| 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
|
|
|
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
|
|
|
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
|
|
|
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. |