A study of randomized controlled trials that have been published in four leading behavioral health journals found that new requirements for registering of trials does not seem to be improving trial design or transparency. The study appeared in the Journal of Psychosomatic Research.
“The extent that randomized controlled trials (RCTs) accurately reflect intervention effectiveness depends on the completeness and accuracy of published results,” the Montreal-based researchers wrote in their abstract. “A previous study found that only 40% of 63 RCTs published in top behavioral health journals in 2008–2009 clearly declared primary and secondary outcomes and only 21% were registered.”
In the new study, the researchers conducted a five-year follow-up “to assess outcome reporting clarity, proportion of registered trials, and adequacy of outcome registration in RCTs in top behavioral health journals.”
They examined RCTs published in the Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2013 to October 2014.
“Of 76 RCT publications reviewed, only 25 (32.9%) adequately declared primary or secondary outcomes, whereas 51 (67.1%) had multiple primary outcomes or did not define outcomes,” the authors wrote.
Though 40 of the 76 trials had been registered, the authors found that, “No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines.”
“The quality of published outcome declarations and trial registrations remains largely inadequate,” the researchers concluded.
Riehm, Kira E, Marleine Azar, and Brett D Thombs. “Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials in Top Psychosomatic and Behavioral Health Journals: A 5-Year Follow-Up.” Journal of Psychosomatic Research 79, no. 1 (July 2015): 1–12. doi:10.1016/j.jpsychores.2015.04.010. (Abstract)
This problem goes beyond the RCTs that are being conducted. A far larger problem, from my experience, is the dearth of RCTs which should be occurring on programs our health care dollars are paying for — i.e. failure to track outcomes on for-profit, mental health treatment programs – i.e. residential eating disorder centers, substance abuse centers, etcetera. It’s one of the biggest flaws about the fact that the U.S. is the only industrialized country which lacks socialized health care. Go to Canada – it’s illegal for anyone to just open up a private mental health facility there and claim expertise they may not have. There is far greater accountability and oversight, and most programs must report outcome data, because they are funded by the government. There are drawbacks to socialized health care, yes (waiting lists, etc.) – but at least you know you’re getting evidence-based treatment in Canada. You’re, for the most part not, if you are receiving treatment from a private mental health care provider in the U.S.
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Should a failure to comply with this policy not result in cutting access to future funding for offenders? And if they rely on private funding – lack of ethics committee approval? Or maybe it’s all just window dressing.
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