• By Laura Whybra
  • Posted on Wednesday 09th December, 2015

Playing catch-up: what trials of psychosocial interventions can learn from drugs trials

strong>Over the last decade, medical clinicians and researchers have become more aware of the need to report financial conflicts of interest. So far, the focus has been on drug research funded by pharmaceutical companies. What about conflicts of interest associated with psychosocial interventions?A new study shows that in more than two-thirds of articles on four internationally disseminated psychosocial interventions, a disclosure of the authors’ financial conflict of interest (CoI) was absent, incomplete or partly misleading. This is higher than the failure rate found in similar studies of pharmaceutical trials. The articles were published between 2008 and 2014, after ethical guidelines requiring CoI disclosure should have been in place. The failure to disclose CoI matters because studies involving the developer of an intervention tend to report more positive results than those that don’t involve the developer. Program developers often benefit financially from an intervention’s success, either through ownership of companies that distribute the program, the receipt of royalties or consulting fees, or through research funding. The research team, led by Manuel Eisner from the University of Cambridge, concluded, “Consumers of research on psychosocial interventions published in peer-reviewed journals cannot currently assume that CoI disclosures are adequate and complete. More efforts are needed to achieve transparency.”Four interventionsThis is the first study that has systematically examined CoI disclosure for commercially disseminated psychosocial interventions. The researchers looked at peer-reviewed articles that were co-authored by the developer of one of four well-known parenting programs: Triple P, Nurse-Family Partnership (NFP), Incredible Years (IY) and Multi-Systemic Therapy (MST). In all four cases the developers have some financial conflicts of interest.Articles published between January 2008 and July 2014 were examined. The start date was selected because the international Committee on Publishing Ethics (COPE) guidelines produced in 2006, which included a call to publish CoI disclosures, were assumed to have been widely in force by 2008.The majority of the 134 relevant publications related to Triple P (59%), with fewer for the others (10% NFP, 12% Incredible Years, 19% MST).Publications were regarded as needing a CoI statement “if they relate to the registration, design, or findings of pertinent trials; if they were overviews of the empirical or theoretical bases of the intervention; or if they discussed research on provider training and implementation.”The overall rate of adequate disclosures was 32%, with substantial differences between programs – in particular between Triple P and the others. Disclosure rates were only 11% for Triple P, compared to 57% for NFP, 63% for IY, and 73% for MST.Room for improvementThe researchers also looked at whether or not editors responded when issues with CoI were drawn to their attention. When journal editors were contacted about 92 published articles with no CoI disclosure or a disclosure that was deemed problematic, the editors published a correction in 71% of cases.“When contacted about missing or contradictory CoI statements, journal editors were generally responsive to our requests and reacted broadly in line with COPE guidance,” the research team said.In some of these cases the editors reported mistakes by the journal in processing the submitted disclosure. But in the majority of cases the editors asked the authors for clarification. The research also examined factors associated with disclosure.A slight increase in disclosure rates since 2008 suggests that the efforts by COPE and other bodies that promote transparency in research are partially successful, but more needs to be done. Disclosure rates were also higher in journals with a published CoI disclosure policy and in journals in the medical sciences.Curiously, journals that were COPE members had lower disclosure rates. The authors suggest that this is probably because many non-members of COPE in the study are journals published by professional organizations such as the American Medical Association that were relatively quick to promote high standards of CoI disclosure.Given errors in handling CoI disclosures by journals in some cases, the research team advocates improved processing of disclosures at editorial level. It also calls for all journals to adopt and publicize CoI disclosure policies.However, the buck does not stop there: “The substantial variability in disclosure rate suggests that much responsibility seems to lie with the authors.” Eisner and his colleagues argue that authors need to pay more attention to the completeness of proofs, and that universities could help authors to comply with guidance on CoI.The research has limitations. The study didn’t determine why authors failed to submit CoI disclosures, or whether findings can be generalized to other psychosocial interventions.The research team stressed that “transparency about CoI in itself does not necessarily improve the quality of research, and researchers with a CoI should not be presumed to conduct less valid scholarship.” But with evidence from systematic reviews and meta-analyses of a positive association between reported effect sizes and authors’ CoI, “transparency is a necessary component for readers to assess the study findings and their context.”**************Reference:Eisner, M., Humphreys, D. K., Wilson, P. & Gardner, F. (2015) Disclosure of financial conflicts of interests in interventions to improve child psychosocial health: a cross-sectional study. PLoS ONE 10(11): e0142803.doi:10.1371/journal.pone.0142803

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