Really Important Papers on Child Development

Our CLAHRC has recently conducted an individually randomised trial of the effect of perinatal (before and after birth) support from lay health workers for women at high social risk. The results have been submitted for publication, but in the meantime the BMJ has reported a 2×2 factorial RCT of an integrated early child development intervention, consisting of micronutrient supplementation and weekly stimulation through local women. The study was conducted across 96 communities in Columbia.[1] While the supplementation yielded a null result, the additional psychosocial stimulation produced marked improvements in cognition and language over an 18 month intervention period. The results partly corroborate a similar recent study reported in the Lancet.[2] This study was also a 2×2 factorial design, again of nutrition (including micronutrients) and stimulation. This study involved 80 communities in Pakistan. They replicated the findings regarding stimulation, but also recorded a positive, albeit smaller, cognitive benefits from the nutritional intervention. Babies and toddlers are little learning machines who love to interact, and benefit themselves and others by doing so. The effect of nutrition may be more context dependent.[3] Our CLAHRC is considering conducting an overview, combining studies that examine antenatal and postnatal interventions, or both, and that compare interventions targeted mainly at the mother, versus those where the infant is the primary focus of attention. In the meantime, here are two excellent cluster factorial designs of similar interventions in two different continents, serendipitously published within weeks of one another.

— Richard Lilford, CLAHRC WM Director

References:

  1. Attanasio OP, Fernandez C, Fitzsimons EO, Grantham-McGregor SM, Meghir C, Rubio-Codina M. Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial. BMJ. 2014; 349: g5785.
  2. Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014; 384: 1282-93.
  3. Black MM & Hurley KM. Investment in early childhood development. Lancet. 2014; 384: 1244-5.
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Scepticism and the Democratisation of Science

Those of us who inhabit the great ivory towers of academia sometimes forget that there is a grassroots passion for science outside the walls of our venerable institutions. I recently attended a talk organised by Skeptics in the Pub, Coventry. It was an encouraging experience, with some interesting lessons.

A speaker called Michael Marshall (no relation) is currently touring various “Skeptics in the Pub” venues. He has an unusual job description, since he is employed as a full-time sceptic by the Good Thinking Society. Backed up with a PowerPoint presentation, he gave an amusing and stimulating pitch – somewhere in the territory between Dave Gorman and Ben Goldacre.

An assortment of self-proclaimed psychics was the first subject of the talk. At first glance they seemed risibly easy targets: but it transpired that some are wealthy and famous; some even inveigle their way into families affected by tragedies such as missing children.[1] Perhaps most unsettling was that at least one had successfully sued The Daily Mail for claiming that she might be receiving instructions through an earpiece while on stage.[2] The speaker was careful not to repeat the allegation: a comment on our nation’s libel laws.

Next up was a beautifully designed and executed ‘n of 1 crossover trial’ of the effects of the Shuzi bracelet on penalty kicking performance.[3] For £59 this device claims to improve sporting prowess using “Nano Vibrational Technology” to “separate your blood cells and enhances brain cognitive abilities”.[4] I hardly need tell you the results, but the device is no longer marketed in the UK.

The final act was the story of the worldwide mass homeopathy overdose organised for 10:23am on 6 February 2011. This dramatically demonstrated that homeopathic remedies, generally diluted so much as to contain no active ingredient, can have no therapeutic effect beyond that of a placebo. The timing of the event, 6/02 at 10:23, obliged the media to explain Avogadro’s number.[5]

Are there any lessons for health care in this? The appetite for knowledge (epistemic greed) is greater than our capacity to produce it, so there is a ready market for pseudo-knowledge. The whole purpose of the scientific method and scepticism is to challenge our innate credulity. The use of the media to raise awareness was masterful. Only one of the examples in the talk is funded by the NHS, so that is progress of a sort. But most importantly, the sceptics and their fellow travellers remind us that the scientific method is not the preserve of a professional elite, it is for anyone to use.[6] The corollary is that belief in the efficacy of water imbued with quasi-spiritual properties (holy water) is not the monopoly of non-professionals.[7]

— Tom Marshall, Deputy Director CLAHRC WM, Prevention and Detection of Diseases

References:

  1. Power J. Joe Power, the man who sees dead people – Police investigations. 2013. [Online]
  2. BBC News UK. Daily Mail payout to Sally Morgan over psychic ‘scam’ article. BBC News [Online]. 2013-06-20.
  3. Marshall M. Is the Shuzi sport band a brilliant technology or a waste of money? The Guardian [Online]. 2012-09-04.
  4. Shuzi. Official Shuzi Website. [Online]. 2013.
  5. The 10:23 Campaign. The 10:23 Challenge 2011. [Online]. 2014.
  6. The Merseyside Skeptics Society. The Merseyside Skeptics Society. [Online]. 2014.
  7. Perry R, Watson LK, Terry R, Onakpoya I, Ernst E. British general practitioners’ attitudes towards and usage of homeopathy: a systematic review of surveys. Focus on Alternative and Complementary Therapies. 2013; 18(2), 51-63.

Origin and Spread of HIV/AIDS

The HIV-1 virus that went on to infect 75 million people, jumped from a chimpanzee to a human in the 1920s. This happened in South Eastern Cameroon and it then travelled to Kinshasa (then Léopoldville), from where a subtype (C) was transported to the mining town Lubumbashi (then Élisabethville) in 1937, and from there to other places in Africa. The CLAHRC WM director likely encountered cases while he was a medical student in Johannesburg. At that time AIDS was unknown. However, Congolese men who had come to work in South Africa’s gold mines presented at Baragwanath Hospital with a disease characterised by wasting opportunistic infections, and Kaposi’s sarcoma. It was given the name “slim” (meaning thin in Afrikaans) disease. Sub-type B meanwhile, made its appearance in Kinshasa around 1944 and jumped to the United States in the 1960s, and hence to the rest of the world, including Africa where the sub-types B and C now co-exist.

How do we know all this? The emergence of HIV can be traced using archive human material to create family trees (phylogenies) and place dates on the origin and branches using a molecular clock (based on the mutation rate of viral DNA).[1] [2]

— Richard Lilford, CLAHRC WM Director

References:

  1. Cohen J. Early AIDS virus may have ridden Africa’s rails. Science. 2014; 346(6205): 21-2.
  2. Faria NR, Rambaut A, Suchard MA. The early spread and epidemic ignition of HIV-1 in human populations. Science. 2014; 346(6205): 56-61.

Effects of Patient Narratives

Researchers from Yorkshire [1] report a fascinating study where the effects of patient narratives on attitude towards safety of newly qualified doctors were investigated in a RCT. Two outcomes measures were used: a scale of safety attitude and a scale of emotional affect. The intervention involved facilitated workshops where patients and early career doctors would discuss harrowing safety narratives. I thought this might be an effective educational intervention. However, there was no measured difference between intervention and control doctors on the safety attitude questionnaire. What about emotional effects? This result was interesting since both positive and negative affect increased in the intervention group; a ‘bimodal’ effect.

I have never been impressed with safety attitude/culture/climate questionnaires which cover all sorts of factual questions, such as whether the respondent knows that fatigue can cause error, so the null result on this end-point was not surprising. That said, the sub-scale dealing with the relevance of patient involvement did improve in the intervention group compared to control. The split effect on emotion is more puzzling and I think could be well explored by qualitative research. Maybe the young doctors felt inhibited in discussing some of their feelings because of the dynamic within the groups. I don’t think we should give up on stories about medical failure and the patient voice surely enriches the narrative.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Jha V, Buckley H, Gabe R, et al. Patients as teachers: a randomised controlled trial on the use of personal stories of harm to raise awareness of patient safety for doctors in training. BMJ Qual Saf. [ePub]

Effects of Salt in Diet

Well there you have it, salt really is bad for you – based on a study of 107 randomised comparisons on the effects of reduced sodium intake on blood pressure, 99 cohorts on the effects of blood pressure on cardiovascular mortality, and a survey of the salt intake of three-quarters of all adults in the world.[1] It is hard to argue with the results of a study like that. Modelling based on the data from the above study, funded by the Bill and Melinda Gates Foundation, concludes that one in every ten deaths from cardiovascular disease can be attributed to a high salt intake. Incidentally, having 107 randomised comparisons makes it possible to examine the correlation between the reduction of salt intake in those trials, and the reduction in blood pressure. It turns out to be linear.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Mozaffarian D, Fahimi S, Singh GM, Micha E, Khatibzadeh S, Engell RE, Lim S, Danaei G, Ezzati M, Powles J. Global Sodium Consumption and Death from Cardiovascular Causes. NEJM. 2014; 371: 624-34.

Can CLAHRC WM Enact Distributed Leadership

Why Distributed Leadership? 

The emergence of ‘Distributed Leadership’ (DL) reflects disillusionment with heroic models of leadership.[1] For Heifetz, the prevalence of ‘wicked issues’ [2] that health and social care organisations are required to address, means that leaders leave many problems unsolved and hence often have to disappoint the expectations of followers. DL offers a potential solution to this problem by seeking to reduce follower dependency by enabling followers to take on leadership; i.e. enact ‘adaptive’ leadership.[1] DL is also viewed as desirable in public services because it is inclusive, and aligns with recent organisational re-structuring towards the flatter organisation. It may foster collaborative and ethical practice, and avoid alienation associated with lack of power by those positioned as followers. Finally, DL leverages skills and strengths across the organisation to enhance organisational resourcefulness [3]; and is considered to be particularly appropriate for complex, contemporary organisations, where knowledge is distributed. Thus, Currie et al. [4] [5] [6] highlights that the government has increasingly viewed DL as a panacea for both poor organisational performance and the democratic deficit within public services. However, the government’s vision of DL as a policy panacea for poor organisational performance has been difficult to enact for two reasons – professional organisation and policy orientation towards individualised accountability.

Distributed Leadership in Health and Social Care? 

Within the health and social care domain, first, power is likely to be concentrated with specialist doctors,[7] so that others have struggle to assert themselves in influencing doctors; e.g. nurses [8] and managers.[9] [10] Further, despite policy encouragement to allow for DL to service users, health and social care delivery is likely to remain professionally defined as a consequence of traditional professional hierarchy.[11]

Second, public managers in England are forced to enact ‘target-based leadership’, which is orientated more towards individualism, rather than collectivism, as accountability has been concentrated in the few, rather than the many.[4] [5] [6] Its effects upon leadership ‘on the ground’ within English health and social care organisations has been highlighted by the way those at the apex of the management hierarchy have been castigated for failures in the delivery of health and social care. Recent examples include the ‘sacking’ of health and social care leaders, such as the Director of Children’s Services, the Haringey Local Safeguarding Children’s Board, following the death of ‘Baby P’,[12] and the resignations of CEOs of hospital trusts at Mid-Staffordshire and Maidstone and Tunbridge Wells, following patient deaths attributed due to poor quality service. Within this context, leadership is likely to be concentrated, rather than distributed, because any leader situated at the top of the organisation may be unwilling to distribute leadership to others, and others unwilling to take on leadership.

In summary, I suggest that in English health and social care organisations, professional hierarchy and traditional power relationships, combined with a strong centralised performance regime, will act to stymie policy makers’ aspirations for enacting DL. As such, the health and social care context creates a paradox for DL.

Distributed Leadership in CLAHRCs?

Readers may reflect upon these points above, in assessing prospects for CLAHRCs to distribute leadership in an authentic manner consistent with the ‘C’ in the CLAHRC acronym; i.e. ‘Collaboration’. Let the debate begin regarding the extent we might distribute leadership across clinician scientists and social scientists, NHS managers and academics, NHS managers and clinicians, extending to patients and carers. Indeed CLAHRCs may constitute an exemplary site for the study of DL – see our study 2 in the Implementation and Organisational Studies theme of CLAHRC WM.

— Graeme Currie, Professor of Public Management, Warwick Business School, Lead IOS Theme & Deputy Director CLAHRC-WM.

References

  1. Heifetz RA. Leadership without Easy Answers. Cambridge, MA: Harvard University Press; 1994.
  2. Rittel H, Webber M. Dilemmas in a General Theory of Planning. Policy Sci. 1973; 4: 155-169.
  3. Gronn P. Distributed leadership as a unit of analysis. Leadership Quart. 2002; 13: 423-451.
  4. Currie G, Lockett A, Suhomlinova O. The institutionalization of distributed leadership: A ‘Catch-22’ in English public services. Hum Relat. 2009; 62(11): 1735-61.
  5. Currie G, Lockett A, Suhomlinova O. Leadership and institutional change in the public sector: The case of secondary schools in England. Leadership Quart. 2009; 20(5): 664-79.
  6. Martin GP, Currie G, Finn R. Leadership, Service Reform and Public-Service Networks: The Case of Cancer-Genetics Pilots in the English NHS. J Public Adm Res Theory. 2009; 19(4): 769-94.
  7. Fitzgerald L, Ferlie E. Professionals: back to the future? Hum Relat. 2000; 53(5): 713-39.
  8. Nancarrow SA, Borthwick AM. Dynamic professional boundaries in the health care workforce. Sociol Health Illn. 2005; 23: 897-919.
  9. Ackroyd S. Traditional and new management in the NHS hospital service and their effects on nursing. In: Soothill K, Henry C, Kendrick K, editors. Themes and Perspectives in Nursing. London: Chapman and Hall; 1996. p. 337-355.
  10. Ferlie E, Ashburner L, Fitzgerald L, Pettigrew A. The new public management in action. Oxford: Oxford University Press; 1996.
  11. Martin GP. ‘Ordinary people only’: knowledge, representativeness and the publics of public participation in healthcare. Sociol Health Illn. 2008; 30(1): 35-54.
  12. Laming, Lord. The Protection of Children in England: A Progress Report. London: The Stationery Office. 2009.

Baby Gender Preferences

A large amount of international research is done sitting at the desk and analysing large datasets. Arguably the largest and most widely used dataset concerning low- and middle-income countries is the Demographic and Health Services (DHS) dataset. This dataset is based on repeated cross-sectional questionnaires in many low- and medium-income countries. The emphasis is on reproductive and infant health. Large databases often disappoint, but DHS is producing some gems.

The authors of a recent World Bank report were interested in a possible preference for sons in sub-Saharan Africa.[1] However, the difference in birth ratio of boys and girls seen in China and India was not found in Africa. So they examined reproductive choices in families where the existing children were all girls or boys. They found that people continue to have children to a greater extent when their existing children are girls rather than boys. There still appears to be a strong cultural preference for boys over much of the world, although manifested in a more subtle way in Africa than in Asia; perhaps because people do not have access to ultrasound to determine the sex of the early foetus, or perhaps because they are less reluctant to have large families. The findings show that many people can control their fertility, suggesting, perhaps, that behavioural factors rather than poor access to contraception is the main cause of the slower decline in family size seen in Africa compared to Asia and South America.

— Richard Lilford, Director CLAHRC WM

Reference:

  1. Milazzo A. Son Preference, Fertility and Family Structure. Evidence from Reproductive Behavior among Nigerian Women. Policy Research Working Paper 6869. Washington, D.C.: World Bank Development Research Group. 2014.

Should Bicyclists Wear Helmets?

Readers of a recent article in the BMJ [1] may have puzzled over the failure of evidence to confirm the intuitive theory that bicycle helmet legislation saves lives. How to explain such a finding when, given a standardised blow to the head, helmets reduce damage in the cranium?[2] One possibility is risk compensation whereby cyclists armed with a helmet are overbold. Another is that drivers are more careful when overtaking a bare-headed cyclist. Support for the latter hypothesis is produced by Walker’s study of 2007, based on telemetric measurements of vehicle distance from bicycles whose riders were, or were not wearing helmets.[3] Beware of theories that are too tidy – subsequent re-analysis of the same data shows that the effect size is tiny after controlling for other variables, and disappears if driver distances are dichotomised into ‘safe’ and ‘unsafe’ at one metre.[4] It is doubtful if the small differences in Walker’s paper could account for the lack of effectiveness observed for bicycle helmets. Should we start again and carry out further empirical work of cyclist-related variables that may affect driver behaviour? Occasionally I see a parent riding with a child to school and I like to think that drivers take extra care in such a situation.

— Richard Lilford, CLAHRC WM Director

References:

  1. Dennis J, Ramsay T, Turgeon AF, Zarychanski R. Helmet legislation and admissions to hospital for cycling related head injuries in Canadian provinces and territories: interrupted time series analysis. BMJ. 2013; 346: f2674.
  2. McIntosh AS, Lai A, Schilter E. Bicycle Helmets: Head Impact Dynamics in Helmeted and Unhelmeted Oblique Impact Tests. Traffic Inj Prev. 2013; 14(5): 501-8.
  3. Walker I. Drivers overtaking bicyclists: objective data on the effects of riding position, helmet use, vehicle type and apparent gender. Accid Anal Prev. 2007; 39(2): 417-25.
  4. Olivier J, Walter SR. Bicycle helmet wearing is not associated with close motor vehicle passing: a re-analysis of Walker, 2007. PLoS One. 2013; 8(9): e75424.

Meta-analysis vs. Pivotal Trial

Which is better – a meta-analysis of all good quality evidence, or the results of the most precise trial contributing to that meta-analysis? Of course there can’t be a definitive answer to that question if there is no gold standard. However, a single large trial does produce the more pessimistic evidence on treatment effect on average, according to Berlin and Golub.[1] Given a premise that bias tends towards ‘optimistic’ results, then the large “definitive” trial is the less biased on average.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Berlin JA, Golub RM. Meta-analysis as Evidence. Building a Better Pyramid. JAMA. 2014; 312(6): 603-5.

Back to the threshold

What is the most a nation should pay for a year of healthy life?

In England, NICE pays £20,000–£30,000 for a healthy year of life – this is not far off the nominal $50,000 evoked by many commentators in the USA. In a recent article,[1] Neumann and colleagues ask whether this is the correct level, especially as it has not changed in two decades, despite inflation and economic growth.

When I directed the Methodology Research Programme in the NHS R&D programme, forerunner of the NIHR, we commissioned a number of research projects to try and find the optional threshold where the value provided per pound by the new technology is exceeded by the value of the services it displaces. Since nobody knows what these displaced services are, let alone their value, the threshold price is enigmatic.

The authors cite evidence from studies showing that Americans are prepared to ‘trade-up’ and would pay more than £50,000 for a healthy life year. The World Bank, for reasons that I have never fully understood, recommends a threshold of three times per capita GDP, which would suggest that both the U.S. and English thresholds are on the low side.

I think the only way to approach the problem is to accept the challenge of finding out what services really are substituted by that gleaming new machine. Granted, what is displaced will vary from place to place. Granted, it will be hard to discern what is displaced because this is implicit not explicit. But detailed observations of decision makers at work could provide evidence of the types of service that are typically rationed in a cost-limited service. I hypothesise that rationing is by “dilution”. That is to say, a nurse is not appointed to ward D17 and there is delay (“slippage”) with the appointment for a new rehabilitation consultant.

The real consequences of setting the threshold too high will be patients waiting longer for their pain relief, less rigorous checks on vital signs, and less comforting words spoken when bad news must be broken. These were the type of opportunity cost I kept in my mind when serving on the NICE appraisal committee.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. N Eng J Med. 2014;371(9):796-7.