Adjustments 2023

Transferfile 2023

Transferfile SBCDB 2023

Adjustments SBCDB/EUSOMA as of 01.01.2023

The SBCDB questionnaire has been completely revised, a visual representation of the changes can be found in the following presentation: Changes SBCDB questionnaire effective 01.01.2023

Adjustment 2022

Transferfile 2022

• Transferfile SBCDB 2022

Adjustments SBCDB/EUSOMA effective 01.01.2022

• Change to check an existing field: The field [1096] “Plastic surgery for primary oncological surgery” must then be mandatorily filled in if the field [1084] “N00: Patient operated on” was filled in with yes. Background: the field is evaluated in dashboard metrics 14b and 14c.

• Change to check an existing field: The field [1051] “D10A: Date of biopsy” must then be mandatory filled if the field [2843] “Clarification External” was not checked. Background: For internally clarified patients, the time difference between the date of the biopsy and the start of therapy is calculated.

• New conditional-mandatory fields: New fields [10592] “Second oncologic breast surgery performed?” and [10593] “Third oncologic breast surgery performed?” have been added to the tumor statistics. The fields must be filled in if the answer to field [1084] “N00: Patient operated on” is affirmative. Background: the fields are evaluated for dashboard measure 14a.

• Change to check an existing field: The field [1117] “F05: Date of second oncologic breast surgery” must then be mandatorily completed if the field [10592] “Second oncologic breast surgery performed?” was affirmative.

• Change to check an existing field: The field [1132] “F38: Date of third oncological breast surgery” must then be mandatorily completed if the field [10593] “Third oncological breast surgery performed?” was affirmative.

• Change to check an existing field: The field [3338] “F200 Re-surgery due to complication” must then be mandatory filled if a date was entered in the field [1117] “F05: Date of second oncological breast surgery”. Background: the field is evaluated for dashboard measure 14c.

Adjustments 2021

Transferfile 2021

• Transferfile SBCDB 2021

Adjustments SBCDB/EUSOMA effective 06.11.2021 (retroactive to 2019/20)

• Change to master data: In field [1180] “I01: principal diagnosis”, code 6 “other incl. ypT0” was rewritten to “other”, i.e. “ypT0” was deleted.

Adjustments SBCDB/EUSOMA as of 17.02.2021 (retroactive to 2019/20)

• New text field: if the value [2] “Rejection by patient” is selected in the field [1306] “L01: Implementation of radiotherapy”, then the new optional text field [8940] “Reason for therapy rejection” will appear.
• New text field: if in field [1429] “M13: Implementation of neoadjuvant chemotherapy (until 2018 “M13_NEO”)” the value [2] “Rejection by patient” was selected, then the new optional text field [6603] “Reason for therapy rejection” appears.
• New text field: if in field [1444] “M18: Implementation of palliative/adjuvant chemotherapy (until 2018 “M13″)” the value [2] “Rejection by patient” was selected, then the new optional text field [6604] “Reason for therapy rejection” appears.
• New text field: if the value [2] “Rejection by patient” was selected in the field [1459] “MA01: Monoclonal AK therapy performed”, then the new optional text field [6605] “Reason for therapy rejection” will appear.
• New text field: if the value [2] “Rejection by patient” was selected in field [1345] “RT01: Primary antihormone therapy (neoadjuvant)”, then the new optional text field [6606] “Reason for therapy rejection” will appear.
• New text field: if the value [2] “Refusal by patient” was selected in the field [1387] “M01: endocrine measure (any form) administered or prescribed”, then the new optional text field [6607] “Reason for therapy refusal” will appear.
• New text field: if in field [1087] “N00A: Reason for non-operation” the value [1] “Refusal by patient” was selected, then the new optional text field [6608] “Reason for refusal of surgery” appears.

Adjustments during the year 2020

• In field [548 1096] “PLASTIC: Additional plastic surgery”, codes 1 “remodeling” and 9 “unknown” were deleted.
• Further, the field was renamed to “Plastic surgery for primary oncologic surgery”.
• The field [8268 1731] “L11_NEO: radiotherapy breast” was renamed to “L11_NEW: radiotherapy breast”.
• The field [8542 1505] “D08NEO: Aspiration cytology result (until 1919 “D08″)” has been renamed to “D08new: Aspiration cytology result (up to 1919 “D08″)”.
• The field [8543 1506] “D09NEO: Punch biopsy result (mammary) (until 1919 “D09″)” has been renamed “D09new: Punch biopsy result (mamma) (until 1919 “D09″)”.
• The field [2510] “Other plastic surgeries” was renamed to “Plastic surgeries for primary oncological surgery”.

Annual Adjustment 2020

Transferfile 2020

• Transferfile SBCDB 2020 (German only)

Adjustment SBCDB/EUSOMA as of 01.01.2020

• A new conditional-facultative field [3819] “Date of monoclonal AK therapy” is added to field [1459] “MA01: Monoclonal AK therapy performed”, to be completed when field [1459] “MA01: Monoclonal AK therapy performed” has been completed with code 1 “yes”. Applies to SBCDB only.
• The code 3 “equivocal” was added to the field [1297] “Her2 (FISH)”. Applies to SBCDB only.
• Code 3 “No due to comorbidity” has been added to field [1306] “L01: radiotherapy delivery”. Applies only to SBCDB.
• New mandatory field [4540] “L01_NEO: Performance of radiotherapy” in level A1 (tumor statistics). Please see TRSF for details. Applies to EUSOMA only.
• New conditional-mandatory field [1731] “L11_NEW: radiotherapy breast” in level A1 (tumor statistics). The field is to be completed if field [1306] “L01: Radiotherapy delivery” was completed with code 1 “yes”. Applies to SBCDB only. Please see TRSF for details.
• The field [3338] “F200 Re-operation due to complication” was extended by the code 9 “no” and deposited as a mandatory field. Applies only to SBCDB.
• The field [1345] “RT01: Primary anti-hormone therapy (neoadjuvant)” was extended by the code 2 “rejection by patient”.Affects only SBCDB.
• The field [2849] “D02: Result of mammography” was extended by the code 7 “Rejection by patient”. Affects SBCDB only.
• For field [1453] “M15A: Chemotherapy regimen”, codes [50] “DOCETAXEL” and [51] “PACLITAXEL” have been hidden.Affects EUSOMA only.
• New mandatory field [1739] “D13A_NEO: Clinical examination” in level A1 (tumor statistics).Affects only EUSOMA. Please see TRSF for details.
• The field [1216] “I13: Pathological grading (“in situ” tumor)” has been renamed to “I13: Pathological grading (DCIS tumor)”. Affects EUSOMA and SBCDB.
• The field [2851] “D24: Preoperative closure recommendation to patient” has been expanded to include codes 11 “Only HT” as well as 12 “Only CT”.Affects SBCDB only.
• The field [1081] “D24: Preoperative closure recommendation to patient [E]” was expanded to include codes 11 “Only HT” as well as 12 “Only CT”. Applies to EUSOMA only.
• The field [1207] “I10: Lymphovascular invasion present” was expanded to include code 2 “uncertain”. Affects EUSOMA and SBCDB.
• The field [1252] “I29B: pN (SN)” has been expanded to include the code 1a “1a”Involves EUSOMA and SBCDB.
• The field [1261] “I28: pN (final)” has been extended by the codes 1b “1b” as well as 1c “1c”. Refers to EUSOMA and SBCDB.
• The field [1036] “D08: Aspiration cytology result” has been removed. Applies only to SBCDB.
• New mandatory field [1505] “D08new: Aspiration cytology result (until 1919 “D08″)” in level A1 (tumor statistics). Applies to SBCDB only.For details, please see TRSF.
• The field [1045] “D09: Punch biopsy result (mamma)” has been removed. Applies only to SBCDB.
• New mandatory field [1506] “D09new: Punch biopsy result (mamma) (until 1919 “D09″)” In level A1 (tumor statistics). Affects SBCDB only. Please see TRSF for details.
• The field [2850] “D06: Result of ultrasound” has been extended by the code 7 “Patient rejection”. Applies only to SBCDB.
• The field [2849] “D02: Result of mammography” has been extended by the code 7 “Patient rejection”. Affects SBCDB.

only.

Adjustments during the year 2019

SBCDB adjustments as of 08.07.2019

Extension of checks for the years 2018 and 2019:

The field [597 1243] “I25A: Minimum DCIS margin distance (mm)” only needs to be completed if the following conditions are met:

• [544 1084] “N00: Patient operated on” = 1 (yes)
• [2506 3337] “I25A unknown” = false (unchecked)
• [578 1186] “I03: Presence/absence of a ductal “in situ” component” = 1 (present)
• [576 1180] “I01: Principal diagnosis” = 2 (in situ) NEW

The field [596 1240] “I24: Minimum tumor margin distance (invasive)(mm)” only needs to be completed if the following conditions are present:

• [2504 3335] “I23: Histolog. Evaluation of the margin of the tissue section in the final histologic report” = filled in
• [2504 3335] “I23: Histolog. Findings” = filled
• [2505 3336] “I24 unknown” = incorrect (unchecked)
• [576 1180] I01: principal diagnosis = not 2 (in situ) NEW

SBCDB adjustments as of 03.04.2019

• Field 559 “Closing Her2 status” has been extended with code 0 “Not performed”, otherwise some cases could not be closed correctly.

Adjustment SBCDB Quality Dashboard as of 03.08.2019

The following filters that are included in the SBCDB Quality Dashboard and Benchmark Report will no longer include only cases with pT = IS, but also cases with ypT = IS.

• Filter 927: [Adj] BC Dash 18.1.0 number of Tis
• Filter 928: [Adj] BC Dash 18.1.1 Ant cases with brusterh Op for tumors Tis
• Filter 2366: [Adj] BC Dash 18.a Cases with [OP1246] I26: pT = IS or ypT = IS

(SBCDB adjustments as of 01.03.2019)

• The field [4500] “Is case for SBCDB? (System)” has been added to the 2018 and 2019 SBCDB filter. The new field is used to distinguish between benign and malignant cases, as only malignant cases count for the SBCDB registry.If the case is malignant, i.e., if the code [2] “in situ”, [3] “microinvasive”, or [4] “invasive” was filled in the field [1180] “I01: Principal diagnosis”, then after the case is saved, the field “Is case for SBCDB? (system)” is filled with [3] “yes (automatic) ” and the field [500] “EUSOMA / DKG / SBCDB case? (for selection/export)” automatically receives a check mark. This case would thus be included in the SBCDB dashboard as well as in the annual benchmark report.If the case is a benign case, i.e. if a code other than those mentioned above is filled in the field [1180] “I01: Main diagnosis”, then after saving the case the field [4500] “Is case for SBCDB? (system)” will be filled with [2] “no (automatic) ” and the field [500] “EUSOMA / DKG / SBCDB case?” will be filled. (for selection/export)” remains empty.

  The check mark at field [500] “EUSOMA / DKG / SBCDB Case? (for selection/export)” can be overridden by the user by entering either [0] in field [4500] “Is case for SBCDB? (System)” either setting [0] “no (manual) ” or [1] “yes (manual) ” and saving the case.

Annual Adjustment 2019

Transferfile 2019

• Transferfile SBCDB 2019

SBCDB Adjustments as of 01.01.2019

• Field 119 “Teaching Assistance” becomes an optional field. The field number remains the same.
• Field 358 “Receipt of Assignment” becomes an optional field. The field number remains the same.
• New conditional-mandatory field 559 “Final Her2 status”; level A1 (operations statistics). The field will not be retrospectively inserted in the questionnaires before 2019. See TRSF for details.
• Field 1072 “D20: cN” will become a required field. The field number remains the same.
• Field 1075 “D21: distant metastases” now only contains the codes “0” and “1”. The code “X” is no longer available for selection. The field number remains the same.
  It will still be possible to select the code “X” in previous questionnaires or to import this code. We will successively change the code “X” to “0” in all cases during 2019.
• Field 1189 “I05: Histology d. benign laesions” will become an optional field. The field number remains the same.
• Field 1228 “I22: Total dimension (invasive tumor + in situ tumor) (mm)” becomes an optional field. The field number remains the same.
• Field 1240 “I24: Minimum tumor margin distance (invasive)(mm)” becomes a conditional mandatory field and only needs to be filled in if field 3335 “I23: Histolog. Evaluation of the margin of the tissue section in the final histologic report” has been filled in. Findings” has been filled in and the check mark for field 3336 “I24 unknown” has not been set. The field number remains the same.
• Field 1279 “ER_PERC: Percentage of ER positive cells” becomes a conditional mandatory field and must be filled only if the field 1276 “I38: Presence of estrogen receptors” with the master date 2 “positive” was filled. The field number remains the same.
• Field 1429 “M13_NEO: Implementation of neoadjuvant chemotherapy” is renamed “M13: Implementation of neoadjuvant chemotherapy (until 2018 “M13_NEO”)”. The field number remains the same.
• Field 1441 “M28: Therapy suspension due to toxicity” is renamed to “M28_NEO: Therapy suspension due to toxicity”. The field number remains the same.
• Field 1444 “M13: Implementation of chemotherapy” is renamed to “M18: Implementation of palliative/adjuvant chemotherapy (until 2018 “M13″)”. The field number remains the same.
• Field 1447 “M14: Date d. therapy start” is renamed to “M19: Date d. pall/adj therapy start (until 2018 “M14″)”. The field number remains the same.
• Field 1450 “M15: Date d. therapy end” is renamed to “M20: Date d. pall/adj therapy end (until 2018 “M15″)”. The field number remains the same.
• Field 2419 “Date d. neoadjuvant therapy start” is renamed to “M14: Date d. neoadjuvant therapy start”. The field number remains the same.
• Field 2846 “Date d. neoadjuvant therapy end” is renamed to “M15: Date d. neoadjuvant therapy end”. The field number remains the same.
• Field 2847 “L09: RT total dose, incl. boost (Gy)” becomes a conditional-mandatory field and only needs to be filled in if field 1327 “L13: Boost technique” was filled in with master data 1 “Electrons”, 2 “x-MV (photons)”, 3 “intersticial brachitherapy”, 4 “other” or 8 “Yes, unknown method”. The field number remains the same.
• Field 2946 “L13(b): Time of boost” becomes a conditional-mandatory field and only needs to be filled in if field 1327 “L13: Boost technique” was filled in with master data 1 “Electrons”, 2 “x-MV (photons)”, 3 “Intersticial brachitherapy”, 4 “Other”, or 8 “Yes, unknown method”. The field number remains the same.

Adjustment EUSOMA as of 01.01.2019

• Field 1429 “M13_NEO: Implementation of neoadjuvant chemotherapy” will be transferred from the SBCDB questionnaire and renamed to “M13: Implementation of neoadjuvant chemotherapy (until 2018 “M13_neo”)” analogous to the above changes. The field number remains the same.
• Analog SBCDB: Field 1444 “M13: Performance of chemotherapy” is renamed to “M18: Performance of chemotherapy (until 2018 “M13″)”. The field number remains the same.
• Analog SBCDB: Field 1447 “M14: Date d. therapy start” is renamed to “M19: Date d. pall/adj therapy start (until 2018 “M14″)”. The field number remains the same.
• Analog SBCDB: Field 1450 “M15: Date d. therapy end” is renamed to “M20: Date d. pall/adj therapy end (until 2018 “M15″)”. The field number remains the same.
• Field 2419 “Date d. neoadjuvant therapy start” will be taken from the SBCDB questionnaire and renamed in analogy to above changes to “M14: Date d. neoadjuvant therapy start”.
• Field 2846 “Date d. neoadjuvant therapy end” is taken from the SBCDB questionnaire and renamed analogous to above changes to “M15: Date d. neoadjuvant therapy end”.
• Field 563 “M18: Adjuvant Chemotherapy”, field 564 “M19: Date of first adjuvant chemotherapy cycle” and field 568 “M20: Date of last adjuvant chemotherapy cycle” are deleted.

2018 Annual Adjustment

Transferfile 2018

• Transferfile SBCDB 2018

Adjustment SBCDB as of 08/31/2018

Change in a field name:

• The field [1295] “I69: Her status (immunohistochemistry)” was changed to [1295] “I69: Her2 (immunohistochemistry)”

Change in an exam:

• Exceptions in field [1189] “I05: Histology d. benign lesions” no longer generate error messages in connection with benign cases, only info messages.

Adjustment SBCDB online report as of 31.08.2018

Deletion of two filters as they were not meaningful due to optional fields:

• Filter 4d1 “Complications to be operated on due to surgery in which immediate reconstruction was performed in the same session”
• Filter 4d2 “Complications to be operated on due to surgery without immediate reconstruction”

Adjustment SBCDB as of 25.06.2018

Change in “Min values”

• For various date fields of the SBCDB questionnaire, only values from 01/01/1980 onwards will be accepted to exclude implausible data entries/imports.

Adjustment SBCDB as of 14.06.2018

Modification of a check

• The field “ypT” with field no. 3375 must now only be filled in if the field “M13_NEO: Implementation of neoadjuvant chemotherapy” (field no. 1429) was filled in with “yes” and the field “N00: Patient operated on” (field no. 1084) was filled in with “yes”.

Adjustment as of 23.04.2018

Changes to the Quality Dashboard 2017

• The 2017 Quality Dashboard includes a new “Derivation of Numbers” spreadsheet that breaks down (complex) filters into their component parts. This should make the dashboard more understandable and transparent.
• Fix a bug in the calculation of index 18

General Adjustments

No adjustments from 2017 to 2018.

Adjustments SBCDB

New field at A1 level (tumor statistics):

• Field #144 “Recurrence?”: With codes “1 – yes” / “0 – no” mandatory to fill in

New fields at A1 level (surgery):

• Field no. 4770 “Internal follow-up”; optional
• Field No. 4771 “External Follow-Up”; optional
• Field No. 4772 “External FU physician”; optional
• Field No. 4773 “FU form sent”; optional
• Field No. 4774 “Date FU form sent”; optional
• Field no. 4775 “FU form received”; optional
• Field No. 4776 “Date FU form received”; optional

All of the above fields were introduced in the “BC Aftercare (Follow Up)” filter for the years 2014-2018.

Adjustments before 2018

• Transferfile SBCDB 2017
• Transferfile SBCDB 2016
• Transferfile SBCDB 2015
• Transferfile SBCDB 2014