Evidence map›Paper›PMID 22917599›Full record

Trial reportContemporary clinical trials2012

Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: methodological insights from a pneumonia prevention trial.

Peter H Van Ness, Peter N Peduzzi, Vincent J Quagliarello

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
1.2field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Oral care measures for preventing nursing home-acquired pneumonia.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Oral care measures for preventing nursing home-acquired pneumonia.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Iowa nursing facility oral hygiene (INFOH) intervention: A clinical and microbiological pilot randomized trial.Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry · 2018
    Trial
  6. Trial
  7. Trial
  8. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Trial
  9. Article
  10. Mouth Care in Assisted Living: Potential Areas for Improvement.Journal of the American Medical Directors Association · 2021
    Article
  11. Article
  12. Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Peter H Van NessDepartment of Internal Medicine, Geriatrics Section, and the Program on Aging, Yale University School of Medicine, USA. peter.vanness@yale.edu
Peter N Peduzzi
Vincent J Quagliarello
Yale University · US

Funding

YALE UNIVERSITY CLINICAL AND TRANSLATIONAL SCIENCE AWARD PROGRAMUL1RR024139 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$56.8M
Yale Study Support Suite (YES3): Dashboard and Web Portal Software Supporting Research Workflow through integrated, customizable REDCap External ModulesP30AG021342 · NIA · YALE UNIVERSITY · PI Albert C Shaw · 2002 to 2026
$37.9M
A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home ResidentsR01AG030575 · NIA · YALE UNIVERSITY · PI QUAGLIARELLO, VINCENT JAMES · 2009 to 2013
$6.3M
Program of Research in Infectious Diseases of EldersK07AG030093 · NIA · YALE UNIVERSITY · PI QUAGLIARELLO, VINCENT JAMES · 2010 to 2014
$672k
NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1RR024139NIA NIH HHS K07 AG030093NIA NIH HHS P30 AG021342NIA NIH HHS P30AG021342NIA NIH HHS R01 AG030575
6 · The paper itself

Abstract

This report discusses how methodological aspects of study efficacy and effectiveness combine in cluster randomized trials in nursing homes. Discussion focuses on the relationships between these study aspects in the Pneumonia Reduction in Institutionalized Disabled Elders (PRIDE) trial, an ongoing cluster randomized clinical trial of pneumonia prevention among nursing home residents launched in October 2009 in Greater New Haven, Connecticut. This clinical trial has enrolled long-term care nursing home residents, over 65years in age, who have either inadequate oral care or swallowing difficulty, previously identified risk factors for pneumonia. It has used a multicomponent intervention consisting of manual tooth/gum brushing, 0.12% chlorhexidine oral rinse administered twice daily by nurses, and upright feeding positioning at meals to reduce rates of radiographically documented pneumonia. Cluster randomization is attractive for nursing home intervention studies because physical proximity and administrative arrangements make it difficult to deliver different interventions to residents of the same nursing home. Implementing an intervention in an entire home requires integration into the daily life of residents and into the administrative procedures of the nursing home. This characteristic of nursing home cluster randomized trials makes them approximate "real-world" research contexts, but implementation can be challenging. The PRIDE trial of pneumonia prevention utilized specific methodological choices that include both efficacy and effectiveness elements. Cluster randomized trials in nursing homes having elements of both efficacy and effectiveness (i.e., hybrid designs) can address some of the methodological challenges of conducting clinical research in nursing homes; they have distinctive advantages and some limitations.

Indexed as

AgedChlorhexidineComparative Effectiveness ResearchDeglutition DisordersFemaleHomes for the AgedHumansMaleMedicaidMedicareMouthwashesNursing HomesOral HygienePneumoniaResearch DesignUnited StatesChlorhexidineMouthwashes

Identifiers

PMID22917599
PMCPMC3468687
OpenAlexW2046568503

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.