Presentation on theme: "Paolo Marchettini SUPSI, Manno Lugano Ospedale San Raffaele, Milano Le linee guida per il dolore neuropatico vanno seguite? No."— Presentation transcript:
Paolo Marchettini SUPSI, Manno Lugano Ospedale San Raffaele, Milano Le linee guida per il dolore neuropatico vanno seguite? No
Clinical governance is a systematic approach to maintaining and improving the quality of patient care within a health system. Clinical governance became important in health care after the Bristol heart scandal in 1995, during which anaesthetist Dr Stephen Bolsin exposed the high mortality rate for paediatric cardiac surgery at the Bristol Royal Infirmary. It was originally elaborated within the United Kingdom National Health Service (NHS), and its most widely cited formal definition describes it as: Bristol heart scandal Stephen BolsinUnited KingdomNational Health Service A framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish. This definition is intended to embody three key attributes: recognisably high standards of care, transparent responsibility and accountability for those standards, and a constant dynamic of improvement. G. Scally and L. J. Donaldson, Clinical governance and the drive for quality improvement in the new NHS in England BMJ (4 July 1998): 61-65
Clinical effectiveness: An approach to clinical trial design more relevant to clinical practice, acknowledging the importance of individual differences R.A. Moorea, S. Derrya,H.J. McQuaya, S. Straubeb, D. Aldingtona, P. Wiffenc, R.F. Belld, E. Kalsoe, M.C. Rowbotham,for the ACTINPAIN writing group of the IASP Special Interest Group (SIG) on Systematic Reviews in Pain Relief Schwartz and Lellouch distinguished between explanatory trials (examining whether an intervention works) and pragmatic trials (how best to use it in clinical practice). Clinical trials of new medicines are undertaken to satisfy the regulatory requirements that drugs be efficacious and safe on average. Regulatory trials are necessary, but not sufficient to answer many questions of practical importance. Are antidepressants better than anticonvulsants in neuropathic pain, and which antidepressant or anticonvulsant is best? Does failure to respond to one drug preclude response to another drug, both within and across classes? We do not yet know how to predict efficacy in individual patients. To guide treatment choice and care pathway development, determining what sequence of interventions produces worthwhile benefit in the largest number in the shortest time involves a different approach to clinically relevant outcomes. Systematic reviews of regulatory trials often pool average data. In acute and chronic pain, however, underlying distributions are commonly not normal, tending to be U-shaped rather than bell-shaped, where the average describes few individuals. Computations using such data can give the wrong answer. Dichotomised responder analyses using a definition of good response may be better in circumstances like these, and can be used to calculate the numbers needed to treat and create league tables of efficacy and useful treatment algorithms. However, guidelines and algorithms are rarely tested to see how well they perform in practice.
Managers and trialists may be happy for treatments to work on average; patients expect their doctors to do better than that. In clinical practice, if one treatment did not work for a particular patient, another remedy was sought until a satisfactory outcome was reached.
Fewer than half with neuropathic pain achieve adequate pain relief with any one therapy. A third of chronic pain patients discontinue opioids in the short term, and up to half with musculoskeletal pain discontinue NSAIDs in longer-term trials. Codeine has no analgesic effect in those unable to metabolise it to morphine, works well in those who can, while supermetabolisers pose problems. In migraine, only 24% achieved rapid and prolonged pain relief without adverse events in one recent series of studies of triptan therapy. Anti-TNF therapy gives substantial levels of benefit to only 40% of patients with rheumatoid arthritis. For fibromyalgia and non-specific low back pain it is recognised that oral medication treatments work in only a small proportion of patients
Fig. 1 Practical consequences of different individual experiences of benefit and harm. R.A. Moore, S. Derry, H.J. McQuay, S. Straube, D. Aldington, P. Wiffen, R.F. Bell, E. Kalso, M.C. Rowbo... Clinical effectiveness: An approach to clinical trial design more relevant to clinical practice, acknowledging the importance of individual differences PAIN Volume 149, Issue
In a simple example, if drug A has a greater analgesic effect but more adverse event discontinuations than drug B, then drug B is likely to be more clinically effective, because it generates pain relief for more people for longer. Costs being equal, drug B would be a sensible initial choice. Measurement of useful longer-term outcomes would strengthen this conclusion and inform health economic assessment. An example of a clinical effectiveness study design might be used to underpin care pathway development in chronic or recurrent painful conditions by testing several drug/dose/titration options chosen from randomised trial and meta-analytic evidence and experience, especially when titration resulted in wide variations in final effective dose and time to achieve it. Patients with insufficient benefit or unacceptable adverse events proceed to another drug or treatment, by physician choice, re-randomisation, or according to a preset schedule, as appropriate. The primary outcome is the proportion achieving a defined level of pain relief with tolerable adverse events, measured for each individual drug and overall for different treatment sequences (A > B > C > D vs C > A > D > B, for instance).
Fig. 2 One possible clinical trial design for chronic or recurrent painful conditions. In this example, failures with drug A would move to drugs B, C, or D after re-randomisation or physician choice; similar actions would apply to any other first... R.A. Moore, S. Derry, H.J. McQuay, S. Straube, D. Aldington, P. Wiffen, R.F. Bell, E. Kalso, M.C. Rowbo... Clinical effectiveness: An approach to clinical trial design more relevant to clinical practice, acknowledging the importance of individual differences PAIN Volume 149, Issue
Dolore neuropatico A. Duloxetina B. Pregabalina C. Duloxetina + Pregabalina D. Duloxetina + Pregabalina + Ossicodone E se non funziona chiamate un medico Prof g. Cruccu, Vienna,
On peut avoir de lincertitude, une vision négative : tâche aveugle, handicap, boulet traîné par une médecine réduite à sa dimension scientifique. On peut aussi la voir, dans le cadre dune clinique où lhumain pondère la science, dune manière positive : lopportunité de transformer lincertitude du diagnostic, du traitement et du pronostic en un espace pour ajuster et optimiser linformation du malade conçue comme une parole qui soigne. Cest cette seconde option qui est développée dans lexposé écrit à partir dune conférence donnée à loccasion dun premier colloque sur « la clinique de lincertitude » organisé à Paris le 24 mars 2011 (Morel) Sullincertezza in Clinica
la clinica è incerta La scienza è necessaria, ma insufficiente al clinico È necessario integrare lincertezza nella scelta terapeutica e riconoscere Lincertezza paralizzante Lincertezza occulta Come creare le condizioni per una valida decisione clinica in situazioni di incertezza Bilanciare lincertezza con certezze negative Definire i punti di incertezza per meglio contenerli Superare lincertezza proiettandosi in una visione futura
Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. This emphasis on the individual recognises that some patients will have the ideal outcome of benefit without adverse events, but others will have either no benefit, or adverse events that are intolerable, making continuation impossible even if they do have benefit