Development of the ASSESS tool: a comprehenSive tool to Support rEporting and critical appraiSal of qualitative, quantitative, and mixed methods implementation reSearch outcomes

BACKGROUND: Several tools to improve reporting of implementation studies for evidence-based decision making have been created; however, no tool for critical appraisal of implementation outcomes exists. Researchers, practitioners, and policy makers lack tools to support the concurrent synthesis and critical assessment of outcomes for implementation research. Our objectives were to develop a comprehensive tool to (1) describe studies focused on implementation that use qualitative, quantitative, and/or mixed methodologies and (2) assess risk of bias of implementation outcomes. METHODS: A hybrid consensus-building approach combining Delphi Group and Nominal Group techniques (NGT) was modeled after comparative methodologies for developing health research reporting guidelines and critical appraisal tools. First, an online modified NGT occurred among a small expert panel (n = 5), consisting of literature review, item generation, round robin with clarification, application of the tool to various study types, voting, and discussion. This was followed by a larger e-consensus meeting and modified Delphi process with implementers and implementation scientists (n = 32). New elements and elements of various existing tools, frameworks, and taxonomies were combined to produce the ASSESS tool. RESULTS: The 24-item tool is applicable to a broad range of study designs employed in implementation science, including qualitative studies, randomized-control trials, non-randomized quantitative studies, and mixed methods studies. Two key features are a section for assessing bias of the implementation outcomes and sections for describing the implementation strategy and intervention implemented. An accompanying explanation and elaboration document that identifies and describes each of the items, explains the rationale, and provides examples of reporting and appraising practice, as well as templates to allow synthesis of extracted data across studies and an instructional video, has been prepared. CONCLUSIONS: The comprehensive, adaptable tool to support both reporting and critical appraisal of implementation science studies including quantitative, qualitative, and mixed methods assessment of intervention and implementation outcomes has been developed. This tool can be applied to a methodologically diverse and growing body of implementation science literature to support reviews or meta-analyses that inform evidence-based decision-making regarding processes and strategies for implementation.