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Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability

Oke Gerke1,2, Mie H Vilstrup3, Ulrich Halekoh4

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Group-sequential testing can help stop diagnostic trials early, saving time and resources. This method is effective for quantitative FDG-PET/CT studies, but requires careful planning and adequate sample sizes.

Keywords:
AgreementBland-Altman plotRepeatabilityReproducibilitySample size

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Area of Science:

  • Medical Imaging
  • Biostatistics
  • Oncology

Background:

  • Group-sequential testing is underutilized in diagnostic research despite its potential for efficiency.
  • Quantitative FDG-PET/CT (Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography) measurements are crucial in oncology.
  • Intra-observer variability studies are essential for reliable diagnostic test interpretation.

Purpose of the Study:

  • To demonstrate a group-sequential analysis strategy for quantitative FDG-PET/CT measurements in an intra-observer study.
  • To explore the potential for early trial termination and associated time and resource savings.
  • To evaluate the feasibility of group-sequential testing in diagnostic accuracy and agreement studies.

Main Methods:

  • Analyzed SUVmax (Standardized Uptake Value maximum) differences from preoperative FDG-PET/CTs in 45 ovarian cancer patients.
  • Applied sequential one-sided hypothesis tests on the standard deviation of SUVmax differences using an alpha spending function.
  • Compared fixed-sample analysis with group-sequential strategies involving one, two, or three interim analyses.

Main Results:

  • Sufficient agreement was concluded early when interim analyses were performed at one-third and two-thirds of the patient sample.
  • Other interim analysis schedules did not support early stopping due to an influential outlier and small sample size.
  • Group-sequential analysis demonstrated potential for early trial cessation under specific conditions.

Conclusions:

  • Group-sequential testing can facilitate early trial termination, leading to significant time and resource savings.
  • Robustness against outliers and reliable conclusions necessitate pre-defined testing strategies and sufficiently large interim sample sizes.
  • Group-sequential methods are applicable and potentially beneficial for diagnostic accuracy and agreement studies.