Cited by 405Health Policy Implementation ScienceHealth Sciences Research and EducationClinical practice guidelines implementation

The DOI matches its Crossref record; 89 of the 91 references it cites were found in a registry or an index; 4 of the 62 sources its claims cite were checked for support.

“Scaling-out” evidence-based interventions to new populations or new health care delivery systems

Open access

Abstract

BACKGROUND: Implementing treatments and interventions with demonstrated effectiveness is critical for improving patient health outcomes at a reduced cost. When an evidence-based intervention (EBI) is implemented with fidelity in a setting that is very similar to the setting wherein it was previously found to be effective, it is reasonable to anticipate similar benefits of that EBI. However, one goal of implementation science is to expand the use of EBIs as broadly as is feasible and appropriate in order to foster the greatest public health impact. When implementing an EBI in a novel setting, or targeting novel populations, one must consider whether there is sufficient justification that the EBI would have similar benefits to those found in earlier trials. DISCUSSION: In this paper, we introduce a new concept for implementation called "scaling-out" when EBIs are adapted either to new populations or new delivery systems, or both. Using existing external validity theories and multilevel mediation modeling, we provide a logical framework for determining what new empirical evidence is required for an intervention to retain its evidence-based standard in this new context. The motivating questions are whether scale-out can reasonably be expected to produce population-level effectiveness as found in previous studies, and what additional empirical evaluations would be necessary to test for this short of an entirely new effectiveness trial. We present evaluation options for assessing whether scaling-out results in the ultimate health outcome of interest. CONCLUSION: In scaling to health or service delivery systems or population/community contexts that are different from the setting where the EBI was originally tested, there are situations where a shorter timeframe of translation is possible. We argue that implementation of an EBI in a moderately different setting or with a different population can sometimes "borrow strength" from evidence of impact in a prior effectiveness trial. The collection of additional empirical data is deemed necessary by the nature and degree of adaptations to the EBI and the context. Our argument in this paper is conceptual, and we propose formal empirical tests of mediational equivalence in a follow-up paper.

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

This conceptual paper introduces “scaling-out” as the deliberate implementation, testing, improvement, and sustainment of evidence-based interventions (EBIs) in new populations and/or new delivery systems. It argues that under some conditions, scale-out can “borrow strength” from prior effectiveness trials if core elements, mechanisms, and mediational pathways are retained or empirically tested.

Key findings

  • The paper defines three scale-out types: Type I (population fixed, different delivery system), Type II (delivery system fixed, different population), and Type III (different population and delivery system); it focuses mainly on Types I and II.
  • It proposes that EBIs in moderately different settings or populations can sometimes borrow strength from prior effectiveness evidence, with additional empirical data needed depending on the nature and degree of adaptations; this requires retaining core elements, preserving mechanisms of action, ensuring sufficient organizational/system support, and testing “mediational equivalence.”
  • It outlines four levels of evidence for scale-out evaluations, from level 0 (minimal or no new empirical evidence) to level 3 (full randomized hybrid trial), mapped to RE-AIM domains; Table 3 gives typical evaluation levels by whether population and delivery system are same or different.
  • Examples include PrEP, where adherence reduced HIV risk by close to 90% in trials, but CDC guidelines did not recommend PrEP for at-risk adolescents due to lack of efficacy/safety evidence; adolescents aged 13–19 accounted for 4% of new HIV diagnoses in 2015. SafeCare was scaled out in one US county with population 3.2 million using an interagency collaborative team.

Methods

  • Conceptual/theoretical paper; no empirical sample, data collection, or primary analysis.
  • Uses external validity theories (Cook’s proximal similarity and heterogeneous irrelevancies), multilevel mediation modeling, RE-AIM, and implementation frameworks including EPIS, the Dynamic Sustainability Framework, and CFIR.
  • Develops a logical framework, tables of scale-out types, four evidence levels, and a sequential mediation schematic; formal statistical tests of mediational equivalence are deferred to a follow-up paper.

Limitations

  • The paper states its argument is conceptual and that formal empirical tests of mediational equivalence are proposed in a follow-up paper.
  • It states that details remain unanswered regarding how best to assess changes in complex implementation systems, and that rigorous non-inferiority statistical methods require additional development.
  • Evident from the text: the proposed framework and evidence levels are not empirically validated here; Type III scale-out is only mentioned and not developed; examples are illustrative rather than evaluated.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1186/s13012-017-0640-6

Cites

89 of 89 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Figures

Fig. 1 Schematic of scaling-out and implementation and effectiveness domains for evaluation
Fig. 1 Schematic of scaling-out and implementation and effectiveness domains for evaluationCC BY · PubMed Central

Verification

Claims the paper makes

34 Not checked yet · 34 Own interpretation · 2 Partly supported · 2 No basis given · accuracy not yet measured

Verify all 58 references — free account

Show all 30 claims

  • Probably not a substantial claim. 33
  • It may state two separate claims as one. 15
42 of 42
  • The paper relies on this without support.

    Adolescents aged 13–19 who engage in risky sexual behavior and/or injection drugs are at increased risk of HIV infection and accounted for 4% of new HIV diagnoses in 2015.

    “However, adolescents between the ages of 13–19 who engage in risky sexual behavior and/or injection drugs are also at increased risk of HIV infection, and accounted for 4% of new HIV diagnoses in 2015.”
  • The authors state this as an assumption.

    The conceptual theory of mediation holds in a scaled-out adaptation.

    “Assuming the conceptual theory of mediation holds in a scaled-out adaptation, relying on Cook’s principles of heterogeneous irrelevancies and proximal similarity, then we could assess impact on the mediating variable using a level 1 design for assessing a proxy outcome.”
  • The authors state this as an assumption.

    The new implementation will follow in the same footsteps as the previous intervention did when it produced findings of health impact.

    “Level 0 depends almost exclusively on the assumption that the new implementation will follow in the same footsteps as the previous intervention did when it produced findings of health impact.”
  • The paper relies on this without support.

    Overly strict intervention fidelity may be at odds with effective implementation of EBIs in real-world practice settings outside highly controlled efficacy trials.

    “However, there is mounting evidence that overly strict intervention fidelity may be at odds with effective implementation of EBIs in real-world practice settings (i.e., outside of highly controlled efficacy trials), thus, raising concern about the balance between delivering EBIs with fidelity and making adaptations believed to be necessary for usual care contexts.”
4 of 4

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Show all 91 references

Research works printed but not linked: 3

  1. Institute of Medicine. National Research Council: preventing mental, emotional, and behavioral disorders among young people: progress and possibilities. Washington, DC: The National Academies Press; 2009.
  2. U.S. Public Health Service. In: Services USDoHaH, editor. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014: a clinical practice guideline. Atlanta: Centers for Disease Control and Prevention; 2014.
  3. MacKinnon DP. Introduction to statistical mediation analysis. Mahwah, NJ: Lawrence Erlbaum Associates; 2008.

Cited by

Sorted by citations

Items 401–405 of 405

Metadata

Authors
Aarons, G. A., Sklar, M., Mustanski, B., Benbow, N., & Brown, C. H.
Affiliations
  • University of California San Diego (US)
  • Brown University (US)
  • Northwestern University (US)
Corresponding author
Aarons, Gregory A.
Venue
Implementation Science
Published
2017-09-06
Volume
12
Issue
1
Pages
111-111
ISSN
1748-5908 (ISSN-L)
OpenAlex
W2751779860
Cited by
399
References
91
Citations by year
2026: 25 · 2025: 52 · 2024: 41 · 2023: 41 · 2022: 56 · 2021: 66 · 2020: 51 · 2019: 51 · 2018: 16
FWCI
5.69
Type
journal article
Language
en
Open access
Locations
  • Implementation Science (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • eScholarship (California Digital Library) (submittedVersion)
  • eScholarship (California Digital Library) (submittedVersion, cc-by)
Funders
  • National Institute on Drug Abuse (P30DA027828, R01DA038466)
  • National Institute of Mental Health (R01MH072961, R01MH092950)
  • Agency for Healthcare Research and Quality (F32HS024192)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
horizontal scaling, evidence-based interventions, generalizability, intervention adaptation, health care delivery systems, multilevel mediation, implementation fidelity, intervention generalizability
MeSH terms
Delivery of Health Care, Health Plan Implementation, Humans, Evidence-Based Medicine

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