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CLINICAL PRACTICE GUIDELINE PROCESS MANUAL
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CLINICAL PRACTICE GUIDELINE, PROCESS MANUAL, 2004 Edition. Prepared by Wendy Edlund Gary Gronseth MD Yuen So MD . PhD and Gary Franklin MD MPH, For the, Quality Standards Subcommittee QSS and the. Therapeutics and Technology Assessment Subcommittee TTA . For more information contact , Wendy Edlund, Associate Director Clinical Practice. American Academy of Neurology, 1080 Montreal Avenue. St Paul MN 55116, 651 695 2716, Fax 651 695 2791, wedlund aan com.
The authors thank James Stevens MD FAAN Michael Glantz MD FAAN and Richard. Dubinsky MD MPH FAAN and other members of the QSS and TTA for their careful review of. drafts of this manuscript and Robert Miller MD for his work in the preparation of a prior edition. of this process manual , Members of QSS Members of TTA. Jacqueline French MD FAAN Co Chair Janis Miyasaki MD FAAN Co Chair . Gary Gronseth MD Co Chair Yuen So MD PhD Co Chair . Charles E Argoff MD Richard Camicioli MD, Eric Ashman MD Vinay Chaudhry MD FAAN. Christopher Bever Jr MD MBA FAAN Richard Dubinsky MD MPH FAAN. John England MD FAAN Cynthia Harden MD, Robert Holloway MD MPH FAAN Cheryl Jaigobin MD. Donald Iverson MD FAAN Irene L Katzan MD, Steven Mess MD Kenneth Mack MD PhD. Leslie A Morrison MD, Samuel Wiebe MD, Dean M Wingerchuck MD FAAN.
Theresa Zesiewicz MD FAAN,Stephen Ashwal MD FAAN Ex Officio . Deborah Hirtz MD Ex Officio , Gary Franklin MD MPH Ex Officio . David Thurman MD Ex Officio , 2005 American Academy of Neurology. Approved by the AAN Board of Directors January 2004. TABLE OF CONTENTS,Introduction 5,Overview 6,1 Topic Development 7. 1 1 Topic Nominations 7, 1 2 Forming the Author Panel 7.
1 3 Completing the Project Development Plan 8, 1 4 Submission of Project Development Plan 13. 2 Data Review and Analysis 13, 2 1 Performing the Literature Search 13. 2 2 Selecting Articles for Inclusion 14, 2 3 Data Extraction and Classification of the Evidence 16. 2 4 Development of the Evidence Tables 22, 2 5 Formulating Conclusions 22. 2 6 Formulating Recommendations 25,3 Writing Revision and Approval 26.
3 1 Drafting the Guideline 26, 3 2 Developing Recommendations for Future Research 28. 3 3 Committee Review 28, 3 4 External Review 29, 3 5 Committee Approval 29. 3 6 Journal Review 29, 3 7 Practice Committee and Board of Directors Approval 29. 3 8 Seeking Endorsements 29,4 Guideline Dissemination 30. 5 Responding to Correspondence 30,6 Guideline Updating Process 30.
Appendices, Appendix 1 Project Development Plan 32. Appendix 2 Suggested Supplementary Materials 35, Appendix 3 Conflict of Interest Disclosure Statement 36. Appendix 4 Evidence Based Medicine Related Terms for Searching MEDLINE 40. Appendix 5 Major Literature Databases 41, Appendix 6 Costs Associated with Guideline Development 45. Appendix 7 Common Formulas for Calculating Effect Size 46. Appendix 8a and 8b Sample Data Extraction Forms 47. Appendix 9 Definitions for Classification of Evidence 49. Appendix 10 Sample Evidence Table 51, Appendix 11 Guideline Format 52. Appendix 12 Sample Revision Table 54, Appendix 13 Grey Literature 55.
INTRODUCTION, This manual has been created to provide instructions for developing an AAN clinical practice guideline . AAN practice guidelines consist of a formalized review of the literature that serves as the foundation for. evidence based practice recommendations The literature review of a guideline is distinct from a typical. literature review in that it is systematic and transparent The recommendations of the guideline are also. distinct in that they are fundamentally evidenced based Detailed instructions on how to complete a. systematic review and formulate recommendations are outlined herein . While reading this manual it is important to keep sight of the big picture of what is to be accomplished . Essentially authors are to identify a clinical question for which AAN members could benefit from. evidence based guidance Then they are to answer the question by employing a methodology most likely. to lead to the correct answer , Asking and answering the question forms the backbone of both the guideline development process and. the resulting manuscript Both should clearly follow the progression of . ASK A CLINICAL QUESTION, , FIND AND ANALYZE RELEVANT EVIDENCE. , STATE CONCLUSIONS, , MAKE RECOMMENDATIONS, First authors identify a clinical question that needs to be answered The question should address an area. of quality concern controversy confusion or variation in practice The question must be answerable with. sufficient scientific data Answering the question must have the potential to improve clinical care and. patient outcomes , Second authors identify and evaluate all pertinent evidence A comprehensive literature search is.
performed The evidence uncovered in the search is evaluated and explicitly rated based on content and. quality , Third the authors make conclusions that synthesize and summarize the evidence in answer to the clinical. question , Finally the authors provide guidance to clinicians by systematically translating the conclusions of the. evidence to action statements in the form of practice recommendations The recommendations are worded. and graded based on the quality of supporting data . 5, OVERVIEW OF AAN CLINICAL PRACTICE GUIDELINES, Overall Objective The AAN develops clinical practice guidelines to assist its members in clinical. decision making particularly in situations of controversy or variation in practice . Background Both the Quality Standards Subcommittee QSS and the Therapeutics and Technology. Assessment Subcommittee TTA develop practice guidelines using the processes discussed in this. manual Both subcommittees form expert panels to critically assess all of the relevant literature on a given. topic or technology Evidence is rated based on quality of study design and clinical practice. recommendations are developed and stratified to reflect the quality and the content of the evidence The. QSS develops practice parameters which are guidelines with a patient centric focus The TTA develops. technology assessments and practice advisories which are guidelines with an intervention centric focus . Key Audiences , Primary Neurologists AAN Guideline Development Process. Secondary Patients payers federal agencies e g CMS . other healthcare providers clinical researchers, Select Guideline Topic.
Definitions , Practice Parameters are strategies for patient Form Balanced Panel of Experts. , management that assist physicians in clinical decision. Develop Clinical Questions, making A practice parameter is a series of specific . , evidence based practice recommendations that answer an Comprehensively Review the Literature. important clinical question e g What pharmacological . interventions reduce sialorrhea in patients with ALS Rate Articles and Summarize Findings. , Practice Advisories present evidence based practice Write Guideline that Makes Explicit Supported.
recommendations for emerging and or newly approved Practice Recommendations. therapies or technologies based on evidence from at least . one Randomized Controlled Trial RCT The evidence Distribute Draft for Extensive Peer Review by. may demonstrate only a limited clinical response the AAN Neurology and Others. statistical evidence may be weak significant cost benefit . questions may exist or there may be substantial or Obtain AAN Approval of Guideline. potential disagreement among practitioners or between. payers and practitioners e g Based on initial studies is. rt PA safe and effective in the treatment of stroke . Technology Assessments are statements that assess the safety utility and effectiveness of new . emerging or established therapies and technologies in the field of neurology e g What is the safety. and utility of SPECT in evaluating neurologic patients . Common Uses of AAN Guidelines, Improve health outcomes for patients Affirm the role of neurologists in the. Stay abreast of the latest in clinical research diagnosis and treatment of neurological. Provide medico legal protection disorders, Advocate for fair reimbursement Influence public or hospital policy. Determine whether one s practice follows Promote efficient use of resources. current best evidence Identify research priorities based on gaps in. Reduce practice variation current literature, 6, 1 TOPIC DEVELOPMENT Table 1. Completing the Justification Statement,Topic Development takes one to six. months and produces a Project The justification statement should be approximately one. Development Plan the project double spaced page in length . blueprint for accepted topics , It should outline the problem to be addressed and include.
examples of specific clinical questions that could be. 1 1 Topic Nominations answered in the guideline , Any AAN member Committee Section Because availability of evidence is crucial to the project s. or an outside organization e g an success it is essential to include sample citations that. organization responsible for generating represent the best available evidence on the topic . health policy may request the, development of a guideline All topic The justification statement should examine the following. suggestions must be submitted in factors on which QSS or TTA will base its decision for. writing in the form of a justification approval , Relevance to neurology. statement see Table 1 , Prevalence of condition, Topics are evaluated quarterly by the Health impact of condition for the individual. QSS TTA Topic Review Panel based Socioeconomic impact. upon neurologists need for guidance Extent of practice variation. the availability of evidence to provide Quality of available evidence. guidance and the potential to improve External constraints on practice e g access issues . patient care and outcomes reimbursement issues paucity of data for setting policy . health policy gaps resource constraints , The Topic Review Panel assigns Urgency for evaluation of new therapy or technology.
accepted topics to either QSS or TTA Potential for significant benefit risk or abuse. based on whether the topic is best,addressed from the perspective of the. patient QSS or a technology or therapy members with expertise relevant to the. TTA topic including panel members that are, nationally recognized experts on the. QSS and TTA initiate projects based topic being addressed i e have. upon the criteria listed in Table 1 and authored clinical publications in high. the availability of resources impact journals , 1 2 Forming the Author Panel It may also be useful to appoint a. general neurologist and or an expert in, QSS or TTA assign a committee guideline methodology to the panel . member to serve as the project, facilitator The facilitator identifies a The facilitator and lead author should.
lead author Together the facilitator and also seek input from other medical. lead author assemble an author panel specialties as appropriate This can be. being careful to seek a variety of accomplished through formal. perspectives and to avoid bias collaboration with another organization. to be coordinated by AAN staff or by, The author panel usually consists of five appointing non neurologists to the panel. to ten individuals Under most without formal collaboration with. circumstances the panel should include corresponding medical specialty. organizations , 7, It may be difficult to form an expert e g literature review and drafting the. panel devoid of potential conflict thus it guideline . is essential to balance the panel, between those with and without Author Panel Member Active. conflicts financial research academic participant in the project Usually. etc The AAN forbids commercial reviews articles classifies evidence and. participation in guideline projects writes portions of the document . The author panel roster is communicated AAN Staff Provides administrative. to QSS or TTA at its next meeting Any support and advice facilitates meetings. subsequent changes to the author panel and group communications coordinates. must be communicated to QSS or TTA resource allocation e g medical. librarian and liaisons to the journal and, Information regarding AAN guideline approval bodies . projects including contact information, of lead authors is shared with the 1 3 Completing the Project.
Cochrane Collaboration their staff may,contact authors to inform them of. Development Plan, pertinent Cochrane reviews AAN A Project Development Plan PDP . Sections may also be alerted to the worksheet is provided in Appendix 1 . development of the guideline and The PDP provides a framework for each. provided an author panel roster panel to define the project and receive. feedback at an early stage in the process , Conflict of Interest The following information is presented. Panel members must sign a conflict of in the completed PDP . interest statement Appendix 3 All real Potential clinical questions. or potential conflicts for the past five Terms and databases to be used in. years must be noted conflicts will be the literature search. disclosed in the guideline Inclusion and exclusion criteria for. article selection,Authorship Project timeline,All par. This manual has been created to provide instructions for developing an AAN clinical practice guideline AAN practice guidelines consist of a formalized review of the literature that serves as the foundation for evidence based practice recommendations The literature review of a guideline is distinct from a typical

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