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Christianne A. van Nieuwenhoven, MD; Erik Buskens, MD,PhD; Frank H. van Tiel, MD,PhD; Marc J. M. Bonten, MD,PhD

JAMA. 2001;286:335-340.

Context  Although meta-analyses of randomized trials have shown that selective digestive decontamination (SDD) prevents nosocomial pneumonia in critically ill patients, the influence of trial quality on the effectiveness of SDD has not been rigorously evaluated.

Objective  To assess the methodological quality of individual studies of SDD and its relation to the reported effects on pneumonia and mortality.

Design  Thirty-two studies were identified in a MEDLINE and reference list search and their methodological quality was assessed using a scoring system (range, 0-13 points) based on allocation and concealment, patient selection, patient characteristics, blinding of the intervention, and the definition of pneumonia.

Main Outcome Measure  Methodological quality of the primary trials and its effect on the relative risk reductions (RRRs) of SDD on pneumonia and mortality.

Results  The mean (SD) methodological quality score was 7.8 (2.9) (range, 1-11). The RRRs ranged from –0.1 to 1.0 for pneumonia and from –0.1 to 0.6 for mortality. The methodological quality score was associated with the RRR for pneumonia so that for each quality-point added, the RRR decreased by 5.8% (95% confidence interval, 2.4%-9.3%). No association between trial quality and the impact of SDD was found on mortality. Of the individual trial quality characteristics, patient selection, allocation of intervention, and blinding most strongly influenced the treatment effect.

Conclusions  The inverse relationship between methodological quality score and the benefit of SDD on the incidence of pneumonia may have resulted in overly optimistic estimates of SDD in prior meta-analyses. This emphasizes the importance of rigorous trial design in evaluating preventive interventions in the intensive care unit.

Author Affiliations: Department of Medical Microbiology, University Hospital Maastricht (Drs van Nieuwenhoven and van Tiel), Julius Center for General Practice and Patient Oriented Research (Dr Buskens) and Department of Internal Medicine, Division of Infectious Diseases and AIDS (Dr Bonten), University Hospital Heidelberglaan, Utrecht, the Netherlands.

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RELATED LETTER

Influence of Methodological Quality on Study Conclusions
Alessandro Liberati, Roberto D'Amico, Luca Brazzi, Silvia Pifferi, Miguel Sánchez García, Jürgen Graf, Uwe Janssens, Kenneth F. Schulz, Willard Cates, Jr, Christianne A. van Nieuwenhoven, Frank H. van Tiel, Erik Buskens, and Marc J. M. Bonten
JAMA. 2001;286(20):2544-2547.
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