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SUPPLEMENTAL MATERIAL
eFigure 1. Forest plot when including the Public-Access Defibrillation trial
eTable 1. Protocol changes
eTable 2. Full search strategies
eTable 3. Risk of bias in included observational studies
eTable 4. Risk of bias in included randomized clinical trials
eTable 5. GRADE overview: Observational studies – all rhythms
eTable 6. GRADE overview: Observational studies – shockable rhythms
eTable 7. GRADE overview: Observational studies – non-Shockable rhythms
eTable 8. GRADE overview: Randomized clinical trials
eAppendix 1. PRISMA checklist
eAppendix 2. Original protocol
eAppendix 3. EXCEL: Detailed overview of observational studies
eAppendix 4. EXCEL: Detailed overview of randomized trials
eAppendix 5. EXCEL: Detailed overview of cost-effectiveness studies
Abbreviations for eAppendix 3-5:
OHCA, out-of-hospital cardiac arrest; EMS, emergency medical services; DNR, do-not-resuscitate; CPR,
cardiopulmonary resuscitation; AED, automated external defibrillator; PAD, public-access defibrillation; CPC,
cerebral performance category; NR, not reported; NA, not applicable
1
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eFigure 1. Forest plot when including the Public-Access Defibrillation trial
Forest plot for survival and favorable neurological outcome in patients with all rhythms when including the
Public-Access Defibrillation (PAD) trial. Since no odds ratio was provided in the original PAD trial, it was
calculated based on available data. In the first analysis (A and B), we calculated the odds ratio while accounting
for potential ascertainment bias in the trial as done by the investigators.(1) We calculated the proportion with
a positive outcome in each group using the number of patients with positive outcomes as the numerator and
the number of definite cardiac arrests in the intervention group as the denominator for both groups. In the
second analysis (C and D), we ignored any potential ascertainment bias and used the actual proportion with
positive outcomes in each group. Results of the meta-analysis did not meaningfully change when the PAD trial
was included.
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eTable 1. Protocol changes
Domain Change Rational
Title Changed the title to “Bystander Automated External Defibrillation Use and Clinical Outcomes after Out-of-Hospital Cardiac Arrest: A Systematic Review and Meta-Analysis”
For clarification
PICO Added “Bystander” to intervention and comparator
For clarification
Inclusion criteria
Included trained first responders (e.g. police and firefighters) for randomized clinical trials
Trained first responders may provide indirect evidence for the main PICO
Exclusion criteria
Excluded studies with less than five exposed patients and studies based on surveys
Likely high risk of bias in these studies and difficult to interpret the findings
Screening Third reviewer screened titles and abstract excluded after the first screening phase
Not necessary to screen included articles as those would be reviewed as full text articles. Assessing those articles initially excluded ensures optimal caption of relevant articles i.e. high sensitivity
GRADE Did not use GRADEpro (McMaster University, 2014) for drafting of GRADE tables
Practical reasons
4
eTable 2. Full search strategy
Medline
(external defibrillator*[tw] OR external defibrillation*[tw] OR public access defibrillation[tw] OR public access defibrillator*[tw] OR public defibrillation[tw] OR public defibrillator*[tw] OR automatic emergency defibrillator*[tw] OR automated emergency defibrillator*[tw] OR automatic external cardioverter-defibrillator*[tw] OR automated external cardioverter-defibrillator*[tw] OR automatic external cardioverter*[tw] OR automated external cardioverter*[tw] OR AED[tw] OR PAD[tw] OR AECD[tw] OR (defibrillators[mesh] AND external[tw]) OR ((defibrillat*[tw] OR cardioverter*[tw]) AND (lay person*[tw] OR lay responder*[tw] OR layperson*[tw] OR bystander*[tw] OR layman[tw] OR laywomen[tw] OR laymen[tw] OR laywoman[tw] OR first responder*[tw]))) AND (heart arrest*[mesh] OR cardiac arrest*[tw] OR sudden cardiac death[mesh] OR return of spontaneous circulation[tw] OR ROSC[tw] OR cardiovascular arrest*[tw] OR asystole[tw] OR pulseless electrical activity[tw] OR ventricular fibrillation[mesh] OR pulseless ventricular tachycardia[tw] OR cardiopulmonary arrest*[tw] OR advanced cardiac life support[mesh] OR ACLS[tw] OR cardiopulmonary resuscitation[mesh] OR CPR[tw] OR heart massage[tw] OR cardiac massage[tw] OR chest compression*[tw]) NOT (letter[publication type] OR comment[publication type] OR editorial[publication type])
Embase
((((‘defibrillation’/exp OR ‘defibrillator’/exp) AND (‘external’:ab,ti OR ‘public’:ab,ti OR ‘automated’:ab,ti OR ‘automatic’:ab,ti)) OR (‘AED’:ab,ti OR ‘AECD’:ab,ti)) AND ('heart arrest':ab,ti OR 'out of hospital cardiac arrest'/exp OR 'cardiopulmonary arrest':ab,ti OR 'cardiovascular arrest':ab,ti OR 'return of spontaneous circulation':ab,ti OR ROSC OR 'pulseless ventricular tachycardia':ab,ti OR 'heart ventricle fibrillation':ab,ti OR 'ventricular fibrillation':ab,ti OR 'pulseless electrical activity':ab,ti OR ‘asystole’:ab,ti OR 'heart massage':ab,ti OR 'cardiac massage':ab,ti OR 'chest compression':ab,ti OR ‘cardiopulmonary resuscitation’:ab,ti OR ‘CPR’:ab,ti)) NOT ('letter':it OR 'editorial':it OR 'note':it OR 'conference abstract':it)
The Cochrane Library
(MeSH descriptor: [Defibrillators] explode all trees) AND (MeSH descriptor: [Heart Arrest] explode all trees)
The Web of Science
(TS=(”external defibrillat*” OR “public access defibrillat*” OR “emergency defibrillat*” OR “external cardioverter defibrillat*” OR “AED” OR “AECD”)) AND (TS=("out-of-hospital cardiac arrest*” OR “heart arrest*" OR "cardiac arrest*" OR "cardiovascular arrest*" OR "cardiopulmonary arrest*" OR "return of spontaneous circulation" OR "ROSC" OR "asystole" OR "pulseless electrical activity" OR "ventricular fibrillation" OR "pulseless ventricular tachycardia" OR "cardiopulmonary resuscitation" OR "CPR" OR "heart massage" OR "cardiac massage" OR "chest compression" OR "advanced cardiac life support" OR "ACLS")) NOT (DT=(“letter” OR “note” OR “editorial material”))
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eTable 3. Risk of bias in included observational studies
Study Confoundinga Selection Classification of
Intervention
Deviation from
intended intervention
Missing data
Outcomes Selective reporting
Overall
Kuisma, 2003 (2) Critical Low Low Low Low Low Moderate Critical
Culley, 2004 (3) Critical Low Moderatec Low Low Low Moderate Critical
Becker, 2008 (4) Critical Low Low Low Low Low Moderate Critical
Colquhoun,2008 (5) Critical Low Low Low Low Low Moderate Critical
Cady, 2009 (6) Serious Low Moderatec Low Low Low Moderate Serious
Berdowski, 2010 (7) Critical Low Low Low Low Low Moderate Critical
Kitamura, 2010 (8) Critical Low Low Low Low Low Moderate Critical
Weisfeldt, 2010 (9) Serious Low Low Low Low Low Moderate Serious
Berdowski, 2011 (10) Serious Low Low Low Low Low Moderate Serious
McNally, 2011 (11) Critical Low Low Low Low Low Moderate Critical
Weisfeldt, 2011 (12) Critical Low Low Low Moderated Low Moderate Critical
Kitamura, 2012 (13) Serious Low Low Low Low Low Moderate Serious
Nakamura, 2012 (14) Critical Low Low Low Low Low Moderate Critical
Akahane, 2013 (15) Serious Low Low Low Low Moderatee Moderate Serious
Drezner, 2013 (16) Critical Moderateb Moderatec Low Moderated Moderatee Moderate Critical
Maron, 2013 (17) Critical Moderateb Moderatec Low Moderated Low Moderate Critical
Mitani, 2013 (18) Serious Low Low Low Low Low Moderate Serious
Wissenberg, 2013 (19) Critical Low Low Low Low Low Moderate Critical
Kim, 2014 (20) Critical Low Low Low Low Low Moderate Critical
Lijovic,2014 (21) Serious Low Low Low Moderated Low Moderate Serious
Murakami, 2014 (22) Critical Low Low Low Low Low Moderate Critical
Agerskov, 2015 (23) Critical Low Moderatec Low Low Low Moderate Critical
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eTable 3. Risk of bias in included observational studies (continued)
Study Confoundinga Selection Classification of
Intervention
Deviation from
intended intervention
Missing data
Outcomes Selective reporting
Overall
Bouland, 2015 (24) Critical Low Moderatec Low Low Low Moderate Critical
Chen, 2015 (25) Critical Low Moderatec Low Moderated Low Moderate Critical
Hansen, 2015 (26) Critical Low Low Low Low Low Moderate Critical
Hansen, 2015 (27) Critical Low Low Low Low Low Moderate Critical
Lai, 2015 (28) Critical Low Low Low Low Low Moderate Critical
Nakahara, 2015 (29) Critical Low Low Low Low Low Moderate Critical
Nishi, 2015 (30) Critical Low Low Low Low Low Moderate Critical
Ringh, 2015 (31) Critical Low Low Low Low Low Moderate Critical
Capucci, 2016 (32) Critical Low Low Low Low Low Moderate Critical
Durand, 2016 (33) Critical Low Moderatec Low Low Low Moderate Critical
Kitamura, 2016 (34) Serious Low Low Low Low Low Moderate Serious
Kiyohara, 2016 (35) Serious Low Low Low Low Low Moderate Serious
Claesson, 2017 (36) Critical Low Low Low Moderated Low Moderate Critical
Fan, 2017 (37) Critical Low Low Low Low Low Moderate Critical
Fan,2017 (38) Critical Low Low Low Low Low Moderate Critical
Fukuda, 2017 (39) Serious Low Low Low Low Low Moderate Serious
Garcia, 2017 (40) Critical Low Low Low Low Low Moderate Critical
Hansen, 2017 (41) Critical Low Low Low Low Low Moderate Critical
Karam,2017 (42) Critical Low Low Low Low Low Moderate Critical
Kiyohara,2017 (43) Critical Low Low Low Low Low Moderate Critical
Kragholm,2017 (44) Critical Low Low Low Low Low Moderate Critical
Yamaguchi,2017 (45) Critical Low Low Low Low Low Moderate Critical
7
a Risk of bias from confounding was considered critical when confounding was not inherently controlled for (i.e. no or very limited adjustment) and serious when at least one known important domain was not appropriately measured or controlled for. Adjusting for a mediator of the relationship between AED use and outcomes (e.g. time to first defibrillation) also resulted in a higher risk of bias. b Selection of participants into the study may have been related to intervention and outcomec Some aspects of the assignments of intervention status were determined retrospectively d Proportions of and reasons for missing participants might differ across interventions groupse There may have been some errors in measuring the outcome that was related to intervention status
8
eTable 4. Risk of bias in included randomized clinical trials
Study Random sequence
generation
Allocation concealment
Blinding of participants/personnel
Blinding of outcome
assessment
Incomplete outcome
data
Selective reporting
Other bias
Overall
Alem, 2003 (46) Uncleara Unclearb Unclearc Low Low Low Low Unclear
PAD, 2004 (47) Uncleara Unclearb Unclearc Low Low Low Uncleard Unclear
Bardy, 2008 (48) Uncleara Unclearb Low Low Low Low Low Unclear
a Method of randomization not providedb Details on allocation concealment not providedc No blinding of participants and personnel and unclear whether this could have biased the results. The non-blinding in the Bardy et al. trial was not considered to introduce bias.d Some imbalances in baseline characteristics with more volunteers trained in the AED group which could have been a potential reason for the larger number of volunteers responding in the AED group. It is unclear whether the increased number of cardiac arrest in the AED group was entirely due to the intervention (i.e. ascertainment bias). It is unclear whether these issues could have biased the results.
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eTable 5. GRADE overview: Observational studies – all rhythms
No. of patients and studies
Risk of Bias Inconsistency Indirectness Imprecision Othera Overall
Survival to hospital discharge/30 days
29,569 patients3 studies(6, 9, 35)
Very seriousb Not serious Not serious Not serious None Very low quality
Favorable neurological outcome at hospital discharge/30 days
12,333 patients2 studies(10, 35)
Very seriousb Not serious Not serious Not serious None Very low quality
Return of spontaneous circulation
15,800 patients2 studies(6, 35)
Very seriousb Not serious Not serious Seriousc None Very low quality
a Includes assessment of publication bias, magnitude of the effect, dose-response gradient, and plausible residual confounding leading to spurious effect when no effect was observed or reduction of a demonstrated effect.b High risk of confounding (see eTable 3) c 95% confidence intervals include both potential harm and potential benefit
10
eTable 6. GRADE overview: Observational studies – shockable rhythms
No. of patients and studies
Risk of Bias Inconsistency Indirectness Imprecision Othera Overall
Survival to hospital discharge/30 days
46,032 patients2 studies(21, 34) Very seriousb Not serious Not serious Not serious None Very low
quality
Favorable neurological outcome at hospital discharge/30 days
46,117 patients2 studies(10, 34) Very seriousb Not serious Not serious Not serious None Very low
quality
Return of spontaneous circulation
43,762 patients1 study(34) Very seriousb Not applicable Not serious Not serious None Very low
quality
a Includes assessment of publication bias, magnitude of the effect, dose-response gradient, and plausible residual confounding leading to spurious effect when no effect was observed or reduction of a demonstrated effect.b High risk of confounding (see eTable 3)
11
eTable 7. GRADE overview: Observational studies – non-shockable rhythms
No. of patients and studies
Risk of Bias Inconsistency Indirectness Imprecision Othera Overall
Favorable neurological outcome at hospital discharge/30 days
2,355 patients1 study(10) Very seriousb Not applicable Not serious Very seriousc None Very low
quality
a Includes assessment of publication bias, magnitude of the effect, dose-response gradient, and plausible residual confounding leading to spurious effect when no effect was observed or reduction of a demonstrated effect.b High risk of confounding (see eTable 3)c 95% confidence intervals include both potential harm and potential benefit
12
eTable 8. GRADE overview: Randomized clinical trials
No. of patients and studies Risk of Bias Inconsistency Indirectness Imprecision Othera Overall
Survival to hospital discharge
235 patients1 study(47) Seriousb Not applicable Not serious Seriousc None Low
quality
Favorable neurological outcome
235 patients1 study(47) Seriousb Not applicable Not serious Seriousc None Low
quality
a Includes assessment of publication bias, magnitude of the effect, dose-response gradient, and plausible residual confounding leading to spurious effect when no effect was observed or reduction of a demonstrated effect.b See eTable 4c Total sample size lower than the optimal information size of 828 patients.(49) The optimal information size was calculated using Fisher’s Exact test and assuming a survival rate of 11% in the control group(50), a relative risk of 1.75, an alpha of 0.05, and 90% power. If a relative risk of 2.0 is assumed instead, the optimal information size is 504 patients.
13
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