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1.
Clin Microbiol Rev ; 29(1): 59-103, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26598385

ABSTRACT

BACKGROUND: Bloodstream infection (BSI) is a major cause of morbidity and mortality throughout the world. Rapid identification of bloodstream pathogens is a laboratory practice that supports strategies for rapid transition to direct targeted therapy by providing for timely and effective patient care. In fact, the more rapidly that appropriate antimicrobials are prescribed, the lower the mortality for patients with sepsis. Rapid identification methods may have multiple positive impacts on patient outcomes, including reductions in mortality, morbidity, hospital lengths of stay, and antibiotic use. In addition, the strategy can reduce the cost of care for patients with BSIs. OBJECTIVES: The purpose of this review is to evaluate the evidence for the effectiveness of three rapid diagnostic practices in decreasing the time to targeted therapy for hospitalized patients with BSIs. The review was performed by applying the Centers for Disease Control and Prevention's (CDC's) Laboratory Medicine Best Practices Initiative (LMBP) systematic review methods for quality improvement (QI) practices and translating the results into evidence-based guidance (R. H. Christenson et al., Clin Chem 57:816-825, 2011, http://dx.doi.org/10.1373/clinchem.2010.157131). SEARCH STRATEGY: A comprehensive literature search was conducted to identify studies with measurable outcomes. A search of three electronic bibliographic databases (PubMed, Embase, and CINAHL), databases containing "gray" literature (unpublished academic, government, or industry evidence not governed by commercial publishing) (CIHI, NIHR, SIGN, and other databases), and the Cochrane database for English-language articles published between 1990 and 2011 was conducted in July 2011. DATES OF SEARCH: The dates of our search were from 1990 to July 2011. SELECTION CRITERIA: Animal studies and non-English publications were excluded. The search contained the following medical subject headings: bacteremia; bloodstream infection; time factors; health care costs; length of stay; morbidity; mortality; antimicrobial therapy; rapid molecular techniques, polymerase chain reaction (PCR); in situ hybridization, fluorescence; treatment outcome; drug therapy; patient care team; pharmacy service, hospital; hospital information systems; Gram stain; pharmacy service; and spectrometry, mass, matrix-assisted laser desorption-ionization. Phenotypic as well as the following key words were searched: targeted therapy; rapid identification; rapid; Gram positive; Gram negative; reduce(ed); cost(s); pneumoslide; PBP2; tube coagulase; matrix-assisted laser desorption/ionization time of flight; MALDI TOF; blood culture; EMR; electronic reporting; call to provider; collaboration; pharmacy; laboratory; bacteria; yeast; ICU; and others. In addition to the electronic search being performed, a request for unpublished quality improvement data was made to the clinical laboratory community. MAIN RESULTS: Rapid molecular testing with direct communication significantly improves timeliness compared to standard testing. Rapid phenotypic techniques with direct communication likely improve the timeliness of targeted therapy. Studies show a significant and homogeneous reduction in mortality associated with rapid molecular testing combined with direct communication. AUTHORS' CONCLUSIONS: No recommendation is made for or against the use of the three assessed practices of this review due to insufficient evidence. The overall strength of evidence is suggestive; the data suggest that each of these three practices has the potential to improve the time required to initiate targeted therapy and possibly improve other patient outcomes, such as mortality. The meta-analysis results suggest that the implementation of any of the three practices may be more effective at increasing timeliness to targeted therapy than routine microbiology techniques for identification of the microorganisms causing BSIs. Based on the included studies, results for all three practices appear applicable across multiple microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), Candida species, and Enterococcus species.


Subject(s)
Catheter-Related Infections/diagnosis , Catheter-Related Infections/drug therapy , Diagnostic Tests, Routine/methods , Practice Guidelines as Topic , Precision Medicine/methods , Sepsis/diagnosis , Sepsis/drug therapy , Humans , Inpatients , Time Factors
2.
Clin Biochem ; 48(4-5): 204-12, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25661303

ABSTRACT

OBJECTIVES: This article is a systematic review of the effectiveness of four practices (assay selection, decision point cardiac troponin (cTn) threshold selection, serial testing, and point of care testing) for improving the diagnostic accuracy Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) in the Emergency Department. DESIGN AND METHODS: The CDC-funded Laboratory Medicine Best Practices (LMBP) Initiative systematic review method for quality improvement practices was used. RESULTS: The current ACC/AHA guidelines recommend using cardiac troponin assays with a 99th percentile upper reference limit (URL) diagnostic threshold to diagnose NSTEMI. The evidence in this systematic review indicates that contemporary sensitive cTn assays meet the assay profile requirements (sensitivity, specificity, PPV, and NPV) to more accurately diagnose NSTEMI than alternate tests. Additional biomarkers did not increase diagnostic effectiveness of cTn assays. Sensitivity, specificity, and NPV were consistently high and low PPV improved with serial sampling. Evidence for use of point of care cTn testing was insufficient to make recommendation, though some evidence suggests that use may result in reduction to patient length of stay and costs. CONCLUSIONS: Based on the review of and the LMBP(TM) A-6 Method criteria, we recommend the use of cardiac troponin assays without additional biomarkers using the 99th percentile URL as the clinical diagnostic threshold for the diagnosis of NSTEMI. We recommend serial sampling with one sample at presentation and at least one additional second sample taken at least 6h later to identify a rise or fall in the troponin level. No recommendation is made either for or against the use of point of care tests. DISCLAIMER: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry (CDC/ATSDR).


Subject(s)
Emergency Service, Hospital/standards , Myocardial Infarction/blood , Myocardial Infarction/diagnosis , Biomarkers/blood , Humans , Practice Guidelines as Topic/standards , Troponin/blood , Troponin I/blood , Troponin T/blood
4.
Clin Biochem ; 45(13-14): 1012-32, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22968086

ABSTRACT

OBJECTIVE: To complete a systematic review of emergency department (ED) practices for reducing hemolysis in blood samples sent to the clinical laboratory for testing. RESULTS: A total of 16 studies met the review inclusion criteria (12 published and 4 unpublished). All 11 studies comparing new straight needle venipuncture with IV starts found a reduction in hemolysis rates, [average risk ratio of 0.16 (95% CI=0.11-0.24)]. Four studies on the effect of venipuncture location showed reduced hemolysis rates for the antecubital site [average risk ratio of 0.45 (95% CI=0.35-0.57]. CONCLUSIONS: Use of new straight needle venipuncture instead of IV starts is effective at reducing hemolysis rates in EDs, and is recommended as an evidence-based best practice. The overall strength of evidence rating is high and the effect size is substantial. Unpublished studies made an important contribution to the body of evidence. When IV starts must be used, observed rates of hemolysis may be substantially reduced by placing the IV at the antecubital site.


Subject(s)
Blood Specimen Collection/standards , Emergency Service, Hospital/standards , Evidence-Based Practice/standards , Hemolysis , Program Evaluation/methods , Blood Specimen Collection/methods , Catheters/statistics & numerical data , Databases, Factual , Humans , Medical Laboratory Personnel/standards , Odds Ratio , Practice Guidelines as Topic , Syringes/statistics & numerical data
5.
Clin Biochem ; 45(13-14): 988-98, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22750145

ABSTRACT

OBJECTIVES: This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors. DESIGN AND METHODS: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. RESULTS: A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing. All 17 studies favored barcoding, with meta-analysis mean odds ratios for barcoding systems of 4.39 (95% CI: 3.05-6.32) and for point-of-care testing of 5.93 (95% CI: 5.28-6.67). CONCLUSIONS: Barcoding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based "best practice." The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence.


Subject(s)
Clinical Laboratory Techniques/standards , Diagnostic Errors/prevention & control , Evidence-Based Practice/standards , Program Evaluation/methods , Centers for Disease Control and Prevention, U.S. , Clinical Laboratory Techniques/methods , Databases, Factual , Electronic Data Processing/methods , Evidence-Based Practice/methods , Humans , Odds Ratio , Practice Guidelines as Topic/standards , Quality Assurance, Health Care/standards , United States
6.
Clin Biochem ; 45(13-14): 979-87, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22750773

ABSTRACT

OBJECTIVE: To conduct a systematic review of the evidence available in support of automated notification methods and call centers and to acknowledge other considerations in making evidence-based recommendations for best practices in improving the timeliness and accuracy of critical value reporting. DESIGN AND METHODS: This review followed the Laboratory Medicine Best Practices (LMBP) review methods (Christenson, et al. 2011). A broad literature search and call for unpublished submissions returned 196 bibliographic records which were screened for eligibility. 41 studies were retrieved. Of these, 4 contained credible evidence for the timeliness and accuracy of automatic notification systems and 5 provided credible evidence for call centers for communicating critical value information in in-patient care settings. RESULTS: Studies reporting improvement from implementing automated notification findings report mean differences and were standardized using the standard difference in means (d=0.42; 95% CI=0.2-0.62) while studies reporting improvement from implementing call centers generally reported criterion referenced findings and were standardized using odds ratios (OR=22.1; 95% CI=17.1-28.6). CONCLUSIONS: The evidence, although suggestive, is not sufficient to make an LMBP recommendation for or against using automated notification systems as a best practice to improve the timeliness of critical value reporting in an in-patient care setting. Call centers, however, are effective in improving the timeliness of critical value reporting in an in-patient care setting, and meet LMBP criteria to be recommended as an "evidence-based best practice."


Subject(s)
Evidence-Based Practice/standards , Practice Guidelines as Topic/standards , Program Evaluation/standards , Centers for Disease Control and Prevention, U.S. , Databases, Factual , Humans , Information Systems/statistics & numerical data , Laboratories/standards , Odds Ratio , Program Evaluation/methods , Quality Assurance, Health Care/standards , Time Factors , United States
7.
Clin Biochem ; 45(13-14): 999-1011, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22709932

ABSTRACT

OBJECTIVES: This article is a systematic review of the effectiveness of three practices for reducing blood culture contamination rates: venipuncture, phlebotomy teams, and prepackaged preparation/collection (prep) kits. DESIGN AND METHODS: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. RESULTS: Studies included as evidence were: 9 venipuncture (vs. versus intravenous catheter), 5 phlebotomy team; and 7 prep kit. All studies for venipuncture and phlebotomy teams favored these practices, with meta-analysis mean odds ratios for venipuncture of 2.69 and phlebotomy teams of 2.58. For prep kits 6 studies' effect sizes were not statistically significantly different from no effect (meta-analysis mean odds ratio 1.12). CONCLUSIONS: Venipuncture and the use of phlebotomy teams are effective practices for reducing blood culture contamination rates in diverse hospital settings and are recommended as evidence-based "best practices" with high overall strength of evidence and substantial effect size ratings. No recommendation is made for or against prep kits based on uncertain improvement.


Subject(s)
Bacteria/isolation & purification , Blood/microbiology , Diagnostic Errors/prevention & control , Phlebotomy/standards , Practice Guidelines as Topic/standards , Program Evaluation/methods , Cell Culture Techniques/standards , Centers for Disease Control and Prevention, U.S. , Equipment Contamination/prevention & control , False Positive Reactions , Humans , Odds Ratio , Quality Improvement/standards , Reagent Kits, Diagnostic/standards , United States
8.
Clin Chem ; 57(6): 816-25, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21515742

ABSTRACT

OBJECTIVE: To develop methods for systematically reviewing evidence for identifying effective laboratory medicine (LM) practices associated with improved healthcare quality outcomes. RELEVANCE: Although many evidence-evaluation systems have been developed, none are designed to include and rate healthcare quality improvement studies to identify evidence-based practices that improve patient safety and LM quality. METHODS: Validated evidence-based medicine methods established by governmental agencies, the Guide to Community Preventive Services, and others were adapted for the LM field. Key methods modifications included (a) inclusion of quality improvement study designs; (b) mechanisms for inclusion of unpublished evidence, (c) combining of individual ratings of study quality, effect size, and relevance of outcome measures to evaluate consistency of practice evidence; and (d) deriving an overall strength rating to support evidence-based best practice recommendations. The methods follow the process steps of: ask; acquire; appraise; analyze; apply; and assess. Expert panels used the systematic evidence review results on practice effectiveness for improving healthcare quality outcomes consistent with the Institute of Medicine's healthcare quality aims (safe, timely, effective, equitable, efficient, and patient-centered). CONCLUSIONS: Adapting and developing methods from validated systems and applying them to systematically review and evaluate practices in LM by using published and unpublished studies is feasible. With these methods, evidence from quality improvement studies can be systematically synthesized and summarized to identify effective LM practices. Practical and scientifically validated demonstration of a positive impact on outcomes ensures that practitioners, policy makers, and decision makers at all levels have the evidence needed for improving healthcare quality and public health.


Subject(s)
Clinical Laboratory Techniques/standards , Quality Assurance, Health Care/standards , Review Literature as Topic , Evidence-Based Practice
9.
J Public Health Manag Pract ; 10(1): 46-53, 2004.
Article in English | MEDLINE | ID: mdl-15018341

ABSTRACT

A 1993 amendment to the authorizing legislation for the Center of Disease Control and Prevention's National Breast and Cervical Cancer Early Detection Program allows direct funding to tribal organizations and urban Native health centers. This study examined tribal programs' implementation of the public education and outreach component utilizing a multisite case study design implemented in partnership with tribal programs. Data were collected from 141 semistructured interviews with key informants and 16 focus groups with program-eligible women. Innovative strategies built on native iconography and personal encounters have encouraged participation and made the programs culturally relevant, providing insights for other communities with little experience in providing early detection services.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/ethnology , Health Education/methods , Health Services, Indigenous/organization & administration , Indians, North American/education , Mass Screening/organization & administration , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/ethnology , Women's Health Services/organization & administration , Community Participation , Community-Institutional Relations , Culture , Female , Financing, Government/legislation & jurisprudence , Health Education/economics , Health Services, Indigenous/statistics & numerical data , Humans , Indians, North American/psychology , Mass Screening/statistics & numerical data , Program Evaluation , Surveys and Questionnaires , Time Factors , United States , Women's Health Services/statistics & numerical data
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