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Medical professionals receive the unique privilege from society to transgress the physical and mental integrity of the patient, conditional on proof of benefit. This was originally an issue for surgeons (the surgical professions), but over time most medical domains have become interventional with catheters or with powerful drugs, and these interventions seriously disturb several physiological systems, leading to morbidity and mortality. Patients undergoing these procedures often navigate in the darkness of uncertainty, most certainly when this damage to their physical and mental integrity is associated with risk. It is, therefore, the duty of society to evaluate this unique privilege for all doctors. This can be done through the evaluation of the operational systems, the application of international therapeutic guidelines or by the evaluation of the outcomes. This manuscript focuses on the outcome analysis. There are many challenges in the evaluation of medical interventions, and adult cardiac surgery provides us with a few interesting but difficult examples of these challenges, as outlined in this editorial. We will address the dilemma of ‘time zero’ and ‘time end’ ,t he conceptual challenges in proving risk and benefit, data and model considerations including the uncertainty of any scientifi co bservation and the ‘fata morgana’ of seeking one model that fits all. THE OBSERVATION INTERVAL: TIME ZERO AND TIME END The mission of the interventional cardiologist or of the interventional cardiac surgeon is not simply to bypass a few arteries or to replace/ repair a valve. Our mission is not organ-specific. Our mission is holistic: to improve the patient’s quality and quantity of life. The correct evaluation of quality should be the optimal balance between early risk and late result; ‘late’ should be defined differently for each pathology since every pathology, treated with interventions, has a different time impact on the quality and quantity of life of the patient. Risk is a possible surrogate for quality but with considerable limitations. In life, we sometimes accept larger costs (risks) for larger benefits (quality), and there may be a danger in avoiding early risks associated with a particular treatment, when in the long-term this treatment is associated with greater benefits compared with a treatment with a low early risk. It is optimal if risk is absent, but some would dare to state that there is no direct correlation between risk and quality. A single sternotomy would certainly carry less risk vs multiple valve repairs and extensive coronary reconstructions; this lesser risk is in most patients no surrogate for better quality of care. Society must understand that the longer the period of observation, the greater will be the correlation between quality and benefit as distinct from the risk of the intervention. If society intends to focus on risk with all its limitations, then again we must clearly define this interval with a complete understanding of the clinical practice and the principles of outcome analysis. In the past ‘time zero’ was often ill defined. Possibilities were: the date of the intervention, the moment the patient entered the interventional area, the start of anaesthesia or maybe the start of the actual intervention. In the past, ‘time end’ of the interval was most frequently the date of discharge from the primary hospital or the closure of the first 30 days after ‘time zero’.

Scientia vincere tenebras! Science should help us see in the darkness