The authors have declared that no competing interests exist.
Conceived and designed the experiments: ZKY LHL. Performed the experiments: ZKY YL. Analyzed the data: ZKY YL XLC. Contributed reagents/materials/analysis tools: ZKY YL XLC. Wrote the paper: ZKY. Revised the manuscript: ZKY YL XLC LHL. Approved the final version of the manuscript: ZKY YL XLC LHL.
Inappropriate use of stress ulcer prophylaxis (SUP) is common in many hospitals. High-quality clinical practice guidelines (CPGs) produce better patient outcomes and promote cost-effective clinical care. Thus, the objective of this study was to evaluate the quality of CPGs for SUP.
A search was conducted for SUP CPGs using PubMed, Embase, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature database (CBM), guideline websites and Google (until March 1, 2015). The quality of CPGs was independently assessed by two assessors using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument, and the specific recommendations in the CPGs were summarized and evaluated.
A total of 7 CPGs for SUP were included. The highest median scores were in the clarity of presentation domain (89%), and the lowest median scores were in the editorial independence domain (0%). The rigor of development, stakeholder involvement, and applicability domains all scored below 40%. The specific recommendations for SUP varied, and the recommendations were inconsistent with the supporting evidence.
The overall quality of CPGs for SUP was relatively low, and no specific SUP CPG can be recommended. Not only should the AGREE II instrument be used to determine the quality of CPGs, but also the recommendations should be appraised based on supporting evidence, which would contribute to the development of high-quality CPGs.
Stress ulcer prophylaxis (SUP) is commonly used to decrease gastrointestinal bleeding in both critically and non-critically ill patients [
Many studies suggested that the inappropriate use of SUP, based on these guidelines, is common in hospital [
To the best of our knowledge, there has been no evaluation of SUP guidelines. Thus, we conducted this study to evaluate the quality of a group of international CPGs for SUP and to help develop, update or improve SUP guidelines, and to help clinicians reduce the inappropriate use of SUP.
We searched PubMed, Embase, China National Knowledge Infrastructure (CNKI) and Chinese Biomedical Literature Database (CBM) for SUP guidelines (until March 1, 2015). The text words and Medical Subject Headings (MeSH) terms were as follows: (guideline or guidelines or consensus) and “stress ulcer prophylaxis”. The CPGs search was conducted on major guideline websites, including the National Guideline Clearinghouse, National Institute for Health and Clinical Excellence, Scottish Intercollegiate Guidelines Network, Guidelines International Network and China Guideline Clearinghouse. The search term was “stress ulcer prophylaxis”. Google was also searched using the terms “guideline” and “stress ulcer prophylaxis”, and we reviewed the first 100 results. No restriction on language was applied.
CPGs for SUP included those that provided clinical recommendations and strategies to assist health care practitioners in making decisions and those that were endorsed by medical specialty associations or relevant professional societies. We excluded guidelines that were not original, were duplications, or were explanations of CPGs.
Two assessors, one with experience in developing and evaluating guidelines (Z.K.Y) and another assessor (Y.L), used the online training tools recommended by the AGREE collaboration before conducting appraisals. They independently evaluated the included guidelines using the AGREE II instrument [
After determining the quality of SUP guidelines using the AGREE II instrument, the specific recommendations made in the included guidelines were summarized and evaluated, including indications for SUP, agents for SUP and duration of prophylaxis.
A total of 600 records were identified, of which, 185 were duplications, 385 were either not relevant to SUP or not guidelines after screening titles and abstracts, and the remaining 30 records were retrieved for full text. Finally, 7 CPGs (ASHP [
ASHP: American Society of Health-System Pharmacists; EAST: Eastern Association for the Surgery of Trauma; ORMC: Orlando Regional Medical Center; VUMC: Vanderbilt University Medical Center; DASAIM: Danish Society of Anesthesiology and Intensive Care Medicine; DSIT: Danish Society of Intensive Care Medicine; EB: Editorial Board; NMJC: National Medical Journal of China; DIC: Drug Information Center; KAUH: King Abdullah University Hospital.
Title | Year of publication | Country/Region | Level of development | Organization | Number of authors | Number of references |
---|---|---|---|---|---|---|
ASHP Therapeutic Guidelines on Stress Ulcer Prophylaxis (ASHP) [ |
1999 | America | National | ASHP | 10 | 278 |
Practice Management Guidelines for Stress Ulcer Prophylaxis (EAST) [ |
2008 | America | Regional | EAST | 8 | 58 |
Stress Ulcer Prophylaxis (ORMC) [ |
2011 | America, Orlando | Regional | ORMC | NR | 14 |
Gastrointestinal Stress Ulcer Prophylaxis Guideline (VUMC) [ |
2005 | America, Tennessee | Regional | VUMC | 2 | 13 |
Guideline for Stress Ulcer Prophylaxis in the Intensive Care Unit (DASAIM) [ |
2014 | Denmark | National | DASAIM/DSIT | 7 | 28 |
Consensus Review for Stress Ulcer Prophylaxis and Treatment (NMJC) [ |
2002 | China | National | EB of NMJC | 10 | NR |
Stress Ulcer Prophylaxis (SUP) Guideline (KAUH) [ |
NR | Jordan | Regional | DIC of KAUH | 1 | 5 |
The domain-standardized scores for SUP CPGs and overall recommendation were presented in
Guideline | Scope and Purpose (%) | Stakeholder Involvement (%) | Rigor of Development (%) | Clarity of Presentation (%) | Applicability (%) | Editorial Independence (%) | Overall Assessment |
---|---|---|---|---|---|---|---|
ASHP [ |
83 | 61 | 65 | 94 | 54 | 17 | Recommended with modifications |
EAST [ |
67 | 39 | 44 | 89 | 29 | 0 | Recommended with modifications |
ORMC [ |
56 | 17 | 27 | 83 | 38 | 0 | Not recommended |
VUMC [ |
72 | 33 | 12 | 89 | 38 | 0 | Not recommended |
DASAIM [ |
100 | 33 | 77 | 94 | 38 | 33 | Recommended with modifications |
NMJC [ |
39 | 39 | 6 | 67 | 21 | 0 | Not recommended |
KAUH [ |
61 | 39 | 19 | 83 | 46 | 0 | Not recommended |
Median (Range) | 67 (39–100) | 39 (17–61) | 27 (6–77) | 89 (67–94) | 38 (21–54) | 0 (0–33) |
The median score for the stakeholder involvement domain was 39% (range 17–61%). Only the AHSP CPG scored above 60% for this domain [
The median score for the rigor of development domain was 27% (range 6–77%). The ASHP and DASAIM CPGs scored above 60% [
The median score for the clarity of presentation domain was 89% (range 67–94%). All guidelines scored above 60%. Most guidelines provided specific, unambiguous and easily identifiable recommendations.
The median score for the applicability domain was 38% (21–54%). No guideline scored above 60%. No guideline systematically described the facilitators and barriers of its applications very well. Most guidelines did not sufficiently consider the costs of applying their recommendations, and no guideline involved a health economist in finding and analyzing cost information.
The median score for the editorial independence domain was 0% (0–33%). No guideline clearly provided funding information. Only the DASAIM CPG described the competing interests of the guideline development group members [
In
NR: not reported; GI: gastrointestinal.
Specific recommendations | ASHP | EAST | ORMC | VUMC | DASAIM | NMJC | KAUH |
---|---|---|---|---|---|---|---|
Indications for SUP | |||||||
Mechanical ventilation | √ | √ | √ | √ | NR | √ | √ |
Coagulopathy | √ | √ | √ | √ | NR | √ | √ |
A history of GI ulceration or bleeding within one year | √ | NR | √ | √ | NR | √ | √ |
Traumatic brain injury | √ | √ | √ | √ | NR | √ | √ |
Major burn injury | √ | √ | √ | NR | NR | √ | √ |
Sepsis | Minor risk | √ | √ | √ | NR | √ | Minor risk |
Multi-trauma | √ | √ | NR | NR | NR | √ | NR |
High-dose corticosteroids | Minor risk | Minor risk | √ | Minor risk | NR | NR | Minor risk |
Agents for SUP | Antacids, H2RAs, sucralfate | H2RAs, PPIs, cytoprotective agents | H2RAs, PPIs | Famotidine, PPIs | PPIs | PPIs, H2RAs, antacids, mucosal protective agents | H2RAs, PPIs, sucralfate, antacids |
Duration of prophylaxis | Until no risk factors | Until not receiving mechanical ventilation or not in ICU, or able to tolerate enteral nutrition | Until no risk factors, or able to tolerate enteral feeding | Until no high risk factors, or able to tolerate enteral feeding | NR | NR | Until no high risk factors |
Recommendations on agents for SUP were not consistent across these guidelines. The DASAIM CPG recommended using proton pump inhibitors (PPIs) rather than histamine 2 receptor antagonists (H2RAs) for SUP, five CPGs (EAST, ORMC, VUMC, NMJC and KAUH) recommended using both PPIs and H2RAs, and the ASHP CPG did not recommended using PPIs. Three CPGs (ASHP, NMJC and KAUH) recommended using antacids for SUP, while two CPGs (ASHP, KAUH) recommended using sucralfate for SUP. The EAST CPG recommended cytoprotective agents for SUP, and the NMJC CPG recommended mucosal protective agents.
The DASAIM CPG recommended using PPIs rather than H2RAs for SUP based on one published systematic review, which suggesting that PPIs were more effective than H2RAs at reducing clinically important upper gastrointestinal bleeding (RR = 0.36, 95%CI 0.19–0.68 P = 0.002). However, after excluding trials at high risk or unclear risk of bias, the results suggested that there was no significant difference between PPIs and H2RAs (RR = 0.60, 95%CI 0.27–1.35 P = 0.21) [
Recommendations on duration of prophylaxis are moderately consistent. Five CPGs (ASHP, EAST, ORMC, VUMC and KAUH) recommended that prophylaxis should be discontinued when there was no risk factor for SUP, three CPGs (EAST, ORMC, VUMC) recommended that prophylaxis be discontinued when the patient can tolerate enteral feeding, and two CPGs (DASAIM and NMJC) did not provide recommendations on duration of prophylaxis. When we evaluated the original studies supporting the recommendations, we found no-high quality studies on duration of prophylaxis.
The DASAIM, ASHP and EAST CPGs were recommended with modifications [
This is the first study to systematically evaluate the quality of SUP guidelines. The overall quality of these CPGs was relatively low; the clarity of presentation domain showed the highest scores, while the editorial independence domain showed the lowest scores. Not only should the AGREE II instrument be used to determine the quality of CPGs, but also the recommendations should be appraised based on supporting evidence.
These guidelines had high clarity of presentation scores, indicating that this domain was more easily achieved than other domains. The editorial independence domain was poorly described. No guideline provided funding information, and only two guidelines described competing interests. Perhaps guideline developers do not like disclosing their funding information, or perhaps they do not realize the importance of conflict of interest disclosures and management. Studies have shown that financial conflicts of interest are prevalent among CPGs in a variety of clinical areas [
The rigor of development, stakeholder involvement and applicability domains all scored below 40%, and there were serious methodological flaws in these three domains. The median score for the rigor of development domain was 27%. Most guidelines described neither systematic methods for evidence searching nor methods for formulating recommendations very well. Only the DASAIM CPG indicated that the guideline was reviewed by external experts, and no guideline provided procedures for updating guidelines. The median score for the applicability domain was 38%. Most guidelines did not consider the potential resource implications of applying recommendations, nor did they pay proper attention to potential barriers to guideline implementation.
The median score for the stakeholder involvement domain was 39%. No guideline considered the views and preferences of target populations; however, the involvement of patients in decision making might promote patient guideline adherence and improve clinical outcomes [
The specific recommendations made in the included CPGs varied, probably due to the lack of high-quality studies on the indications for SUP and the duration of prophylaxis. Guideline developers failed to critically appraise the validity of the evidence, which led to the inconsistency between the recommendations and the supporting evidence. The DASAIM CPG rated the quality of evidence and graded the strength of recommendations using the GRADE approach, and recommendations were formulated based on a systematic review, thus scoring the highest in the rigor of development. However, high AGREE II domain scores do not imply that a guideline should be recommended. When we appraised the DASAIM CPG, we found that some recommendations were not consistent with the supporting evidence. The outcomes of trials with low risk of bias did not suggest that PPIs were better than H2RAs. Guideline developers should critically appraise the validity of systematic reviews and other sources of evidence formulating recommendations.
All potentially relevant studies were retrieved by searching medical databases, five guideline websites and Google. This study also has limitation. The AGREE II instrument established an evaluation system for guideline development and reporting, but the appraisal of guideline recommendations is not stated.
In conclusion, the overall quality of CPGs for SUP was relatively low, no specific SUP CPG can be recommended to guide clinical practice. Not only should the AGREE II instrument be used to determine the quality of CPGs, but also the recommendations should be appraised based on supporting evidence, which would contribute to the development of high-quality SUP CPGs.
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The authors thank Suo-Di Zhai for his expertise regarding guideline evaluation and Meng-Meng Zhang for her suggestions.