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CTRI Number  CTRI/2025/02/080827 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Survey 
Study Design  Other 
Public Title of Study   GROUP ANALYSIS ON GENDER DISCRIMINATION IN CRITICAL CARE 
Scientific Title of Study   DELPHI PROCESS TO ACHIEVE GLOBAL CONSENSUS ON GENDER EQUITY IN CRITICAL CARE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Main Building,Second Floor, Dr E Borges Road, Parel Mumbai Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Main Building,Second Floor, Dr E Borges Road, Parel Mumbai Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Main Building,Second Floor, Dr E Borges Road, Parel Mumbai Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital,  
Address  Dr E Borges Road, Parel Mumbai-400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     Australia
Brazil
Canada
Germany
India
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila N Myatra  Tata Memorial Hospital, Mumbai  MB 101 and 201, Intensive Care Units, First and Second Floor, Main Building, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA 
9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Medical Ssciences Institute of Medical Sciences Banaras Hindu University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Working in Critical Care department 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Professionals working in Intensive Care, Critical Care Practitioner, Scientists, or Researcher
2.Any one of the following: having publications, engagement in advocacy related to gender equity, and currently or in the past holding an official leadership position in the Critical Care Society, Intensive care unit, or a healthcare institution
3.Completed the Harvard Implicit Association Test (IAT)5

We will also include 3-5 critical care trainees, for whom these criteria would be liberalized. The identity of the panelists will not be revealed to each other until the end of the Delphi rounds.
 
 
ExclusionCriteria 
Details  1.consent refusal
2. under 18 years of age healthcare professionals
3. healthcare professionals not working in Critical care.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To generate consensus among global critical care practitioners on position statements aimed at addressing gender equity (all genders) in critical care.  1 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION: Gender inequalities in healthcare, including among critical care professionals, have been widely recognized over the last decade. Significant gender disparities persist in areas including leadership, academia, research, workplace remuneration, and medical publication among critical care professionals. Furthermore, there remains a notable gap in knowledge and awareness regarding gender equity (all genders) and inclusivity among healthcare professionals.

 

Given the limited research and evidence on these issues, we propose employing the Delphi methodology to generate consensus among global critical care practitioners on position statements aimed at addressing gender equity (all genders) in critical care.

 

OBJECTIVES: To generate consensus among a diverse panel of critical care practitioners, scientists, and researchers on the strategic measures to achieve gender equity in critical care within healthcare institutions, professional societies, organizations, and boards in various professional domains.

 

 

METHODOLOGY: An International Steering Committee (SC) comprised of healthcare professionals involved in the advocacy of gender equity among professionals working in the field of critical care medicine has been constituted. The Steering Committee will select a diverse global panel

 

STATISTICAL ANALYSIS: A descriptive analysis of each Delphi round will be performed and cumulative voting will be used for consensus. Consensus will be defined as at least 75% of panelists agreeing or disagreeing with a Likert-scale statement or selecting a specific option in multiple-choice questions. The stability of the responses will be evaluated by non-parametric chi-square tests or Kruskal-Wallis test from round two onwards. A response will be considered stable if the p-value is 0.05 when comparing results across two consecutive rounds. Statements will continue through the Delphi rounds until stability is attained. Final position statements will be those that demonstrate both consensus and stability.

 
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