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The GOING-FWD
(Gender Outcomes INternational Group: to
Further Well-being Development)
Project
HOW TO INTEGRATE SEX AND GENDER
IN CLINICAL PRACTICE
September 13, 2019
Valeria Raparelli, Maria Trinidad Herrero, Elizabeth O. Johnson, Alexandra Kautzky-Willer,
Karolina Kublickiene, Colleen M. Norris, Louise Pilote
I DO NOT have any
relevant FINANCIAL relationships to disclose.
Disclosures Statement
20/11/2019 Titolo Presentazione Pagina 3
Raparelli V, Proietti M, Basili S. Heart. 2018 Dec;104(23):1900-01
INTEGRATION OF SEX AND GENDER DIMENSIONS IN CLINICAL
RESEARCH …IS A PRIORITY BUT IT IS CHALLENGING…
Lack of standard
measurement
How can we measure such
psycho-socio-cultural
complexity?
December 2017 December 2018 March 2019
GOOD HEALTH AND WELL-BEING IN NON-COMMUNICABLE
CHRONIC DISEASES: Call for Action
Topic 1.3. SEX, GENDER AND HEALTH
Colleen M. Norris Louise Pilote Valeria Raparelli
Maria Trinidad Herrero
Elizabeth O. Johnson
Alexandra Kautzky-Willer
Karolina Kublickiene
The overarching aims of this large consortium
are to integrate sex and gender dimensions
in applied health research, to evaluate their
impact on clinical cost-sensitive outcomes
and patients reported outcomes (PROMs)
related to quality of life in Non-Communicable
Diseases (NCD)
GOING-FWD AIM
CANADIAN COORDINATION L. Pilote (CAN) C. Norris (CAN)
V. Raparelli (CAN)
(Lead Investigators)
SCIENTIFIC ADVISORY COMMITTEE Vera Regitz-Zagrosek (GER)
Rachel Dreyer (USA) Londa Schiebinger (USA)
Carole Clair (SWI)
Work Package 3 Aim: KT and Dissemination
• K. Kublickiene (SWE) • M. Parry (CAN) • M.T. Herrero (ESP)
Deliverable 1 Gender Variables-derived Database/Gender Scores/Modeling risk
•Publication •Interventions •eHealth App
•Training Modules •Online Tools
Site Principal Investigator Spain
M.T. Herrero
Site Principal Investigator Austria
A. Kautzy-Willer
Site Principal Investigator Sweden
K. Kublickiene
Site Principal Investigator Cyprus
E. Johnson
Site Principal Investigator Canada L. Pilote
Deliverable 2
AVAILABLE DATABASE
(Administrative/Prospective Cohorts)
CARDIOVASCULAR DISEASE
CAN, AUT, SWE, ESP
METABOLIC DISEASE
CAN, AUT, ESP
CHRONIC KIDNEY DISEASE
CAN, AUT, SWE
NEUROLOGICAL DISORDERS
CAN, ESP, CYP
INTERNATIONAL NETWORK RESEARCH MULTIDISCIPLINARY EXPERTISE IN GENDER AND NON COMMUNICABLE CHRONIC DISEASE
Site Investigators Pilote L: Gender Expert, Epidemiology /CVD Collen N: Gender Expert, Epidemiology /CVD Raparelli V: CVD, Endocrinology Humphries K: Women CV Health Parry M: Health Outcomes/Nursing/IT/KT Bacon S: Patient Oriented research/Methodology Sapir-Pichhadze R: Kidney Disease Abrahamowicz M: Biostatistician Fishman J: Biomedical Ethics
Site Investigators Kautzy-Willer: Gender Expert/Endocrinology Etter SB: Methodology, Network Analysis Klimek P: Methodology, Network Analysis Dorner T: Public Health/Social Science Harreiter J: Endocrinology, Pregnancy, Gender Medicine Deischinger C: PhD Student
Site Investigators Kublickiene K: Gender Expert/Gendered KT Innovation Alliance Post-doctoral Program Rashid Qureshi A: Methodology/Biostatistician Stenvinkel P: Kidney Disease Bruchfeld A: Kidney Disease
Site Investigators Johnson E: Neurology/ Psychoneuroendocrinology /Education Johnson E: Neurological Disease Stephanou A: CVD/Knowledge Translation Pantzaris M: Neurology Themistokleous S: Post-Doc
Site Investigators Herrero MT: Neurology/Communication Lozano MLP: Post-doc/MD Fernandez-Villalba E: Neurology Palma Mendez J: Computer Science Fernandez Aleman JL: Computer Science Navarro Noguerra: PhD Psychology Mascarell Llorens: PhD Student
Work Package 2
Aim: Identification of Cost-Sensitive and PROMs
• K. Humphries & Team (CAN) • A. Kautzy-Willer & Team (AUT)
Work Package 1
Aim: Identification GENDER-RELATED VARIABLES
• C. Norris & team (CAN) • E. Johnson & team (CYP)
STEERING COMMITTEE
L. Pilote (CAN) C. Norris (CAN) V. Raparelli (CAN) A.Kautzy-Willer (AUT)
K. Kublickiene (SWE) M.T. Herrero (ESP) E. Johnson (CYP)
Cardiovascular
disease
Metabolic disease -
Diabetes
Chronic Kidney
Disease
Neurological
Disease
Non-communicable Chronic Disease
Gender-Related Factors Gender framework of the Women Health Research Network
Outcomes 1 – Clinical Cost Sensitive
Mortality
Hospitalization
Readmission
Disease-Specific Outcomes
Diabetes Chronic Kidney Disease Coronary Artery Disease
International Consortium for Health Outcomes Measurement
Patient Reported Outcome
Measures (PROMs)
Patient Reported Experience
Measures (PREMs)
Measures impact of an illness or
health condition from the patient’s
perspective
Captures the patient’s view of what
happened during their healthcare visit
(process of healthcare)
Examples:
quality of life, symptom severity,
functional status, health status
Examples:
Communication and trust in staff,
cleanliness, timeliness
Used to monitor the progress of a
health condition or whether a treatment
has been effective by comparing
results over time
Used to evaluate and monitor service
delivery
Measured from the patient’s perspective, usually via questionnaires
Used together to assess quality of care and services from patient’s viewpoint
Outcomes 1 – Patient Related
Sex and Gender Determinants
SEX -Biomedical Factors -Laboratory Biomarkers -Traditional Risk Factors
GENDER
-Roles -Identity -Institutionalized Gender -Relations
Disease/
Conditions
Cardiovascular Disease
Metabolic Syndrome
Chronic Kidney Disease
Neurological Disease
Outcomes
Clinical/ Cost-Sensitive
Outcomes
Patient-Reported Outcome Measures
-Mortality -Hospitalization -Readmission -Disease
Progression
-Patient Surveys -Questionnaires
Conceptual Framework
32 Cohorts
30 Million of patients
30 Investigators
5 Countries
4 main clinical areas
GOING-FWD
NUMBERS
STEP 1 - IDENTIFICATION OF GENDER-RELATED VARIABLES
STEP 2 - DEFINITION OF OUTCOMES
STEP 3 –
BUILDING OF FEASIBLE FINAL VARIABLES LIST
STEP 4 - RETROSPECTIVE DATA HARMONIZATION
STEP 5 - DEFINITION OF DATA STRUCTURE
GOING-FWD METHODOLOGY
MULTISTEP PROCESS
We developed a standard methodology that can be
applied in pre-existing cohort studies for the integration
of gender-related factors in assessing their impact on
health outcomes
Each variable was discussed
at the inaugural meeting
(April 2019, Montreal) of the
GOING-FWD investigators
and consensus was reached
on a final list of “gender-
related” and “outcome”
variables.
STEP 1 and 2 – DEFINITION OF VARIABLE WISH LIST
STEP 1- IDENTIFICATION OF GENDER-RELATED VARIABLES Roles
Primary earner status
Employment Status
Occupation
Paid Work hours per week
Unpaid work hours per week(eg care giver hours)
Full/part time work
Child caregiver responsibilities The individual or others
Adult caregiver responsibilities
Number of hours per week spent on housework
Status of household’s primary responsibility
Number of children
Relations
Marital/Relationship Status
Family or local network (social capital)
Social support
Social support (any recognized social support instrument)
Availability of Caretaker (for self)
Institutionalized variables
Educational Level
SES/Income
Monthly finances
Income (personal, household)
Number of persons living in household
Retirement eligibilities
Perceived Social Standing Questionnaire *McArthur Scale
GII (Gender inequality index) Questionnaire *
Maternity Paternity related variables
Identity
Stress
14-Item Perceived stress scale (PSS) *
Stress level at work (any measure of stress)
Stress level at home (any measure of stress)
Stress management
Personality traits
Emotional intelligence Questionnaire *
Any validated measures of personality (NEO classic 5 personality traits
BEMS (instrument) measurement of gender identity
Depression/Anxiety
Patient Health Questionnaire-9 *
HAD Scale - Hospital Anxiety and Depression Scale*
Anxiety/Depression any scale
Childhood trauma (reported history)
Discrimination
Day-to-day experiences
Perceived bias
Stigmatization
Violence (hx or present)
Intimate partner domestic
Ethnic violence
Sexual orientation
Immigration Status
Behavioral/Lifestyle Risk Factors
European Health Determinants Module
Current smoking
Smoking history
Cigarettes per day
Physical activity
Physical activity (self-reported: PPAQ)
Physical activity (accelerometer)
Food diary - Diet quality index
Alcohol consumption
Substance use (Use of drugs)
Nutrition
Overall diet quality index
Physical activity barriers (fatigue, lack of motivation, etc.)
Nutrition barriers (enpensiveness, lack of motivation, etc.)
Physical activity facilitators (social support, self-motivation, etc.)
Nutrition facilitators (social support, self-motivation, etc.)
WISH
LIST 1
STEP 1- IDENTIFICATION OF GENDER-RELATED VARIABLES
WISH
LIST 1
STEP 1- IDENTIFICATION OF GENDER-RELATED VARIABLES
WISH
LIST 1
STEP 1- IDENTIFICATION OF GENDER-RELATED VARIABLES
WISH
LIST 1
STEP 1- IDENTIFICATION OF GENDER-RELATED VARIABLES
WISH
LIST 1
Each of the cohort data dictionaries were
screened for outcomes of interest outlined in
the GOING FWD proposal
Clinical Outcomes and Patient-Reported
Outcome Measures (specific for disease)
STEP 2 - DEFINITION OF OUTCOMES
International Consortium for Health Outcomes Measurement
WISH
LIST 2
Work Package 2
Aim: Identification of Cost-Sensitive and PROMs
• K. Humphries & Team (CAN) • A. Kautzy-Willer & Team (AUT)
A cross-validation (double blinded) between variables (i.e.
gender-related factors and outcomes) available per database (data
dictionary) was performed.
In case of disagreement or discordant definitions of variables, a
more inclusive approach was pursued for both gender-related
variables and outcomes.
STEP 3 - BUILDING OF FEASIBLE FINAL VARIABLE LIST
Cross-Check
WISH LIST ACTUAL DATA
Finally, a list of harmonized variables will be created using the Maelstrom Research guidelines for rigorous retrospective data harmonization and merging when possible.
STEP 4 - RETROSPECTIVE DATA HARMONIZATION
HARMONIZATION - Process of bringing together data of
varying formats in order to generate one cohesive data set
Vienna – September 11° 2019, 2nd GOING FWD Meeting
STEP 5 – DEFINITION OF DATA STRUCTURE
Summary data meta-analysis
Study-specific data analyses done locally followed by a meta-analysis combining the study-level estimates
Pooled analysis
Data pooled and analyzed in a central location
Federated analysis
Analyses done centrally, but the individual-level participant data can remain on local servers
Sharing of IPD Harmonization: local or
central Analysis: central
Sharing (or not) of IPD Harmonization: local or
central Analysis: central
No sharing of IPD Harmonization: local
Analysis: local
Depending on the type of database, each partner then provided the data management structure and the
analysis plan based on the following options:
• Personalized medicine approach is increasingly appreciated in
clinical research.
• Analysis of already collected data requires a proper definition
of variables and measures included.
• The existing lack of a standardized gender measure poses
challenges which might be mitigated via application of a
systematic multistep approach (5 steps) currently suggested
and currently tested by our multidisciplinary team.
CONCLUSION
• Understanding of how sex and gender-related factors
impact NCDs will help to improve clinical and patient-
related outcomes.
• Potential to identify gender variables (psycho-
social factors) that can be collected prospectively
• Tailor future interventions with a sex- and gender-
specific approach.
CONCLUSION
WHAT’S NEXT?
• Finalize Ethical Approval for Each Country/database
• Starting the harmonization process: evaluate harmonization potential
• Systematic Reviews
• Define the best data analysis plan: traditional vs artificial intelligence approach based on the data and research question
STAY TUNED!!!
https://mcgill.ca/going-fwd4gender/
GOINGFWD2019@outlook.com
Work Package 3 Aim: KT and Dissemination
• K. Kublickiene (SWE) • M. Parry (CAN) • M.T. Herrero (ESP)
THANK YOU TO ALL THE MEMBERS OF
THE GOING-FWD CONSORTIUM
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