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Fixed or random effects meta-analysis? Common methodological issues in systematic reviews of effectiveness
Abstract
Systematic review aims to systematically identify, critically appraise, and summarize all relevant studies that match predefined criteria and answer predefined questions. The most common type of systematic review is that assessing the effectiveness of an intervention or therapy. In this article, we discuss some of the common methodological issues that arise when conducting systematic reviews and meta-analyses of effectiveness data, including issues related to study designs, meta-analysis, and the use and interpretation of effect sizes.
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“Additionally, it was recommended that the protocol should define the methods to be used for risk of bias assessment, meta-analysis and exploration of heterogeneity [41, 42, 44].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [44]
In the citing paper
“The articles recommended that the protocol should state the objectives, hypotheses to be tested and the rationale of the review, [29] and that it should describe eligibility criteria [29, 33, 35, 36, 38, 39, 41], define the type of studies to be included [35, 37, 42, 44], and give the reason when including observational studies in the review [35, 37, 40].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [44]
In the citing paper
“Twenty-five (27%) articles gave recommendations on item “considering different study designs” [8, 29, 34, 35, 37–39, 42, 44, 49, 51, 56, 61, 65, 70, 73, 75, 76, 77–83], with publication dates between 1995 and 2016 (median year of publication 2007).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [44]
In the citing paper
“A variation of this recommendation was to exclude studies that are at high risk of bias [42, 44, 54, 73, 82].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [44]
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“Although the Q value confirms consistency on depression among included studies, we decided to apply random effect model to be consistent with other variables that showed statistical heterogeneity [47].”
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“The random effects model was used in all analyses regardless of heterogeneity as recent evidence suggests that it can provide more robust outcome measures in comparison to the fixed effectsmodel (32).”
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“If I(2) >50%, a DerSimonian and Laird random effects model was used; otherwise, a Mantel-Haenszel fixed effects model was used.(17) Subgroup analyses were performed to evaluate the effect on outcome of modifying any potentially key covariates, stratified by gender.”
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“[24] and in consistent with previous systematic review [16].”
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“[20] Statistical heterogeneity was assessed through I 2 and Cochran Q test values, with I 2 values around 25%, ~50%, and ~75% indicating low, moderate, and high heterogeneity, respectively.”
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“Fixed effects models were only used if fewer than 5 trials were present for an outcome [35].”
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“Statistical analyses were then performed using random-effects models only in the presence of moderate to high heterogeneity (I2 > 50%), and in their absence, fixedeffects models were used instead [34].”
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“Random-effects models should be used if eligible studies are characterized by heterogeneous methodology, and thus it is unreasonable to assume that they share a common effect (Tufanaru et al., 2015).”
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“The meta-analysis was also repeated using a fixed effects model to assess the effects of small studies on results.(26) A p value of <0.”
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“The random effect model assumes that each study estimated different values from the distribution of population parameters, which would be flexible to heterogeneous effect sizes and the conservative nature of estimation (Tufanaru et al., 2015).”
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“A random-effect meta-regression was used to supplement the findings of the meta-analysis, as the studies were not considered sufficiently similar for a fixed-effects model [31].”
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“74 When medians and ranges were provided, the means and SDs were calculated by the first author.”
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“However, fixed effect model was considered irrespective of the degree of heterogeneity if the number of studies included in analysis was small (<five) [13].”
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“However, random effects models were used in all analysis regardless of heterogeneity as recent evidence suggests that it provides more robust outcome measures compared to the alternative fixed effects models (23).”
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“[28] The primary outcome variable was ever and current cigarette smoking.”
BackgroundNagelhout, G. E., Ebisch, R. M. F., van der Hel, O., Meerkerk, G., Magnée, T., de Bruijn, T. M., & van Straaten, B. (2021) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2021.1888719 · Cited by 73
“When more than five eligible studies were included in the analyses, a random-effects model was used [12,13].”
BackgroundPascual‐Morena, C., Cavero‐Redondo, I., Reina‐Gutiérrez, S., Saz‐Lara, A., López‐Gil, J. F., & Martínez‐Vizcaíno, V. (2022) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2022.05.015 · Cited by 67
Effects of mental toughness on athletic performance: a systematic review and meta-analysis
Hsieh, Y.-C., Lu, F. J.-H., Gill, D. L., Hsu, Y., Wong, T.-L., & Kuan, G. (2023) · International Journal of Sport and Exercise Psychology · doi:10.1080/1612197x.2023.2204312 · Cited by 67
Tamarozzi, F., Martello, E., Giorli, G., Fittipaldo, V. A., Staffolani, S., Montresor, A., Bisoffi, Z., & Buonfrate, D. (2019) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.18-0895 · Cited by 67
“However, we also present the resultsof thefixedeffectsmodels toprovideamorecomplete picture of the summary effect.(16)”
BackgroundGe, X., Wang, W., Hou, L., Yang, K., & Fa, X. (2018) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2018.02.105 · Cited by 66
“If I(2) > 50%, indicating significant heterogeneity, a random-effects model was applied; otherwise, a fixed-effects model was used.(8) We further performed subgroup analyses according to the surgery type, type of PPCs, and IMT time.”
MethodCadmium exposure and risk of breast cancer: A meta-analysis
Flórez‐García, V., Guevara-Romero, E., Hawkins, M. M., Bautista, L., Jenson, T. E., Yu, J. S., & Kalkbrenner, A. (2022) · Environmental Research · doi:10.1016/j.envres.2022.115109 · Cited by 64
“…studies, we were waiting for some heterogeneity and we were conservative in the interpretations, we preferred the random effects model, although we also checked whether results differed for the overall meta-analysis when using a fixed effect model (Tufanaru et al., 2015; Higgins et al., 2022).”
MethodDonovan, R. L., Edwards, T., Judge, A., Blom, A. W., Kunutsor, S. K., & Whitehouse, M. R. (2022) · Osteoarthritis and Cartilage · doi:10.1016/j.joca.2022.07.011 · Cited by 62
Intake of legumes and cardiovascular disease: A systematic review and dose–response meta-analysis
Mendes, V., Niforou, A., Kasdagli, M., Ververis, E., & Naska, A. (2022) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2022.10.006 · Cited by 68
Hou, M., Xing, H., Cai, Y., Li, B., Wang, X., Pan, L., Hu, X., & Chen, J. (2017) · The Journal of Headache and Pain · doi:10.1186/s10194-017-0750-1 · Cited by 61
“Otherwise, the random-effect model is considered [32, 33].”
Kebede, H. K., Mwanri, L., Ward, P., & Gesesew, H. A. (2021) · Infectious Diseases of Poverty · doi:10.1186/s40249-021-00822-7 · Cited by 60
“Pooled odds ratio (OR) [32] estimates and their 95% confidence intervals (CI) was calculated using random or fixed effect meta-analysis based on the degree of heterogeneity and number of studies [31, 33, 34].”
BackgroundMethodMassara, P., Zurbau, A., Glenn, A. J., Chiavaroli, L., Khan, T. A., Viguiliouk, E., Mejía, S. B., Comelli, E. M., Chen, V., Schwab, U., et al. (2022) · Diabetologia · doi:10.1007/s00125-022-05760-z · Cited by 68
“Fixed-effects models were used when fewer than five comparisons were available [50].”
MethodKhalafi, M., Sakhaei, M. H., Kheradmand, S., Symonds, M. E., & Rosenkranz, S. K. (2022) · Advances in Nutrition · doi:10.1016/j.advnut.2022.10.001 · Cited by 73
Lynch, C., Bird, S., Lythgo, N., & Selva-Raj, I. (2020) · American Journal of Health Promotion · doi:10.1177/0890117119895204 · Cited by 58
Guo, X., Su, W., Li, N., Song, Q., Wang, H., Liang, Q., Li, Y., Lowe, S., Bentley, R., Zhou, Z., et al. (2022) · Environmental Science and Pollution Research · doi:10.1007/s11356-022-22353-w · Cited by 58
“Random effects model was used in all analyses as evidence suggests that it can provide more robust outcome measures in comparison to the fixed effects model (Tufanaru et al. 2015).”
MethodAnxiety, Depression, and Colorectal Cancer Survival: Results from Two Prospective Cohorts
Trudel‐Fitzgerald, C., Tworoger, S. S., Zhang, X., Giovannucci, E. L., Meyerhardt, J. A., & Kubzansky, L. D. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9103174 · Cited by 55
“Primary analyses include meta-analyzed estimates from each cohort using fixed effects [42]; findings by cohort are reported as additional analyses.”
MethodLi, Y., Li, J., & Hu, X. (2023) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2023.104588 · Cited by 58
Lantéri‐Minet, M., Ducros, A., François, C., Olewińska, E., Nikodem, M., & Benjamin, L. (2022) · Cephalalgia · doi:10.1177/03331024221123058 · Cited by 59
“First, we applied a random-effects model to account for the uncertainty of the pooled results (54).”
BackgroundMethodYong, J. N., Lim, W. H., Ng, C. H., Tan, D. J. H., Xiao, J., Tay, P. W. L., Lin, S. Y., Syn, N. L. X., Chew, N., Nah, B. K. Y., et al. (2021) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2021.11.014 · Cited by 55
Naseri, C., Haines, T. P., Etherton‐Beer, C., McPhail, S., Morris, M. E., Flicker, L. A., Netto, J., Francis‐Coad, J., Lee, D. A., Shorr, R. I., et al. (2018) · Age and Ageing · doi:10.1093/ageing/afy043 · Cited by 54
Firouzabadi, F. D., Shab‐Bidar, S., & Jayedi, A. (2022) · Pharmacological Research · doi:10.1016/j.phrs.2022.106100 · Cited by 53
Kim, R., Lee, T. L., Lee, H., Ko, D.-K., Lee, J. H., Shin, H., Lim, D., Jun, J., Byun, K., Park, K., et al. (2023) · Parkinsonism & Related Disorders · doi:10.1016/j.parkreldis.2023.105908 · Cited by 60
Factors Influencing eHealth Literacy Worldwide: Systematic Review and Meta-Analysis
Hua, Z., Song, Y., Qianwen, L., & Chen, H. (2025) · Journal of Medical Internet Research · doi:10.2196/50313 · Cited by 55
“In addition, the fixed effects model was considered if the number of studies that reported eHealth literacy’s influencing factors was small ( 5) [23,24].”
Almuwallad, A., Cole, E. M., Ross, J., Perkins, Z., & Davenport, R. A. (2021) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0000000000003120 · Cited by 52
“Data Analysis To measure the effect of TXA on outcomes within individual studies, an OR with 95% confidence interval (CI) was calculated for each mortality time point presented (24 hours, and 28 to 30 days) and the incidence of VTE, using binary logistic regression, IBM SPSS version 24.(24) Meta-analysis with a random…”
MethodCognitive impairment after a stroke in young adults: A systematic review and meta-analysis
Weterings, R., Kessels, R. P. C., de Leeuw, F., & Piai, V. (2023) · International Journal of Stroke · doi:10.1177/17474930231159267 · Cited by 51
Zhang, S., Li, J., Zhang, Y., & Hu, X. (2025) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2025.105096 · Cited by 51
Yong, J. N., Ng, C. H., Lee, C. W.-M., Chan, Y. Y., Tang, A. S. P., Teng, M. L. P., Tan, D. J. H., Lim, W. H., Quek, J., Xiao, J., et al. (2022) · Hepatology International · doi:10.1007/s12072-022-10319-6 · Cited by 51
“All analyses were conducted in random effects regardless of heterogeneity measures as it has been shown to produce more robust estimates compared to the fixed effects models [22].”
ResultDol, J., Richardson, B., Murphy, G. T., Aston, M. L., McMillan, D., & Campbell-Yeo, M. L. (2019) · The JBI Database of Systematic Reviews and Implementation Reports · doi:10.11124/jbisrir-2017-004022 · Cited by 48
Papanastasiou, C. A., Zegkos, T., Karamitsos, T. D., Rowin, E. J., Maron, M. S., Parcharidou, D. G., Kokkinidis, D. G., Karvounis, H. I., Rimoldi, O. E., Maron, B. J., et al. (2021) · International Journal of Cardiology · doi:10.1016/j.ijcard.2021.03.056 · Cited by 51
Tan, D. J. H., Quek, S. X. Z., Yong, J. N., Suresh, A., Koh, K. X. M., Lim, W. H., Quek, J., Tang, A. S. P., Tan, C., Nah, B. K. Y., et al. (2022) · Clinical and Molecular Hepatology · doi:10.3350/cmh.2022.0136 · Cited by 56
Hsieh, C., Li, P.-S., Wang, C., Lin, S.-L., Hsu, T.-C., & Tsai, C.-M. (2023) · Gerontology · doi:10.1159/000529849 · Cited by 49
Gesesew, H. A., Ward, P., Hajito, K. W., Feyissa, G. T., Mohammadi, L., & Mwanri, L. (2017) · PLoS ONE · doi:10.1371/journal.pone.0169651 · Cited by 48
Metadata
- Authors
- Tufanaru, C., Munn, Z., Stephenson, M., & Aromataris, E.
- Affiliations
- The University of Adelaide (AU)
- Venue
- International Journal of Evidence-Based Healthcare
- Published
- 2015-09
- Volume
- 13
- Issue
- 3
- Pages
- 196-207
- ISSN
- 1744-1595 (ISSN-L)
- 1744-1609
- OpenAlex
- W2180006680
- Cited by
- 1,057
- References
- 62
- Citations by year
- 2026: 77 · 2025: 151 · 2024: 204 · 2023: 167 · 2022: 157 · 2021: 101 · 2020: 65 · 2019: 57 · 2018: 48 · 2017: 22 · 2016: 8
- FWCI
- 4.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Evidence-Based Healthcare (publishedVersion)
- PubMed (publishedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- fixed-effects meta-analysis, random-effects meta-analysis, systematic review methodology, intervention effectiveness, effect size, research design
- MeSH terms
- Humans, Research Design, Review Literature as Topic, Meta-Analysis as Topic, Odds Ratio, Guidelines as Topic, Cross-Over Studies, Evidence-Based Medicine, Observational Studies as Topic
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