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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 Ringe