Evidence Analysis Library, Evidence Analysis Process and Evidence-Based Nutrition Practice Guidelines and Toolkits Updated Feb 2007 ADA Staff ©2007 American Dietetic Association Research: Foundation of the Dietetics Profession Evidence-Based Dietetics Practice is the use of systematically reviewed scientific evidence in making food and nutrition practice decisions by integrating best available evidence with professional expertise and client values to improve outcomes.” definition Why Evidence-based Practice? • To improve patient outcomes • To improve safety, quality, efficiency • To take advantage of “exploding” biomedical knowledge (thousands of new research studies appear every month) ADA Evidence Analysis Library www.adaevidencelibrary.com Online Resource with the best available research on important dietetics topics in a practitioner-friendly format Free to all ADA Members Sign-in: Use Your ADA Member ID & password What are the steps in ADA’s Evidence Analysis Process? 1. Select topic & appoint expert work group 3. Conduct literature review for each question 2. Define questions and determine inclusion/ exclusion criteria 4. Analyze Articles/ Critical Appraisal 5. Overview Table & Evidence summary 6. Develop conclusion statement & assign grade 7. Publish to online EAL Evidence-Analysis Process Steps 8. Review, Revise, Update Roles and Responsibilities of EBP Committee Oversight Evidence analysis process Evidence analysis library Evidence-based Guidelines Evidence-based Toolkits Promotion Functions Promote the implementation of evidence-based dietetic practice Appoint workgroup members Prioritize evidence analysis projects Determine format and content of products Evaluate EA process Structure of EvidenceBased Practice Committee Nutrition Care Process Ambulatory Care Dietetic Practice-Based Research Network Public Health Research ADA EBP Committee Long-Term Care Practice • Joint ADA • House of Delegates -&Board of Directors appointed committee Quality Management Board Of Directors Acute Care Practice Trained as evidence analysts ADA Evidence-based Practice Committee Evidence-Based Practice Committee Members 2006-2007 • Marion Franz, MS, RD, CDE (Chair) • Kathleen Niedert, MBA, RD, LD, FADA (Vice Chair) • Elvira Johnson, MS, RD, CDE, LDN • Margie Tate, MS, RD • David Frankenfield, MS, RD • Nancy Lewis, PhD, RD, FADA • Kim Robien, PhD, RD, FADA, CNSD • Rita Johnson, PhD, RD, LDN, FADA • Trisha Furman, MS, RD, LD, FADA EBP Committee reports jointly to ADA House of Delegates and ADA Board of Directors EBP Committee Members Expert Work Group (6-8 persons for each project) Experts in the field/project topic Appointed by EBP Committee Work by Functions Teleconferences • Develop questions & search criteria • Review materials (articles, worksheets, summaries) • Form conclusion statements – Assign Grade to strength of the evidence • Develop Guidelines, if appropriate Evidence Analysis Work Groups Evidence Analysts Experts in critically analyzing articles Must have at least Master’s degree; many have PhD’s Trained at ADA’s EA workshop Mentored by ADA Staff and Lead Analysts Read and analyze articles Work Online o o o o Complete worksheets Complete quality checklists Complete overview tables Complete evidence summaries Contributors • All members of each Evidence Analysis team are listed in the Contributors section on the EAL, including work group members, evidence analysts, lead evidence analysts, project managers, and sponsors. Current List of ADA EAL Projects Diseases & Conditions Adult Diabetes 1 & 2 (revision) Adult Weight Management Childhood Overweight Chronic Kidney Disease (revision) Chronic Obstructive Pulmonary Disease (COPD) Critical Illness Disorders of Lipid Metabolism (Hyperlipidemia revision) Gestational Diabetes (revision) Gluten Intolerance/ Celiac Heart Failure HIV/AIDS Hydration Diseases & Conditions (continued) Hypertension Nutrition in Athletic Performance Nutrition Care in Bariatric Surgery Oncology Pediatric Weight Management Spinal Cord Injury & Nutrition Unintended Weight Loss Nutrition Care Process Estimating Energy Expenditure/Indirect Calorimetry Nutrition Counseling Foods Non-nutritive Sweetener Vegetarian Nutrition Nutrients Fiber Navigate through the library by selecting from tabs: EAL Drill down to the amount of information you desire on EAL • Question • Search Plan & Results • Conclusion Statement/Grade of the strength and quality of the evidence • Evidence Summary • Bibliography/Worksheets on each article • Quality Checklists 1. Select from list of Diseases & Conditions 2. Choose a Topic Disorders of Lipid Metabolism Macronutrients Trans-fatty acids 3. Then, choose a sub-topic Example: View EA Question What is the relationship between diets high in trans fatty acids and serum cholesterol levels? Bibliography for Topic Search Plan & Results for each question Reports Inclusion & Exclusion Criteria Date of Search Inclusion Criteria: •Age •Setting (outpatient) •Sample Size •Acceptable dropout rate •Year Range •English Language Databases Searched Search Terms List of Articles Example: Search Plan & Results Included articles and Excluded articles (with reason) List Reason for exclusion for each article not Included in the Analysis; e.g. Sample size Too small Example: Search Plan & Results2 Excluded Articles Example: Conclusion Statement (answer to question) and Grade “Mouse over” Question to see Conclusion & Grade or click on question to continue drilling down. Conclusion Statement Trans-fatty acids raise total cholesterol and LDL-C. Unlike saturated fatty acids, trans-fatty acids do not increase and may decrease HDL-C. Trans-fatty acids increase the TC/HDL-C ratio in a dose dependent manner. GRADE I Explanation of Grades Example: Evidence Summary Narrative SummaryAll articles used to Of theanswer question are summarized here. research available to answer question Narrative Evidence Summary Example: Summary of evidence for Low Glycemic Diets question Overview Table Low Glycemic Diets Lists Citation, Study Design, Quality Rating, Sample Size, Interventions and Outcomes in table format – enables user to compare studies side by side Example: Overview Table Evidence Summary - bibliography Each citation in bibliography LINKS to Worksheet Example: Evidence Summary2 bibliography Example: Worksheet for each article •Citation / PubMed ID •Date •Study Design •Class •Rating (+/0/-) •Research Purpose •Inclusion Criteria •Exclusion Criteria •Description of Study Protocol •Data Collection Summary •Description of Actual Data Sample •Summary of Results •Author Conclusion •Reviewer Comments Example: Quality Criteria Checklist •Primary Research or •Narrative Review Determine Quality Rating of Article Transition from Evidence to Evidence-Based Guideline Evidence Summaries/Conclusion Statements = what the evidence says Guideline = course of action for the practitioner based on the evidence ADA’s Evidence-Based Guidelines • Use best available evidence in making clinical decisions • Use a systematic process for identifying, assessing, analyzing and synthesizing evidence as a basis for development • Promote use of professional expertise where evidence is weak or lacking Criteria and Classification for Guideline Development • Criteria used to develop: • Guideline Elements Model (GEM) • AGREE Instrument • National Guidelines Clearinghouse standards • Classification: • Recommendation ratings adapted from American Academy of Pediatrics Transition from evidence to Guideline • Formulation of: • Recommendations: a series of guiding statements that propose a course of action for practitioners • Clinical Algorithms: step-by-step flowchart for treatment of the specific disease/condition • Introduction: scope, intent, methods, benefits/harms • Appendices: food tables, etc. • Glossary • External review • Publish on EAL Features of Guideline Introduction • Scope: disease/condition, objective, intended users, target population • Statement of Intent • Guideline Methods: process of guideline development, inclusion/exclusion criteria • Implementation of Guideline • Benefits and Potential Risks/Harms of Implementing Features of Guideline Recommendations • Written for the practitioner, as a course of action • Describe “what” the practitioner should do and “why” it should be done • Display rating using ADA scale Strong, Fair, Weak, Consensus, Insufficient Evidence • List potential risks/harms for implementing • Provide a brief narrative illustrating the supporting evidence • Provide rationale for the recommendation rating • List any minority opinions • Link to supporting evidence Evidence-Based Guidelines Homepage Select Guidelines from Guideline List Example: Select Disorders of Lipid Metabolism Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Main Menu Choose a Category Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Introduction •Guideline Overview •Scope of Guideline •Statement of Intent •Guideline Methods •Implementation •Benefits and Risks/harms Select a Category within Introduction Scope of Guideline Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Scope of Guideline Disease/Condition Guideline Category Intended Users Objectives Target Population Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Introduction: Guideline Methods Method for Creating Guidelines Inclusion and Exclusion Criteria Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Main Menu: Major Recommendations Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Select a Recommendation (listed by topic) Macronutrients: Fat Sub-topic: Trans-fatty Acid Intake Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Recommendation domains: Recommendation & Rating Risks/Harms Conditions of Application Potential Costs Narrative Rationale for Rating Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline E.g.Recommendation: Trans-fatty acids consumption should be as low as possible. A cardioprotective dietary pattern should contain less than 7% of calories from saturated fat and trans-fatty acids. Trans-fatty acids raise total cholesterol and LDL-C and may decrease HDL-C, thereby increasing the TC/HDL-C and LDL-C/HDL-C ratios. Increasing trans-fatty acid intake increases risk of CHD events. Statement Rating Definition Implication for Practice Strong A Strong recommendation means that the workgroup believes that the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits in the case of a strong negative recommendation), and that the quality of the supporting evidence is excellent/good (grade I or II). In some clearly identified circumstances, strong recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. Fair A Fair recommendation means that the workgroup believes that the benefits exceed the harms (or that the harms clearly exceed the benefits in the case of a negative recommendation), but the quality of evidence is not as strong (grade II or III). In some clearly identified circumstances, recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. Practitioners should generally follow a Fair recommendation but remain alert to new information and be sensitive to patient preferences. Weak A Weak recommendation means that the quality of evidence that exists is suspect or that well-done studies (grade I, II, or III) show little clear advantage to one approach versus another. Practitioners should be cautious in deciding whether to follow a recommendation classified as Weak, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Consensus A Consensus recommendation means that Expert opinion (grade IV) supports the guideline recommendation even though the available scientific evidence did not present consistent results, or controlled trials were lacking. Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. Insufficient Evidence An Insufficient Evidence recommendation means that there is both a lack of pertinent evidence (grade V) and/or an unclear balance between benefits and harms. Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Insufficient Evidence and should exercise judgment and be alert to emerging publications that report evidence that clarifies the balance of benefit versus harm. Patient preference should have a substantial influencing role. Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Scroll down recommendation page for links to the supporting evidence and worksheets What is the relationship between diets high in trans fatty acids and risk for CHD? Disorders of Lipid Metabolism EAL Trans fatty acids question View Conclusion Statement and Grade Drill down to the Evidence Summary Disorders of Lipid Metabolism EAL Trans fatty acids question Evidence Summary Scroll down for worksheets Disorders of Lipid Metabolism EAL Trans fatty acids question Drill down to Quality rating And worksheets Disorders of Lipid Metabolism Evidence-Based Nutrition Practice Guideline Main Menu: Algorithms Main Algorithm for Disorders of Lipid Metabolism View recommendations organized within a treatment plan Nutrition Care Process Assessment Diagnosis Intervention Monitoring & Evaluation Link to another level within the Algorithm Select: Determine Meal Plan and Nutrition Recommendations Red = link to different level in algorithm Blue = link to recommendation •View second level algorithm •Link to Recommendation Recommend Intake of as Few Trans Fatty Acids as Possible Select •View Recommendation • Drill down as needed Evidence-Based Toolkits • Set of companion documents for application of the practice guideline • Disease or condition specific • Include: • documentation forms • outcomes monitoring sheets • client education resources • case studies • MNT protocol for treatment of disease/condition • Incorporate Nutrition Care Process and Standardized Language • Electronic download purchase item Disorders of Lipid Metabolism Toolkit STORE • Choose Quantity • Add to Cart Disorders of Lipid Metabolism Toolkit Contents MNT Protocol • Summary Page for DLM and DLM with Metabolic Syndrome • MNT Flowchart of Encounters • MNT Encounter Process Documentation Forms • Instructions for Sample Referral Form • MNT Sample Referral Form • Initial and Follow-up Nutrition Progress Note • Sample Case Study #1 • Sample Case Study #2 Summary Page for DLM: based on evidence Outcomes Assessment Factors • e.g. soluble fiber intake Expected Outcomes • increased intake Ideal Goals of MNT • >25g dietary fiber of which 7-13g soluble fiber per day ©2006 American Dietetic Association Disorders of lipid Metabolism Toolkit Encounter Process for Disorders of Lipid Metabolism ENCOUNTER: Initial Encounter 45 to 90 minutes Encounter Process: detailed process for assessment, diagnosis, intervention and monitoring and evaluation of patients with DLM Assessment Obtain the following from client, medical record/information system or clinical referral form within 30 days of encounter. Client History consists of four areas: medication and supplement history, social history, medical/health history, and personal history. •Medication and Supplement History includes, for instance, prescription lipid-lowering, antihypertensive, diabetes, and thyroid medications, over the counter (OTC) drugs, herbal and dietary supplements (for example folate, B-complex vitamins, Co-enzyme Q10, those with potential for food/drug interaction), and illegal drugs. • Social History may include such items as smoking history, alcohol intake (frequency and amount), socioeconomic status, social and medical support, cultural and religious beliefs, housing situation, and social isolation/connection. •Medical/Health History includes chief nutrition complaint, present/past illness particularly of cardiovascular disease, diabetes, thyroid disease, evaluate risk factors for cardiovascular disease, metabolic syndrome, family medical history, especially of premature cardiovascular disease, mental/emotional health and cognitive abilities. •Personal History consists of factors including age, occupation, role in family, and education level. Biochemical Data includes laboratory data, for example, lipid profile, glucose, hemoglobin A1C, liver function tests, thyroid, Lp(a), homocysteine, and high-sensitivity C reactive protein. Anthropometric Measurements include height, weight, weight history, body mass index (BMI), waist circumference (WC), waist to hip ratio (WHR) Physical Exam Findings includes blood pressure, general physical appearance (abdominal girth and presence of xanthomas) muscle and subcutaneous fat wasting, and affect Food and Nutrition History consists of four areas: Food consumption, nutrition and health awareness and management, physical activity and exercise, and food availability Case Studies: • Initial and Follow-up Encounters • Illustrates the Nutrition Care Process • Uses new SL for Nutrition Diagnosis and Intervention DLM Toolkit Contents Client Education Resources • Executive Summary and List of ADA Client Education Resources • Client Agreement for Care • Other Client Education Resources Alcohol Soluble Fiber Tips The Low-down on Trans Fats Health Benefits of Nuts Omega-3 Fatty Acids Sample Menu #1 and #2 • Appendices Client Education Materials: 6-7th grade reading level DLM Toolkit Contents Outcomes Monitoring Forms • Individual Outcomes Monitoring Form • Aggregate Input Form • Aggregate Outcomes Monitoring Form • Sample Individual Outcomes Form • Sample Aggregate Input Form • Sample Aggregate Outcomes Form Monitoring Outcomes: use for individuals or a population –monitor change (e.g. kcal, lipid values) • document over several encounters • programmed formulas for % change and averages Published and Upcoming Evidence-Based Guidelines and Toolkits Published: •Disorders of Lipid Metabolism Guideline and Toolkit •Adult Weight Management Guideline •Critical Illness Guideline Coming Soon: •Adult Weight Management Toolkit •Pediatric Weight Management Guideline •Critical Illness Toolkit Upcoming guidelines and toolkits: •Diabetes Type 1 and 2 •Oncology •Hypertension •Heart Failure •Gestational Diabetes •Spinal Cord Injury •COPD •Chronic Kidney Disease •Unintended Weight Loss These resources can assist you in: • Implementing evidence-based practice • Implementing Nutrition Care Process • Using recommendations based on a collective body of evidence • Training new staff, students and interns • Understand treatment for an unfamiliar topic • Meeting regulations based on current standards of practice –best practice Other EAL Features Robust Search Help and FAQs Evidence Analysis Process (describes methods in detail) Contributors (lists workgroup members, analysts, and sponsors for each project) Resources • Check Resources on EAL for additional PowerPoint presentations. ADA’s Evidence Analysis Library can be found at www.adaevidencelibrary.com For questions: see HELP and Frequently Asked Questions, or contact: eal@adaevidencelibrary.com ©2007 American Dietetic Association