Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology

Li, Xiaoqian; Yang, Geliang; Tao, Kun‐Ming; Zhang, Huiqing; Zhou, Qing-Hui; Ling, Changquan

doi:10.3109/00365521.2013.845909

Cited by 24 publications

(21 citation statements)

References 38 publications

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“…Other studies of selective outcome reporting across various fields of medicine support our findings [15, 27, 34–37]. The vast majority (85.2%) of hematology RCTs we evaluated were registered before the end of patient enrollment.…”

Section: Discussionsupporting

confidence: 85%

Evidence of selective reporting bias in hematology journals: A systematic review

et al. 2017

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IntroductionSelective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored.MethodsOur primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included.ResultsOf 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes.ConclusionOur results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making.

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Section: Discussionsupporting

confidence: 85%

Evidence of selective reporting bias in hematology journals: A systematic review

et al. 2017

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“…2 documents the disposition of the review process. We located 38 articles that analyzed the effectiveness of interventions to prevent or reduce publication bias [20–57] . The included research provides evidence regarding: prospective trial registration; the peer review process; disclosure of conflicts of interest (CoIs); and open-access publishing.…”

Section: Resultsmentioning

confidence: 99%

“…We located 30 studies that evaluated aspects of prospective trial registration related to publication bias [20–49] . These studies offered data on several key issues: whether the International Committee of Medical Journal Editors (ICMJE) policy on accepting only manuscripts of prospectively registered trials has increased the proportion of trials registered (use of registries); whether prospective trial registration decreases the proportion of scientific publications that report different key outcomes or methods than those initially registered (i.e., discourages selective outcome-reporting bias); the quality and accuracy of information contained in trial registries (i.e., for systematic reviewers to be able to detect selective outcome-reporting bias if it occurs); and finally, whether the FDA Amendment Act 2007 mandating that trial results be available in registries is effective.…”

Section: Resultsmentioning

confidence: 99%

“…Fourteen studies of registry entries provide evidence that the problem of positive outcome-reporting bias still exists, even for prospectively registered trials (low QoE). Specifically, between 30% and 50% of primary outcomes and up to 65% of secondary outcomes are changed between the first and last entry of study information in trial registries or differ between registry entry and journal publication [22,23,27–30,35,36,40–42,44,47,49] .…”

Section: Resultsmentioning

confidence: 99%

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Inadequate use and regulation of interventions against publication bias decreases their effectiveness: a systematic review

Thaler

Kien

Nußbaumer

et al. 2015

Journal of Clinical Epidemiology

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ObjectivesTo determine the effectiveness of interventions designed to prevent or reduce publication and related biases.Study Design and SettingWe searched multiple databases and performed manual searches using terms related to publication bias and known interventions against publication bias. We dually reviewed citations and assessed risk of bias. We synthesized results by intervention and outcomes measured and graded the quality of the evidence (QoE).ResultsWe located 38 eligible studies. The use of prospective trial registries (PTR) has increased since 2005 (seven studies, moderate QoE); however, positive outcome-reporting bias is prevalent (14 studies, low QoE), and information in nonmandatory fields is vague (10 studies, low QoE). Disclosure of financial conflict of interest (CoI) is inadequate (five studies, low QoE). Blinding peer reviewers may reduce geographical bias (two studies, very low QoE), and open-access publishing does not discriminate against authors from low-income countries (two studies, very low QoE).ConclusionThe use of PTR and CoI disclosures is increasing; however, the adequacy of their use requires improvement. The effect of open-access publication and blinding of peer reviewers on publication bias is unclear, as is the effect of other interventions such as electronic publication and authors' rights to publish their results.

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“…Further discrepancies could be found in full reports with respect to funding, sample-size calculations, randomization, blinding, conclusions, or other aspects compared with their corresponding registrations or protocols (51). One study concluded that the inconsistent reporting problem of RCTs published in gastroenterology and hepatology journals may have improved from 2009 to 2012; however, as emphasized in the study's Discussion section, this conclusion was probably influenced by sampling bias (52).…”

Section: Inconsistency Between Protocols or Registrations And Fullmentioning

confidence: 99%

Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions

Bhatt

Wang

et al. 2018

Proc. Natl. Acad. Sci. U.S.A.

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Evidence from a well-designed randomized controlled trial (RCT) is generally considered to be the gold standard that can inform clinical practice and guide decision-making. However, several deficiencies in the reporting of RCTs have frequently been identified, including incomplete, selective, and biased or inconsistent reporting. Such suboptimal reporting may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct. In this article, we present an overview of the reporting of RCTs in the biomedical literature with a focus on the three most common reporting problems: (i) lack of adherence to reporting guidelines, (ii) inconsistencies between trial protocols or registrations and full reports, and (iii) inconsistencies between abstracts and their corresponding full reports. Unsatisfactory levels of adherence to guidelines and frequent inconsistencies between protocols or registrations and full reports, and between abstracts and full reports, were consistently found in various biomedical research fields. A variety of factors were found to be associated with these reporting challenges. Improved reporting can build public trust and credibility of science, save resources, and enhance the ethical integrity of research. Therefore, joint efforts from the various sectors of the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers) are needed to reduce and reverse the current suboptimal state of RCT reporting in the literature.randomized controlled trial | reporting quality | transparency | guideline adherence | inconsistent reporting I n evidence-based medicine, evidence from well-designed randomized controlled trials (RCTs) is generally considered to be the gold standard to inform clinical practice and guide decisionmaking (1). However, several deficiencies in the reporting of RCTs have been frequently identified, including incomplete, selective, and biased or inconsistent reporting. For example, it was found that only about 60% of RCT reports provided adequate information on interventions (2). This suboptimal reporting of clinical trials may lead to irreproducible results, substantial waste of resources, impaired study validity, erosion of public trust in science, and a high risk of research misconduct mainly due to the potential consequence of patients suffering and dying unnecessarily (3). Moreover, enhancing the quality and transparency of reporting is an ethical and scientific obligation in order to avoid wasting research resources, minimize risk of harms and maximize benefits of therapies, and enhance research integrity (4-6). Therefore, improving reporting of health research is an imperative that requires a variety of efforts by the biomedical community (researchers, journal editors and reviewers, educators, healthcare providers, and other research consumers). In this article, we highlight and provide some insights into the three most co...

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Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology

Cited by 24 publications

References 38 publications

Evidence of selective reporting bias in hematology journals: A systematic review

Evidence of selective reporting bias in hematology journals: A systematic review

Inadequate use and regulation of interventions against publication bias decreases their effectiveness: a systematic review

Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions

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