Table 1.
Quality indicators of colorectal cancer care according to diagnostic-therapeutic process (diagnosis, pathology, treatment—surgery, chemotherapy and radiotherapy—and outcome) and tumour site
| Clinical domain | Site | Quality indicator | Numerator | Denominator | Medical documentation | Rationale | Reference | |
|---|---|---|---|---|---|---|---|---|
| Diagnosis (n=6) | C&R | Proportion of patients with colorectal cancer and diagnosis based on symptoms vs screening vs accidental finding | Number of patients with colorectal cancer whose diagnosis is based on symptoms, defined as appearance or persistence of clinical events and signs, such as rectal bleeding, occult blood in stool, weight loss with no apparent cause, general abdominal discomfort, bowel obstruction, change in bowel habits, constant tiredness, anaemia |
Number of patients with colorectal cancer | Request form of endoscopic examination, endoscopy and surgical pathology reports, reports/discharge letters coming from all hospital units/departments (ie, surgery, medicine, radiation oncology, medical oncology) | Assessment of the patient's take charge | 18 34–38 | |
| Number of patients with colorectal cancer whose diagnosis is based on screening, defined as regular examination, such as faecal occult blood test (FOBT) or colonoscopy in asymptomatic patients |
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| Number of patients with colorectal cancer whose diagnosis is an accidental finding following examinations or therapies for other diseases (eg, hospital admission for other causes…) |
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| C&R | Proportion of patients with colorectal cancer, evaluated by preoperative colonoscopy | Number of patients with colorectal cancer who have been evaluated by a preoperative colonoscopy | Number of patients with colorectal cancer undergoing surgery | Endoscopy report, request form of pathology examination, pathology report of endoscopy | Planning of further diagnostic procedures and treatments, comprehensiveness of diagnostic and staging evaluation |
7 16 18 40–41 | ||
| R | Proportion of patients with rectal cancer and description of the tumour localisation (distance ab ano) in the endoscopic/pathological documentation | Number of patients with rectal cancer who have the description of the tumour localisation, in terms of distance ab ano, in the endoscopic/pathological documentation |
Number of patients with rectal cancer undergoing endoscopy | Endoscopy report, request form of pathology examination, pathology report of endoscopy | Planning of further diagnostic procedures and treatments, comprehensiveness of diagnostic and staging evaluation | 1 19 56 57 | ||
| C&R | Proportion of patients with colorectal cancer and requests for an initial CT and/or an MRI examination completed by clinical information according to the ACR guidelines | Number of patients with colorectal cancer for which the request of an initial CT and/or an MRI examination is completed by clinical information according to the ACR guidelines |
Number of patients with colorectal cancer undergoing initial CT and/or MRI examination | Radiology (CT and/or MRI examination) report | Providing the necessary information for a comprehensive radiological examination, assessment of the quality of the flux of clinical information | 7 58 | ||
| R | Proportion of patients with low rectal* cancer undergoing pelvic MRI of staging | Number of patients with low rectal* cancer who have undergone a pelvic MRI of staging | Number of patients with low rectal* cancer | Radiology (MRI examination) report, discharge letters coming from all hospital units/departments (ie, surgery, medicine, medical oncology, radiation oncology) |
Planning of further diagnostic procedures and treatments, comprehensiveness of diagnostic and staging evaluation | 19 59–61 | ||
| R | Proportion of patients with rectal cancer and a preoperative MRI reporting the description of the radial margin status (mm) | Number of patients with rectal cancer who have undergone a preoperative MRI reporting the description of the radial margin status (mm) |
Number of patients with rectal cancer undergoing preoperative MRI | Radiology (MRI examination) report | Planning of further diagnostic procedures and treatments, comprehensiveness of diagnostic and staging evaluation | 62 | ||
| Pathology (n=3) | R | Proportion of patients with rectal cancer for which the request for the pathological examination includes the information of neo-adjuvant RT±ChT | Number of patients with rectal cancer for which the request for the pathological examination includes the information of neo-adjuvant RT±ChT | Number of patients with rectal cancer undergoing neo-adjuvant RT±ChT and surgery† | Request form of pathology examination, surgical pathology report | Providing the necessary information for a comprehensive pathological examination, assessment of the quality of the flux of clinical information |
Proposed by the QC3 CRC-WG |
|
| C&R | Proportion of patients with colorectal cancer and a sufficient number of tumour samples (≥3) | Number of patients with colorectal cancer for which 3 or more tumour samples were processed for the pathological analysis |
Number of patients with colorectal cancer undergoing surgery† | Surgical pathology report | Comprehensiveness of pathology examination | Proposed by the QC3 CRC-WG |
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| C&R | Proportion of patients with colorectal cancer and a surgical pathology report including the following characteristics:▸ Surgical intervention description ▸ Sample length ▸ Tumour localisation according to WHO ▸ Tumour size ▸ Histological type according to WHO ▸ Histological grade ▸ Resection margins ▸ Lymph-vascular invasion ▸ Perineural invasion ▸ Tumour deposits (discontinuous extramural extension) ▸ Pathological staging (AJCC pTNM) ▸ Number of retrieved lymph nodes ▸ Treatment effect ▸ Macroscopic integrity of the mesorectum (for the rectum only) (this quality indicator should be provided for each characteristic) |
Number of patients with colorectal cancer whose pathological report includes the following characteristics: ▸ Surgical intervention description ▸ Sample length ▸ Tumour localisation according to WHO ▸ Tumour size ▸ Histological type according to WHO ▸ Histological grade ▸ Resection margins ▸ Lymph-vascular invasion ▸ Perineural invasion ▸ Tumour deposits (discontinuous extramural extension) ▸ Pathological staging (AJCC pTNM) ▸ Number of retrieved lymph nodes ▸ Treatment effect ▸ Macroscopic integrity of the mesorectum (for the rectum only) |
Number of patients with colorectal cancer undergoing surgery† | Surgical pathology report | Comprehensiveness and standardisation of surgical pathology report, comprehensiveness of staging evaluation, planning of further treatments | 18 19 63 64 | ||
| Treatment (n=16) | C&R | Proportion of patients with colorectal cancer who have been operated in emergency‡ | Number of patients with colorectal cancer who have been operated in emergency‡ | Number of patients with colorectal cancer undergoing surgery† |
Radiology and surgery report/discharge letter, surgical pathology report | Assessment of the patient's take charge | 65–67 | |
| C&R | Proportion of patients with colorectal cancer and dead within 30 days and 6 months from the surgery (postoperative mortality) | Number of patients with colorectal cancer and dead within 30 days from the surgery† Number of patients with colorectal cancer and dead within 6 months from the surgery |
Number of patients with colorectal cancer undergoing surgery† | Surgery report/discharge letter, surgical pathology report, access to regional Office of Population Registry Rosters for the assessment of patients’ vital status | Assessment of the quality of surgical procedure | 68–71 | ||
| C&R | Proportion of patients with colorectal cancer and postoperative multidisciplinary discussion | Number of patients with colorectal cancer for which there has been a multidisciplinary discussion after surgery† | Number of patients with colorectal cancer undergoing surgery† | Surgery, oncology, radiation oncology reports/discharge letters, multidisciplinary discussion documentation |
Planning of further diagnostic procedures and treatments | 72 73 | ||
| R | Proportion of patients with malignant rectal polyp (pT1) and complete endoscopic polypectomy | Number of patients with malignant rectal polyp (pT1) who have undergone a complete endoscopic polypectomy |
Number of patients with malignant rectal polyp (pT1) | Endoscopy report, endoscopic pathology reports | Assessment of the quality of surgical procedure | Proposed by the QC3 CRC-WG | ||
| R | Proportion of patients with low rectal* cancer who have undergone a surgical intervention with sphincter preservation |
Number of patients with low rectal* cancer who have undergone a surgical intervention with sphincter preservation | Number of patients with low rectal* cancer undergoing surgery† |
Surgical pathology report, surgery report/discharge letter | Assessment of the quality of surgical procedure | 7 74–76 | ||
| R | Proportion of patients with rectal cancer undergoing TEM with R0 resection | Number of patients with rectal cancer who have undergone TEM with R0 resection |
Number of patients with rectal cancer undergoing TEM | Surgical pathology report, surgery report/discharge letter | Assessment of the quality of surgical procedure | 77–79 | ||
| C&R | Proportion of patients with colorectal cancer and a number of resected lymph nodes ≥12 | Number of patients with colorectal cancer with a number of resected lymph nodes ≥12 | Number of patients with colorectal cancer undergoing surgery†, but no neo-adjuvant therapy |
Surgical pathology report, surgery report/discharge letter | Assessment of the quality of surgical procedure and pathology examination | 7 14 16 40 41 80–85 | ||
| C&R | Proportion of patients with colorectal cancer operated on with free margins | Number of patients with colon cancer who have undergone surgery and have free margins |
Number of patients with colorectal cancer undergoing surgery† | Surgical pathology report, surgery report/discharge letter | Assessment of the quality of surgical procedure | 7 86 87 | ||
| C&R | Proportion of patients with colorectal cancer and AJCC TNM clinical stage I (from T2N0M0) to III (any T, N1M0) undergoing a surgical resection with anastomosis | Number of patients with colorectal cancer and AJCC TNM clinical stage I (from T2N0M0) to III (any T, N1M0) who have undergone a surgical resection with anastomosis |
Number of patients with colorectal cancer and AJCC TNM stage I (from T2N0M0) to III | Radiology report, surgical pathology report,surgery report/discharge letter | Assessment of the quality of surgical procedure | 40 41 86 87 | ||
| C | Proportion of patients with colon cancer and AJCC TNM stage II (T3N0M0, T4N0M0) high-risk (presence of at least one of the following factors: LN<12, G3, lymph-vascular or perineural invasion, tumour obstruction, tumour perforation, pT4) or III undergoing adjuvant ChT | Number of patients with colon cancer and AJCC TNM stage II (T3N0M0, T4N0M0) high-risk (presence of at least one of the following factors: LN<12, G3, lymph-vascular or perineural invasion, tumour obstruction, tumour perforation, pT4) or III, who have undergone adjuvant ChT |
Number of patients with colon cancer and AJCC TNM stage II high-risk or III, undergoing surgery† | Radiology report, surgical pathology report, surgery, oncology reports/discharge letters | Assessment of the quality of oncological treatment | 16 18 40–41 88–91 | ||
| C | Proportion of patients with colon cancer AJCC TNM stage II high-risk or stage III undergoing adjuvant ChT within 8 weeks from surgical resection | Number of patients with colon cancer and AJCC TNM stage II high-risk or III, who have undergone adjuvant ChT within 8 weeks from surgical resection | Number of patients with colon cancer and AJCC TNM stage II high-risk or III undergoing surgery† and adjuvant ChT |
Radiology report, surgical pathology report, surgery, oncology reports/discharge letters | Assessment of the quality of oncological treatment | 18 92 | ||
| C&R | Proportion of patients with colorectal cancer and histology of the primary tumour or metastases obtained before the beginning of ChT |
Number of patients with colorectal cancer and histology of the primary tumour or metastases obtained before the beginning of ChT | Number of patients with colorectal cancer undergoing primary ChT | Radiology and pathology reports, oncology report/discharge letter | Assessment of the quality of oncological treatment | 40 41 | ||
| C&R | Proportion of patients with colorectal cancer and unresectable metastases undergoing first-line ChT or bio-ChT | Number of patients with colorectal cancer and unresectable metastases who have undergone a first-line ChT or bio-ChT | Number of patients with colorectal cancer and unresectable metastases |
Radiology and pathology reports, oncology report/discharge letter | Assessment of the quality of oncological treatment | 93–96 | ||
| C&R | Proportion of patients with colorectal cancer and hepatic metastases primarily unresectable turned into resectable metastases after neo-adjuvant ChT | Number of patients with colorectal cancer and hepatic metastases primarily unresectable turned into resectable metastases after neo-adjuvant ChT | Number of patients with colorectal cancer and unresectable hepatic metastases undergoing neo-adjuvant ChT |
Radiology report, oncology report/discharge letter | Assessment of the quality of oncological treatment | 96 | ||
| R | Proportion of patients with locally advanced rectal cancer (T3-4 and/or any T, N+ and M0) undergoing neo-adjuvant RT±ChT | Proportion of patients with locally advanced rectal cancer (T3-4 and/or any T, N+ and M0) who have undergone neo-adjuvant RT±ChT |
Number of patients with locally advanced rectal cancer undergoing surgery† | Endoscopic pathology report, radiology report, radiation oncology and oncology reports/discharge letters | Assessment of the quality of oncological and radio-oncological treatment | 97 98 | ||
| R | Proportion of patients with rectal cancer and undergoing neo-adjuvant RT±ChT operated within 6–8 weeks after the end of neo-adjuvant RT±ChT | Number of patients with rectal cancer who have undergone neo-adjuvant RT±ChT and were operated within 6–8 weeks after the end of neo-adjuvant RT±ChT |
Number of patients with rectal cancer undergoing neo-adjuvant RT±ChT followed by surgery† | Endoscopic pathology report, radiology report, radiation oncology and oncology reports/discharge letters, surgical pathology report | Assessment of the quality of oncological and radio-oncological treatment | 18 98 | ||
| Outcome (n=2) | C&R | Analysis of overall survival at 1, 3, 5 and 10 years from diagnosis | Number of patients with colorectal cancer who survive at 1, 3, 5 and 10 years from diagnosis | Number of patients with colorectal cancer | Access to regional Office of Population Registry Rosters for the assessment of patients vital status | Assessment of overall survival | 7 99 | |
| C&R | Analysis of disease-free survival at 1, 3, 5 and 10 years from the curative treatment | Number of patients with colorectal cancer who are disease-free at 1, 3, 5 and 10 years from the curative treatment | Number of patients with colorectal cancer curatively treated | Reports/discharge letters coming from all hospital units/department (ie, surgery, medicine, oncology, radio-oncology) | Assessment of disease-free survival | 7 99 |
*Low rectum: 4–7.5 cm from the dentate line.100
†Surgery excludes endoscopic resection and colostomy.
‡Emergency: within 24 h from the onset of symptoms.
ACR, American College of Radiology; AJCC, American Joint Committee on Cancer; C, colon; C&R, colon-rectum; ChT, chemotherapy; CT, computed tomography; MRI, magnetic resonance imaging; R, rectum; RT, radiotherapy; TEM, transanal endoscopic microsurgery; WHO, World Health Organization.