Is impractical clinical guidance putting doctors and patients at risk?
Dr Dermot Ryan argues guideline-directed care causes harm while Dr Adam Firth argues guidance helps GPs better inform their patients
Clinical guidelines, designed to help GPs give patients the best care possible, are impractical and even dangerous. How can I argue this?
First, they are constructed by methodologists, with limited clinical input. Grade A evidence used to construct NICE guidelines comes from randomised controlled trials or meta-analyses of these. Most RCTs ask one specific question and patients are selected to control for as many variables as possible. This excludes more than 90% of the population from any given trial. Meta-analysis is a process whereby data from similar trials are combined using sophisticated statistical methods to give a composite estimate of benefit or harm.
So the body of evidence used is derived from a small portion of the population, subject to statistical manipulation, which is used to produce a recommendation for the whole population, including those excluded from the trial.
Thus construction of guidelines and the recommendations derived from them are, at best, imperfect.
Second, the problem of the imperfect guideline is compounded by the fact they are created for single conditions, somewhat at variance with reality, where many patients have two or more comorbidities¹. The treatment for one condition may conflict with that for others. Comorbidity is complicated by other variables, such as age, ethnicity, general health, social status, nutrition and education, to name but a few. All have an impact on any intervention.²
A good clinician recognises the strengths and limitations of guidelines and uses clinical skills to meet the needs of the individual patient, taking into account these and other variables. This is personalised medicine. But the third and critical challenge is the interpretation of guidelines by politicians and managers who do not recognise clinical reasoning or the art of medicine, but use guidelines to direct care, even when they are plainly wrong. For example, NHS Health Checks have been justified by references to guidelines3 that simply do not stack up4.
Our role must be to put the patient at the centre of what we do, using guidelines to inform the care we propose to them and involving them in decision-making. This is guideline-informed, evidence-based medicine. Guideline-directed care, however, is little more than a blunderbuss approach, causing harm.
Dr Dermot Ryan is a retired GP, an honorary clinical research fellow at the University of Edinburgh and a former NICE adviser
Without clinical guidance patients would be at risk, because, as individual GPs, we do not have the time and skills required to access and appraise the primary research in order to remain up to date.
So, although I have on occasion felt disappointed that a guideline appears to reduce my treatment options, I am grateful for the fact that a rigorous process has been employed to assess the evidence so I can have an informed discussion about the courses of action I suggest. Sharing clinical uncertainty with patients is never easy but without high-quality evidence syntheses, I’m not sure I’d know where to begin.
I have heard concerns about conflicts of interest among guideline committee members, risk of litigation for doctors unable to implement recommendations where tests are unavailable, and a view that NICE does not want GPs involved in its work.
I do not share these concerns. I feel the risk of litigation should be minimal if decisions stem from commissioners’ failure to provide GP access to a recommended test, or if the Bolam principle is applied: that doctors can deviate from guidance if they are acting in accordance with a ‘responsible body of reasonable medical opinion’5.
But the difficulty in applying study evidence from trial populations frequently drawn from hospital settings to our multimorbid, autonomous patients is significant. At Pulse Live in 2014, NICE chair Professor David Haslam emphasised that NICE produces ‘guidelines not tramlines’; a concept echoed in the presentations delivered by NICE in its introductory material for guideline committees to define the remit of the work6.
The statement that ‘NICE guidelines are intended to inform and not replace clinical judgement’ is prominently placed in all the institute’s clinical guidelines, emphasising the fact that GPs are able to use these in a way that is practical for them.
Finally, if my experiences of working on two NICE guideline committees is the norm, then I am confident that GPs are valued alongside all committee members and also that potential conflicts of interest are considered and managed appropriately.
Dr Adam Firth is a GP in Stockport. He is a member on the NICE End of life care guideline committee and was on the committee for the 2015 Care of dying adults in the last days of life guideline.
1. Barnett K, Mercer SW, Norbury M, et al. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet 2012;380:37-43
2. Boyd CM, Leff B, Wolff JL, et al. Informing clinical practice guideline development and implementation: prevalence of coexisting conditions among adults with coronary heart disease. J Am Geriatr Soc 2011;59:797-805.
3. National Institute for Health and Clinical Excellence (NICE). Prevention of cardiovascular disease at a population level. London: NICE; 2010.
4. General health checks don’t work. BMJ 2014;348
5. Can you ignore guidelines? BMJ Careers.
6. NICE to move to multimorbidity guidance, chief says. Pulse.