Surrogate Outcomes
Oral care in the adult intensive care unit
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Summary
Posted By: Sharon McKinley
E-Mail: sharon.mckinley@uts.edu.au
Posted Date: 8 January, 2003
Title: Oral care in the adult intensive care unit
Authors: Julie A Fitch;Cindy L Munro;Connie A Glass;Joan M Pellegrini;
Reference: Fitch JA et al. Am J Crit Care 1999; 8: 314-318
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: BACKGROUND Nurses have not been formally trained in assessing the oral status of patients in intensive care units, and no oral care protocols for these patients are available.
OBJECTIVES To assess the oral status of patients in an intensive care unit, evaluate the effects of a defined oral care protocol on the oral health status of patients in an intensive care unit, and compare oral assessments of a dental hygienist with those of intensive care nurses.
METHODS A nonequivalent comparison group, longitudinal design with repeated measures was used. In phase 1, oral assessment data on the comparison group were collected by a dental hygienist. In phase 2, nurses were instructed in oral assessment and an oral care protocol. In phase 3, the oral care protocol was implemented in the treatment group, and oral assessment data were collected separately by the dental hygienist and by nurses.
RESULTS The mean inflammation score was significantly lower (t test P = .03) in the treatment group (mean, 3.9; SEM, 3.0) than in the comparison group (mean, 12.4; SEM, 2.2). Although not significant, the mean scores of the treatment group were also lower than those of the comparison group on scales of candidiasis, purulence, bleeding, and plaque. Correlations between scores for individual items on the oral assessment tool obtained by the dental hygienist and those obtained by nurses were all greater than 0.6386.
CONCLUSION Implementation of a well-developed oral care protocol by bedside nurses can improve oral health of patients in the intensive care unit (American Journal of Critical Care. 1999;8:314-318)
 
Are the Results Valid?
1. Is there a strong, independent, consistent association between the surrogate end point and the clinical end point?
Studies have shown that the oral mucosa of ventilated patients is often colonised with respiratory pathogens (Scannapieco et al., 1992; Treloar & Stechmiller, 1995), and that oral colonisation is related to ventilator-associated pneumonia (VAP) (e.g. Treloar & Stechmiller, 1995; Abele-Horn et al., 1996). (Reviews: Vincent et al., 2001; Mehta & Niederman, 2002). There is little or no evidence of association with mortality or length of ICU stay. Fitch et al. did not quantitate oral colonisation, but the observational grading of infection of the mucosa was the only outcome of their study that was significantly reduced by the oral hygiene protocol intervention.
2. Is there evidence from randomized trials in other drug classes that improvement in the surrogate end point has consistently lead to improvement in the target outcome?
There is evidence from randomized trials that interventions that reduce oral colonisation rates do reduce (VAP) (Johanson et al., 1988; Abele-Horn et al.; 1996; Bergmans et al., 2001). The most commonly evaluated intervention is topically applied antimicrobial agents.
3. Is there evidence from randomized trials in the same drug class that improvement in the surrogate end point has consistently lead to improvements in the target outcome?
No other studies were found in which a mouth care protocol based on brushing the teeth, gums and tongue was evaluated for its effect on oral inflammation or colonisation, VAP or patient comfort.
What are the Results?
1. How large, precise and lasting was the treatment effect?
Comparison vs intervention group on 100mm VAS:
  • Inflammation 12.4 vs 3.9 (p=.03); 8.5% difference
  • Candidiasis 20.8 vs 0.00 (NS)
  • Purulence 0.02 vs 0.0 (NS)
  • Bleeding 0.9 vs 0.0 (NS)
  • Plaque 08.3 vs 14.2 (NS)
  • Salivary flow 33.9 vs 34.3 (NS)

    SEM for inflammation 2.2 vs 3.0, therefore fairly large variability in scores for intervention group.

    That is: inflammation was reduced but the improvement was probably quite small in some patients. There was no evaluation of the duration of the effect, but if the mouth care protocol was used for the duration of the patientís intubation there could be sustained improvement in oral hygiene. It appears that the investigators did not evaluate patient comfort, which is another clinically important outcome of mouth care.

  • Will the Results Help Me In Caring For My Patients?
    1. Are the likely treatment benefits worth the potential harms and costs?
    Potential harms and costs are minimal. The authors argue that prevention of colonisation of the oral mucosa may reduce pulmonary colonisation and VAP, but the link to that clinical end point is weak. However intensive care nurses routinely provide mouth care to intubated, ventilated patients to maintain hygiene and promote patient comfort. The evidence base for effective mouth care practices in these patients is slim. The study of Fitch et al. provides some weak evidence that a mouth care protocol incorporating brushing of the teeth, gums and tongue confers some benefit in reducing inflammation of the oral mucosa. Such practices may also promote greater patient comfort and reduce the risk of VAP, but these outcomes have not been studied. Click here for a review of the study using the Therapy Users's Guide.

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