Publication bias in clinical trials due to statistical significance or direction of trial results

Hopewell, Sally; Loudon, Kirsty; Clarke, Mike; Oxman, Andrew D; Dickersin, Kay

doi:10.1002/14651858.mr000006.pub3

Cited by 667 publications

(556 citation statements)

References 38 publications

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“…Language of publication(s). 367 (88) 25 (6) 27 (6) 259 (62) Single-centre study 159 (38) 1 (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18) 129 (81) 16 (10) 14 (9) 158 (99) Multi-centre study 260 (62) 1 238 (92) 9 (3) 13 (5) 101 ( perceived as an overestimation of the publication proportion. We excluded conference abstracts and other so-called 'grey literature' because those publications are often not indexed in electronic databases (in particular, abstracts of smaller conferences).…”

Section: Discussionmentioning

confidence: 99%

Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication

Blümle

Meerpohl

Schumacher

et al. 2016

Research Ethics Forum

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Section: Discussionmentioning

confidence: 99%

Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication

Blümle

Meerpohl

Schumacher

et al. 2016

Research Ethics Forum

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“…Our findings may have been affected by publication bias if studies finding null results were not published and therefore were not captured in this review. 51 …”

Section: Limitationsmentioning

confidence: 99%

The psychological impact of genetic information on children: a systematic review

Wakefield

Hanlon

Tucker

et al. 2016

Genetics in Medicine

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Purpose: This review assessed the psychological impact that acquiring personal and familial genetic information has on children. We also examined the concordance between the available empirical data and clinical guidance/perspectives articles. Methods:We screened 591 abstracts and identified 13 studies, representing 966 children. Ten studies assessed 386 children tested for familial adenomatous polyposis (n = 171), hereditary cardiac disease (n = 134), and other conditions (n = 81). Three studies addressed the impact of BRCA1/2 testing of a family member on 580 children.Results: Serious adverse psychological outcomes were uncommon. Most studies reported no significant increase in mean anxiety, depression, and distress scores (n = 8, 61.5%); however, some children experienced intrafamilial distress, discrimination, and guilt/regret. Some children were more concerned about their own health or their family members' health. There was limited consistency between anticipated adverse impact and empirical data. Conclusions:The review identified little conclusive evidence of deleterious psychological consequences for children acquiring genetic information. However, there is a lack of data regarding genetic testing for conditions that may not be treatable/modifiable, as well as a dearth of longitudinal studies. Therefore, clinical caution remains essential for the ethical integration of genetic testing into pediatrics. Further research assessing the potential positive and negative effects of genetic testing in childhood is warranted.

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“…• Publication or dissemination bias-Several systematic reviews of empirical studies have found that clinical trials with statistically significant (P<0.05) or positive results are more likely to be published than those with non-significant or negative results (39)(40)(41). Investigators' decisions not to submit papers with negative results for publication, rather than editors' rejection of such papers, tend to be the main source of publication bias (42).…”

mentioning

confidence: 99%

Laryngeal preneoplastic lesions and cancer: challenging diagnosis. Qualitative literature review and meta-analysis.

Mannelli

Cecconi

Gallo

2016

Critical Reviews in Oncology/Hematology

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Abstract.Background: Multi-step cancerogenesis guides laryngeal cancer onset and it includes a wide variety of pre-cancerous lesions that are macroscopically challenging to identify and distinguish from initial cancerous foci. Since the treatment of laryngeal cancer and its precursor lesions has a great impact on important laryngeal basic functions, early detection and preoperative assessment are important for a curative and function-preserving therapy. Nowadays, despite the high number of more advanced diagnostic techniques and methods, unfortunately, it is not uncommon for different clinicians to use different nomenclature or to identify different stage for the same laryngeal lesion. From these observations, it is obvious that an instrument offering the possibility to detect precancerous lesions, early cancerous lesions, and satellite foci or second primaries would be the key to improving management and outcome in laryngeal patients. Object. Different modalities of diagnostic techniques of laryngeal lesions exist. Rather than difference between benign and obvious malignant diseases, more difficult is to detect the presence of precancerous epithelial alterations. Not all tests achieve the same diagnostic accuracy, hence this meta-analysis of literature aimed to synthesize the validity of each single diagnostic technique in identifying and staging laryngeal disease. Methods: A systematic review of literature was led searching for articles mentioning the following terms including their various combinations to maximize the yield: larynx, laryngeal precancerous lesions, laryngeal cancer, white light (WL) endoscopy, stroboscopy, contact endoscopy (CE), autofluorescence (AF), ultrasound (US), narrow band imaging (NBI), computed axial tomography (CAT), magnetic resonance imaging (MRI), positron emission tomography (PET), CAT/PET. Then, a quantitative analysis was carried on for paper published after 2005 onward, reporting a minumun series of 10 patients each study, declaring sensitivity and specificity of each diagnostic system. Results: The search identified 7215 publications, of which 3616 published after 2005, with a final results of a total of 214 articles stratified and included by our selection criteria. 42 out of 214 articles were selected for quantitative synthesis. 25 out of 41 studies had a quality score of ≥ 6 (good), 16 presented a score between 4 and 5 (fair). While objections can be raised about the pooling of different diagnostic procedures under the same group and the high level of heterogeneity in the meta-analyses, the inclusion of over 4400 laryngeal lesions makes the results fairly robust. Conclusions: A comprehensive overview of the most recent advances in laryngeal imaging technology combined with all of the information needed to interpret findings and successfully manage patients with voice disorders can be found herein. With these data, clinicians can riskstratify patients and select proper examination modalities in order to provide appropriate care. Moreover, study limitations, together with p...

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Publication bias in clinical trials due to statistical significance or direction of trial results

Cited by 667 publications

References 38 publications

Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication

Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publication

The psychological impact of genetic information on children: a systematic review

Laryngeal preneoplastic lesions and cancer: challenging diagnosis. Qualitative literature review and meta-analysis.

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