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Updated: Jan 9, 2026

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Building process improvement capacity in epidemiologic research operations: The Nurses' Health Study experience.

Leanna Bassett1, Vedika Vilas Patankar2, Cizz-L N Lockhart2

  • 1Research Operations, Brigham and Women's Hospital, Boston, Massachusetts, United States.

Medrxiv : the Preprint Server for Health Sciences
|December 3, 2025
PubMed
Summary

Lean Six Sigma (LSS) training improved operational efficiency in large cohort studies. This initiative enhanced data quality and reduced turnaround times, supporting the sustainability of epidemiologic research platforms.

Keywords:
clinical researchcohortepidemiologylean six sigmaprocess improvementquality improvement

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Area of Science:

  • Epidemiology
  • Health Services Research
  • Operational Excellence

Background:

  • Large-scale epidemiologic cohort studies face declining infrastructure funding, necessitating continuous process improvement.
  • Sustaining research quality and impact requires modernizing operations and building internal capacity for efficiency.
  • The Nurses' Health Studies, a long-standing cohort, implemented a Lean Six Sigma initiative to address these challenges.

Purpose of the Study:

  • To modernize operations within the Nurses' Health Studies using Lean Six Sigma (LSS).
  • To build internal capacity for process improvement among operational staff.
  • To assess the adaptability and impact of LSS in non-clinical trial epidemiologic research.

Main Methods:

  • A structured Lean Six Sigma curriculum was delivered to twenty operational staff members.
  • Staff completed three data-driven improvement projects focusing on operational bottlenecks.
  • Outcomes measured included turnaround time, questionnaire deliverability, and maintenance efficiency.

Main Results:

  • Median turnaround time for medical record retrieval decreased by 90%.
  • The proportion of undeliverable questionnaires was reduced by 31%.
  • Biweekly freezer maintenance time was cut by 43 person-minutes per cycle, saving an estimated 6.5 person-weeks annually.

Conclusions:

  • Lean Six Sigma can be successfully adapted to improve efficiency and data quality in epidemiologic research.
  • The LSS training increased staff understanding and confidence in process improvement methods.
  • Broader adoption of continuous improvement efforts can enhance the sustainability of research platforms.