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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any treatments regimen | Other | Participants may receive any treatments in accordance with standard clinical practice, based on physicians' recommendations and patients' preferences. |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-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. | 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. | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Cutoff value for M-score/BISSI to defined clinical complete remission. |
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Inclusion Criteria:
Exclusion Criteria:
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Female diagnosed with NL-GLM/PDM in China
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaozhou Maternal and Child Health Hospital | Chaozhou | Guangdong | 521000 | China | ||
| Dongguan Maternal and Child Health Care Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34820185 | Result | Heron E, McArdle A, Karim MN, Cooper M, Geddes D, McKenna L. Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions. PeerJ. 2021 Nov 16;9:e12439. doi: 10.7717/peerj.12439. eCollection 2021. | |
| 39443446 | Result | Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2. |
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If the study can be completed and the data have been collected, sharing IPD with the approval from the administrator would be feasible.
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|
Investigate the optimal cutoff value of the M-score/BISSI for defining clinical complete remission. |
| 8 weeks |
| Correlation between the M-score and BISSI scores. | Examine the correlation between the M-score and BISSI scores. | 8 weeks |
| Dongguan |
| Guangdong |
| 523000 |
| China |
| Sun Yat-sen memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| Jiangmen Maternity and Child Health Care Hospital | Jiangmen | Guangdong | 529051 | China |
| Shenshan Medical Center, Sun Yat-sen Memorial Hospital | Shanwei | Guangdong | 516600 | China |
| ID | Term |
|---|---|
| D058890 | Granulomatous Mastitis |
| ID | Term |
|---|---|
| D008413 | Mastitis |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000305 | Adrenal Cortex Hormones |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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