Gastronet Et kvalitetssikringsprogram for gastrointestinal endoskopi En plattform for forskning Geir Hoff
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.
Gastronet Kort presentasjon av noen forskningsprosjekter
NORCCAP Gastronet NordICC CRC screening i Norge
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 2002 2. Larsen IK, et al. Continuous evaluation of patient satisfaction in endoscopy centres. SJG 2002 3. Bretthauer M, et al. CO2 insufflation reduces patient discomfort due to screening flexible sigmoidoscopy for colorectal cancer. SJG 2002 4. Bretthauer M, et al. Systematisk kvalitetssikring ved et endoskopisenter. TDNLF 2004 5. Skovlund E, et al. Sensitivity of pain rating scales in an endosopy trial. Clin J Pain 2005 6. Huppertz-Hauss G, et al. Polyethylene Glycol versus Sodium Phosphate in bowel cleansing for colonoscopy: a randomized trial. Endoscopy 2005 7. Bretthauer M, et al. Carbon dioxide insufflation for colonoscopy: safe also in sedated patients. Endoscopy 2005 8. Hoff G, et al. Evaluation of a novel colonoscope designed for easier passage of flexures: an RCT. Endoscopy 2005 9. Hoff G, et al. The Norwegian Gastronet project. Continuous quality improvement of colonoscopy in 14 Norwegian centers. SJG 2006 10. Bretthauer M, et al. Carbon dioxide insufflation for more comfortable ERCP: An RCT. Endoscopy 2007 11. 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 2007 12. Seip B, et al. Patient s satisfaction an important factor in quality control of gastroscopies. SJG 2008 13. Hoff G, et al. Quality assurance as an integrated part of EPJ a prototype applied for colonoscopy. SJG 2009 14. Seip B, et al. Sustaining the vitality of colonoscopy quality improvement programmes over time. SJG 2010 15. Seip B, et al. Patients satisfaction with on-demand sedation for out-patient colonoscopies. Endoscopy 2010 16. Glomsaker T, et al. A national audit of temporal trends in ERCP in Norway. SJG 2011 17. Hoff G, Moritz V, et al. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: An RCT. SJG 2011 18. Holme Ø, et al. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: An RCT. Gastrointest Endoscopy 2011 19. Hoff G, Moritz V, et al. Gastronet survey on the use of one- or two-person technique for colonoscopy insertion. BMC Gastroenterol 2011 20. Glomsaker T, et al. Contemporary use of ERCP: a Norwegian prospective, multicenter study. SJG 2011 21. Løberg M, et al. Nitrous oxide for analgesia in unsedated colonoscopy. Gastrointestinal Endoscopy 2012 22. Hoff G, Moritz V et al. Incontinence after colonoscopy an unrecognised and preventable problem. Endoscopy 2012 23. Moritz V, et al. Withdrawal time as a quality indicator for colonoscopy a nationwide analysis. Endoscopy 2012 24. Garborg K,et al. Reduced pain during screening colonoscopy with an ultrathin colonoscope a randomised controlled trial. Endoscopy 2012 25. Seip B, et al.doctor s experience with a quality assurance programme. Clinical Governance 2012 26. Glomsaker T, et al. Patterns and predictive factors of complications after ERCP: A prospective multicentre study. Br J Surg 2013 27. Holme Ø. et al. Risk stratification to predict pain during unsedated colonoscopy. Endoscopy 2013 28. Holme Ø, et al. Smerter ved koloskopi i Norge. Tidsskr Nor Legeforen 2013 29. Glomsaker T, et al. Patient reported outcome measures (PROMs) after ERCP. A prospectove multicenter study. SJG 2013 30. 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)
Gastronet forskning Michael Bretthauer: Sigmo- og koloskopidata PhD disputas 2004 - CO2 insufflation studies. Use of disposable sheath endoscopes.inter-endoscopist variation in polyp and neoplasia detection Inger Kristin Larsen: Sigmo- og koloskopidata PhD disputas 2007 - Inter-endoscopist variation in performance of painfree endoscopy. Lifestyle and screening. Birgitte Seip: Koloskopidata PhD disputas 2012 - 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 2013. - A national audit of temporal trends in ERCP in Norway. Scand J Gastroenterol 2011 - Contemporary use of ERCP: A Norwegian prospective muliticentre study. SJG 2011 - Patterns and predictive factors of complications after ERCP 2013. Br J Surg 2013 - 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
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 8988 1,3 1,19-1,46 <0,001 Alder (5-års kategorier) 10.532 1,2 1,20-1,24 <0,001 Mndr. siden oppstart 16.149 0,98 0,97-0,98 <0,001 Sedasjon Ingen sed./analgesi 10.283 Referanse Sedasjon/analgesi gitt 5670 0,7 0,61-0,76 <0,001 Caecum intubasjon Caecum nådd 14.557 Referanse Caecum ikke nådd 1430 0,6 0,54-0,76 <0,001 B Seip et al. Scand J Gastroenterol 2010;45:362-9
NORCCAP Andel smertefrie sigmoidoskopier per skopør i mester/svenn situasjon Larsen IK et al.: Scand J Gastroenterol 2002;37:850-5
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;38:1268-74
Andel pasienter smertefrie under og 1-24 timer etter koloskopi insufflering med CO 2 vs luft 10 90 80 70 60 50 40 30 * * * Percentageofpatscoring0onVAS 20 10 0 duringexam. 1hour 3hours6hours24hours Bretthauer et al. GUT 2002;50:604-7
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
EU Guidelines Publisert februar 2011 The case of CO 2 insufflation. Level of evidence: I Strength of recommendation: A
TDNLF juni 2013
Legelisten.no: Sykehusenes identitet bør offentliggjøres
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 www.legelisten.no som katalysator)
Gastronet 2003-2013 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 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Publik. 1 4 1 2 1 1 2 5 5 4 PhD M Bretthauer (NORCCAP) PhD IK Larsen (NORCCAP) PhD B Seip PhD T Glomsaker
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
«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