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--- a +++ b/230725_PATIENTreadme_v2.txt @@ -0,0 +1,323 @@ +RDG README File Template --- General --- Version: 0.1 (2022-10-04) + +This README file was generated on [2023-07-25] by [Allix-Béguec Caroline]. +Last updated: [2023-10-24]. + +# GENERAL INFORMATION + +## Dataset title: +Long-term effectiveness of a stent-less strategy in patients with coronary artery disease: 3-year follow-up of a prospective all-comers observational study (SCRAP3y) + +## DOI: +10.5281/zenodo.8182420 + +## Contact email: +recherche.clinique@ght-atlantique17.fr + + +# METHODOLOGICAL INFORMATION + +## Environmental/experimental conditions: +Cohort study + +## Description of sources and methods used to collect and generate data: +Data were collected from medical records and follow-up at one and three years + +## Methods for processing the data: +*CardioReport has generated the initial database. +*A code was used for each patient consisting of the first letter of the surname and first name, followed by a number. +*Follow-up data were collected on Excel by a study site coordinator. + +## Quality -assurance procedures performed on the data: +*Inclusion criteria, primary and secondary outcomes were monitored by clinical research assistants. +*In case of inconsistencies, queries were sent to the study site coordinator for confirmation or correction. +*Before closing the database, outliers were detected by the statistician and queries were sent to the study site coordinator for confirmation or correction. + + +# DATA & FILE OVERVIEW + +## File naming convention: +date_file content_version.extension + + +# DATA-SPECIFIC INFORMATION FOR: 230203_Data_V01.csv + +## Variable/Column List: +For each variable or column name : + -- full “human readable” name of the variable, + -- description of the variable, + -- unit of measurement if applicable, + -- decimal separator *i.e.* comma or point if applicable + -- allowed values : list of values or range, or domain + -- format if applicable, e.g. date> + +* -- ID Patient + -- Patient unique key + -- + -- + -- + -- Text + +* -- Sex + -- + -- + -- + -- 1:female ; 2:male + -- Option + +* -- Age + -- + -- year + -- + -- + -- Number + +* -- BMI + -- Body mass index + -- kg/m2 + -- point + -- + -- Number + +* -- Family history of CAD + -- Family history of coronary artery disease + -- + -- + -- 0:no history ; 1:history + -- Option + +* -- Diabetes + -- + -- + -- + -- 0:no diabetes ; 1:diabetes + -- Option + +* -- Hypertension + -- Hypertension arterial + -- + -- + -- 0:no hypertension ; 1:hypertension + -- Option + +* -- Smoking + -- Tobacco use + -- + -- + -- 0:non-tobacco user ; 1:tobacco user ; 2:ex-tobacco user + -- Option + +* -- History of revascularization + -- History of coronary revascularization + -- + -- + -- 0:no history ; 1:history + -- Option + +* -- Bypass + -- History of arterial bypass operation + -- + -- + -- 0:no history ; 1:history + -- Option + +* -- History of myocardial infarction + -- + -- + -- + -- 0:no history ; 1:history + -- Option + +* -- History of stroke + -- + -- + -- + -- 0:no history ; 1:history + -- Option + +* -- Peripheral arterial occlusive disease + -- History of peripheral arterial occlusive disease + -- + -- + -- 0:no history ; 1:history + -- Option + +* -- LVEF + -- Left ventricular ejection fraction + -- + -- + -- 1:≥ 50% ; 2:35-50% ; 3:≤ 35% + -- Option + +* -- Indication + -- Type of cardiac disorder + -- + -- + -- 1:STEMI ; 2: Non STEMI ; 3:chronic coronary syndrom + -- Option + +* -- Angioplasty strategy + -- + -- + -- + -- 1: conventional-DES; 2: BO-DES; 3: DCB only + -- Option + +* -- One year follow-up + -- Type of contact with the patients + -- + -- + -- 0:Lost to follow-up ; 1:phone ; 2:in-hospital ; 3:consultation ; 4:deceased + -- Option + +* -- Lost to follow-up reason + -- + -- + -- + -- + -- Text + +* -- ASA + -- acetyl salicilic acid + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- APA + -- anti-platelet agent + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- ACO + -- anticoagulant + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- MACE + -- Major adverse cardiac event + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- Type of MACE + -- + -- + -- + -- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes) + -- Option + +* -- Comment + -- + -- + -- + -- + -- Text + +* -- 3-year follow-up + -- Type of contact with the patients + -- + -- + -- 0:Lost to follow-up ; 1:phone ; 2:in-hospital ; 3:consultation ; 4:deceased; 5:consent withdrawal + -- Option + +* -- MACE 3-year follow-up + -- Major adverse cardiac event that happened between 1 and 3 years after the procedure + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- Type of MACE 1 + -- + -- + -- + -- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes) + -- Option + +* -- Type of MACE 2 + -- + -- + -- + -- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes) + -- Option + +* -- N MACE + -- Number of MACE + -- + -- + -- + -- Number + +* -- ISR/TLR + -- lesion revascularization + -- + -- + -- 1:intra-stent revascularization; 2:target lesion revascularization after DCB; 3:ISR+TLR + -- Option + +* -- ASA at 3-year follow-up + -- acetyl salicilic acid + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- APA at 3-year follow-up + -- anti-platelet agent + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- ACO at 3-year follow-up + -- anticoagulant + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- Covid-19 + -- confirmed by PCR within the 3-year follow-up + -- + -- + -- 0:no ; 1:yes + -- Option + +* -- Time to 1-year MACE + -- + -- months + -- + -- + -- Number + +* -- Time to 3-year MACE 1 + -- + -- months + -- + -- + -- Number + +* -- Time to 3-year MACE 2 + -- + -- months + -- + -- + -- Number + +* -- Time to last follow-up + -- + -- months + -- + -- + -- Number + + +## Missing data codes: +Blank for missing data +NA for non applicable