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Enrollment Allocation Follow-Up Analysis

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Enrollment Allocation Follow-Up Analysis SUPPLEMENTARY DATA Supplementary Figure 1. Patients with suspected MI at participating sites during trial period 1 Randomized in DETO2X-AMI trial (N=6629) Enrollment Allocation Allocated to oxygen treatment (N=3311) Allocated to ambient air (N=3318) All except AMI All except AMI excluded excluded (N=826) (N=793) Enrolled in DETO2X-DM trial Enrolled in DETO2X-DM trial (N=2485 of which 445 with DM, 2040 without) (N=2525 of which 489 with DM, 2036 without) Follow-Up Lost to follow-up (N=0) Analysis Analyzed in primary ITT analysis 2 Analyzed in primary ITT analysis 2 (N=2485) (N=2525) ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 SUPPLEMENTARY DATA Eligible patients with suspected myocardial infarction who presented to the ambulance service, emergency departments, coronary care units, or catheterization laboratories of participating hospitals were evaluated for inclusion. Shown are the numbers of patients who were enrolled in the main trial (DETO2X-AMI), randomly assigned to a study group, and followed up in the present subgroup analysis of patients with confirmed acute myocardial infarction (AMI) divided by known diabetes status at enrollment (DETO2X-DM). DETO2X•AMI denotes Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction trial, DM diabetes mellitus, ITT intention to treat. 1: The trial design and limited resources didn’t allow a detailed screening log on all patients with suspected AMI evaluated for enrollment as the majority of the patients with suspected AMI only at presentation but who receive a different final diagnosis, never get registered in SWEDEHEART. 2: As the present analysis consists of a prespecified subgroup analysis from the DETO2X-AMI trial, only an ITT analysis was performed. Of all the patients analyzed (N=5010), 288 (5.7%) developed hypoxemia and received supplemental outside the study protocol (2.3% in the oxygen group, 9.1% in the ambient-air group). Furthermore, 217 (4.3%) did not complete the allocated treatment period, 164 (3.2%) patients allocated to oxygen, and 52 (1.1%) allocated to ambient air. Reasons for not fulfilling randomized therapy were as follows (oxygen/ambient air): patients’ unwillingness to continue therapy, 4.4%/0.4%; change of clinical circumstances, 0.8%/0.4%; mistakes (technical, communication), 1.0%/1.0%. ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 SUPPLEMENTARY DATA CONSORT CHECKLIST Table. CONSORT 2010 Checklist of Information to Include When Reporting a Randomized Triala Reported Item on Section and Topic No. Checklist Item Page No. Title and abstract 1a Identification as a randomized trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) Introduction Background 2a Scientific background and explanation of rationale and objectives 2b Specific objectives or hypotheses Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomization Sequence 8a Method used to generate the random allocation sequence generation 8b Type of randomization; details of any restriction (such as blocking and block size) Allocation concealment 9Mechanismusedtoimplementtherandomallocationsequence(suchassequentiallynumbered mechanism containers), describing any steps taken to conceal the sequence until interventions were assigned Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the similarity of interventions Statistical 12a Statistical methods used to compare groups for primary and secondary outcomes methods 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Results Participant flow 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, (a diagram is strongly and were analyzed for the primary outcome recommended) 13b For each group, losses and exclusions after randomization, together with reasons Recruitment 14a Dates defining the periods of recruitment and follow-up 14b Why the trial ended or was stopped Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Numbers analyzed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its and estimation precision (such as 95% confidence interval) 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Comment Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalizability 21 Generalizability (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol can be accessed, if available Funding 25 Sources of funding and other support (such as supply of drugs), role of funders aWe strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomized trials, noninferiority and equivalence trials, nonpharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up-to-date references relevant to this checklist, see http://www.consort-statement.org. ©2010 American Medical Association. All rights reserved. (Reprinted) JAMA, July 7, 2010—Vol 304, No. 1 E1 ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 SUPPLEMENTARY DATA SUPPLEMENTAL MATERIAL ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 SUPPLEMENTARY DATA This supplement to the DETO2X trial contains the following items: 1. Original protocol 2. Original statistical analysis plan 3. Participating centers and investigators ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 1 SUPPLEMENTARY DATA 1. Original protocol This protocol was the original and final version of the DETO2X trial. No major changes occurred during the trial. ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 2 SUPPLEMENTARY DATA DETermination of the role of OXygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial version March 2013, 26/11-2013 Principal investigators Leif Svensson, MD, PhD Karolinska Institutet, Department of Medicine, Solna, Sweden, and Department of Cardiology, Södersjukhuset, 11863 Stockholm, Sweden Email: [email protected] Phone: +46732703844 Johan Herlitz, MD, PhD Department of Health Sciences, University of Borås, Sweden and Department of Cardiology, Sahlgrenska University Hospital, 41345 Gothenburg, Sweden Email: [email protected] Phone: +46734612002 ©2019 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0590/-/DC1 3 SUPPLEMENTARY DATA Steering committee Robin Hofmann, MD Nils Witt, MD, PhD Mats Frick, MD, PhD Karolinska Institutet, Department of Clinical Science and Education, Division of Cardiology, Södersjukhuset, Stockholm Tomas Jernberg, MD, PhD Karolinska Institutet, Department of Medicine and Karolinska University Hospital, Department of Cardiology, Stockholm Mattias Ekström, MD, PhD Rickard Linder, MD, PhD Karolinska Institute, Department of Clinical Science and Department of Cardiology, Danderyd University Hospital, Stockholm Lennart Nilsson, MD, PhD Joakim Alfredsson, MD, PhD Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping David Erlinge, MD, PhD David Zughaft, BSc Ulf Ekelund, MD, PhD Department of Cardiology and Emergency
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