title: Research in Nursing and Nutrition: Is Randomized Clinical Trial the Actual Gold Standard?
abstract: The aim of this study was to assess the quality of reporting of nurse-driven randomized controlled trials involving a direct nutritional intervention. A bibliometric search for randomized controlled trials involving a direct nutritional intervention from 1991 to 2011 in nursing research was conducted. Both quality of the study and design aspects were evaluated. The prevalent randomized controlled trial design used is 2-arm parallel, individual, and randomized with a continuous primary endpoint. Global numbers of randomized controlled trials and the proportion of good-quality randomized controlled trials began a steady and marked rise, more than doubling, from the 1990s to about 2001 and increased slowly thereafter. Studies are overall sufficiently well designed, although there is still room for quality improvement. Additionally, implementation of new randomized controlled trial designs exists and should be advocated.
authors.affiliation: Ileana Baldi, PhD, is Assistant Professor of Medical Statistics, Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy. Nicola Soriani, PhD, is Research Assistant of Medical Statistics, Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy. Giulia Lorenzoni, RN, is Research Assistant of Medical Statistics, Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy. Danila Azzolina, BSc, is Research Assistant of Medical Statistics, Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy. Elisa Dal Lago, RN, is Nurse, Public Relations Office, General Direction Staff Unit, Santorso Hospital, Vicenza, Italy. Sara De Bardi, RN, is Nurse, Department of Cardiology, P. Cosma Hospital, Camposampiero, Italy. Elvira Verduci, CCN, is Assistant Professor of Pediatrics, Department of Pediatrics, San Paolo Hospital and University of Milano, Milan, Italy. Renzo Zanotti, PhD, is Associate Professor, Laboratory of Nursing Studies, Public Health Section, Department of Molecular Medicine, University of Padova, Padua, Italy. Dario Gregori, PhD, is Associate Professor of Medical Statistics, Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy.
authors.forename: Ileana
authors.initials: I
authors.lastname: Baldi
authors.forename: Nicola
authors.initials: N
authors.lastname: Soriani
authors.forename: Giulia
authors.initials: G
authors.lastname: Lorenzoni
authors.forename: Danila
authors.initials: D
authors.lastname: Azzolina
authors.forename: Elisa
authors.initials: E
authors.lastname: Dal Lago
authors.forename: Sara
authors.initials: S
authors.lastname: De Bardi
authors.forename: Elvira
authors.initials: E
authors.lastname: Verduci
authors.forename: Renzo
authors.initials: R
authors.lastname: Zanotti
authors.forename: Dario
authors.initials: D
authors.lastname: Gregori
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D015399:Nursing Research / Q000592:standards*; D015596:Nutrition Assessment; D009752:Nutritional Status; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012015:Reference Standards