Gastronet. Et kvalitetssikringsprogram for gastrointestinal endoskopi En plattform for forskning. Geir Hoff

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1 Gastronet Et kvalitetssikringsprogram for gastrointestinal endoskopi En plattform for forskning Geir Hoff

2 NEJM Oct 2013: «Look to Sweden» (and Gastronet?): Utfør randomiserte studier innenfor rammene av kvalitetsregistre «The *TASTE investigators designed a large-scale trial to answer an important clinical question and carried it out at a remarkably low cost by building on the platform of an alreadyexisting high-quality observational registry» «Today it may be possible to design and conduct megatrials with what we have: bigger data and smaller budgets» *Fröbert O, et al. Thrombus aspiration during ST-segment elevation MI. NEJM 2013.

3 Gastronet Kort presentasjon av noen forskningsprosjekter

4 NORCCAP Gastronet NordICC CRC screening i Norge

5 Gastronet originalpublikasjoner 1. Bretthauer M, et al. NORCCAP : A randomised trial to assess the safety and efficacy of CO2 versus air insufflation in colonoscopy. GUT Larsen IK, et al. Continuous evaluation of patient satisfaction in endoscopy centres. SJG Bretthauer M, et al. CO2 insufflation reduces patient discomfort due to screening flexible sigmoidoscopy for colorectal cancer. SJG Bretthauer M, et al. Systematisk kvalitetssikring ved et endoskopisenter. TDNLF Skovlund E, et al. Sensitivity of pain rating scales in an endosopy trial. Clin J Pain Huppertz-Hauss G, et al. Polyethylene Glycol versus Sodium Phosphate in bowel cleansing for colonoscopy: a randomized trial. Endoscopy Bretthauer M, et al. Carbon dioxide insufflation for colonoscopy: safe also in sedated patients. Endoscopy Hoff G, et al. Evaluation of a novel colonoscope designed for easier passage of flexures: an RCT. Endoscopy Hoff G, et al. The Norwegian Gastronet project. Continuous quality improvement of colonoscopy in 14 Norwegian centers. SJG Bretthauer M, et al. Carbon dioxide insufflation for more comfortable ERCP: An RCT. Endoscopy Hoff G, et al. Improvement in caecal intubation rate and pain reduction by using 3-dimentional magnetic imaging for unsedated colonoscopy. A randomised trial of patients referred for colonoscopy. SJG Seip B, et al. Patient s satisfaction an important factor in quality control of gastroscopies. SJG Hoff G, et al. Quality assurance as an integrated part of EPJ a prototype applied for colonoscopy. SJG Seip B, et al. Sustaining the vitality of colonoscopy quality improvement programmes over time. SJG Seip B, et al. Patients satisfaction with on-demand sedation for out-patient colonoscopies. Endoscopy Glomsaker T, et al. A national audit of temporal trends in ERCP in Norway. SJG Hoff G, Moritz V, et al. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: An RCT. SJG Holme Ø, et al. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: An RCT. Gastrointest Endoscopy Hoff G, Moritz V, et al. Gastronet survey on the use of one- or two-person technique for colonoscopy insertion. BMC Gastroenterol Glomsaker T, et al. Contemporary use of ERCP: a Norwegian prospective, multicenter study. SJG Løberg M, et al. Nitrous oxide for analgesia in unsedated colonoscopy. Gastrointestinal Endoscopy Hoff G, Moritz V et al. Incontinence after colonoscopy an unrecognised and preventable problem. Endoscopy Moritz V, et al. Withdrawal time as a quality indicator for colonoscopy a nationwide analysis. Endoscopy Garborg K,et al. Reduced pain during screening colonoscopy with an ultrathin colonoscope a randomised controlled trial. Endoscopy Seip B, et al.doctor s experience with a quality assurance programme. Clinical Governance Glomsaker T, et al. Patterns and predictive factors of complications after ERCP: A prospective multicentre study. Br J Surg Holme Ø. et al. Risk stratification to predict pain during unsedated colonoscopy. Endoscopy Holme Ø, et al. Smerter ved koloskopi i Norge. Tidsskr Nor Legeforen Glomsaker T, et al. Patient reported outcome measures (PROMs) after ERCP. A prospectove multicenter study. SJG Moritz V, et al. Ten years with Gastonet: Time trends of quality indicators (submitted) 31. Moritz V, et al. Colonoscopist performance: Discrepancy between self-esteemed and observed quality (in prep. for publication)

6 Gastronet forskning Michael Bretthauer: Sigmo- og koloskopidata PhD disputas CO2 insufflation studies. Use of disposable sheath endoscopes.inter-endoscopist variation in polyp and neoplasia detection Inger Kristin Larsen: Sigmo- og koloskopidata PhD disputas Inter-endoscopist variation in performance of painfree endoscopy. Lifestyle and screening. Birgitte Seip: Koloskopidata PhD disputas Studies on patient s satisfaction with gastroscopy and colonoscopy. Selection bias in voluntary registers. Qualitative study on endoscopist s experience with Gastronet. Tom Glomsaker: ERCPdata PhD disputas A national audit of temporal trends in ERCP in Norway. Scand J Gastroenterol Contemporary use of ERCP: A Norwegian prospective muliticentre study. SJG Patterns and predictive factors of complications after ERCP Br J Surg Patient reported outcome measures after ERCP. SJG 2013 Volker Moritz: Koloskopidata. - Withdrawal time as quality indicator for colonoscopy ;10 yrs of experience with Gastronet Øivind Holme: Gastronet verktøy benyttet i egen RTC - Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointestinal Endoscopy 2011 Magnus Løberg: Gastronet verktøy benyttet i egen RTC - Nitrous oxide for analgesia in unsedated colonoscopy. Gastrointest Endoscopy 2011 Kjetil Garborg: Gastronet verktøy benyttet i egen RTC - Improved colonoscopy screening with a novel super-slim colonoscope a randomized controlled trial. Endoscopy 2012

7 Koloskopi i Gastronet: Justerte Odds Ratio for å motta pasientsvarskjema (=samtykke) Antall u.s. Justert OR 95% CI P-verdi Kjønn Mann 7141 Referanse Kvinne ,3 1,19-1,46 <0,001 Alder (5-års kategorier) ,2 1,20-1,24 <0,001 Mndr. siden oppstart ,98 0,97-0,98 <0,001 Sedasjon Ingen sed./analgesi Referanse Sedasjon/analgesi gitt ,7 0,61-0,76 <0,001 Caecum intubasjon Caecum nådd Referanse Caecum ikke nådd ,6 0,54-0,76 <0,001 B Seip et al. Scand J Gastroenterol 2010;45:362-9

8 NORCCAP Andel smertefrie sigmoidoskopier per skopør i mester/svenn situasjon Larsen IK et al.: Scand J Gastroenterol 2002;37:850-5

9 NORCCAP Erfarne (grønne) og ny-opplærte (røde) skopørers evne til å påvise avansert neoplasi ved sigmoidoskopi (antall u.s.) M.Bretthauer. Scand J Gastroenterol 2003;38:

10 Andel pasienter smertefrie under og 1-24 timer etter koloskopi insufflering med CO 2 vs luft * * * Percentageofpatscoring0onVAS duringexam. 1hour 3hours6hours24hours Bretthauer et al. GUT 2002;50:604-7

11 Luft- eller CO 2 - insufflering ved koloskopi. Rapporterte tilfeller av ufrivillig lekkasje etter u.s. 60% reduksjon med CO 2 Hoff G et al Endoscopy 2012

12 EU Guidelines Publisert februar 2011 The case of CO 2 insufflation. Level of evidence: I Strength of recommendation: A

13 TDNLF juni 2013

14 Legelisten.no: Sykehusenes identitet bør offentliggjøres

15 Konsekvenser av forskningen i Gastronet Dokumentert seleksjonsbias i frivillige kvalitetsregistre med fare for «feel-good» registre som pasientene ikke er tjent med Oppmyking av Datatilsynets og Helsedirektoratets fortolkning av lovog regelverk Sterkt bidragende til innføring av CO 2 insufflering ved gastrointestinal skopi Påvirkning av europeiske retningslinjer for screening og diagnostikk Opprettelse av skopørskole i Norge Modell for integrering av kvalitetsregistre i DIPS Arena Fortgang i prosessen fram mot publisering av sykehusdata (med som katalysator)

17 Gastronet DIPS samarbeid integrering Gastronet i EPJ Disp. taushetsplikt ERCP register Publisert Coloreg EPJ DT, tilbakeføring data til HF Gastronet Opprettet (Kolo) Årlig bevilgn. HSØ DT, pers.oppl. lovens 9h Nasj. kval.reg. status Publik PhD M Bretthauer (NORCCAP) PhD IK Larsen (NORCCAP) PhD B Seip PhD T Glomsaker

18 Gastronet Started September 2003 Covers 1/3 of 4000 ERCPs and 50,000 colonoscopies annually performed in Norway Poland Sweden Latvia Iceland Norwegian centres Arendal Drammen Bærum Diakonhjemmet Flekkefjord Fredrikstad Kongsberg Kragerø Kristiansand S Kristiansund N Larvik Molde Moss Notodden Rikshospitalet Skien Stavanger Haugesund Tromsø Harstad Tynset Tønsberg Volda

19 «The true fate of quality in the wake of cutbacks is usually not evaluated and never tested by scientific research standards» «Politicians may easily find at least one useless endpoints that rarely change to support a statement that quality has not been compromized «(e.g. were you satisfied with the service provided ) «If legislation is such that quality assessment of public health service is jeopardized, this may be considered a serious impingement on public interests and in some cases misuse of taxpayers money» Hoff G. Quality assurance in gastroenterology: QA in research, and reserch in QA. Best Pract Research Clin Gastroenterol 2011;25:427-34

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