Preoperative Survey to Evaluate Patient Allergy List, Type of Response to Listed Medication, and Its Relevance to Perioperative Care
Conditions: Allergy Drug, Allergic Reaction, Pediatric, Surgery
Sponsor: Nationwide Children's Hospital

 
Preoperative survey to evaluate patient allergy list, type of response to listed 
medication, and its relevance to perioperative care 
 
 
NCT05670756 
 
May 3, 2023 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 1 of 8 
HRP-580  v.04.17.19 
PROTOCOL TITLE: 
Preoperative survey to evaluate patient allergy list, type of response to listed medication, 
and its relevance to perioperative care 
 
PRINCIPAL INVESTIGATOR: 
Joseph D. Tobias, MD 
Department of Anesthesiology & Pain Medicine 
614-722-4200 
Joseph.Tobias@nationwidechildrens.org 
 
VERSION NUMBER/DATE: 
Ver. 2/May 3, 2023 
 
Revision History 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
5/3/2023 
Adding OU as a relying site. 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 2 of 8 
HRP-580  v.04.17.19 
 
1.0 
 Study Summary  
 
Study Title 
Preoperative survey to evaluate patient allergy list, type of 
response to listed medication, and its relevance to 
perioperative care 
Study Design 
Anonymous, patient survey 
Primary Objective 
To determine allergies listed by patient and type of response 
which resulted in the allergy determination 
Secondary 
Objective(s) 
To determine the impact of the allergy list on anesthetic care 
Study Population 
Patients neonate to 21 years of age presenting for anesthetic 
care 
Sample Size 
1000 
Study Duration  
3 years 
 
2.0  Methods 
2.1 Although perioperative hypersensitivity reactions including 
anaphylaxis are rare, they may result in significant morbidity and 
mortality. The incidence of perioperative hypersensitivity reactions 
to medications, surgical equipment, and biological substances varies 
widely. Studies using large databases from France, Australia, and the 
United Kingdom (UK) have reported a significant variation in 
incidence ranging from 1:1361 to 1:20,000. Neuromuscular blocking 
agents (NMBAs), latex containing products, and antibiotics are 
identified as the agents most commonly responsible for perioperative 
hypersensitivity reactions. Newer NMBAs such as rocuronium may 
be associated with more frequent allergic reactions compared to 
older NMBAs, while the incidence of hypersensitivity to latex is 
decreasing as a result of its elimination from the perioperative 
environment and identification of at-risk patients. 
2.2 Part of the routine preoperative evaluation is identification of 
previous allergies and avoidance of those medications during the 
perioperative period. For the purpose of our routine anesthetic care, 
we rely on the electronic medical record and the list of allergies 
provided.  Although this is generally effective, it may be that 
allergies are erroneously listed and not based on good medical 
practice. For example, apnea following administration of an opioid 
such as fentanyl or diarrhea with the administration of Augmentin 
may be listed as allergies.  The purpose of the current study is to 
evaluate allergies listed in the electronic medical record (EMR) of 
patients presenting for surgery and determine through a brief 
interview of the parent or guardian when that allergy was identified 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 3 of 8 
HRP-580  v.04.17.19 
and the exact symptomatology that resulted in determination of the 
allergy.  
2.3 In addition to acute and chronic issues associated with substance 
abuse, these medications and substances can impact the perioperative 
care of patients and interact with anesthetic agents.  Preoperative 
screening for these issues is now undertaken by an on-line 
preoperative questionnaire sent to the parents to complete prior to 
anesthetic care. Given the nature of such concerns and these issues, it 
is likely that there is under-reporting of these problems for various 
reasons. 
2.4 Regardless of the history that is provided by the parents, no change 
in the allergy listing will be made and no specific change in the 
anesthetic plan mandate. The study will only involve identification 
of the listed allergies from the EMR 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.  For example, when patients are labelled as 
penicillin-allergic, it may be decided not to use cefazolin for 
prophylaxis of surgical site infections. Instead other antibiotics with 
a greater adverse effect profile such as vancomycin or clindamycin 
may be used. 
2.5 The participants will be asked to complete a survey in REDCap 
using an iPad during the visit.  
2.6 The information collected will include only demographic data 
including age, weight, gender, race and ethnicity. Survey data will be 
coded and will not include patient information. Completion of the 
survey will take approximately 10-15 minutes. Explanation of the 
study, its confidentiality, and the purpose will take approximately 5-
10 minutes. 
2.7 OU will be a relying site since one of their medical students will be 
collecting data for the study.  All patients and data will come from 
NCH and all work on the study will be done at NCH.   
3.0 Data Banking 
3.1 All data collected during this study will be stored in a secure location, and 
only the collaborators directly involved with this research project will have 
access to this information. In addition, all electronic files will be stored on a 
secure, password-protected network. No data will be shared with OU. 
3.2 Data will be stored for 6 years after the study is completed. 
3.3 Data will not be stored for future use. 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 4 of 8 
HRP-580  v.04.17.19 
4.0  Inclusion and Exclusion Criteria 
4.1 Inclusion: Patients 0-21 years of age presenting for surgery or procedure 
requiring anesthesia. 
4.2 Exclusion: Patients who are not able cognitively to complete the 
computerized survey due to physical or intellectual impairment or 
communication issues related to non-English speaking patients.   
5.0 Vulnerable Populations 
5.1 This research involves children but does not involve greater than minimal 
risk under 21 CFR §50.51/45 CFR §46.404.  
5.2 All data collected during this study will be stored in a secure location, and 
only the collaborators directly involved with this research project will have 
access to this information. In addition, all electronic files will be stored on a 
secure, password-protected network.  
 
5.3 The subjects will not be exposed to greater than minimal risk. 
 
5.4 Parents/legal guardians will be asked to give verbal consent and children 
will provide assent.  
 
6.0 Number of Subjects (Records) 
6.1 1000.  
7.0 Recruitment Methods 
7.1 Patients will be identified using the operating room schedule. The 
study coordinator, PI, or sub-investigators will screen and identify 
appropriate participants. Screening participants will occur according 
to the protocol defined inclusion and exclusion criteria under the 
auspices of a partial waiver in accordance with the HIPAA privacy 
rule.  
7.2 Potential subjects will be approached in the pre-op area on the day of 
surgery by a member of the research team.  The study will be 
explained to the patient and parents/guardians and they will be 
provided a copy of the consent form to review. 
8.0 Withdrawal of Subjects 
8.1 Patients may withdraw from the study at any time.  
8.2 There are no anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
9.0 Data Management and Confidentiality 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 5 of 8 
HRP-580  v.04.17.19 
9.1 All data collected during this study will be stored in secure password 
protected computer files to which only trained members of the 
research team and collaborators directly involved with this research 
project will have access.  
9.2 The data will be stored for the duration of the study and retained for 
6 years after the study is completed per NCH as this meets both 
HIPAA and OHRP regulations.  
9.3 No data will be transmitted to or from external institutions.  
9.4 Subjects will be assigned a study identification number and no 
identifiers will be entered into REDCap.  Names and MRNs will not 
be recorded. 
10.0 
Provisions to Protect the Privacy Interests of Subjects 
10.1 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
10.2 Only the absolute minimum information necessary for this study will 
be collected from the patient’s records. Access to the patients’ charts 
will be limited to only the research team who have completed all the 
necessary training.  
10.3 We will only be publishing de-identified research information.  
11.0 
Economic Burden to Subjects 
11.1 There will be no costs to subjects and subjects will not receive any 
compensation. 
12.0 
Consent Process 
12.1 The consent process will begin in the preoperative surgery unit on 
the day of surgery, by PI, Sub­Investigators, Study Coordinators, 
and/or trained research staff.  
12.2 The study will be thoroughly explained to the patient and their 
family. There will be ample time allotted for questions and answers. 
An explanation of voluntary participation will take place, and the 
family will be asked if they are interested in participating in the 
study. The patient will then be enrolled in the study with the 
understanding that they can elect to stop the study and be withdrawn 
from the study at any time. 
12.3 Potential subjects will be provided a written information sheet and verbal 
consent will be obtained. 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 6 of 8 
HRP-580  v.04.17.19 
13.0 
Setting 
13.1 Potential subjects will be identified from the surgery schedule in Epic and 
recruited from the pre-op area of the surgery unit.  Surveys will be 
completed via REDCap on iPads in the pre-op area.  
14.0 
Resources Available 
14.1 The research team is comprised of 2 PhD research scientists, a research 
nurse, a research coordinator, two research associates, and two research 
interns. All team members will meet with the PI, co-investigators, and the 
research team for a study start up meeting for training about the protocol, 
research procedures, and their duties and functions. 
15.0 
Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☐  Complete Address 
☐  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☐  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☐  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☒  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 7 of 8 
HRP-580  v.04.17.19 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. Other 
Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
Identifying information on each participant will be retained for 6 years after the 
research is complete which meets both HIPAA and OHRP regulations. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. Subjects will be assigned a study identification number and no 
identifiers will be entered into REDCap.  Names and MRNs will not be recorded. 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy     
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.)  Subject information will not be given to any other 
investigators. Subjects and their information will be closely monitored and 
guarded by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only be shared 
and discussed between study staff specific to this study 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 

NATIONWIDE CHILDREN’S HOSPITAL 
SHORT PROTOCOL (Waiver of Consent or Verbal Consent) 
 
PROTOCOL TITLE:  Preoperative survey to evaluate patient allergy 
 
 
Page 8 of 8 
HRP-580  v.04.17.19 
☒  Demographics (age, gender, educational level) 
☐  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☐  Procedures/Treatments received 
☐  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☐  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☐  Name of treatment provider 
☐  Surgical reports 
☐  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above.  
It is necessary to review the above health information to enable us to describe our 
patient population, ensure they meet the study inclusion specifications and 
evaluate our study outcomes. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary 
to achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☒ Yes  ☐ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a 
means of protecting the confidentiality of the information collected?  ☐ Yes   
☒ No