11. Quality Indicators – Colorectal Cancer
Quality indicators (QI) are measured variables that serve to evaluate the quality of structures, processes or results they are based on [1142][1143][1128]. Quality- indicators are an important part of quality management. Their aim is to continuously improve the level of care by presenting, critically reflecting on and (where necessary) correcting the results of that care. The quality indicators used in this guideline were selected according to the methodology of the Guideline Program in Oncology [1144]. A working group under the name “WG Quality Indicators” was formed for this purpose. The working group created the final set of quality indicators based on the existing quality indicators of the 2013 guideline, the new strong recommendations (grade of recommendation A, “must/has to”) of the updated guideline, the results of the existing quality indicators from the certified colorectal cancer centres of the German Cancer Society9 and the results from reviews of existing national and international QIs. The exact procedure and the composition of the working group are explained in the Guideline Report. Following a face-to-face meeting and a telephone conference of the working group, 4 new indicators were accepted (QI 1-4). These were added to the 7 existing indicators (QI 5–11), resulting in a final set of 11 quality indicators.
Recording of family history (new in 2017)
Numerator
No. of patients who completed the patient questionnaire
Denominator
All patients with the initial diagnosis CRC
Quality target / reference range
Quality objective:
As often as possible: completed patient questionnaires to record the family history.
Notes
Reference Recommendation: None
Rationale for this QI:
The analysis of the internationally applied QIs (here in particular ASCO) showed that international QIs for obtaining the family history are described. The guideline group believes this area to be relevant; therefore, this QI is included in the guideline without a strong consensus recommendation.
Comment: Patient questionnaire:
Reference recommendations
Complete report after tumour resection in CRC (new in 2017)
Numerator
Number of patients with a report containing details of: • Tumour type according to WHO classification • Tumour invasion depth (pT classification) • Regional lymph node status (pN classification) • Number of lymph nodes examined • Grading • Distance from the resection margins (for rectal cancer, also circumferential) • R-classification
Denominator
All patients with CRC and surgical resection
Notes
Quality objective:
As often as possible: Complete reports following tumour resection for CRC.
Reference recommendations
Mutation determination in mCRC (new in 2017)
Numerator
Number of patients in whom the RAS (= KRAS and NRAS mutations) and BRAF mutation was determined at the start of first-line therapy
Denominator
All patients with mCRC and first-line therapy
Quality target / reference range
GoR A, LoE 1
Quality objective:
As often as possible: Mutation determination prior to first-line therapy in mCRC.
Notes
Where possible, (All) RAS and BRAF mutations should be determined prior to initiating first-line therapy.
Comment:
Determination “at baseline” = date of mutation determination max. +15d from the start date of first- line therapy
Reference recommendations
Combination chemotherapy in mCRC (new in 2017)
Numerator
Number of patients with combination chemotherapy
Denominator
All patients with mCRC, ECOG 0-1 and systemic first-line therapy.
Quality target / reference range
GoR A, LoE 1a
Quality objective:
As often as possible: Combination therapy in the first- line therapy of patients with mCRC, ECOG 0-1.
Notes
In first-line chemotherapy, and under the condition of good overall health and high motivation, a fluoropyrimidine- based combination regimen with infusions of 5-fluorouracil, such as FOLFIRI, FOLFOX or FOLFOXIRI, or with the oral fluoropyrimidine capecitabine (mainly with oxaliplatin, CAPOX) should primarily be used.
Reference recommendations
Report on distance to the mesorectal fascia (since 2013, formerly: CRC 1)
Numerator
All patients with documented distance to the mesorectal fascia in the report.
Denominator
All patients with rectal cancer and MRI or thin- layer CT of the pelvis.
Quality target / reference range
EC
(Expert Consensus)
Quality objective:
As often as possible: Details of the distance to the mesorectal fascia if MRI/CT was carried out in rectal cancer.
Notes
The report should include information on the distance to the mesorectal fascia.
Reference recommendations
The report should include information on the distance of the tumor to the mesorectal fascia.
- Consensus
- Strong consensus
Quality of TME (since 2013, formerly: CRC 3)
Numerator
Number of all patients with good or moderate quality (grade 1: mesorectal fascia intact or grade 2: intramesorectal tears) TME.
Denominator
All patients with radically operated rectal cancer.
Notes
As often as possible: Good or moderate quality of TME in rectal cancer.
Reference recommendations
Since the quality of the surgical resection specimens according to the abovementioned categories allows conclusions on the prognosis of local recurrence, it must be described in the pathohistological report as follows:
The quality of the resection specimens is graded by the integrity of the mesorectal fascia in 3 categories:
- Grade1 (good): mesorectal fascia is intact
- Grade 2 (moderate): intramesorectal surface tearing
- Grade 3 (poor): tearing down to the muscularis propria or the tumor
In case of rectal extirpation, preparation irregularities and tumor positive circumferential safety margins are not as frequent with a complete resection of the levator musculature. [829]
Therefore, the pathohistological report must describe the radicality in the levator musculature region. The following categories should be used:
- Grade 1 (good): levator musculature included in resection, no opening of the intestine or tumor
- Grade 2 (moderate): muscularis propria intact, no opening of the intestine or tumor
- Grade 3 (poor): parts of the muscularis propria are missing or opening of the intestine or tumor
The analysis has to be performed by a pathologist.
- Consensus
- Consent
Presentation in tumour conference (since 2013, formerly: CRC 5)
Numerator
Number of patients who were presented in an interdisciplinary tumour conference before therapy.
Denominator
All patients with rectal cancer and all patients with stage IV colon cancer.
Notes
EC
(Expert Consensus)
Quality objective:
As often as possible: Presentation of patients with rectal cancer and of patients with stage IV colon cancer in the pretherapeutic tumour conference.
Reference recommendations
All CRC patients should be presented in an interdisciplinary tumor conference after they have completed their primary therapy (e.g. operation, chemotherapy).
Patients with the following constellations should already be presented before therapy:
- every rectal cancer
- every stage IV colon cancer
- metachronic distant metastases
- local recurrence
- before every local ablative procedure, e.g. RFA/LITT/SIRT
- Consensus
- Consent
Adjuvant chemotherapy (since 2013, formerly: CRC 6)
Numerator
Number of patients who have undergone adjuvant chemotherapy.
Denominator
All patients with colon cancer UICC stage III who have had an R0 resection of the primary tumour.
Notes
Recommendation LoE 1a, strong consensus
Quality objective:
Adequate performance of adjuvant chemotherapy after R0 resection in stage III colon cancer.
Reference recommendations
QI 11: Marking of stoma position (since 2013, formerly: CRC 10)
Numerator
Number of patients with anastomotic leakage grade B (with administration of antibiotics or interventional drainage or transanal lavage/drainage) or C ((re- )-laparotomy) after elective interventions.
Denominator
All patients with rectal cancer with creation of an anastomosis during elective primary tumour resection.
Quality target / reference range
Reference Recommendation: None
Rationale for this QI:
Comment:
The guideline committee has decided that not only quality goals based on structural issues, but also on results should be taken into consideration. Therefore, this quality indicator is included in the guideline without strong consensus recommendation.
Notes
No evidence basis to support a strong recommendation, since this indicator was not derived from a recommendation.
Quality objective:
As seldom as possible: Grade B or C anastomotic leakage following the creation of an anastomosis during surgery to treat rectal cancer.
Reference recommendations
Anastomotic leakage in colon cancer (since 2013, formerly: CRC 9)
Numerator
Number of patients with anastomotic leakage requiring re-intervention after elective interventions.
Denominator
All patients with colon cancer with creation of an anastomosis during elective tumour resection.
Quality target / reference range
Reference Recommendation: None
Rationale for this QI:
Comment:
The guideline committee has decided that not only quality goals based on structural issues, but also on results should be taken into consideration. Therefore, this quality indicator is included in the guideline with strong consensus recommendation.
Notes
No evidence basis to support a strong recommendation, since this indicator was not derived from a recommendation.
Quality objective:
As seldom as possible: Grade D anastomotic leakage requiring re-intervention following the creation of an anastomosis during surgery to treat colon cancer.
Reference recommendations
Marking of stoma position (since 2013, formerly: CRC 10)
Numerator
Number of patients with preoperatively marked stoma position
Denominator
All patients with rectal cancer who have had surgery with stoma construction
Quality target / reference range
EC
(Expert Consensus)
Quality objective:
As often as possible: Preoperatively marked stoma position.
Notes
EC
(Expert Consensus)
Quality objective:
As often as possible: Preoperatively marked stoma position.
Reference recommendations
References
[1142] (ÄZQ), Ärztliches Zentrum für Qualität in der Medizin, E, Gramsch, JD, Hoppe, G, Jonitz, A, Köhler, al., Ollenschläger G et, Kompendium Q-M-A. Qualitätsmanagement in der ambulanten VersorgungDt. Ärzte-Verl., 2008.
[1143] Hoensch, H., Groh, B., Edler, L., Kirch, W., Prospective cohort comparison of flavonoid treatment in patients with resected colorectal cancer to prevent recurrence, World J Gastroenterol, 2008. 14(14): p. 2187-93., http://www.ncbi.nlm.nih.gov/pubmed/18407592
[1128] Chau, I., Allen, M. J., Cunningham, D., Norman, A. R., Brown, G., Ford, H. E., et.al. The value of routine serum carcino-embryonic antigen measurement and computed tomography in the surveillance of patients after adjuvant chemotherapy for colorectal cancer, J Clin Oncol, 2004. 22(8): p. 1420-9., http://www.ncbi.nlm.nih.gov/pubmed/15007086
[1144] Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft (DKG), Deutsche Krebshilfe (DKH), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF)), Entwicklung von Leitlinien basierten Qualitätsindikatoren. Methodenpapier für das Leitlinienprogramm Onkologie. Version 2.0. 2017., 2017., http://leitlinienprogramm-onkologie.de/Informationen-zur-Methodik.53.0.html