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. 2022 Apr 1;110(2):185-204.
doi: 10.5195/jmla.2022.1306.

Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies

Hiba El Masri  1 , Treasure M McGuire  2 , Christine Dalais  3 , Mieke van Driel  4 , Helen Benham  5 , Samantha A Hollingworth  6
Affiliations

Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies

Hiba El Masri et al. J Med Libr Assoc. .

Abstract

Introduction: Poor indexing and inconsistent use of terms and keywords may prevent efficient retrieval of studies on the patient-based benefit-risk assessment (BRA) of medicines. We aimed to develop and validate an objectively derived content search strategy containing generic search terms that can be adapted for any search for evidence on patient-based BRA of medicines for any therapeutic area.

Methods: We used a robust multistep process to develop and validate the content search strategy: (1) we developed a bank of search terms derived from screening studies on patient-based BRA of medicines in various therapeutic areas, (2) we refined the proposed content search strategy through an iterative process of testing sensitivity and precision of search terms, and (3) we validated the final search strategy in PubMed by firstly using multiple sclerosis as a case condition and secondly computing its relative performance versus a published systematic review on patient-based BRA of medicines in rheumatoid arthritis.

Results: We conceptualized a final search strategy to retrieve studies on patient-based BRA containing generic search terms grouped into two domains, namely the patient and the BRA of medicines (sensitivity 84%, specificity 99.4%, precision 20.7%). The relative performance of the content search strategy was 85.7% compared with a search from a published systematic review of patient preferences in the treatment of rheumatoid arthritis. We also developed a more extended filter, with a relative performance of 93.3% when compared with a search from a published systematic review of patient preferences in lung cancer.

Keywords: Medical Subject Headings; attribute development; benefit-risk assessment; bibliographic; databases; information storage and retrieval/methods; information storage and retrieval/standards; patient preference; patient-based benefit-risk assessment; prescription drug; reproducibility of results; risk assessment/methods; terminology as topic.

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Figures

Figure 1
Figure 1
Flow diagram depicting the iterative process of developing a search term bank, refining the search strategy, and then validating the final strategy
See this image and copyright information in PMC

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References

    1. Stowasser DA, Allinson YM, O'Leary M. Understanding the medicines management pathway. JPPR. 2004;34(4):293–6.
    1. Muhlbacher AC, Juhnke C, Beyer AR, Garner S. Patient-focused benefit-risk analysis to inform regulatory decisions: the European Union perspective. Value Health. 2016;19(6):734–40. - PubMed
    1. Curtin F, Schulz P. Assessing the benefit: risk ratio of a drug-randomized and naturalistic evidence. Dialogues Clin Neurosci. 2011;13(2):183–90. - PMC - PubMed
    1. Eichler HG, Abadie E, Raine JM, Salmonson T. Safe drugs and the cost of good intentions. N Engl J Med. 2009;360(14):1378–80. - PubMed
    1. Harrison M, Milbers K, Hudson M, Bansback N. Do patients and health care providers have discordant preferences about which aspects of treatments matter most? Evidence from a systematic review of discrete choice experiments. BMJ Open. 2017;7(5):e014719. - PMC - PubMed

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