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The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication allergy | Patients who have a medication allergy listed in their electronic medical record. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy. |
| Measure | Description | Time Frame |
|---|---|---|
| True Allergy (Consistent With an IgE-mediated Reaction) | Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction) | Cutaneous reactions (rash, skin redness) longer than 6 h after the dose | Baseline |
| Not True Allergy (Not Related to IgE-mediated Reaction) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting for surgery at a children's hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication Allergy | Patients who have a medication allergy listed in their electronic medical record. Survey: Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication Allergy | Patients who have a medication allergy listed in their electronic medical record. Survey: Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | True Allergy (Consistent With an IgE-mediated Reaction) | Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose | In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications. | Posted | Number | Allergies | Baseline | Allergies | Allergies |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication Allergy | Patients who have a medication allergy listed in their electronic medical record. Survey: Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph D. Tobias, MD | Nationwide Children's Hospital | 614-722-4200 | joseph.tobias@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2023 | Jun 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2023 | Oct 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Allergy listed in the medical record but instead: Recognized adverse effect of the medication, Family history of allergy, Based on medical history or other reasons, or Parents reported their child has no allergy
| Baseline |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Participants |
|
| Allergies |
|
|
| Secondary | Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction) | Cutaneous reactions (rash, skin redness) longer than 6 h after the dose | In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications. | Posted | Number | Allergies | Baseline | Allergies | Allergies |
|
|
|
| Secondary | Not True Allergy (Not Related to IgE-mediated Reaction) | Allergy listed in the medical record but instead: Recognized adverse effect of the medication, Family history of allergy, Based on medical history or other reasons, or Parents reported their child has no allergy | In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications. | Posted | Number | Allergies | Baseline | Allergies | Allergies |
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| 0 |
| 250 |
| 0 |
| 250 |
| 0 |
| 250 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |