Reflections on 10 years of effectiveness-implementation hybrid studies

Abstract

This article provides new reflections and recommendations from authors of the initial effectiveness-implementation hybrid study manuscript and additional experts in their conceptualization and application. Given the widespread and continued use of hybrid studies, critical appraisals are necessary. The article offers reflections across five conceptual and methodological areas. It begins with the recommendation to replace the term “design” in favor of “study.” The use of the term “design” and the explicit focus on trial methodology in the original paper created confusion. The essence of hybrid studies is combining research questions concerning intervention effectiveness and implementation within the same study, and this can and should be achieved by applying a full range of research designs. Supporting this recommendation, the article then offers guidance on selecting a hybrid study type based on evidentiary and contextual information and stakeholder concerns/preferences. A series of questions are presented that have been designed to help investigators select the most appropriate hybrid type for their study situation. The article also provides a critique on the hybrid 1-2-3 typology and offers reflections on when and how to use the typology moving forward. Further, the article offers recommendations on research designs that align with each hybrid study type. Lastly, the article offers thoughts on how to integrate costs analyses into hybrid studies.

Stand Down–Think Before You Drink: protocol for an effectiveness-implementation trial of a mobile application for unhealthy alcohol use with and without peer support

“…This trial is a hybrid type 1 study. 23 The primary goal of such studies is to evaluate the effectiveness of an intervention in an RCT, with a secondary goal of gathering data from stakeholders on the implementation context of the intervention. At two VA medical centres, primary care patients will be enrolled in the study, complete a baseline phone interview, randomly assigned to one of the three conditions—usual care (UC), UC+access to Stand Down (App) or UC+Peer-Supported Stand Down (PSSD)—and complete assessments by phone at 8-weeks, 20-weeks and 32-weeks postbaseline.…”

Testing psychosocial interventions in the contexts they are meant to be delivered.

“…alongside the evaluation of intervention effectiveness (e.g., symptom reduction and improved well-being). These studies are designed to understand contextual determinants of implementation and implementation strategies (Curran et al, 2012(Curran et al, , 2022. In cases where efficacy work is still needed due to concerns about safety or unintended negative consequences, trialists still can design for dissemination, implementation, sustainment, and equity while developing the evidence.…”

“…First, consider moving right to effectiveness or pragmatic trials, as the most valid test of an intervention is the test of that intervention in the context(s) in which it is intended. Second, when designing effectiveness studies, consider investigating questions related to both effectiveness (i.e., does the intervention improve clinical outcomes) and implementation (i.e., what supports are needed to deploy the intervention routinely in that context) to accelerate impact (Curran et al, 2012(Curran et al, , 2022.…”

Social determinants of health and US cancer screening interventions: A systematic review

“…Approximately one third of studies (36.1%) reported on an implementation outcome-most commonly acceptability and penetrationbut, overall, the sample lacked implementation studies or hybrid trials in which effectiveness and implementation were investigated together. 181 SDOH are often described as part of the broader implementation context (e.g., outer setting health policies 182,183 ); yet, to make progress in developing implementation strategies that incorporate SDOH to advance equity in cancer screening, the field must look toward attempting change at the community and systems levels. 6,12,174,178 Findings from our review-particularly the major emphasis on individual-level intervention approaches and measurement-point toward the need for additional evidence at these broader levels of influence.…”