Clinical therapeutics最新文献

{"title":"Systemic Estrogen Therapy and Thrombosis: A Call for Individualized Clinical Decision Making in the Acute Care Setting.","authors":"Valentina Restrepo, Kelsey Martin, Layla Van Doren","doi":"10.1016/j.clinthera.2024.09.026","DOIUrl":"10.1016/j.clinthera.2024.09.026","url":null,"abstract":"<p><p>Systemic estrogen therapies (SETs) are integral to health care, playing critical roles in reproductive rights, managing heavy menstrual bleeding (HMB), alleviating menopausal symptoms, and supporting gender-affirming hormone therapy (GAHT) for transwomen. However, SETs are associated with an increased risk of venous thromboembolism (VTE), posing a challenge in the acute care setting. Here, we explore the nuanced management of SETs in patients who present with a hormone-related VTE in the acute care setting. The prevailing practice of discontinuing SETs in this setting may lead to significant adverse effects, including exacerbation of HMB, unintended pregnancy, menopausal symptoms, and psychological distress from interrupted GAHT or hormone replacement therapy. The discontinuation of SETs can severely affect patients' health, quality of life, and adherence to anticoagulation therapy in the case of HMB, increasing the risk of VTE recurrence. We challenge the practice of broadly discontinuing SETs in the acute care setting, advocating for a patient-centered approach that considers the underlying reasons for SET use, potential adverse effects of abrupt cessation, and individual patient needs. We underscore the importance of shared decision making and individualized care, particularly for historically marginalized groups in health care, cis women, transwomen, and individuals with HMB, to ensure safe, equitable, and affirming health care. A tailored approach to managing SETs in the acute care setting will enhance health care delivery and reduce health inequities. Lastly, we highlight the need for further research, particularly regarding GAHT-related VTE for transwomen.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"949-952"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Influence of Invasive Candida Infections on Prognosis and Analysis of Their Risk Factors After Liver Transplantation.","authors":"Chunjiao Long, Weiting Peng, Jie Zhao, Qiquan Wan","doi":"10.1016/j.clinthera.2024.09.012","DOIUrl":"10.1016/j.clinthera.2024.09.012","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to investigate the incidence, timing, risk factors, and impacts of invasive Candida infections (ICIs) within 3 months after liver transplantation (LT) on LT recipients' prognosis.</p><p><strong>Methods: </strong>Patients undergoing LT from January 2015 to December 2022 in a tertiary university hospital were investigated the incidence, onset, and risk factors of ICIs and the effects of ICIs on the outcome of LT recipients using statistical methods.</p><p><strong>Findings: </strong>The mean age of involved 389 LT recipients was 47.3 ± 10.5 years, with 322 (82.8%) being men. The incidence of ICIs was 3.3% (13/389), and the median time between LT and onset of ICIs was 5.0 days. The univariate analysis of predictors of ICIs identified that massive blood loss, prolonged duration of central line and urethral catheter, and prophylactic antifungal therapy were related to post-LT ICI risk. Multivariate logistic regression analysis adjusted for men and age identified that intraoperative blood loss ≥5000 mL (odds ratio [OR] = 7.005, 95% CI: 2.084-23.542, P = 0.002) and central line duration >14 days (OR = 5.270, 95% CI: 1.556-17.854, P = 0.008) were independently associated with the development of post-LT ICIs. Post-LT prophylactic antifungal therapy >3 days reduced ICIs (OR = 0.103, 95% CI: 0.021-0.501, P = 0.005). Regarding clinical outcomes, patients with ICIs were more likely to stay in the intensive care unit for 7 days or longer compared with those without ICIs (OR = 6.910, 95% CI: 1.737-27.493, P = 0.006). ICIs had no impact on hospitalization stay and 1-month all-cause mortality after LT.</p><p><strong>Implications: </strong>ICIs are frequent and occur early after LT. Predictors of post-LT ICIs were massive intraoperative blood loss and prolonged duration of the central line. However, post-LT prophylactic antifungal therapy reduced ICIs. Patients with ICIs stayed longer in the intensive care unit than those without ICIs.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1041-1048"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expanding the Frontiers of Sex and Gender in Acute Care Medicine.","authors":"Paul Beninger","doi":"10.1016/j.clinthera.2024.10.017","DOIUrl":"10.1016/j.clinthera.2024.10.017","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"941-942"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142708910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Experience With Efanesoctocog Alfa for Severe Hemophilia A: Results From the XTEND-1 Phase 3 Clinical Study Exit Interviews.","authors":"Dana DiBenedetti, Daniela Neme, Brigitte Pan-Petesch, Annemieke Willemze, Tung Wynn, Nana Kragh, Amanda Wilson","doi":"10.1016/j.clinthera.2024.09.010","DOIUrl":"10.1016/j.clinthera.2024.09.010","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Purpose: &lt;/strong&gt;Hemophilia A is a rare bleeding disorder that leads to recurrent hemarthrosis, which can ultimately result in reduced mobility and poor quality of life. Qualitative exit interviews provide insights into patient perspectives and support the interpretation of quantitative trial data, such as patient-reported outcome measures. In the Phase 3 XTEND-1 study (NCT04161495) of efanesoctocog alfa in participants with severe hemophilia A, exit interviews were conducted to understand pre- and post-study experiences with pain and physical functioning and to evaluate participants' treatment experiences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In XTEND-1, participants (≥12 years old) received once-weekly efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks (Arm A) or on-demand efanesoctocog alfa 50 IU/kg for 26 weeks followed by 26 weeks once-weekly prophylaxis (50 IU/kg; Arm B). Optional qualitative exit interviews were conducted using a semi-structured guide in a subset of participants following study completion. Interviews included open-ended questions about participants' pre- and post-study experiences with hemophilia A and targeted questions relating to improvements in patient-reported outcomes assessed during XTEND-1, including the Haemophilia Quality of Life Questionnaire for Adults Physical Health subscale (Haem-A-QoL PH). Content validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a measure was also assessed, particularly the worst pain item.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Exit interviews were conducted with 29 of 159 patients enrolled in XTEND-1 (mean [range] age 40 [16-73] years). Of 17 participants enrolled in Arm A, 13 (76.5%) reported a \"wearing off\" feeling with pre-study treatment, including more aches/pain, breakthrough bleeds, and limited physical activities. Joint pain was the most reported pre-study symptom (96.6%; n = 28/29), followed by a reduced ability to move without pain (89.7%, n = 26/29). Improvements following efanesoctocog alfa prophylaxis in ≥1 Haem-A-QoL PH domain were reported by 89.7% (n = 26/29) of participants, with improvements in joint pain, the ability to move without pain, and painful swellings reported by at least 21 (84%) participants. Participants reported that the PROMIS Pain Intensity 3a items were relevant, clear, and easy to answer. Most participants (96.6%) were \"quite satisfied\" or \"very satisfied\" with efanesoctocog alfa prophylaxis. All participants preferred efanesoctocog alfa over pre-study treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Implications: &lt;/strong&gt;The exit interviews demonstrated that once-weekly efanesoctocog alfa prophylaxis resulted in patient-relevant and meaningful improvements in pain and physical functioning, consistent with the quantitative findings from XTEND-1. These results support the validity of the Haem-A-QoL PH and PROMIS Pain Intensity 3a assessed during XTEND-1, demonstrating the potential for change with efficacious treatment.&lt;/p&gt;&lt;p","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1016-1023"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex Differences in Advanced Therapeutic Interventions for Intermediate- and High-Risk Pulmonary Embolism.","authors":"Christiana K Prucnal, Christopher Kabrhel, Nora K Horick, Angela F Jarman","doi":"10.1016/j.clinthera.2024.10.018","DOIUrl":"10.1016/j.clinthera.2024.10.018","url":null,"abstract":"<p><strong>Purpose: </strong>Advanced interventions are increasingly used to treat intermediate- and high-risk acute pulmonary embolism (PE). While sex-based differences exist in treatment of other diseases, it is unknown whether these disparities extend to PE.</p><p><strong>Methods: </strong>This is a secondary analysis of a prospective cohort study of adult patients diagnosed with radiographically confirmed intermediate- and high-risk acute PE at a tertiary hospital between 1/1/2012 and 12/31/2021 for whom the PE Response Team was activated. Primary outcome was receipt of any advanced intervention. Descriptive and inferential analyses using Chi-square tests, t tests, and logistic regression were performed to evaluate for factors associated with the primary outcome.</p><p><strong>Findings: </strong>We analyzed 902 patients, of whom 439 (49%) were female. Although women were more likely to present with right heart strain on echo (78.6% vs 71.1% P = 0.012) and elevated NT-proBNP (69.2% vs 55.7% P < 0.001), there was no significant sex-based difference in clinical PE severity, defined as intermediate- versus high-risk, at presentation. Primary outcome did not differ significantly by sex (18.7% vs 23.5% P = 0.129). In multivariate models, high-risk PE decreased odds of receiving an advanced therapy (0.50 [0.31, 0.79] P = 0.003), while receiving assisted ventilation (4.70 [2.90, 7.62], P < 0.001) and full code status (4.18 [1.60, 10.91], P = 0.003) increased odds.</p><p><strong>Implications: </strong>This study adds to the scant literature on sex differences in interventions for acute PE. Significant baseline variation exists between female and male patients presenting with acute PE. Clinical factors were predictive of receiving advanced PE therapies, while sex was not.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"967-973"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex Differences in Tryptophan Metabolism via the Kynurenine Pathway in Acute Ischemic Stroke.","authors":"Layne Dylla, Hannah M Higgins, Sharon N Poisson, Thao Vu, Julie A Reisz, Paco S Herson, Andrew Monte","doi":"10.1016/j.clinthera.2024.10.015","DOIUrl":"10.1016/j.clinthera.2024.10.015","url":null,"abstract":"<p><strong>Purpose: </strong>Females are at increased lifetime risk of stroke and experience worse outcomes compared with males. Tryptophan metabolism through the kynurenine pathway, resulting in decreased tryptophan concentrations, is associated with poor outcomes (larger infarct volume, higher National Institutes of Health Stroke Scale [NIHSS] score, and increased early mortality). This metabolic pathway activity varies by sex in healthy adults. However, evaluation of potential sex differences in tryptophan metabolism after an acute ischemic stroke (AIS) is lacking and could contribute to the disparate outcomes by sex. This study characterized sex differences in tryptophan metabolism via the kynurenine pathway in patients with AIS.</p><p><strong>Methods: </strong>Whole blood from patients with AIS enrolled in the University of Colorado Health Emergency Medicine Specimen Bank was analyzed using high-throughput mass spectrometry-based metabolomics at the time of arrival to the emergency department and at 12, 24, and 48 hours thereafter. Descriptive statistics characterized the cohort and metabolite levels. Potential sex differences in tryptophan metabolites at individual time points and their change over time were estimated using linear regression models to control for known factors influencing metabolite levels, initial NIHSS score, therapeutic interventions, and time to last known well (or symptom onset). A multivariable linear regression model examined the interaction effect between sex and metabolite level (at 12 hours after admission) on 24-hour NIHSS score while controlling for initial metabolite level, initial NIHSS score, time to last known well, factors influencing metabolite level, and factors influencing neurologic outcomes.</p><p><strong>Findings: </strong>After adjusting for covariates, females with AIS had significantly lower levels of tryptophan at 12 hours after admission compared with males (point estimate, -5.80; P = 0.03). Females and males neither differ in levels of tryptophan, kynurenine, quinolinic acid, or kynurenic acid at any other time point nor did they differ in change in metabolite concentration over time. Only increased quinolinic acid levels across both sexes at 12 hours after admission were associated with increased 24-hour NIHSS scores (point estimate, 0.49; P = 0.0002).</p><p><strong>Implications: </strong>Overall, females and males have similar levels and changes in tryptophan and kynurenine pathway metabolites after an AIS. However, females have lower levels of tryptophan early after a stroke. Increased quinolinic acid levels across both sexes were associated with worsening neurologic function as measured by an NIHSS score. Future evaluation of alternative metabolic pathways downstream of tryptophan is needed to explain differences in tryptophan levels but similar levels of downstream kynurenine metabolites in females and males with AIS.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"960-966"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11637908/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecular Detection of Carbapenemases in Acinetobacter baumannii Strains of Portugal and Association With Sequence Types, Capsular Types, and Virulence.","authors":"Rita Domingues, Ricardo Oliveira, Sónia Silva, Daniela Araújo, Carina Almeida, Gyu-Sung Cho, Charles M A P Franz, Maria José Saavedra, Joana Azeredo, Hugo Oliveira","doi":"10.1016/j.clinthera.2024.09.005","DOIUrl":"10.1016/j.clinthera.2024.09.005","url":null,"abstract":"<p><strong>Purpose: </strong>Carbapenem-resistant Acinetobacter baumannii (CRAB) is an important nosocomial pathogen. The capsular type (K-type) is considered a major virulence factor, contributing to the evasion of host defenses. The global spread and dissemination dynamics between K-types, sequence types (ST), antibiotic resistance genes, and virulence factors remain largely unknown in Portugal.</p><p><strong>Methods: </strong>A collection of 96 CRAB clinical samples collected between 2005 and 2019 in the northern region of Portugal were tested for antimicrobial susceptibility profile and screened by polymerase chain reaction for resistance genetic determinants. A subset of 26 representative isolates was subjected to whole-genome sequencing to assess K types, ST types, and genomic relatedness. The pathogenicity of distinct K-types was also tested using Galleria mellonella model.</p><p><strong>Findings: </strong>For the 96 CRAB isolates analyzed, high antimicrobial resistance (>90%) was observed to the carbapenems, fluoroquinolones, and miscellaneous agents. Greater antimicrobial susceptibility (∼30%-57%) was observed for aminoglycosides, particularly tobramycin, and amikacin. Genotypically, 75 strains (78.5%) carried bla_OXA-23-like, 18 strains (18.8%) carried bla_IMP-like, and 11 strains (14.9%) carried bla_OXA-40-like carbapenem resistance genes, respectively. Associations between OXA and ST/capsular locus (KL) types were observed over the years (eg, OXA-40-like/ST46^Past/KL120 and OXA-23-like/ST2^Past/KL2). ST2^Past of clonal complex II was present in most strains, a dominant drug-resistant lineage in the United States and Europe. KL7 was also the most prevalent KL-type (38.5%), followed by KL2 (34.6%), KL120 (23.1%), and KL9 (3.8%). Virulence assessment for different K-types in a Galleria mellonella model revealed a significantly increased virulence for KL120 when compared with KL7, KL9, and KL2.</p><p><strong>Implications: </strong>There are specific CRAB serotypes circulating in Portugal, accounting by the low diversity of acquired carbapenemase genes (OXA-23-like and OXA-40-like), ST types (ST2 and ST46) and KL types (KL2, KL7, KL9, and KL120) identified. The high prevalent of ST2, especially when associated with KL2 and bla_OXA-23-like, suggest that antibiotic resistance has been driven by clonal expansion of clonal complex II. Such findings provide useful information on the diversity of multidrug-resistant bacterium that might be relevant for antibacterial interventions.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"e9-e15"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Heart Breaking Differences: A Narrative Review of Sex and Gender Disparities in Sports-Related Sudden Cardiac Death.","authors":"Mallory E Shasteen, Mary K Wurzelmann, Alyson J McGregor, Neha P Raukar","doi":"10.1016/j.clinthera.2024.11.002","DOIUrl":"10.1016/j.clinthera.2024.11.002","url":null,"abstract":"<p><strong>Purpose: </strong>Sports-related sudden cardiac death (srSCD) represents a rare yet significant occurrence. This review aims to explore the epidemiology, etiology, and prevention of srSCD, with a particular focus on the influence of sex and gender. It seeks to analyze existing literature to elucidate the impact of biological variables, societal factors, and preventive measures in understanding and addressing srSCD among athletes.</p><p><strong>Methods: </strong>A narrative review approach was utilized to synthesize relevant literature on srSCD, using a validated PubMed Search tool for sex and gender-related factors. The review focused on primary data investigating sex differences that may contribute to srSCD, as well as pertinent review articles.</p><p><strong>Findings: </strong>The review highlights the complexity of defining and studying srSCD, with challenges stemming from varied reporting methods and lack of standardized definitions. Disparities in incidence rates between male and female athletes are evident, with males exhibiting a disproportionately higher risk. Biological factors, including cardiac adaptations to exercise and sex hormone influences, contribute to these sex-specific differences in srSCD rates. While screening programs, particularly utilizing electrocardiograms, show promise in identifying at-risk individuals, debates persist regarding their implementation and efficacy. Furthermore, legislative gaps in mandating the availability of automatic external defibrillators (AEDs) in public settings underscore the need for unified advocacy efforts to improve access to life-saving interventions.</p><p><strong>Implications: </strong>Understanding the multifaceted nature of srSCD, including its biological underpinnings and societal implications, is crucial for developing effective preventive strategies. Sex-specific screening programs tailored to the unique risk profiles of male and female athletes, as well as legislative initiatives promoting AED placement and cardiopulmonary resuscitation training, are essential components of comprehensive srSCD prevention efforts. By addressing disparities and implementing evidence-based interventions, this paper advocates for a holistic approach to mitigate the risk of srSCD and enhance the safety and well-being of athletes across all levels of competition.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"982-987"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aqneursa (levacetylleucine).","authors":"Paul Beninger","doi":"10.1016/j.clinthera.2024.10.011","DOIUrl":"10.1016/j.clinthera.2024.10.011","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1091-1092"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Sex and Gender in Precision Emergency Medicine: A Scoping Review and Proposed Hierarchy.","authors":"Angela F Jarman, Madeleine G Wolfe, Bryn E Mumma, Tracy E Madsen, Basmah Safdar, Marna R Greenberg, Jeannette J Wolfe, Bridget Gunn, Lauren A Walter, Brandon C Maughan, Alyson J McGregor","doi":"10.1016/j.clinthera.2024.10.007","DOIUrl":"10.1016/j.clinthera.2024.10.007","url":null,"abstract":"<p><strong>Background: </strong>Precision medicine utilizes individual patient data to guide decision making. Sex and gender medicine is likewise focused on individual patients' biological sex or sociocultural gender as determinants of disease. How these two fields intersect with one another and with acute care medicine is unclear.</p><p><strong>Methods: </strong>We conducted a scoping literature review utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews to evaluate the primary research in three related areas: sex & gender medicine, emergency medicine, and precision medicine. We searched six databases and screened eligible studies for inclusion. Included studies were reviewed in full, and study characteristics were compiled using a standardized data extraction form. Research questions were drafted by workgroup members and ranked by all participants of the consensus conference.</p><p><strong>Results: </strong>A total of 401 studies were screened for inclusion. Of these, 70 met inclusion criteria and were evaluated in full text. The majority (84%, 59/70) reported evaluating sex, whereas only 16% (11/70) reported evaluating gender. The most common clinical topics were cardiovascular diseases and trauma/injury prevention, comprising 50% (35/70) of the included manuscripts. Cumulatively, 77% (54/70) of the manuscripts reviewed cited at least one funding source. The vast majority (66/70, 94%) of studies were included because their statistical analysis accounted for sex or gender, and very few studies (4/70, 6%) were included due to their use of biomarker or genomic data.</p><p><strong>Conclusions: </strong>Sex- and gender-based medicine and research commonly employ precision medicine concepts to evaluate the effects of sex and gender in a variety of clinical topic areas, but much of this literature is not commonly described as precision medicine. We propose a hierarchy to categorize, label, and advance sex and gender precision medicine research. Fundamental to this advancement are implementation of guidelines regarding the correct use of sex and gender and continued research funding for sex and gender precision EM research.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"974-981"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}