Transcript

The Fragility of Statistically Significant Findings in Randomized Controlled Anaesthesiology Trials – a Systematic Review

SUPPLEMENTARY ONLINE CONTENT

Guido Mazzinari1, Lorenzo Ball2, Ary Serpa Neto3,4, Carlos L. Errando5,

Arjen M. Dondorp6, Lieuwe D. Bos4, Marcelo Gama de Abreu7,

Paolo Pelosi2, Marcus J. Schultz4,6

Hospital de Manises, Valencia, Spain

1Research Group in Perioperative Medicine Hospital Universitario y Politecnico La Fe, Valencia, Spain

Policlinico San Martino Hospital – IRCCS for Oncology, Genoa, Italy

2Department of Surgical Sciences and Integrated Diagnostics

Hospital Israelita Albert Einstein, São Paulo, Brazil

3Department of Critical Care Medicine

Academic Medical Center, Amsterdam, The Netherlands

4Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A)

Consorcio Hospital General Universitario de Valencia, Valencia, Spain

5Department of Anesthesiology, Resuscitation and Pain Treatment

Mahidol University, Bangkok, Thailand

6Mahidol Oxford Research Unit (MORU)

Technische Universität Dresden, Dresden, Germany

7Department of Anesthesiology and Intensive Care Therapy

eTable 1 – List of Journals

Anesthesiology

Impact Factor1

Chest

6.136

British Journal of Anaesthesia

5.616

Anesthesiology

5.264

Anesthesia & Analgesia

3.827

Anaesthesia

3.794

Regional Anesthesia and Pain Medicine

3.459

European Journal of Anaesthesiology

3.364

Journal of Neurosurgical Anesthesiology

2.828

Canadian Journal of Anaesthesia

2.139

Acta Anaesthesiologica Scandinavica

2.049

International Journal of Obstetric Anesthesia

2.040

Minerva Anestesiologica

2.036

Journal of Cardiothoracic and Vascular Anesthesia

1.519

Journal of Clinical Anesthesia

1.284

Anaesthesia and Intensive Care

1.283

General medicine

The New England Journal of Medicine

59.558

The Lancet

44.020

The Journal of American Medical Association

37.680

British Medical Journal

19.697

Annals of Internal Medicine

16.593

1 2015 Journal Citation Reports Impact Factor

PubMed full search criteria

(1991 : 2016[dp]) AND (((((((((((((((("dead"[Title/Abstract] OR "death"[Title/Abstract] OR "died"[Title/Abstract] OR "mortality"[Title/Abstract] OR "surviv*"[Title/Abstract]) OR "delirium"[Title/Abstract] OR "cognitive dysfunction"[Title/Abstract]) OR "myocardial ischemia"[Title/Abstract] OR "perioperative ischemia"[Title/Abstract]) OR "venous thrombosis"[Title/Abstract]) OR "pulmon*"[Title/Abstract]) OR "renal insufficiency"[Title/Abstract] OR "acute kidney injury"[Title/Abstract] OR "acute renal failure"[Title/Abstract]) OR "blood transfusion"[mh]) OR "postoperative complication"[Title/Abstract] OR "postoperative complications"[mh]) OR "postoperative residual curarization"[Title/Abstract] OR "postoperative residual paralysis"[Title/Abstract] OR "postoperative residual neuromuscular block"[Title/Abstract] OR "postoperative residual neuromuscular blockade"[Title/Abstract]) OR "delayed emergence from anesthesia"[mh]) OR "failed intubation"[Title/Abstract] OR "airway management"[mh] OR "intubation, intratracheal"[mh] OR "laryngeal Masks"[mh]) OR "injections, epidural"[mh] OR "injections, spinal"[mh] OR "anesthesia, conduction"[mh]) OR "perioperative care"[mh]) OR "hemodynamics"[mh]) OR "surgical wound infection"[mh]) OR "cesarean section"[Title/Abstract] OR "postpartum hemorrhage"[Title/Abstract] OR "eclampsia"[Title/Abstract] OR "preeclampsia"[Title/Abstract] OR "pre-eclampsia"[Title/Abstract] OR "hellp syndrome"[Title/Abstract] OR "neonatal mortality"[Title/Abstract] OR "anesthesia, obstetrical"[mh]) OR ("anesthesia and analgesia"[mh]) NOT (pediatric[Title/Abstract] OR children[Title/Abstract] OR infant*[Title/Abstract] OR neonate*[Title/Abstract] OR protocol[Title/Abstract] OR fetal[Title/Abstract] OR post hoc[Title/Abstract]) AND (english[Language]) AND (randomized controlled trial[Publication Type]).

eTable2 – GRADE1 rank of outcomes

Importance of outcomes

GRADE rank

Outcome (examples)

9

· Mortality

CRITICAL

Requiring major interventions, prolonged monitoring, or admission to ICU

8

· Organ failures, including major pulmonary complications, major cardiac events, kidney failure requiring RRT, delirium, need for inotropic drugs/vasopressors, severe stroke, pulmonary aspiration

7

· CP bypass weaning failure

· Mild stroke

· Pulmonary embolism

· Eclampsia/ HELLP syndrome

· Post ERCP Pancreatitis

IMPORTANT

Requiring simple interventions

6

· Surgical infection

· Cognitive dysfunction

· Transient perioperative hemodynamic instability requiring drug treatment

· Airway management faiure

5

· Deep Vein Thrombosis (DVT)

· Residual curarization

· Arrythmia

· Blood Transfusion

· Regional block related complications (Spinal failure, diaphragmatic paralysis)

4

· Surgical pain

· Postdural punction headache

LOW IMPORTANCE

Requiring no immediate actions

3

· Nausea

2

· Hoarseness

1

· Sore Throat

1 Grading of Recommendations Assessment, Development, and Evaluation.

Trials with outcomes of low importance were excluded from the analysis.

eTable3 – List of studies included in the analysis

Year

Journal

Title

Outcome

Analyzed

Number of patients

2016

Lancet

Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial.

Post ERCP Pancreatitis

2600

2016

JAMA

Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery. A Randomized Clinical Trial.

Reintubation

300

2016

BJA

Extrafascial injection for interscalene brachial plexus block reduces respiratory complications compared with a conventional intrafascial injection: a randomized, controlled, double-blind trial.

Diaphragmatic paralysis

40

2016

Lancet

Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial

Delirium

700

2016

BJA

The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial.

Vocal Cords Injury

140

2016

Anesthesiology

Dexmedetomidine versus Propofol Sedation Reduces Delirium after Cardiac Surgery. A Randomized Controlled Trial.

Delirium

185

2016

J Clin Anesth

Total intravenous anesthesia with propofol is associated with a lower rate of postoperative delirium in comparison with sevoflurane anesthesia in elderly patients

Delirium

59

2016

NEJM

Adjunctive Azithromycin Prophylaxis for Cesarean Delivery.

Infection

2013

2016

NEJM

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

Infection

1147

2015

Anesth Analg

Nicardipine is superior to esmolol for the management of postcraniotomy emergence hypertension: a randomized open-label study.

Hypertension Treatment

52

2015

Reg Anesth Pain Med

Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial.

Diaphragmatic paralysis

64

2015

Anaesthesia

Incidence of intravascular injection and the spread of contrast media during S1 transforaminal epidural steroid injection by two approaches: anteroposterior vs oblique

Vertebral IV Injection

208

2015

Anesthesiology

Effects of an Innovative Psychotherapy Program for Surgical Patients: Bridging Intervention in Anesthesiology--A Randomized Controlled Trial.

Psychological Followup

220

2015

JAMA

Effect of Remote Ischemic Preconditioning on Kidney Injury Among High-Risk Patients Undergoing Cardiac Surgery. A Randomized Clinical Trial

AKI

240

2015

Chest

A Double-Blind Placebo-Controlled Study of the Effects of Olprinone, a Specifi c PhosphodiesteraseIII Inhibitor, for Preventing Postoperative Atrial Fibrillation in Patients Undergoing Pulmonary Resection for Lung Cancer

Arrythmia

50

2015

Anesthesiology

Transfusion Requirements in Surgical Oncology Patients A Prospective, Randomized Controlled Trial

Mortality

198

2015

BJA

Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study

Postoperative Residual Curarization

154

2014

BJA

6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.

Hemodynamic

167

2014

JAMA

Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial.

Adverse Cardiac Outcome

360

2014

J Neurosurg Anestheiol

A comparison of the GlideScope with the Macintosh laryngoscope for nasotracheal intubation in patients with ankylosing spondylitis.

Airway success

60

2014

EJA

The effect of adjusting tracheal tube cuff pressure during deep hypothermic circulatory arrest. A randomised trial

Subglottic

Aspiration

24

2014

EJA

Reduction in the incidence of acute kidney injury after aortic arch surgery with low-dose atrial natriuretic peptide.A randomised controlled trial

AKI

50

2014

Anesthesiology

Restrictive Deferred Hydration Combined with Preemptive Norepinephrine Infusion during Radical Cystectomy Reduces Postoperative Complications and Hospitalization Time. A Randomized Clinical Trial

Composite

167

2014

Anaesthesia

Prophylactic vs therapeutic blood patch for obstetric patients with accidental dural puncture – a randomised controlled trial

Post Dural Punction Headache

116

2014

EJA

Comparison of Aintree and Fastrach techniques for low-skill fibreoptic intubation in patients at risk of secondary cervical injury. A randomised controlled trial

Airway Success

80

2014

BJA

Tracheal intubation in patients with odentogenous abscesses and reduced mouth opening

Airway Failure

100

2013

BJA

Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction

Delirium

1277

2013

NEJM

A Trial of Intraoperative Low-Tidal-Volume Ventilation in Abdominal Surgery

Composite

400

2013

J Cardiothorac Vasc Anesth

Morphine is a Reasonable Alternative to Haloperidol in the Treatment of Postoperative Hyperactive-Type Delirium After Cardiac Surgery

Delirium

53

2013

J Neurosurg Anesthesiol

BIS-guided Anesthesia Decreases Postoperative Delirium and Cognitive Decline

Cognitive Dysfunction

921

2012

Anesth Analg

Reduction in Intraoperative Bacterial Contamination of Peripheral Intravenous Tubing Through the Use of a Passive Catheter Care System

Bacterial Contamination

594

2012

Anesthesiology

Early Treatment with Risperidone for Subsyndromal Delirium after On-pump Cardiac Surgery in the Elderly. A Randomized Trial

Delirium

101

2012

Anesth Analg

Tranexamic Acid Reduces Blood Loss After Off-Pump Coronary Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Blood Transfusion

260

2012

Anesthesiology

Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway

Airway Success

300

2012

Anesthesiology

Association between the apolipoprotein E4 and postoperative cognitive dysfunction in elderly patients undergoing intravenous anesthesia and inhalation anesthesia

Cognitive dysfunction

2000

2011

Anesthesiology

Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery

Blood transfusion

74

2011

Anesthesiology

Intraoperative acceleromyography monitoring reduces symptoms of muscle weakness and improves quality of recovery in the early postoperative period

Curarization

155

2011

Anesthesiology

Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks

Spinal anesthesia success

145

2011

EJA

Effect of auditory evoked potential-guided anaesthesia on consumption of anaesthetics and early postoperative cognitive dysfunction: a randomised controlled trial

Cognitive dysfunction

451

2011

Acta Anaesthesiol Scand

Intraoperative warming and post-operative cognitive dysfunction after total knee replacement

Cognitive Dysfunction

150

2011

EJA

The influence of residual neuromuscular block on the incidence of critical respiratory events. A randomised, prospective, placebo-controlled trial

Pulmonary

114

2011

JAMA

Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study

Pulmonary

150

2011

Anaesthesia

The influence of propofol or desflurane on postoperative cognitive dysfunction in patients undergoing coronary artery bypass surgery

Cognitive dysfunction

182

2011

J Neurosurg Anesth

Deeper total intravenous anesthesia reduced the incidence of early postoperative cognitive dysfunction after microvascular decompression for facial spasm

Cognitive dysfunction

96

2010

Anesthesiology

Comparison of Single-use and Reusable Metal Laryngoscope Blades for Orotracheal Intubation during Rapid Sequence Induction of Anesthesia

Airway Failure

1072

2010

Anesthesiology

Perioperative Intravenous Amiodarone Does Not Reduce the Burden of Atrial Fibrillation in Patients Undergoing Cardiac Valvular Surgery

Arrythmia

120

2010

NEJM

Preventing surgical-site infections in nasal carriers of Staphylococcus aureus

Infection

918

2010

NEJM

Apixaban versus Enoxaparin for Thromboprophylaxis after Hip Replacement

Composite

5407

2010

Anesthesiology

Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture

Postdural Puncttion Headache

95

2010

Lancet

Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.

Mortality

20211

2010

JAMA

Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial

Lung transplant validity

118

2009

Minerva Anestesiol

Training resident anesthesiologists in adult challenging intubation comparing

Truview EVO2™ and Macintosh laryngoscope: a preliminary study

Airway Failure

30

2009

JAMA

Effects of Donor Pretreatment With Dopamine on Graft Function After Kidney Transplantation. A Randomized Controlled Trial

Dyalisis

505

2009

Chest

Prophylactic Nasal Continuous Positive Airway Pressure Following Cardiac

Surgery Protects From Postoperative Pulmonary Complications A Prospective, Randomized, Controlled Trial in 500 Patients

Pulmonary

500

2009

Anesthesiology

Continuous Perioperative Insulin Infusion Decreases Major Cardiovascular Events in Patients Undergoing Vascular Surgery. A Prospective, Randomized Trial

Composite

242

2009

Anesthesiology

Safety and Efficacy of Intensive Insulin Therapy in Critical Neurosurgical Patients

Hypoglucemia

483

2009

J Cardiothorac Vasc Anesth

Ketamine Attenuates Delirium After Cardiac Surgery With

Cardiopulmonary Bypass

Delirium

58

2009

EJA

Retrograde autologous priming of the cardiopulmonary bypass circuit reduces blood transfusion in small adults: a prospective, randomized trial

Blood Transfusion

120

2009

Acta Anaesthesiol Scand

Ketamine attenuates post-operative cognitive dysfunction after cardiac surgery

Cognitive dysfunction

52

2009

BMJ

Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial

Infection

1014

2008

Anesth Analg

Tranexamic Acid and Aprotinin in Primary Cardiac Operations: An Analysis of 220 Cardiac Surgical Patients Treated with Tranexamic Acid or Aprotinin

Blood Transfusion

220

2008

Anesthesiology

Success of Tracheal Intubation with Intubating Laryngeal Mask Airways A Randomized Trial of the LMA Fastrach™ and LMA CTrach™

Airway success

271

2008

BJA

Tracheal intubation of morbidly obese patients: a randomized trial comparing performance of Macintosh and Airtraq laryngoscopes

Airway Failure

106

2008

Lancet

Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial

Composite

9298

2008

Anesthesiology

Intraoperative acceleromyographic monitoring reduces the risk of residual neuromuscular blockade and adverse respiratory events in the postanesthesia care unit

Curarization

185

2008

BJA

Pentax-AWS, a new videolaryngoscope, is more effective than the Macintosh laryngoscope for tracheal intubation in patients with restricted neck movements: a randomized comparative study

Airway success

203

2008

J Cardiothorac Vasc Anesth

Jugular bulb venous oxygen saturation during one-lung ventilation under sevoflurane- or propofol-based anesthesia for lung surgery

Cerebral desaturation

52

2008

NEJM

Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty

Deep Venous Thrombosis

3364

2007

J Neurosurg Anesthesiol

The Effect of Intensive Insulin Therapy on Infection Rate, Vasospasm, Neurologic Outcome, and Mortality in Neurointensive Care Unit After Intracranial Aneurysm Clipping in Patients With Acute Subarachnoid Hemorrhage. A Randomized Prospective Pilot Trial

Infection

78

2007

Anaesth Int Care

Efficacy of risperidone for prevention of postoperative delirium in cardiac surgery

Delirium

126

2007

Anaesthesia

Incidence and duration of residual paralysis at the end of surgery after multiple administrations of cisatracurium and rocuronium

Curarization

338

2007

J Cardiothorac Vasc Anesth

Fenoldopam infusion for renal protection in high-risk cardiac surgery patients: a randomized clinical study

AKI

194

2006

Anesthesiology

Comparison of Plastic Single-use and Metal Reusable Laryngoscope Blades for Orotracheal Intubation during Rapid Sequence Induction of Anesthesia

Airway Failure

284

2006

JAMA

Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination

of the Nasopharynx and Oropharynx With Chlorhexidine Gluconate. A Randomized Controlled Trial

Infection

991

2006

JAMA

Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial

Pulmonary

279

2005

J Clin Anesth

Intraoperative myocardial ischemia in peripheral vascular surgery: general anesthesia vs combined sciatic and femoral nerve blocks

Myocardial Ischemia

50

2005

Anesthesiology

Prevention of hypotension during spinal anesthesia for cesarean delivery: an effective technique using combination phenylephrine infusion and crystalloid cohydration

Hemodynamic

112

2005

JAMA

Prophylactic Oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, Valve Replacement, or Repair: PAPABEAR: a randomized controlled trial

Arrythmia

601

2005

JAMA

Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial

Intubation

209

2004

Anaesth Int Care

Gum Elastic Bougie-guided Insertion of the ProSeal Laryngeal Mask Airway

Airway success

100

2004

Anesth Analg

Continuous positive airway pressure versus noninvasive pressure support ventilation to treat atelectasis after cardiac surgery

Atelectasis

150

2004

JAMA

Surgical site infection and the routine use of perioperative hyperoxia in a general surgical population: a randomized controlled trial

Infection

160

2004

Can J Anaesth

Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study

Cognitive Dysfunction

36

2003

BJA

Randomized comparison of the classic Laryngeal Mask Airway with the Airway Management Device during anaesthesia

Airway Failure

100

2003

J Neurosurg Anesthesiol

Hemodynamic Stability, Myocardial Ischemia, and Perioperative Outcome After Carotid Surgery with Remifentanil/Propofol or Isoflurane/Fentanyl Anesthesia

Cardiac Ischemia

59

2003

Acta Anaesthesiol Scand

Slow rewarming improves jugular venous oxygen saturation during rewarming

Cerebral Oxygen Desaturation

100

2003

Anesth Analg

Recovery of neuromuscular function after cardiac surgery: pancuronium versus rocuronium

Curarization

82

2003

Anesthesiology

Preoperative Cardiac Events in Elderly Patients with Hip Fracture Randomized to Epidural or Conventional Analgesia

Cardiac Event

68

2002

Anesth Analg

Endotracheal Intubation with a Gum-Elastic Bougie in Unanticipated Difficult Direct Laryngoscopy: Comparison of a Blind Technique Versus Indirect Laryngoscopy with a Laryngeal Mirror

Airway Failure

60

2002

Anesthesiology

A Multicenter Study Comparing the ProSeal and Classic Laryngeal Mask Airway in Anesthetized, Nonparalyzed Patients

Airway success

384

2002

Can J Anaesth

Antidepressant treatment for chronic depressed patients should not be discontinued prior to anesthesia

Delirium

80

2002

EJA

Myocardial Ischemia in Ptients with Impaired Left VEntricular Function Undeergoing Coronary Artery Bypass Grafting - Milrinone versus Nifedipine

Cardiac Ischemia

30

2002

Anesth Analg

The Effect of Lidocaine on Early Postoperative Cognitive Dysfunction After Coronary Artery Bypass Surgery

Cognitive Dysfunction

118

2002

Anesthesiology

Effectiveness of acute normovolemic hemodilution to minimize allogeneic blood transfusion in major liver resections

Blood Transfusion

78

2002

Lancet

Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial

Eclampsia

10141

2002

Lancet

Effect of preoperative smoking intervention on postoperative complications: a randomised clinical trial

Composite

120

2001

Anesth Analg

A Prospective Randomized Study of the Potential Benefits of Thoracic Epidural Anesthesia and Analgesia in Patients Undergoing Coronary Artery Bypass Grafting

Arrythmia

420

2001

Anesthesiology

Gel Lubrication of the Tracheal Tube Cuff Reduces

Pulmonary Aspiration

Pulmonary Aspiration

36

2001

Anesth Analg

The Clinical Relevance of Embolic Events Detected by Transesophageal Echocardiography During Cemented Total Hip Arthroplasty: A Randomized Clinical Trial

Embolia

120

2001

Chest

Diltiazem treatment does not alter renal function after thoracic surgery

Arrythmia

330

2001

Lancet

Postoperative enteral versus parenteral nutrition in malnourished patients with gastrointestinal cancer: a randomised multicentre trial

Composite

317

2001

Lancet

Oral amiodarone for prevention of atrial fibrillation after open heart surgery, the Atrial Fibrillation Suppression Trial (AFIST): a randomised placebo-controlled trial

Arrythmia

220

2001

BJA

Fast-track cardiac anaesthesia in the elderly: effect of two different anaesthetic techniques on mental recovery

Cognitive Dysfunction

83

2001

BJA

Autologous blood transfusion in total knee replacement surgery

Blood Transfusion

231

2001

J Cardiothorac Vasc Anesth

Tranexamic acid in aortic valve replacement

Blood Transfusion

300

2000

Anaesth Int Care

The Prevention of Pulmonary Aspiration with Control of Tracheal Wall Pressure using a Silicone Cuff

Aspiration

12

2000

Anesth Analg

Nitrous Oxide-Induced Increased Homocysteine Concentrations Are Associated with Increased Postoperative Myocardial Ischemia in Patients Undergoing Carotid Endarterectomy

Cardiac Ischemia

90

2000

Lancet

Prevention of pulmonary embolism and deep vein thrombosis with low dose aspirin: Pulmonary Embolism Prevention (PEP)

trial

Venous Thrombosis

13356

2000

Anesthesiology

Randomized trial of diaspirin cross-linked hemoglobin solution as an alternative to blood transfusion after cardiac surgery. The DCLHb Cardiac Surgery Trial Collaborative Group

Blood Transfusion

209

2000

Anesth Analg

Postoperative prophylactic administration of beta-adrenergic blockers in patients at risk for myocardial ischemia

Myocardial Ischemia

109

2000

Anaesthesia

Prophylactic amrinone for weaning from cardiopulmonary bypass

Cardio pulmonary BP weaning

234

2000

JAMA

Noninvasive ventilation for treatment of acute respiratory failure in patients undergoing solid organ transplantation: a randomized trial

Intubation

40

1999

Anaesthesia

A comparison of two silicone-reinforced tracheal tubes with different bevels for use with the intubating laryngeal mask

Airway success

70

1999

Anesth Analg

The effect of heart rate control on myocardial ischemia among high-risk patients after vascular surgery

Myocardial Ischemia

26

1999

NEJM

The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group

Mortality

112

1999

BMJ

Double blind randomised controlled trial of effect of metoprolol on myocardial ischaemia during endoscopic cholangiopancreatography

Myocardial Ischemia

48

1998

Acta Anaesthesiol Scand

Puncture technique and postural postdural puncture headache. A randomised, double-blind study comparing transverse and parallel puncture

Postdural Punction Headache

218

1998

Acta Anaesthesiol Scand

Tactile evaluation of the response to double burst stimulation decreases, but does not eliminate, the problem of postoperative residual paralysis

Curarization

60

1998

Acta Anaesthesiol Scand

Postural post-dural puncture headache after spinal and epidural anaesthesia. A randomised, double-blind study

Postdural Punction Headache

224

1998

Acta Anaesthesiol Scand

Obstetric outcome following epidural analgesia with bupivacaine-adrenaline 0.25% or bupivacaine 0.125% with sufentanil--a prospective randomized controlled study in 1000 parturients

Instrumental Delivery

1000

1998

Anesthesiology

Beta Adrenergic Blockade Accelerates Conversion of Postoperative Supraventircular Tachyarrythmias

Arrythmia

64

1998

Anesthesiology

Prophylactic Atenolol Reduces Postoperative Myocardial Ischeia

Cardiac Ischemia

200

1997

J Cardiothorac Vasc Anesth

A Placebo-Controlled Trial Verifying the Efficacy of Milrinone in Weaning High-Risk Patients From Cardiopulmonary Bypass

CPB weaning

32

1997

BJA

Low molecular weight heparin associated with spinal anaesthesia and gradual compression stockings in total hip replacement surgery. Arar Study Group

Deep Venous Thrombosis

170

1997

J Cardiothorac Vasc Anesth

Perioperative metoprolol reduces the frequency of atrial fibrillation after thoracotomy for lung resection

Arrythmia

30

1997

NEJM

Preoperative amiodarone as prophylaxis against atrial fibrillation after heart surgery

Arrythmia

124

1996

Anesthesiology

Small, Oral Dose of Clonidine Reduces the Incidence of Intraoperative Myocardial Ischemia in Patients Having Vascular Surgery

Cardiac Ischemia

297

1996

Chest

Chlorhexidine Gluconate 0.12% Oral Rinse Reduces the Incidence of Total

Nosocomial Respiratory Infection and Nonprophylactic Systemic Antibiotic Use

in Patients Undergoing Heart Surgery

Infection

353

1996

Anesth Analg

Tranexamic acid reduces transfusions and mediastinal drainage in repeat cardiac surgery

Blood Transfusion

31

1996

Chest

The efficacy of pneumatic compression stockings in the prevention of pulmonary embolism after cardiac surgery

Embolia

2786

1996

NEJM

Effect of atenolol on mortality and cardiovascular morbidity after noncardiac surgery. Multicenter Study of Perioperative Ischemia Research Group.

Adverse Cardiac Outcome

200

1995

Acta Anaesthesiol Scand

Perioperative Monitoring of Neuromuscular Transmission using Acceleromyography Prevents Residual neuromuscular block following pancuronium

Postoperative Residual Curarization

40

1995

Anaesthesia

Comparison between two fibrescopes with different diameter insertion cords for fibreoptic intubation

Airway failure

84

1995

Anesth Analg

Procaine is effective for minimizing postischemic ventricular fibrillation in cardiac surgery

Arrythmia

58

1994

Anaesth Intensive Care

High-dose aprotinin in cardiac surgery--a prospective, randomized study

Blood Transfusion

100

1994

Anaesth Intensive Care

Incidence of ventricular fibrillation after aortic cross-clamp release using lignocaine cardioplegia

Arrythmia

146

1993

J Cardiothorac Vasc Anesth

Clonidine Imrpoves Perioperative Myocardial Ischemia, Reduces Anesthetic Requirements, and Alters Hemodynamic Parameters in Patients Undergoing Coronary Artery Bypass Surgery

Cardiac Ischemia

43

1993

Anesth Analg

Myocardial Ischemia: A comparison between Isoflurane and Enflurane in Coronary Artery Bypass

Cardiac Ischemia

38

1993

Anesthesiology

Rnadomized Evaluation of Pulse Oxymetry in 20802 Patients: II. Perioperative Events and Postoperative Complications

Composite

20802

1993

Lancet

Beneficial effect of autologous blood transfusion on infectious complications after colorectal cancer surgery

Infection

120

1992

JAMA

Comparison of Warfarin and External Pneumatic Compression in Prevention of Venous Thrombosis After Total Hip Replacement

Deep Venous Thrombosis

220

BJA: British Journal pf Anaesthesia; EJA: European Journal of Anaesthesiology; Anesth Analg: Anesthesia & Analgesia; NEJM: The New England Journal of Medicine; JAMA: The Journal of American Mecial Association; BMJ: British Medical Journal; J Cardiothorac Vasc Anesth: Journal of Cardiothoracis and Vascular Anesthesia; J Neurosurg Anesthesiol: Journal of Neurosurgical Anesthesiology; Anaesth Int Care: Anaesthesia and Intensive Care; Acta Anaesthesiol Scand: Acta Anaesthesiologica Scandinavica; Can J Anaesth: Canadian Journal of Anaesthsia; J Clin Anesth: Journal of Clinical Anesthesia; Reg Anesth Pain Med: Regional Anesthesia and Pain Medicine; Minerva Anestesiol: Minerva Anestesiologica

eTable4 – Correlation matrix between continuous variables and fragility index

Fragility Index

Year of Publication

Impact Factor

Number of Patients

Subject lost to follow-up

Number of centers

Reported P - Value

Number of events

Number needed to Treat/Harm (Absolute Value)

Fragility Index

1

Year of Publication

0.1046*

1

Impact Factor

0.2826**

0.1232*

1

Number of Patients

0.3967****

0.1828*

0.5432****

1

Subject lost to follow-up

0.0878*

0.1256*

0.0674*

0.3233***

1

Number of Centers

0.1638*

0.0724*

0.5355****

0.4631****

0.1949*

1

Reported P- value

-0.7406****

-0.0649*

-0.1178*

-0.0924*

-0.0095*

-0.0351*

1

Number of events

0.4247****

0.2668*

0.3871****

0.7375****

0.2246*

0.3686****

-0.0829*

1

Number needed to Treat/Harm

(Absolute Value)

-0.0965*

0.0707*

0.4149****

0.8002****

0.2709**

0.4001****

0.2304*

0.4050****

1

*p >0.05, ** p≤0.05, *** p<0.01, **** p<0.001

eFIGURE 1. Scatterplot matrix between continuous variables

eFIGURE2. Fragility index as a function of number of patients recruited. Figure at the top right is an enlargement of the red rectangle.

eFIGURE3. Fragility index as a function of reported P–value. Red line: polynomial fit curve. Only values below 60 are reported to improve visibility


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