Evidence map›Paper›PMID 39623370›Full record

SynthesisBMC medicine2024

Integration of non-randomized studies with randomized controlled trials in meta-analyses of clinical studies: a meta-epidemiological study on effect estimation of interventions.

Fan Mei, Minghong Yao, Yuning Wang, Jiayidaer Huan, Yu Ma, Guowei Li, Kang Zou, Ling Li, Xin Sun

Abstract readMeta-Analysis
In one paragraph

Synthesis in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Fan Mei *Institute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
Minghong Yao *Institute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
Yuning WangInstitute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
Jiayidaer HuanInstitute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
Yu MaInstitute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
Guowei LiDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Kang ZouInstitute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
Ling LiInstitute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China. liling@wchscu.cn.
Xin SunInstitute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-Based Medicine Center, Cochrane China and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China. sunxin@wchscu.cn.

Funding

1.3.5 project for disciplines of excellence, West China Hospital, Sichuan University ZYGD23004National Natural Science Foundation of China 72204173National Natural Science Foundation of China 82274368National Science Fund for Distinguished Young Scholars 82225049special fund for traditional Chinese medicine of Sichuan Provincial Administration of Traditional Chinese Medicine 2024zd023
6 · The paper itself

Abstract

backgroundsSyntheses of non-randomized studies of interventions (NRSIs) and randomized controlled trials (RCTs) are increasingly used in decision-making. This study aimed to summarize when NRSIs are included in evidence syntheses of RCTs, with a particular focus on the methodological issues associated with combining NRSIs and RCTs.

methodsWe searched PubMed to identify clinical systematic reviews published between 9 December 2017 and 9 December 2022, randomly sampling reviews in a 1:1 ratio of Core and non-Core clinical journals. We included systematic reviews with RCTs and NRSIs for the same clinical question. Clinical scenarios for considering the inclusion of NRSIs in eligible studies were classified. We extracted the methodological characteristics of the included studies, assessed the concordance of estimates between RCTs and NRSIs, calculated the ratio of the relative effect estimate from NRSIs to that from RCTs, and evaluated the impact on the estimates of pooled estimates when NRSIs are included.

resultsTwo hundred twenty systematic reviews were included in the analysis. The clinical scenarios for including NRSIs were grouped into four main justifications: adverse outcomes (n = 140, 63.6%), long-term outcomes (n = 36, 16.4%), the applicability of RCT results to broader populations (n = 11, 5.0%), and other (n = 33, 15.0%). When conducting a meta-analysis, none of these reviews assessed the compatibility of the different types of evidence prior, 203 (92.3%) combined estimates from RCTs and NRSIs in the same meta-analysis. Of the 203 studies, 169 (76.8%) used crude estimates of NRSIs, and 28 (13.8%) combined RCTs and multiple types of NRSIs. Seventy-seven studies (35.5%) showed "qualitative disagree" between estimates from RCTs and NRSIs, and 101 studies (46.5%) found "important difference". The integration of NRSIs changed the qualitative direction of estimates from RCTs in 72 out of 200 studies (36.0%).

conclusionsSystematic reviews typically include NRSIs in the context of assessing adverse or long-term outcomes. The inclusion of NRSIs in a meta-analysis of RCTs has a substantial impact on effect estimates, but discrepancies between RCTs and NRSIs are often ignored. Our proposed recommendations will help researchers to consider carefully when and how to synthesis evidence from RCTs and NRSIs.

Indexed as

Epidemiologic StudiesRandomized Controlled Trials as TopicHumansMeta-Analysis as TopicNon-Randomized Controlled Trials as TopicSystematic Reviews as TopicMeta-analysisMeta-epidemiologyNon-randomized studies of interventionsRandomized controlled trialsSystematic review

Identifiers

PMID39623370
PMCPMC11613474

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.