25. Quality indicators – Cervical Carcinoma
J. Rückher, S. Wesselmann
J. Rückher, S. Wesselmann
Quality indicators are measurement variables for which data are collected to assess the quality of the structures, processes, and events they represent. Quality indicators are an important tool for quality management. The aim in using them is to achieve constant improvement in medical care by presenting, critically reflecting on, and if necessary improving the results of the care provided. The present selection of quality indicators is based on the methodology of the Oncology Guideline Program [867]. To compile them, a Quality Indicators Working Group was set up. The group established the final set of quality indicators on the basis of the quality indicators already existing in the 2014 guideline, the new strong recommendations (“must”) in the updated guideline, the results of the existing quality indicators from the German Cancer Society’s certified gynecological cancer centers, and the results of research on existing national and international quality indicators. The precise procedure and composition of the Working Group are outlined in the guideline report.
Following two online meetings of the Working Group, one new quality indicator was adopted (QI 10) and one quality indicator was deleted from the previous set (QI 9, R0 resection in exenteration). The annual report of the gynecological cancer centers showed that in 2018, only 43 exenterations were performed in 23 centers nationally (range 1–8 exenterations per center), while 123 centers did not report any exenterations — so that the informative value of the indicator was rated as low [857]. The final set thus still consists of nine quality indicators.
In addition, the Working Group has asked the clinical cancer registry to provide a stage-specific figure for sentinel lymphadenectomy alone for the next update of the guideline, in accordance with Statement 8.4, Staining for sentinel lymphadenectomy alone.
Notes on the QIs: The numerator is always a subset of the denominator. Quality indicators 1, 5, 6, and 7 are to be documented using the basic oncology dataset of the cancer registries (as of October 2020).
Presentation at the tumor conference (checked 2021)
Numerator
no. of patients presented at the tumor conference
Denominator
all patients with a first diagnosis, recurrence, or newly developed distant metastasis of cervical carcinoma
Quality target / reference range
EC
Quality goal:
Presentation of patients in the tumor conference as frequently as possible.
Notes
Participants in the tumor conference include a gyneco-oncologist, a pathologist, a radiologist, and a radio-oncologist.
Reference recommendations
The cases of all patients with cervical carcinoma shall be presented at an interdisciplinary tumor conference.
- Consensus
- Strong consensus
Details given in the medical report at first diagnosis and tumor resection (checked 2021)
Numerator
no. of patients with medical reports including details on: - Histological type (WHO) - Grading - Evidence/absence of lymphatic or venous invasion (L and V status) - Evidence/absence of perineural sheath infiltration (Pn status) - Staging (pTNM and FIGO) in patients who have undergone conization, taking the conization findings into account - Depth of invasion and extent in millimeters in pT1a1 and pT1a2 - Depth of invasion relative to the thickness of the cervical wall (metric or percentage) in radical hysterectomy - Three-dimensional tumor size in centimeters (starting from pT1b1) - Minimum distance to the resection margins (in pT1b tumors, endocervical stroma) - R classification (UICC)
Denominator
all patients with a first diagnosis of cervical carcinoma and tumor resection
Quality target / reference range
EC
Quality goal:
Complete reports of findings as often as possible for initial diagnosis of cervical carcinoma and tumor resection
Notes
Reference recommendations
Tumor classification shall be carried out on the basis of the currently valid edition of the WHO classification.
- Consensus
- Strong consensus
Staging shall be carried out in accordance with the current edition of the TNM classification.
- Consensus
- Strong consensus
Change note
The staging should follow the latest edition of the TNM classification.A diagnosis of microinvasive cervical carcinoma shall be based on the definitions given in the current editions of both the WHO and TNM classifications.
- Consensus
- Strong consensus
Morphological processing shall take place in such a way that all therapeutically and prognostically relevant parameters can be assessed. The report shall be produced on the basis of the currently valid WHO classification for tumor type and the current TNM classification for staging, as well as the R classification (UICC).
- Consensus
- Consent
The tracheclectomy report shall include the following details:
- Histological type (WHO)
- Grading
- Presence/absence of lymphatic or venous invasion (L and V status)
- Presence/absence of perineural sheath infiltration (Pn status)
- Staging (TNM),
- Depth of invasion and extent in millimeters in pT1a1 and pT1a2
- Three-dimensional tumor size in centimeters (from pT1b1)
- Minimum distance from the resection margins (endocervical stroma in pT1b tumors)
- R classification (UICC).
- Consensus
- Consent
Change note
The report of findings for trachelectomy should include the following information: - histological type according to WHO, - grading, - evidence/absence of lymphatic or venous infiltrates (L- and V- status), - evidence/absence of perineural sheath infiltrates (Pn-status), - staging (TNM), - depth of invasion and extension in mm for pT1a1 and pT1a2, - three-dimensional tumor size in cm (from pT1b1), - minimal distance to resection margins, - R-classification (UICC).Morphological processing shall take place in such a way that all therapeutically and prognostically relevant parameters can be assessed. The report shall be produced on the basis of the currently valid WHO classification for tumor type and the current TNM classification for staging, as well as the R classification (UICC).
- Consensus
- Strong consensus
The radical hysterectomy report shall include the following details:
- WHO histological type
- Grading
- Presence/absence of lymphatic or venous invasion (L and V status)
- Presence/absence of perineural sheath infiltration (Pn status)
- Staging (TNM), taking the conization findings into account in patients who have undergone conization
- Depth of invasion and extension in millimeters in pT1a1 and pT1a2
- Depth of invasion relative to the cervical wall thickness (measurement or percentage figure)
- Three-dimensional tumor size in centimeters (from pT1b1)
- Minimum distance from the resection margins (endocervical stroma in pT1b tumors, vagina in pT2a tumors, and parametrium in pT2b tumors)
- R classification (UICC)
- Consensus
- Strong consensus
Change note
The findings report for radical hysterectomy should include the following information: - histological type according to WHO, - grading, - evidence/absence of lymphatic or venous invasion (L- and V- status), - evidence/absence of perineural sheath infiltrates (Pn-status), - staging (TNM), depth of invasion and extension in mm for pT1a1 and pT1a2, - three-dimensional tumour size in cm (from pT1b1), - minimum distance to the resection margins, - R-classification (UICC).Details in the medical report with lymphadenectomy (checked 2021)
Numerator
no. of patients with medical reports including details on: - No. of affected lymph nodes relative to removed lymph nodes - Correlation with site of biopsy removal (pelvic/para-aortic) - Details of the largest extent of the largest lymph-node metastasis, in mm/cm - Details of the absence/presence of capsular penetration by the lymph-node metastasis - Details of isolated tumor cells or micrometastases
Denominator
all patients with cervical carcinoma and lymphadenectomy
Quality target / reference range
EC
Quality goal:
Complete reports of findings as often as possible for patients with cervical carcinoma and lymphadenectomy
Reference recommendations
In lymphadenectomy specimens obtained during surgical treatment for cervical carcinoma, all removed lymph nodes shall be histologically examined.
- Consensus
- Strong consensus
Evidence of isolated tumor cells or micrometastases should be mentioned in the histological report and included in the TNM classification.
- Consensus
- Strong consensus
The report on lymph nodes shall include the following details: number of affected lymph nodes relative to the number of lymph nodes removed, correlated with the location of removal (pelvic/para-aortic).
- Consensus
- Consent
Cytological / histological lymph-node staging (checked 2021)
Numerator
no. of patients with cytological/histological lymph-node staging
Denominator
All patents with cervical carcinoma in FIGO stage ≥ IA2–IVA
Quality target / reference range
EC
Quality goal:
Cytological/histological lymph-node staging as often as possible for cervical carcinoma in FIGO stage ≥ IA2–IVA
Notes
Cytological/histological lymph-node staging = for diagnosis; not lymphadenectomy.
Reference recommendations
Treatment must be administered relative to the histological tumor stage, verified using surgical staging or interventional diagnosis.
- Consensus
- Consent
Cisplatin-containing radiochemotherapy (checked 2021)
Numerator
no. of patients with cisplatin-containing chemotherapy
Denominator
all patients with a first diagnosis of cervical carcinoma and primary radiochemotherapy
Quality target / reference range
Grade of recommendation A, level of evidence 1++
Quality goal:
To provide cisplatin-containing radiochemotherapy as often as possible to patients with an initial diagnosis of cervical carcinoma and primary radiochemotherapy.
Reference recommendations
In patients with cervical carcinoma in whom there is an indication for primary radiotherapy from stage IB2 onwards, the radiotherapy shall be combined with cisplatin-based chemotherapy.
Adjuvant radio(chemo)therapy (checked 2021)
Numerator
no. of patients with adjuvant radio(chemo)therapy
Denominator
all patients with a first diagnosis of cervical carcinoma and radical hysterectomy
Quality target / reference range
Derived from one of the goals in the guideline:
To ascertain the status quo in medical care, particularly with regard to quality indicator 6 on adjuvant radio(chemo)therapy, as there are no data available on how many patients are treated adjuvantly on a stage-appropriate basis with combined cisplatin-containing radio(chemo)therapy.
Quality goal:
Currently: ascertaining the status quo.
In the longer term: reducing adjuvant therapy in favor of primary surgery alone or radio(chemo)therapy alone in the group at risk (unimodal therapy)
Notes
Reference recommendations
Histological confirmation (checked 2021)
Numerator
no. of patients with pretherapeutic histological confirmation
Denominator
all patients with cervical carcinoma and treatment for a local recurrence
Quality target / reference range
EC
Quality goal:
Pretherapeutic histological confirmation as often as possible in patients with cervical carcinoma and treatment for a local recurrence.
Reference recommendations
If a locoregional recurrence is suspected, histological confirmation shall be obtained.
- Consensus
- Consent
Diagnosis of spread in local recurrence (checked 2021)
Numerator
All patients with imaging diagnosis (CT of chest and abdomen) to exclude distant metastases
Denominator
All patients with local recurrence of cervical carcinoma
Quality target / reference range
EC
Quality goal:
Imaging diagnosis as often as possible in patients with local recurrence of a cervical carcinoma.
Reference recommendations
If a local recurrence develops, the appropriate imaging diagnostic procedures shall be carried out to exclude distant metastases and for treatment planning.
- Consensus
- Strong consensus
Complete medical report on conization findings (new 2021)
Numerator
all patients in the denominator with medical reports on: - Type of lesion (CIN, AIS, SMILE) - Location (endocervical, ectocervical) - Extent - In case of invasion, with details of size and lymph-node invasion, vascular invasion, and perineural sheath invasion - Grading - Status of resection margins (R status)
Denominator
All patients with HSIL (CIN II/III), AIS, SMILE and/or cervical carcinoma who have undergone conization.
Quality target / reference range
Quality goal:
Complete medical report as often as possible for patients with conization.
Notes
Data on this indicator are to be collected by dysplasia units/services and gynecological cancer centers.
Reference recommendations
The histological report shall note the type of lesion (CIN, ACIS and its variants in the form of stratified mucin-producing intraepithelial lesions [SMILE]), its location (endocervical, ectocervical), and its extent, as well as the presence of invasive tumor. When there is evidence of invasion, details shall also be given of its extent and of lymphatic, vascular and perineural sheath invasion, as well as grading. The status of the resection margins shall also be noted.
- Consensus
- Strong consensus
Change note
The type of lesion (CIN, ACIS), its location (endocervical, ectocervical) and its extent as well as the presence of an invasive tumour should be noted in the histological report. If invasion is detected, the size extension should also be indicated and a statement made on lymphatic, blood vessel and perineural sheath invasion as well as grading. The status of the resection margins should be commented on.Notes on the QIs: The numerator is always a subset of the denominator. Quality indicators 1, 5, 6, and 7 are to be documented using the basic oncology dataset of the cancer registries (as of October 2020).
References
[867] Tian, W. J., Zhang, M. Q., Shui, R. H., Prognostic factors and treatment comparison in early-stage small cell carcinoma of the uterine cervix, Oncol Lett, 2012. 3: p. 125-130., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3362381/
[857] Kohler, C., Oppelt, P., Favero, G., Morgenstern, B., Runnebaum, I., Tsunoda, A., et.al. How much platinum passes the placental barrier? Analysis of platinum applications in 21 patients with cervical cancer during pregnancy, Am J Obstet Gynecol, 2015. 213(2): p. 206 e1-5., https://www.ncbi.nlm.nih.gov/pubmed/25731691
[396] Green, J., Kirwan, J., Tierney, J., Vale, C., Symonds, P., Fresco, L., et.al. Concomitant chemotherapy and radiation therapy for cancer of the uterine cervix, Cochrane Database Syst Rev, 2005. p. CD002225.
[397] Wang, N., Guan, Q. L., Wang, K., Zhou, X., Gao, C., Yang, H. T., et.al. Radiochemotherapy versus radiotherapy in locally advanced cervical cancer: a meta-analysis (Structured abstract), Archives of Gynecology and Obstetrics, 2011. 283: p. 103-108.