title: Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial.
abstract: Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge.
  
  
  
  The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle.
  
  
  
  The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care.
  
  
  
  ClinicalTrials.gov, NCT02645357.
authors.affiliation: Department of Biomedical Sciences for Health, University of Milan, Via Pascal 36, 20133, Milan, Italy. lorenzo.moja@unimi.it.|Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy. lorenzo.moja@unimi.it.
authors.forename: Lorenzo
authors.identifier: 0000-0001-6680-6507
authors.initials: L
authors.lastname: Moja
authors.affiliation: Medical Oncology Unit, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Passardi
authors.affiliation: School of Specialization in Hygiene and Preventive Medicine, University of Milan, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Capobussi
authors.affiliation: IRCCS Mario Negri Institute for Pharmacological Research, Via La Masa 19, 20156, Milan, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Banzi
authors.affiliation: Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ruggiero
authors.affiliation: Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy.
authors.forename: Koren
authors.initials: K
authors.lastname: Kwag
authors.affiliation: Cambridge Centre for Health Services Research (CCHSR), Department of Public Health and Primary Care, Cambridge Institute of Public Health, Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK.
authors.forename: Elisa Giulia
authors.initials: EG
authors.lastname: Liberati
authors.affiliation: Medilogy Srl, Viale Monza 133, 20125, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Mangia
authors.affiliation: Duodecim Medical Publications Ltd, Kaivokatu 10 A, 00101, Helsinki, Finland.
authors.forename: Ilkka
authors.initials: I
authors.lastname: Kunnamo
authors.affiliation: IRCCS Mario Negri Institute for Pharmacological Research, Via La Masa 19, 20156, Milan, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Cinquini
authors.affiliation: Medical Oncology Unit, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Vespignani
authors.affiliation: Medical Oncology Unit, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
authors.forename: Americo
authors.initials: A
authors.lastname: Colamartini
authors.affiliation: Medical Oncology Unit, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Di Iorio
authors.affiliation: Medical Oncology Unit, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Massa
authors.affiliation: Department of Biomedical Sciences for Health, University of Milan, Via Pascal 36, 20133, Milan, Italy.|Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Via Galeazzi 4, 20161, Milan, Italy.
authors.forename: Marien
authors.initials: M
authors.lastname: González-Lorenzo
authors.affiliation: School of Specialization in Hygiene and Preventive Medicine, University of Milan, Milan, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Bertizzolo
authors.affiliation: Duodecim Medical Publications Ltd, Kaivokatu 10 A, 00101, Helsinki, Finland.
authors.forename: Peter
authors.initials: P
authors.lastname: Nyberg
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute and Department of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8 L6, Canada.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Grimshaw
authors.affiliation: Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
authors.forename: Stefanos
authors.initials: S
authors.lastname: Bonovas
authors.affiliation: Medical Oncology Unit, IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
authors.forename: Oriana
authors.initials: O
authors.lastname: Nanni
mesh_terms: D020000:Decision Support Systems, Clinical; D057286:Electronic Health Records; D019317:Evidence-Based Medicine / Q000379:methods*; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design
keywords: Computerized decision support systems; Electronic health records; Electronic patient records; Evidence-based medicine; Oncology; Pragmatic trial; Randomized controlled trial; Reminder systems