To ensure the accuracy of the action statements, it is helpful to have the completed literature grid on each topic available for reference by the GDG. The content of articles and their critical appraisal scores are immediately available when decisions are made about the quality of the supporting evidence for a particular recommendation. The BRIDGE-Wiz action statements are completed as a GDG group activity, to reduce the bias that might occur if only 1 person were to generate an action statement. The related weighted evidence should be summarized for each recommendation using the following headings, most of which are generated by BRIDGE-Wiz.
* (Grade) Action Statement. A statement generated by BRIDGE-Wiz with the following parenthetical indicator (Evidence Quality: (number), Rec. Strength: (Strong, Moderate, or Weak). The assigned letter grade should precede the action statement.
* Benefits: Written during the use of BRIDGE-Wiz.
* Risk, harm, cost: Written during the use of BRIDGE-Wiz.
* Benefit-harm assessment: Generated by BRIDGE-Wiz.
* Value judgments: Written after BRIDGE-Wiz generates an action statement.
* Intentional vagueness: Written after BRIDGE-Wiz generates an action statement.
* Role of patient preferences: Written after BRIDGE-Wiz generates an action statement.
* Exclusions: Written after BRIDGE-Wiz generates an action statement.
* Supporting Evidence and Clinical Interpretation. This heading is not generated by the BRIDGE-Wiz software and thus needs to be inserted manually. It is written after BRIDGE-Wiz generates an action statement to summarize the strength of the literature that supports the action statement. These sections may be assigned to individual GDG members whose expertise lies in specific topical areas.
A list of the action statements should be a “stand alone” part of the CPG, typically appearing as the first pages in the document. Detailed rationales for the recommendations should follow in the body of the CPG. Best Practice points (P) can be used when common procedures are recommended in the absence of research literature that directly supports the procedure, or to minimize risk or to comply with documentation standards. (For example, a P level recommendation may be to take a blood pressure on the individual prior to supervised exercise because that is considered safe practice, even if no citations are provided specific to the topic of the CPG that indicates that blood pressure should be taken.)
Research recommendations (R) are listed under the Supporting Evidence and Clinical Interpretation section of each recommended Action Statement. These recommendations identify gaps in the evidence for which physical therapy related research is needed.
Review and Dissemination of the Clinical Practice Guideline
There are 3 phases of preparing the CPG for public dissemination. The first phase is the review process during which various stakeholders can provide critical comments for revisions. The second phase is the publication phase when the manuscript is prepared for formal submission to a journal, and the third phase entails submission of an application for posting the CPG on guidelines.gov.
Phase 1: Review by Content and Methods Experts.
Identify the initial stakeholders who will review the first draft of the CPG and a method of dissemination. The stakeholders should include representation from multiple clinical and lay groups for which the CPG is intended. This first group of reviewers should include PTs with expertise in the topic and several non-PTs, preferably physicians, payers, nurses, and/or other professions from the public and private sectors who work within the CPG topic. The review process includes the following:
* Establishing a format or process for receiving feedback on the draft document from reviewers. The draft document should be sent as a PDF with a “Draft” watermark and line numbers to simplify referencing comments.
* Drafting an e-mail invitation to the first-round reviewers and instructions to explain the process (see Resources IV and V, Supplemental Digital Content 4 and 5, http://links.lww.com/PPT/A39 and http://links.lww.com/PPT/A40, respectively).
* Drafting a notification letter to send out with the document (see Resource VI, Supplemental Digital Content 6, http://links.lww.com/PPT/A41).
* Creating a standardized form with guiding questions for draft reviewers to complete in order to organize their feedback (see Resource VII, Supplemental Digital Content 7, http://links.lww.com/PPT/A42).
* Submitting the first draft to first-round reviewers, including the CPG coordinator.
* Revising the draft on the basis of survey comments and sending it out for the second review.
The manuscript is revised on the basis of the first-round review comments. The manuscript is then prepared for a broader, second review and should include the intended journal's editor, the section CPG coordinator, PTs, and other clinical professions, including physicians, as well as patients and/or families of patients, payers, policy makers, and any other consumers or stakeholders who may use the guideline. This second version with a “DRAFT” watermark is then posted on the Section Web site with the e-mail address for comments. After a specified period for comments, the manuscript is revised again on the basis of public input. Depending on the extent of revisions, a third review can be conducted.
Phase 2: Publication and Journal Review Process.
After the final comments have been integrated from the review process, the manuscript is prepared for submission to the section journal according to the instructions for authors.
Members of the GDG should have determined the rules for authorship for the publication of the guideline at the start of the process. Typically, the team coordinator would be the lead author and have more responsibility for organizing the process and preparing the manuscript for submission. Remaining authors may be listed alphabetically or in order of the proportion of the work contributed. Regardless of the method, agreement should be reached on the method and expected order of authorship when the team is formed.
The CPG coordinator will minimally receive last authorship on any guidelines that are published if the GDG requires substantive guidance through the process or assistance with the document. Earlier listing may be negotiated depending on the amount of direct writing and editing completed by the coordinator. If the GDG has published a previous guideline according to SoP standards, then authorship is negotiable on the basis of mutual agreement among the organizing team and the CPG coordinator.
All literature searchers, critical appraisers, and invited reviewers and funding sources of the CPG should be identified and acknowledged at the end of the manuscript submitted for publication; maintaining accurate records of this information is an important part of the process.
Journal editors are responsible for ensuring the document's consistency of language, format, and style of the journal. Peer review of the CPG is part of the publication process and is conducted at the time the manuscript is submitted for publication.
Phase 3: Postpublication Application to Guidelines.gov.
Following publication of the CPG, a member of the GDG, in coordination with the SoP Guideline coordinator, will prepare an application for dissemination through Guidelines.gov. A Guideline Submission kit can be downloaded from the National Guideline Clearinghouse Web site (http://guidelines.gov/submit/index.aspx). This phase is critical for providing widespread distribution of the CPG and serves to meet the criteria of a guideline that is free and publically available.
Coordination of CPG Revisions.
In coordination with the SoP Guideline Coordinator, the GDG should establish a date of expiration for the guideline, a timeline to initiate a revision process, and recommended revision team members. Both the GDG team leader and the SoP Guideline Coordinator should retain electronic copies of the literature grid and evidence tables used to develop the initial CPG. This will provide the reference foundation for the CPG revision team, thus quickening the revision process.
Additional Considerations by the CMT CPG Group
Financial support is available and should be requested by means of a motion presented to the SoP Executive Board. Money may be requested for document retrieval, clerical support to organize literature repository and critical appraisal assignments, time limited memberships to Survey Monkey or other online survey tools to conduct topical survey, or travel for the GDG for writing meetings as needed. The GDG is encouraged to apply for any grants that may support the process as well.
The GOC is a group appointed by the SoP who may serve as consultants to GDGs during the development of new guidelines. Their purposes are to ensure that procedures are followed, to serve as a resource, and to provide decisions about CPG content or processes when a GDG is unable to resolve a conflict. The initial GOC is composed of the first GDG for the CMT CPG, who established the initial procedures and will update procedures, as clarifications are needed.
The CPG Coordinator is a member of the GOC and will serve as a consultant to each GDG to ensure that the processes and written product meets the content and style formats set out in this document. In addition, the CPG coordinator will review the manuscript prior to the first review to ensure that it is consistent with the expected standards and formats, and guide the GDG through publication and submission to Guidelines.gov. The CPG coordinator may receive an honorarium by agreement with the SoP Board for each CPG published.
SECTION 2: CLINICAL PRACTICE GUIDELINE—SUGGESTED CONTENT OUTLINE AND RATIONALE
The following headings are a recommended starting point for guidelines but should be modified on the basis of the unique aspects of each topic and the scope of the CPG.
* Title page
* Tables with levels of evidence and grades of recommendations
* Summary of action statements: These can be organized under headings with common themes but should follow the same order as the body of the manuscript.
* Introduction: Provides an overview of the scope and need for the guideline, including relevant history as to how the topic or question was selected.
* Purpose of the guideline: Provide a succinct description of the purpose of the guideline. This section could include a description of the diagnostic group or condition if the guideline addresses complete physical therapy management, or it might include a Patient, Intervention and Outcome (PIO), a Patient, Intervention, Comparison Intervention and Outcome (PICO)15 or a Patient, Exposure, Comparison Exposure, Outcome and Timeframe (PECOT)16 question if the guideline is focused on a specific management or outcome question for a diagnostic group (see Table 3). For example, a guideline could address the overall management of a condition, such as the CMT CPG, and thus would include information for each element of the patient management model17 as well as the PT's roles relative to other professions. Other guidelines can limit the focus to a PIO/PICO/PECOT question on an intervention within a diagnostic group, such as comparing the use of biofeedback versus verbal feedback for children with cerebral palsy,18 or focus on a specific outcome of interest. The purpose is determined by the GDG and should focus on outcomes that are valued by the intended audience or consumers. The GDG recommends the latter strategy of focusing on an answerable question to maximize the relevance of the guideline and minimize time and financial costs. This section should also identify the professionals, lay readers, and other stakeholders for whom the guideline is intended.
* Background and need for the guideline: Provide a brief introduction to the problems or challenges that led to the selection of the topic and scope of the guideline. A series of questions that will be answered or should be answered by the guideline may be identified in this section.
* Scope of the guideline: This section describes more specifically the patient population or condition that is the focus of the CPG, and includes the time frame during which the literature searches were completed, and the specific topics that were covered under the condition or PIO/PICO/PECOT question. In some cases, the Purpose of the Guideline and the Scope can be combined.
* Statement of intent: The following standard statement should be included in all CPGs.
This guideline is intended for clinicians, family members, educators, researchers, policy makers and payers. It is not intended to be construed or to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient/client and are subject to change as scientific knowledge and technology advance, patterns of care evolve, and patient/family values are integrated. This CPG is a summary of practice recommendations that are supported with current published literature that has been reviewed by expert practitioners and other stakeholders. These parameters of practice should be considered guidelines only. Adherence to them will not ensure a successful outcome in every patient, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate decision regarding a particular clinical procedure or treatment plan must be made using the clinical data presented by the patient/client/family, the diagnostic and treatment options available, the patient's values, expectations and preferences, and the clinician's scope of practice. However, we suggest that significant departures from accepted guidelines should be documented in a patient's records at the time the relevant clinical decision is made.19(pA3)
* Determining purpose, scope, and outline of content: Describe how the purpose and scope of the guideline were determined and validated as important to practice.
* Literature review: Describe the search process used to amass the literature/evidence, including databases, key words, inclusion and exclusion criteria, who conducted the searches, and the date at which searching ended.
* Critical appraisal of articles: Critical appraisal forms that generate scores are included as examples for diagnosis and intervention studies, adapted from Fetters and Tilson3 (Appendixes 1 and 2). Appraisal scores are included in the evidence table and are used in the determination of the grades of recommendation. Other appraisal forms may be used if they generate scores but must be referenced and included in the CPG document.
* Levels of evidence: Various scales are available for labeling levels of evidence and grades of recommendations; however, all SoP guidelines will use the definitions included in Tables 1a and 1b that are imbedded in the SoP adaptation of BRIDGE-Wiz, and the practice (P) and research (R) recommendations in the Action Statements as described previously in the Section on Writing Clinical Guidelines.
* Document structure: Briefly describe how the rest of the document content is organized.
* Topic Heading (eg, CMT)
* Incidence and progression inclusive of risk factors: This is a broad overview of the issues that sets up the need for the recommendations.
* Initial referrals: Briefly describe, if appropriate, the typical routes of referral that patients will use to be seen by a PT. Since practice acts vary geographically, the route of referral may influence the generalizability of the selected action statements.
* Key Action Statements. This is the heart of the CPG, where the statements are presented with the appraised literature. When appropriate, the statements should be organized to follow the steps of patient management and integrate the domains of the International Classification of Function, Disability, and Health (ICF).20 They may address any or all of the following as appropriate to the purpose and scope of the intended guideline. In each case, the Action Statement and its evidence profile, generated by BRIDGE-Wiz, is presented first with the supporting literature, and optional research recommendations can follow by topic.
* History: Identify the key variables that should be recorded in the history. Provide clear distinctions among those that are evidence based, consensus based, or deemed good practice in the absence of evidence.
* Parent/family interview: Identify the key variables that should be determined through parent/family interview if applicable. Provide clear distinctions among those that are evidence based, consensus based, or deemed good practice in the absence of evidence. Based on the literature, the following topics may be included.
* Obstetrical history
* Medical history
* Developmental history
* Family history
* Screen: Describe the screening process for the diagnosis or problem of interest. If the guideline addresses a particular intervention, describe the screening process to determine who might benefit from the intervention.
* Systems review: Identify the key variables that should be recorded in each section of the systems review as appropriate to the diagnosis. Provide clear distinctions among those that are evidence based, consensus based, or deemed good practice in the absence of evidence.
* Differential diagnosis and classification: Identify the key variables that should be tested for red flags and determine a classification within the diagnosis, if such a classification exists. Provide clear distinctions among those that are evidence based, consensus based, or deemed good practice in the absence of evidence. Recommendations for the most reliable and valid methods of testing by PTs should be included.
* Initial examination and evaluation: Identify the key variables that should be recorded in the clinical assessment for each of the ICF domains. Provide clear distinctions among those that are evidence based, consensus based, or deemed good practice in the absence of evidence. Recommendations for the most reliable and valid methods of measurement should be included. Normative and abnormal values, as well as discharge criteria, should be provided if available. The ICF terminology should be used, for example, body structure measures including pain, function and activity measures, and participation and social measures. Standardized instruments or testing procedures and special tests should be included if not addressed under prior headings.
* Prognosis: Describe the clinical decision making process to determine a prognosis for the intensity of intervention and the duration of care as they relate to expected outcomes.
* Follow-up measures: Identify variables to measure at each follow-up visit as indicators of change and their minimal clinically important differences if known, along with established psychometrics. Recommendations should address the preferred methods of measurement, the clinical decision making variables that would suggest 1 outcome measure over another when 2 may be equally reasonable.
* Physical therapy interventions: Describe the physical therapy interventions that are reported in the literature and common press. Include evidence of effectiveness and potential adverse reactions known for each intervention and dosage variation. Where intervention approaches address the same problem but have variations in names, clarify the terminology and make recommendations for a consistent singular term that clinicians can use. Terminology from the ICF may be helpful for determining common labels and organizing the discussion.
* Body structure level
* Neuromuscular interventions
* Musculoskeletal flexibility, extensibility, or strengthening
* Cardiopulmonary interventions
* Integumentary interventions
* Activity level
* Functional training (ICF model)
* Activities of daily living
* Instrumental activities of daily living
* Participation level
* Higher-level activities related to work, sport, and leisure.
* Participation measures
* Environmental management
* Personal factors
* Patient education and self-management
* Home programs
* Family support and education
* Other management
* Pharmacological: When appropriate, describe typical pharmacological approaches to management of the problem that affect patient care/status, clinical decision making about interventions and expected outcomes, or PT roles and collaborations; however, it is not expected that PTs will make recommendations regarding pharmacological management.
* Surgical management: Describe the typical surgical interventions that might be used with the diagnosis as background for the types of postsurgical outcomes that PTs may need to address.
* Prognostic indicators: Describe the prognostic indicators for surgery.
* Presurgical Management: Describe the role, if any, of the PT in presurgical preparation, and the cost-benefit of that role.
* Postsurgical management: Describe the role, if any, of the PT in postsurgical management, and the cost-benefit of that role.
* Interdisciplinary management and referral: Describe the evidence for interdisciplinary management and/or referral to other professions for variables related to the diagnosis or its related consequences.
* Family education and support: Describe the evidence for family education, best educational strategies for parents and clients, and available support or resources (eg, Internet, community, social services), outlining the topics that should be addressed. Provide clear distinctions among those that are evidence based, consensus based, or deemed good practice in the absence of research evidence.
* Discontinuation and discharge criteria
* Long-term follow-up
* Implementation and Audit Recommendations: Describe strategies for implementation of the guideline into practice, with recommendations for pragmatic application and outcome measurement to determine effectiveness of implementation.
* Development of the Guideline: Describe the processes and deviations from this recommended outline as relevant, in the development of the individual guideline.
* Literature search and organization of results
* Participants at each phase: For each phase of development and review, list the names of those involved. Identify participants by title or profession to distinguish PTs from other professionals and consumers.
* Conflict-of-interest statements
* Statement of Internal Review: Describe the evaluation process. Each guideline should be submitted for scoring using the AGREE II Collaboration scale available online at http://www.agreecollaboration.org/comparison/index3.php.
* Definitions and Concepts. (Optional) provide definitions of key terms, with references when available. When multiple definitions exist for a single term, identify the operational definition to be used in the guideline. The GDG should see this as an opportunity to establish a preferred taxonomy for the topic and consistency throughout the CPG. A definition of the diagnosis and terms related to a PIO/PICO/PECOT question are included in this section as the foundation for the remaining content (see Table 3).
* Abbreviations. (Optional) provide a glossary of all abbreviations used in the document.
* ICF codes/International Classification of Diseases (ICD) 10 codes.21 Identify the relevant ICF codes that might apply to the impairments of body structures and function, functional limitations, and participation challenges that patients may have. These ICD 9/10 codes and/or CPT codes should be included as more limitations are being imposed on payment, and appropriate coding may be assisted with proper documentation.
* References. Provide a complete list of the references used to develop the guidelines. References-formatting style should be consistent with Pediatric Physical Therapy.
* Appendixes and Tables. Should be included as needed.
* Evidence Tables. Provide a summary table in spreadsheet format of the articles that support selected recommendations, minimally including author names and date, level of evidence, subjects studied, dependent variables of interest, measures, interventions, and outcomes. The intent is that these evidence tables may be available online for member use, and for future CPG revision teams to build on one, rather than starting over. It is up to the GDG to determine the extent of the evidence tables that might be available to readers, versus the detail of a spreadsheet intended for the CPG revision group.
* Quick Reference Guide. This is an optional product that the GDG may choose to create.
* Documentation Suggestions (Optional). If the GDG feels that a suggested template for documentation might enhance the implementation of the guideline action statements, a template can be offered as an appendix.
This document is intended for the members of the APTA SoP and its designated GDGs. It outlines the process of CPG development including aspects of the process that generalize to the creation of CPGs on various topics, by various groups and aspects that are specific to the creation of CPGs for the APTA SoP. Many sections in the document include a bulleted list of items that are intended to clarify the actions necessary for successful completion of that aspect of the CPG. Files are included with the document, for example, appraisal sheets and template letters, that can assist writing groups in completing the bulleted items. The explanations of processes and the suggestions for organizing the tasks are intended to serve as a guide to facilitate creation of clinically useful and transparent guidelines.
The authors collaborated with representatives of the Section on Orthopedics GDG and the leadership of both sections to initiate the first SoP CPG (on Congenital Muscular Torticollis), as well as to develop generic procedures for future SoP guideline developers. They are volunteers with varying levels of knowledge and expertise that complement the requirements of the CPG development process. All have pediatric clinical backgrounds, doctoral degrees, and research and publication experience. Dr Coulter brings clinical expertise on the diagnosis; Dr Fetters brings academic, research and systematic review expertise; and Dr Kaplan brings academic, research and expertise on guideline structure and development.
1. Rosenfeld RM, Shiffman RN. Clinical practice guidelines: a manual for developing evidence-based guidelines to facilitate performance measurement and quality improvement. Otolaryngol Head Neck Surg. 2006;135:S1–S28.
2. Graham R, Mancher M, Wolman DM. Clinical Practice Guidelines We Can Trust. Washington, DC: Institute of Medicine of the National Academies; 2011.
3. Fetters L, Tilson J. Evidence Based Physical Therapy. Philadelphia, PA: FA Davis Co; 2012.
4. Scottish Intercollegiate Guideline Network. SIGN 50: A Guideline Developer's Handbook. Edinburgh, Scotland: National Health Service; 2011.
5. Owens DK, Nease RF. Development of outcome-based practice guidelines: a method for structuring problems and synthesizing evidence. Jt Comm J Qual Improv. 1993;19(7):248–263.
6. National Health and Medical Research Council. A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines. Canberra: Australian Government Publishing Service; 1999.
7. National Institute for Health and Clinical Excellence. How NICE Clinical Guidelines Are Developed: An Overview for Stakeholders, the Public and the NHS. London, UK: National Institute for Health and Clinical Excellence; 2009.
8. Institute of Medicine. Knowing What Works in Health Care: A Roadmap for the Nation. Washington, DC: National Academies Press; 2008.
9. Field MJ, Lohr KN. Guidelines for Clinical Practice: From Development to Use. Washington, DC: National Academies Press; 1992.
10. AGREE Next Steps Consortium. The AGREE II Instrument. http://www.agreetrust.org
. Published May 2009. Accessed March 21, 2013.
12. Whiting P, Rutjes AWS, Reitsma Jb, Bossuyt PMM, Kleijnen J. The Development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol. 2003;3:25. doi:10.1186/1471-2288-3-25.
14. Mlika-Cabanne N, Harbour R, de Beer H, Laurence M, Cook R, Twaddle S. Sharing hard labour: developing a standard template for data summaries in guideline development. BMJ Qual Saf. 2011;20:141–145.
15. Sackett DL, Richardson WS, Rosenberg W, Haynes RB. Evidence-Based Medicine: How to Practice and Teach EBM. New York: Churchill Livingstone; 2000.
16. Jackson R, Ameratunga S, Broad J, et al. The GATE frame: critical appraisal with pictures. Evidence Based Med. 2006;11:35–38.
17. American Physical Therapy Association. Guide to Physical Therapist Practice. Phys Ther. 2001;81(1):1–768.
18. Conner S, Maignan S, Burch C, Christensen C, Colvin C, Hall K. Cincinnati Children's Hospital Medical Center: Best Evidence Statement for Biofeedback Intervention for Children With Hemiplegic Cerebral Palsy. Vol BESt 035. Cincinnati, OH: Cincinnati Children's Hospital Medical Center; 2010:1–4.
19. McPoil TG, Martin RL, Cornwall MW, Wukich DK, Irrgang JJ, Godges JJ. Heel pain-plantar fasciitis: Clinical practice guidelines linked to the International Classification of Function, Disability, and Health from the Orthopaedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008;38(4):A1–A18.
decision making; evidence-based practice/standards; pediatrics/standards; physical therapy; practice guidelines as topic/standards
Supplemental Digital Content
© 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins and the Section on Pediatrics of the American Physical Therapy Association.