Audit of the Congenital Hypothyroidism Screening Program in 15 Provinces of Iran.

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.

Evaluation of the congenital hypothyroidism screening programme in Iran: a 3-year retrospective cohort study.

OBJECTIVE: To evaluate the newborn screening programme for congenital hypothyroidism (CH) in Iran from diagnosis to management and follow-up for 3 years from 2011 to 2014. DESIGN: Retrospective cohort. SETTING AND PATIENTS: Seventeen university districts were randomly selected from 30 provinces. Central data in each district were gathered and collectively analysed. Congenital hypothyroid subjects were followed for 3 years. MAIN OUTCOME MEASURES: Programme coverage, screening and treatment age, recall rate, compliance to follow-ups. RESULTS: The total number of births in 2011 was 501 726, of which 452 918 neonates (90.3%) were screened and 15 671 (3.46%) were recalled; 1085 (1:462, 0.22%) were confirmed as having CH (57.1%: permanent, 42.9%: transient) and followed for 3 years. Positive predictive value (PPV) for the first screening test was 6.9%. After the second screening, recall rate was reduced to 0.69% and PPV increased to 31.3%. Median age at screening was 6 (3-9) days and for 90.6% of patients treatment was initiated before 40 days of age with a median levothyroxine dosage of 25 µg/day; 131 (13.4%) were lost to follow-up. Mean number of follow-up visits over 3 years was 5.7 (95% CI 5.5 to 5.9) and 23% (n=225) had total compliance to all follow-ups. Median time for thyroid stimulating hormone normalisation was 45 days, 95% CI (41.1 to 48.8). CONCLUSION: In Iran, despite well-established protocols of screening and detecting CH subjects, stricter implementation of a structured system for monitoring and surveillance is needed to promote the management of patients and to reduce rates of loss to follow-up. Determining and addressing the causes of high false positive rates must be prioritised.

Worldwide Recall Rate in Newborn Screening Programs for Congenital Hypothyroidism.

CONTEXT: Neonatal mass screening program for congenital hypothyroidism provides the best tool for prevention of its devastating effects on mental development. Despite the overall success of the screening programs in detecting congenital hypothyroidism and eliminating its sequelae and new developments made in the program design, high recall rate and false positive results impose a great challenge worldwide. Lower recall rate and false positive results may properly organize project expenses by reducing the unnecessary repeated laboratory tests, increase physicians and parents' assurance and cooperation, as well as reduce the psychological effects in families. EVIDENCE ACQUISITION: In this review, we assessed the recall rate in different programs and its risk factors worldwide. METHODS: Publications reporting the results of the CH screening program from 1997 to 2016 focusing on the recall rate have been searched. RESULTS: Recall rates vary from 0.01% to 13.3% in different programs; this wide range may be due to different protocols of screening (use of T4 or TSH or both), different laboratory techniques, site of sample collection, recall cutoff, iodine status, human error, and even CH incidence as affected by social, cultural, and regional factors of the population. CONCLUSIONS: It is suggested to implement suitable interventions to reduce the contributing factors by improving the quality of laboratory tests, selecting conservative cut off points, control iodine deficiency, use of iodine free antiseptic during delivery, and use of more specific markers or molecular tests. Applying an age dependent criteria for thyrotropin levels can be helpful in regions with a varied time of discharge after delivery or for preterm babies.