Scientific Clinical Decision-making Rounds: Presentation Guide
Initially your presentation might last up to 15 minutes, but with minimal practice it should last no longer than 10 minutes
1. Describe the case or problem that attracted you to this paper.
2. Explain how you came across this article.
3. Describe the study.
4. Describe the research question.
5. State the importance/relevance/context of this question.
6. Describe the methods by giving more detail on the question components.
P-patients
I-intervention
C-comparison/control
O-outcomes
7. State your answers to the critical appraisal questions on validity (see appropriate University of Alberta Critical Appraisal Form).
8. Summarize the primary results & only important secondary results.
9. Describe why you think the results can or cannot be applied to your patients/situation.
10. Conclude with your own decision about the utility of the study in your practice-resolve the case or question with which you began (see # 1 above).
11. Prepare a 1 page summary of the outline above as a handout (see example next page).
See example on the following page.
Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomized trial. PD Gluckman, et al. Lancet 2005;365:663-70.
Rebecca Cline-Barnett, June 10,2009
(1) A new baby arrived to Dr. Ball’s clinic & a review of the medical records noted that as a newborn he had been on the “CoolCap Protocol.” One of my fellowship attendings next year is involved in studying the efficacy of head cooling for newborns with hypoxic-ischemic encephalopathy. The CoolCap is like a helmet placed on the newborn to cool their head for 24-72 hours & is most effective is begun within 6 hours of injury.
(2) I searched scholar.google.com with search terms: head cooling newborn encephalopathy & found 1,950 articles. However, the selected article was highly cited, randomized, and the most recent therapeutic trial.
(3) This was a multinational, randomized, unblinded, controlled trial of therapy and the first to answer the question:
(4) “Does 72 h of selective head cooling with mild systemic hypothermia, started within 6 h of birth, improve neurodevelopmental outcome at 18 months in infants with moderate or severe neonatal encephalopathy?”
(5) Hypoxic-ischemic encephalopathy occurs in about 1-2 babies per 1,000 term births and has poor long-term outcomes. No specific intervention has been shown to alter outcome. Previous studies demonstrated the safety of head cooling in the NICU and some short-term positive outcomes. No studies have evaluated longer term neurodevelopmental outcomes.
(6) This study included 234 infants with moderate to severe neonatal encephalopathy and abnormal EEG. Within 6 h of birth 116 were randomized to head cooling for 72 h with a rectal temperature of 34-35o C & 118 controls received conventional care. The primary outcome was death or severe disability at 18 months. Severe disability was defined as gross motor scores of 3-5 on the Bayley II scale. Results were also stratified by degree of encephalopathy.
(7) Were pts randomized? YES
Was randomization concealed? NO
Were pts analyzed in the groups to which they were randomized? YES, Intention to Treat
Were groups similar re known prognostic factors? YES, see Table 1
Were participants blind to group allocation? NO
Was follow up complete? NO. 8 lost to follow up in each treatment group.
(8) The rate of poor outcome was less (55% vs 66%, P=.10) in the cooled babies, but not statistically significant. However, when the babies were divided into those with more severe & less severe EEG changes at birth the cooling was found to be effective (OR=0.42, P=.009) among babies with less severe EEG changes. There were no significant harms associated with the therapy.
(9) These findings do appear to be applicable to my patient population.
(10) Head cooling appears to be a safe therapy when done in a NICU and effective at decreasing the risk of death or severe disability at 18 months among babies with less severe EEG changes at birth (NNT=6). However, further studies are required to confirm this and clarify specific populations in whom it is most effective.