PROGNOSIS Cohort studies Cohort studies Useful for z Assessing prognosis, natural history of disease z Assessing risk factors z Testing aetiological hypotheses Distressed 3100g male newborn z At delivery z z z z z Limp, cyanotic, no spontaneous respiratory effort, heart rate 50 beats/min. Suction - no grimace, cough or sneeze Vigorous resuscitation At 1 minute: Apgar score = 1 At 5 minutes: Apgar score = 2, 110 beats/min. z At 10 minutes: Apgar score = 3 Score The values for each of the five categories are added to yield a result from 0 to 10 Sign 0 1 2 Heart rate (beats/min) Absent <100 ≥100 Respiration Absent Slow, irregular Regular, crying Muscle tone Limp Slow flexion Active motor Blue, pale Body pink, extremities blue Completely pink None Grimace Cough, sneeze Colour Reflex response to catheter in nostril APGAR SCORE FOR EVALUATION OF NEONATAL ASPHYXIA Adapted from Apgar V, James LS. Am J Dis Child 1962; 104:419 Distressed 3100g male newborn z At delivery z z z z z Limp, cyanotic, no spontaneous respiratory effort, heart rate 50 beats/min. Suction - no grimace, cough or sneeze Vigorous resuscitation At 1 minute: Apgar score = 1 At 5 minutes: Apgar score = 2, 110 beats/min. z At 10 minutes: Apgar score = 3 z PROGNOSIS?? Objectives z Cohort study z z z describe structure and analysis interpret and calculate relative and absolute measures of effect identify potential for bias RCT / Cohort DISEASE EXPOSED GROUP (eg treatment) NO DISEASE DISEASE NON EXPOSED GROUP (eg no treatment) NO DISEASE START Apgar scores as predictors of chronic neurologic disabilities z Nelson KB, Ellenberg JH, Pediatrics, 1981; 68:36 z 49000 infants followed for 7 years. z z Apgar scores recorded at 1 and 5 minutes (and for infants with AS<8 at 10, 15 & 20 minutes) Histories recorded at 4, 12, 18 months and then yearly to age 7 Dead 'Exposed' Total 42 Not dead 80 43 302 345 85 382 467 122 (Apgar score 0 - 3) 'Not exposed' (Apgar score 4 - 6) Total Relationship between 10-minute Apgar scores and risk of death in the 1st year of life among children with birth weight of at least 2500g Risk in ‘exposed’ = Risk in ‘less’ exposed = Relative risk = Risk difference = Attributable risk % = RD/ R(exp) = ? ? ? ? ? Dead 'Exposed' Total 42 Not dead 80 43 302 345 85 382 467 122 (Apgar score 0 - 3) 'Not exposed' (Apgar score 4 - 6) Total Relationship between 10-minute Apgar scores and risk of death in the 1st year of life among children with birth weight of at least 2500g Risk in exposed = 42 / 122 = 0.344 = 34.4% Risk in less exposed = 43 / 345 = 0.125 = 12.5% Relative risk = 0.344 / 0.125 = 2.8 Risk difference = 34.4 - 12.5 = 21.9% Attributable risk % = RD / R(exp) = 0.219 / 0.344 = 64% Bad outcome eg death, h'capped infant If exposure good/protective If exposure harmful (folate supplements, high AS (foetal distress, smoking) <1 1 >1 Relative risk If exposure harmful If exposure good Good outcome eg cure, 'normal' infant z z 55% of cerebral palsy (CP children had 1 minute scores >= 7 99 survivors with scores 0 - 3 (at 10, 15 or 20 minutes, all birth weights) z z 80% free of major handicap 12 had CP 11 mentally retarded, 1 normal z 10 had had seizures on day of birth z z 1 in 8 asphyxiated neonates have CP and developmental delays z << 1in 8 of those without seizures What is key difference between RCT and cohort study? z RCT z z Random allocation of intervention/exposure by investigator Cohort z Self selection of exposure/risk factor
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