Quality Colonoscopy in US and Europe: How Are They Moving?

Transcription

1 Symposium Symposium III - Lower GI : Quality Colonoscopy Quality Colonoscopy in US and Europe: How Are They Moving? Jae Myung Cha Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea Introduction The Institute of Medicine (IOM) defined health-care quality as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. At 2000 and 2001, two IOM publications highlighted widespread gaps in health-care quality. To Err Is Human reported that tens of thousands of Americans die each year from errors in their care, and hundreds of thousands suffer or barely escape nonfatal injuries. Crossing the Quality Chasm concluded that between the health care we have and the care we could have lies not just a gap, but a chasm. These two reports were a call to action-demanding accountability from the health-care system and implying that system-wide changes were necessary to substantially improve care. The growing interest in quality of care that was ignited with the IOM reports has continued to gain momentum, particularly in the era of health-care reform and its emphasis on performance, accountability, and value in health care. On the current landscape, multiple stakeholders have emerged with strong interests in defining what quality is, how it should be measured, and how the results should be used. As the quality landscape continues to change, so too will its impact on the practicing clinician. On this subject, current trend of quality colonoscopy in US and Europe will be discussed. Review Defining quality colonoscopy is less straightforward than it might seem and will often mean something different to different stakeholders. From the endoscopist s view, doing a complete colonoscopy, seeing everything there is to see and removing all polyps safely are paramount. In a recent decade, data about quality colonoscopy are progressively increasing. There is a significant quality gap in colonoscopy between endoscopists and endoscopic centers, and there is a significant room for quality improvement in colonoscopy, even in USA and Europe. Development of quality indicators The US Preventive Services Task Force recommends colonoscopy as an effective method of screening for colorectal cancer in adults aged years. In 2000 the ASGE was the first group to put forth a list of colonoscopy quality indicators, and 2 years later these indicators were updated by a multi-society task force. In 2006 a combined ASGE/ACG task force published a set of 14 quality indicators (Table 1). The European Society of Gastrointestinal Endoscopy (ESGE) commissioned the Position Statement. The recommendations has been produced under the auspices of the ESGE with the aim of providing clear and simple advice for countries setting up organized screening programs, to allow assessment of safety and quality relevant to screening colonoscopy. The Position Statement of ESGE document proposes thresholds for acceptable colonoscopic practice, however, the precise quality assurance thresholds will depend on the details of a country s screening program. The list of rec- S58 62 nd Congress of the Korean Society of Gastrointestinal Endoscopy Clin Endosc Vol. 45 Suppl 1, 2012

2 Jae Myung Cha Table 1. Quality Indicators for Colonoscopy, Proposed by the American Society for Gastrointestinal Endoscopy/American College of Gastroenterology Task Force 1. Appropriate indication 2. Informed consent is obtained, including specific discussion of risks associated with colonoscopy 3. Use of recommended postpolypectomy and post-cancer resection surveillance intervals 4. Use of recommended ulcerative colitis/crohn s disease surveillance intervals 5. Documentation in the procedure note of the quality of the preparation 6. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo-documentation of landmarks should be present in every procedure) 7. Detection of adenomas in asymptomatic individuals (screening) 8. Withdrawal time: mean withdrawal time should be >6 minutes in colonoscopies with normal results performed in patients with intact anatomy 9. Biopsy specimens obtained in patients with chronic diarrhea 10. Number and distribution of biopsy samples in ulcerative colitis and Crohn s colitis surveillance. Goal: 4 per 10-cm section of involved colon or approximately 32 specimens per case of pancolitis 11. Mucosally based pedunculated polyps and sessile polyps <2 cm in size should be endoscopically resected or documented for unresectability 12. Incidence of perforation by procedure type (all indications versus screening) is measured 13. Incidence of postpolypectomy bleeding is measured 14. Postpolypectomy bleeding managed nonoperatively ommendations is summarized in Table 2, and Table 3 details the information that should be included in the screening colonoscopy report. Recently, Spanish Society of Gastroenterology (SSE) and Spanish Society of Gastrointestinal Endoscopy (SSGE) Working Group developed clinical practice guidelines on quality of colonoscopy in colorectal cancer screening. Table 4 summarizes the quality indicators and auditable outcomes for quality monitoring in screening colonoscopy. The quality indicators of colonoscopy have changed to definite, evidence-based guidelines from primitive previous indicators. The previous quality indicators are provider oriented, however, up to date quality indicators are oriented to safety and patient s experience. Development of quality assurance in USA In 2008, the AGA, ASGE, and ACG, along with the AMA-convened Physician Consortium for Performance Improvement (PCPI), developed three measures regarding colonoscopy and polyp surveillance. One of these measures (colonoscopy interval for patients with a history of adenomatous polyps-avoidance of inappropriate use) was incorporated into the Medicare Physician Quality Reporting Initiative (PQRI) as measure number 185. More recently, this and another measure (appropriate follow-up interval for normal colonoscopy in average-risk patients) were endorsed by the National Quality Forum (NQF), virtually ensuring the permanence of these measures and making it likely that they will be adopted by quality-reporting incentive programs offered by many payers. In conjunction with measure development, the AGA has developed the Digestive Health Outcomes Registry (DHOR), which contains all of the current NQF-endorsed colonoscopy measures in addition to IBD measures, and other gastroenterology-specific Physician Quality Reporting System (PQRS) measures. DHOR is a revolutionary national outcomes-driven registry, and it allows practices to use a single registry to meet all current and pending NQF- or PQRS-endorsed quality measures ( The performance measures for the DHOR were developed in a collaborative process using an expert panel. Colorectal cancer prevention (CRC-P) and inflammatory bowel disease, and clinical practice workflow experts were identified from within the AGA membership community to develop a performance measure set. For example, CRC-P measures are composed of CRC-P 1: Identification of CRC Risk, CRC-P 2: Endoscopic Examination Interval, Clin Endosc Vol. 45 Suppl 1, nd Congress of the Korean Society of Gastrointestinal Endoscopy S59

3 Quality Colonoscopy in US and Europe: How Are They Moving? Table 2. Quality Assurance (QA) in Screening Colonoscopy: Summary of Recommendations QA item Consent and withdrawal of consent Experience of the screening colonoscopist Bowel cleansing Sedation, analgesia, and comfort Unadjusted cecal intubation rate Adenoma and cancer detection rates Proposed standard Audit the number of patients who decline colonoscopy on the day of the procedure and the number of intraprocedural withdrawals of consent. Proposed standard: fewer than 5% of cases to withdraw consent on the day of the procedure and fewer than1% during the procedure We recommend that a minimum lifetime colonoscopy experience together with a minimum number of annual screening colonoscopies should be agreed. The state of bowel cleansing should be audited. Proposed standard: at least 90% of examinations should be rated as adequate bowel cleansing or better Audit of sedation practices, including average doses used of medication together with comfort scores. Proposed standard: no more than 1% of patients should become hypoxic (saturation below 85% for more than 30 seconds) or for other reasons require administration of a reversal agent Audit the completion rate for all colonoscopies. Proposed standard: unadjusted cecal intubation rate of at least 90% The number of detected adenomas and cancers should be audited. Colonoscope withdrawal time Average withdrawal times should be audited. Proposed standard: a minimum of 6 minutes in at least 90% of purely diagnostic examinations Polyp retrieval rate Screening programs anticipate that all resected polyps are retrieved for histological analysis. Proposed standard: 90% of resected polyps should be retrieved for histological analysis Significant interval lesions Specialist referral for removal of larger polyps Cleaning and disinfection Tattooing sites of larger polyps and cancers We recommend that screening programs monitor size, appearance, location, and histology of all polyps larger than 1 cm and cancers found between screening examinations as well as after the patient has been discharged from a screening program. We anticipate that the removal of larger polyps will be deferred to a dedicated clinical session, perhaps at a separate tertiary referral centre. Screening programs should record how larger polyps detected at screening are managed, together with details of outcomes. Adoption of manufacturers, national, and European standards for disinfection. Proposed standard: routine microbiological testing at intervals not exceeding 3 months We recommend that screening programs set standards regarding which polyp sites should be tattooed. Proposed standard: the placement of tattoos following the removal of all polyps 2 cm or larger outside of fixed colonic landmarks such as the cecum and rectum Unscheduled readmissions We recommend that screening programs record details of all emergency admissions within 30 days of the screening colonoscopy. Perforation rate We recommend that details should be recorded of all perforations complicating diagnostic and therapeutic procedures, that require surgical repair and that occur up to 2 weeks after endoscopy. Proposed standard: fewer than 1:1000 diagnostic or therapeutic examinations should result in a perforation requiring surgical repair Bleeding rate All cases of immediate and late bleeding following polypectomy should be recorded. Proposed standard: fewer than 1:20 cases of bleeding should ultimately require surgical intervention CRC-P 3: Use of Anesthesia Professionals, CRC-P 4: Procedure-Related Complications, CRC-P 5: Colonoscopy Assessment (Procedural Adequacy), CRC-P 6: Adenoma Detection Rate. S60 62 nd Congress of the Korean Society of Gastrointestinal Endoscopy Clin Endosc Vol. 45 Suppl 1, 2012

4 Jae Myung Cha Table 3. Details to Be Included in the Colonoscopy Report Patient details Endoscope used Name and position of endoscopist and ancillary staff Indication for the procedure Bowel cleansing Intubation Disease detected and management Development of quality assurance in Europe Manufacturer, model, and serial number Number of screening round Details and interval to the recent screening investigation Follow-up polypectomy after previous screening colonoscopy Bowel cleansing regimen given Patient tolerance of bowel cleansing regimen Mucosal views obtained Limit of examination including reason why examination was incomplete Duration of intubation to limit of examination Duration of extubation Site of each lesion Size of the lesion (as estimated by the endoscopist) Growth morphology (Paris classification) Crypt pattern of each lesion (Kudo s classification) Endoscopic diagnosis of each lesion Action taken for each lesion Success and complications in removing each lesion Diathermy settings used for cautery Final histological diagnosis Before 2001 the experience of patients undergoing an endoscopy in the UK was poor. Three reports identified waiting times of up to a year, poor infrastructure, inadequate training, and low standards, particularly of colonoscopy. In 2004, it was estimated that more than 250,000 people were waiting for an endoscopy without an appointment. A confidential inquiry into deaths occurring within 30 days of an endoscopy identified futile procedures performed on very sick patients and procedures carried out by unsupervised trainees with significant risks. Some post-procedure deaths were attributed to excess sedation and others to inadequate subsequent care of patients. There was clearly considerable room for quality improvement in the UK. In 2001 the NHS Modernisation Agency began work in the endoscopy service with focuses on analyzing demand and capacity and on redesigning the service to achieve greater efficiency. The Agency initiated pilot work with the main of an efficient service with low waits. A completely separate initiative sponsored by the Department of Health s cancer policy team began in 2001 with the aim improve training, particularly in colonoscopy. Effective leadership at all levels and strong partnerships between leaders were significant factors in the changes to the service in the UK. The Joint Advisory Group (JAG) on Gastrointestinal Endoscopy represents all professional stakeholders involved in the service, including physicians, surgeons, nurses, radiologists, pediatricians, and general practitioners. The JAG was originally created to oversee standards in endoscopy training and in 2004 its remit was extended to include quality assuring service delivery within endoscopy units. The JAG now has 3 working groups overseeing the quality assurance of training, individual endoscopists, and endoscopy units. It is seen as the principal body responsible for quality control of endoscopy in the UK. Clinicians in the UK are often sceptical of overly bureaucratic process and/or have an independent disposition. Furthermore, they consider performance monitoring an unnecessary imposition, and a small minority also resists the development of robust quality assurance because they know they will fall below the standards. To engaging doctors, the Clin Endosc Vol. 45 Suppl 1, nd Congress of the Korean Society of Gastrointestinal Endoscopy S61

5 Quality Colonoscopy in US and Europe: How Are They Moving? Table 4. Quality Indicators and Auditable Outcomes for Quality Monitoring in Colorectal Cancer Screening Indicator Definition Acceptable level Adenoma detection rate Proportion of colonoscopies performed in asymptomatic individuals over 50 > 20% (ADR) in which at least one adenoma has been detected. ADR after positive FOBT Proportion of colonoscopies performed in individuals after a positive FOBT in > 40% which at least one adenoma has been detected. Colonoscopy withdrawal time Mean time from cecal intubation to colonoscopy extraction through the anus. > 6 minutes Endoscopist experience Number of colonoscopies performed during the endoscopist career (previous) and during the last year (annual) Previous: 400 Annual: 200 Cecal intubation rate Proportion of procedures in which cecal intubation is achieved > 95% Waiting time from positive Time from communication of positive FOBT result to follow-up colonoscopy. < 6 weeks FOBT to CFS Use of sedation Proportion of colonoscopies performed under sedation > 90% Appropriate bowel cleansing Proportion of procedures in which colon cleansing is considered excellent or > 90% good. Colon perforation rate Proportion of procedures in which a colon perforation is direct consequence of the procedure. < 1/1,000 colonoscopies Post-polypectomy bleeding rate Description of polyp characteristics Staff, infrastructures, and endoscopy unit equipment Independent screening colonoscopy program Record of complications Endoscopic resection of pedunculated polyps and sessile/flat polyps Retrieval rate of resected polyps Information and consent CFS complications due to lack of previous assessment Proportion of individuals who have a significant bleeding requiring hospitalization as a consequence of an endoscopic polypectomy. Appropriate description of polyps in shape, size, location and type following the Paris classification At least 2 endoscopists fulfill acceptable level Screening colonoscopies are performed in independent programs, separated from diagnostic or therapeutic procedures performed in symptomatic patients. Existence of an active record of the complications arising in screening colonoscopies All pedunculated polyps and sessile or flat polyps smaller than 2 cm are endoscopically resected. Proportion of resected polyps that are retrieved for pathological study. Existence of an information sheet and a consent document signed by all the persons before the CFS. Colonoscopy complications related to the lack of knowledge of patient history or use of antiplatelet or anticoagulant therapy < 1/200 polypectomies Attempt: Extirpation > 95% > 95%: > 10mm > 80%: < 10 mm < 10% Decontamination indicators Appropriate control of endoscopy disinfection measures Every 3 months Existence of a program of Endoscopy unit is following an appropriate quality control program. Yearly quality improvement ADR, adenoma detection rate; CFS, colonoscopy; FOBT, fecal occult blood test National Endoscopy Team recruited 28 clinical leads in , 1 for each of the 28 regional health authorities that existed at the time, and 10 training leads, 1 for each training center. These 38 leaders, fronted by the National Team and the JAG, played a substantial role in setting an example and persuading their peers to adopt the training, quality improvement, and quality assurance methodologies. For local leadership in endoscopy units, the Team Leadership Programme (TLP) is developed and aimed at the doctors, nurses, and managers. Its curriculum includes the following: strategic and organizational responsibilities; shared leadership; team culture, working, and processes; individual leadership skills; managing S62 62 nd Congress of the Korean Society of Gastrointestinal Endoscopy Clin Endosc Vol. 45 Suppl 1, 2012

6 Jae Myung Cha projects; and effective communication. The National Endoscopy Team, together with the 38 regional clinical and training leads, created a measuring instrument called the endoscopy Global Rating Scale ( The 12 items are divided into 2 domains : clinical quality and quality of the patient experience. The first version of the GRS had descriptors to define levels of achievement from level D to level A, where D indicated a very basic service and A an excellent service. The paper-based process was converted into a Web-based scoring tool. Each endoscopy team is required to self-assess using the GRS twice a year in April and October. The final upload of scores must be signed off by the clinical and nurse leads and a manager. There have been 13 national censuses with compliance of 98% in each for the past few years. A knowledge management system (KMS) was created to enable teams to share best examples of policies and processes, local and national guidelines, and improvement case studies. The KMS is an integral part of the GRS: it is designed so that information is hyperlinked to the relevant measure. In JAG accreditation system, a peer review team consists of 2 medical endoscopists assessing the training environment and the clinical aspects of the service, and a third assessor (usually a nurse), is responsible for assessing the physical environment, nurse processes, decontamination, etc. The endoscopy GRS domains are used as a standards framework for the assessment. A large part of the process requires validation of self-assessed scores using evidence submitted by the team. The status following a visit is passed, deferred, or failed. Most units are deferred for between 2 and 6 months, and passed units are accredited for 5 years. Conclusion Quality measurement and improvement have now become a central component of the practice of medicine. To date, much of the quality-of-care work in the gastrointestinal community has concentrated on the development of measures for accountability and reimbursement. Incorporation of quality improvement principles into clinical practice will ultimately be needed to improve care and outcomes for our patients. The current landscape of quality assurance in USA and Europe will provide a roadmap for a quality assurance of Korea. References 1. Lohr KN (ed). Medicare: A Strategy for Quality Assurance. Institute of Medicine. National Academy Press: Washington, DC, Kohn LT, Corrigan JM, Donaldson MS (eds). To Err Is Human: Building a Safer Health System. Institute of Medicine. National Academy Press: Washington, DC, Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academy Press: Washington, DC, Dorn SD. United States health care reform in 2009: a primer for gastroenterologists. Clin Gastroenterol Hepatol 2009;7: Rembacken B, Hassan C, Riemann JF, et al. Quality in screening colonoscopy: positin statement of the European Society of Gastrointestinal Endoscopy (ESGE). Endoscopy 2012;44: Jover R, Herraiz M, Alarcon O, et al; Spanish Society of Gastroenterology; Spanish Society of Gastrointestinal Endoscopy Working Group. Clinical practice guidelines: quality of colonoscopy in colorectal cancer screening. Endoscopy 2012;44: Kappelman MD, Dorn SD, Peterson E, et al. Quality of care for gastrointestinal conditions: a primer for gastroenterologists. Am J Gastroenterol 2011;106: Valori R. Quality improvement in endoscopy in England. Tech Gastrointest Endosc 2012;14: Clin Endosc Vol. 45 Suppl 1, nd Congress of the Korean Society of Gastrointestinal Endoscopy S63