345
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Sequential Monitoring Using the Second Generation P-Value with Type I Error Controlled by Monitoring Frequency

ORCID Icon, , &
Received 22 Apr 2022, Accepted 06 May 2024, Published online: 28 Jun 2024

References

  • Anderson, T. W. (1960), “A Modification of the Sequential Probability Ratio Test to Reduce the Sample Size,” The Annals of Mathematical Statistics, 101, 102505. DOI: 10.1214/aoms/1177705996.
  • Birnbaum, A. (1962), “On the Foundations of Statistical Inference,” Journal of the American Statistical Association, 57, 269–306. DOI: 10.1080/01621459.1962.10480660.
  • Blume, J. D., DAgostino McGowan, L., Dupont, W. D., and Greevy Jr., R. A. (2018), “Second-Generation P-Values: Improved Rigor, Reproducibility, & Transparency in Statistical Analyses,” PloS One, 13, e0188299. DOI: 10.1371/journal.pone.0188299.
  • Blume, J. D., Greevy, R. A., Welty, V. F., Smith, J. R., and Dupont, W. D. (2019), “An Introduction to Second-Generation p-Values,” The American Statistician, 73, 157–167. DOI: 10.1080/00031305.2018.1537893.
  • Freedman, L. S., Lowe, D., and Macaskill, P. (1984), “Stopping Rules for Clinical Trials Incorporating Clinical Opinion,” Biometrics, 40, 575–586.
  • Goodman, S. N., Zahurak, M. L., and Piantadosi, S. (1995), “Some Practical Improvements in the Continual Reassessment Method for Phase I Studies,” Statistics in Medicine, 14, 1149–1161. DOI: 10.1002/sim.4780141102.
  • Hobbs, B. P., and Carlin, B. P. (2008), “Practical Bayesian Design and Analysis for Drug and Device Clinical Trials,” Journal of Biopharmaceutical Statistics, 18, 54–80. DOI: 10.1080/10543400701668266.
  • Jennison, C., and Turnbull, B. W. (1989), “Interim Analyses: The Repeated Confidence Interval Approach,” Journal of the Royal Statistical Society, Series B, 51, 305–334. DOI: 10.1111/j.2517-6161.1989.tb01433.x.
  • Korn, E. L., Midthune, D., Chen, T. T., Rubinstein, L. V., Christian, M. C., and Simon, R. M. (1994), “A Comparison of Two Phase I Trial Designs,” Statistics in Medicine, 13, 1799–1806. DOI: 10.1002/sim.4780131802.
  • Kruschke, J. K. (2011), “Bayesian Assessment of Null Values via Parameter Estimation and Model Comparison,” Perspectives on Psychological Science, 6, 299–312. DOI: 10.1177/1745691611406925.
  • ——(2013), “Bayesian Estimation Supersedes the t test,” Journal of Experimental Psychology. General, 142, 573–603.
  • ——(2018), “Rejecting or Accepting Parameter Values in Bayesian Estimation,” Advances in Methods and Practices in Psychological Science, 1, 270–280. DOI: 10.1177/2515245918771304.
  • Mayberry, L. S., Berg, C. A., Greevy, R. A., Nelson, L. A., Bergner, E. M., Wallston, K. A., Harper, K. J., and Elasy, T. A. (2020), “Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults’ Type 2 Diabetes Self-Care,” Annals of Behavioral Medicine, 55, 165–178. DOI: 10.1093/abm/kaaa041.
  • Mayberry, L. S., Bergner, E. M., Harper, K. J., Laing, S., and Berg, C. A. (2019), “Text Messaging to Engage Friends/Family in Diabetes Self-Management Support: Acceptability and Potential to Address Disparities,” Journal of the American Medical Informatics Association, 26, 1099–1108. DOI: 10.1093/jamia/ocz091.
  • Nelson, L. A., Greevy, R. A., Spieker, A., Wallston, K. A., Elasy, T. A., Kripalani, S., Gentry, C., Bergner, E. M., LeStourgeon, L. M., Williamson, S. E., and Mayberry, L. S. (2021), “Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial,” Diabetes Care, 44, 26–34. DOI: 10.2337/dc20-0961.
  • Nelson, L. A., Wallston, K. A., Kripalani, S., Greevy Jr., R. A., Elasy, T. A., Bergner, E. M., Gentry, C. K., and Mayberry, L. S. (2018), “Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial,” JMIR Research Protocols, 7, e92. DOI: 10.2196/resprot.9443.
  • Royall, R. (1997), Statistical Evidence: A Likelihood Paradigm (Vol. 71), Boca Raton, FL: CRC Press.
  • Sirohi, D., Chipman, J., Barry, M., Albertson, D., Mahlow, J., Liu, T., Raps, E., Haaland, B., Sayegh, N., Li, H., Rathi, N., Sharma, P., Agarwal, N., and Knudsen, B. (2022), “Histologic Growth Patterns in Clear Cell Renal Cell Carcinoma Stratify Patients into Survival Risk Groups,” Clinical Genitourinary Cancer, 20, e233–e243. DOI: 10.1016/j.clgc.2022.01.005.
  • Stewart, T. G., and Blume, J. (2019), “Second-Generation p-values, Shrinkage, and Regularized Models,” Frontiers in Ecology and Evolution, 7, 486. DOI: 10.3389/fevo.2019.00486.
  • US Food and Drug Administration. (2010), Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials, Maryland: US Food and Drug Administration.
  • Wald, A. (1945), “Sequential Tests of Statistical Hypotheses,” The Annals of Mathematical Statistics, 16, 117–186. DOI: 10.1214/aoms/1177731118.
  • Zuo, Y., Stewart, T. G., and Blume, J. D. (2021), “Variable Selection With Second-Generation P-Values,” American Statistician, 76, 91–101. DOI: 10.1080/00031305.2021.1946150.