title: Completeness of Outcomes Description Reported in Low Back Pain Rehabilitation Interventions: A Survey of 185 Randomized Trials.
abstract: Purpose:To assess reporting completeness of the most frequent outcome measures used in randomized controlled trials (RCTs) of rehabilitation interventions for mechanical low back pain.Methods:We performed a cross-sectional study of RCTs included in all Cochrane systematic reviews (SRs) published up to May 2013. Two authors independently evaluated the type and frequency of each outcome measure reported, the methods used to measure outcomes, the completeness of outcome reporting using a eight-item checklist, and the proportion of outcomes fully replicable by an independent assessor.Results:Our literature search identified 11 SRs, including 185 RCTs. Thirty-six different outcomes were investigated across all RCTs. The 2 most commonly reported outcomes were pain (n=165 RCTs; 89.2%) and disability (n=118 RCTs; 63.8%), which were assessed by 66 and 44 measurement tools, respectively. Pain and disability outcomes were found replicable in only 10.3% (n=17) and 10.2% (n=12) of the RCTs, respectively. Only 40 RCTs (21.6%) distinguished between primary and secondary outcomes.Conclusions:A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting an opportunity for a standardized approach to reporting in rehabilitation science.
authors.affiliation: Center of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano-Bicocca, Monza; Clinical Epidemiology Unit, IRCCS Orthopaedic Institute Galeazzi.
authors.forename: Silvia
authors.initials: S
authors.lastname: Gianola
authors.affiliation: Child and Adolescent Neuropsychiatric Unit, ASST Grande Ospedale Metropolitano Niguarda.
authors.forename: Pamela
authors.initials: P
authors.lastname: Frigerio
authors.affiliation: Kinematics and Robotics Laboratory, IRCCS Fondazione Ospedale San Camillo, Venice.
authors.forename: Michela
authors.initials: M
authors.lastname: Agostini
authors.affiliation: Physiotherapy Service, National Institute of Injury Insurance.
authors.forename: Rosa
authors.initials: R
authors.lastname: Bolotta
authors.affiliation: Clinical Epidemiology Unit, IRCCS Orthopaedic Institute Galeazzi; Department of Biomedical Sciences for Health, University of Milan.
authors.forename: Greta
authors.initials: G
authors.lastname: Castellini
authors.affiliation: Functional Recovery Unit, Ospedale San Raffaele, Milan.
authors.forename: Davide
authors.initials: D
authors.lastname: Corbetta
authors.affiliation: Department of Rehabilitation, Azienda sanitaria locale (Local Health Unit) Biella.
authors.forename: Monica
authors.initials: M
authors.lastname: Gasparini
authors.affiliation: APSS Tn, Villa Igea, Trento.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gozzer
authors.affiliation: La Quiete Casa di Cura, Varese, Italy.
authors.forename: Erica
authors.initials: E
authors.lastname: Guariento
authors.affiliation: Department of Physical Therapy, University of British Columbia; Arthritis Research Centre of Canada, Vancouver.
authors.forename: Linda C
authors.initials: LC
authors.lastname: Li
authors.affiliation: Child and Adolescent Neuropsychiatric Unit, ASST Grande Ospedale Metropolitano Niguarda.
authors.forename: Valentina
authors.initials: V
authors.lastname: Pecoraro
authors.affiliation: Functional Recovery Unit, Ospedale San Raffaele, Milan.
authors.forename: Valeria
authors.initials: V
authors.lastname: Sirtori
authors.affiliation: Kinematics and Robotics Laboratory, IRCCS Fondazione Ospedale San Camillo, Venice.
authors.forename: Andrea
authors.initials: A
authors.lastname: Turolla
authors.affiliation: Center of Biostatistics for Clinical Epidemiology, School of Medicine and Surgery, University of Milano-Bicocca, Monza.
authors.forename: Anita
authors.initials: A
authors.lastname: Andreano
authors.affiliation: Clinical Epidemiology Unit, IRCCS Orthopaedic Institute Galeazzi; Department of Biomedical Sciences for Health, University of Milan.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Moja
keywords: data reporting; low back pain; outcome measures; randomized controlled trials, as topic; rehabilitation; survey