Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
Conditions: Pediatric Sedation
Sponsor: Duke University

 
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VALIDATION OF CLINICIAN REPORTED OUTCOME 
MEASURES OF PEDIATRIC SEDATION  
 
A qualitative study aimed at assessing the content validity of clinician 
reported pediatric sedation measures via cognitive interviewing. 
 
 
 
 
 
Pro00102030 
 
 
 
 
 
 
Version 1.2 
 
 
Date 
28 March 2019 
 
 
 
 

 
 
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Regulatory Sponsor: 
Christy Zeigler, PhD, Co-PI 
Department of Population Health Sciences 
Duke School of Medicine 
215 W. Morris St., Suite 210, Durham, NC, 27701 
919.684.3549 
 
Bryce Reeve, PhD, Co-PI 
Department of Population Health Sciences 
Duke School of Medicine 
215 W. Morris St., Suite 210, Durham, NC, 27701 
919.613.7812 
 
Funding Sponsor: 
 
 
Contact: Perdita Taylot-Zapta 
National Institute of Child Health and Human Development 
(NICHD) 
6710B Rockledge Drive, Rm 2323c 
Bethesda, MD 20817 
301.496.9584 
 
 
 
 
Study Investigators: 
Co-PI: Bryce Reeve, PhD 
Co-PI: Christy Zigler, PhD 
Co-I: Kanecia Zimmerman, MD 
 

 
 
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Table of Contents 
STUDY SUMMARY ................................................................................................................................................... 1 
1 
INTRODUCTION .............................................................................................................................................. 2 
1.1 
BACKGROUND .................................................................................................................................................. 2 
2 
STUDY OBJECTIVES ...................................................................................................................................... 2 
3 
STUDY DESIGN ................................................................................................................................................ 2 
3.1 
GENERAL DESIGN ............................................................................................................................................ 2 
3.2 
PRIMARY STUDY ENDPOINTS ........................................................................................................................... 2 
4 
SUBJECT SELECTION AND WITHDRAWAL............................................................................................ 3 
4.1 
INCLUSION CRITERIA ....................................................................................................................................... 3 
4.2 
EXCLUSION CRITERIA ...................................................................................................................................... 3 
4.3 
SUBJECT RECRUITMENT AND SCREENING ........................................................................................................ 3 
4.4 
SUBJECT CONSENT ........................................................................................................................................... 4 
4.5 
EARLY WITHDRAWAL OF SUBJECTS ................................................................................................................. 4 
4.5.1 
When and How to Withdraw Subjects .................................................................................................... 4 
5 
STUDY PROCEDURES .................................................................................................................................... 4 
6 
STATISTICAL PLAN ....................................................................................................................................... 4 
6.1 
SAMPLE SIZE DETERMINATION ........................................................................................................................ 5 
6.2 
STATISTICAL METHODS ................................................................................................................................... 6 
6.3 
SUBJECT POPULATION(S) FOR ANALYSIS ......................................................................................................... 6 
7 
DATA HANDLING AND RECORD KEEPING ............................................................................................ 6 
7.1 
CONFIDENTIALITY ............................................................................................................................................ 6 
7.2 
SOURCE DOCUMENTS ....................................................................................................................................... 6 
7.3 
CASE REPORT FORMS....................................................................................................................................... 7 
7.4 
RECORDS RETENTION ...................................................................................................................................... 7 
8 
STUDY MONITORING, AUDITING, AND INSPECTING ......................................................................... 7 
8.1 
STUDY MONITORING PLAN .............................................................................................................................. 7 
8.2 
AUDITING AND INSPECTING ............................................................................................................................. 8 
9 
ETHICAL CONSIDERATIONS ...................................................................................................................... 8 
10 
STUDY FINANCES ........................................................................................................................................... 8 
10.1 
FUNDING SOURCE ....................................................................................................................................... 8 
10.2 
CONFLICT OF INTEREST ............................................................................................................................... 9 
10.3 
SUBJECT STIPENDS OR PAYMENTS .............................................................................................................. 9 
11 
PUBLICATION PLAN ...................................................................................................................................... 9 
12 
REFERENCES ................................................................................................................................................... 9 
13 
ATTACHMENTS ............................................................................................................................................ 10 
 

 
 
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List of Abbreviations 
 
 
 

 
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Study Summary 
Title 
Validation of Clinician Reported Outcome Measures of Pediatric 
Sedation 
Short Title 
Pediatric Sedation   
Protocol Number 
Pro00102030 
Phase 
N/A 
Methodology 
Qualitative: Cognitive Interviewing  
Study Duration 
1 hour  
Study Center(s) 
Single-center 
Objectives 
Validation of clinician reported measures of pediatric sedation  
Number of Subjects 
24 
Diagnosis and Main 
Inclusion Criteria 
Pediatric anesthesiologists and pediatric critical care physicians will be 
enrolled 
Statistical 
Methodology 
Qualitative: Thematic Analysis  
 

 
 
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1 Introduction 
This document is a protocol for a human research study. This study is to be conducted according 
to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and 
International Conference on Harmonization guidelines), applicable government regulations and 
Institutional research policies and procedures.  
1.1 Background 
 
Anesthesia and analgesia are increasingly recognized as integral parts of inpatient and outpatient 
management of infants, children, and adolescents.1 However, many anesthetics and analgesics are not 
approved by the US Food and Drug Administration for use in children due to inadequate information on 
drug efficacy, safety, and dosing in pediatric populations.2,3 In order to assure optimal pharmacotherapy, 
it is imperative to select the correct drug dose. The Pediatric Trials Network (PTN) seeks to complete 
safety and efficacy studies of understudied but commonly-administered anesthetics to children, The 
studies will help define an optimal dosing regimen for pediatric populations. In order to complete these 
studies and submit data to the US FDA for update of pediatric labeling, the PTN requires outcome 
measures for sedation levels that have been thoroughly validated. Existing clinician report pediatric 
sedation scales do not have adequate qualitative evidence to support content validity for any of these 
scales to be used as outcome measures. 
 
This Study 
 
This study will conduct qualitative interviews to provide evidence for the content validity and 
comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia 
to facilitate a diagnostic or surgical procedure.  Information gained from this study will inform the use of 
the measure in studies that are part of the PTN. 
 
2 Study Objectives 
Primary Objective 
To assess the content validity and physician understanding of the Pediatric Sedation State Scale 
(PSSS) and the University of Michigan Sedation Scale (UMSS) via cognitive interviewing 
methods. 
3 Study Design 
3.1 General Design 
This is a qualitative, questionnaire validation study using 1 hour, phone-based cognitive 
interviews with pediatric anesthesiologists and pediatric critical care physicians.  Participation 
will last for the duration of the 1 hour phone interview.  
3.2 Primary Study Endpoints 
The two co-primary study endpoints are physicians’ 1) comprehension of items and response 
options on clinician reported pediatric sedation scales, and 2) evaluation of the relevance of the 
scale to capture sedation levels.  

 
 
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4 Subject Selection and Withdrawal 
4.1 Inclusion Criteria 
1. Is a practicing clinician in a clinical care environment  
2. Cares for pediatric patients >50% of their time 
3. Treats or works with pediatric patients who are sedated/anesthetized for diagnostic 
and/or therapeutic procedures 
4. Holds one of the following titles/positions 
a. Anesthesiologist  
b. Pediatric critical care physician 
c. Clinical pharmacist (PharmD) 
d. Nurse anesthetist  
e. Nurse practitioner 
f.    Physician assistant  
g. Nurse (with a BSN/RN or higher) 
5. Is over the age of 18 years 
6. Can speak English  
7. Is capable of giving informed verbal consent 
4.2 Exclusion Criteria 
1. Lack of access to a telephone for interview 
4.3 Subject Recruitment and Screening 
Participants will recruited via phone and email.  
 
Emails will be sent to clinicians by Pediatric Trials Network (PTN) staff members and study 
staff. The email will contain brief information about the study (recruitment materials), a Study 
Information Sheet attachment (in place of a consent form with approval of a waiver of 
documentation of informed consent), and contact information for study personnel.  Clinicians 
interested in participating may use the information in the email to contact study personnel.  
 
Phone calls will be made by study staff to PTN member clinicians. An approved IRB phone 
script will be used by study staff making calls to potential participants.  
 
Because clinicians are busy, we expect that recruitment for the study will require a number of 
contacts before we can schedule physicians for the interview. We will keep a list of any 
clinicians who refuse participation so that they will not be subsequently contacted during the 
recruitment period. 
 
Study staff will review the Study Information Sheet with potential participants, answer any 
questions the clinician has about the study, and screen interested clinicians for eligibility using 
self-reported information obtained over the phone or via email.  

 
 
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4.4 Subject Consent  
Given the design and topic of this interview study (content validity and comprehension of 
clinician reported outcome measures of pediatric sedation), we believe this study qualifies for 
Exempt Research status under 45 CFR 46.104(d)(2)(ii) because: 
 
 The research involves only the use of standard interview procedures; and 
 
 We will have robust confidentiality protections in place to protect the data—but even in 
the unlikely event of participants’ responses being disclosed in identifiable form, we do 
not believe participants would reasonably be placed at risk of criminal or civil liability or 
that the responses would be damaging to the subjects' financial standing, employability, 
or reputation. Our topic is neither personal nor sensitive, and the questions posed to 
participants are intended to ascertain whether the design of a survey is adequate to 
assume content validity and comprehension of survey items and responses by users of the 
questionnaire, not right or wrong answers. 
 
This study does not involve patients; participants will be health care professionals. Participants 
will be provided with a Study Information Sheet that includes a brief description of the study 
objectives and procedures, along with information on data safety and confidentiality.  
 
Agreement to participate in the survey and/or interview will serve as consent to participate in the 
study.  
 
4.5 Early Withdrawal of Subjects 
4.5.1 When and How to Withdraw Subjects 
As this study is a qualitative interview study lasting for only 1-hour, we do not anticipate having 
to withdraw subjects from the study based on safety or non-compliance. However, there may be 
instances in which a participant needs to end the interview early. In these instances, we will work 
to schedule a new time to complete the interview within the following two weeks. If the 
interview cannot be scheduled for completion within 14 days, we will retain the already collected 
data from the participant and consider any uncollected data as missing.  
5 Study Procedures 
Participants will take part in a semi-structured qualitative interview (~1 hour).  
 
One day before the interview, the participant will receive a reminder email with details about 
their phone interview time, the study information sheet, and three documents for use during the 
interview: Definitions (of sedation levels), Scale A (PSSS), and Scale B (UMSS).  
 
At the start of the interview, the interviewer will ask the participant if they received the email 
with the attachments and ask them to pull the email up as the materials will be referenced during 
the interview. The interviewer will send a new copy of the materials if the participant cannot 
locate them.  

 
 
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Participants will then be given a demographic survey, which will be read aloud to them over the 
phone and completed by the interviewer based on answers given by the participant.  
 
After the demographics survey, the interviewer will begin the interview using the interview 
guide. The interview will consist of cognitive interviewing questions related to the survey 
instructions and the surveys’ items and response options on 2 different clinician report pediatric 
sedation scales, the Pediatric Sedation State Scale and the University of Michigan Sedation 
Scale.  
 
Example questions may include:  
 
1. Which scales have you previously used to measure sedation levels in your pediatric patients? 
a. [For any scale mentioned] 
i. How long have you used the [name of referenced scale]? 
ii. What strengths do you think the [name of referenced scale] has? 
iii. What limitations do you think the [name of referenced scale] has? 
2. How clear are the scale instructions?  
3. Looking at the sedation level categories in this scale, how clearly do you think each level is 
defined? 
a. How distinct do you think each category’s definition is from the others? 
b. Are there any terms or phrases that are unclear or might create confusion when scoring 
a child on these levels? 
c. Are they appropriate for pediatric patients in the following age ranges? 
i. <2 year  
ii. 2-6 
iii. 6-12 
iv. 12-18 
 
At the conclusion of the interview, the interviewer will thank the participant for their time and send the 
participant the forms to complete for participant payment. Once forms are completed and returned, the 
interviewer will process an AP check request to have the participant paid.  
6 Statistical Plan 
6.1 Sample Size Determination 
Cognitive interviewing seeks to assess the way in which questionnaire content is understood to 
ensure that what is expected to be measured is actually being measured. The type of logical and 

 
 
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structural problems that we wish to identify are relatively independent of sample size and 
approximately 5-15 interviews per round is a generally accepted guideline for cognitive 
interviews.4 Multiple rounds may be needed if questions need to be revised and retested. Our 
sample minimum sample size will be 18 and the maximum will be 24. This will provide a more 
than adequate sample size. Additionally, the sample will include a minimum of 2 
anesthesiologists, 2 critical care physicians, and 2 nurses to ensure we obtain responses from a 
variety of clinical care professionals.  
6.2 Statistical Methods 
Qualitative research does not incorporate standard statistical methodology, but rather uses 
qualitative analysis methodologies. In this study, at least two analysts will independently review 
transcripts and debriefing forms. During the initial transcript reviews, transcripts will be double 
coded (the same transcript independently coded by two analysts) and coding results compared. 
This will continue until an inter-coder reliability of at least 90% is reached on double coded 
transcripts. After inter-coder reliability is reached, transcripts will be coded individually by only 
one analyst with the exception of every 6th transcript, which will be double coded to ensure the 
continuation of inter-coder reliability. Once review and coding is complete, we will create an 
item-tracking matrix to document changes to the measure, as well as reasons for those changes. 
A summary report will be compiled with our analysis, detailing our process and our findings 
from the cognitive interviews. 
6.3  Subject Population(s) for Analysis 
All participants enrolled into the study who complete phone interviews will be included in the 
study analysis.  
7 Data Handling and Record Keeping 
7.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to Good 
Clinical Practice (GCP) guidelines. All paper based data will be stored in a locked filing cabinet 
in the locked file room of the Population Health Sciences Department. All electronic data will be 
stored on the secure network server of the Department of Population Health sciences where study 
space accessible to only IRB approved study personnel will have access to the study space. 
Identifiable information such as names, phone numbers and email addresses will only be 
recorded for the purposes of scheduling and tracking enrollment/refusals and will be destroyed 
once enrollment is complete. Audio recordings will be destroyed at the completion of data 
analysis.  
 
This study does not collect protected health information (or health information of any kind).  
7.2 Source Documents 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  Source 
data are contained in source documents.   Examples of these original documents, and data 
records include: hospital records, clinical and office charts, laboratory notes, memoranda, 

 
 
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subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate and 
complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject 
files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments 
involved in the clinical trial. 
7.3 Case Report Forms 
The study case report form (CRF) is the primary data collection instrument for the study.  All 
data requested on the CRF must be recorded.  All missing data must be explained.  If a space on 
the CRF is left blank because the procedure was not done or the question was not asked, write 
“N/D”.  If the item is not applicable to the individual case, write “N/A”.  All entries should be 
printed legibly in black ink.  If any entry error has been made, to correct such an error, draw a 
single straight line through the incorrect entry and enter the correct data above it.  All such 
changes must be initialed and dated.  DO NOT ERASE OR WHITE OUT ERRORS.  For 
clarification of illegible or uncertain entries, print the clarification above the item, then initial and 
date it. 
7.4 Records Retention 
 
It is the investigator’s responsibility to retain study essential documents for at least 3 years after 
the study is completed, in compliance with NIH policies. Essential documents include financial 
and programmatic records, supporting documents, statistical records, and all other records that 
are required by the terms of a grant, or may reasonably be considered pertinent to a grant. 
Individual participant data will be retained, at a minimum, through the completion of data 
analysis, but no longer than 3 years. Study results will be retained in participant’s research record 
for at least six years after the study is completed. At that time the research information will be 
destroyed or information identifying participants will be removed from such study results at 
DUHS. No information from this study is entered into DUHS Medical Records.  
 
8 Study Monitoring, Auditing, and Inspecting 
8.1 Study Monitoring Plan 
This study will be monitored via weekly data review meetings and quality control (QC) reviews 
of data files. Weekly data review meetings will include review of study operations including 
enrollment progress, recruitment issues, and review of data summaries from interviews 
completed in the previous week. Data summary reviews will include discussion of completeness 
of data, quality of data, and how effective the interview guides are at collecting the desired data.  
Weekly QC checks for the study will include checking that enrollment logs, participant 
identifiers for scheduling and for the do not re-contact” list, all audio recordings, and all 
transcripts are stored in the appropriate folder on the secure DPHS server. Consent will be 
obtained verbally, so no consent form review will occur. All encrypted audio recorders will be 
checked weekly to ensure no audio files are left on them after being moved to the DPHS secure 
folder for this study. Additionally, the first 3 interview transcripts obtained on the study and 10% 
of subsequent transcripts will be checked to ensure that interviewers are not deviating from 

 
 
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interview scope and are completing interviews as planned. The investigator and Research 
Program Leader will allocate adequate time for such monitoring activities.   
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, the 
sponsor, government regulatory bodies, and University compliance and quality assurance groups 
of all study related documents (e.g. source documents, regulatory documents, data collection 
instruments, study data etc.).  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable University compliance and quality assurance 
offices. 
9 Ethical Considerations 
Given the study design (qualitative interview) and the study topic (content validity and 
comprehension of questionnaire items), we believe this study may qualify for Exempt Research 
status under 45 CFR 46.104(d)(2)(ii). This is because the research involves only the use of 
standard interview procedures. In addition, no personal health information will be collected, and 
the audio-recordings will be destroyed after publication of the interview findings. In the unlikely 
event of interviewees’ responses being disclosed in identifiable form, we do not believe they 
would reasonably be placed at risk of criminal or civil liability or be damaging to the subjects' 
financial standing, employability, or reputation. 
 
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), 
applicable government regulations and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
Ethics Committee (EC) or Institutional Review Board (IRB), in agreement with local legal 
prescriptions, for formal approval of the study conduct.  The decision of the EC/IRB concerning 
the conduct of the study will be made in writing to the investigator and a copy of this decision 
will be provided to the sponsor before commencement of this study.  The investigator should 
provide a list of EC/IRB members and their affiliate to the sponsor. 
 
Per the waiver of documentation of informed consent obtained by this study, all subjects for this 
study will be provided a Study Information Sheet and allowed to ask questions about the study 
prior to agreeing to participate in the study. Agreement to participate in the study will constitute 
consent. The Study Information Sheet will be submitted with the protocol for review and 
approval by the EC/IRB for the study.   
10 Study Finances 
10.1 Funding Source 
This study is funded by a grant from the National Institutes of Health, NICHD, awarded to the 
Pediatric Trials Network. 

 
 
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10.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the 
conflict reviewed by a properly constituted Conflict of Interest Committee with a Committee-
sanctioned conflict management plan that has been reviewed and approved by the study sponsor 
prior to participation in this study.  . 
10.3 Subject Stipends or Payments 
Participants will be paid $100 for participating in the study.  
11 Publication Plan 
The Duke Center for Health Measurement (CHM) acknowledges that this study is funded by the 
Pediatric Trials Network (PTN) and that any publication resulting from this study must undergo 
review by a PTN publication committee.   
 
The study team in CHM shall submit all proposed publications, abstracts and oral presentations 
to the Publication Committee for review and comment at least thirty (30) days prior to 
submission for publications, seven (7) days for abstracts, and thirty (30) days for oral 
presentations, and shall consider in good faith all comments provided by the Publication 
Committee during that review period.  Should this review determine that the manuscript contains 
patentable matter requiring protection, the Duke CHM team shall delay publication for a period 
of not longer than an additional sixty (60) days to allow such protection to be sought. 
 
Publications and Publicity shall be governed by the requirements set forth in HHSAR Clause 
352.227-70 of Exhibit A..  In addition, all publications shall comply with the NIH Public Access 
Policy (http://publicaccess.nih.gov/) and acknowledge NIH support whenever publicizing the 
work under this contract in any media by including an acknowledgment substantially as follows: 
“This project has been funded in whole or in part with Federal funds from the Eunice Kennedy 
Shriver National Institute of Child Health and Human Development, National Institutes of 
Health, Department of Health and Human Services, under Contract No. HHSN275201000003I.” 
Where registration is required for publication of the results in International Committee of 
Medical Journal Editors (“ICMJE”) journals, or if otherwise required to be registered by law or 
regulation, DUKE shall insure that the STUDY is registered with either www.clinicaltrials.gov, 
or another registry meeting the requirements of the International Committee of Medical Journal 
Editors (“ICMJE”) in effect at the time the STUDY is initiated. 
12 References 
1. 
Mahmoud M, Mason KP. A forecast of relevant pediatric sedation trends. Current 
opinion in anaesthesiology. 2016;29 Suppl 1:S56-67. 
2. 
Sachs AN, Avant D, Lee CS, Rodriguez W, Murphy MD. Pediatric information in drug 
product labeling. Jama. 2012;307(18):1914-1915. 
3. 
Wang LA, Cohen-Wolkowiez M, Gonzalez D. Advances in Pediatric Pharmacology, 
Therapeutics, and Toxicology. Advances in pediatrics. 2016;63(1):227-254. 
4. 
Willis GB. Cognitive Interviewing: A Tool for Improving Questionnaire Design. 
Thousand Oaks, California: Sage Publications; 2005. 

 
 
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13 Attachments 
Attached Documents:  
 Appendix A – Study Information Sheet  
 Appendix B – Recruitment Email 
 Appendix C – Recruitment Flyer 
 Appendix D – Phone Script  
 Appendix E – Definitions 
 Appendix F – Scale A (PSSS) 
 Appendix G – Scale B (UMSS) 
 Appendix H – Demographics Form  
 Appendix I – Interview Guide – PSSS First 
 Appendix J – Interview Guide – UMSS First 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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14 Appendix A – Study Information Sheet (SIS) 
 
 
 
 

 
 
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15 Appendix B – Recruitment Email 
 

 
 
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16 Appendix C – Recruitment Flyer 
 
 

 
 
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17 Appendix D – Phone Script  
 
 

 
 
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18 Appendix E – Definitions 
 

 
 
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19 Appendix F – Scale A 
 

 
 
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20 Appendix G – Scale B 
 

 
 
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21 Appendix H – Demographics  
 

 
 
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22 Appendix I– Interview Guide – PSSS First 
 

 
 
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23 Appendix I– Interview Guide – UMSS First  
 

 
 
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