Assessment of Language and Indexing Biases Among Chinese-Sponsored Randomized Clinical Trials

Jia, Yuanxi; Huang, Doudou; Wen, Jiajun; Wang, Yehua; Rosman, Lori; Chen, Qingkun; Robinson, Karen A.; Gagnier, Joel; Ehrhardt, Stephan; Celentano, David D.

doi:10.1001/jamanetworkopen.2020.5894

Cited by 13 publications

(21 citation statements)

References 25 publications

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“…Third, although the eligible studies had an overall good methodological quality, in five trials a concealed allocation was not carried out [ 59 , 61 , 63 , 64 , 66 ], which could lead to an overestimation of the exercise training effects [ 86 ]. Lastly, the possibility of language bias should not be neglected because only studies published in English were considered to inclusion [ 87 ].…”

Section: Discussionmentioning

confidence: 99%

Effect of Exercise Training on Quality of Life after Colorectal and Lung Cancer Surgery: A Meta-Analysis

Machado

Pimenta

Oliveiros

et al. 2021

Cancers

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Surgical treatment affects health-related quality of life (HRQoL) and increases fatigue symptoms in patients with lung cancer (LC) and colorectal cancer (CRC). We aimed to systematically review the effect of exercise training on HRQoL and fatigue after LC and CRC surgery. Randomized controlled trials published before 21 March 2021, were searched in PubMed, Scopus, Web of Science, SPORTDiscus and PEDro. Eligible trials compared the effect of exercise interventions initiated preoperatively or in the first 3 months after surgery versus usual care on postoperative HRQoL and fatigue. Standardized mean differences (SMD) were pooled using random-effects models. Twelve studies with a total of 777 patients were included. In LC patients (10 studies, n = 651), exercise training in general led to a moderate improvement in the physical domain of HRQoL (0.68: 95% CI: [0.47; 0.89]) and a small reduction in fatigue levels after surgery (SMD = 0.28: 95% CI: [0.02; 0.53]), while no effects were found in other HRQoL domains. In CRC (two studies, n = 126), exercise training showed no effects on HRQoL and fatigue after surgery. Exercise training is an effective intervention to improve physical function and fatigue after LC surgery. Further studies are necessary to clarify the effects of exercise on HRQoL and fatigue after CRC surgery.

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Section: Discussionmentioning

confidence: 99%

Effect of Exercise Training on Quality of Life after Colorectal and Lung Cancer Surgery: A Meta-Analysis

Machado

Pimenta

Oliveiros

et al. 2021

Cancers

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“…We searched three English bibliographic databases (PubMed, Embase, and Cochrane Controlled Register of Trials (CENTRAL)), plus four Chinese bibliographic databases (SinoMed (formerly known as Chinese Biomedical Database), the China National Knowledge Infrastructure (CNKI), Wanfang Data, and the China Science and Technology Journal Database (VIP, http://qikan.cqvip.com )). 12 The supplemental file presents the search terms. We performed the initial search on 1 January 2020 and completed an updated search on 19 October 2020.…”

Section: Methodsmentioning

confidence: 99%

Effect of redundant clinical trials from mainland China evaluating statins in patients with coronary artery disease: cross sectional study

Jia

Wen

Qureshı

et al. 2021

BMJ

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Objective To identify redundant clinical trials evaluating statin treatment in patients with coronary artery disease from mainland China, and to estimate the number of extra major adverse cardiac events (MACEs) experienced by participants not treated with statins in those trials. Design Cross sectional study. Setting 2577 randomized clinical trials comparing statin treatment with placebo or no treatment in patients with coronary artery disease from mainland China, searched from bibliographic databases to December 2019. Participants 250 810 patients with any type of coronary artery disease who were enrolled in the 2577 randomized clinical trials. Main outcome measures Redundant clinical trials were defined as randomized clinical trials that initiated or continued recruiting after 2008 (ie, one year after statin treatment was strongly recommended by clinical practice guidelines). The primary outcome is the number of extra MACEs that were attributable to the deprivation of statins among patients in the control groups of redundant clinical trials—that is, the number of extra MACEs that could have been prevented if patients were given statins. Cumulative meta-analyses were also conducted to establish the time points when statins were shown to have a statistically significant effect on coronary artery disease. Results 2045 redundant clinical trials were identified published between 2008 and 2019, comprising 101 486 patients in the control groups not treated with statins for 24 638 person years. 3470 (95% confidence interval 3230 to 3619) extra MACEs were reported, including 559 (95% confidence interval 506 to 612) deaths, 973 (95% confidence interval 897 to 1052) patients with new or recurrent myocardial infarction, 161 (132 to 190) patients with stroke, 83 (58 to 105) patients requiring revascularization, 398 (352 to 448) patients with heart failure, 1197 (1110 to 1282) patients with recurrent or deteriorated angina pectoris, and 99 (95% confidence interval 69 to 129) unspecified MACEs. Conclusions Of more than 2000 redundant clinical trials on statins in patients with coronary artery disease identified from mainland China, an extra 3000 MACEs, including nearly 600 deaths, were experienced by participants not treated with statins in these trials. The scale of redundancy necessitates urgent reform to protect patients.

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“…The process to retrieve registry records from trial registries and the corresponding journal articles from bibliographic databases has been described previously. 20 Briefly, we considered RCTs to be eligible if…”

Section: Identifying Rcts From Trial Registries and Databasesmentioning

confidence: 99%

“…In contrast, simply excluding the Chinese literature is inappropriate as it may lead to other negative consequences such as missing relevant RCTs. 14 Moreover, language bias has been found among RCTs from mainland China; excluding the Chinese literature may increase the risk of overestimating treatment effects, as RCTs with positive findings are more likely to be published inEnglish than those with negative findings 20. The coverage of Chinese journals by major English bibliographic databases has been increasing gradually while increasing numbers of systematic reviews have recently begun to include Chinese bibliographic databases to reduce bias 18.…”

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confidence: 99%

Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials

et al. 2020

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IMPORTANCE Duplicate publications of randomized clinical trials are prevalent in the health-related literature. To date, few studies have assessed the interaction between duplicate publication and the language of the original publication. OBJECTIVE To assess the existence of duplicate publication and the extent to which duplicate publication is associated with the language of the original publication. DESIGN, SETTING, AND PARTICIPANTSIn this retrospective cohort study, eligible randomized clinical trials were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible randomized clinical trials were for drug interventions from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. The trial registries were either primary registries recognized by the World Health Organization or the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration. EXPOSURES Individual randomized clinical trials with positive vs negative results. MAIN OUTCOMES AND MEASURES Journal articles were classified as main articles (determined by largest sample size and longest follow-up among all journal articles derived from that randomized clinical trial) and duplicates. The duplicates were classified into 4 types: (1) unreferenced subgroup analysis (article did not disclose itself as a subgroup analysis or reference its main article); (2) unreferenced republication (article did not disclose itself as a replicate of the main article or reference it); (3) unreferenced interim analysis (article did not disclose itself as an interim analysis or reference its main article); and (4) partial duplicate (article did not disclose its sharing a subset of participants with other articles or reference them). RESULTS Among 470 randomized clinical trials published by August 2019 as journal articles, 55 (11.7%) had 75 duplicates, of which 53 (70.7%) were cross-language duplicates. Of the 75 duplicates, 33 (44.0%) were unreferenced republications, 25 (33.3%) unreferenced subgroup analyses, 15 (20.0%) unreferenced interim analyses, and 2 (2.7%) partial duplicates. When the main article of a randomized clinical trial was published in Chinese, those with positive findings were 2.48 (95% CI, 1.08-5.71) times more likely to have subsequent duplicate publication than those with negative findings. CONCLUSIONS AND RELEVANCE In this study, most duplicates were cross-language duplicates and the most common type was unreferenced republication of the main article. Duplicate publication (continued) Key Points Question Are publication language (English and Chinese) and trial results associated with duplicate publication of randomized clinical trials conducted in mainland China? Findings This cohort study included 470 Chinese-sponsored randomized clinical trials identified from clinical trial registries and published between 2008 and 2019. Approximately 12% of those randomized clinical trials have at least 1 duplicate publicati...

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Assessment of Language and Indexing Biases Among Chinese-Sponsored Randomized Clinical Trials

Cited by 13 publications

References 25 publications

Effect of Exercise Training on Quality of Life after Colorectal and Lung Cancer Surgery: A Meta-Analysis

Effect of Exercise Training on Quality of Life after Colorectal and Lung Cancer Surgery: A Meta-Analysis

Effect of redundant clinical trials from mainland China evaluating statins in patients with coronary artery disease: cross sectional study

Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials

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