{"id":26742,"date":"2024-11-01T04:20:00","date_gmt":"2024-10-31T20:20:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=26742"},"modified":"2024-11-01T05:41:34","modified_gmt":"2024-10-31T21:41:34","slug":"jama-netw-open%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%a4%a7%e8%a7%84%e6%a8%a1%e5%92%8c%e5%b0%8f%e8%a7%84%e6%a8%a1%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%9a%84%e4%b8%80%e8%87%b4%e6%80%a7","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=26742","title":{"rendered":"[JAMA Netw Open\u53d1\u8868\u8bba\u6587]\uff1a\u5927\u89c4\u6a21\u548c\u5c0f\u89c4\u6a21\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e00\u81f4\u6027"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

Statistics and Research Methods<\/p>\n\n\n\n

September 6, 2024<\/p>\n\n\n\n

Agreement Between Mega-Trials and Smaller Trials: A Systematic Review and Meta-Research Analysis<\/h1>\n\n\n\n

Lum Kastrati, Hamidreza Raeisi-Dehkordi, Erand Llanaj, et al<\/h3>\n\n\n\n

JAMA Netw Open. <\/em>2024;7(9):e2432296. doi:10.1001\/jamanetworkopen.2024.32296<\/h3>\n\n\n\n

<\/a>Key Points<\/p>\n\n\n\n

Question<\/strong>  Are the results of mega-trials with 10\u202f000 participants or more similar to meta-analysis of trials with smaller sample sizes for the primary outcome and\/or all-cause mortality?<\/p>\n\n\n\n

Findings<\/strong>  In this meta-research analysis of 82 mega-trials, meta-analyses of smaller studies showed overall comparable results with mega-trials, but smaller trials published before the mega-trials gave more favorable results than mega-trials. There were very low rates of significant results for the primary outcome and all-cause mortality for mega-trials.<\/p>\n\n\n\n

Meaning<\/strong>  The findings of this study suggest that mega-trials need to be performed more often, given the relative low number of mega-trials found, their low significant rates, and the fact that smaller trials published prior to mega-trial reported more beneficial results than mega-trials and subsequent smaller trials.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  Mega-trials can provide large-scale evidence on important questions.<\/p>\n\n\n\n

Objective<\/strong>  To explore how the results of mega-trials compare with the meta-analysis results of trials with smaller sample sizes.<\/p>\n\n\n\n

Data Sources<\/strong>  ClinicalTrials.gov was searched for mega-trials until January 2023. PubMed was searched until June 2023 for meta-analyses incorporating the results of the eligible mega-trials.<\/p>\n\n\n\n

Study Selection<\/strong>  Mega-trials were eligible if they were noncluster nonvaccine randomized clinical trials, had a sample size over 10\u202f000, and had a peer-reviewed meta-analysis publication presenting results for the primary outcome of the mega-trials and\/or all-cause mortality.<\/p>\n\n\n\n

Data Extraction and Synthesis<\/strong>  For each selected meta-analysis, we extracted results of smaller trials and mega-trials included in the summary effect estimate and combined them separately using random effects. These estimates were used to calculate the ratio of odds ratios (ROR) between mega-trials and smaller trials in each meta-analysis. Next, the RORs were combined using random effects. Risk of bias was extracted for each trial included in our analyses (or when not available, assessed only for mega-trials). Data analysis was conducted from January to June 2024.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  The main outcomes were the summary ROR for the primary outcome and all-cause mortality between mega-trials and smaller trials. Sensitivity analyses were performed with respect to the year of publication, masking, weight, type of intervention, and specialty.<\/p>\n\n\n\n

Results<\/strong>\u00a0\u00a0Of 120 mega-trials identified, 41 showed a significant result for the primary outcome and 22 showed a significant result for all-cause mortality. In 35 comparisons of primary outcomes (including 85 point estimates from 69 unique mega-trials and 272 point estimates from smaller trials) and 26 comparisons of all-cause mortality (including 70 point estimates from 65 unique mega-trials and 267 point estimates from smaller trials), no difference existed between the outcomes of the mega-trials and smaller trials for primary outcome (ROR, 1.00; 95% CI, 0.97-1.04) nor for all-cause mortality (ROR, 1.00; 95% CI, 0.97-1.04). For the primary outcomes, smaller trials published before the mega-trials had more favorable results than the mega-trials (ROR, 1.05; 95% CI, 1.01-1.10) and subsequent smaller trials published after the mega-trials (ROR, 1.10; 95% CI, 1.04-1.18).<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>  In this meta-research analysis, meta-analyses of smaller studies showed overall comparable results with mega-trials, but smaller trials published before the mega-trials gave more favorable results than mega-trials. These findings suggest that mega-trials need to be performed more often given the relative low number of mega-trials found, their low significant rates, and the fact that smaller trials published prior to mega-trial report more beneficial results than mega-trials and subsequent smaller trials.<\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  Statistics and Research Me […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26742"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26742"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26742\/revisions"}],"predecessor-version":[{"id":27065,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26742\/revisions\/27065"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26742"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26742"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}