Jean Philippe de Jong1, Gerben Ter Riet, Dick Ludolf Willems. 1. Division of Clinical Methods and Public Health, Academic Medical Center, University of Amsterdam, Meibergdreef 15, Amsterdam, The Netherlands. j.ph.dejong@amc.uva.nl
Abstract
OBJECTIVE: To identify prognostic indicators of the publication rate of clinical studies, available to research ethics committees (RECs) during review. STUDY DESIGN AND SETTING: Retrospective survival study of a random sample of 100 studies, approved by a Dutch academic REC, with follow-up information by questionnaire and bibliographic searches. Multivariate Cox regression analysis of the association between publication rate and seven factors available during review: six study characteristics and the number of letters sent by the committee during review representing the length of the review process. RESULTS: Two factors were associated with publication rate: studies with possible therapeutic benefit to participants were less likely to be published than nontherapeutic studies (adjusted hazard ratio [AHR]: 0.16; 95% confidence interval [CI]: 0.03-0.54); with every letter sent, publication was less likely (AHR: 0.46 per letter; 95% CI: 0.17-0.98). Possibly, studies with more-than-minimal burdens to participants were more likely to be published than studies with minimal burdens (AHR: 3.90, 95% CI: 1.03-16.64). CONCLUSION: We identified two prognostic indicators of publication rate. After suitable replication, RECs might explore using prognostic indicators, such as these, to target study protocols at high risk for nonpublication. Discussing the risk of nonpublication with investigators could help prevent nonpublication.
OBJECTIVE: To identify prognostic indicators of the publication rate of clinical studies, available to research ethics committees (RECs) during review. STUDY DESIGN AND SETTING: Retrospective survival study of a random sample of 100 studies, approved by a Dutch academic REC, with follow-up information by questionnaire and bibliographic searches. Multivariate Cox regression analysis of the association between publication rate and seven factors available during review: six study characteristics and the number of letters sent by the committee during review representing the length of the review process. RESULTS: Two factors were associated with publication rate: studies with possible therapeutic benefit to participants were less likely to be published than nontherapeutic studies (adjusted hazard ratio [AHR]: 0.16; 95% confidence interval [CI]: 0.03-0.54); with every letter sent, publication was less likely (AHR: 0.46 per letter; 95% CI: 0.17-0.98). Possibly, studies with more-than-minimal burdens to participants were more likely to be published than studies with minimal burdens (AHR: 3.90, 95% CI: 1.03-16.64). CONCLUSION: We identified two prognostic indicators of publication rate. After suitable replication, RECs might explore using prognostic indicators, such as these, to target study protocols at high risk for nonpublication. Discussing the risk of nonpublication with investigators could help prevent nonpublication.
Authors: Cornelis A van den Bogert; Patrick C Souverein; Cecile T M Brekelmans; Susan W J Janssen; Manon van Hunnik; Gerard H Koëter; Hubertus G M Leufkens; Lex M Bouter Journal: BMJ Open Date: 2015-07-07 Impact factor: 2.692
Authors: Christine Schmucker; Lisa K Schell; Susan Portalupi; Patrick Oeller; Laura Cabrera; Dirk Bassler; Guido Schwarzer; Roberta W Scherer; Gerd Antes; Erik von Elm; Joerg J Meerpohl Journal: PLoS One Date: 2014-12-23 Impact factor: 3.240
Authors: Cornelis A van den Bogert; Patrick C Souverein; Cecile T M Brekelmans; Susan W J Janssen; Gerard H Koëter; Hubert G M Leufkens; Lex M Bouter Journal: PLoS One Date: 2016-12-14 Impact factor: 3.240
Authors: Gerben ter Riet; Daniel A Korevaar; Marlies Leenaars; Peter J Sterk; Cornelis J F Van Noorden; Lex M Bouter; René Lutter; Ronald P Oude Elferink; Lotty Hooft Journal: PLoS One Date: 2012-09-05 Impact factor: 3.240
Authors: Stuart G Nicholls; Tavis P Hayes; Jamie C Brehaut; Michael McDonald; Charles Weijer; Raphael Saginur; Dean Fergusson Journal: PLoS One Date: 2015-07-30 Impact factor: 3.240