Evaluation of Excess Significance Bias in Animal Studies of Neurological Diseases
Publication Date
July 16, 2013
Journal
PLOS Biology
Authors
Konstantinos K. Tsilidis, Orestis A. Panagiotou, Emily S. Sena, Eleni Aretouli, et al
Volume
11
Issue
7
Pages
e1001609
DOI
http://doi.org/10.1371/journal.pbio.1001609
Publisher URL
http://journals.plos.org/plosbiology/article?id=10.1371%2Fjournal.pbio.1001609
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/23874156
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3712913
Europe PMC
http://europepmc.org/abstract/MED/23874156
Web of Science
000322592700013
Scopus
84880934207
Mendeley
http://www.mendeley.com/research/evaluation-excess-significance-bias-animal-studies-neurological-diseases
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{"title"=>"Evaluation of Excess Significance Bias in Animal Studies of Neurological Diseases", "type"=>"journal", "authors"=>[{"first_name"=>"Konstantinos K.", "last_name"=>"Tsilidis", "scopus_author_id"=>"12789243400"}, {"first_name"=>"Orestis A.", "last_name"=>"Panagiotou", "scopus_author_id"=>"36570789200"}, {"first_name"=>"Emily S.", "last_name"=>"Sena", "scopus_author_id"=>"23028918000"}, {"first_name"=>"Eleni", "last_name"=>"Aretouli", "scopus_author_id"=>"24068716000"}, {"first_name"=>"Evangelos", "last_name"=>"Evangelou", "scopus_author_id"=>"22957065200"}, {"first_name"=>"David W.", "last_name"=>"Howells", "scopus_author_id"=>"7005218848"}, {"first_name"=>"Rustam Al Shahi", "last_name"=>"Salman", "scopus_author_id"=>"6701462635"}, {"first_name"=>"Malcolm R.", "last_name"=>"Macleod", "scopus_author_id"=>"7202645361"}, {"first_name"=>"John P A", "last_name"=>"Ioannidis", "scopus_author_id"=>"35377033000"}], "year"=>2013, "source"=>"PLoS Biology", "identifiers"=>{"sgr"=>"84880934207", "isbn"=>"1545-7885 (Electronic)\\r1544-9173 (Linking)", "pmid"=>"23874156", "doi"=>"10.1371/journal.pbio.1001609", "scopus"=>"2-s2.0-84880934207", "issn"=>"15449173", "pui"=>"369462995"}, "id"=>"c7941806-5202-3e0f-a00c-2b57b2104f4b", "abstract"=>"Animal studies generate valuable hypotheses that lead to the conduct of preventive or therapeutic clinical trials. We assessed whether there is evidence for excess statistical significance in results of animal studies on neurological disorders, suggesting biases. We used data from meta-analyses of interventions deposited in Collaborative Approach to Meta-Analysis and Review of Animal Data in Experimental Studies (CAMARADES). The number of observed studies with statistically significant results (O) was compared with the expected number (E), based on the statistical power of each study under different assumptions for the plausible effect size. We assessed 4,445 datasets synthesized in 160 meta-analyses on Alzheimer disease (n = 2), experimental autoimmune encephalomyelitis (n = 34), focal ischemia (n = 16), intracerebral hemorrhage (n = 61), Parkinson disease (n = 45), and spinal cord injury (n = 2). 112 meta-analyses (70%) found nominally (p</=0.05) statistically significant summary fixed effects. Assuming the effect size in the most precise study to be a plausible effect, 919 out of 4,445 nominally significant results were expected versus 1,719 observed (p<10(-)(9)). Excess significance was present across all neurological disorders, in all subgroups defined by methodological characteristics, and also according to alternative plausible effects. Asymmetry tests also showed evidence of small-study effects in 74 (46%) meta-analyses. Significantly effective interventions with more than 500 animals, and no hints of bias were seen in eight (5%) meta-analyses. Overall, there are too many animal studies with statistically significant results in the literature of neurological disorders. This observation suggests strong biases, with selective analysis and outcome reporting biases being plausible explanations, and provides novel evidence on how these biases might influence the whole research domain of neurological animal literature.", "link"=>"http://www.mendeley.com/research/evaluation-excess-significance-bias-animal-studies-neurological-diseases", "reader_count"=>185, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>12, "Librarian"=>2, "Researcher"=>59, "Student > Doctoral Student"=>9, "Student > Ph. D. Student"=>37, "Student > Postgraduate"=>7, "Other"=>10, "Student > Master"=>16, "Student > Bachelor"=>16, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>2, "Professor"=>11}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>12, "Librarian"=>2, "Researcher"=>59, "Student > Doctoral Student"=>9, "Student > Ph. D. Student"=>37, "Student > Postgraduate"=>7, "Other"=>10, "Student > Master"=>16, "Student > Bachelor"=>16, "Lecturer"=>2, "Lecturer > Senior Lecturer"=>2, "Professor"=>11}, "reader_count_by_subject_area"=>{"Unspecified"=>10, "Agricultural and Biological Sciences"=>70, "Philosophy"=>1, "Chemistry"=>2, "Computer Science"=>2, "Economics, Econometrics and Finance"=>1, "Engineering"=>5, "Biochemistry, Genetics and Molecular Biology"=>6, "Mathematics"=>3, "Medicine and Dentistry"=>50, "Neuroscience"=>13, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Physics and Astronomy"=>1, "Psychology"=>13, "Social Sciences"=>4, "Linguistics"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>50}, "Social Sciences"=>{"Social Sciences"=>4}, "Physics and Astronomy"=>{"Physics and Astronomy"=>1}, "Psychology"=>{"Psychology"=>13}, "Mathematics"=>{"Mathematics"=>3}, "Unspecified"=>{"Unspecified"=>10}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}, "Engineering"=>{"Engineering"=>5}, "Chemistry"=>{"Chemistry"=>2}, "Neuroscience"=>{"Neuroscience"=>13}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>70}, "Computer Science"=>{"Computer Science"=>2}, "Linguistics"=>{"Linguistics"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>6}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"United States"=>13, "Japan"=>1, "United Kingdom"=>1, "Switzerland"=>1, "Spain"=>1, "New Zealand"=>1, "Canada"=>4, "Netherlands"=>3, "Austria"=>1, "Belgium"=>1, "China"=>1, "Denmark"=>1, "Brazil"=>2, "Australia"=>1, "Chile"=>1, "France"=>1, "Germany"=>5}, "group_count"=>14}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1119588"], "description"=>"a<p>Expected number of statistically significant studies using the effect of the most precise study of each meta-analysis as the plausible effect size.</p>b<p>Expected number of statistically significant studies using the summary fixed effects estimate of each meta-analysis as the plausible effect size.</p>*<p><i>p</i>-value of the excess statistical significance test· All statistical tests were two-sided.</p><p>7-OH-DPAT, a dopamine D3 receptor agonist; NP, not pertinent, because the estimated E is larger than the O, and there is no evidence of excess statistical significance based on the assumption made for the plausible effect size; NXY-059, disufenton sodium; PHNO, a dopamine D2 receptor agonist; S32504, a dopamine D3/D2 receptor agonist; SKF 82958, a benzazepine D1/D5 dopamine agonist; SKF 38393, a benzazepine D1/D5 dopamine agonist; SKF 83959, a benzazepine D1/D2 dopamine agonist.</p>", "links"=>[], "tags"=>["epidemiology", "Clinical epidemiology", "neurology", "dementia", "Parkinson disease", "Spinal cord diseases", "studies", "49", "meta-analyses", "excess", "plausible", "equals"], "article_id"=>745993, "categories"=>["Medicine"], "users"=>["Konstantinos K. Tsilidis", "Orestis A. Panagiotou", "Emily S. Sena", "Eleni Aretouli", "Evangelos Evangelou", "David W. Howells", "Rustam Al-Shahi Salman", "Malcolm R. Macleod", "John P. A. Ioannidis"], "doi"=>"https://dx.doi.org/10.1371/journal.pbio.1001609.t002", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Observed_and_expected_number_of_8220_positive_8221_studies_in_the_49_meta_analyses_with_a_significant_excess_of_8220_positive_8221_studies_under_the_assumption_that_the_plausible_effect_size_equals_the_effect_of_the_most_precise_study_in_each_meta_analys/745993", "title"=>"Observed and expected number of “positive” studies in the 49 meta-analyses with a significant excess of “positive” studies under the assumption that the plausible effect size equals the effect of the most precise study in each meta-analysis.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-16 01:55:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/1119586"], "description"=>"a<p>Standardized mean difference and 95% CI of the most precise study (smallest standard error) in each meta-analysis.</p><p>PPAR, peroxisome proliferator-activated receptor; A86929, a dopamine receptor agonist; SKF 80723, a benzazepine D1 dopamine agonist.</p>", "links"=>[], "tags"=>["epidemiology", "Clinical epidemiology", "neurology", "dementia", "Parkinson disease", "Spinal cord diseases", "47", "meta-analyses", "respective", "had", "nominally"], "article_id"=>745991, "categories"=>["Medicine"], "users"=>["Konstantinos K. Tsilidis", "Orestis A. Panagiotou", "Emily S. Sena", "Eleni Aretouli", "Evangelos Evangelou", "David W. Howells", "Rustam Al-Shahi Salman", "Malcolm R. Macleod", "John P. A. Ioannidis"], "doi"=>"https://dx.doi.org/10.1371/journal.pbio.1001609.t001", "stats"=>{"downloads"=>0, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Description_of_the_47_meta_analyses_where_the_respective_most_precise_study_had_a_nominally_statistically_significant_effect_/745991", "title"=>"Description of the 47 meta-analyses where the respective most precise study had a nominally statistically significant effect.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-16 01:55:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/1119587"], "description"=>"a<p>Expected number of statistically significant studies using the effect of the most precise study of each meta-analysis as the plausible effect size.</p>b<p>Expected number of statistically significant studies using the summary fixed effects estimate of each meta-analysis as the plausible effect size.</p>*<p><i>p</i>-Value of the excess statistical significance test. All statistical tests were two-sided.</p><p>NP, not pertinent, because the estimated E is larger than the O, and there is no evidence of excess statistical significance based on the assumption made for the plausible effect size.</p>", "links"=>[], "tags"=>["epidemiology", "Clinical epidemiology", "neurology", "dementia", "Parkinson disease", "Spinal cord diseases", "studies", "neurological"], "article_id"=>745992, "categories"=>["Medicine"], "users"=>["Konstantinos K. Tsilidis", "Orestis A. Panagiotou", "Emily S. Sena", "Eleni Aretouli", "Evangelos Evangelou", "David W. Howells", "Rustam Al-Shahi Salman", "Malcolm R. Macleod", "John P. A. Ioannidis"], "doi"=>"https://dx.doi.org/10.1371/journal.pbio.1001609.t003", "stats"=>{"downloads"=>1, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Observed_and_expected_number_of_8220_positive_8221_studies_by_type_of_neurological_disease_/745992", "title"=>"Observed and expected number of “positive” studies by type of neurological disease.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-16 01:55:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/1119585"], "description"=>"a<p>Expected number of statistically significant studies using the effect of the most precise study of each meta-analysis as the plausible effect size.</p>b<p>Expected number of statistically significant studies using the summary fixed effects estimate of each meta-analysis as the plausible effect size.</p>*<p><i>p</i>-Value of the excess statistical significance test· All statistical tests were two-sided.</p>c<p>Quartiles of the weight of the most precise study in each meta-analysis.</p><p>NP, not pertinent, because the estimated E is larger than the O, and there is no evidence of excess statistical significance based on the assumption made for the plausible effect size.</p>", "links"=>[], "tags"=>["epidemiology", "Clinical epidemiology", "neurology", "dementia", "Parkinson disease", "Spinal cord diseases", "studies", "neurological", "diseases"], "article_id"=>745990, "categories"=>["Medicine"], "users"=>["Konstantinos K. Tsilidis", "Orestis A. Panagiotou", "Emily S. Sena", "Eleni Aretouli", "Evangelos Evangelou", "David W. Howells", "Rustam Al-Shahi Salman", "Malcolm R. Macleod", "John P. A. Ioannidis"], "doi"=>"https://dx.doi.org/10.1371/journal.pbio.1001609.t004", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Observed_and_expected_number_of_8220_positive_8221_studies_for_all_neurological_diseases_in_subgroups_/745990", "title"=>"Observed and expected number of “positive” studies for all neurological diseases in subgroups.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-16 01:55:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/1119584"], "description"=>"<p>We plotted the number of studies with a total sample size of at least 500 animals; those which showed a nominally (<i>p</i>≤0.05) statistically significant effect per fixed-effects synthesis; those that had no evidence of small-study effects; and those that had no evidence of excess significance. The numbers represent the studies that have two or more of the above characteristics according to the respective overlapping areas.</p>", "links"=>[], "tags"=>["epidemiology", "Clinical epidemiology", "neurology", "dementia", "Parkinson disease", "Spinal cord diseases", "diagrams", "meta-analyses", "studies", "neurological"], "article_id"=>745989, "categories"=>["Medicine"], "users"=>["Konstantinos K. Tsilidis", "Orestis A. Panagiotou", "Emily S. Sena", "Eleni Aretouli", "Evangelos Evangelou", "David W. Howells", "Rustam Al-Shahi Salman", "Malcolm R. Macleod", "John P. A. Ioannidis"], "doi"=>"https://dx.doi.org/10.1371/journal.pbio.1001609.g001", "stats"=>{"downloads"=>1, "page_views"=>30, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Venn_diagrams_of_the_meta_analyses_of_animal_studies_of_neurological_disorders_/745989", "title"=>"Venn diagrams of the meta-analyses of animal studies of neurological disorders.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-07-16 01:55:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/1119589"], "description"=>"<div><p>Animal studies generate valuable hypotheses that lead to the conduct of preventive or therapeutic clinical trials. We assessed whether there is evidence for excess statistical significance in results of animal studies on neurological disorders, suggesting biases. We used data from meta-analyses of interventions deposited in Collaborative Approach to Meta-Analysis and Review of Animal Data in Experimental Studies (CAMARADES). The number of observed studies with statistically significant results (O) was compared with the expected number (E), based on the statistical power of each study under different assumptions for the plausible effect size. We assessed 4,445 datasets synthesized in 160 meta-analyses on Alzheimer disease (<i>n</i> = 2), experimental autoimmune encephalomyelitis (<i>n</i> = 34), focal ischemia (<i>n</i> = 16), intracerebral hemorrhage (<i>n</i> = 61), Parkinson disease (<i>n</i> = 45), and spinal cord injury (<i>n</i> = 2). 112 meta-analyses (70%) found nominally (<i>p</i>≤0.05) statistically significant summary fixed effects. Assuming the effect size in the most precise study to be a plausible effect, 919 out of 4,445 nominally significant results were expected versus 1,719 observed (<i>p</i>&lt;10<sup>−9</sup>). Excess significance was present across all neurological disorders, in all subgroups defined by methodological characteristics, and also according to alternative plausible effects. Asymmetry tests also showed evidence of small-study effects in 74 (46%) meta-analyses. Significantly effective interventions with more than 500 animals, and no hints of bias were seen in eight (5%) meta-analyses. Overall, there are too many animal studies with statistically significant results in the literature of neurological disorders. This observation suggests strong biases, with selective analysis and outcome reporting biases being plausible explanations, and provides novel evidence on how these biases might influence the whole research domain of neurological animal liter", "links"=>[], "tags"=>["epidemiology", "Clinical epidemiology", "neurology", "dementia", "Parkinson disease", "Spinal cord diseases", "excess", "studies", "neurological"], "article_id"=>745994, "categories"=>["Medicine"], "users"=>["Konstantinos K. Tsilidis", "Orestis A. Panagiotou", "Emily S. Sena", "Eleni Aretouli", "Evangelos Evangelou", "David W. Howells", "Rustam Al-Shahi Salman", "Malcolm R. Macleod", "John P. A. Ioannidis"], "doi"=>"https://dx.doi.org/10.1371/journal.pbio.1001609", "stats"=>{"downloads"=>2, "page_views"=>26, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Evaluation_of_Excess_Significance_Bias_in_Animal_Studies_of_Neurological_Diseases/745994", "title"=>"Evaluation of Excess Significance Bias in Animal Studies of Neurological Diseases", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-04-12 17:44:10"}

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