title: Quality of reporting of chemotherapy compliance in randomized controlled trials of breast cancer treatment.
abstract: OBJECTIVE
  The Consolidated Standards of Reporting Trials statement requires detailed reporting of interventions for randomized controlled trials. We hypothesized that there was variable reporting of chemotherapy compliance in published randomized controlled trials in breast cancer, and therefore surveyed the literature to assess this parameter and determine the study characteristics associated with reporting quality.
  
  
  METHODS
  Published Phase III randomized controlled trials (January 2005-December 2011; English language) evaluating chemotherapy in breast cancer were identified through a systematic literature search. Articles scored 1 point each for reporting of the four measures: number of chemotherapy cycles, dose modification, early treatment discontinuation and relative dose intensity. Logistic regression identified study characteristics associated with reporting quality score of ≥ 2.
  
  
  RESULTS
  Of the 115 eligible randomized controlled trials, 79 (69%) were published in high-impact journals, 66 (57%) were published since 2008, 43 (37%) reported advanced-stage disease and 37 (32%) were industry sponsored. Relative dose intensity, number of cycles, dose modification and early treatment discontinuation were reported in 70 (61%), 53 (46%), 65 (57%) and 81 (70%) articles, respectively. Eighty-two (71%) articles showed a quality score of ≥ 2; 25 (22%) articles reported all four compliance measures. Articles published since 2008 (P = 0.035) and those reporting advanced-stage disease (P < 0.001) showed significantly higher quality of compliance.
  
  
  CONCLUSIONS
  Our results demonstrate variable reporting of chemotherapy compliance in published randomized controlled trials with a modest improvement noted in recent years. Incorporating standards for reporting chemotherapy compliance in scientific guidelines or the journal peer review process may decrease the variability and improve the quality of reporting.
authors.affiliation: Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia drtwairqi@hotmail.com aaltwairqi@kfmc.med.sa.
authors.forename: Abdullah K
authors.initials: AK
authors.lastname: Altwairgi
authors.affiliation: Comprehensive Cancer Center, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Ali H
authors.initials: AH
authors.lastname: Alfakeeh
authors.affiliation: Department of Community Health and Epidemiology, Queen's University, Kingston.
authors.forename: Wilma M
authors.initials: WM
authors.lastname: Hopman
authors.affiliation: NCIC Clinical Trials Group, Queen's University, Kingston, Canada.
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Parulekar
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic / Q000592:standards*; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D058028:Research Report / Q000592:standards*; D016903:Drug Monitoring
chemical_list: D000970:Antineoplastic Agents
keywords: breast cancer; chemotherapy compliance; randomized controlled trials; review