The Covid-19 HEalth caRe wOrkErS (HEROES) Study (HEROES)

March 26, 2021 updated by: Rubén Alvarado, University of Chile

The Impact of the Covid-19 Pandemic on the Mental Health of Workers in Health Services: The Covid-19 HEalth caRe wOrkErS (HEROES) Study

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress).

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Study Overview

Detailed Description

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Based on the literature to date, Covid-19 is significantly larger than previous pandemics in terms of the number of affected people worldwide, its spread across countries, its impact on healthcare systems and the severity of measures that have been taken by governments. Immediate consequences are palpable in the health care system. Many healthcare workers are overwhelmed by the increased workload; the lack of supplies and materials to provide appropriate treatment; the lack of clinical guidelines on prioritization and triage; and the increased feelings of isolation and loneliness. Previous research indicates that these negative effects can last over time and lead to the development of serious mental health problems such as post-traumatic stress disorder.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). Also, it is necessary to take into account the nature and the extent of the health response (e.g., deployment, increased workload) in order to advance our understanding of these complex phenomenon and to inform policy and develop the kind of supports that this population deems useful.

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Participants will complete an online questionnaire, which will be completely self-administered. It will take approximately 12 minutes and includes sociodemographic data, questions on work activity, training, fears and concerns related to Covid-19, as well as the GHQ-12 and a series of questions on other mental health issues (e.g., suicide, acute stress), resilience and psycho/social factors (e.g., formal and informal support).

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Chubut
      • Rawson, Chubut, Argentina, 9103
        • Recruiting
        • Universidad del Chubut
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcela Inés Freytes Frey, PhD
        • Sub-Investigator:
          • María Belén Pastrián, PhD
        • Sub-Investigator:
          • Mónica Elba Borile
        • Sub-Investigator:
          • Amanda Gotti
        • Sub-Investigator:
          • María Verónica Vila
        • Sub-Investigator:
          • Juliana Andrieu, PhD
        • Sub-Investigator:
          • Marina Veleda
        • Sub-Investigator:
          • Maura Rojas
        • Sub-Investigator:
          • Cecilia Pedernera
        • Sub-Investigator:
          • Leticia Macerla Baéz
        • Sub-Investigator:
          • Soledad Fabiana Peña
        • Sub-Investigator:
          • Marcelo Fabián Vaccaro
        • Sub-Investigator:
          • Nancy Copa
        • Sub-Investigator:
          • Cecilia Russo
        • Sub-Investigator:
          • Paula Ulivarri
        • Sub-Investigator:
          • Amelia Clark
        • Sub-Investigator:
          • Virginia Jaime
        • Sub-Investigator:
          • Laura Rojo
        • Sub-Investigator:
          • María Virginia Jaime
        • Sub-Investigator:
          • Efi Jockers
        • Sub-Investigator:
          • Verónica Cuevas
        • Sub-Investigator:
          • Víctor Igarribay
        • Sub-Investigator:
          • Miguel Tolaba
      • Yerevan, Armenia, 0051
        • Recruiting
        • National Institute of Health Named After Academician S. Avdalbekyan
        • Contact:
        • Principal Investigator:
          • Arin A Balalian, MD, MPH
        • Sub-Investigator:
          • Anna Isahakyan, MD
        • Sub-Investigator:
          • Khachatur Gasparyan, PhD
        • Sub-Investigator:
          • Alexander Bazarchyan, MD, PhD
    • New South Wales
      • Sidney, New South Wales, Australia, 2031
        • Not yet recruiting
        • University of Sydney
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sonja Memedovic, PhD
        • Sub-Investigator:
          • Clare McCormack, PhD
        • Sub-Investigator:
          • Louisa Degenhardt, PhD
    • Chuquisaca
      • Sucre, Chuquisaca, Bolivia
        • Not yet recruiting
        • Salud Global
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Teresa Solís Soto, MD, PhD
        • Sub-Investigator:
          • Armando Basagoitia Echalar, MD, MsC
        • Sub-Investigator:
          • Víctor Estrada, MD, MsC
      • Santiago, Chile
        • Not yet recruiting
        • University of Chile
        • Contact:
        • Sub-Investigator:
          • Sara Schilling, MPH
        • Sub-Investigator:
          • Eric Tapia, MPH
        • Principal Investigator:
          • Ruben Alvarado, PhD
      • Heredia, Costa Rica, 863000
        • Not yet recruiting
        • Universidad Nacional de Costa Rica
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan José Romero Zúñiga, PhD
        • Sub-Investigator:
          • Marianela Rojas Garbanzo, PhD
        • Sub-Investigator:
          • Iliana Araya Ramírez, PhD
        • Sub-Investigator:
          • María Chaves Villalobos, MsC
        • Sub-Investigator:
          • Alejandra Gamboa Jiménez, MD
        • Sub-Investigator:
          • Omar Barrantes Sotela, MsC
        • Sub-Investigator:
          • Raúl Ortega Moreno, MsC
        • Sub-Investigator:
          • Zaida Salazar Mora, MD
    • Bohemia
      • Kladno, Bohemia, Czechia, 27201
        • Recruiting
        • Society for Emergecy and Disaster Medicine CzMA JEP
        • Contact:
          • Jana Seblova, MD, PhD
          • Phone Number: 00420724568877
          • Email: seblo@volny.cz
        • Principal Investigator:
          • Jana Seblova, MD, PhD
        • Sub-Investigator:
          • Dominika Seblova, PhD
        • Sub-Investigator:
          • Dita Protopovová, MD, PhD
        • Sub-Investigator:
          • Roman Gregor, MD, MBA
    • Niedersachsen
      • Emden, Niedersachsen, Germany, 26723
        • Recruiting
        • Hochschule Emden/Leer
        • Contact:
        • Contact:
          • Marta Natan
        • Principal Investigator:
          • Jutta Lindert, MD, PhD
        • Sub-Investigator:
          • Marta Natan
        • Sub-Investigator:
          • Felix Sisenop
      • Guatemala City, Guatemala, 01011
        • Recruiting
        • Centro de Investigaciones de las Ciencias de la Salud -CICS- Facultad de Ciencias Médicas Universidad de San Carlos de Guatemala -USAC-
        • Contact:
        • Contact:
        • Principal Investigator:
          • Víctor Puac-Polanco, MD, MsC
        • Sub-Investigator:
          • Alejandra Paniagua-Avila, MD, MPH
        • Sub-Investigator:
          • Aida Barrera, MD, MsC
        • Sub-Investigator:
          • Erwin Calgua Guerra, MD, MsC
        • Sub-Investigator:
          • Dorian Ramírez Flores, MD, MsC, MPH
      • Cagliari, Italy
        • Not yet recruiting
        • University of Cagliari
        • Contact:
        • Sub-Investigator:
          • Mauro Carta, MD
        • Principal Investigator:
          • Francesca Moro, MD
    • CA
      • Cagliari, CA, Italy, 09124
        • Recruiting
        • University of Cagliari
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Francesca Moro, MD
        • Sub-Investigator:
          • Mauro Giovanni Carta, MD
        • Sub-Investigator:
          • Peter K Kurotschka, MD
      • Beirut, Lebanon, 11002110
        • Not yet recruiting
        • The Institute for Development Research Advocacy and Applied Care (IDRAAC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elie Karam, MD
        • Sub-Investigator:
          • Georges Karam, MD
        • Sub-Investigator:
          • Rachad Rayess, MD
        • Sub-Investigator:
          • Rita Khoury, MD
        • Sub-Investigator:
          • Aimée Karam, PhD
        • Sub-Investigator:
          • Caroline Cordahi, DEA
        • Sub-Investigator:
          • Youmna Cassir, DESS
        • Sub-Investigator:
          • Zaher Krayem, PhD
        • Sub-Investigator:
          • Dahlia Saab, MPH
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45170
        • Recruiting
        • Logotipo del comercio Instituto Jalisciense De Salud Mental (SALME)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sol Durand Arias, MD, MsC
        • Sub-Investigator:
          • Jaime Carmona Huera, MD, PhD
        • Sub-Investigator:
          • Allen Ackel Rodriguez, BsC
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229
        • Not yet recruiting
        • Maastricht University
        • Contact:
        • Principal Investigator:
          • Els van der Ven, PhD
        • Sub-Investigator:
          • Bart Rutten, MD, PhD
        • Sub-Investigator:
          • Frederike Schirmbeck, PhD
        • Sub-Investigator:
          • Nikki Lee, PhD
        • Sub-Investigator:
          • Afra van der Markt, MD
    • Oyo State
      • Ibadan, Oyo State, Nigeria, 200220
        • Not yet recruiting
        • University of Ibadan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oye Gureje, MD, PhD
        • Sub-Investigator:
          • Olatunde Ayinde, MD, MsC
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • Ponce Health Sciences University
        • Contact:
        • Principal Investigator:
          • Eliut Rivera-Segarra, PhD
        • Sub-Investigator:
          • Malynie Blanco, MD
        • Sub-Investigator:
          • Mirna Luz Arroyo Miranda, PhD, JD
        • Sub-Investigator:
          • Irma Torres, PsyD
        • Sub-Investigator:
          • Alíxida Ramos-Pibernus, PhD, MRC
        • Sub-Investigator:
          • Normarie Torres-Blasco, PhD
        • Sub-Investigator:
          • Ernesto Rosario-Hernández, PhD
    • Central
      • Riyadh, Central, Saudi Arabia, 11522
        • Not yet recruiting
        • King Abdullah International Medical Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sulaiman Alghnam, PhD
        • Sub-Investigator:
          • Lubna Alnasser, BDS, MPH
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital La Paz Institute for Health Research (IdiPAZ)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria-Fe Bravo-Ortiz, MD, PhD
        • Sub-Investigator:
          • Eduardo Fernández-Jiménez, PhD
        • Sub-Investigator:
          • Gonzalo Martínez-Alés, MD
        • Sub-Investigator:
          • Roberto Mediavilla, PhD
    • La Manouba
      • Tunis, La Manouba, Tunisia
        • Recruiting
        • Razi Hospital La Manouba
        • Contact:
        • Contact:
        • Principal Investigator:
          • Uta Ouali, MD
        • Sub-Investigator:
          • Fethi Nacef, MD
        • Sub-Investigator:
          • Amira Jamoussi, MD
        • Sub-Investigator:
          • Dorra Khattech, MsC
    • Sariyer
      • Istanbul, Sariyer, Turkey, 34450
        • Active, not recruiting
        • Koc University
    • New York
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University
    • Aragua
      • Maracay, Aragua, Venezuela, 2103
        • Recruiting
        • PNFA Salud Colectiva Instituto de Altos Estudios Dr Arnoldo Gabaldon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Maria Rodrigues Rodrigues, MsC
        • Sub-Investigator:
          • Juan Quintana, PhD
        • Sub-Investigator:
          • Francis Saavedra, MsC
        • Sub-Investigator:
          • Julián Díaz, MsC
        • Sub-Investigator:
          • Pedro Alcalá, PhD
        • Sub-Investigator:
          • Oscar Feo, MsC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services)

Description

Inclusion Criteria:

  • Legal age
  • Currently working on a health service that provides care to COVID-19 patients
  • Give informed consent

Exclusion Criteria:

  • Inability to use electronic devices (required to complete the survey)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthcare workers
Workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services)
This is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depressive symptoms
Time Frame: 12 months
The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences, fears and concerns about the Covid-19
Time Frame: Baseline
Ad hoc survey on experiences, fears, and concerns about Covid-19
Baseline
Experiences, fears and concerns about the Covid-19
Time Frame: 3 months
Ad hoc survey on experiences, fears, and concerns about Covid-19
3 months
Experiences, fears and concerns about the Covid-19
Time Frame: 6 months
Ad hoc survey on experiences, fears, and concerns about Covid-19
6 months
Experiences, fears and concerns about the Covid-19
Time Frame: 12 months
Ad hoc survey on experiences, fears, and concerns about Covid-19
12 months
Training and resource prioritization
Time Frame: Baseline
Ad hoc survey on Covid-19 training and resource prioritization
Baseline
Training and resource prioritization
Time Frame: 3 months
Ad hoc survey on Covid-19 training and resource prioritization
3 months
Training and resource prioritization
Time Frame: 6 months
Ad hoc survey on Covid-19 training and resource prioritization
6 months
Training and resource prioritization
Time Frame: 12 months
Ad hoc survey on Covid-19 training and resource prioritization
12 months
Suicide ideation (presence)
Time Frame: Baseline
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Baseline
Suicide ideation (presence)
Time Frame: 3 months
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
3 months
Suicide ideation (presence)
Time Frame: 6 months
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
6 months
Suicide ideation (presence)
Time Frame: 12 months
Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
12 months
Suicide ideation (frequency)
Time Frame: Baseline
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Baseline
Suicide ideation (frequency)
Time Frame: 3 months
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
3 months
Suicide ideation (frequency)
Time Frame: 6 months
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
6 months
Suicide ideation (frequency)
Time Frame: 12 months
5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
12 months
Acute stress symptoms
Time Frame: Baseline
Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Baseline
Acute stress symptoms
Time Frame: 3 months
Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
3 months
Acute stress symptoms
Time Frame: 6 months
Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
6 months
Acute stress symptoms
Time Frame: 12 months
Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
12 months
Psycho/social support and network
Time Frame: Baseline
Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
Baseline
Psycho/social support and network
Time Frame: 3 months
Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
3 months
Psycho/social support and network
Time Frame: 6 months
Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
6 months
Psycho/social support and network
Time Frame: 12 months
Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
12 months
Resilience
Time Frame: Baseline
The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
Baseline
Resilience
Time Frame: 3 months
The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
3 months
Resilience
Time Frame: 6 months
The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
6 months
Resilience
Time Frame: 12 months
The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
12 months
Anxiety and depressive symptoms
Time Frame: Baseline
The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
Baseline
Anxiety and depressive symptoms
Time Frame: 3 months
The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
3 months
Anxiety and depressive symptoms
Time Frame: 6 months
The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Rubén Alvarado, PhD, University of Chile [Universidad de Chile]
  • Principal Investigator: Ezra Susser, MD DrPH, Columbia University
  • Principal Investigator: Franco Mascayano, MPH, Columbia Universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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