Reporting of adverse events in surgical trials: Critical appraisal of current practice

World Journal of Surgery

Volumn 39, Issue 1, 2014, Pages 80-87

  Rosenthal, Rachel ^a   Hoffmann, Henry ^a   Dwan, Kerry ^b   Clavien, Pierre Alain ^c   Bucher, Heiner C ^d  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^d UNIVERSITY HOSPITAL BASEL   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

DOCUMENTATION; GENERAL SURGERY; HUMAN; INTRAOPERATIVE COMPLICATIONS; OUTCOME ASSESSMENT; POSTOPERATIVE COMPLICATIONS; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS;

DOCUMENTATION; GENERAL SURGERY; HUMANS; INTRAOPERATIVE COMPLICATIONS; OUTCOME ASSESSMENT (HEALTH CARE); POSTOPERATIVE COMPLICATIONS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84928105334     PISSN: 03642313     EISSN: 14322323     Source Type: Journal    
DOI: 10.1007/s00268-014-2776-8     Document Type: Article

References (44)

1. Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332
2. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P (2008) Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 148:295-309
3. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D (2004) Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141:781-788
4. Martin RC, Brennan MF, Jaques DP (2002) Quality of complication reporting in the surgical literature. Ann Surg 235:803-813
5. Clavien PA, Sanabria JR, Strasberg SM (1992) Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery 111:518-526
6. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santiba es E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M (2009) The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 250:187-196
7. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205-213
8. Pillai SB, van Rij AM, Williams S, Thomson IA, Putterill MJ, Greig S (1999) Complexity- and risk-adjusted model for measuring surgical outcome. Br J Surg 86:1567-1572
9. Pomposelli JJ, Gupta SK, Zacharoulis DC, Landa R, Miller A, Nanda R (1997) Surgical complication outcome (SCOUT) score: a new method to evaluate quality of care in vascular surgery. J Vasc Surg 25:1007-1014
10. Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA (2013) The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg 258:1-7
11. Strasberg SM, Linehan DC, Hawkins WG (2009) The accordion severity grading system of surgical complications. Ann Surg 250:177-186
12. Tou S, Malik AI, Wexner SD, Nelson RL (2011) Energy source instruments for laparoscopic colectomy. Cochrane Database Syst Rev (5):CD007886
13. Morino M, Rimonda R, Allaix ME, Giraudo G, Garrone C (2005) Ultrasonic versus standard electric dissection in laparoscopic colorectal surgery: a prospective randomized clinical trial. Ann Surg 242:897-901
14. Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A (2012) Laparoscopic entry techniques. Cochrane Database Syst Rev (2):CD006583
15. Rosenthal R, Dwan K (2013) Comparison of randomized controlled trial registry entries and content of reports in surgery journals. Ann Surg 257:1007-1015
16. Martin RC, Jaques DP, Brennan MF, Karpeh M (2002) Achieving RO resection for locally advanced gastric cancer: is it worth the risk of multiorgan resection? J Am Coll Surg 194:568-577
17. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG (1992) CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 13:606-608
18. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR (1999) Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 20:250-278
19. Wilson AP, Treasure T, Sturridge MF, Gruneberg RN (1986) A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet 1:311-313
20. Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M (2005) Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery 138:8-13
21. Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW (2007) Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 142:761-768
22. Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW (2007) Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery 142:20-25
23. Fox KA, Mehta SR, Peters R, Zhao F, Lakkis N, Gersh BJ, Yusuf S (2004) Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for non-ST-elevation acute coronary syndrome: the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) Trial. Circulation 110:1202-1208
24. Clavien PA (2013) Targeting quality in surgery. Ann Surg 258:659-668
25. Bonrath EM, Dedy NJ, Zevin B, Grantcharov TP (2013) Defining technical errors in laparoscopic surgery: a systematic review. Surg Endosc 27:2678-2691
26. Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG (2001) Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg 88:1157-1168
27. Peel AL, Taylor EW (1991) Proposed definitions for the audit of postoperative infection: a discussion paper. Surgical Infection Study Group. Ann R Coll Surg Engl 73:385-388
28. Bruce J, Russell EM, Mollison J, Krukowski ZH (2001) The quality of measurement of surgical wound infection as the basis for monitoring: a systematic review. J Hosp Infect 49:99-108
29. Russell EM, Bruce J, Krukowski ZH (2003) Systematic review of the quality of surgical mortality monitoring. Br J Surg 90:527-532
30. Ioannidis JP, Contopoulos-Ioannidis DG (1998) Reporting of safety data from randomised trials. Lancet 352:1752-1753
31. Ioannidis JP, Lau J (2001) Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 285:437-443
32. Sokol DK, Wilson J (2008) What is a surgical complication? World J Surg 32:942-944
33. Dindo D, Clavien PA (2008) What is a surgical complication? World J Surg 32:939-941
34. Cunningham SC, Kavic SM (2009) What is a surgical complication? World J Surg 33:1099-1100
35. Wilson J, Sokol DK (2009) Do we need a concept of intraoperative complication? World J Surg 33:1102
36. Mehran R, Leon MB, Feigal DA, Jefferys D, Simons M, Chronos N, Fogarty TJ, Kuntz RE, Baim DS, Kaplan AV (2004) Postmarket approval surveillance: a call for a more integrated and comprehensive approach. Circulation 109:3073-3077
37. International Medical Device Regulators Forum (2006) Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices. http://www.imdrf.org/ docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n54r8-guidance-adverse-events-061130.pdf. Accessed 23 Oct 2013
38. Kram R (2008) Critical incident reporting system in emergency medicine. Curr Opin Anaesthesiol 21:240-244
39. Leape LL (1994) Error in medicine. JAMA 272:1851-1857
40. Reason J (2000) Human error: models and management. BMJ 320:768-770
41. Catchpole K (2010) Errors in the operating theatre-how to spot and stop them. J Health Serv Res Policy 15(Suppl 1):48-51
42. Bonrath EM, Zevin B, Dedy NJ, Grantcharov TP (2013) Error rating tool to identify and analyse technical errors and events in laparoscopic surgery. Br J Surg 100:1080-1088
43. Morissette K, Tricco AC, Horsley T, Chen MH, Moher D (2011) Blinded versus unblinded assessments of risk of bias in studies included in a systematic review. Cochrane Database Syst Rev (9):MR000025
44. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P (2012) Developing core outcome sets for clinical trials: issues to consider. Trials 13:132