scholarly journals Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies

Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 476 ◽  
Author(s):  
Flavia Franconi ◽  
Ilaria Campesi ◽  
Delia Colombo ◽  
Paola Antonini
Keyword(s):  
Clinical Trials ◽  
Environmental Factors ◽  
Gender Gap ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Sex And Gender ◽  
Key Factors ◽  
And Gender ◽  
Scientific Value ◽  
Racial Ethnic

There is a clear sex–gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex–gender into clinical trials.

scholarly journals Statins in Heart Failure: The Paradox Between Large Randomized Clinical Trials and Real Life

2012 ◽  
Vol 87 (6) ◽  
pp. 555-560 ◽  
Author(s):  
Paloma Gastelurrutia ◽  
Josep Lupón ◽  
Marta de Antonio ◽  
Agustin Urrutia ◽  
Crisanto Díez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Real Life

Reverse tomboy: (Re)definitions of gender fluidity through sensory engagement with material culture

2020 ◽  
Vol 5 (2-3) ◽  
pp. 149-170
Author(s):  
Charlie Athill
Keyword(s):  
Material Culture ◽  
Subject Position ◽  
Sex And Gender ◽  
Key Factors ◽  
Sensory Ethnography ◽  
The United Kingdom ◽  
Cross Dressing ◽  
And Gender ◽  
Embodied Practice

This narrative case study explores how material culture, in the form of dress, grooming and accessories, is utilized to establish a gender-fluid presentation of the self. It focuses on Tim Mustoe, a 42-year-old heterosexual creative living and working in London, whose embodied practice contributes to the problematization of gender normativity through a disruption of culturally established links between appearance, gender and sex. The study considers how a particular form of non-spectacular cross dressing is used to integrate into a work environment and also operate within a non-queer social environment. The study explores the affective power of material culture in the reification of subject position and as a means of resilience and empowerment through everyday practice and also considers its significance on a social, intersubjective level. The methodology used for this case draws on sensory ethnography and includes a queer reflexive turn to consider parallels and contrasts between my own and Tim’s experience and practice. Conceptualizations of subjectivity, sex, gender are considered in relation to those on material culture, and the study draws on scholarship related to cross-dressing in the United Kingdom. Tim identifies as a man, as do I; however, his embodied practice and gender identification proffer a particular response to culturally embedded norms relating to the binaries of sex and gender. Therefore, in relation to male femininity, I propose the notion of feminizing as an amendment to the concept of femaling, which assumes the identification with or transition to a cisgender position. This study explores the phenomenology of dress as an expressive tool of gratification and as a means of integration for which the imperatives of professionalism, age and respectability are key factors.

scholarly journals Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis

2021 ◽  
Vol 17 (4) ◽  
pp. 584-593
Author(s):  
S. R. Gilyarevsky
Keyword(s):  
Clinical Trials ◽  
Big Data ◽  
Clinical Practice ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Hierarchy Of Evidence

The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed. 

scholarly journals Science in service of theology: Gender and sexual orientation

2021 ◽  
Vol 55 (1) ◽  
Author(s):  
Pieter H. Labuschagne
Keyword(s):  
Sexual Orientation ◽  
Environmental Factors ◽  
Natural Sciences ◽  
Theological Reflection ◽  
Future Research ◽  
Sex And Gender ◽  
Medical Sciences ◽  
And Gender ◽  
The Cost ◽  
The Way

By reflecting on sexuality, gender and gender roles, this article compared the contributions of two sources: one from the medical sciences and one from theology. These publications paved the way for an informed theological reflection on the ministry of people from an LGBT orientation. The motivation for this article was McHugh and Mayer’s statement that science offers limited answers to gender matters and that help should be sought from the humanities. The interdisciplinary nature of the research challenged us to consider non-theological data and to formulate our theological convictions better. An integrative literature review was used as research method and key research concepts included sex, gender and what influences these predispositions. The findings were analysed and synthesised and presented in a way that posed new questions for future research. It encouraged us to make informed decisions when offering theological responses to sex and gender. The inability of the natural sciences to identify causative factors of gender confusion opened the door to the humanities. It afforded theology an opportunity to engage with other sciences while addressing sex and gender from a faith perspective. This article presented a broad multi-disciplinary understanding of gender and sexual orientation and paved the way for theological reflection that is scientifically sound. Shifting our focus from causative to environmental factors in gender research was a profitable endeavour. Our first responsibility as religious practitioners is not to protect truth and condemn behaviour at the cost of people, but to liberate people to share in the fulness of life.Contribution: This article promoted collaboration between theology and the natural sciences on matters of gender and sexual orientation. It was found that there is room for theology to investigate the role that environmental factors play in this regard. This approach corresponds with the aim of In die Skriflig/In Luce Verbi to promote multi-disciplinary research where religious studies engage with social sciences, human sciences, or even natural sciences.

scholarly journals The Person’s Care Requires a Sex and Gender Approach

2021 ◽  
Vol 10 (20) ◽  
pp. 4770
Author(s):  
Ilaria Campesi ◽  
Andrea Montella ◽  
Giuseppe Seghieri ◽  
Flavia Franconi
Keyword(s):  
Gender Gap ◽  
Life Experiences ◽  
Interdisciplinary Studies ◽  
Decision Makers ◽  
Single Individual ◽  
Sex And Gender ◽  
Care Providers ◽  
High Interindividual Variability ◽  
And Gender ◽  
Present Life

There is an urgent need to optimize pharmacology therapy with a consideration of high interindividual variability and economic costs. A sex–gender approach (which considers men, women, and people of diverse gender identities) and the assessment of differences in sex and gender promote global health, avoiding systematic errors that generate results with low validity. Care for people should consider the single individual and his or her past and present life experiences, as well as his or her relationship with care providers. Therefore, intersectoral and interdisciplinary studies are urgently required. It is desirable to create teams made up of men and women to meet the needs of both. Finally, it is also necessary to build an alliance among regulatory and ethic authorities, statistics, informatics, the healthcare system and providers, researchers, the pharmaceutical and diagnostic industries, decision makers, and patients to overcome the gender gap in medicine and to take real care of a person in an appropriate manner.

scholarly journals Lack of consideration of sex and gender in clinical trials for COVID-19

2020 ◽  
Author(s):  
Emer Brady ◽  
Mathias Wullum Nielsen ◽  
Jens Peter Andersen ◽  
Sabine Oertelt-Prigione
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Sex And Gender ◽  
Therapeutic Approaches ◽  
Planning Stage ◽  
New Therapeutic Approaches ◽  
Analysis Phase ◽  
Potential Risks ◽  
And Gender ◽  
Sex And Gender Differences

Sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences characterize the frequency and severity of pharmacological side effects. A large number of clinical trials are ongoing to develop new therapeutic approaches and vaccines for COVID-19. We investigated the inclusion of sex and/or gender in currently registered studies on ClinicalTrials.gov. Only 416 (16.7%) of the 2,484 registered SARS-CoV-2/COVID-19 trials mention sex/gender as recruitment criterion and only 103 (4.1%) allude to sex/gender in the description of the analysis phase. None of the 11 clinical trials published in scientific journals on June 2020 reported sex-disaggregated results. Hence, lack of consideration upon registration does not seem to be corrected during trial execution and reporting. Given the biological relevance and the potential risks of unwanted side effects, we urge researchers to focus on sex-disaggregated analyses already at the planning stage of COVID-19 trials.

Gender, Sexuality, and Borders in Popular Culture

2020 ◽  
Author(s):  
Karleen Pendleton Jiménez
Keyword(s):  
Popular Culture ◽  
Mixed Race ◽  
Gloria Anzaldua ◽  
Sex And Gender ◽  
Sexual Diversity ◽  
Mexico Border ◽  
And Gender ◽  
Music Film ◽  
Borderland Theory ◽  
Racial Ethnic

The theorizing of gender, sexuality, and borders emerged from borderland theory as conceptualized by Chicana lesbian writer Gloria Anzaldúa. Enacted in this theory are racial, ethnic, sexual, and gender identities and relationships to land, and the U.S.–Mexico border in particular. Borderland theory embraces the immigrants, the exiles, the mixed-race, the queers, the nonnormative, the crossers of binaries, broadly defined. Borderland pedagogies build upon borderland theory, encouraging recognition of diverse experiences, critical and flexible thinking, creativity, and acceptance of one’s contradictions. Popular culture serves as an important tool for borderland pedagogies, both as a resource for classroom teaching and as a broad-reaching medium to promote public learning. Music, film, literature, and television provide rich sources for learning and unlearning. Gender and sexual diversity in borderland popular culture are the outliers of heteronormativity and challenge dualistic notions of sex and gender. The borderland provide the symbolic location of the restrictions and wounds caused by binary thinking, as well as the place to recuperate, to heal, to learn, and to transform.

scholarly journals Pregnancy Rates with Recombinant versus Urinary Human Chorionic Gonadotropin in In Vitro Fertilization: An Observational Study

2011 ◽  
Vol 11 ◽  
pp. 1781-1787 ◽  
Author(s):  
József Zeke ◽  
Katalin Kanyó ◽  
Helga Zeke ◽  
Áron Cseh ◽  
Barna Vásárhelyi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Clinical Characteristics ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
In Vitro Fertilisation ◽  
Vitro Fertilization ◽  
Equal Efficacy

Randomized clinical trials (RCTs) demonstrated the equal efficacy of urinary human chorionic gonadotropin (uhCG) and recombinant hCG (rhCG) products in in vitro fertilisation (IVF). However, limitations inherent with RCTs necessitate the reinforcement of RCT results in real-life. We retrospectively analyzed pregnancies after treatment with rhCG and uhCG products (n=391, and 96, resp.). We found that laboratory-verified pregnancy occurred more frequently in rhCG patients than in those on uhCG (43% versus 30%,P=0.02). The association remains significant (P=0.002) after its adjustment for clinical characteristics. The prevalence of laboratory-verified pregnancies was higher with GnRH agonist use (P=0.012) and BMI under 30 kg/m2(P=0.053) while decreased the age (P=0.014) and the number of previous failed attempts (P=0.08). Similar (but not significant) trends were observed with rates of pregnancy filled the 24th week. These results reinforce RCTs supporting the notion that rhCG is more efficient as uhCG during IVF.

Sign in / Sign up

Export Citation Format

Share Document