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

Sun Yat-sen University

Status: Enrolling

Conditions: Granulomatous Mastitis; Mastitis Chronic

Treatments: Other: Any treatments regimen

Study type: Observational

Funder types: Other

Identifiers

NCT06667609

SYSKY-2024-699-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

1

Description:

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.

Treatment:

Other: Any treatments regimen