Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis

The purpose of this study is to evaluate the validity and reliability of the Mastitis-score (M-score) and the Breast Inflammatory Symptom Severity Index (BISSI) as measures for assessing symptom severity in non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). This research aims to provide a valid and reliable tool for evaluating both symptom severity and treatment efficacy in NL-GLM/PDM.

Study Overview

• Status: Active, not recruiting
• Conditions: Granulomatous Mastitis; Mastitis Chronic
• Intervention / Treatment: Other: Any treatments regimen

Detailed Description

Non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM) are inflammatory breast diseases with unclear etiology, usually manifested as palpable breast mass, accompanied by breast pain and abscesses, erythema or fistula formation. There is no well-recognized assessment tool for evaluating the symptom severity and treatment efficacy of NL-GLM/PDM. In our previous studies with NL-GLM, we used the Mastitis-score (M-score) as a physician-directed measure of the symptom severity. However, there were no patient-reported outcome measure for NL-GLM/PDM. The Breast Inflammatory Symptom Severity Index(BISSI) was reported as a valid patient-reported outcome measure for lactational mastitis. Its clinical validity as a measure of Symptom Severity for NL-GLM/PDM are still unclear.

In this multicenter, prospective cohort study, we will validate the validity and reliability of the M-score, a physician-directed measure, and the Breast Inflammatory Symptom Severity Index (BISSI), a patient-reported outcome (PRO) measure, for assessing symptom severity in patients with non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). Establishing the validity of these two approaches will facilitate the objective measurement of treatment efficacy for NL-GLM/PDM in the future.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Chaozhou, Guangdong, China, 521000
      • Chaozhou Maternal and Child Health Hospital
    • Dongguan, Guangdong, China, 523000
      • Dongguan Maternal and Child Health Care Hospital
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Jiangmen, Guangdong, China, 529051
      • Jiangmen Maternity and Child Health Care Hospital
    • Shanwei, Guangdong, China, 516600
      • Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female diagnosed with NL-GLM/PDM in China

Description

Inclusion Criteria:

1. Female, age between 18 and 65 years;
2. Clinically considered as Non-Lactational mastitis;
3. Clinically and Pathologically confirmed NL-GLM/PDM;
4. Patients planning to receive treatment or observation alone;
5. Signed the informed consent form

Exclusion Criteria:

1. Patients with confirmed or suspected malignant breast tumors
2. Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
3. Pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; This is an observational study with no predefined treatments for the enrolled patients. Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.	Other: Any treatments regimen; Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.; Other Names: Corticosteroids; Surgery; Ductal lavage; Anti-TB treatments; Observations; Aspirations; Immuno-suppression medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater Reliability	This assesses the consistency of results from different evaluators regarding the various dimensions of the Mscore and the total M-score for the same patients at the same time.	8 weeks
Test-Retest Reliability	This assesses the consistency of the M-score/BISSI results for the same patient at different times (within 1 week after enrollment), prior to treatment initiation and when symptoms have not changed significantly.	8 weeks
Clinical Validity	This aims to estimate the correlation between the M-score/BISSI and its changes, and the BISSI and its changes, with traditional evaluator assessments or traditional patient self-assessments of treatment efficacy and its changes.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the M-score/BISSI with laboratory indicators	Explore the correlation between the M-score/BISSI with white blood cell counts, neutrophil counts, lymphocyte counts, neutrophil/lympocyte ratio, CRP, ESR, TNF-alpha, and IL-6.	8 weeks
Cutoff value for M-score/BISSI to defined clinical complete remission.	Investigate the optimal cutoff value of the M-score/BISSI for defining clinical complete remission.	8 weeks
Correlation between the M-score and BISSI scores.	Examine the correlation between the M-score and BISSI scores.	8 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

General Publications

• Heron E, McArdle A, Karim MN, Cooper M, Geddes D, McKenna L. Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions. PeerJ. 2021 Nov 16;9:e12439. doi: 10.7717/peerj.12439. eCollection 2021.
• Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: validity; reliability; M-score
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Skin Diseases; Breast Diseases; Puerperal Disorders; Skin and Connective Tissue Diseases; Mastitis; Granulomatous Mastitis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Surgical Procedures, Operative; Watchful Waiting; Adrenal Cortex Hormones
• Other Study ID Numbers: SYSKY-2024-699-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If the study can be completed and the data have been collected, sharing IPD with the approval from the administrator would be feasible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No