title: Quantitative and qualitative assessment of real world data comparative effectiveness research of systemic therapies in lung oncology: A systematic review.
abstract: The growing interest in comparative effectiveness research (CER) based on data from routine clinical practice also extends towards lung oncology. Although CER studies using real world data (RWD) have the potential to assist clinical decision-making, concerns about the quality and validity of studies with observational data subsist. The primary objective of the present study is to assess the current status of observational CER in the field of lung oncology, both quantitatively as qualitatively.
  
  
  
  We performed a systematic electronic literature database search in MEDLINE and EMBASE (up to 1 July 2015). The quality of all selected studies was assessed according to the Good ReseArch for Comparative Effectiveness (GRACE) checklist.
  
  
  
  The first selection included 657 publications. After screening the corresponding abstracts and full-text papers, 38 studies remained. A total of 36 studies included patients with advanced NSCLC. The comparison of the effectiveness of gefitinib versus erlotinib was the main objective in 22% of the studies. The median number of patients per study was 202 (range 21-10064). The number of publications increased over the years whereas the quality score remained stable over the years with several common shortcomings (checklist items M5, D1, D4, D6).
  
  
  
  The growing interest in clinical oncology CER studies using RWD is reflected in an increasing number of publications in the recent years. The studies have several common methodological shortcomings possibly limiting their applicability in clinical decision-making. To fulfil the promise of RWD CER in lung oncology effort should be continued to overcome these shortcomings.
authors.affiliation: Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands; Department of Clinical Pharmacology and Pharmacy, VU University Medical Center, Amsterdam, The Netherlands. Electronic address: b.peters@antoniusziekenhuis.nl.
authors.forename: Bas J M
authors.initials: BJM
authors.lastname: Peters
authors.affiliation: Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands.
authors.forename: Vivi E M T
authors.initials: VEMT
authors.lastname: Janssen
authors.affiliation: Department of Pulmonary Diseases, St Antonius Hospital, Utrecht/Nieuwegein, The Netherlands.
authors.forename: Franz M
authors.initials: FM
authors.lastname: Schramel
authors.affiliation: Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands; Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Ewoudt M W
authors.initials: EMW
authors.lastname: van de Garde
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000628:therapy*
keywords: Comparative effectiveness research; Lung cancer; Lung oncology; Observational research; Real world data; Systematic review