Principal investigator(s)
Fabio Efficace
GIMEMA
Rome, Italy
Project coordinator(s)
Francesco Sparano
GIMEMA
Rome, Italy

Project summary

The aim of the DIRECTORY project is to go beyond inspection of methodological issues of QoL implementation in RCTs, broadening the focus to include the identification of challenges related to interpretation of PRO data from RCTs, and the investigation of how authors “translate” (combined) clinical and PRO results into overall treatment recommendations. For this purpose, we are thus creating a large Data Repository of “traditional” clinical outcomes (e.g. overall survival, progression-free survival or clinical response) and PRO results across all cancer RCTs. We are also collecting data on the magnitude of these outcomes as well as other information on trial characteristics.

Achievements

We have screened 33528 abstracts and 2482 full-text articles, selecting a total of 593 RCTs on breast, lung, colorectal, prostate and gynecological cancers. Data extraction and statistical analysis for these diseases were completed.

Future plans

  • June 2018: statistical analyses.
  • September 2018: drafting of papers.

For patients

In recent years, patients’ evaluation of their own health status has become an important aspect, along with other clinical and laboratory data, to assess new cancer treatments. We aim to investigate if these two different type of “measurements” (clinical/laboratory data versus patients’ self-reported data) provide concordant (or discordant) information in the context of randomized controlled trials (RCTs). Also, we aim at examining how this information is translated into clinical recommendations by Investigators when summarizing findings from their RCTs.

Publications

  • Sparano F, Rees J, Blazeby J, Pezold M, Pusic A, Aaronson N, Sprangers M, Fayers P, Deliu N, Anota A, Efficace F, On behalf of GIMEMA and EORTC Quality of Life Group. Patient-Reported Outcomes (PROs) in Randomized Controlled Trials of Colorectal Cancer. Methodological Quality of Reporting Over Time. 24th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Philadelphia, USA. Quality of Life Research, 26(1):65 (abs.1051), 201
  • Efficace F, Aaronson N, Sparano F, Sprangers M, Fayers P, Pusic A, Anota A, Cottone F, Rees J, Deliu N, Piciocchi A, La Sala E, Haas A, Kieffer J, Wang W, Pezold M, Fuzesi S, Isharwal S, Yeung J, Wan C, Blazeby J, On behalf of GIMEMA and EORTC Quality of Life Group. Concordance between patient reported and clinical outcomes in randomized controlled trials (RCTs) of cancer treatment. 24th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Philadelphia, USA. Quality of Life Research, 26(1):103 (abs.2026), 2017
  • Efficace F, Aaronson N, Sparano F, Sprangers M, Fayers P, Pusic A, Haas A, Anota A, Cottone F, Deliu N, Rees J, Kieffer J, Wang W, Fuzesi S, Isharwal S, Yeung J, Wan C, Blazeby J, On behalf of GIMEMA and EORTC Quality of Life Group. Type and Magnitude of EORTC QLQ-C30 Outcomes in Cancer Clinical Trials. 24th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Philadelphia, USA. Quality of Life Research, 26(1):104 (abs.2030), 2017
  • Efficace F, Aaronson N, Sparano F, Sprangers M, Fayers P, Pusic A, Haas A, Piciocchi A, La Sala E, Anota A, Cottone F, Deliu N, Rees J, Kieffer J, Wang W, Pezold M, Fuzesi S, Isharwal S, Yeung J, Wan C, Blazeby J, On behalf of GIMEMA and EORTC Quality of Life Group. Quality of Patient-Reported Outcome (PRO) Reporting in Randomized Controlled Trials (RCTs) over time. Evidence from 480 RCTs from 2004 to 2016. 24th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Philadelphia, USA. Quality of Life Research, 26(1):139 (abs.3056), 2017