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Experimental and quasi-experimental designs in implementation research
Open accessAbstract
Implementation science is focused on maximizing the adoption, appropriate use, and sustainability of effective clinical practices in real world clinical settings. Many implementation science questions can be feasibly answered by fully experimental designs, typically in the form of randomized controlled trials (RCTs). Implementation-focused RCTs, however, usually differ from traditional efficacy- or effectiveness-oriented RCTs on key parameters. Other implementation science questions are more suited to quasi-experimental designs, which are intended to estimate the effect of an intervention in the absence of randomization. These designs include pre-post designs with a non-equivalent control group, interrupted time series (ITS), and stepped wedges, the last of which require all participants to receive the intervention, but in a staggered fashion. In this article we review the use of experimental designs in implementation science, including recent methodological advances for implementation studies. We also review the use of quasi-experimental designs in implementation science, and discuss the strengths and weaknesses of these approaches. This article is therefore meant to be a practical guide for researchers who are interested in selecting the most appropriate study design to answer relevant implementation science questions, and thereby increase the rate at which effective clinical practices are adopted, spread, and sustained.
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“Quasiexperiments are appropriate for practical situations and ethical compliance for studies involving vulnerable participants such as older adults, 17 and allow scholars to conduct rigorous studies under certain limitations and non-control conditions. 18”
From Mixed reality technology for older adults: Evaluating the impact of a novel virtual humanoid coach in a community-based physical exercise program in the Philippines (2024) · cites this paper as [18]
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“However, quasi-experiments offer practicality and external validity, while RCTs provide strong internal validity but may be resource-intensive and less applicable to real-world contexts (Miller et al. 2020).”
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“The type in this research is included in the true experimental design with pretest-post-test control group design (Miller et al., 2020).”
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“The qualitative aproach is chosen because it allows for a deep exploration of the learning process and students' experiences in a natural setting (Hamilton & Finley, 2019; Jan et al., 2023; Miller et al., 2020).”
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MethodThe role of implementation science in improving epilepsy surgery utilization
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“In analyzing the data, the researcher first tested the normality of the data distribution using the Ala-mogordo Smirnoff test, and obtained results that the variables of knowledge, attitude, and behavior were normally distributed (p > 0.05), (Miller et al., 2020).”
InfluentialJawhar, D. S., Khan, A. H., Alam, K., & Ahmad, R. (2025) · Research in Social and Administrative Pharmacy · doi:10.1016/j.sapharm.2025.11.002 · Cited by 5
Kurniawan, H. E., Saputro, S., Suranto, S., & Ramli, M. (2025) · Journal of Baltic Science Education · doi:10.33225/jbse/25.24.935 · Cited by 3
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“The study's implementation employed a quasi-experimental design, as randomization was not feasible due to limitations in the school setting (Miller et al., 2020).”
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“…experimental designs in nursing research can help generate credible evidence about effectiveness and ef fi cacy of new procedures and processes, offering an evidence base upon which health-care practitioners can con fi dently base their clinical decisions (Miller et al., 2020; Siedlecki, 2020).”
The impact of the case-based learning model and learning motivation on learning outcomes
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“The design employed in this study is a non-equivalent control group design, where the treatment and comparison groups are not randomly assigned but share similar characteristics (Miller et al., 2020).”
Knapp, A., O’Brien, J., Cruz, M., Walker, M. E., Kawchuk, J., Brons, C., & Valiani, S. (2025) · Palliative Medicine Reports · doi:10.1089/pmr.2024.0091 · Cited by 1
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Exploration of the implementation of project-based learning in technical drawing courses toward
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“After the instructional period, a test will be administered to both groups (Miller et al., 2020).”
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“This unique feature stems from their inherent ability to achieve similarity between treatment and control subjects in terms of both measured and unmeasured characteristics [4–7].”
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“For this, the value greater than or equal to 40 determines gazing to the right (head right), while gazing to the left A quantitative methodological approach has been chosen with a quasi-experimental (Miller et al., 2020) and case study design Participants Four participants Age of Participants.”
Husseini, A. E., El-Aziz, W. A. A., Sanad, M., & Seada, A. A. (2024) · Mansoura Nursing Journal · doi:10.21608/mnj.2024.350497 · Cited by 4
“It is the best design used to answer research questions because of the effects of various confounding variables (Miller, Smith, & Pugatch, 2020; Rogers, & Revesz, 2019) .”
BackgroundDigital Musical Storytelling to Enhance First-Grade Elementary School Students' Listening Skills
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“as prepost with non-equivalent control group style (21).”
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“Namun, pertanyaan sains implementasi lainnya lebih cocok untuk desain quasi-experiment, yang dimaksudkan untuk memperkirakan efek intervensi tanpa adanya pengacakan [30].”
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“where the net benefit is largest (see Figure 5), which has been used in some implementation science contexts.(50) In”
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“Thus, internal validity is the degree to which changes in the dependent variable can be attributed to the intervention and is maximized by decreasing bias using design features such as random assignment, allocation concealment, and blinding (Miller et al., 2020).”
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“Além disso, a efetividade também pode ser afetada pelo tempo de seguimento dos estudos, pois investigação constatou que os desfechos podem melhorar com o aumento do seguimento do estudo(22).”
BackgroundInfluentialWork-family conflict and mental health: A systematic review and meta-analysis
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“Future quasi-experimental studies with matched exposed and unexposed groups could strengthen causal evidence [85,86].”
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Santosa, Y. T., Hastuti, W., Ismiyati, I., Ferdianto, J., & Kholid, M. (2026) · Jurnal Varidika · doi:10.23917/varidika.v38i2.13706 · Cited by 3
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“Further, to assess dose, quality of delivery, professionals ’ responsiveness, and programme differentiation (33), the exposure of professionals/centres/centres to the strategies will be measured by a questionnaire developed ad-hoc for this project.”
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“The study utilized a non-equivalent control group design involving the experimental group and the control group, which were selected nonrandomly (Miller et al., 2020).”
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“Despite the solid internal validity of the study and this design, future studies should consider following an experimental design (C. Miller et al., 2020).”
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“…research, aims to track behavioral changes in a single person or a small group of people in response to a treatment or intervention that is repeated over a set amount of time, such as once per day, once per week, or once per month (Catagnus, Garcia, & Zhang, 2023; Miller, Smith, & Pugatch, 2020).”
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“In addition, it provides information on the intervention’s feasibility and acceptability by the participants as recommended by the literature (8, 10, 11).”
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“This research applied quasi-experimental design by using two groups (Rogers & Revesz, 2019; Reichardt, 2019; Miller et al., 2020); they were experimental class and control class.”
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“Pre and post test design is useful in evaluating the impact of the adoption of new programs on program specific outcomes in real world settings (Brown et al., 2017; Miller et al., 2020).”
BackgroundGalehdarifard, A., Radfar, M., Gholami, M., Khademi, M., Ebrahimzadeh, F., & Imani-Nasab, M. (2020) · BMC Health Services Research · doi:10.1186/s12913-020-05377-1 · Cited by 3
“Adopting experimental design allows controlling the effect of contextual variables [22] which affect empathy.”
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“This design is often used to measure the impact of implementing a programme or an educational intervention (Güvenir & Türkmen, 2024; Karpudewan & Mohd Ali Khan, 2017; Miller, Smith & Pugatch, 2020).”
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Peer support in mental health services to reduce loneliness and emotional symptoms in Latin American
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“The control group in the pretest-posttest nonequivalent control group design is matched to the group that received the intervention rather than being randomly assigned (Miller et al ., 2020).”
A stage-sensitive approach to evaluating social prescribing in complex and evolving health systems
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Tjakrawerdaja, W., Wıbowo, F. C., Kustandi, C., & Arymbekov, B. (2025) · Journal of Environment and Sustainability Education · doi:10.62672/joease.v3i4.169 · Cited by 5
“This study employed a quasi-experimental one-group pretest–posttest design, in which a single class received learning using deep-learning-based digital storytelling comics (Ilhan et al., 2021; Le & Schmid, 2022; Maciejewski, 2020; Miller et al., 2020).”
Patient navigation programmes for symptomatic lung cancer patients: a scoping review
Bautista-González, E., Reyes-García, H. T., Barragán-Carrillo, R., Martínez-Cannon, B. A., Quintero-Leyra, A., Pikhart, H., Peasey, A., & Vindrola‐Padros, C. (2025) · Archives of Public Health · doi:10.1186/s13690-025-01786-y
“Our study shows that not all studies are RCT [22] and that there is frequent use of quasi-experimental design with no control group [28].”
Jannah, R., Amini, R., Muhammadi, M., & Desyandri, D. (2025) · Jurnal Penelitian Pendidikan IPA · doi:10.29303/jppipa.v11i8.11941 · Cited by 2
“According to (Miller et al., 2020), the purpose of Quasi Experimental research is to evaluate the effect of a treatment or intervention on research subjects in conditions where randomization is not possible.”
Cross, A. J., Blakeley, B., Laver, K., Haines, T. P., Hilmer, S. N., Manek, A., Bennett, A., Martini, A., Quirke, L., Kulh, M. A., et al. (2025) · Implementation Science · doi:10.1186/s13012-025-01449-0 · Cited by 2
“Interrupted time series analyses are considered a strong quasi experimental design for evaluating quality improvement initiatives and uptake of clinical practice guidelines [21, 22].”
Female athletes' knowledge of biopsychosocial puberty-related topics in sports. What is missing?
Radovan, F., Solstad, B., Kjær, J., Melin, A., Ausland, Å., Bjärsholm, D., Ivarsson, A., Torstveit, M. K., Laxdal, A., Augustsson, S. R., et al. (2025) · Frontiers in Sports and Active Living · doi:10.3389/fspor.2025.1596418 · Cited by 2
Nguyen, M., & Vu, K.-T. T. (2025) · Pacific Early Childhood Education Research Association · doi:10.17206/apjrece.2025.19.2.181 · Cited by 2
“Because of practical and ethical barriers, the controlled group, the experimental group before and after the quasi-experimental study, was conducted instead of the random group (Miller et al., 2020).”
ENHANCING EFL STUDENTS’ SPEAKING SKILLS AND ENGAGEMENT THROUGH TURN-TAKING STRATEGIES
Gaffar, M., Rismayanti, R., Ilmi, H., & Nuryani, S. (2025) · English Review: Journal of English Education · doi:10.25134/erjee.v13i1.10363 · Cited by 2
“The researcher used a quasi-experimental research design with non-equivalent control groups (pre-posttest) design to help allay worries over disparities in selection and not having of a comparison (Miller et al., 2020; Leavy, 2022).”
Aldahadha, B., Dwakat, M. A., & Alnawiseh, M. A. (2024) · Islamic Guidance and Counseling Journal · doi:10.25217/0020247525500
Bjerregaard, M., Axelin, A., Carlsen, E. M., Birk, H. O., Poulsen, I., Palisz, P., Kallemose, T., & Brødsgaard, A. (2024) · Pediatric Investigation · doi:10.1002/ped4.12420 · Cited by 2
“52,53 The quasi-experimental design is particularly suitable when the blinding procedure is not possible for either the performer or receiver of the intervention.”
BackgroundKuswahyudi, K., Lobo, J., Setiawan, E., Tanucan, J. C., Miller, J. C., Celso, R. T., Gani, R. A., Aljahni, M., Alfonso, A., Valdez, A., et al. (2023) · Fizjoterapia Polska · doi:10.56984/8zg20a710 · Cited by 2
Exploring the Effectiveness of a Battery of Physical Fitness Tests via Virtual Learning Environment
Lobo, J., Prevandos, F. G., Bautista, C., Dios, D. A. D., Dimalanta, G., & Gazali, N. (2023) · Physical Education Theory and Methodology · doi:10.17309/tmfv.2023.4.01 · Cited by 2
“A well-designed experiment will yield the most precise results available, allowing researchers to draw the most definitive conclusions feasible about a hypothesis (Miller et al., 2020) appropriate use, and sustainability of effective clinical practices in real world clinical settings.”
BackgroundGallego, B. R., Martínez‐Vázquez, S., Amezcua‐Prieto, C., Martínez‐Galiano, J. M., Romero‐Gonzalez, B., Peralta‐Ramírez, M. I., Durán, E. L., & Caparrós-González, R. A. (2023) · Clínica y Salud · doi:10.5093/clysa2023a20 · Cited by 3
Estimating Policy Effects in a Social Network with Independent Set Sampling
Ang, E. T. Y., Bhattacharya, P., & Lim, A. (2023) · Soc. Networks · doi:10.48550/arxiv.2306.14142 · Cited by 2
“Policy evaluation studies use either experimental or quasi-experimental approaches (Cook et al., 2002; Gertler et al., 2016; Coly & Parry, 2017; White & Raitzer, 2017) and involve a controlled (or quasi-controlled) exposure of specific groups to the policy to estimate its impact.”
MethodDwedar, L., Mahmoud, F. Z., Eldin, A. I. E., & Hamid, A. A. (2022) · Egyptian Journal of Health Care · doi:10.21608/ejhc.2022.395015 · Cited by 2
Classroom Context Influence on Pre-Service Teacher Pupil Control Ideology
Herron, J. P., & Hennessey, M. N. (2021) · The Teacher Educator · doi:10.1080/08878730.2021.1974627 · Cited by 2
“However, because we decided to utilize this design we were unable to control for certain variables that may have contributed to participant PCI scores of perceptions of the contextual variables (Miller et al., 2020).”
MethodApps “SIPITUNG”: Flipped-classroom training in basic cardiopulmonary life support
Wulandari, A. T., Mintaroem, K., & Suharsono, T. (2020) · doi:10.30595/medisains.v18i2.7650 · Cited by 2
“This stage was the trial or experimental phase.(28) The flipped classroom learning method that used a”
MethodGonzález-Daza, B., & Feijóo-García, M. (2022) · International Conference on Computer-Human Interaction Research and Applications · doi:10.5220/0011543300003323 · Cited by 2
“We evaluated the participants’ perception of satisfaction before and after using the application through questionnaires to analyze the behavior and impact of the solution preliminary— we followed a pre-post experimentation approach (Miller et al., 2020).”
MethodSaleh, F., Pazokian, M., Esmaili, M. R. H., Sanaie, N., & Nasiri, M. (2026) · Scientific Reports · doi:10.1038/s41598-026-58061-5 · Cited by 1
“…a concurrent control group, these changes cannot be unambiguously attributed to the intervention and may also reflect concurrent threats to internal validity such as history, maturation, testing, seasonal variation in clinical workload, and Hawthorne effects related to direct observation 38,39 .”
Kat, B., & Aydın, A. (2026) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-026-07393-2 · Cited by 1
Alam, S., & Ansari, D. (2026) · Journal of Research in Childhood Education · doi:10.1080/02568543.2026.2657313 · Cited by 1
Piscayanti, K. S., Utami, I., Rismadewi, N. W. M., Wistiananta, I. W., & Kurniawan, P. R. H. (2026) · Glosains Jurnal Sains Global Indonesia · doi:10.59784/glosains.v7i2.743 · Cited by 1
“Random assignment was not possible because of class conditions, teacher readiness, and school policies; therefore, the existing classes were used as a quasi-experimental design (Maciejewski, 2020; Madadizadeh, 2022; Miller et al., 2020; Siedlecki, 2020).”
The impact of guided doodle note-taking on reading comprehension
DeWald, K., & Lunde, R. (2026) · Discover Education · doi:10.1007/s44217-026-01551-5 · Cited by 1
“Existing differences between the two treatment groups could lead to results that are not attributed to the treatment [42].”
Lemamsha, H., Randhawa, G., Najem, R., Almabrouk, R., Edries, A., Abdalla, E., & Sulemen, A. (2026) · Derna Academy Journal for Applied Sciences · doi:10.71147/6fq0z070 · Cited by 1
Silva, T. L., Ray-Barruel, G., Ullman, A. J., Takashima, M., de Souza, S., Moura, J. W. D. S., de Moura, S. D., dos Santos, L. M., & Rocha, P. K. (2026) · Journal of Research in Nursing · doi:10.1177/17449871261429815 · Cited by 1
“…analyses require at least three data collection points in the pre-and post-intervention periods to adequately assess trends, allowing for a more robust evaluation of whether the observed changes exceed random or transient variation (Handley et al., 2018; Miller et al., 2020; Turner et al., 2019).”
He, Y., Liu, Y.-J., Pan, W.-Y., Tian, W.-H., Zhao, Y., Guo, Y., & Feng, X.-Q. (2026) · Frontiers in Public Health · doi:10.3389/fpubh.2026.1785677 · Cited by 1
“Eating behavior plays a central role in both the development and management of obesity, representing a modifiable determinant of nutritional status (8).”
Bridging the gap with highway cap: Reshaping urban landscapes without gentrification
Janatabadi, F., & Ermagun, A. (2026) · Cities · doi:10.1016/j.cities.2026.106860 · Cited by 1
Ilmiawan, Mundandar, A., & Wahyuni, D. (2026) · Jurnal Pedagogi dan Pembelajaran · doi:10.23887/jp2.v9i1.109564 · Cited by 1
Enhancing Modeling Competencies in Industrial Robotics Via a Remote Lab
Tapia-Siles, C., Almancy-Becerra, S., Villanueva-Sánchez, S., Itamari, S., Velasco, S. B., Salazar, E., & Villazón, A. (2026) · 2026 IEEE Engineering Education World Conference (EDUNINE) · doi:10.1109/edunine62390.2026.11547139 · Cited by 1
“We applied the quasi-experimental design [9] pre-test / post-test methodology, as it eliminates individual differences be-tween groups (sampling error), which allows for highlighting the impact of the intervention.”
Emerole, C., Obasi, C., Emerole, C. G., Iwuala, C., Dozie, U. W., Iwuoha, G., Akam, N. V., & Ekeleme, U. (2026) · BMC Public Health · doi:10.1186/s12889-026-26672-2 · Cited by 1
Nigatu, D., Azage, M., Misgan, E., Enquobahrie, D. A., Kebebaw, T., Abate, E., Alemneh, E., Woldie, M. K., & Girma, T. (2026) · Reproductive Health · doi:10.1186/s12978-026-02279-z · Cited by 2
“This design uses a control group in place of a randomized comparator population [37–39].”
Liu, X.-Y., Zhao, H., Song, S., Wen, R.-H., Liu, B., & Luo, Y. (2026) · Geriatric Nursing · doi:10.1016/j.gerinurse.2026.103943 · Cited by 1
Lestari, I., Marlianto, F., Sulistiyarini, D., Sabirin, F., & Wahab, N. A. (2026) · Jurnal Pendidikan Progresif · doi:10.23960/jpp.v16i1.pp345-366
“This study employed a quasi-experimental design, namely one that involves an experimental group and a control group without full random assignment at the individual level, yet still allows examination of cause-and-effect relationships (Capili & Anastasi, 2024; Miller et al., 2020).”
de Weegh, A. O., Ruiter, S., & Nivette, A. E. (2026) · Evidence Base · doi:10.1080/30679125.2026.2629375 · Cited by 1
“Randomization is particularly valued in implementation research for its ability to isolate the causal impact of an intervention by reducing the influence of both measured and unmeasured confounding variables (Miller et al., 2020).”
Novitandari, E., Nursalim, M., & Rahmasari, D. (2026) · Multidisciplinary Science Journal · doi:10.31893/multiscience.2026447 · Cited by 1
Metadata
- Authors
- Miller, C. J., Smith, S. N., & Pugatch, M.
- Affiliations
- United States Department of Veterans Affairs (US)
- University of Michigan (US)
- Corresponding author
- Miller, Christopher J.
- Venue
- Psychiatry Research
- Publisher
- Elsevier BV
- Published
- 2020-01
- Volume
- 283
- Pages
- 112452
- ISSN
- 0165-1781 (ISSN-L)
- PMC
- PMC6923620
- OpenAlex
- W2951715721
- Cited by
- 373
- References
- 67
- Citations by year
- 2026: 63 · 2025: 89 · 2024: 67 · 2023: 63 · 2022: 56 · 2021: 20 · 2020: 14
- FWCI
- 4.18
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Psychiatry Research (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health
- U.S. Department of Veterans Affairs
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- implementation research, implementation science, experimental design, quasi-experimental design, randomized controlled trials, interrupted time series, stepped wedge design, pre-post design, research design selection, clinical adoption, intervention sustainability
- MeSH terms
- Implementation Science, Humans, Research Design, Randomized Controlled Trials as Topic, Control Groups, Biomedical Research
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