statements when appropriate, and full methods and results are available in separate publications (13, 14). Delphi Consensus Process Each statement was graded to indicate the level of evidence available and the strength of the recommendation by using the classification system of the Canadian Task Force on the Periodic Health Examination (Table 1) (25). This scheme was developed to assess therapeutic literature, not literature addressing prognosis (25). Table 1. Categorization of Evidence, Classification of Recommendations, and Voting Schema General Organization A 2-day consensus conference was held in June 2002 under the auspices of the Canadian Association of Gastroenterology. The conference was conducted according to generally accepted standards for the development of clinical practice guidelines (15, 16). At the consensus conference, data were presented and the statements and the grades attributed to evidence were discussed, modified if necessary, and voted on by each participant according to the recognized criteria shown in Table 1 (26). The Canadian Association of Gastroenterology, which administered all aspects of the meeting, secured multipartner funding from industry sponsors. Additional funds were obtained through a peer-review grant received by the Canadian Institutes of Health Research and an internal award from the Research Institute of the McGill University Health Centre. Statements of conflicts of interest were obtained from all voting participants, and additional ethical information was collected (27). Preparation Process and Format of the Report A working group drafted the manuscript, which was then reviewed by all voting conference participants and the nonvoting chair, who approved the final draft. A brief narrative summary regarding the pediatric patient was prepared and can be accessed at www.cag-acg.org/cag_at_glance/positions.htm. An algorithm specifically designed for use in Canada is also under development. Role of the Funding Sources The funding sources had no role in the design, conduct, and reporting of the study or in the decision to submit the results for publication. Recommendation Statements A summary of all of the recommendations is provided in Table 2. Table 2. Summary of Consensus Recommendations for the Management of Patients with Nonvariceal Upper Gastrointestinal Bleeding Initial Management Recommendation 1: Hospitals should develop institution-specific protocols for multidisciplinary management, which should include access to an endoscopist with training in endoscopic hemostasis. Recommendation: C (vote: a, 100%); Evidence: III Previous consensus groups have recommended a multidisciplinary approach with early involvement of a gastroenterologist and surgeon (9, 11, 12, 28). Hospitals with endoscopy services should have a multidisciplinary team in place with a prespecified chain of notification. Not all institutions have immediate access to these specialists, and not all patients require urgent endoscopy; thus, institution-specific protocols should be developed and updated. Endoscopy privileges should be reserved for practitioners who are properly trained according to established credentialing recommendations (29, 30). Recommendation 2: Support staff trained to assist in endoscopy should be available for urgent endoscopy. Recommendation: C (vote: a, 92%; b, 8%); Evidence: III Support staff, including appropriately trained endoscopy assistants, should be available to assist with urgent endoscopies. Any patient identified as high risk for rebleeding ideally should be admitted to a monitored setting for at least the first 24 hours (9). If intensive care beds are unavailable, wards with more intensive monitoring than standard units can be considered. Recommendation 3: Immediate evaluation and appropriate resuscitation are critical to proper management. Recommendation: C (vote: a, 96%; b, 4%); Evidence: III Patients with acute bleeding should be evaluated immediately on presentation. Resuscitation, including stabilization of blood pressure and restoration of intravascular volume (9, 11, 12, 28), should precede further diagnostic and therapeutic measures. Recommendation 4: In selected patients, the placement of a nasogastric tube can be considered because the findings may have prognostic value. Recomme