Comments on the proposed ICMJE Disclosure Form

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Displaying 16 - 20 of 129 comments
  • Are Brean
    Journal of the Norwegian Medical Association
    Role(s): A journal editor
    Date Submitted: Thursday, April 30, 2020 - 11:33

    It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
    • Yes
    Comments: Thank you for the opportunity to comment on the proposed disclosure form. We support the idea behind the new form, but would like to suggest a few amendments. Firstly, the meaning of the wording is not always evident. This might especially be the case for authors who do not have English as their first language. This applies for, at least, some of the alternatives listed in the first column (i.e. "Receipt of equipment, materials, drugs, writing, or other services"). We therefore suggest to include definitions or examples. Furthermore it would be helpful with a couple of examples of "Name of the relationship or activity" in the second column. An idea is to supply some fictitious examples; person A and B with diverse relationships and activities, and how the form would look like for those persons. These examples could possibly be posted on the website to facilitate the understanding of how to use the form.

    The information collected by the ICMJE Disclosure Form is appropriate.
    • Yes
    Comments: We generally think it is a good idea to let the reader judge whether relationships and activities are potential conflicts of interest, and to list all. However, we consider the form to be quite extensive and detailed, which may result in reduced, rather than increased, transparency. Important conflicts of interest (pardon my French) might be secluded in between less relevant activities. We would therefore suggest two amendments: 1. Order the categories from top to bottom by the severity of the activity/relationship. I.e. most readers would consider owning stocks in the drug company in question as a more serious conflict, than to participate in a guideline panel. 2. Merge some of the rows. I.e. " Participation on a Data Safety Monitoring Board, Advisory Board, or Guideline Panel" could be merged with "Leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid", and "Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events" could be merged with "Payment for expert testimony".

  • Joanne Khabsa
    American University of Beirut
    Role(s):
    • An author who publishes work in medical journals
    • A health care professional
    • A reader of medical journals
    Date Submitted: Thursday, April 30, 2020 - 05:54

    It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
    • Yes
    Comments: Overall, the form is clear. I have the following suggestions: 1. being explicit that any relationship should be included (of any value, regardless of a certain threshold); 2. being explicit about including the source of the conflict (e.g. name of the company); 3. adding a clarification that non-financial institutional relationships may also be relevant to disclose (e.g., adoption of certain political or religious positions). These suggestions were discussed with Dr. Elie Akl.

    The information collected by the ICMJE Disclosure Form is appropriate.
    • Yes
    Comments: Overall, information collected is appropriate. I have the following suggestions: 1. adding disclosure by “close relatives” with examples (spouse/partner, children, etc); 2. including planned or expected relationships; 3. asking about the amount; 4. adding the following as types: employment, food and beverage, gifts, “benefit through professional status” (e.g., clinician performing a procedure of relevance for a professional fee); 5. including non-financial relationships as its own separate category to give it its due value, with specific examples (e.g., public adoption of a well formed point of view on a controversial issue). These suggestions were discussed with Dr. Elie Akl.

  • Aftab Ahmed
    Apollo Hospital
    Role(s): A health care professional
    Date Submitted: Wednesday, April 29, 2020 - 19:19

    The information collected by the ICMJE Disclosure Form is appropriate.
    • Yes

  • Vishnu Parvathareddy
    Role(s):
    Date Submitted: Wednesday, April 29, 2020 - 16:39

  • Thomas Lempert
    Department of Neurology, Schlosspark-Klinik, Berlin
    Role(s):
    • An author who publishes work in medical journals
    • A health care professional
    • A patient
    • A reader of medical journals
    Date Submitted: Wednesday, April 29, 2020 - 11:44

    It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
    • No
    Comments: The Expert Committee for Transparency and Independence of the Drug Commission of the German Medical Association (DCGMA) welcomes the ICMJE proposal for a revised declaration of interests. We would like to propose the following amendments: 1. The ICMJE defines the “potential for conflict of interest” and leaves open what actually constitutes a conflict of interest (COI). This “softening of language” makes the concept of COI opaque. The IOM-definition unambiguously states that a COI is a risk situation. The situation poses an increased risk for a biased judgement. The risk is caused by the concurrent existence of a primary and a secondary interest. Bias results from the secondary interest outweighing the primary interest. A COI is the characteristic of a situation, regardless if the outcome is a biased judgment or not. The strength of the IOM-definition is the evaluation of COI ex ante. It is important to stress that the concept of COI means to evaluate and judge a situation, not a person. From this perspective, COI does not imply any stigma and has nothing to do with wrongdoing. In our opinion, it is not advisable to soften the language at the cost of clarity.

    The information collected by the ICMJE Disclosure Form is appropriate.
    • No
    Comments: 2. We agree that it is useful to emphasize direct and topically related interests. However, a financial relationship between an author and an industrial company may cause COI even if this relationship is not topically related to the content of the article in question. The principle of reciprocity which underlies most COI is activated by receiving something from someone, no matter for which project or purpose. When reading the proposed rules for disclosure, authors may feel that topically unrelated payments from a sponsor - who nevertheless may have an interest in the content of the work reported - may not be relevant and can be omitted. Therefore, we feel that a statement about this type of COI needs to be included. 3. We propose to ask peer reviewers to declare their COI as well. Many reviewers tend to have similar COI as authors which may lead to a particularly high risk of bias. Prof. Thomas Lempert, M.D. Prof. David Klemperer, M.D. Birke Schneider, M.D. Prof. Klaus Lieb, M.D. Head of the Expert Committee for Transparency and Independence Prof. Wolf-Dieter Ludwig, M.D., Head of the Drug Commission of the German Medical Association Prof. Bruno Müller-Oerlinghausen, M.D. Prof. Johannes Koebberling, M.D.

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