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.
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
300
Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.
Chaozhou Maternal and Child Health Hospital
Chaozhou, Guangdong, China
RECRUITINGDongguan Maternal and Child Health Care Hospital
Dongguan, Guangdong, China
RECRUITINGSun Yat-sen memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGJiangmen Maternity and Child Health Care Hospital
Jiangmen, Guangdong, China
RECRUITINGShenshan Medical Center, Sun Yat-sen Memorial Hospital
Shanwei, Guangdong, China
RECRUITINGInter-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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 8 weeks
Correlation between the M-score and BISSI scores.
Examine the correlation between the M-score and BISSI scores.
Time frame: 8 weeks
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