Canadian Journal of Anesthesia Journal canadien d’anesthésie

Published by the Canadian Anesthesiologists’ Society

Editor-in-Chief: Donald R. Miller, MD Editorial Assistant: Carolyn Gillis The Ottawa Hospital - General Campus CCW Department of Anesthesia, Room 1401 501 Smyth Road Ottawa (Ontario) K1H 8L6 Phone: 450-477-7607 Fax: 450-477-8472 E-mail: [email protected]

February 15th, 2013 Notice of Retraction The articles in Table 1 by Yoshitaka Fujii were retracted in 2012. At that time, the articles in Table 2 were still under review by the University of Tsukuba. The University of Tsukuba has completed its review, and based upon their findings, and further to the Expression of Concern* posted online on March 13th, 2012, and the Editors-in-Chief Request for Determination of April 9, 2012†, and further to the Canadian Journal of Anesthesia Notice of Retraction of 17 articles by Dr. Yoshitaka Fujii, dated September 6th 2012,‡ the following 16 additional articles are hereby retracted as a result of: 1. overwhelming evidence of fabrication relating to the fact that the distributions of many variables reported by Dr. Fujii in these studies are exceedingly unlikely;1,2 and 2. the inability of Dr. Fujii’s institutions to attest to the integrity of the studies and/or the data conducted under their auspices, as set out in the Joint Editors-in-Chief Request for Determination of April 9, 2012.† There are now 33 articles retracted from the Journal, written by Dr Fujii. The University of Tsukuba has affirmed the validity of three articles3-5 published in the Journal by Dr. S. Takahashi, for which Dr. Fujii was a coauthor. In addition, Tokyo Medical and Dental University has affirmed two other articles published in the Journal, one by Dr. T. Ebata6 and the other by Dr. Y. Saitoh,7 for which Dr. Fujii was a coauthor. These five articles shall remain part of the unimpeached medical literature. We extend our sincere appreciation to the universities in Japan for their review of the status of Dr. Fujii’s research, and to the investigating committees for their review of his research findings.

Donald R. Miller, MD Editor-in-Chief Canadian Journal of Anesthesia ----------------------------* http://www.springer.com/medicine/anesthesiology/journal/12630. † http://www.aaeditor.org/Fujii_Joint_EIC_Stmt.pdf (accessed September 2012). ‡ http://www.springer.com/medicine/anesthesiology/journal/12630,

1

References 1. 2. 3.

4.

5.

6. 7.

Carlisle JB. The analysis of 168 randomised controlled trials to test data integrity. Anaesthesia 2012; 67: 521-37. Kranke P, Apfel CC, Roewer N, Fujii Y. Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. are incredibly nice! Anesth Analg 2000; 90: 1004-7. Takahashi S, Fujii Y, Inomata S-I, Miyabe M, Toyooka H. Landiolol decreases a dysrhythmogenic dose of epinephrine in dogs during halothane anesthesia. Can J Anesth 1999; 46: 599-604. Takahashi S, Fujii Y, Hoshi T, Inomata S-I, Miyabe M, Toyooka H. Modifications of the hemodynamic consequences of theophylline intoxication with landiolol in halothaneanesthetized dogs. Can J Anesth 2000; 47: 265-72. Takahashi S, Fujii Y, Hoshi T, Uemura A, Miyabe M, Toyooka H. Milrinone attenuates the negative inotropic effects of landiolol in halothane-anesthetized dogs. Can J Anesth 2003; 50: 830-4 Ebata T, Fujii Y, Toyooka H. Dobutamine increases diaphragmatic contractility in dogs. Can J Anaesth 1992; 39: 375-80. Saitoh Y, Fujii Y, Toyooka H, Amaha K. Post-tetanic burst count: a stimulating pattern for profound neuromuscular blockade. Can J Anaesth 1995; 42: 1096-100.

2

TABLE 1 Articles written by Dr. Yoshitaka Fujii retracted in 2012

1. Fujii Y, Tanaka H, Toyooka H. Granisetron reduces postoperative nausea and vomiting throughout menstrual cycle. Can J Anaesth 1997; 44: 489-93. 2. Fujii Y, Tanaka H, Toyooka H. Granisetron reduces the incidence and severity of nausea and vomiting after laparoscopic cholecystectomy. Can J Anaesth 1997; 44: 396-400. 3. Fujii Y, Tanaka H, Toyooka H. Prophylactic antiemetic efficacy of granisetron in patients with and without previous postoperative emesis. Can J Anaesth 1997; 44: 273-7. 4. Fujii Y, Tanaka H, Toyooka H. Granisetron and dexamethasone provide more improved prevention of postoperative emesis than granisetron alone in children. Can J Anaesth 1996; 43: 1229-32. 5. Fujii Y, Toyooka H, Tanaka H. Antiemetic efficacy of granisetron and metoclopramide in children undergoing ophthalmic or ENT surgery. Can J Anaesth 1996; 43: 1095-9. 6. Fujii Y, Toyooka H, Tanaka H. Effective dose of granisetron for preventing postoperative emesis in children. Can J Anaesth 1996; 43: 660-4. 7. Fujii Y, Toyooka H, Tanaka H. Antiemetic effects of granisetron on postoperative nausea and vomiting in patients with and without motion sickness. Can J Anaesth 1996; 43: 110-4. 8. Fujii Y, Tanaka H, Toyooka H. Granisetron reduces vomiting after strabismus surgery and tonsillectomy in children. Can J Anaesth 1996; 43: 35-8. 9. Fujii Y, Tanaka H, Toyooka H. Prevention of postoperative nausea and vomiting with granisetron: a randomised, double-blind comparison with droperidol. Can J Anaesth 1995; 42: 852-6. 10. Fujii Y, Tanaka H, Saitoh Y, Toyooka H. Effects of calcium channel blockers on circulatory response to tracheal intubation in hypertensive patients: nicardipine versus diltiazem. Can J Anaesth 1995; 42: 785-8. 11. Fujii Y, Tanaka H, Toyooka H. Granisetron-dexamethasone combination reduces postoperative nausea and vomiting. Can J Anaesth 1995; 42: 387-90. 12. Fujii Y, Toyooka H, Amaha K. Amrinone improves contractility of fatigued diaphragm in dogs. Can J Anaesth 1995; 42: 80-6. 13. Fujii Y, Tanaka H, Toyooka H. Circulatory responses to laryngeal mask airway insertion or tracheal intubation in normotensive and hypertensive patients. Can J Anaesth 1995; 42: 32-6. 14. Fujii Y, Tanaka H, Toyooka H. Optimal anti-emetic dose of granisetron for preventing postoperative nausea and vomiting. Can J Anaesth 1994; 41: 794-7. 15. Fujii Y, Toyooka H, Amaha K. Nicardipine enhances diaphragmatic fatigue. Can J Anaesth 1994; 41: 435-9. 16. Fujii Y, Tanaka H, Toyooka H. Reduction of postoperative nausea and vomiting with granisetron. Can J Anaesth 1994; 41: 291-4. 17. Fujii Y, Toyooka H, Ebata T, Amaha K. Contractility of fatigued diaphragm is improved by dobutamine. Can J Anaesth 1993; 40: 453-8.

3

TABLE 2 Articles written by Dr. Yoshitaka Fujii that are retracted, based upon review by the University of Tsukuba

1. Fujii Y, Nakayama M. A lidocaine/metoclopramide combination decreases pain on injection of propofol. Can J Anesth 2005; 52: 474-7. 2. Numazaki M, Fujii Y. Antiemetic efficacy of propofol at small doses for reducing nausea and vomiting following thyroidectomy. Can J Anesth 2005; 52: 333-4. 3. Fujii Y. Pretreatment with flurbiprofen axetil and venous occlusion to reduce pain during injection of propofol. Can J Anesth 2004; 51: 1047-8. 4. Nakano M, Fujii Y. Prevention of nausea and vomiting after dental surgery: a comparison of small doses of propofol, droperidol, and metoclopramide. Can J Anesth 2003; 50: 1085. 5. Fujii Y, Toyooka H. High-dose colforsin daropate increases diaphragmatic contractility in dogs. Can J Anesth 2002; 49; 877-9. 6. Fujii Y, Toyooka H. Different effects of olprinone on contractility in nonfatigued and fatigued diaphragm in dogs. Can J Anesth 2000; 47: 1243-8. 7. Hoshi T, Fujii Y, Takahashi S, Toyooka H. Effect of xenon on diaphragmatic contractility in dogs. Can J Anesth 2000; 47: 819-22. 8. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anesth 1999; 46: 991-3. 9. Fujii Y, Saitoh Y, Takahashi S, Toyooka H. Combined diltiazem and lidocaine reduces cardiovascular responses to tracheal extubation and anesthesia emergence in hypertensive patients. Can J Anesth 1999; 46: 952-6. 10. Fujii Y, Saitoh Y, Takahashi S, Toyooka H. Diltiazem-lidocaine combination for the attenuation of cardiovascular responses to tracheal intubation in hypertensive patients. Can J Anaesth 1998; 45: 933-7. 11. Fujii Y, Kihara S-I, Takahashi S, Tanaka H, Toyooka H. Calcium channel blockers attenuate cardiovascular responses to tracheal extubation in hypertensive patients. Can J Anaesth 1998; 45: 655-9. 12. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Prophylactic antiemetic therapy with granisetron-droperidol combination in patients undergoing laparoscopic cholecystectomy. Can J Anaesth 1998; 45: 541-4. 13. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Cardiovascular responses to tracheal extubation or LMA removal in children. Can J Anaesth 1998; 45: 178-81. 14. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Prevention of PONV with granisetron, droperidol or metoclopramide in patients with postoperative emesis. Can J Anaesth 1998; 45: 153-6. 15. Fujii Y, Toyooka H, Tanaka H. Cardiovascular responses to tracheal extubation or LMA removal in normotensive and hypertensive patients. Can J Anaesth 1997; 44: 1082-6. 16. Fujii Y, Toyooka H, Tanaka H. Prevention of PONV with granisetron, droperidol and metoclopramide in female patients with history of motion sickness. Can J Anaesth 1997; 44: 820-4.

4

Canadian Journal of Anesthesia Journal canadien d’anesthésie

Published by the Canadian Anesthesiologists’ Society

Editor-in-Chief: Donald R. Miller, MD Editorial Assistant: Carolyn Gillis The Ottawa Hospital - General Campus CCW Department of Anesthesia, Room 1409 501 Smyth Road Ottawa (Ontario) K1H 8L6 Phone: 450-477-7607 Fax: 450-477-8472 E-mail: [email protected]

September 6th, 2012 Notice of Retraction Further to the Expression of Concern* posted online on March 13th, 2012, the 17 articles listed in Table 1 by Dr. Yoshitaka Fujii are hereby retracted as a result of: 1. overwhelming evidence of fabrication relating to the fact that the distributions of many variables reported by Dr. Fujii in these studies are exceedingly unlikely;1,2 and 2. the inability of Dr. Fujii’s institutions to attest to the integrity of the studies and/or the data conducted under their auspices, as set out in the Joint Editors-in-Chief Request for Determination of April 9, 2012.* The University of Tsukuba has affirmed the validity of three articles3-5 by Dr. S. Takahashi for which Dr. Fujii was a coauthor. In addition, Tokyo Medical and Dental University has affirmed two other articles published in the Journal, one by Dr. T. Ebata6 and the other by Dr. Y. Saitoh,7 for which Dr. Fujii was a coauthor. These five articles shall remain part of the unimpeached medical literature. Another 17 articles listed in Table 2 by Dr. Fujii remain under review by the University of Tsukuba. These articles are considered compromised until they are assessed by the University. Articles in Table 2 that are not affirmed as valid by the University of Tsukuba will be retracted. Kobe University was mistakenly listed as one of the responsible institutions in the initial Joint Editors-in-Chief Request for Determination Regarding Papers Published by Dr. Yoshitaka Fujii. Kobe University has never been associated with Dr. Fujii.

Donald R. Miller, MD Editor-in-Chief Canadian Journal of Anesthesia ----------------------------* http://www.springer.com/medicine/anesthesiology/journal/12630. … /2

References 1. 2. 3.

4.

5.

6. 7.

Carlisle JB. The analysis of 168 randomised controlled trials to test data integrity. Anaesthesia 2012; 67: 521-37. Kranke P, Apfel CC, Roewer N, Fujii Y. Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. are incredibly nice! Anesth Analg 2000; 90: 1004-7. Takahashi S, Fujii Y, Inomata S-I, Miyabe M, Toyooka H. Landiolol decreases a dysrhythmogenic dose of epinephrine in dogs during halothane anesthesia. Can J Anesth 1999; 46: 599-604. Takahashi S, Fujii Y, Hoshi T, Inomata S-I, Miyabe M, Toyooka H. Modifications of the hemodynamic consequences of theophylline intoxication with landiolol in halothaneanesthetized dogs. Can J Anesth 2000; 47: 265-72. Takahashi S, Fujii Y, Hoshi T, Uemura A, Miyabe M, Toyooka H. Milrinone attenuates the negative inotropic effects of landiolol in halothane-anesthetized dogs. Can J Anesth 2003; 50: 830-4 Ebata T, Fujii Y, Toyooka H. Dobutamine increases diaphragmatic contractility in dogs. Can J Anaesth 1992; 39: 375-80. Saitoh Y, Fujii Y, Toyooka H, Amaha K. Post-tetanic burst count: a stimulating pattern for profound neuromuscular blockade. Can J Anaesth 1995; 42: 1096-100.

… /3

Table 1: Articles retracted from the Canadian Journal of Anesthesia 1. Fujii Y, Tanaka H, Toyooka H. Granisetron reduces postoperative nausea and vomiting throughout menstrual cycle. Can J Anaesth 1997; 44: 489-93. 2. Fujii Y, Tanaka H, Toyooka H. Granisetron reduces the incidence and severity of nausea and vomiting after laparoscopic cholecystectomy. Can J Anaesth 1997; 44: 396-400. 3. Fujii Y, Tanaka H, Toyooka H. Prophylactic antiemetic efficacy of granisetron in patients with and without previous postoperative emesis. Can J Anaesth 1997; 44: 273-7. 4. Fujii Y, Tanaka H, Toyooka H. Granisetron and dexamethasone provide more improved prevention of postoperative emesis than granisetron alone in children. Can J Anaesth 1996; 43: 1229-32. 5. Fujii Y, Toyooka H, Tanaka H. Antiemetic efficacy of granisetron and metoclopramide in children undergoing ophthalmic or ENT surgery. Can J Anaesth 1996; 43: 1095-9. 6. Fujii Y, Toyooka H, Tanaka H. Effective dose of granisetron for preventing postoperative emesis in children. Can J Anaesth 1996; 43: 660-4. 7. Fujii Y, Toyooka H, Tanaka H. Antiemetic effects of granisetron on postoperative nausea and vomiting in patients with and without motion sickness. Can J Anaesth 1996; 43: 110-4. 8. Fujii Y, Tanaka H, Toyooka H. Granisetron reduces vomiting after strabismus surgery and tonsillectomy in children. Can J Anaesth 1996; 43: 35-8. 9. Fujii Y, Tanaka H, Toyooka H. Prevention of postoperative nausea and vomiting with granisetron: a randomised, double-blind comparison with droperidol. Can J Anaesth 1995; 42: 852-6. 10. Fujii Y, Tanaka H, Saitoh Y, Toyooka H. Effects of calcium channel blockers on circulatory response to tracheal intubation in hypertensive patients: nicardipine versus diltiazem. Can J Anaesth 1995; 42: 785-8. 11. Fujii Y, Tanaka H, Toyooka H. Granisetron-dexamethasone combination reduces postoperative nausea and vomiting. Can J Anaesth 1995; 42: 387-90. 12. Fujii Y, Toyooka H, Amaha K. Amrinone improves contractility of fatigued diaphragm in dogs. Can J Anaesth 1995; 42: 80-6. 13. Fujii Y, Tanaka H, Toyooka H. Circulatory responses to laryngeal mask airway insertion or tracheal intubation in normotensive and hypertensive patients. Can J Anaesth 1995; 42: 32-6. 14. Fujii Y, Tanaka H, Toyooka H. Optimal anti-emetic dose of granisetron for preventing postoperative nausea and vomiting. Can J Anaesth 1994; 41: 794-7. 15. Fujii Y, Toyooka H, Amaha K. Nicardipine enhances diaphragmatic fatigue. Can J Anaesth 1994; 41: 435-9. 16. Fujii Y, Tanaka H, Toyooka H. Reduction of postoperative nausea and vomiting with granisetron. Can J Anaesth 1994; 41: 291-4. 17. Fujii Y, Toyooka H, Ebata T, Amaha K. Contractility of fatigued diaphragm is improved by dobutamine. Can J Anaesth 1993; 40: 453-8.

… /4

Table 2: Articles written by Dr. Yoshitaka Fujii that are indeterminate 1. Fujii Y, Nakayama M. A lidocaine/metoclopramide combination decreases pain on injection of propofol. Can J Anesth 2005; 52: 474-7. 2. Numazaki M, Fujii Y. Antiemetic efficacy of propofol at small doses for reducing nausea and vomiting following thyroidectomy. Can J Anesth 2005; 52: 333-4. 3. Fujii Y. Pretreatment with flurbiprofen axetil and venous occlusion to reduce pain during injection of propofol. Can J Anesth 2004; 51: 1047-8. 4. Nakano M, Fujii Y. Prevention of nausea and vomiting after dental surgery: a comparison of small doses of propofol, droperidol, and metoclopramide. Can J Anesth 2003; 50: 1085. 5. Fujii Y, Toyooka H. High-dose colforsin daropate increases diaphragmatic contractility in dogs. Can J Anesth 2002; 49; 877-9. 6. Saitoh Y, Kaneda K, Fujii Y, Oshima T. Nicorandil accelerates recovery of neuromuscular block caused by vecuronium. Can J Anesth 2001; 48: 28-33. 7. Fujii Y, Toyooka H. Different effects of olprinone on contractility in nonfatigued and fatigued diaphragm in dogs. Can J Anesth 2000; 47: 1243-8. 8. Hoshi T, Fujii Y, Takahashi S, Toyooka H. Effect of xenon on diaphragmatic contractility in dogs. Canadian Can J Anesth 2000; 47: 819-22. 9. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anesth 1999; 46: 991-3 10. Fujii Y, Saitoh Y, Takahashi S, Toyooka H. Combined diltiazem and lidocaine reduces cardiovascular responses to tracheal extubation and anesthesia emergence in hypertensive patients. Can J Anesth 1999; 46: 9526. 11. Fujii Y, Saitoh Y, Takahashi S, Toyooka H. Diltiazem-lidocaine combination for the attenuation of cardiovascular responses to tracheal intubation in hypertensive patients. Can J Anaesth 1998; 45: 933-7. 12. Fujii Y, Kihara S-I, Takahashi S, Tanaka H, Toyooka H. Calcium channel blockers attenuate cardiovascular responses to tracheal extubation in hypertensive patients. Can J Anaesth 1998; 45: 655-9. 13. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Prophylactic antiemetic therapy with granisetron-droperidol combination in patients undergoing laparoscopic cholecystectomy. Can J Anaesth 1998; 45: 541-4. 14. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Cardiovascular responses to tracheal extubation or LMA removal in children. Can J Anaesth 1998; 45: 178-81. 15. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Prevention of PONV with granisetron, droperidol or metoclopramide in patients with postoperative emesis. Can J Anaesth 1998; 45: 153–6. 16. Fujii Y, Toyooka H, Tanaka H. Cardiovascular responses to tracheal extubation or LMA removal in normotensive and hypertensive patients. Can J Anaesth 1997; 44: 1082-6. 17. Fujii Y, Toyooka H, Tanaka H. Prevention of PONV with granisetron, droperidol and metoclopramide in female patients with history of motion sickness. Can J Anaesth 1997; 44: 820-4.

http://www.springer.com/journal/12630

Canadian Journal of Anesthesia Journal canadien d’anesthésie

Published by the Canadian Anesthesiologists’ Society

Editor-in-Chief: Donald R. Miller, MD Editorial Assistant: Carolyn Gillis The Ottawa Hospital General Campus CCW Department of Anesthesia, Room 1409 501 Smyth Road Ottawa (Ontario) K1H 8L6 Phone: 450-477-7607 Fax: 450-477-8472 E-mail: [email protected]

Expression of Concern Online posting to the Canadian Journal of Anesthesia Release Date: March 13, 2012 To our readers: In 2011, the Canadian Journal of Anesthesia received an article submission entitled: "Effects of colforsin daropate on hypercapnic depression of diaphragmatic contractility in pentobarbital-anesthetized dogs". The authors were Yoshitaka Fujii, MD and Aki Uemura, MD from the First Department of Anesthesiology, Toho University School of Medicine. At the time of article submission, we were aware of ongoing concerns regarding Dr. Fujii's work that extended as far back as 2000. A Letter to the Editor by Drs. Kranke et al.1 published in Anesthesia & Analgesia raised concerns about the implausibility of data from a large number of articles published by Dr. Fujii across a number of journals, including the Canadian Journal of Anesthesia. We were also aware of an ongoing analysis of 169 randomized controlled trials being undertaken by Dr. John Carlisle, the results of which were recently published in Anaesthesia.2 This unique article provides overwhelming statistical evidence that “the distribution of continuous and categorical variables reported in Fujii’s papers, both animal and human, are extremely unlikely to have arisen by chance and if so, in many cases with likelihoods that are infinitesimally small.”

As a result of an internal investigation in the Department of Anesthesia at Toho University, it was determined that the article submitted to the Canadian Journal of Anesthesia in 2011 had no ethical approval but also that the data had been fabricated. These events resulted in the launch of a more extensive review by the Investigating Committee of the Faculty of Medicine at Toho University. The results of the university Discipline Committee were released on March 8, 2012:

1

 

            “Since all of Dr. Fujii’s clinical studies that appeared in these 9 publications [below] were conducted at Ushiku Aiwa General Hospital, which has no relation to his research activity in Toho University, the investigation committee contacted the head of the hospital. As far as the head of the hospital knows, there was only one clinical study listed by Dr. Fujii as having been conducted at the hospital. The other eight clinical studies were conducted without any ethics committee’s approval, and this was judged sufficient to decide that 8 of his publications (No. 2 to 9) should be retracted since they did not conform to the global standard of ethics for clinical studies. After the investigation, the committee asked Dr. Yoshitaka Fujii and his co-author, Dr. Michiyo Itakura, to explain the whole circumstances. Dr. Fujii admitted that the clinical studies were done without any ethics committee’s approval. Dr. Itakura, however, was not involved in this misconduct. Dr. Yoshitaka Fujii sent letters of retraction to the affected journals. We organized a disciplinary committee and decided that a disciplinary dismissal was appropriate for Dr. Fujii effective from February 29, 2012. Dr. Fujii has already been dismissed from Toho University.”

Below is the list of nine publications in which it was determined that Dr. Fujii did not receive ethical approval:

1.

Fujii Y, Itakura M. Efficacy of the lidocaine/flurbiprofen axetil combination for reducing pain during

the injection of propofol. Minerva Anestesiol 2011 Jul; 77(7): 693-7.

2.

Fujii Y, Itakura M. Antiemetic efficacy of low-dose midazolam in patients undergoing thyroidectomy.

Otolaryngol Head Neck Surg 2011 Feb; 144(2): 206-9.

3.

Fujii Y, Itakura M. A prospective, randomized, double-blind, placebo-controlled study to assess the

antiemetic effects of midazolam on postoperative nausea and vomiting in women undergoing laparoscopic gynecologic surgery. Clin Ther 2010 Aug; 32(9): 1633-7.

4.

Fujii Y, Itakura M. Reduction of postoperative nausea, vomiting, and analgesic requirement with

dexamethasone for patients undergoing laparoscopic cholecystectomy. Surg Endosc 2010 Mar; 24(3): 6926.

2

5.

Fujii Y, Itakura M. A comparison of pretreatment with fentanyl and lidocaine preceded by venous

occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebocontrolled study in adult Japanese surgical patients. Clin Ther 2009 Oct; 31(10): 2107-12.

6. Fujii Y, Itakura M. Low-dose propofol to prevent nausea and vomiting after laparoscopic surgery. Int J Gynaecol Obstet 2009 Jul; 106(1): 50-2.

7.

Fujii Y, Itakura M. Pretreatment with flurbiprofen axetil, flurbiprofen axetil preceded by venous

occlusion, and a mixture of flurbiprofen axetil and propofol in reducing pain on injection of propofol in adult Japanese surgical patients: a prospective, randomized, double-blind, placebo-controlled study. Clin Ther 2009 Apr; 31(4): 721-7 8. Fujii Y, Itakura M. Comparison of propofol, droperidol, and metoclopramide for prophylaxis of postoperative nausea and vomiting after breast cancer surgery: a prospective, randomized, double-blind, placebo-controlled study in Japanese patients. Clin Ther 2008 Nov; 30(11): 2024-9.

9.

Fujii Y, Itakura M. Comparison of lidocaine, metoclopramide, and flurbiprofen axetil for reducing pain

on injection of propofol in Japanese adult surgical patients: a prospective, randomized, double-blind, parallel-group, placebo-controlled study. Clin Ther 2008 Feb; 30(2): 280-6.

The announcement by Toho University follows a joint effort by editors-in-chief of a number of anesthesia journals. I extend my personal thanks to Dr. Steven Shafer, Editor-in-Chief of Anesthesia & Analgesia, and Dr. Steven Yentis, Editor-in-Chief of Anaesthesia, both of whom have played pivotal roles in pursuing the question of possible scientific misconduct of Dr. Fujii’s work. While none of the nine articles on the above list was published in the Canadian Journal of Anesthesia, the egregious ethical misconduct that has already been confirmed and the overwhelming concerns of scientific misconduct now cast a shadow of serious doubt relating to every one of the articles that Dr. Yoshitaka Fujii has ever published. Accordingly, it is important that we provide a complete list of articles written by Dr. Yoshitaka Fujii that were published in the Canadian Journal of Anesthesia: ● Ebata T, Fujii Y, Toyooka H. Dobutamine increases diaphragmatic contractility in dogs. Can J Anaesth 1992; 39: 375-80. 3

● Fujii Y, Toyooka H, Ebata T, Amaha K. Contractility of fatigued diaphragm is improved by dobutamine. Can J Anaesth 1993; 40: 453-8. ● Fujii Y, Tanaka H, Toyooka H. Reduction of postoperative nausea and vomiting with granisetron. Can J Anaesth 1994; 41: 291-4. ● Fujii Y, Toyooka H, Amaha K. Nicardipine enhances diaphragmatic fatigue. Can J Anaesth 1994; 41: 435-9. ● Fujii Y, Tanaka H, Toyooka H. Optimal anti-emetic dose of granisetron for preventing postoperative nausea and vomiting. Can J Anaesth 1994; 41: 794-7. ● Fujii Y, Tanaka H, Toyooka H. Circulatory responses to laryngeal mask airway insertion or tracheal intubation in normotensive and hypertensive patients. Can J Anaesth 1995; 42: 32-6. ● Fujii Y, Toyooka H, Amaha K. Amrinone improves contractility of fatigued diaphragm in dogs. Can J Anaesth 1995; 42: 80-6. ● Fujii Y, Tanaka H, Toyooka H. Granisetron-dexamethasone combination reduces postoperative nausea and vomiting. Can J Anaesth 1995; 42: 387-90. ● Fujii Y, Tanaka H, Saitoh Y, Toyooka H. Effects of calcium channel blockers on circulatory response to tracheal intubation in hypertensive patients: nicardipine versus diltiazem. Can J Anaesth 1995; 42: 785-8. ● Fujii Y, Tanaka H, Toyooka H. Prevention of postoperative nausea and vomiting with granisetron: a randomized, double-blind comparison with droperidol. Can J Anaesth 1995; 42: 852-6. ● Saitoh Y, Fujii Y, Toyooka H, Amaha K. Post-tetanic burst count: a stimulating pattern for profound neuromuscular blockade. Can J Anaesth 1995; 42: 1096-100. ● Fujii Y, Tanaka H, Toyooka H. Granisetron reduces vomiting after strabismus surgery and tonsillectomy in children. Can J Anaesth 1996; 43: 35-8. ● Fujii Y, Toyooka H, Tanaka H. Antiemetic effects of granisetron on postoperative nausea and vomiting in patients with and without motion sickness. Can J Anaesth 1996; 43: 110-4. ● Fujii Y, Toyooka H, Tanaka H. Effective dose of granisetron for preventing postoperative emesis in children. Can J Anaesth 1996; 43: 660-4. ● Fujii Y, Toyooka H, Tanaka H. Antiemetic efficacy of granisetron and metoclopramide in children undergoing ophthalmic or ENT surgery. Can J Anaesth 1996; 43: 1095-9. ● Fujii Y, Tanaka H, Toyooka H. Granisetron and dexamethasone provide more improved prevention of postoperative emesis than granisetron alone in children. Can J Anaesth 1996; 43: 1229-32. ● Fujii Y, Tanaka H, Toyooka H. Prophylactic antiemetic efficacy of granisetron in patients with and without previous postoperative emesis. Can J Anaesth 1997; 44: 273-7. 4

● Fujii Y, Tanaka H, Toyooka H. Granisetron reduces the incidence and severity of nausea and vomiting after laparoscopic cholecystectomy. Can J Anaesth 1997; 44: 396-400. ● Fujii Y, Tanaka H, Toyooka H. Granisetron reduces postoperative nausea and vomiting throughout menstrual cycle. Can J Anaesth 1997; 44: 489-93. ● Fujii Y, Toyooka H, Tanaka H. Prevention of PONV with granisetron, droperidol and metoclopramide in female patients with history of motion sickness. Can J Anaesth 1997; 44: 820-4. ● Fujii Y, Toyooka H, Tanaka H. Cardiovascular responses to tracheal extubation or LMA removal in normotensive and hypertensive patients. Can J Anaesth 1997; 44: 1082-6. ● Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Prevention of PONV with granisetron, droperidol or metoclopramide in patients with postoperative emesis. Can J Anaesth 1998; 45: 153-6. ● Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Cardiovascular responses to tracheal extubation or LMA removal in children. Can J Anaesth 1998; 45: 178-81. ● Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Prophylactic antiemetic therapy with granisetron-droperidol combination in patients undergoing laparoscopic cholecystectomy. Can J Anaesth 1998; 45: 541-4. ● Fujii Y, Kihara S, Takahashi S, Tanaka H, Toyooka H. Calcium channel blockers attenuate cardiovascular responses to tracheal extubation in hypertensive patients. Can J Anaesth 1998; 45: 655-9. ● Fujii Y, Saitoh Y, Takahashi S, Toyooka H. Diltiazem-lidocaine combination for the attenuation of cardiovascular responses to tracheal intubation in hypertensive patients. Can J Anaesth 1998; 45: 933-7. ● Takahashi S, Fujii Y, Inomata S, Miyabe M, Toyooka H. Landiolol decreases a dysrhythmogenic dose of epinephrine in dogs during halothane anesthesia. Can J Anesth 1999; 46: 599-604. ● Fujii Y, Saitoh Y, Takahashi S, Toyooka H. Combined diltiazem and lidocaine reduces cardiovascular responses to tracheal extubation and anesthesia emergence in hypertensive patients. Can J Anesth 1999; 46: 952-6. ● Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Can J Anesth 1999; 46: 991-3. ● Takahashi S, Fujii Y, Hoshi T, Inomata S, Miyabe M, Toyooka H. Modifications of the hemodynamic consequences of theophylline intoxication with landiolol in halothane-anesthetized dogs. Can J Anesth 2000; 47: 265-72. ● Hoshi T, Fujii Y, Takahashi S, Toyooka H. Effect of xenon on diaphragmatic contractility in dogs. Can J Anesth 2000; 47: 819-22. ● Fujii Y, Toyooka H. Different effects of olprinone on contractility in nonfatigued and fatigued diaphragm in dogs. Can J Anesth 2000; 47: 1243-8. 5

● Saitoh Y, Kaneda K, Fujii Y, Oshima T. Nicorandil accelerates recovery of neuromuscular block caused by vecuronium. Can J Anesth 2001; 48: 28-33. ● Fujii Y, Toyooka H. High-dose colforsin daropate increases diaphragmatic contractility in dogs. Can J Anesth 2002; 49: 877-9. ● Takahashi S, Fujii Y, Hoshi T, Uemura A, Miyabe M, Toyooka H. Milrinone attenuates the negative inotropic effects of landiolol in halothane-anesthetized dogs. Can J Anesth 2003; 50: 830-4. ● Nakano M, Fujii Y. Prevention of nausea and vomiting after dental surgery: a comparison of small doses of propofol, droperidol, and metoclopramide. Can J Anesth 2003; 50: 1085. ● Fujii Y. Pretreatment with flurbiprofen axetil and venous occlusion to reduce pain during injection of propofol. Can J Anesth 2004; 51: 1047-8. ● Numazaki M, Fujii Y. Antiemetic efficacy of propofol at small doses for reducing nausea and vomiting following thyroidectomy. Can J Anesth 2005; 52: 333-4. ● Fujii Y, Nakayama M. A lidocaine/metoclopramide combination decreases pain on injection of propofol. Can J Anesth 2005; 52: 474-7.

The editors of the affected journals will jointly contact the Deans of the Faculties of Medicine of the six universities from which Dr. Fujii published his work to alert them of these concerns and to request that they provide unequivocal evidence of Institutional Review Board approval and data veracity regarding all of the studies cited in the Carlisle article. This review will be complex as it involves a number of institutions. In the absence of the aforementioned documentation, it is possible that many or all of the affected articles may be retracted in due course.

In general, health practice and policy is rarely changed based on the results of a single primary study. More often, change happens after a systematic review or practice guideline (resulting from a systematic review). In the case of Dr. Fujii, it will also be important to ascertain whether any of his primary research has been included in systematic reviews, as the results could be potentially misleading until such time as they can be re-analyzed without the problem primary studies.

We deeply regret the shadow of serious doubt that has been cast over such a large body of scientific literature. I have previously expressed my personal views regarding scientific misconduct.3 In a recent editorial,4 Dr. Elizabeth Wager, Chair of the Committee on Publication Ethics, explored the challenging and complex issue concerning who is responsible for investigating suspected research misconduct. As stated by Dr. Wager in her recent editorial, “Research misconduct is hard to prevent because it represents a systems 6

failure, so its causes and solutions are multifactorial. Similarly, systems for investigating misconduct appear to be difficult to establish, fund and monitor…unless we establish better methods for investigating misconduct, researchers and clinicians will be left with lingering doubt about the purity and therefore trustworthiness of the evidence they rely on to make decisions.”

Donald R. Miller, MD Editor-in-Chief Canadian Journal of Anesthesia

 

   

References 1.

Kranke P, Apfel CC, Roewer N. Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. are incredibly nice! Anesth Analg 2000; 90: 1004-7.

2.

Carlisle JB. The analysis of 169 randomised controlled trials to test data integrity. Anaesthesia 2012; DOI: 10.1111/j.1365-2044.2012.07128.x.

3.

Miller DR. Special notice to readers and authors on scientific misconduct. Can J Anesth 2009; 56: 408-11.

4.

Wager E. Who is responsible for investigating research misconduct? Anaestheia 2012; DOI: 10.1111/j.1365-2044.2012.07132.x.

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http://www.springer.com/journal/12630

Editors-in-Chief Statement Regarding Published Clinical Trials Conducted without IRB Approval by Joachim Boldt

March 4, 2011 To our readers: Landesärztekammer Rheinland-Pfalz (“LÄK-RLP”), the State Medical Association of Rheinland-Pfalz, Germany serves as the Institutional Review Board (IRB) for clinical research at Klinikum Ludwigshafen, where Dr. Joachim Boldt’s recent research was conducted. On February 25, 2011, LÄK-RLP provided the involved journals with the results of their evaluation of the status of IRB approval for research conducted by Dr. Boldt dating back to 1999. LÄKRLP determined, to the best of its ability, the status of IRB approval for 102 articles published by Dr. Boldt. Table 1 lists 88 articles for which LÄK-RLP was unable to verify IRB approval. Table 2 lists 12 articles for which LÄK-RLP was able to verify IRB approval. Table 3 lists 2 articles for which LÄK-RLP determined that IRB approval was not necessary. The undersigned Editors-in-Chief of medical journals affected by these findings will retract the articles in our respective journals that are listed in table 1. Formal retraction notices will appear in each journal. The retraction of the articles in Table 1 for lack of IRB approval means that the research was unethical, and that IRB approval for the research was misrepresented in the published article. It does not mean that the research results per se are fraudulent. Klinikum Ludwigshafen has commissioned an investigating committee to systematically assess the veracity of the findings presented in Dr. Boldt’s articles against patient and laboratory records. We will communicate to our readers any finding of data fabrication, falsification, or misrepresentation identified by the investigating committee at Klinikum Ludwigshafen. We, the undersigned Editors-in-Chief, on behalf of our Editorial Boards, affiliated societies, and publishers, extend our appreciation to LÄK-RLP for their review of the status of IRB approval for Dr. Boldt’s research and to the investigating committee at Klinikum Ludwigshafen for their ongoing review of his research findings. Amendments: 1. March 4, 2011: LÄK-RLP has verified IRB approval for Boldt J, Schöllhorn T, Münchbach J, Pabsdorf M. A total balanced volume replacement strategy using a new balanced hydoxyethyl starch preparation (6% HES 130/0.42) in patients undergoing major abdominal surgery. Eur J Anaesthesiol. 2007;24:267-75. This article was moved from table 1 (articles without documented IRB approval) to table 2 (articles with documented IRB approval).

March 4, 2011 2

EIC Joint J Statemennt

On behallf of our resp pective journ nals,

Lars S. Rasmussen Editor-in-C Chief, Acta An naesthesiologicca Scandinavicca

Steven M. Yentis Editor-in-C Chief, Anaesth hesia

Hugo Van Aken On behalf of the Editoriaal Board, Anästthesiolgie Inteensivmedizin N Notfallmedizin Schmerztheraapie

Steven L. Shafer S Editor-in-C Chief, Anestheesia & Analgessia

James C. Eisenach E Editor-in-C Chief, Anestheesiology

Charles S. Reilly Editor-in-C Chief, British Journal J of Ana aesthesia

Donald R. Miller Editor-in-C Chief, Canadia an Journal of Anesthesia/Jou A urnal canadieen d'anesthésiee

Joseph E. Parrillo P Editor-in-C Chief, Critical Care Medicine

Bernd Zwiissler On behalf of the Editoriaal Board and his CoEditor-in-Chief, Rolf Roossaint, Der An nästhesist

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March 4, 2011 2

EIC Joint J Statemennt

Martin R. Tramèr T Editor-in-C Chief, Europea an Journal of Anaesthesiolog A gy

Massimo Antonelli A Editor-in-C Chief, Intensivve Care Mediciine

Joel A. Kaaplan Editor-in-C Chief, Journall of Cardiothorracic and Vasccular Anesthessia

Jörg Wiltfaang Editor-in-C Chief, Journall of Cranio-Ma axillo-Facial Surgery S

George B. Stefano Editor-in-C Chief, Medicall Science Moniitor

Davide Ch hiumello Editor-in-C Chief, Minerva a Anestesiologiica

Wolfgang R. Mayr Editor-in-C Chief, Vox San nguinis

3

March 4, 2011

EIC Joint Statement

4

Table 1: Articles without evidence of IRB approval as determined by LÄK-RLP Acta Anaesthesiologica Scandinavica Mengistu AM, Mayer J, Boldt J, Röhm KD. Whole-blood aggregometry: are there any limits with regard to platelet counts? Acta Anaesthesiol Scand. 2009;53:72-6 Röhm KD, Piper SN, Suttner S, Schuler S, Boldt J. Early recovery, cognitive function and costs of a desflurane inhalational vs. a total intravenous anaesthesia regimen in long-term surgery. Acta Anaesthesiol Scand. 2006;50:14-8 Boldt J, Kumle B, Suttner S, Haisch G. Point-of-care (POC) testing of lactate in the intensive care patient. Accuracy, reliability, and costs of different measurement systems. Acta Anaesthesiol Scand. 2001;45:194-9

Anaesthesia Röhm KD, Riechmann J, Boldt J, Schuler S, Suttner SW, Piper SN. Physostigmine for the prevention of postanaesthetic shivering following general anaesthesia - a placebo-controlled comparison with nefopam. Anaesthesia. 2005;60:433-8 Piper SN, Röhm KD, Suttner SW, Maleck WH, Kranke P, Boldt J. A comparison of nefopam and clonidine for the prevention of postanaesthetic shivering: a comparative, double-blind and placebo-controlled doseranging study. Anaesthesia. 2004;59:559-64 Roehm KD, Piper SN, Maleck WH, Boldt J. Prevention of propofol-induced injection pain by remifentanil: a placebo-controlled comparison with lidocaine. Anaesthesia. 2003;58:165-70 Piper SN, Kumle B, Maleck WH, Suttner SW, Fent MT, Boldt J. Effects of postoperative sedation with propofol and midazolam on pancreatic function assessed by pancreatitis-associated protein. Anaesthesia. 2001;56:836-40 Piper SN, Suttner SW, Schmidt CC, Kumle B, Maleck WH, Boldt J. Acute phase response to nitroprussideinduced controlled hypotension in patients undergoing radical prostatectomy. Anaesthesia. 2000;55:131-6 Piper SN, Suttner SW, Schmidt CC, Maleck WH, Kumle B, Boldt J. Nefopam and clonidine in the prevention of postanaesthetic shivering. Anaesthesia. 1999;54:695-9

Anästhesiolgie Intensivmedizin Notfallmedizin Schmerztherapie Triem JG, Röhm KD, Boldt J, Piper SN. [Comparison of a propofol-based anesthesia regimen using optimated-target-controlled-infusion (OTCI) and manually-controlled infusion (MCI) technique]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006;41:150-5 Piper SN, Triem JG, Röhm KD, Maleck WH, Schöllhorn TA, Boldt J. ProSeal-laryngeal mask versus endotracheal intubation in patients undergoing gynaecologic laparoscopy]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2004;39:132-7 Piper SN, Haisch G, Kumle B, Walz GA, Breining T, Mattinger P, Boldt J. [Effects of esmolol- and sodium nitroprusside-induced controlled hypotension on hepatocellular integrity in patients undergoing endonasal sinus surgery]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2003;38:781-6 Röhm KD, Piper SN, Schöllhorn TA, Suttner SW, Maleck WH, Boldt J. [Injection pain secondary to propofol-MCT/LCT and propofol-LCT--comparison of prophylaxis with lidocaine]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2003;38:643-7 Piper SN, Kumle B, Röhm KD, Suttner SW, Lang J, Blome M, Boldt J. [Influence of cardiopulmonary bypass (CPB) on the natriuretic peptides ANP and BNP. A comparison between long and short duration of CPB and off pump surgery]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2003;38:463-9 Piper SN, Röhm KD, Papsdorf M, Maleck WH, Mattinger P, Boldt J. [Dolasetron reduces pain on injection of propofol]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2002;37:528-31

Anesthesia & Analgesia Riesmeier A, Schellhaass A, Boldt J, Suttner S. Crystalloid/colloid versus crystalloid intravascular volume administration before spinal anesthesia in elderly patients: the influence on cardiac output and stroke volume. Anesth Analg. 2009;108:650-4

March 4, 2011

EIC Joint Statement

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Boldt J, Brosch Ch, Röhm K, Lehmann A, Mengistu A, Suttner S. Is albumin administration in hypoalbuminemic elderly cardiac surgery patients of benefit with regard to inflammation, endothelial activation, and long-term kidney function? Anesth Analg. 2008;107:1496-503 Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008;106:867-72 Mengistu AM, Röhm KD, Boldt J, Mayer J, Suttner SW, Piper SN. The influence of aprotinin and tranexamic acid on platelet function and postoperative blood loss in cardiac surgery. Anesth Analg. 2008;107:391-7 Boldt J, Wolf M, Mengistu A. A new plasma-adapted hydroxyethylstarch preparation: in vitro coagulation studies using thrombelastography and whole blood aggregometry. Anesth Analg. 2007;104:425-30 Mayer J, Boldt J, Schellhaass A, Hiller B, Suttner SW. Bispectral index-guided general anesthesia in combination with thoracic epidural analgesia reduces recovery time in fast-track colon surgery. Anesth Analg. 2007;104:1145-9 Boldt J, Schölhorn T, Mayer J, Piper S, Suttner S. The value of an albumin-based intravascular volume replacement strategy in elderly patients undergoing major abdominal surgery. Anesth Analg. 2006;103:191-9 Mayer J, Boldt J, Röhm KD, Scheuermann K, Suttner SW. Desflurane anesthesia after sevoflurane inhaled induction reduces severity of emergence agitation in children undergoing minor ear-nose-throat surgery compared with sevoflurane induction and maintenance. Anesth Analg. 2006;102:400-4 Suttner S, Lang K, Piper SN, Schultz H, Röhm KD, Boldt J. Continuous intra- and postoperative thoracic epidural analgesia attenuates brain natriuretic peptide release after major abdominal surgery. Anesth Analg. 2005;101:896-903 Boldt J, Brosch C, Lehmann A, Suttner S, Isgro F. The prophylactic use of the beta-blocker esmolol in combination with phosphodiesterase III inhibitor enoximone in elderly cardiac surgery patients. Anesth Analg. 2004;99:1009-17 Suttner S, Piper SN, Kumle B, Lang K, Röhm KD, Isgro F, Boldt J. The influence of allogeneic red blood cell transfusion compared with 100% oxygen ventilation on systemic oxygen transport and skeletal muscle oxygen tension after cardiac surgery. Anesth Analg. 2004;99:2-11 Boldt J, Brenner T, Lang J, Kumle B, Isgro F. Kidney-specific proteins in elderly patients undergoing cardiac surgery with cardiopulmonary bypass. Anesth Analg. 2003;97:1582-9 Lehmann A, Karzau J, Boldt J, Thaler E, Lang J, Isgro F. Bispectral index-guided anesthesia in patients undergoing aortocoronary bypass grafting. Anesth Analg. 2003;96:336-43 Boldt J, Haisch G, Suttner S, Kumle B, Schellhase F. Are lactated Ringer's solution and normal saline solution equal with regard to coagulation? Anesth Analg. 2002;94:378-84 Lehmann A, Boldt J, Thaler E, Piper S, Weisse U. Bispectral index in patients with target-controlled or manually-controlled infusion of propofol. Anesth Analg. 2002;95:639-44 Piper SN, Röhm KD, Maleck WH, Fent MT, Suttner SW, Boldt J. Dolasetron for preventing postanesthetic shivering. Anesth Analg. 2002;94:106-11 Lang K, Boldt J, Suttner S, Haisch G. Colloids versus crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery. Anesth Analg. 2001;93:405-9 Haisch G, Boldt J, Krebs C, Kumle B, Suttner S, Schulz A. The influence of intravascular volume therapy with a new hydroxyethyl starch preparation (6% HES 130/0.4) on coagulation in patients undergoing major abdominal surgery. Anesth Analg. 2001;92:565-71 Piper SN, Maleck WH, Boldt J, Suttner SW, Schmidt CC, Reich DG. A comparison of urapidil, clonidine, meperidine and placebo in preventing postanesthetic shivering. Anesth Analg. 2000;90:954-7 Suttner SW, Schmidt CC, Boldt J, Hüttner I, Kumle B, Piper SN. Low-flow desflurane and sevoflurane anesthesia minimally affect hepatic integrity and function in elderly patients. Anesth Analg. 2000;91:206-12 Suttner S, Boldt J, Schmidt C, Piper S, Kumle B. Cost analysis of target-controlled infusion-based anesthesia compared with standard anesthesia regimens. Anesth Analg. 1999;88:77-82 Suttner SW, Boldt J, Schmidt CC, Piper SN, Schuster P, Kumle B. The effects of sodium nitroprussideinduced hypotension on splanchnic perfusion and hepatocellular integrity. Anesth Analg. 1999;89:1371-7

March 4, 2011

EIC Joint Statement

Anesthesiology Suttner SW, Lang K, Boldt J, Kumle B, Maleck WH, Piper SN. The influence of hyperoxic ventilation during sodium nitroprusside-induced hypotension on skeletal muscle tissue oxygen tension. Anesthesiology. 2002;96:1103-8

Annals of Thoracic Surgery Kumle B, Boldt J, Suttner SW, Piper SN, Lehmann A, Blome M. Influence of prolonged cardiopulmonary bypass times on splanchnic perfusion and markers of splanchnic organ function. Ann Thorac Surg. 2003;75:1558-64 Boldt J, Brosch C, Lehmann A, Haisch G, Lang J, Isgro F. Prophylactic use of pentoxifylline on inflammation in elderly cardiac surgery patients. Ann Thorac Surg. 2001;71:1524-9

British Journal of Anaesthesia Mayer J, Boldt J, Beschmann R, Stephan A, Suttner S. Uncalibrated arterial pressure waveform analysis for less-invasive cardiac output determination in obese patients undergoing cardiac surgery. Br J Anaesth. 2009;103:185-90 Suttner S, Boldt J, Mengistu A, Lang K, Mayer J. Influence of continuous perioperative beta-blockade in combination with phosphodiesterase inhibition on haemodynamics and myocardial ischaemia in high-risk vascular surgery patients. Br J Anaesth. 2009;102:597-607 Boldt J, Suttner S, Brosch C, Lehmann A, Mengistu A. Influence on coagulation of a potato-derived hydroxethylstarch (HES 130/0.42) and a maize-derived hydroxethylstarch (HES 130/0.4) in patients undergoing cardiac surgery. Br J Anaesth. 2009;102:191-7 Boldt J, Brosch Ch, Röhm K, Papsdorf M, Mengistu A. Comparison of the effects of gelatin and a modern hydroxyethyl starch solution on renal function and inflammatory response in elderly cardiac surgery patients. Br J Anaesth. 2008;100:457-64 Mayer J, Boldt J, Schöllhorn T, Röhm KD, Mengistu AM, Suttner S. Semi-invasive monitoring of cardiac output by a new device using arterial pressure waveform analysis: a comparison with intermittent pulmonary artery thermodilution in patients undergoing cardiac surgery. Br J Anaesth. 2007;98:176-82 Piper SN, Röhm KD, Boldt J, Faust KL, Maleck WH, Kranke P, Suttner SW. Inspired oxygen fraction of 0.8 compared with 0.4 does not further reduce postoperative nausea and vomiting in dolasetron-treated patients undergoing laparoscopic cholecystectomy. Br J Anaesth. 2006;97:647-53 Boldt J, Haisch G, Suttner S, Kumle B, Schellhaass A. Effects of a new modified, balanced hydroxyethyl starch preparation (Hextend) on measures of coagulation. Br J Anaesth. 2002;89:722-8 Boldt J, Hüttner I, Suttner S, Kumle B, Piper SN, Berchthold G. Changes of haemostasis in patients undergoing major abdominal surgery--is there a difference between elderly and younger patients? Br J Anaesth. 2001;87:435-40 Suttner SW, Piper SN, Lang K, Hüttner I, Kumle B, Boldt J. Cerebral effects and blood sparing efficiency of sodium nitroprusside-induced hypotension alone and in combination with acute normovolaemic haemodilution. Br J Anaesth. 2001;87:699-705 Hüttner I, Boldt J, Haisch G, Suttner S, Kumle B, Schulz H. Influence of different colloids on molecular markers of haemostasis and platelet function in patients undergoing major abdominal surgery. Br J Anaesth. 2000;85:417-23 Boldt J, Weber A, Mailer K, Papsdorf M, Schuster P. Acute normovolaemic haemodilution vs controlled hypotension for reducing the use of allogeneic blood in patients undergoing radical prostatectomy. Br J Anaesth. 1999;82:170-4

Canadian Journal of Anesthesia/Journal canadien d'anesthésie Piper SN, Kumle B, Maleck WH, Kiessling AH, Lehmann A, Röhm KD, Suttner SW, Boldt J. Diltiazem may preserve renal tubular integrity after cardiac surgery. Can J Anesth. 2003;50:285-92 Lang K, Suttner S, Boldt J, Kumle B, Nagel D. Volume replacement with HES 130/0.4 may reduce the inflammatory response in patients undergoing major abdominal surgery. Can J Anesth. 2003;50:1009-16

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March 4, 2011

EIC Joint Statement

Piper SN, Suttner SW, Röhm KD, Maleck WH, Larbig E, Boldt J. Dolasetron, but not metoclopramide prevents nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Can J Anesth. 2002;49:1021-8 Piper SN, Fent MT, Röhm KD, Maleck WH, Suttner SW, Boldt J. Urapidil does not prevent postanesthetic shivering: a dose-ranging study. Can J Anesth. 2001;48:742-7 Piper SN, Boldt J, Schmidt CC, Maleck WH, Brosch C, Kumle B. Hemodynamics, intramucosal pH and regulators of circulation during perioperative epidural analgesia. Can J Anesth. 2000;47:631-7

Critical Care Medicine Boldt J, Brosch C, Ducke M, Papsdorf M, Lehmann A. Influence of volume therapy with a modern hydroxyethylstarch preparation on kidney function in cardiac surgery patients with compromised renal function: a comparison with human albumin. Crit Care Med. 2007;35:2740-6 Boldt J, Brosch C, Piper SN, Suttner S, Lehmann A, Werling C. Influence of prophylactic use of pentoxifylline on postoperative organ function in elderly cardiac surgery patients. Crit Care Med. 2001;29:952-8

Der Anästhesist Triem JG, Röhm KD, Boldt J, Piper SN. [Propofol administration systems. Handling, hemodynamics and propofol consumption]. Anaesthesist. 2009;58:231-4, 236-9 Piper SN, Triem JG, Röhm KD, Kranke P, Maleck WH, Boldt J. [Prevention of post-operative nausea and vomiting. Randomised comparison of dolasetron versus dolasetron plus dexamethasone]. Anaesthesist. 2003;52:120-6

European Journal of Anaesthesiology Boldt J, Mengistu A. Balanced hydroxyethylstarch preparations: are they all the same? In-vitro thrombelastometry and whole blood aggregometry. Eur J Anaesthesiol. 2009;26:1020-5 Mayer J, Boldt J, Triem JG, Schellhaass A, Mengistu AM, Suttner S. Individual titration of propofol plasma target improves anaesthetic stability in patients undergoing major abdominal surgery: a comparison with manually controlled infusion. Eur J Anaesthesiol. 2008;25:741-7 Piper SN, Röhm KD, Boldt J, Odermatt B, Maleck WH, Suttner SW. Hepatocellular integrity in patients requiring parenteral nutrition: comparison of structured MCT/LCT vs. a standard MCT/LCT emulsion and a LCT emulsion. Eur J Anaesthesiol. 2008;25:557-65 Mengistu AM, Wolf MW, Boldt J, Röhm KD, Suttner SW, Piper SN. Influence of controlled hypotension using esmolol and sodium nitroprusside on natriuretic peptides in patients undergoing endonasal sinus surgery. Eur J Anaesthesiol. 2007;24:529-34 Röhm KD, Suttner SW, Boldt J, Schöllhorn TA, Piper SN. Insignificant effect of desflurane-fentanylthiopental on hepatocellular integrity--a comparison with total intravenous anaesthesia using propofolremifentanil. Eur J Anaesthesiol. 2005;22:209-14 Röhm KD, Schöllhorn TA, Gwosdek MJ, Piper SN, Maleck WH, Boldt J. Do we necessarily need local anaesthetics for venous cannulation? A comparison of different cannula sizes. Eur J Anaesthesiol. 2004;21:214-6 Piper SN, Suttner SW, Maleck WH, Kumle B, Haisch G, Boldt J. Effects of sodium nitroprusside-induced controlled hypotension on pancreatic function assessed by pancreatitis-associated protein in patients undergoing radical prostatectomy. Eur J Anaesthesiol. 2002;19:609-13 Piper SN, Triem JG, Maleck WH, Fent MT, Hüttner I, Boldt J. Placebo-controlled comparison of dolasetron and metoclopramide in preventing postoperative nausea and vomiting in patients undergoing hysterectomy. Eur J Anaesthesiol. 2001;18:251-6

Intensive Care Medicine Boldt J, Suttner S, Brosch C, Lehmann A, Röhm K, Mengistu A. The influence of a balanced volume replacement concept on inflammation, endothelial activation, and kidney integrity in elderly cardiac surgery patients. Intensive Care Med. 2009;35:462-70

7

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8

Suttner S, Schöllhorn T, Boldt J, Mayer J, Röhm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006;32:2053-8 Boldt J, Ducke M, Kumle B, Papsdorf M, Zurmeyer EL. Influence of different volume replacement strategies on inflammation and endothelial activation in the elderly undergoing major abdominal surgery. Intensive Care Med. 2004;30:416-22 Boldt J, Brenner T, Lehmann A, Lang J, Kumle B, Werling C. Influence of two different volume replacement regimens on renal function in elderly patients undergoing cardiac surgery: comparison of a new starch preparation with gelatin. Intensive Care Med. 2003;29:763-9 Boldt J, Brosch C, Suttner S, Piper SN, Lehmann A, Werling C. Prophylactic use of the phospodiesterase III inhibitor enoximone in elderly cardiac surgery patients: effect on hemodynamics, inflammation, and markers of organ function. Intensive Care Med. 2002;28:1462-9

Journal of Cardiothoracic and Vascular Anesthesia Mengistu AM, Mayer J, Boldt J, Röhm KD, Suttner SW. Usefulness of monitoring platelet function by multiple electrode aggregometry in primary coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2011;25:42-7 Boldt J, Mayer J, Brosch C, Lehmann A, Mengistu A. Volume replacement with a balanced hydroxyethyl starch (HES) preparation in cardiac surgery patients. J Cardiothorac Vasc Anesth. 2010;24:399-407 Boldt J, Mengistu A. A new plasma-adapted hydroxyethyl starch preparation: in vitro coagulation studies. J Cardiothorac Vasc Anesth. 2010;24:394-8 Mengistu AM, Wolf MW, Boldt J, Röhm KD, Lang J, Piper SN. Evaluation of a new platelet function analyzer in cardiac surgery: a comparison of modified thromboelastography and whole-blood aggregometry. J Cardiothorac Vasc Anesth. 2008;22:40-6 Lehmann A, Boldt J, Römpert R, Thaler E, Kumle B, Weisse U. Target-controlled infusion or manually controlled infusion of propofol in high-risk patients with severely reduced left ventricular function. J Cardiothorac Vasc Anesth. 2001;15:445-50 Haisch G, Boldt J, Krebs C, Suttner S, Lehmann A, Isgro F. Influence of a new hydroxyethylstarch preparation (HES 130/0.4) on coagulation in cardiac surgical patients. J Cardiothorac Vasc Anesth. 2001;15:316-21 Heck M, Kumle B, Boldt J, Lang J, Lehmann A, Saggau W. Electroencephalogram bispectral index predicts hemodynamic and arousal reactions during induction of anesthesia in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2000;14:693-7 Lehmann A, Zeitler C, Thaler E, Isgro F, Boldt J. Comparison of two different anesthesia regimens in patients undergoing aortocoronary bypass grafting surgery: sufentanil-midazolam versus remifentanil-propofol. J Cardiothorac Vasc Anesth. 2000;14:416-20 Piper SN, Boldt J, Schmidt CC, Brosch C, Maleck WH, Berchtold C. Influence of dopexamine on hemodynamics, intramucosal pH, and regulators of the macrocirculation and microcirculation in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2000;14:281-7

Journal of Cranio-Maxillo-Facial Surgery Piper SN, Röhm K, Boldt J, Kranke P, Maleck W, Seifert R, Suttner S. Postoperative nausea and vomiting after surgery for prognathism: not only a question of patients' comfort. A placebo-controlled comparison of dolasetron and droperidol. J Craniomaxillofac Surg. 2008;36:173-9

Medical Science Monitor Piper SN, Beschmann RB, Mengistu A, Maleck WH, Boldt J, Röhm KD. Postoperative analgosedation with S(+)-ketamine decreases the incidences of postanesthetic shivering and nausea and vomiting after cardiac surgery. Med Sci Monit. 2008;14:PI59-65 Röhm KD, Riechmann J, Boldt J, Suttner SW, Piper SN. Total intravenous anesthesia with propofol and remifentanil is associated with a nearly twofold higher incidence in postanesthetic shivering than desfluranefentanyl anesthesia. Med Sci Monit. 2006;12:CR452-6

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EIC Joint Statement

Minerva Anestesiologica Piper SN, Beschmann R, Mengistu A, Kalenka A, Maleck WH, Boldt J, Röhm KD. Assessment of recovery, dreaming, hemodynamics, and satisfaction in postcardiac surgery patients receiving supplementary propofol sedation with S(+)-ketamine. Minerva Anestesiol. 2009;75:363-73

The Thoracic and Cardiovascular Surgeon Piper SN, Kiessling AH, Suttner SW, Ducke M, Boldt J, Röhm KD. Prevention of atrial fibrillation after coronary artery bypass graft surgery using a potassium-magnesium-aspartate solution (Inzolen). Thorac Cardiovasc Surg. 2007;55:418-23

Vox Sanguinis Boldt J, Mengistu A, Seyfert UT, Vogt A, Hellstern P. The impact of a medium molecular weight, low molar substitution hydroxyethyl starch dissolved in a physiologically balanced electrolyte solution on blood coagulation and platelet function in vitro. Vox Sang. 2007;93:139-44

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Table 2: Articles with IRB approval verified by LÄK-RLP 1.

Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010;113:892-905

2.

Mayer J, Boldt J, Mengistu AM, Röhm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14:R18

3.

Piper SN, Schade I, Beschmann RB, Maleck WH, Boldt J, Röhm KD. Hepatocellular integrity after parenteral nutrition: comparison of a fish-oil-containing lipid emulsion with an olivesoybean oil-based lipid emulsion. Eur J Anaesthesiol. 2009;26:1076-82

4.

Röhm KD, Mengistu A, Boldt J, Mayer J, Beck G, Piper SN. Renal integrity in sevoflurane sedation in the intensive care unit with the anesthetic-conserving device: a comparison with intravenous propofol sedation. Anesth Analg. 2009;108:1848-54

5.

Suttner S, Boldt J, Lang K, Röhm KD, Piper SN, Mayer J. Association of N-terminal pro-brain natriuretic peptide and cardiac troponin T with in-hospital cardiac events in elderly patients undergoing coronary artery surgery. Eur J Anaesthesiol. 2008;25:834-41.

6.

Suttner S, Boldt J, Lang K, Mayer J, Röhm K, Piper SN. [Continuous beta-block with esmolol in combination with enoximone: influence on cardiac function in high risk patients undergoing vascular surgery]. Anaesthesist. 2008;57:231-41

7.

Röhm KD, Wolf MW, Schöllhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med. 2008;34:1683-9

8.

Boldt J, Schöllhorn T, Münchbach J, Pabsdorf M. A total balanced volume replacement strategy using a new balanced hydoxyethyl starch preparation (6% HES 130/0.42) in patients undergoing major abdominal surgery. Eur J Anaesthesiol. 2007;24:267-75

9.

Lehmann A, Schmidt M, Zeitler C, Kiessling AH, Isgro F, Boldt J. Bispectral index and electroencephalographic entropy in patients undergoing aortocoronary bypass grafting. Eur J Anaesthesiol. 2007;24:751-60

10.

Röhm KD, Riechmann J, Boldt J, Schöllhorn T, Piper SN. Do patients profit from physostigmine in recovery from desflurane anaesthesia? Acta Anaesthesiol Scand. 2007;51:278-83

11.

Suttner SW, Sürder C, Lang K, Piper SN, Kumle B, Boldt J. Does age affect liver function and the hepatic acute phase response after major abdominal surgery? Intensive Care Med. 2001;27:1762-9

12.

Boldt J, Lehmann A, Römpert R, Haisch G, Isgro F. Volume therapy with a new hydroxyethyl starch solution in cardiac surgical patients before cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2000;14:264-8

10

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Table 3: Articles that do not require IRB approval as determined by LÄK-RLP 1.

Röhm KD, Schöllhorn T, Boldt J, Wolf M, Papsdorf M, Piper SN. Nutrition support and treatment of motility disorders in critically ill patients - results of a survey on German intensive care units. Eur J Anaesthesiol. 2008;25:58-66

2.

Lehmann A, Lang J, Boldt J, Isgro F, Kiessling AH. Levosimendan in patients with cardiogenic shock undergoing surgical revascularization: a case series. Med Sci Monit. 2004;10:MT89-93

11

http://www.springer.com/journal/12630

http://www.springer.com/journal/12630

http://www.springer.com/journal/12630