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Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence: A Randomized Trial

JoAnne Robbins, PhD; Gary Gensler, MS; Jacqueline Hind, MS; Jeri A. Logemann, PhD; Anne S. Lindblad, PhD; Diane Brandt, BS; Herbert Baum, PhD; David Lilienfeld, MD, PhD; Steven Kosek, MS; Donna Lundy, PhD; Karen Dikeman, MA; Marta Kazandjian, MA; Gary D. Gramigna, MS; Susan McGarvey-Toler, MS; and Patricia J. Miller Gardner, JD
[+] Article and Author Information

From William S. Middleton Memorial Veterans Hospital, Geriatric Research Education and Clinical Center, and University of Wisconsin, Madison, Wisconsin; EMMES Corporation and American Speech-Language-Hearing Association, Rockville, Maryland; Northwestern University, Evanston, Illinois; ORC Macro, Calverton, Maryland; Stanford University School of Medicine, Palo Alto, California; Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota; University of Miami Hospital and Clinics, Miami, Florida; New York Hospital Medical Center–Queens, Flushing, New York; Veterans Affairs Boston Healthcare System, West Roxbury, Massachusetts; and Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana.


ClinicalTrials.gov registration number: NCT00000362.

Acknowledgment: The authors thank Susi Nehls, BS, for editing expertise; Abby Duane, BS, for preparing the manuscript; E. Kenneth Sullivan, PhD, for study design and statistical analysis; Carol Caperton Wenck, MS, CCRA, for coordination of the project; and Jeffrey Glassroth, MD, and Jeffrey Grossman, MD, for sharing their perspectives on critical care of patients with pneumonia.

Grant Support: By the National Institute on Deafness and Other Communication Disorders, National Institutes of Health (DC03206). Additional support for the grant was provided by Novartis and E-Z-EM to the American Speech-Language-Hearing Association, Communication Sciences and Disorders Clinical Trials Research Group.

Potential Financial Conflicts of Interest:Honoraria: J. Robbins (E-Z-EM). Grants received: G. Gensler (National Institute on Deafness and Other Communication Disorders, National Institutes of Health), A.S. Lindblad (National Institute on Deafness and Other Communication Disorders, National Institutes of Health), D. Brandt (National Institute on Deafness and Other Communication Disorders, National Institutes of Health). Patents received: J. Robbins (Wisconsin Alumni Research Association). Receipt of payment for manuscript preparation: G. Gensler (National Institute on Deafness and Other Communication Disorders, National Institutes of Health), A.S. Lindblad (National Institute on Deafness and Other Communication Disorders, National Institutes of Health), D. Brandt (National Institute on Deafness and Other Communication Disorders, National Institutes of Health). Royalties: J. Robbins (Wisconsin Alumni Research Association).

Reproducible Research Statement:Study protocol: Available from the Communication Sciences and Disorders Research Group Executive Policy Board (CSDRG-EPB). Statistical code: Not available. Data set: Available from Dr. Jeri Logemann (e-mail, j-logemann@northwestern.edu).

Requests for Single Reprints: JoAnne Robbins, PhD, William S. Middleton Memorial Veterans Hospital, 2500 Overlook Terrace, Geriatric Research Education and Clinical Center 11G, Madison, WI 53705; e-mail, jrobbin2@wisc.edu.

Current Author Addresses: Dr. Robbins and Ms. Hind: William S. Middleton Memorial Veterans Hospital, 2500 Overlook Terrace, Geriatric Research Education and Clinical Center 11G, Madison, WI 53705.

Mr. Gensler, Dr. Lindblad, and Ms. Brandt: The EMMES Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850.

Dr. Logemann: Northwestern University, Communicative Sciences and Disorders, 2240 Campus Drive, Evanston, IL 60208.

Dr. Baum: ORC Macro, 11785 Beltsville Drive, Calverton, MD 20705.

Dr. Lilienfeld: FibroGen, Inc., 225 Gateway Boulevard, South San Francisco, CA 94080.

Mr. Kosek: Minneapolis Veterans Affairs Medical Center, One Veterans Drive, Minneapolis, MN 55417.

Dr. Lundy: University of Miami Miller School of Medicine, UMHC-4035, 1475 Northwest 12th Avenue, Miami, FL 33136.

Ms. Dikeman and Ms. Kazandjian: Silvercrest Center for Nursing and Rehabilitation, 144-45 87th Avenue, Briarwood, NY 11435.

Mr. Gramigna: Veterans Affairs Boston Healthcare System, 1400 VFW Parkway, West Roxbury, MA 02132.

Ms. McGarvey-Toler: Richard L. Roudebush Veterans Affairs Medical Center, 1481 West 10th Street, Indianapolis, IN 46202.

Ms. Miller Gardner: American Speech-Language-Hearing Association, 2200 Research Boulevard, #245, Rockville, MD 20850.

Author Contributions: Conception and design: J. Robbins, J.A. Logemann, A.S. Lindblad, H. Baum, D. Lilienfeld.

Analysis and interpretation of the data: J. Robbins, G. Gensler, J.A. Logemann, A.S. Lindblad, D. Brandt, D. Lilienfeld.

Drafting of the article: J. Robbins, G. Gensler, J. Hind, J.A. Logemann, A.S. Lindblad, D. Brandt, P.J. Miller Gardner.

Critical revision of the article for important intellectual content: J. Robbins, G. Gensler, J. Hind, J.A. Logemann, A.S. Lindblad, D. Brandt, H. Baum, D. Lilienfeld, S. Kosek, D. Lundy, K. Dikeman, M. Kazandjian, G.D. Gramigna, S. McGarvey-Toler.

Final approval of the article: J. Robbins, G. Gensler, J.A. Logemann, A.S. Lindblad, P.J. Miller Gardner.

Provision of study materials or patients: J. Robbins, J. Hind, J.A. Logemann, S. Kosek, D. Lundy, K. Dikeman, M. Kazandjian, G.D. Gramigna, S. McGarvey-Toler.

Statistical expertise: G. Gensler, A.S. Lindblad.

Obtaining of funding: J. Robbins, J.A. Logemann, A.S. Lindblad, H. Baum, D. Lilienfeld.

Administrative, technical, or logistic support: J. Robbins, J. Hind, J.A. Logemann, D. Brandt, H. Baum, P.J. Miller Gardner.

Collection and assembly of data: J. Robbins, J. Hind, J.A. Logemann, D. Brandt, S. Kosek, D. Lundy, K. Dikeman, M. Kazandjian, G.D. Gramigna, S. McGarvey-Toler.


Ann Intern Med. 2008;148(7):509-518. doi:10.7326/0003-4819-148-7-200804010-00007
Text Size: A A A

We compared 2 common but untested interventions to prevent pneumonia—chin-down posture and thickened liquids—in persons with dementia or Parkinson disease (or both conditions) who had a known tendency to aspirate liquid. By performing a systematic search of PubMed from January 1990 to December 2007 using the terms dysphagia, pneumonia, Parkinson's disease, and dementia, we identified no other studies that compared outcomes of such treatments in these populations.

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Figures

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Figure 1.
Study flow diagram.

SLP = speech-language pathologist. *“Lost to follow-up” is a subset of those who discontinued the intervention.

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Figure 2.
Cumulative incidence of pneumonia in the chin-down posture and thickened-liquid groups.

P = 0.53, log-rank test.

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Figure 3.
Forest plots showing the primary intervention effect for pneumonia (top) and for pneumonia or death (bottom) in subgroups.
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Comments

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Ethics of a control arm
Posted on May 28, 2008
Dimitri Drekonja
University of Minnesota; Minneapolis VA Medical Center
Conflict of Interest: None Declared

The report by Robbins et al. (1) on interventions to reduce aspiration pneumonia strikes me as a well executed, thoroughly reported trial that suffers from a fatal flaw of not including a no-treatment control arm. It is mentioned several times in the introduction and discussion that the interventions studied are "untested" and that there is an "absence of efficacy data," which indicates that there is sufficient clinical equipose to justify the inclusion of a no-treatment control arm. These assertions also make one question the statement supporting the lack of such a group, that such an arm would be "unethical in the context of standard clinical care."

I would argue that the exclusion of such a control group severely weakens the findings of this study, as we are unable to determine if the lower than expected rate of pneumonia observed in the study is due to the interventions (a finding that would be of clinical importance), or rather some other tmporally associated factor. Given the assertions that the interventions are of unproven efficacy, I am unclear as to how including a no-treatment control arm would be unethical. Indeed, one could argue that expending large amounts of energy, time, and funding, in order to produce a result that is severely limited by the lack of a control arm, is ethically questionable in its own right.

1- Robbins et al. Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence. Ann Intern Med. 2008;148:509-18. [PMID: 18378947]

Conflict of Interest:

None declared

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Summary for Patients

Can Thickened Liquids or Chin-Down Posture Prevent Aspiration?

The summary below is from the full report titled “Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence. A Randomized Trial.” It is in the 1 April 2008 issue of Annals of Internal Medicine (volume 148, pages 509-518). The authors are J. Robbins, G. Gensler, J. Hind, J.A. Logemann, A.S. Lindblad, D. Brandt, H. Baum, D. Lilienfeld, S. Kosek, D. Lundy, K. Dikeman, M. Kazandjian, G.D. Gramigna, S. McGarvey-Toler, and P.J. Miller Gardner.

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