Practical Clinical Trials for Translating Research to Practice: Design and Measurement Recommendations
Abstract
RATIONALE: There is a pressing need for practical clinical trials (PCTs) that are more relevant to clinicians and decision-makers, but many are unaware of these trials. Furthermore, such trials can be challenging to conduct and to report. OBJECTIVE: The objective of this study was to build on the seminal paper by Tunis et al (Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624-1632.) and to provide recommendations and examples of how practical clinical trials can be conducted and the results reported to enhance external validity without sacrificing internal validity. KEY ISSUES: We discuss evaluating practical intervention options, alternative research designs, representativeness of samples participating at both the patient and the setting/clinician level, and the need for multiple outcomes to address clinical and policy implications. CONCLUSIONS: We provide a set of specific recommendations for issues to be reported in PCTs to increase their relevance to clinicians and policymakers, and to help reduce the gap between research and practice.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
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?
D&I research explicitly attends to external validity, whereas most randomized efficacy and effectiveness trials mainly emphasize internal validity.
“Dissemination and implementation research pays explicit (although not exclusive) attention to external validity, in contrast to the main emphasis on internal validity in most randomized efficacy and effectiveness trials (20, 48, 52).”
From An Overview of Research and Evaluation Designs for Dissemination and Implementation (2017) · cites this paper as [48]
Cites
The central role of the propensity score in observational studies for causal effects
ROSENBAUM, P. R., & RUBIN, D. B. (1983) · Biometrika · doi:10.1093/biomet/70.1.41 · Cited by 31,241 · see citing works
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
(2002) · New England Journal of Medicine · doi:10.1056/nejmoa012512 · Cited by 19,011 · see citing works
Methods for the Economic Evaluation of Health Care Programmes
Drummond, M. E., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. L. (2005) · doi:10.1093/oso/9780198529446.001.0001 · Cited by 13,648 · see citing works
Evaluating the public health impact of health promotion interventions: the RE-AIM framework.
Glasgow, R. E., Vogt, T. M., & Boles, S. M. (1999) · American Journal of Public Health · doi:10.2105/ajph.89.9.1322 · Cited by 7,217 · see citing works
Self-citationQuasi-experimentation: Design and analysis issues for field settings
Shrout, P. E. (1980) · Evaluation and Program Planning · doi:10.1016/0149-7189(80)90063-4 · Cited by 6,091 · see citing works
The quality of health care delivered to adults in the United States
McGlynn, E. A., Asch, S. M., Adams, J., Keesey, J., Hicks, J., DeCristofaro, A., & Kerr, E. A. (2003) · New England Journal of Medicine · doi:10.1056/nejmsa022615 · Cited by 5,079 · see citing works
Crossing the Quality Chasm: A New Health System for the 21st Century
Bloom, B. S. (2002) · JAMA · doi:10.1001/jama.287.5.646-a · Cited by 3,732 · see citing works
Moher, D. (2001) · JAMA · doi:10.1001/jama.285.15.1987 · Cited by 2,545 · see citing works
Lorig, K. R., Sobel, D. S., Stewart, A. L., Brown, B. W., Bandura, A., Ritter, P., Gonzalez, V. M., Laurent, D. D., & Holman, H. R. (1999) · Medical Care · doi:10.1097/00005650-199901000-00003 · Cited by 2,261 · see citing works
Disseminating Innovations in Health Care
Berwick, D. M. (2003) · JAMA · doi:10.1001/jama.289.15.1969 · Cited by 1,878 · see citing works
Glasgow, R. E., Lichtenstein, E., & Marcus, A. C. (2003) · American Journal of Public Health · doi:10.2105/ajph.93.8.1261 · Cited by 1,836 · see citing works
Self-citationThe Dependability of Behavioral Measurements: Theory of Generalizability for Scores and Profiles
Merrifield, P. R., Cronbach, L. J., Gleser, G. C., Nanda, H., & Rajaratnam, N. (1974) · American Educational Research Journal · doi:10.2307/1162145 · Cited by 1,819 · see citing works
Tunis (2003) · doi:10.1001/jama.290.12.1624 · Cited by 1,724 · see citing works
Evidence-Based Medicine: How to Practice and Teach EBM
Satya-Murti, S. (2000) · JAMA · doi:10.1001/jama.284.18.2382 · Cited by 1,659 · see citing works
Primary Care: Is There Enough Time for Prevention?
Yarnall, K. S. H., Pollak, K. I., Østbye, T., Krause, K. M., & Michener, J. L. (2003) · American Journal of Public Health · doi:10.2105/ajph.93.4.635 · Cited by 1,641 · see citing works
Single case experimental designs: Strategieṡ for studying behavior change
Matson, J. L. (1985) · Applied Research in Mental Retardation · doi:10.1016/0270-3092(85)90012-8 · Cited by 1,193 · see citing works
Recommendations for Reporting Cost-effectiveness Analyses
Siegel, J. E. (1996) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1996.03540160061034 · Cited by 1,147 · see citing works
Siegel, J. E. (1996) · JAMA · doi:10.1001/jama.276.16.1339 · Cited by 1,040 · see citing works
Users' Guides to the Medical Literature
McGinn, T. G., Guyatt, G., Wyer, P. C., Naylor, C. D., Stiell, I. G., Richardson, W. S., & for the Evidence-Based Medicine Working Group (2000) · JAMA · doi:10.1001/jama.284.1.79 · Cited by 1,009 · see citing works
Tactics of Scientific Research: Evaluating Experimental Data in Psychology
PETERS, H. N., & Sidman, M. (1961) · The American Journal of Psychology · doi:10.2307/1419766 · Cited by 982 · see citing works
Flay, B. R. (1986) · Preventive Medicine · doi:10.1016/0091-7435(86)90024-1 · Cited by 723 · see citing works
Glasgow, R. E., Klesges, L. M., Dzewaltowski, D. A., Bull, S. S., & Estabrooks, P. (2004) · Annals of Behavioral Medicine · doi:10.1207/s15324796abm2701_2 · Cited by 635 · see citing works
Self-citationMeinert, C. L. (1986) · DigitalGeorgetown (Georgetown University Library) · doi:10.1093/acprof:oso/9780195035681.001.0001 · Cited by 509 · see citing works
From Research to “Best Practices” in Other Settings and Populations
Green, L. W. (2001) · American Journal of Health Behavior · doi:10.5993/ajhb.25.3.2 · Cited by 407 · see citing works
Klesges, L. M., Estabrooks, P. A., Dzewaltowski, D. A., Bull, S. S., & Glasgow, R. E. (2005) · Annals of Behavioral Medicine · doi:10.1207/s15324796abm2902s_10 · Cited by 325 · see citing works
Self-citationCost-effectiveness of a routine varicella vaccination program for U.S. children
(1994) · The Journal of Pediatrics · doi:10.1016/s0022-3476(94)70148-2 · Cited by 306 · see citing works
Tactics of Scientific Research: Evaluating Experimental Data in Psychology
Senf, R. (1962) · American Journal of Psychiatry · doi:10.1176/ajp.118.8.763 · Cited by 294 · see citing works
Cost-effectiveness of a Routine Varicella Vaccination Program for US Children
Lieu, T. A. (1994) · JAMA · doi:10.1001/jama.1994.03510290057037 · Cited by 271 · see citing works
Relationship Between Modifiable Health Risks and Short-term Health Care Charges
Pronk, N. P. (1999) · JAMA · doi:10.1001/jama.282.23.2235 · Cited by 264 · see citing works
Avoiding Type III Errors in Health Education Program Evaluations: A Case Study
Basch, C. E., Sliepcevich, E. M., Gold, R. S., Duncan, D. F., & Kolbe, L. J. (1985) · Health Education Quarterly · doi:10.1177/109019818501200311 · Cited by 244 · see citing works
Cox, K. L., Burke, V., Gorely, T., Beilin, L. J., & Puddey, I. B. (2002) · Preventive Medicine · doi:10.1006/pmed.2002.1134 · Cited by 192 · see citing works
Behavior change intervention research in healthcare settings
Glasgow, R. E., Bull, S. S., Gillette, C., Klesges, L. M., & Dzewaltowski, D. A. (2002) · American Journal of Preventive Medicine · doi:10.1016/s0749-3797(02)00437-3 · Cited by 181 · see citing works
Self-citationPractice-Based Research Networks Answer Primary Care Questions
Nutting, P. A. (1999) · JAMA · doi:10.1001/jama.281.8.686 · Cited by 156 · see citing works
Lorig, K. R., Ritter, P. L., Laurent, D. D., & Fries, J. F. (2004) · Medical Care · doi:10.1097/01.mlr.0000118709.74348.65 · Cited by 151 · see citing works
The significance of quality of life in health care
Kaplan, R. M. (2003) · Quality of Life Research · doi:10.1023/a:1023547632545 · Cited by 140 · see citing works
Stange, K. C., Woolf, S. H., & Gjeltema, K. (2002) · American Journal of Preventive Medicine · doi:10.1016/s0749-3797(02)00413-0 · Cited by 138 · see citing works
Translating Research to Practice
Glasgow, R. E. (2003) · Diabetes Care · doi:10.2337/diacare.26.8.2451 · Cited by 132 · see citing works
Self-citationA brief smoking cessation intervention for women in low-income planned parenthood clinics
Glasgow, R. E., Whitlock, E. P., Eakin, E., & Lichtenstein, E. (2000) · American Journal of Public Health · doi:10.2105/ajph.90.5.786 · Cited by 107 · see citing works
Self-citationCost-Effectiveness of a Hospital-Based Smoking Cessation Intervention
Meenan, R. T., Stevens, V. J., Hornbrook, M. C., Chance, P.-A. L., Glasgow, R. E., Hollis, J. F., Lichtenstein, E. H., & VOGT, T. M. (1998) · Medical Care · doi:10.1097/00005650-199805000-00007 · Cited by 100 · see citing works
Self-citationGlasgow, R. E., Toobert, D. J., Hampson, S. E., & Strycker, L. A. (2002) · Patient Education and Counseling · doi:10.1016/s0738-3991(02)00025-3 · Cited by 97 · see citing works
Self-citationHealth Care Costs among Smokers, Former Smokers, and Never Smokers in an HMO
Fishman, P. A., Khan, Z., Thompson, E., & Curry, S. J. (2003) · Health Services Research · doi:10.1111/1475-6773.00142 · Cited by 87 · see citing works
Take Heart II: Replication of a Worksite Health Promotion Trial
Glasgow, R. E., Terborg, J. R., Strycker, L. A., et al. (1997) · Journal of Behavioral Medicine · doi:10.1023/a:1025578627362 · Cited by 57 · see citing works
Self-citationSample size calculation in economic evaluations
Al, M., van Hout, B. A., Michel, B. C., & Rutten, F. (1998) · Health Economics · doi:10.1002/(sici)1099-1050(199806)7:4 · Cited by 56 · see citing works
Quality of Life in Behavioral Medicine Research
de Leon, C. F. M. (1996) · Psychosomatic Medicine · doi:10.1097/00006842-199609000-00017 · Cited by 44 · see citing works
Quality of Life in Behavioral Medicine Research
Dimsdale, J. E., Baum, A., & Baum, A. S. (2013) · Psychology Press eBooks · doi:10.4324/9781315827438 · Cited by 31 · see citing works
Developing and Evaluating a Cardiovascular Risk Reduction Project.
Brownson, R. C., Mayer, J. P., Dusseault, P., Dabney, S., Wright, K., Jackson‐Thompson, J., Malone, B., & Goodman, R. (1997) · American Journal of Health Behavior · Cited by 24 · see citing works
Janisse, T., & Vuckovic, N. H. (2002) · Europe PMC (PubMed Central) · Cited by 8 · see citing works
Beck, A. L., Breth, G., Ellis, J. L., et al. (2002) · Europe PMC (PubMed Central) · Cited by 1 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Palinkas, L. A., Horwitz, S. M., Green, C. A., Wisdom, J. P., Duan, N., & Hoagwood, K. (2015) · Administration and Policy in Mental Health and Mental Health Services Research · doi:10.1007/s10488-013-0528-y · Cited by 12,038 · see citing works
“While RCT designs provide the highest level of evidence, ''in many clinical and community settings, and especially in studies with underserved populations and low resource settings, randomization may not be feasible or acceptable'' (Glasgow et al. 2005, p. 554).”
BackgroundImproving the reporting of pragmatic trials: An extension of the CONSORT statement
Zwarenstein, M., Treweek, S., Gagnier, J. J., Altman, D. G., Tunis, S., Haynes, B., Oxman, A. D., Moher, D., & groups, F. T. C. A. P. T. I. H. (. (2008) · BMJ · doi:10.1136/bmj.a2390 · Cited by 1,813 · see citing works
Generalization in quantitative and qualitative research: Myths and strategies
Polit, D. F., & Beck, C. T. (2010) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2010.06.004 · Cited by 1,767 · see citing works
How Can We Increase Translation of Research into Practice? Types of Evidence Needed
Glasgow, R. E., & Emmons, K. M. (2007) · Annual Review of Public Health · doi:10.1146/annurev.publhealth.28.021406.144145 · Cited by 1,050 · see citing works
Self-citationA pragmatic view on pragmatic trials
Patsopoulos, N. A. (2011) · Dialogues in Clinical Neuroscience · doi:10.31887/dcns.2011.13.2/npatsopoulos · Cited by 844 · see citing works
Jack, C. R., Knopman, D. S., Weigand, S. D., Wiste, H. J., Vemuri, P., Lowe, V., Kantarci, K., Gunter, J. L., Senjem, M. L., Ivnik, R. J., et al. (2012) · Annals of Neurology · doi:10.1002/ana.22628 · Cited by 602 · see citing works
Glasgow, R. E. (2006) · Health Education Research · doi:10.1093/her/cyl081 · Cited by 565 · see citing works
Self-citationAn Overview of Research and Evaluation Designs for Dissemination and Implementation
Brown, C. H., Curran, G., Palinkas, L. A., Aarons, G. A., Wells, K. B., Jones, L., Collins, L. M., Duan, N., Mittman, B. S., Wallace, A., et al. (2017) · Annual Review of Public Health · doi:10.1146/annurev-publhealth-031816-044215 · Cited by 509 · see citing works
A Proposal to Speed Translation of Healthcare Research Into Practice
Kessler, R., & Glasgow, R. E. (2011) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2011.02.023 · Cited by 376 · see citing works
Self-citationGlasgow, R. E., & Riley, W. T. (2013) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2013.03.010 · Cited by 318 · see citing works
Self-citationDeveloping Robust, Sustainable, Implementation Systems Using Rigorous, Rapid and Relevant Science
Glasgow, R. E., & Chambers, D. (2012) · Clinical and Translational Science · doi:10.1111/j.1752-8062.2011.00383.x · Cited by 278 · see citing works
Self-citationRapid, responsive, relevant (R3) research: a call for a rapid learning health research enterprise
Riley, W. T., Glasgow, R. E., Etheredge, L., & Abernethy, A. P. (2013) · Clinical and Translational Medicine · doi:10.1186/2001-1326-2-10 · Cited by 267 · see citing works
Self-citationHurley, M. V., Walsh, N. E., Mitchell, H. L., Pimm, T. J., Patel, A., Williamson, E., Jones, R. H., Dieppe, P. A., & Reeves, B. C. (2007) · Arthritis Care & Research · doi:10.1002/art.22995 · Cited by 262 · see citing works
Translating what we have learned into practice
Glasgow, R. E., Goldstein, M. G., Ockene, J. K., & Pronk, N. P. (2004) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2004.04.019 · Cited by 239 · see citing works
Self-citationEngagement in a Diabetes Self-management Website: Usage Patterns and Generalizability of Program Use
Glasgow, R. E., Christiansen, S. M., Kurz, D., King, D. K., Woolley, T., Faber, A. J., Estabrooks, P. A., Strycker, L., Toobert, D., & Dickman, J. (2011) · Journal of Medical Internet Research · doi:10.2196/jmir.1391 · Cited by 219 · see citing works
Self-citationCosting behavioral interventions: a practical guide to enhance translation
Ritzwoller, D. P., Sukhanova, A., Gaglio, B., & Glasgow, R. E. (2009) · Annals of Behavioral Medicine · doi:10.1007/s12160-009-9088-5 · Cited by 130 · see citing works
Self-citationA thematic analysis of theoretical models for translational science in nursing: Mapping the field
Mitchell, S. A., Fisher, C. A., Hastings, C. E., Silverman, L. B., & Wallen, G. R. (2010) · Nursing Outlook · doi:10.1016/j.outlook.2010.07.001 · Cited by 138 · see citing works
The 5 R's: An Emerging Bold Standard for Conducting Relevant Research in a Changing World
Peek, C. J., Glasgow, R. E., Stange, K. C., Klesges, L. M., Purcell, E. P., & Kessler, R. S. (2014) · The Annals of Family Medicine · doi:10.1370/afm.1688 · Cited by 108 · see citing works
Self-citationBrown, C. H., Chamberlain, P., Saldana, L., Padgett, C., Wang, W., & Cruden, G. (2014) · Implementation Science · doi:10.1186/s13012-014-0134-8 · Cited by 89 · see citing works
Computer-based and online therapy for depression and anxiety in children and adolescents
Stasiak, K., Fleming, T., Lucassen, M. F. G., Shepherd, M. J., Whittaker, R., & Merry, S. N. (2016) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2015.0029 · Cited by 87 · see citing works
“We may need to change the way in which we collect evidence, to reduce the lag between program development and implementation (Glasgow et al. 2005).”
Sohanpal, R., Hooper, R., Hames, R., Priebe, S., & Taylor, S. (2012) · Systematic Reviews · doi:10.1186/2046-4053-1-66 · Cited by 51 · see citing works
Glasgow, R. E., Strycker, L. A., Kurz, D., Faber, A., Bell, H., Dickman, J. M., Halterman, E., Estabrooks, P. A., & Osuna, D. (2010) · Annals of Behavioral Medicine · doi:10.1007/s12160-010-9189-1 · Cited by 60 · see citing works
Self-citationTranslating effective web-based self-help for problem drinking into the real world
Riper, H., Kramer, J., Conijn, B., Smit, F., Schippers, G., & Cuijpers, P. (2009) · Alcoholism Clinical and Experimental Research · doi:10.1111/j.1530-0277.2009.00970.x · Cited by 50 · see citing works
Critical Measurement Issues in Translational Research
Glasgow, R. E. (2009) · Research on Social Work Practice · doi:10.1177/1049731509335497 · Cited by 42 · see citing works
Self-citationRitzwoller, D. P., Sukhanova, A. S., Glasgow, R. E., Strycker, L. A., King, D. K., Gaglio, B., & Toobert, D. J. (2011) · Translational Behavioral Medicine · doi:10.1007/s13142-011-0037-z · Cited by 40 · see citing works
Self-citationInteractive media for diabetes self-management: issues in maximizing public health impact
Glasgow, R. E. (2010) · Medical Decision Making · doi:10.1177/0272989x10385845 · Cited by 38 · see citing works
Self-citationSearching for maintenance in exercise interventions for cancer survivors
Jankowski, C. M., Ory, M. G., Friedman, D. B., Dwyer, A., Birken, S. A., & Risendal, B. (2014) · Journal of Cancer Survivorship · doi:10.1007/s11764-014-0386-y · Cited by 36 · see citing works
How can primary care cross the quality chasm?
Solberg, L. I., Elward, K. S., Phillips, W. R., Gill, J. M., Swanson, G., Main, D. S., Yawn, B. P., Mold, J. W., Phillips, R. L., & for the Napcrg Committee on Advancing the Science of Family Medicine (2009) · The Annals of Family Medicine · doi:10.1370/afm.951 · Cited by 24 · see citing works
Palinkas, L. A., Holloway, I. W., Rice, E., Brown, C. H., Valente, T. W., & Chamberlain, P. (2013) · Implementation Science · doi:10.1186/1748-5908-8-133 · Cited by 20 · see citing works
Addicted to discovery: Does the quest for new knowledge hinder practice improvement?
Perl, H. I. (2011) · Addictive Behaviors · doi:10.1016/j.addbeh.2011.01.027 · Cited by 15 · see citing works
A Community-Based Partnership to Promote Exercise Among Cancer Survivors: Lessons Learned
Pinto, B. M., Waldemore, M., & Rosen, R. (2015) · International Journal of Behavioral Medicine · doi:10.1007/s12529-014-9395-5 · Cited by 13 · see citing works
- Authors
- Glasgow, R. E., Magid, D. J., Beck, A., Ritzwoller, D., & Estabrooks, P. A.
- Affiliations
- Kaiser Permanente (US)
- Venue
- Medical Care
- Published
- 2005-06
- Volume
- 43
- Issue
- 6
- Pages
- 551-557
- ISSN
- 0025-7079 (ISSN-L)
- OpenAlex
- W2079257641
- Cited by
- 308
- References
- 49
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 4 · 2023: 8 · 2022: 2 · 2021: 6 · 2020: 10 · 2019: 14 · 2018: 7 · 2017: 13 · 2016: 8 · 2015: 18 · 2014: 25 · 2013: 22 · 2012: 27
- FWCI
- 45.59
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Medical Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Kaiser Permanente
- Agency for Healthcare Research and Quality (HS-10123)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- research-practice gap, generalizability, internal validity, research design, sample representativeness, multiple outcomes, clinical decision-making, health policy
- MeSH terms
- Clinical Trials as Topic, Decision Making, Humans, Research Design, Reproducibility of Results, Randomized Controlled Trials as Topic, Treatment Outcome, Evidence-Based Medicine
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
