Department of Health Convergence, Ewha Womans University, Seoul, Korea
Copyright © 2020 Korean Society of Cardiovascular Disease Prevention; Korean Society of Cardiovascular Pharmacotherapy.
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Feature | ECTs | PCTs |
---|---|---|
Question | Efficacy: does the intervention work under ideal setting? | Effectiveness: does the intervention benefit when used in routine practice? |
Inclusion criteria of participants | Strict criteria to exclude high-risk or poorly adherent participants | Broader criteria to include various participants |
Setting | Highly controlled experimental setting | Normal practice setting |
Intervention | Thorough delivery and monitoring of intervention | Flexible delivery and monitoring of intervention |
Comparator | Generally placebo control | Routine clinical treatment, mostly not placebo control |
Outcomes | A restricted set of events or surrogated outcomes | A broad set of events or determined in the routine course of clinical practice |
Sample size | Comparatively small | Comparatively large |
Relevance to practice | Low relevance to practice | High relevance to practice |
Follow-up period | Relatively short-term follow-up | Relatively long-term follow-up |
Domain | Outline | Highly pragmatic approach |
---|---|---|
Eligibility | To what extent are the participants in the trial similar to those who would receive this intervention if it was part of usual care? | Anyone covered elderly, children, people with comorbidities was included. |
Recruitment | How much extra effort is made to recruit participants over and above what would be used in the usual care setting to engage with patients? | People who visit the hospital with the condition of interested were included without overt recruitment effort. |
Setting | How different are the settings of the trial from the usual care setting? | Trials were performed in an identical setting to clinical practice that applies the results. |
Organization | How different are the resources, provider expertise, and the organization of care delivery in the intervention arm of the trial from those available in usual care? | Trials slotted the intervention into the usual healthcare organization, trying to use of the existing healthcare staff and resources. |
Flexibility (delivery) | How different is the flexibility in how the intervention is delivered and the flexibility anticipated in usual care? | Methodology of how to deliver the intervention was not strictly prescriptive, and it did not dictate which other interventions were permitted. |
Flexibility (adherence) | How different is the flexibility in how participants are monitored and encouraged to adhere to the intervention from the flexibility anticipated in usual care? | Trials allowed the full flexibility in how end-user recipients engage with the intervention with no specific measures to enforce engagement or compliance. |
Follow-up | How different is the intensity of measurement and follow-up of participants in the trial from the typical follow-up in usual care? | Trials had no more follow-up than usual care and collected minimal additional data. |
Primary outcome | To what extent is the trial's primary outcome directly relevant to participants? | Trials chose obviously important outcomes to patients and measured them in a way that was the same or similar to the way they are measured in practice. |
Primary analysis | To what extent are all data included in the analysis of the primary outcome? | Trials used an intention-to-treat analysis about all available data. |
Trial | Year | Ref. | Question | Inclusion criteria of participants (No. of participants; No. of sites) | Intervention (No. of participants) vs. Comparator (No. of participants) | Randomization | Study period |
Primary outcomes | Results |
---|---|---|---|---|---|---|---|---|---|
CRASH-2 | 2020 | 56 | Whether the early administration of tranexamic acid reduces death, vascular occlusive events, and the receipt of blood transfusion | Adult trauma patients with significant haemorrhage and who were within 8 hours of injury (n=20,211; n=274) | Tranexamic acid (n=10,060) vs. Placebo (n=10,067) | Central randomization at the level of individuals | May 2005 to Mar 2010 (4 weeks) | Death in hospital | Tranexamic acid safely reduced the risk of death in bleeding trauma patients |
Post-MI FREEE | 2011 | 61 | Whether full prescription drug coverage for statins, β-blockers, ACE inhibitors, and ARBs is more effective to patients after MI | Adults discharged alive from hospital after MI who received health services and prescription drug benefits through Aetna, Inc. (n=5,855; N/A |
Full prescription coverage (n=2,845) vs. Usual prescription coverage (n=3,010) | Cluster randomization at the level of the plan sponsor | Nov 2007 to Nov 2010 (≥1 year) | First vascular event or revascularization | The removal of copayments for drugs prescribed after being discharged due to MI did not significantly reduce rates of the primary outcome |
TASTE | 2013 | 62 | Whether thrombus aspiration before PCI reduces mortality than usual care in patients with STEMI | Patients in a registry for coronary angiography and angioplasty (n=7,244; n=31) | Thrombus aspiration before PCI (n=3,621) vs. Usual care (n=3,623) | Registry based randomization | Jul 2010 to Aug 2013 (30 days) | All-cause death | Thrombus aspiration before PCI did not reduce 30-day mortality in patients with STEMI compared to PCI alone |
SLS | 2016 | 64 | Whether the effectiveness and safety of the once-daily inhaled combination of fluticasone furoate–vilanterol is better than existing maintenance therapy | Adults (≥40) who received diagnosis of COPD and who had ≥1 COPD exacerbations in the previous 3 years in 75 general practices (n=2,799; n=75) | Fluticasone furoate- vilanterol (n=2,799) vs. Usual care (n=1,403) | Central randomization at the level of individuals | Mar 2012 to Nov 2015 (1 year) | Mean annual rate of exacerbations | Once-daily combined treatment of fluticasone furoate and vilanterol decreased the rate of exacerbations without a further risk of serious adverse events than usual care |
High-STEACS | 2018 | 66 | Whether the use of hs-cTnI assay reduces MI or cardiovascular death compared with standard troponin assay | Patients with acute coronary syndrome suspects in 10 Scotland hospitals (n=48,282; n=10) | Reclassified as MI by hs-cTnI assay (n=1,771) vs. Classified as MI by cardiac troponin I assay (n=8,589) | Stepped wedge cluster randomization at the level of the hospital site | Jun 2013 to Mar 2017 (1 year) | Subsequent MI or cardiovascular death | High-sensitivity assay did not reduce in MI or cardiovascular death within 1 year |
ECT = explanatory clinical trial; PCT = pragmatic clinical trial.
Information in the table is referred to Loudon et al. PRECIS = PRagmatic Explanatory Continuum Indicator Summary.
ACE = angiotensin-converting enzyme; ARBs = angiotensin II receptor blockers; CRASH-2 = Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage; COPD = chronic obstructive pulmonary disease; High-STEACS = High-Sensitivity Troponin in the Evaluation of patients with Acute Coronary Syndrome; hs-cTnI = high-sensitivity cardiac troponin I; MI = myocardial infarction; PCI = percutaneous coronary intervention; PCT = randomized controlled trial; Post-MI FREEE = The Post-Myocardial Infarction Free Rx and Economic Evaluation; SLS = Salford Lung Study; STEMI = ST-segment elevation myocardial infarction; TASTE = Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia. N/A (not available) means that accurate information was not available in the reference literature. Study periods of each trial were referred to ClinicalTrials.gov.