Cohort
Ilene Claudius and Thomas KeensDo All Infants With Apparent Life-Threatening Events Need to Be Admitted?
Pediatrics
2007;119;679-683
- Submitted by:Daniel Bates - Medical Student - Year 4
- Institution:Michigan State University College of Human Medicine
- Date submitted:18th September 2007
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
The objective of this study was to identify criteria that would allow low-risk infants presenting with an apparent-life threatening event to be discharged safely from the ED instead of being admitted.
2
Design
2.1
Is the study design suitable for the objectives?
Yes.
2.2
Who / what was studied?
The study population was composed of all previously healthy infants less than 12 months old that presented at an urban tertiary center with ALTE over a three year period. Infants were excluded if they had (1) a history of extreme prematurity, (2) uncorrected cardiac disease, (3) a known seizure disorder, (4) significant developmental delay, and/or (5) a chronic lung disease. They were also excluded if they were under the care of a pulmonologist or a neonatologist for previous ALTEs.
2.3
Was a control group used if appropriate?
N/A
2.4
Were outcomes defined at the start of the study?
This study used the NIH definition of ALTE to identify patients. All infants were categorized retrospectively into Hospitalization Required (HR) or Hospitalization NOT Required (HNR) categories regardless of whether they were admitted. HNR infants were defined as having (1) subsequent events requiring hospitalization, (2) subsequent ALTEs and an identifiable pathologic condition, (3) a diagnosis made after discharge from the ED that would normally necessitate admission, and/or (4) the development of a life-threatening condition during hospitalization.
2.5
Was this the right sample to answer the objectives?
Yes.
2.6
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
The sample size was not sufficiently powered to give a conclusive answer. However, it was adequate for a pilot study.
2.7
Were all subjects accounted for?
Yes. Of the 59 patients included in the study, 55 were admitted to the hospital for observation and 4 were discharged home.
2.8
Were all appropriate outcomes considered?
Yes.
2.9
Has ethical approval been obtained if appropriate?
Yes. Ethical approval was received from the institutional review board.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
The study looked at eleven characteristics in each patient: family history of SIDS, patient history of prematurity, previous ALTEs, patient age, presence of URI symptoms, duration of the ALTE, interventions required, appearance of the child in the ED, suspicion of child abuse, and whether the patient had multiple ALTEs within the past 24 hours. The study then compared the prevalence of these characteristics between HR and HNR patients.
3.2
Was the assessment of outcomes blinded?
The assessment was not blinded. Patients were labeled retrospectively as HR or HNR infants by research personnel.
3.3
Was follow up sufficiently long and complete?
Yes. All discharged from the ED patients were contacted within 24-72 hours. If the patient was admitted, the chart was reviewed after discharge from the hospital.
3.4
Are the measurements valid?
Yes.
3.5
Are the measurements reliable?
Yes.
3.6
Are the measurements reproducible?
This study was purely observational
4
Presentation of results
4.1
Are the basic data adequately described?
Yes.
4.2
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes, Tables 1-4
4.3
How large are the effects within a specified time?
None of the patients > 30 days old that were diagnosed with a first-time ALTE required hospitalization in retrospect, even though most were admitted. Therefore, the negative predictive value and sensitivity was 100%. However, the 95% Confidence Interval was quite large: 90-100% and 69-100% respectively.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes.
5
Analysis
5.1
Are the data suitable for analysis?
Yes.
5.2
Are the methods appropriate to the data?
Odds ratios were calculated by using univariate analyses. A multivariate analysis was not performed because of the small number of patients that retrospectively required admission. The significance was then tested by using Fisher's exact tests. Sensitivity, specificity, predictive values, and confidence intervals were also calculated for the study's' recommendation of admitting all patients < 30 days old or with a history of multiple ALTEs.
5.3
Are any statistics correctly performed and interpreted?
Yes.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes. The article discussed several studies that either supported or opposed the idea that ALTEs are precursors to SIDS. It suggests that patients > 30 days old without previous ALTEs can be safely discharged to home, but does not actually make any recommendations. A larger, more comprehensive study is required.
6.2
Is the discussion biased?
No.
7
Interpretation
7.1
Are the author's conclusions justified by the data?
Yes. The data is interesting, but the authors recognized that the study as too small to affect clinical practice. They argued that a larger study is warranted given the potential savings from decreased admissions.
7.2
What level of evidence has this paper presented? (using CEBM levels)
2B
7.3
Does this paper help me to answer my problem?
No. This paper is interesting, but does not warrant a change in clinical practice.
8
Implementation
8.1
Can any necessary change be implemented in practice?
No.
8.2
What aids to implementation exist?
N/A
8.3
What barriers to implementation exist?
N/A
8.4
Are the study patients similar to your own?
Yes.
8.5
Does the paper give any conclusions that will affect what you will offer or tell your patient?
No. The study is too small to warrant a change in clinical practice.