Evidence map›Paper›PMID 30204252›Full record

ArticleClinical pharmacology and therapeutics2019

Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs.

Emily A F Holmes, Catrin Plumpton, Gus A Baker, Ann Jacoby, Adele Ring, Paula Williamson, Anthony Marson, Dyfrig A Hughes

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Benefit-risk evaluation: the past, present and future.Therapeutic advances in drug safety · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Emily A F HolmesCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.
Catrin PlumptonCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.
Gus A BakerDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Ann JacobyDepartment of Public Health and Policy, University of Liverpool, Liverpool, UK.
Adele RingInstitute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Paula WilliamsonMedical Research Council North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.
Anthony MarsonDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Dyfrig A HughesCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.

Funding

Department of Health PB-PG-0909-20161Medical Research Council MR/K025635/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2
6 · The paper itself

Abstract

Regulatory decisions may be enhanced by incorporating patient preferences for drug benefit and harms. This study demonstrates a method of weighting clinical evidence by patients' benefit-risk preferences. Preference weights, derived from discrete choice experiments, were applied to clinical trial data to estimate the expected utility of alternative drugs. In a case study, the rank ordering of antiepileptic drugs (AEDs), as indicated from clinical studies, was compared with ordering based on weighting clinical evidence by patients' preferences. A statistically significant change in rank ordering of AEDs was observed for women of childbearing potential who were prescribed monotherapy for generalized or unclassified epilepsy. Rank ordering inferred from trial data, valproate > topiramate > lamotrigine, was reversed. Modeling the expected utility of drugs might address the need to use more systematic, methodologically sound approaches to collect patient input that can further inform regulatory decision making.

Indexed as

AdolescentAdultAgedAnticonvulsantsDrug DevelopmentFemaleFocus GroupsHumansMaleMiddle AgedPatient-Centered CareQualitative ResearchRisk AssessmentSeizuresYoung AdultAnticonvulsants

Identifiers

PMID30204252
PMCPMC6491963

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.