Selective outcome reporting is present in randomized controlled trials in lung cancer immunotherapies

Aggarwal, Reenika; Oremus, Mark

doi:10.1016/j.jclinepi.2018.10.010

Cited by 12 publications

(17 citation statements)

References 15 publications

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“…The high prevalence of new secondary outcomes (63.3%) in our investigation was similar to previous reports (Aggarwal & Oremus, ; Fleming et al., ; Hartung et al., ). Interestingly, the introduction of a new secondary outcome favoured significant results.…”

Section: Discussionsupporting

confidence: 93%

“…In contrast to earlier findings (Aggarwal & Oremus, ; Chan et al., ; Jones & Platts‐Mills, ; Killeen, Sourallous, Hunter, Hartley, & Grady, ; Mathieu et al., ; Wayant et al., ; Zhang et al., ), SOR was not associated with significant results of primary outcomes. One possible explanation was that 34.8% of the publications did not identify which was the primary outcome reported.…”

Section: Discussioncontrasting

confidence: 90%

“…This is one of the reasons why registration of clinical trials and pre‐specification of all outcomes reported and their time frames is mandatory. However, investigations still show a high prevalence of selective outcome reporting in the medical literature (Aggarwal & Oremus, ; Chan et al., ; Fleming et al., ; Jones et al., ; Koufatzidou et al., ; Mathieu et al., ; Weston et al., ; Zhang et al., ). Likewise, our study confirmed the existence of discrepancies between registered trial protocols and publications in the field of dental implants.…”

Section: Discussionmentioning

confidence: 99%

“…However, selective outcome reporting is still prominent in the literature. Major discrepancies between registered and published outcomes in medical trials are still being reported (Aggarwal & Oremus, ; Fleming, Koletsi, Dwan, & Pandis, ; Jones, Keil, Holland, Caughey, & Platts‐Mills, ; Weston et al., ; Zhang et al., ), in most of the cases favouring significant results.…”

Section: Introductionmentioning

confidence: 99%

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Selective outcome reporting in randomized clinical trials of dental implants

Sendyk

Rovai

Souza

et al. 2019

J Clinic Periodontology

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Aim: Selective outcome reporting (SOR) is a type of bias that occurs when the primary outcome of a trial protocol is changed or omitted in the paper. The purpose of this study was to evaluate the prevalence of SOR in publications of randomized clinical trials (RCT) concerning dental implants. Materials and Methods:Two reviewers independently screened protocols registered at ClinicalTrials.gov until February/2019. If the protocol met the eligibility criteria, the reviewers tried to identify the corresponding publication. Data extraction was carried out by the same reviewers. Primary and secondary outcomes were recorded for each trial and compared to outcomes previously described in protocols. Results:A total of 49 protocols were included. SOR was identified in 27 (55.1%) trials.The major discrepancies were as follows: protocol-defined primary outcome omitted in the publication (n = 6, 12.2%), new primary outcome introduced (n = 8, 16.3%), discrepancy in the primary outcome time frame (n = 17, 34.7%) and new secondary outcome introduced (n = 31, 63.3%). SOR was significantly associated with industry funding (p = 0.04) and timing of registration (p = 0.04). Conclusions:Our results indicate a high rate of SOR in dental implants clinical trials.Use of registry data during the peer-review process may help decreasing SOR. K E Y W O R D S dental implant, randomized clinical trials, selective reporting | 759 SENDYK Et al. S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section at the end of the article. How to cite this article: Sendyk DI, Rovai ES, Souza NV, Deboni MCZ, Pannuti CM. Selective outcome reporting in randomized clinical trials of dental implants. J Clin Periodontol. 2019;46:758-765. https ://doi.

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Section: Discussionsupporting

confidence: 93%

Section: Discussioncontrasting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Selective outcome reporting in randomized clinical trials of dental implants

Sendyk

Rovai

Souza

et al. 2019

J Clinic Periodontology

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“…Comparisons between preregistration documents and published reports enable independent researchers to determine whether this form of bias has likely occurred. Multiple studies indicate that selective reporting bias is a pervasive problem in the medical literature [12][13][14][15][16] including psychotherapy trials. 17 18 They found that 28% of trials in their sample showed evidence of selective outcome reporting.…”

Section: Main Findingsmentioning

confidence: 99%

Assessment of transparent and reproducible research practices in the psychiatry literature

et al. 2020

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BackgroundReproducibility is a cornerstone of scientific advancement; however, many published works may lack the core components needed for study reproducibility.AimsIn this study, we evaluate the state of transparency and reproducibility in the field of psychiatry using specific indicators as proxies for these practices.MethodsAn increasing number of publications have investigated indicators of reproducibility, including research by Harwicke et al, from which we based the methodology for our observational, cross-sectional study. From a random 5-year sample of 300 publications in PubMed-indexed psychiatry journals, two researchers extracted data in a duplicate, blinded fashion using a piloted Google form. The publications were examined for indicators of reproducibility and transparency, which included availability of: materials, data, protocol, analysis script, open-access, conflict of interest, funding and online preregistration.ResultsThis study ultimately evaluated 296 randomly-selected publications with a 3.20 median impact factor. Only 107 were available online. Most primary authors originated from USA, UK and the Netherlands. The top three publication types were cohort studies, surveys and clinical trials. Regarding indicators of reproducibility, 17 publications gave access to necessary materials, four provided in-depth protocol and one contained raw data required to reproduce the outcomes. One publication offered its analysis script on request; four provided a protocol availability statement. Only 107 publications were publicly available: 13 were registered in online repositories and four, ten and eight publications included their hypothesis, methods and analysis, respectively. Conflict of interest was addressed by 177 and reported by 31 publications. Of 185 publications with a funding statement, 153 publications were funded and 32 were unfunded.ConclusionsCurrently, Psychiatry research has significant potential to improve adherence to reproducibility and transparency practices. Thus, this study presents a reference point for the state of reproducibility and transparency in Psychiatry literature. Future assessments are recommended to evaluate and encourage progress.

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