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                - This publication is provided for historical reference only and the information may be out of date or incorrect.

**This publication is provided for historical reference only and the information may be out of date or incorrect.**

Bookshelf ID: NBK33017

# Diagnosis and Treatment of Swallowing Disorders (Dysphagia) in Acute-Care                Stroke Patients

*Evidence Reports/Technology Assessments, No. 8*

ECRI Health Technology Assessment Group.

Agency for Health Care Policy and Research (US)

Copyright Notice: http://www.ncbi.nlm.nih.gov/books/about/copyright/

## Structured Abstract

#### Objectives:

This report was requested by the Health Care Financing                Administration, which sought an evidence-based assessment of methods for diagnosing                and treating swallowing disorders (dysphagia) in elderly individuals with neurologic                diseases, and specifically those methods associated with the services provided by                speech-language pathologists. About 6,228,000 Americans over age 60 have dysphagia,                and about 300,000 to 600,000 people are affected by dysphagia resulting from                neurologic disorders each year.

This report addresses four questions: (1) How does diagnosis of dysphagia or                aspiration affect treatment courses and patient outcomes? (2) What are the                indications for diagnosing patients using a full bedside exam (BSE), modified barium                swallow, fiberoptic endoscopy, or other instrumented exams? (3) Is one diagnostic                technology more effective than any other? and (4) When is noninvasive therapy                appropriate, and when should feeding tubes be used in certain patient populations?

#### Search Strategy:

We used broad-based literature searching to ensure that                we found all relevant information. Thus, we searched 23 electronic databases,                including MEDLINE and Embase. Search terms included those relevant to the disorder,                diagnostics, epidemiology, etiology, and treatment of dysphagia. Search dates                depended on the database, but ranged from 1945 to July 1998. We also searched 23                World Wide Web sites, conducted hand searches of article bibliographies, and sought                published and unpublished information from experts in the field.

#### Selection Criteria:

We adopted broad criteria to ensure retrieval of all                relevant information. Articles were retrieved if they were clinical studies of any                design containing information derived from 10 or more patients. Two researchers                independently requested articles. Disputes were resolved in favor of obtaining the                article.

#### Data Collection and Analysis:

Data from clinical trials on diagnostic                test performance and/or patient outcomes were entered directly into evidence tables.                This information included study size, design, diagnostic method(s), patient                selection criteria and characteristics, and patient outcomes.

Studies were separated by their design, but their quality was not necessarily ranked                according to it. We did not rigidly adhere to a formal quality ranking scheme                because some randomized controlled trials (RCTs) had flaws serious enough to render                their results unreliable. Similarly, we did not always consider case-controlled                studies to provide more reliable information than case series because of certain                flaws in the former.

To reach our conclusions, we performed two cost-effective analyses, a meta-analysis                of the efficacy of the 3-ounce water test, a similar meta-analysis of the BSE, an                exploratory meta-analysis (so called because the control data were derived from                historical sources) on the effects of dysphagia diagnosis and treatment programs on                patient outcomes, an illustrative meta-analysis that addresses the technical issue                of the low statistical power of vote-counting procedures, and numerous other                quantitative analyses. The need to perform these original calculations is a                reflection on the relatively poor reporting in this literature.

#### Main Results:

We focused on dysphagia diagnosis and treatment                    *programs* because assessment of dysphagia diagnosis and                treatment independent of one another provides only limited information. The emphasis                of our analysis was on stroke victims, which reflects the preponderance of the                literature. Stroke victims also comprise the largest group of patients with                neurologic disease who have dysphagia. Outcomes of particular interest were                aspiration pneumonia, malnutrition, dehydration, and quality of life (QOL), but the                most data were available for aspiration pneumonia.

The evidence regarding the first question, which is the most significant of our key                questions, suggests that dramatic reductions in the occurrence of pneumonia are                observed when a systematic program of diagnosis and treatment of dysphagia in an                acute stroke management plan is implemented. Because these data are from                historically controlled studies rather than RCTs (which may be unethical in this                context), the exact magnitude of this reduction in pneumonia rates is difficult to                determine. Also for this reason, it is equally difficult to determine the                contribution of the dysphagia-specific aspects of the management programs to these                rate reductions (as opposed to those aspects of the stroke management program not                related to diagnosis and treatment of dysphagia). However, because the effects                observed in these studies are substantial, it would be imprudent to ignore them.                Therefore, these results must be taken as evidence of efficacy of these programs.                Malnutrition, dehydration, and QOL were not addressed in available studies.

Regarding the second question, the risk for developing aspiration pneumonia cannot be                accurately predicted from any single clinical sign or symptom. There is a clear-cut                need to optimize a brief initial exam that employs several key signs and symptoms to                accurately detect patients with possible unsafe swallows and who therefore need more                extensive testing.

The results of the studies of diagnostic test performance that address the third                question are erroneous because treatment necessarily follows diagnosis of a                swallowing disorder. This treatment makes it impossible to distinguish between the                true- and false-positive results of these tests. Because of this, the purely                diagnostic abilities of the various tests cannot be determined; thus, the tests can                only be compared by assessing how they direct treatment and influence adverse                patient outcomes, as addressed in our first question above.

We constructed two cost-effectiveness models to address this issue, and their results                suggest that use of the full BSE in dysphagia programs reduces costs. These models,                which are based on published protocols and findings, assume that patients will                receive a preliminary bedside assessment, and that one result of this assessment is                that no more than about 39 percent of patients will be referred for further                evaluation, as occurred in the best study we evaluated. Under these conditions, our                cost-effectiveness analysis suggests that dysphagia diagnosis and treatment programs                that employ the full BSE would either save money or have very little net cost if                they reduced pneumonia rates by amounts similar to those obtained in certain                published studies. In addition, our results indicate that the slightly higher costs                of videofluoroscopy would be offset if it provided slightly less than an additional                10 percent reduction in pneumonia rates, again assuming that no more than about 39                percent of patients are referred for videofluoroscopy or the full BSE.

Evidence related to the fourth question consists of limited data from a single RCT                concluding that a soft mechanical diet including thickened liquids results in lower                morbidity than does a pureed diet. Although numerous other studies have been                conducted on dysphagia treatments, their designs make it impossible to assess the                efficacy of individual treatments. A single RCT with low statistical power reported                inconclusive results about the effect of treatment intensity level on patient                outcomes.

A well-designed trial that compares dysphagia management programs using different                diagnostic modalities is needed. This trial should take into account the current                lack of a demonstrated gold standard diagnostic test, have acceptable statistical                power, and consider the fact that treatment of patients distorts measures of                diagnostic test performance. Because of this urgent need, we provide a detailed                description of the design and analysis of a trial that would answer several major                unanswered questions.

#### Conclusions:

Available evidence on the diagnosis and treatment of                dysphagia is extremely limited. Nevertheless, current data suggest that                implementation of dysphagia management programs for stroke patients in the                acute-care setting is accompanied by a reduction in pneumonia rates. Use of the full                BSE in these programs appears to be cost-effective. The limitations of available                evidence do not allow us to determine the extent to which videofluoroscopy or                fiberoptic endoscopy reduce pneumonia rates compared with the full BSE despite the                fact that it is reasonable to believe the additional information they provide would                lead to improved patient outcomes. Although the added benefits provided by                instrumented exams are likely to be small, videofluoroscopy may be cost-effective if                used in programs in which no more than about 39 percent of all patients are referred                to this test, and if its use leads to an additional 10 percent reduction in                pneumonia rates, compared with the full BSE. There is a clear-cut need to optimize a                brief initial exam that accurately detects patients with possible unsafe swallows                who may therefore need more extensive testing. Study designs used in the evaluation                of noninvasive therapy have made it impossible to assess the efficacy of individual                treatments. However, there is evidence supporting the use of a soft mechanical diet                over a pureed diet for preventing aspiration pneumonia in stroke patients with                dysphagia who have a history of aspiration pneumonia. The evidence on whether                treatment that is more intensive yields better patient outcomes than less intensive                treatments is inconclusive. Well-designed studies, particularly those that compare                diagnostic modalities, are needed.

## Contents

                  - Preface
                  - Summary
                  -  1. Introduction                     - Purpose of This Report
                  -  2. Methodology                     - Focus and Refinement of Topic
                    - Databases and Other Sources Searched
                    - Information Retrieved
                    - Evidence Model
                    - Study Quality
                    - Quantitative Methods
                    - Quality Control Methods
                  -  3. Results                     - 1. How does the diagnosis of dysphagia or aspiration affect the subsequent course of treatment and outcomes?
                    - 2. What are the appropriate clinical indications or components of a preliminary BSE useful for referring patients for a full BSE or instrumented exams?
                    - 3. Is there any evidence that one diagnostic technology is preferable/is more effective/gives more information than any other diagnostic technology?
                    - 4. When is noninvasive swallow therapy or diet modification appropriate? Do these therapies work particularly well in any particular patient population? What can the evidence tell us about these therapies? Is PEG useful as a primary therapy or is it a last resort?
                  - 4. Conclusions
                  -  5. Future Research                     - Shortcomings of Available Research
                    - Specific Areas of Recommendation
                    - Clinical Trial Suggestion
                  - Supplemental Analysis
                  - Supplemental Evidence Tables
                  -  Appendixes                     - Appendix A. Epidemiology
                    - Appendix B. Burden of Illness of Dysphagia and Its Complications in Neurologic Diseases
                    - Appendix C. Detailed Search Strategies for Data Collection
                    - Appendix D. Time Distribution of Pneumonia Cases in Acute Stroke Patients
                    - Appendix E. Methods for Evaluation of Diagnostic Tests
                    - Appendix F. Extension and Cost-Effectiveness Analysis of Suggested Clinical Trial
                    - Appendix G. The Effect of Treatment on Diagnostic Test Results
                    - Appendix H. Original Calculations in This Report
                  - Evidence Tables
                  - References
                  - Bibliography

Prepared for: Agency for Health Care Policy and Research, U.S. Department                of Health and Human Services.1                 Contract No. 290-97-E020.                Prepared by: ECRI, Plymouth Meeting,                    Pennsylvania.

#### Suggested citation:

Diagnosis and Treatment of Swallowing Disorders                    (Dysphagia) in Acute-Care Stroke Patients. Evidence Report/Technology Assessment                    No. 8. (Prepared by ECRI Evidence-based Practice Center under Contract No.                    290-97-0020.) AHCPR Publication No. 99-E024. Rockville, MD: Agency for Health                    Care Policy and Research. July 1999.

The authors of this report are responsible for its content. Statements in the report                should not be construed as endorsement by the Agency for Health Care Policy and                Research or the U.S. Department of Health and Human Services of a particular drug,                device, test, treatment, or other clinical service.

                  - 1
                  - 2101 East Jefferson Street, Rockville, MD 20852. www.ahcpr.gov

Copyright Notice: http://www.ncbi.nlm.nih.gov/books/about/copyright/

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