Roadmap for Publishing Clinical Practice Guidelines in PTJ Philip Van der Wees and James J Irrgang PHYS THER. 2014; 94:753-756. doi: 10.2522/ptj.2014.94.6.753

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Editorial Roadmap for Publishing Clinical Practice Guidelines in PTJ Development and implementation of clinical practice guidelines (CPGs) are the focus of policy for many professional bodies. The Institute of Medicine (IOM) defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”1 The American Physical Therapy Association (APTA) stimulates the development of CPGs by providing training and financial support for their development. To be eligible for that support, the CPG must be produced with the active involvement and sponsorship of an APTA section.2 PTJ has published practice guidelines (eg, the Ottawa Panel Evidence-Based Clinical Practice Guidelines3–8); however, PTJ did not have a specific policy regarding the review and publication of guidelines. During the PTJ Editorial Board meeting at APTA Combined Sections Meeting in February, the Editorial Board considered options for publishing CPGs in a structured and systematic way, with the aim of stimulating the dissemination and use of CPGs. Several examples of such initiatives exist. Within the field of physical therapy, the Orthopedic Section of APTA publishes guidelines in collaboration with the Journal of Orthopaedic and Sports Physical Therapy (JOSPT). Examples from other professions include the American College of Physicians (ACP) and Annals of Internal Medicine and the American Academy of Orthopaedic Surgery and the Journal of the American Academy of Orthopaedic Surgeons (JAAOS). In this editorial, we describe PTJ’s roadmap for the publication of CPGs. The eligibility criteria for publication of CPGs in PTJ are related to: • The target groups of guideline developers • The review process, focusing on the rigor of the guideline development process and on the scope and content of the guideline. Target Groups of Guideline Developers Given APTA’s CPG development initiative, PTJ’s primary target groups are the APTA sections that are engaged in developing guidelines and that are supported by an APTA award. APTA-awarded projects meet basic criteria that ensure development of trustworthy guidelines, based on use of sound methodology and stakeholder involvement. Other groups within and outside the United States also may want to submit their guidelines for publication in PTJ. PTJ will consider submissions from other international groups, with the expectation that these groups use a rigorous and transparent process to ensure the publication of trustworthy guidelines. Review Process To be eligible for publication, CPG development groups are required to prospectively submit their project proposal to PTJ for consideration. The Editorial Board will review the proposal and assess eligibility based on the planned procedures that will be used by the guideline development group. Acceptance of the proposal will not guarantee acceptance of the guideline for publication. PTJ will have a transition period to allow groups to submit their proposals even though they have already started their projects.

To comment, submit a Rapid Response to this editorial posted online at ptjournal.apta.org.

Upon submission of the actual guideline, 2 members of the Editorial Board will conduct the review. The review of proposals and the review of guidelines will be guided by the following criteria.

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Editorial Rigor of the Guideline Development Process The Guidelines International Network (G-I-N) has developed key elements of guideline development as a first step in establishing international standards9 to ensure a rigorous development process. Because these elements are generic, they allow for flexibility. Standards for trustworthy guidelines as developed by the IOM are more strict and, to some extent, aspirational.1 The AGREE Trust has developed criteria for the assessment of the quality of guidelines, although they are not standards as such.10,11 In addition, many guideline development organizations around the world have produced handbooks for guideline development with (implicit) standards for organization and structure, scope and objectives, development process, validation, dissemination and implementation, and evaluation and revision.12,13 PTJ has decided to use the G-I-N standards (Figure) as a criteria list for guideline development groups that want to submit their guidelines to PTJ. An important aspect of the guideline development process is the grading of the evidence and the strength of the recommendations derived from the evidence after consideration of relevant factors (eg, harms vs benefits, feasibility, acceptability, costs). Multiple grading systems exist, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system that is being used by many guideline developers and that is endorsed by the Cochrane Collaboration.14 The Orthopaedic Section of APTA used an adapted version of criteria described by the Oxford Centre for Evidence-Based Medicine.15–17 Although PTJ’s Editorial Board would like to see a move toward one accepted grading system, at this point we allow for different established grading systems, which should be clearly described in the methods section of the CPG. Scope and Content of the Guideline CPGs should have an integrated approach and address impairments, activities, and participation based on an underlying health problem. Guidelines typically are not aimed at (only) providing guidance about a specific intervention (eg, a certain type of exercise therapy or manual therapy). Pending developments within the APTA sections, PTJ will develop guidance based on existing documents. For instance, the Orthopaedic Section has developed criteria for scope and content: (a) identify (musculoskeletal) conditions that are commonly treated by physical therapists, (b) identify common impairments, activity limitations, and participation restrictions that are linked to the International Classification of Functioning, Disability and Health (ICF)18 classification system that can serve as outcome measures or prognostic variables, (c) describe the target groups of patients in homogeneous subsets, and (d) describe interventions and evidence supporting the interventions. Publication Format A recognizable, consistent format may enhance the guidelines published in PTJ and help stimulate uptake and use by practitioners. However, the variety among guideline development groups from different APTA sections and international groups may preclude the use of a strict format. PTJ will publish summaries or extended synopses of CPGs in regular issues of PTJ with a link to the full online version of the CPG. APTA section groups will be provided the opportunity to publish the full guideline in print in PTJ.

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Editorial PTJ looks forward to working with guideline development groups in disseminating their important work. A collaborative approach is needed for building a body of knowledge through the development, dissemination, and implementation of CPGs. PTJ is pleased to be able to assist in creating this body of knowledge. Philip Van der Wees, and James J. Irrgang P. Van der Wees, PT, PhD, is Senior Researcher in the Scientific Institute for Quality of Healthcare, Celsus Academy for Sustainable Healthcare, Radboud University Medical Center, Nijmegen, The Netherlands. He is a PTJ Editorial Board member. J.J. Irrgang is Professor and Director of Clinical Research in the Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine. He is a PTJ Editorial Board member.

References 1 Institute of Medicine. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. 2 Request for Proposals: Clinical Practice Guideline and Clinical Practice Appraisal Development. Alexandria, VA: American Physical Therapy Association; 2013. 3 Brosseau L, Wells GA, Tugwell P, et al. Ottawa Panel evidence-based clinical practice guidelines for the management of osteoarthritis in adults who are obese or overweight. Phys Ther. 2011;91:843–861. 4 Brosseau L, Wells GA, Tugwell P, et al. Ottawa Panel evidence-based clinical practice guidelines for strengthening exercises in the management of fibromyalgia: part 2. Phys Ther. 2008;88:873–886. 5 Brosseau L, Wells GA, Tugwell P, et al. Ottawa Panel evidence-based clinical practice guidelines for aerobic fitness exercises in the management of fibromyalgia: part 1. Phys Ther. 2008;88:857–871. 6 Ottawa Panel. Ottawa Panel evidence-based clinical practice guidelines for therapeutic exercises and manual therapy in the management of osteoarthritis. Phys Ther. 2005;85:907–971. 7 Ottawa Panel. Ottawa Panel evidence-based clinical practice guidelines for electrotherapy and thermotherapy interventions in the management of rheumatoid arthritis in adults. Phys Ther. 2004;84:1016–1043. 8 Ottawa Panel. Ottawa Panel evidence-based clinical practice guidelines for therapeutic exercises in the management of rheumatoid arthritis in adults. Phys Ther. 2004;84:934–972. 9 Qaseem A, Forland F, Macbeth F, et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156(7):525-531. 10 Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE II, part 2: assessment of validity of items and tools to support application. CMAJ. 2010;182(10):E472–E478. 11 Brouwers MC, Kho ME, Browman GP, et al. Development of the AGREE II, part 1: performance, usefulness and areas for improvement. CMAJ. 2010;182(10):1045–1052. 12 Van der Wees PJ, Hendriks EJ, Custers JW, et al. Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy. BMC Health Serv Res. 2007;7:191. 13 Van der Wees PJ, Moore AP, Powers CM, et al. Development of clinical guidelines in physical therapy: perspective for international collaboration. Phys Ther. 2011;91:1551–1563. 14 Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924–926. 15 McPoil TG, Martin RL, Cornwall MW, et al. Heel pain—plantar fasciitis: clinical practice guildelines 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. 16 Irrgang JJ, De Florian T. Orthopaedic Section 40th anniversary: a time of growth and leadership. Orthopaedic Physical Therapy Practice. 2014;26(1):10–15. Available at: https://www.orthopt.org/uploads/content_files/Downloads/OPTP/26_1/OP_v26no1_FINAL_web.pdf 17 Oxford Centre for Evidence Based Medicine. OCEBM Levels of Evidence System. Available at: http://www. cebm.net/index.aspx?o=5513. Accessed May 9, 2014. 18 International Classification of Functioning, Disability and Health: ICF. Geneva, Switzerland: World Health Organization; 2011. Available at: http://www.who.int/classifications/icf/en/. Accessed May 5, 2014. [DOI: 10.2522/ptj.2014.94.6.753]

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Editorial

Organization and Structure • Prepare a project proposal for the development process. • Submit the proposal to PTJ for assessment of appropriateness for the CPG to be published in PTJ. • Establish a guideline development panel that includes diverse and relevant stakeholders, such as health professionals, methodologists, experts, and patients. • Consider having a small group (2 or 3 people) that is responsible for the review of the literature. • Include disclosure of financial and nonfinancial conflicts of interest for members of the guideline development group. • Establish a process for reaching consensus among the members of the guideline development group. This process should be established before the start of guideline development.

Scope and Objectives Specify the scope and objectives of the guideline based on the following criteria: • Identify a condition that is commonly treated by physical therapists. • Identify current problems in physical therapist management that provide the rationale for developing a guideline (eg, gap between theory and practice, unwarranted variation in practice). • Identify common impairments, activity limitations, and participation restrictions that are linked to the International Classification of Functioning, Disability and Health (ICF) classification system that can serve as outcome measures or prognostic variables. • Describe the target groups of patients in homogeneous subsets. • Formulate key questions for diagnosis, prognosis, treatment, and prevention by physical therapists to be addressed in the guideline.

Development Process • Conduct a systematic literature review to identity evidence to address each of the key questions for diagnosis, prognosis, treatment, and prevention by physical therapists. • Provide recommendations that are supported by careful consideration of the evidence, quantification of magnitude of benefits and harms, resources, feasibility, patient and physical therapist preferences, and ethical and legal matters. • Provide actionable and active voiced recommendations and avoid using ambiguous words and phrases, unless real uncertainty exists. Use standard wording for recommendations based on the strength of the evidence. • Use the ICF to address impairments, activity limitations, and participation restrictions in the guideline recommendations. • Use an established rating system such as GRADE [Grading of Recommendations Assessment, Development and Education] or Oxford [Centre for Evidence Based Medicine Levels of Evidence] to communicate the quality and reliability of both the evidence and the strength of the recommendations.

Validation • Provide peer review and stakeholder consultations of the draft guideline. The consultation should include physical therapist experts from different “schools of thought” on the guideline topic. • In addition, provide an open consultation for interested physical therapists, outside experts, and the public.

Format of the Guideline • Include the following documents in the guideline: • A summary of the guideline with all recommendations, including a rating of the quality and reliability of both the evidence and the strength of the recommendations. • A flowchart (algorithm) to describe the process of diagnosis and treatment. • Extended synopsis of the guideline with the following sections: introduction, methods, impairment/functionbased diagnosis, prognosis, examination, interventions, assessment of outcome. • Identify the expiration date of the guideline and/or describe the process that the guideline group will use to update the guideline. • Disclose financial support for the development of the guideline. Figure. Guidance for guideline development groups to help develop trustworthy clinical practice guidelines, based on Guidelines International Network (G-I-N) Standards.9

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Roadmap for Publishing Clinical Practice Guidelines in PTJ Philip Van der Wees and James J Irrgang PHYS THER. 2014; 94:753-756. doi: 10.2522/ptj.2014.94.6.753

References

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