Attachment_4_-_Technical_Brief_Report_Content_Guidance_(v3).pdf

Draft Technical Brief Number XX (Provided by AHRQ)

[title]

Prepared for:

Agency for Healthcare Research and Quality US Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov

Contract No.

Prepared by:

Investigators:

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This report is based on research conducted by the x Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No.). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

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This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted, for which further reproduction is prohibited without the specific permission of copyright holders.

Suggested Citation:

None of the investigators has any affiliation or financial involvement that conflicts with the material presented in this report.

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Acknowledgments

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Preface

The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care Program as part of its mission to organize knowledge and make it available to inform decisions about healthcare. As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Congress directed AHRQ to conduct and support research on the comparative outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and healthcare services to meet the needs of Medicare, Medicaid, and the State Children’s Health Insurance Program (SCHIP).

AHRQ has an established network of Evidence-based Practice Centers (EPCs) that produce Evidence Reports/Technology Assessments and Comparative Effectiveness Reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care.

Technical Briefs are the most recent addition to this body of knowledge.

A Technical Brief provides an overview of key issues related to a clinical intervention or health care service—for example, current indications for the intervention, relevant patient population and subgroups of interest, outcomes measured, and contextual factors that may affect decisions regarding the intervention. Technical Briefs generally focus on interventions for which there are limited published data and too few completed protocol-driven studies to support definitive conclusions. The emphasis, therefore, is on providing an early objective description of the state of science, a potential framework for assessing the applications and implications of the new interventions, a summary of ongoing research, and information on future research needs.

Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an e-mail list to learn about new program products and opportunities for input.

Comparative Effectiveness Reviews will be updated regularly, while Technical Briefs will serve to inform new research development efforts.

Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H.

Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality

Director Task Order Officer Evidence-Based Practice Center Program Evidence-Based Practice Center Program Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Rockville, MD Rockville, MD

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Contents

Background Guiding Questions Methods Findings Summary and Implications Next Steps References

Table of Tables

Table of Figures

Table of Appendices

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Structured Abstract 250 words or less, provide a description of the background which gave rise to this intervention, the purpose of the report, methods, and main findings of the technical brief.

Do not spend more than a few sentences on methodology. Focus instead on what you found that was important and what should be done about it.

Background

Purpose

Methods

Findings i

Background A description of the clinical problem that the new intervention is meant to address. The EPC shall also provide a discussion of current medical practice as it relates to the clinical problem. This section should demonstrate what need the new technology or healthcare intervention has arisen to fill.

Guiding Questions Based on the guiding questions that have been proposed and finalized during the development of the Technical Brief, the EPC shall state the four guiding questions for the topic and the most important sub-questions (select a few to help the reader understand what the important take home message will be, but do not be exhaustive). If the Guiding Questions or the scope have changed substantially since the protocol, point this out and explain why.

Methods Provide a brief description of the methods used in the research of the topic. Research techniques shall include interviews of Key Informants (include description of type of Key Informant, how engaged, etc, and their role in shaping the report ), searches of the grey literature, and systematic searches of the published literature. A detailed description is not necessary, as additional details may be included in the appendices.

Findings Describe the results of applying the EPC’s research protocol to answer the Technical Brief guiding questions. If the report covers a range of different devices or interventions, it may be helpful to present an overall framework to help readers understand how they relate to each other and to the clinical problem they address. In integrating information from Key Informants, gray literature, and the published literature, be very conscious of how you use different sources. Information from Key Informants and the gray literature is primarily useful for background and for generating questions. It should be crosschecked and, if no confirmatory data is found, should be presented as unconfirmed. In most cases, the material in the report should follow the order of the Guiding Questions, but occasionally some rearrangement may be needed to produce the most coherent and logical narrative. Consider using graphs, tables, analytic frameworks and other tools to convey your message.

a. Description of proposed intervention: How the new intervention works;

proposed use (population, indications, and settings); theoretical advantage over existing practice; potential risks; different models/variations/vendors, FDA and/or commercial status; accreditation or training issues (if applicable); information on diffusion of the technology/intervention in healthcare; whether it is commonly considered standard of care or experimental; and any important ethical, privacy, equity, and/or cost considerations. This

Version 2 2/8/2011 section may rely on information from published narrative reviews and information in the grey literature, including lay press, such as news reports. All statements of opinion should be clearly labeled as such. Additionally, the sources of opinions should be identified, and the reader should be referred to the evidence map to verify what evidence is available to support each opinion included in the final report.

b. Evidence Map: What types of studies involving the technology/intervention under consideration have been completed or are underway, and what kinds of questions can they answer? This may involve searches for:

• Published literature (Medline, etc.)

• Ongoing clinical trials on the topic from clinicaltrials.gov and other clinical trial registries or systematic reviews.

• Abstracts published at recent scientific meetings for potential breaking scientific developments.

The EPCs shall also perform a literature scan on the methodology used in identified studies and provide a summary of study variables, such as patient selection criteria, study design issues, comparators used, and outcomes measured.

Summary and Implications What are the most important issues that should be considered for this medical technology/intervention? This discussion should tie together assertions on theoretical benefits and harms with the evidence described above. In addition to providing a summary of the available evidence that addresses questions of efficacy/effectiveness, safety and appropriate patient populations, the EPC shall discuss, when appropriate, the ethical, privacy, access, equity, and/or economic efficiency considerations that impact diffusion of the technology/intervention, decision-making and/or conceptual thinking around the technology/intervention. What are the key decisional uncertainties? What kind of conceptual framework could help organize future research and policy?

Next Steps Based on the research findings above and as highlighted in the proposed conceptual framework, what should be done to resolve the most important questions?

References

Version 2 2/8/2011 http://clinicaltrials.gov/