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Gu Q, Zhu C, Huang J. Risk factors for gastrointestinal bleeding in patients with intracerebral hemorrhage: A propensity score matching analysis. J Clin Neurosci 2024; 127:110772. [PMID: 39106607 DOI: 10.1016/j.jocn.2024.110772] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 06/20/2024] [Revised: 07/30/2024] [Accepted: 08/01/2024] [Indexed: 08/09/2024]
Abstract
BACKGROUND Gastrointestinal bleeding (GIB) is a common complication of intracerebral hemorrhage (ICH). Rate pressure product (RPP) is an objective hemodynamic index that is closely related to the prognosis of cardia-cerebrovascular disease. The purpose of this study was to investigate the relationship between RPP and GIB in ICH patients. METHODS We retrospectively analyzed data from ICH patients admitted to the neurosurgery department of Nanchang University affiliated with Ganzhou Hospital from January 2019 to December 2021. The patients were divided into a GIB group and a non-GIB group according to whether they had GIB. Propensity score matching was used to match between the two groups. Univariate analysis was used to select factors affecting GIB, and multivariate conditional logistic regression was used to analyze the independent factors associated with GIB. RESULTS There were 1232 patients included in the study, including 182 in the GIB group and 1050 in the non-GIB group, and 182 pairs of patients were successfully matched through propensity score matching. The univariate analysis showed that high RPP, low Glasgow coma score (GCS), fibrinogen, D-dimer and PPIs were factors associated with GIB. Multivariate conditional logistic regression showed that high RPP, low GCS and urokinase were independent risk factors for GIB, and PPIs was a protective factor for GIB. CONCLUSIONS High RPP, low GCS and urokinase were independent risk factors for GIB, and PPIs was a protective factor for GIB. Patients with a high risk of developing GIB should be monitored closely. Nevertheless, multicenter prospective studies with more patients are needed to further validate the results.
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Affiliation(s)
- Qiuping Gu
- Department of Gastroenterology, Nanchang University Affiliated Ganzhou Hospital, Ganzhou People's Hospital, Ganzhou, Jiangxi 341000, China.
| | - Chunping Zhu
- Department of Gastroenterology, Nanchang University Affiliated Ganzhou Hospital, Ganzhou People's Hospital, Ganzhou, Jiangxi 341000, China.
| | - Jiaming Huang
- Department of Gastroenterology, Nanchang University Affiliated Ganzhou Hospital, Ganzhou People's Hospital, Ganzhou, Jiangxi 341000, China; Department of Gastroenterology, Xinfeng People's Hospital, Xinfeng, Jiangxi 341000, China.
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Zhao JL, Tofani C, Infantolino A. An Updated Review and a Case Report: Stress Ulcer Prophylaxis. Cureus 2024; 16:e60811. [PMID: 38910681 PMCID: PMC11190804 DOI: 10.7759/cureus.60811] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Accepted: 05/19/2024] [Indexed: 06/25/2024] Open
Abstract
After encountering a unique patient case, we revisit the updated literature on stress ulcer prophylaxis with more updated studies. A 47-year-old male came to the hospital and was found to have acute cholecystitis. After undergoing urgent cholecystectomy, the patient developed melena and a 6 mg/dL drop from 12.5 g/dL to 6.5 g/dL in hemoglobin. He was found to have a gastric ulcer and was started on a proton pump inhibitor, which posed the question of whether or not stress ulcer prophylaxis was indicated. Therefore, the pathophysiology of stress ulcer prophylaxis is refreshed, discussing the various mechanisms through which stress ulcers form in a clinical context. Then, the main risk factors and indications for stress ulcer prophylaxis are defined based on current literature, further investigating whether or not stress ulcer prophylaxis has shown benefit and protection in various patient groups. Additionally, this review discusses the adverse effects of stress ulcer prophylaxis, including dysbiosis, community-acquired pneumonia, nutritional deficiencies, drug interactions, and fractures. Finally, inappropriate stress ulcer prophylaxis and contributing factors to overutilization are discussed, and alternative approaches to prevent stress ulcer formation are covered, including early enteral nutrition. Overall, there are mixed conclusions on the effectiveness of stress ulcer prophylaxis in noncritical patients. There are many adverse effects and unnecessary costs associated with inappropriate administration, and many studies have found that it should be reserved for specific clinical indications.
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Affiliation(s)
- Joy L Zhao
- Department of Gastroenterology and Hepatology, Sidney Kimmel Medical College, Philadelphia, USA
| | - Christina Tofani
- Division of Gastroenterology and Hepatology, Cooper University Hospital, Mount Laurel, USA
| | - Anthony Infantolino
- Division of Gastroenterology and Hepatology, Cooper University Hospital, Mount Laurel, USA
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Macias Alonso AK, Hirt J, Woelfle T, Janiaud P, Hemkens LG. Definitions of digital biomarkers: a systematic mapping of the biomedical literature. BMJ Health Care Inform 2024; 31:e100914. [PMID: 38589213 PMCID: PMC11015196 DOI: 10.1136/bmjhci-2023-100914] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 09/27/2023] [Accepted: 03/06/2024] [Indexed: 04/10/2024] Open
Abstract
BACKGROUND Technological devices such as smartphones, wearables and virtual assistants enable health data collection, serving as digital alternatives to conventional biomarkers. We aimed to provide a systematic overview of emerging literature on 'digital biomarkers,' covering definitions, features and citations in biomedical research. METHODS We analysed all articles in PubMed that used 'digital biomarker(s)' in title or abstract, considering any study involving humans and any review, editorial, perspective or opinion-based articles up to 8 March 2023. We systematically extracted characteristics of publications and research studies, and any definitions and features of 'digital biomarkers' mentioned. We described the most influential literature on digital biomarkers and their definitions using thematic categorisations of definitions considering the Food and Drug Administration Biomarkers, EndpointS and other Tools framework (ie, data type, data collection method, purpose of biomarker), analysing structural similarity of definitions by performing text and citation analyses. RESULTS We identified 415 articles using 'digital biomarker' between 2014 and 2023 (median 2021). The majority (283 articles; 68%) were primary research. Notably, 287 articles (69%) did not provide a definition of digital biomarkers. Among the 128 articles with definitions, there were 127 different ones. Of these, 78 considered data collection, 56 data type, 50 purpose and 23 included all three components. Those 128 articles with a definition had a median of 6 citations, with the top 10 each presenting distinct definitions. CONCLUSIONS The definitions of digital biomarkers vary significantly, indicating a lack of consensus in this emerging field. Our overview highlights key defining characteristics, which could guide the development of a more harmonised accepted definition.
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Affiliation(s)
- Ana Karen Macias Alonso
- Department of Applied Natural Sciences, Technische Hochschule Lübeck, Lübeck, Germany
- Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland
| | - Julian Hirt
- Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland
- Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
- Department of Health, Eastern Switzerland University of Applied Sciences, St.Gallen, Switzerland
| | - Tim Woelfle
- Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland
- Department of Neurology and MS Center, University Hospital Basel and University of Basel, Basel, Switzerland
| | - Perrine Janiaud
- Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland
- Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
| | - Lars G Hemkens
- Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland
- Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
- Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA
- Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany
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Tsige AW, Beyene DA, Wondmkun YT, Endalifer BL, Habteweld HA, Gebretadik FA, Gebeyehu AA, Azene BA, Alamneh MA, Tesfaye DZ, Fered MA, Girma MT, Mekonen MB, Dessie TY, Ayele SG. Assessment of the appropriateness of stress ulcer prophylaxis use and its determinants among admitted surgical patients at Debre Berhan University Hakim Gizaw Hospital, Ethiopia. A hospital-based cross-sectional study. Front Med (Lausanne) 2024; 11:1345144. [PMID: 38646554 PMCID: PMC11026640 DOI: 10.3389/fmed.2024.1345144] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 12/21/2023] [Accepted: 03/07/2024] [Indexed: 04/23/2024] Open
Abstract
Introduction Pharmacological stress ulcer prophylaxis (SUP) has been recommended for many years to reduce the risk of clinically significant upper gastrointestinal (GI) bleeding caused by stress ulcers (SUs). Stress-related ulcer bleeding in surgical patients significantly increases morbidity and mortality. Therefore, preventing stress-induced hemorrhage is the most appropriate measure for patients who are at increased risk. However, the inappropriate use of SUP has increased in recent years, and its use in Ethiopian surgical patients has not been well studied. Objective The aim of this study was to assess the appropriateness of SUP use and its determinants among admitted surgical patients at Debre Berhan University Hakim Gizaw Hospital (DBUHGH), Ethiopia. Methods We randomly selected 230 patients from the whole cross-sectional group of all surgical patients at DBUHGH from 1 February to 30 June 2023. The risk of stress ulcer (SU) development was assessed using the modified American Society of Health-System Pharmacists (ASHP) guidelines. For data analysis, we used SPSS version 25. Results The mean age of study participants was 47.2 years (SD ± 20.4), and out of the total of 230, 130 (56.5%) were women. Approximately 66% of study participants took inappropriate SUP based on ASHP guidelines criteria. The most commonly used drug class for SUP was histamine-2 receptor blockers 115 (50%). Study participants who have a Charlson Comorbidity Index Score of moderate and GI bleeding have been significantly associated with the inappropriate use of SUP. Conclusion In our study, inappropriate SUP use was common in the surgical ward of DBUHGH. This may be an area that requires further and more focused working together among clinical pharmacists and medical professionals in an institution-specific SUP protocol that aids clinicians in identifying appropriate candidates for SUP medication.
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Affiliation(s)
- Abate Wondesen Tsige
- Department of Pharmacy, College of Health Sciences, Debre Berhan University, Debre Berhan, Ethiopia
| | - Dessale Abate Beyene
- Department of Pharmacy, College of Health Sciences, Debre Berhan University, Debre Berhan, Ethiopia
| | | | - Bedilu Linger Endalifer
- Department of Pharmacy, College of Health Sciences, Debre Berhan University, Debre Berhan, Ethiopia
| | | | | | - Aregahegn Adafir Gebeyehu
- Department of Pharmacy, College of Health Sciences, Debre Berhan Health Science College, Debre Berhan, Ethiopia
| | - Belayneh Abebaw Azene
- Department of Pharmacy, Debre Berhan University Hakim Gizaw Hospital, Debre Berhan, Ethiopia
| | - Misganaw Abebaw Alamneh
- Department of Pharmacy, Debre Berhan University Hakim Gizaw Hospital, Debre Berhan, Ethiopia
| | - Daniel Zebene Tesfaye
- Department of Pharmacy, Debre Berhan University Hakim Gizaw Hospital, Debre Berhan, Ethiopia
| | - Misganaw Aynalem Fered
- Department of Pharmacy, Debre Berhan University Hakim Gizaw Hospital, Debre Berhan, Ethiopia
| | - Mandefro Teje Girma
- Department of Pharmacy, Debre Berhan University Hakim Gizaw Hospital, Debre Berhan, Ethiopia
| | | | - Tigist Yazezew Dessie
- Department of Pharmacy, Debre Berhan University Hakim Gizaw Hospital, Debre Berhan, Ethiopia
| | - Siraye Genzeb Ayele
- Department of Midwifery, School of Nursing and Midwifery, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia
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Fischbach W, Bornschein J, Hoffmann JC, Koletzko S, Link A, Macke L, Malfertheiner P, Schütte K, Selgrad DM, Suerbaum S, Schulz C. Update S2k-Guideline Helicobacter pylori and gastroduodenal ulcer disease of the German Society of Gastroenterology, Digestive and Metabolic Diseases (DGVS). ZEITSCHRIFT FUR GASTROENTEROLOGIE 2024; 62:261-321. [PMID: 38364851 DOI: 10.1055/a-2181-2225] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Academic Contribution Register] [Indexed: 02/18/2024]
Affiliation(s)
| | - Jan Bornschein
- Translational Gastroenterology Unit John, John Radcliffe Hospital Oxford University Hospitals, Oxford, United Kingdom
| | - Jörg C Hoffmann
- Medizinische Klinik I, St. Marien- und St. Annastiftskrankenhaus, Ludwigshafen, Deutschland
| | - Sibylle Koletzko
- Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital, LMU-Klinikum Munich, Munich, Deutschland
- Department of Paediatrics, Gastroenterology and Nutrition, School of Medicine Collegium Medicum University of Warmia and Mazury, 10-719 Olsztyn, Poland
| | - Alexander Link
- Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum Magdeburg, Magdeburg, Deutschland
| | - Lukas Macke
- Medizinische Klinik und Poliklinik II Campus Großhadern, Universitätsklinikum Munich, Munich, Deutschland
- Deutsches Zentrum für Infektionsforschung, Standort Munich, Munich, Deutschland
| | - Peter Malfertheiner
- Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum Magdeburg, Magdeburg, Deutschland
- Medizinische Klinik und Poliklinik II Campus Großhadern, Universitätsklinikum Munich, Munich, Deutschland
| | - Kerstin Schütte
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Niels-Stensen-Kliniken Marienhospital Osnabrück, Osnabrück, Deutschland
| | - Dieter-Michael Selgrad
- Medizinische Klinik Gastroenterologie und Onkologie, Klinikum Fürstenfeldbruck, Fürstenfeldbruck, Deutschland
- Klinik für Innere Medizin 1, Universitätsklinikum Regensburg, Regensburg, Deutschland
| | - Sebastian Suerbaum
- Universität Munich, Max von Pettenkofer-Institut für Hygiene und Medizinische Mikrobiologie, Munich, Deutschland
- Nationales Referenzzentrum Helicobacter pylori, Pettenkoferstr. 9a, 80336 Munich, Deutschland
- Deutsches Zentrum für Infektionsforschung, Standort Munich, Munich, Deutschland
| | - Christian Schulz
- Medizinische Klinik und Poliklinik II Campus Großhadern, Universitätsklinikum Munich, Munich, Deutschland
- Deutsches Zentrum für Infektionsforschung, Standort Munich, Munich, Deutschland
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6
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Aktualisierte S2k-Leitlinie Helicobacter
pylori und gastroduodenale Ulkuskrankheit der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) – Juli 2022 – AWMF-Registernummer: 021–001. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2023; 61:544-606. [PMID: 37146633 DOI: 10.1055/a-1975-0414] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Academic Contribution Register] [Indexed: 05/07/2023]
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7
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Chen H, Feng Y. Moving Forward to the Future: A Review of Microbial Food Safety Education in China. Foodborne Pathog Dis 2021; 18:547-566. [PMID: 33667118 DOI: 10.1089/fpd.2020.2889] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 11/13/2022] Open
Abstract
Millions of foodborne illness cases occur in China annually, causing significant social and economic burdens. Improper food handling has been observed not only among commercial food handlers but also among residential food handlers. It is critical to conduct a comprehensive scoping review of previous efforts to identify food safety knowledge gaps, explore the factors impacting knowledge levels, and synthesize the effectiveness of all types of food safety educational interventions for commercial and residential food handlers in China. This review aims to analyze food safety education studies published over the past 20 years and provide foundations for developing more effective food safety educational interventions in China. A total of 35 studies were included in this review. Most studies reported that Chinese commercial and residential food handlers had insufficient food safety knowledge, especially in the areas of foodborne pathogens and safe food-handling practices. The factors impacting food handlers' knowledge levels included education level, gender, income level, residency (rural vs. urban), the use of WeMedia, college students' major, and food safety training experiences. Food handlers in the following demographic groups tend to have lower levels of food safety knowledge: lower education levels, the elderly, males, lower-income levels, rural residents, those who do not use WeMedia, those without food safety training experience, or college students in nonbiology-focused majors. Many food handlers did not always follow recommended food safety practices, such as proper meat handling practices, handwashing practices, and cleaning and sanitation practices. Thirteen studies evaluated the effectiveness of educational interventions, and knowledge increases were reported after all interventions. The findings of this review provide guidance to researchers, educators, and government agencies in their future efforts to develop education programs emphasizing the importance of microbial food-safety content and behavior change regarding food safety and hygiene practices.
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Affiliation(s)
- Han Chen
- Department of Food Science, Purdue University, West Lafayette, Indiana, USA
| | - Yaohua Feng
- Department of Food Science, Purdue University, West Lafayette, Indiana, USA
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Gupta P, Sankar J, Kumar BK, Jat KR, Mukherjee A, Kapil A, Kabra SK, Lodha R. Twenty-Four-Hour Esophageal pH Measurement in Mechanically Ventilated Children: A Prospective Cohort Study. Pediatr Crit Care Med 2021; 22:e203-e212. [PMID: 33534390 DOI: 10.1097/pcc.0000000000002664] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Indexed: 01/10/2023]
Abstract
OBJECTIVES To assess the prevalence of gastroesophageal reflux in mechanically ventilated children using 24-hour esophageal pH-metry and its role as a risk factor for ventilator-associated pneumonia. DESIGN Prospective cohort study. SETTING PICU of a tertiary care hospital from North India. PATIENTS Mechanically ventilated children 1-15 years old in PICU from July 2015 to June 2017, excluding those receiving acid suppressants, known cases of gastroesophageal reflux disease, having upper gastrointestinal bleed. INTERVENTION Demographic details, baseline investigations, diagnosis, treatment details, and Pediatric Risk of Mortality III score were recorded at enrollment. Gastroesophageal reflux was evaluated using 24-hour esophageal pH-metry. Children were followed up for 7 days or 48 hours after extubation for development of ventilator-associated pneumonia using Centers for Disease Control and Prevention criteria. Pathologic acidic gastroesophageal reflux was defined as fall in esophageal pH less than 4 for more than 4% of total time, whereas pathologic alkaline gastroesophageal reflux as rise in esophageal pH greater than 7 for more than 17% of total time. MEASUREMENTS AND MAIN RESULTS Sixty-one children (median [interquartile range], age 73 mo [30-132 mo]; 44 boys [72%]) were enrolled. Median Pediatric Risk of Mortality III score was 10.0 (3-16). Median duration of ventilation was 6 days (3-9 d). Pathologic gastroesophageal reflux (acidic or alkaline) was present in 47 children (77%). Twelve children (19.7%) met criteria for pathologic acidic gastroesophageal reflux, whereas 44 children (72.1%) had pathologic alkaline gastroesophageal reflux; nine children (14.7%) had both pathologic acidic and alkaline gastroesophageal reflux. Of the enrolled children, 17 (27.9 %) developed ventilator-associated pneumonia. No patient had both pathologic acidic gastroesophageal reflux and ventilator-associated pneumonia. Of 17 children who developed ventilator-associated pneumonia, 12 (70.5%) had pathologic alkaline gastroesophageal reflux as compared to 32 children (72.7%) among the 44 children who did not develop ventilator-associated pneumonia (p = 0.87). CONCLUSIONS The current study shows high incidence of gastroesophageal reflux on 24-hour esophageal pH-metry in mechanically ventilated children with medical diagnoses. The significance of this finding and its impact on ventilator-associated pneumonia and other ventilator-associated events need to be examined in larger studies.
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Affiliation(s)
- Priyanka Gupta
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - Jhuma Sankar
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - B Kiran Kumar
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - Kana Ram Jat
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - Aparna Mukherjee
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - Arti Kapil
- Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India
| | - Sushil K Kabra
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
| | - Rakesh Lodha
- Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
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McKeown S, Mir ZM. Considerations for conducting systematic reviews: evaluating the performance of different methods for de-duplicating references. Syst Rev 2021; 10:38. [PMID: 33485394 PMCID: PMC7827976 DOI: 10.1186/s13643-021-01583-y] [Citation(s) in RCA: 71] [Impact Index Per Article: 17.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 09/08/2020] [Accepted: 01/06/2021] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Systematic reviews involve searching multiple bibliographic databases to identify eligible studies. As this type of evidence synthesis is increasingly pursued, the use of various electronic platforms can help researchers improve the efficiency and quality of their research. We examined the accuracy and efficiency of commonly used electronic methods for flagging and removing duplicate references during this process. METHODS A heterogeneous sample of references was obtained by conducting a similar topical search in MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and PsycINFO databases. References were de-duplicated via manual abstraction to create a benchmark set. The default settings were then used in Ovid multifile search, EndNote desktop, Mendeley, Zotero, Covidence, and Rayyan to de-duplicate the sample of references independently. Using the benchmark set as reference, the number of false-negative and false-positive duplicate references for each method was identified, and accuracy, sensitivity, and specificity were determined. RESULTS We found that the most accurate methods for identifying duplicate references were Ovid, Covidence, and Rayyan. Ovid and Covidence possessed the highest specificity for identifying duplicate references, while Rayyan demonstrated the highest sensitivity. CONCLUSION This study reveals the strengths and weaknesses of commonly used de-duplication methods and provides strategies for improving their performance to avoid unintentionally removing eligible studies and introducing bias into systematic reviews. Along with availability, ease-of-use, functionality, and capability, these findings are important to consider when researchers are selecting database platforms and supporting software programs for conducting systematic reviews.
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Affiliation(s)
- Sandra McKeown
- Bracken Health Sciences Library, Queen's University, 18 Stuart Street, Kingston, Ontario, K7L 2V5, Canada.
| | - Zuhaib M Mir
- Departments of Surgery and Public Health Sciences, Queen's University & Kingston Health Sciences Centre, 76 Stuart Street, Kingston, Ontario, K7L 2V7, Canada
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Effects of daily treatment with acid suppressants for stress ulcer prophylaxis on risk of ventilator-associated events. Infect Control Hosp Epidemiol 2021; 41:187-193. [PMID: 31818336 DOI: 10.1017/ice.2019.323] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 11/06/2022]
Abstract
OBJECTIVE To estimate the effects of continuous daily treatment with different acid suppressants on the risk of ventilator-associated events in critically ill patients. DESIGN Retrospective cohort study. PATIENTS Adult critically ill patients who underwent mechanical ventilation for ≥3 days during an inpatient admission between January 2006 and December 2014. METHODS We estimated the 30-day cumulative risk ratios (RRs) for ventilator-associated events comparing daily proton pump inhibitor (PPI) versus daily histamine-2-receptor antagonist (H2RA) strategies while controlling for time-fixed and time-varying confounding and accounting for competing events. RESULTS Of 6,133 patients, on ventilation day 3, 58.8% received H2RAs, 26.1% received PPIs, and 4.1% received sucralfate. Patients frequently changed treatment throughout follow-up. Among 4,595 patients receiving PPIs or H2RAs on day 3, we found no differences in risk estimates for ventilator mortality and extubation alive comparing daily PPI versus daily H2RA strategies: RR, mortality, 1.03 (95% CI, 0.89-1.22); extubation alive, 1.00 (95% CI, 0.96-1.03). We found similar results after accounting for PPI dose. For possible ventilator-associated pneumonia (PVAP) and infection-related ventilator-associated complication (IVAC), point estimates were larger, but the 95% CIs crossed 1.0: RR PVAP, 1.25 (95% CI, 0.80-1.94); IVAC, 0.89 (95% CI, 0.64-1.17). The magnitude of effect estimates depended on PPI dose. The RR for PVAP, high-dose PPI versus H2RA, was 1.53 (95% CI, 0.82-2.51), and for low-dose PPI versus H2RA, the RR was 0.97 (95% CI, 0.47-1.63). For IVAC, high-dose PPI versus H2RA, the RR was 1.01 (95% CI, 0.66-1.42), and for low-dose PPI versus H2RA, the RR was 0.78 (95% CI, 0.50-1.11). CONCLUSIONS We estimated no effect of daily PPI versus daily H2RA on risk of mortality or extubation alive in critically ill patients. Further investigation with larger samples is warranted for PVAP and IVAC.
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Singh-Franco D, Mastropietro DR, Metzner M, Dressler MD, Fares A, Johnson M, De La Rosa D, Wolowich WR. Impact of pharmacy-supported interventions on proportion of patients receiving non-indicated acid suppressive therapy upon discharge: A systematic review and meta-analysis. PLoS One 2020; 15:e0243134. [PMID: 33270710 PMCID: PMC7714117 DOI: 10.1371/journal.pone.0243134] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 02/27/2020] [Accepted: 11/16/2020] [Indexed: 12/13/2022] Open
Abstract
Objective Conduct a systematic review and meta-analysis to estimate the impact of pharmacy-supported interventions on the proportion of patients discharged from the hospital on inappropriate acid suppressive therapy (AST). Methods To identify studies, the following databases were systematically searched on October 14th, 2018 and repeated on September 12th, 2019: Ovid MEDLINE(R) and In-Process & Other Non-Indexed Citations and Daily, Embase.com, CINAHL, Web of Science, Cochrane CENTRAL (EBSCO), and ClinicalTrials.gov. Eligible studies consisted of adults, intervention and historical/usual care groups, description of active pharmacy-supported intervention, and proportion of patients discharged on inappropriate AST. Qualitative assessments and quantitative analyses were performed. Modified funnel plot analysis assessed heterogeneity. Preferred reporting items of systematic reviews and meta-analyses (PRISMA) methodology was used to evaluate studies in this review. Results Seventeen publications resulting in 16 studies were included in the review. Using random effects model, meta-analysis showed a significant reduction in the odds of being discharged on inappropriate AST from the hospital in the pharmacist-supported intervention arm versus comparator (Odds Ratio 0.33 [95%CI 0.20 to 0.53]), with significant heterogeneity (I2 = 86%). Eleven studies favored pharmacy-supported interventions, four were inconclusive and one favored usual care. Using modified funnel plot analysis, our final evaluation was distilled to 11 studies and revealed a similar outcome (OR 0.36 [95%CI 0.27 to 0.48]), but with less heterogeneity (I2 = 36%). Conclusion This systematic review and meta-analysis showed that pharmacy-supported interventions were associated with a significantly reduced probability of patients discharged on inappropriate AST. However, heterogeneity was high and may affect interpretation of results. Using funnel plot optimization method, three positive and two negative studies were objectively removed from analyses, resulting in a similar effect size, but with less heterogeneity. To improve study quality, future researchers should consider utilizing a pre-post, multi-arm, prospective design with sampling randomization, training of data extractors (preferably two extractors), re-evaluating a small dataset to check for agreement and providing a comprehensive methodology in subsequent publications.
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Affiliation(s)
- Devada Singh-Franco
- Department of Pharmacy Practice, Nova Southeastern University, College of Pharmacy, Fort Lauderdale, Florida, United States of America
- * E-mail:
| | - David R. Mastropietro
- Department of Pharmaceutical Sciences, Nova Southeastern University, Fort Lauderdale, Florida, United States of America
| | - Miriam Metzner
- Department of Pharmacy Practice, Nova Southeastern University, College of Pharmacy, Fort Lauderdale, Florida, United States of America
| | - Michael D. Dressler
- Department of Pharmaceutical Sciences, Nova Southeastern University, Fort Lauderdale, Florida, United States of America
| | - Amneh Fares
- Department of Pharmacy Practice, Nova Southeastern University, College of Pharmacy, Fort Lauderdale, Florida, United States of America
| | - Melinda Johnson
- Martin and Gail Press Health Professions Division Library, Nova Southeastern University, Fort Lauderdale, Florida, United States of America
| | - Daisy De La Rosa
- Martin and Gail Press Health Professions Division Library, Nova Southeastern University, Fort Lauderdale, Florida, United States of America
| | - William R. Wolowich
- Department of Pharmacy Practice, Nova Southeastern University, College of Pharmacy, Fort Lauderdale, Florida, United States of America
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Mills KI, Albert BD, Bechard LJ, Duggan CP, Kaza A, Rakoff-Nahoum S, Vlamakis H, Sleeper LA, Newburger JW, Priebe GP, Mehta NM. Stress ulcer prophylaxis versus placebo-a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD). Trials 2020; 21:590. [PMID: 32600393 PMCID: PMC7322718 DOI: 10.1186/s13063-020-04513-w] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 12/27/2019] [Accepted: 06/15/2020] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND Critically ill infants with congenital heart disease (CHD) are often prescribed stress ulcer prophylaxis (SUP) to prevent upper gastrointestinal bleeding, despite the low incidence of stress ulcers and limited data on the safety and efficacy of SUP in infants. Recently, SUP has been associated with an increased incidence of hospital-acquired infections, community-acquired pneumonia, and necrotizing enterocolitis. The objective of this pilot study is to investigate the feasibility of performing a randomized controlled trial to assess the safety and efficacy of withholding SUP in infants with congenital heart disease admitted to the cardiac intensive care unit. METHODS A single center, prospective, double-blinded, randomized placebo-controlled pilot feasibility trial will be performed in infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for > 24 h. Patients will be randomized to receive a histamine-2 receptor antagonist (H2RA) or placebo until they are discontinued from respiratory support. Randomization will be performed within 2 strata defined by admission type (medical or surgical) and age (neonate, age < 30 days, or infant, 1 month to 1 year). Allocation will be a 1:1 ratio using permuted blocks to ensure balanced allocations across the two treatment groups within each stratum. The primary outcomes include feasibility of screening, consent, timely allocation of study drug, and protocol adherence. The primary safety outcome is the rate of clinically significant upper gastrointestinal bleeding. The secondary outcomes are the difference in the relative and absolute abundance of the gut microbiota and functional microbial profiles between the two study groups. We plan to enroll 100 patients in this pilot study. DISCUSSION Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects. The role of SUP in infants with CHD has not been examined, and there is equipoise on the risks and benefits of withholding this therapy. In addition, this therapy has been discontinued in other neonatal populations due to the concern for hospital-acquired infections and necrotizing enterocolitis. Furthermore, exploring changes to the microbiome after exposure to SUP may highlight the mechanisms by which SUP impacts potential microbial dysbiosis of the gut and its association with hospital-acquired infections. Assessment of the feasibility of a trial of withholding SUP in critically ill infants with CHD will facilitate planning of a larger multicenter trial of safety and efficacy of SUP in this vulnerable population. TRIAL REGISTRATION ClinicalTrials.gov , NCT03667703. Registered 12 September 2018, https://clinicaltrials.gov/ct2/show/NCT03667703?term=SUPPRESS+CHD&draw=2&rank=1 . All WHO Trial Registration Data Set Criteria are met in this manuscript.
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Affiliation(s)
- Kimberly I Mills
- Department of Cardiology, Boston Children's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
| | - Ben D Albert
- Harvard Medical School, Boston, MA, USA
- Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA
| | - Lori J Bechard
- Harvard Medical School, Boston, MA, USA
- Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA
| | - Christopher P Duggan
- Harvard Medical School, Boston, MA, USA
- Center for Nutrition, Boston Children's Hospital, Boston, MA, USA
| | - Aditya Kaza
- Harvard Medical School, Boston, MA, USA
- Department of Cardiac Surgery, Boston Children's Hospital, Boston, MA, USA
| | - Seth Rakoff-Nahoum
- Harvard Medical School, Boston, MA, USA
- Department of Pediatrics, Boston Children's Hospital, Boston, MA, USA
| | | | - Lynn A Sleeper
- Department of Cardiology, Boston Children's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
| | - Jane W Newburger
- Department of Cardiology, Boston Children's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
| | - Gregory P Priebe
- Harvard Medical School, Boston, MA, USA
- Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA
| | - Nilesh M Mehta
- Harvard Medical School, Boston, MA, USA.
- Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.
- Center for Nutrition, Boston Children's Hospital, Boston, MA, USA.
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13
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McKeown S. PRISMA guideline compliance is imperative for systematic review appraisal. Can J Kidney Health Dis 2020; 7:2054358120927594. [PMID: 32551132 PMCID: PMC7281638 DOI: 10.1177/2054358120927594] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 01/08/2023] Open
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Abstract
Stress ulcer prophylaxis (SUP) with acid-suppressive drug therapy is widely utilized in critically ill patients following neurologic injury for the prevention of clinically important stress-related gastrointestinal bleeding (CIB). Data supporting SUP, however, largely originates from studies conducted during an era where practices were vastly different than what is considered routine by today's standard. This is particularly true in neurocritical care patients. In fact, the routine provision of SUP has been challenged due to an increasing prevalence of adverse drug events with acid-suppressive therapy and the perception that CIB rates are sparse. This narrative review will discuss current controversies with SUP as they apply to neurocritical care patients. Specifically, the pathophysiology, prevalence, and risk factors for CIB along with the comparative efficacy, safety, and cost-effectiveness of acid-suppressive therapy will be described.
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15
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Palpacuer C, Hammas K, Duprez R, Laviolle B, Ioannidis JPA, Naudet F. Vibration of effects from diverse inclusion/exclusion criteria and analytical choices: 9216 different ways to perform an indirect comparison meta-analysis. BMC Med 2019; 17:174. [PMID: 31526369 PMCID: PMC6747755 DOI: 10.1186/s12916-019-1409-3] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 05/10/2019] [Accepted: 08/14/2019] [Indexed: 11/17/2022] Open
Abstract
BACKGROUND Different methodological choices such as inclusion/exclusion criteria and analytical models can yield different results and inferences when meta-analyses are performed. We explored the range of such differences, using several methodological choices for indirect comparison meta-analyses to compare nalmefene and naltrexone in the reduction of alcohol consumption as a case study. METHODS All double-blind randomized controlled trials (RCTs) comparing nalmefene to naltrexone or one of these compounds to a placebo in the treatment of alcohol dependence or alcohol use disorders were considered. Two reviewers searched for published and unpublished studies in MEDLINE (August 2017), the Cochrane Library, Embase, and ClinicalTrials.gov and contacted pharmaceutical companies, the European Medicines Agency, and the Food and Drug Administration. The indirect comparison meta-analyses were performed according to different inclusion/exclusion criteria (based on medical condition, abstinence of patients before inclusion, gender, somatic and psychiatric comorbidity, psychological support, treatment administered and dose, treatment duration, outcome reported, publication status, and risk of bias) and different analytical models (fixed and random effects). The primary outcome was the vibration of effects (VoE), i.e. the range of different results of the indirect comparison between nalmefene and naltrexone. The presence of a "Janus effect" was investigated, i.e. whether the 1st and 99th percentiles in the distribution of effect sizes were in opposite directions. RESULTS Nine nalmefene and 51 naltrexone RCTs were included. No study provided a direct comparison between the drugs. We performed 9216 meta-analyses for the indirect comparison with a median of 16 RCTs (interquartile range = 12-21) included in each meta-analysis. The standardized effect size was negative at the 1st percentile (- 0.29, favouring nalmefene) and positive at the 99th percentile (0.29, favouring naltrexone). A total of 7.1% (425/5961) of the meta-analyses with a negative effect size and 18.9% (616/3255) of those with a positive effect size were statistically significant (p < 0.05). CONCLUSIONS The choice of inclusion/exclusion criteria and analytical models for meta-analysis can result in entirely opposite results. VoE evaluations could be performed when overlapping meta-analyses on the same topic yield contradictory result. TRIAL REGISTRATION This study was registered on October 19, 2016, in the Open Science Framework (OSF, protocol available at https://osf.io/7bq4y/ ).
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Affiliation(s)
- Clément Palpacuer
- Centre d'Investigation Clinique INSERM 1414, Hôpital de Pontchaillou, 2 rue Henri le Guilloux, 35033, Rennes cedex 9, France. .,Department of Biostatistics, Institut de Cancérologie de l'Ouest Centre René-Gauducheau, Saint-Herblain, France.
| | - Karima Hammas
- Department of Epidemiology and Biostatistics and Clinical Research, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat Claude Bernard, Paris, France.,Inserm, CIC-EC 1425, Hôpital Bichat Claude Bernard, Paris, France
| | - Renan Duprez
- Fondation Saint Jean de Dieu, Centre Hospitalier Dinan/St Brieuc, Dinan, France
| | - Bruno Laviolle
- Centre d'Investigation Clinique INSERM 1414, Hôpital de Pontchaillou, 2 rue Henri le Guilloux, 35033, Rennes cedex 9, France.,Department of Biological and Clinical Pharmacology and Pharmacovigilance, Rennes University Hospital, Rennes, France.,Laboratory of Experimental and Clinical Pharmacology, Rennes 1 University, Rennes, France
| | - John P A Ioannidis
- Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.,Departments of Medicine, of Health Research and Policy, Biomedical Data Science, and Statistics, Stanford University, Stanford, CA, USA
| | - Florian Naudet
- Centre d'Investigation Clinique INSERM 1414, Hôpital de Pontchaillou, 2 rue Henri le Guilloux, 35033, Rennes cedex 9, France.,Department of Biological and Clinical Pharmacology and Pharmacovigilance, Rennes University Hospital, Rennes, France.,Laboratory of Experimental and Clinical Pharmacology, Rennes 1 University, Rennes, France.,Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA
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16
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Marchina S, Doros G, Modak J, Helenius J, Aycock DM, Kumar S. Acid-suppressive medications and risk of pneumonia in acute stroke patients: A systematic review and meta-analysis. J Neurol Sci 2019; 400:122-128. [DOI: 10.1016/j.jns.2019.02.041] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 08/29/2018] [Revised: 12/20/2018] [Accepted: 02/28/2019] [Indexed: 01/08/2023]
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Kwok CS, Sirker A, Farmer AD, Kontopantelis E, Potts J, Ayyaz Ul Haq M, Ludman P, Belder M, Townend J, Zaman A, Large A, Kinnaird T, Mamas MA. In‐hospital gastrointestinal bleeding following percutaneous coronary intervention. Catheter Cardiovasc Interv 2019; 95:109-117. [DOI: 10.1002/ccd.28222] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 11/28/2018] [Revised: 02/26/2019] [Accepted: 03/23/2019] [Indexed: 01/07/2023]
Affiliation(s)
- Chun Shing Kwok
- Keele Cardiovascular Research Group, Keele University Stoke‐on‐Trent UK
- Department of CardiologyRoyal Stoke University Hospital Stoke‐on‐Trent UK
| | - Alex Sirker
- Department of CardiologyUniversity College London Hospitals and St. Bartholomew's Hospital London UK
| | - Adam D. Farmer
- Department of Gastroenterology and Institute of Applied Clinical SciencesRoyal Stoke University Hospital Stoke‐on‐Trent UK
| | | | - Jessica Potts
- Department of CardiologyQueen Elizabeth Hospital Birmingham UK
| | - Muhammad Ayyaz Ul Haq
- Keele Cardiovascular Research Group, Keele University Stoke‐on‐Trent UK
- Department of CardiologyRoyal Stoke University Hospital Stoke‐on‐Trent UK
| | - Peter Ludman
- Department of CardiologyThe James Cook University Hospital Middlesbrough UK
| | - Mark Belder
- Department of CardiologyFreeman Hospital and Institute of Cellular Medicine, Newcastle University Newcastle Upon Tyne UK
| | - John Townend
- Department of CardiologyThe James Cook University Hospital Middlesbrough UK
| | - Azfar Zaman
- Department of CardiologyFreeman Hospital and Institute of Cellular Medicine, Newcastle University Newcastle Upon Tyne UK
| | - Adrian Large
- Department of CardiologyRoyal Stoke University Hospital Stoke‐on‐Trent UK
| | - Tim Kinnaird
- Department of CardiologyUniversity Hospital of Wales Cardiff UK
| | - Mamas A Mamas
- Keele Cardiovascular Research Group, Keele University Stoke‐on‐Trent UK
- Department of CardiologyRoyal Stoke University Hospital Stoke‐on‐Trent UK
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18
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Alshami A, Barona SV, Varon J, Surani S. Gastrointestinal stress ulcer prophylaxis in the intensive care unit, where is the data? World J Meta-Anal 2019; 7:72-76. [DOI: 10.13105/wjma.v7.i3.72] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 03/27/2019] [Revised: 03/28/2019] [Accepted: 03/28/2019] [Indexed: 02/06/2023] Open
Abstract
Stress-induced gastrointestinal ulcers are common among patients admitted to the intensive care unit (ICU). These ulcers impose significant morbidity and mortality, therefore, stress ulcer prophylaxis (SUP) is a common clinical practice among healthcare providers dealing with these critically-ill patients. Several strategies for SUP have been suggested over the past four decades, with acid suppressive therapies being the most commonly used in the ICU. Whether SUP is effective and safe, or not, remains a topic of controversy. The data is still conflicting, and provision of a simple answer is not feasible at the present time. Recently, a large phase IV, multicenter, randomized clinical trial (SUP-ICU), negated the benefits (and harms) of proton pump inhibitors as SUP. This article reviews some of these controversies.
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Affiliation(s)
- Abbas Alshami
- Dorrington Medical Associates, Houston, TX 77030, United States
- University of Baghdad College of Medicine, Baghdad 12114, Iraq
| | - Sheily Vianney Barona
- Dorrington Medical Associates, Houston, TX 77030, United States
- Benemerita Universidad Autonoma de Puebla, Puebla 72000, Mexico
| | - Joseph Varon
- United General Hospital, 7501 Fanin Street Houston, TX 77054, United States
- Critical Care Services, United Memorial Medical Center, Houston, TX 77091, United States
- Acute and Continuing Care, University of Texas Health Science Center at Houston, Houston, TX 77030, United States
- Medicine, University of Texas Medical Branch at Galveston Houston, Galveston, TX 77555, United States
| | - Salim Surani
- Department of Pulmonary, Critical Care and Sleep Medicine, Texas A&M University, Health Science Center, Bryan, TX 77807, United States
- Pulmonary and Critical Care Fellowship Program, Bay Area Medical Center, Marinette, WI 54143, United States
- Medical Critical Care Services, Christus Spohn Hospitals-Corpus Christi, Corpus Christi, TX 78404, United States
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Stapleton RD, Suratt BT, Neff MJ, Wurfel MM, Ware LB, Ruzinski JT, Caldwell E, Hallstrand TS, Parsons PE. Bronchoalveolar fluid and plasma inflammatory biomarkers in contemporary ARDS patients. Biomarkers 2019; 24:352-359. [PMID: 30744430 DOI: 10.1080/1354750x.2019.1581840] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 12/27/2022]
Abstract
Purpose: Bronchoalveolar fluid (BALF) and plasma biomarkers are often endpoints in early phase randomized trials (RCTs) in acute respiratory distress syndrome (ARDS). With ARDS mortality decreasing, we analyzed baseline biomarkers in samples from contemporary ARDS patients participating in a prior RCT and compared these to historical controls. Materials and methods: Ninety ARDS adult patients enrolled in the parent trial. BALF and blood were collected at baseline, day 4 ± 1, and day 8 ± 1. Interleukins-8/-6/-1β/-1 receptor antagonist/-10; granulocyte colony stimulating factor; monocyte chemotactic protein-1; tumour necrosis factor-α; surfactant protein-D; von Willebrand factor; leukotriene B4; receptor for advanced glycosylation end products; soluble Fas ligand; and neutrophil counts were measured. Results: Compared to historical measurements, our values were generally substantially lower, despite our participants being similar to historical controls. For example, our BALF IL-8 and plasma IL-6 were notably lower than in a 1999 RCT of low tidal volume ventilation and a 2007 biomarker study, respectively. Conclusions: Baseline biomarker levels in current ARDS patients are substantially lower than 6-20 years before collection of these samples. These findings, whether from ICU care changes resulting in less inflammation or from variation in assay techniques over time, have important implications for design of future RCTs with biomarkers as endpoints.
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Affiliation(s)
- Renee D Stapleton
- a Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Vermont College of Medicine , Burlington , VT , USA
| | - Benjamin T Suratt
- a Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Vermont College of Medicine , Burlington , VT , USA
| | - Margaret J Neff
- b Department of Medicine , Stanford University , Palo Alto , CA , USA
| | - Mark M Wurfel
- c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA
| | - Lorraine B Ware
- d Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine , Vanderbilt University , Nashville , TN , USA
| | - John T Ruzinski
- c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA.,e Department of Medicine , Division of Nephrology, University of Washington , Seattle, WA , USA
| | - Ellen Caldwell
- c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA
| | - Teal S Hallstrand
- c Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Washington , Seattle , WA , USA
| | - Polly E Parsons
- a Department of Medicine, Division of Pulmonary and Critical Care Medicine , University of Vermont College of Medicine , Burlington , VT , USA
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20
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Reynolds PM, MacLaren R. Re-evaluating the Utility of Stress Ulcer Prophylaxis in the Critically Ill Patient: A Clinical Scenario-Based Meta-Analysis. Pharmacotherapy 2018; 39:408-420. [PMID: 30101529 DOI: 10.1002/phar.2172] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 11/06/2022]
Abstract
STUDY OBJECTIVE Because recent studies have challenged the efficacy of stress ulcer prophylaxis (SUP) in the critically ill patient, our objective was to evaluate the efficacy of SUP with proton pump inhibitors (PPIs) or histamine2 -receptor antagonists (H2 RAs) against placebo, control, no therapy, or enteral nutrition alone in critically ill adults. DESIGN Meta-analysis with trial sequential analysis (TSA) of 34 randomized controlled trials. PATIENTS A total of 3220 critically ill adults who received PPIs or H2 RAs versus placebo, control, no therapy, or enteral nutrition. MEASUREMENTS AND MAIN RESULTS A systematic review was performed using a random effects meta-analysis with TSA according to a predefined protocol. Randomized controlled trials comparing PPIs or H2 RAs with either placebo, control, no therapy, or enteral nutrition alone were identified through a comprehensive search of the literature. Two blinded reviewers independently assessed studies for inclusion, risk of bias, and extracted data using Cochrane Collaborative methodology. The predefined primary outcomes were clinically important, overt, and any (clinically important plus overt) gastrointestinal bleeding. Secondary outcomes included pneumonia, Clostridium difficile-associated diarrhea (CDAD), and mortality. Subgroup analyses were conducted for the primary outcome by PPI or H2 RA use, intensive care unit (ICU) subtype, studies published after early goal-directed therapy (EGDT), the presence of risk factors for stress ulceration, and enteral nutrition use. Of the 34 trials included, 33 were judged as high risk of bias and 1 was judged as low risk. Use of SUP significantly reduced clinically important bleeding (risk ratio [RR] 0.53, 95% confidence interval [CI] 0.37-0.76, p<0.001; I2 = 0%), overt bleeding (RR 0.55, 95% CI 0.39-0.76, p=0.0003; I2 = 53%), and any bleeding (RR 0.54, 95% CI 0.41-0.71, p<0.00001; I2 = 58%). TSA confirmed these findings. No significant differences in pneumonia, CDAD, or mortality were noted. Subgroup analyses revealed significant reductions in clinically important bleeding with SUP in neurosurgical patients (RR 0.37, p<0.05) but not in surgery/trauma or medical ICU patients with risk factors. SUP provided no benefit in studies published after EGDT. SUP significantly reduced clinically important bleeding regardless of the use of enteral nutrition (p<0.05). CONCLUSION This meta-analysis demonstrated that SUP use was associated with significant reductions in bleeding but not mortality. SUP should not be abandoned until large randomized trials demonstrate the futility of this intervention.
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Affiliation(s)
- Paul M Reynolds
- University of Colorado Skaggs School of Pharmacy, Aurora, Colorado
| | - Robert MacLaren
- University of Colorado Skaggs School of Pharmacy, Aurora, Colorado
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21
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Use of Enteral Nutrition for Gastrointestinal Bleeding Prophylaxis in the Critically Ill: Review of Current Literature. Curr Nutr Rep 2018; 7:116-120. [PMID: 29974343 DOI: 10.1007/s13668-018-0232-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 10/28/2022]
Abstract
PURPOSE OF REVIEW This review provides a comprehensive overview of the etiology of stress-related mucosal disease, current acid suppression therapy recommendations, and the role enteral nutrition may play in disease prevention. RECENT FINDINGS Recent literature indicates enteral nutrition may prevent complications of stress-related mucosal disease by increasing splanchnic blood flow, enhancing gastrointestinal motility, and promoting cellular immunity and integrity through local nutrient delivery. Stress-related mucosal disease is a common complication of hospitalization in the critically ill which may lead to overt gastrointestinal bleeding and enhanced mortality. High-risk patients have historically been prescribed acid suppression therapy, though enteral nutrition may also have a role in disease mitigation.
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22
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Toews I, George AT, Peter JV, Kirubakaran R, Fontes LES, Ezekiel JPB, Meerpohl JJ. Interventions for preventing upper gastrointestinal bleeding in people admitted to intensive care units. Cochrane Database Syst Rev 2018; 6:CD008687. [PMID: 29862492 PMCID: PMC6513395 DOI: 10.1002/14651858.cd008687.pub2] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND Upper gastrointestinal (GI) bleeding due to stress ulcers contributes to increased morbidity and mortality in people admitted to intensive care units (ICUs). Stress ulceration refers to GI mucosal injury related to the stress of being critically ill. ICU patients with major bleeding as a result of stress ulceration might have mortality rates approaching 48.5% to 65%. However, the incidence of stress-induced GI bleeding in ICUs has decreased, and not all critically ill patients need prophylaxis. Stress ulcer prophylaxis can result in adverse events such as ventilator-associated pneumonia; therefore, it is necessary to evaluate strategies that safely decrease the incidence of GI bleeding. OBJECTIVES To assess the effect and risk-benefit profile of interventions for preventing upper GI bleeding in people admitted to ICUs. SEARCH METHODS We searched the following databases up to 23 August 2017, using relevant search terms: MEDLINE; Embase; the Cochrane Central Register of Controlled Trials; Latin American Caribbean Health Sciences Literature; and the Cochrane Upper Gastrointestinal and Pancreatic Disease Group Specialised Register, as published in the Cochrane Library (2017, Issue 8). We searched the reference lists of all included studies and those from relevant systematic reviews and meta-analyses to identify additional studies. We also searched the World Health Organization International Clinical Trials Registry Platform search portal and contacted individual researchers working in this field, as well as organisations and pharmaceutical companies, to identify unpublished and ongoing studies. SELECTION CRITERIA We included randomised controlled trials (RCTs) and quasi-RCTs with participants of any age and gender admitted to ICUs for longer than 48 hours. We excluded studies in which participants were admitted to ICUs primarily for the management of GI bleeding and studies that compared different doses, routes, and regimens of one drug in the same class because we were not interested in intraclass effects of drugs. DATA COLLECTION AND ANALYSIS We used standard methodological procedures as recommended by Cochrane. MAIN RESULTS We identified 2292 unique records.We included 129 records reporting on 121 studies, including 12 ongoing studies and two studies awaiting classification.We judged the overall risk of bias of two studies as low. Selection bias was the most relevant risk of bias domain across the included studies, with 78 studies not clearly reporting the method used for random sequence generation. Reporting bias was the domain with least risk of bias, with 12 studies not reporting all outcomes that researchers intended to investigate.Any intervention versus placebo or no prophylaxisIn comparison with placebo, any intervention seems to have a beneficial effect on the occurrence of upper GI bleeding (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.39 to 0.57; moderate certainty of evidence). The use of any intervention reduced the risk of upper GI bleeding by 10% (95% CI -12.0% to -7%). The effect estimate of any intervention versus placebo or no prophylaxis with respect to the occurrence of nosocomial pneumonia, all-cause mortality in the ICU, duration of ICU stay, duration of intubation (all with low certainty of evidence), the number of participants requiring blood transfusions (moderate certainty of evidence), and the units of blood transfused was consistent with benefits and harms. None of the included studies explicitly reported on serious adverse events.Individual interventions versus placebo or no prophylaxisIn comparison with placebo or no prophylaxis, antacids, H2 receptor antagonists, and sucralfate were effective in preventing upper GI bleeding in ICU patients. Researchers found that with H2 receptor antagonists compared with placebo or no prophylaxis, 11% less developed upper GI bleeding (95% CI -0.16 to -0.06; RR 0.50, 95% CI 0.36 to 0.70; 24 studies; 2149 participants; moderate certainty of evidence). Of ICU patients taking antacids versus placebo or no prophylaxis, 9% less developed upper GI bleeding (95% CI -0.17 to -0.00; RR 0.49, 95% CI 0.25 to 0.99; eight studies; 774 participants; low certainty of evidence). Among ICU patients taking sucralfate versus placebo or no prophylaxis, 5% less had upper GI bleeding (95% CI -0.10 to -0.01; RR 0.53, 95% CI 0.32 to 0.88; seven studies; 598 participants; moderate certainty of evidence). The remaining interventions including proton pump inhibitors did not show a significant effect in preventing upper GI bleeding in ICU patients when compared with placebo or no prophylaxis.Regarding the occurrence of nosocomial pneumonia, the effects of H2 receptor antagonists (RR 1.12, 95% CI 0.85 to 1.48; eight studies; 945 participants; low certainty of evidence) and of sucralfate (RR 1.33, 95% CI 0.86 to 2.04; four studies; 450 participants; low certainty of evidence) were consistent with benefits and harms when compared with placebo or no prophylaxis. None of the studies comparing antacids versus placebo or no prophylaxis provided data regarding nosocomial pneumonia.H2 receptor antagonists versus proton pump inhibitorsH2 receptor antagonists and proton pump inhibitors are most commonly used in practice to prevent upper GI bleeding in ICU patients. Proton pump inhibitors significantly more often prevented upper GI bleeding in ICU patients compared with H2 receptor antagonists (RR 2.90, 95% CI 1.83 to 4.58; 18 studies; 1636 participants; low certainty of evidence). When taking H2 receptor antagonists, 4.8% more patients might experience upper GI bleeding (95% CI 2.1% to 9%). Nosocomial pneumonia occurred in similar proportions of participants taking H2 receptor antagonists and participants taking proton pump inhibitors (RR 1.02, 95% CI 0.77 to 1.35; 10 studies; 1256 participants; low certainty of evidence). AUTHORS' CONCLUSIONS This review shows that antacids, sucralfate, and H2 receptor antagonists might be more effective in preventing upper GI bleeding in ICU patients compared with placebo or no prophylaxis. The effect estimates of any treatment versus no prophylaxis on nosocomial pneumonia were consistent with benefits and harms. Evidence of low certainty suggests that proton pump inhibitors might be more effective than H2 receptor antagonists. Therefore, patient-relevant benefits and especially harms of H2 receptor antagonists compared with proton pump inhibitors need to be assessed by larger, high-quality RCTs to confirm the results of previously conducted, smaller, and older studies.
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Affiliation(s)
- Ingrid Toews
- Medical Center, Faculty of Medicine, University of FreiburgEvidence in Medicine / Cochrane GermanyBreisacher Straße 153FreiburgBaden‐WürttembergGermany79110
| | - Aneesh Thomas George
- Christian Medical CollegeCochrane South Asia, Prof. BV Moses Centre for Evidence‐Informed Healthcare and Health PolicyCarman Block II FloorCMC Campus, BagayamVelloreTamil NaduIndia632002
| | - John V Peter
- Christian Medical College & HospitalMedical Intensive Care UnitIda Scudder RoadVelloreTamil NaduIndia632004
| | - Richard Kirubakaran
- Christian Medical CollegeCochrane South Asia, Prof. BV Moses Centre for Evidence‐Informed Healthcare and Health PolicyCarman Block II FloorCMC Campus, BagayamVelloreTamil NaduIndia632002
| | - Luís Eduardo S Fontes
- Petrópolis Medical SchoolDepartment of Evidence‐Based Medicine, Intensive Care, GastroenterologyAv Barao do Rio Branco, 1003PetrópolisRJBrazil25680‐120
| | - Jabez Paul Barnabas Ezekiel
- Christian Medical CollegeCochrane South Asia, Prof. BV Moses Centre for Evidence‐Informed Healthcare and Health PolicyCarman Block II FloorCMC Campus, BagayamVelloreTamil NaduIndia632002
| | - Joerg J Meerpohl
- Medical Center, Faculty of Medicine, University of FreiburgEvidence in Medicine / Cochrane GermanyBreisacher Straße 153FreiburgBaden‐WürttembergGermany79110
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Use acid-suppressing drugs appropriately with an individualized approach to minimize the risk of infection. DRUGS & THERAPY PERSPECTIVES 2018. [DOI: 10.1007/s40267-017-0473-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 02/07/2023]
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Abstract
This narrative review summarises the benefits, risks and appropriate use of acid-suppressing drugs (ASDs), proton pump inhibitors and histamine-2 receptor antagonists, advocating a rationale balanced and individualised approach aimed to minimise any serious adverse consequences. It focuses on current controversies on the potential of ASDs to contribute to infections-bacterial, parasitic, fungal, protozoan and viral, particularly in the elderly, comprehensively and critically discusses the growing body of observational literature linking ASD use to a variety of enteric, respiratory, skin and systemic infectious diseases and complications (Clostridium difficile diarrhoea, pneumonia, spontaneous bacterial peritonitis, septicaemia and other). The proposed pathogenic mechanisms of ASD-associated infections (related and unrelated to the inhibition of gastric acid secretion, alterations of the gut microbiome and immunity), and drug-drug interactions are also described. Both probiotics use and correcting vitamin D status may have a significant protective effect decreasing the incidence of ASD-associated infections, especially in the elderly. Despite the limitations of the existing data, the importance of individualised therapy and caution in long-term ASD use considering the balance of benefits and potential harms, factors that may predispose to and actions that may prevent/attenuate adverse effects is evident. A six-step practical algorithm for ASD therapy based on the best available evidence is presented.
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Kodadek LM, Jones C. Stress Gastritis and Stress Ulcers: Prevention and Treatment. SURGICAL CRITICAL CARE THERAPY 2018:231-239. [DOI: 10.1007/978-3-319-71712-8_21] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Academic Contribution Register] [Indexed: 01/02/2025]
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Sridharan K, Sivaramakrishnan G, Gnanaraj J. Pharmacological interventions for stress ulcer prophylaxis in critically ill patients: a mixed treatment comparison network meta-analysis and a recursive cumulative meta-analysis. Expert Opin Pharmacother 2017; 19:151-158. [DOI: 10.1080/14656566.2017.1419187] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 01/21/2023]
Affiliation(s)
- Kannan Sridharan
- Department of Pharmacology and Therapeutics, College of Medicine and Medical Sciences, Arabian Gulf University, Manama, Bahrain
| | - Gowri Sivaramakrishnan
- Prosthodontics, School of Oral Health, College of Medicine, Nursing and Health Sciences, Fiji National University, Suva, Fiji
| | - Jerome Gnanaraj
- Department of Medicine, Johns Hopkins Bayview Medical Center, School of Medicine, Johns Hopkins University, Baltimore, MD, USA
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Abstract
INTRODUCTION Meta-analyses are considered to be an important source of evidence. This review aims to systematically assess the quality of meta-analyses addressing topics in plastic surgery. METHODS Electronic databases were selected for systematic review. A search was performed focusing on communication addresses containing terms related to plastic surgery, and detailed inclusion criteria were used. Related data were extracted and recorded according to the items of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. To assess the quality of the meta-analyses over time, studies published before and after PRISMA were evaluated. RESULTS A total of 116 meta-analyses were included. There was 1 study that was fully in compliance with the PRISMA items. The main flaws impacting the overall quality of the included studies were in the following areas: structured summary (48%), protocol and registration (2%), full electronic search strategy (35%), risk of bias in individual studies (41%), additional analyses (27%), risk of bias within studies (47%), additional analysis (30%), and funding (47%). Study quality was evaluated using relative risks (RR) with a 95% confidence interval (95% CI); this revealed that there were few significant improvements in adherence to the PRISMA statement after its release, especially in selection (RR, 1.80; 95% CI, 1.08-2.99), results of individual studies (RR, 2.88; 95% CI, 1.41-5.91), synthesis of results (RR, 3.08; 95% CI, 1.32-7.17), and funding (RR, 1.65; 95% CI, 1.21-2.24). CONCLUSIONS There have been measurable improvements in the quality of meta-analyses over recent years. However, several serious deficiencies remain according to the PRISMA statement. Future reviewers should pay more attention to not only reporting the main findings but also encouraging compliance with proper standards.
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Aksan A, Işık H, Radeke HH, Dignass A, Stein J. Systematic review with network meta-analysis: comparative efficacy and tolerability of different intravenous iron formulations for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2017; 45:1303-1318. [PMID: 28326596 DOI: 10.1111/apt.14043] [Citation(s) in RCA: 74] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 10/03/2016] [Revised: 11/01/2016] [Accepted: 02/22/2017] [Indexed: 12/21/2022]
Abstract
BACKGROUND Iron deficiency anaemia (IDA) is a common complication of inflammatory bowel disease (IBD) associated with reduced quality of life and increased hospitalisation rates. While the best way of treating IDA in IBD patients is not clearly established, current European guidelines recommend intravenous iron therapy in IBD patients with severe anaemia or intolerance to oral iron compounds. AIM To compare the efficacy and tolerability of different intravenous iron formulations used to treat IDA in IBD patients in a systematic review and Bayesian network meta-analysis (NMA), PROSPERO registration number: 42016046565. METHODS In June 2016, we systematically searched for studies analysing efficacy and safety of intravenous iron for IDA therapy in IBD. Primary outcome was therapy response, defined as Hb normalisation or increase ≥2 g/dL. RESULTS Five randomised, controlled trials (n = 1143 patients) were included in a network meta-analysis. Only ferric carboxymaltose was significantly more effective than oral iron [OR=1.9, 95% CrI: (1.1;3.2)]. Rank probabilities showed ferric carboxymaltose to be most effective, followed by iron sucrose, iron isomaltose and oral iron. Pooled data from the systematic review (n = 1746 patients) revealed adverse event rates of 12.0%, 15.3%, 12.0%, 17.0% for ferric carboxymaltose, iron sucrose, iron dextran and iron isomaltose respectively. One drug-related serious adverse event (SAE) each was reported for ferric carboxymaltose and iron isomaltoside, and one possibly drug-related SAE for iron sucrose. CONCLUSIONS Ferric carboxymaltose was the most effective intravenous iron formulation, followed by iron sucrose. In addition, ferric carboxymaltose tended to be better tolerated. Thus, nanocolloidal IV iron products exhibit differing therapeutic and safety characteristics and are not interchangeable.
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Affiliation(s)
- A Aksan
- Hacettepe University, Faculty of Health Sciences, Ankara, Turkey.,Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany
| | - H Işık
- Hacettepe University, Faculty of Sciences, Ankara, Turkey
| | - H H Radeke
- Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany.,Pharmazentrum frankfurt, Institute of Pharmacology and Toxicology, Hospital of the Goethe University, Frankfurt/Main, Germany
| | - A Dignass
- Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany.,Agaplesion Markus Krankenhaus, Department of Gastroenterology, Frankfurt/Main, Germany
| | - J Stein
- Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany.,DGD Clinics Sachsenhausen, Department of Gastroenterology and Clinical Nutrition, Frankfurt/Main, Germany
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Brunström M, Eliasson M, Nilsson PM, Carlberg B. Blood pressure treatment levels and choice of antihypertensive agent in people with diabetes mellitus. J Hypertens 2017; 35:453-462. [DOI: 10.1097/hjh.0000000000001183] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 12/20/2022]
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Abstract
Although urgent surgical hematoma evacuation is necessary for most patients with subdural hematoma (SDH), well-orchestrated, evidenced-based, multidisciplinary, postoperative critical care is essential to achieve the best possible outcome. Acute SDH complicates approximately 11% of mild to moderate traumatic brain injuries (TBIs) that require hospitalization, and approximately 20% of severe TBIs. Acute SDH usually is related to a clear traumatic event, but in some cases can occur spontaneously. Management of SDH in the setting of TBI typically conforms to the Advanced Trauma Life Support protocol with airway taking priority, and management breathing and circulation occurring in parallel rather than sequence.
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Affiliation(s)
- Fawaz Al-Mufti
- Endovascular Surgical Neuroradiology Program, Rutgers University-New Jersey Medical School, Newark, NJ, USA
| | - Stephan A Mayer
- Department of Neurology, Henry Ford Health System, 2799 W Grand Boulevard, Detroit, MI 48202, USA.
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Satoh T, Isozaki O, Suzuki A, Wakino S, Iburi T, Tsuboi K, Kanamoto N, Otani H, Furukawa Y, Teramukai S, Akamizu T. 2016 Guidelines for the management of thyroid storm from The Japan Thyroid Association and Japan Endocrine Society (First edition). Endocr J 2016; 63:1025-1064. [PMID: 27746415 DOI: 10.1507/endocrj.ej16-0336] [Citation(s) in RCA: 99] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Indexed: 11/23/2022] Open
Abstract
Thyroid storm is an endocrine emergency which is characterized by multiple organ failure due to severe thyrotoxicosis, often associated with triggering illnesses. Early suspicion, prompt diagnosis and intensive treatment will improve survival in thyroid storm patients. Because of its rarity and high mortality, prospective intervention studies for the treatment of thyroid storm are difficult to carry out. We, the Japan Thyroid Association and Japan Endocrine Society taskforce committee, previously developed new diagnostic criteria and conducted nationwide surveys for thyroid storm in Japan. Detailed analyses of clinical data from 356 patients revealed that the mortality in Japan was still high (∼11%) and that multiple organ failure and acute heart failure were common causes of death. In addition, multimodal treatment with antithyroid drugs, inorganic iodide, corticosteroids and beta-adrenergic antagonists has been suggested to improve mortality of these patients. Based on the evidence obtained by nationwide surveys and additional literature searches, we herein established clinical guidelines for the management of thyroid storm. The present guideline includes 15 recommendations for the treatment of thyrotoxicosis and organ failure in the central nervous system, cardiovascular system, and hepato-gastrointestinal tract, admission criteria for the intensive care unit, and prognostic evaluation. We also proposed preventive approaches to thyroid storm, roles of definitive therapy, and future prospective trial plans for the treatment of thyroid storm. We hope that this guideline will be useful for many physicians all over the world as well as in Japan in the management of thyroid storm and the improvement of its outcome.
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Affiliation(s)
- Tetsurou Satoh
- Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma 371-8511, Japan
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Hammond DA, Kathe N, Shah A, Martin BC. Cost-Effectiveness of Histamine 2 Receptor Antagonists Versus Proton Pump Inhibitors for Stress Ulcer Prophylaxis in Critically Ill Patients. Pharmacotherapy 2016; 37:43-53. [PMID: 27809338 DOI: 10.1002/phar.1859] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 12/15/2022]
Abstract
STUDY OBJECTIVE To determine the cost-effectiveness of stress ulcer prophylaxis with histamine2 receptor antagonists (H2RAs) versus proton pump inhibitors (PPIs) in critically ill and mechanically ventilated adults. DESIGN A decision analytic model estimating the costs and effectiveness of stress ulcer prophylaxis (with H2RAs and PPIs) from a health care institutional perspective. PATIENTS Adult mixed intensive care unit (ICU) population who received an H2RA or PPI for up to 9 days. MEASUREMENTS AND MAIN RESULTS Effectiveness measures were mortality during the ICU stay and complication rate. Costs (2015 U.S. dollars) were combined to include medication regimens and untoward events associated with stress ulcer prophylaxis (pneumonia, Clostridium difficile infection, and stress-related mucosal bleeding). Costs and probabilities for complications and mortality from complications came from randomized controlled trials and observational studies. A base case scenario was developed with pooled data from an observational study and meta-analysis of randomized controlled trials. Scenarios based on observational and meta-analysis data alone were evaluated. Outcomes were expected and incremental costs, mortalities, and complication rates. Univariate sensitivity analyses were conducted to determine the influence of inputs on cost, mortality, and complication rates. Monte Carlo simulations evaluated second-order uncertainty. In the base case scenario, the costs, complication rates, and mortality rates were $9039, 17.6%, and 2.50%, respectively, for H2RAs and $11,249, 22.0%, and 3.34%, respectively, for PPIs, indicating that H2RAs dominated PPIs. The observational study-based model provided similar results; however, in the meta-analysis-based model, H2RAs had a cost of $8364 and mortality rate of 3.2% compared with $7676 and 2.0%, respectively, for PPIs. At a willingness-to-pay threshold of $100,000/death averted, H2RA therapy was superior or preferred 70.3% in the base case and 97.0% in the observational study-based scenario. PPI therapy was preferred 87.2% in the meta-analysis-based scenario. CONCLUSION Providing stress ulcer prophylaxis with H2RA therapy may reduce costs, increase survival, and avoid complications compared with PPI therapy. This finding is highly sensitive to the pneumonia and stress-related mucosal bleeding rates and whether observational data are used to inform the model.
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Affiliation(s)
- Drayton A Hammond
- Department of Pharmacy Practice, University of Arkansas for Medical Sciences, College of Pharmacy, Little Rock, Arkansas
| | - Niranjan Kathe
- Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, College of Pharmacy, Little Rock, Arkansas
| | - Anuj Shah
- Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, College of Pharmacy, Little Rock, Arkansas
| | - Bradley C Martin
- Department of Pharmacy Practice, University of Arkansas for Medical Sciences, College of Pharmacy, Little Rock, Arkansas.,Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, College of Pharmacy, Little Rock, Arkansas
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The Impact of Excluding Trials from Network Meta-Analyses - An Empirical Study. PLoS One 2016; 11:e0165889. [PMID: 27926924 PMCID: PMC5142775 DOI: 10.1371/journal.pone.0165889] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 01/31/2016] [Accepted: 10/01/2016] [Indexed: 01/09/2023] Open
Abstract
Network meta-analysis (NMA) expands the scope of a conventional pairwise meta-analysis to simultaneously compare multiple treatments, which has an inherent appeal for clinicians, patients, and policy decision makers. Two recent reports have shown that the impact of excluding a treatment on NMAs can be substantial. However, no one has assessed the impact of excluding a trial from NMAs, which is important because many NMAs selectively include trials in the analysis. This article empirically examines the impact of trial exclusion using both the arm-based (AB) and contrast-based (CB) approaches, by reanalyzing 20 published NMAs involving 725 randomized controlled trials and 449,325 patients. For the population-averaged absolute risk estimates using the AB approach, the average fold changes across all networks ranged from 1.004 (with standard deviation 0.004) to 1.072 (with standard deviation 0.184); while the maximal fold changes ranged from 1.032 to 2.349. In 12 out of 20 NMAs, a 1.20-fold or larger change is observed in at least one of the population-averaged absolute risk estimates. In addition, while excluding a trial can substantially change the estimated relative effects (e.g., log odds ratios), there is no systematic difference in terms of changes between the two approaches. Changes in treatment rankings are observed in 7 networks and changes in inconsistency are observed in 3 networks. We do not observe correlations between changes in treatment effects, treatment rankings and inconsistency. Finally, we recommend rigorous inclusion and exclusion criteria, logical study selection process, and reasonable network geometry to ensure robustness and generalizability of the results of NMAs.
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Reilly J, Fennerty MB. Stress Ulcer Prophylaxis: The Prevention of Gastrointestinal Bleeding and the Development of Nosocomial Infections in Critically Ill Patients. J Pharm Pract 2016. [DOI: 10.1177/089719009801100603] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 01/15/2023]
Affiliation(s)
| | - M. Brian Fennerty
- Section Chief of Gastroenterology, Oregon Health Sciences University, Portland, Oregon
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Scarpignato C, Gatta L, Zullo A, Blandizzi C. Effective and safe proton pump inhibitor therapy in acid-related diseases - A position paper addressing benefits and potential harms of acid suppression. BMC Med 2016; 14:179. [PMID: 27825371 PMCID: PMC5101793 DOI: 10.1186/s12916-016-0718-z] [Citation(s) in RCA: 274] [Impact Index Per Article: 30.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 08/13/2016] [Accepted: 10/14/2016] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The introduction of proton pump inhibitors (PPIs) into clinical practice has revolutionized the management of acid-related diseases. Studies in primary care and emergency settings suggest that PPIs are frequently prescribed for inappropriate indications or for indications where their use offers little benefit. Inappropriate PPI use is a matter of great concern, especially in the elderly, who are often affected by multiple comorbidities and are taking multiple medications, and are thus at an increased risk of long-term PPI-related adverse outcomes as well as drug-to-drug interactions. Herein, we aim to review the current literature on PPI use and develop a position paper addressing the benefits and potential harms of acid suppression with the purpose of providing evidence-based guidelines on the appropriate use of these medications. METHODS The topics, identified by a Scientific Committee, were assigned to experts selected by three Italian Scientific Societies, who independently performed a systematic search of the relevant literature using Medline/PubMed, Embase, and the Cochrane databases. Search outputs were distilled, paying more attention to systematic reviews and meta-analyses (where available) representing the best evidence. The draft prepared on each topic was circulated amongst all the members of the Scientific Committee. Each expert then provided her/his input to the writing, suggesting changes and the inclusion of new material and/or additional relevant references. The global recommendations were then thoroughly discussed in a specific meeting, refined with regard to both content and wording, and approved to obtain a summary of current evidence. RESULTS Twenty-five years after their introduction into clinical practice, PPIs remain the mainstay of the treatment of acid-related diseases, where their use in gastroesophageal reflux disease, eosinophilic esophagitis, Helicobacter pylori infection, peptic ulcer disease and bleeding as well as, and Zollinger-Ellison syndrome is appropriate. Prevention of gastroduodenal mucosal lesions (and symptoms) in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet therapies and carrying gastrointestinal risk factors also represents an appropriate indication. On the contrary, steroid use does not need any gastroprotection, unless combined with NSAID therapy. In dyspeptic patients with persisting symptoms, despite successful H. pylori eradication, short-term PPI treatment could be attempted. Finally, addition of PPIs to pancreatic enzyme replacement therapy in patients with refractory steatorrhea may be worthwhile. CONCLUSIONS Overall, PPIs are irreplaceable drugs in the management of acid-related diseases. However, PPI treatment, as any kind of drug therapy, is not without risk of adverse effects. The overall benefits of therapy and improvement in quality of life significantly outweigh potential harms in most patients, but those without clear clinical indication are only exposed to the risks of PPI prescription. Adhering with evidence-based guidelines represents the only rational approach to effective and safe PPI therapy. Please see related Commentary: doi: 10.1186/s12916-016-0724-1 .
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Affiliation(s)
- Carmelo Scarpignato
- Clinical Pharmacology & Digestive Pathophysiology Unit, Department of Clinical & Experimental Medicine, University of Parma, Maggiore University Hospital, Cattani Pavillon, I-43125, Parma, Italy.
| | - Luigi Gatta
- Clinical Pharmacology & Digestive Pathophysiology Unit, Department of Clinical & Experimental Medicine, University of Parma, Maggiore University Hospital, Cattani Pavillon, I-43125, Parma, Italy
- Gastroenterology & Endoscopy Unit, Versilia Hospital, Azienda USL Toscana Nord Ovest, Lido di Camaiore, Italy
| | - Angelo Zullo
- Division of Gastroenterology & Digestive Endoscopy, Nuovo Regina Elena Hospital, Rome, Italy
| | - Corrado Blandizzi
- Division of Pharmacology, Department of Clinical & Experimental Medicine, University of Pisa, Pisa, Italy
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Paxton BE, Arepally A, Alley CL, Kim CY. Bariatric Embolization: Pilot Study on the Impact of Gastroprotective Agents and Arterial Distribution on Ulceration Risk and Efficacy in a Porcine Model. J Vasc Interv Radiol 2016; 27:1923-1928. [PMID: 27717647 DOI: 10.1016/j.jvir.2016.07.021] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 02/15/2016] [Revised: 07/16/2016] [Accepted: 07/24/2016] [Indexed: 02/07/2023] Open
Abstract
PURPOSE To assess whether the number of fundal arteries embolized and use of gastroprotective agents have an impact on ghrelin suppression and gastric ulceration rates. MATERIALS AND METHODS Twenty-two healthy, growing swine (mean, 38.4 kg; range, 30.3-47.0 kg) were evaluated. Six control swine underwent a sham procedure. Gastric embolization was performed by the infusion of 40-µm microspheres selectively into some or all gastric arteries supplying the gastric fundus. In group 1, 6 swine underwent embolization of all 4 arteries to the gastric fundus. In group 2, 5 swine underwent embolization of 2 gastric fundal arteries. In group 3, 5 swine underwent embolization of 1 gastric fundal artery. Animals in groups 2 and 3 were treated with gastroprotective agents (sucralfate and omeprazole). Weight and fasting plasma ghrelin levels were analyzed at baseline and at week 4. Upon animal euthanasia, gross analysis was performed for identification of ulcers. RESULTS Only group 1 animals exhibited changes in serum ghrelin levels that rendered them significantly lower than those in control animals (P = .049). Group 3 animals exhibited marked elevations in serum ghrelin levels compared with control animals (P = .001). Gross pathologic evaluation revealed 0 ulcers in the control animals, 3 ulcers (50%) in group 1, 2 ulcers (40%) in group 2, and 2 ulcers (40%) in group 3. CONCLUSIONS Administration of gastroprotective agents and embolization of fewer arteries to the gastric fundus did not prevent gastric ulceration in treated animals. Only animals that underwent embolization of all gastric arteries exhibited significant decreases in serum ghrelin levels.
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Affiliation(s)
- Ben E Paxton
- Division of Interventional Radiology, Prescott Radiologists, Prescott, Arizona
| | - Aravind Arepally
- Division of Interventional Radiology, Piedmont Healthcare, Atlanta, Georgia
| | | | - Charles Y Kim
- Division of Vascular and Interventional Radiology, Duke University Medical Center, Box 3808, 2301 Erwin Rd., Durham, NC 27710
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Another Piece to the Puzzle: "A Riddle Wrapped in a Mystery Inside an Enigma"-Winston Churchill. Pediatr Crit Care Med 2016; 17:1001-1003. [PMID: 27705986 DOI: 10.1097/pcc.0000000000000928] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Indexed: 11/25/2022]
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Abstract
Stress-related mucosal damage (SRMD) is an erosive process of the gastroduodenum that occurs frequently in critically ill patients. Symptomatic lesions may range from overt bleeding (by hematemesis, melena, bloody or coffee ground aspirates, or hematochezia) to clinically significant hemorrhage (hypotension, tachycardia, or acute anemia requiring transfusion). SRMD is caused by mucosal ischemia that produces an imbalance between injurious factors and the protective mechanisms. Common patient risk factors include mechanical ventilation, coagulopathy, shock, hepatic dysfunction, renal dysfunction, thermal injury, trauma, kidney or liver transplant, head injury or spinal cord injury, recent gastrointestinal hemorrhage, and pharmacologic interventions. Stress ulcer prophylaxis may be provided by administering one of the following pharmacologic agents: an antacid, a histamine2 receptor antagonist, sucralfate, or a proton pump inhibitor. All agents possess equal efficacies but differ in their mechanisms of action, adverse event profile, drug interactions, monitoring requirements, costs, and personnel requirements for preparation and administration. Implementation of institution-specific protocols for stress ulcer prophylaxis provides cost minimization by maximizing appropriate drug usage.
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Affiliation(s)
- Robert MacLaren
- School of Pharmacy, University of Colorado Health Sciences Center, 4200 East Ninth Avenue (C238), Denver, CO 80262,
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Abstract
POLICY POINTS Currently, there is massive production of unnecessary, misleading, and conflicted systematic reviews and meta-analyses. Instead of promoting evidence-based medicine and health care, these instruments often serve mostly as easily produced publishable units or marketing tools. Suboptimal systematic reviews and meta-analyses can be harmful given the major prestige and influence these types of studies have acquired. The publication of systematic reviews and meta-analyses should be realigned to remove biases and vested interests and to integrate them better with the primary production of evidence. CONTEXT Currently, most systematic reviews and meta-analyses are done retrospectively with fragmented published information. This article aims to explore the growth of published systematic reviews and meta-analyses and to estimate how often they are redundant, misleading, or serving conflicted interests. METHODS Data included information from PubMed surveys and from empirical evaluations of meta-analyses. FINDINGS Publication of systematic reviews and meta-analyses has increased rapidly. In the period January 1, 1986, to December 4, 2015, PubMed tags 266,782 items as "systematic reviews" and 58,611 as "meta-analyses." Annual publications between 1991 and 2014 increased 2,728% for systematic reviews and 2,635% for meta-analyses versus only 153% for all PubMed-indexed items. Currently, probably more systematic reviews of trials than new randomized trials are published annually. Most topics addressed by meta-analyses of randomized trials have overlapping, redundant meta-analyses; same-topic meta-analyses may exceed 20 sometimes. Some fields produce massive numbers of meta-analyses; for example, 185 meta-analyses of antidepressants for depression were published between 2007 and 2014. These meta-analyses are often produced either by industry employees or by authors with industry ties and results are aligned with sponsor interests. China has rapidly become the most prolific producer of English-language, PubMed-indexed meta-analyses. The most massive presence of Chinese meta-analyses is on genetic associations (63% of global production in 2014), where almost all results are misleading since they combine fragmented information from mostly abandoned era of candidate genes. Furthermore, many contracting companies working on evidence synthesis receive industry contracts to produce meta-analyses, many of which probably remain unpublished. Many other meta-analyses have serious flaws. Of the remaining, most have weak or insufficient evidence to inform decision making. Few systematic reviews and meta-analyses are both non-misleading and useful. CONCLUSIONS The production of systematic reviews and meta-analyses has reached epidemic proportions. Possibly, the large majority of produced systematic reviews and meta-analyses are unnecessary, misleading, and/or conflicted.
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Affiliation(s)
- John P A Ioannidis
- Stanford University School of Medicine, Stanford University School of Humanities and Sciences, Meta-Research Innovation Center at Stanford (METRICS), Stanford University.
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Pneumonia prevention in intubated patients given sucralfate versus proton-pump inhibitors and/or histamine II receptor blockers. J Surg Res 2016; 206:398-404. [PMID: 27884335 DOI: 10.1016/j.jss.2016.08.028] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 04/08/2016] [Revised: 06/07/2016] [Accepted: 08/04/2016] [Indexed: 11/19/2022]
Abstract
BACKGROUND Ventilator-associated pneumonia (VAP) is a common cause of infectious morbidity and mortality in the intensive care unit (ICU). The type of stress-ulcer prophylaxis (SUP) given to ventilated patients may, in part, be responsible. We observed an increase in VAP as ventilator bundle compliance increased and a decrease in VAP when bundle compliance decreased. We reasoned that SUP which raises gastric pH such as proton-pump inhibitors (PPIs) and histamine II (H2) receptor antagonists as opposed to SUP which does not raise pH such as sucralfate (S) may be responsible and also may alter the causative bacteria. MATERIALS AND METHODS This is a single-center retrospective cohort analysis of all intubated, adult surgical patients admitted to the surgical ICU between January and June during the 3-y period 2012-2014. Demographics, APACHE II, Injury Severity Score, VAP occurrence, culprit bacteria, ventilator days, and ICU days were recorded based on the type of SUP given. RESULTS There were 45 instances of VAP in the 504 study patients, 33 in the PPI/H2 group, and 12 in the S group (P < 0.01). VAP per 1000 ventilator days were 10.2 for PPI/H2 and 3.7 for S (P < 0.01). Culprit bacteria were mostly Pseudomonas, gram-negative bacilli, and methicillin-resistant Staphylococcus aureus in PPI/H2 patients (n = 29) compared with oropharyngeal flora in S patients (n = 6; P < 0.001). CONCLUSIONS There was a substantial difference in VAP occurrence and in the culprit bacteria between S and PPI/H2 treated patients due perhaps to gastric alkalization.
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Abstract
Ventilator-associated pneumonia is the most frequent intensive care unit (ICU)-related infection in patients requiring mechanical ventilation. In contrast to other ICU-related infections, which have a low mortality rate, the mortality rate for ventilator-associated pneumonia ranges from 20% to 50%. These clinically significant infections prolong duration of mechanical ventilation and ICU length of stay, underscoring the financial burden these infections impose on the health care system. The causes of ventilator-associated pneumonia are varied and differ across different patient populations and different types of ICUs. This varied presentation underscores the need for the intensivist treating the patient with ventilator-associated pneumonia to have a clear knowledge of the ambient microbiologic flora in their ICU. Prevention of this disease process is of paramount importance and requires a multifaceted approach. Once a diagnosis of ventilator-associated pneumonia is suspected, early broad-spectrum antibiotic administration decreases morbidity and mortality and should be based on knowledge of the sensitivities of common infecting organisms in the ICU. De-escalation of therapy, once final culture results are available, is necessary to minimize development of resistant pathogens. Duration of therapy should be based on the patient’s clinical response, and every effort should be made to minimize duration of therapy, thus further minimizing the risk of resistance.
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Affiliation(s)
- Kimberly A Davis
- Department of Surgery, Division of Trauma, Surgical Critical Care and Burns, Loyola University Medical Center, Maywood, IL, USA.
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Akpinar B, Săgbaş E, Güden M, Kemertaş K, Sönmez B, Bayindir O, Demiroğlu C. Acute Gastrointestinal Complications after Open Heart Surgery. Asian Cardiovasc Thorac Ann 2016. [DOI: 10.1177/021849230000800204] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 11/17/2022]
Abstract
Retrospective analysis revealed that 24 of 4401 adult patients (0.5%) developed severe gastrointestinal complications after open heart surgery during a 3-year period from January 1995. There were 4 women (17%) and 20 men (83%). Mean age was 61.7 ± 2.02 years. Gastrointestinal bleeding (33.3%), mesenteric ischemia (20.8%), pancreatitis (20.8%), hepatic dysfunction (16.7%), and cholecystitis (16.7%) were the most common complications. Mortality was 41.7% (10 patients). During the same period, mortality in the patients who did not develop gastrointestinal complications was 1.89% (p < 0.0001). Emergency basis, reoperation, combined operations, peripheral vascular disease, diabetes mellitus, chronic lung disease, and impaired left ventricle function were found to be risk factors for the development of postoperative gastrointestinal complications.
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Affiliation(s)
| | | | | | - Kubilay Kemertaş
- Department of General Surgery Kadir Has University Medical Faculty Florence Nightingale Hospital Istanbul, Turkey
| | | | - Osman Bayindir
- Department of Anesthesia Kadir Has University Medical Faculty Florence Nightingale Hospital Istanbul, Turkey
| | - Cem'i Demiroğlu
- Department of Cardiology Kadir Has University Medical Faculty Florence Nightingale Hospital Istanbul, Turkey
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Hurley JC. Inapparent Outbreaks of Ventilator-Associated Pneumonia An Ecologic Analysis of Prevention and Cohort Studies. Infect Control Hosp Epidemiol 2016; 26:374-90. [PMID: 15865274 DOI: 10.1086/502555] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Academic Contribution Register] [Indexed: 01/15/2023]
Abstract
AbstractObjective:To compare ventilator-associated pneumonia (VAP) rates and patterns of isolates across studies of antibiotic and non-antibiotic methods for preventing VAP.Design:With the use of 42 cohort study groups as the reference standard, the prevalence of VAP was modeled in two linear regressions: one with the control groups and the other with the intervention groups of 96 VAP prevention studies. The proportion of patients admitted with trauma and the VAP diagnostic criteria were used as ecologic correlates. Also, the patterns of pathogenic isolates were available for 117 groups.Results:In the first regression model, the VAP rates for the control groups of antibiotic-based prevention studies were at least 18 (CI95, 12 to 24) per 100 patients higher than those in the cohort study groups (P< .001). By contrast, comparisons of cohort study groups with all other control and intervention groups in the first and second regression models yielded differences that were less than 6 per 100 and not significant (P> .05). For control groups with VAP rates greater than 35%, the patterns of VAP isolates, such as the proportion ofStaphylococcus aureus,more closely resembled those in the corresponding intervention groups than in the cohort groups.Conclusions:The rates of VAP in the control groups of the antibiotic prevention studies were significantly higher than expected and the patterns of pathogenic isolates were unusual. These observations suggest that inapparent outbreaks of VAP occurred in these studies. The possibility remains that antibiotic-based VAP prevention presents a major cross-infection hazard.
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Affiliation(s)
- James C Hurley
- Infection Control Committees of St. John of God Hospital and Ballarat Health Services, Ballarat, Victoria, Australia.
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Ye ZK, Liu Y, Cui XL, Liu LH. Critical Appraisal of the Quality of Clinical Practice Guidelines for Stress Ulcer Prophylaxis. PLoS One 2016; 11:e0155020. [PMID: 27152836 PMCID: PMC4859569 DOI: 10.1371/journal.pone.0155020] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 10/07/2015] [Accepted: 04/22/2016] [Indexed: 12/28/2022] Open
Abstract
Background and Objective 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. Methods 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. Results 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. Conclusions 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.
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Affiliation(s)
- Zhi-Kang Ye
- Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
| | - Ying Liu
- Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
| | - Xiang-Li Cui
- Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
| | - Li-Hong Liu
- Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
- * E-mail:
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Abstract
Ventilator-associated pneumonia (VAP) is the most frequently occurring nosocomial infection, accounting for considerable morbidity and mortality. Diagnosis can be difficult, creating important therapeutic challenges for intensivists. Early therapy is important in maximizing outcomes, but inappropriate antibacterial treatment has its own risks. A balance needs to be struck between the necessary therapeutic benefits and the negative effects (selection of resistant pathogens, costs, and adverse effects) of antibacterials. Several studies have indicated, in various groups of critically ill patients including those with VAP, that starting treatment with an ineffective antibacterial can increase hospital and intensive care unit length of stay and mortality. When the responsible microorganisms cannot be defined, it may be better to start treatment with a broad-spectrum antibacterial regimen, taking into account individual patient factors and local bacteriology patterns, including antibacterial resistance. As soon as the nature of the pathogen has been defined, the antibacterial agent(s) should be modified accordingly, with the primary aim to reduce the antibacterial spectrum. The optimal duration of therapy is controversial and probably best tailored to the individual patient depending on clinical response and resolution of the factors used to diagnose VAP in that patient. Consultation with an infectious disease specialist may facilitate these therapeutic decisions. With the high morbidity and mortality associated with VAP, prevention is an important issue. General measures include adequate hand hygiene. Physicians must be aware of the risk factors for VAP and of accepted and effective strategies of prevention.
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Affiliation(s)
- Jean-Louis Vincent
- Department of Intensive Care Medicine, Erasme Hospital, Free University of Brussels, Brussels, Belgium
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Affiliation(s)
- Shoshana J Herzig
- Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA, USA. .,Harvard Medical School, Boston, MA, USA.
| | - Robert J Nardino
- Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, USA
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Riaz IB, Khan MS, Riaz H, Goldberg RJ. Disorganized Systematic Reviews and Meta-analyses: Time to Systematize the Conduct and Publication of These Study Overviews? Am J Med 2016; 129:339.e11-8. [PMID: 26522792 DOI: 10.1016/j.amjmed.2015.10.009] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Academic Contribution Register] [Received: 09/09/2015] [Revised: 10/09/2015] [Accepted: 10/09/2015] [Indexed: 10/22/2022]
Abstract
The number of meta-analyses published annually has increased more than 20-fold between 1994 (n = 386) and 2014 (n = 8203). In examining how much of this increase in meta-analysis publication has genuinely represented novel contributions to clinical medicine and public health, it became clear that there was an abundance of redundant and disorganized meta-analyses, creating confusion and generating considerable debate. Ironically, meta-analyses, which should prevent redundant research, have become a victim of it. Recently, 17 meta-analyses were published based on the results of only 3 randomized controlled trials that studied the role of transcatheter closure of patent foramen ovale for prevention of cryptogenic stroke. In our search of the published literature, we identified at least 10 topics that were the subject of 10 meta-analyses. In the context of overlapping meta-analyses, one questions what needs to be done to put this "runaway train" back on track. In this review we examine the practice of redundant meta-analyses and the reasons for its disturbing "popularity." The registration of systematic reviews should be mandatory in prospective registries, such as PROSPERO, and the PRISMA checklist should be updated to incorporate new evidence and mandate the reference of previously published reviews and rationale for any new study.
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Affiliation(s)
| | | | - Haris Riaz
- Department of Medicine, Cleveland Clinic, Ohio
| | - Robert J Goldberg
- Division of Epidemiology, Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester
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Rosen L, Suhami R. The art and science of study identification: a comparative analysis of two systematic reviews. BMC Med Res Methodol 2016; 16:24. [PMID: 26911333 PMCID: PMC4766738 DOI: 10.1186/s12874-016-0118-2] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Academic Contribution Register] [Received: 10/08/2015] [Accepted: 02/02/2016] [Indexed: 12/29/2022] Open
Abstract
BACKGROUND Systematic reviews (SRs) form the foundation for guidelines and evidence-based policy in medicine and public health. Although similar systematic reviews may include non-identical sets of studies, and it is recognized that different sets of studies may lead to different conclusions, little work has been published on why SR study cohorts differ. METHODS We took advantage of concurrent publication of two SRs on the same topic - prevention of child exposure to tobacco smoke - to understand why study cohorts differed in the two reviews. We identified all studies included in just one review, investigated validity of specified reasons for exclusions, and, using database records, explored reasons for study non-identification. We assessed review methods and discordancy, and attempted to assess whether changes in study cohorts would have changed conclusions. RESULTS Sixty-one studies were included in the two reviews. Thirty-five studies were present in just one review; of these, twenty were identified and excluded by the parallel review. Omissions were due to: review scope (9 studies, 26%), outcomes of interest not measured (8 studies, 23%), exclusion of reports with inadequate reporting (6 studies, 17%), mixed or unclear reasons (3 studies, 8%), search strategies concerning filters, tagging, and keywords (3 studies, 8%), search strategies regarding sources (PUBMED not searched) (2 studies, 6%); discordant interpretation of same eligibility criteria (2 studies, 6%), and non-identification due to non-specific study topic (2 studies, 6%). Review conclusions differed, but were likely due to differences in synthesis methods, not differences in study cohorts. CONCLUSIONS The process of study identification for SRs is part art and part science. While some differences are due to differences in review scope, outcomes measured, or reporting practices, others are caused by search methods or discrepancies in reviewer interpretations. Different study cohorts may or may not be a cause of differing SR results. Completeness of SR study cohorts could be enhanced by 1 - independent identification of studies by at least two reviewers, as recommended by recent guidelines, 2 - searching PUBMED with free-text keywords in addition to MEDLINE to identify recent studies, and 3 - Using validated search filters.
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Affiliation(s)
- Laura Rosen
- Deparment of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, 69978, Israel.
| | - Ruth Suhami
- Gitter-Smolarz Library of Life Sciences and Medicine, Tel Aviv University, Ramat Aviv, 69978, Israel.
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