Guidelines: the difficult application between clinics, science, law, economic and organizational sustainability
Parole chiave: Linee guida; Ipertensione arteriosa; Dislipidemia; Diabete mellito; Società Europea di Cardiologia.
Introduction. The guidelines are recommendations with different levels of evidence developed by experts identified by the Regulatory Authorities and by the Scientific Societies to allow the best standards of diagnostic and therapeutic intervention currently available. They became compliant with jurisprudential law in Italy with Law 24/2017, even if the ministerial recommendations provided for are still lacking today.
Purpose. The aim of the study is the evaluation in the current cardiological outpatient practice of adherence to the guidelines of the European Society of Cardiology regarding the 3 main cardiovascular risk factors: those on hypertension published in 2018, on dyslipidemia and diabetes mellitus published in 2019. We evaluated the clinical, administrative and organizational critical issues that make their application difficult.
Methods and results. Target blood pressure values recommended by the guidelines in patients with chronic hypertensive coronary syndrome involve decision-making challenges, especially regarding the persistence of elevated systolic pressure with diastolic < 70 mmHg, considered dangerous by the guidelines, systolic values <130 mmHg in people of age <65 years, or <120 mmHgin older patients. Also in these patients, with dyslipidemia, the current legislation does not provide for the reimbursement of PCSK9 when LDL levels are higher than the indicated target of 55 mg/dl but lower than 100 mg/dl. In diabetic patients at very high risk is not foreseen by the cardiologist the possibility of prescribing hypoglycemic drugs belonging to the SGLT2-I and GLP1-AR categories despite these drugs are recommended in class I A. For the organizational difficulties encountered, the prescription is limited to 15-20 % of patients at very high cardiovascular risk.
Conclusions. The guidelines represent recommendations for the best available therapy from mainstream medicine. They help the physician to make the most appropriate therapeutic decision to the state of the art. Clinical, administrative and organizational issues make challenging the adequate diagnostic-therapeutic and assistance pathways necessary for their application; the treatment of the 3 main cardiovascular risk factors such as hypertension, dyslipidemia and diabetes may therefore not be optimal. Therapeutic inertia resulting from bureaucratic fatigue could expose the doctor to medico-legal problems attributable more to system mechanisms than to his professional competence.
Key words: Guidelines; Hypertension; Dyslipidemia; Diabetes mellitus; European Society of Cardiology.