Tag Archives: Director’s Choice – From the Journals

Medically Unexplained Symptoms – Nocebo Effects Provide a Non-Pejorative Way to Explain Them

My hero – Michael Balint – was aware of the power of words in his classic ‘The Doctor, his Patient and the Illness.’[1] [2] He discusses patients with medically unexplained symptoms. This constellation is the subject of a study in which CLAHRC WM and the WM-AHSN are collaborating.

One tricky issue concerns getting patients off the diagnostic treadmill without annoying them by implying that the symptoms originate in their mind. When I was in practice I used to say that medically unexplained does not mean the symptoms are not real – I suffered headaches and they were real enough, for all that I did not have any specific disease. Now, writing in JAMA, Arthur Barsky makes a further helpful suggestion.[3] He advises clinicians to tell patients about the nocebo effect. Tell patients that their beta-blocker might cause erectile dysfunction, for example, and you will cause more erectile dysfunction than if the topic is not mentioned – 32% if they are warned instead of 13% if they are not.[4] Likewise, patients who have lower back pain and are randomised to receive MRI suffer more pain, more visits and more disability than those randomised to no imaging. The author argues that explaining that the mind is quite capable of amplifying symptoms will help patients understand that symptoms can be amplified as a result of anxiety and that more testing is likely to make matters worse.

The findings do create something of a dilemma for patients and their doctors with respect to information disclosure when people are offered a chance to participate in trials. On the one hand, it is unethical not to tell patients about potential side effects, while on the other the probability of those very side-effects is increased by disclosing that they may occur. The author suggests an interesting way out – he suggests that the clinician should seek permission not to disclose the details of symptoms that are known to be labile and that do not threaten life and limb.

The deeper message from this paper is the focus on the importance of words in clinical consultations. They really do matter, but there can be a clash between words that please and words that are honest.[5]

 — Richard Lilford, CLAHRC WM Director

References:

  1. Balint M. The Doctor, his Patient, and the IllnessLancet. 1955; 265(6866): 683-8.
  2. Balint M. The Doctor, his Patient, and the Illness. 2nd Edinburgh: Churchill Livingstone, 2000.
  3. Barsky AJ. The Iatrogenic Potential of the Physician’s Words. JAMA. 2017; 318(24): 2425-6.
  4. Cocco G. Erectile dysfunction after therapy with metoprolol: the Hawthorne effect. Cardiology. 2009; 112(3): 174-7.
  5. Lilford RJ. Ethics of clinical trials from a Bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ. 2003; 326: 980-1.
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Education Before Surgery

Within developed countries the most frequently performed major surgery is of the upper abdomen. However, research has shown that between 10-50% of patients suffer a postoperative pulmonary complication (PPC), which is strongly associated with an increase in mortality and morbidity, as well as healthcare costs. Some studies have suggested that education and training in breathing exercises prior to the surgery could reduce the risk of developing PPC (75% reduction in relative risk, 20% reduction in absolute risk), but these studies may have been subject to methodological biases. Now researchers in Australia have conducted an international, multicentre, blinded, parallel group RCT to assess the efficacy of preoperative physiotherapy in reducing PPCs.[1] They enrolled 441 patients to receive an information booklet alone (control), or with an additional 30-minute physiotherapy education and breathing exercise training session. The intervention group saw a significant reduction in the incidence of PPC (including hospital-acquired pneumonia) within 14 days of the operation (adjusted hazard ratio 0.48, 95% CI 0.30-0.75). This amounted to an absolute risk reduction of 15% (95% CI 7-22%).

— Peter Chilton, CLAHRC WM Research Fellow

Reference:

  1. Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. 2018; 360: j5916.

A Heretical Suggestion!

The locus of health care is moving increasingly towards the community. In high-income countries (HIC) the greatest burden of health falls to frail elderly people with multiple chronic diseases. Hospital is often bad news for such people, both from a psychological and physical point of view.[1] There are good arguments for avoidance of admissions, and for increasing care provision in the community in HICs. In low- and middle-income countries (LMICs) there are also good arguments for community care. The WHO estimates that over three-quarters of all care could be most appropriately delivered in the community. The Declaration of Alma Ata and the Bamako Initiative from the United Nations both support the development of community care for LMICs. In this News Blog I wish to probe this subject more deeply. I will argue that community care is entirely appropriate for preventive outreach care. However, I will argue that we should re-examine the case for promoting community over hospital settings for demand-led care, especially in deprived urban environment.

My re-examination of this subject came about as a result of recent tours of eight slums within Nigeria, Kenya, Pakistan and Bangladesh. While all of these areas have a strong need for supply-side preventive care in the community, I have come to question the wisdom of trying to develop demand-led care within slum localities. My misgivings are based on a number of personal observations and from a reading of the relevant literature.

On site observations suggest that local residents prefer to use hospital facilities, even when this is less convenient than a more accessible community clinic. Some, but not all, slums are reasonably well supplied by local clinics. These clinics are usually staffed by medical officers or nurses rather than doctors. In many cases they have been provided by NGOs. I have observed that these clinics do not have many clients. When I draw attention to this, I am often told that this is because I have come at a quiet period. However, when I probe more deeply, I learn that the outpatients departments of nearby hospitals receive the bulk of the patients. Certainly that is my impression on visits to hospitals in LMICs where outpatient departments ‘heave’ with patients. This finding triangulates with work that colleagues and I have carried out in India under MRC sponsorship.

Not only do local residents seem to prefer hospital-based outpatient’s care, but my reading of the literature suggests that they are right to do so. Working with colleagues, I am carrying out a review of the quality of care provided in local settings in LMICs. The literature shows that such care is almost universally of a low standard, irrespective of whether the provider is private or public. Care given by doctors is generally better than that given by non-medical personnel, but even so is of a poor standard when delivered in the community. The quality of care across both settings is a topic of enquiry in the NIHR Unit on Health Service Provision in Slums that I direct. However, I suspect that the hospital will come out on top.

The corollary of the above, rather preliminary findings, is that we should be cautious about wholesale, and perhaps ideologically-driven, policies to deliver demand-based healthcare coverage in community settings  in low-income urban environments. Pending further research I hypothesise that it may be better to improve access and quality in hospital settings, at least in the first instance. Before taking fixed positions on these important issues we need to understand more about access to healthcare at the demand-side, the quality of such healthcare, and the most-cost effective approaches to driving up the quality of health care.

Please note that all of the above remarks apply to healthcare at the demand-side. That is to say, where a person has sought care for a perceived health problem. We fully support outreach primary preventive services to ensure vaccination, detect malnutrition, and ensure that people stick to their HIV and other treatment regimes.

Box A. Section VI of the Declaration of Alma-Ata

Primary health care is essential health care based on practical, scientifically sound and socially acceptable methods and technology made universally accessible to individuals and families in the community [emphasis added] through their full participation and at a cost that the community and country can afford to maintain at every stage of their development in the spirit of selfreliance and self-determination. It forms an integral part both of the country’s health system, of which it is the central function and main focus, and of the overall social and economic development of the community. It is the first level of contact of individuals, the family and community with the national health system bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care process.”

— Richard Lilford, CLAHRC WM Director

References:

  1. Lilford RJ. Intensive Care Harmful in Elderly Patients. NIHR CLAHRC West Midlands News Blog. 7 December 2017.

How to Go About Non-Directive Consulting

I used to spend a lot of time talking to couples about their choices in reproductive medicine – whether to have prenatal testing or have a termination of pregnancy, for example. I learned from a psychotherapist with whom I worked, Susie Godsil, the importance of not just launching in with the facts, but first giving people a chance to express their feelings and establish a relationship. Only then would I start describing the alternatives and associated probabilities of outcomes. I was prepared to blend my approach to the particular couple. So I was interested to read a multi-stage framework for decision-making in the BMJ.[1] In my opinion it is a mistake to over-elaborate the process and apply a sequential approach. Consultation is partly tacit and, like good education, it should be reactive to the particular person you are consulting. The general principle holds – supporting patients’ decisions is neither a translational exchange of laying out the probabilities, nor a purely empathetic exploration of feelings, but a subtle blend of both. Shoehorning this nuanced approach into a flow diagram seems like overly codifying human interchange. I suppose this controversy could be put to an empirical test, but I would not participate in such a trial as I am not in equipoise.[2]

— Richard Lilford, CLAHRC WM Director

References:

  1. Elwyn G, Durand MA, Song J, Aarts J, Barr PJ, Berger Z, et al. A three-talk model for shared decision making: multistage consultation process. BMJ. 2017; 359: j4891.
  2. Lilford RJ & Jackson J. Equipoise and the Ethics of Randomization. J R Soc Med. 1995; 88(10): 552-9.

Dieting Does a Lot of Good, Even If You Don’t Lose Much Weight

Well this paper gave me pause for thought.[1] I have always been rather nihilistic about dieting. The effect sizes in terms of actual weight loss seem nugatory and transient – a couple of kilograms after three years would be fairly typical. Well I was prompted to change my mind as a result of a recent meta-analysis of 54 RCTs of diet vs. no-diet. Most of the diets stressed saturated fat reduction as part of the diet, and most advocated exercise as well as a diet (although in only half of these trials were patients referred to a specific exercise programme). As I would have predicted weight loss was small in the intervention group vs. control – 3.4kg at one year, and 2.5kg at two years. Despite these small effect sizes, all-cause mortality was reduced by 18% (0.7-0.95) in the diet group. This finding held good, even when only the 34 best quality RCTs were retained in the analysis. There was a borderline significant reduction in cancer death in the diet groups among the eight trails that recorded this outcome. In an earlier study of abnormal liver function tests [2] we noted improvement in fatty livers in people who lost only small amounts of weight. My conclusion – it is worth persuading people to lose weight through diet and exercise. Even if the effects on weight are small they are not, after all, nugatory.

— Richard Lilford, CLAHRC WM Director

References:

  1. Ma C, Avenell A, Bolland M, Hudson J, Stewart F, Robertson C, Sharma P, Fraser C, MacLennan G. Effects of weight loss interventions for adults who are obese on mortality, cardiovascular disease, and cancer: systematic review and meta-analysis. 2017; 359: j4849.
  2. Lilford RJ, Bentham L, Girling A, Litchfield I, Lancashire R, Armstrong D, Jones R, Marteau T, Neuberger J, Gill P, Cramb R, Olliff S, Arnold D, Khan K, Armstrong MJ, Houlihan DD, Newsome PN, Chilton PJ, Moons K, Altman D. Birmingham and Lambeth Liver Evaluation Testing Strategies (BALLETS): a prospective cohort study. Health Technol Assess. 2013; 17(28):1-307.

Involving Families in Neonatal Care

It is an unfortunate fact that some children need to be admitted into a neonatal intensive care unit (NICU) soon after birth, and this physical separation can often impact on the physical, psychological and emotional health of both the parents and the babies. In many NICUs the parents are expected to take a step back, with NICU staff providing the great majority of day-to-day care of the baby. An alternative approach, that is not widely used, is the Family Integrated Care (FICare) programme, which facilitates collaboration between parents and the NICU staff. Parents become involved in all aspects of their baby’s care, such as feeding, changing, bathing, as well as decision-making and taking part in medical rounds. A recent paper in the Lancet Child and Adolescent Health looked at the effectiveness of an FICare programme in 26 NICUs in Canada, Australia and New Zealand.[1] Premature babies (born at 33 weeks or earlier) were randomly assigned to receive standard NICU care (n=891), or be provided with FICare (n=895). Parents in the FICare group had to commit to be present for at least six hours each day, attend educational sessions, and provide active care for their baby. At 21 day follow-up the babies in the FICare group had significantly greater weight gain and an average daily weight gain of 26.7g (vs. 24.8g) (both p<0.0001). Mothers in the FICare group also had significantly higher rates of exclusive breastmilk feeding (p=0.016).  Further, parents had significantly lower scores on mean levels of stress (p<0.00043) and anxiety (p=0.0045). There were no significant differences in mortality, major morbidity, oxygen therapy duration, or length of hospital stay.

— Peter Chilton, Research Fellow

Reference:

  1. O’Brien K, Robson K, Bracht M, et al. Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial. Lancet Child & Adol Health. 2018.

Modern Chemotherapy for Severe Mental Disorders in a Prayer Camp

I thank Prof Swaran Singh for drawing my attention to a randomised trial of traditional faith healing with chemotherapy versus traditional faith healing alone for patients with serious psychiatric disorders.[1] The study took place in a faith-based healing centre. Belief in spiritual origins for mental illness is common in many countries. A randomised trial was conducted to evaluate the additional benefits of pharmacotherapy for patients with a range of psychotic conditions. The outcome of the trial was based on the brief psychiatric rating scale. Patients in the intervention group had much better outcomes than patients in the control group over the first six weeks following randomisation. That is to say, adding chemotherapy to faith healing produced a marked improvement in outcome.

The interesting feature of this trial was that it combined modern medical treatment with traditional healing methods. Thus it is not a head-to-head of the two different approaches; rather it is a trial of both methods compared with traditional methods alone.

Although the study produces interesting findings, the traditional methods did not sit comfortably with the medical approach; for instance patients were often put in chains so that they could not escape or harm themselves or others. This invokes the deeper question about whether the two methods (allopathic and traditional) can really exist side-by-side on a routine basis. Many providers of psychiatric services would find it difficult to live with a situation in which patients for whom they felt responsible were also subjected to practices that they consider degrading, if not outright harmful. The question can be fairly asked as to whether medical practitioners in the study were endorsing or even colluding in these practices. I tackled the moral and epistemological Implications of trying to integrate enlightenment science and spiritual practices within the same system of care, in a recent news blog.[2] The above research paper seems to reinforce my opinion that integration of modern medicine and traditional practices is much more than simply a technical issue. While clinical trials such as the one cited above can produce useful information, they cannot, by themselves, resolve the deeper issues.

— Richard Lilford, CLAHRC WM Director

References:

  1. Ofori-Atta A, Attafuah J, Jack H, et al. Joining Psychiatric Care and Faith Healing in a Prayer Camp in Ghana: Randomised trial. Br J Psychiatry. 2018; 212: 34-41.
  2. Lilford RJ. Traditional Healers and Mental Health. NIHR CLAHRC West Midlands News Blog. 12 January 2018.

Corroboration of Previous Reports on Vitamin D and on Coffee

In recent News Blogs we have provided evidence that vitamin D and calcium are useless in preventing osteoporotic fractures in elderly people with no obvious risk factors.[1] [2] This is now powerfully corroborated in a paper in JAMA by Zhao, et al.,[3] who carried out a systematic review and meta-analysis involving over 50,000 participants. They found absolutely no beneficial or harmful effects of either vitamin D or calcium or a combination of the two compared to placebo in reducing the risk of either vertebral hip or other non-vertebral fractures. The absolute risk difference was zero with an upper confidence limit of 0.01. Hopefully this puts the matter to bed once and forever.

Likewise a recent umbrella review in the BMJ [4] corroborated previous news blogs on the generally health promoting effects of coffee.[5] It would appear that these benefits are also seen in equal measure with de-caffeinated coffee, suggesting that it is the other components of coffee that benefit health.

— Richard Lilford, CLAHRC WM Director

References:

  1. Lilford RJ. Effects of Vitamin D Supplements. NIHR CLAHRC West Midlands News Blog. 24 March 2017.
  2. Lilford RJ. Yet Another Null Result on Vitamin D and Calcium Supplementation in Older Women. NIHR CLAHRC West Midlands News Blog. 5 May 2017.
  3. Zhao J-G, Zeng X-T, Wang J, et al. Association Between Calcium or Vitamin D Supplementation and Fracture Incidence in Community-Dwelling Older Adults: A Systematic Review and Meta-analysis. JAMA. 2017; 318(24): 2466-82.
  4. Poole R, Kennedy OJ, Roderick P, Fallowfield JA, Hayes PC, Parkes J. Coffee consumption and health: umbrella review of meta-analyses of multiple health outcomes. BMJ. 2017; 359: j5024.
  5. Lilford RJ. Should You Keep Drinking Coffee? NIHR CLAHRC West Midlands News Blog. 1 September 2017.

Does Physical or Cognitive Training Slow Decline in Cognition with Age, or Delay the Onset of Dementia?

Two careful reviews in the Annals of Medicine review current trial evidence.[1] [2] This is a hard topic to study because interventions are heterogeneous; outcomes are multiple and vary between studies, and long-term follow-up is required. As far as exercise is concerned, the evidence is simply insufficient. Cognitive training reduces cognitive decline in the particular cognitive task targeted by the training, but does not seem to produce a global effect. These studies were both based on people with normal functioning at baseline.

— Richard Lilford, CLAHRC WM Director

References:

  1. Brasure M, Desai P, Davila H, Nelson VA, Calvert C, Jutkowitz E, et al. Physical Activity Interventions in Preventing Cognitive Decline and Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018; 168: 30-8.
  2. Butler M, McCreedy E, Nelson VA, Desai P, Ratner E, Fink HA, et al. Does Cognitive Training Prevent Cognitive Decline?: A Systematic Review. Ann Intern Med. 2018; 168: 63-8.

Factors Associated with De-Adoption

CLAHRC WM News Blog readers know about factors associated with adoption of new technology. Where the treatment is within the gift of a single clinician, then the following barriers / facilitators determine the probability of adoption:

  1. The strength of the evidence.
  2. Prior beliefs – when a person has no strong opinion, then evidence of given strength will be more influential than when it must compete with strong prior beliefs.[1] For example, I would take some convincing that homeopathy is effective.
  3. Psychological approach – when the new evidence requires practitioners to give up something they are accustomed to doing, then change is harder to achieve. (X-rays came into routine use within four years of Röentgen’s discovery, while antisepsis took over a generation.)
  4. Psychological predisposition – according to Rogers, some people are psychologically predisposed to be early adopters or laggards (but this can be specific to the technology concerned).
  5. Role models and other forms of influence from the social environment.
  6. The presence of subconscious ‘clues’ in the environment – nudge theory.[2]
  7. Financial incentives at the personal level – but watch out for perverse effects.

When adoption is not in the gift of individual clinicians, the organisation as a whole has to respond. Many barriers / facilitators can be encountered.

  1. Changing supply chains so that the appropriate technology is available and can be maintained. This is a large barrier in low-income countries.
  2. Arranging for training / education when a new technology supplants an existing technology.
  3. Support across the organisational hierarchy to send out the right social ‘signals’ (see also above).
  4. Co-ordination across barriers – different professions and across organisational boundaries. We have discussed barriers and facilitators to cross-border facilitation in previous blogs.[3]
  5. Financial incentives at the organisational level,[4] although again these can have negative side-effects.[5] [6]
  6. Fit with established workflows and the immediate demands of a situation – a particular problem with IT, as described in previous blogs.[7] [8] Put simply, the more disruptive the technology, the harder change is to achieve and the greater the risk that any adoption will introduce new risks.

All of the above problems require an organisation to have time and people to help solve problems – the concept of absorptive capacity, which has been explored in our CLAHRC.[9]

But what about de-adoption; does that have different features? This topic was studied in a recent issue of the BMJ.[10] They looked at different individual features associated with de-adoption of carotid revascularisation procedures that are falling from vogue, but which are still indicated in some cases. Here clinicians should ‘exnovate’ by scaling back rather than eschewing the procedure completely. More experienced physicians and smaller practices were associated with faster exnovation, but patient factors, strangely, were not. The authors suggest that early adopters tend to be early de-adopters. Far from convincing me that there is something special about de-adoption / exnovation, the evidence actually presented did not suggest that the factors are qualitatively different to those associated with adoption in the first place.

— Richard Lilford, CLAHRC WM Director

References:

  1. Johnson SR, Tomlinson GA, Hawker GA, Granton JT, Feldman BM. Methods to elicit beliefs for Bayesian priors: a systematic review. J Clin Epidemiol. 2010; 63(4): 355-69.
  2. Lilford RJ. Demystifying Theory. NIHR CLAHRC West Midlands News Blog. 10 April 2015.
  3. Lilford RJ. Evaluating Interventions to Improve the Integration of Care (Among Multiple Providers and Across Multiple Sites). NIHR CLAHRC West Midlands News Blog. 10 February 2017.
  4. Combes G, Allen K, Sein K, Girling A, Lilford R. Taking hospital treatments home: a mixed methods case study looking at the barriers and success factors for home dialysis treatment and the influence of a target on uptake rates. Implement Sci. 2015; 10: 148.
  5. Lilford RJ. Financial Incentives for Providers of Health Care: The Baggage Handler and the Intensive Care Physician. NIHR CLAHRC West Midlands News Blog. 25 July 2014.
  6. Lilford RJ. Two Things to Remember About Human Nature When Designing Incentives. NIHR CLAHRC West Midlands News Blog. 27 January 2017.
  7. Lilford RJ. Introducing Hospitals IT Systems – Two Cautionary Tales. NIHR CLAHRC West Midlands News Blog. 4 August 2017.
  8. Lilford RJ. New Framework to Guide the Evaluation of Technology-Supported Services. NIHR CLAHRC West Midlands News Blog. 12 January 2018.
  9. Currie G, Croft C. Enhancing absorptive capacity of healthcare organizations: The case of commissioning service interventions to avoid undesirable older people’s admissions to hospitals. In: Swan J, Newell S, Nicolini D. Mobilizing Knowledge in Healthcare. Oxford: Oxford University Press; 2016. p.65-81.
  10. Bekelis K, Skinner J, Gottlieb D, Goodney P. De-adoption and exnovation in the use of carotid revascularization: retrospective cohort study. BMJ. 2017; 359: j4695.