Others titles

  • NGC Guideline Summaries
  • Evidence-based Clinical Practice Guidelines
  • Guidline Summaries by Clinical Speciality
  • Guidline Summaries by Category
  • Guidline Summaries by Intended Users

Keywords

  • Clinical Guidelines
  • Practice Guidelines
  • Guideline Attributes
  • Inclusion Criteria
  • Guideline Summary
  • MESH Terminology

Clinical Practice Guideline Summaries

This dataset contains summaries of evidence-based clinical practice guidelines. Clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.

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Description

National Guideline Clearinghouse (NGC) provides structured summaries containing information from clinical practice guidelines. NGC is an initiative of the Agency for Healthcare Research and Quality (AHRQ),U.S. Department of Health and Human Services.

NGC supports AHRQ’s mission to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable by providing objective, detailed information on clinical practice guidelines, and to further their dissemination, implementation, and use in order to inform health care decisions.

NGC uses a systematic approach to decide when it is appropriate to include author, year citations in the Major Recommendations field and full citations in the References Supporting the Recommendations field. Two criteria drive the decision-making process: (1) the recommendations are explicitly stated, and (2) those explicit statements are referenced. The first criterion means that the recommendations in the guideline document are easily identified, stand-alone and action-oriented statements. Explicit recommendation statements are not interspersed among rationale in the guideline document. The rationale for the recommendations may be provided in sections before or after the actual recommendations but not within the same body of content as the recommendations. The second criterion means that the reference(s) supporting the explicit recommendation is (are) provided at the end of the statement. References cited in the rationale for the recommendation are not captured.

NGC’s master’s level indexers apply terms from selected UMLS vocabularies to each guideline summary to facilitate searching and browsing and to create relationships between similar documents. These vocabularies are:
-Healthcare Common Procedure Coding System (HCPCS)
-International Classification of Diseases – Clinical Modification (ICD-9-CM)
-Medical Subject Headings (MeSH)
-Physician Data Query (PDQ)
-Standard Product Nomenclature (SPN)
-Systemized Nomenclature of Medicine (Clinical Terms) (SNOMED CT)
-UMLS Metathesaurus (MTH)
-Universal Medical Device Nomenclature System (UMDNS)

As part of the NGC Annual Verification, many guidelines are withdrawn from the Web site at the end of every year because they no longer meet the Inclusion Criteria with respect to date. NGC’s inclusion criteria specifically require that guidelines represented in their database have been developed, reviewed, or revised within the last five years. All guidelines that no longer meet this criterion are removed from the Web site at the end of each calendar year.

About this Dataset

Data Info

Date Created

1997

Last Modified

2018-07-02

Version

2018-07-02

Update Frequency

Never

Temporal Coverage

N/A

Spatial Coverage

N/A

Source

John Snow Labs; National Guideline Clearinghouse (NGC);

Source License URL

Source License Requirements

N/A

Source Citation

National Guideline Clearinghouse (NGC). Guideline summary [insert title of summary]. In National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD) Agency for Healthcare Research and Quality (AHRQ); [cited YYYY Mon DD]. Available http//www.guideline.gov.

Keywords

Clinical Guidelines, Practice Guidelines, Guideline Attributes, Inclusion Criteria, Guideline Summary, MESH Terminology

Other Titles

NGC Guideline Summaries, Evidence-based Clinical Practice Guidelines, Guidline Summaries by Clinical Speciality, Guidline Summaries by Category, Guidline Summaries by Intended Users

Data Fields

Name Description Type Constraints
Guideline_IDThe Guideline unique identifierintegerrequired : 1level : Nominal
Guideline_TitleIdentifies the complete title of the guideline.stringrequired : 1
Bibliographic_SourcesIdentifies the complete bibliographic source(s) for the published guideline as disseminated by the guideline developer(s). The number of references cited is included for each source.string-
Guideline_StatusIdentifies the current status of the summary including whether the guideline is an updated version of a previously issued document, whether an update is in progress, and whether the guideline meets the 2013 (revised) inclusion criteria.string-
Regulatory_AlertIdentifies important warnings and/or revised regulatory information released by the U.S. Food and Drug Administration (FDA) or other official regulatory body for a drug and/or device for which recommendations are provided in the original guideline document.string-
Scope_Disease_ConditionsIdentifies the major areas of clinical medicine or health care addressed in the guideline. Values are expressed using the natural language expressions found in the text of the guideline.string-
Scope_Other_Disease_ConditionsIndicates the presence of multiple chronic conditions by listing co-existing or comorbid chronic diseases or conditions for which specific recommendations are provided.string-
Scope_Guideline_CategoryClassifies the major focus of the guideline. Values are selected from the appropriate concepts in the Classification Scheme.string-
Scope_Clinical_SpecialityClassifies the clinical specialties that might use the guideline professionally. Values are selected from the appropriate concepts in the Classification Scheme.string-
Scope_Intended_UsersClassifies the groups intended to use the guideline. Values are selected from the appropriate concepts in the Classification Scheme.string-
Scope_Guideline_ObjectivesDescribes the objectives of the guideline as specified in the original guideline document.string-
Scope_Target_PopulationDescribes the target population(s) addressed in the guideline.string-
Scope_Interventions_and_Practices_ConsideredIdentifies the specific clinical interventions and practices considered in the guideline. Values are expressed using natural language expressions found in the text of the guideline.string-
Scope_Major_Outcomes_ConsideredDescribes the most important specific outcomes or performance measures considered in the guideline. Includes patient outcomes described in treatment guidelines and diagnostic test performance characteristics described in diagnosis or screening guidelines.string-
Methodology_EvidenceClassifies the methods used to collect and select the evidence that were evaluated. Values are selected from the appropriate concepts in the Classification Scheme.string-
Methodology_Description_EvidenceDescribes/summarizes the specific methods used to collect and select the evidence, as identified in the text of the guideline or by the guideline developer. Can include detailed search strategies, lists of journals scanned, keywords, database sources, inclusion and exclusion criteria, etc.string-
Methodology_Number_of_DocumentsIdentifies the number of source documents that were identified by the methods described above under "Methodology_Description_Evidence".string-
Methodology_Quality_and_Strength_EvidenceClassifies the methods used by the guideline developer to determine what relative importance to give the evidence they obtained. Values are selected from the appropriate concepts in the Classification Scheme.string-
Methodology_Rating_Scheme_EvidencePresents the rating scheme for strength of evidence, when given.string-
Methodology_AnalysisClassifies the methods used by the guideline developer to evaluate the data in the evidence they obtained. Values are selected from the appropriate concepts in the Classification Scheme.string-
Methodology_Description_AnalysisDescribes the methods used to analyze the evidence. Presents additional definition for the values presented under "Methodology_Analysis" (for example, defines "systematic" or summarizes the details of the meta-analyses).string-
Methodology_RecommendationsIdentifies the methods used to translate evidence into statements that will assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances. Values are selected from the appropriate concepts in the Classification Scheme.string-
Methodology_Description_RecommendationsCaptures the details of the methods used to translate evidence into recommendation statements. Issues considered by the guideline developers during recommendation formulation such as cost, patient preference, and values, are also captured.string-
Methodology_Rating_Scheme_RecommendationsCaptures the weighted scheme used by the guideline developer to determine what relative strength or importance to give to the recommendations being made.string-
Methodology_Cost_AnalysisDescribes any formal cost analysis performed and any published cost analyses reviewed.string-
Methodology_Guideline_ValidationLists the method(s) used to validate the recommendations of the guideline.string-
Methodology_Description_Guideline_ValidationCaptures the details of the method(s) used by the guideline developer to validate the guideline.string-
Recommendations_MajorIdentifies the major recommendations of the guideline.string-
Recommendations_Clinical_AlgorithmsIdentifies the recommendations expressed in the form of clinical algorithm(s) and where the algorithm(s) are providedstring-
Supporting_Recommendations_ReferencesLists the references of evidence supporting the recommendations when applicable. This field opens in a new window and PubMed links are provided when available.string-
Supporting_Recommendations_Evidence_TypeDescribes the type of evidence supporting the recommendations.string-
Implementing_Recommendations_Potential_BenefitsDescribes the anticipated benefits associated with implementing the guideline's recommendations. When applicable, the field also includes information on the major subgroup(s) of patients within the target population most likely to benefit from the guideline recommendations.string-
Implementing_Recommendations_Potential_HarmsDescription of the anticipated harms, potential risks or adverse consequences associated with the guideline's recommendations, as stated in the guideline text, to target populations or intended users.string-
ContraindicationsIdentifies the instances (e.g., co-morbidities) that might render the use of medications or procedures improper, undesirable, or inadvisable.string-
Qualifying_StatementsPresents qualifying statements or important caveats pertaining to the major recommendations of the guideline. Identifies areas of uncertainty and presents a brief description of how the guideline developer addressed this uncertainty in developing the recommendations.string-
Guidelines_Implementation_StrategyDescribes specific strategies, aims, performance measures, or plans for implementing the guideline recommendations.string-
Guidelines_Implementation_ToolsIdentifies the types of implementation tools provided by the guideline developer to facilitate the implementation of the guideline. Values are selected from the appropriate concepts in the Classification Schemestring-
Guidelines_Implementation_NQMC_MeasuresIdentifies link(s) to related quality measures in the National Quality Measures Clearinghouse™ (NQMC).string-
IOM_Care_NeedClassifies the guideline into one of four Institute of Medicine (IOM) care need classifications: End of life care; Getting better; Living with illness; Staying healthy.string-
IOM_DomainClassifies the guideline into one or more of the four Institute of Medicine (IOM) care domains: Effectiveness; Patient-centeredness; Safety; Timeliness.string-
Information_AdaptationIdentifies that the guideline has been adapted from another guideline and identifies the source document.string-
Information_Date_ReleasedIdentifies the date the guideline was released to the public.string-
Information_Guideline_DevelopersIdentifies the organization(s) responsible for the development of the guideline.string-
Information_Guideline_Developers_CommentIf the guideline developer is a consortium or represents a group of organizations, this field identifies the individual organizations by name.string-
Information_Source_FundingIdentifies source(s) of financial support for guideline development, as identified in the guideline text or by the guideline developer. Lists any gran numbers associated with funding, as identified in the guideline text or by the guideline developer.string-
Information_Guideline_CommitteeIdentifies formal name, if any, of committee/subcommittee within the guideline developer organization(s) responsible for developing the guideline.string-
Information_Guideline_Author_GroupDescribes the composition of the group/committee that authored the guideline, including professional degrees and affiliations, and lists the names of individual committee members, where given.string-
Information_Conflicts_of_InterestCaptures relationships between individuals of the guideline development committee/group and for-profit and not-for-profit companies or organizations that could potentially influence that individual's contribution to the guideline's development.string-
Information_EndorsersIdentifies organization(s) that have endorsed the guideline. Each organization is classified by the major designation or function (derived from the Organization Type attribute), such as "Medical Specialty Society" or "Professional Association."string-
Information_Guideline_AvailabilityIdentifies information about the availability of the guideline. Provides links to the full-text document and ordering information for print copies.string-
Information_Companion_Document_AvailabilityIdentifies the companion documents produced by the guideline developer that are considered relevant to the guideline.string-
Information_Patient_ResourcesIdentifies patient resources that are directly related (i.e., derived and/or prepared from the guideline by the guideline developer) to the guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.string-
Information_NGC_StatusIdentifies when the guideline was completed or revised by ECRI Institute, and verified by the developing organization(s).string-
Information_Copyright_StatementProvides the copyright statement of the organization that submitted the guideline.string-
NGC_DisclaimerProvides disclaimer information about the relationship between NGC (including its sponsor, the Agency for Healthcare Research and Quality (AHRQ), and its contractor, ECRI Institute) and the guidelines and guideline developers represented on the Web site.string-

Data Preview

Guideline_IDGuideline_TitleBibliographic_SourcesGuideline_StatusRegulatory_AlertScope_Disease_ConditionsScope_Other_Disease_ConditionsScope_Guideline_CategoryScope_Clinical_SpecialityScope_Intended_UsersScope_Guideline_ObjectivesScope_Target_PopulationScope_Interventions_and_Practices_ConsideredScope_Major_Outcomes_ConsideredMethodology_EvidenceMethodology_Description_EvidenceMethodology_Number_of_DocumentsMethodology_Quality_and_Strength_EvidenceMethodology_Rating_Scheme_EvidenceMethodology_AnalysisMethodology_Description_AnalysisMethodology_RecommendationsMethodology_Description_RecommendationsMethodology_Rating_Scheme_RecommendationsMethodology_Cost_AnalysisMethodology_Guideline_ValidationMethodology_Description_Guideline_ValidationRecommendations_MajorRecommendations_Clinical_AlgorithmsSupporting_Recommendations_ReferencesSupporting_Recommendations_Evidence_TypeImplementing_Recommendations_Potential_BenefitsImplementing_Recommendations_Potential_HarmsContraindicationsQualifying_StatementsGuidelines_Implementation_StrategyGuidelines_Implementation_ToolsGuidelines_Implementation_NQMC_MeasuresIOM_Care_NeedIOM_DomainInformation_AdaptationInformation_Date_ReleasedInformation_Guideline_DevelopersInformation_Guideline_Developers_CommentInformation_Source_FundingInformation_Guideline_CommitteeInformation_Guideline_Author_GroupInformation_Conflicts_of_InterestInformation_EndorsersInformation_Guideline_AvailabilityInformation_Companion_Document_AvailabilityInformation_Patient_ResourcesInformation_NGC_StatusInformation_Copyright_StatementNGC_Disclaimer
9962Adverse events associated with EUS and EUS with FNA.ASGE Standards of Practice Committee, Early DS, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf RN, Shergill AK, Cash BD. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc. 2013 Jun;77(6):839-43. [63 references] PubMedThis is the current release of the guideline.Diseases and conditions requiring endoscopic ultrasound (EUS) and EUS with fine-needle aspiration (FNA)Management;Prevention;Risk AssessmentGastroenterology;Internal MedicineAdvanced Practice Nurses;Physician Assistants;PhysiciansTo provide information that may assist endoscopists in providing care to patients undergoing endoscopic ultrasound (EUS) and EUS with fine-needle aspiration (FNA) and increase knowledge of potential adverse events of these proceduresPatients undergoing endoscopic ultrasound (EUS) and EUS with fine-needle aspiration (FNA) Awareness of potential adverse events associated with endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration (FNA), their expected frequency, and the risk factors associated with their occurrence Careful patient selection Familiarity with the planned procedure and available technology Preparation for and management of any adverse events Review of complications to reduce future risk and improve overall quality Reduction of future adverse events Quality improvement Hand-searches of Published Literature (Primary Sources);Hand-searches of Published Literature (Secondary Sources);Searches of Electronic DatabasesA search of the medical literature was performed by using PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When few or no data exist from well-designed prospective trials, emphasis is given to results of large series and reports from recognized experts. The time frame for all searches was January 1990 to January 2013.Not statedExpert ConsensusNot applicableReview of Published Meta-Analyses;Systematic ReviewExpert ConsensusNot applicableA formal cost analysis was not performed and published cost analyses were not reviewed.Internal Peer ReviewThis document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.Adverse events are inherent in the performance of endoscopic ultrasound (EUS) and EUS-fine-needle aspiration (FNA). As these procedures assume larger roles in the management of gastrointestinal (GI) and non-GI disorders, the potential for adverse events will likely increase. Knowledge of potential adverse events secondary to EUS and EUS-FNA, their expected frequency, and their associated risk factors may help to minimize their occurrence. Endoscopists are expected to carefully select patients for the appropriate intervention, be familiar with the planned procedure and available technology, and be prepared to manage any adverse events that may arise. Once an adverse event occurs, early recognition and prompt intervention may minimize the morbidity and mortality associated with that adverse event. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.None providedThe type of evidence supporting the recommendations is not specifically stated.Appropriate understanding of adverse events associated with endoscopic ultrasound (EUS) and EUS with fine-needle aspiration (FNA) may help to reduce the risk of future adverse events and improve the overall quality of endoscopy.Not statedAn implementation strategy was not provided.Getting Better;Living with Illness;Staying HealthyEffectiveness;SafetyNot applicable: The guideline was not adapted from another source.2013 JunAmerican Society for Gastrointestinal EndoscopyStandards of Practice CommitteeCommittee Members: Dayna S. Early, MD; Ruben D. Acosta, MD; Vinay Chandrasekhara, MD; Krishnavel V. Chathadi, MD; G. Anton Decker, MD; John A. Evans, MD; Robert D. Fanelli, MD, SAGES Representative; Deborah A. Fisher, MD; Lisa Fonkalsrud, RN, SGNA Representative; Joo Ha Hwang, MD; Terry L. Jue, MD; Mouen A. Khashab, MD; Jenifer R. Lightdale, MD; V. Raman Muthusamy, MD; Shabana F. Pasha, MD; John R. Saltzman, MD; Ravi N. Sharaf, MD; Amandep K. Shergill, MD; Brooks D. Cash, MD (Chair)The following authors disclosed a financial relationship relevant to this publication: Dr Fisher, consultant to Epigenomics, Inc; Dr Hwang, consultant to U.S. Endoscopy and speaker for Novartis; Dr Pasha, research support from Capervision. The other authors disclosed no financial relationships relevant to this publication.Electronic copies: Available from the American Society for Gastrointestinal Endoscopy Web site. Print copies: Available from the American Society for Gastrointestinal Endoscopy, 1520 Kensington Road, Suite 202, Oak Brook, IL 60523None availableNone availableThis NGC summary was completed by ECRI Institute on September 25, 2013.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
10358The clinical utility of sperm DNA integrity testing: a guideline.Practice Committee of the American Society for Reproductive Medicine. The clinical utility of sperm DNA integrity testing: a guideline. Fertil Steril. 2013 Mar 1;99(3):673-7. [45 references] PubMedThis is the current release of the guideline.Male infertilityDiagnosis;Technology AssessmentMedical Genetics;UrologyPhysiciansTo assess the evidence pertaining to the clinical utility of sperm deoxyribonucleic acid (DNA) integrity testing and target areas that require more studyInfertile menThe following sperm deoxyribonucleic acid (DNA) integrity tests were considered but there is insufficient evidence to recommend their routine use: Sperm chromatin structure assay (SCSA) Deoxynucleotidyl transferase-mediated deoxynucleotide triphosphate (dUTP) nick end labeling assay (TUNEL) Single-cell gel electrophoresis assay (COMET) Sperm chromatin dispersion test (SCD) Likelihood ratios Pregnancy and fertilization rates Association of sperm deoxyribonucleic acid (DNA) damage with reproductive outcomes Searches of Electronic DatabasesA systematic literature search was performed using the search strategy: sperm AND (DNA OR chromatin) AND (fragmentation OR damage OR integrity) AND (pregnancy [title/abstract] OR embryo [title/abstract]) AND (Humans [mesh] AND English [language]) (204 citations). The search was restricted to MEDLINE citations published in the English language from 1966 to November 2011. Studies were eligible if they met one of the following criteria: primary evidence (clinical trials) that assessed the predictive potential using predictive statistics, meta-analyses, and relevant articles from bibliographies of identified articles.The comprehensive literature search yielded 74 citations eligible for full review.Weighting According to a Rating Scheme (Scheme Given)Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-1: Evidence obtained from well-designed controlled trials without randomization. Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.Review of Published Meta-Analyses;Systematic ReviewExpert ConsensusLevel A: There is good evidence to support the recommendations, either for or against. Level B: There is fair evidence to support the recommendations, either for or against. Level C: There is insufficient evidence to support a recommendation, either for or againstA formal cost analysis was not performed and published cost analyses were not reviewed.Internal Peer ReviewThe Practice Committee and the Board of Directors of the American Society for Reproductive Medicine (ASRM) have approved this report. This document was reviewed by ASRM members and their input was considered in the preparation of the final document.Definitions for the strength of the recommendations (Level A-C) are given at the end of the "Major Recommendations" field. Summary Existing data do not support a consistent relationship between abnormal deoxyribonucleic acid (DNA) integrity and reproductive outcomes At present, the results of sperm DNA integrity testing alone do not predict pregnancy rates achieved through natural conception or with intrauterine insemination (IUI), in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI). However, further re-search may lead to validation of the clinical utility of these tests. Recommendation There is insufficient evidence to recommend the routine use of sperm DNA integrity tests in the evaluation and treatment of the infertile couple (Level C). Definitions: Level A: There is good evidence to support the recommendations, either for or against. Level B: There is fair evidence to support the recommendations, either for or against. Level C: There is insufficient evidence to support a recommendation, either for or against.None availableThe type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).Proper use of sperm deoxyribonucleic acid (DNA) integrity testingNot statedAn implementation strategy was not provided.Staff Training/Competency MaterialLiving with IllnessEffectiveness;Patient-centerednessNot applicable: The guideline was not adapted from another source.2013 Mar 1American Society for Reproductive MedicineThe Practice Committee of the American Society for Reproductive MedicineCommittee Members: Samantha Pfeifer, M.D.; Jeffrey Goldberg, M.D.; Roger Lobo, M.D.; Michael Thomas, M.D.; Margareta Pisarska, M.D.; Eric Widra, M.D.; Mark Licht, M.D.; Jay Sandlow, M.D.; John Collins, M.D.; Marcelle Cedars, M.D.; Mitchell Rosen, M.D.; Michael Vernon, Ph.D.; Owen Davis, M.D.; Daniel Dumesic, M.D.; Clarisa Gracia, M.D., M.S.C.E.; William Catherino, M.D., Ph.D.; Randall Odem, M.D.; Kim Thornton, M.D.; Robert Rebar, M.D.; Andrew La Barbera, Ph.D.All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document.Electronic copies: Available from the American Society for Reproductive Medicine Web site. Print copies: Available from American Society for Reproductive Medicine, 1209 Montgomery Highway, Birmingham, Alabama 35216-2809; Phone: (205) 978-5000; Fax: (205) 978-5005; E-mail: asrm@asrm.org; Web site: www.asrm.org. The following is available: CME credit related to this guideline is available from the American Society for Reproductive Medicine Web site. None availableThis NGC summary was completed by ECRI Institute on June 27, 2014. The information was verified by the guideline developer on July 22, 2014. This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
9368A.S.P.E.N. clinical guidelines: nutrition support of adult patients with hyperglycemia.McMahon MM, Nystrom E, Braunschweig C, Miles J, Compher C, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support of adult patients with hyperglycemia. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):23-36. [60 references] PubMedThis is the current release of the guideline. Conditions or disease states requiring nutrition support Hyperglycemia Diagnosis;Evaluation;ManagementCritical Care;Endocrinology;Gastroenterology;Geriatrics;Nursing;Nutrition;PharmacologyAdvanced Practice Nurses;Allied Health Personnel;Health Care Providers;Hospitals;Nurses;Pharmacists;Physician Assistants;PhysiciansTo summarize the most current evidence and provides guidelines for the desired blood glucose goal range in hospitalized patients receiving nutrition support, the definition of hypoglycemia, and the rationale for use of diabetes-specific enteral formulas in hospitalized patients Note: This guideline does not address other specific strategies for managing hyperglycemia in patients receiving nutrition support, as there are little to no data to support clinical practice recommendations in this area.Adult hospitalized patients receiving nutrition support Target blood glucose goals Criteria for defining hypoglycemia in hospitalized patients receiving nutrition support Diabetes specific enteral formulas for adult patients with hyperglycemia (considered but not recommended). Mortality Adverse outcomes associated with hyperglycemia Glycemic and lipid control Searches of Electronic DatabasesFor the current Clinical Guideline, inclusion criteria of adult subjects, complication of hyperglycemia, and hospital setting were used. Search terms of diabetes mellitus, hyperglycemia, hypoglycemia, clinical outcomes, parenteral nutrition, and enteral nutrition were applied in various combinations to CENTRAL (The Cochrane Library), MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, and CINAHL (until December 2011).Not statedWeighting According to a Rating Scheme (Scheme Given)Level of Evidence High: Further research is very unlikely to change the authors' confidence in the estimate of effect Moderate: Further research is likely to have an important impact on the authors' confidence in the estimate of effect and may change the estimate Low: Further research is very likely to have an important impact on the authors' confidence in the estimate of effect and is likely to change the estimate Very Low: Any estimate of effect is very uncertainSystematic Review with Evidence TablesExpert ConsensusGrade of Recommendation Strong: Net benefits outweigh harms Weak: Tradeoffs for patient are important Further research needed: Uncertain tradeoffsA cost analysis was not performed and published cost analyses were not reviewed.External Peer Review;Internal Peer ReviewA consensus process was used to develop the clinical guideline recommendations prior to external and internal review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors.Definitions for the grading of recommendations (Strong, Weak, Further Research Needed) and levels of evidence (High, Moderate, Low, Very Low) are provided at the end of the "Major Recommendations" field. What is the Desired Blood Glucose Goal Range in Adult Hospitalized Patients Receiving Nutrition Support? The authors recommend a target blood glucose goal range of 140180 mg/dL (7.810 mmol/L). (Strong) How is Hypoglycemia Defined in Adult Hospitalized Patients Receiving Nutrition Support? The authors recommend that hypoglycemia be defined as a blood concentration of 70 mg/dL (3.9 mmol/L). (Strong) Should Diabetes-Specific Enteral Formulas Be Used for Adult Hospitalized Patients With Hyperglycemia? The authors cannot make a recommendation at this time. (Further research needed) Definitions: Level of Evidence High: Further research is very unlikely to change the authors' confidence in the estimate of effect Moderate: Further research is likely to have an important impact on the authors' confidence in the estimate of effect and may change the estimate Low: Further research is very likely to have an important impact on the authors' confidence in the estimate of effect and is likely to change the estimate Very Low: Any estimate of effect is very uncertain Grade of Recommendation Strong: Net benefits outweigh harms Weak: Tradeoffs for patient are important Further research needed: Uncertain tradeoffsNone providedThe type of supporting evidence ranges from prospective randomized trials to expert opinion/consensus.In hospitalized patients receiving nutrition support: Reduction in adverse outcomes due to hyperglycemia Improvement in assessment (definition/target range) of blood glucose control Both hyperglycemia and hypoglycemia (resulting from attempts to correct hyperglycemia) are associated with adverse outcomes in diabetic as well as nondiabetic patients.An implementation strategy was not provided.ResourcesGetting Better;Living with IllnessEffectivenessNot applicable: The guideline was not adapted from another source.2013 JanAmerican Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)Not statedAuthors: M. Molly McMahon, MD; Erin Nystrom, PharmD, BCNSP; Carol Braunschweig, PhD, RD; John Miles, MD; Charlene Compher, PhD, RD, CNSC, LDN, FADA; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of DirectorsFinancial disclosure: none declaredElectronic copies: Available from the Journal of Parenteral and Enteral Nutrition Web site.The following is available: Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). 2012 Jan. 5 p. Electronic copies: Available from the Journal of Parenteral and Enteral Nutrition Web site. None availableThis NGC summary was completed by ECRI Institute on December 27, 2012. The information was verified by the guideline developer on January 21, 2013.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
10031ACMG practice guideline: lack of evidence for MTHFR polymorphism testing.Hickey SE, Curry CJ, Toriello HV. ACMG practice guideline: lack of evidence for MTHFR polymorphism testing. Genet Med. 2013 Feb;15(2):153-6. [77 references] PubMedThis is the current release of the guideline.ThrombophiliaAssessment of Therapeutic Effectiveness;Counseling;EvaluationFamily Practice;Hematology;Medical Genetics;Obstetrics and GynecologyPhysiciansTo review the latest evidence on 5,10-methylenetetrahydrofolate reductase (MTHFR) polymorphism testing as part of a routine evaluation for thrombophiliaWomen of childbearing age and patients at risk for thrombophilia 5,10-methylenetetrahydrofolate reductase (MTHFR) polymorphism testing (not recommended) Evaluation of symptoms in patients in whom an MTHFR polymorphism(s) is found Fasting total plasma homocysteine Folic acid supplementation Not statedHand-searches of Published Literature (Primary Sources);Hand-searches of Published Literature (Secondary Sources);Searches of Electronic DatabasesThe guideline authors searched PubMed and the Cochrane Database of Systematic Reviews from January 1995 to the present. In the literature search, priority was given to original research, with highest emphasis on meta-analyses, followed by case-control and cohort studies. The Literature search excluded review articles, case reports, and articles in languages other than English. Bibliographies of articles deemed to be of the highest quality for their specific topic were combed for additional articles that may have been missed by the initial literature search. In addition, the guidelines of other professional bodies on the same, or related, topic were reviewed. The databases were searched using the following terms: MTHFR, MTHFR polymorphism, MTHFR thermolabile variant, methylenetetrahydrofolate reductase, and hyperhomocysteinemia. Combined searches were done on specific questions of interest including: MTHFR and stroke, MTHFR and recurrent pregnancy loss, MTHFR and venous thromboembolism, and MTHFR and coronary artery disease. The same combined searches were done for hyperhomocysteinemia and stroke, etc.Not statedNot statedNot applicableReviewExpert ConsensusNot applicableA formal cost analysis was not performed and published cost analyses were not reviewed.Internal Peer ReviewThe final manuscript was reviewed by the American College of Medical Genetics and Genomics (ACMG) Policy Practice Guideline Committee Members, followed by the Board of Directors, and then opened up for general college membership comment.American College of Medical Genetics and Genomics (ACMG) Recommendations 5,10-methylenetetrahydrofolate reductase (MTHFR) polymorphism genotyping should not be ordered as part of the clinical evaluation for thrombophilia or recurrent pregnancy loss. MTHFR polymorphism genotyping should not be ordered for at-risk family members. A clinical geneticist who serves as a consultant for a patient in whom an MTHFR polymorphism(s) is found should ensure that the patient has received a thorough and appropriate evaluation for his or her symptoms. If the patient is homozygous for the "thermolabile" variant c.665CT, the geneticist may order a fasting total plasma homocysteine, if not previously ordered, to provide more accurate counseling. MTHFR status does not change the recommendation that women of childbearing age should take the standard dose of folic acid supplementation to reduce the risk of neural tube defects as per the general population guidelines (Zacho et al., 2011; De Stefano et al., 2000; Institute of Medicine, Food and Nutrition Board, 1998; "Prevention of neural tube," 1991; Czeizel Duds, 1992; "Recommendations for the use of folic acid," 1992; Toriello, 2011). None providedCzeizel AE, Dudas I. Prevention of the first occurrence of neural-tube defects by periconceptional vitamin supplementation. N Engl J Med. 1992 Dec 24;327(26):1832-5. PubMed;De Stefano V, Casorelli I, Rossi E, Zappacosta B, Leone G. Interaction between hyperhomocysteinemia and inherited thrombophilic factors in venous thromboembolism. Semin Thromb Hemost. 2000;26(3):305-11. [32 references] PubMed;Institute of Medicine, Food and Nutrition Board. Dietary reference intakes: thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington (DC): National Academy Press; 1998. ;Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. MRC Vitamin Study Research Group. Lancet. 1991 Jul 20;338(8760):131-7. PubMed;Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR Recomm Rep. 1992 Sep 11;41(RR-14):1-7. [14 references] PubMed;Toriello HV, Policy and Practice Guideline Committee of the American College of Medical. Policy statement on folic acid and neural tube defects. Genet Med. 2011 Jun;13(6):593-6. PubMed;Zacho J, Yazdanyar S, Bojesen SE, Tybjaerg-Hansen A, Nordestgaard BG. Hyperhomocysteinemia, methylenetetrahydrofolate reductase c.677C>T polymorphism and risk of cancer: cross-sectional and prospective studies and meta-analyses of 75,000 cases and 93,000 controls. Int J Cancer. 2011 Feb 1;128(3):644-52. PubMedThe type of evidence supporting the recommendations is not specifically stated.Appropriate use of 5,10-methylenetetrahydrofolate reductase (MTHFR) polymorphism testing in routine evaluation for thrombophiliaNot statedAn implementation strategy was not provided.Staying HealthyEffectiveness;Patient-centerednessNot applicable: The guideline was not adapted from another source.2013 FebAmerican College of Medical Genetics and GenomicsNot statedAuthors: Scott E. Hickey, MD, FACMG, Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA; Cynthia J. Curry, MD, FACMG, Genetic Medicine Central California, University of California, San FranciscoFresno, Fresno, California, USA; Helga V. Toriello, PhD, FACMG, Department of Pediatrics/Human Development, Spectrum Health Hospitals and College of Medicine, Michigan State University, Grand Rapids, Michigan, USAThe authors declare no conflict of interest.Electronic copies: Available from the American College of Medical Genetics and Genomics (ACMG) Web site.None availableNone availableThis NGC summary was completed by ECRI Institute on November 19, 2013.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
10225The prognostic value of the DNMT3A biomarker in cytogenetically normal patients with acute myeloid leukemia.Leber B, Ismaila N, Kamel-Reid S, Rutherford M, Molecular Oncology Advisory Committee. The prognostic value of the DNMT3A biomarker in cytogenetically normal patients with acute myeloid leukemia. Toronto (ON): Cancer Care Ontario (CCO); 2013 Nov 27. 17 p.(Recommendation report; no. MOAC-1). [23 references]This is the current release of the guideline. The RECOMMENDATION report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities. Please visit the Cancer Care Ontario Web site for details on any new evidence that has emerged and implications to the guidelines.Acute myeloid leukemia (AML)Evaluation;Risk AssessmentInternal Medicine;Medical Genetics;OncologyOther;Patients;PhysiciansTo determine if testing for deoxyribonucleic acid (DNA) methyltransferase 3A (DNMT3A) mutation in cytogenetically normal patient population with acute myeloid leukemia (AML) determines prognosis with standard indication and consolidation therapy, as a guide to choosing alternative treatment if appropriateAcute myeloid leukemia (AML) patients with a normal cytogenetic profileDeoxyribonucleic acid (DNA) methyltransferase 3A (DNMT3A) mutation testing Overall survival Disease-free survival Relapse-free survival Event-free survival Complete remission Hand-searches of Published Literature (Primary Sources);Hand-searches of Published Literature (Secondary Sources);Searches of Electronic Databases;Searches of Unpublished DataLiterature Search Strategy The primary search is up to date as of July 26, 2012. Published literature was retrieved via searching the following electronic databases: MEDLINE (1946 to July Week 3, 2012) with in-process records and other non-indexed citations and daily updates via Ovid (July 25, 2012); EMBASE (1980 to Week 29, 2012) via Ovid; and The Cochrane Central Register of Controlled Trials (2012, Issue 7) via Ovid. Terms used were related to AML (acute myeloid leukemia OR acute myelogenous leukemia OR acute myelocytic leukemia) and DNMT3A (DNA methyltransferase 3A OR DNA [cytosine-5]-methyltransferase 3A human OR DNMT3A protein). Study Selection Criteria and Protocol Studies must have included cytogenetically normal (CN) patients stratified to the intermediate-risk group. Pediatric AML was not included for analysis (15 years of age); no upper age limit was specified. Comparators under investigation were normal cytogenetic risk groups defined with the DNMT3A mutation versus normal cytogenetic risk groups without the DNMT3A mutation (wild type). The exact nature of the treatment administered was not of primary interest but was documented if the study provided the information. Primary outcomes of interest include overall survival (OS), complete remission (CR), cumulative incidence of relapse (CIR) and relapse-free survival (RFS). Co-occurring molecular aberrations, along with where the mutation was located in the gene, were documented for further research. Inclusion criteria encompassed systematic reviews, meta-analyses, clinical practice guidelines, randomized control trials, cohort studies (prospective and retrospective) or case-control studies with an analysis or subgroup analysis of DNMT3A biomarker status and investigated DNMT3A in patients with previously treated or untreated AML. Exclusion criteria was applied to articles published in a language other than English, were non-systematic reviews, letters, editorials, commentaries, or historical articles, or if patients had secondary AML. Eight studies met the inclusion criteria and were included in the review. Six of the eight studies were included in quantitative synthesis (meta‐analysis). Expert ConsensusNot applicableMeta-Analysis;Review of Published Meta-Analyses;Systematic Review with Evidence TablesExpert ConsensusNot applicableA formal cost analysis was not performed and published cost analyses were not reviewed.Internal Peer ReviewInternal Review Almost all Program in Evidence-based Care (PEBC) documents undergo internal review. With recommendation reports, this review is conducted by the Director of the PEBC. The Working Group is responsible for considering the changes, and if those changes could be made without substantially altering the recommendations, the altered draft would not need to be resubmitted for approval again.Recommendation Deoxyribonucleic acid (DNA) methyltransferase 3A (DNMT3A) mutation testing should be included as a biomarker test in cytogenetically normal acute myeloid leukemia (AML) patients.None providedThe recommendations are supported by prospective and retrospective studies.Assessing deoxyribonucleic acid (DNA) methyltransferase 3A (DNMT3A) mutational status provides important prognostic information for acute myeloid leukemia (AML) patients with a normal karyotype.Not statedAn implementation strategy was not provided.Quick Reference Guides/Physician GuidesGetting Better;Living with IllnessEffectivenessNot applicable: The guideline was not adapted from another source.2013 Nov 27The Program in Evidence-based Care (PEBC) is a provincial initiative of Cancer Care Ontario supported by the Ontario Ministry of Health and Long-Term Care. All work produced by the PEBC is editorially independent from the Ontario Ministry of Health and Long-Term Care.Molecular Oncology Advisory CommitteeAuthors: B. Leber, N. Ismaila, S. Kamel-Reid, M. RutherfordIn accordance with the Program in Evidence-based Care (PEBC) Conflict of Interest (COI) Policy, the guideline authors, Molecular Oncology Advisory Committee (MOAC) members, and internal and external reviewers were asked to disclose potential conflicts of interest. The authors, members, and reviewers reported that they had no conflicts of interest.Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site.The following are available: The prognostic value of the DNMT3A biomarker in cytogenetically normal patients with acute myeloid leukemia. Summary. Toronto (ON): Cancer Care Ontario (CCO); 2013 Nov 27. 5 p. Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site. Program in Evidence-based Care handbook. Toronto (ON): Cancer Care Ontario (CCO); 2012. 14 p. Available in PDF from the Cancer Care Ontario Web site. None availableThis NGC summary was completed by ECRI Institute on April 10, 2014.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please refer to the Copyright and Disclaimer Statements posted at the Program in Evidence-based Care section of the Cancer Care Ontario Web site.
9906Mature oocyte cryopreservation: a guideline.Practice Committees of American Society for Reproductive Medicine, Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. [48 references] PubMedThis is the current release of the guideline.InfertilityCounseling;Management;Technology AssessmentInternal Medicine;Obstetrics and GynecologyPhysiciansTo outline the current technology, clinical outcomes, and risks of mature oocyte cryopreservation and provide recommendations for clinical applicationsWomen of reproductive ageOocyte cryopreservation Fertilization and pregnancy rates Implantation rates Oocyte survival Searches of Electronic DatabasesThe Committee performed a systematic literature search using the MEDLINE site up to April 2012. In order to compare the efficacy (clinical pregnancy and live birth rates) of embryo transfers using fresh or cryopreserved/thawed oocytes, the search utilized combinations of medical subject headings "oocyte," "cryopreservation," "vitrification," "frozen," "birth," "delivery," and "pregnancy." In order to assess the safety of oocyte cryopreservation, the search included the terms "safe," "risk," "birth defect," "karyotype," and "abnormal" to the search. Only English language articles were selected, and the search was restricted to published articles. Review articles were included. 80 articles were determined to be relevant for oocyte cryopreservation efficacy 32 articles were determined to be relevant for oocyte cryopreservation safety Expert Consensus (Committee)Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-2: Evidence obtained from well-designed controlled trials without randomization. Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.Systematic ReviewExpert ConsensusLevel A: There is good evidence to support the recommendations, either for or against. Level B: There is fair evidence to support the recommendations, either for or against. Level C: There is insufficient evidence to support a recommendation, either for or against.A formal cost analysis was not performed and published cost analyses were not reviewed.Internal Peer ReviewThe Practice Committees and the Board of Directors of American Society for Reproductive Medicine (ASRM) and Society for Assisted Reproductive Technology (SART) have approved this report. It has been reviewed by the SART presidential chain and edited based on their comments. This document was reviewed by ASRM members and their input was considered in the preparation of the final document.Definitions for the strength of the recommendations (Level A-C) are given at the end of the "Major Recommendations" field. In patients facing infertility due to chemotherapy or other gonadotoxic therapies, oocyte cryopreservation is recommended with appropriate counseling (Level B). More widespread clinic-specific data on the safety and efficacy of oocyte cryopreservation in donor populations are needed before universal donor oocyte banking can be recommended (Level B). There are not yet sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women (Level B). More data are needed before this technology should be used routinely in lieu of embryo cryopreservation (Level B). Definitions: Level A: There is good evidence to support the recommendations, either for or against. Level B: There is fair evidence to support the recommendations, either for or against. Level C: There is insufficient evidence to support a recommendation, either for or against.None availableThe type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field). Successful in vitro fertilization (IVF), pregnancy, and birth with cryopreserved oocytes No increase in chromosomal abnormalities, birth defects, and developmental deficits in the offspring born from cryopreserved oocytes when compared to pregnancies from conventional IVF/intracytoplasmic sperm injection (ICSI) and the general population. Successful oocyte cryopreservation has the potential to simplify oocyte donation. Most vitrification protocols use an "open" system, in which oocytes are directly exposed to liquid nitrogen to maximize ultra-rapid cooling and minimize ice crystal formation. A theoretical concern regarding such "open" systems is their potential to expose oocytes to infectious organisms present in contaminated liquid nitrogen. There are risks associated with ovarian stimulation and oocyte retrieval. Since embryo transfer is not being performed in most individuals cryopreserving oocytes, the risks of ovarian hyperstimulation syndrome (OHSS) are very low. Studies suggest that implantation and pregnancy rates may be lower when frozen oocytes are used compared with fresh or frozen embryos. An implementation strategy was not provided.Staff Training/Competency MaterialLiving with IllnessEffectiveness;Patient-centerednessNot applicable: The guideline was not adapted from another source.2013 JanAmerican Society for Reproductive MedicinePractice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive TechnologyCommittee Members: Samantha Pfeifer, M.D.; Jeffrey Goldberg, M.D.; R. Dale McClure, M.D.; Roger Lobo, M.D.; Michael Thomas, M.D.; Eric Widra, M.D.; Mark Licht, M.D.; John Collins, M.D.; Marcelle Cedars, M.D.; Catherine Racowsky, Ph.D.; Michael Vernon, Ph.D.; Owen Davis, M.D.; Clarisa Gracia, M.D., M.S.C.E.; William Catherino, M.D., Ph.D.; Kim Thornton, M.D.; Robert Rebar, M.D.; Andrew La Barbera, Ph.D.All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document.Electronic copies: Available from the American Society for Reproductive Medicine Web site. Print copies: Available from American Society for Reproductive Medicine, 1209 Montgomery Highway, Birmingham, Alabama 35216-2809; Phone: (205) 978-5000; Fax: (205) 978-5005; E-mail: asrm@asrm.org; Web site: www.asrm.org.The following is available: CME credit related to this guideline is available from the American Society for Reproductive Medicine Web site. None availableThis NGC summary was completed by ECRI Institute on September 13, 2013. The information was verified by the guideline developer on October 9, 2013.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
10583Society of Interventional Radiology position statement on injection safety: improper use of single-dose/single-use vials.Silberzweig JE, Khorsandi AS, Dixon RG, Gross K, Nikolic B. Society of Interventional Radiology position statement on injection safety: improper use of single-dose/single-use vials. J Vasc Interv Radiol. 2013 Jan;24(1):111-2. [12 references] PubMedThis is the current release of the guideline.Infections due to improper use of single-dose/single-use vialsPreventionInternal Medicine;Preventive Medicine;RadiologyAdvanced Practice Nurses;Hospitals;Nurses;Pharmacists;Physician Assistants;PhysiciansTo provide guidelines for prevention of improper use of single-dose or single-use vialsPatients receiving injections of a medication packaged in single-dose or single-use vialsUse of safe injection practices for single-dose or single-use vials of medicationsInfection outbreak riskSearches of Electronic DatabasesAn in-depth literature search was performed using electronic medical literature databases, including the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and Medline databases. No inclusion/exclusion criteria were applied. The literature search was conducted from 1995 to 2012. Search terms used were injection, infection, and safe use of single-dose/single-use vial.Not statedNot statedNot applicableReviewExpert ConsensusNot applicableA formal cost analysis was not performed and published cost analyses were not reviewed.Not statedNot applicableAn essential feature of injection practice involves the safe administration of a medication packaged in a single-dose vial (SDV) or single-use vial. The Centers for Disease Control and Prevention (CDC) note that improper use of a medication packaged in an SDV can place a patient at increased risk for acquiring a health carerelated infection. Medication from an SDV is intended for parenteral administration for a single patient during a single procedure. SDVs are labeled as such in the manufacturer's package insert. The CDC states that SDVs must not be used for multiple patients. Even if an SDV contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use in the same patient.In contrast with an SDV, a multidose vial (MDV) of a medication contains more than a single medication dose. MDVs are labeled as such by the manufacturer and typically contain an antimicrobial preservative agent to help prevent bacterial growth. The preservative agent has no effect on viruses and does not protect against contamination when health care personnel fail to follow safe injection practices. MDVs are discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. An MDV used for more than one patient is required to be kept in a centralized medication area and not accessed in the immediate patient treatment area (e.g., procedure room, patient room). If MDVs enter the treatment area, they should be dedicated for single-patient use and discarded immediately after use.A medication in an SDV can become contaminated and act as an infection source if administered to multiple patients. The infection outbreak risk is particularly increased with repeated SDV access with more than one needle whenever an SDV is used for more than one patient. Since the CDC safe injection guidelines were published in 2007, the CDC has reported 21 outbreaks associated with SDV medications administered for multiple patients: seven outbreaks involved infections transmitted through contamination by blood, and 14 involved bacterial infections. Two recently reported outbreaks of invasive Staphylococcus aureus infection were confirmed in 10 patients being treated for pain in outpatient clinics in Delaware and Arizona, in which SDVs were reused for multiple patients. Transmission of life-threatening but preventable bacterial infections by failing to follow safe-injection recommendations can result in an infection outbreak that causes unnecessary morbidity and draws attention of the media and regulatory agencies.Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs to health care providers. On May 2, 2012, the CDC restated its 2007 position regarding the use of SDVs in response to "inaccuracies" being disseminated to health care providers. The CDC recognized the problem of drug shortages; however, such shortages are noted to be the result of manufacturing, shipping, and other issues unrelated to the guidelines. The CDC noted that lowering safety standards will not address the problem of drug shortages.Under certain conditions, however, such as during limited drug availability, it is permissible for health care facilities to repackage SDVs into smaller doses, each intended for a single patient use. Repackaging is allowable if performed by qualified health care personnel under specific conditions according to standards in United States Pharmacopeia (USP) General Chapter 797, Pharmaceutical CompoundingSterile Preparations, as well as the manufacturer's recommendations pertaining to safe storage of that medication outside of its original container. On June 15, 2012, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum that stated that health care providers that do not comply with USP standards for SDVs may be cited for deficiencies under applicable federal infection control standards.SDVs must never be used for multiple patients unless specific conditions allow repackaging by qualified health care personnel under USP standards. It is the responsibility of interventional radiologists and other licensed personnel to adhere to best care practices for the safe performance of minimally invasive treatments.None providedThe type of evidence supporting the recommendations is not specifically stated.Safe administration of a medication packaged in a single-dose vial (SDV) or single-use vialNot statedAn implementation strategy was not provided.Staying HealthyEffectiveness;SafetyNot applicable: The guideline was not adapted from another source.2013 JanSociety of Interventional RadiologySociety of Interventional Radiology Safety and Health CommitteeCommittee Members: James E. Silberzweig, MD, Department of Radiology, Beth Israel Medical Center, New York, New York; Azita S. Khorsandi, MD, Department of Radiology, Beth Israel Medical Center, New York, New York; Robert G. Dixon, MD, Department of Radiology, University of North Carolina, Chapel Hill, North Carolina; Kathleen Gross, MSN, RN-BC, CRN, Department of Interventional Radiology, Greater Baltimore Medical Center, Baltimore, Maryland; Boris Nikolic, MD, MBA, Department of Radiology, Albert Einstein Medical Center, Philadelphia, PennsylvaniaNone of the authors have identified a conflict of interest.Electronic copies: Available from the Society of Interventional Radiology Web site Print copies: Available from the Society of Interventional Radiology, 10201 Lee Highway, Suite 500, Fairfax, VA 22030None availableNone availableThis NGC summary was completed by ECRI Institute on January 23, 2015.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
10130Screening for sudden cardiac death before participation in high school and collegiate sports.Mahmood S, Lim L, Akram Y, Alford-Morales S, Sherin K, ACPM Prevention Practice Committee. Screening for sudden cardiac death before participation in high school and collegiate sports: American College of Preventive Medicine position statement on preventive practice. Am J Prev Med. 2013 Jul;45(1):130-3. [23 references] PubMedThis is the current release of the guideline.Sudden cardiac death (SCD)Prevention;Risk Assessment;ScreeningCardiology;Family Practice;Internal Medicine;Pediatrics;Preventive Medicine;Sports MedicineAdvanced Practice Nurses;Nurses;Physician Assistants;PhysiciansTo outline the American College of Preventive Medicine's (ACPM) perspective on critical preventive medicine issues, in a timely fashion, in order to exert a positive influence on policy, practice, and research dealing with screening for sudden cardiac death (SCD) before participation in high school and collegiate sportsStudents playing high school and collegiate sports in the United States without personal risk factors Note: This guideline does not include individuals who may be identified by their healthcare provider as "above average" risk.Standardized history and physical (HP): Personal history Family history Physical examination Note: Electrocardiogram (ECG), echocardiography, and genetic testing were considered but not recommended. Instances of sudden cardiac death (SCD) Detection of underlying cardiac conditions and disease progression Mortality rates Specificity and sensitivity of screening tests Cost-effectiveness of SCD screening Searches of Electronic DatabasesPubMed, MEDLINE, and Google Scholar were the databases used for the qualitative literature search with a time frame of 1980 to 2013. No inclusion/exclusion criteria were used in the search. The following search terms were used: Sudden cardiac death Screening for sudden cardiac death Sudden cardiac death in young athletes Pre-participation screening of sudden cardiac death Cost-effectiveness of pre-participation screening of sudden cardiac death Not statedExpert ConsensusNot applicableReviewExpert ConsensusNot applicable A limited number of studies suggest that combining history and physical (HP) and electrocardiogram (ECG) screening for sudden cardiac death (SCD) may be cost effective. An Italian cost-effectiveness analysis of 33,735 athletes, using a more conservative approach (10% of affected athletes would live an additional 20 years), estimated the cost per year of life saved at approximately $20,000 for the Italian model (HP and ECG) and about $53,350 for the U.S. model (HP alone). The American Heart Association (AHA) estimates the cost of mass ECG screening, followed by echocardiogram and other indicated testing, to be $2.0 billion for 10 million middle and high school athletes. Pending further prospective studies involving U.S. participants, the cost effectiveness of routinely combining HP and ECG in cardiovascular pre-participation screening in students cannot be conclusively determined. Comparison with Guidelines from Other GroupsThe guidelines from the following major professional and health organizations were used for comparison of recommendations on screening for sudden cardiac death before participation in high school and collegiate sports: American Heart Association European Society of Cardiologists International Olympic Committee American College of Sports Medicine The American College of Preventive Medicine (ACPM) supports an evaluation prior to participating in high school and collegiate sports using a standardized history and physical (HP) (i.e., using standardized items as developed by the American Heart Association [AHA] to ensure uniformity and consistency in risk factor assessment [see the table below]). ACPM recommends against routine screening for potential sudden cardiac death (SCD) with electrocardiogram (ECG), echocardiography, and genetic testing in individuals without personal risk factors. The recommendations by ACPM address only mass screening approaches to detecting SCD and are not targeted toward individuals who may be identified by their healthcare provider as "above average" risk who may benefit from additional testing with the modalities mentioned above. ACPM supports the adoption of the National Heart, Lung, and Blood Institute (NHLBI) Working Group research agenda to evaluate the effectiveness of any screening program in reducing SCD, its costbenefit ratio, and its impact on health outcomes (see Table 2 in the original guideline document). Table: The 12-element AHA Recommendations for Pre-Participation Cardiovascular Screening of Competitive Athletes Medical Historya Personal History Exertional chest pain/discomfort Unexplained syncope/near-syncopeb Excessive exertional and unexplained dyspnea/fatigue, associated with exercise Prior recognition of a heart murmur Elevated systemic blood pressure Family History Premature death (sudden and unexpected, or otherwise) before age 50 years due to heart disease, in 1 relative Disability from heart disease in a close relative aged 50 years Specific knowledge of certain cardiac conditions in family members: hypertrophic or dilated cardiomyopathy, long-QT syndrome or other ion channelopathies, Marfan syndrome, or clinically important arrhythmias Physical Examination Heart murmurc Femoral pulses to exclude aortic coarctation Physical stigmata of Marfan syndrome Brachial artery blood pressure (sitting position) aParental verification is recommended for high school and middle school athletes. bJudged not to be neurocardiogenic (vasovagal); of particular concern when related to exertion. cAuscultation should be performed in both supine and standing positions (or with Valsalva maneuver), specifically to identify murmurs of dynamic left ventricular outflow tract obstruction.None providedThe type of evidence supporting the recommendations isnot specifically stated.Reduction in mortality from sudden cardiac death (SCD)Although a history and physical (HP) costs less, requires minimal resources, and is efficient to administer, it has low sensitivity in detecting hypertrophic cardiomyopathy and other asymptomatic cardiac diseases. Another limitation is the poor utilization of a standardized HP for pre-participation sports evaluation.An implementation strategy was not provided.Staying HealthyEffectiveness;Patient-centerednessNot applicable: The guideline was not adapted from another source.2013 JulAmerican College of Preventive Medicine (ACPM)American College of Preventive Medicine Prevention Practice CommitteeCommittee Members: Shamail Mahmood, MD, MPH; Lionel Lim, MD, MPH, FACPM; Yasir Akram, MD; Samantha Alford-Morales, MD, MPH, FACPM; Kevin Sherin, MD, MPH, MBA, FACPMNo financial disclosures were reported by the authors of this paper.Electronic copies: Available in Portable Document Format (PDF) from the American College of Preventive Medicine Web site. Print copies: Available from American College of Preventive Medicine, 1307 New York Ave, N.W., Suite 200, Washington, DC 20005-5603.None availableNone availableThis NGC summary was completed by ECRI Institute on February 4, 2014. The information was verified by the guideline developer on March 13, 2014.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
9386Adjuvant radiation for malignant melanoma.Alberta Provincial Cutaneous Tumour Team. Adjuvant radiation for malignant melanoma. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2012 Mar. 7 p.(Clinical practice guideline; no. CU-003). [28 references]This is the current release of the guideline.Malignant melanomaManagement;TreatmentDermatology;Oncology;Radiation OncologyPhysiciansTo evaluate if adjuvant radiation therapy should be offered to patients who have been rendered disease-free following the resection of cutaneous melanomas and who are at high risk for subsequent recurrenceAdults over the age of 18 years with malignant melanoma Note: Different principles may apply to pediatric patients.Adjuvant post-operative radiation therapy Disease control/recurrence rates Disease-specific, disease-free, and distant metastases-free survival rates Searches of Electronic DatabasesResearch Questions Specific research questions to be addressed by the guideline document were formulated by the guideline lead(s) and Knowledge Management (KM) Specialist using the PICO question format (patient or population, intervention, comparisons, outcomes). Guideline Question Should adjuvant radiation therapy be offered to patients who have been rendered disease-free following the resection of cutaneous melanomas and who are at high risk for subsequent recurrence? Search Strategy The MEDLINE (1966 through January 2011), CINAHL, Cochrane, ASCO Abstracts and proceedings, and CANCERLIT databases were searched. The search included practice guidelines, systematic reviews, meta-analyses, randomized controlled trials, and clinical trials. Search terms included: radiation or adjuvant radiation and malignant melanoma. For the 2012 update of the guideline, PubMed was searched for evidence on radiation therapy in cutaneous melanoma. The search term "melanoma" was used and results were limited to clinical trials, published between January 2011 and January 2012. Citations were hand-searched for studies pertaining to radiation therapy, resulting in no additional clinical trials. Updates to the National Comprehensive Cancer Network guideline (2012) on melanoma were cross referenced with this guideline as well. Following a review of the evidence by the Alberta Provincial Cutaneous Tumour Team, no changes to the recommendations were made.Not statedExpert ConsensusNot applicableSystematic Review with Evidence TablesExpert ConsensusNot applicableA formal cost analysis was not performed and published analyses were not reviewed.Internal Peer ReviewThis guideline was reviewed and endorsed by the Alberta Provincial Cutaneous Tumour Team. When the draft guideline document is completed, revised, and reviewed by the Knowledge Management Specialist and the working group members, it is sent to all members of the Provincial Tumour Team for review and comment. The working group members then make final revisions to the document based on the received feedback, as appropriate. Once the guideline is finalized, it is officially endorsed by the Provincial Tumour Team Lead and the Executive Director of Provincial Tumour Programs. Most patients with in-situ or early-stage melanoma (Stage 0; Stage 1A/B; Stage II, 1 mm thick with ulceration or Clark level IV, V or 1 mm thick, any characteristic; and Stage III, sentinel node positive): There is no recommendation for the use of adjuvant radiation therapy, as most of these patients will be cured by primary excision alone (National Comprehensive Cancer Network [NCCN], 2009). Post-operative radiotherapy may be used after close or positive margins where further excision is not practical or possible, inoperative lentigo maligna, rapid or multiple recurrences or extensive perineural spread (as seen with Desmoplastic melanoma). Patients with Stage IIIC or Stage IV disease should be referred for the consideration of adjuvant radiation therapy to improve local and regional control of their disease (NCCN, 2009) Stage IIIC with multiple nodes involved or extranodal extension: consider radiation therapy to nodal basin. Stage III in transit: consider radiation therapy. Stage IV metastatic: if disseminated (unresectable) with brain metastases, consider radiation for symptomatic patients. Consider the following for patients with recurrence (NCCN, 2009): Recurrence (true local scar): base treatment on stage of recurrence. Recurrence (local, satellitosis, and/or in-transit): consider radiation therapy. Recurrence (nodal): consider adjuvant radiation therapy. Recurrence (distant): if disseminated (unresectable) with brain metastases, consider radiation for symptomatic patients. If interferon is to be part of the treatment regimen: Radiation should not be given concurrently. Interferon may act as a radiosensitizer, and patients receiving both may experience increased toxicities. Radiation therapy may be delayed until completion of the induction phase of interferon administration. None providedNational Comprehensive Cancer Network (NCCN). Melanoma guidelines. Fort Washington (PA): National Comprehensive Cancer Network (NCCN); 2009. The recommendations are partially supported by a practice guideline (see the "Major Recommendations" field).Appropriate use of adjuvant radiation for malignant melanomaseveral non-randomized studies have suggested that postoperative radiation to the neck or axilla after radical lymph node dissection decreases regional recurrence rates in node-positive patients.Radiation should not be given concurrently with interferon. Interferon may act as a radiosensitizer, and patients receiving both may experience increased toxicities. Present the guideline at the local and provincial tumour team meetings and weekly rounds. Post the guideline on the Alberta Health Services website. Send an electronic notification of the new guideline to all members of Alberta Health Services, Cancer Care. Getting Better;Living with IllnessEffectivenessNot applicable: The guideline was not adapted from another source.2012 MarAlberta Health Services, Cancer CareAlberta Provincial Cutaneous Tumour TeamNot statedParticipation of members of the Alberta Provincial Cutaneous Tumour Team in the development of this guideline has been voluntary and the authors have not been remunerated for their contributions. There was no direct industry involvement in the development or dissemination of this guideline. Alberta Health Services, Cancer Care recognizes that although industry support of research, education and other areas is necessary in order to advance patient care, such support may lead to potential conflicts of interest. Some members of the Alberta Provincial Cutaneous Tumour Team are involved in research funded by industry or have other such potential conflicts of interest. However the developers of this guideline are satisfied it was developed in an unbiased manner.Electronic copies: Available in Portable Document Format (PDF) from the Alberta Health Services Web site.The following is available: Guideline utilization resource unit handbook. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2011 Dec. 5 p. Electronic copies: Available in Portable Document Format (PDF) from the Alberta Health Services Web site. None availableThis NGC summary was completed by ECRI Institute on December 11, 2012. The information was verified by the guideline developer on January 23, 2013.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
11089Consensus statement: using laryngeal electromyography for the diagnosis and treatment of vocal cord paralysis.Munin MC, Heman-Ackah YD, Rosen CA, Sulica L, Maronian N, Mandel S, Carey BT, Craig E, Gronseth G. Consensus statement: using laryngeal electromyography for the diagnosis and treatment of vocal cord paralysis. Muscle Nerve. 2016 Jun;53(6):850-5. [31 references] PubMedThis is the current release of the guideline. This guideline meets NGC's 2013 (revised) inclusion criteria. Recurrent laryngeal neuropathy (RLN) Vocal fold paralysis Diagnosis;Evaluation;TreatmentNeurology;Otolaryngology;Physical Medicine and RehabilitationPhysiciansTo develop an evidence-based consensus statement regarding use of laryngeal electromyography (LEMG) for diagnosis and treatment of vocal fold paralysis after recurrent laryngeal neuropathy (RLN)Patients with acute unilateral or bilateral vocal fold paralysis after recurrent laryngeal neuropathy (RLN)Laryngeal electromyography (LEMG)Recovery of vocal fold motionSearches of Electronic DatabasesIn October 2012, PubMed was used to search Medline to identify all potential abstracts. The search strategy for this study included the keywords, MeSH terms, and text words. The search terms included laryngeal electromyography, motor unit recruitment, fibrillation potentials, positive wave potentials, laryngeal synkinesis, turns-to-amplitude ratio, quantitative electromyography, thyroarytenoid muscle, cricothyroid muscle, lateral cricoarytenoid muscle, posterior cricoarytenoid muscle, recurrent laryngeal nerve injury, recurrent laryngeal neuropathy, and vocal fold paralysis. This produced 1,540 English-only abstracts that matched the search terms, including human and highly relevant animal studies and all age groups, published between 1960 and October 2012. Use of laryngeal electromyography (LEMG) for intraoperative monitoring of nerve activity was an exclusion criterion. Titles were reviewed for relevance, which yielded 273 articles. At least 2 investigators then reviewed abstracts for 254 publications, because 19 could not be located. This level of review resulted in 65 publications for full manuscript data abstraction. After each was reviewed in its entirety by 2 investigators, 14 were identified as relevant for this guideline. To be considered relevant, the article had to describe both: (1) patients with a neurologic disease affecting the laryngeal muscles; and (2) subjects with and without LEMG abnormalities. The results of the LEMG (the index test) had to be compared with the reference standard of recovery of vocal fold motion as detected by laryngoscopy. All included publications evaluated a minimum of 10 subjects and described the LEMG technique in detail. Studies on clinical management were required to describe how patient treatment was altered by the results of the LEMG. Studies that evaluated whether LEMG predicted recovery of vocal fold mobility were required to use laryngoscopy at the onset of symptoms and at interval recovery periods until at least 6 months after onset of symptoms. If the initial LEMG was performed 6 months after onset of injury, the data for those individual patients were excluded, because the correlation of late LEMG studies to outcomes is known to be low. Late LEMG prognostic information does not add further value, as spontaneous recovery after 6 months of paralysis is quite rare. In addition, synkinetic reinnervation could yield normal motor unit potential (MUP) recruitment without any vocal fold motion. 14 articles were identified as relevant for this guideline.Expert Consensus;Weighting According to a Rating Scheme (Scheme Given)The 14 relevant publications were rated using the American Academy of Neurology grading system.Meta-Analysis;Systematic Review with Evidence TablesExpert ConsensusNot applicableA formal cost analysis was not performed and published cost analyses were not reviewed.Internal Peer ReviewThe article was reviewed by the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) in January 2016 and approved by the AANEM Board of Directors on February 8, 2016.Summary Recommendations If prognostic information is required on ultimate vocal fold mobility in a patient with vocal fold paralysis that is 4 weeks and 6 months in duration, laryngeal electromyography (LEMG) should be performed. LEMG may be performed to clarify treatment decisions in a patient with vocal fold immobility that is presumed to be caused by recurrent laryngeal neuropathy (RLN). None providedThe type of evidence supporting the recommendations is not specifically stated. Laryngeal electromyography (LEMG) adds value by changing the clinical management of a patient with vocal fold paralysis approximately 48% of the time by suggesting diagnoses other than recurrent laryngeal neuropathy (RLN). LEMG can provide clarity between the clinical presentation of RLN versus mechanical cricoarytenoid joint abnormality, because the latter would have normal LEMG findings. If LEMG data show signs of reinnervation and recovery, then this can inform the patient and clinician to pursue a continued period of observation or to use a temporary treatment (e.g., vocal fold injection with a material that dissipates in 2 to 3 months). If the LEMG data reveal a poor prognosis based on lesion severity, permanent surgical treatment can be offered sooner for appropriate patients. Treatment of bilateral vocal fold paralysis generally is irreversible, involving destruction of some part of the vocal fold and/or arytenoid to enlarge the glottic airway. Information provided by LEMG before embarking on this permanent surgical treatment also may help select a side for the surgical intervention. Not statedAn implementation strategy was not provided.Getting Better;Living with IllnessEffectivenessNot applicable: The guideline was not adapted from another source.2016 JunAmerican Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)Professional Practice Committee of the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)Committee Members: Michael C. Munin, MD, Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; Yolanda D. Heman-Ackah, MD, MS, Department of OtolaryngologyHead and Neck Surgery, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA, Sidney Kimmel Medical College, Philadelphia, Pennsylvania, USA; Clark A. Rosen, MD, Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; Lucian Sulica, MD, Department of OtolaryngologyHead Neck Surgery, Weill Cornell Medical College, New York, New York, USA; Nicole Maronian, MD, Ear, Nose and Throat Institute, Case Western Reserve University, Cleveland, Ohio, USA; Steven Mandel, MD, Department of Neurology, Hofstra North Shore LIJ School of Medicine, Hempstead, New York, USA; Bridget T. Carey, MD, Department of Neurology, Weill Cornell Medical College, New York, New York, USA; Earl Craig, MD, Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, Indianapolis, Indiana, USA; Gary Gronseth, MD, Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USANot statedAvailable from the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Web site.None availableNone availableThis NGC summary was completed by ECRI Institute on January 18, 2017. The information was not verified by the guideline developer.This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.