Research Practice and Methodology

Multimorbidity, polypharmacy, and disability represent the triad that characterizes older people experiencing an unsuccessful aging process. Related needs and burden of care frequently prevent this population from living and dying at home. Long-term care (LTC), including nursing homes (NHs), host a continuously rising fraction of older people. To date, more than 1.5 million persons live in more than 15,500 Medicare- and Medicaid-certified NHs across the United States. 1 NHs require skilled medical assistance and related services for their guests. The recent COVID-19 pandemic has clearly shown that their organization and timely adoption of preventive measures are crucial to mitigate the effects of the pandemic. It follows that NHs should be the object of special interest for medical research because of their constantly adapting role in elderly care. Continuously growing research in LTC, especially in NHs, underlines a pivotal advantage for dedicated geriatric investigations.

Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way.

Research in the quality and safety field often necessitates an approach that supports the development of an in-depth understanding of how a complex phenomenon occurs, or how an intervention works. Realist review is an increasingly popular form of evidence synthesis that provides a theory-driven, interpretive approach to secondary research. Realist reviews offer quality and safety researchers the opportunity to draw on diverse types of evidence to develop explanatory theory about how, when and for whom interventions ‘work’ or outcomes occur. The approach is flexible, iterative and practical, typically drawing on the experience of policymakers, practitioners and patients throughout the review. With the increasing use of realist reviews, some common misconceptions about the approach have become evident in the literature. This paper introduces what is involved when planning and conducting a realist review, and where the approach can offer most value, as well as outlining common challenges that researchers may face when adopting the approach, and recommended solutions. Our aim is to support researchers who are considering conducting a realist review to understand the key principles and concepts involved, and how they can go about producing high-quality work.

BACKGROUND: The existing grant review criteria do not consider unique methods and priorities of Dissemination and Implementation Science (DIS). The ImplemeNtation and Improvement Science Proposals Evaluation CriTeria (INSPECT) scoring system includes 10 criteria based on Proctor et al.’s “ten key ingredients” and was developed to support the assessment of DIS research proposals. We describe how we adapted INSPECT and used it in combination with the NIH scoring system to evaluate pilot DIS study proposals through our DIS Center. METHODS: We adapted INSPECT to broaden considerations for diverse DIS settings and concepts (e.g., explicitly including dissemination and implementation methods). Five PhD-level researchers with intermediate to advanced DIS knowledge were trained to conduct reviews of seven grant applications using both the INSPECT and NIH criteria. The INSPECT overall scores range from 0 to 30 (higher scores are better), and the NIH overall scores range from 1 to 9 (lower scores are better). Each grant was independently reviewed by two reviewers, then discussed in a group meeting to compare the experiences using both criteria to evaluate the proposal and to finalize scoring decisions. A follow-up survey was sent to grant reviewers to solicit further reflections on each scoring criterion. RESULTS: Averaged across reviewers, the INSPECT overall scores ranged from 13 to 24, while the NIH overall scores ranged from 2 to 5. Reviewer reflections highlighted the unique value and utility for each scoring criterion. The NIH criteria had a broad scientific purview and were better suited to evaluate more effectiveness-focused and pre-implementation proposals not testing implementation strategies. The INSPECT criteria were easier to rate in terms of the quality of integrating DIS considerations into the proposal and to assess the potential for generalizability, real-world feasibility, and impact. Overall, reviewers noted that INSPECT was a helpful tool to guide DIS research proposal writing. CONCLUSIONS: We confirmed complementarity in using both scoring criteria in our pilot study grant proposal review and highlighted the utility of INSPECT as a potential DIS resource for training and capacity building. Possible refinements to INSPECT include more explicit reviewer guidance on assessing pre-implementation proposals, providing reviewers with the opportunity to submit written commentary with each numerical rating, and greater clarity on rating criteria with overlapping descriptions.