A National Clinical Strategy for Scotland

5. The Need For "Realistic" Medicine

There is a need to improve the basis of clinical decision making to ensure that there is a clearer focus on the provision of healthcare of greatest value to the individual in a way that has the least potential to harm, and is most in line with the patient's wishes.

There is evidence of a growing cultural shift among clinicians, many of whom feel uneasy at times regarding the level of tests, interventions and medications that are provided for patients. While a considerable amount of modern medicine is based on evidence from clinical trials and research, this evidence is often subject to amendment in the light of further research, or the evidence may be relied on beyond the context of the evidence. For example many medications prescribed for elderly patients with multiple illnesses are often prescribed on the basis of trials in much younger patients with single illnesses. The benefits may exist for older patients, but there are increased risks to them from drug-drug interactions and increased likelihood of side-effects.

The potential over-use of medicines is a cause of concern. Figures recently released by Healthcare Improvement Scotland suggest that around 20% of the population is taking five or more prescribed medicines on a regular basis. Many elderly patients may be taking considerably more than that, and it is not uncommon for patients being admitted to hospital to be on over ten different medications. The volume of medications prescribed has been increasing steadily every year by up to 6%. This has been driven by disease-specific guidelines - some of which are based on evidence from clinical trials, and some of which are based on expert opinion. There is also concern that there is an excessive emphasis on a bio-medical model in developing guidelines - in other words concerns when treatment is aimed at, and measured by, physiological or biochemical targets, which may or may not have direct relevance to outcomes that people value.

The increased use of medicines has also been driven by a shift to treating risk, as opposed to treating illness. It can be seen that this has advantages for the manufacturers of medicines as a far greater proportion of the population will potentially be at risk from an illness than actually suffering from it. The treatment of risk is strongly promoted by medicine manufacturers, by expert opinion and evidence-based guidelines. The strength of the rationale for treating a particular risk with a particular treatment can be assessed by measuring the "NNT" - the "number needed to treat". This measure indicates how many patients will need to be treated for one year to prevent a certain outcome. In many cases this may be hundreds of patients: unfortunately this means that hundreds of people may take a medicine and derive no benefit - and indeed may experience side-effects from the medication.

There is sometimes poor information provided on the benefits of medicines. For example a medicine may be described as reducing the risk of a specified event by 25%. This is often understood to be suggesting that one in four patients will avoid the specified event. But if the absolute risk of the specified event is only one in 25 without treatment, then the absolute reduction in risk is only from 5% to 4% - a 1% reduction in absolute risk. Poor communication of risk and benefits may result in doctors and patients using medicines that they might otherwise have chosen not to use.

Many doctors confirm that they are prompted to provide more treatment rather than less by a range of pressures including clinical guidelines, fear of litigation, peer pressure and patient expectation. The Quality and Outcomes Framework of the GP contract (being removed in April 2016) acted as a strong prompt for doctors to provide treatment based on evidence and guidelines arguably without always the same degree of consideration to patient context. For example whilst there may have frequently been evidence of possible benefit, that evidence was often based on the evidence from single disease trials and therefore not as readily applicable to patients with multi-morbidity (most patients with Long-term Conditions have at least one condition).

We must ensure that non-medical interventions are tried first (or concurrently) much more frequently in a wide range of conditions - there is significant evidence that shows benefit to overall wellbeing from this approach. This concern is not about the financial consequences of wide-spread medication use - it is concern about the adverse impacts of medication use. Estimates vary widely, but studies suggest that between 5% and 16% of admissions to hospital are related to medication use.

It is recognised that many of the long-term conditions are related to life style factors such as obesity, lack of exercise, smoking, excessive alcohol intake and poor diet. Recent evidence suggests that clinicians may be too ready to move to medication rather than helping individuals make serious progress in lifestyle change. Promoting lifestyle change is difficult, and all too often unsuccessful, but studies in type 2 diabetes have shown that significant changes in diet and exercise, leading to weight loss can return the underlying biochemistry to near normal - in effect delaying the onset of diabetes and its associated morbidity by some years.

The Royal College of Surgeons have recently urged surgeons to promote increased exercise in patients prior to any elective surgery. Not only does this reduce mortality associated with surgery, it also reduces overall recovery time after surgery, and may, on occasions obviate the need for surgery - such as hip replacement or pelvic floor repair - completely.

We need to develop a medical culture that seeks to use the least invasive or the least interventional approach as a first step. This may reduce the potential for harm to patients, and may also bring significant other benefits, including mental health benefits. It is difficult, and clinicians will describe their frustration at not seeing more patients succeed in lifestyle changes. However there is a risk that if we discount less interventional approaches (such as physiotherapy, diet and lifestyle modification) as being unlikely to be of benefit, then we recommend them less routinely to patients, and thus potentially deprive them of effective and safe solutions.

More subtly, by advocating for a more interventional approach clinicians may be removing from the individual responsibility for managing their own health. By favouring intervention, the impact of patient resilience is undermined and, at a transactional level, responsibility for improvement is handed over to the clinician from the patient. A longer-term approach which encourages self-management where possible, and the building of resilience and capability within patients, may have less potential to cause harm, and may have wider benefits to their health and wellbeing.

This is not to argue that doctors should not provide interventions and treatment - there are many instances where treatment produces dramatic, life-altering results - but we require to ensure that the balance between active involvement of patients in their own recovery, and the provision of clinician directed care is carefully calibrated.

These concerns, and others, have led to a number of initiatives. The British Medical Journal has for the last two years produced a series of articles on "Too Much Medicine" a campaign aiming to "Highlight the threat to human health from over-diagnosis and the waste of resources on un-necessary care". The Journal of the American Medical Association has run, over a similar period, a series of articles under the heading of "Less is More", arguing that in numerous situations, less intervention or prescribing can result in better outcomes. Last year the Welsh Government launched the concept of "Prudent Healthcare" aiming to make better use of resources and get better outcomes by providing "Healthcare that fits the needs and circumstances of the patient, and avoids wasteful or harmful care". The Prudent Healthcare movement in Wales is driven not by a desire to save on resources, but driven by a desire to engage in co-production (mutually agreeing treatment plans and objectives) with patients, ensuring that they are fully informed on the benefits and dis-benefits of any treatment or intervention, and supporting them to make choices according to their individual preferences. All of the evidence shows that this results in greater satisfaction with outcomes - and that as a consequence of the approach, patients usually prefer less treatment rather than more.

In November 2014 the Academy of Royal Colleges published "Protecting Resources, Promoting Value: a doctor's guide to cutting waste in clinical care". It reminds doctors of their obligation to use resources effectively, and indicates that significant waste is caused by poor quality or unwanted care resulting in high cost and poor outcomes. Subsequently, the Academy has launched this year its "Choosing wisely" campaign, following similar initiatives in the United States. In the briefing regarding the initiative, it is noted:

"The Academy believes:

• There is evidence of a considerable volume of inappropriate clinical interventions
• The reasons for this are complex and various but form part of a culture of over-medicalisation
• The result is sub-optimal care for patients which, at best, adds little or no value and, at worst, may cause harm
• This is, therefore an issue for clinicians about the quality and appropriateness of care"

An output from the Choosing Wisely campaign is a list of tests or procedures, from each speciality, that should not be carried out on the grounds of minimal benefit or potential for harm.

In 2012, the King's Fund published a paper called "Patients' Preferences Matter" in which they demonstrated a wealth of evidence that doctors misjudged what a patient would most want if fully informed, and also showed that the rates of prescribing testing and surgical interventions were significantly affected by "Supply led demand". The paper made a number of observations:

• Patients make different decisions when well informed.
• People often lack full understanding of the prognosis of their illness (or the risk of developing a specified harmful event). They may make different decisions if they are fully informed about their condition, and the treatment options available. Often they will choose less treatment rather than more. While this is seen most markedly when discussing treatment options for cancers, or advanced stages of long-term conditions, it is also seen before elective surgery or starting long-term medication.
• It is of concern that generally doctors chose less treatment for themselves than they recommend for their patients.
• There are significant variations in care across geographic regions, which are not explained by patient needs or preferences.
• Evidence across all countries shows that there are significant variations in the use of diagnostic tests, the rate of operations, the rate of initiation of medications etc. The variation is considerably in excess of the natural variation that would be expected in patient's choices, and in excess of variation in measureable patient need. Evidence suggests that the variation is invariably clinician driven, suggesting that there is both wasteful over-use of some interventions but also some possible underuse of potentially beneficial interventions.
• Variation that is unwarranted is potentially harmful (because the patient may not need it and will not benefit from it), and wasteful. We must improve data collection so that variation can be measured accurately, and embrace a new culture where individual clinicians can expect to be asked to justify their clinical behaviour in the event of significant variation. This approach has been helpful in addressing some of the variation seen between practices in referral and admission rates. It should be recognised that there will always be some variation, and change is slow, but can significantly improve overall quality (and may identify un-met need).

Benefits of co-production (equal participation in deciding on treatment options between clinician and patient) can include meeting patient preferences, improvement of patient specific outcomes, personalised treatment, overall quality improvement, more effective patient pathways, reduced pressure on care services and better value for money. The ability for clinicians and patients to make informed decisions together is however greatly influenced by the availability of information, and so decision aids for patients should be further developed - an essential part of the current "Patient Centred Care" approach seen above.

Considerable work has been done to improve end of life care. Doctors may feel difficulty in communicating poor prognoses, and may feel emotionally pressurised into providing treatments that may not significantly prolong life. Often treatment at this stage is intensive, carries significant side-effects, and may, at worse, result in a death that is preceded by a prolonged period of discomfort or distress due to the treatment. While it may be appropriate for a patient to prefer such treatment in the hope of extending life, it is not always the case, and professionals have to spend time in giving honest assessments of prognosis and potential benefit. Many patients will choose to forego the discomfort of treatment now for potential limited benefit in the future. Time taken to communicate effectively and honestly, with outlines of prognosis including descriptions of uncertainty, can ensure that people are able to make informed and supported choices that match their individual values. This must become the default position for engaged person-centred care. While many clinicians appreciate the need to have emotionally challenging conversations regarding patient aspirations and what matters to them, this is not universal. This may be a consequence of consultation slots that are too short, and care must be taken to support clinicians who need to discuss very difficult options.

The NHS collects a huge array of information and this valuable resource can be put to use by creating the concept of a learning care system in which decision making is supported by outcomes of previous decisions as well as research and analysis. We are already developing a national roadmap for Clinical Decision Support and NHS Information Strategy, the implementation of which will be crucial for ensuring clinical care decisions are optimised. As part of the move towards more extensive co-production and patient empowerment, there will be an increasing need to integrate professional care information with data recorded by the patient. The long-term vision is for an electronic patient record which can be viewed and added to by both the health and care services and the patient, allowing a joined up approach to self-management and professional care. The content requirements could usefully include patient reported outcomes and selected self-monitoring data in addition to the professional data requirements.

Over-treatment, wasteful treatment and variation is a broad subject, and an important one. It is important that it is addressed in Scotland so that we can be more confident that the use of resources is targeted to producing outcomes that matter to patients. It is proposed that a significant resource should be put towards a national collaborative movement, similar to the Prudent Healthcare programme in Wales, set up to understand the scope of the issues, and to influence both clinician and patient behaviour so that wasteful and ineffective care is significantly reduced.

Summary

We have had successful initiatives in Scotland that have developed improvement in safety and person centred care. We need to invest more time in promoting clinical effectiveness - understanding that this effectiveness must be measured in relation to individuals and their contexts.

The issues described above highlight the need to have a national movement that seeks to understand these complex issues, to build clinical consensus, to provide tools for leading change (such as information sources and risk communication resources) so that we can ensure that care is an appropriate personalised synthesis between clinical advice and patient choice.

Where a lesser intervention is possible, this should be selected first in most cases. It may be provided more appropriately outside traditional health delivery models - for example in Edinburgh the development of a COPD Choir allows patients to have an enjoyable activity that provides pulmonary rehabilitation and social integration - as well as community benefit.

The importance and potential of self-management needs to be better understood. It is more than simple disease management; it is the motivation of patients to change lifestyles, preserve responsibility for, and control of, their illness, and move from being a dependent recipient of medical care to a more independent and selective consumer of healthcare, utilising, where possible, their own resources. This is particularly true with long-term illnesses. Failure to address these important issues poses a potential risk of avoidable harm to individuals and wasteful use of resources.