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The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database.

Publication ,  Journal Article
Maynard, C; Selker, HP; Beshansky, JR; Griffith, JL; Schmid, CH; Califf, RM; D'Agostino, RB; Laks, MM; Lee, KL; Wagner, GS
Published in: Med Decis Making
1995

The thrombolytic predictive instrument (TPI) was developed to identify those patients most likely to benefit from thrombolytic therapy for acute myocardial infarction as well as to facilitate the earliest possible administration of this treatment. The TPI consists of predictive models derived from clinical data obtained from both clinical trials and data registries. These models are subject to potential bias due to combinations of primary data from different sources. The purpose of this investigation was to assess the influence of gender in developing the TPI database. In this database, there were 1,096 (22%) women and 3,826 (78%) men; only 38% of the women were enrolled in clinical trials, whereas 46% of the men were (p < 0.0001). Within clinical trials, there were few significant eligibility differences between women and men, as the vast majority of patients met eligibility standards for entry in these trials. However, within clinical registries, the women were older (p < 0.0001) and more often had elevated blood pressure on admission (p = 0.002). Multivariate logistic regression indicated that after adjustment for significant predictors of trial inclusion, women were 25% less likely to be included in clinical trials (odds ratio = 0.76, 95% confidence interval = 0.60, 0.96). In order to counter bias introduced by the exclusion of women from clinical trials, the TPI database included patients from non-trial settings. Carefully including patients from clinical registries or non-trial settings may be an important strategy in constructing generally applicable predictive instruments.

Duke Scholars

Published In

Med Decis Making

DOI

ISSN

0272-989X

Publication Date

1995

Volume

15

Issue

1

Start / End Page

38 / 43

Location

United States

Related Subject Headings

  • Women's Health
  • Thrombolytic Therapy
  • Sex Factors
  • Selection Bias
  • Research Design
  • Registries
  • Predictive Value of Tests
  • Patient Selection
  • Myocardial Infarction
  • Multivariate Analysis
 

Citation

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Maynard, C., Selker, H. P., Beshansky, J. R., Griffith, J. L., Schmid, C. H., Califf, R. M., … Wagner, G. S. (1995). The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database. Med Decis Making, 15(1), 38–43. https://doi.org/10.1177/0272989X9501500107
Maynard, C., H. P. Selker, J. R. Beshansky, J. L. Griffith, C. H. Schmid, R. M. Califf, R. B. D’Agostino, M. M. Laks, K. L. Lee, and G. S. Wagner. “The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database.Med Decis Making 15, no. 1 (1995): 38–43. https://doi.org/10.1177/0272989X9501500107.
Maynard C, Selker HP, Beshansky JR, Griffith JL, Schmid CH, Califf RM, et al. The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database. Med Decis Making. 1995;15(1):38–43.
Maynard, C., et al. “The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database.Med Decis Making, vol. 15, no. 1, 1995, pp. 38–43. Pubmed, doi:10.1177/0272989X9501500107.
Maynard C, Selker HP, Beshansky JR, Griffith JL, Schmid CH, Califf RM, D’Agostino RB, Laks MM, Lee KL, Wagner GS. The exclusion of women from clinical trials of thrombolytic therapy: implications for developing the thrombolytic predictive instrument database. Med Decis Making. 1995;15(1):38–43.
Journal cover image

Published In

Med Decis Making

DOI

ISSN

0272-989X

Publication Date

1995

Volume

15

Issue

1

Start / End Page

38 / 43

Location

United States

Related Subject Headings

  • Women's Health
  • Thrombolytic Therapy
  • Sex Factors
  • Selection Bias
  • Research Design
  • Registries
  • Predictive Value of Tests
  • Patient Selection
  • Myocardial Infarction
  • Multivariate Analysis