Importance of Breast Sensation After Mastectomy: Evidence from Three Sources.

Background: Every year, more than 90,000 U.S. women undergo mastectomy. More than 40% have reconstruction. Following reconstruction, most women experience persistent partial or complete numbness of the reconstructed breasts, and many experience pain. Yet, breast reconstruction procedures focus largely on esthetic outcomes with mixed impact on sensory outcomes and little attention to pain. This study examines whether and how breast sensation is important to women. Materials and Methods: Conventional content analysis of extant qualitative data from a clinical registry (29 women with prior breast surgery for cancer, 2008-2022), a volunteer community sample (qualitative interviews with 6 women with and 5 without breast cancer, 2019), and from a Twitter social media survey (N = 32, 2022). Results: Functions of the breast identified by women with and without cancer include breastfeeding, sexual function, and femininity. Five interrelated themes on the importance of breast sensation emerged among women with breast cancer history: sexual function, experience of partnered sex or relationship with one's sexual partner, breast embodiment, effect of breast pain on sexual function, and importance to psychological wellbeing. Women, advocates, and clinicians described a lack of patient-physician communication in this domain that exacerbates the negative impact of breast sensation loss on health and wellbeing. Conclusions: Breast sensation is important to women following mastectomy, yet a gap exists in patient-physician communication about the impact of mastectomy and reconstruction on breast sensory function. Lessons for physicians, scientists, and skeptics are conveyed about why the basic integrity of women's bodies matters for practice and science.

Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children: A Randomized Clinical Trial.

Importance: Health-related social risks (HRSRs), like food and housing insecurity, are stigmatized conditions that, when addressed in clinical settings, could inadvertently compromise health care experiences. Objective: To test the noninferiority hypothesis that a low-intensity, high-scale social care intervention does not promote experiences of discrimination or diminish satisfaction with care compared to usual care. Design, Setting, and Participants: This was a double-blind randomized clinical trial conducted from November 2020 to June 2022 with 12-month follow-up analyzing data obtained 1 week after baseline intervention at a 155-bed academic urban children's hospital with 5300 annual admissions. Participants were recruited from their children's hospital rooms during their children's inpatient hospital stays. Inclusion criteria were identifying as the primary caregiver of a child younger than 18 years who was hospitalized in the general, intensive care, or transplant units; living in 1 of 42 target zip codes; and consenting to receive text messages. Caregivers of healthy newborns and caregivers of children expected to be hospitalized for less than 24 hours or greater than 30 days were excluded. A total of 637 eligible parents and caregivers were enrolled. Interventions: Participants were randomized to usual care or usual care plus CommunityRx, a low-intensity, universally delivered, electronic medical record-integrated social care assistance intervention providing personalized information about local resources alongside education about HRSRs and how to access additional support. Usual care included an admission brochure about hospital-based free food options and nonsystematic provision of resource information. Main Outcomes and Measures: Experiences of discrimination, measured using the Discrimination in Medical Settings Scale (range 7-35; higher scores indicate more frequent discrimination) and satisfaction with hospital discharge 1 week postdischarge using Child HCAHPS (range 0-100; higher scores indicate higher satisfaction). The a priori noninferiority margins (control minus intervention) were -0.9 (discrimination) and 1.6 (satisfaction). Results: Of 637 eligible caregiver participants, most identified as female (n = 600 [94.3%]), Black (n = 505 [79.4%]), and had household income less than $50 000 per year (n = 488 [78.5%]). One-third were experiencing food insecurity (n = 223). Half of participants reported discrimination experiences during the pediatric hospitalization (n = 259). Discrimination experiences among the intervention group were noninferior to those among the control group (mean [SD] score: control, 10.3 [4.7] vs intervention, 10.0 [4.6]; difference, 0.2; 90% CI, -0.5 to 0.9). Mean (SD) satisfaction with discharge was high (control, 84.2 [23.8] vs intervention, 81.9 [24.8]), but evidence was insufficient to support intervention noninferiority for this end point (difference, 2.3; 90% CI, -1.2 to 5.8). Food security status did not moderate the relationship between intervention and either outcome. Conclusions and Relevance: The findings suggest that a universally delivered social care assistance intervention did not promote caregiver experiences of discrimination during a child's hospitalization but were inconclusive regarding satisfaction. Trial Registration: ClinicalTrials.gov Identifier: NCT04171999.

CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials.

BACKGROUND: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago's South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers. METHODS AND FINDINGS: CommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in the first 12 months than originally projected for in-person enrollment. DISCUSSION: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. TRIAL REGISTRATION: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).

Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care.

Background: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers ("caregivers") at the point of healthcare to address health-related social risks (HRSRs). CommunityRx-Hunger is a double-blind randomized controlled trial (RCT) that enrolls caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT that enrolls caregivers of community-residing people with dementia. Clinical trials that enroll caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify and track caregivers. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the CommunityRx protocols from in-person to remote operations. This study describes the novel methods used to iterate existing RCT protocols and factors contributing to their successful iteration. Methods: CommunityRx uses individual-level data to generate personalized community resource referrals for basic, health and caregiving needs. Our research program uses an asset-based, community-engaged approach including study-specific community advisory boards (CABs). In early 2020, both RCT protocols were pre-tested in-person. In March 2020, when pandemic conditions prohibited enrollment during clinical encounters, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Results: Enabled by engaged CABs and ARCTICS, both RCTs quickly adapted to remote operations. Designed before the pandemic, we had planned to launch both trials by March 2020 and complete enrollment by December 2021. The pandemic postponed launch until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in 12 months than originally projected in-person. Conclusions: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration to remote trial operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. Trial Status: Both studies are registered on ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999); CommunityRx for Caregivers (NCT04146545); My Diabetes My Community (NCT04970810).

Unwanted sexual activity among United States women early in the COVID-19 pandemic.

BACKGROUND: Female sexual activity and, accordingly, birth rates tend to decline in times of stress, such as a pandemic. In addition, when resources are scarce or exogenous conditions are threatening, some women may engage in sexual activity primarily to maintain socioeconomic security. Having unwanted sex may indicate sexual activity in exchange for economic security. OBJECTIVE: This study aimed to describe patterns and correlates of unwanted sex, defined as having sex more frequently than desired, among US women early in the COVID-19 pandemic. STUDY DESIGN: The National US Women's Health COVID-19 Study was conducted in April 2020, using a nested quota sample design to enroll 3200 English-speaking women (88% cooperation rate) aged 18 to 90 years recruited from a research panel. The quota strata ensured sufficient sample sizes in sociodemographic groups of interest, namely, racial and ethnic subgroups. Patterns of sexual activity, including unwanted sex early in the pandemic, were described. To further elucidate the experiences of women reporting unwanted sex, open-ended responses to an item querying "how the coronavirus pandemic is affecting your sex life" were assessed using conventional content analysis. Logistic regression analyses-adjusting for sociodemographic characteristics, self-reported health, and prepandemic health-related socioeconomic risk factors, including food insecurity, housing instability, utilities and transportation difficulties, and interpersonal violence-were used to model the odds of unwanted sex by a pandemic-related change in health-related socioeconomic risk factors. RESULTS: The proportion of women who were sexually active early in the pandemic (51%) was about the same as in the 12 months before the pandemic (52%), although 7% of women became active, and 7% of women became inactive. Overall, 11% of sexually active women were having unwanted sex in the early pandemic. The rates of anxiety, depression, traumatic stress symptoms, and each of the 5 health-related socioeconomic risk factors assessed were about 2 times higher among women having unwanted sex than other women (P<.001). Women having unwanted sex were also 5 times more likely than other women to report an increased frequency of sex since the pandemic (65% vs 13%; P<.001) and 6 times more likely to be using emergency contraception (18% vs 3%; P<.001). Women reporting unwanted sex commonly described decreased libido or interest in sex related to mood changes since the pandemic, having "more sex," fear or worry about the transmission of the virus because of sex, and having sex to meet the partner's needs. Among sexually active women, the odds of unwanted sex (adjusting for demographic, reproductive, and health factors) were higher among women with 1 prepandemic health-related socioeconomic risk factor (adjusted odds ratio, 2.0; 95% confidence interval, 1.1-3.8) and 2 or more prepandemic health-related socioeconomic risk factors (adjusted odds ratio, 6.0; 95% confidence interval, 3.4-10.6). Among sexually active women with any prepandemic health-related socioeconomic risk factor, those with new or worsening transportation difficulties early in the pandemic were particularly vulnerable to unwanted sex (adjusted odds ratio, 2.7; 95% confidence interval, 1.7-4.3). CONCLUSION: More than 1 in 10 sexually active US women was having unwanted sex early in the COVID-19 pandemic. Socioeconomically vulnerable women, especially those with new or worsening transportation problems because of the pandemic, were more likely than others to engage in unwanted sex. Pandemic response and recovery efforts should seek to mitigate unwanted sexual activity and related health and social risks among women.