New Research Area: Scientific Research vs Healthcare Delivery Research

Conventional Scientific Research Vs. Health Care Delivery Improvement Research: Both are important

I write with the confidence that many of you would already know about this..........

Research is about finding out if a proposed intervention works better than the current one. Is a new drug, operation, investigation, procedure, etc effective compared to an existing one? To find that out by definition research is a must and RCTs are essential (as RCTs are considered to be the highest form of conventional scientific research). Since the question is about the proposed intervention (and not about anything else) the confounding variables are reduced to minimum (inclusion and exclusion criteria etc). That will be conventional scientific research.

We all know real life clinical practice is not delivered under controlled research conditions.

Healthcare Delivery research (operational research) therefore becomes important. The question here is, what worked elsewhere and how to make it work for us in real practice where there will be all sorts of variables. This kind of research is important for two reasons: a) to put into practice the good things discovered by research (introduction and roll out of research findings - could probably be called innovation) and b) to discover what actually works (or does not work) in our location and to see if we can do better (clinical improvement)

I believe an example is the critical care outreach teams; apparently RCTs have not conclusively shown that they work. But in some hospitals they work very well. Now, we have such outreach teams in all hospitals; however it works in some hospitals and does not in others (again so much like RCTs finding different things when variables are changed) obviously the operational variables are different in each hospital. The point though is not if critical care outreach teams have been proven by RCTs but why it works in some places and do we want to make it work in our place?

So in practice, the question for healthcare delivery research is not whether something works (as that is an RCT question); the real question would be 'it works in St Elsewhere (even though it may or may not have been proven in RCTs); how do we make it work for us?' Where we know what works it is also about how to deliver that to every patient in our care.

As a surgeon I can say that the common operation of laparoscopic cholecystectomy surged to popularity even before any strong RCTs were done.

Let me state very clearly, that I am not for a moment supporting/encouraging dubious practices. I am talking about the existence of a different branch of research in which doctors have not been engaged actively in the past. I am suggesting that for most of us practising in normal day to day circumstances clinical operational research and/or management to benefit healthcare delivery could be equally relevant in providing good care (as RCTs). Most often the ideas for operational research comes from proven conventional research findings.

I would fully understand if trainees do not engage in this due to the expectation that they do conventional research. Doctors who are not in training ie consultants, SAS and specialty doctors could consider getting involved in this kind of work (clinical operational improvement work). This is not operational research from a management or administrative perspective. This is clinical care delivery operational research. If you thought this is managerial or admin work, sorry, you are mistaken. This is as directly clinical as it gets.

Clinicians have been taught what is best. This new area of activity and research shows us how to deliver that best to every patient at all times.

You could make a start by learning more about this. Check out IHI various courses including the on-line ones, NHS Institute's courses and of course the CQI course at NLG NHS are basic starting points to kindle interest in the area. Warwick's CSI course is reputed to get you thinking in this direction.

Know when mortality increases and try to prevent it

When junior doctor changes over (in UK it is usually February, August and a couple of other months), there is a higher mortality.
Weekends have a higher mortality.
Major operations on a Friday have a higher mortality.
Winter has a higher mortality.

There are other mortality peaks as well. The question is not what the 'evidence' is around this topic. The question is 'Does it happen in your hospital?'. Do you know? If you don't know - should you know? If you know that you have such a peak in mortality, what are you doing about it? What can be done about it? (If you know you do not have such a peak - do you know how you managed to avoid it?)

These types of mortality cannot be made better by 'better coding' and by 'building hospices'. But can certainly be dealt with by taking specific preventative upstream action.

Take care. Take preventative upstream action.

Biggest Lean Deployment in the World

The American Army has the largest lean six sigma deployed in the world.

The American army budget is currently more than $240billion
The US Army has deployed Lean since 2006 and saved $19.1 billion dollars
so far. In 2011 alone they are conducting 2111 lean improvement projects
to save $3.6 billion.
They have 5700 green belts, 2400 Black Belts and 175 Master Black Belts
and 48 Lean Deployment Directors. Their return on these investments have
been very good.

Most of the projects have been about logistics but their health care is
also heavily into lean. They have seen great successes.

Here is an interesting anecdote from one of their early projects -
obviously dated but the learning value is undiminished.

According to the principles of lean six sigma, US Army Medical Command
looked into high volume areas, 'waste' and 'customer satisfaction'
problems and found that they had:

The largest army call centre with more than 10000 calls per week
Low customer satisfaction at 68%
Average wait time of 3.14 minutes (wait is one of the classic wastes in
lean)
Call abandon rate of 26% - with a peak time call abandon rate of 49%

Obviously they found this very unsatisfactory and ran a lean project to
improve this. And they improved:

Average wait time reduced to 33 seconds (a six-fold improvement)
Call abandon rate reduced to 3% with peak time call abandon rate down to 22%
Call volume reduced 20% due to less call backs
and so on

These results were far better than the aims they set themselves for the
projects

Apparently the customer satisfaction got worse!!

While people were getting their calls attended in record time they could
not get appointments to see doctors in clinics because the clinics had
capacity and scheduling problems - so the issue was, what is the point
in answering the phone quickly if they could not address the real need
which is patients to see doctors quickly.

Do not despair!

They have since addressed that issue and that has had an even bigger
effect on their call centre

The average waiting time has fallen to 3 seconds (yes, you read it right
THREE seconds - from their starting point of 3 minutes and 14 seconds)!!

There are two messages, a) system wide thinking is difficult but very
important b) it is even more important to solve the real issue (rather
than what is immediately apparent).

HEMADRI

Note: The above is written from my recollection and notes of a brilliant presentation made at the WCBF Lean Six Sigma in healthcare conference 2011; with thanks to the presenters from the US Army Health Command and their collaborators.

Single Visit Surgical Service

When we look at providing healthcare services we should look at it from a patient's perspective. For instance, ''how often would the patient have to travel to the hospital to obtain healthcare services?'' is not the top question in any providers mind when they design the service.

This results in the patients traveling often to secondary care services even for obviously clear problems such as hernias, varicose veins etc.

At Goole Hospital we provide a single visit general surgery service for patients who need day case and short stay surgical procedures. This may mean procedures likes superficial lumps and bumps, toe-nails, etc. This also means patients who have groin hernias including recurrent groin hernias and gall stones (needing laparoscopic cholecystectomy).  Obviously there has to be a clear cut diagnosis based on obvious findings followed by some appropriate investigations by the general practitioners. These patients visit Goole Hospital only once to obtain their surgical care. The patients are telephone pre-assessed. They come to the hospital at about 8 am and are seen by nurses, anaesthetists, surgeons and residual simple investigations are performed instantly; they are operated during the day and discharged when they meet clinical criteria often within the day. They are not offered specific follow up out patient appointments but can ring to make one if they felt they needed it.

We do inguinal hernia repairs, laparoscopic cholecystectomies and many other procedures as a part of this service. The service has been running for a good few years.

My personal calculations are that this saves money overall, especially saves on travel costs for patients and their relatives. My feeling is many of the services provided by healthcare are currently very hospital focussed. When the processes becomes patient focussed there is a good chance that quality could improve while saving on costs at the same time. It is up to us to manage our services and processes maturely - our poor design should not trouble the patients.

© HEMADRI

Follow me on twitter @HemadriTweets

Warning & Disclaimer:
We do not claim superior clinical results. We only describe our process/pathway. Not all patients with any of the conditions stated above or with other similar conditions are suitable for this service. Your GP is best placed to advice the kind of pathway that could be suitable to you. This blog/website does not give clinical/medical advice. The views expressed are my personal views and not those of my hospital or the NHS.

 

Laser surgery for piles

Many of you will be aware that piles is a very common problem presenting usually as bleeding and/or swelling from the anus. If the piles involves an external swelling at the anus along with the bleeding then a surgical operation may be indicated.
Currently the standard method of doing a piles operation involves a general anaesthetic, cutting out the piles (called open haemorrhoidectomy or Milligan-Morgan technique) and possibly an overnight hospital stay though more centres are doing piles operations as day cases.

We (Peter Moore, Consultant Surgeon, now retired and I) have been performing a technique called Laser Seal Haemorrhoidectomy for a few years where we use a local anaesthetic with mild sedation and use a laser to seal the cut edges of the piles. Patients are able to go home about 2 hours after the operation (they may be able to go home earlier but sedation guidelines kick in I suppose), we believe that this procedure gives better pain relief in the early days http://www.nlg.nhs.uk/services/laserhaemorrhoidectomy/default.asp  

We learnt this procedure a few years ago from Peter Thomas from Arizona  http://laserhemorrhoids.com/; of course we don't do it exactly like him and he has been doing it for 25 years.  A public thanks to Peter.

I think to change an operation that involves a general anaesthetic and often one or two nights of stay in the hospital to a local anaesthetic (with mild sedation) with a two hour stay is our local technical example of Success in Healthcare. Surely not an earth shattering example, only a small one but hopefully relevant for some. The point is to try and pursue every activity that improves quality and decreases cost at the same time.

 © HEMADRI 
Follow me on twitter @HemadriTweets

Warning & Disclaimer
1) There are many causes of bleeding from the anus and many causes of swelling in the anus, some of those may be more serious conditions than piles - please consult your doctor whose advise will be the only thing relevant to you personally. This blog does not give you medical advise.
2) We do not claim scientifically superior results. We describe only our process and some of our beliefs.We use the laser seal haemorrhoidectomy as a clinical process improvement example not as scientific proof of any treatment.

Amended on 30 August 2014

Shell & Healthcare

A SHELL FOR SAFETY

Learning from other industries is important, airlines and pilots have been the common sources for healthcare; the oil industry, especially SHELL is also a very good source.

THE CHALLENGE THROWN TO HEALTHCARE

The oil company SHELL has an extremely high priority for safety. When SHELL do any construction work the area is marked 'This is a safe work place'. It is not a warning or an advisory, it is a statement. At the International Forum for Quality and Safety in Healthcare at Amsterdam in 2011, the question and the challenge that was posed was, which hospital actually has a sign that says 'this is a safe hospital' and which hospitals are working towards that explicit goal?

That is very interesting. Would it be possible to guarantee safety in healthcare? As an enthusiast I would argue that it would be possible in many areas, well at least in some areas, but as a realist I know it would be difficult.

Mr. Rein Willems was the Chairman of SHELL and is now a member of the upper house in Netherlands. He has authored the brief but powerful report which is now the basis of improving safety and quality of healthcare in Netherlands. He spoke at the Forum in Amsterdam. I share some of the messages here.

RED LINES AND DISCIPLINE

In Shell, the by-line for 'this is a safe work place' is ''here you work safely or you don't work here at all''. Willems said that there was an occasion when a worker despite adequate warning and training persisted in the unsafe practise of smoking in a non-smoking zone in a production site and the CEO physically escorted that employee out of the premises and the employee was sacked on the spot.

Though it is a dramatic example it illustrates the seriousness with which safety is taken in Shell. What is our equivalent example in healthcare? We may do that for fraud or for smoking near the oxygen tanks – those are important but are general to any facility – what is the example that relates to clinical care delivery?

MANAGING VERSUS SOLVING

Willems went on to use the iceberg analogy that for every single fatality there were 50s of 'lost time accidents', 100s of property damage or minor injury, 1000s of accidents/incidents with no injury and 10000s of small events/breaches. To avoid that single fatality the underlying causes of 'small incidents' have to be fixed. Managing small events without fixing the underlying causes will eventually escalate into major problems.

In healthcare we are very good at emphasising on 'risk management'. As far as I am aware risk management is about identifying and understanding risks and minimising them. Which is at least a bit different from enhancing safety – which is about continuously increasing the standard of practice to the best that is currently possible. In terms of quality, risk management could probably equate to the principle of quality control by checking the products. Safety in healthcare would probably be the equivalent of getting it right as we go along. There lies the difference.

Having said that, it is possible that some of the people who are currently doing governance and risk are also doing safety; hats off to them since they have to cope with varying threads within a concept. I suspect most people may not be doing this.

EVERYONE DOING THE SAME THING

Willems also touched on the concept of uniformity of shared practices. In Shell they have a policy where 'all employees should have one hand on the stair rail when they are going up or down stairs' this was implemented in their sites (oil fields and refineries). On one occasion Willem and his CEO were photographed in the head office walking the stairs with papers in hand without holding the side-rails. An employee wrote to Willem querying if the rule applied only to lower level staff. With a view to leading by example and with a view to having similar rules for everyone in Shell it is now the policy that whether one is on the field/rig/factory sites or in offices that one hand must be on the rails while going up or down stairs.

We in healthcare are no SHELL but to be fair I have seen a senior board director removing her jewellery before entering a ward, though she was there for administrative reasons. That is a good sign.

I think the core idea was that senior leadership has to play a very visible, proactive and hands-on role in the area of shared baselines, analysing data, resolving issues and safety. These concepts are essential for safe healthcare but are not often done in comprehensive or meaningful ways; that is what we ought to get right.

Shell and Willems do have generic lessons for us in healthcare.

HEMADRI

NOTE: The writing in italics are my personal views. The normal type is what Mr Willems said or his views.

Duty of candour: Voluntary or statutory?

Duty of candour: Voluntary or statutory?

Candour is the quality of being honest and telling the truth, especially about a difficult or embarrassing subject[1]. When things go wrong and especially when patients are harmed whether it is due to natural circumstances or due to error by individuals or systems candour becomes very important. One of the components of such candour is to offer an apology to the patients and their families. It is important to understand that as clinicians we may not be apologise for in a ‘conventional’ sense when there is no individual error is involved; what we would be apologising for in all cases is for the fact that the patients’ expectations were unable to be fulfilled on that occasion.

Compensation Act 2006 states: ‘An apology, offer of treatment or other redress shall not of itself amount to an omission of negligence or breach of statutory duty. The medical indemnity providers have always held a similar view that apologising does not put a clinician at risk of being accused of anything in the future – it is not an admission of liability.

In the document ‘The Coalition: our programme for government’[2] it says "We will enable patients to rate hospitals and doctors according to the quality of care they received, and we will require hospitals to be open about mistakes and always tell patients if something has gone wrong".  The words ‘will’, ‘require’ and ‘always’ seems to indicate that the government is inclined towards introducing  statutory candour or some version of it.

The CMO has been recommending a statutory duty of candour for a good few years and there are currently deliberations including the GMC on this subject. There has been parliamentary health select committee recommendation to consider this subject.

Understandably patient groups especially the AvMA are in full support of a legal duty of candour; understandable because of the powerful case studies[3] they use where a statutory duty could have either avoided prolonged and vexatious interactions with authorities involved in those case studies or would have helped to bring events to a closure quickly. 

The MDU does not support the consideration of a statutory duty of candour based on the argument that there is already an ethical duty backed up by adequate GMC sanctions.[4] The MPS also seems to take a similar view. The NPSA’s new ‘being open’ policy (as opposed to its ‘open disclosure’ policy) is based on the premise that doctors apologising would prevent many unnecessary complaints and possibly some of the litigation that follows. There is international evidence that litigation occurs less often when an apology is offered and accepted upfront.

The GMC guidance on good medical practice[5] states ‘‘if a patient under your care has suffered harm or distress, you must act immediately to put matters right, if that is possible. You should offer an apology and explain fully and promptly to the patient what has happened and the likely short-term and long-term effects’’. However, a 2008 survey by the MPS[6] showed that while more than 90% of professionals believed that patients are less likely to litigate after errors if they received an explanation and an apology but only 68% were willing to be open when something went wrong. Clearly the issue of liability and blame still plays in the minds of doctors.

This raises the question whether the duty of candour should be statutory or mandatory.

Clinicians especially doctors really would not want statutory duty of candour as they would like to think that they are doing the right thing because it is the right thing and not because it is simply required by law. The GMC and other bodies, regulatory or not, take a very poor view of lack of transparency. Actioning after an event of low transparency is like many other triggers may turn out to be subjective, discretionary and inconsistent. However, in practice once the issue reaches the 'authorities' there are significant consequences which inevitably follow. Therefore a culture change route is preferable for clinicians.

The next issue to consider is how we design a response to the call of ‘duty of candour’. What the profession needs to understand is whether there was a rising trend that doctors and other clinicians are getting less transparent, if there is no such trend whether there are frequent examples of lack of candour. There seems to be no general trend that doctors are getting less transparent. Hence, a culture change approach using the voluntary duty supported by a strong view from the GMC and other bodies would certainly make a difference from the perspective of clinical professionals; with aberrant doctors dealt with strongly by using the full force of current systems. 

There are however, very frequent examples of outliers. This is when we have to recognise that institutional candour is a different situation. While individuals are all for openness, the current system of risk, clinical governance, complaints and legal actions inevitably raises doubts on the relevance of the extent of candour and its impact on future action against organisations. Further, often in inefficient and overspent circumstances or in situations of poor organisational vision, what is not required by the force of law or the force of higher authority is actively prevented from happening. This is understandable from an organisation's perspective but would be unacceptable to patients. There are examples of individual clinical candour followed by organisational resistance that happen in sequence. This is obviously unsatisfactory.

On balance, it seems that under current moral mores of our society a statutory duty of candour is probably going to be inevitable.  The question is of course is whether individual clinicians or the organisation would be legally responsible for the statutory duty of candour. It would make sense for the organisation to be responsible for such a statutory duty. The issue of candour after serious untoward incidents has extremely personal and wide ramifications at the same time, that it becomes clearly outside the remit of individual personal clinical responsibility. Further, organisations and organisational responsibility is likely to cover everyone in the organisation which would include doctors - any aberrations on the grounds of candour by doctors would therefore be dealt with by their organisation and by the GMC.

There might be a case for parallel dual responsibility (which has the risk of diluting responsibility) or for purely individual responsibility (where it could become 'fault', 'witch-hunt'  and 'scape goating' usual suspects). In a broad sense since the responsibility for quality moved from consultants to chief executives in the mid 80s, candour as such should therefore be an organisational responsibility delivered by individuals rather than individual responsibility enforced by personally applicable law.


© HEMADRI

Follow me on twitter @HemadriTweets

The department of health has launched a consultation on duty of candour: http://www.dh.gov.uk/health/2011/10/candour-consultation/ Please respond to it.

 

---

[1] Cambridge Advanced Learner’s Dictionary

[2] The Coalition: Our programme for government: http://www.direct.gov.uk/prod_consum_dg/groups/dg_digitalassets/@dg/@en/documents/digitalasset/dg_187876.pdf

[3] http://www.avma.org.uk/pages/legal_duty_of_candour_-_robbies_law.html 

[4] http://www.the-mdu.com/section_medical_students/topnav_News_3/hidden_Article.asp?articleID=2011&contentType=Media+release&articleTitle=MDU+supports+apologies+to+patients+but+says+no+need+for+duty+of+candour

[5] http://www.gmc-uk.org/guidance/good_medical_practice/relationships_with_patients_open_and_honest.asp

[6] http://www.medicalnewstoday.com/articles/127194.php