| 4. 3. From the evidence to the final recommendation | |
| 4.3.1. QUALITY OF THE EVIDENCE | |
| HIGH quality | Evidence of the effects of treatment with hypothermia in newborns with HIE evaluated at 18-24 months comes from well-designed studies, with high quality |
| MODERATE quality | There are fewer data on the effects of long-term effects (6-7 years) of hypothermia treatment. |
| 4.3.2. RISKS AND BENEFITS | |
| Adverse effects of treatment with hypothermia were analyzed in the MA by Shah 2010 which included safety results available from 13 RCTs (…) This high quality MA only found differences between patients treated with hypothermia compared to control in: -Arritmias (5 studies / 806 patients): RAR 4% (1-6%), RR 4.08 (1.55 to 10.74), NNH 25 (16-100). -Thrombocytopenia (4 studies / 638 patients): RAR 10% (3-18%), RR 1.28 (1.07 to 1.52), NNH 10 (5-33). Most arrhythmias consisted of sinus bradycardia, (…) | |
| 4.3.3. COSTS | |
| 4 authors evaluated costs of hypothermia treatment for neonatal HIE (…) The study by Regier 2010 presents data obtained from 3 large hypothermia RCT (…) Hypothermia implies a cost increase € 5,155 (95% CI 3398-16694) (…) the rate of incremental cost-effectiveness by AVGLD is € 26,290. | |
| 4.3.4 PATIENTS´VIEWS | |
| There are no published studies specifically evaluating the values and preferences of parents of newwborns treated with hypothermia (…) Based on the qualitative studive performed by the CPG group (…) parents, of newborn with HIE (…) verbalize their need for more information on causes. "Personally I need to know the cause of things and why" "What I never had clear is what this disease is." "You want to know more" (…) | |