First the Heart, Now the Brain

I always wondered whether it may be possible that just as clot-busting medicine preceded clot-removing endovascular surgery for acute heart attack, so the same sequence of events would unfold for acute stroke caused by a clot in the proximal artery. And so it has – endovascular clot removal improved functional outcomes following thrombolytic stroke in two recent trials.[1] [2] Survival also improved in the larger trial, while the other was under-powered for this end-point. The larger trial also showed an improvement in the visual-analogue scale of the EQ-5D. The favourable effects confirmed the result of a previous trial in the Netherlands,[3] and both trials were stopped earlier than planned as a result of the weight of positive evidence. In order to be eligible for this treatment a patient must have good collateral flow distal to the block and a relatively small infarct. Time is of the essence and the interval between CT scan and endovascular clot removal in the trials was little over an hour; a logistic challenge.

How should the NHS respond to this information? NICE has already considered the issue,[4] but this preceded the above results that are hot off the press. Nevertheless NICE advocated that the treatment may be used with appropriate safeguards. This decision was informed by safety evidence from numerous, mostly non-experimental, studies along with ‘proof of principle’ evidence that recanalisation of thrombosed arteries is enhanced by endovascular treatment. It is clear that some UK centres are offering this therapy and participating in a UK-based RCT.[5] One suspects that the data-monitoring committee of this RCT will be reconvened. The treatment has the potential to be cost-effective, based on a previous study that pieced information together from multiple sources.[6] This can now be updated with direct evidence from RCTs. The survival rate was improved by eight percentage points in the above trial, and if this is taken at face value, and if the mean duration of each life gained is 7 years, then the (undiscounted) DALY gain is (7 x 0.08) = 0.56. So even before considering quality of life, the treatment is cost-effective if it costs less than about £11,000 at the NICE willingness-to-pay threshold. The stage seems set for phased introduction of this therapy, since the main areas of uncertainty are likely to migrate from clinical effectiveness to appropriate service delivery. I hesitate to say it, but this technical development is likely to add to the argument for further consolidation of stroke units.

How should the NHS in England proceed? We propose an integrated and co-ordinated response between NICE and NHS England as follows:

DCB - Heart and Brain

— Richard Lilford, CLAHRC WM Director

References:

  1. Campbell BCV, Mitchell PJ, Kleinig TJ, et al. Endovascular Therapy for Ischemic Stroke with Perfusion-Imaging Selection. N Eng J Med. 2015; 372: 1009-18.
  2. Goyal M, et al. Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke. N Eng J Med. 2015. 372: 1019-30.
  3. Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015; 372: 11-20
  4. National Institute for Health and Care Excellence. Mechanical clot retrieval for treating acute ischaemic stroke. NICE interventional procedure guidance IPG458. 2013.
  5. The University of Glasgow. Pragmatic Ischaemic Stroke Thrombectomy Evaluation: PISTE. 2015. [Online].
  6. Nguyen-Huynh MN, & Johnston SC. Is mechanical clot removal or disruption a cost-effective treatment for acute stroke? AJNR Am J Neuroradiol. 2011; 32(2): 244-9.
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Lay Community Health Workers

In discussing possible solutions to health problems in CLAHRC Africa, the role of Lay Community Health Workers (LCHWs) often comes up. In fact, there is seldom a large-scale health problem that someone does not suggest can be laid at the door of LCHWs.

What are LCHWs?

  1. LCHWs (sometimes referred to as Lay Health Workers or Community Health Workers) cover a range of functions. However, LCHWs tend to have the following features:
  2. They are of the community in the sense that they live among the people they serve. They tend to be nominated/selected by their local community.
  3. They have a connection to the health service – for example, they have established lines of communication and can refer.
  4. They are not full-time and generally have other roles/jobs in the community.
  5. They may receive some monetary payment from health services, but this is small in amount relative to substantive health care workers.

What is the history of LCHWs?

The CLAHRC WM Director finds it difficult to follow the evolution of present day LCHWs, but he fancies that some people have differentiated themselves to provide services to their community from the beginning of time, for example, providing birth assistance. The present day CHW:

  1. is differentiated from traditional healers and hews, to some extent at least, to an Enlightenment-based scientific model;
  2. performs a role that forms part of, or complements, the local health service.

Recent examples of initiatives that relied on LCHWs include:

  1. The “barefoot doctor” programme in China.[1]
  2. An extensive reproductive health programme in Iran associated with a steep drop in fertility.[2]
  3. An extensive child health programme in Brazil that was associated with a large (over 50%) and precipitate drop in childhood mortality.[3]
  4. The anti-retroviral programme in Africa where LCHWs played a part in identifying cases and helping clients adhere to exacting treatment regimes. [4]

Lay workers are also found in high-income countries and may even be making something of a come-back. Our CLAHRC, for instance, has evaluated the role of such volunteer support workers in the case of vulnerable women over the perinatal period.[5]

Are LCHWs effective?

This question invites the response “compared to what?” They played a large (arguably essential) part in the above programmes and the programmes were themselves successful. LCHWs make a small call on the public purse and so there are good reasons to think they are cost-effective compared to health service personnel who might be deployed to perform the same function. There is empirical support for the theoretical idea that being part and parcel of the local community and being selected by local people provides credibility and enhances the effectiveness of LCHWs. A collaborator of the CLAHRC WM Director, Dr Alex Plowright, argues that the empathy they display is especially important where health systems are weak and staff are often disaffected. Summative evaluations (82 RCTs) show that LCHWs are effective on average, but the results, as with many service interventions, are heterogeneous.[6] This reflects, at least in part, the fact that LCHWs are deployed in very different social and political environments that might be neutral, supportive, or antipathetic to their efforts.[7] [8] Salient questions include the education of LCHWs (how much, in what form, over what time periods), whether LCHWs should specialise, and what functions they should perform.

Towards a theory of LCHWs deployment

The argument proposed here has two premises:

  1. LCHWs do not tend to have detailed theoretical knowledge, nor a deep understanding of patho-physiological pathways. If they did, they would not be LCHWs.
  2. Most health gains in deprived communities in low- and middle-income countries turn not on intensive medical practice, but on a small number of conceptually straightforward processes – basic nutrition, bed nets, oral rehydration, vaccination, access to contraception, and so on.

Putting these two ideas together can help shape an answer to the above question relating to role definitions. First, it would suggest that LCHWs should not become a type of “dumping ground” for all ills – mental health, untreated ear disease, skin infections, etc. Rather, they should learn what the red flags are and have a generally low threshold of referral to a health facility. A corollary of this idea is that LCHWs should not be required to specialise, though this is not to say that they should not develop a special interest. Childbearing might be an exception, since a type of CHW called a traditional birth attendant can improve outcomes of labour, at least where trained midwives are not available.[9] Once the above fundamentals are covered, then one can imagine a role in health promotion – for example, discouraging salt and sugar and perhaps checking for the silent killer that is hypertension, as recommended by Margaret Thorogood.[10]

— Richard Lilford, CLAHRC WM Director

References:

  1. Rosenthal MM, & Greiner JR. The Barefoot Doctors of China: From Political Creation to Professionalization. Hum Organ. 1982; 41(4): 330-341.
  2. Hoodfar H, & Assadpour S. The Politics of Population Policy in the Islamic Republic of Iran. Stud Family Plann. 2000; 31(1): 19-34.
  3. UNICEF. The State of the World’s Children 2008. New York, NY: UNICEF. 2007.
  4. Hermann K, Van Damme W, Pariyo GW, Schouten E, Assefa Y, Cirera A, Massovon W. Community health workers for ART in sub-Saharan Africa: learning from experience – capitalizing on new opportunities. Hum Resour Health. 2009; 7: 31.
  5. Lilford R. Improve long-term development of children. 20 Feb 2015. [Online].
  6. Lewin S, Munabi-Babigumira S, Glenton C, et al. Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases. Cochrane Database Syst Rev. 2010; 3: CD004015.
  7. Glenton C, Colvin CJ, Carlsen B, Swartz A, Lewin S, Noyes J, Rashidian A. Barriers and facilitators to the implementation of lay health worker programmes to improve access to maternal and child health: qualitative evidence synthesis. Cochrane Database Syst Rev. 2013; 10: CD010414.
  8. Kok MC, Kane SS, Tulloch O, et al. How does context influence performance of community health workers in low- and middle-income countries? Evidence from the literature. Health Res Policy Syst. 2015; 13(1): 1.
  9. Jokhio AH, Winter HR, Chang KK. An intervention involving traditional birth attendants and perinatal and maternal mortality in Pakistan. N Engl J Med. 2005; 352(20): 2091-9.
  10. Thorogood M, Goudge J, Bertram M, et al. The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial. Trials. 2014; 15: 435.

Demystifying Theory

A recent article in BMJ Quality and Safety offers a lively and useful account of the role of theory in applied research, with examples taken from service delivery research.[1] The authors explain repeatedly that theory is always present when a service is changed, and that the choice lies in making theory formal and explicit versus leaving it vague and implicit. The article covers grand theories (such as the idea of culture); mid-range theories (such as social behavioural theory, which emphasises the effect of social clues on behaviour); and programme theories (which map out the territory between cause [e.g. more nurses] and outcome [e.g. healthier, happier patients]). A detailed discussion of programme theory was recently published by CLAHRC Northwest London.[2]

One of the problems that provokes the CLAHRC WM Director is the observation that the same theory may go under different names (‘the same wine in new bottles’) or that theories may overlap. For example, Ferlie and Shortell,[3] and Richard Grol [4] have both developed a similar theory (that successful organisational change requires co-ordinated responses from different levels in the organisational hierarchy). Also, in many circumstances, it may be necessary to determine which theories are relevant and which are not. For example, should an intervention be designed according to nudge theory, social behavioural theory, the theory of planned behaviour, or one of the other 64 psychological theories of behavioural change? Here, one turns to a theory of theories – for example, the transtheoretical model.[5] [6]

— Richard Lilford, CLAHRC WM Director

References:

  1. Davidoff F, Dixon-Woods M, Leviton L, Michie S. Demystifying theory and its use in improvement. BMJ Qual Saf. 2015; 24: 228-38.
  2. Reed JE, McNicholas C, Woodcock T, Issen L, Bell D. Designing quality improvement initiatives: the action effect method, a structured approach to identifying and articulating programme theory. BMJ Qual Saf. 2014. [ePub].
  3. Ferlie EB & Shortell SM. Improving the quality of health care in the United Kingdom and the United States: a framework for change. Milbank Q. 2001; 79(2): 281-315.
  4. Grol R, Wensing M, Eccles M, Davis D, eds. Improving patient care: the implementation of change in health care. Hoboken, NJ: John Wiley & Sons. 2013.
  5. Prochaska JO, Velicer WF. The transtheoretical model of health behaviour change. Am J Health Promot. 1997; 12(1): 38-48.
  6. Michie S, Johnston M, Francis J, Hardeman W, Eccles M. From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Appl Psychol. 2008; 57(4): 660-80.

Conceptualising and measuring teamwork

Readers will know that the CLAHRC WM Director is interested in, and a little sceptical of, the utility of constructs describing latent properties of health care organisations ­– culture, for example. Teamworking is such a construct that is hard to pin down and, for that reason, hard to measure. Those who want to go beyond sound-bite management and slogans are encouraged to read a scholarly article by Deitz et al.[1] The article resists a succinct summary, save to say that teamwork is probably most important in scenarios that really are team based (for example, advanced life support), compared to those that turn on the cognitive excellence of individuals (for example, diagnosis). Certainly, the construct appears to be more useful in the cockpit than the admissions ward, and we should not think of teamwork as some kind of panacea. Individual relationships and the ability of expert clinicians to spot things that are not obvious, remain key qualities.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Deitz AS, Pronovost PJ, Benson KN, Mendez-Tellez PA, Dwyer C, Wyskiel R, Rosen MA. A systematic review of behavioural marker systems in healthcare: what do we know about their attributes, validity and application. BMJ Qual Saf. 2014; 23:1031-1039.

 

Radical or what?

As far as the CLAHRC WM Director can discern, the massive closure of in-patient psychiatric beds in the 1970s was not evidence based. It was driven by all sorts of social forces and ideology. That does not mean it was necessarily a bad thing – and of course some psychiatric beds remain. So the real question is “what is the optimal provision for severe mental illness?” According to Sisti et al.[1] current provision is far too low. Some who need beds end up in prison services. Many others may also benefit from inpatient care. Careful comparison between community and hospital care among equipoised patients [2] (i.e. those with no real preference) would go a long way to identifying optimal provision. In the meantime, the CLAHRC WM Director and his colleague Celia Taylor are collaborating with RAND Europe on the evaluation of Liaison and Diversion services, so that people with severe mental illness are diverted to mental health services when they have been arrested. Some of these diverted patients will need inpatient care.

— Richard Lilford, CLAHRC WM Director

References:

  1. Sisti DA, Segal AG, Emmauel EJ. Improving Long-term Psychiatric Care: Bring Back the Asylum. JAMA. 2015; 313(3): 243-4.
  2. Lilford RJ, Jackson J. Equipoise and the ethics of randomization. J R Soc Med. 1995; 88(10): 552-9.

Can We Do Without Heroism in Health Care?

Two icons of patient safety, Peter Pronovost (Time magazine’s Top 100, 2008) and Ara Darzi (British House of Lords) have recently penned a manifesto. It calls for a systems approach to safety assurance and less reliance on heroism to make up for weak systems.[1] The document is well written, persuasive and wrong. Well, not wrong, just not right!

Let’s start with the systems point. The argument put forward by Pronovost and Darzi echoes a constant refrain from safety pundits that goes something like this:

Health care is beset by safety problems; Adverse events (AEs) are more likely when weak systems leave gaping holes that link up to cause adverse events, as per Reason’s “Swiss Cheese” model; Systems approaches have massively reduced AEs in other industries; But two decades of trying to replicate these achievements have yielded little progress in health care; By Jupiter, we must try harder to improve the system!

However, it would seem more reasonable to conclude that health care is not like other industries – as argued in a previous post, only about one quarter of AEs arise from archetypal system problems in the sense that their root cause lies in the host organisation. The remainder follow diagnostic errors (broadly defined) and procedure-related errors. These both lie in the province of front-line doctors failing to exhibit sufficient skill. Of course manifest skill can be influenced by local conditions, for instance if the doctor has to care for more patients than she can cope with. And they emanate from a broader system concerned with selection, training and so on (see ‘Bring Back the Ward Round’ below). But it is hard for a hospital to indemnify itself against a surge in demand, and recruiting and training doctors plays out over decades.

Things that can be systemised are being addressed to good effect. Hospital-acquired infections are massively down; severe pressure ulcers down; medication error heading south; and wrong site surgery is right down.

The patient safety ‘industry’ needs to move on from its preoccupation with infection, falls, medication errors, pressure ulcers, and rare egregious errors. And to be fair, Pronovost has campaigned elsewhere for more emphasis on diagnosis,[2] while Darzi is a world leader in surgical training.[3]

And that is where we need to turn to this issue of heroism. Here the story goes something like this:

It took heroes, such as Charles Lindbergh, to establish aviation; But a modern airline pilot with a barn-storming attitudeis a “bloody nuisance”; Medicine also needed adventurous doctors like Christiaan Barnard in its heroic phase; But now we need bland team players who can follow guidelines

Now I am not arguing for the return of Sir Lancelot Spratt and fully understand that it is patients, not doctors, who put their lives on the line. But treating health care workers like office clerks is wrong – again and again clinicians have to go above and beyond, doing hard cognitive, physical and emotional work – a good doctor, has to ‘give of herself’.

A good doctor who has done a hard night in A&E has not just spent the evening following guidelines; she has made sound judgements under uncertainty, maintained her composure under abuse, coped with a stream of patients arriving faster than they can be seen, and she has kept a cheerful demeanour throughout. She may have helped hit the government’s four hour target. Doctors in many parts of the world feel demoralised, but medicine cannot go back to the hands-off approach of yesteryear – scrutiny and regulations are here to stay for very good reason. But don’t let the pendulum swing too far – recognise that the work is hard, that it cannot be completely codified, and that it is deeply personal, and leave space for just a little heroism.

— Richard Lilford, CLAHRC WM Director

References:

  1. Pronovost PJ, Ravitz AD, Stoll RA, Kennedy SB. Transforming Patient Safety: A Sector-wide Systems Approach. Doha, Qatar: World Innovation Summit for Health. 2015.
  2. Newman-Toker DE, & Pronovost PJ. Diagnostic Errors – The Next Frontier for Patient Safety. JAMA. 2009; 301(10): 1060-2.
  3. Singh P, & Darzi A. Surgical training. Br J Surg. 2013; 100: 307-9.

 

Bring Back the Ward Round

Diagnosis, diagnosis, diagnosis. Both this and a previous post have made the argument that diagnostic errors should receive more attention. An important and elegant paper from previous CLAHRC WM collaborator, Wolfgang Gaissmaier,[1] shows that diagnostic accuracy is improved when medical students work in pairs. Of course, paired working is not possible most of the time, but it does suggest that opportunities for doctors to ‘put their heads together’ should be created whenever possible. The old-fashioned ward round had much to commend it.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Hautz WE, Kämmer JE, Schauber SK, Spies CD, Gaissmaier W. Diagnostic Performance by Medical Students Working Individually or in Teams. JAMA. 2015; 313(3): 303-4.

Slums – Exploding Urban Myths!

The CLAHRC WM Director has recently returned from a two week attachment to the African Population Health Research Center (APHRC) in Nairobi. He stayed in the home of the Director, Dr Alex Ezeh, and his charming wife Nkee, to whom he extends his sincere thanks. APHRC is the foremost African centre for the study of slums*. The APHRC were among the first centres to question the idea (discussed in a previous post) that slums provide a frequent conduit from rural poverty to middle class urban life. In fact, for a large proportion of families, they are a sink; three generations can frequently be seen living in a single dwelling.

The APHRC have also exploded another myth – that while urban poverty appears more extreme than rural poverty to the casual observer, slum dwellers enjoy better health than their rural cousins. Research carried out by the APHRC showed that this was not the case for Kenya,[1] and this finding has since been replicated in Bangladesh.[2]

The Director visited the Viwandani slum in the company of APHRC staff with whom he is collaborating on a project on urban regeneration. Although a cursory inspection would suggest that one slum is much like another, deeper examination shows that this is not the case. Slum populations are more transitory in some places than others, suggesting that for some, slum life really is a step on the path to economic emancipation. There is a pronounced economic gradient within slums, with poverty increasing with distance from centres of employment. One thing that struck the Director was the need to pay for every item of service, including water and even access to the lavatory.

Despite the privations that people live under, and the malodorous crowded conditions outside, many slum dwellers maintain a remarkably high standard of personal hygiene, and the homes we were graciously invited to visit were absolutely spotless. The slum we visited had been exposed to a vigorous programme (in which APHRC is participating) promoting exclusive breast-feeding to the age of six months, and the babies we saw were sleek and healthy. One exception was a toddler with a crusty skin infection on his outer ear. The CLAHRC WM Director, pining after his days as a clinician, diagnosed impetigo and referred the child for urgent antibiotic treatment to reduce the risk of acute glomerulonephritis.

The health of slum dwellers has received much less attention than rural health – for example, there are upwards of 30 Health and Demographic Surveillance Sites (HDSS) in Africa, but until last year only one (managed by APHRC) in a slum area. You might ask what is different about slum vs. rural health – people in both areas are exposed to parasites, water-borne disease, and other afflictions of poverty. However, the spectrum of conditions differ and so do many of the solutions. Providing safe water and ensuring adequate garbage disposal are particular problems. So is the stress and danger of over-crowding, and the risk of fires and burns is high for many reasons. Slum health is mentioned in the Millennium Development Goal 7, but a recent Lancet editorial stated that this document “underestimated the magnitude of the problem by tenfold”.[3]

* Some people prefer the term “informal settlement”, perhaps because it is seen as less stigmatising or offensive to the people who live there. However, Africans speak of slums and this term is used in the research literature. Perhaps it is felt that a blander term would do more harm than good by ‘sanitising’ a harsh reality and reducing a sense of urgency?

— Richard Lilford, CLAHRC WM Director

References:

  1. African Population and Health Research Center. Population and health dynamics in Nairobi’s informal settlements. Nairobi (Kenya): African Population Health Research Center. 2002.
  2. UNICEF. Understanding urban inequalities in Bangladesh: a prerequisite for achieving vision 2021. A study based on the 2009 multiple indicator cluster survey, 2010. [Online].
  3. The Lancet. Urban health post-2015. Lancet. 2015; 385: 745.

CBT and Guided Self-Help is Effective in Reducing Depression in People with Physical Co-Morbidity (Diabetes or Cardiovascular Disease)

The effectiveness of an intervention to reduce depression in people with diabetes or cardiovascular disease was tested by means of a parallel cohort cluster trial.[1] The reported trial showed an improvement of 0.3 of a standard deviation in the depression score, as well as improved patient satisfaction. The CLAHRC WM Director always worries that consent to take part or propensity to drop out could interact with designation as intervention or control status when individuals are recruited to cluster studies, but the results of this study seem consistent with the bulk of literature on CBT. A similar study is underway under CLAHRC WM, but this time in patients with musculo-skeletal disease. It is being led by Clare Jinks at Keele University.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Coventry P, Lovell K, Dickens C, et al. Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease. BMJ. 2015; 350: h638.

Another null result from a trial of an intervention to improve outcomes for people with cognitive impairment

In this substantial cluster trial [1] of 1,042 stroke survivors in no less than 228 care homes, occupational therapy was not associated with improved scores for activities of daily living. Do we need a better understanding of the interaction between people and their social and physical environment to design an intervention that really will lift mood and improve the ability of elderly people with failing brains to engage with the world?

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Sackley CM, Walker MF, Burton CR, et al. An occupational therapy intervention for residents with stroke relayed disabilities in UK care homes (OTCH): cluster randomised controlled trial. BMJ. 2015; 350: h468.