Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration
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{"title"=>"Is mandatory prospective trial registration working to prevent publication of unregistered trials and selective outcome reporting? An observational study of five psychiatry journals that mandate prospective clinical trial registration", "type"=>"journal", "authors"=>[{"first_name"=>"Amelia", "last_name"=>"Scott", "scopus_author_id"=>"56878125700"}, {"first_name"=>"Julia J.", "last_name"=>"Rucklidge", "scopus_author_id"=>"56053959900"}, {"first_name"=>"Roger T.", "last_name"=>"Mulder", "scopus_author_id"=>"55800861000"}], "year"=>2015, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"606153967", "pmid"=>"26287998", "doi"=>"10.1371/journal.pone.0133718", "issn"=>"19326203", "scopus"=>"2-s2.0-84942694111", "sgr"=>"84942694111", "isbn"=>"1932-6203 (Electronic)\r1932-6203 (Linking)"}, "id"=>"e32d5ef3-f2c9-3afb-85e2-63c0120b7190", "abstract"=>"OBJECTIVE: To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.\\n\\nMATERIALS AND METHODS: Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.\\n\\nRESULTS: Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.\\n\\nDISCUSSION: Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.", "link"=>"http://www.mendeley.com/research/mandatory-prospective-trial-registration-working-prevent-publication-unregistered-trials-selective-o", "reader_count"=>26, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Student > Doctoral Student"=>3, "Researcher"=>4, "Student > Ph. D. Student"=>1, "Student > Master"=>3, "Other"=>3, "Student > Bachelor"=>3, "Lecturer"=>3, "Professor"=>4}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Student > Doctoral Student"=>3, "Researcher"=>4, "Student > Ph. D. Student"=>1, "Student > Master"=>3, "Other"=>3, "Student > Bachelor"=>3, "Lecturer"=>3, "Professor"=>4}, "reader_count_by_subject_area"=>{"Unspecified"=>3, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>12, "Agricultural and Biological Sciences"=>1, "Neuroscience"=>2, "Psychology"=>1, "Social Sciences"=>3, "Computer Science"=>1, "Economics, Econometrics and Finance"=>1, "Business, Management and Accounting"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>12}, "Neuroscience"=>{"Neuroscience"=>2}, "Social Sciences"=>{"Social Sciences"=>3}, "Psychology"=>{"Psychology"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Unspecified"=>{"Unspecified"=>3}}, "reader_count_by_country"=>{"United States"=>1, "Luxembourg"=>1, "United Kingdom"=>1, "Australia"=>1, "Peru"=>1, "Spain"=>1}, "group_count"=>1}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/2217509"], "description"=>"<p><sup>a</sup>one study reported no source of funding,</p><p><sup>b</sup>includes 3 articles where we were unable to determine whether POMs retro updated in trial registry.</p><p>Funding source of research across different categories of registration.</p>", "links"=>[], "tags"=>["1 January 2009", "ICMJE guidelines", "impacting psychiatry publications", "Selective Outcome Reporting", "psychiatry journals", "Clinical Trial Registration ObjectiveTo address", "trial registration information", "Medical Journal Editors", "psychiatry", "trial registration guidelines", "Trial Registration Working", "31 July 2013", "pom", "participant numbers"], "article_id"=>1514789, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Amelia Scott", "Julia J. Rucklidge", "Roger T. Mulder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0133718.t003", "stats"=>{"downloads"=>6, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Funding_source_of_research_across_different_categories_of_registration_/1514789", "title"=>"Funding source of research across different categories of registration.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-08-19 04:01:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/2217507"], "description"=>"<p>Length of time taken after start date for trial registration to be created for trials that were retrospectively registered.</p>", "links"=>[], "tags"=>["1 January 2009", "ICMJE guidelines", "impacting psychiatry publications", "Selective Outcome Reporting", "psychiatry journals", "Clinical Trial Registration ObjectiveTo address", "trial registration information", "Medical Journal Editors", "psychiatry", "trial registration guidelines", "Trial Registration Working", "31 July 2013", "pom", "participant numbers"], "article_id"=>1514787, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Amelia Scott", "Julia J. Rucklidge", "Roger T. Mulder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0133718.t001", "stats"=>{"downloads"=>5, "page_views"=>17, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Length_of_time_taken_after_start_date_for_trial_registration_to_be_created_for_trials_that_were_retrospectively_registered_/1514787", "title"=>"Length of time taken after start date for trial registration to be created for trials that were retrospectively registered.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-08-19 04:01:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/2217508"], "description"=>"<p>Differences in Primary Outcome Measures between Trial Registry and Published Article for Prospectively Registered Trials with Clear Descriptions of Outcome Measures and Differences in Primary Outcomes Favouring Statistically Significant Results.</p>", "links"=>[], "tags"=>["1 January 2009", "ICMJE guidelines", "impacting psychiatry publications", "Selective Outcome Reporting", "psychiatry journals", "Clinical Trial Registration ObjectiveTo address", "trial registration information", "Medical Journal Editors", "psychiatry", "trial registration guidelines", "Trial Registration Working", "31 July 2013", "pom", "participant numbers"], "article_id"=>1514788, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Amelia Scott", "Julia J. Rucklidge", "Roger T. Mulder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0133718.t002", "stats"=>{"downloads"=>3, "page_views"=>14, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Differences_in_Primary_Outcome_Measures_between_Trial_Registry_and_Published_Article_for_Prospectively_Registered_Trials_with_Clear_Descriptions_of_Outcome_Measures_and_Differences_in_Primary_Outcomes_Favouring_Statistically_Significant_Results_/1514788", "title"=>"Differences in Primary Outcome Measures between Trial Registry and Published Article for Prospectively Registered Trials with Clear Descriptions of Outcome Measures and Differences in Primary Outcomes Favouring Statistically Significant Results.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-08-19 04:01:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/2217506"], "description"=>"<p>Flowchart of Articles Used to Assess Registration and Selective Reporting.</p>", "links"=>[], "tags"=>["1 January 2009", "ICMJE guidelines", "impacting psychiatry publications", "Selective Outcome Reporting", "psychiatry journals", "Clinical Trial Registration ObjectiveTo address", "trial registration information", "Medical Journal Editors", "psychiatry", "trial registration guidelines", "Trial Registration Working", "31 July 2013", "pom", "participant numbers"], "article_id"=>1514786, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Amelia Scott", "Julia J. Rucklidge", "Roger T. Mulder"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0133718.g001", "stats"=>{"downloads"=>5, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flowchart_of_Articles_Used_to_Assess_Registration_and_Selective_Reporting_/1514786", "title"=>"Flowchart of Articles Used to Assess Registration and Selective Reporting.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-08-19 04:01:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/2217518", "https://ndownloader.figshare.com/files/2217519"], "description"=>"<div><p>Objective</p><p>To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.</p><p>Materials and Methods</p><p>Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.</p><p>Results</p><p>Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.</p><p>Discussion</p><p>Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.</p></div>", "links"=>[], "tags"=>["1 January 2009", "ICMJE guidelines", "impacting psychiatry publications", "Selective Outcome Reporting", "psychiatry journals", "Clinical Trial Registration ObjectiveTo address", "trial registration information", "Medical Journal Editors", "psychiatry", "trial registration guidelines", "Trial Registration Working", "31 July 2013", "pom", "participant numbers"], "article_id"=>1514791, "categories"=>["Biological Sciences", "Science Policy"], "users"=>["Amelia Scott", "Julia J. Rucklidge", "Roger T. Mulder"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0133718.s001", "https://dx.doi.org/10.1371/journal.pone.0133718.s002"], "stats"=>{"downloads"=>6, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Is_Mandatory_Prospective_Trial_Registration_Working_to_Prevent_Publication_of_Unregistered_Trials_and_Selective_Outcome_Reporting_An_Observational_Study_of_Five_Psychiatry_Journals_That_Mandate_Prospective_Clinical_Trial_Registration_/1514791", "title"=>"Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2015-08-19 04:01:19"}

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Relative Metric

{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
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