Comparison of 2 interventions for liquid aspiration on pneumonia incidence: a randomized trial.

BACKGROUND: Aspiration pneumonia is common among frail elderly persons with dysphagia. Although interventions to prevent aspiration are routinely used in these patients, little is known about the effectiveness of those interventions. OBJECTIVE: To compare the effectiveness of chin-down posture and 2 consistencies (nectar or honey) of thickened liquids on the 3-month cumulative incidence of pneumonia in patients with dementia or Parkinson disease. DESIGN: Randomized, controlled, parallel-design trial in which patients were enrolled for 3-month periods from 9 June 1998 to 19 September 2005. SETTING: 47 hospitals and 79 subacute care facilities. PATIENTS: 515 patients age 50 years or older with dementia or Parkinson disease who aspirated thin liquids (demonstrated videofluoroscopically). Of these, 504 were followed until death or for 3 months. INTERVENTION: Participants were randomly assigned to drink all liquids in a chin-down posture (n = 259) or to drink nectar-thick (n = 133) or honey-thick (n = 123) liquids in a head-neutral position. MEASUREMENTS: The primary outcome was pneumonia diagnosed by chest radiography or by the presence of 3 respiratory indicators. RESULTS: 52 participants had pneumonia, yielding an overall estimated 3-month cumulative incidence of 11%. The 3-month cumulative incidence of pneumonia was 0.098 and 0.116 in the chin-down posture and thickened-liquid groups, respectively (hazard ratio, 0.84 [95% CI, 0.49 to 1.45]; P = 0.53). The 3-month cumulative incidence of pneumonia was 0.084 in the nectar-thick liquid group compared with 0.150 in the honey-thick liquid group (hazard ratio, 0.50 [CI, 0.23 to 1.09]; P = 0.083). More patients assigned to thickened liquids than those assigned to the chin-down posture intervention had dehydration (6% vs. 2%), urinary tract infection (6% vs. 3%), and fever (4% vs. 2%). LIMITATIONS: A no-treatment control group was not included. Follow-up was limited to 3 months. Care providers were not blinded, and differences in cumulative pneumonia incidence between interventions had wide CIs. CONCLUSION: No definitive conclusions about the superiority of any of the tested interventions can be made. The 3-month cumulative incidence of pneumonia was much lower than expected in this frail elderly population. Future investigation of chin-down posture combined with nectar-thick liquid may be warranted to determine whether this combination better prevents pneumonia than either intervention independently.

Overview, Definitions, and Goals for ASHA's Treatment Outcomes and Clinical Trials Activities (What Difference Do Outcome Data Make to You?).

This article examines differences between efficacy and effectiveness, describes two research designs related to measuring efficacy and effectiveness, and describes the American Speech-Language-Hearing Association's (ASHA's) efforts relative to these research designs, with examples presented for how each of these designs can be used in the school setting. Outcomes studies and clinical trials research are the particular focus of the article. The characteristics of each type of research are described and related to the school setting.

Speech-Language Hearing Interventions in the Schools: A Public Health Perspective on Measuring Their Short-Term and Long-Term Impact.

Prevalence of studies of speech, language, and hearing disorders do not yet adequately define the frequency of specific communication disorders in children. Such data are needed to provide a strong rationale for funding of research on the effectiveness of our interventions. Establishing the effectiveness of our treatments is critical to continued support of our services. This article emphasizes the importance of collecting prevalence data and of measuring both the short-term and long-term impact of our interventions in the schools.

Collecting Outcomes Data in Schools: Needs and Challenges.

The definition of treatment outcomes, its interpretive limitations, and the need for this type of information are discussed. The activities of the American Speech-Language-Hearing Association's (ASHA's) Task Force on Treatment Outcomes and Cost-Effectiveness and the development of the National Outcomes Measurement System for Speech-Language Pathology and Audiology (NOMS) are reviewed, with an emphasis on the NOMS: K-12 (Education) component. How outcomes data can be used and the challenges its collection presents in school settings are also discussed.

Conducting Clinical Trials in the Public Schools.

This manuscript explores the general whys and hows clinicians in the public school can and should be involved in clinical trials research and describes the Communication Sciences and Disorders Research Group (CSDRG). The CSDRG is a group of clinicians, clinical investigators, basic scientists, epidemiologists, and statisticians in communication sciences and disorders (funded by the National Institutes of Health) who came together to design and implement clinical trials examining the effectiveness of interventions with speech, hearing, language, balance, and voice/swallowing disorders. Clinical trials are a very specific type of treatment research requiring the randomization of children to several different treatment arms. Because of the required characteristics of clinical trials, conducting them in the school setting poses unique challenges and logistic issues that are described, along with potential solutions.