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July 12, 2020 by Yin Mo et al | BMJ

Non-adherence in non-inferiority trials: pitfalls and recommendations

Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome reporting to reduce bias in treatment estimates and improve transparency in reporting.

Randomised controlled trials that test for non-inferiority of the experimental arm are performed when a new treatment is compared with an established standard of care. Instead of being required to have superior clinical efficacy, the new treatment might be preferred for its improved safety, convenience, or reduced cost. These trials are increasingly prevalent because highly efficacious standard-of-care treatments have been established for many diseases, making demonstration of superiority against standard-of-care implausible and placebo controlled trials without any active comparators unethical to perform.1,2

A basic weakness of non-inferiority trials, compared with superiority trials, is that poor conduct of the trial or deviations from the protocol could result in false rejection of the null hypothesis that the experimental treatment is inferior. Most trials report that some participants do not adhere to their allocated treatment. Intention-to-treat analysis estimates the treatment effect accounting for this real world adherence pattern by comparing outcomes between groups of participants defined by their allocated treatment; it measures the effect of allocating a treatment on participant outcomes, instead of the actual effect of treatment (often called an effectiveness trial). If the primary research interest is the causal effect of assigning treatments, then this estimate is likely to be the most relevant. In other situations, the question of primary interest is the causal effect of the treatment itself. Because many patterns of non-adherence result in reduced observed differences between the comparison arms, there is a risk that relying on the intention-to-treat analysis to conclude non-inferiority will lead to the adoption of treatments which, when taken, lead to worse outcomes.

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July 12, 2020 by Micah Ingle, MA |

Psychiatrists Divided on Understandings of Psychosis

Researchers find that UK psychiatrists are at odds with one another and support divergent understandings of psychosis.

A recent study published in The International Journal of Social Psychiatry analyzes how psychiatrists in the UK understand psychosis. Through interviews, the authors found several prominent “positions” on psychosis. They discovered three dominant positions—a biomedical understanding, a critical perspective focused on social context, and an ambivalent stance. The authors, Therese O’Donoghue and Jon Crossley from the Department of Neuroscience at the University of Leicester, also note several key themes discussed by psychiatrists, such as orthodox medical training, power hierarchies in the field, and the need for psychiatrists to appear invulnerable.

“Recently, there has been support from several influential figures in the field for a broader perspective on psychosis. Jim van Os argued that what are currently regarded as mental illnesses are better framed as vulnerabilities, as they are seldom ‘cured.’ They critiqued the evidence-based symptom reduction model which dominates service organizations because of its disconnection from the needs of patients,” O’Donoghue and Crossley write.

Separately, the prominent psychiatrist Sir Robin Murray publicly stated that he regretted ignoring social factors throughout his research career, and called for more research on environmental factors and epigenetics. He cautioned that those still clinging to a Kraepelinian model were refusing to accept the evidence base to the detriment of their patients.”

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July 12, 2020 by James Moore |

World Benzodiazepine Awareness Day 2020

Educating communities on dangers of prescribed benzodiazepines

This week we present the second part of our podcast to join in the events for World Benzodiazepine Awareness Day 2020 (W-BAD). In part one, we interviewed Angela Peacock and talked about her experiences of taking and coming off benzodiazepines and also her involvement in the film Medicating Normal, which had a special screening and panel discussion on July the 11th at 1:00 PM EST.

And before we go on, I just wanted to say that these podcasts would not be possible without the efforts of W-BAD lead operations volunteer Nicole Lamberson, who goes above and beyond to make these interviews possible. Later in this episode, we will hear from Baylissa Frederick, who is a therapeutic coach and psychotherapist with over two decades’ experience working with clients affected by prescribed drug injury. But before we chat with Baylissa, I’m delighted to get the chance to talk with clinical pharmacologist Dr. Jim Wright.

Jim is Emeritus Professor in the Departments of Anesthesiology, Pharmacology, and Therapeutics in Medicine at the University of British Columbia. Jim obtained his MD from the University of Alberta in 1968, and his PhD in pharmacology from McGill University in 1976. He is a practicing specialist in internal medicine and clinical pharmacology. He is also Editor in Chief of the Therapeutics Letter and he sits on the editorial boards of PLoS One and the Cochrane Library. Dr. Wright’s research focuses on issues relating to the appropriate use of prescription drugs, clinical pharmacology, clinical trials, systematic review, meta-analysis, and knowledge translation.

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July 11, 2020 by Tim Beck, PhD |

New Directions for Service User Involvement in Mental Health Research and Practice

An overview of UK mental health service user involvement underscores new possibilities for the 21st century.

A paper published recently in the journal Research Involvement and Engagement overviews the current state of service user involvement in mental health research and practice in the UK. Peter Beresford, the author of the paper and self-described “writer, researcher, educator, activist, and (long term mental health) service user,” draws on his wide range of personal and professional experiences to summarize 40 years of public and service user involvement.

“I have been privileged to be part of the emerging psychiatric system survivor and disabled people’s movements over that period, as well as being involved in UK government developments at a high level, and in voluntary organizations, user-led and disabled people’s organizations (ULOs and DPULOs) and activities and also international schemes, as well as initiatives in other countries,” Beresford writes.

“This has offered me close-up insights into theory, policy, and practice developments over this period as well as opportunities to be part of them. It has introduced me to many people involved in such activities as policymakers, educators, practitioners, service users, and family carers.”

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July 10, 2020 by Andrew Solomon | The New York Times

What Happens When You’re Disabled but Nobody Can Tell

The author and clinical psychologist Andrew Solomon examines the disabilities that ramps and reserved parking spots don’t address.

Hayley Wall

I have depression and anxiety. These conditions are well-controlled most of the time, but when I have a significant dip, no one makes anything easier for me unless I explain it all to them — an unpleasant effort at the best of times and beyond my ken at the worst. When my depression mushrooms, I shun visibility; I walk so close to buildings that my shoulder becomes dirty. Because my intermittent disability is invisible, in the thick of it I have often felt compelled to make myself invisible. I neither anticipate nor receive public compassion.

Such social insensitivity is endemic to the lives of people with permanent but invisible disabilities that affect their daily functioning, who are likewise deprived of outer symbols to signal their condition.

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July 10, 2020 by Madison Natarajan, MS |

Misleading Beliefs about Antidepressants Prevalent in Psychiatry

Researchers argue that academic psychiatry maintains at least two false beliefs about antidepressants that have far-reaching implications for the treatment of depression.

A 2018 article published in Ethical Human Psychology and Psychiatry argues that there are two primary false beliefs held by academic psychiatry related to the efficacy of antidepressants. The article was written by researchers with expertise on antidepressants and suicide risk, Michael Hengartner of Zurich University in Switzerland and Martin Plöderl of Paracelsus Medical University in Salzburg, Austria.

First, they explain that physicians often attribute antidepressant effects to pharmacological action rather than placebo effects. Second, academic psychiatry maintains that physical dependence on antidepressant drugs does not exist, and therefore any withdrawal or discontinuation symptoms are benign and affect only a small minority of users. These two remain pervasive within the field of psychiatry, despite a wealth of evidence suggesting that they are untrue. Hengartner and Plöderl point to the undue influence of the pharmaceutical industry as one of the forces maintaining the popularity of these misleading beliefs about antidepressants.

“The problem is presumably less with erroneous views expressed by patients and researchers critical of psychopharmacological drugs, but rather with false beliefs held by academic psychiatry and promoted by the pharmaceutical industry,” the authors write.

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July 8, 2020 by Sadie Cathcart |

Youth Depression Screening Will Lead to Over-Diagnosis, Experts Warn

Adolescent and pediatric psychiatry organizations continue to promote youth depression screening despite numerous concerns.

In a recent commentary in Adolescent Psychiatry, psychiatrist Edmund Levin addresses conflicting positions assumed by various key opinion leaders and major organizations regarding adolescent depression screening. Levin reveals that although organizations including the American Academy of Child and Adolescent Psychiatry (AACAP) and the American Academy of Pediatrics (AAP) have promoted the idea of scaling up youth depression screening, research increasingly indicates that this approach falls short in reality.

Levin argues that screening fails to improve outcomes for teens who screen positive. Drawing from personal, clinical experience with a patient whose “severe depression” classification he links to various contextual determinants, Levin illustrates the importance of more sophisticated evaluation methods than screening alone.

“Over-diagnosis needs to be considered as a contributor to the trend of increasing percentages of youth being diagnosed and medicated for a variety of mental health conditions, including depression,” Levin writes. “The possibility of over-diagnosis is magnified if screening is developed and promoted as a marketing tool by pharmaceutical companies, which in fact may be the case of calls for the use of depression screening devices.”

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July 8, 2020 by UN News

Move away from outdated ‘mad or bad’ approach to mental illness, urges independent UN expert

WHO/P. Virot Patients at the Institute of Human Behaviour and Allied Sciences in Delhi, India.

States, civil society, psychiatric organizations and the World Health Organization (WHO) itself must change the way they address mental health challenges, a UN independent rights expert said, calling for a shift towards understanding the context behind mental distress.

While welcoming international recognition of mental health, Dainius Pūras, UN Special Rapporteur on the right to physical and mental health, told the Human Rights Council on Monday that “much more is still needed”.

“The global mental health status quo should move away from the outdated ‘mad or bad’ approach which seeks to prevent behaviours deemed as ‘dangerous’ or provide treatment considered ‘medically necessary’ without consent,” he said.

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July 6, 2020 by Peter Simons |

Randomized Controlled Trial Confirms That Antipsychotics Damage the Brain

A new study published in JAMA Psychiatry connects antipsychotics with damage to the brain in multiple areas.

In a new study published in JAMA Psychiatry, the use of antipsychotics (in this case, olanzapine) was associated with damage to the brain in multiple areas. The researchers used a randomized, controlled trial (RCT) design, which allows them to suggest that the drugs cause the observed effect on the brain. The researchers found “widespread” cortical thinning in those who took the drug versus those who took a placebo.

“Unlike uncontrolled studies, our randomized, double-blind placebo-controlled clinical trial design provides potential evidence for causation: olanzapine administration may cause a decrease in cortical thickness in humans,” the researchers write.

Exposure to olanzapine for just 36 weeks resulted in a loss of cortical thickness equal to up to four times the loss, on average, over the entire lifespan of someone who did not take the drug.

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July 5, 2020 by Samantha Lilly |

Patient Advocacy Groups Betray Consumers for Pharma Money

Researchers detail how patient advocacy groups have moved away from protecting consumers and toward safeguarding Big Pharma.

In a new article in the Journal of Bioethical Inquiry, researchers reveal how grassroots patient advocacy groups began to fail consumers after taking money from pharmaceutical companies. The authors, led by Sharon Batt, a bioethicist from Dalhousie University in Canada, argue that pharmaceutical industry funding of consumer advocacy groups altered the goals and research priorities of these organizations. Batt and her co-authors, Judy Butler, Olivia Shannon, and Adriane Fugh-Berman, write:

“Accepting industry money would result in vulnerable patients being susceptible to the parroting of certain marketing messages that distorted scientific evidence, with the potential to cause needless suffering, misplaces hope, premature deaths, and misspent funds.”

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The contents of this Headlines page are provided for informational purposes. Any material, conclusions, or opinions presented in the linked articles are not necessarily endorsed by the Foundation for Excellence in Mental Health Care.