Developing Evidence-Based

Physical Therapy Clinical

Practice
Guidelines
Sandra L. Kaplan, PT, DPT, PhD; Colleen Coulter, PT, DPT, PhD, PCS; Linda Fetters, PT, PhD, FAPTA
Department of Rehabilitation and Movement Sciences (Dr Kaplan), University of Medicine and Dentistry of New
Jersey,
Newark, New Jersey; Orthotics and Prosthetics Department (Dr Coulter), Childrens Healthcare of Atlanta, Atlanta,
Georgia; Division of Biokinesiology & Physical Therapy and Department of Pediatrics (Dr Fetters), Keck School of
Medicine, University of Southern California, Los Angeles, California.
Purpose: Recommended strategies for developing evidence-based clinical practice guidelines (CPGs)
are provided.
Key Points: The intent is that future CPGs developed with the support of the Section on Pediatrics of
the American Physical Therapy Association would consistently follow similar developmental processes to
yield
consistent quality and presentation. Steps in the process of developing CPGs are outlined and resources
are
provided to assist CPG developers in carrying out their task. These recommended processes may also be
useful
to CPG developers representing organizations with similar structures, objectives, and resources. (Pediatr
Phys
Ther 2013;25:257270) Key words: decision making, evidence-based practice/standards,
pediatrics/standards,
physical therapy, practice guidelines as topic/standards
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, theexpertise 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 Associations (APTAs) 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 manuals47 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.












INTENDED AUDIENCE
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.

CONTENT ORGANIZATION
This document is organized into 2 sections. The firstsection 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
Topic Selection
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. 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 nonphysical 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.
GDG Credentials. 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 theinternational guideline community
than single professionwriting 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.
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 ofmanuscript 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. Variablesmight 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 welldefined 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.
Establishing Reliability.
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.
Appraisal Process.
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 the history, and relevant issues, and proceedwith 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 BRIDGEWiz.
_ 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 BRIDGEWiz 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 firstround
review comments. The manuscript is then prepared
for a broader, second review and should include the
intended journals 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 documents
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
theGDG, in coordinationwith the SoPGuideline 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 theGDGteam 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
GUIDELINESUGGESTED 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
_ Abstract
_ 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 PTs 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
patients values, expectations and preferences, and
the clinicians scope of practice. However, we suggest
that significant departures from accepted guidelines
should be documented in a patients records at the
time the relevant clinical decision is made.19(pA3)
_ Methods
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 onWriting
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
Environmental management
Equipment
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. Referencesformatting
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.
SUMMARY
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.
ACKNOWLEDGMENTS
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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