Heroes Not Zombies

The placebo effect is not a zero effect. It’s an effect. It induces change.
Irving Kirsch in his The Emperor’s New Clothes prints a simple bar chart comparing antidepressants, placebo and doing nothing in terms of clinical improvement in patients with depression. That chart shows two things.
The difference between antidepressants and placebo is so small he argues there is no clinically significant difference (apart from in patients with severe depression).
The difference between doing nothing and the effects of giving a patient an antidepressant or a placebo is huge.
In other words, despite the fact there is a barely discernible difference between antidepressants and placebo, he does not recommend doing nothing instead.
Some claim that if a treatment shows no significantly greater effects than placebo we should stop providing that treatment. But if the treatment is replaced with doing nothing there will be a reduction in the benefits experienced by the patients.
All drugs work partially through the placebo effect. In fact, every treatment contains a placebo effect. Randomised controlled trials (RCTs) comparing one group which receives the drug, and one which receives a chemically inert substance (termed placebo) mislead people into thinking there is no placebo effect in the drug group. But there is. The placebo effect is embedded, inextricably.
It is impossible to discern, in an individual case, what proportion of the improvement is due to the direct effects of the treatment and which are due to the placebo effect.
RCTs don’t help clarify that in individual cases. Don’t we need more comparative studies instead? Comparing treatment A to treatment B raises a different set of questions from comparing either to a “placebo group”. As does comparing either treatment group to a “no treatment” group.
I repeat. The placebo effect is not a zero effect.

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Research studies routinely use different ways to present their conclusions. In particular they present “relative risk”, “absolute risk”, and/or “numbers needed to treat” information. Gigerenzer is brilliantly clear about this. He says

Gigerenzer shows how drugs companies and authorities routinely use Relative Risk to emphasise the potential benefits of their treatment while at the same time presenting the potential harms as Absolute Risks to minimize the impression of adverse potential.

This week in the BMJ, there is a study where researchers have looked at the use of relative and absolute risk reporting in studies which examine inequalities in health. Their argument is quite modest – that to fully understand any study BOTH relative and absolute risks should be reported. They say this is best practice. So, how often does it occur?

Almost never.

75% (258/344) of all articles reported only relative measures in the full text; among these, 46% (119/258) contained no information on absolute baseline risks that would facilitate calculation of absolute effect measures. 18% (61/344) of all articles reported only absolute measures in the full text, and 7% (25/344) reported both absolute and relative measure

But in fact, the literature is even more skewed than those conclusions suggest because

We found that nearly 90% of studies with quantitative estimates in the abstract presented only relative measures, and 75% of all articles reported only relative measures in the full text.

Why is the bias towards relative risk even greater in the abstract than in the full text? Because its the abstract which most people read, and it is probably the abstract which is used to write the PR headlines.

Does this matter? Yes it does. The authors argue that the choices of relative or absolute risk reporting influence policy making.

Makes you wonder how often the “evidence” is produced to fit the policy, rather than the policy being produced from the evidence…….and that applies across the board from the writing of guidelines and protocols, to decisions about health care spending, to individual doctors deciding what treatment to offer an individual patient.

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The current set of concepts being used to organise health care prioritise a certain reductionist view and assume the ability to predict outcomes of actions – as if health and health care were linear systems (hint – they’re not! They are complex and non-linear). One of the consequences of this way of thinking is to break professional roles down to a series of tasks. Once a simple task is examined, it is usually possible to argue that only a little training and knowledge is required to carry out that task (just the skills and knowledge required for this particular task). What we lose sight of, is a person-level perspective, and hence a professional one.

Let’s consider one type of health care professional. A doctor. What is a doctor? What’s a doctor’s role? Actually,that’s not so easy to answer, but if you read “Tomorrow’s Doctors” by the General Medical Council, which is their attempt to describe what a doctor should be able to do, you’ll find a strong emphasis on leadership.

So, it was interesting to come across the concept of “humble leadership” which is beginning to attract attention.

In the midst of spectacular failures of the “superman” type of leader in the financial, corporate and political sectors, people are beginning to question the wisdom of seeking such charismatic but frequently arrogant individuals whose main strength seems to be the conviction of the rightness of their own decisions.

So what is a humble leader? Leadership humility…

generally involves how leaders tend to view themselves (more objectively), others (more appreciatively), and new information or ideas (more openly) 

And

The humble leader behaviors we identified (e.g. acknowledging mistakes, spotlighting follower strengths, modeling teachability) as well as the mechanisms (e.g. legitimization of uncertainty and personal development) were often described as directly challenging the more popular top-down conceptions of leadership.

As doctors are expected to be able to handle complexity and uncertainty, it would seem that humble leadership skills might be highly relevant. Wouldn’t you like your doctors to observe themselves more objectively, you and their colleagues appreciatively, and to be continuously open to new information and ideas?

Such a shift to humble leadership could completely change the doctor-patient relationship for the better. It is a much more appropriate way to deal with the reality of the complexity and uncertainty which is characteristic of human health and disease.

The researchers who are studying leadership humility identify two key characteristics or qualities – competence and sincerity.

Hard to argue with that!

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What We Do

At the NHS Centre for Integrative Care in Glasgow Homeopathic Hospital this is what we do…..
The NHS Centre for Integrative Care provides a range of services for patients with Long Term Conditions. At the first consultation patients receive an integrative, holistic assessment which has three goals. 1. A comprehensive, biopsychosocial understanding of the person and their illness; 2. An orientation of care towards supporting vitality and resilience achieved through individual empowerment and skills required to maximise self-healing and self-management; 3. The creation of an individualised therapeutic plan. Therapeutic plans can involve a number of elements delivered one-to-one or in groups, in ambulatory outpatient, day case, or inpatient environments, as appropriate.
Care is delivered by multidisciplinary teams of generalist medical doctors, nurses and Associated Healthcare Professionals.
Interventions include patient education programmes, relaxation, meditation and cognitive behavioural classes, Tai Chi, Yoga, massage, Art Therapy, Counselling, Acupuncture and Homeopathy. All interventions are drug-free and intended to improve well-being and reduce the long term need for medication and surgery.
The Centre is particularly able to help patients with “Medically Unexplained Symptoms”, multiple co-morbidities and those who have exhausted other possible solutions to their problems.

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Dee Mangin, Iona Heath and Marc Jamoulle have published this week, in the BMJ, one of the best editorials I’ve ever read. It gives me hope.

They comment on a report from the US Institute of Medicine on people with chronic illnesses living well and right at the outset say it doesn’t go nearly far enough. They claim we need a shift in emphasis from “reducing mortality” to “living well”.

In recent years the single disease model has become an end in itself as disease management frameworks and targets for single conditions have become embedded in evidence based guidance and care pathways. Focus has shifted from patients and their experience of diseases to measuring parameters of the diseases themselves. Although evidence based models of single diseases in isolation work well for patients with one disease, they can lead to “siloing” of care for people with multiple conditions, and this can result in chaotic care. One study found that applying individual disease guidelines to a patient with five chronic conditions would result in the prescription of 19 doses of 12 different drugs, taken at five time points during the day, and carrying the risk of 10 attendant interactions or adverse events. Care that is “measurably better” may be meaningfully worse and a nightmare for the patient.

The prioritising a disease model approach over a person centred one leads to polypharmacy and steadily increasing numbers of patients being harmed, or even dying, from the very drugs prescribed to help them. As the authors point out, a lot of the problem comes from excessive and inappropriate use of guidelines –

The use of guidelines as standards enshrines polypharmacy and therapeutic positivism

and

Recommendations in guidelines are often based on the average response in study populations that are usually selected to be free of comorbidity and polypharmacy. Applying such evidence to the treatment of those with comorbidity who are taking a variety of drugs reduces benefit to an unknown extent and increases the potential for harm. The evidence base for the effect of treatments in the context of comorbidity is poor and does not account for variability in the genesis, expression, and progression of illness; the interaction of illnesses; the physiological damage caused by the stress from life events; and the impact of biopsychosocial interventions

One of the most important and stand out sentences in this editorial is

Chronic illness is characterised by its variability

Well, human beings, actually are characterised by their variability. Everyone is unique. No two people share the same story, the same life events, the same experiences. No two people make sense of their lives the same way or respond to their illnesses the same way. It’s time we redesigned our health care to take that simple fact on board.

There is a pressing need to reverse the current trend towards management of individual diseases in silos so that care of patients with chronic comorbid illness is much more closely driven by their particular symptoms, needs, and treatment effects and their own priorities for care. An improvement in health status must be seen not as an end in itself but as the means to fulfilment and possibility in the life of the patient. Furthermore, healthcare systems need to start to value and provide adequate support for the kind of iterative generalist care that focuses more on the person than on the disease entity and the necessary variation this entails. This would place equal value on the art of “not doing”—making complex decisions not to give treatments, not to order tests, and to stop current treatments when in the best interests of the patient.

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