title: [Review of patient reported outcomes in the summary of the product characteristics of medicines approved in Spain].
abstract: BACKGROUND
  The term "Patient Reported Outcomes" (PRO) is defined as any result assessed directly by the patient and based on his perception of the illness and its treatment. The scope of the study is to determine and compare the use of PRO measures with other types of effectiveness endpoints in the summary of the products characteristics (SPC) of medicines with active substances approved by first time from 2000 to 2012 in Spain.
  
  
  METHODS
  A review and descriptive analysis of the effectiveness endpoints used in the clinical trials described in the SPCs studied, classifying them into the following categories: PRO, clinician-reported outcomes (CROs), and laboratory test/device measurement endpoints (ML). Chi-square and Fisher exact texts were used for comparative purposes, and odds ratio to determine the strongest of association.
  
  
  RESULTS
  PROs were included in 65 (19.7%) of the SPCs studied. CRO were the most frequently reported 188 (57%) cases, followed by ML:128 (38,7%). PROs were included as only effectiveness endpoint in 6 medicines. A growing trend toward statistical significance (R2=0.525; p=0.079) has been observed in reporting PROs during the period of time studied.
  
  
  CONCLUSIONS
  The use frequency of PRO in SPCs is clearly minor compared to other efficacy endpoints considered, being the difference significantly higher in case of its use as only efficacy endpoint. The therapeutic areas where PROs were most reported were nervous system medicines, immunologic system modulator medicines, respiratory system, muscle and skeleton system.
authors.forename: José Ignacio
authors.initials: JI
authors.lastname: Pueyo Velasco
authors.forename: Javier
authors.initials: J
authors.lastname: Rejas Gutiérrez
mesh_terms: D000328:Adult; D017277:Drug Approval; D006306:Health Surveys; D006801:Humans; D063868:Patient Outcome Assessment; D055553:Prescription Drugs / Q000627:therapeutic use*; D011788:Quality of Life; D013030:Spain; D016896:Treatment Outcome
chemical_list: D055553:Prescription Drugs