Conditions that influence coping mechanisms in Latina mothers affected by incarceration: A secondary analysis using the vulnerability framework.

The objective of this study is to assess women's vulnerability to becoming involved with the legal system as it relates to their exposure, sensitivity, and resiliency to specific experiences associated with incarceration before, during, and after their confinement using the vulnerability framework. We sampled 12 women who self-identified as Latina mothers from local jail annexes, probation department offices, and substance use treatment centers in South Central Texas. We conducted a qualitative, secondary analysis. Three overarching themes emerged: (1) "[The abuse] just kept happening;" (2) "[Incarceration] was an excessive interference;" and (3) "I wasn't there back then [for my children], but now I can be [there for them] in some way." We also identified subthemes. More research and culturally tailored programming are needed to bridge services across legal system sites (jails, prisons, probation) that interact with this population of women to provide supportive services. PUBLIC CONTRIBUTION: We would like to recognize community stakeholders who work in the local jail, probation, and medication treatment centers who helped with the distribution of fliers and participant recruitment along with the women who shared their experiences following incarceration for the original study's data used in this secondary analysis.

Pandemic perspectives from the frontline-The nursing stories.

AIM: To describe the experiences of registered nurses working in a US healthcare system during the COVID-19 pandemic. DESIGN: This qualitative thematic analysis study is a secondary analysis of stories submitted by nurses to a repository established by the parent study. METHODS: Registered nurses working in various roles in a healthcare system submitted stories (N = 45) to open-ended prompts via an online repository between June 2020 and February 2021. A team of three nurse scientists coded the stories using Dedoose software. Initial codes were then reviewed by the team to synthesize initial coding into themes. The COREQ checklist was used to ensure research reporting guidelines were met. RESULTS: Thematic analysis revealed three themes in a global theme of COVID-19 pandemic-related personal and professional evolution: (1) The art and science of pandemic nursing, (2) Persisting despite challenges; and (3) Learning as we went. Each of the three organizing themes were supported by basic themes. CONCLUSIONS: Identified themes affirm some of nursing's long-standing core values, such as the central role of human connectedness in restoring health, but findings also reflect new evolutionary processes of moral identity formation that occurred among nurses and the nursing profession during the COVID-19 pandemic. IMPACT: Findings from this study describe the processes by which nurses' moral identity evolved during a segment of the COVID-19 pandemic. Collectively, these evolutions represent important shifts in the nursing profession. Using findings from this study, nurse educators, nurse managers and healthcare administrators will be able to implement effective, sustainable policies and processes that meet the needs of both the community and the workforce. NO PATIENT OR PUBLIC CONTRIBUTION: This study was designed to capture the experiences of nurses employed by one healthcare organization. However, it was not conducted using input or suggestions from the public or the patient population served by the organization.

Health and Disability Among Young Black Men.

BACKGROUND: Black men experience the highest rate of disability compared to White, Asian, and Hispanic men. Yet, we know little about how Black men with disabilities experience the embodiment of their gender, race, social class, and disability positionalities and how they draw from their cultural backgrounds as they engage in health-seeking behaviors. OBJECTIVES: The purpose of this study was to explore how young Black men experienced the onset of chronic disabling conditions while negotiating health-promoting activities in the context of gender, race, social class, disability positionalities, and culture. METHODS: This descriptive study used hermeneutic phenomenology to achieve study objectives. This study's research questions were answered using audiotaped, one-on-one qualitative interviews, along with detailed field notes. Each participant was interviewed twice at a mutually decided upon location to ensure their privacy and comfort. RESULTS: In relation to their embodied interactions of self in the context of disability, these men described their health-related decisions using four themes: maintaining manhood, economic constraints, the "risk" of healthcare, and health promotion. CONCLUSIONS: By examining the experiences of young adult Black men living with disabilities, knowledge of their perspectives and experiences at earlier stages in their life course contributes to the understanding of their personal challenges, health needs, and their perspectives of health-promoting strategies.

An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates.

With a new generation of antibody-drug conjugates (ADCs) that contain a drug-to-antibody ratio (DAR) of 2, the question remains whether advances in technology have resulted in more stable and tumor-specific ADCs. These ADCs are anticipated to cause minimal systemic exposures of payloads, with toxicities being evident mainly at tumor sites. We examined 15 ADCs with PBD-dimer payloads and a DAR of 2 and concluded that dose limiting toxicities in animals and in humans are generally related to the payload. Both the payloads and the ADCs had pro-inflammatory responses causing severe toxicities that were at times of low incidence, making it difficult to assess a cause-effect relationship. Due to their low incidence, single-patient cohorts may not detect these events and such design may not be suitable in first-in-human (FIH) trials. The commonly proposed approach by the sponsors for FIH dose selection was 1/6th highest non-severely toxic dose (HNSTD) in monkeys. This approach resulted in an acceptable balance of safety and efficient dose escalation in phase 1 trials, when using data from repeat-dose toxicology studies and body surface area for scaling. No sponsor used the data generated in rodents or proposed novel approaches for FIH dose selection.

Does Simulation Training for Acute Care Nurses Improve Patient Safety Outcomes: A Systematic Review to Inform Evidence-Based Practice.

BACKGROUND: Simulation is increasingly used as a training tool for acute care medical-surgical nurses to improve patient safety outcomes. A synthesis of the evidence is needed to describe the characteristics of research studies about acute care nurse simulation trainings and patient safety. An additional purpose is to examine the effects of acute care registered nurse (RN) simulation trainings on patient safety outcomes. METHODS: Five Internet databases were searched for articles published on any date through October 2018 examining the effect of RN simulation trainings on patient safety outcomes in the adult acute care setting. SAMPLE: N = 12 articles represented 844 RNs of varying experience levels and 271 interprofessional participants. RESULTS: Nine studies (75%) used high-fidelity scenarios developed locally about high risk but infrequent events. Five studies (42%) incorporated interdisciplinary team members in the scenarios and/or outcome evaluations. Outcome measures were self-reported, direct observation, or clinical indicators. All studies in this review achieved improved patient safety outcomes. It is unknown how outcomes vary for different groups of RNs because of insufficient gender, ethnicity/race, and age reporting. LINKING EVIDENCE TO ACTION: Findings support the design of simulation training research studies for patient safety outcomes and use of simulation training and research in acute care RNs. Additional high-quality research is needed to support this field. Future studies should include descriptors that characterize the sample (i.e., age, gender, education level, type of nursing degree, ethnicity or race, or years of experience); incorporate interdisciplinary teams; evaluate a combination of outcome measure types (i.e., self-report, direct observation, and clinical outcomes) both proximal and distal to the simulation; and that utilize standardized scenarios, validated outcome measure instruments, and standardized debriefing tools.

FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum-Containing Chemotherapy.

Until recently in the United States, no products were approved for second-line treatment of advanced urothelial carcinoma. On May 18, 2016, the U.S. Food and Drug Administration approved atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody and represents the first approved product directed against PD-L1. This accelerated approval was based on results of a single-arm trial in 310 patients with locally advanced or metastatic urothelial carcinoma who had disease progression after prior platinum-containing chemotherapy. Patients received atezolizumab 1,200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity. Key efficacy measures were objective response rate (ORR), as assessed by Independent Review per RECIST 1.1, and duration of response (DoR). With a median follow-up of 14.4 months, confirmed ORR was 14.8% (95% CI: 11.1, 19.3) in all treated patients. Median DoR was not reached and response durations ranged from 2.1+ to 13.8+ months. Of the 46 responders, 37 patients had an ongoing response for ≥ 6 months. The most common adverse reactions (≥20%) were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. Infection and immune-related adverse events also occurred, including pneumonitis, hepatitis, colitis, endocrine disorders, and rashes. Overall, the benefit-risk assessment was favorable to support accelerated approval. The observed clinical benefits need to be verified in confirmatory trial(s). IMPLICATIONS FOR PRACTICE: This accelerated approval of atezolizumab for second-line use in advanced urothelial carcinoma provides patients with an effective, novel treatment option for the management of their disease. This represents the first immunotherapy approved in this disease setting.

An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection.

We retrospectively examined the nonclinical studies conducted with 17 CD3 bispecific constructs in support of first-in-human (FIH) trials in oncology. We also collected information on the design of dose-finding clinical trials. Sponsors have used different MABEL approaches for FIH dose selection. To better assess acceptable approaches, FIH doses were computed from nonclinical studies and compared to the maximum tolerated doses (MTDs) in patients, to the highest human doses (HHDs) when an MTD was not identified, or to the recommended human dose (RHD) for blinatumomab. We concluded that approaches based on receptor occupancy, highest non-severely toxic dose, or no-observed adverse effect level are not acceptable for selecting the FIH dose as they resulted in doses close to or above the MTDs, HHDs, or the RHD. A FIH dose corresponding to 10%-30% pharmacologic activity (PA) was an acceptable approach. A FIH dose corresponding to 50% PA was acceptable for all except one construct, potentially due to its biological or structural properties. The most common toxicities in animals and patients were those related to cytokine release. Doses were better tolerated when intra-animal or intra-patient dose escalation was used. Exposing naïve patients to an MTD achieved with intra-patient dose escalation design may be unsafe.

Advancing Equity in Maternal Health Care.

Actionable strategies nurses can implement at the bedside.

Protect and Provide: Perceptions of Manhood and Masculinities Among Disabled Violently Injured Black Men in a Hospital-Based Violence Intervention Program.

Exploring the post-injury lives of those who have survived gunshot wounds is essential to understanding the entire scope of firearm violence. The lives of Black male firearm violence survivors are transformed in various ways due to their injuries both visible and invisible. This study explored how Black men who suffer from disabilities via a firearm negotiated their masculine identities. Semi-structured, qualitative interviews were conducted with 10 violently injured Black men participating in a hospital-based violence intervention program. Survivors expressed their thoughts on how their injuries impacted their manhood and masculinities. Three themes emerged: (1) perceptions of manhood, (2) loss of independence and burden on others, and (3) and mobility. These themes highlighted and described how their lives were impacted post-injury and characterized their psychological and physical experience of recovery. The research findings suggest the need for more qualitative studies to further explore the relationship between firearm injury, Black masculinity, and perceptions of manhood. While Black men are understudied in health research and invisible in disability research, they continue to be hyper-invisible when discussing violently acquired disabilities.

FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.

PURPOSE: This article summarizes the US Food and Drug Administration (FDA) review of the data leading to approval of olaparib plus abiraterone for the treatment of patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test. PATIENTS AND METHODS: Approval was based on the results from PROpel, a double-blind trial that randomly assigned 796 patients with mCRPC to abiraterone plus prednisone or prednisolone with either olaparib or placebo. The primary end point was radiographic progression-free survival (rPFS) per investigator assessment. RESULTS: There was a statistically significant improvement in rPFS for olaparib plus abiraterone versus placebo plus abiraterone, with a median rPFS of 25 versus 17 months and a hazard ratio (HR) of 0.66 (95% CI, 0.54 to 0.81) in the intention-to-treat population. In an exploratory analysis of the subgroup of 85 patients with BRCAm mCRPC, the HR for rPFS was 0.24 (95% CI, 0.12 to 0.45) and the HR for overall survival (OS) was 0.30 (95% CI, 0.15 to 0.59). In an exploratory analysis of the subgroup of 711 patients without an identified BRCA mutation, the HR for rPFS was 0.77 (95% CI, 0.63 to 0.96) and the HR for OS was 0.92 (95% CI, 0.74 to 1.14). Adding olaparib to abiraterone resulted in increased toxicity, including anemia requiring transfusion in 18% of patients. CONCLUSION: In patients with mCRPC, efficacy of the combination of olaparib plus abiraterone was primarily attributed to the treatment effect in the BRCAm subgroup, the indicated population for the approval. For patients without BRCAm, the FDA determined that the modest rPFS improvement, combined with clinically significant toxicities, did not demonstrate a favorable risk/benefit assessment.

US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

PURPOSE: The US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: The approval was based on the HRR gene-mutated (HRRm) population of TALAPRO-2, a randomized, double-blind trial that randomly assigned 1,035 patients with mCRPC to receive enzalutamide with either talazoparib or placebo. Two cohorts enrolled sequentially: an all-comer population (Cohort 1), followed by an HRRm-only population (Cohort 2). The independent primary end points were radiographic progression-free survival (rPFS) per blinded independent central review (BICR) in Cohort 1 (all-comers) and in the combined HRRm population (all HRRm patients from Cohorts 1 and 2). Overall survival (OS) was a key secondary end point. RESULTS: A statistically significant improvement in rPFS by BICR was demonstrated in both the all-comers cohort and the combined HRRm population, with hazard ratio (HR) of 0.63 (95% CI, 0.51 to 0.78; P < .0001) and 0.45 (95% CI, 0.33 to 0.61; P < .0001), respectively. In an exploratory analysis of the 155 patients with BRCA-mutated (BRCAm) mCRPC, rPFS HR was 0.20 (95% CI, 0.11 to 0.36). In the non-HRRm/unknown stratum of Cohort 1 (n = 636), the rPFS HR was 0.70 (95% CI, 0.54 to 0.89). OS was immature. CONCLUSION: Despite a statistically significant rPFS improvement in the all-comer cohort, FDA did not consider the magnitude of rPFS clinically meaningful in the context of the broad indication, combination treatment, and safety profile. Approval was therefore limited to patients with HRRm mCRPC, for whom there was a statistically significant and clinically meaningful improvement in rPFS and favorable OS results. This represents the first approval for the first-line treatment of patients with HRRm mCRPC.

US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer.

PURPOSE: The US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy (ET). PATIENTS AND METHODS: Approval was based on EMERALD (Study RAD1901-308), a randomized, open-label, active-controlled, multicenter trial in 478 patients with ER+, HER2- advanced or metastatic breast cancer, including 228 patients with ESR1 mutations. Patients were randomly assigned (1:1) to receive either elacestrant 345 mg orally once daily (n = 239) or investigator's choice of ET (n = 239). RESULTS: In the ESR1-mut subgroup, EMERALD demonstrated a statistically significant improvement in progression-free survival (PFS) by blinded independent central review assessment (n = 228; hazard ratio [HR], 0.55 [95% CI, 0.39 to 0.77]; P value = .0005). Although the overall survival (OS) end point was not met, there was no trend toward a potential OS detriment (HR, 0.90 [95% CI, 0.63 to 1.30]) in the ESR1-mut subgroup. PFS also reached statistical significance in the intention-to-treat population (ITT, N = 478; HR, 0.70 [95% CI, 0.55 to 0.88]; P value = .0018). However, improvement in PFS in the ITT population was primarily attributed to results from patients in the ESR1-mut subgroup. More patients who received elacestrant experienced nausea, vomiting, and dyslipidemia. CONCLUSION: The approval of elacestrant in ER+, HER2- advanced or metastatic breast cancer was restricted to patients with ESR1 mutations. Benefit-risk assessment in the ESR1-mut subgroup was favorable on the basis of a statistically significant improvement in PFS in the context of an acceptable safety profile including no evidence of a potential detriment in OS. By contrast, the benefit-risk assessment in patients without ESR1 mutations was not favorable. Elacestrant is the first oral estrogen receptor antagonist to receive FDA approval for patients with ESR1 mutations.

Translation cost, quality, and adequacy.

PURPOSE: Although the inclusion of non-native-speaking participants in nursing research is important in every country where nursing research takes place, the literature contains little on the method of achieving quality translation while simultaneously addressing cost containment. We describe a process for evaluating translation adequacy and demonstrate its use in comparing procedures for translating data from non-native-speaking interviews. ORGANIZING CONSTRUCT: This work demonstrates a process for establishing, evaluating, and achieving translation adequacy when conducting qualitative research for cross-cultural comparisons. METHODS: In an ethnographic investigation of disability in Mexican American women, we describe a process for obtaining translation adequacy, defined here as the methodological goal whereby the quality of the translated text meets the needs of the specified study. Using a subset of responses transcribed from Spanish audiotapes into Spanish text, the text was subjected to two separate translation processes, which were compared for adequacy based on error rates and accuracy of meaning, as well as for cost. FINDINGS: The process for discriminating translation adequacy was sensitive to differences in certified versus noncertified translators. While the noncertified translation initially appeared to be seven times less expensive than the certified process, auditing and correcting errors in noncertified translations substantially increased cost. No errors were found with the certified translations. CONCLUSIONS: The level of translation adequacy needed for any qualitative study should be considered before beginning the study itself. Based on a predetermined level, translation choices can be assessed using specified methods, which can also lead to greater transparency in the research process. CLINICAL RELEVANCE: An ongoing process to verify translation outcomes including cost, a component minimally discussed in the current literature, is relevant to nurses worldwide. Awareness of expense and quality issues makes greater methodological transparency possible in the design of translation projects and research studies.

What is Known About Reproductive Autonomy Among Justice-Involved Black Women?: A Scoping Review.

OBJECTIVE: There are approximately 231,000 women detained daily within the nation's jail and prison systems with women of color making up nearly half of those experiencing incarceration. The purpose of this scoping review was to synthesize the literature on the reproductive autonomy of Black women influenced by incarceration, using the three tenets of reproductive justice. METHODS: We searched PubMed, CINAHL, SocINDEX, and PsycINFO for research related to reproductive justice written in English and published in the United States from 1980 to 2022. A review of 440 article titles and abstracts yielded 32 articles for full-text review; nine articles met inclusion. RESULTS: Eight addressed Tenet 1; five mentioned Tenet 2; none addressed Tenet 3. Recognition of the influence of incarceration on the reproductive autonomy of Black women is limited. CONCLUSION: The findings from this review suggest a need to address (a) reproductive choice, (b) support goals, and (c) support of justice-involved Black women.

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

On December 10, 2021, the FDA expanded the indications for ribociclib to include male patients for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Ribociclib is now indicated in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy in adult patients, or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy (ET), in postmenopausal women or in men. The efficacy of ribociclib + AI for male patients was primarily based on previous favorable benefit-risk assessments of ribociclib from MONALEESA-2 and MONALEESA-7 trials, and supported by COMPLEEMENT-1, an open-label, single-arm, multicenter clinical trial, in which 39 male patients (n = 3,246 total patients) received ribociclib + letrozole + goserelin/leuprolide. The overall response rate (ORR) based on confirmed responses in male patients with measurable disease at baseline was 46.9% [95% confidence interval (CI), 29.1-65.3], consistent with an ORR of 43.6% (95% CI, 41.5-45.8) in the overall population. Overall, adverse reactions occurring in male patients were similar to those occurring in female patients treated with ribociclib + ET. The efficacy of ribociclib + fulvestrant for male patients was primarily based on the previous findings of a favorable benefit-risk assessment from the MONALEESA-3 trial, supported by FDA review of clinical data of a limited number of male patients treated in clinical practice receiving ribociclib + fulvestrant. The known mechanism of action, biologic rationale, and clinical information available adequately demonstrate that the efficacy and safety of ribociclib + AI/fulvestrant are similar in male and female patients. This article summarizes the FDA's decision-making and data supporting the approval of ribociclib in male patients with breast cancer, and discusses regulatory insights.

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer.

On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The recommended 177Lu-PSMA-617 dose is 7.4 gigabecquerels (GBq; 200 mCi) intravenously every 6 weeks for up to six doses, or until disease progression or unacceptable toxicity. The FDA granted traditional approval based on VISION (NCT03511664), which was a randomized (2:1), multicenter, open-label trial that assessed the efficacy and safety of 177Lu-PSMA-617 plus best standard of care (BSoC; n = 551) or BSoC alone (n = 280) in men with progressive, PSMA-positive mCRPC. Patients were required to have received ≥1 androgen receptor pathway inhibitor, and one or two prior taxane-based chemotherapy regimens. There was a statistically significant and clinically meaningful improvement in overall survival (OS), with a median OS of 15.3 months in the 177Lu-PSMA-617 plus BSoC arm and 11.3 months in the BSoC arm, respectively (HR: 0.62; 95% confidence interval: 0.52-0.74; P < 0.001). The most common adverse reactions (≥20%) occurring at a higher incidence in patients receiving 177Lu-PSMA-617 were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline in ≥30% of patients receiving 177Lu-PSMA-617 were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. This article summarizes the FDA review of data supporting traditional approval of 177Lu-PSMA-617 for this indication.

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.

On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic therapies. The VENTANA FOLR1 (FOLR-2.1) RxDx Assay was approved as a companion diagnostic device to select patients for this indication. Approval was based on Study 0417 (SORAYA, NCT04296890), a single-arm, multicenter trial. In 104 patients with measurable disease who received mirvetuximab soravtansine-gynx, the overall response rate was 31.7% [95% confidence interval (CI), 22.9-41.6] with a median duration of response of 6.9 months (95% CI, 5.6-9.7). Ocular toxicity was included as a Boxed Warning in the U.S. Prescribing Information (USPI) to alert providers of the risks of developing severe ocular toxicity including vision impairment and corneal disorders. Pneumonitis and peripheral neuropathy were additional important safety risks included as Warnings and Precautions in the USPI. This is the first approval of a targeted therapy for FRα-positive, platinum-resistant ovarian cancer and the first antibody-drug conjugate approved for ovarian cancer. This article summarizes the favorable benefit-risk assessment leading to FDA's approval of mirvetuximab soravtansine-gynx.

Discrimination, acculturation and other predictors of depression among pregnant Hispanic women.

OBJECTIVE: The purpose of our study was to examine the effects of socioeconomic status, acculturative stress, discrimination, and marginalization as predictors of depression in pregnant Hispanic women. DESIGN: A prospective observational design was used. SETTING: Central and Gulf coast areas of Texas in obstetrical offices. PARTICIPANTS: A convenience sample of 515 pregnant, low income, low medical risk, and self-identified Hispanic women who were between 22-24 weeks gestation was used to collect data. MEASURES: The predictor variables were socioeconomic status, discrimination, acculturative stress, and marginalization. The outcome variable was depression. RESULTS: Education, frequency of discrimination, age, and Anglo marginality were significant predictors of depressive symptoms in a linear regression model, F (6, 458) = 8.36, P<.0001. Greater frequency of discrimination was the strongest positive predictor of increased depressive symptoms. CONCLUSIONS: It is important that health care providers further understand the impact that age and experiences of discrimination throughout the life course have on depressive symptoms during pregnancy.

Undoing Racism and Mitigating Bias Among Healthcare Professionals: Lessons Learned During a Systematic Review.

BACKGROUND: Research indicates that the implicit biases and racist attitudes of healthcare workers are fundamental contributing factors to race-based health inequities. However, few studies and reviews appear to have examined the provision and effects of anti-racist education and training on post-licensure healthcare workers. The purpose of this systematic literature review was to explore what research methods are being used to ascertain the training healthcare workers are receiving post-licensure and to identify the goals and outcomes of this training. METHODS: Using PubMed, CINAHL, and Google Scholar databases, peer-reviewed articles meeting inclusion criteria were identified and reviewed by the authors from March through October of 2020 in alignment with the renewed national focus on anti-racism and racial justice. Studies or initiatives involving students were excluded as were commentaries on studies and studies not specific to racism or anti-racism. RESULTS: Eleven articles were identified as meeting stipulated inclusion criteria. Few were outcome studies (n = 3), and many articles did not clearly delineate training methods, content, or outcomes assessed. Identified methods included group discussion, case studies, and online modules. Reported outcomes included increased self-awareness of implicit biases and racism. Only two studies focused specifically on nurses, with the majority of studies centering on physicians (n = 5). CONCLUSIONS: A considerable knowledge gap exists regarding effective methods, tools, and outcomes to use for undoing racism and mitigating bias in healthcare professionals. Nothing less than a seismic paradigm shift is called for, one in which an anti-racist perspective informs all healthcare education, research, and practice.

FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma.

On March 10, 2021, the FDA granted regular approval to tivozanib for treatment of patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Approval was based on the TIVO-3 study, a randomized trial of tivozanib versus sorafenib in patients with R/R advanced RCC. In TIVO-3, patients were randomized to receive either tivozanib 1.34 mg orally once daily for 21 consecutive days of every 28-day cycle or sorafenib 400 mg orally twice daily continuously. The primary endpoint was progression-free survival (PFS) per RECIST v1.1. Tivozanib demonstrated efficacy compared with sorafenib with an improvement in PFS [HR, 0.73; 95% confidence interval (CI), 0.56-0.95; P = 0.016]. The estimated median PFS was 5.6 months and 3.9 months in the tivozanib and sorafenib arms, respectively. There was no evidence of a detrimental effect on overall survival: HR, 0.97 (95% CI, 0.75-1.24). The most common grade 3 to 4 adverse reaction on the tivozanib arm was hypertension (24%). Compared with sorafenib, tivozanib was associated with lower rates of grade 3 to 4 diarrhea, rash, and palmar-plantar erythrodysesthesia. Patients receiving tivozanib in TIVO-3 had lower rates of dose reduction, interruption, or permanent discontinuation than those receiving sorafenib.