Colorectal  Cancer  Audit Lars  Påhlman Dept.  Surgery,  Colorectal  unit, University  Hospital,  Uppsala,  Sweden
Quality  control in  surgery
Quality  control  in  surgery <ul><li>There  is  only  one  way </li></ul><ul><li>Registration  and  audit ! </li></ul>
Quality  control  in  surgery <ul><li>The  Swedish  model </li></ul><ul><li>National  registries </li></ul><ul><li>Populat...
Quality  control  in  surgery <ul><li>Requirements  for  a  ‘good’  registry  </li></ul><ul><li>Population - based </li></...
Quality  control  in  surgery <ul><li>If  not  100 % ? </li></ul><ul><li>At  least  those  hospitals  involved  should  in...
Why  100 % ?
Quality  control  in  surgery <ul><li>The  ‘Lap-chole’  Registry </li></ul><ul><li>One  end - point  was  injury  to  the ...
Quality  control  in  surgery <ul><li>The  ‘Lap-chole’  Registry </li></ul><ul><li>The  common  bile - duct  injuries  was...
Quality  control  in  surgery <ul><li>How  to  use  registries ? </li></ul><ul><li>Interpret  unexpected  findings </li></...
Unexpecting  findings
Swedish  Rectal  Cancer  Registry <ul><li>Anastomotic  leaks  (%)  after  ant.  resection </li></ul>
Anastomotic  leakage  study <ul><li>Leakage  rate </li></ul><ul><li>Stapler  A   84/1,150   7 % </li></ul><ul><li>Stapler ...
Anastomotic  leakage  study <ul><li>Conclusion </li></ul><ul><li>How  come  these  results ? </li></ul><ul><li>Confounding...
Stapler  trial <ul><li>The  randomised  trial </li></ul><ul><li>Tyco  has  a  new  stapler  we  must  stop  the  trial </l...
Stapler  trial <ul><li>Results </li></ul><ul><li>Leakage  overall 8,3 % </li></ul><ul><li>Tyco  18/259 6,9 % </li></ul><ul...
Conclusion <ul><li>A  fool  with  a  tool </li></ul><ul><li>is  still  just  a  fool </li></ul>
Evaluate  outcomes
Swedish  Hip  Replacement  Registry <ul><li>>  200.000  Hip  Replacements </li></ul><ul><li>Some  are  good </li></ul><ul>...
Conclusion <ul><li>Why  do  not  surgical  devices  undergo  the  same  critical  evaluations  as  drugs ? </li></ul>
Define  end-points
Quality  Assurance  in  Surgery <ul><li>Rectal  Cancer  ideal </li></ul><ul><li>End - points  well  defined </li></ul><ul>...
Quality  Control  in  Surgery <ul><li>Rectal  Cancer;  end - points </li></ul><ul><li>Postop.  morbidity  and  mortality <...
Transparent  reports
Swedish  Rectal  Cancer  Registry <ul><li>Data  report </li></ul><ul><li>Feed - back  to  surgeons </li></ul><ul><li>Natio...
Swedish  Rectal  Cancer  Registry <ul><li>30 days  mortality  according  to  volume  (AR, APR  and  Hartmann)  1995 - 2004...
Postoperative  mortality
Swedish  Rectal  Cancer  Registry <ul><li>Postop.  mortality;  ASA  IV </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Postop.  MDT-conference </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Postop.  MDT-conference </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Included  in  trials </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Included  in  trials </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Protecting  stoma </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Peroperative  bleeding </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>More  than  12  lymph  nodes </li></ul>
Local recurrence High  volume hospital
Local  recurrence  rate
5-year  survival
Hospital  volume
Volume  -  fact  or  fancy <ul><li>What  is  a  low  volume  ? </li></ul><ul><li>One  procedure / week </li></ul><ul><li>O...
Swedish  Rectal  Cancer  Registry <ul><li>Proportion  procedures  AR,  APR  or  Hartmann  according  to  hospital  volume ...
Swedish  Rectal  Cancer  Registry <ul><li>Local  recurrence  rates  according  to  </li></ul><ul><li>hospital  volume   19...
Quality  Control  in  Surgery <ul><li>Differences  among  hospitals </li></ul><ul><li>The  differences  between  low - and...
Aim - related  scores
Swedish  Rectal  Cancer  Registry <ul><li>Important  data  from  2001 </li></ul><ul><li>Total  number  1,510 </li></ul><ul...
Rectal  Cancer  in  Sweden <ul><li>A  tremendous  change ! </li></ul><ul><li>From  > 30 %   local  failure  rate  at </li>...
 
Smoking  is  dangerous
Swedish  Rectal  Cancer  Registry <ul><li>Local  recurrence  rates   1995 - 2002 </li></ul><ul><li>All  patients   R 0  su...
Swedish  Rectal  Cancer  Registry <ul><li>Local  recurrence  rates   1995 - 2002 </li></ul><ul><li>Stage  I -II   Stage  I...
Swedish  Rectal  Cancer  Registry <ul><li>Relative  survival  according  to  geographic  region  1995 - 2007 </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Relative  survival  according  to  stage  1995 – 2007 </li></ul><ul><li>Stage  I...
Swedish  Rectal  Cancer  Registry <ul><li>Relative  survival  according  to  stage  1995 – 2007 </li></ul><ul><li>Stage II...
Quality  Assurance  in  Surgery <ul><li>How  to  improve  further ? </li></ul><ul><li>Close  the  hospital ? </li></ul><ul...
Swedish  Rectal  Cancer  Registry <ul><li>Adjuvant  chemotherapy </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Hospital  stay  </li></ul>
Swedish  Rectal  Cancer  Registry <ul><li>Irrigation  of  rectal  stump </li></ul><ul><li>1999 - 2002   2003 - 2007 </li><...
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MCC 2011 - Slide 23

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MCC 2011 - Slide 23

  1. 1. Colorectal Cancer Audit Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital, Uppsala, Sweden
  2. 2. Quality control in surgery
  3. 3. Quality control in surgery <ul><li>There is only one way </li></ul><ul><li>Registration and audit ! </li></ul>
  4. 4. Quality control in surgery <ul><li>The Swedish model </li></ul><ul><li>National registries </li></ul><ul><li>Population - based data </li></ul><ul><li>All hospitals involved ! </li></ul><ul><li>Mandatory to participate </li></ul><ul><li>Transparent reports </li></ul>
  5. 5. Quality control in surgery <ul><li>Requirements for a ‘good’ registry </li></ul><ul><li>Population - based </li></ul><ul><li> 100 % of patients registered </li></ul><ul><li>All hospitals involved </li></ul><ul><li>Few ‘missing’ data in all parameters </li></ul><ul><li>‘ Good’ follow-up </li></ul>
  6. 6. Quality control in surgery <ul><li>If not 100 % ? </li></ul><ul><li>At least those hospitals involved should include 100 % ! </li></ul>
  7. 7. Why 100 % ?
  8. 8. Quality control in surgery <ul><li>The ‘Lap-chole’ Registry </li></ul><ul><li>One end - point was injury to the common bile - duct </li></ul><ul><li>95 % of all patients registered </li></ul><ul><li>No increased risk compared to open surgery ! </li></ul>
  9. 9. Quality control in surgery <ul><li>The ‘Lap-chole’ Registry </li></ul><ul><li>The common bile - duct injuries was found among the 5 % not registered ! </li></ul><ul><li>They were referred to a tertiary hospital for treatment and were missed ! </li></ul>
  10. 10. Quality control in surgery <ul><li>How to use registries ? </li></ul><ul><li>Interpret unexpected findings </li></ul><ul><li>Evaluate outcomes ? </li></ul><ul><li>Define end - points ! </li></ul><ul><li>Compare units ? </li></ul>
  11. 11. Unexpecting findings
  12. 12. Swedish Rectal Cancer Registry <ul><li>Anastomotic leaks (%) after ant. resection </li></ul>
  13. 13. Anastomotic leakage study <ul><li>Leakage rate </li></ul><ul><li>Stapler A 84/1,150 7 % </li></ul><ul><li>Stapler B 126/1,173 11 % </li></ul><ul><li>Unknown 83/993 8 % </li></ul><ul><li>p = 0.0039 </li></ul>Folkesson et al. Colorectal Disease 2004
  14. 14. Anastomotic leakage study <ul><li>Conclusion </li></ul><ul><li>How come these results ? </li></ul><ul><li>Confounding factors ? </li></ul><ul><li>Do we just measure individual surgeons ? </li></ul><ul><li>Place for a randomised trial ? </li></ul>Folkesson et al. Colorectal Disease 2004
  15. 15. Stapler trial <ul><li>The randomised trial </li></ul><ul><li>Tyco has a new stapler we must stop the trial </li></ul><ul><li>> 500 patients included </li></ul><ul><li>Interim analysis showed less leakage than calculated >1,600 must than be included </li></ul><ul><li>Several centres were using the new Tyco stapler </li></ul>
  16. 16. Stapler trial <ul><li>Results </li></ul><ul><li>Leakage overall 8,3 % </li></ul><ul><li>Tyco 18/259 6,9 % </li></ul><ul><li>Ethicon 25/254 9,8 % </li></ul><ul><li>p = 0.33 </li></ul>Folkesson et al. Manuscript
  17. 17. Conclusion <ul><li>A fool with a tool </li></ul><ul><li>is still just a fool </li></ul>
  18. 18. Evaluate outcomes
  19. 19. Swedish Hip Replacement Registry <ul><li>> 200.000 Hip Replacements </li></ul><ul><li>Some are good </li></ul><ul><li>Some (4 different providers) have such bad results that they have been ‘thrown out’ from Sweden ! </li></ul><ul><li>Why invest in the bad one ? </li></ul><ul><li>How to avoid providers with bad devices if they have no data ! </li></ul>
  20. 20. Conclusion <ul><li>Why do not surgical devices undergo the same critical evaluations as drugs ? </li></ul>
  21. 21. Define end-points
  22. 22. Quality Assurance in Surgery <ul><li>Rectal Cancer ideal </li></ul><ul><li>End - points well defined </li></ul><ul><li>A common disease </li></ul><ul><li>Surgery an important treatment option </li></ul>
  23. 23. Quality Control in Surgery <ul><li>Rectal Cancer; end - points </li></ul><ul><li>Postop. morbidity and mortality </li></ul><ul><li>Sphincter preservation </li></ul><ul><li>Local recurrence </li></ul><ul><li>Survival </li></ul><ul><li>Quality of life </li></ul>
  24. 24. Transparent reports
  25. 25. Swedish Rectal Cancer Registry <ul><li>Data report </li></ul><ul><li>Feed - back to surgeons </li></ul><ul><li>National report every year </li></ul><ul><li>Data divided for each region </li></ul><ul><li>Data divided for each unit </li></ul><ul><li>Data based on volume </li></ul>
  26. 26. Swedish Rectal Cancer Registry <ul><li>30 days mortality according to volume (AR, APR and Hartmann) 1995 - 2004 </li></ul>
  27. 27. Postoperative mortality
  28. 28. Swedish Rectal Cancer Registry <ul><li>Postop. mortality; ASA IV </li></ul>
  29. 29. Swedish Rectal Cancer Registry <ul><li>Postop. MDT-conference </li></ul>
  30. 30. Swedish Rectal Cancer Registry <ul><li>Postop. MDT-conference </li></ul>
  31. 31. Swedish Rectal Cancer Registry <ul><li>Included in trials </li></ul>
  32. 32. Swedish Rectal Cancer Registry <ul><li>Included in trials </li></ul>
  33. 33. Swedish Rectal Cancer Registry <ul><li>Protecting stoma </li></ul>
  34. 34. Swedish Rectal Cancer Registry <ul><li>Peroperative bleeding </li></ul>
  35. 35. Swedish Rectal Cancer Registry <ul><li>More than 12 lymph nodes </li></ul>
  36. 36. Local recurrence High volume hospital
  37. 37. Local recurrence rate
  38. 38. 5-year survival
  39. 39. Hospital volume
  40. 40. Volume - fact or fancy <ul><li>What is a low volume ? </li></ul><ul><li>One procedure / week </li></ul><ul><li>One procedure / month </li></ul><ul><li>One procedure / year </li></ul>
  41. 41. Swedish Rectal Cancer Registry <ul><li>Proportion procedures AR, APR or Hartmann according to hospital volume </li></ul>
  42. 42. Swedish Rectal Cancer Registry <ul><li>Local recurrence rates according to </li></ul><ul><li>hospital volume 1995 - 2002 </li></ul><ul><li>irradiated not irradiated </li></ul>
  43. 43. Quality Control in Surgery <ul><li>Differences among hospitals </li></ul><ul><li>The differences between low - and high - volume hospitals is less than; </li></ul><ul><li>the differences between some high volume hospitals </li></ul>
  44. 44. Aim - related scores
  45. 45. Swedish Rectal Cancer Registry <ul><li>Important data from 2001 </li></ul><ul><li>Total number 1,510 </li></ul><ul><li> 48 % LAR 24 % APR </li></ul><ul><li> 46 % preop. irradiation </li></ul><ul><li> 35 % overall postop. complications </li></ul><ul><li> 9 % re-operations within 30 days </li></ul><ul><li> 2.5 % postop. mortality </li></ul><ul><li> 7 % local recurrence rate </li></ul><ul><li> 47 % OS 60 % RS </li></ul>
  46. 46. Rectal Cancer in Sweden <ul><li>A tremendous change ! </li></ul><ul><li>From > 30 % local failure rate at </li></ul><ul><li>the end of the 80’s in most centres </li></ul><ul><li>to  7 % in the new century. </li></ul><ul><li>Survival improved ! </li></ul>
  47. 48. Smoking is dangerous
  48. 49. Swedish Rectal Cancer Registry <ul><li>Local recurrence rates 1995 - 2002 </li></ul><ul><li>All patients R 0 surgery </li></ul>
  49. 50. Swedish Rectal Cancer Registry <ul><li>Local recurrence rates 1995 - 2002 </li></ul><ul><li>Stage I -II Stage III </li></ul>
  50. 51. Swedish Rectal Cancer Registry <ul><li>Relative survival according to geographic region 1995 - 2007 </li></ul>
  51. 52. Swedish Rectal Cancer Registry <ul><li>Relative survival according to stage 1995 – 2007 </li></ul><ul><li>Stage I Stage II </li></ul>
  52. 53. Swedish Rectal Cancer Registry <ul><li>Relative survival according to stage 1995 – 2007 </li></ul><ul><li>Stage III Stage IV </li></ul>
  53. 54. Quality Assurance in Surgery <ul><li>How to improve further ? </li></ul><ul><li>Close the hospital ? </li></ul><ul><li>Propose training </li></ul><ul><li>Supervise surgery </li></ul><ul><li>Aim – related scores </li></ul>
  54. 55. Swedish Rectal Cancer Registry <ul><li>Adjuvant chemotherapy </li></ul>
  55. 56. Swedish Rectal Cancer Registry <ul><li>Hospital stay </li></ul>
  56. 57. Swedish Rectal Cancer Registry <ul><li>Irrigation of rectal stump </li></ul><ul><li>1999 - 2002 2003 - 2007 </li></ul>13 42 39 103 52 52 41 56 48 40 51 85 69 85 88 89 62 91 79 185 74 97 66 40 36 73 32 28 21 28 22 17 20 28 21 17 17 14 9 11 7 5 2 0 0% 20% 40% 60% 80% 100% Huddinge Eskilstuna Skövde Östra sjukhuset Karlstad Örebro Gävle Lund Karolinska, Solna Linköping Kristianstad Södersjukhuset Danderyd St Görans Malmö Uppsala Borås Uddevalla Umeå Ersta Falun Västerås Sköljda Ej sköljda

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