title: A new method to facilitate valid and consistent grading cardiac events in childhood cancer survivors using medical records.
abstract: BACKGROUND
  Cardiac events (CEs) are among the most serious late effects following childhood cancer treatment. To establish accurate risk estimates for the occurrence of CEs it is essential that they are graded in a valid and consistent manner, especially for international studies. We therefore developed a data-extraction form and a set of flowcharts to grade CEs and tested the validity and consistency of this approach in a series of patients.
  
  
  METHODS
  The Common Terminology Criteria for Adverse Events version 3.0 and 4.0 were used to define the CEs. Forty patients were randomly selected from a cohort of 72 subjects with known CEs that had been graded by a physician for an earlier study. To establish whether the new method was valid for appropriate grading, a non-physician graded the CEs by using the new method. To evaluate consistency of the grading, the same charts were graded again by two other non-physicians, one with receiving brief introduction and one with receiving extensive training on the new method. We calculated weighted Kappa statistics to quantify inter-observer agreement.
  
  
  RESULTS
  The inter-observer agreement was 0.92 (95% CI 0.80-1.00) for validity, and 0.88 (0.79-0.98) and 0.99 (0.96-1.00) for consistency with the outcome assessors who had the brief introduction and the extensive training, respectively.
  
  
  CONCLUSIONS
  The newly developed standardized method to grade CEs using data from medical records has shown excellent validity and consistency. The study showed that the method can be correctly applied by researchers without a medical background, provided that they receive adequate training.
authors.affiliation: Department of Pediatric Oncology, Emma Children's Hospital/Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
authors.forename: Elizabeth Lieke A M
authors.initials: EL
authors.lastname: Feijen
authors.affiliation: Department of Oncology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
authors.forename: Helena J
authors.initials: HJ
authors.lastname: van der Pal
authors.affiliation: Department of Pediatric Oncology, Emma Children's Hospital/Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
authors.forename: Elvira C
authors.initials: EC
authors.lastname: van Dalen
authors.affiliation: Department of Pediatric Oncology, Emma Children's Hospital/Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
authors.forename: Renee L
authors.initials: RL
authors.lastname: Mulder
authors.affiliation: 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary.
authors.forename: Edit
authors.initials: E
authors.lastname: Bardi
authors.affiliation: Department of Pediatric Oncology, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors.forename: Claudia
authors.initials: C
authors.lastname: Kuehni
authors.affiliation: Department of Pediatric Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Wim J E
authors.initials: WJ
authors.lastname: Tissing
authors.affiliation: Department of Pediatric Oncology, Emma Children's Hospital/Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
authors.forename: Leontine C M
authors.initials: LC
authors.lastname: Kremer
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D066126:Cardiotoxicity / Q000175:diagnosis; D002648:Child; D002675:Child, Preschool; D005260:Female; D006333:Heart Failure / Q000139:chemically induced / Q000175:diagnosis*; D006801:Humans; D007223:Infant; D008297:Male; D009369:Neoplasms / Q000628:therapy*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D017741:Survivors
chemical_list: D000970:Antineoplastic Agents