I-O Optimise: a novel multinational real-world research platform in thoracic malignancies

Our plain-English summary of I-O Optimise: a novel multinational real-world research platform in thoracic malignancies, by S. Ekman, F. Griesinger, P. Baas, et al (Future Oncology, 2019).

The study

• Authors: S. Ekman, F. Griesinger, P. Baas, D. Chao, C. Chouaid, J.C. O'Donnell, J.R. Penrod, M. Daumont, L. Lacoin, A. McKenney, M. Khovratovich, R.E. Munro, I. Durand-Zaleski, S.P. Johnsen
• Journal: Future Oncology
• Published: 2019;15(14):1551-1563
• Cited by: 27 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Aim: To describe I-O Optimise, a multinational program providing real-world insights into lung cancer management. Materials & methods: Real-world data source selection for I-O Optimise followed a structured approach focused on population coverage, key variable capture, continuous/consistent data availability, record duration and data latency, and database expertise. Results: As of 31 October 2018, seven real-world data sources were included in I-O Optimise, providing data on characteristics, treatment patterns and clinical outcomes from more than 45,000 patients/year with non-small-cell lung cancer, small-cell lung cancer and mesothelioma across Denmark, Norway, Portugal, Spain, Sweden and the UK. Conclusion: The ongoing I-O Optimise initiative has the potential to provide a broad, robust and dynamic research platform to continually address numerous research objectives in the lung cancer arena.

In plain English

This article described how I-O Optimise, a multinational research program sponsored by Bristol-Myers Squibb and run with IQVIA, was set up. It draws on existing hospital records and registries on lung cancer and mesothelioma. The article did not study asbestos exposure and reported no treatment or survival results. By 31 October 2018, 594 data sources had been considered. Of these, 173 were shortlisted and approached, and 36 were selected. Of the 29 that completed initial assessment, 12 went on to full assessment. Three linked Scandinavian sources also entered full assessment without an initial assessment, making 15 in total. Seven were included, covering Denmark, Norway, Portugal, Spain, Sweden and the UK. Together they provided data on more than 45,000 patients a year with non-small-cell lung cancer, small-cell lung cancer and mesothelioma. Six of the seven were judged suitable for mesothelioma, with average yearly new cases ranging from 47 to 355. The authors noted that not all sources capture every variable, and that the data cannot be fully merged because methods differ. The authors concluded that the platform can continually address numerous research objectives in lung cancer.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Methodology article describing how a multinational real-world data research platform was set up and how its data sources were selected; sponsored by Bristol-Myers Squibb, with IQVIA as facilitator
• Who was studied: Seven real-world data sources (hospital records, a hospital electronic case report form, and regional or national registries) covering patients with non-small-cell lung cancer, small-cell lung cancer and mesothelioma in Denmark, Norway, Portugal, Spain, Sweden and the UK, as of 31 October 2018
• Exposure: Not applicable: the article describes a data platform for lung cancer and mesothelioma care and does not study asbestos or any other exposure
• Main results:
  • Of 594 data sources considered, 173 were shortlisted and approached, and 36 were selected to take part in initial assessment
  • 29 data sources completed initial assessment, and 12 of them were selected for full assessment
  • Three linked Scandinavian sources were added to full assessment without initial assessment, giving 15 sources in full assessment
  • Seven of the 15 sources were included; 8 were still being assessed at the cut-off date
  • The seven sources together provide data on more than 45,000 patients a year with non-small-cell lung cancer, small-cell lung cancer and mesothelioma
  • Where available, the average number of new cases per year per source ranged from 435 to 30,900 for non-small-cell lung cancer and from 49 to 4262 for small-cell lung cancer
  • Six of the seven sources were judged suitable for mesothelioma, with averages of 47 to 355 new mesothelioma cases per year; the seventh had fewer than ten new cases a year
  • Data were available from 2005 onward, and the delay before data became available ranged from 24 hours to 13 months where known
  • All seven sources include information on overall survival
• The authors' conclusion: The authors concluded that I-O Optimise uses multiple real-world data sources to provide a broad, robust and dynamic research platform that can continually address numerous research objectives in lung cancer
• Limitations the authors state:
  • Not all data sources capture all variables of interest
  • Data across the sources cannot be fully merged because the sources use different methods
  • Information on adverse events may be missing from patient records and may be reported in inconsistent terms
  • None of the included sources were originally collecting health-related quality of life data
  • Actual cost data are likely to be limited
  • Incomplete or missing data and differences in methods are main concerns for studies that combine several data sources

Topics

Medical terms in this study, explained in our Lexicon: Lung Cancer, Latency, Mesothelioma.

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