Cited by 204Advanced Causal Inference TechniquesMeta-analysis and systematic reviewsStatistical Methods in Epidemiology

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Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

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Dahabreh, Issa J., Sheldrick, Radley C., Paulus, Jessica K., Chung, Mei, Varvarigou, Vasileia, Jafri, Haseeb, Rassen, Jeremy A., Trikalinos, Thomas A., Kitsios, Georgios D.·2012·European Heart Journal

DOI 10.1093/eurheartj/ehs114PMC PMC3409422

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Abstract

AIMS: Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of therapeutic interventions because randomization protects from biases inherent in observational studies. Propensity score (PS) methods, proposed as a potential solution to confounding of the treatment-outcome association, are widely used in observational studies of therapeutic interventions for acute coronary syndromes (ACS). We aimed to systematically assess agreement between observational studies using PS methods and RCTs on therapeutic interventions for ACS. METHODS AND RESULTS: We searched for observational studies of interventions for ACS that used PS methods to estimate treatment effects on short- or long-term mortality. Using a standardized algorithm, we matched observational studies to RCTs based on patients' characteristics, interventions, and outcomes ('topics'), and we compared estimates of treatment effect between the two designs. When multiple observational studies or RCTs were identified for the same topic, we performed a meta-analysis and used the summary relative risk for comparisons. We matched 21 observational studies investigating 17 distinct clinical topics to 63 RCTs (median = 3 RCTs per observational study) for short-term (7 topics) and long-term (10 topics) mortality. Estimates from PS analyses differed statistically significantly from randomized evidence in two instances; however, observational studies reported more extreme beneficial treatment effects compared with RCTs in 13 of 17 instances (P = 0.049). Sensitivity analyses limited to large RCTs, and using alternative meta-analysis models yielded similar results. CONCLUSION: For the treatment of ACS, observational studies using PS methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant.

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BackgroundResult
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“Although such cross-study comparisons can be informative when the compared studies are very carefully matched (95, 96), the data we collected could not support such matching.”
Result
Clinical Outcomes of Laparoscopic Versus Laparotomic Distal Gastrectomy in Gastric Cancer Patients: A Multilevel Analysis Based on a Nationwide Administrative Database in Japan
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“Compared with randomized controlled trials, use of the propensity score method may also overestimate the effect, although the differences are suggested to be rarely statistically significant [33].”
Method
Pharmacotherapy and mortality in atrial fibrillation--a cohort of men and women 75 years or older in Sweden
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Background
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Reply
Jiménez, D., Muriel, A., Monréal, M., & Yusen, R. D. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.05.046 · Cited by 7
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“It has been shown that analyses of such balanced databases often yield aggregate results very similar to those obtained in experimental trials (Anglemyer et al., 2014; Dahabreh et al., 2012).”
Result
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“12,13 Matchedpairs based onthe propensityscores were created using the greedy algorithm.”
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“ACS is the most serious medical emergency caused by myocardial ischemia/hypoxia following coronary atherosclerotic plaque formation, with clinical manifestations of UA and acute MI (45).”
Background
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“In addition, it has been reported that observational studies such as case-matched studies and cohort studies may overestimate treatment effects [44].”
Background
Effect of cardiovascular drugs on mortality in atrial fibrillation and chronic heart failure
Wändell, P. E., Carlsson, A. C., Sundquist, J., Johansson, S., Bottai, M., & Sundquist, K. (2014) · Scandinavian Cardiovascular Journal · doi:10.3109/14017431.2014.941002 · Cited by 5
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“Age and sex were entered as the covariates in the propensity scores.(3) Fischer's exact probability test and the t-test were used.”
Method
A Two‐Step Framework for Validating Causal Effect Estimates
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Utilizing propensity score matching analysis to examine the effects of postsecondary education on the employment outcomes of young adults with mental illnesses
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“To strengthen causal inference, the study utilized propensity score matching (PSM) technique to create matched samples of state VR consumers who received college or university training (the treatment group) and those who did not (the comparison group; Dahabreh et al., 2012; Rosenbaum & Rubin, 1983).”
S2AI vs. iliac screws in spinopelvic fixation for adult spinal deformity: a propensity score-matched analysis
Gómez-Rice, A., Núñez-Pereira, S., Haddad, S., Raganato, R., Charles, Y. P., Pérez-Grueso, F., Kleinstück, F. S., Obeid, I., Alanay, A., Pellisé, F., et al. (2025) · European Journal of Orthopaedic Surgery & Traumatology · doi:10.1007/s00590-025-04215-6 · Cited by 3
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“ferences except that PSA studies overestimated treatment effects.[30,31] Selective reporting of only positive studies and publication bias prejudice observational data to account for this overestimation as RCTs with even small”
Background
Serum Ferritin Has Limited Prognostic Value on Mortality Risk in Patients with Decompensated Cirrhosis: A Propensity Score Matching Analysis
Guo, G., Sun, M., Li, Y., Yang, W., Wang, X., Yu, Z., Li, C., Hui, Y., Fan, X., Jiang, K., et al. (2022) · Laboratory Medicine · doi:10.1093/labmed/lmac064 · Cited by 3
Score de propension : intérêts, utilisation et limites. Un guide pratique pour le clinicien
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“[2] Dahabreh IJ, Sheldrick RC, Paulus JK, Chung M, Varvarigou V, Jafri H, et al.”
Method
Response by Pasupathy et al to Letters Regarding Article, “Early Use of N-acetylcysteine (NAC) With Nitrate Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction Reduces Myocardial Infarct Size (The NACIAM Trial [ N -Acetylcysteine in Acute Myocardial Infarction])”
Pasupathy, S., Tavella, R., & Beltrame, J. F. (2018) · Circulation · doi:10.1161/circulationaha.117.032512 · Cited by 3
Impact of neoadjuvant chemotherapy on short-term outcomes after simple and complex minimally invasive minor hepatectomy for colorectal liver metastases: A propensity-score matched and coarsened exact matched study
Hoogteijling, T. J., Hilal, M. A., Zimmitti, G., Aghayan, D. L., Wu, A. G. R., Cipriani, F., Gruttadauria, S., Scatton, O., Long, T. C. D., Herman, P., et al. (2024) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2024.108309 · Cited by 2
Immortal time bias tends to be more pronounced in methodological studies than in empirical studies: a metaepidemiological study
Zhang, X., Xu, J., He, Q., Wang, Y., Xie, S., Zhang, X., Zou, K., Wang, W., & Sun, X. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111936 · Cited by 2
Comparative cost analysis of liquid embolization systems for brain arteriovenous malformation using a real-world US hospital database: TRUFILL ® versus Onyx TM
Satti, S. R., Fan, X., Kottenmeier, E., Khanna, R., & Rai, A. (2022) · Interventional Neuroradiology · doi:10.1177/15910199221103325 · Cited by 2
“19 The patient population in this study only represents bAVM patients who received healthcare services from hospitals which provided data to PHD.”
Background
Effect of epidural labor analgesia on maternal and infant outcomes in parturients with gestational diabetes mellitus—A prospective cohort study
Li, G., Qi, X., Tan, X., Wu, M., Wang, H., Wen, P., Huang, X., & Li, Y. (2022) · Frontiers in Pediatrics · doi:10.3389/fped.2022.1022291 · Cited by 2
“Many studies have reported that PSM produces results similar to those of RCTs (9).”
Result
Influence of smoking on patient-reported outcome measures (PROMs) in patients undergoing surgery for adult spinal deformity: a propensity score‐matched analysis
Gómez-Rice, A., Capdevila-Bayo, M., Núñez-Pereira, S., Haddad, S., Pérez-Grueso, F., Kleinstück, F. S., Obeid, I., Alanay, A., Pellisé, F., Pizones, J., et al. (2024) · Spine Deformity · doi:10.1007/s43390-024-00821-2 · Cited by 2
“To address potential confounding variables [29] and ensure alignment with effect measures from randomized clinical trials [30], we employed propensity index matching.”
Lean Research Culture: Measurement, Analysis, and Revitalization of Processes and Outcomes of Contemporary Research Practices
Paulmani, G. (2017) · IEEE International Conference on Advanced Learning Technologies (ICALT) · doi:10.1109/icalt.2017.88 · Cited by 2
“To prevent this, Propensity Score Analysis (PSA) is proposed a method used in medical field and economic policy making most often to address the same ethical concern [12].”
Method
Effect of early percutaneous coronary intervention on one-year risk of pneumonia and pneumonia-related adverse outcomes in patients with acute myocardial infarction
Lin, C., Chang, Y., Chi, N., Chuang, M., & Chien, L. (2018) · EuroIntervention · doi:10.4244/eij-d-16-00840 · Cited by 2
The Impact of Perioperative Use of a Statin–Magnesium Combination on Opioid Consumption in Patients Who Underwent Cardiac Surgery: A Retrospective Study with Propensity-Score Matching
Lee, C., & So, C. H. (2020) · Chonnam Medical Journal · doi:10.4068/cmj.2020.56.2.130 · Cited by 2
Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis
Gilyarevsky, S. R. (2021) · Rational Pharmacotherapy in Cardiology · doi:10.20996/1819-6446-2021-08-01 · Cited by 2
Randomized trials and propensity score analyses in transcatheter aortic valve replacement: how should we interpret the results?
Freemantle, N., & Pagano, D. (2018) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezy120 · Cited by 2
Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry
Gautier, A., Roffi, M., Laanmets, P., Munir, S. M., Malik, F. T., Íñiguez, A., Maluenda, G., Kuramitsu, S., Angioı̈, M., Wijns, W. C., et al. (2023) · American Heart Journal · doi:10.1016/j.ahj.2023.02.016 · Cited by 1
Diverse criteria and methods are used to compare treatment effect estimates: a scoping review
Brignardello‐Petersen, R., Carrasco‐Labra, A., Jadad, A. R., Johnston, B. C., & TOMLINSON, G. A. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.02.001 · Cited by 1
Accounting for differences in healthcare utilization and expenditures among US males with haemophilia by type of health insurance
Guh, S., Grosse, S. D., Ullman, M. M., & Soucie, J. M. (2017) · Haemophilia · doi:10.1111/hae.13161 · Cited by 1
Ethical Considerations for Conducting a Randomized Controlled Trial in Transport
Reimer, A. P., & Daly, B. J. (2014) · Air Medical Journal · doi:10.1016/j.amj.2014.06.009 · Cited by 1
Contact‐ versus noncontact‐guided ablation of the right ventricular outflow tract arrhythmias: A propensity score matched analysis
Chen, X., Sun, L. V., Chen, Q., Kojodjojo, P., Chen, H., Ju, W., Zhu, W., Zhu, Y., Zhao, P., Zhang, F., et al. (2020) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.13935 · Cited by 1
Signals were broadly positive for months, but never definitive: the tocilizumab story
Cozzi‐Lepri, A., Smith, C. J., & Mussini, C. (2021) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.10.018 · Cited by 1
Resection or ablation for very early hepatocellular carcinoma and the fundamental problem of causal inference
Cucchetti, A., & Serenari, M. (2017) · HepatoBiliary Surgery and Nutrition · doi:10.21037/hbsn.2017.05.03 · Cited by 1
Should Network Meta-analysis Become the Standard in Evidence-based Clinical Practice?
Brignardello‐Petersen, R. (2016) · TSpace (University of Toronto) · Cited by 1
The Rise of Comparative Effectiveness Research
Hochman, M. E., & McCormick, D. (2013) · Springer eBooks · doi:10.1007/978-1-4614-7735-8_7
“While concerns persist about the ability of even these newer techniques to properly control for confounding factors [ 22 ], some evidence suggests that observational study results are valid most of the time [ 23 ].”
Background
An Historical Perspective of the Future of Pharmacovigilance
Moore, N. D. (2014) · doi:10.1002/9781118820186.ch53
Can a Mendelian Randomization Study Predict the Results of a Clinical Trial? Yes and No
Abbate, A., Dinarello, C. A., Peruzzi, M., Sciarretta, S., Frati, G., & Biondi‐Zoccai, G. (2016) · International Journal of Statistics in Medical Research · doi:10.6000/1929-6029.2016.05.01.6
“From stratification to logistic regression and propensity score matching, traditional adjustment methods have become more and more refined, and in many cases carefully conducted and analyzed observational studies appear to agree with the corresponding megatrials [11].”
“Second best”: A good start
Hui, D. S., & Lee, R. (2016) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2016.09.031
Uso de estatinas em pacientes com doença isquêmica do coração: análise de custo-efetividade
Luque, A. (2016) · Digital Library of Theses and Dissertations (Universidade de São Paulo) · doi:10.11606/t.5.2017.tde-06032017-102120
Coronary Artery Bypass Surgery for Patients Presenting with Ventricular Arrhythmias: Propensity Matched Early and Late Outcome
Habib, A. M., Hussain, A., Jarvis, M., Cale, A. R., Cowen, M. E., Ngaage, D. L., Chaudhry, M., & Loubani, M. (2018) · World Journal of Cardiovascular Surgery · doi:10.4236/wjcs.2018.82005
“Nevertheless, PSM has been assessed by other studies to validate the effect of treatment on observational data [7] [19] [20].”
MethodResult
エンドトキシン吸着カラム（PMX-DHP）は有用か？
俊彦, 真., 瑠里, 首., 明日実, 椎., 直哉, 舛., 直通, 岡., 直人, 佐., 悠人, 手., 真志, 草., 倫太郎, 秋., 一平, 宮., et al. (2018) · 日本外科感染症学会雑誌 · doi:10.24679/gekakansen.15.3_242
Audit and Evaluation
Doherty, P., Harrison, A., Petre, C., & Onion, N. (2020) · doi:10.1002/9781119071006.ch9
Machine Learning Methods for Causal Inference with Observational Biomedical Data
Averitt, A. (2020) · doi:10.7916/d8-je06-eh12
Re: ‘Methodological evaluation of bias in observational COVID-19 studies on drug effectiveness’ by Wolkewitz et al.
Cozzi‐Lepri, A., Guaraldi, G., Meschiari, M., & Mussini, C. (2021) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.04.026
“, is to compare its results with those of the reference randomized trial [5,7,8].”
Result
Propensity score-matched case–control study of convalescent plasma in treatment of patients with moderate and severe COVID-19
Raman, N., Kishore, K., Rana, S., Vardhan, V., Thareja, S., Padmaprakash, K. V., Muthukrishnan, J., Rajmohan, K., Agarwal, M., Ashta, K. K., et al. (2022) · The Journal of Association of Chest Physicians · doi:10.4103/jacp.jacp_44_21
Postoperative patient-reported outcomes after revision total knee arthroplasty: Propensity-score-matched comparison with primary total knee arthroplasty
Ishizu, K., Hamai, S., Tsushima, H., Harada, T., Harada, S., Kameyama, M., Kawahara, S., Akasaki, Y., & Nakashima, Y. (2026) · Journal of Orthopaedic Reports · doi:10.1016/j.jorep.2026.100995
Considerations for clinical trial design and conduct in the evaluation of novel advanced therapeutics in neurodegenerative disease
Drew, C. J. G., & Busse, M. E. (2022) · International review of neurobiology · doi:10.1016/bs.irn.2022.09.006 · Cited by 1
Characteristics and Effect of Rivaroxaban on Venous Thromboembolism in Korean Patients Compared to Western Population: A Subgroup Analysis from XALIA(-LEA) Study
Min, S., Kim, J. S., Kim, J. Y., Park, U. J., Lee, T., Kang, J. M., Park, S. C., Choi, W.-I., Park, K. H., & Gebel, M. (2022) · Vascular Specialist International · doi:10.5758/vsi.220039
Multiple Imputation of missing values for randomized controlled trials: A step-by-step tutorial using micePreprint
Lecuona, O. Z., Angulo-Brunet, A., Ciudad-Fernández, V., & Olmos, R. (2023) · doi:10.31234/osf.io/bpk5h
Enoxaparin is not an oral factor Xa inhibitor. Response to Sutton et al. real-world clinical outcomes among US veterans with oral factor Xa inhibitor–related major bleeding treated with andexanet alfa or 4-factor prothrombin complex concentrate
Buka, R. J., Sutton, D. J., & Nicolson, P. L. R. (2024) · Journal of Thrombosis and Thrombolysis · doi:10.1007/s11239-024-02948-5
“While it can remove most bias in some minor or medium confounding scenarios it is particularly unreliable in situations with complex or unmeasured confounding [4, 5].”
Antidepressant Remission and Manic Switch in Bipolar Depression: A Propensity Score Analysis
Vöhringer, P. A., Barroilhet, S. A., Palma, B. A., & Perlis, R. H. (2025) · Acta Psychiatrica Scandinavica · doi:10.1111/acps.13822
“While large randomized controlled trials remain the gold standard, comparing treatment effect estimators drawn from this statistical procedure with outcomes from randomized data shows that the results may be quite close to each other [22].”
Evaluating the Potential of Prevalent New User Design as an Alternative When New User Design is Impractical
Koinuma, T., & Akazawa, M. (2025) · Pragmatic and Observational Research · doi:10.2147/por.s517514
“37 In this study, the Prevalent New User Design was used as an effective method to control for ITB.”
Long-Term Effectiveness of Acetylsalicylic Acid in Primary Prevention of Cardiovascular Diseases and Mortality in Patients at High Risk, a Retrospective Cohort Study—The JOANA Study
Alves‐Cabratosa, L., López, C., García-Gil, M., Tornabell‐Noguera, È., Comas‐Cufí, M., Blanch, J., Martí‐Lluch, R., Ponjoan, A., Domínguez‐Armengol, G., Zacarías‐Pons, L., et al. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14165710
“However, this type of observational studies could tend to overestimate the effect size of certain interventions [37] if several key points are not well addressed.”
Additional file 1 of Comparative effectiveness and safety of pharmaceuticals assessed in observational studies compared with randomized controlled trials
Hong, Y. D., Jansen, J. P., Guerino, J., Berger, M. L., Crown, W. H., Goettsch, W., Mullins, C. D., Willke, R. J., & Orsini, L. S. (2021) · Figshare · doi:10.6084/m9.figshare.17127300
Additional file 2 of Comparative effectiveness and safety of pharmaceuticals assessed in observational studies compared with randomized controlled trials
Hong, Y. D., Jansen, J. P., Guerino, J., Berger, M. L., Crown, W. H., Goettsch, W., Mullins, C. D., Willke, R. J., & Orsini, L. S. (2021) · Figshare · doi:10.6084/m9.figshare.17127303
Additional file 3 of Comparative effectiveness and safety of pharmaceuticals assessed in observational studies compared with randomized controlled trials
Hong, Y. D., Jansen, J. P., Guerino, J., Berger, M. L., Crown, W. H., Goettsch, W., Mullins, C. D., Willke, R. J., & Orsini, L. S. (2021) · Figshare · doi:10.6084/m9.figshare.17127306
Multicenter study on right Glissonean pedicle management in laparoscopic right hepatectomy: main trunk vs. sectoral pedicle transection approaches
Yang, Y., Peng, Y., Li, J., Cheng, W., Liang, X., Zhang, Q., Wang, X., Wang, Q., Cao, J., Cao, L., et al. (2025) · Surgical Endoscopy · doi:10.1007/s00464-025-12443-4

Authors: Dahabreh, I. J., Sheldrick, R. C., Paulus, J. K., Chung, M., Varvarigou, V., Jafri, H., Rassen, J. A., Trikalinos, T. A., & Kitsios, G. D.
Affiliations: Tufts Medical Center (US)
Tufts University (US)
Harvard University (US)
Johns Hopkins University (US)
Brigham and Women's Hospital (US)
Lahey Hospital and Medical Center (US)
Corresponding author: Dahabreh, Issa J.
ORCID: Dahabreh, Issa J.
Sheldrick, Radley C.
Paulus, Jessica K.
Chung, Mei
Rassen, Jeremy A.
Trikalinos, Thomas A.
Kitsios, Georgios D.
Venue: European Heart Journal
Publisher: Oxford University Press (OUP)
Published: 2012-06-17
Volume: 33
Issue: 15
Pages: 1893-1901
ISSN: 0195-668X (ISSN-L)
1522-9645
DOI: 10.1093/eurheartj/ehs114
PMC: PMC3409422
OpenAlex: W2162409127
Cited by: 204
References: 40
Citations by year: 2026: 4 · 2025: 9 · 2024: 10 · 2023: 10 · 2022: 23 · 2021: 22 · 2020: 18 · 2019: 14 · 2018: 18 · 2017: 15 · 2016: 12 · 2015: 13 · 2014: 24 · 2013: 10 · 2012: 2
FWCI: 14.97
Type: journal article
Language: en
Open access: green
europepmc.org
Locations: European Heart Journal (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Center for Research Resources (UL1RR025752)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Keywords: propensity score methods, acute coronary syndrome, observational studies, randomized controlled trials, treatment effect estimation, confounding, mortality
MeSH terms: Humans, Regression Analysis, Risk Factors, Reproducibility of Results, Randomized Controlled Trials as Topic, Treatment Outcome, Acute Coronary Syndrome, Propensity Score

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Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

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