Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry

Perlis, Roy H.; Perlis, Clifford S.; Wu, Yelena P.; Hwang, Cindy S.; Joseph, Megan S; Nierenberg, Andrew A.

doi:10.1176/appi.ajp.162.10.1957

Cited by 303 publications

(191 citation statements)

References 21 publications

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“…For example, zscore neurofeedback aims to alter brain activity in participants to match an averaged signal (Bekelman & Gross, 2003;Perlis et al, 2005), the expansive pharmaceutical literature (Antonuccio, Danton, & McClanahan, 2003;Rabipour, Delpero, & Raz, 2011), prevalent brain training programs (Underwood, 2016), and to a lesser, but non-negligible extent, research on psychological therapies (Lieb, Osten-Sacken, Stoffers-Winterling, Reiss, & Barth, 2016). Even in the absence of financial interest, moreover, comparative studies across behavioral treatment, psychotherapy, and pharmacology, tend to skew findings towards the specific choice-oftreatment espoused by the authors (Luborsky et al, 1999;Maj, 2008).…”

Section: Animals Respond To Eeg-nf But Do Not Respond To Placebosmentioning

confidence: 99%

The psychology of neurofeedback: Clinical intervention even if applied placebo.

Thibault

Raz

2017

American Psychologist

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Advocates of neurofeedback make bold claims concerning brain regulation, treatment of disorders, and mental health. Decades of research and thousands of peer-reviewed publications support neurofeedback using electroencephalography (EEG-nf); yet, few experiments isolate the act of receiving feedback from a specific brain signal as a necessary precursor to obtain the purported benefits. Moreover, while psychosocial parameters including participant motivation and expectation, rather than neurobiological substrates, seem to fuel clinical improvement across a wide range of disorders, for-profit clinics continue to sprout across North America and Europe. Here, we highlight the tenuous evidence supporting EEG-nf and sketch out the weaknesses of this approach. We challenge classic arguments often articulated by proponents of EEG-nf and underscore how psychologists and mental health professionals stand to benefit from studying the ubiquitous placebo influences that likely drive these treatment outcomes.

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Section: Animals Respond To Eeg-nf But Do Not Respond To Placebosmentioning

confidence: 99%

The psychology of neurofeedback: Clinical intervention even if applied placebo.

Thibault

Raz

2017

American Psychologist

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“…These findings raise doubts about whether average effects can be generalized to populationwide prevention that aims at having long-term impact. Finally, evidence suggests that independent evaluations report, on average, lower effect sizes than studies conducted by the developers or distributors of a treatment (Friedman and Richter 2004;Perlis et al 2005;Petrosino and Soydan 2005). In prevention research, failed attempts to replicate findings from developer-led studies include substance abuse programs (e.g., Hallfors et al 2006;St.…”

mentioning

confidence: 99%

Effects of a Universal Parenting Program for Highly Adherent Parents: A Propensity Score Matching Approach

et al. 2012

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This paper examines the effectiveness of a group-based universal parent training program as a strategy to improve parenting practices and prevent child problem behavior. In a dissemination trial, 56 schools were first selected through a stratified sampling procedure, and then randomly allocated to treatment conditions. 819 parents of year 1 primary school children in 28 schools were offered Triple P. 856 families in 28 schools were allocated to the control condition. Teacher, primary caregiver and child selfreport data were collected at baseline, post, and two follow-up assessments. Analyses were constrained to highly adherent parents who completed all four units of the parenting program. A propensity score matching approach was used to compare parents fully exposed to the intervention with parents in the control condition, who were matched on 54 baseline characteristics. Results suggest that the intervention had no consistent effects on either five dimensions of parenting practices or five dimensions of child problem behavior, assessed by three different informants. These findings diverge from findings reported by program developers and distributors. Potential explanations for the discrepancy and implications for future research are discussed. Abstract This paper examines the effectiveness of a groupbased universal parent training program as a strategy to improve parenting practices and prevent child problem behavior. In a dissemination trial, 56 schools were first selected through a stratified sampling procedure, and then randomly allocated to treatment conditions. 819 parents of year 1 primary school children in 28 schools were offered Triple P. 856 families in 28 schools were allocated to the control condition. Teacher, primary caregiver and child selfreport data were collected at baseline, post, and two followup assessments. Analyses were constrained to highly adherent parents who completed all four units of the parenting program. A propensity score matching approach was used to compare parents fully exposed to the intervention with parents in the control condition, who were matched on 54 baseline characteristics. Results suggest that the intervention had no consistent effects on either five dimensions of parenting practices or five dimensions of child problem behavior, assessed by three different informants. These findings diverge from findings reported by program developers and distributors. Potential explanations for the discrepancy and implications for future research are discussed.

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“…However, numerous studies have shown that the results that are found by an RCT depend on who is paying the bill. Researchers who are paid by drugs companies find results that favour drugs companies (Perlis et al 2005, Baker et al 2003. Here we not need to consider the mechanisms via which this occurs, we just need to note that it happens.…”

Section: Demanding High Epistemic Standards Across the Boardmentioning

confidence: 99%