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Update information

Update information

Minor changes since publication

March 2024:

  • We added information about external validity bias to the section on risk of bias.

  • We added a passage describing approaches for sampling in new studies requiring primary data collection.

  • We added a new section on assessing external validity bias and adjusting for differences between the study sample and the target population.

July 2023:

  • We updated links to recent case studies in the section on use of real-world evidence in NICE guidance.

  • We added a link to the HARmonized Protocol Template to Enhance Reproducibility (HARPER) tool for protocol design in the section on conduct of quantitative real-world evidence studies.

  • We added clarifying information on:

    • searching for fit-for-purpose data in the section on conduct of quantitative real-world evidence studies

    • federated data networks and how they relate to common data models in the section on assessing data suitability

    • describing the uses of instrument-based approaches and quasi-experimental studies and a correction around measurement error for risk ratios and rate ratios in the section on methods for real-world studies of comparative effects.

  • We updated links to NICE Decision Support Unit reports.

  • We updated the link to the hospital episode statistics GDPR webpage in appendix 1.

  • We updated appendix 3 to provide additional information on reporting quasi-experimental studies.

We made minor changes to style and language throughout without changing the meaning.

ISBN: 978-1-4731-4640-2