A practitioner's guide to conducting and analysing embedded randomized single-case experimental designs.

Single-case experimental designs (SCEDs) are a class of experimental designs suited for answering research questions at an individual level. The main designs available in SCED research are phase designs, multiple baseline designs, alternation designs, and changing criterion designs. Embedded designs, also referred to as combination or hybrid designs, consist of one of these basic designs forms embedded in another design (e.g., a changing criterion design embedded in a multiple baseline design). Systematic reviews of SCEDs have repeatedly indicated that embedded designs are frequently used in applied SCED research. In spite of their popularity, specific recommendations on the conduct and analysis of embedded SCED designs are lacking to date. The purpose of the present article is therefore to provide guidance to applied researchers wishing to conduct embedded SCED designs in terms of design options, design requirements, randomization, and data analysis.

From Research Training to Scientific Advancement-Contributions from the Implementation Research Institute: An Introduction to the Special Issue.

The special series is designed to provide examples of funded implementation research conducted by alumni of the first four cohorts of the Implementation Research Institute (IRI). The introduction links the six substantive papers to the conceptual and methodological challenges laid out in a 2009 publication in this journal which led to the IRI training program in the emerging science of implementation with a special focus on behavior health settings. The 7th paper in the series illustrates an innovative evaluative approach to design and measurement of IRI fellow publications and grants informed by the training program such as bibliometrics. The introduction also notes some elements identified in the 2009 foundational paper not represented in these papers such as costs as well as important developments and foci in the decade since 2009 such as de-implementation, sustainability, dynamic adaptation processes, and hybrid designs that need to be an integral part of training programs in implementation research.

Innovations in Mixed Methods Evaluations.

Mixed methods research-i.e., research that draws on both qualitative and quantitative methods in varying configurations-is well suited to address the increasing complexity of public health problems and their solutions. This review focuses specifically on innovations in mixed methods evaluations of intervention, program or policy (i.e., practice) effectiveness, and implementation. The article begins with an overview of the structure, function, and process of different mixed methods designs and then provides illustrations of their use in effectiveness studies, implementation studies, and combined effectiveness-implementation hybrid studies. The article then examines four specific innovations: procedures for transforming (or "quantitizing") qualitative data, application of rapid assessment and analysis procedures in the context of mixed methods studies, development of measures to assess implementation outcomes, and strategies for conducting both random and purposive sampling, particularly in implementation-focused evaluation research. The article concludes with an assessment of challenges to integrating qualitative and quantitative data in evaluation research.

Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial.

BACKGROUND: Underage drinking and related risky sexual behavior (RSB) are major public health concerns on United States college campuses. Although technology-delivered personalized feedback interventions (PFIs) are considered a best practice for individual-level campus alcohol prevention, there is room for improving the effectiveness of this approach with regard to alcohol-related RSB. OBJECTIVE: The aims of this study are to (1) evaluate the impact of a brief PFI that integrates content on alcohol use and RSB and is adapted to include a novel cross-tailored dynamic feedback (CDF) component for at-risk first-year college students and (2) identify implementation factors critical to the CDF's success to facilitate future scale-up in campus settings. METHODS: This study uses a hybrid type 1 effectiveness-implementation design and will be conducted in 3 phases. Phase 1 is a stakeholder-engaged PFI+CDF adaptation guided by focus groups and usability testing. In phase 2, 600 first-year college students who drink and are sexually active will be recruited from 2 sites (n=300 per site) to participate in a 4-group randomized controlled trial to examine the effectiveness of PFI+CDF in reducing alcohol-related RSB. Eligible participants will complete a baseline survey during the first week of the semester and follow-up surveys at 1, 2, 3, 6, and 13 months post baseline. Phase 3 is a qualitative evaluation with stakeholders to better understand relevant implementation factors. RESULTS: Recruitment and enrollment for phase 1 began in January 2022. Recruitment for phases 2 and 3 is planned for the summer of 2023 and 2024, respectively. Upon collection of data, the effectiveness of PFI+CDF will be examined, and factors critical to implementation will be evaluated. CONCLUSIONS: This hybrid type 1 trial is designed to impact the field by testing an innovative adaptation that extends evidence-based alcohol programs to reduce alcohol-related RSB and provides insights related to implementation to bridge the gap between research and practice at the university level. TRIAL REGISTRATION: ClinicalTrials.gov NCT05011903; https://clinicaltrials.gov/ct2/show/NCT05011903. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43986.

Corrigendum: Beyond effectiveness evaluation: Contributing to the discussion on complexity of digital health interventions with examples from cancer care.

[This corrects the article DOI: 10.3389/fpubh.2022.883315.].

Beyond effectiveness evaluation: Contributing to the discussion on complexity of digital health interventions with examples from cancer care.

Digital health interventions (DHIs) have become essential complementary solutions in health care to enhance support and communication at a distance, with evidence of improving patient outcomes. Improving clinical outcomes is a major determinant of success in any health intervention, influencing its funding, development, adoption and implementation in real-world practice. In this article we explore our experiences of developing and testing DHIs to identify and discuss complexity challenges along their intervention research lifecycle. Informed by the case study research approach, we selected three individual DHIs aimed at satisfying the supportive and educational needs of people living with cancer. The Care Expert, the Digi-Do and the Gatapp were underpinned on different complexity frameworks i.e., the Medical Research Council framework and the Non-adoption, Abandonment, Scale-up, Spread and Sustainability framework. This variance on the methodological underpinning was expected to prompt a multifaceted discussion on the complexity dimensions endorsed by each of the frameworks. Our discussion endorses the adoption of mixed-methods research designs, to gather the perspectives of stakeholders and end-users, as well as pragmatic evaluation approaches that value effectiveness outcomes as much as process outcomes. Furthermore, the dissemination and sustainability agenda of DHIs needs to be considered from early-stage development with the inclusion of a business model. This business plan should be worked in partnership with healthcare services, regulatory bodies and industry, aiming to assure the management of the DHI throughout time.

Adapting rapid assessment procedures for implementation research using a team-based approach to analysis: a case example of patient quality and safety interventions in the ICU.

BACKGROUND: Innovations to improve quality and safety in healthcare are increasingly complex, targeting multiple disciplines and organizational levels, and often requiring significant behavior change by those delivering care. Learning health systems must tackle the crucial task of understanding the implementation and effectiveness of complex interventions, but may be hampered in their efforts by limitations in study design imposed by business-cycle timelines and implementation into fast-paced clinical environments. Rapid assessment procedures are a pragmatic option for producing timely, contextually rich evaluative information about complex interventions implemented into dynamic clinical settings. METHODS: We describe our adaptation of rapid assessment procedures and introduce a rapid team-based analysis process using an example of an evaluation of an intensive care unit (ICU) redesign initiative aimed at improving patient safety in four academic medical centers across the USA. Steps in our approach included (1) iteratively working with stakeholders to develop evaluation questions; (2) integration of implementation science frameworks into field guides and analytic tools; (3) selecting and training a multidisciplinary site visit team; (4) preparation and trust building for 2-day site visits; (5) engaging sites in a participatory approach to data collection; (6) rapid team analysis and triangulation of data sources and methods using a priori charts derived from implementation frameworks; and (7) validation of findings with sites. RESULTS: We used the rapid assessment approach at each of the four ICU sites to evaluate the implementation of the sites' innovations. Though the ICU projects all included three common components, they were individually developed to suit the local context and had mixed implementation outcomes. We generated in-depth case summaries describing the overall implementation process for each site; implementation barriers and facilitators for all four sites are presented. One of the site case summaries is presented as an example of findings generated using the method. CONCLUSIONS: A rapid team-based approach to qualitative analysis using charts and team discussion using validation techniques, such as member-checking, can be included as part of rapid assessment procedures. Our work demonstrates the value of including rapid assessment procedures for implementation research when time and resources are limited.