Review of MBS colonoscopy items
Prepared BY DLA PIPER AUSTRALIA
for theDepartment of Health and Ageing
Review of MBS Colonoscopy items
Table of contents
Terms and abbreviations used in this review
Summary of findings of the review
Background
Guidance for colonoscopy in Australia
International guidance for colonoscopy
Justification for this review
Clinical and research questions addressed in this review
Literature review methods
Types of studies considered for the review
Search strategies for identifying studies
Search terms for identifying studies
Study selection
Data extraction
Quality assessment of studies
Data analysis
Factors affecting rates of colonoscopy
Analysis of Medicare data
Key trends in MBS utilisation of colonoscopy and related items
Systematic review of the literature - results of search strategy
Introduction
Findings for individual clinical and research questions
Question 1 - For patients with non-acute indications for colonoscopy, what is the appropriate timing between colonoscopies?
Question 1a: Patients with a family history of bowel cancer
Question 1b: Patients with a genetic predisposition to bowel cancer
Question 1c: Patients with inflammatory bowel disease
Question 1d: Older people
Question 1e: Patients with a past history of bowel cancer
Question 1f: Patients with a past history of adenoma
MBS data for timing of colonoscopy
Question 2 - What is the effectiveness of colonoscopy in improving outcomes in each target population?
Question 2a: What is the effectiveness of colonoscopy in cancer prevention?
Question 2b: What is the effectiveness of colonoscopy in diagnosis of pathology in symptomatic patients?
Question 2c: What is the likelihood of a single colonoscopy leading to the detection of an adenoma and / or colorectal cancer?
Question 2d: What is the relationship between appropriateness criteria for colonoscopy and diagnostic yield?
Question 3: How do safety and quality outcomes of colonoscopy vary according to the procedural volumes of colonoscopists and with certification / re-certification processes?
Question 3a: How do safety and quality outcomes of colonoscopy vary according to the procedural volumes of colonoscopists?
Question 3b: How do safety and quality outcomes of colonoscopy vary according to certification / re-certification processes?
Question 4 - How cost-effective is colonoscopy in each target population?
Question 5 - Are all patient groups in whom colonoscopy should be used able to access colonoscopy?
Question 5a - What are the factors that influence access to colonoscopy?
Question 5b: What is the evidence for interventions that improve access to colonoscopy services?
Question 5c: What is the impact of open access service configuration on access to colonoscopy services?
Consumer perspectives
Discussion
General findings
Implications for the MBS - colonoscopy in individuals with no known risk factors and no relevant symptoms
Implications for the MBS - colonoscopy in individuals with known risk factors, established disease and/or relevant symptoms
References
Included studies
Excluded studies
Other references
Appendix 1 – Search terms for identifying studies
Appendix 2 – Study assessment criteria
Appendix 3 – Evidence hierarchy
Appendix 4 – Characteristics of excluded studies
Appendix 5 – Tables of included studies
Review Question 1a: Appropriate timing of colonoscopy in patients with a family history of bowel cancer
Review Question 1b: Appropriate timing of colonoscopy in patients with a genetic predisposition to bowel cancer
Review Question 1c: Appropriate timing of colonoscopy in patients with inflammatory bowel disease
Review Question 1d: Appropriate timing of colonoscopy in older people
Review Question 1e: Appropriate timing of colonoscopy in patients with a past history of colorectal cancer
Review Question 1f: Appropriate timing of colonoscopy in patients with a past history of adenoma
Review Question 2a: Effectiveness of colonoscopy in cancer prevention
Review Question 2b: Effectiveness of colonoscopy in diagnosis of pathology in symptomatic patients
Review Question 2c: Likelihood of a single colonoscopy leading to the detection of an adenoma and / or colorectal cancer
Review Question 2d: What is the relationship between appropriateness criteria for colonoscopy and diagnostic yield?
Review Question 3a: How do safety and quality outcomes of colonoscopy vary according to the procedural volumes of colonoscopists?
Review Question 4: How cost-effective is colonoscopy in each target population?
Review Question 5a: Are all patient groups in whom colonoscopy should be used able to access colonoscopy?
Review Question 5b: What is the evidence for interventions that improve access to colonoscopy services?
Review Question 5c: What is the impact of open access service configuration on access to colonoscopy services?
1Review of MBS Colonoscopy items
Terms and abbreviations used in this review
ABS / Australian Bureau of StatisticsAFAP / Attenuated familial adenomatous polyposis
AIHW / Australian Institute of Health and Welfare
ASGE / American Society for Gastrointestinal Endoscopy
CEA / Carcinoembryonic antigen
CINAHL / Cumulative Index of Nursing and Allied Health Literature
CT / Computerised tomography
EPAGE / European Panel for the Appropriateness of Gastrointestinal Endoscopy
FAP / Familial adenomatous polyposis
FOBT / Faecal occult blood test
GENCA / Gastroenterological NursesCollege of Australia
GESA / Gastroenterological Society of Australia
HNPCC / Hereditary non-polyposis colorectal carcinoma
ICER / Incremental cost-effectiveness ratio
MBS / Medicare Benefits Schedule
NHMRC / National Health and Medical Research Council
QALY / Quality-adjusted life year
Summary of findings of the review
Clinical Research Questions / Findings1. For patients with non-acute indications for colonoscopy, what is the appropriate timing between colonoscopies? / i. Family History:Risk of development of colorectal cancer in patients with a family history is categorised in currently endorsed guidelines as ‘at or slightly above’ (Category 1) risk, at ‘moderately increased’ (Category 2) risk and at ‘potentially high’ (Category 3) risk. According to these guidelines, patients with Category 1 risk require bowel cancer surveillance equivalent to that required by the general population. Studies included in this review demonstrate that decisions regarding commencement and frequency of surveillance colonoscopy in patients with Category 2 or Category 3 risk are based on the strength of family history and findings of index colonoscopy, particularly the presence and features of adenomas identified at index colonoscopy.
ii. Genetic predisposition: Patients with a genetic predisposition to bowel cancer are at increased risk of developing adenoma and colorectal carcinoma. Appropriate intervals between surveillance colonoscopies vary according to the type of genetic condition affecting the patient, the patient’s age, findings from preceding colonoscopies and the presence of other risk factors for colorectal cancer. As a result, recommended surveillance intervals for subsequent colonoscopies in this group of patients vary between several months and 5 years or longer. Published studies support the commencement of colonoscopic surveillance for patients with a defined genetic predisposition to bowel cancer at a younger age than for other groups of patientsrequiring surveillance colonoscopy.
iii. Inflammatory Bowel Disease:Patients with inflammatory bowel disease are at increased risk of colorectal cancer. Risk of development of colorectal cancer varies according to the patient’s individual risk factors. These include disease duration, disease extent as well as the presence of other risk factors for colorectal cancer such as primary sclerosing cholangitis, family history of sporadic colorectal cancer, the presence of strictures, pseudopolyps and mucosal dysplasia and the severity of endoscopic and histological inflammation, and factors that are independent of the patient’s inflammatory bowel disease status such as patient age and the presence of concurrent familial bowel cancer syndromes.
In patients without additional risk factors, included studies suggest that colonoscopic surveillance commenced from 8 to 10 years of diagnosis is warranted for pancolitis, and from 12 years in left sided colitis. In patients with additional risk factors for colorectal cancer, evidence suggests that surveillance may commence sooner, depending on the nature of the additional risk factors.
Empirical data are limited regarding the frequency with which surveillance colonoscopy should be performed in patients with inflammatory bowel disease. Available evidence suggests that ongoing colonoscopic surveillance should be performed at intervals of between ≤12 months and 5 years, depending on the endoscopic findings and clinical risk factors in the individual patient. The body of literature regarding the use of surveillance colonoscopy in inflammatory bowel disease is mostly related to the management of patients with ulcerative colitis.
iv. Older people: There was no direct evidence supporting cessation of colonoscopic screening based solely on the patient’s age. There were no trials identified in this review that assessed optimal intervals between colonoscopy examinations in older versus younger people for specific clinical conditions in which colonoscopic surveillance was indicated.
v. Patients with a past history of bowel cancer: Studies included in this review demonstrate a significant risk of synchronous and metachronous cancers and adenomas after resection of colorectal cancer. Colonoscopy is indicated pre- or peri-operatively to identify and manage synchronous lesions.
Studies included in this review suggest that post-operative colonoscopy performed within 12 months of surgery reduces the incidence of high-risk lesions at 1 year, including advanced adenomas, new cancer diagnoses and localised recurrence of malignancy.
Decisions regarding subsequent post-operative colonoscopies are determined according to the clinical features of the individual case. Five years is the maximum timeframe within which repeat colonoscopy is recommended in studies of patients with normal post-operative index colonoscopy. In patients with abnormal colonoscopy, repeat colonoscopy was performed at between 1 and 3 years, depending on the patients risk for subsequent neoplasia, in included studies.
vi. Patients with a past history of adenoma: The recommended timing of surveillance colonoscopy in patients with a past history of adenoma varies according to adenoma size, number and histological features. Surveillance intervals proposed across published studies vary between several months (in patients with incompletely removed adenomas) and 10 years (in patients with one or two lower risk adenomas and no other risk factors for colorectal cancer). In general, patients with larger adenomas, adenomas with higher grades of dysplasia, adenomas with villous components, patients with multiple adenomas and patients with other risk factors for development of colorectal neoplasia require more frequent surveillance. Patients with incomplete or inadequate colonoscopic examination require re-examination within 12 months of the prior examination.
MBS Data:The majority (68%) of patients receiving MBS-rebated colonoscopy have not had another MBS-rebated colonoscopy in the 10 years preceding the procedure. Patient aged between 50 and 74 years receive the majority of repeat MBS-rebated colonoscopies.
Approximately 1.5% of patients received 5 or more MBS-rebated colonoscopies over a 10-year period. Available MBS data do not provide information regarding the clinical indications for colonoscopies at this higher frequency.
2. What is the effectiveness of colonoscopy in improving outcomes in key target populations receiving colonoscopy?
What is the likelihood of a single colonoscopy leading to the detection of an adenoma and / or colorectal cancer? / Cancer prevention: Colonoscopy is adiagnostic and therapeutic tool that is used for the prevention and early identification of colorectal neoplasia in patients in whom the procedure is indicated. Colonoscopy appears to prevent colorectal cancer from developing in many at-risk patients through the identification and removal of pre-malignant tumours; appears to assist in the identification of malignant tumours at an earlier disease stage than would otherwise be detected; and may be colon-sparing in some patients with inflammatory bowel disease.
Diagnosis of pathology in symptomatic patients: The effectiveness of colonoscopy in the diagnosis of pathology in symptomatic patients varies according to the personal and clinical characteristics of the patient. Rates of diagnosis of significant pathology are higher in older compared with younger patients; and in patients whose symptoms include rectal bleeding or unexplained weight loss. Older compared with young patients with iron deficiency anaemia and patients with abnormal imaging and / or elevated carcinoembryonic antigen (CEA) levels also have higher rates of diagnosis of significant pathology at colonoscopy.
Detection of an adenoma and / or colorectal cancer: The likelihood of a single colonoscopy leading to the detection of an adenoma and / or carcinoma varied across studies according to the clinical and personal characteristics of the patient and according to the technical aspects of the colonoscopy itself. Colorectal carcinoma was detected in between 0.3% and 6% of patients in ‘usual’ colonoscopic practice in this review; and adenomas were diagnosed in up to 25% of patients.
Appropriateness criteria and diagnostic yield: Appropriateness criteria identify patients in whom the diagnostic yield from colonoscopy is greater. Patients in whom appropriateness criteria assess colonoscopy as ‘inappropriate’ may also have significant pathology present, although the diagnostic yield in this group is lower.
3. How do safety and quality outcomes of colonoscopy vary according to:
- the procedural volumes of providers performing colonoscopy?
- certification / re-certification processes for providers performing colonoscopy? / Procedural volume: Procedural volume is one of a range of factors affecting the procedural quality of colonoscopy. Included studies demonstrate a trend towards improved procedural quality with increasing numbers of procedures performed, provided the colonoscopist is appropriately trained.
Relationships between the procedural volume of the colonoscopist and detection of adenomas, development of subsequent colorectal cancer and adverse outcomes associated with colonoscopy have been observed. There is no clearly identifiable threshold volume of colonoscopy procedures below which procedural quality and safety declines noticeably in studies included within this review.
Medicare data indicate that the majority of providers performing MBS-rebated colonoscopy achieve procedural volumes above the minimum threshold recommended by the Quality Working Group of the National Bowel Cancer Screening Program. Medicare data are insufficient to determine the procedural volumes of all colonoscopists as procedures performed in public settings are not included in this dataset.
Certification / re-certification processes: No studies were identified that appraised the impact of certification or re-certification processes on the safety and quality outcomes of colonoscopy.
The Quality Working Group of the National Bowel Cancer Screening Program recommends that “compulsory certification by the Conjoint Committee should be introduced for all proceduralists performing colonoscopies as a prerequisite for making claims under the MBS and participating in the NBCSP”.
4. How cost-effective is colonoscopy in key target populations? / Cost-effectiveness of colonoscopy: Colonoscopy appears to be a cost-effective procedure across a broad range of clinical conditions. The personal and clinical characteristics of the patient, the skills and experience of the colonoscopist and the setting in which the colonoscopy is performed contribute to the cost-effectiveness of the procedure.
5. Are all patient groups in whom colonoscopy should be used able to access colonoscopy?
What is the impact of open access colonoscopy on access? / Access to colonoscopy: Analysis of Medicare data demonstrates a lower number of providers per 1,000 population for people in small rural and remote areas. However, access to colonoscopy services for patients in remote and very remote areas may occur through the public sector and may not be MBS-rebated. No peer-reviewed studies were identified that examined whether all patient groups in whom colonoscopy should be used are able to access the procedure.
Interventions to improve access: Waiting list audit and the use of a patient navigator may improve access to colonoscopy services. Available published and unpublished data on the impact of waiting list audit on subsequent morbidity and mortality of patients whose colonoscopy was cancelled or delayed have not been assessed in studies included in this review.
Open access colonoscopy: Open access colonoscopy, where a patient is referred by a clinician for a colonoscopy without a prior consultation with the specialist performing the colonoscopy, may improve access to services. There is some evidence suggesting that open access colonoscopy is associated with reduced waiting times but not with an increase in the number of colonoscopies performed that are not clinically indicated. No studies were included that systematically addressed adverse outcomes from open access colonoscopy.
Background
Colonoscopy is an endoscopic procedure for examination of the terminal ileal, colonic and rectal mucosa. It is used in the diagnosis, management and ongoing follow-up of patients with a range of clinical conditions including neoplastic, inflammatory and familial conditions. Although colonoscopy services are predominantly provided to adult patients, the procedure is also performed in paediatric patients.
Colonoscopy is the gold standard for the examination of the bowel lining. It allows direct mucosal inspection to the terminal ileum and biopsy of or definitive treatment by polypectomy. Patients generally adopt a liquid diet one or more days prior to examination, followed by ingestion of oral lavage solutions and / or use of laxatives to stimulate bowel movements. Patients receive sedation or an anaesthetic to make the procedure more comfortable (Schroy 2007; Zubarik 2002).
A principal benefit of colonoscopy is that it allows for a full structural examination of the bowel in a single session and for the removal or biopsy of lesions identified during the procedure. Other forms of colon investigation, if positive, usually require colonoscopy as a follow up procedure (Winawer 2003).
Colonoscopy is widely available throughout both Australia’s public and private sectors. Services are provided predominantly in public and private hospital settings. However, settings such as stand-alone day units may also be utilised. Clinicians who perform colonoscopy may possess specialist gastroenterology, general medicine, surgical or primary care specialty qualifications. Approximately 75% of all colonoscopies performed on an admitted patient basis in Australiain 2008/09were performed in the private sector, compared with 63% in 2001/02 (National Admitted Patient Care Dataset, 2001/02 to 2008/09).
There is an existing Australian process for formal recognition of training in colonoscopy by the Conjoint Committee for the Recognition of Training in Gastrointestinal Endoscopy, a conjoint committee of the RoyalAustralasianCollege of Surgeons, the Gastrointestinal Society of Australia and the RoyalAustralasianCollege of Physicians (Conjoint Committee 2011). Conjoint committee recognition is not a requirement for access to MBS items.
Guidance for colonoscopy in Australia
Clinicians access a variety of sources of guidance regarding the use of colonoscopy in specific disease states.