Screening for Distress and Depression vs Optimizing Support and Compassion in Medical Care

My upcoming talks at the Dutch International Congress on Insurance Medicine 2017

screening bookOn Thursday November 9, 2017  I am  pleased to be presenting two talks at the Dutch Society for Insurance Medicine (NVVG) and the Dutch Association of Medical Officers in Private Insurances (GAV) 9th Annual Congress, international day in English on Thursday 9th November 2017.

The Congress is intended for medical officers, insurance and occupational health physicians and others interested in this particular field. Approximately 350 medical doctors in insurance medicine and social benefits are expected to attend. The congress is described as highly appreciated by the participants, and many outstanding and inspiring speakers have contributed over the past years.

I am very pleased to be having another opportunity to present my updated views on screening for depression and distress, as well as whether screening is the optimal way to provide support and compassion in busy routine medical care. Those who are familiar with my work are aware of my skepticism that routine screening improves patient outcomes.

Congress venue:

Van der Valk Hotel Almere

Veluwezoom 45

1327 AK Almere

The Netherlands

Thursday, November 9, 201

9:15- 10:00 Plenary Speaker

The optimal way of providing psychosocial care and care for depression to medical patients

Summary

Provision f routine psychosocial care to medically ill patients can be negatively impacted by assuming that basic supportive care needs are primarily mental health issues. Management of depression poses distinct challenges. Care for chronic and acute medical conditions can create competing demands and  disrupt existing care  for depression. Much co-occurring depression apparent during medical care is among patients represents recurrences with recent or past depression care. Much depression care initiated during medical treatment is with inadequate diagnosis, monitoring, and follow up. Optimization of care depends on recognizing depression is largely a chronic, episodic condition with variable course and incomplete remission. The management of depression care can become out of sync with the course of patients’ depression.

14:40- 15:15 Round 1: Parallel sessions

Screening for distress and procedures versus routine compassion in cancer care

Summary

Screening for distress among cancer is increasingly mandated internationally without regard to the character of existing health systems and psychosocial care. A lack of robust evidence that screening for distress actually improves patient outcomes is being ignored. The invented concept of “distress” does not map well onto distinct sources of patient discomfort and unmet needs. Depending on the health system, introduction of routine screening can tax existing supportive care and uncover needs that  supportive services cannot address. Access to affordable, accessible care consistent with patient preferences is more challenging that detecting ambiguous “distress” among cancer patients. In moderate to high functioning health systems, exisiting provision of supportive and compassionate care can be disrupted by introduction of screening with a greater emphasis on billable procedures and risk of unnecessary treatment.

Readings

Here are a couple of relevant past blog post that you can expect will be updated in my talks:

Where’s the evidence that screening for distress benefits cancer patients? 

Distress- the 6th vital sign for cancer patients?

Psychosocial care focuses too much on young, attractive patients successfully coping with cancer. https://www.coyneoftherealm.com/blogs/mind-the-brain/psychosocial-care-focuses-too-much-on-young-attractive-patients-successfully-coping-with-cancer

And a key review paper with an outstanding group of co-authors:

Thombs BD, Coyne JC, Cuijpers P, De Jonge P, Gilbody S, Ioannidis JP, Johnson BT, Patten SB, Turner EH, Ziegelstein RC. Rethinking recommendations for screening for depression in primary care. Canadian Medical Association Journal. 2012 Mar 6;184(4):413-8.

 

 

 

 

 

 

 

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Unethical: Why Bristol University SMILE trial should not have been conducted with chronically ill children

If it should have been conducted at all, the first clinical trial of Lightning Process should not have been conducted with chronically ill children. Safety and efficacy had neither been established with adults, nor healthy children.

Phil Parker, developer of the trademarked, commercial Lightning Process package claims that is not a psychological treatment, but a physical one. He further claims its scientific basis is an amalgamation of neurolinguistic programming, osteopathy, and life coaching.

not psychologicalThere is no plausible scientific mechanism by which Lightning Process would work. A small minority of vulnerable adult and child patients with chronic fatigue syndrome are drawn to the false claims of the health benefits lightning process, which the UK Advertising Standards Authority now forbids posting on the web. This is a truth-in-advertising-problem, not justification for launching a clinical trial. 

Researching the Lightning Process is no more ethically and scientifically justified than researching Prince Charles’s claims that (organic) coffee enemas can slow progression of cancer. Yet, the logic is the same that has been used to justify the SMILE trial.

Protecting-children-520x350Pediatrician Esther Crawley should undergo remedial ethics training and I recommend an excellent source below.

No parents should consent to their children participating in clinical trials of Bristol University, until a transparent independent inquiry reports how and why the SMILE trial was approved.

A belated praise to the parents who stood up against Professor Esther Crawley and all her nastiness. She should apologize to you.

Required reading for Professor Crawley and relevant administrative staff of Bristol University

Ethical Conduct of Clinical Research Involving Children. Edited by Marilyn J. Field and Richard E. Behrman. 448 pp., illustrated. Washington, D.C., National Academies Press, 2004. $57. ISBN 0-309-09207-8

Although the price is listed as US$57. A free downloadable PDF is available here 

No excuse, Professor Crawley, overcoming your being ethically challenged can start with some free reading.

An excellent summary is here Institute of Medicine (US) Committee on Clinical Research Involving Children; Field MJ, Behrman RE, editors. Ethical Conduct of Clinical Research Involving Children. Washington (DC): National Academies Press (US); 2004. Summary.

Ethical Conduct of Clinical Research Involving Children.

REGULATORY CONTEXT  

INTERPRETING RESEARCH RISK AND OTHER REGULATORY CONCEPTS 

UNDERSTANDING AND AGREEING TO CHILDREN’S PARTICIPATION IN RESEARCH  

REGULATORY COMPLIANCE, QUALITY IMPROVEMENT, AND ACCCREDITATION  

ROLES AND RESPONSIBILITIES IN PROTECTING CHILDREN INVOLVED IN RESEARCH  

Some key excerpts

The special ethical and regulatory protections for children may preclude potentially important clinical studies that would be approved for adult participation. This prospect can put pressure on those involved in developing or reviewing studies that include infants, children, or adolescents. A strong system of protections for adult and child participants in research will provide support and guidance for all involved to help them fulfill their legal and ethical responsibilities in such situations.

And

Notwithstanding the expected benefits of policies to increase the amount of research involving infants, children, and adolescents, some caution is appropriate. Unlike most adults, children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf. Their vulnerability demands special consideration from researchers and policymakers and additional protections beyond those provided to mentally competent adult participants in research.

And

As discussed later in this chapter, instances of unethical research practices involving children have prompted public criticism and concern that has contributed to the development of current federal regulations to protect both child and adult participants in research. Since the 1960s, policymakers, researchers, research institutions, and research sponsors have taken a number of steps to strengthen ethical standards and policies for human research and to create formal programs, including institutional review boards (IRBs), to approve and monitor research. Clinical studies funded, conducted, or regulated by the government are now subject to a (mostly) common set of provisions for the protection of human participants in research, including special protections for children. One result is that some potentially important clinical studies that would be approved for adult participation cannot be approved for participation by children.

a9062388703d9f42237ea708b2e088f1--protective-boyfriend-quotes-protective-quotesParents’  “intimate and profound duty to protect and promote their child safety and well-being in research”

…The committee recognizes the important role of parents. They have a most intimate and profound duty and desire to protect and promote their child’s safety and well-being in research, as in all realms of life. Chapter 5, in particular, has discussed how investigators, IRBs, and others can effectively and compassionately support parents in fulfilling their responsibilities and, thereby, help them to feel that they have done the right thing for their child, whatever their choices about the child’s participation in research. Once parents have agreed to their child’s participation in research, they—and older children and adolescents—may sometimes have crucial responsibilities for following the research protocol (e.g., administering medicines or bringing the child in for research appointments). Investigators need to make sure that parents and older children and adolescents understand any such responsibilities before they agree to research participation and that they have appropriate support in adhering to the protocol during the course of the research

Selected Recommendations

Recommendation 4.1: In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

In Section 406 of 45 CFR 46, federal regulations permit research that involves a minor increase over minimal risk without the prospect of direct benefit if the research involves children with a disorder or condition, is likely to yield vital knowledge about that disorder or condition, and entails research experiences that are reasonably similar to those that such children encounter in certain other situations. Consistent with the interpretation of minimal risk, the interpretation of this level of research risk should not allow a higher threshold of risk for children who are exposed to more risk in other aspects of their lives (Recommendation 4.2). Also, consistent with the language of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which defined this standard in 1977, the risk allowed under this category can be only slightly above minimal risk.

Recommendation 4.3: In determining whether proposed research involving a minor increase over minimal risk and no direct benefit can be approved, the term condition should be interpreted as referring to a specific (or a set of specific) physical, psychological, neurodevelopmental, or social characteristic(s) that an established body of scientific evidence or clinical knowledge has shown to negatively affect children’s health and well-being or to increase their risk of developing a health problem in the future.

Recommendation 4.1 In evaluating the potential harms or discomfort posed by a research protocol that includes children, investigators, and reviewers of research protocols should

Interpret minimal risk in relation to the normal experiences of average, healthy, normal children;

Focus on the equivalence of potential harms or discomfort anticipated in research with the harms or discomfort that average, healthy, normal children may encounter in their daily lives or experience in routine physical or psychological examinations or tests;

Consider the risk of harms or discomfort in relation to the ages of the children to be studied; and

Assess the duration as well as the probability and magnitude of potential harms or discomfort in determining the level of risk.

Parents should have been warned about unprofessional providers in Esther Crawley’s SMILE trial

The providers of Lightning Process in the SMILE trial were not credentialed health professionals and are not bound by ethical codes.

giphyEsther Crawley’s overdue publication of results from the SMILE trial  deserves close scrutiny for lots of reasons. But especially for what is said about the supervision and qualifications of Lightning Process practitioners who delivered the treatment.

Readers can easily gloss over a seemingly straightforward description of these practitioners in the paper. Yet, a little probing and checking of sources should cause some alarm among the parents who agreed to their children participating in the trial.

The details are alarming enough to cause worry about participating in any clinical trial involving Esther Crawley. She does not look after the safety and rights of children in her care.

This trial was approved by a number of committees at Bristol University. Assured by those well-publicized approvals, parents undoubtedly assumed that their children were protected from risks and needless exposure to quack treatments or providers not bound by enforceable ethical codes. The children did not have these protections, which should give pause to anyone contemplating allowing their children to participate in a trial regulated by Bristol University.

What was said in the published paper

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP. Following the diploma, LP practitioners undertake a further course to learn the tools and delivery required for the LP after which they must pass both a practical and written examination. Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge. They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

Let’s isolate and probe some of these statements.

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy.

advanced practitionerComment: This is does not represent anything approaching a degree from an accredited university or training institute. Phil Parker has been sanctioned by the UK Advertising Standards Authority for false claims about treating and even curing complex medical conditions. Yet the SMILE trial presented the Lighting Process as a treatment to the parents and children.

It would be fascinating to debrief the parents to discover what they assumed in consenting to their children’s participating in the trial. Did they think the children were being treated? Were they informed that the ASA forbade billing Lightning Process as a treatment? That the treatment providers were not chartered or qualified medical or mental health providers?

Neurolinguistic Programming has been widely discredited as quackery and is no longer is discussed in the scientific or clinical literatures.

Life Coaching is so vague a term as to be meaningless. There is no regulation or consistent specification of what is done or forbidden to be done in life coaching.

Clinical Hypnotherapy is not a restricted, independently recognized, nor chartered class of provider. Anyone can call themselves a clinical hypnotherapist. Phil Parker’s institute issues meaningless certificates that be hung on providers’ walls to confuse consumers.

This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP.

 Comment: Sounds impressive, huh? The ‘written and practical examinations’ involve showing adeptness in delivering a quack treatment that involves making false claims and offering pseudoscientific explanations to patients- messages defined by those who sell the training products.  Ability to meet these criteria involves taking trademarked training courses in quackery. Any deficiencies in knowledge or practice that examiners perceive are remedied by taking more courses. Essentially, this is a pyramid scheme from which Phil Parker benefits financially.

Reassured that providers are accredited by “British Institute of Hypnotherapy and NLP?” Go visit the website and you can readily see that it is an extension of Phil Parker’s marketing effort, not something independent or otherwise chartered or regulated. The site offers courses in referrals to people who have completed courses.

At the website a rotating variety of pseudoscientific explanations are provided with claims of dramatic effects of hypnosis that are at odds with the evidence. Visitors are led to believe that hypnotherapy is effective for reducing blood pressure and stopping smoking:

Hypnotherapy can help you kick the habit of smoking into touch for good.

Compare that to what is said by the Cochrane Collaboration:

Does hypnotherapy help people who are trying to stop smoking?

We have not shown that hypnotherapy has a greater effect on six-month quit rates than other interventions or no treatment. There is not enough evidence to show whether hypnotherapy could be as effective as counselling treatment. The effects of hypnotherapy on smoking cessation claimed by uncontrolled studies were not confirmed by analysis of randomized controlled trials.

The site also falsely claims that hypnotherapy can reduce blood pressure. The site is basically an advertisement for exaggerated claims about hypnosis backed by pseudoscientific explanations of how it works.

Hypnotherapists now understood neurology and physiology of using hypnosis and have the evidence of neurosciences support this understanding.

not psychologicalNonsense. This British Institute of Hypnotherapy and NLP is set up and run by a guy who claims neuroscience, osteopathy and neurolingustic programming explain the effects of the Lightning  Process, which are claimed to be physiological, not psychological. Who believes these additional claims about hypnosis are valid?

Consumer beware.

Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge.

But the supervision is in use of a commercial product with a pseudoscientific explanation. So, apparently practitioners are supervised in their willingness and ability to adhere to the scripts they have received as part of products they have purchased. The “continuous professional development” is taking a steady stream of Phil Parker’s training courses. Because his materials are trademarked, no one who is not authorized by Parker to sell his merchandise.

They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

There is a financial conflict of interest in Phil Parker offering courses and training and what the ASA has said cannot be described as treatment and then setting up a professional conduct committee is tied directly to his products.

What should parents be able to expect in bringing their children to a recognized, regulated healthcare site, like the NHS? The treatment providers should be professionals licensed by a governmental or independent body separate from any marketing of training. If not fully licensed or regulated professionals, they should be supervised by professionals, such as medical or mental health clinicians.

The class of providers should also be licensed or chartered so that sanctions with legal consequences can be applied for misconduct or unethical behavior. Providers working with children should be held to some ethical standards in terms of the safety and rights of both children and their parents.

None of these features are present in the treatment provided in the SMILE trial.

Christine Fenton, a retired Deputy Head of two high schools in the UK notes she was responsible for child protection in those roles. She expressed this concern about the basic conflict of Lightning Process and tenets of childhood protection:

LP participants are directed to not talk to others about it – keep secrets – to report positively regardless of their internal view is appalling to me. Child Protection has a key tenet ‘secrets are not ok’ – if an adult tells a youngster to keep a secret it is a form of control & creates an environment in which abuse can occur more easily.

Teachers, like other professionals coming in contact with children are required to take courses about child protective services and the duty to report abuse. They are held legally responsible for violation of the associated rules. However, legally, providers of the lightning process are only ordinary citizens, not professionals and are not held responsible in this manner.

In obtaining approval for the conduct of the SMILE trial from Bristol University, Pediatrician Esther Crawley claimed that sessions of the writing process were taped and that she had responsibility for reviewing the tapes. It strains credibility to claim that she actually listened to all the tapes from the study.

But what does it mean for a physician to supervise a quack treatment provided by quack providers who are not being allowed to call what they do treatment? How does Crawley react when physically ill, impaired children are instructed to deny their fatigue and pain to authority figures such as teachers and parents?

Truly mind-boggling to consider.

CDC – Don’t just discreetly change recommendations for treating chronic fatigue syndrome, publicize the changes!

 

Original Title: BLDG21_0023.jpgNo one is going to notice important changes to Center for Disease Control recommendations for treating chronic fatigue syndrome unless explanations are often and disseminated.

Unless you stumbled on it by accident, you had to be a routine watcher of the CDC website to have noticed a discrete last summer in the agency’s recommendations for treating chronic fatigue syndrome/myalgic encephalomyelitis.

CDC Removes Reference to Disputed ME/CFS Therapies From Website

Last summer: David Tuller University of California, Berkeley lecturer in public health and journalism and activists noted

The CDC website now advises patients to develop an individual management strategy with a health care provider and warns them not to overexert themselves. (However, a separate page about ME/CFS in the CDC’s features section still includes advice about “graded exercise.”)

And

In an email sent in response to questions about the changes, the CDC did not specifically mention graded exercise therapy and cognitive behavior therapy, or concerns about the PACE trial, but said that it rewrote the website section to avoid “confusion” associated with its previous recommendations and to eliminate medical jargon.

“We continue to believe that exercise can be useful for some ME/CFS patients, and also are trying to emphasize that people need to be careful not to overdo it and push themselves so far that it harms their health,” the emailed statement reads. “We also state that talking to a therapist to help find strategies to cope with their illness may be helpful. We know from our past discussions with patients and their loved ones that there has been confusion about what we recommend related to exercise and therapy. We hope that the updated website provides more clarity.”

At the time, the CDC made in promised to Tuller and the patient community that has not been kept:

The CDC also promised to disseminate information about the website changes once the agency has updated the companion pages for health professionals.

Now, a new article by Tuller and science and health journalist Julie Rehmeyer asks

Why did it take the CDC so long to reverse course on debunked treatments for chronic fatigue syndrome?

I highly recommend this article and agree:

While the CDC deserves credit for having removed information based on bad science, that alone is not enough. The agency must also undo the damage it has caused.

I agree well as with Tuller and Rehmeyer’s three recommendations to the CDC:

Acknowledge more publicly that the CDC got things wrong.

And

CDC must actively disseminate the news that it no longer recommends these two ineffective and possibly harmful therapies and that no legitimate evidence supports their use.

And

Reach out directly to health care and medical organizations, such as Kaiser Permanente and the Mayo Clinic, to urge them to stop recommending the treatments and ensure that the information they provide is truly up to date. That outreach should include the UK’s National Institute for Health and Care Excellence.

 

 

 

 

Bristol University should start cleaning up its clinical trial registries by publishing two psychosocial intervention studies

A story in the feisty Bristol Cable revealed Bristol University ignores its responsibilities to publish results of clinical trials. A follow up story announced the university’s pledge to remedy the situation.

The investigation of hidden data involved drug and medical device trials and excluded psychotherapy or psychosocial intervention trials. But here are two trials for which publication is overdue.

One of the trials evaluates a quack treatment, which the Advertising Standards Authority (ASA) advises cannot make claims about health benefits. Its promoter was paid handsomely for the treatment provided in the trial. He capitalized heavily on the trial to advertise his treatment as being evaluated in a clinical trial. Was the trial simply a lucrative infomercial for his discredited product?

box score

There is some evidence that these trials did not go as planned, but that is all the more reason to publish results so that we can understand what went wrong.

lack of transparency

The situation is sufficiently problematic for me to recommend:

Patients should not enroll in psychotherapy trials associated with Bristol University until results of these trials are published.

Patients should be advised that the burden and inconvenience of participating in research is not warranted if the results remain unpublished. You are not obligated to participate in research. Don’t let anyone tell you differently.

A headline in the investigative journalism platform Bristol Cable read:

Medical research in Bristol violates international transparency …

A joint investigation by TranspariMED and the Bristol Cable shows that the University of Bristol has not posted summary results for a single clinical trial onto registries. On the main European trial registry, the university is listed as the sponsor of 14 drug trials involving over 1,600 healthy volunteers and patients. Three trials that ended in 2009, 2011 and early 2016 have still not posted results there. Most of the remaining 11 trials also seem to have been completed, but are still listed as ‘ongoing’, suggesting that the university is not keeping its medical research records up to date.

On Clinicaltrials.gov, the main American registry, the university has registered 16 research projects; it has posted summary results for none of them.

A follow up headline read

Bristol University pledges clinical trial registry cleanup

A spokesperson for the university responded that Bristol had recently started adding results to the European registry. He also explained that until last year, “anyone could set up an account naming the University as the umbrella organisation” on Clinicaltrials.gov. The university has now assumed central control over those registry entries and is working to clean up its data, the spokesperson said.

The founders of the Bristol Cable told The Guardian: ‘We’re holding people to account for their actions’

The investigation was part of a larger international effort to uncover and correct a scandal: results of many drug trials are never published. Or published reports switch outcomes to make the manufacturers’ drugs appear more effective than they actually were in the trials.

Psychotherapy trials are excluded from these investigations. Yet, publishing results of psychotherapy trials consistent with the originally planned outcomes is undoubtedly less common because of lack regulatory oversight of psychotherapy trials. The confirmation bias in published of psychotherapy trials could even be stronger than with drug trials.

But we really cannot get a precise estimate of how many results of psychotherapy trials are being kept out of view. Many psychotherapy researchers do not even register their trials – or register only after they have already peeked at some of their results and can revise what were the originally intended outcomes being investigated.

This situation is unacceptable because it allows the promotion of ineffective and even harmful treatments.

Moreover, investigators have a moral and ethical responsibility to patients who consent to participate in clinical trials. In a trial comparing an intervention the investigators expect to be effective to a control group, half of the patients will not be randomized to the intervention. In many trials, this means the patients will be assigned to the no-treatment control group and get nothing. But these patients will be burdened with extra visits to complete the outcome assessments needed to evaluate the active treatment given to the patients in the other group.

Presumably, if the patients assigned to the control group are not simply confused or misinformed, they voluntarily continue to show up because they believe they are contributing to science and to knowledge that will help others in their predicament, if not themselves.

 

The first trial

The trial registration is ISRCTN72645894 DOI 10.1186/ISRCTN72645894

Early intervention in fatigue: a feasibility study

Study hypothesis

The overall aim of this study is to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to investigate the effectiveness and cost effectiveness of early intervention for chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) compared with standard medical care in primary care.

Intervention

Early intervention for fatigue. The intervention is based on the principles of cognitive, behavioural and graded exercise and is delivered by a trained therapist in an individual face-to-face session with telephone follow-up sessions. Follow up length: 6 month(s); Study entry: single randomisation only

Primary outcome measure: Recruitment, adherence and follow up. Timepoint(s): 3 and 6 months

Secondary outcome measures: Not provided at time of registration

Note that the primary outcomes are not patient clinical outcomes, i.e., whether patients benefited from being assigned to active treatment versus control. The study was explicitly described as a feasibility and acceptability study.

Psychotherapy studies are commonly described in the literature as pilot and feasibility studies, mainly to escape the criticism that the study was small and underpowered.  But, if so, effect sizes for patient outcomes should be presented because they are likely to be exaggerated and not generalizable to what would occur in a larger, better controlled study or in routine practice.

I wonder if the consent forms provided to patients indicated that the investigators were not interested in whether they benefited from treatment.

What results of a freedom of information act request revealed

Feasibility: We aimed to recruit 100 participants to this study, but were only able to recruit 44.  In addition, 9 (32%) who should have received EI did not have all the sessions offered.

Acceptability: Although 12 of the participants told us that some of EI was useful, 11 of these participants also found some parts unacceptable. Four participants were still experiencing fatigue after completing EI and two felt they wanted more help at the end. Four of those we talked to did not find EI acceptable and withdrew. Reasons included: not liking the treatment model, or the way it was delivered.

Fatigue, pain, mood and work status were no different between the two groups at the end of the study however the study was not large enough to show an effect.

Our results show that this type of study is not feasible and EI was not acceptable to a lot of participants

It is a disservice to the patients who participated in the trial that there is no published acknowledgement that the study did not reach its accrual goal because patients did not wish to participate.  Patients who consented to treatment did not generally find it helpful.  Publication of this study could serve as a warning that most primary care patients suspected of having chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) are not interested in treatment based on the principles of cognitive, behavioural and graded exercise. The minority who consented to participate did not find the experience helpful.

The second trial: SMILE

 The trial registration is http://www.isrctn.com/ISRCTN81456207

The study protocol:

Crawley E, Mills N, Hollingworth W, Deans Z, Sterne JA, Donovan JL, Beasant L, Montgomery A. Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Trials. 2013 Dec 26;14(1):444.

An overlapping pilot study

This protocol is also cited for a pilot for which no full report was published, only a summary. The results of this pilot study resulted in the outcomes being switched for the main study.

Crawley E, Mills N, Beasant L, Johnson D, Collin SM, Deans Z, White K, Montgomery A. The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials. 2013 Dec 5;14(1):415.

Was this really a separate pilot study or an abortive failed start to the study described in the protocol? We can’t tell.

Among the  sparse details from the pilot study:

Recruitment rates were lower than anticipated, meaning that recruitment continued for longer than planned. This was mainly due to an underestimate of the number of eligible patients at the start of the study (nearly half were not eligible). However, a recruitment rate of 35.9% does not preclude a full study.

And

In addition to the difficulty measuring change in school attendance for those transitioning from GCSEs to A levels, it may be a poor outcome measure for those who do not consider school attendance their primary goal. We suggest that a full study uses other primary outcomes, such as the SF-36 or the Chalder Fatigue Scale and uses school attendance as a secondary outcome.

So, at a time when other evaluations of interventions for ME/CFS were undergoing coordinated switching of outrcomes because of null findings from the FINE trial with the original scoring, the SMILE trial seems to have switched outcomes as well.

The treatment being evaluated in the main study is described as:

The Phil Parker Lightning Process® (LP) is a trademarked intervention that is used for a variety of conditions including CFS/ME. It has been developed from osteopathy, life coaching and neuro-linguistic programming. The intervention includes three group sessions on consecutive days where young people are taught skills that they can try out for themselves including looking at their sitting and standing posture. Families currently pay approximately £620 to attend the LP course.

Even though over 250 children and young people a year use the LP as an intervention for their CFS/ME, there are currently no reported studies investigating the effectiveness or possible side effects (for example serious adverse events) of the LP.

This is an exceedingly weak rationale for inflicting a quack treatment on unsuspecting children. Ethically, there must be a scientific rationale for exposing children to an unproven treatment that might be ineffective or even harmful.

The Advertising Standards Authority (ASA) guidance has ruled that LP cannot be advertised as a treatment:

To date, neither the ASA nor CAP [Committee of Advertising Practice] has seen robust evidence for the health benefits of LP. Advertisers should take care not to make implied claims about the health benefits of the three-day course and must not refer to conditions for which medical supervision should be sought.

Yet, the information sheet for the trial is describing it as a treatment to patients.

The materials patients must read as part of participating in the trial reek of pseudoscientific misinformation.

LP trains individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations.

* Learn about the detailed science and research behind the Lightning Process and how it can help you resolve your issues.

* Start your training in recognising when you’re using your body, nervous system and specific language patterns in a damaging way

 What if you could learn to reset your body’s health systems back to normal by using the well researched connection that exists between the brain and body?

The Lightning Process does this by teaching you how to spot when the PER is happening and how you can calm this response down, allowing your body to re-balance itself.

 The Lightning Process will teach you how to use Neuroplasticity to break out of any destructive unconscious patterns that are keeping you stuck, and learn to use new, life and health enhancing ones instead.

 The Lightning Process is a training programme which has had huge success with people who want to improve their health and wellbeing.

The intervention imposes strange demands on patients that encourage dishonesty, including in completing the outcome evaluations:

  1. Responsibility of patients:

Believe that Lightning Process will heal you. Tell everyone that you have been healed. Perform magic rituals like standing in circles drawn on paper with positive Keywords stated on them. Learn to render short rhyme when you feel symptoms, no matter where you are, as many times as required for the symptoms to disappear. Speak only in positive terms and think only positive thoughts. If symptoms or negative thoughts come, you must stretch forth your arms with palms facing outward and shout “Stop!” You are solely responsible for ME. You can choose to have ME. But you are free to choose a life without ME if you wish. If the method does not work, it is you who are doing something wrong.

Bristol University at first rejected a freedom of information act requests for how much developers of the treatment were paid but on appeal revealed mean cost of a course for trial participants was £567. This means £14,000 wasted on a junk intervention in the pilot study and much more was paid for the full trial.

Special thanks to John Peters for his assistance and his excellent detective work and use of the Freedom of Information Act.

See his blog posts here:

THE SMILE TRIAL (part 1): Why the trial should never have been allowed in the first place.

THE SMILE TRIAL (part 2): A trial so flawed as to be worthless.

THE SMILE TRIAL (part 3): The only one to benefit is Parker. 

And also my post

http://blogs.plos.org/mindthebrain/2016/09/23/before-you-enroll-your-child-in-the-magenta-chronic-fatigue-syndrome-study-issues-to-be-considered/

Parker start your journey

 

Beware of the pinkwashing of suicide prevention

Cause marketing of cosmetics to prevent suicide could mark the return of exploitation of a good cause for profit.

Just as with we learned with Breast Cancer Pink Ribbon campaigns, we need to ask questions about where the profits are going and whether we should object.

Two companies announced special deals on cosmetics to reduce suicide.

Brandt Skincare ‘s $38 limited-edition #sayiloveyou skin-care kit

brandt kit with tattooBrandt skin care announced it was launching a special deal in #sayiloveyou skin-care kit for suicide awareness month

 

After renowned celebrity dermatologist Dr. Fredric Brandt died by suicide in 2015, his friends and colleagues (given that he was known for being unfailingly warm and outgoing, the two often overlapped) started the Dr. Brandt Foundation in his honor to raise awareness by encouraging meaningful, empathetic conversations around mental illness and provide a support system for those whose lives have been affected by its devastating effects.

This Sunday, to coincide with Suicide Prevention Awareness Month, the Foundation is set to launch a new social media campaign to help raise money, promote understanding, and encourage fans and followers to join the fight against suicide and depression. Getting involved is easy: For every image of a heart posted to Instagram with the hashtag #sayiloveyou, the Foundation will donate $1 to its suicide prevention project up to $100,000.

Dr. Brandt Skincare will also offer a $38 limited-edition #sayiloveyou skin-care kit, available September 10, that includes a collection of the brand’s best-selling products, a signature tote bag, and a temporary heart tattoo (yes, for the ‘gram), with a percentage of the proceeds going to the Dr. Brandt Foundation. (Of course, you can always donate directly to the cause, too.)

Not to be outdone, NYX announced #LuvOutLoud

way to go

NYX’s #LuvOutLoud donates $6,000 to The Trevor Project, a non-profit that helps provide support and suicide prevention for LGTBQ youth.

Whether it’s black lipstick, bold brows, or something as simple as faux freckles, makeup can send a meaningful message about who you are, what you stand for, and the way you want to be seen. But the process of turning your personal beauty choices into part of your identity can start even before it makes its way to your face, like when you buy a tube of Luv Out Loud, a new collection of liquid lipsticks from NYX Professional Makeup,.

And

The lipsticks don’t just represent the NYX mantra of “inclusivity, acceptance, and artistry for all” in name alone: The brand teamed up with makeup artist and social-media influencer Angel Merino, aka @mac_daddyy, to donate $6,000 to The Trevor Project, a non-profit that helps provide support and suicide prevention for LGTBQ youth.

NYX’s new lipstick line supports the LGBTQ+ community 

Makeup for the win!

NYX has new matte lipsticks coming out — and they benefit a beautiful cause. It’s always great when our makeup addictions serve a higher purpose, right?

The brand has partnered with celebrity makeup artist Angel Merino to raise money for the LGBTQ+ community with its Luv Out Loud collection.

NYX and Angel will donate $6000 to The Trevor Project — an organization that fights to keep suicide rates down among LGBTQ+ youth.

The brand is also hosting a contest that allows people to enter to win $10,000 that will be donated to the charity of their choice.

All you have to do is post a video of yourself talking about how a part of your life represents one of the empowering shade names in the new collection.

“It’s déjà vu all over again.” – Yogi Berra 

Pinkwashing 

Pinkwashing was first applied to:

The practice of a company using support of breast cancer-related charities to promote itself and its products or services.

But then became:

(LGBT) The practice of a state or company presenting itself as gay-friendly and progressive, in order to downplay their negative behavior.

Pink Ribbon Blues

folgersBreast Cancer, Concept Brand with Pink Ribbon Logo Breast Cancer, Concept Brand with Pink Ribbon Logo

Gayle Sulik, author of Pink Ribbon Blues: How Breast Cancer Culture explained:

A brand must inspire people to spread the word about your “product.” One of most powerful ways to do this is through an emotional connection that encourages consumers to identify with the brand message.

Nike’s “Just Do It” slogan with accompanying “swoosh” logo dared consumers to take action and challenge themselves. Igniting a purpose beyond the mere purchase of athletic gear, the company tapped into an American belief about the importance of hard work and getting ahead. Many brands are designed to influence how people think of themselves. Am I classic, trendy, healthy, conscientious, rugged, interesting? In the context of Nike’s product line, “doing it” also meant engaging in physical activity that likely required Nike gear. But it was the message not the product that led to sales.

The pink ribbon works in a similar way. It functions as a logo for a “set of expectations, memories, stories and relationships that, taken together, account for a consumer’s decision to choose” the breast cancer brand.

The breast cancer brand draws from a collection of symbols, images, and meanings within pink ribbon culture to maintain the principal message that breast cancer is a vitally important cause, and that supporting it indicates good will toward women. The brand encourages people to buy and display pink in the name of increased awareness, improvement in women’s lives, faith in medical science, and hope for a future without breast cancer. The brand capitalizes on emotional responses related to fear of the disease, hope for a cure, and the goodness of the cause.

pinkwashed productsThe movie Pink Ribbon Blues, Inc slammed “pink-washing” in breast cancer marches and awareness campaigns

The film questioned

the priorities of the campaigns and the broad use of the pink-ribbon logo as a fight-breast-cancer addition to products as diverse as T-shirts, toilet tissue and handguns.

 

And

“For me, pink ribbons were something very innocent,” said Lea Pool, director of the made-in-Canada documentary, which emphasizes the corporate sponsors of many of the events.

“I think it’s still not a bad idea, but I was very afraid of all the corporations and how they hijacked the disease and how they made profits out of that, and how there is pink-washing in the process of doing fund-raising.”

And

“It’s not about raising money it’s asking the question about where that money is going,” said Pool. Coining a phrase from an activist web site, she added: “Think before you pink.”

Think Before You Pink

Breast Cancer Action launched an effective campaign to get people asking questions before they participated or donated to a breast cancer walk.

Each year, hundreds of thousands of people come together to participate in breast cancer walks and runs across the U.S. Since the first breast cancer walks began in the 1980s, they have become one of the most common ways for people to try to do something about breast cancer.

Some of these walks have become huge affairs that are hosted by multi-million dollar charities and sponsored by multi-billion dollar corporations that raise millions to “end breast cancer.” And yet each year, 250,000 women are diagnosed with breast cancer and 40,000 women die of this disease.

NFL cheerleaderThe NFL Pink October, A Perfect Catch was launched and  came under particular scrutiny

NFL’s A Perfect Catch

Overview of the NFL’s Fundraising Efforts for the American Cancer Society

The NFL does not profit from the sale or auction of breast cancer awareness-identified (“Pink”) merchandise. Since 2009, the first year of the NFL’s “A Crucial Catch” campaign, the NFL’s work has raised approximately $4.5 million for the American Cancer Society, with the majority of the contribution coming from the sale of Pink items at retail and via the NFL Auction website. Beginning with the 2011 “A Crucial Catch” Campaign, money raised via the campaign supports the American Cancer Society’s Community Health Advocates National Grants for Empowerment (CHANGE) program. This program promotes health equity and addresses cancer screening disparities through community based cancer prevention and early detection programs that increase access to breast cancer screenings. The program officially launched in 2012 within 17 communities across the country (each within 100 miles of an NFL city) where data showed that the population had lower breast cancer screening rates and higher mortality rates relative to other communities. The goal of the program is to add multiple locations in 2013 and beyond; and assist even more women in their efforts to prevent cancer and find cancer early.

buy pink nfl

Here’s why the NFL’s annual pink campaign does almost nothing to fight breast cancer

The NFL has its own perilous health issues that the league has attempted to cover up. And in fact, they toned down all the pink last year in what appeared to be an effort to avoid looking too hypocritical – after the league bungled several domestic violence cases involving players.

The issue with football’s self-congratulatory awareness month goes beyond pink pom-poms, pink penalty flags and pink cleats. Hardly any of the money raised during this month even reaches the American Cancer Society. But the criticism – many from breast cancer survivors – hasn’t phased the NFL or many of its partners.

And

Business Insider wrote in 2013 that just 8.01 percent of money from NFL Breast Cancer Awareness merchandise goes to research efforts. Even worse, VICE Sports reported last year that none of that money goes toward cancer research programs. A spokeswoman for the American Cancer Society told VICE the NFL donations go to awareness, education and screenings.

The NFL program promoted breast cancer screening without regard to the evidence questioning its effectiveness and risks versus benefits, especially among younger women.

“Screening doesn’t save lives and screening mammography … is different from diagnostic mammography,” Jagger says. “The NFL has no business providing medical advice to women that is outdated, unproven, and misguided.”

Jagger quotes well-regarded and independently conducted research that shows screening mammography has no overall impact on survival rates of women with the disease.

The NFL Won’t Turn Pink In 2017

http://www.refinery29.com/amp/2016/12/133074/nfl-foundation-pink-october-breast-cancer-charity

After eight straight Octobers of painting fields, cleats, and helmets with pink ribbons, the NFL has decided to discontinue its “pink October” initiative, The MMBQ reports.

Since 2009, NFL games in the month of October have featured football players wearing pink in support of awareness and screening initiatives alongside the American Cancer Society. However, the league will now expand the campaign in an effort to raise awareness and screening for other forms of cancer as well.

The new campaign, which will keep the original name of “A Crucial Catch,” will allow individual teams to choose the cause that they’ll champion during a three-week window in October.

The move comes after years of criticism that the NFL’s “pinkwashing” actually does very little for breast cancer patients in terms of funding research for the cure. The new campaign will still focus on education and screenings, instead of raising funds for research.

I will soon be offering e-books providing skeptical eBook_Mindfulness_345x550lookseBook_PositivePsychology_345x550at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills so they dan decide for themselves. I also be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

Sign up at my website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites. Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

How advice gurus sell more products when corporations discover mindfulness training doesn’t work

competative advantage

Corporations purchasing expensive mindfulness training packages for corporate leadership and rank and file employees inevitably discover they do not obtain the benefits that are claimed for mindfulness. How can this become a strategic opportunity for advice gurus to sell more products?

value of happinessIn a recent article in Harvard Review of Business (HBR) article, Daniel Goleman and Matt Lippincott deftly explain that if corporations still believe in the promises of mindfulness, they should purchase their product, training in emotional intelligence. They claim the support of unpublished research, but, as we will see, the published research casts doubts on their product being backed by much evidence.

book cover_24582677-2ecc-4456-a2c1-c2eadfcb8d5b.jpgNo matter. We have a fascinating example of associations with Harvard, research, and University of Pennsylvania being used to brand an advice product as effective and backed by science.  It is a strategy that Amy Cuddy used to present herself as an advice guru before the launch of power posing. Elizabeth Dunn and Michael Norton use the HRB to launch their campaign for the science of smarter spending, how money can buy you happiness, if you follow their advice.

The click link “What really makes mindfulness works” suggests an article from Harvard Review of Business explainswhat really makes mindfulness training work. Actrually, the article actually pitches products for when corporations find mindfulness does not  live up to expectations.

Without Emotional Intelligence, Mindfulness Doesn’t Work

The first two paragraphs skillfully criticize mindfulness as a fad, but argue for a “complicated relationship” between mindfulness and improved executive performance, setting the reader up for a pitch for their product, which provides a more effective route.

Mindfulness has become the corporate fad du jour, a practice widely touted as a fast-track to better leadership. But we suspect that not all the benefits laid at its feet actually belong there. Our research and analysis has revealed a complicated relationship between mindfulness and executive performance—one that is important for leaders to understand as they seek to develop in their careers.

 Mindfulness is a method of shifting your attention inward to observe your thoughts, feelings, and actions without interpretation or judgment. A mindfulness practice often begins simply by focusing on your breath, noticing when your mind wanders, and then bringing it back to your breath. As you strengthen your ability to concentrate, you can then shift to simply noting your inner experience without getting lost in it at any point in your day. The benefits attributed to this kind of practice range from stronger relationships with others to higher levels of leadership performance.

The next paragraph introduces Sean, “a senior leader at a Fortune 100 corporation” who will tell you that mindfulness played a critical role in transforming his career.

To allay readers’ suspicions that Sean may be a fiction contrived by the authors to make a point, they next claim he is one of  “42 senior leaders from organizations throughout the world who practice mindfulness and whom one of us (Matt Lippincott) studied at the University of Pennsylvania.”

This “research” is described in HBR as producing a promoter’s dream list of benefits to practicing mindfulness. Unfortunately, no link is provided to an actual report of methods and results.

I Googled Matt Lippincott. A link to ResearchGate came up

Lippincott has no published research listed, but there was a link to an unpublished dissertation.

This qualitative research study examined detailed reports by senior organizational leaders linking mindfulness to improved leadership effectiveness. Extensive research supports the existence of a relationship between mindfulness and cognitive, physiological, and psychological benefits that may also have a positive impact on leadership effectiveness. Currently, however, little is known about the processes potentially enabling mindfulness to directly influence leadership effectiveness, and as a result this study was designed to explore this gap in the literature. Data was collected through in-depth interviews with forty-two organizational leaders in North and South America and Europe, many with a history of leadership roles at multiple global organizations. Participants credited mindfulness for contributing to enduring improvements to leadership capabilities, and data analysis revealed new findings clarifying the perceived relationship between mindfulness and tangible results for organizational leaders. Specifically, the results indicate that mindfulness is perceived to contribute to the development of behaviors and changes to awareness associated with improved leadership effectiveness. A potential relationship between mindfulness and the development of emotional intelligence competencies linked to increased leadership performance was revealed as well. The contribution of this study to current literature is also discussed, as are recommendations for future research.

So a dissertation with a weak methodology that allows invoking “research” and “University of Pennsylvania” for credibility.

Back to the wrap up of the HBR article, we get the buy-our-product punch line:

We believe that by focusing on mindfulness-as-corporate-fad, leaders run the risk of missing other opportunities to develop their critical emotional skills. Instead, executives would be better served by deliberately assessing and improving their full range of emotional intelligence capabilities. Some of that work may well involve mindfulness training and practice, but it can also include formal EQ assessment and coaching. Other tools and approaches include role-playing, modeling other leaders you admire, and rehearsing in your mind how you might handle emotional situations differently. By understanding that the mechanism behind mindfulness is the improvement of broader emotional intelligence competencies, leaders can more intentionally work on all of the areas that will have the strongest impact on their leadership.

The two authors

Daniel Goleman is Co-Director of the Consortium for Research on Emotional Intelligence in Organizations at Rutgers University, co-author of Primal Leadership: Leading with Emotional Intelligence, and author of The Brain and Emotional Intelligence: New Insights, Leadership: Selected Writings, and A Force For Good: The Dalai Lama’s Vision for Our World. His latest book is Altered Traits: Science Reveals How Meditation Changes Your Mind, Brain, and Body.

Matthew Lippincott is a business owner, researcher, and author involved in the creation of new leadership development solutions. He holds a doctoral degree from the University of Pennsylvania, and has previously held leadership positions at two of the world’s largest software companies.

We get a sense of former Psychology Today editor Daniel Goleman trying to create a brand of advice that unites the Dalai Lama, the good, and corporate competitiveness. Lippincott has delivered a Penn Wharton dissertation uniting mindfulness and emotional intelligence. He got work on this basis.

Hmm, did the link emerge from the data, or is this dissertation simply an informercial aimed at getting a job marketing the combo of mindfulness and emotional intelligence?

The scientific status of emotional intelligence

According to Wikipedia:

Emotional intelligence (EI) is the capability of individuals to recognize their own and other people’s emotions, discern between different feelings and label them appropriately, use emotional information to guide thinking and behavior, and manage and/or adjust emotions to adapt to environments or achieve one’s goal(s).[1]

Although the term first appeared in a 1964 paper by Michael Beldoch, it gained popularity in the 1995 book by that title, written by the author, psychologist, and science journalist Daniel Goleman. Since this time, Goleman’s 1995 analysis of EI has been criticized within the scientific community,[2] despite prolific reports of its usefulness in the popular press.

The Wikipedia offers three stinging critiques backed by links to references.

Emotional intelligence cannot be recognized as form of intelligence

Goleman’s early work has been criticized for assuming from the beginning that EI is a type of intelligence or cognitive ability. Eysenck (2000)[57] writes that Goleman’s description of EI contains unsubstantiated assumptions about intelligence in general, and that it even runs contrary to what researchers have come to expect when studying types of intelligence:

“[Goleman] exemplifies more clearly than most the fundamental absurdity of the tendency to class almost any type of behavior as an ‘intelligence’… If these five ‘abilities’ define ’emotional intelligence’, we would expect some evidence that they are highly correlated; Goleman admits that they might be quite uncorrelated, and in any case if we cannot measure them, how do we know they are related? So the whole theory is built on quicksand: there is no sound scientific basis.”

Emotional Intelligence confuses skills with moral qualities.

Adam Grant warned of the common but mistaken perception of EI as a desirable moral quality rather than a skill, Grant asserting that a well-developed EI is not only an instrumental tool for accomplishing goals, but has a dark side as a weapon for manipulating others by robbing them of their capacity to reason.

Emotional Intelligence has little predictive value.           

Landy (2005)[61] claimed that the few incremental validity studies conducted on EI have shown that it adds little or nothing to the explanation or prediction of some common outcomes (most notably academic and work success).

Some further links I also discovered

Steve Topak’s Don’t Believe the Hype Around ‘Emotional Intelligence’ 

What if I said that emotional intelligence is the ability to recognize, understand and control emotions – not just our own but the emotions of others, as well? What if I said it can be used to manipulate behavior? That sounds a bit different, doesn’t it? Not such a no-brainer anymore, is it?

And

This is not some sort of rhetoric slight of hand nor is that definition controversial. It’s common doctrine. But if authors, consultants and executive coaches were to say that Adolf Hitler was as adept at emotional intelligence as Martin Luther King Jr. – as Adam Grant explains in The Atlantic – they would not sell many books or book a lot of gigs.

Excerpts from a nice comprehensive review

Kilduff M, Chiaburu DS, Menges JI. Strategic use of emotional intelligence in organizational settings: Exploring the dark side. Research in organizational behavior. 2010 Dec 31;30:129-52.

Just as the cognitively smart person may be able to understand options and draw conclusions quickly and competently, so the emotionally intelligent person may be able to assess and control emotions to facilitate the accomplishment of various goals, including the one of getting ahead. We suggest that high-EI people (relative to those low on EI) are likely to benefit from several strategic behaviors in organizations including: focusing emotion detection on important others, disguising and expressing emotions for personal gain, using misattribution to stir and shape emotions, and controlling the flow of emotion-laden communication.

And

We have shown that the strategic disguise of one’s own emotions and the manipulation of others’ emotions for strategic ends are behaviors evident not only on Shakespeare’s stage but also in the offices and corridors where power and influence are traded.

Take away messages.

Don’t expect top quality science from Harvard Business Review, but sliced and diced stuff to sell products a research-based.

Be skeptical of researchers who promote their studies in HBR. They are often publishing an infomercial that to be effective must make extravagant claims that require stronger and more unambiguous findings than research  can possibly produce.

eBook_Mindfulness_345x550I will soon be offering e-books providing skeptical lookseBook_PositivePsychology_345x550 at mindfulness and positive psychology, and arming citizen scientists with critical thinking skills so they dan decide for themselves. I also be offering scientific writing courses on the web as I have been doing face-to-face for almost a decade. I want to give researchers the tools to get into the journals where their work will get the attention it deserves.

Sign up at my website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites. Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

Acceptance and Commitment Therapy and Positive Psychology: Theoretical integration or product line expansion?

doritosDoes combining ACT and positive psychology yield something like a Nacho Cheese Doritos® Locos Tacos Supreme? A product line expansion for ACT?

As documented in a previous blog post, the founders of Acceptance and Commitment Therapy seem to be crafting themselves as workshop gurus. This is at the expense of attending to the pressing need to develop a base of evidence appropriate to the claims being made for the efficacy of ACT.

By the usual standards, the evidence is weak that ACT is an effective treatment for any of a range of clinical problems. There is no evidence that ACT is superior to the already disseminated psychotherapies its promoters would replace.

ACT joining forces with the huge  positive psychology movement could be a strategic next step, if expanding the market for ACT products is the goal. There are obvious theoretical differences between ACT and positive psychology, but signs are that these differences are sidestepped in joint marketing ventures. Press releases are on the web for a “historic “captains of both ships” Barbara ‘Positivity’ Fredrickson and Steven ‘ACT’ Hayes having a “historic meeting in Berlin.

Talks by Fredrickson and Hayes are also jointly being promoted here. 

A historic meeting of Positive Psychology and ACT

Zegers Hein interviews  Barbara Fredrickson & Steven Hayes

Some excerpts from the article and interview:

Positive Psychology and ACT (Acceptance and Commitment Therapy) are different movements within psychology. Yet they also have quite a lot in common. We witnessed the two captains of both ships meet for the very first time: Barbara ‘Positivity’ Fredrickson and Steven ‘ACT’ Hayes. Here is an exclusive report of this historic meeting in Berlin, Germany1. This meeting is indicative of Positive Psychology 2.0, the so-called ‘second wave positive psychology’ that embraces ‘negative’ emotions. Questions are raised that are highly relevant for this MOOC, such as: Would you prefer to feel all kinds of emotions or just to be happy? Can ‘negative’ emotions be positive?

Positive Psychology and Acceptance and Commitment therapy (‘ACT’ for short, pronounced as one word) both appeared at about the same time within the history of psychology. Since its inception, Positive Psychology has always held ‘The Meaningful Life’ as a central pillar. Similarly, within ACT, moving towards meaningful ‘Valued Living’ is a core process. What, then, are the differences between both movements?

Positive’ Psychology vs. ‘Dark’ ACT?

Fredrickson: ‘Positive Psychology, to me, is not a separate domain of psychology. It’s an emphasis, a leaning, a call within psychology to also focus on positive aspects.’ But isn’t this positive emphasis different from what ACT proclaims?

Hayes: ‘When ACT first got popular attention with a story in ‘Time’, this story was titled ‘Happiness is not normal’. Which is of course something we’d never said, but some reporter wrote down. Another headline of that time was ‘Hello Darkness’. And I get that (laughs). From the beginning, we’ve cared about meaning and purpose and values-based action. Constructing the sort of lives that make life worth living.’ Turning towards his neighbor: ‘And Barbara has, throughout her career, really focused on the relationship between positive emotions and behaviour. And that is of central importance, I think, to ACT.’

Sweet Sadness

ACT consciously tries to avoid labeling emotions ‘positive’ or ‘negative’. How would you define positive emotions for ACT? Hayes: ‘It seems to be so contextually bound, that you can flip it. Take for instance sadness, is that negative? Clearly not. If my mother died last spring, sadness is what I would want, right? Is that a negative emotion? No, it’s not a negative emotion. In fact, are there any negative emotions (that are not contextually bound)? If you live them fully, and put them into your life that leads you in a values-based direction?’

So what ‘negative’ are we talking about here? Fredrickson: ‘I think that, as a field, we’ve inherited some language in terms of calling classes of emotions ‘positive’ and ‘negative’, and there’s so much levels at which you could define that ‘positive’ and ‘negative’. I think that what’s meant by it, is this: ‘If all other things were equal, would this be a wanted state? Would you want the state to continue?’ Hayes nods in agreement when Fredrickson continues: ‘Negative emotions are useful if connected to context, but become negative if disconnected from context.’

When pressed for a further clarification of this distinction, Fredrickson continues: ‘I think of it as a can opener. Positive emotions, or hedonic well-being, is a way to open people up, in a way so they can see and appreciate more meaning. And experiencing meaning more is in itself an emotional uplift too’.

‘By the way, speaking of opening up’, Fredrickson smiles, ‘another illustration may be the licence plate I have chosen to put on the car I drive. The licence plate on my car reads: “Be Open”.’

Choose to feel

Hayes: ‘Exactly. Be Open. And for me, that includes openness to sadness. The point is that openness to sadness – including seeing the suffering of others, and being moved by it – is critical to compassion and happiness. Said in another way, the poets are right: it is our tears that scoop out a place for our laughter to reside.

But Barbara’s license plate on her car is right on: ‘Be Open’. Note, it is not “Be Happy.” It’s “Be Open”’, Hayes points out. ‘I have a similar sign on the wall of my office: “Choose to Feel.”

None of this is in any way theoretically clear, but maybe it is unfair to apply the standards of an entirely different form of discourse.  “Pepsi’s the One”  is advertising, not a theoretical propositon or an evidence-bassed statement. Probably the same for some of the sloganeering in this interview. But was does this do for the credibility of Hayes and Fredrickson when they want to speak more seriously?

I can’t wait for next year’s model, Positive Psychology 2.0, or did I miss it and  now have to wait for the fall release of Positive Psychology 3.0?

Personally, I am a great fan of traditional tacos and all their regional Latin Amercian variations. Some neuva ola and fusion tacos are tasty, too. But  I can’t bring myself even to go near a Nacho Cheese Doritos® Locos Taco Supreme. Just not authentic enough and the fake cheese is gross.

eBook_PositivePsychology_345x550I will soon be offering e-books providing skeptical looks at positive psychology and mindfulness, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

Sign up at my website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites. Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

Psychological interventions do not reduce pain, despite claims of proponents

A provocative review finds a “lack of strong supporting empirical evidence for the effectiveness of psychological treatments for pain management.”

The open access paper

Georgios Markozannes, Eleni Aretouli, Evangelia Rintou, Elena Dragioti, Dimitrios Damigos, Evangelia Ntzani, Evangelos Evangelou and Konstantinos K. Tsilidis. An umbrella review of the literature on the effectiveness of psychological interventions for pain reduction, BMC Psychology https://doi.org/10.1186/s40359-017-0200-5

This article received open or public peer review . The three versions, reviewers’ comments, and author responses are available here 

Why this review was needed

According to the review:

Psychological interventions were introduced over 40 years ago and are now well established in clinical practice [5]

…the effect sizes across all meta-analyses are modest, only rising above a medium-size effect (i.e., standardised mean difference larger than 0.5) in lower quality studies [4].

… Because of the wide implementation of psychological interventions in pain management and the elevated likelihood for biases in this field as shown in prior relevant empirical research [19, 20], we used an umbrella review approach [21, 22] that systematically appraises the evidence on an entire field across many meta-analyses. In the present study we aimed to broaden the scope of a typical umbrella review by further evaluating the strength of the evidence and the extent of potential biases [23, 24, 25, 26, 27] on this body of literature.

What is an umbrella review?

 A key source defines an umbrella review:

Ioannidis JP. Integration of evidence from multiple meta-analyses: a primer on umbrella reviews, treatment networks and multiple treatments meta-analyses. CMAJ. 2009;181(8):488–93.

Umbrella reviews (Figure 1) are systematic reviews that consider many treatment comparisons for the management of the same disease or condition. Each comparison is considered separately, and meta-analyses are performed as deemed appropriate. Umbrella reviews are clusters that encompass many reviews. For example, an umbrella review presented data from 6 reviews that were considered to be of sufficiently high quality about nonpharmacological and nonsurgical interventions for hip osteoarthritis. 9 Ideally, both benefits and harms should be juxtaposed to determine trade-offs between the risks and benefits. 10

ioannidis umbrella review

Ioannidis provides the following caveat about umbrella reviews and data syntheses more generally:

Integrating data from multiple meta-analyses may provide a wide view of the evidence landscape. Transition from a single patient to a study of many patients is a leap of faith in generalizability. A further leap is needed for the transition from a single study to meta-analysis and from a traditional meta-analysis to a treatment network and multiple treatments meta-analysis, let alone wider domains. With this caveat, zooming out toward larger scales of evidence may help us to understand the strengths and limitations of the data guiding the medical care of individual patients.

Discrepancy of this review with past evaluations

Our results come in discordance with the generally strong belief in the literature that psychological therapies are universally effective on a variety of pain conditions [76, 77, 78]. However, this belief is mainly established based on a limited number of small primary studies, and future larger studies are warranted. Notably, the median number of individuals in the intervention and control groups in each individual study included in our systematic evaluation was only 33 and 28 respectively, whereas the median number of studies included in each meta-analysis was only three. Our evaluation revealed that the reported effectiveness is usually overstated in the existing studies. The nominally statistically significant associations between psychological interventions and pain were confirmed in less than half of the examined meta-analyses. In addition, the random effects estimates were statistically significant in only 20% of the meta-analyses, when a P-value threshold of 0.001 was applied. Furthermore, in only nine meta-analyses the prediction interval excluded the null value, thus suggesting that only 6% of future studies are expected to demonstrate substantial “positive” (i.e. not null) associations between psychological interventions and pain treatment.

The punchline and the remedy

In conclusion, the present findings support that the effectiveness of psychological treatments for pain management is overstated and the supporting empirical evidence is weak. The present findings combined with the fact that psychological intervention trials are still at an early research stage and fall short compared to drug trials [87] underline the necessity for larger and better-conducted RCTs [85] Future research should further focus on building networks involving all stakeholder groups to achieve consensus and develop guidance on best practices for assessing and reporting pain outcomes [88, 89]. The use of standardized definitions and protocols for exposures, outcomes, and statistical analyses may diminish the threat of biases and improve the reliability of this important literature.

ebook_mindfulness_345x550I will soon be offering e-books providing skeptical looks at mindfulness and positive psychology, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

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Rising early career female academics and second-to-last authorship

Anyone wanna talk gender now?

Are female early career academics getting less credit for work done on behalf of (usually male) faculty who get unearned senior authorships?

My posting of a link to a PLOS One article on gender differences in academic productivity at the wonderful Reviewer 2 Must Be Stopped Facebook page drew some interesting comments. I encourage more commenting at the Facebook pages and at this blog as well.

vicious cycle journal.pone.0183301.g007

My post

Always good when data enter into discussions of whether there are gender differences in productivity and impact and, if so, why? Here are some big data….

I have noticed in the Netherlands a tendency for early career women to be next-to-last author with senior (usually male) faculty last. Knowing the circumstances of this authorship order, I think this is due to rising women taking over responsibility for more day to day supervision of PhD students, but the head of the lab keeping last authorship. Some in the NL accord more prestige or credit to next to last author, but it does necessarily get appreciated elsewhere. Does anyone else notice such practices in the NL or elsewhere?

A comment from a female Australian vision scientist

Yes, been there with next-to-last authorship. I had to fight for last authorship on a PhD student paper for which I did ALL the supervision work.

A comment from a female academic in engineering

I feel there is a huge flaw with assigning such importance to the last authorship position aspect, as I am aware that it is different between disciplines even within a country (in this case Sweden, which happens to be highly relevant). Similarly to what Kyle and others have brought up, in my field the fight is for the first positions and second positions (to escape the oblivion of “et al.,”) while the last position is reserved for the person who probably has most cred already but did the absolute least (this is debatable, because some regard getting money for the project as a full justification for being included as an author even if you do f*-all on the actual paper, while others don’t – at any rate, such aspects should have been defined explicitly in the assumption of who is “productive”, and I sure couldn’t see that in the Methods section). When I was up for tenure it was my first authorships that were counted.

And at the same time I am aware that the medical sciences (where my father does research) regards the last few authorship positions very highly. Even within engineering I am skeptical that we all reason the same regarding author position, since some disciplines (e.g. bioengineering/pharma) may collaborate with medical researchers who adhere to their ideal order…

So in the end, it bothers me VERY much that someone would want to “make science” out of making an incorrect blanket assumption about authorship order when it may vary across disciplines. Especially when I as a young female researcher have used the last position of a paper to send a message to a higher-up coauthor that “we all know you didn’t help at all.” That in particular really bothers me that it could be interpreted as being the most productive/meaningful scientist in the bunch. Anyone wanna talk gender now?

A PhD comic suggested by one commentator

phd comics authorship

The open access article to which I posted a link is interesting in itself and worth a look.

van den Besselaar P, Sandström U. Vicious circles of gender bias, lower positions, and lower performance: Gender differences in scholarly productivity and impact. PLOS One. 2017 Aug 25;12(8):e0183301.

An excerpt from the abstract:

“As the analysis shows, in order to have impact quantity does make a difference for male and female researchers alike—but women are vastly underrepresented in the group of most productive researchers. We discuss and test several possible explanations of this finding, using a data on personal characteristics from several Swedish universities. Gender differences in age, authorship position, and academic rank do explain quite a part of the productivity differences.”

Some key quotes from the article itself:

Several possible explanations of the gender differences in productivity have been suggested. (i) Female researchers are on average substantially younger than male researchers (see Fig 1), and the high productive researchers are to be found in the more senior (higher age) groups [5; 6]. If this would be the only factor, one would expect that the observed productivity differences would further decline (in line with the Xie & Schauman study [9]) and disappear over time. But also other structural and/or behavioral factors may underlie gender productivity differences, hampering female academic careers [7; 15] and leading to a waste of talent. (ii) Women are rather strongly overrepresented in the lower academic positions, and in positions with a temporary contract (Fig 2), positions which are generally characterized by a higher teaching load, less access to funding, less career perspectives, and less opportunities for research [16; 17; 18; 19]. Indeed, there is a positive relation between job level and productivity. This situation is less prone to gradual change, as it may be the effect of gender bias and of a sustained existence of the glass ceiling in academic institutions [15]

iii) Women may have less access to research funding, whereas winning prestigious research grants is characterized by gender biased in favor of men, and above that very influential for the grant winners’ career [15; 14]. (iv) Female researchers have a lower status within teams and collaboration networks, and get less opportunities to become an independent researcher. This is reflected in different author positions on papers. Women more often get the less prestigious positions: the last author (= team leader) is more often a male researcher, whereas female researchers more often occupy ‘in between’ author positions. This may result in a slower career of female researchers compared to the career of male researchers [8; 13]. More directly, Van den Besselaar & Sandström showed that men progress faster through the various academic ranks [22]. (v) Productivity relates to the organizational environment where a researcher works [23], and if female researchers have more problems in being hired in top environments [24], this is expected to affect productivity differences between men and women.

In fact, gender differences may be the effect of a combination of these five factors….

From the integrated results and discussion:

What about the gender differences? In Biology, Life & Medical sciences and in Science and Engineering, women in the higher productivity classes outperform the male researchers, as they have on average a higher number of CSS3 papers: the dotted curves (representing female researchers) for these fields are above the straight curves (representing male researchers). Also in Psychology & Education we see such trend, although in the highest productivity class the scores are equal. In Agriculture and Food Sciences, and in the Social Sciences, the pattern is opposite. As already said, in the Humanities and in Computer Science & Mathematics the pattern is somewhat fuzzy, but in the latter field there are no female researchers in the highest productivity class to compare with male counterparts.

From the Conclusion:

The first question we aim to answer is whether the positive relation between productivity and impact differs between male and female researchers. We showed that this is not the case, and the relation between productivity and the number of high impact papers is about the same for men and women within the distinguished productivity classes. On average, female researchers have a at least similar impact as equally productive male researchers. In fact, we found cases where the ratio between top cited papers and productivity is considerable higher for women than for men. More specifically, the disciplinary demography seems to produce this effect: the lower the share of women in a discipline, the higher their impact compared to male researchers within the same productivity class. This may refer to gendered selection and/or to gendered self-selection.

Secondly, we found that the higher productivity classes are numerically dominated by male researchers. This leads to a lower overall productivity for female researchers, which is also in our sample about 70% of male productivity. This ratio seems to be stable over time. We should however be careful with averages in Lotka distributed data, although nonparametric tests (Mann-Whitney) show that women are outperformed by male researchers is we do not take other factors into consideration.

Thirdly, we investigated whether other variables influence productivity, and therefore explain part of the gendered productivity differences. We indeed found that a variety of factors have an effect on performance, and controlling for those reduced the effect of gender on performance considerable. So, a good part of the productivity differences are due to the fact that men are older and in higher positions, and that those in higher positions are more productive. Female researchers also occupy less last author positions than men do, and this factor also has a negative effect on female productivity. That women more often are in the middle author positions than men, reflects that women have on average lower positions, and that they are less often (conceived as) leader of a team or a collaboration network. This finding reflects that male researchers show a faster career than their female counterparts.