SIDS group of 35 cases was small but sufficient to yield moderate effects with a power of 0.8 for general tests.
Investigators also assessed the patients' symptoms using a four-graded scale: 0 = none: no symptoms; 1 = mild: awareness of sign or symptom, but easily tolerated; 2 = moderate: discomfort sufficient to cause interference with normal activities; 3 = severe: incapacitating with inability to perform normal activities.
Investigators also assessed the severity of patients' dyspepsia symptoms by asking the patients and then recording the answer using a four-point graded scale (0 = none: no symptoms; 1 = mild: awareness of sign or symptom, but easily tolerated; 2 = moderate: discomfort sufficient to cause interference with normal activities; 3 = severe: incapacitating with inability to perform normal activities).
AEs intensity was determined by subjective evaluation of the patient and classified as mild (signs or symptoms easily tolerated), moderate (discomfort sufficient to cause interference with normal activities) and severe (incapacitating with inability to do work or undertake normal activity).
AEs severity was determined by subjective evaluation of the patient and classified as mild (signs or symptoms easily tolerated), moderate (discomfort sufficient to cause interference with normal activities), and severe (incapacitating with inability to do work or undertake normal activity).
We hypothesized that a moderate and sufficient increase of ROS during early reperfusion is required to activate effectively the downstream protective signaling pathways, whereas the endogenous ROS generated during early reperfusion does not reach the threshold for efficient cardioprotection.
As primary outcome parameter patient satisfaction was assessed by verbal rating scale: poor (5), moderate (4), sufficient (3), good (2) and excellent (1) both at 2 and 4 weeks after start of the study treatment.
The modelling had included only severe hypoglycaemia, and the point was made that moderate hypoglycaemia, sufficient to interrupt activities of daily living, might, because of greater frequency, have more cumulative effect on QoL than severe hypoglycaemia.
The semi-structured interviews revealed 2 very different groups depending on how the patients and their families experienced the first postoperative year after SEMLS. 2 patients had an uneventful postoperative year with little or moderate pain, sufficient rehabilitation, and an overall satisfactory experience of SEMLS.
