title: Differences between the real and the desired worlds in the results of clinical trials.
abstract: OBJECTIVE
  We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification.
  
  
  METHODS
  A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy (<25), moderate efficacy (25-50), moderate effectiveness (51-75), and high effectiveness (<75).
  
  
  RESULTS
  A total of 844 randomized trials were analyzed. No analyzed trials used the criteria proposed by the indicator summary tool. Approximately 44% of the trials were classified as having moderate effectiveness, and 43.82% were classified as having moderate efficacy.
  
  
  CONCLUSIONS
  Most clinical trials used the term "efficacy" to illustrate the application of results in clinical practice, but the majority of those were classified as having moderate effectiveness according to our proposed score. The classification based on the 0-100 score is still highly subjective and can be easily misunderstood in all domains based on each investigator's own experiences and knowledge.
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Regina
authors.initials: R
authors.lastname: El Dib
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Eliane Chaves
authors.initials: EC
authors.lastname: Jorge
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Amélia
authors.initials: A
authors.lastname: Kamegasawa
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Solange Ramires
authors.initials: SR
authors.lastname: Daher
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Regina Stella
authors.initials: RS
authors.lastname: Spagnuolo
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Marise Pereira da
authors.initials: MP
authors.lastname: Silva
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Gabriel Pereira
authors.initials: GP
authors.lastname: Braga
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Enilze
authors.initials: E
authors.lastname: Volpato
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Norma Sueli Pinheiro
authors.initials: NS
authors.lastname: Módolo
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Marluci
authors.initials: M
authors.lastname: Betini
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Adriana do
authors.initials: Ad
authors.lastname: Valle
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Ione
authors.initials: I
authors.lastname: Corrêa
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Bazan
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Ricardo Augusto M B
authors.initials: RA
authors.lastname: Almeida
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Silke Anna Theresa
authors.initials: SA
authors.lastname: Weber
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Silvana
authors.initials: S
authors.lastname: Molina
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Hugo
authors.initials: H
authors.lastname: Yoo
authors.affiliation: Faculdade de Medicina, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: Paulo
authors.initials: P
authors.lastname: Villas Boas
authors.affiliation: Bioscience Institute, Biostatistics Department, Universidade Estadual Paulista, Botucatu/SP, BR.
authors.forename: José Eduardo
authors.initials: JE
authors.lastname: Corrente
authors.forename: Joseph
authors.initials: J
authors.lastname: Mathew
authors.forename: Anil
authors.initials: A
authors.lastname: Kapoor
authors.forename: Raíssa
authors.initials: R
authors.lastname: Carvalho
authors.forename: Roberto Bezerra
authors.initials: RB
authors.lastname: Vital
authors.forename: Leandro Gobbo
authors.initials: LG
authors.lastname: Braz
authors.forename: Paulo do Nascimento
authors.initials: Pdo N
authors.lastname: Junior
mesh_terms: D015706:Bibliometrics; D002986:Clinical Trials as Topic / Q000145:classification; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000145:classification / Q000706:statistics & numerical data*; D012107:Research Design; D016896:Treatment Outcome