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Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials
Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in...
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Economic evaluations performed alongside randomized implementation trials in clinical settings: a systematic review
BackgroundEconomic evaluations alongside implementation trials compare the outcomes and costs of competing implementation strategies to identify the...
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What is the role of randomised trials in implementation science?
BackgroundThere is a consistent demand for implementation science to inform global efforts to close the gap between evidence and practice. Key...
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Use of routine healthcare data in randomised implementation trials: a methodological mixed-methods systematic review
BackgroundRoutine data are increasingly used in randomised controlled trials evaluating healthcare interventions. They can aid participant...
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The unrecognized role of fidelity in effectiveness-implementation hybrid trials: simulation study and guidance for implementation researchers
BackgroundEffectiveness-implementation hybrid designs are a relatively new approach to evaluate efficacious interventions in real-world settings...
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A systematic review of goal attainment scaling implementation practices by caregivers in randomized controlled trials
BackgroundGoal attainment scaling (GAS), an established individualized, patient-centred outcome measure, is used to capture the patient’s voice....
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From trials to communities: implementation and scale-up of health behaviour interventions
BackgroundTo maximise their potential benefits to communities, effective health behaviour interventions need to be implemented, ideally ‘at scale’,...
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Randomized controlled trials in de-implementation research: a systematic sco** review
BackgroundHealthcare costs are rising, and a substantial proportion of medical care is of little value. De-implementation of low-value practices is...
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Outcomes in deprescribing implementation trials and compliance with expert recommendations: a systematic review
BackgroundDeprescribing, defined as discontinuing or reducing the dose of medications that are no longer needed or for which the risks outweigh the...
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Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies
BackgroundWith recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-related activities...
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Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework
BackgroundFor the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the...
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Reporting of costs and economic impacts in randomized trials of de-implementation interventions for low-value care: a systematic sco** review
BackgroundDe-implementation of low-value care can increase health care sustainability. We evaluated the reporting of direct costs of...
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Integrating qualitative research within a clinical trials unit: develo** strategies and understanding their implementation in contexts
Background/aimsThe value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within...
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Implementation of the HOME core outcome set for clinical trials of atopic eczema—barriers and opportunities: the HOME IX meeting report
The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019....
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Design, implementation, and inferential issues associated with clinical trials that rely on data in electronic medical records: a narrative review
Real world evidence is now accepted by authorities charged with assessing the benefits and harms of new therapies. Clinical trials based on real...
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Special considerations in the design and implementation of pediatric otoprotection trials
PurposeCisplatin-induced hearing loss (CIHL) is a common late effect after childhood cancer treatment having profound, lifelong consequences that...
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Comparing standard versus enhanced implementation of an evidence-based HIV prevention program among Bahamian sixth grade students: findings from nationwide implementation trials
BackgroundEffective implementation strategies are needed to address the challenges encountered by teachers in implementation of evidence-based HV...
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Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention
BackgroundPatients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical...
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Supporting translation of research evidence into practice—the use of Normalisation Process Theory to assess and inform implementation within randomised controlled trials: a systematic review
BackgroundThe status of randomised controlled trials (RCTs) as the ‘gold standard’ for evaluating efficacy in healthcare interventions is...
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Implementation of coordinated spontaneous awakening and breathing trials using telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH): a type II hybrid effectiveness-implementation cluster-randomized trial
BackgroundIntensive care unit (ICU) patients on mechanical ventilation often require sedation and analgesia to improve comfort and decrease pain....
