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Protocol
14 July 2025

A protocol for three observational cohort studies evaluating adverse outcomes, excess costs and repeat procedures after surgery for breast cancer in the USA

Authors: Sam E Wing https://orcid.org/0000-0003-4393-966X [email protected], Yuki Liu https://orcid.org/0009-0006-7806-9325, Jonathan C Johnson, Kristin J Moore https://orcid.org/0000-0003-2179-6565, and Feibi Zheng https://orcid.org/0000-0001-7590-5566Author Info & Affiliations
Volume 14, Number 8
https://doi.org/10.57264/cer-2025-0013
PDFFormats

Abstract

Aim: Surgical therapy for early-stage breast cancer, including lumpectomy and mastectomy, are common treatments for early-stage breast cancer. Despite having favorable survival outcomes, these procedures can lead to repeat surgeries, adverse outcomes, excess costs and potentially aggressive resections. This is a protocol for a study aims to evaluate three main areas: the risk factors, costs and complications of re-operations following lumpectomy (‘Lumpectomy Cohort’), the identification of patients potentially overtreated with mastectomy (‘Mastectomy Cohort’) and the cost and healthcare resource utilization associated with nipple necrosis following nipple-sparing mastectomy (NSM) (‘Nipple Necrosis Cohort’). Materials & methods: A retrospective cohort analysis will be conducted using Optum’s de-identified Market Clarity Data (2007–2023), which integrates medical and pharmacy claims with electronic health records. Patients will be included based on specific procedure and diagnosis codes, with additional data extracted from unstructured clinical notes using natural language processing. The study will analyze patient demographics, baseline health, surgical details, and outcomes, including costs, complications, reoperations and mortality. Data will be analyzed descriptively, with Kaplan–Meier analyses for time-to-event outcomes and Wilcoxon Signed Rank tests for cost comparisons. Results: Preliminary cohorts are expected to include 26,472 lumpectomy patients, 16,836 mastectomy patients and 6828 NSM patients with 541 cases of nipple necrosis. Conclusion: This study will provide comprehensive insights into the patient journey – highlighting the costs and patient outcomes following lumpectomy, mastectomy and NSM – potentially guiding better clinical decision-making and resource allocation.

Plain language summary

What is this article about?

This article describes a plan for a study that looks at the outcomes and costs of different surgeries for early-stage breast cancer. It focuses on three main areas: the reasons and costs for needing more surgeries after a lumpectomy, identifying demographic and clinical profiles of patients undergoing mastectomies and the costs and problems related to nipple damage after nipple-sparing mastectomies.

What methodology will be followed?

The study will use past medical records and data from 2007 to 2023, utilizing information from medical insurance claims and electronic health records. The study will look at patient details, health status, surgery information and outcomes like costs and complications.

Why is this important?

We aim to provide a better understanding of the patient experience and identify areas where care can be improved for those undergoing breast cancer surgeries. By learning about the factors and costs associated with additional surgeries, aggressive resections and complications, the findings could help doctors make better decisions and use resources more effectively.

Supplementary Material

File (supplementary material.docx)

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