Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

Ann Oncol. 2016 Dec;27(12):2294-2299. doi: 10.1093/annonc/mdw422. Epub 2016 Sep 28.


Background: Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated.

Patients and methods: A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques.

Results: Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life.

Conclusion: A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials.

Keywords: German; PRO-CTCAE; cancer; patient-reported outcomes; questionnaire; validation.

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Female
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / drug therapy
  • Neoplasms / epidemiology*
  • Patient Outcome Assessment*
  • Quality of Life
  • Surveys and Questionnaires


  • Antineoplastic Agents