跳至主要内容
临床试验/NCT05513456
NCT05513456招募中不适用

Ethnic and Gender Based Admittance Patterns in the ICU, a Multicenter, International Randomized Survey Study

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
2
主要终点
Ratio of ICU admission men vs women

研究概览

简要总结

The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown.

Factors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity.

This study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons?

The investigators propose testing this hypothesis using a blinded randomized factorial survey study.

详细描述

Background Differing treatment of men and women in several fields of health care is receiving growing attention. This includes care of the critically ill, as awareness of intensive care has dramatically increased during the last years. Critically ill patients are treated in Intensive Care Units (ICU), one of the most expensive and advanced types of care. It is therefore essential that resources are adequately used so that the patient most in need is selected for intensive care, but also that no patient in need is left without.

The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. It has also been shown that women and men with severe sepsis receive differential care in the emergency department. These differences do not unambiguously translate into a survival benefit for men; studies show conflicting results. One could only speculate if survival figures would be altered if women were admitted to ICU in the same extent. Sex is a biological variable that affects the immune system and changes throughout life. It is proposed that sex hormones have an impact on how the severity of an illness progresses, where female sex hormones are suggested to have a protective effect. This could partly explain male dominance in the ICU. There is no clear evidence that care given in the ICU should be tailored after the sex of the patient. Then again, there is no clear evidence that the medical care should not be tailored after the sex of the patient. Differing care provided to men and women is therefore controversial. If differences exist, it must be ruled out that it is caused by gender bias, unintentional or not.

As discussed in a recently published Guidance on Reporting of Race and Ethnicity in Medical and Science Journals, Ethnicity are social constructs, without scientific or biological meaning. However, studies including ethnicity may be useful to improve understanding and knowledge of disparities and inequities in health care. Three decades ago, US Department of Health and Human Services published a report on Black and minority health, highlighting ethnic differences. (S Department of Health and Human Services. Report of the Secretary's Task Force on Black and Minority Health. 1985. https://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset). Whilst recent studies show reductions in racial and ethnic differences in self-reported health status and health care access and affordability, variances persist. During the COVID-19 pandemic it has become apparent that differences in progression to severe disease exist. In a cohort study using the OpenSAFELY platform in England, including more than 17 million adults, some minority ethnic populations had increased risk of severe COVID-19 as compared with the White population, also after taking other factors of importance into account.

Specific aims When admitting patients to our ICUs, do clinicians discriminate against certain ethnicities? Are thresholds for admitting men lower than for women? The investigators hypothesize that differing ICU admission thresholds exist, due to non-medical reasons.

Method The investigators propose testing this hypothesis using a blinded randomized factorial survey study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • We will include intensive care physicians, both in training and specialists as responders in this randomized survey study

排除标准

  • We will exclude "button-mashers", i.e. participating respondents that toggle through the case descriptions faster than they possibly could read the case description. A case answered <20 seconds will be ruled out.

结局指标

主要结局

Ratio of ICU admission men vs women

时间窗: Through study completion, an average of 1 year

Exact same case descriptions except for the fact that the sex/gender is randomized

Ratio of ICU admission ethnic background

时间窗: Through study completion, an average of 1 year

Exact same case descriptions except for the fact that the name/ethnic background is randomized

次要结局

  • Time to ICU admission men vs women(Through study completion, an average of 1 year)
  • Time to ICU admission ethnic background(Through study completion, an average of 1 year)
  • Time-out sex/gender(Through study completion, an average of 1 year)
  • Time-out described ethnicity(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Max Bell

Principal Investigator

Karolinska Institutet

研究点 (2)

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