The purpose of this study is to evaluate the validity and reliability of theMastitis-score (M-score) and the Breast Inflammatory Symptom Severity Index (BISSI) asmeasures for assessing symptom severity in non-lactational granulomatouslobular/periductal mastitis (NL-GLM/PDM). This research aims to provide a valid andreliable tool for evaluating both symptom severity and treatment efficacy in NL-GLM/PDM.
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.
Other: Any treatments regimen
Participants may receive any treatments in accordance with standard clinical practice,
based on physicians' recommendations and patients' preferences.
Other Name: Surgery,Corticosteroids,Ductal lavage,Anti-TB treatments,Observations,Aspirations,Immuno-suppression medications
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.
Chaozhou Maternal and Child Health Hospital
Chaozhou, Guangdong, China
Sun Yat-sen memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Jiangmen Maternity and Child Health Care Hospital
Jiangmen, Guangdong, China
Kai Chen
86-20-34070463
chenkai23@mail.sysu.edu.cn
Not Provided