Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2016 Mar 22:16:35.
doi: 10.1186/s12874-016-0136-0.

Meta-analyses including non-randomized studies of therapeutic interventions: a methodological review

Affiliations
Meta-Analysis

Meta-analyses including non-randomized studies of therapeutic interventions: a methodological review

Timor Faber et al. BMC Med Res Methodol. .

Abstract

Background: There is an increasing number of meta-analyses including data from non-randomized studies for therapeutic evaluation. We aimed to systematically assess the methods used in meta-analyses including non-randomized studies evaluating therapeutic interventions.

Methods: For this methodological review, we searched MEDLINE via PubMed, from January 1, 2013 to December 31, 2013 for meta-analyses including at least one non-randomized study evaluating therapeutic interventions. Etiological assessments and meta-analyses with no comparison group were excluded. Two reviewers independently assessed the general characteristics and key methodological components of the systematic review process and meta-analysis methods.

Results: One hundred eighty eight meta-analyses were selected: 119 included both randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSI) and 69 only NRSI. Half of the meta-analyses (n = 92, 49%) evaluated non-pharmacological interventions. "Grey literature" was searched for 72 meta-analyses (38%). An assessment of methodological quality or risk of bias was reported in 135 meta-analyses (72%) but this assessment considered the risk of confounding bias in only 33 meta-analyses (18%). In 130 meta-analyses (69%), the design of each NRSI was not clearly specified. In 131 (70%), whether crude or adjusted estimates of treatment effect for NRSI were combined was unclear or not reported. Heterogeneity across studies was assessed in 182 meta-analyses (97%) and further explored in 157 (84%). Reporting bias was assessed in 127 (68%).

Conclusions: Some key methodological components of the systematic review process-search for grey literature, description of the type of NRSI included, assessment of risk of confounding bias and reporting of whether crude or adjusted estimates were combined-are not adequately carried out or reported in meta-analyses including NRSI.

Keywords: Meta-analyses; Non-randomized studies; Reporting; Therapeutic evaluation.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Study selection flowchart

References

    1. Castillo RC, Scharfstein DO, MacKenzie EJ. Observational studies in the era of randomized trials: finding the balance. J Bone Joint Surg Am. 2012;94(Suppl 1):112–117. doi: 10.2106/JBJS.L.00242. - DOI - PubMed
    1. Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med. 2005;142(12 Pt 2):1090–1099. doi: 10.7326/0003-4819-142-12_Part_2-200506211-00009. - DOI - PubMed
    1. Grootendorst DC, Jager KJ, Zoccali C, Dekker FW. Observational studies are complementary to randomized controlled trials. Nephron. 2010;114(3):c173–177. - PubMed
    1. Yang W, Zilov A, Soewondo P, Bech OM, Sekkal F, Home PD. Observational studies: going beyond the boundaries of randomized controlled trials. Diabetes Res Clin Pract. 2010;88(Suppl 1):S3–9. doi: 10.1016/S0168-8227(10)70002-4. - DOI - PubMed
    1. Black N. Why we need observational studies to evaluate the effectiveness of health care. Bmj. 1996;312(7040):1215–1218. doi: 10.1136/bmj.312.7040.1215. - DOI - PMC - PubMed

LinkOut - more resources