Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial

Anders Kehlet Nørskov; Lars Hyldborg Lundstrøm; Charlotte Vallentin Rosenstock; Jørn Wetterslev

doi:10.1186/1745-6215-15-173

Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial

Anders Kehlet Nørskov, Lars Hyldborg Lundstrøm, Charlotte Vallentin Rosenstock, Jørn Wetterslev

Department of Clinical Medicine

5 Citations (Scopus)

Abstract

BACKGROUND: Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist. The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias and selective reporting, we hereby present a detailed statistical analysis plan as an amendment (update) to the previously published protocol for the DIFFICAIR trial.

METHOD/DESIGN: The DIFFICAIR trial is a stratified, parallel group, cluster (cluster = department) randomized multicenter trial involving 28 departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index (SARI) or by a usual non-specific assessment. Data from patients' preoperative airway assessment are registered in the Danish Anesthesia Database. An objective score for intubation grading the severity, that is the severity of the intubations, as well as the frequency of unanticipated difficult intubation, is measured for each group.Primary outcome measures are the fraction of unanticipated difficult and easy intubations.The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls.Data recruitment was commenced in October 2012 and ended in ultimo December 2013.

CONCLUSION: We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT01718561.

Original language	English
Article number	173
Journal	Trials
Volume	15
Pages (from-to)	1-7
Number of pages	7
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-15-173
Publication status	Published - 15 May 2014

Keywords

Clinical Protocols
Data Interpretation, Statistical
Decision Support Techniques
Denmark
Humans
Intubation, Intratracheal
Laryngoscopy
Models, Statistical
Preoperative Care
Research Design
Risk Assessment
Risk Factors

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10.1186/1745-6215-15-173

Cite this

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title = "Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial",

abstract = "BACKGROUND: Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist. The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias and selective reporting, we hereby present a detailed statistical analysis plan as an amendment (update) to the previously published protocol for the DIFFICAIR trial.METHOD/DESIGN: The DIFFICAIR trial is a stratified, parallel group, cluster (cluster = department) randomized multicenter trial involving 28 departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index (SARI) or by a usual non-specific assessment. Data from patients' preoperative airway assessment are registered in the Danish Anesthesia Database. An objective score for intubation grading the severity, that is the severity of the intubations, as well as the frequency of unanticipated difficult intubation, is measured for each group.Primary outcome measures are the fraction of unanticipated difficult and easy intubations.The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls.Data recruitment was commenced in October 2012 and ended in ultimo December 2013.CONCLUSION: We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan.TRIAL REGISTRATION: ClinicalTrials.gov: NCT01718561.",

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author = "N{\o}rskov, {Anders Kehlet} and Lundstr{\o}m, {Lars Hyldborg} and Rosenstock, {Charlotte Vallentin} and J{\o}rn Wetterslev",

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doi = "10.1186/1745-6215-15-173",

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T1 - Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial

AU - Nørskov, Anders Kehlet

AU - Lundstrøm, Lars Hyldborg

AU - Rosenstock, Charlotte Vallentin

AU - Wetterslev, Jørn

PY - 2014/5/15

Y1 - 2014/5/15

N2 - BACKGROUND: Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist. The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias and selective reporting, we hereby present a detailed statistical analysis plan as an amendment (update) to the previously published protocol for the DIFFICAIR trial.METHOD/DESIGN: The DIFFICAIR trial is a stratified, parallel group, cluster (cluster = department) randomized multicenter trial involving 28 departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index (SARI) or by a usual non-specific assessment. Data from patients' preoperative airway assessment are registered in the Danish Anesthesia Database. An objective score for intubation grading the severity, that is the severity of the intubations, as well as the frequency of unanticipated difficult intubation, is measured for each group.Primary outcome measures are the fraction of unanticipated difficult and easy intubations.The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls.Data recruitment was commenced in October 2012 and ended in ultimo December 2013.CONCLUSION: We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan.TRIAL REGISTRATION: ClinicalTrials.gov: NCT01718561.

AB - BACKGROUND: Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist. The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias and selective reporting, we hereby present a detailed statistical analysis plan as an amendment (update) to the previously published protocol for the DIFFICAIR trial.METHOD/DESIGN: The DIFFICAIR trial is a stratified, parallel group, cluster (cluster = department) randomized multicenter trial involving 28 departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index (SARI) or by a usual non-specific assessment. Data from patients' preoperative airway assessment are registered in the Danish Anesthesia Database. An objective score for intubation grading the severity, that is the severity of the intubations, as well as the frequency of unanticipated difficult intubation, is measured for each group.Primary outcome measures are the fraction of unanticipated difficult and easy intubations.The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls.Data recruitment was commenced in October 2012 and ended in ultimo December 2013.CONCLUSION: We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan.TRIAL REGISTRATION: ClinicalTrials.gov: NCT01718561.

KW - Clinical Protocols

KW - Data Interpretation, Statistical

KW - Decision Support Techniques

KW - Denmark

KW - Humans

KW - Intubation, Intratracheal

KW - Laryngoscopy

KW - Models, Statistical

KW - Preoperative Care

KW - Research Design

KW - Risk Assessment

KW - Risk Factors

U2 - 10.1186/1745-6215-15-173

DO - 10.1186/1745-6215-15-173

M3 - Journal article

C2 - 24885548

SN - 1745-6215

VL - 15

SP - 1

EP - 7

JO - Trials

JF - Trials

M1 - 173

ER -

Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial

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Keywords

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