title: Designing randomized-controlled trials to improve head-louse treatment: systematic review using a vignette-based method.
abstract: Head-louse infestation remains a public health problem. Despite published randomized-controlled trials, no consensus-based clinical practice guidelines for its management emerged because of the heterogeneity of trial methodologies. Our study was undertaken to attempt to find an optimal trial framework: minimizing the risk of bias, while taking feasibility into account. To do so, we used the vignette-based method. A systematic review first identified trials on head-louse infestation; 49 were selected and their methodological constraints assessed. Methodological features were extracted and combined by arborescence to generate a broad spectrum of potential designs, called vignettes, yielding 357 vignettes. A panel of 48 experts then rated one-on-one comparisons of those vignettes to obtain a ranking of the designs. Methodological items retained for vignette generation were income level of the population, types of treatments compared, randomization unit, blinding, treatment-administration site, diagnosis method and criteria, and primary outcome measure. The expert panel selected vignettes with cluster randomization, centralized treatment administration, and blinding of the outcome assessor. The vignette method identified optimal designs to standardize future head-louse treatment trials, thereby obtaining valid conclusions and comparable data from future trials, and appears to be a reliable way to generate evidence-based guidelines.
authors.affiliation: Department of Dermatology, Groupe Hospitalier Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France; INSERM U738, Paris, France.
authors.forename: Giao
authors.initials: G
authors.lastname: Do-Pham
authors.affiliation: Department of Dermatology, Groupe Hospitalier Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Le Cleach
authors.affiliation: INSERM U738, Paris, France; Centre d'Investigation Clinique 202, INSERM Tours, Centre Hospitalier Régional Universitaire de Tours, Université François-Rabelais, Tours, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
authors.affiliation: Department of Dermatology, Centre Hospitalier Régional Universitaire de Tours, Université François-Rabelais, Tours, France.
authors.forename: Annabel
authors.initials: A
authors.lastname: Maruani
authors.affiliation: Department of Dermatology, Groupe Hospitalier Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France; Université Paris-Est Créteil, Créteil, France; French Cochrane Centre, Paris, France; Centre d'Investigation Clinique 006, INSERM Créteil, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chosidow
authors.affiliation: INSERM U738, Paris, France; Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, APHP Paris, France; Université Paris Descartes-Sorbonne Paris Cité, Paris, France; EHESP School of Public Health, Paris, France; Department of Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USA. Electronic address: philippe.ravaud@htd.aphp.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
mesh_terms: D000818:Animals; D015982:Bias; D019317:Evidence-Based Medicine / Q000379:methods* / Q000592:standards; D006801:Humans; D010373:Lice Infestations / Q000188:drug therapy*; D010374:Pediculus / Q000187:drug effects*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards