Quality Indicators for Colonoscopy

Douglas K Rex MD; Philip S Schoenfeld MD, MSEd, MSc (Epi); Jonathan Cohen MD; Irving M Pike MD; Douglas G Adler MD; M Brian Fennerty MD; John G Lieb MD; Walter G Park MD, MS; Maged K Rizk MD; Mandeep S Sawhney MD, MS; Nicholas J Shaheen MD, MPH; Sachin Wani MD; David S Weinberg MD, MSc

Disclosures

Am J Gastroenterol. 2015;110(1):72-90.

Abstract and Introduction

Introduction

Colonoscopy is widely used for the diagnosis and treatment of colon disorders. Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Visualization of the mucosa of the entire large intestine and distal terminal ileum usually is possible during colonoscopy. Polyps can be removed during colonoscopy, thereby reducing the risk of colon cancer. Colonoscopy is the preferred method to evaluate the colon in most adult patients with large-bowel symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon, positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In addition, colonoscopy is the most commonly used CRC screening test in the United States.^[1] Based on 2010 data, over 3.3 million outpatient colonoscopies are performed annually in the United States, with screening and polyp surveillance accounting for half of indications.^[2]

Optimal effectiveness of colonoscopy depends on patient acceptance of the procedure, which depends mostly on acceptance of the bowel preparation.^[3] Preparation quality affects the completeness of examination, procedure duration, and the need to cancel or repeat procedures at earlier dates than would otherwise be needed.^[4,5] Ineffective preparation is a major contributor to costs.^[6] Meticulous inspection^[7,8] and longer withdrawal times^[9–14] are associated with higher adenoma detection rates (ADR). A high ADR is essential to rendering recommended intervals^[15] between screening and surveillance examinations safe.^[16,17] Optimal technique is needed to ensure a high probability of detecting dysplasia when present in inflammatory bowel disease.^[17–21] Finally, technical expertise and experience will help prevent adverse events that might offset the benefits of removing neoplastic lesions.^[22]

Recent studies report that colonoscopy is less effective in preventing proximal colon cancer and cancer deaths (ie, colon cancer proximal to the splenic flexure) compared with distal cancer (ie, colon cancer at or distal to the splenic flexure).^[23–28] Decreased protection against right-sided CRC is likely due to multiple factors. These include missed adenomas or incompletely resected adenomas; suboptimal bowel preparation; precancerous lesions that are endoscopically subtle or difficult to remove, such as sessile serrated polyps and flat and/or depressed adenomas, and differences in tumorigenesis between right-sided and left-sided cancers. Improving prevention of right-sided colon cancer is a major goal of colonoscopy quality programs.

Five studies have established that gastroenterologists are more effective than surgeons or primary care physicians at preventing CRC by colonoscopy.^[27,29–32] This most likely reflects higher rates of complete examinations (ie, cecal intubation)^[30] and higher rates of adenoma detection among gastroenterologists.^[33,34] All endoscopists performing colonoscopy should measure the quality of their colonoscopy. Institutions where endoscopists from multiple specialties are practicing should reasonably expect all endoscopists to participate in the program and achieve recommended quality benchmarks.

The quality of health care can be measured by comparing the performance of an individual or a group of individuals with an ideal or benchmark.^[35] The particular parameter that is being used for comparison is termed a quality indicator. A quality indicator often is reported as a ratio between the incidence of correct performance and the opportunity for correct performance^[4] or as the proportion of interventions that achieve a predefined goal.^[35] Quality indicators can be divided into 3 categories: (1) structural measures—these assess characteristics of the entire health care environment (eg, participation by a physician or other clinician in systematic clinical database registry that includes consensus endorsed quality measures), (2) process measures—these assess performance during the delivery of care (eg, ADR and adequate biopsy sampling during colonoscopy for chronic ulcerative colitis), (3) outcome measures—these assess the results of the care that was provided (eg, the prevention of cancer by colonoscopy and reduction in the incidence of colonoscopic perforation).

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Abstract and Introduction
Methodology
Conclusion
References

Table 1. Grades of recommendation ^a
Grade of recommendation	Clarity of benefit	Methodologic strength supporting evidence	Implications
1A	Clear	Randomized trials without important limitations	Strong recommendation, can be applied to most clinical settings
1B	Clear	Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws)	Strong recommendation, likely to apply to most practice settings
1C+	Clear	Overwhelming evidence from observational studies	Strong recommendation, can apply to most practice settings in most situations
1C	Clear	Observational studies	Intermediate-strength recommendation, may change when stronger evidence is available
2A	Unclear	Randomized trials without important limitations	Intermediate-strength recommendation, best action may differ depending on circumstances or patients' or societal values
2B	Unclear	Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws)	Weak recommendation, alternative approaches may be better under some circumstances
2C	Unclear	Observational studies	Very weak recommendation, alternative approaches likely to be better under some circumstances
3	Unclear	Expert opinion only	Weak recommendation, likely to change as data become available

^aAdapted from Guyatt G, Sinclair J, Cook D, et al. Moving from evidence to action. Grading recommendations—a qualitative approach. In: Guyatt G, Rennie D, editors. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599–608.

Table 2. Summary of proposed quality indicators common to all endoscopic procedures (38) ^a
Quality indicator	Grade of recommendation	Measure type	Performance target (%)
Preprocedure
1. Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications, and the indication is documented (priority indicator)	1C+	Process	>80
2. Frequency with which informed consent is obtained and fully documented	3	Process	>98
3. Frequency with which preprocedure history and directed physical examination are performed and documented	3	Process	>98
4. Frequency with which risk for adverse events is assessed and documented before sedation is started	3	Process	>98
5. Frequency with which prophylactic antibiotics are administered for appropriate indication (priority indicator)	Varies	Process	>98
6. Frequency with which a sedation plan is documented	Varies	Process	>98
7. Frequency with which management of antithrombotic therapy is formulated and documented before the procedure (priority indicator)	3	Process	N/A
8. Frequency with which a team pause is conducted and documented	3	Process	>98
9. Frequency with which endoscopy is performed by an individual who is fully trained and credentialed to perform that particular procedure	3	Process	>98
Intraprocedure
10. Frequency with which photodocumentation is performed	3	Process	N/A
11. Frequency with which patient monitoring during sedation is performed and documented	3	Process	>98
12. Frequency with which the doses and routes of administration of all medications used during the procedure are documented	3	Process	>98
13. Frequency with which use of reversal agents is documented	3	Process	>98
14. Frequency with which procedure interruption and premature termination due to sedation-related issues is documented	3	Process	>98
Postprocedure
15. Frequency with which discharge from the endoscopy unit according to predetermined discharge criteria is documented	3	Process	>98
16. Frequency with which patient instructions are provided	3	Process	>98
17. Frequency with which the plan for pathology follow-up is specified and documented	3	Process	>98
18. Frequency with which a complete procedure report is created	3	Process	>98
19. Frequency with which adverse events are documented	3	Process	>98
20. Frequency with which adverse events occur	3	Outcome	N/A
21. Frequency with which postprocedure and late adverse events occur and are documented	3	Outcome	N/A
22. Frequency with which patient satisfaction data are obtained	3	Process	N/A
23. Frequency with which communication with referring provider is documented	3	Process	N/A

N/A, not available.
^aThis list of potential quality indicators is meant to be a comprehensive list of measurable end points. It is not the intention of the task force that all end points be measured in every practice setting. In most cases, validation may be required before a given end point may be adopted universally.

Table 3. Appropriate indications for colonoscopy (39)
Evaluation of an abnormality on barium enema or other imaging study that is likely to be clinically significant, such as a filling defect or stricture
Evaluation of unexplained GI bleeding
Hematochezia
Melena after an upper GI source has been excluded
Presence of fecal occult blood
Unexplained iron deficiency anemia
Screening and surveillance for colon neoplasia
Screening of asymptomatic, average-risk patients for colon neoplasia
Examination to evaluate the entire colon for synchronous cancer or neoplastic polyps in a patient with treatable cancer or neoplastic polyp
Colonoscopy to remove synchronous neoplastic lesions at or around the time of curative resection of cancer followed by colonoscopy at 1 year and, if examination normal, then 3 years, and, if normal, then 5 years thereafter to detect metachronous cancer
Surveillance of patients with neoplastic polyps
Surveillance of patients with a significant family history of colorectal neoplasia
For dysplasia and cancer surveillance in select patients with long-standing ulcerative or Crohn's colitis
For evaluation of patients with chronic inflammatory bowel disease of the colon, if more precise diagnosis or determination of the extent of activity of disease will influence management
Clinically significant diarrhea of unexplained origin
Intraoperative identification of a lesion not apparent at surgery (eg, polypectomy site, location of a bleeding site)
Treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site
Intraoperative evaluation of anastomotic reconstructions (eg, evaluation for anastomotic leak and patency, bleeding, pouch formation)
As an adjunct to minimally invasive surgery for the treatment of diseases of the colon and rectum
Management or evaluation of operative adverse events (eg, dilation of anastomotic strictures)
Foreign body removal
Excision or ablation of lesions
Decompression of acute megacolon or sigmoid volvulus
Balloon dilation of stenotic lesions (eg, anastomotic strictures)
Palliative treatment of stenosing or bleeding neoplasms (eg, laser, electrocoagulation, stenting)
Marking a neoplasm for localization

Table 4. Summary of proposed quality indicators for colonoscopy ^a
Quality indicator	Grade of recommendation	Measure type	Performance target (%)
Preprocedure
1. Frequency with which colonoscopy is performed for an indication that is included in a published standard list of appropriate indications, and the indication is documented	1C+	Process	>80
2. Frequency with which informed consent is obtained, including specific discussions of risks associated with colonoscopy, and fully documented	1C	Process	>98
3. Frequency with which colonoscopies follow recommended post-polypectomy and post-cancer resection surveillance intervals and 10-year intervals between screening colonoscopies in average-risk patients who have negative examination results and adequate bowel cleansing (priority indicator)	1A	Process	≥90
4. Frequency with which ulcerative colitis and Crohn's colitis surveillance is recommended within proper intervals	2C	Process	≥90
Intraprocedure
5. Frequency with which the procedure note documents the quality of preparation	3	Process	>98
6. Frequency with which bowel preparation is adequate to allow the use of recommended surveillance or screening intervals	3	Process	≥85 of outpatient examinations
7. Frequency with which visualization of the cecum by notation of landmarks and photodocumentation of landmarks is documented in every procedure (priority indicator)	1C	Process
Cecal intubation rate with photography (all examinations)			≥90
Cecal intubation rate with photography (screening)			≥95
8. Frequency with which adenomas are detected in asymptomatic average-risk individuals (screening) (priority indicator)	1C	Outcome
Adenoma detection rate for male/female population			≥25
Adenoma detection rate for male patients			≥30
Adenoma detection rate for female patients			≥20
9a. Frequency with which withdrawal time is measured	2C	Process	>98
9b. Average withdrawal time in negative-result screening colonoscopies	2C	Process	≥6 min
10. Frequency with which biopsy specimens are obtained when colonoscopy is performed for an indication of chronic diarrhea	2C	Process	>98
11. Frequency of recommended tissue sampling when colonoscopy is performed for surveillance in ulcerative colitis and Crohn's colitis	1C	Process	>98
12. Frequency with which endoscopic removal of pedunculated polyps and sessile polyps <2 cm is attempted before surgical referral	3	Outcome	>98
Postprocedure
13. Incidence of perforation by procedure type (all indications vs colorectal cancer screening/polyp surveillance) and post-polypectomy bleeding	1C	Outcome
Incidence of perforation—all examinations			<1:500
Incidence of perforation—screening			<1:1000
Incidence of post-polypectomy bleeding			<1%
14. Frequency with which post-polypectomy bleeding is managed without surgery	1C	Outcome	≥90
15. Frequency with which appropriate recommendation for timing of repeat colonoscopy is documented and provided to the patient after histologic findings are reviewed	1A	Process	≥90

^aThis list of potential quality indicators is meant to be a comprehensive listing of measurable end points. It is not the intention of the task force that all end points be measured in every practice setting. In most cases, validation may be required before a given end point may be adopted universally.

Table 5. Priority quality indicators for colonoscopy ^a
Frequency with which adenomas are detected in asymptomatic average-risk individuals (screening)
Frequency with which colonoscopies follow recommended post-polypectomy and post-cancer resection surveillance intervals and 10-year intervals between screening colonoscopies in average-risk patients who have negative examination results and adequate bowel cleansing
Frequency with which visualization of the cecum by notation of landmarks and photodocumentation of landmarks is documented in every procedure

^aSee text for specific targets and discussion.