We have just registered our new protocol on the Open Science Framework. We are planning a new study about conflict of interests in academia. Here is the protocol.
Correlation between gifts from pharmaceutical companies to French medical academics and their scientific productivity patterns: a protocol for a retrospective study using the French Transparency in Healthcare
Alexandre Scanff1, Ioana Cristea2,3, Pierre Etienne Savourat1, Thomas Clément1, Benjamin Bastian1, Marion Taburet1, Alain Braillon4, Florian Naudet, Professor1,*
1: Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d’Investigation Clinique de Rennes), France
2: Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, St.Republicii 37, 400015 Cluj-Napoca, Romania
3: University of Pavia, Department of Brain and Behavioral Sciences, 27100 Pavia, IT
4: FORMERLY: Alcohol Treatment Unit, University Hospital, 80054 Amiens CEDEX 1. France
* : corresponding author ; orcid.org/0000-0003-3760-3801 ;
BACKGROUND
The scientific impact of academics is appraised with their ability to produce knowledge. Funding, promotion of individuals and survival of their team depends on their publication records and some quantitative citations metrics.
Many projects such in genomics [1] can only be conducted in collaboration and new ideas often arise by conversations with colleagues. Collaboration driven by industrialists may also have an impact on researchers' productivity at the price of potential financials conflicts of interest (COIs). Prolific academics are often identified and pushed by industrialists as "Key Opinion Leaders" on the ground of their publication records, lectures, and their participation on different groups [2]. For example, in the field of oncology, financial COIs were correlated with metrics of academic reputation and success [3].
And indeed, committees hiring academics use indicators such as scientific productivity (i.e. number of published papers) and quality. For quality, two proxies are generally used: a) the journal impact factor (JIF) and b) the Hirsch Index (h-index), corresponding to the largest number h of papers one has published that have been cited at least h times. [4]
We aim to investigate the relationship between the presently used measures of academic success (publications/citations/h-index) with the potential financial COIs.
METHODS
Study design and participants
The project will be based on a protocol that has been registered on 03/27/2021 on the Open Science Framework prior any data collection.
In France, academic duties require both an active clinical activity and a research activity. While clinical skills are only evaluated qualitatively, assessment of research activity entails publication metrics, which are easy to quantify and investigate. This study will be conducted and reported to the Standards for Reporting Diagnostic Accuracy. [5]
One researcher will identify all French Medical Professors and associated professors (and their academic discipline) from lists of the different universities and the “annuaire santé” that also details sex and medical specialty (i.e. academic discipline). Then we will extract from online databases (e.g. Google Scholar, Web of Science, Scopus) the year of their first paper (an indicator of seniority) and quantitative indicators of productivity for the 2014-2019 period (h-index over the period, number of papers and number of citations).
For each academic, the amount of money declared by the industry during the 2014-2019 period will be extracted from the French database registering all direct gifts (e.g., meals or congress-related hotel, and travel costs) perceived by healthcare players. This open access database was created in 2012 (https://www.transparence.sante.gouv.fr/) and the industry is required by law to report. We will use only the “advantage” table, comprising all industry funding which in theory is not associated with a contractual obligation of the recipient. Two more tables exist, which report “conventions” and “remunerations” when there is a contractual obligation for the recipient, but reporting the monetary value was not mandatory and poorly implemented during the all the study period, and thus the amount is almost-always lacking. An automatic search will be developed, possibly completed by manual checks to explore the possibility of misidentification.
Ethics
This research has been approved by the CNGE [Collège National des Généralistes Enseignants] Ethics Committee (approval number 110321260). The procedure toward protection of persons complies with the data protection regulations (GDPR). In view of the large number of subjects studied, we cannot afford to contact all of them. Moreover, this step would risk adding a social desirability bias to the results of our study that may invalidate the study results. In addition, general information are publicly available in this blog post on the Reither website detailing the protocol, the use that will be made of the data, with a contact information (Pr Florian Naudet: Florian.NAUDET@chu-rennes.fr). This information will also be detailed in the thesis references and in the paper once those documents will be published to indicate to the interested parties the right of access to any data concerning them. Importantly, data collected are not considered as sensitive data by the French law.
Indexes
The f-index will be defined as the sum of gifts received by each academic in the 2014-2019 period (meals, and/or travel/accommodation expenses). The gold standard used for the purpose of the study will be high scientific productivity defined for an academic as an h-index over the period 2014-2019 in the top quartile of h-indexes in the group analysed and in subgroups defined by all academic discipline for subgroup analyses. As no gold standard exists but institutions need to take decisions under constraints of limited time and budgets, we opted for this standard. It reflects the fact that in the current system effectively only a few top researchers can expect promotion.
Outcomes and analysis
First, a descriptive analysis will be performed, consisting of numbers and percentages for categoric outcomes, and means, standard-deviations for quantitative outcomes. Then, Pearson’s correlations will be used to explore the association between indicators and several characteristics of the academics, after logarithmic transformation (index value+1), if needed.
Receiver Operating Characteristic (ROC) curves will be drawn by plotting sensitivity vs. one minus specificity and the optimal threshold will be determined according to Youden’s J measure. The main outcome for this study will be the diagnostic properties (sensitivity, specificity, positive predictive value, negative predictive value) of the f-index to objectively reflect high scientific productivity. [6]
Finally, to account for possible variations according to subspecialty, subgroup analyses (f-index, h-index, correlation between f-index and h-index, optimal threshold) will be explored by academic discipline separately. 95% confidence intervals for test parameters will be estimated by bootstrap procedure.
An exploratory analysis of the effect of sex and year of first paper on the f-index will be realized by linear mixed model, using a random intercept for academic speciality.
REFERENCES
1. Lehner T, Senthil G, Addington AM. Convergence of advances in genomics, team science, and repositories as drivers of progress in psychiatric genomics. Biological psychiatry 2015;77(1):6-14.
2. Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? bmj 2008;336(7658):1402-03.
3. Lammers A, Edmiston J, Kaestner V, et al. Financial Conflict of Interest and Academic Influence Among Experts Speaking on Behalf of the Pharmaceutical Industry at the US Food and Drug Administration's Oncologic Drugs Advisory Committee Meetings. Mayo Clinic proceedings 2017;92(7):1164-66. doi: 10.1016/j.mayocp.2017.04.014 [published Online First: 2017/07/10]
4. Hirsch JE. An index to quantify an individual’s scientific research output. Proc Natl Acad Sci U S A 2005;102:16569–72. doi:10.1073/pnas.0507655102
5. Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015;351:h5527. doi:10.1136/bmj.h5527
6. Perkins NJ, Schisterman EF. The Inconsistency of “Optimal” Cut-points Using Two ROC Based Criteria. Am J Epidemiol 2006;163:670–5. doi:10.1093/aje/kwj063
Information related to the "TRANSPARENCE SANTE" database (in French) :
"Le droit de rectification s'effectue à partir de la page contenant la déclaration dont il est demandé la rectification. Les personnes morales bénéficiaires de conventions, d'avantages ou de rémunérations peuvent procéder à une demande de modification des informations publiées en s'adressant directement à l'entreprise ayant procédé à la déclaration. Le droit d'opposition prévu à l'article 38 de la loi du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés ne s'applique pas aux données publiées sur ce site."
La base légale de ce traitement est l’exécution d’une mission d’intérêt public (article 6 (1) e RGPD).