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 1815395, Guangdong 1809935, China
Dongguan Maternal and Child Health Care Hospital
Dongguan 1812545, Guangdong 1809935, China
Sun Yat-sen memorial Hospital, Sun Yat-sen University
Guangzhou 1809858, Guangdong 1809935, China
Jiangmen Maternity and Child Health Care Hospital
Jiangmen 1806299, Guangdong 1809935, China
Shenshan Medical Center, Sun Yat-sen Memorial Hospital
Shanwei 1795928, Guangdong 1809935, China
Kai Chen
86-20-34070463
chenkai23@mail.sysu.edu.cn
Not Provided