Showing posts with label Conflict of Interest. Show all posts
Showing posts with label Conflict of Interest. Show all posts

Thursday, September 24, 2020

Pre-Print of PRISMA 2020 Updated Reporting Guidelines Released

Upon their publication in 2009, the PRISMA guidelines have become the standard for reporting in systematic reviews and meta-analyses. Now, 11 years later, the PRISMA checklist has received a fresh facelift for 2020 that incorporates the methodological advances that have taken place over the intervening years.

In a recently released pre-print, Page and colleagues describe their approach to designing the new and improved PRISMA. Sixty reporting documents were reviewed to identify any new items deserving of consideration and 110 systematic review methodologists and journal editors were surveyed for feedback. The new PRISMA 2020 draft was then developed based on discussion at an in-person meeting and iteratively revised based on co-author input and a sample of 15 experts.



The result is an expanded, 27-item checklist replete with elaboration of the purpose for each item, a sub-checklist specifically for reporting within the abstract, and revised flow diagram templates for both original and updated systematic reviews. Here are some of the major changes and additions to be aware of:

  • Recommendation to present search strategies for all databases instead of just one.
  • Recommendation that authors list "near-misses," or studies that met many but not all inclusion criteria, in the results section.
  • Recommendation to assess certainty of synthesized evidence.
  • New item for declaration of Conflicts of Interest.
  • New item to indicate whether data, analytic code, or other materials have been made publicly available.
Page, M., McKenzie, J., Bossuyt, P., Boutron, I., Hoffman, T., Mulow, C., ... & Moher, D. 2020. The PRISMA 2020 Statement: An updated guideline for reporting systematic reviews. 

Pre-print available from MetaArXiv here. 

Monday, September 14, 2020

Timing and Nature of Financial Conflicts of Interest Often Go Unreported, Systematic Survey Finds

The proper disclosure and management of financial Conflicts of Interest (FCOI) within the context of a published randomized controlled trial is vital to alerting the reader to the sources of funding for the research and other financial factors that may influence the design, conduct, or reporting of the trial.

A recently published cross-sectional survey by Hakoum and colleagues examined the nature of FCOI reporting in a sample of 108 published trials found that 99% of these reported individual author disclosures, while only 6% reported potential sources of FCOI at the institutional level. Individual authors reported a median of 2 FCOIs. Among the 2,972 FCOIs reported by 806 individuals, the greatest proportion came from personal fees other than employment income (50%) and from grants (34%). Further, of those disclosing individual FCOI, a large majority (85%) were provided by private-for-profit entities. Notably, only one-third (33%) of these disclosures included the timing of the funding in relation to the trial, 17% reported the relationship between the funding source and the trial, and just 1% reported the monetary value.


Click to enlarge.
 

Using a multivariate regression, the authors found that the reporting of FCOI by individual authors was positively associated with nine factors, most strongly with the authors being from an academic institution (OR: 2.981; 95% CI: 2.415 – 3.680), with the funding coming from an entity other than private-for-profit (OR: 2.809; 95% CI: 2.274 – 3.470), and the first author’s affiliation being from a low- or middle-income country (OR: 2.215; 95% CI: 1.512 – 3.246).

 

More explicit and complete reporting of FCOIs, the authors conclude, may improve readers’ level of trust in the results of a published trial and in the authors presenting them. To improve the nature and transparency of FCOI reporting, researchers may consider disclosing details related to the funding’s source, including the timing of the funding in relation to the conduct and publication of the trial, the relationship between the funding source and the trial, and the monetary value of the support.

Hakoum, M.B., Noureldine, H., Habib, J.R., Abou-Jaoude, E.A., Raslan, R., Jouni, H., ... & Akl, E.A. (2020). Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: A cross-sectional survey. J Clin Epidemiol 127:49-58.

Manuscript available from the publisher's website here