IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v44y2021i10d10.1007_s40264-021-01079-7.html
   My bibliography  Save this article

Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines

Author

Listed:
  • Daniel Eek

    (AstraZeneca Gothenburg)

  • Katarina Halling

    (AstraZeneca Gothenburg)

  • Emuella Flood

    (AstraZeneca Gaithersburg)

  • Matthew Blowfield

    (IQVIA)

  • Oren Meyers

    (IQVIA Inc)

  • Meredith Venerus

    (IQVIA)

  • Jean Paty

    (IQVIA Inc)

  • Richard Hermann

    (AstraZeneca Gaithersburg)

Abstract

Introduction There is a need to understand how patients assess perceived benefits and risks of treatments. Objectives The study aimed to (i) elucidate how patients evaluate treatment experiences and (ii) develop a brief patient-reported outcome (PRO) instrument for use across disease areas for perceived benefit–risk evaluation of a new medicine in a clinical trial setting. Methods Concepts relating to patient-perceived benefit–risk were identified from literature reviews and qualitative concept elicitation interviews with patients across a variety of primary medical conditions. Draft instrument items were developed from identified concepts and evaluated for clarity, relevance and appropriateness of response options in cognitive interviews. Items were iteratively revised to address patient feedback. Results Qualitative interviews were conducted with 47 patients (primary condition: 20 oncological, 12 respiratory, 10 metabolic, 5 cardiovascular), of whom 32 contributed to concept elicitation and 42 to cognitive debriefing. Elicited concepts could be grouped into four medication-related categories: effectiveness of treatment, burden of side effects, convenience of use and overall acceptance/satisfaction. Cost, trial experience and altruism were additional concept categories unrelated to medication. The final instrument contained one item each on the medication’s effectiveness, side effects and convenience, and an overall item capturing patient benefit–risk assessment. An upfront question was included to separate out non-medication aspects of patients’ experiences. Conclusion We developed a brief PRO instrument, the Patient Global Impression of Benefit–Risk (PGI-BR), which can be applied across disease areas to assess patient views of benefit–risk of a new medicine in the clinical trial setting.

Suggested Citation

  • Daniel Eek & Katarina Halling & Emuella Flood & Matthew Blowfield & Oren Meyers & Meredith Venerus & Jean Paty & Richard Hermann, 2021. "Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines," Drug Safety, Springer, vol. 44(10), pages 1059-1072, October.
  • Handle: RePEc:spr:drugsa:v:44:y:2021:i:10:d:10.1007_s40264-021-01079-7
    DOI: 10.1007/s40264-021-01079-7
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-021-01079-7
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.

    File URL: https://libkey.io/10.1007/s40264-021-01079-7?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Adam Gater & Matthew Reaney & Amy Findley & Catherine Brun-Strang & Kate Burrows & My-Liên Nguyên-Pascal & Aude Roborel de Climens, 2020. "Development and First Use of the Patient’s Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit–Harm of Drugs Received During Clinical," Drug Safety, Springer, vol. 43(2), pages 119-134, February.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Renly Lim & Lisa Kalisch Ellett & Elizabeth E. Roughead & Phaik Yeong Cheah & Nashwa Masnoon, 2021. "Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review," IJERPH, MDPI, vol. 18(22), pages 1-17, November.
    2. Matthew Reaney & Jennifer Cline & James C. Wilson & Michael Posey, 2021. "Generating Relevant Information from Patients in the Technology-Enhanced Era of Patient-Focused Drug Development: Opportunities and Challenges," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 14(1), pages 11-16, January.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:44:y:2021:i:10:d:10.1007_s40264-021-01079-7. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.