Hypothyroidism
Conditions
Keywords
Hypothyroidism,, children,, iodinated contrast agents,, retrospective cohort,, database
Brief summary
This study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, which were exposed to iodinated contrast agent through having a diagnostic procedure.
Interventions
Use of iodine contrast agents and doses following the decision of the treating physician.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
* Children under age 4 in the Kaiser Permanente Northern California (KPNC) database, who had a diagnostic procedure with an iodinated contrast agent. * Participants should be member of the KPNC for at least 3 months before the iodinated contrast exposure, except where the child is under 3 months of age at time of initial exposure, and 2 weeks after the exposure.
Exclusion criteria
* Diagnosis of hypothyroid any time prior to the iodine contrast exposure. * Lab values for low thyroid (TSH \> 5 mU/L for children) any time before the exposure * Thyroid replacement therapy, Hashimoto thyroiditis, or congenital hypothyroidism any time prior to exposure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice | In the 365 days post exposure to an iodinated contrast agent | Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk. |
Secondary
| Measure | Time frame |
|---|---|
| Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Time From First Iodinated Contrast to First Hypothyroidism Event | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Classification of Hypothyroidism by Etiology | Up to 365 days after a diagnostic scan with iodinated contrast agent |
| Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to 365 days after a diagnostic scan with iodinated contrast agent |
Countries
United States
Participant flow
Recruitment details
This study was a retrospective cohort study, using the data from the years 2008 to June of 2016 in the database of Kaiser Permanente Northern California.
Pre-assignment details
There were 2320 children identified in Kaiser Permanente Northern California who met our study population criteria: patients who had a procedure that used iodinated contrast agent and were under the age of 4, during the years 2008 to June of 2016.
Participants by arm
| Arm | Count |
|---|---|
| Iodine Contrast Agent Children under age 4, from the US-based Kaiser Permanente Northern California database, who were exposed to iodinated contrast agent through having a diagnostic procedure. | 2,320 |
| Total | 2,320 |
Baseline characteristics
| Characteristic | Iodine Contrast Agent |
|---|---|
| Age, Customized <1 month | 197 Participants |
| Age, Customized 1 to 3 months | 174 Participants |
| Age, Customized 1 to 4 years | 1518 Participants |
| Age, Customized 3 to 6 months | 174 Participants |
| Age, Customized 6 months to 1 year | 257 Participants |
| Race/Ethnicity, Customized African American | 174 Participants |
| Race/Ethnicity, Customized Asian/Pacific islander | 425 Participants |
| Race/Ethnicity, Customized Hispanic | 726 Participants |
| Race/Ethnicity, Customized Other or missing | 195 Participants |
| Race/Ethnicity, Customized White | 800 Participants |
| Sex: Female, Male Female | 1032 Participants |
| Sex: Female, Male Male | 1288 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice
Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk.
Time frame: In the 365 days post exposure to an iodinated contrast agent
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Iodine Contrast Agent | Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice | 15.9 events per 1,000 person years |
Secondary
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 1 to 3 months | 6 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 3 to 6 months | 6 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 6 months to 1 year | 4 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 1 to 4 years | 14 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | <1 month | 4 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | <1 month | 193 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 1 to 4 years | 1504 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 3 to 6 months | 168 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 1 to 3 months | 168 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 6 months to 1 year | 253 Participants |
Secondary
Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | White | 13 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Hispanic | 6 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | African American | 4 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Asian/Pacific islander | 9 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Other or missing | 2 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Asian/Pacific islander | 416 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Other or missing | 193 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | White | 787 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | African American | 170 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Hispanic | 720 Participants |
Secondary
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Male | 24 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Female | 10 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Male | 1264 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Female | 1022 Participants |
Secondary
Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | CT scan | 18 Iodine contrast exposure |
| Iodine Contrast Agent | Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | Heart catheterization | 16 Iodine contrast exposure |
| Non-hypothyroidism Cases | Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | CT scan | 1762 Iodine contrast exposure |
| Non-hypothyroidism Cases | Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort | Heart catheterization | 528 Iodine contrast exposure |
Secondary
Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2015 | 6 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | through August 2016 | 0 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2008 | 4 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2009 | 3 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2010 | 9 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2011 | 2 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2012 | 2 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2013 | 4 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2014 | 4 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2013 | 263 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2015 | 241 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2011 | 260 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | through August 2016 | 105 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2008 | 300 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2012 | 266 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2009 | 320 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2014 | 234 Participants |
| Non-hypothyroidism Cases | Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort | 2010 | 297 Participants |
Secondary
Classification of Hypothyroidism by Etiology
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Classification of Hypothyroidism by Etiology | Iodine induced cases | 23 Participants |
| Iodine Contrast Agent | Classification of Hypothyroidism by Etiology | Other etiology cases | 11 Participants |
Secondary
Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Subclinical hypothyroidism | 15 Participants |
| Iodine Contrast Agent | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Manifest hypothyroidism | 2 Participants |
| Iodine Contrast Agent | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Treatment or diagnosis with no TSH test | 1 Participants |
| Non-hypothyroidism Cases | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Subclinical hypothyroidism | 9 Participants |
| Non-hypothyroidism Cases | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Manifest hypothyroidism | 1 Participants |
| Non-hypothyroidism Cases | Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure | Treatment or diagnosis with no TSH test | 6 Participants |
Secondary
Time From First Iodinated Contrast to First Hypothyroidism Event
Time frame: Up to 365 days after a diagnostic scan with iodinated contrast agent
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Time From First Iodinated Contrast to First Hypothyroidism Event | <30 days | 4 Participants |
| Iodine Contrast Agent | Time From First Iodinated Contrast to First Hypothyroidism Event | 30 - 59 days | 4 Participants |
| Iodine Contrast Agent | Time From First Iodinated Contrast to First Hypothyroidism Event | 60+ days | 10 Participants |
| Non-hypothyroidism Cases | Time From First Iodinated Contrast to First Hypothyroidism Event | <30 days | 3 Participants |
| Non-hypothyroidism Cases | Time From First Iodinated Contrast to First Hypothyroidism Event | 30 - 59 days | 3 Participants |
| Non-hypothyroidism Cases | Time From First Iodinated Contrast to First Hypothyroidism Event | 60+ days | 10 Participants |