[Acute coronary syndrome].

Abstract

s will be excluded as it is expected there will be sufficient full text published studies available. 11 . Context N/A 12 . Primary outcomes (critical outcomes) • All-cause mortality short term (≤30 days) • All-cause mortalityintermediate term (up to 1 year) • All-cause mortalitylong term (>1 year) • Myocardial re-infarction short term (≤30 days) • Myocardial re-infarction intermediate term (up to 1 year) • Myocardial re-infarction short term (≤30 days) • stroke short term (≤30 days) • stroke long term (>1 year) • stroke short term (≤30 days) • Complications related to bleeding short term (≤30 days), intermediate term (up to 1 year), and long term (>1 year) including haemorrhagic stroke –(access bleeding and non-access bleeding need to be differentiated)the following hierarchy of bleeding scales will be used: o BARC o Author’s definition o TIMI o GUSTO Where possible, bleeding outcomes will be categorised into: o Major bleeding (including BARC 3-5 and as reported by author) o Minor bleeding (including BARC 2, TIMI and as reported by author). – 1 year • Health-related quality of life including EQ5D and SF-36. 13 . Secondary outcomes (important outcomes) • Withdrawal of study drug due to any side effects • Probable and/or definite stent thrombosis at 1 year 14 . Data extraction (selection and coding) EndNote will be used for reference management, sifting, citations and bibliographies. Titles and/or abstracts of studies retrieved using the search strategy and those from additional sources will be screened for inclusion. The full text of potentially eligible studies will be retrieved and will be assessed for eligibility in line with the criteria outlined above. 10% of the abstracts will be reviewed by two reviewers, with any disagreements resolved by discussion or, if necessary, a third independent reviewer. Acute coronary syndromes: DRAFT FOR CONSULTATION Combination therapy © National Institute for Health and Care Excellence, 2020 45 An in-house developed database; EviBase, will be used for data extraction. A standardised form is followed to extract data from studies (see Developing NICE guidelines: the manual section 6.4) and for undertaking assessment of study quality. Summary evidence tables will be produced including information on: study setting; study population and participant demographics and baseline characteristics; details of the intervention and control interventions; study methodology’ recruitment and missing data rates; outcomes and times of measurement; critical appraisal ratings. A second reviewer will quality assure the extracted data. Discrepancies will be identified and resolved through discussion (with a third reviewer where necessary). 15 . Risk of bias (quality) assessment Risk of bias will be assessed using the appropriate checklist as described in Developing NICE guidelines: the manual. For Intervention reviews the following checklist will be used according to study design being assessed: • Systematic reviews: Risk of Bias in Systematic Reviews (ROBIS) • Randomised Controlled Trial: Cochrane RoB (2.0) Disagreements between the review authors over the risk of bias in particular studies will be resolved by discussion, with involvement of a third review author where necessary. 16 . Strategy for data synthesis Where possible, data will be meta-analysed. Pairwise metaanalyses will be performed using Cochrane Review Manager (RevMan5) to combine the data given in all studies for each of the outcomes stated above. A fixed effect meta-analysis, with weighted mean differences for continuous outcomes and risk ratios for binary outcomes will be used, and 95% confidence intervals will be calculated for each outcome. Heterogeneity between the studies in effect measures will be assessed using the I2 statistic and visually inspected. We will consider an I2 value greater than 50% indicative of substantial heterogeneity. Sensitivity analyses will be conducted based on pre-specified subgroups using stratified meta-analysis to explore the heterogeneity in effect estimates. If this does not explain the heterogeneity, the results will be presented using random-effects. GRADE pro will be used to assess the quality of each outcome, taking into account individual study quality and the metaanalysis results. The 4 main quality elements (risk of bias, indirectness, inconsistency and imprecision) will be appraised for each outcome. Publication bias is tested for when there are more than 5 studies for an outcome. Acute coronary syndromes: DRAFT FOR CONSULTATION Combination therapy © National Institute for Health and Care Excellence, 2020 46 Other bias will only be taken into consideration in the quality assessment if it is apparent. Where meta-analysis is not possible, data will be presented and quality assessed individually per outcome. If sufficient data is available to make a network of treatments, WinBUGS will be used for network meta-analysis. 17 . Analysis of subgroups • Indication for anticoagulant (mechanical heart values vs. VTE • Type of treatment of MI (PCI or CABG or medical) • Types of stents (bare metal stent vs. drug eluting stent) 18 . Type and method of review ☒ Intervention ☐ Diagnostic ☐ Prognostic ☐ Qualitative ☐ Epidemiologic ☐ Service Delivery ☐ Other (please specify) 19 . Language English 20 . Country England 21 . Anticipated or actual start date 30/04/19 22 . Anticipated completion date 14/05/20 23 . Stage of review at time of this submission Review stage Started Completed Preliminary searches Piloting of the study selection process Formal screening of search results against eligibility criteria Acute coronary syndromes: DRAFT FOR CONSULTATION Combination therapy © National Institute for Health and Care Excellence, 2020 47 Data extraction Risk of bias (quality) assessment