APPENDIX A

Guideline Development Process

The development of the VA/DoD Clinical Practice Guideline for the Management of Traumatic Stress Symptoms was initiated in May 2002 and continued through March 2003. The development process followed the steps described in "Guideline for Guideline," an internal working document of VHA's National Clinical Practice Guideline Council, which requires an ongoing review of the work in progress.

Target Audience

The guideline is designed for providers in primary care clinics and mental health centers, including PTSD special programs and VET centers. Specific modules in this guideline:

• Address prevention and health surveillance that may affect any person in the DoD or VA setting
• Outline the actions of individuals who provide early interventions or consultations in the immediate response to trauma events, mass catastrophic events, or combat situations during ongoing military operations
• Provide recommendations for the treatment of PTSD

Guideline Development Process

The Offices of Quality and Performance and Patient Care Service, in collaboration with the network Clinical Managers, the Deputy Assistant Under Secretary for Health, and the Medical Center Command of the DoD identified clinical leaders to champion the guideline development process. During a preplanning conference call, the clinical leaders defined the scope of the guideline and identified a group of clinical experts from the VA and DoD that formed the Guideline Development Working Group.

The Working Group participated in several face-to-face sessions to reach a consensus about the guideline recommendations and to prepare a draft document. The draft was revised by the experts through numerous conference calls and individual contributions to the document.

The final draft was reviewed mental health and primary care experts in the VA and DoD. Their feedback was integrated into the final draft. Nonetheless, this document is a work in progress. It will be updated every two years, or when significant new evidence is published.

The guideline is the product of many months of diligent effort and consensus building among knowledgeable individuals from the VA, DoD, academia, and guideline facilitators from the private sector. An experienced moderator facilitated the multidisciplinary Working Group. The list of participants is included in the introduction to the guideline.

Formulating of Questions

The Working Group developed eighteen researchable questions and associated key terms after orientation to the seed guidelines and to goals that had been identified by the Working Group. The questions specified (adapted from the Evidence-Based Medicine [EBM[ toolbox, Centre for Evidence-Based Medicine), (http://www.cebm.net):

• Population – characteristics of the target patient population
• Intervention – exposure, diagnostic, or prognosis
• Comparison – intervention, exposure, or control used for comparison
• Outcome –outcomes of interest

These specifications served as the preliminary criteria for selecting studies.

Selection of Evidence

Published, peer-reviewed, randomized controlled trials (RCTs) were considered to constitute the strongest level of evidence in support of guideline recommendations. This decision was based on the judgment that RCTs provide the clearest, scientifically sound basis for judging comparative efficacy. The Working Group made this decision recognizing the limitations of RCTs, particularly considerations of generalizability with respect to patient selection and treatment quality. Meta-analyses that included random controlled studies were also considered to be the strongest level of evidence, as well as reports of evidence-based systematic reviews.

A systematic search of the literature was conducted. It focused on the best available evidence to address each key question and ensured maximum coverage of studies at the top of the hierarchy of study types: evidence-based guidelines, meta-analyses, and systematic reviews. When available, the search sought out critical appraisals already performed by others that described explicit criteria for deciding what evidence was selected and how it was determined to be valid. The sources that have already undergone rigorous critical appraisal include Cochrane Reviews, Best Evidence, Technology Assessment, and EPC reports.

The search continued using well-known and widely available databases that were appropriate for the clinical subject. In addition to Medline/PubMed, the following databases were searched: Database of Abstracts of Reviews of Effectiveness (DARE) and Cochrane Central Register of Controlled Trials (CCTR). For Medline/PubMed, limits were set for language (English), date of publication (1998 through July 2002) and type of research (RCT and meta-analysis). For most of the pharmacotherapy topics the only limit was date, 1990 through March 2003).

Once definitive reviews or clinical studies that provided valid relevant answers to the question were identified, the search ended. The search was extended to studies/reports of lower quality (observational studies) only if there were no high quality studies.

Exclusion criteria included reviews that omitted clinical course or treatment. Some retrieved studies were rejected on the basis of published abstracts, and a few were rejected after the researchers scanned the retrieved citation for inclusion criteria. Typical exclusions included studies involving children and adolescents.

The results of the search were organized and reported using reference manager software. At this point, additional exclusion criteria were applied. The bibliographies of the retrieved articles were hand-searched for articles that may have been missed by the computer search. Additional experts were consulted for articles that may also have been missed.

Literature Review and Inclusion Criteria

The articles identified during the literature reviews formed the basis for formulating the guideline recommendations. The literature search for the guideline development was validated by: (1) comparing the results to a search conducted by the independent research and appraisal team; (2) a review of the database by the expert panel; and (3) requesting articles pertaining to special topics from the experts in the working group.

Preparation of Evidence Tables (reports)

A group of clinician reviewers and other researchers in health care, with experience in evidence-based appraisal, independently read and coded each article that met inclusion criteria. Each article was turned into a one-page summary of the critical appraisal by the research team and added to a central electronic database. Clinicians from the Center for Evidence-Based Practice at the State University of New York [SUNY], Upstate Medical University, Department of Family Medicine contributed several of the appraisal reports. Each of the evidence reports covered:

• Summary of findings
• Methodology
• Search terms
• Resources searched
• Summary table of findings
• Critical appraisal of each study

Recommendation and Overall Quality Rating

Evidence-based practice involves integrating clinical expertise with the best available clinical evidence derived from systematic research. The Working Group reviewed the evidence and graded it using the rating scheme developed by the United States Preventive Service Task Force (USPSTF) (2001). The experts themselves, after an orientation and tutorial on the evidence grading process, formulated Quality of Evidence ratings (see Table 1), a rating of Overall Quality (see Table 2), a rating of the Net Effect of the Intervention (see Table 3), and an overall Recommendation (see Table 4).

Abstract of the USPSTF:

• Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor.
• Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages that generalize to the general primary care population and connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain, such that the connection between the preventive service and health outcomes is uncertain.
• For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative.

The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an “I” recommendation in situations in which the evidence is insufficient to determine net benefit (Harris et al., 2001).

Lack of Evidence – Consensus of Experts

The majority of the literature supporting the science for these guidelines is referenced throughout the document and is based upon key RCTs and longitudinal studies published from 1998 through December 2002. Following the independent review of the evidence, a consensus meeting was held to discuss discrepancies in ratings and formulate recommendations. Where existing literature was ambiguous or conflicting, or where scientific data was lacking on an issue, recommendations were based on the clinical experience of the Working Group. These recommendations are indicated in the evidence tables as based on “Working Group Consensus”.

Algorithm Format

The goal in developing the guideline for Management of Tobacco Use was to incorporate the information from several existing reports, recommendations, and statements into a format which would maximally facilitate clinical decision making. The use of the algorithm format was chosen because of the evidence that such a format improves data collection, diagnostic and therapeutic decision-making and changes patterns of resource use. The algorithm format may help the clinician sort out the logic and sequence of the decision-making process for choosing the appropriate interventions to help survivors during the disorientation that often follows a trauma.

The algorithmic format allows the provider to follow a linear approach to critical information needed at the major decision points in the clinical process, and includes:

• An ordered sequence of steps of care
• Recommended observations
• Decisions to be considered
• Actions to be taken.

A clinical algorithm diagrams a guideline into a step-by-step decision tree. Standardized symbols are used to display each step in the algorithm (Society for Medical Decision-Making Committee [SMDMC], 1992). Arrows connect the numbered boxes indicating the order in which the steps should be followed.

	Rounded rectangles represent a clinical state or condition.
	Hexagons represent a decision point in the guideline, formulated as a question that can be answered Yes or No. A horizontal arrow points to the next step if the answer is YES. A vertical arrow continues to the next step for a negative answer.
	Rectangles represent an action in the process of care.
	Ovals represent a link to another section within the guideline.

A letter within a box of an algorithm refers the reader to the corresponding annotation. The annotations elaborate on the recommendations and statements that are found within each box of the algorithm. Included in the annotations are brief discussions that provide the underlying rationale and specific evidence tables. Annotations indicate whether each recommendation is based on scientific data or expert opinion. A complete bibliography is included in the guideline.