Article type
Year
Abstract
Background: Complex interventions are widely used in healthcare and public health and are increasingly the subject of systematic reviews. Inconsistencies and shortcomings in the reporting of complex interventions hamper systematic review efforts.
Objectives: To develop a standard list of critical elements to report in publications of research and reviews of complex interventions.
Methods: We reviewed the literature, interviewed international experts, and conducted a modified Delphi consensus process among international experts in evidence reviews, research, and implementation of complex interventions to generate a final checklist of reporting items for publications of complex interventions.
Results: Items considered for reporting of research and reviews of complex interventions included: intervention characteristics such as the number and type of components, adaptation over time, active and optional components, independence versus dependence among components, theoretical, conceptual, and/or functional foundation for the intervention, governance, skills and training of agents delivering the intervention; population characteristics including the intended recipient (e.g. individual, population, health system), cultural, educational, demographic, medical, and skills required to participate; setting/context characteristics including organizational readiness to change or adoption of intervention, key attributes of champions; comparator characteristics including describing 'usual care' and rival activities; and outcomes including expected outcomes, unintended consequences, resource utilization, and cost. We will report Delphi results including the final reporting elements checklist.
Conclusions: Space is limited in publications yet sufficient details are required to enable wide-scale successful adoption. This checklist may help authors with consistent language and reporting of individual studies, help systematic reviewers focus on key considerations, and inform future research.
Objectives: To develop a standard list of critical elements to report in publications of research and reviews of complex interventions.
Methods: We reviewed the literature, interviewed international experts, and conducted a modified Delphi consensus process among international experts in evidence reviews, research, and implementation of complex interventions to generate a final checklist of reporting items for publications of complex interventions.
Results: Items considered for reporting of research and reviews of complex interventions included: intervention characteristics such as the number and type of components, adaptation over time, active and optional components, independence versus dependence among components, theoretical, conceptual, and/or functional foundation for the intervention, governance, skills and training of agents delivering the intervention; population characteristics including the intended recipient (e.g. individual, population, health system), cultural, educational, demographic, medical, and skills required to participate; setting/context characteristics including organizational readiness to change or adoption of intervention, key attributes of champions; comparator characteristics including describing 'usual care' and rival activities; and outcomes including expected outcomes, unintended consequences, resource utilization, and cost. We will report Delphi results including the final reporting elements checklist.
Conclusions: Space is limited in publications yet sufficient details are required to enable wide-scale successful adoption. This checklist may help authors with consistent language and reporting of individual studies, help systematic reviewers focus on key considerations, and inform future research.