Granulomatous Mastitis, Mastitis Chronic
Conditions
Keywords
M-score, validity, reliability
Brief summary
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.
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.
Interventions
OTHERAny treatments regimen
Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater Reliability | 8 weeks | 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. |
| Test-Retest Reliability | 8 weeks | 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. |
| Clinical Validity | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the M-score/BISSI with laboratory indicators | 8 weeks | 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. |
| Cutoff value for M-score/BISSI to defined clinical complete remission. | 8 weeks | Investigate the optimal cutoff value of the M-score/BISSI for defining clinical complete remission. |
| Correlation between the M-score and BISSI scores. | 8 weeks | Examine the correlation between the M-score and BISSI scores. |
Countries
China
Outcome results
None listed