University Number: 2011979141

CMED 6400 : Evidence-Based Practice : An introduction to clinical epidemiology and decision analysis Please answer the following questions based on the article provided to you (Koppel RI, et al). Effectiveness of pulse oximetry screening for congenital heart disease in asymptomatic newborns. Pediatrics 2003;111(3):451-55. 1. What question is this study attempting to answer? (2%) Ans: This study is attempting to answer if pulse oximetry is an effective screening tool for Congenital Heart Disease namely in Asymptomatic newborns. In order to do this, the study wishes to determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of the pulse oximetry screening test of asymptomatic newborn to detect critical CCVM (congenital cardiovascular malformation) 2. What is the population being screening? (2%) Ans: Essentially the population being screened is all the asymptomatic newborns (that numbers to 11, 281 subjects in total) that are located in the wellinfant nurseries from 2 hospital in the New York state and asymptomatic here refers to the fact that they did not manifest any of these clinical findings; cyanosis, tachypnea, grunting, flaring, retraction, murmur, active precordium, or diminished pulses. Infant who did present any of the following clinical features are then effectively transferred to the neonatal intensive care unit for further management and not included within the purview of the analysis. 3. What is the screening test? (2%) Ans: The screening test administered here was a single postductal oxygen saturation on all asymptomatic newborn by means of using a pulse oximetry test. The postductal oximetry of 95% and less will undergo further evaluation of echocardiography. The screening test using pulse oximetry is hoped to be able to screen for critical congenital cardiovascular malformation. 4. What is the reference (gold) standard and do you think it is appropriate? Why or Why not? (3%) Ans: The reference standard or gold start used in the study is the echocardiography. Echocardiography is appropriately a good diagnostic tool to confirm or deny findings from the oximetry screening (screening test) that has been initially done. Echocardiography is a good tool to use as it could accuratelly describe the cardiovascular condition of the fetus. The downside of using the echocardiography was that, the use of this tool is considered very expensive and hence only was limited to subjects that has posductal saturation of 95% in this study. In the literature, the use of routine fetal echocardiography has helped in detecting CCVMs in many if not all the affected fetus. Other tools such as the routine physical examination is unreliable as it could fail to detect > 50% of infants with CCVM. In addition, use of obstetrical ultrasound also is not very good in detecting several life threatening CCVMs.

University Number: 2011979141

5. Did all participants receive both the screening test and the reference test? (2%) Ans: No, not all the participants included in this had received both the screening and the reference test. Only participants who had the postductal saturation of 95% during the screening test were needed to undergo the reference test. This test will function as a means of diagnosis (diagnostic tool) to confirm or deny the presence of congenital cardiovascular malformation. 6. Were the results of the screening test interpreted without the knowledge of the reference test and vice versa? (2%) Ans: Yes, the results of the screening test were interpreted without the knowledge of the reference test. However, the results of the reference test were definitely interpreted with the knowledge of the screening test. This is because only the newborns screened and had the postductal saturation 95% was required to undergo echocardiography (reference test) to look for any critical cardiovascular malformation but not the other way around. It is clearly noted here that the echocardiography result was being interpreted with the full knowledge of the low postductal saturation of the screening test. 7. Describe the study enrollment procedure. Would this type of enrollment be prone to bias? Why or Why not? (3%) Ans: The study enrolment procedure was as followed. All the asymptomatic newborn from well-infant nurseries at 2 hospitals (aptly named here as Hospital A and Hospital B) in the New York state were screened by doing a one time postductal oximetry screening using pulse oximetry. These data or subject for study was collected at a given period that is from May 1998 to November 1999. Only asymptomatic newborn infants are included. Infants showing symptoms of cyanosis, tachypnea, grunting, flaring, retraction, murmur, active precordium, or diminished pulses were excluded from this study. I would conclude that this type of enrolment would be prone to bias. My reason for this statement would be the fact that there could be a selection bias (as the hospital involved in the study could show geographical, ethnicity or socioeconomic status bias) and there was no randomization in the subject selection. All the newborn that are asymptomatic at the given interval or time in these hospital were included in the study as a convenient sampling. Additionally, no allocation concealment was stated anywhere in the study. 8. Construct a 2 x 2 table to represent the data given on asymptomatic newborns (2%) D+ T+ T3 2 Sensitivity: D1 11275 Specificity: Positive Predictive Value: 75% Negative Predictive Value: 99.98%

University Number: 2011979141

60%

99.95%

9. How many of the screened infants tested positive (i.e. their pulse oximetry test was abnormal)? How many tested negative (ie. normal pulse oximetry test)? (2%) Ans: Out of 11281 infants who were screened, 4 infant tested positive while 11277 were tested to be negative or as having normal pulse oximetry 10. What would you tell the parents of an infant testing positive (i.e. abnormal pulse oximetry test) who are asking if their child has something wrong with his/her heart? (4%) Ans: I would inform the parents, based on the abnormal pulse oximetry which tested the infant as positive; the likelihood of their child having any abnormality in his or her heart would be 75%. In other words, having the test coming out positive would mean the child has a chance to have the cardiac malformation. However, this diagnosis of the cardiac malformation can only be concluded with an echocardiography which will be carried out to confirm or deny whether the child has any abnormality in his/her heart. Having said, to be positive in the oximetry test alone doesnt mean a complete certainty of the diagnosis but rather a means of scrutiny to ensure only children who really need to undergo echocardiography will do so and finally confirm the condition status. 11. If the test is performed in a hospital whose doctors routinely screen all pregnant women with fetal echocardiography in utero to detect congenital heart disease (CHD), will the prevalence of undetected CHD be increased or decreased in asymptomatic newborns? How will this change in prevalence affect the positive and negative predictive value of the screening test? (4%) Ans: If this screening test (oximetry test) is done in a hospital that routinely screens all pregnant women with fetal echocardiography in utero to the detect the congenital heart disease (CHD), the prevalence of undetected CHD will be decreased in the asymptomatic newborns as the echocardiography will diagnose infants with CHD condition prenatally and therefore will not need to be screened for detection. This directly translates to the reduction of infants who will be detected through the screening. Naturally the prevalence will be reduced for the undetected CHD in asymptomatic newborn. The reduced prevalence will cause the reduction of the positive predictive value and increased in the negative predictive value 12. Does this article present evidence that routine screening will reduce mortality and morbidity from congenital heart disease? (2%) Ans: This article had quoted another study and stated that screening programs have been noted to provide important service in identifying newborns with congenital conditions that could be managed effectively with early intervention. However, having said that the paper also clearly stated that whether oximetric screening would improve the perioperative or the long term outcome for the invalid infants is beyond the scope of study. Some studies have shown favourable outcome with fetal detection of certain congenital cardiac condition as compared to a neonatal detection and

University Number: 2011979141

hence the article indicates that the early screening of the congenital condition would prove to have a better outcome in reducing mortality and morbidity as compared to infants readmitted from home.

END Students must submit a softcopy of the midterm quiz on Moodle by 9am 6th June 2012 and bring a hard copy of the midterm quiz to the examination. You will be asked to submit your hardcopy to the course TA before the examination. Remember to put in your student number on the top right corner of every page of your assignment.