Requirements of Clinical Journals for Authors’ Disclosure of Financial and Non-Financial Conflicts of Interest: A Cross Sectional Study

<div><p>Importance</p><p>It is unclear how medical journals address authors’ financial and non-financial conflict of interest (COI).</p><p>Objective</p><p>To assess the policies of clinical journals for disclosure of financial and non-financial COI.</p><p>Methods</p><p>Cross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine’s “core clinical journals”. The study did not involve human subjects. Investigators who abstracted the data, reviewed “instructions for authors” on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person.</p><p>Results</p><p>All but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process.</p><p>Conclusion</p><p>While financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies.</p></div

Matrix of assumptions about missing participant data respectively in intervention and control arms of a trial.

<p>Assumptions of incidence among participants with missing data in the intervention arm typically decrease going from right (100%) to left. Assumptions of incidence among participants with missing data in the control arm typically decrease going from bottom (100%) to top. Assumptions shaded in green take into account the incidence rates in all trials included in the systematic review, and not only the trial under consideration. Assumptions shaded in yellow take into account the incidence rates within the trial under consideration. RILTFU/FU can have different values in the control and intervention groups respectively. Assumptions shaded in orange are extreme and typically implausible.</p

Flow of participants in a trial that excluded participants from analysis for missing participant data.

<p>Flow of participants in a trial that excluded participants from analysis for missing participant data.</p

Analytic methods to account for participants with missing data.

¶<p><i>y</i> and <i>z</i> refer to RI_LTFU/FU in the intervention and control arm respectively: <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0057132#pone.0057132-Akl2" target="_blank">[6]</a>.</p>*<p>This is a special case of RI_LTFU/FU method where <i>y</i> = <i>z</i>  = 1.</p

Characteristics of conflicts of interest (COI) policies (N = 116).

<p>Characteristics of conflicts of interest (COI) policies (N = 116).</p

General characteristics of the journals (N = 117).

<p>General characteristics of the journals (N = 117).</p

Status of participants and their outcome data at both the trial and systematic review levels.

<p> † It is possible that the investigators collected but did not report the data. * Data analysis might have included assumptions about missing participant data. ITT =  intention to treat; CCA =  complete case analysis. § Refers to ineligible participants mistakenly randomized and meeting the conditions for appropriate exclusion (see text), and to participants with other reasons for appropriate exclusion (e.g., subsequently found not to have condition of interest, or never underwent a procedure for which the intervention is intended).</p

Requirements for financial conflicts of interest (COI) disclosure; N = 116.

<p>Requirements for financial conflicts of interest (COI) disclosure; N = 116.</p

Types for non-financial COI for which disclosure is required; N = 66.

<p>Types for non-financial COI for which disclosure is required; N = 66.</p

Risk of bias.

<p>Risk of bias.</p