Inclusion of nonrandomized studies of interventions in systematic reviews of interventions: updated guidance from the Agency for Health Care Research and Quality Effective Health Care program

Saldanha, Ian J.; Adam, Gaelen P; Bañez, Lionel L.; Bass, Eric B; Berliner, Elise; Devine, Beth; Hammarlund, Noah; Jain, Anjali; Norris, Susan L.; Skelly, Andrea C.; Ley, Kelly Vander; Wang, Zhen; Wilt, Timothy J; Viswanathan, Meera

doi:10.1016/j.jclinepi.2022.08.015

Cited by 16 publications

(5 citation statements)

References 19 publications

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“…In brief, we considered all randomized controlled trials and nonrandomized studies (e.g. quasi-experimental, cohort, or case–control) [10] that enrolled postpartum individuals aged 18 years or older, evaluated a lifestyle (i.e. nonpharmacologic) intervention, and included blood pressure as a primary, secondary, or exploratory outcome.…”

Section: Methodsmentioning

confidence: 99%

The effect of postpartum lifestyle interventions on blood pressure: a systematic literature review

Horwitz

Tabani

Bredy

et al. 2023

Journal of Hypertension

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Postpartum lifestyle modification is recommended to hypertension risk. We conducted a systematic literature review to assess the evidence for postpartum lifestyle interventions to reduce blood pressure. We searched for relevant publications from 2010 through November 2022. Two authors independently conducted article screening and data extraction; a third resolved discrepancies. Ultimately, nine studies met inclusion criteria. Most were randomized controlled trials and had sample sizes <100. In all but one of the eight studies reporting race data, nearly all participants identified as White. None of the studies reported a significant intervention effect on blood pressure. However, most interventions were associated with improvements in other outcomes, such as physical activity. Overall, the evidence for postpartum lifestyle interventions to reduce blood pressure is limited to a handful of studies characterized by small sample sizes and a lack of racial diversity. Additional research with larger samples, more diverse populations, and intermediate outcomes is warranted.

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Section: Methodsmentioning

confidence: 99%

The effect of postpartum lifestyle interventions on blood pressure: a systematic literature review

Horwitz

Tabani

Bredy

et al. 2023

Journal of Hypertension

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“…This quasi-experimental study used a non-randomized control group design, where interventions were applied to both an experimental and a control group without randomization (Harris et al, 2006;Saldanha et al, 2022). This design allowed the comparison of the effects of two teaching methods on the critical thinking skills of fourthgrade students at SD Negeri 02 Nabire.…”

Section: Methodsmentioning

confidence: 99%

Fostering Critical and Creative Thinking in Mathematics: A Study on Brain-Based and Problem-Based Learning

Telussa,

Kaihatu,

Arjanto

2024

PiJIES

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The study looked at how using brain-based learning (BBL) and problem-based learning (PBL) together could help 7th-grade students improve their critical and creative thinking in math at SD Negeri 02 Nabire. They wanted to see if these methods could fill gaps in traditional teaching by making learning more inclusive. They used a type of research design that compares two groups, one getting the new teaching methods and the other not, to see if there's a difference. They tested 58 students before and after the new methods using various statistical tools and found that both BBL and PBL made a big difference in how well students could think critically and creatively. This study adds to what we know about how BBL and PBL can make math learning better. It shows that when teaching matches how students learn best, they do better in math and are more ready for future challenges.

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“…The RWE studies considered herein are referred to as observational or experimental studies of the effectiveness and/or harms of interventions, in which participants are not randomized to intervention groups 14 . Such studies include non‐RCTs, cohort studies, and case‐controlled studies 15 . We assume that the relative effects from RWE studies are estimated by using appropriate causal inference methods in epidemiological design and statistical analysis that minimizes bias 16 .…”

Section: Statistical Methods For Combining Rcts and Rwe Studiesmentioning

confidence: 99%

“…14 Such studies include non-RCTs, cohort studies, and case-controlled studies. 15 We assume that the relative effects from RWE studies are estimated by using appropriate causal inference methods in epidemiological design and statistical analysis that minimizes bias. 16 The risk of bias in both RCTs and RWE studies has been well evaluated.…”

Section: Statistical Methods For Combining Rcts and Rwe Studiesmentioning

confidence: 99%

Comparison of statistical methods for integrating real‐world evidence in a rare events meta‐analysis of randomized controlled trials

Yao

Wang

Ren

et al. 2023

Research Synthesis Methods

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Rare events meta‐analyses of randomized controlled trials (RCTs) are often underpowered because the outcomes are infrequent. Real‐world evidence (RWE) from non‐randomized studies may provide valuable complementary evidence about the effects of rare events, and there is growing interest in including such evidence in the decision‐making process. Several methods for combining RCTs and RWE studies have been proposed, but the comparative performance of these methods is not well understood. We describe a simulation study that aims to evaluate an array of alternative Bayesian methods for including RWE in rare events meta‐analysis of RCTs: the naïve data synthesis, the design‐adjusted synthesis, the use of RWE as prior information, the three‐level hierarchical models, and the bias‐corrected meta‐analysis model. The percentage bias, root‐mean‐square‐error, mean 95% credible interval width, coverage probability, and power are used to measure performance. The various methods are illustrated using a systematic review to evaluate the risk of diabetic ketoacidosis among patients using sodium/glucose co‐transporter 2 inhibitors as compared with active‐comparators. Our simulations show that the bias‐corrected meta‐analysis model is comparable to or better than the other methods in terms of all evaluated performance measures and simulation scenarios. Our results also demonstrate that data solely from RCTs may not be sufficiently reliable for assessing the effects of rare events. In summary, the inclusion of RWE could increase the certainty and comprehensiveness of the body of evidence of rare events from RCTs, and the bias‐corrected meta‐analysis model may be preferable.

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Inclusion of nonrandomized studies of interventions in systematic reviews of interventions: updated guidance from the Agency for Health Care Research and Quality Effective Health Care program

Cited by 16 publications

References 19 publications

The effect of postpartum lifestyle interventions on blood pressure: a systematic literature review

The effect of postpartum lifestyle interventions on blood pressure: a systematic literature review

Fostering Critical and Creative Thinking in Mathematics: A Study on Brain-Based and Problem-Based Learning

Comparison of statistical methods for integrating real‐world evidence in a rare events meta‐analysis of randomized controlled trials

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