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Publication - Consultation Paper

Review of colorectal cancer quality performance indicators: consultation

Published: 10 Mar 2017
Part of:
Health and social care
ISBN:
9781786528339

Consultation to gather views on NHSScotland's approach to treating colorectal cancer.

41 page PDF

604.4kB

41 page PDF

604.4kB

Contents
Review of colorectal cancer quality performance indicators: consultation
7. Quality Performance Indicators for Colorectal Cancer

41 page PDF

604.4kB

7. Quality Performance Indicators for Colorectal Cancer

QPI 1 - Radiological Diagnosis and Staging

QPI Title:

Patients with colorectal cancer should be evaluated with appropriate imaging to detect extent of disease and guide treatment decision making.

Description:

Proportion of patients with colorectal cancer who undergo CT chest, abdomen and pelvis (colorectal cancer) plus MRI pelvis (rectal cancer only) before definitive treatment.

Please note: The specifications of this QPI are separated to ensure clear measurement of both patients with:

(i) Colon cancer who undergo CT chest, abdomen and pelvis;

(ii) Rectal cancer who undergo CT chest, abdomen and pelvis and MRI.

Rationale and Evidence:

Accurate staging is necessary to detect metastatic disease, guide treatment and avoid inappropriate surgery 2 .

All patients with colorectal cancer should be staged by contrast enhanced CT of the chest, abdomen and pelvis, to estimate the stage of disease, unless the use of intravenous iodinated contrast is contraindicated 3, 4.

MRI of the rectum is recommended for local staging of patients with rectal cancer. Patients with rectal cancer who are potential surgical candidates need to be appropriately staged with MRI and discussed by a multi disciplinary team ( MDT) preoperatively. The risk of local recurrence based on MRI findings should be ascertained 3, 4.

Specification (i):

Numerator:

Number of patients with colon cancer who undergo CT chest, abdomen and pelvis before definitive treatment.

Denominator:

All patients with colon cancer.

Exclusions:

  • Patients who refuse investigation.
  • Patients who undergo emergency surgery.
  • Patients undergoing supportive care only.
  • Patients who undergo palliative treatment (chemotherapy or surgery)

Target:

95%

Specification (ii):

Numerator:

All patients with rectal cancer undergoing definitive treatment (chemoradiotherapy or surgical resection) who undergo CT chest, abdomen and pelvis and MRI pelvis before definitive treatment.

Denominator:

All patients with rectal cancer undergoing definitive treatment (chemoradiotherapy or surgical resection).

  • Patients who refuse investigation.
  • Patients who undergo emergency surgery.
  • Patients with a contraindication to MRI.
  • Patients who undergo Transanal Endoscopic Microsurgery ( TEM).
  • Patients who undergo palliative treatment (chemotherapy, radiotherapy or surgery).

Target:

95%

Revision(s):

Spec (i) Colon Cancer - added exclusion for Patients who undergo palliative treatment (chemotherapy or surgery).

Spec (ii) Rectal Cancer - added exclusions for Patients who undergo Transanal Endoscopic Microsurgery ( TEM) and Patients who undergo palliative treatment (chemotherapy, radiotherapy or surgery). There will also be specific operation codes not included pertaining to Endoscopic Mucosal Resection.

QPI 2 - Pre-Operative Imaging of the Colon

QPI Title:

Patients with colorectal cancer undergoing surgical resection should have the whole colon visualised pre-operatively.

Description:

Proportion of patients with colorectal cancer who undergo surgical resection who have the whole colon visualised by colonoscopy or CT colonography pre-operatively, unless the non-visualised segment of colon is to be removed.

Rationale and Evidence:

The whole colon is visualised preoperatively to avoid missing synchronous tumours and to remove synchronous adenomas 2 .

Where colorectal cancer is suspected clinically, the whole of the large bowel should be examined to confirm a diagnosis of cancer. CT colonography can be used as a sensitive and safe alternative to colonoscopy 3, 4.

Specifications:

Numerator:

Number of patients who undergo elective surgical resection for colorectal cancer who have the whole colon visualised by colonoscopy or CT colonography before surgery, unless the non visualised segment of the colon has been removed.

Denominator:

All patients who undergo elective surgical resection for colorectal cancer.

Exclusions

  • Patients who undergo palliative surgery.

Target:

95%

The tolerance within this target is designed to account for situations where patients are deemed clinically unsuitable or unfit to undergo colonoscopy or CT colonography.

Revision(s):

Exclusion added for patients that undergo palliative surgery.

QPI 3 - Multi-Disciplinary Team ( MDT) Meeting

QPI Title:

Patients should be discussed by a multidisciplinary team prior to definitive treatment.

Description:

Proportion of patients with colorectal cancer who are discussed at MDT meeting before definitive treatment.

Rationale and Evidence:

Evidence suggests that patients with cancer managed by a multi-disciplinary team have a better outcome. There is also evidence that the multidisciplinary management of patients increases their overall satisfaction with their care 5 .

Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately.

Specifications:

Numerator:

Number of patients with colorectal cancer discussed at the MDT before definitive treatment.

Denominator:

All patients with colorectal cancer.

Exclusions:

  • Patients who died before first treatment.
  • Patients undergoing emergency surgery.
  • Patients undergoing treatment with endoscopic polypectomy only.

Target:

95%

The tolerance within this target level accounts for situations where patients require treatment urgently.

Revision(s):

No changes to QPI. Data definitions updated to account for supportive care patients discussed at MDT

QPI 4 - Stoma Care

QPI Title:

Patients with colorectal cancer who require a stoma are assessed and have their stoma site marked pre-operatively by a nurse with expertise in stoma care.

Description:

Proportion of patients with colorectal cancer who undergo elective surgical resection which involves stoma creation who are seen and have their stoma site marked pre-operatively by a nurse with expertise in stoma care.

Rationale and Evidence:

All patients who may require stoma formation (permanent or temporary) should be referred and assessed by a stoma nurse specialist before admission to hospital 3 .

Access to a nurse with expertise in stoma care increases patient satisfaction and optimal independent functioning 2 . Furthermore, there is significant evidence to suggest that patients not marked preoperatively can have significant problems with their stoma post operatively and this can affect their recovery and rehabilitation.

Before surgery, all patients should be offered information about the likelihood of having a stoma, why it might be necessary, and how long it might be needed for. A trained stoma professional should give specific information on the care and management of stomas to all patients considering surgery that might result in a stoma 4 .

Specifications:

Numerator:

Number of patients with colorectal cancer who undergo elective surgical resection which involves stoma creation who are seen by and have their stoma site marked preoperatively by a nurse with expertise in stoma care.

Denominator:

All patients with colorectal cancer who undergo elective surgical resection which involves stoma creation.

Exclusions:

  • Patients who refuse to be seen by a nurse with expertise in stoma care.

Target:

95%

The tolerance within this target is designed to account for situations where unexpected findings or technical difficulties at surgery mean that a stoma was fashioned when not originally planned.

Revision(s):

No changes to QPI.

QPI 5 - Lymph Node Yield

QPI Title:

For patients undergoing resection for colorectal cancer the number of lymph nodes examined should be maximised.

Description:

Proportion of patients with colorectal cancer who undergo surgical resection where ≥12 lymph nodes are pathologically examined.

Rationale and Evidence:

Maximising the number of lymph nodes resected and analysed enables reliable staging which influences treatment decision making 2 .

Specifications:

Numerator:

Number of patients with colorectal cancer who undergo curative surgical resection where ≥12 lymph nodes are pathologically examined.

Denominator:

All patients with colorectal cancer who undergo curative surgical resection (with or without neo-adjuvant short course radiotherapy).

Exclusions:

  • Patients with rectal cancer who undergo long course neo-adjuvant chemo radiotherapy or radiotherapy.
  • Patients who undergo transanal endoscopic microsurgery or transanal resection of tumour.

Target:

90%

The tolerance within this target accounts for situations where patients are not fit enough to undergo extensive lymphadenectomy.

Please note: varying evidence exists regarding the most appropriate target level therefore this may need redefined in the future, to take account of new evidence or as further data becomes available.

Revision(s):

Increased target from 80% to 90%.

QPI 6 - Neo-adjuvant Therapy

QPI Title:

Patients with locally advanced rectal cancer should receive neo-adjuvant therapy designed to facilitate a margin-negative resection.

Description:

Proportion of patients with locally advanced rectal cancer with threatened or involved circumferential resection margin ( CRM) on preoperative MRI who receive neo-adjuvant therapy, designed to facilitate a margin-negative resection, defined as:

(i) Long course chemoradiotherapy [a] ;

(ii) Short course radiotherapy with long course intent (delay to surgery [b] ); or

(iii) Neo-adjuvant chemotherapy

Rationale and Evidence:

Patients with rectal tumours that involve or threaten the mesorectal fascia on preoperative imaging may benefit from preoperative radiotherapy 2 .

Patients with rectal cancer who require downstaging of the tumour because of encroachment on the mesorectal fascia should receive neo-adjuvant therapy, followed by surgery at an interval to allow cytoreduction 3 .

For patients with rectal cancer MRI is utilised to assess the extent of disease prior to treatment, a statement regarding margin status is required within the MRI report as this will determine the treatment offered to patients, i.e. whether pre-operative radiotherapy is considered.

Specifications:

Numerator:

Number of patients with rectal cancer with a threatened or involved CRM on preoperative MRI undergoing surgery who receive neo-adjuvant therapy.

Denominator:

All patients with rectal cancer with a threatened or involved CRM on preoperative MRI undergoing surgery.

Exclusions:

  • Patients who refused neo-adjuvant therapy.
  • Patients in whom neo-adjuvant therapy is contraindicated.
  • Patients who presented as an emergency for surgery.

Target:

90%

The tolerance within this target is designed to account for situations where patient's fitness levels preclude neo-adjuvant therapy.

Revision(s):

Title changed from Neo-adjuvant Radiotherapy to Neo-adjuvant Therapy.

QPI now incorporating other methods of Neo-adjuvant therapy - Long course chemoradiotherapy, Short course radiotherapy with long course intent (delay to surgery) and Neo-adjuvant chemotherapy. Delay to surgery defined as planned surgery performed a minimum of 6 weeks after completion of neo-adjuvant therapy.

Wording of exclusions and tolerance updated accordingly.

QPI 7 - Surgical Margins

QPI Title:

Rectal cancers undergoing surgical resection should be adequately excised.

Description:

Proportion of patients with rectal cancer who undergo surgical resection in which the circumferential margin is clear of tumour.

Please note:

The specifications of this QPI are separated to ensure clear measurement of both patients who receive:

(i) Primary surgery, or immediate / early [c] surgery following neo-adjuvant short course radiotherapy; and

(ii) Surgery following neo-adjuvant chemotherapy, long course chemoradiotherapy, or short course radiotherapy with long course intent (delay to surgery [b] ).

Rationale and Evidence:

The circumferential margin is an independent risk factor for the development of distant metastases and mortality. It is recognised that local recurrence of rectal cancer can be accurately predicted by pathological assessment of circumferential margin involvement in these tumours 3 .

This indicator is a measure of the quality of both pre-operative assessment and resection.

Specification (i):

Numerator:

Number of patients with rectal cancer who undergo elective primary surgical resection or immediate / early [c] surgical resection following neo-adjuvant short course radiotherapy in which the circumferential margin is clear of tumour.

Denominator:

All patients with rectal cancer who undergo elective primary surgical resection or surgical resection following neo-adjuvant short course radiotherapy.

Exclusions:

  • Patients who undergo transanal endoscopic microsurgery or transanal resection of tumour.

Target:

95%

Specification (ii):

Numerator:

Number of patients with rectal cancer who undergo elective surgical resection following neo-adjuvant chemotherapy, long course chemoradiotherapy, or short course radiotherapy with long course intent (delay to surgery) in which the circumferential margin is clear of tumour.

Denominator:

All patients with rectal cancer who undergo elective surgical resection following neo-adjuvant chemotherapy, long course chemoradiotherapy, or short course radiotherapy with long course intent (delay to surgery).

Exclusions:

  • Patients who undergo transanal endoscopic microsurgery or transanal resection of tumour.

Target:

85%

The tolerance within this target is designed to account for the fact that patients who undergo neo-adjuvant radiotherapy are already acknowledged to have a tumour threatening the circumferential margin therefore are more likely to have positive surgical margins.

Revision(s):

Spec (i) updated to define immediate / early surgical resection as surgery performed less than 6 weeks after completion of neo-adjuvant therapy.

Spec (ii) updated to include other methods of neo-adjuvant therapy as per QPI 6.

QPI 8 - Re-operation Rates

QPI Title:

For patients undergoing surgery for colorectal cancer re-operation should be minimised.

Description:

Proportion of patients who undergo surgical resection for colorectal cancer who return to theatre to deal with complications related to the index procedure (within 30 days of surgery).

Rationale and Evidence:

It is important to minimise morbidity and mortality related to the treatment of colorectal cancer. Re-operation rates may offer a sensitive and relevant marker of surgical quality 6,7,8,9 .

Specifications:

Numerator:

Number of patients with colorectal cancer who undergo surgical resection who return to theatre following initial surgical procedure (within 30 days of surgery) to deal with complications related to the index procedure.

Denominator:

All patients with colorectal cancer who undergo surgical resection.

Exclusions:

No exclusions

Target:

<10%

Revision(s):

QPI to now be measured via audit data rather than SMR01 data.

QPI 9 - Anastomotic Dehiscence

QPI Title:

For patients who undergo surgical resection for colorectal cancer anastomotic dehiscence should be minimised.

Description:

Proportion of patients who undergo surgical resection for colorectal cancer with anastomotic leak as a post operative complication.

Please note:

The specifications of this QPI are separated to ensure clear measurement of patients who undergo:

(i) Colonic anastomosis; and

(ii) Rectal anastomosis (including: anterior resection with total mesorectal excision ( TME)).

Rationale and Evidence:

Anastomotic dehiscence is a major cause of morbidity and a measure of the quality of surgical care 2 .

Anastomotic leakage is an important and potentially fatal complication of colorectal cancer surgery, and measures to minimise it should be taken 4 .

Specification (i):

Numerator:

Number of patients with colorectal cancer who undergo a surgical procedure involving anastomosis of the colon having anastomotic leak requiring intervention (radiological or surgical).

Denominator:

All patients with colorectal cancer who undergo a surgical procedure involving anastomosis of the colon.

Exclusions:

  • No exclusions.

Target:

<5%

Specification (ii):

Numerator:

Number of patients with rectal cancer who undergo a surgical procedure involving anastomosis of the rectum (including: anterior resection with TME) having anastomotic leak requiring intervention (radiological or surgical).

Denominator:

All patients with rectal cancer who undergo a surgical procedure involving anastomosis of the rectum (including: anterior resection with TME).

Exclusions:

  • No exclusions

Target:

<10 %

Revisions:

No changes to QPI.

QPI 10 - 30 and 90 Day Mortality Following Surgical Resection

QPI Title:

Mortality after surgical resection for colorectal cancer.

Description:

Proportion of patients with colorectal cancer who die within 30 or 90 days of emergency or elective surgical resection.

Rationale and Evidence:

Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team ( MDT) 3 .

Outcomes of treatment, including treatment-related morbidity and mortality should be regularly assessed 3 .

Patients with poor performance status, who are therefore at a greater risk of treatment-related morbidity and mortality, are increasingly being considered for radical interventions. These interventions may be curative but their impact needs to be balanced against the overall prognosis of the patient 4 .

Specifications:

Numerator:

Number of patients with colorectal cancer who undergo emergency or elective surgical resection who die within 30 or 90 days of surgery.

Denominator:

All patients with colorectal cancer who undergo emergency or elective surgical resection.

Exclusions:

  • No exclusions

Target:

Elective surgical resection

30 day mortality <3%

90 day mortality <4%

Emergency surgical resection

30 day mortality <15%

90 day mortality <20%

These target levels have been agreed based on current Scottish and UK audit data.

In the most recent UK National Bowel Cancer Audit Report 10 , the 90 day mortality figure following elective surgery was 2.1% and following emergency surgery was 14.5%.

Revision(s):

Elective surgical resection:

30 day target changed from <5% to <3%

90 day target added - <4%

Emergency surgical resection:

90 day target added <20%.

QPI 11 - Adjuvant Chemotherapy

QPI Title:

Patients with Dukes C and high risk Dukes B colorectal cancer should be considered for adjuvant chemotherapy.

Description:

Proportion of patients between 50 and 74 years of age at diagnosis with Dukes C, or high risk Dukes B [d] , colorectal cancer who receive adjuvant chemotherapy [e] .

Rationale and Evidence:

All patients with Dukes C and high risk Dukes B colorectal cancer should be considered for adjuvant chemotherapy to reduce the risk of local and systemic recurrence 3,4 .

Treatment is not restricted by age and is considered on an individual patient basis. Treatment may be restricted by co-morbidities, which are more common in the older patient group. Due to the difficulties associated with accurate measurement of co-morbidities and patient fitness these cannot be utilised as exclusions within this QPI. To ensure focussed measurement and a QPI examining expected outcomes the age range of 50-74 years has been selected. This represents the majority of patients and therefore provides a good proxy for access to adjuvant chemotherapy in the whole patient population.

Patients over 74 years of age have been poorly represented in previous clinical trials meaning that the evidence base for benefit in the over 74 age group is extremely limited. Patients are considered for treatment on an individual basis.

Specifications:

Numerator:

Number of patients between 50 and 74 years of age at diagnosis with Dukes C, or high risk Dukes B, colorectal cancer who undergo surgical resection who receive adjuvant chemotherapy.

Denominator:

All patients between 50 and 74 years of age at diagnosis with Dukes C, or high risk Dukes B, colorectal cancer who undergo surgical resection.

Exclusions:

  • Patients who refuse chemotherapy.

Target:

Patients with Dukes C colorectal cancer 70%

Patients with high risk Dukes B colorectal cancer 50%

The tolerance within this target is designed to account for situations where patients may have post operative complications or fitness levels that preclude adjuvant chemotherapy treatment.

Target levels for Dukes C and high risk Dukes B colorectal cancer differ as the risk of recurrence is less with Dukes B disease the absolute benefit of adjuvant chemotherapy is therefore less than for Dukes C disease.

Revisions:

Definition of high risk Dukes B changed to include T3 tumours with extramural venous invasion.

Please note: Although this QPI specifically measures patients between 50 and 74 years of age (bowel screening population), NHS Boards and Regional Cancer Networks will continue to report on adjuvant chemotherapy rates for all patients with Dukes C and high risk Dukes B colorectal cancer regardless of age. No target level will be assigned to this patient group at the present time.

QPI 12 - 30 and 90 Day Mortality Following Chemotherapy or Radiotherapy

QPI Title:

Mortality after chemotherapy or radiotherapy treatment for colorectal cancer.

Description:

Proportion of patients with colorectal cancer who die within 30 or 90 days of chemotherapy or radiotherapy treatment.

Rationale and Evidence:

Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team ( MDT) 3 .

Patients with poor performance status, who are therefore at a greater risk of treatment-related morbidity and mortality, are increasingly being considered for radical interventions. These interventions may be curative but their impact needs to be balanced against the overall prognosis of the patient 4 .

Specification(i):

Numerator:

Number of patients with colorectal cancer who undergo neo-adjuvant chemoradiotherapy, radiotherapy or adjuvant chemotherapy with curative intent who die within 30 or 90 days of treatment.

Denominator:

All patients with colorectal cancer who undergo neo-adjuvant chemoradiotherapy, radiotherapy or adjuvant chemotherapy with curative intent.

Exclusions:

  • No exclusions.

Please note: This indicator will be reported by treatment modality, i.e. chemoradiotherapy, radiotherapy and adjuvant chemotherapy, as opposed to one single figure.

Target:

<1%

Specification(ii):

Numerator:

Number of patients with colorectal cancer who undergo palliative chemotherapy who die within 30 days of treatment.

Denominator:

All patients with colorectal cancer who undergo palliative chemotherapy.

Exclusions:

  • No exclusions.

Target:

<10%

Revisions:

Spec (i) curative intent - target changed from <2% to <1%.

Spec (ii) been added - palliative chemotherapy with a target of <10%.

QPI 13 - Clinical Trial Access

QPI Title:

All patients should be considered for participation in available clinical trials, wherever eligible.

Description:

Proportion of patients with Colorectal cancer who are enrolled in an interventional clinical trial or translational research.

Rationale and Evidence:

Clinical trials are necessary to demonstrate the efficacy of new therapies and other interventions. Furthermore evidence suggests improved patient outcomes from participation in clinical trials 5 .

Clinicians are therefore encouraged to enter patients into well-designed trials and to collect longer-term follow-up data.

High accrual activity into clinical trials is used as a goal of an exemplary clinical research site.

Specifications:

Numerator:

Number of patients with Colorectal cancer enrolled in an interventional clinical trial or translational research.

Denominator:

All patients with Colorectal cancer.

Exclusions:

  • No exclusions.

Target:

Interventional clinical trials - 7.5%

Translational research - 15%

The clinical trials QPI will be measured utilising SCRN data and ISD incidence data, as is the methodology currently utilised by the Chief Scientist Office ( CSO) and NCRI. The principal benefit of this approach is that this data is already collected utilising a robust mechanism. At present a 'clinical trial' data item is contained within all tumour specific datasets, however in order to avoid any duplication of effort, and focus resources appropriately, SCRN data is the preferred option.

Utilising SCRN data allows for comparison with CSO published data and ensures capture of all clinical trials recruitment, not solely first line treatment trials, as contained in the clinical audit data. Given that a significant proportion of clinical trials are for relapsed disease this is felt to be particularly important in driving quality improvement. This methodology utilises incidence as a proxy for all patients with cancer. This may slightly over, or underestimate, performance levels, however this is an established approach currently utilised by NHSScotland. For clinical trials definitions please see appendix 4.

The full Clinical Trials QPI document can be found at:

Healthcare Improvement Scotland - Cancer Quality Performance Indicators


Contact

Email: Chris Booth