Supporting Information 2. ESGE QIC Lower GI Delphi voting process: Round 1 Working chair: Michal F. Kaminski, Poland Population Interventions Comparator Outcome Additional evidence 1.1 Rate of adequate bowel preparation In patients undergoing screening or diagnostic bowel preparation quality should be recorded using a validated scale with high intraobserver reliability. A service should have >90% procedures with adequate bowel preparation. Adequate bowel preparation using Aronchick, Ottawa, general scales (other scales) Lower than analyzed caecal intubation Interval cancer 1.1 PREPROCEDURE 1 list pdfs of papaers with inter-observer reliability and achieved s of adequate bowel prep in 93.30 4.6 1.2 Rate of adequate bowel preparation In patients undergoing screening or diagnostic bowel preparation quality should be recorded using a validated scale with high intraobserver reliability. A service should have >90% procedures with adequate bowel preparation. Adequate bowel Adequate bowel preparation <95 (80%) % preparation 95 (80%) of cases % of cases \ proximal PDR 1.2 PREPROCEDURE 2 list pdfs of papaers with inter-observer reliability and achieved s of adequate bowel prep in 86.70 4.3 1.3 1.4 1.5 2.1 2.2 2.3 Time slot for Indication for Withdrawn consent for Cecal intubation Cecal intubation Photodocument ed cecal intubation Colonoscopy needs adequate time allocated for insertion, extubation and therapy. Routine procedures should be allocated a minimum 30 minutes and following positive fecal occult blood testing should be allocated a minimum 45 minutes to allow for therapeutic intervention. Colonoscopy report should include an explicit indication for the procedure categorized according to existing guidelines on appropriateness of use. The number informed consent for withdrawals should be recorded. Complete requires caecal intubation with complete visualization of caecal caput and its landmarks. A service should have a minimum unadjusted caecal intubation of 90% and aspirational of 95%. Complete examination should be documented in both written and photo or video report. More than 30 minutes (45min/ 1 hour) Audit using EPAGEII guidelines Photo documented caecal intubation + written report ( + what photographed) 30 minutes (45min) Audit using ASGE guidelines No PICO; the statement created following discussion during the TC on Sept 28, 2015 adjusted for obstructing tumors and poor bowel prep Photo documented caecal intubation + written report ( + what photographed) Documentation of caecal intubation included only in written report not adjusted for obstructing tumors and poor bowel prep Documentation of caecal intubation included only in written report / Diagnostic yield of cancer and/or need for repeat procedure\proximal polyp detection cancer and/or need for repeat procedure cancer and/or need for repeat procedure\proximal polyp detection 1.3 PREPROCEDURE 3 No evidence 73.30 4.0 1.4 PREPROCEDURE 4 only 80.00 3.9 None PREPROCEDURE 5 No evidence 33.30 3.0 2.1 2.2 2.1 COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE 6 In addition Baxter paper 100.00 4.7 7 Papers from UK on adjusted and unadjusted CIR 93.30 4.5 8 Additional evidence 2.3_1 93.30 4.5
ESGE QIC Lower GI Delphi voting process: Round 1 2.4 2.5 3.1 3.2 3.3 3.4 3.5 Terminal ileum intubation Rate of complete sigmoidoscopy Adenoma detection Adenoma detection Adenoma detection Adenoma detection Polypectomy 3.6 Withdrawal time 3.7 4.1 4.2 Rectal retroversion Adequate description of polyp morphology Incomplete resection Population Interventions Comparator Outcome Complete diagnostic in patients with chronic diarrhea requires terminal ileum intubation. Complete sigmoidoscopy requires visualization of rectum and sigmoid colon. Further advancement of endoscope depends on patients experience. should be used as a of adequate identification of pathology at screening or diagnostic. should be used as a of adequate identification of pathology at screening or diagnostic. should be used as a of adequate identification of pathology at screening or diagnostic. should be used as a of adequate identification of pathology at screening or diagnostic. Polypectomy should be used as a supportive of adequate identification of pathology. A mean withdrawal time should be used as a supportive of adequate identification of pathology at negative. A mean withdrawal time of at least 6 minutes should be used as a benchmark. Routine rectal retroversion could help to improve detection of adenomas at Paris classification should be routinely used to describe the morphology of polypoid and non-polypoid lesions identified at. In patients undergoing colonoscopic polypectomy the of incomplete polyp removal should be monitored. Patients with diarrhea undergoing diagnostic screening sigmoidoscopy removal of removal of non-polypoid colorectal lesions Terminal ileum intubation Length of the scope inserted (60cm?) Polyp detection (overall or only for >=5mm polyps) Proximal adenoma detection Advanced adenoma detection ( 10mm, or HGD, or villous component) Serd polyp detection Polyp detection (overall or only for 5mm polyps) Minimum mean withdrawal time Routine retroversion in the rectum Paris classification Therapeutic therapeutic Estimated reach of the splenic flexure Less than I No/non-routine retroversion in the rectum Three categories: stalked, sessile, non polypoid (flat and depressed) No applicable Need for repeat procedure (because of lack of biopsies\photodocumen tation second outcome) cancer / polyp detection /Polyp detection /Rate of missed adenomas\ patient experience\crc /Interrupted procedure \complication Incomplete polyp removal and/or need for repeat procedure 2.4 2.3 3.1 3.2 3.3 3.4 3.1 3.6 3.10 3.9 4.1 COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE of of of of of of of 9 10 Additional evidence Search for yield of TI intubation It has been rephrased following extensive discussion during TC on Sept 28, 2015 73.30 3.9 73.30 3.9 11 only 93.30 4.5 12 only 93.30 4.6 13 only 86.70 4.3 14 only 73.30 4.2 15 16 17 + 3.2_1+3.2_2 (Baxter and paper from Mayo clinic) + Shaukat from Gastro + Lee TJW (Gut 2012) 66.70 3.5 86.70 4.1 66.70 3.7 18 No evidence 73.30 4.0 19 86.70 4.1 2
ESGE QIC Lower GI Delphi voting process: Round 1 4.3 4.4 Incomplete resection Advanced imaging Population Interventions Comparator Outcome In patients undergoing colonoscopic polypectomy the of incomplete polyp removal should be monitored. In patients undergoing removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or non-granular or mixedtype laterally spreading tumors conventional or virtual chromoendoscopy should be used to improve delineation of lesion margins and predict potential depth of invasion. enbloc polyp removal (polypectomy, EMR, ESD) removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or nongranular or mixedtype laterally spreading tumors Completeness of removal assessed by pathologist Minimum of use of conventional chromoendoscopy or virtual (NBI, FICE, high scan) Completeness of removal assessed by endoscopist Less than I Interval CRC and/or need for repeat procedure/ recurrence at surveillance /Interrupted procedure / cancer detection 4.2 4.4 Additional evidence 20 60.00 3.5 21 No evidence 86.70 4.2 4.5 Tattooing resection sites In patients undergoing removal of lesions with a depressed component (0- removal of colorectal IIc according to the Paris classification) lesions with a depressed or non-granular or mixed-type laterally component (0-IIc spreading tumors located between ascending and sigmoid colon tattooing of the resection site should be used to improve future relocation of the resection site. according to the Paris classification) or nongranular or mixed-type laterally spreading tumors Tattooing resection sites No tattooing Ability to relocate resection site/ interval cancer 4.5 22 No evidence 100.00 4.3 4.6 Appropriate polypectomy technique Adequate resection technique of small and diminutive colorectal polyps includes biopsy forceps removal of polyps 3mm in size and snare polypectomy for larger polyps. removal of colorectal lesions Minimum of use of appropriate polypectomy technique (type of accessory used for lesion size) Less than I /Interrupted procedure, complications 4.6 23 + M.Ferlitsch paper 80.00 4.0 4.7 En-bloc resection In to decrease the risk of incomplete removal and polyp recurrence en-bloc resection of nonstalked colorectal polyps up to 2cm in size should be attempted. A service should have en-bloc resection of 85%. removal of non-stalked colorectal polyps up to (1) 2cm En-bloc resection Piecemeal resection /need for repeated procedure/ of recurrence/complication s 4.7 24 + CARE study + SEO JY, GIE 2015 for the of en-bloc resection 66.70 4.0 4.8 Polyp retrieveal The non-diminutive polyp retrieval should be monitored. A service should have polyp retrieval of 90%. No PICO; the statement created following discussion during the TC on Sept 28, 2015 None 25 Lee TJW, Gut 2012 80.00 4.1 5.1 Complication In patients undergoing a 6- day readmission and 30-day mortality should be monitored using a reliable system. /dia gnostic+biopsy/therape utic 30-day readmission using healthcare registries/hospital records review Patient reporting on bleeding/perforation Mortality/Hospital stay/patient experience 5.2 COMPLICATIONS 26 + Sarkar S, et al. Eur J Gastroenterol Hepatol 2012 + Munich polyp study and Adler A, et al. Endoscopy 2013 92.90 4.2 3
ESGE QIC Lower GI Delphi voting process: Round 1 5.2 Complication 6.1 Competence Population Interventions Comparator Outcome In patients undergoing a 6- day readmission and 30-day mortality should be monitored using a reliable system. Validated competence tools should be used to document progress and proficiency level during training. /dia gnostic+biopsy/therape utic Endoscopists performing Phone call/paper or electronic survey after 30 days on bleeding/perforation/ hospital records review Learning curves/semiobjective tools (like DOPS) Patient reporting on bleeding/perforation Minimum number of Mortality/ access to emergency department/hospital stay/frequency of complications/ 30 days readmission /adenoma detection /need for assistance from colleagues / patient experience 5.1 COMPLICATIONS 27 6.2 Additional evidence + Sarkar S, et al. Eur J Gastroenterol Hepatol 2012 + Munich polyp study and Adler A, et al. Endoscopy 2013 93.30 4.5 28 86.70 4.1 6.2 Minimum number of On average 300 and 300 polypectomies are needed to achieve competence in caecal intubation and complete resection of polyps, respectively. Endoscopists performing Minimum number of (overall or annual) Lower than I /adenoma detection /need for assistance from colleagues / patient experience 6.1 29 66.70 3.9 6.3 Leveles of competence in 7.1 Patient experience 7.2 Patient experience All certified colonoscopists should have EU level 2 competence in (removal of sessile and stalked lesions <25 mm providing there is good access). Patient experience during and after or sigmoidoscopy should be routinely d. Patient experience with or sigmoidoscopy should be self-reported by a patient using a validated scale. No PICO; the statement created following discussion during the TC on Sept 28, 2015 /th erapeutic or sigmoidoscopy with mode/no sedation /th erapeutic or sigmoidoscopy with mode/no sedation Assessed by the patients on the day after the procedure (phone/mailed survey) Assessed by endoscopist/nurse (questionnaire) Self-reported immediately after the procedure Self-reported Rate of patients reporting to be prepared for repeat procedure, Rate of severe/mode pain or no pain/ anxiety, discomfort Rate of severe/mode pain or no pain/ patient experience (i.e. anxiety, discomfort, of patients reporting to be prepared for repeat procedure) None 7.3 7.1 PATIENT EXPERIENCE PATIENT EXPERIENCE 30 EU guidelines 86.70 4.1 31 80.00 4.3 32 86.70 4.2 7.3 Patient experience Patient experience with or sigmoidoscopy should be self-reported by a patient using a validated scale. /th erapeutic or sigmoidoscopy with mode/no sedation VRS VAS Rate of severe/mode pain or no pain/other s (validity, responsiveness etc). 7.2 PATIENT EXPERIENCE 33 86.70 4.2 4
ESGE QIC Lower GI Delphi voting process: Round 1 8.1 The of appropriate postpolypectomy surveillance Appropriate post-plypectomy recommendations should be surveillance monitored. The reason for deviation recommendatio from national/european guidelines ns should always be provided. Population Interventions Comparator Outcome No PICO; the statement created following discussion during the TC on Sept 28, 2015 None POST- PROCEDURE 34 Additional evidence van Heijningen EM, et al. Gut 2015, maybe more 93.30 4.3 5
ESGE QIC Lower GI Delphi voting process: Round 2 N1.1 Rate of adequate bowel preparation Population Interventions Comparator Outcome In patients undergoing screening or diagnostic bowel preparation quality should be recorded using a validated scale with high intraobserver reliability. Adequate bowel preparation using Aronchick, Ottawa, general scales (other scales) Adequate bowel preparation using Boston Bowel Preparation Scale (each segment at least 2 points) / proximal Polyps DR/advanced adenoma detection /intraobserver reliability 1.1 PREPROCEDURE 1 1.1_1-5 100.00 4.8 N1.2 Rate of adequate bowel preparation A service should have a minimum of 90% procedures and a target of 95% procedures with adequate bowel preparation assessed using a validated scale with high intra-observer reliability. Adequate bowel preparation <95 (80%) % of cases Adequate bowel preparation 95 (80%) % of cases >90% of cases with adequate bowel preparations as assessed by a validated scale/adenoma detection /advanced adenoma detection / proximal PDR 1.2 PREPROCEDURE 2 1.2_1-2 100.00 4.6 N1.3 N1.4 1.5 N2.1 Time slot for Indication for Full consent for Colonoscopy needs adequate time allocated for insertion, extubation and therapy. Routine procedures should be allocated a minimum 30 minutes and following positive faecal occult blood testing should be allocated a minimum 45 minutes to allow for therapeutic intervention. For audit purposes, the report should include an explicit indication for the procedure, categorized according to existing guidelines on appropriateness of use. Informed consent for every possible action undertaken during should be taken prior to examination. Complete requires caecal intubation with complete visualization of the whole caecum and its landmarks. At least 30 minutes (45min/ 1 hour) Complete documentation of the indications for Informed consent for all potential actions taken during the Caecum reached and caecal intubation recorded, landmarks visualised. Less than 30 minutes (45min) Incomplete documentation of the indications for No or partial consent for all actions taken during a Caecum not reached, caecal intubation not recorded/ no landmarks visualised / / reported time of procedure between 30 and 45 minutes. Completeness of documentation using EPAGEII guidelines or ASGE guidelines/ Diagnostic yield of (cancer, adenoma, relevant diagnostic findings) /polyp detection and/or need for repeat procedure/risks and harms associated with failure to obtain consent. Documented caecal intubation /Interval colorectal cancer and/or need for repeat procedure/proximal polyp detection 1.3 PREPROCEDURE 3 1.3_1 93.80 4.2 1.4 PREPROCEDURE 4 2.1 only 93.80 4.3 PREPROCEDURE 5 No evidence 50.00 3,6 COMPLETENESS of PROCEDURE 6 2.1 100.00 4.9 6
ESGE QIC Lower GI Delphi voting process: Round 2 N2.2 N2.3 N2.4 N2.5 Photo documented caecal intubation Terminal ileum intubation Rate of complete sigmoidoscopy Population Interventions Comparator Outcome A service should have a minimum unadjusted caecal intubation of 90% and a target of 95% as a of the completeness of examination. Complete (caecal intubation) should be documented in both written form and a photo or video report. Complete diagnostic in Patients with diarrhoea patients with chronic diarrhoea requires undergoing diagnostic terminal ileum intubation. Complete sigmoidoscopy requires visualization of rectum and sigmoid colon. screening sigmoidoscopy not adjusted for obstructing tumours and poor bowel preparation Photo documented caecal intubation + written report (+ photographic images) Intubation of the terminal ileum intubation Complete sigmoidoscopy assessed by visualization of rectum and sigmoid colon adjusted for obstructing tumours and poor bowel preparation Documentation of caecal intubation included only in written report No intubation of the terminal ileum Complete sigmoidoscopy assessed by other means (length of the scope inserted (60cm?)/ estimated reach of the splenic flexure / EMI imaging minimum 90% target 95%/Interval colorectal cancer and/or need for repeat procedure Documented (written and photo) caecal intubation s / cancer and/or need for repeat procedure/proximal polyp detection Rates of terminal ileum Intubation/ Secondary outcome: Need for repeat procedure (because of lack of biopsies/photo documentation) Documented visualization of rectum and sigmoid colon/ cancer / polyp detection / need for repeat procedure/patient experience 2.1, 2.2 2.1, 2.3 2.4 2.3 COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE 7 2.1, 2.2 93.80 4.6 8 2.3_1 100.00 4.8 9 2.4_1 75.00 3.9 10 It has been rephrased following extensive discussion during TC on Sept 28, 2015 87.50 4.3 N3.1 Adenoma detection should be used as a of adequate inspection at in patients aged 50 years or more. Patients aged 50 years or more undergoing Alternative s of adequate inspection 3.1 of 11 only 100.00 4.7 N3.2 N3.3 Proximal adenoma detection Advanced adenoma detection Proximal adenoma detection should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. Advanced adenoma detection should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. Patients aged 50 years or more undergoing Patients aged 50 years or more undergoing Proximal adenoma detection Advanced adenoma detection ( 10mm, or HGD, or villous component) Alternative s of adequate inspection Alternative s of adequate inspection 3.2 3.3 of of 12 13 only only 37.50 3.2 56.30 3.4 7
ESGE QIC Lower GI Delphi voting process: Round 2 Population Interventions Comparator Outcome N3.4 Serd polyp detection N3.5 Polypectomy Serd polyp detection should be used as a of adequate inspection at in patients aged 50 years or more. Polypectomy should be used as a of adequate inspection at in patients aged 50 years or more. Serd polyp detection Polypectomy Alternative s of adequate inspection Alternative s of adequate inspection 3.4 3.1, 3.5 of of 14 15 only + 3.5_1+3.5_2 46.70 3.5 43.80 3.3 N3.6 Withdrawal time A mean withdrawal time of at least 6 minutes should be used as a supportive of adequate identification of pathology at negative screening or diagnostic. Minimum withdrawal time of at least 6 minutes Less than six minutes Reported withdrawal time/adenoma detection /Polyp detection 3.6 of 16, 3.6_1 87.50 4.1 N3.7 Rectal retroversion Routine rectal retroversion could help to improve detection of adenomas at Routine retroversion in the rectum No/non-routine retroversion in the rectum /Rate of missed adenomas/ patient experience/crc/ Adverse effects of routine rectal retroversion 3.10, 3.7 of 17 + 3.7_1 68.80 3.8 N4.1 Adequate description of polyp morphology Paris classification should be routinely used to describe the morphology of polypoid and non-polypoid lesions identified at. removal of removal of Paris classification non-polypoid colorectal lesions Non-Paris classification, i.e. classification into three categories: stalked, sessile, non polypoid (flat and depressed) /Interrupted procedure /adverse events/ 3.9, 4.1 18 4.1_1 75.00 3.9 N4.2 Incomplete resection N4.3 Incomplete resection In patients undergoing colonoscopic polypectomy the of incomplete polyp removal should be monitored. The completeness of polyp removal should be assessed by pathologists. colonoscopic polypectomy enbloc polyp removal (polypectomy, EMR, ESD) Incomplete polypectomy monitored Completeness of removal assessed by pathologist Incomplete polypectomy not monitored Completeness of removal assessed by endoscopist Incomplete polyp removal and/or need for repeat procedure Interval CRC and/or need for repeat procedure/ recurrence at surveillance 4.1 4.2 19 68.80 3.9 20 62.50 3.4 N4.4 Advanced imaging In patients undergoing removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or non-granular or mixedtype laterally spreading tumours, conventional or virtual chromoendoscopy should be used to improve delineation of lesion margins and predict potential depth of invasion. removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or nongranular or mixedtype laterally spreading tumours Use of conventional chromoendoscopy or virtual (NBI, FICE, high scan) with high definition endoscope No use of advanced imaging /Interrupted procedure 4.4 21 No evidence 93.30 4.1 8
ESGE QIC Lower GI Delphi voting process: Round 2 N4.5 Tattooing resection sites Population Interventions Comparator Outcome In patients undergoing removal of lesions with a depressed component (0- IIc according to the Paris classification) or non-granular or mixed-type laterally spreading tumours located between ascending and sigmoid colon the resection site should be tattooed to improve future relocation of the resection site. removal of colorectal lesions with a depressed component (0-IIc according to the Paris Tattooing resection sites No tattooing classification) or nongranular or mixed-type laterally spreading tumours Ability to relocate resection site/ interval cancer / Adverse effects of tattooing 4.5 22 No evidence 93.30 4.5 N4.6 Appropriate polypectomy technique Adequate resection technique of small and diminutive colorectal polyps includes biopsy forceps removal of polyps 3mm in size and snare polypectomy for larger polyps. removal of colorectal lesions Biopsy forceps removal of polyps 3mm in size and snare polypectomy for larger polyps. Other methods of polyp removal Rate of use of appropriate polypectomy technique (type of accessory used for lesion size) / /Interrupted procedure, / interval cancer / adverse effects and harms of polyp removal 4.6 23 + 4.6_1 93.30 4.1 N4.7 N4.8 En-bloc resection En-bloc resection In to decrease the risk of incomplete removal and polyp recurrence en-bloc resection of nonstalked colorectal polyps up to 2cm in size should be attempted and d. removal of non-stalked colorectal polyps up to (1) 2cm A service should have en-bloc resection removal of non-stalked of non-stalked colorectal polyps up colorectal polyps up to to 2cm in size of 85%. (1) 2cm En-bloc resection En-bloc resection 85% Piecemeal resection En-bloc resection <85% /need for repeated procedure/ of recurrence/adverse effects En-bloc resection of 5%/ Incomplete resection /need for repeated procedure/ of recurrence/adverse effects of en-bloc resection 4.7 4.7, 4.8 24 24 + 4.7_1-2 + 4.8_1-2 73.30 4.0 68.80 3.6 N4.9 Polyp retrieval The non-diminutive polyp retrieval should be monitored. A service should have polyp retrieval of 90%. removal of diminutive polyps. Polyp resection 90% Polyp resection <90% Polyp retrieval of 90%/need for repeated procedure/ of recurrence/complication s 4.9 25 4.9_1-2 86.70 4.3 9
ESGE QIC Lower GI Delphi voting process: Round 2 Population Interventions Comparator Outcome N5.1 Complication In patients undergoing a 6- day readmission and 30-day mortality should be monitored using a reliable system. /di agnostic +biopsy/therapeutic Monitoring Six-Day readmission s and 30 day mortality s using a reliable system Failure to monitor six day readmission s and 30 day mortality s using a reliable system 30-day readmission using healthcare registries/patient reporting on bleeding/perforation/m ortality/hospital stay/patient experience 5.2, 5.1 COMPLICATIONS 26 + 5.1_1-3 93.80 4.3 N6.1 Competence Validated competence tools should be used to document progress and proficiency level during training. Endoscopists performing Validated competence tools e.g. learning curves/semiobjective tools (like DOPS) Minimum number of Progress documented using validated competence tools/ /adenoma detection /need for assistance from colleagues / patient experience 6.2 28 93.80 4.4 N6.2 Minimum number of On average 300 are needed to achieve competence in caecal intubation. Endoscopists performing 300 as a Fewer than the minimum number of minimum number of (overall or in "I" annual) /adenoma detection /need for assistance from colleagues / patient experience 6.1 29 87.50 4.3 N6.3 Minimum number of polypectomies On average 300 at least 250 polypectomies are needed to achieve competence in complete and en-block resection of polyps. Endoscopists performing 300 250 polypectomies as a minimum number of polypectomies (overall or annual) Fewer than the minimum number of polypectomies in "I" Need for assistance from colleagues /complete removal of polyps/ competence in polypectomy using validated scale/patient experience 6.1 30 68.60 3.7 N6.4 Levels of competence in All certified colonoscopists should have Endoscopists EU level 2 competence in performing (removal of sessile and stalked lesions <25 mm providing there is good access). EU level 2 competence in (removal Other s of of sessile and stalked competence lesions <25 mm /adenoma detection /need for assistance from colleagues / patient experience 31 EU guidelines 93.80 4.2 N7.1 Patient experience Patient experience during and after unsedated or modely sedated or sigmoidoscopy should be routinely d. / therapeutic or sigmoidoscopy with mode/no sedation No sedation or mode sedation Deep sedation Rate of severe/mode pain or no pain/ anxiety, discomfort/ adverse effects of sedation 7.3, 7.1 PATIENT EXPERIENCE 32 7.1_1-4 93.80 4.4 10
ESGE QIC Lower GI Delphi voting process: Round 2 Population Interventions Comparator Outcome N7.2 Patient experience N8.1 Appropriate postpolypectomy surveillance recommendations Patient experience with or sigmoidoscopy should be self-reported by a patient using a validated scale. Adherence to post-polypectomy surveillance recommendations should be monitored. The reason for deviation from national/european guidelines should always be provided. / therapeutic or sigmoidoscopy with mode/no sedation colonoscopic polypectomy Self-reported Monitoring of postpolypectomy surveillance recommendations according to national or European guidelines Assessed by endoscopist/nurse (Using validated questionnaire) Failure to monitor Rate of severe/mode pain or no pain/ patient experience (i.e. anxiety, discomfort, of patients reporting to be prepared for repeat procedure)/ other adverse events following Monitoring s/interval between /adherenc e with national and European guidelines as assessed by audit/ provision of reasons for deviation from guidelines recorded. 7.1 PATIENT EXPERIENCE 33 93.80 4.5 8.1 POST-PROCEDURE 34 8.1_1 93.80 4.6 11
ESGE QIC Lower GI Delphi voting process: Round 3 Population Interventions Comparator Outcome N1.3 N2.4 N2.5 N3.2 N3.3 N3.4 N3.5 Time slot for Terminal ileum intubation Rate of complete sigmoidoscopy Proximal polyp detection Advanced adenoma detection Serd polyp detection Polyp detection Colonoscopy needs adequate time allocated for insertion, extubation and therapy. Routine should be allocated a minimum 30 minutes. olonoscopies following positive faecal occult blood testing should be allocated a minimum 45 minutes to allow for therapeutic intervention. Complete diagnostic in patients with chronic diarrhoea requires terminal ileum intubation and biopsy. Complete sigmoidoscopy requires visualization of rectum and sigmoid colon. Further advancement of endoscope depends on patients experience. Proximal polyp detection should be used as a of adequate inspection at in patients aged 50 years or more. Advanced adenoma detection should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. Serd polyp detection should be used as a of adequate inspection at in patients aged 50 years or more. Polyp detection should be used as a of adequate inspection at in patients aged 50 years or more. Patients with diarrhoea undergoing diagnostic screening sigmoidoscopy Patients aged 50 years or more undergoing Patients aged 50 years or more undergoing At least 30 minutes (45min/ 1 hour) Intubation of the terminal ileum intubation Complete sigmoidoscopy assessed by visualization of rectum and sigmoid colon Proximal polyp detection Advanced adenoma detection ( 10mm, or HGD, or villous component) Serd polyp detection Polypectomy Less than 30 minutes (45min) No intubation of the terminal ileum Complete sigmoidoscopy assessed by other means (length of the scope inserted (60cm?)/ estimated reach of the splenic flexure / EMI imaging Alternative s of adequate inspection Alternative s of adequate inspection Alternative s of adequate inspection Alternative s of adequate inspection / / reported time of procedure between 30 and 45 minutes. Rates of terminal ileum Intubation/ Secondary outcome: Need for repeat procedure (because of lack of biopsies/photo documentation) Documented visualization of rectum and sigmoid colon/ cancer / polyp detection / need for repeat procedure/patient experience 1.3 PREPROCEDURE 3 1.3_1 100.00 4.3 2.4 2.3 3.2 3.3 3.4 3.1, 3.5 COMPLETENESS of PROCEDURE COMPLETENESS of PROCEDURE of of of of 9 2.4_1 53.80 4.5 10 12 13 14 15 It has been rephrased following extensive discussion during TC on Sept 28, 2015 only only only + 3.5_1+3.5_2 46.20 3.4 23.10 2.7 38.50 2.8 30.80 2.8 84.60 4.1 12
ESGE QIC Lower GI Delphi voting process: Round 3 N3.7 Rectal retroversion N4.1 Adequate description of polyp morphology N4.2 Incomplete resection N4.3 Incomplete resection N4.7 N4.8 N6.2 En-bloc resection En-bloc resection Minimum number of Population Interventions Comparator Outcome Routine rectal retroversion improves the detection of adenomas at in patients aged 50 years or more undergoing. Paris classification should be routinely used to describe the morphology of non-polypoid lesions identified at. In patients undergoing colonoscopic polypectomy the of incomplete polyp removal should be monitored. The completeness of polyp removal should be assessed by pathologists. In to decrease the risk of incomplete removal and polyp recurrence en-bloc resection of nonstalked colorectal polyps up to 15mm in size should be attempted. removal of removal of non-polypoid colorectal lesions colonoscopic polypectomy enbloc polyp removal (polypectomy, EMR, ESD) removal of non-stalked colorectal polyps up to 15mm A service should have en-bloc resection removal of non-stalked of non-stalked colorectal polyps up colorectal polyps up to to 15mm in size of at least 85%. 15mm On average 300 are needed to achieve competence in caecal intubation. Endoscopists performing Routine retroversion in the rectum Paris classification Incomplete polypectomy monitored Completeness of removal assessed by pathologist En-bloc resection En-bloc resection at least (greater than or equal to) 85% 300 as a minimum number of (overall or annual) No/non-routine retroversion in the rectum Non-Paris classification, i.e. classification into three categories: stalked, sessile, non polypoid (flat and depressed) Incomplete polypectomy not monitored Completeness of removal assessed by endoscopist Piecemeal resection En-bloc resection <85% Fewer than the minimum number of in "I" /Rate of missed adenomas/ patient experience/crc/ Adverse effects of routine rectal retroversion /Interrupted procedure /adverse events/ Incomplete polyp removal and/or need for repeat procedure Interval CRC and/or need for repeat procedure/ recurrence at surveillance /need for repeated procedure/ of recurrence/adverse effects En-bloc resection of 85%/ Incomplete resection /need for repeated procedure/ of recurrence/adverse effects of en-bloc resection /adenoma detection /need for assistance from colleagues / patient experience 3.10, 3.7 of 3.9, 4.1 4.1 4.2 4.7 4.7, 4.8 6.1 MANAGEMENT of MANAGEMENT of MANAGEMENT of MANAGEMENT of MANAGEMENT of 17 + 3.7_1 46.20 3.5 18 4.1_1 84.60 4.0 19 53.80 3.5 20 53.80 3.1 24 24 + 4.7_1-2 + 4.8_1-2 76.90 3.8 46.20 3.1 29 92.30 4.2 13
ESGE QIC Lower GI Delphi voting process: Round 3 Population Interventions Comparator Outcome N6.3 Minimum number of polypectomies On average at least 250 polypectomies are needed to achieve competence in complete and en-bloc resection of polyps. Endoscopists performing 250 polypectomies as a minimum number of polypectomies (overall or annual) Fewer than the minimum number of polypectomies in "I" Need for assistance from colleagues /complete removal of polyps/ competence in polypectomy using validated scale/patient experience 6.1 30 61.50 3.4 14
ESGE QIC Lower GI Delphi voting process: Accepted final statements N1.1 N1.2 Rate of adequate bowel preparation Rate of adequate bowel preparation Population Interventions Comparator Outcome In patients undergoing screening or diagnostic bowel preparation quality should be recorded using a validated scale with high intra-observer reliability. A service should have a minimum of 90% procedures and a target of 95% procedures with adequate bowel preparation assessed using a validated scale with high intraobserver reliability. Adequate bowel preparation using Aronchick, Ottawa, general scales (other scales) Adequate bowel preparation <95 (80%) % of cases Adequate bowel preparation using / proximal Polyps Boston Bowel DR/advanced adenoma Preparation Scale (each detection segment at least 2 /intraobserver points) reliability Adequate bowel preparation 95 (80%) % of cases >90% of cases with adequate bowel preparations as assessed by a validated scale/adenoma detection /advanced adenoma detection / proximal PDR Voting round KPM = 1, APM=2 1.1 PREPROCEDURE 1 2 1.1_1-5 100.00 4.8 1 1.2 PREPROCEDURE 2 2 1.2_1-2 100.00 4.6 1 N1.3 N1.4 N2.1 N2.2 Time slot for Indication for Colonoscopy needs adequate time allocated for insertion, extubation and therapy. Routine should be allocated a minimum 30 minutes. Colonoscopies following positive faecal occult blood testing should be allocated a minimum 45 minutes to allow for therapeutic intervention. For audit purposes, the report should include an explicit indication for the procedure, categorized according to existing guidelines on appropriateness of use. Complete requires caecal intubation with complete visualization of the whole caecum and its landmarks. A service should have a minimum unadjusted caecal intubation of 90% and a target of 95% as a of the completeness of examination. At least 30 minutes (45min/ 1 hour) Complete documentation of the indications for Caecum reached and caecal intubation recorded, landmarks visualised. Less than 30 minutes (45min) Incomplete documentation of the indications for Caecum not reached, caecal intubation not recorded/ no landmarks visualised not adjusted for adjusted for obstructing obstructing tumours tumours and poor and poor bowel bowel preparation preparation / / reported time of procedure between 30 and 45 minutes. Completeness of documentation using EPAGEII guidelines or ASGE guidelines/ Diagnostic yield of (cancer, adenoma, relevant diagnostic findings) Documented caecal intubation / cancer and/or need for repeat procedure/proximal 1.3 PREPROCEDURE 3 3 1.3_1 100.00 4.3 2 1.4 PREPROCEDURE 4 2 2.1 COMPLETENESS of PROCEDURE polyp detection minimum 90% target 95%/Interval 2.1, 2.2 COMPLETENESS colorectal cancer and/or of PROCEDURE need for repeat procedure only 93.80 4.3 2 6 2 2.1 100.00 4.9 1 7 2 2.1, 2.2 93.80 4.6 1 15
ESGE QIC Lower GI Delphi voting process: Accepted final statements N2.3 Photo documented caecal intubation N3.1 Adenoma detection N3.5 Polyp detection N3.6 Withdrawal time N4.1 Adequate description of polyp morphology Population Interventions Comparator Outcome Complete (caecal intubation) should be documented in both written form and a photo or video report. should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. Polyp detection should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. A mean withdrawal time of at least 6 minutes should be used as a supportive of adequate identification of pathology at negative. Paris classification should be routinely used to describe the morphology of non-polypoid lesions identified at. Patients aged 50 years or more undergoing removal of nonpolypoid colorectal lesions Photo documented caecal intubation + written report ( + photographic images) Polyp detection Minimum withdrawal time of at least 6 minutes Paris classification Documented (written and photo) caecal Documentation of intubation s caecal intubation / included only in written cancer and/or need for report repeat procedure/proximal polyp detection Alternative s of adequate inspection Alternative s of adequate inspection Less than six minutes Non-Paris classification, i.e. classification into three categories: stalked, sessile, non polypoid (flat and depressed) Reported withdrawal time/adenoma detection /Polyp detection /Interrupted procedure /adverse events/ 2.1, 2.3 COMPLETENESS of PROCEDURE 3.1 of 3.1, 3.5 of 3.6 3.9, 4.1 of Voting round KPM = 1, APM=2 8 2 2.3_1 100.00 4.8 1 11 2 15 3 16 2 only + 3.5_1+3.5_2, 3.6_1 100.00 4.7 1 84.60 4.1 2 87.50 4.1 2 18 2 4.1_1 84.60 4.0 2 N4.4 Advanced imaging In patients undergoing removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or non-granular or mixed-type laterally spreading tumours, conventional or virtual chromoendoscopy should be used to improve delineation of lesion margins and predict potential depth of invasion. removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or nongranular or mixedtype laterally spreading tumours Use of conventional chromoendoscopy or virtual (NBI, FICE, high scan) with high definition endoscope No use of advanced imaging /Interrupted procedure 4.4 21 3 No evidence 93.30 4.1 2 16
ESGE QIC Lower GI Delphi voting process: Accepted final statements N4.5 N4.6 Tattooing resection sites Appropriate polypectomy technique Population Interventions Comparator Outcome In patients undergoing removal of lesions with a depressed component (0-IIc according to the Paris classification) or non-granular or mixed-type laterally spreading tumours located between ascending and sigmoid colon the resection site should be tattooed to improve future relocation of the resection site. Adequate resection technique of small and diminutive colorectal polyps includes biopsy forceps removal of polyps 3mm in size and snare polypectomy for larger polyps. removal of colorectal lesions with a depressed component (0-IIc according to the Paris Tattooing resection sites No tattooing classification) or nongranular or mixed-type laterally spreading tumours removal of colorectal lesions Biopsy forceps removal of polyps 3mm in size and snare polypectomy for larger polyps. Other methods of polyp removal Ability to relocate resection site/ interval cancer / Adverse effects of tattooing Rate of use of appropriate polypectomy technique (type of accessory used for lesion size) / /Interrupted procedure, / interval cancer / adverse effects and harms of polyp removal 4.5 4.6 Voting round KPM = 1, APM=2 22 2 No evidence 93.30 4.5 2 23 2 + 4.6_1 93.30 4.1 1 N4.9 Polyp retrieval The non-diminutive polyp retrieval should be monitored. A service removal of diminutive should have polyp retrieval of polyps. 90%. Polyp resection 90% Polyp resection <90% Polyp retrieval of 90%/need for repeated procedure/ of recurrence/complicatio ns 4.9 25 2 4.9_1-2 86.70 4.3 2 N5.1 Complication In patients undergoing a 6-day readmission and 30- day mortality should be monitored using a reliable system. /di agnostic +biopsy/therapeutic Monitoring Six-Day readmission s and 30 day mortality s using a reliable system Failure to monitor six day readmission s and 30 day mortality s using a reliable system 30-day readmission using healthcare registries/patient reporting on bleeding/perforation/m ortality/hospital stay/patient experience 5.2, 5.1 COMPLICATIONS 26 2 + 5.1_1-3 93.80 4.3 1 N6.1 Competence Validated competence tools should be used to document progress and proficiency level during training. Endoscopists performing Validated competence tools e.g. learning curves/semiobjective tools (like DOPS) Minimum number of Progress documented using validated competence tools/ /adenoma detection /need for assistance from colleagues / patient experience 6.2 28 2 93.80 4.4 1 17
ESGE QIC Lower GI Delphi voting process: Accepted final statements Population Interventions Comparator Outcome Voting round KPM = 1, APM=2 N6.2 Minimum number of On average 300 are needed to achieve competence in caecal intubation. Endoscopists performing 300 as a minimum number of (overall or annual) Fewer than the minimum number of in "I" /adenoma detection /need for assistance from colleagues / patient experience 6.1 29 3 92.30 4.2 2 N6.4 Levels of competence in All certified colonoscopists should have EU level 2 competence in (removal of sessile and stalked lesions <25 mm providing there is good access). Endoscopists performing EU level 2 competence in (removal Other s of of sessile and stalked competence lesions <25 mm /adenoma detection /need for assistance from colleagues / patient experience 31 2 EU guidelines 93.80 4.2 2 N7.1 Patient experience Patient experience during and after unsedated or modely sedated or sigmoidoscopy should be routinely d. /th erapeutic or sigmoidoscopy with mode/no sedation No sedation or mode sedation Deep sedation Rate of severe/mode pain or no pain/ anxiety, discomfort/ adverse effects of sedation 7.3, 7.1 PATIENT EXPERIENCE 32 2 7.1_1-4 93.80 4.4 1 N7.2 Patient experience Patient experience with or sigmoidoscopy should be self-reported by a patient using a validated scale. /th erapeutic or sigmoidoscopy with mode/no sedation Self-reported Assessed by endoscopist/nurse (Using validated questionnaire) Rate of severe/mode pain or no pain/ patient experience (i.e. anxiety, discomfort, of patients reporting to be prepared for repeat procedure)/ other adverse events following 7.1 PATIENT EXPERIENCE 33 2 93.80 4.5 1 N8.1 Appropriate postpolypectomy surveillance recommendations Adherence to post-polypectomy surveillance recommendations should be monitored. The reason for deviation from national/european guidelines should always be provided. colonoscopic polypectomy Monitoring of postpolypectomy surveillance recommendations according to national or European guidelines Failure to monitor Monitoring s/interval between /adherenc e with national and European guidelines as assessed by audit/ provision of reasons for deviation from guidelines recorded 8.1 POST- PROCEDURE 34 2 8.1_1 93.80 4.6 1 18
ESGE QIC Lower GI Delphi voting process: Final performance s Domain (PM) KPM = 1, APM=2 Rate of adequate PREPROCEDURE N1.1 1 bowel preparation PREPROCEDURE N1.2 PREPROCEDURE N1.3 COMPLETENESS of PROCEDURE N2.1 Time slot for Indication for 1 2 2 In patients undergoing bowel preparation quality should be recorded using a validated scale with high intra-observer reliability. A service should have a minimum of 90% procedures and a target of 95% procedures with adequate bowel preparation assessed using a validated scale with high intra-observer reliability. Colonoscopy needs adequate time allocated for insertion, extubation and therapy. Routine should be allocated a minimum 30 minutes. Colonoscopies following positive faecal occult blood testing should be allocated a minimum 45 minutes to allow for therapeutic intervention. For audit purposes, the report should include an explicit indication for the procedure, categorized according to existing guidelines on appropriateness of use. Complete requires caecal intubation with complete visualization of the whole caecum and its landmarks. A service should have a minimum unadjusted caecal intubation of 90% and a target of 95% as a of the completeness of examination. Complete (caecal intubation) should be documented in both written form and a photo or video report. 100.00 4.8 100.00 4.6 100.00 4.3 93.80 4.3 100.00 4.9 93.80 4.6 100.00 4.8 of N3.1 1 should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. 100.00 4.7 of N3.2 Withdrawal time 2 A mean withdrawal time of at least 6 minutes should be used as a supportive of adequate identification of pathology at negative. 87.50 4.1 of N3.3 Polyp detection 2 Polyp detection should be used as a of adequate inspection at screening or diagnostic in patients aged 50 years or more. 84.60 4.1 N4.1 Adequate description of polyp morphology 2 Paris classification should be routinely used to describe the morphology of non-polypoid lesions identified at. 84.60 4.0 N4.2 Polyp retrieval 2 The non-diminutive polyp retrieval should be monitored. A service should have polyp retrieval of 90%. 86.70 4.3 19
ESGE QIC Lower GI Delphi voting process: Final performance s Domain (PM) KPM = 1, APM=2 N4.3 N4.4 N4.5 Appropriate polypectomy technique Advanced imaging Tattooing resection sites COMPLICATIONS N5.1 Complication 1 N6.1 N6.2 Competence Levels of competence in 2 2 1 1 2 Adequate resection technique of small and diminutive colorectal polyps includes biopsy forceps removal of polyps 3 mm in size and snare polypectomy for larger polyps. In patients undergoing removal of colorectal lesions with a depressed component (0-IIc according to the Paris classification) or non-granular or mixed-type laterally spreading tumours, conventional or virtual chromoendoscopy should be used to improve delineation of lesion margins and predict potential depth of invasion. In patients undergoing removal of lesions with a depressed component (0-IIc according to the Paris classification) or non-granular or mixed-type laterally spreading tumours located between ascending and sigmoid colon the resection site should be tattooed to improve future relocation of the resection site. In patients undergoing a 6-day readmission and 30-day mortality should be monitored using a reliable system. Validated competence tools should be used to document progress and proficiency level during training. All certified colonoscopists should have EU level 2 competence in (removal of sessile and stalked lesions <25 mm providing there is good access). 93.30 4.1 93.30 4.1 93.30 4.5 93.80 4.3 93.80 4.4 93.80 4.2 N6.3 Minimum number of 2 On average 300 are needed to achieve competence in caecal intubation. 92.30 4.2 PATIENT EXPERIENCE N7.1 POST-PROCEDURE N8.1 Patient experience 1 Appropriate postpolypectomy surveillance recommendations 1 Patient experience during and after unsedated or modely sedated or sigmoidoscopy should be routinely d. Patient experience with or sigmoidoscopy should be self-reported by a patient using a validated scale. Adherence to post-polypectomy surveillance recommendations should be monitored. The reason for deviation from national/european guidelines should always be provided. 93.80 4.4 93.80 4.5 93.80 4.6 20