Use of Theory-Based Implementation Research to Evaluate Barriers and Facilitators to Implementation of a Novel Digital Inhaler Technology in Clinical Practice

Schafer, Ewa; Mosnaim, Giselle; Bajowala, Sakina; Bansal, Priya; Jiang, Yihui; Skolnik, Neil; Sumino, Kaharu; Vega, Charles; Williams, Paul; Yawn, Barbara P.; Drummond, Bradley; Anatchkova, Milena D.; Walsh, Marissa; Boe, Amanda; Hill, Tanisha

doi:10.1016/j.jaci.2022.12.512

Cited by 2 publications

(24 citation statements)

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“…Study sample sizes ranged from a low of 18 (physicians) [45] to a high of 21,211 (patients) [46]. Approximately half of the studies (n = 5) had sample sizes under 50 [21,42,43,45,47]. Samples were highly diverse in type.…”

Section: Sample Size and Type Of Participantsmentioning

confidence: 99%

“…Six of the studies focused on a single disease or condition (i.e., HIV, opioid misuse or overdose, stroke prevention, cardiovascular disease, falls and fall-related injuries, and asthma) [21,42,[44][45][46][47]. Three other studies involved all diseases and medical conditions that required treatment by a prescription drug, including those drugs that had Food and Drug Administration (FDA)-mandated drug safety program commitments [40,41,43].…”

Section: Target Disease or Medical Conditionmentioning

confidence: 99%

“…The Consolidated Framework for Implementation Research (CFIR), a determinant framework, [34] was the most frequently used TMF (3 of 9 studies) [21,40,47] (see Table 3). Another determinant framework, the Theoretical Domains Framework (TDF), was used by Kalim et al Except for one study [40], all of the studies used only one TMF.…”

Section: Use Of Implementation Tmfsmentioning

confidence: 99%

“…[Insert Table 3 here] Studies varied in use across implementation phases and speci c application. Six studies reported using the IS TMF after implementation of the intervention [40,41,43,44,46,47]. Three of the post-implementation studies [43,44,46] used the TMFs to guide the planning of data collection tools and analysis.…”

Section: Use Of Implementation Tmfsmentioning

confidence: 99%

“…Two studies used TMFs to map constructs included in regulatory guidance on evaluating Risk Evaluation and Mitigation Strategy (REMS) programs, and in REMS program assessment plans [40,41]. One study used the TMF to identify barriers and facilitators to implementation of an intervention (e.g., a digital asthma inhaler) [47].…”

Section: Use Of Implementation Tmfsmentioning

confidence: 99%

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The use of implementation science theories, models, and frameworks in implementation research for medicinal products: a scoping review

Smith,

Gaglio,

Anatchkova

2023

Preprint

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Background: The uptake, adoption, and integration of new medicines and treatment regimens within healthcare delivery can take a decade or more. Increasingly, implementation science (IS) research is being used to bridge this gap between the availability of new therapeutic evidence and its actual application in clinical practice. Little is known, however, about the quality of IS research in this area, including the degree to which theories, models, and frameworks (TMFs) are being used. The objective of this study was to conduct a scoping review of the use of TMFs in implementation research involving medicinal products. Methods: A search was conducted for English language abstracts and manuscripts describing the application of TMFs in IS studies for medicinal products. Eligible publications were those published between January 1, 1974, and December 12, 2022. All records were screened at the title and abstract stage; included full-text papers were abstracted using data extraction tables designed for the study. Study quality was appraised using the Implementation Research Development Tool. Results: The initial scoping search identified 2,697 publications, of which nine were ultimately eligible for inclusion in the review. Most studies were published after 2020 and varied in their objectives, design, and therapeutic area. Most studies had sample sizes of fewer than 50 participants, and all focused on the post-marketing phase of drug development. The TMF most frequently used was the Consolidated Framework for Implementation Research (CFIR). Although most studies applied all TMF domains, TMF use was limited to instrument development and/or qualitative analysis. Quality appraisals indicated the need for engaging patients and other stakeholders in the implementation research, reporting on the cost of implementation strategies, and evaluating the unintended consequences of implementation efforts. Conclusions: We found that few IS studies involving medicinal products reported using TMFs. Those that did encompassed a wide variety of therapeutic indications and medicinal products; all were in the post-marketing phase and involved limited application of the TMF. Researchers should consider conducting IS in earlier phases of drug development and integrate the TMF throughout the research process. More consistent and in-depth use of TMFs may help advance research in this area.

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Section: Sample Size and Type Of Participantsmentioning

confidence: 99%

Section: Target Disease or Medical Conditionmentioning

confidence: 99%

Section: Use Of Implementation Tmfsmentioning

confidence: 99%

Section: Use Of Implementation Tmfsmentioning

confidence: 99%

Section: Use Of Implementation Tmfsmentioning

confidence: 99%

See 3 more Smart Citations

The use of implementation science theories, models, and frameworks in implementation research for medicinal products: a scoping review

Smith,

Gaglio,

Anatchkova

2023

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review

Smith,

Gaglio,

Anatchkova

2024

Health Res Policy Sys

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View full text Add to dashboard Cite

Background The uptake, adoption and integration of new medicines and treatment regimens within healthcare delivery can take a decade or more. Increasingly, implementation science (IS) research is being used to bridge this gap between the availability of new therapeutic evidence and its actual application in clinical practice. Little is known, however, about the quality of IS research in this area, including the degree to which theories, models and frameworks (TMFs) are being used. The objective of this study was to conduct a scoping review of the use of TMFs in implementation research involving medicinal products. Methods A search was conducted for English language abstracts and manuscripts describing the application of TMFs in IS studies for medicinal products. Eligible publications were those published between 1 January 1974 and 12 December 2022. All records were screened at the title and abstract stage; included full-text papers were abstracted using data extraction tables designed for the study. Study quality was appraised using the Implementation Research Development Tool. Results The initial scoping search identified 2697 publications, of which 9 were ultimately eligible for inclusion in the review. Most studies were published after 2020 and varied in their objectives, design and therapeutic area. Most studies had sample sizes of fewer than 50 participants, and all focused on the post-marketing phase of drug development. The TMF most frequently used was the Consolidated Framework for Implementation Research (CFIR). Although most studies applied all TMF domains, TMF use was limited to instrument development and/or qualitative analysis. Quality appraisals indicated the need for engaging patients and other stakeholders in the implementation research, reporting on the cost of implementation strategies, and evaluating the unintended consequences of implementation efforts. Conclusions We found that few IS studies involving medicinal products reported using TMFs. Those that did encompassed a wide variety of therapeutic indications and medicinal products; all were in the post-marketing phase and involved limited application of the TMFs. Researchers should consider conducting IS in earlier phases of drug development and integrating the TMFs throughout the research process. More consistent and in-depth use of TMFs may help advance research in this area.

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Use of Theory-Based Implementation Research to Evaluate Barriers and Facilitators to Implementation of a Novel Digital Inhaler Technology in Clinical Practice

Cited by 2 publications

References 0 publications

The use of implementation science theories, models, and frameworks in implementation research for medicinal products: a scoping review

The use of implementation science theories, models, and frameworks in implementation research for medicinal products: a scoping review

The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review

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