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Audit of the Congenital Hypothyroidism Screening Program in 15 Provinces of Iran
Ladan Mehran1, Shahin Yarahmadi2, Davood Khalili3
1Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
Iran's national newborn screening program for congenital hypothyroidism (CH) shows good coverage but a high false positive rate. Further improvements are needed for neonatal TSH levels and screening accuracy.
Area of Science:
- Public Health
- Endocrinology
- Neonatal Medicine
Background:
- The national newborn screening (NBS) program for congenital hypothyroidism (CH) was established in Iran in 2005.
- This study evaluates the NBS program's effectiveness in 15 provinces between 2011 and 2014.
Purpose of the Study:
- To assess the performance and identify challenges within Iran's national newborn screening program for congenital hypothyroidism.
- To evaluate key indicators such as program coverage, diagnostic accuracy, incidence rates, and treatment initiation.
Main Methods:
- Retrospective analysis of aggregated screening, diagnosis, and management data from 17 districts across 15 provinces in 2011.
- Data included screening coverage, positive predictive value, transient CH prevalence, sampling errors, recall rates, CH incidence, screening age, treatment timing, and TSH normalization time.
Main Results:
- Program coverage was high (77-100%), but the positive predictive value was low (1.3-15.5%).
- Congenital hypothyroidism incidence was notable (highest: 1:241 in Zanjan), with transient CH observed in over 3% of neonates in some districts.
- Screening and treatment initiation generally occurred within recommended timeframes, but TSH normalization varied significantly.
Conclusions:
- Key performance indicators for the NBS program have met national goals.
- High false positive rates and non-optimal neonatal TSH levels require further investigation and program refinement.
Background:
The newborn screening (NBS) program for congenital hypothyroidism (CH) was launched on a national scale in Iran since 2005; we evaluated the program in 15 provinces, from 2011 to 2014.
Methods:
Fifteen provinces, including 17 districts, were included in the study. Aggregated data of screening, diagnosis, and management of all neonates born in each district in 2011 were retrospectively gathered and collectively analyzed.
Results:
Program coverage ranged from 77 to 100% in different districts. The positive predictive value was low and widely ranged from 1.3 to 15.5. Transient congenital hypothyroidism (TCH) distribution values were over 5 mU/L in more than 3% of the population and were reported in 9 out of 17 districts. Repeated screening test due to inappropriate sampling varied from 0.9% in Lorestan to 36% in Zabol. Recall rate varied from 0.16 in Ardebil to 1.58 in Zanjan. CH incidence was high, with the highest value being observed in Zanjan (1:241 newborns). Screening age at 3-5 days from birth were highly observed in Gonabad (95.2%) and Zanjan (94.5%), with the lowest values observed in Giroft, Zabol, Kerman and Tehran. CH treatment was initiated before 40 days of age in 90.6% of cases. Survival time for TSH normalization event varied among the districts from 25 to 163 days. After withholding treatment at 3 years of age, TCH was identified in 30%-60% of hypothyroid cases.
Conclusion:
Main indicators of the screening program have reached the optimal goals defined by the Ministry of Health and Medical Education. However, high false positive rate and non-optimal neonatal TSH distribution values necessitate readdressing these challenging issues.
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