INTRODUCTION TO THE CLINICAL PRACTICE GUIDELINE PROCESS
An evidence-based clinical practice guideline (CPG) is a collection of action statements based on a systematic review of the literature on the topic of choice that reflects current recommended clinical practice intended to optimize patient care, minimize harm, and reduce unnecessary variability.1,2 The evidence in the systematic literature review is weighted through a transparent process of appraisal, and the recommendations are graded on the basis of the strength of the supporting literature, the expertise of the guideline development group (GDG) and stakeholder input, including, for example, patients, families, payers, and policy makers.3,4
The initiative to develop pediatric physical therapy CPGs grew out of the work of the Knowledge Translation Task Group of the American Physical Therapy Association's (APTA's) Section on Pediatrics (SoP). Assembled in May 2009, the group was charged to develop recommendations for activities and services that would support SoP members’ ability to translate knowledge derived from research to inform and guide clinical practice. One of the many recommendations was the desire to have evidence-based CPGs that would synthesize research and make its application to practice clearer through graded recommendations.
This document reflects the processes selected for the development of the first SoP guideline with explanations for the choices that were made, advice about the process and resources, and procedural variations that can be adapted by future guideline developers. These procedures were derived from the review of selected guideline development manuals4–7 to meet the goals of the SoP, to produce guidelines that would parallel international processes, and to provide future GDGs with suggested processes to facilitate completion of CPGs. The development of guidelines is an evolving science. As recently as March 2011, the Institute of Medicine of the National Academies published best practice standards for CPGs.2 The Guidelines International Network (http://www.g-i-n.net) has working groups addressing methods for literature synthesis, adaptation, and implementation of guidelines. In addition, innovative software that facilitates collaboration (eg, the Systematic Review Data Repository, http://srdr.ahrq.gov/) and transparent decision-making (eg, BRIDGE-Wiz, http://gem.med.yale.edu/BRIDGE-Wiz/) undergoes development and constant revision. This document presents processes with the caveat that as methods or resources change, or the needs of end users change, this document will be revised to reflect those changes.
This document is intended for the members of the APTA SoP and its designated GDGs. It may be useful to other APTA section GDGs as well as other guideline developers. The document describes the process of developing CPGs so that all guidelines produced by the SoP might follow a similar process to yield consistent quality and organization. Given that professional organizations approach the development of guidelines with different administrative arrangements and resources, these processes may also be useful to guideline developers in professions with similar structures and resources.
This document is organized into 2 sections. The first section presents a recommended chronology of steps to complete the work of creating a guideline for the SoP. The second section is a generic content outline of what should or could be considered for inclusion in each SoP guideline. Where appropriate, it describes the options and rationale for choices that were made.
SECTION 1: STEPS TO CREATE A SOP GUIDELINE
This first step of selecting a topic should be taken with great care and deliberation. Clinical practice guidelines can focus on the management of a diagnosis or condition in its entirety, or more narrowly, on measurement of the condition, or interventions for the condition. The Institute of Medicine has identified 8 criteria to assist with the selection of a topic for a CPG: the burden of the disease or condition on the patient, family, or society; existing controversy on aspects of measuring or managing the condition; the economic costs related to having the condition or for procedures and interventions; the availability of sufficient evidence; the availability of new evidence that might change prior recommendations; the potential to improve health outcomes; public or provider interest; and the desire to reduce unwarranted variations in care.8
Topics can be solicited in several ways, but since CPG development requires financial and publication support, the SoP Board, a CPG coordinator, and/or a committee that reports to the SoP Board of Directors (Board) should organize topic selection. A formal request for topics can be sent to Pediatric Section members to determine clinician needs or an individual can propose a topic to the SoP Board for consideration (see Resource I Clinical Practice Guideline Proposal Form, Supplemental Digital Content 1, http://links.lww.com/PPT/A36). The Section CPG coordinator may recommend topics to the SoP Board.
Section support for the development of a guideline is dependent on the availability and applicability of existing guidelines on the topic and availability of a qualified and willing CPG team leader and GDG. Need for the guideline is based on clinician interest, consumer demand, prevalence of the diagnosis in physical therapy, levels of variability in practice, abundance of literature or conflicting results within the literature, the effect of the guideline in terms of cost of recommended care, or its importance for reimbursement and policy development. The number of guidelines under development at any one time may be limited by available financial support for the process.
Final topic approval is the responsibility of the SoP Board. Each topic request should contain a brief rationale addressing the purpose and scope of the proposed guideline, the results of a recent literature search for existing guidelines, systematic reviews and primary studies, and a timetable for the process. The GDG member files a Motion Action Plan with the SoP Board for approval, inclusive of an estimated budget.
Identifying the GDG: Membership and Responsibilities
The GDG is determined through a combination of self-identification by interested SoP members, recruitment by the SoP CPG coordinator, and recruitment by GDG members for non–physical therapist (PT) participation. Ideally, the GDG should include representation from multiple disciplines, with both clinical and methodological expertise, and with patient or public participation.2 All members of the GDG should determine with their supervisors or employers if work on the CPG will be a part of their work responsibilities or if CPG work will be on personal time. This determination is essential to the group selection; if most members are contributing to the CPG on personal time, completion of the CPG may take longer. Increasing the number of members who contribute to the CPG may offset the potential extended duration for completion.
GDG Team Leader Credentials.
The team leader will be appointed by the SoP Board in cooperation with the SoP Guideline Oversight Committee (GOC) or CPG coordinator and those proposing the topic. The team leader can be someone with content expertise or an interested person with background in evidence-based practice principles and strategies, research design and statistics, expertise in synthesizing literature, and publication experience. When available, training in the organization of guidelines should be provided by the CPG coordinator or through another mechanism.
The GDG comprises clinicians and scholars with knowledge of evidence-based practice principles and strategies, research design, expertise in synthesizing literature, and clinical expertise in the topic, who agree to collectively develop the guideline; a balance of methodology, statistics, and publication experience within the group is essential.
Responsibilities of the GDG.
The ultimate responsibility of the GDG team leader is to facilitate assignment of tasks to GDG members based on their individual strengths and the nature of the tasks that need to be completed. The tasks typically fall into 1 of 3 areas: administration, methodology, and content expertise. The specific tasks include but are not limited to the following:
- Identification of and invitation of others to be team members and/or reviewers. Consideration should be given to including clinicians from other disciplines, such as physicians if the topic addresses the interface of medicine and physical therapy, or payer representation if reimbursement may be affected by guideline recommendations. Interprofessional writing groups hold greater validity in the international guideline community than single profession writing groups.
- Determining the number of members who will be contributing on the basis of personal time versus work time, and the final size of the GDG.
- Setting up a chronology of events. While this proposed timeline undoubtedly would be fluid, targets keep the process moving forward.
- Establishing authorship rules with the GDG.
- Providing administrative oversight for the project including setting up conference calls, establishing a working draft of the proposed guideline, organizing internet resources, repositories and e-mail accounts so that the GDG has full access, and organization of abstract submissions for presentation of guidelines at annual meetings.
- Communicating progress with the Guideline Coordinator and the Practice Committee of the SoP; submitting semiannual reports prior to the SoP Board meeting held at Combined Sections Meeting and prior to the SoP strategic planning meeting in late summer.
- Requesting support from the SoP Board or other funding sources. Estimated budgets may be submitted to the Section each year by the GDG prior to the SoP strategic planning meeting in late summer. Clinical practice guidelines may cost minimally from $3000 to $8000 for such expenses as clerical assistance during CPG development, article acquisition, 1 or 2 writing meetings for the authors, professional librarian fees for conducting a comprehensive literature search, or software program purchases. Costs for CPGs may be as high as several $100 000s when institutions or government agencies purchase the services of guideline developers.9 The costs of volunteer hours are inconsistently calculated into the overall costs that are reported.
- Overseeing clerical assistance if available. Depending on the availability of clerical assistance through a paid assistant, work-study students, doctoral students, or volunteers, the GDG team leader will be monitoring and assigning tasks and keeping track of hours and payment.
- Organizing communication mechanisms for team and stakeholders directly or through delegation.
- Setting up an e-mail communication process. This may be a unique e-mail address or an established one. Using a unique account with a name that reflects the title of the CPG provides a log of the communications with reviewers and external stakeholders. The e-mail account is used as a repository for communications on the project that the GDG can access. The owner that sets up the e-mail account needs to provide the username and password to GDG members who should have log-in access.
- Setting up a repository for document drafts. Free online programs such as Google Docs or Dropbox are useful for posting current editions of manuscript drafts. Permissions or sharing needs to be established for the GDG members to have access. Maintaining a date stamped master copy of the documents allows the GDG to access the latest version, eliminating redundant cross-referencing on separate versions.
- Setting up a repository of article files in Adobe Portable Document Format (PDF). Mendeley Desktop (www.mendeley.com), Endnote (www.endnote.com), and Zotero (www.zotero.org) are reference manager software programs that allow the creation of a virtual library of the PDFs that the entire team can access. These programs also have varying levels of “cite while you write” capability. Regardless of the repository form, the collection of PDFs cannot be publicly shared, as this would violate copyright protections.
- Setting up conference calls. Skype (http://beta.skype.com/en), Blackboard Collaborate Web Conferencing and its Elluminate Live (www.elluminate.com), Join.Me (https://join.me/), or other online meeting and blackboard programs are efficient methods of facilitating progress on the guideline. These programs allow conferencing among the organizing team members and the ability to share the desktop, so documents can be viewed and edited in real time. Some programs require modest fees to access all of the services. FreeConferenceCall.com is an example of a free conference call service. The call can be set up just minutes before the group call and the cost is only whatever the users pay to access an 800 number (or long-distance charges for some plans). Using these expense-free services reduces the overall costs of producing the CPG. If available, hospital- and/or university-based resources may be used to set up conference calls at no additional expense to the SoP; however, individual permissions may be required by the institutions.
- Drafting standard letters to literature appraisers and draft reviewers (see Resource IIa and IIb, Supplemental Digital Content 2, http://links.lww.com/PPT/A37) that explain the process of developing the guidelines and invite their participation, and describe the process for conducting literature searches. Clinician volunteers may be chosen through SoP committees and/or member willingness to participate in the generation of the CPG. Communication with interested clinicians includes the following:
- Request for clinician ideas on what the guideline should cover (online survey).
- Request for clinician ranking of collected ideas (see Resource III, Supplemental Digital Content 3, http://links.lww.com/PPT/A38).
- Request for critical appraisers (solicited at APTA and SoP meetings and events).
- Orientation of critical appraisers to the reliability testing process.
- Follow-up of reliability testing results with individual appraisers.
- Assignment and follow-up of assigned articles for critical appraisal.
- Organizing initial meeting with SoP CPG coordinator and Pediatric Physical Therapy journal editor to discuss expected timeline and topic. Provide updates to the journal editor as the formal review process is under way so that the issue of the journal in which the CPG will be published can be estimated.
- Soliciting literature searches from interested clinicians.
- Conducting searches and combining findings from multiple searches; updating searches periodically before the manuscript submission.
- Determining the inclusion and exclusion criteria for the body of literature to be reviewed and validating the search process.
- Selecting critical appraisal tools to determine the quality of the evidence, depending on the study design, such as Appraisal of Guidelines for Research and Evaluation (AGREE II) for clinical guidelines,10 Physiotherapy Evidence Database (PEDro) for intervention studies,11 QUADAS for diagnostic accuracy studies,12 COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for the properties of health measurement tools,13 or other available appraisal checklists. The critical appraisal forms used by the CMT GDG are included with this document as examples (Appendices 1 and 2).
- Establishing reliability for the critical appraisal process of diagnosis, prognosis, and intervention studies.
- Screening abstracts for relevance of citations in searches for inclusion in the appraisal process.
- Assisting with critical appraisals of articles or the organization of distributed appraisals.
- Participating in the development of the recommendations.
- Writing assigned portions of the guideline.
- Editing the guideline following reviews.
- Collaborating to prepare/edit abstracts, slide presentations, and handouts for submission if presenting guideline process updates at APTA national meetings. (Note: Draft recommendations should not be presented before completing the full review process. Updates are about the process, not the content.)
- Assisting with application for Guidelines.gov in coordination with the CPG coordinator or other person responsible for Section submissions to Guidelines.gov.
- Submitting the guideline for publication to an appropriate professional journal. In the case of CPGs supported by the SoP, submission to Pediatric Physical Therapy is expected.
- Assisting with any other tasks as identified by the GDG team coordinator.
Reviewer and Stakeholder Credentials.
A wide range of volunteers should be included in as many stages of development as possible. Focus groups, consumers invited from private and public sectors, and interested clinicians should all be encouraged to assist with content validation, critical appraisals, and review of the draft guideline for clarity, content validity, and overall usefulness to practice.
Development of CPG Guiding Questions
The GDG should solicit topics or questions from as many stakeholders as possible to determine what the guideline should address. Soliciting information about the breadth and depth of content needed by the intended audiences helps with determining the scope of the guideline. Based on this large qualitative reporting by individuals, the GDG should identify a complete list of topics or themes without overlap or redundancy. Rating or ranking the importance of the topics can be accomplished through an online survey (see Resource III, Supplemental Digital Content 3, http://links.lww.com/PPT/A38) sent to all interested parties. The scope of the guideline can be defined through a topical outline that is based on consensus among the GDG clinical experts and the rankings of importance of the topics from the survey. The GDG should determine whether the CPG will include the full range of patient management (ie, examination, evaluation, diagnosis, prognosis, intervention, and outcomes) or whether the CPG will focus more narrowly on a specific question.
Conducting a Comprehensive Search and Appraisal of the Literature
A comprehensive search of the literature is the foundation of an evidence-based CPG. There are several methods for ensuring a comprehensive search. It is recommended that the GDG work with a reference librarian at the beginning of CPG development. A reference librarian can assist with establishing the optimal hierarchy of search terms and databases to generate a comprehensive search. In addition, the search can be set up to provide automatic updates. The GDG should record inclusion and exclusion criteria for the literature search as this will need to be reported in the final document.
Invite interested stakeholders to contribute literature searches. This might be through invitations to SoP members with an interest in the CPG topic. Search histories should be sent to the designated CPG e-mail account, include search terms and databases used, and state the number of studies excluded.
Finally, the GDG members conduct searches throughout the writing process to ensure that newly published evidence can be incorporated. It is particularly important to routinely search databases that are not part of a library collection, such as those maintained by professional associations and charitable foundations for a specific disease or condition.
Once the search results/abstracts have been reviewed, the GDG needs to collect the full-text articles and post them into a literature repository and reference manager to allow access for GDG members. A full reference list is published with the guideline, but access to the PDF collection is not provided. Requesting copies of PDFs to which stakeholders may have access, in order to establish the literature collection, saves time, and virtually expands the library holdings/resources available to the GDG. Care should be taken to observe copyright restrictions. Support funds from the Section may be used to purchase relevant full-text copies that are otherwise unavailable.
Create a Literature Grid/Evidence Table
A master grid of all the articles, reviewers, critical appraisal scores, and relevant variables for the guideline content can be created in a spreadsheet and is most useful for tracking progress. Variables might include the purpose, the sample size and characteristics, specific tests and measures, outcomes, or other variables that the GDG deems relevant to the guideline. Use of an electronic spreadsheet allows the team to add variable columns, sort the articles on the basis of selected variables, and group relevant articles together. The grid facilitates efficient literature summaries and serves as the basis for evidence tables. It should be maintained so that the future CPG revision team can start its work on the basis of that collection. Note: When using a spreadsheet to manage text entries, maintain a single heading line. Avoid nesting headings and merging cells, as this will not allow sorting of the literature grid according to a selected variable.
The Evidence Table Working Group of the Guidelines International Network defines an evidence table as “Methodological and outcome summaries that present data from a number of related studies. They answer a well-defined question in a consistent format, aim to demonstrate overall trends in the evidence, and enable the process of making recommendations,”14(p143) and has developed a recommended template for content. Evidence tables may be constructed for the final document as appendixes or as weblinks and can be derived from the literature grid that will have more detail than is feasible to publish.
Critically Appraising the Literature
The basis of the CPG is the critical appraisal of the literature. To increase transparency for the assignment of levels of evidence, the appraisal process should be reliable and described in the methods section of the CPG. The SoP can support GDGs by posting requests for appraisers on its Web site. Regional directors and Special Interest Group coordinators can send requests for appraisers via their newsletters and communications.
Use the following steps to establish reliability of the critical appraisal volunteers:
- Create letters describing the critical appraisal process, assignment of articles, and follow-up reminders (Resources IIa and IIb, Supplemental Digital Content 2, http://links.lww.com/PPT/A37).
- Determine which categories of literature to be critically appraising, based on the extent of the topic, that is, diagnosis, intervention, and prognosis.
- Establish reliability among the GDG members using 1 article from each category chosen (eg, diagnosis, treatment, and prognosis). The questions for appraisal are different based on the category (see Appendixes 1 and 2).
- Identify literature appraisers and establish reliability with the organizing team.
Given the low number of items within each critical appraisal form, the authors recommend establishing 90% or more reliability between the literature appraisers and the GDG members, essentially allowing for a difference of 1 answer among appraisers.
For appraisers who do not meet the reliability threshold, depending on the body of literature and the number of volunteers, the GDG may choose to mentor those readers who score less than 90% agreement. This process will require establishing reliability for an additional article(s) to enable repeat testing.
Articles are individually sent to randomly paired appraisers, each appraiser having achieved reliability. Each pair of appraisers reads the article separately, scores it, and confers with the partner appraiser. Discrepant scores are discussed to achieve consensus. If consensus cannot be reached, the appraisers communicate that with the GDG. A third reader (from the GDG) will determine a final score in collaboration with the original pair of appraisers. Final scores are entered in the Literature Grid. Randomizing the appraiser pairings minimizes the opportunity for bias to enter the appraisal process.
Writing the Clinical Practice Guideline
The writing of the CPG can take place in phases, as the critical appraisal of literature for selected topics is completed. Each document should begin with an introduction to the problem, the history, and relevant issues, and proceed with the Scope, the Intended Audience, the Statement of Intent, and the additional content items (please see the Content Outline in Section II). The introductory information can be developed in advance of completing the critical appraisals.
The action statements/recommendations should be written using the BRIDGE-Wiz software (http://gem.med.yale.edu/BRIDGE-Wiz/). BRIDGE-Wiz was adapted by Dr Richard Shiffman for the SoP to accommodate the agreed-upon definitions of levels of evidence (Table 1) and grades of recommendation (Table 2).
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.
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decision making; evidence-based practice/standards; pediatrics/standards; physical therapy; practice guidelines as topic/standards
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