Abstract
Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. We performed a meta-epidemiological study. We systematically reviewed meta- analyses including both split-mouth and parallel-arm RCTs with binary or continuous outcomes published up to February 2013. Two independent authors selected studies and extracted data. We used a two-step approach to quantify the differences between split-mouth and parallel-arm RCTs: for each meta-analysis. First, we derived ratios of odds ratios (ROR) for dichotomous data and differences in standardized mean differences (∆SMD) for continuous data; second, we pooled RORs or ∆SMDs across meta-analyses by random-effects meta-analysis models. We selected 18 systematic reviews, for 15 meta-analyses with binary outcomes (28 split-mouth and 28 parallel-arm RCTs) and 19 meta-analyses with continuous outcomes (28 split-mouth and 28 parallel-arm RCTs). Effect estimates did not differ between split-mouth and parallel-arm RCTs (mean ROR, 0.96, 95% confidence interval 0.52–1.80; mean ∆SMD, 0.08, -0.14–0.30). Our study did not provide sufficient evidence for a difference in intervention effect estimates derived from split-mouth and parallel-arm RCTs. Authors should consider including split-mouth RCTs in their meta-analyses with suitable and appropriate analysis.
Highlights
Erratum The original version of this article contained a mistake in the Abstract
* Correspondence: violaine.smail-faugeron@parisdescartes.fr 1Institut National de la Santé et de la Recherche Médicale, U1138, Equipe 22, Centre de Recherche des Cordeliers, Paris, France 2Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Service d’Odontologie, Paris, France Full list of author information is available at the end of the article
Summary
Erratum The original version of this article contained a mistake in the Abstract. Erratum to: “Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study”
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