Cited by 3,922Health Policy Implementation ScienceDiabetes Management and EducationHealth Sciences Research and Education

How we design feasibility studies

Open access
Bowen, Deborah J., Kreuter, Matthew, Spring, Bonnie, Cofta-Woerpel, Ludmila, Linnan, Laura, Weiner, Diane, Bakken, Suzanne, Kaplan, Cecilia Patrick +3 more·2009·American Journal of Preventive Medicine

Abstract

Public health is moving toward the goal of implementing evidence-based interventions. To accomplish this, there is a need to select, adapt, and evaluate intervention studies. Such selection relies, in part, on making judgments about the feasibility of possible interventions and determining whether comprehensive and multilevel evaluations are justified. There exist few published standards and guides to aid these judgments. This article describes the diverse types of feasibility studies conducted in the field of cancer prevention, using a group of recently funded grants from the National Cancer Institute. The grants were submitted in response to a request for applications proposing research to identify feasible interventions for increasing the utilization of the Cancer Information Service among underserved populations.

Integrity signals

Registry

Crossref · 10.1016/j.amepre.2009.02.002

Cites

12 of 12 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 1 cited sources checked · 0 supported · 0 flagged

  • Interpretationnone given

    Deriving an effect-size estimate for the treatment is a major feasibility issue before a full evaluation trial is mounted.

    “A major feasibility issue that precedes the mounting of a full evaluation trial is the need to derive an effect-size estimate for the treatment.”
    Quote in the paperSubstantial claim
  • Interpretationreasoning

    A cohort feasibility study, relative to a case-control design, can establish the timing and direction of effects.

    “The advantage of the cohort design, compared to the case-control design, is that it establishes the timing and directionality of effects.”
    Quote in the paperSubstantial claim
  • Interpretationreasoning

    Phase-I/II feasibility trials usually use an RCT because it provides the greatest internal validity and maximizes confidence that outcome changes are causally attributable to treatment.

    “Usually the design is an RCT because that study design affords the greatest internal validity (i.e., it maximizes confidence that changes in outcomes can be attributed causally to the treatment).”
    Quote in the paperSubstantial claim
  • Interpretationreasoning

    Compared with an RCT, a cohort study's main weakness is that treatment is not randomly assigned, so outcome differences may reflect pre-existing differences in participants or circumstances rather than the intervention.

    “Compared to an RCT, the cohort study’s main disadvantage is that participants are not assigned randomly to treatment. Thus, their outcomes may differ not because of the intervention but because the participants or their circumstances were inherently different from the outset.”
    Quote in the paperNot a substantial claim
  • Interpretationreasoning

    The tight control of efficacy research makes causal inference more feasible from the designs used, which are often randomized trials.

    “The highly controlled nature of efficacy research is good in that it is likely more possible to draw causal inferences from the designs used (often randomized trials).”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 8
  • May combine two claims. 2
  • Classified as probably not a substantial claim.

    Interpretationreasoning

    Small-scale experiments can efficiently test safety, optimal dose, and treatment sequencing before a full-scale clinical trial begins.

    “Questions about safety; optimal dose (treatment intensity, frequency, duration); and the sequencing of treatment all can be tested efficiently in experiments before the launching of a full-scale clinical trial.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Premisecitation

    Green and Glasgow noted a mismatch between growing demands for evidence-based practice and the fact that most evidence-based recommendations for behavioral interventions come from tightly controlled efficacy trials.

    “Green and Glasgow9 have pointed out the incongruity between increasing demands for evidence-based practice and the fact that most evidence-based recommendations for behavioral interventions are derived from highly controlled efficacy trials.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Green and Glasgow9

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Interpretationnone given

    Experiments offer a time- and cost-effective method for testing whether an intervention could work.

    “Second, experiments afford a very time- and cost-effective means of testing whether an intervention could work.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationreasoning

    An emphasis on internal validity in efficacy research can lower external relevance and generalizability, which can restrict dissemination.

    “But this focus on internal validity can reduce external relevance, and generalizability can decrease, limiting dissemination.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S4 (based).

    Premisenone given

    Resource limits mean that not every intervention can be evaluated for both efficacy and effectiveness.

    “Clearly, because of resource constraints, not all interventions can be tested for both efficacy and effectiveness.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    Cohort studies require follow-up and therefore take longer to finish.

    “The disadvantage is that the need for follow-up means that cohort studies take longer to complete.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    Feasibility questions about new treatment-delivery channels are typically first addressed with qualitative interviews and surveys, then experimentation.

    “Usually, these feasibility questions and others will be addressed initially through qualitative interviewing and surveys, followed by experimentation.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    Experimental feasibility studies have comparatively limited external validity.

    “The drawback of experimental feasibility studies is that they have relatively limited external validity.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    Phase-I/II trials generally have smaller samples than full Phase-III efficacy/effectiveness trials.

    “Typically, the Phase-I or -II trial entails a smaller sample size than a full Phase-III efficacy/effectiveness trial.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationreasoning

    Experiments allow random or unbiased assignment to intervention conditions, so a comparison with an unbiased control from the same population is possible.

    “First, experiments permit random or unbiased assignment to intervention conditions. Therefore, some comparison to an unbiased control from the same population is available.”
    Quote in the paperNot a substantial claim
10 of 10
  • The paper relies on this without support.

    Published standards and guides for judging feasibility and for designing and evaluating feasibility studies are lacking.

    “There exist few published standards and guides to aid these judgments.”
    “The published literature does not propose standards to guide the design and evaluation of feasibility studies.”
  • The paper relies on this without support.

    Feasibility studies are expected to yield findings that inform decisions about recommending an intervention for efficacy testing.

    “Feasibility studies are relied on to produce a set of findings that help determine whether an intervention should be recommended for efficacy testing.”
  • The paper relies on this without support.

    Feasibility studies help decide if an intervention merits further testing and if the underlying ideas and results can be made relevant and sustainable.

    “Feasibility studies are used to determine whether an intervention is appropriate for further testing; in other words, they enable researchers to assess whether or not the ideas and findings can be shaped to be relevant and sustainable.”
  • The authors state this as an assumption.

    Which design is best varies with the chosen focus, both in feasibility work and in other research.

    “The choice of an optimal research design depends upon the selected area of focus. This premise holds equally for feasibility studies and for other kinds of research.”
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?

  • Non-hybrid pilot implementation studies typically occur when the effectiveness of a clinical or public health intervention is well established, but robust strategies to promote its broader uptake and integration into clinical or public health services remain untested.

    “Non-hybrid pilot implementation studies are undertaken in the absence of a broader effectiveness trial. Such studies typically occur when the effectiveness of a clinical or public health intervention is well established, but robust strategies to promote its broader uptake and integration into clinical or public health services remain untested [15].”

    From Guidance for conducting feasibility and pilot studies for implementation trials (2020) · cites this paper as [15]

    The “Will It Work?” section (page unavailable) says that, ideally, an intervention has shown efficacy and effectiveness before broad implementation, when feasibility questions about dissemination and integration arise. The “Appropriate Areas of Focus” section (page unavailable) also identifies implementation and integration as subjects of feasibility research. The paper does not establish that non-hybrid pilot implementation studies typically occur at this stage or that robust uptake strategies remain untested. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • The field of implementation science has identified the need for nuanced guidance because of differences between implementation trials and conventional clinical or public health efficacy trials.

    “However, given the differences between implementation trials and conventional clinical or public health efficacy trials, the field of implementation science has identified the need for nuanced guidance [14–16, 19, 20].”

    From Guidance for conducting feasibility and pilot studies for implementation trials (2020) · cites this paper as [15]

    The Introduction says guidance and standards for feasibility studies are needed, and “Relating to the Real World” contrasts highly controlled efficacy trials with research suited to practice settings. The paper does not specifically identify a need for guidance on implementation trials as distinct from conventional efficacy trials. Page numbers are unavailable in our copy. (LLM, conf=0.85)

    Experimental — accuracy not yet measured
  • In implementation research, feasibility and pilot studies focus on developing or refining implementation strategies, refining research methods for an implementation intervention trial, or undertaking preliminary testing of implementation strategies.

    “In implementation research, feasibility and pilot studies perform the same functions as those for intervention trials, however with a focus on developing or refining implementation strategies, refining research methods for an implementation intervention trial, or undertake preliminary testing of implementation strategies [14, 15].”

    From Guidance for conducting feasibility and pilot studies for implementation trials (2020) · cites this paper as [15]

    The Employing Feasibility Studies section says these studies can refine research methods and protocols, and Does It Work? describes small-scale testing before a full intervention trial. Will It Work? discusses feasibility questions during implementation, but the paper does not specifically describe developing or preliminarily testing implementation strategies for an implementation intervention trial. Page numbers were not available in our copy. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • Implementation trials are more pragmatic than conventional clinical or public health efficacy trials.

    “In addition, where conventional clinical or public health efficacy trials are typically conducted under controlled conditions and directed mostly by researchers, implementation trials are more pragmatic [15].”

    From Guidance for conducting feasibility and pilot studies for implementation trials (2020) · cites this paper as [15]

    “Relating to the Real World” describes efficacy trials as highly controlled and calls for studies that test interventions under community constraints. “Will It Work?” discusses implementation in diverse practice systems. The paper does not explicitly compare implementation trials with efficacy trials or say that efficacy trials are directed mostly by researchers. Page numbers were not available in our copy. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • Although guidance for implementation trials has recently been standardised, information on conducting feasibility and pilot studies for implementation interventions remains limited, potentially contributing to a lack of exploratory work and a limited evidence base for effective implementation intervention design and conduct.

    “Although there have been many recent developments in the standardisation of guidance for implementation trials, information on the conduct of feasibility and pilot studies for implementation interventions remains limited, potentially contributing to a lack of exploratory work in this area and a limited evidence base to inform effective implementation intervention design and conduct [15].”

    From Guidance for conducting feasibility and pilot studies for implementation trials (2020) · cites this paper as [15]

    Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

Cites

Flagged first, then by citations

3 of the 15 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. Green, 1994, Study of participatory research in health promotion: review and recommendations for the development of participatory research in health promotion in Canada

Cited by

Sorted by citations

Authors
Bowen, D. J., Kreuter, M., Spring, B., Cofta-Woerpel, L., Linnan, L., Weiner, D., Bakken, S., Kaplan, C. P., Squiers, L., Fabrizio, C., & Fernandez, M.
Affiliations
  • Boston University (US)
  • Saint Louis University (US)
  • Northwestern University (US)
  • The University of Texas MD Anderson Cancer Center (US)
  • Mashantucket Pequot Tribal Nation (US)
  • Columbia University (US)
  • University of California, San Francisco (US)
  • National Institutes of Health (US)
  • Yale Cancer Center (US)
Corresponding author
Bowen, Deborah J.
Venue
American Journal of Preventive Medicine
Publisher
Elsevier BV
Published
2009-05
Volume
36
Issue
5
Pages
452-457
ISSN
0749-3797 (ISSN-L)
OpenAlex
W2014261733
Cited by
3,922
References
15
Citations by year
2026: 368 · 2025: 441 · 2024: 438 · 2023: 435 · 2022: 404 · 2021: 353 · 2020: 317 · 2019: 229 · 2018: 220 · 2017: 168 · 2016: 111 · 2015: 91 · 2014: 69 · 2013: 20 · 2012: 16
FWCI
18.14
Type
journal article
Language
en
Open access
Locations
  • American Journal of Preventive Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion)
  • The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
Keywords
feasibility study, cancer prevention, evidence-based interventions, intervention selection, multi-level evaluation, cancer information services, underserved populations
MeSH terms
Feasibility Studies, Financing, Government, Humans, Medically Underserved Area, Neoplasms, Preventive Medicine, Public Health

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