Gold Standards Framework

Had an update on the end of life management policies in Cornwall through the Gold Standards Framework (GSF).

"[GSF] was first piloted in Yorkshire in 2001 in Phase 1, followed by a national phased programme supported by the NHS, Macmillan and more recently the DH End of Life Care Programme. An intrinsic element of the work has been the internal and external evaluations, originally using questionnaires and more recently the on-line After Death Analysis audit tool, plus several independent University based evaluations, which contributed to the further development of the work. National spread was enabled through a strategic national cascade plan with the GSF Central Team supporting local facilitators, enabling best implementation of the work, overseeing training and audit plus developing further adaptations and resources."

Recent progress in Cornwall includes the adoption of the same version 12 of the Liverpool integrated care pathway for the dying patient (LCP) in primary care, secondary care and care homes. There is ongoing negotiation about the implementation of the GSF in Cornwall.

These approaches both originated from examples of best practice in the NHS. The LCP from the NHS Beacon Programme in 2001/2 [1] and the GSF at a similar time being taken up by the National Council for Palliative Care from 2003. They are both widely adopted. I'm looking forward to reading more about the evaluations they have undergone [2,3] and the particular challenges of evaluating this type of quality improvement [4]. Do they make a difference?[5]


1. Ellershaw J, Ward C. Care of the dying patient: the last hours or days of life. BMJ 2003 Jan;326(7379):30-34. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12511460

2. Costantini M, Ottonelli S, Canavacci L, Pellegrini F, Beccaro M. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial. BMC Health Serv Res 2011;11:13. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21261949

3. Duffy A, Payne S, Timmins F. The Liverpool Care Pathway: does it improve quality of dying? [corrected]. Br J Nurs 2011 Sep;20(15):942-946. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21841661

4. Pugh EJ, McEvoy M, Blenkinsopp J. Use of the proportion of patients dying on an End of Life Pathway as a quality marker: considerations for interpretation. Palliat Med 2010 Jul;24(5):544-547. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20501514

5. Kinley J, Froggatt K, Bennett MI. The effect of policy on end-of-life care practice within nursing care homes: A systematic review. Palliative Medicine 2012 Jan; Available from: http://www.ncbi.nlm.nih.gov/pubmed/22218097

Irrational thinking

Great talk at the Truro Grand Round today on irrational thinking, cognitive bias, and generally things psychological that affect medical decisions and the behaviour of healthcare professionals.

It included this classic video of selected attention. Basically it was introduced as follows - "There is a gender difference in detailed attention. Watch this video very carefully and count exactly how many times the white team pass a basketball to each other. They will move around a lot so count carefully and we'll see who does better - male doctors or female doctors."

About half of those in the room had excellent sensory attention and the other half, including me, did not notice one thing in particular.

Other topics covered were:
The Monty Hall problem
Thinking, Fast and Slow. Daniel Kahneman
The hidden Dalmatian dog illusion

Science, Business, Politics or naivety in telehealth / telecare

Would the telehealth / telecare community and the evaluation team of the Whole System Demonstrator Programme please get their act together? If you are sceptical then be scientific. If you are frustrated at the slow uptake of technologies then be political. Don't try to mix the two.

The UK Department of Health (DH) funded research on telehealth and telecare, the Whole System Demonstrator programme, had its 'headline findings' published in December 2011. A press release described it as

"The Whole System Demonstrator (WSD) programme is the largest randomised control trial of telehealth and telecare in the world, involving 6191 patients, 238 GP practices across three sites, Newham, Kent and Cornwall.  WSD was set up to look at cost effectiveness, clinical effectiveness, organisational issues, effect on carers and workforce issues.  It focused on three conditions, diabetes, COPD and coronary heart disease.  The programme will provide a clear evidence base to support important investment decisions and show how technology supports people to live independently, take control and be responsible for their own health and care."

On 19th January 2012 Paul Birstow, Minister for Care Services, announced a Concordat with industry "to enhance the lives of three million people over the next 5 years by accelerating the roll-out of telehealth and telecare in the NHS and social care".

The headline findings of the Whole System Demonstrator, described by DH as one of the most complex trials it has undertaken designed to answer the question "Does the use of technology as a remote intervention make a difference?" are impressive.

"The early indications show that if used correctly telehealth can deliver a 15% reduction in A&E visits, a 20% reduction in emergency admissions, a 14% reduction in elective admissions, a 14% reduction in bed days and an 8% reduction in tariff costs. More strikingly they also demonstrate a 45% reduction in mortality rates."

However, there are a number of questions about the study:

• 45% reduction in mortality rates! Really? So why is the data that has been hanging around for over a year not being scrutinised?
• How come the DH can publish the results of a large Randomised Controlled Trial without peer review, quoting Relative Risk Reductions, no drop-out rates, and no confidence intervals? (Prof Trish Greenhalgh).
• What incentives did the general practices have for putting the patients into the trial?
• Apparently the detailed research is undergoing 'peer-review' so I wonder what the final report will look like. Is it presumptuous to talk about 'watershed' moments and "There's been more pilots in this space than British Airways. What we need to do now is drive forward at scale." Are you going to look at the evidence or not?
• What is going to be presented in March 2012 at the Kings Fund meeting?
• The last data was collected in September 2010, the results were asked for at a Kings Fund meeting on telehealth in March 2011 where the design was presented along with recruitment demographics and research themes. Then, later in March, the trial design was submitted (and published in August 2011) with an endnote saying that "In practice it was found that the majority of patients were exposed to one technology alone, and therefore the simpler design was eventually adopted." When was that 'eventually'? Looks like post-hoc. It is common practice to submit trial designs before recruiting patients. The GP practices were clearly biased to the fact that they thought the telehealth / telecare would be beneficial and it shouldn't be withheld from some patients.
• Why is the Whole System Demonstrator variously described as a Randomised Controlled Trial, a field trial, a complex evaluation among other things?
• The rumour from the test sites was that about 10% of the benefit was perhaps from the technology. Presumably the rest was from the engagement with the health professionals. If it is not all about the technology why does it appear the thrust of the investment conclusion is towards equipment? Healthcare staff will require new competencies for remote and asynchronous healthcare if they are to provide that 90% benefit.

I have a prior belief that telehealth and telecare is effective. I suspect it would be useful for certain types of patients but it may not be beneficial for all. For some it may be harmful by leaving them remotely managed but requiring face-to-face care. I'd like to be able to answer accurately the patient who asks me "so this remote monitoring equipment is going to work for me is it?" or the Medical Director who asks "Hey you're a techie type aren't you? How much of our budget should be assigned to this telehealth / telecare stuff?" I'd like to answer those uncertainties with some data.

See also:
Storify of Twitter discussion and links about #WSD
Paper by Davies & Newman on evaluating telecare and telehealth interventions including a description of 'pragmatic RCT'

Stroke mimics

Case presentation and discussion of stroke mimics at the lunchtime meeting. Can't remember the exact details of the case but it was someone presenting with acute ischaemic stroke being considered from thrombolysis - the learning point was "but what about those conditions that may present as stroke but are not?"

There was a nice presentation about the different presentations and how they may be differentiated clinically.

This is an important issue. [1-3]

Found a good summary lecture online - Stroke Differential Diagnosis - Mimics and Chameleons.


1. Förster A, Griebe M, Wolf ME, Szabo K, Hennerici MG, Kern R. How to identify stroke mimics in patients eligible for intravenous thrombolysis?. Journal of Neurology 2012 Jan; Available from: http://www.ncbi.nlm.nih.gov/pubmed/22231865
2. Winkler DT, Fluri F, Fuhr P, Wetzel SG, Lyrer PA, Ruegg S, Engelter ST. Thrombolysis in stroke mimics: frequency, clinical characteristics, and outcome. Stroke 2009 Apr;40(4):1522-1525. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19164790
3. Artto V, Putaala J, Strbian D, Meretoja A, Piironen K, Liebkind R, Silvennoinen H, Atula S, Häppölä O. Stroke mimics and intravenous thrombolysis. Ann Emerg Med 2012 Jan;59(1):27-32. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22000770

LIFENOX study - TED stockings good enough for VTE prophylaxis in medical patients?

Good discussion at the lunchtime meeting today about the recent study, reported in the NEJM, on the use of low-molecular weight heparin vs. placebo in medically ill patients - the LIFENOX study.[1]

"The use of enoxaparin plus elastic stockings with graduated compression, as compared with elastic stockings with graduated compression alone, was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients."

All the patients (who were medical inpatients with CCF or severe infection with one risk factor for venous thromboembolism or had a diagnosis of cancer) had TED stockings and either enoxaparin or placebo. The authors wondered if the TED stockings did a good enough job of preventing VTE.

A Now@NEJM blog about the study provides a good overview and which points out:

"Although elastic stockings with graduated compression have been shown to be effective in reducing the risk of deep-vein thrombosis in moderate-risk surgical patients and other medical patient populations, the use of stockings  did not prevent the occurrence of deep-vein thrombosis in patients recuperating from severe, disabling stroke who  were participants in the Clots in Legs or Stocking after Stroke trial (CLOTS)."

Another interesting point about the study is that it involved sites less commonly seen in publications - China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia.

1. Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann J-F. Low-molecular-weight heparin and mortality in acutely ill medical patients. N. Engl. J. Med. 2011 Dec;365(26):2463-2472. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22204723

Time to retire the PDSA cycle?

We are told that the Deming (or Shewhart) cycle of Plan-Do-Study-Act, originally described in 1950 as a quality improvement tool, can help in the following ways:

"Using PDSA cycles enables you to test out changes before wholesale implementation and gives stakeholders the opportunity to see if the proposed change will work." NHS Institute of Innovation and Improvement

"The Plan-Do-Study-Act (PDSA) Worksheet is a useful tool for documenting a test of change." Institute for Healthcare Improvement

It is sold as a 'scientific method' dating back to Galileo and Francis Bacon.

I beg to differ.

I think it is not fit for its wider purpose promoted by its proponents as part of a culture of overall quality improvement in healthcare.

It is good at improving the issue that it is targetting but only when it is in isolation. Seeing healthcare as an industrial process that consists of conveyor belts of treatment pathways that are separate from each other is not how I see the world. This PDSA cycle is good for manufacturing where the process can be controlled and isolated but healthcare is more complex. There are uncertainties about which patients should be on which pathways. Patients have more than one condition or require more than one treatment and the simple view of a PDSA cycle (which is good at improving car manufacture) is too simple for the real world of clinical medicine. Yes it can be used as a strategy for a single focussed task in medicine but it is not fit for using more widely as it is too dumb a tool for the job. In short it is a good 'in vitro' tool but not so good an 'in vivo' tool.

Also, the PDSA cycle may have unintended consequences. If, for example, on an emergency medicine unit we use PDSA cycles to improve our quality of care for community-acquired pneumonia patients this may have the unintended consequence of reducing quality (by de-prioritising) in other conditions such as acute stroke or anything that does not have its own PDSA cycle.

Is it time to recognise PDSA cycles for what they are; useful tools for focussed tasks but too simple an intervention to be used widely in medicine where it may do more harm than good?

Bisphosphonates improve joint replacements - retrospective GPRD cohort

A retrospective cohort study on joint replacements using the UK's General Practice Research Database (GPRD) is published in the BMJ.[1]

Researchers from Oxford looked at the records of almost 42,000 patients who had a knee or hip replacement and found that 1912 of them had bisphosphonates. They concluded,

"In patients undergoing lower limb arthroplasty, bisphosphonate use was associated with an almost twofold increase in implant survival time. These findings require replication and testing in experimental studies for confirmation."

It is important to remember that this is a non-randomised study and is observational in nature. Controversy exists on how this type of data should be used and, as the researchers suggest, it requires experimental study.

With the recent news of the potential release of routine NHS data these types of observations will become more frequent. Should we act on them in the interests of improving quality or consider them hypotheses that require testing?

1. Prieto-Alhambra D, Javaid MK, Judge A, Murray D, Carr A, Cooper C, Arden NK. Association between bisphosphonate use and implant survival after primary total arthroplasty of the knee or hip: population based retrospective cohort study. BMJ 2011 Dec;343(dec06 1):d7222-d7222. Available from: http://www.bmj.com/content/343/bmj.d7222