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BACKGROUND: Radical cystectomy (RC) has the potential for profound changes to health-related quality of life (HRQOL). OBJECTIVE: To evaluate a broad range of HRQOL outcomes in a large RC cohort. DESIGN, SETTING, AND PARTICIPANTS: A single-center prospective study enrolled RC patients from 2008 to 2014. We collected 14 separate patient-reported outcome measures at the presurgical visit and at 3, 6, 12, 18, and 24 mo after RC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: To visualize the patterns of recovery over time across domains, we used generalized estimating equations (GEEs) with nonlinear terms. Given substantial differences in patient selection for the type of urinary diversion, we separately modeled longitudinal HRQOL within conduit and continent diversion groups. The mean pre-RC scores were compared to illustrate the baseline HRQOL differences between diversion groups. RESULTS AND LIMITATIONS: The analyzed cohort included 411 patients (n = 205 ileal conduit, n = 206 continent diversion). At baseline, patients receiving continent diversion reported better mean physical (p < 0.001), urinary (p = 0.006), and sexual function (p < 0.001), but lower social function (p = 0.015). After RC, GEE modeling showed physical function scores decreasing 5/100 points by 6 mo, and subsequently stabilizing or returning to baseline. By 12 mo, social function improved by 10/100 points among continent diversions, while remaining stable among ileal conduits. Global quality of life exceeded baseline scores by 6 mo. Sexual function scores were low before RC, with limited recovery. Psychosocial domains were stable or improved, except for 10/100-point worsening of body image among ileal conduits. CONCLUSIONS: RC patients reported favorable HRQOL recovery within 24 mo in most areas other than body image (ileal conduits) and sexual function (both). Importantly, large measurable decreases in scores were not reported by 3 mo after RC. These contemporary outcomes and the excellent locoregional control provided by RC further support it as the gold standard therapy for high-risk bladder cancer. PATIENT SUMMARY: We review quality of life in the 24 mo following radical cystectomy. Large decreases in health-related quality of life were not reported, with most areas returning to, or exceeding, baseline, except for sexual function and body image.

Isolated endobronchial inflammatory myofibroblastic tumors (IMT) are rare, accounting for about 1% of primary endobronchial tumors in children. The mainstay of treatment for this tumor has been surgical resection. Recently, the identification of anaplastic lymphoma kinase (ALK) gene mutations in half of IMTs and promising results of treatment with ALK inhibitors in other ALK-positive tumors have opened the possibility of alternative approaches. We present a 4-year-old child with an ALK-positive endobronchial IMT, treated with endoscopic resection and neoadjuvant therapy with crizotinib, without evidence of tumor recurrence 2 years after the initial resection.

INTRODUCTION AND OBJECTIVE:Radical cystectomy (RC) with urinary diversion is the gold standard therapy for high risk invasive bladder cancer, however the procedure affects multiple organ systems wi...

PURPOSE: Optimal cancer care requires patient self-management and coordinated timing and sequence of interdependent care. These are challenging, especially in safety-net settings treating underserved populations. We evaluated the 4R Oncology model (4R) of patient-facing care planning for impact on self-management and delivery of interdependent care at safety-net and non–safety-net institutions. METHODS: Ten institutions (five safety-net and five non–safety-net) evaluated the 4R intervention from 2017 to 2020 with patients with stage 0-III breast cancer. Data on self-management and care delivery were collected via surveys and compared between the intervention cohort and the historical cohort (diagnosed before 4R launch). 4R usefulness was assessed within the intervention cohort. RESULTS: Survey response rate was 63% (422/670) in intervention and 47% (466/992) in historical cohort. 4R usefulness was reported by 79.9% of patients receiving 4R and was higher for patients in safety-net than in non–safety-net centers (87.6%, 74.2%, P = .001). The intervention cohort measured significantly higher than historical cohort in five of seven self-management metrics, including clarity of care timing and sequence (71.3%, 55%, P < .001) and ability to manage care (78.9%, 72.1%, P = .02). Referrals to interdependent care were significantly higher in the intervention than in the historical cohort along all six metrics, including primary care consult (33.9%, 27.7%, P = .045) and flu vaccination (38.6%, 27.9%, P = .001). Referral completions were significantly higher in four of six metrics. For safety-net patients, improvements in most self-management and care delivery metrics were similar or higher than for non–safety-net patients, even after controlling for all other variables. CONCLUSION: 4R Oncology was useful to patients and significantly improved self-management and delivery of interdependent care, but gaps remain. Model enhancements and further evaluations are needed for broad adoption. Patients in safety-net settings benefited from 4R at similar or higher rates than non–safety-net patients, indicating that 4R may reduce care disparities.

Research using rodent models has established a relationship between the steroid hormone estrogen and dopamine function, by revealing changes throughout the estrous cycle and by directly manipulating neuroendocrine signaling through ovariectomy and administration of estrogen. However, a direct link between estrogen levels and dopamine signaling had not been established in humans. The goal of this study, therefore, was to assess the relationship between circulating 17β-estradiol and dopamine signaling in the human brain by testing for a relationship between two proxies for these variables: peripheral 17β-estradiol and striatal dopamine D(2)-type receptor availability, measured with [(18)F]fallypride and positron emission tomography (PET). Sixteen (23–45 years of age) women were tested on 2 days of the menstrual cycle estimated prospectively to occur during (a) the early follicular phase, when estrogen levels are near their nadir, and (b) the periovulatory phase, when estrogen levels peak. PET scans with [(18)F]fallypride were performed on these 2 days, and serum 17β-estradiol was measured using radioimmunoassay. Dopamine D(2)-type receptor availability did not differ significantly in the whole striatum or the caudate, putamen, or accumbens subregions during the high-estrogen vs. the low-estrogen phases of the menstrual cycle. We conclude that circulating estrogen levels do not affect dopamine D(2)-type receptor availability in the human striatum although other indices of dopaminergic function may be affected.

There are nearly 70,000 new cancer diagnoses made annually in adolescents and young adults (AYAs) in the United States. Historically, AYA patients with cancer, aged 15 to 39 years, have not shown the same improved survival as older or younger cohorts. This article reviews the contemporary cancer incidence and survival data through 2015 for the AYA patient population based on the National Cancer Institute's Surveillance, Epidemiology, and End Results registry program and the North American Association of Central Cancer Registries. Mortality data through 2016 from the Centers for Disease Control and Prevention's National Center for Health Statistics are also described. Encouragingly, absolute and relative increases in 5-year survival for AYA cancers have paralleled those of childhood cancers since the year 2000. There has been increasing attention to these vulnerable patients and improved partnerships and collaboration between adult and pediatric oncology; however, obstacles to the care of this population still occur at multiple levels. These vulnerabilities fall into 3 significant categories: research efforts and trial enrollment directed toward AYA malignancies, access to care and insurance coverage, and AYA-specific psychosocial support. It is critical for providers and health care delivery systems to recognize that the AYA population remains vulnerable to provider and societal complacency.

Background Context Underlying cognitive factors have been found to influence patients’ symptom experience. Current evidence suggests that concomitant changes in appraisal must be taken into account to accurately interpret change as measured by standard spine patient-reported outcomes (PROs). Purpose To investigate changes in patients’ minimally important differences (MID) over recovery from spinal surgery; whether and how cognitive appraisal processes are implicated in the change trajectories. Study Design/Setting Longitudinal cohort study with up to 12 months follow-up. Patient Sample Surgical patients (n = 167) with a diagnosis of disc herniation or spinal stenosis. Outcome Measures Standard spine patient-reported PROs were used (Rand-36, Oswestry Disability Index, Numerical Rating Scale for pain, PROMIS Pain Impact). Methods This study was funded by the Feldberg Chair in Spinal Research, Sunnybrook Health Sciences Centre and the authors have no conflicts of interest. MID used an anchor technique and was computed by global assessment of change (GAC) grouping. Participants were binned into groups based on their GAC response patterns at all time points: Consistently better post-surgery, consistently worse post-surgery, and bouncers, whose GAC ratings fluctuate (ie, better-then-worse-then-better; or vice versa). Individuals’ longitudinal quality of life (QOL) and appraisal slope scores were computed. QOL-appraisal slopes’ correlations were computed by GAC group. Fisher's Z transformation tested the hypothesis that GAC groups differed in the QOL-appraisal relationship over time. Results Moderate to large changes are recognized as clinically important in the early stages of recovery (ie, 6 weeks post-surgery), and over time smaller and smaller changes become important. The three pattern groups emphasized and deemphasized different standards of comparison over time, with the Better group emphasizing personal goals and the Worse and Bouncers deemphasizing doctors’ input. These group differences translated to differential relationships between PRO change and appraisal changes over time. Conclusions The MID reflects increasingly subtle change over time in PROs. Appraisal may influence how patients experience the same (MID) change over time, with better outcomes associated with emphasizing long-term goals. PRO change seems to be driven by different standards of comparison. Potential avenues for clinical intervention are discussed.

Objective The Patient-Reported Outcomes Measurement Information System (PROMIS®) Network has developed a comprehensive repository of electronic patient reported outcomes measures (ePROs) of major symptom domains that have been validated in cancer patients. Their use for patients with gynecologic cancer has been understudied. Our objective was to establish feasibility and acceptability of PROMIS ePRO integration in a gynecologic oncology outpatient clinic and assess if it can help identify severely symptomatic patients and increase referral to supportive services. Methods English-speaking patients with a confirmed history of gynecologic cancer completed PROMIS ePROs on iPads in the waiting area of an outpatient gynecologic oncology clinic. Symptom scores were calculated for each respondent and grouped using documented severity thresholds. Response data was compared with clinicopathologic characteristics across symptom domains. Severely symptomatic patients were offered referral to ancillary services and asked to complete post-exposure surveys assessing acceptability of the ePRO. Results Of the 336 patients who completed ePROs, 35% had active disease and 19% had experienced at least one disease recurrence. Sixty-nine percent of the cohort demonstrated moderate to severe physical dysfunction (60%), pain (36%), fatigue (28%), anxiety (9%), depression (8%), and sexual dysfunction (32%). Thirty-nine (12%) severely symptomatic patients were referred to services such as psychiatry, palliative care, pain management, social work or integrative oncology care. Most survey respondents identified the ePROs as helpful (78%) and easy to complete (92%). Conclusions Outpatient PROMIS ePRO administration is feasible and acceptable to gynecologic oncology patients and can help identify severely symptomatic patients for referral to ancillary support services.

BACKGROUND Lack of access to primary care physicians (PCPs) may be an important contributor to mortality differences attributed to race/ethnicity. This study examined the effects of primary care access on mortality of lung cancer patients in an underserved community. METHODS Medical records of all newly diagnosed patients with primary lung cancer from 2012 to 2016 at a National Cancer Institute (NCI)-designated center in Bronx, New York were reviewed. Demographic data, PCP status, and residence in primary care shortage areas (PCSAs) were collected. Survival data from time of first imaging to death or the end of follow-up on January 1, 2018 were recorded. Survival analysis was performed using Kaplan-Meier and Cox hazards modeling. RESULTS Among 1062 patients, 874 (82%) were PCSA residents, 314 (30%) were Hispanic, and 445 (42%) were African American. PCSA residents were likely Hispanics (P

PURPOSE: To evaluate patient-reported outcomes (PROs) for bladder cancer patients undergoing neoadjuvant chemotherapy (NAC) prior to radical cystectomy (RC) using longitudinal data and propensity-matched scoring analyses. METHODS: 155 patients with muscle-invasive bladder cancer scheduled for RC completed the European Organization for Research and Treatment of Cancer questionnaires, EORTC QLQ-C30, EORTC QLQ-BLM30, Fear of Recurrence Scale, Mental Health Inventory and Satisfaction with Life Scale within 4 weeks of surgery. A propensity-matched analysis was performed comparing pre-surgery PROs among 101 patients who completed NAC versus 54 patients who did not receive NAC. We also compared PROs pre- and post-chemotherapy for 16 patients who had data available for both time points. RESULTS: In propensity-matched analysis, NAC-treated patients reported better emotional and sexual function, mental health, urinary function and fewer financial concerns compared to those that did not receive NAC. Longitudinal analysis showed increases in fatigue, nausea and appetite loss following chemotherapy. CONCLUSION: Propensity-matched analysis did not demonstrate a negative effect of NAC on PRO. Several positive associations of NAC were found in the propensity-matched analysis, possibly due to other confounding differences between the two groups or actual clinical benefit. Longitudinal analysis of a small number of patients found small to modest detrimental effects from NAC similar to toxicities previously reported. Our preliminary findings, along with known survival and toxicity data, should be considered in decision-making for NAC.

To effectively mobilize community-based organizations (CBOs) and international non-governmental organizations (NGOs) in research, important ethical issues must be addressed. A memorandum of understanding (MOU), providing a framework and a tool to be used for establishing effective community-research partnerships, was developed by the Community Collaboration Core (CCC) of the HIV Center for Clinical and Behavioral Studies. Aims of the CCC include: (1) Initiating and sustaining successful partnerships in HIV prevention research in areas of sexuality, gender, mental health, and of mutual benefit to communities; (2) Advancing the science of collaboration among researchers, practitioners, and government in HIV prevention. Developed and assessed over a two-year period by researchers, CBO/NGO and public health representatives, this MOU can be used by potential research and community partners to address the most important issues early in a collaborative research project. Clarifying essential roles, responsibilities, and relationships, establishing trust and transparency in that process, can guide collaborators in planning the important steps for beginning and sustaining an ethical and successful research project.

Background In our companion paper, random intercept models (RIMs) investigated response-shift effects in a clinical trial comparing Eculizumab to Placebo for people with neuromyelitis optica spectrum disorder (NMOSD). RIMs predicted Global Health using the EQ-5D Visual Analogue Scale item (VAS) to encompass broad criteria that people might consider. The SF36™v2 mental and physical component scores (MCS and PCS) helped us detect response shift in VAS. Here, we sought to “back-translate” the VAS into the MCS/PCS scores that would have been observed if response shift had not been present. Methods This secondary analysis utilized NMOSD clinical trial data evaluating the impact of Eculizumab in preventing relapses (n = 143). Analyses began by equating raw scores from the VAS, MCS, and PCS, and computing scores that removed response-shift effects. Correlation analysis and descriptive displays provided a more comprehensive examination of response-shift effects. Results MCS and PCS crosswalks with VAS equated the scores that include and exclude response-shift effects. These two sets of scores had low shared variance for MCS for both groups, suggesting that corresponding mental health constructs were substantially different. The shared variance contrast for physical health was distinct only for the Placebo group. The larger MCS response-shift effects were found at end of study for Placebo only and were more prominent at extremes of the MCS score distribution. Conclusions Our results reveal notable treatment group differences in MCS but not PCS response shifts, which can explain null results detected in previous work. The method introduced herein provides a way to provide further information about response-shift effects in clinical trial data.

The changing political landscape has had a significant impact on abortion training in the United States. Access to training in medical and surgical abortion has been improving over the past several decades, though significant barriers exist in training providers adequately. We sought to evaluate access to abortion training to providers, including obstetrician-gynecologists, family practice physicians, and advanced practice providers. Training in contraception, miscarriage management, medication abortion and surgical abortion procedures is a requirement for Obstetrics and Gynecology residents. Limited information exists about the details of residency training, though larger percentages of graduating residents are reporting access to comprehensive family planning training. Initiatives by groups such as Medical Students for Choice and the Kenneth J. Ryan Program have greatly improved access to abortion training by increasing opportunities for resident involvement. Abortion training opportunities exist for Family Medicine residents and advanced practice clinicians, though this training is not mandated and as such, often not standardized. In light of increasingly restrictive legislation and decreasing numbers of abortion providers, concerns exist about the sustainability of abortion training access. Other noteworthy barriers to provider training include hospital policy, lack of expert faculty, and state laws. Ensuring integrated evidence-based and standardized abortion training is important in maintaining access to a full range of family planning services.

Highlights • HEALing Communities Study is a parallel-group cluster randomized controlled trial. • Communities That HEAL intervention’s goal is to reduce opioid overdose deaths. • Structured consensus decision-making strategy guided study measure development. • More than 80 study measure specifications and a common data model were developed. • The study will provide methodology and longitudinal community data for research., Background Opioid overdose deaths remain high in the U.S. Despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. The primary aim of the HEALing Communities Study (HCS) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (EBPs) on reducing opioid overdose deaths. Methods The HCS is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. Communities (n = 67) in Kentucky, Massachusetts, New York and Ohio are randomized to active intervention (Wave 1), which starts the intervention in Year 1 or the wait-list control (Wave 2), which starts the intervention in Year 3. The HCS will test a conceptually driven framework to assist communities in selecting and adopting EBPs with three components: 1) A community engagement strategy with local coalitions to guide and implement the intervention; 2) A compendium of EBPs coupled with technical assistance; and 3) A series of communication campaigns to increase awareness and demand for EBPs and reduce stigma. An implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of EBPs. The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1. Numerous secondary outcomes will be examined. Discussion The HCS is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses.

RationaleNicotine patches may be less effective in female compared with male smokers. However, it is unknown if negative affect and physical symptoms influence transdermal nicotine patch-related effects on smoking behaviors.MethodsEighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal) and were randomized to patch condition (nicotine [21mg] vs. placebo [0mg] transdermal patch). Negative affect and physical symptoms were assessed prior to patch administration. The patch was removed 5h post-administration, and participants completed a smoking reinstatement task. Multilevel linear models tested associations of patch condition, negative affect and physical symptoms, and their interaction on smoking behavior.ResultsThere was a significant patch condition × Negative Affect and Pain symptoms interaction on the number of cigarettes smoked (p

Unresectable hepatocellular carcinoma (HCC) was first removed successfully with total hepatectomy and liver transplantation (LT) in a child over five decades ago. Since then, children with unresectable liver cancer have benefitted greatly from LT and a confluence of several equally important endeavors. Regional and trans-continental collaborations have accelerated the development and standardization of chemotherapy regimens, which provide disease control to enable LT, and also serve as a test of unresectability. In the process, tumor histology, imaging protocols, and tumor staging have also matured to better assess response and LT candidacy. Significant trends include a steady increase in the incidence of and use of LT for hepatoblastoma, and a significant improvement in survival after LT for HCC with each decade. Although LT is curative for most unresectable primary liver sarcomas, such as embryonal sarcoma, the malignant rhabdoid tumor appears relapse-prone despite chemotherapy and LT. Pediatric liver tumors remain rare, and diagnostic uncertainty in some settings can potentially delay treatment or lead to the selection of less effective chemotherapy. We review the current knowledge relevant to diagnosis, LT candidacy, and post-transplant outcomes for these tumors, emphasizing recent observations made from large registries or larger series.

Background Premenstrual dysphoric disorder (PMDD) is an understudied, debilitating disorder of women. Given evidence for prefrontal cortical and limbic dysfunction in PMDD, we compared intrinsic connectivity of the executive control network (ECN), default mode network (DMN), and amygdala in women with PMDD vs. controls. Methods Thirty-six women (18 PMDD, 18 control) participated in fMRI during the follicular and luteal phases of the menstrual cycle. At each time, resting-state functional connectivity was evaluated both before and after participants performed an emotion regulation task. The ECN was identified using independent components analysis, and connectivity of left and right amygdala seeds was also evaluated. Results Nonparametric permutation testing identified a cluster in the left middle temporal gyrus (MTG) with significantly stronger connectivity to the left ECN in women with PMDD vs. controls in all four fMRI sessions. Women with PMDD exhibited no difference in functional connectivity between menstrual cycle phases. Amygdala connectivity did not differ between the groups but differed significantly with menstrual phase, with left amygdala connectivity to cingulate cortex being significantly stronger during the follicular vs. luteal phase. Right amygdala connectivity to the middle frontal gyrus was also stronger during the follicular vs. luteal phase, with no group differences. These findings suggest that women with PMDD have different intrinsic network dynamics in the left executive control network compared to healthy controls.

OBJECTIVE: To evaluate rates of presumptive anovulation in eumenorrheic adolescents and young adults with moderate to severe primary dysmenorrhea and those without primary dysmenorrhea. PARTICIPANTS: Thirty-nine adolescents and young adults (ages 16–24) with primary dysmenorrhea and 52 age-matched controls. DESIGN: Participants completed luteinizing hormone surge ovulation predictor test kits. Anovulatory cycles were defined by never receiving a positive result prior to the next menstrual period; participants were grouped as anovulatory if they experienced at least one anovulatory cycle during study participation. Participants rated daily level of menstrual pain on a 0–10 numeric rating scale. SETTING: A university-based clinical research laboratory. RESULTS: One hundred and sixty-eight cycles were monitored, 29.8% of which were anovulatory (37.1% vs. 17.5% of cycles in control and dysmenorrhea groups respectively). During study participation, control girls were significantly more likely to have had at least one anovulatory cycle than were girls with primary dysmenorrhea (44.2% vs. 17.9% of participants respectively, p.05). CONCLUSION: Data support previous findings of increased rates of ovulation in primary dysmenorrhea. However, menstruation following anovulatory cycles can be as painful as menstruation following ovulatory cycles. These data support the idea that regular menses do not necessarily indicate that a normal ovulatory cycle has occurred. Previous implications that ovulation is necessary for the development of substantial menstrual pain are incomplete.

There has been a recent trend toward delaying newborn baths because of mounting evidence that delayed bathing promotes breastfeeding, decreases hypothermia, and allows for more parental involvement with newborn care. A multidisciplinary team from a maternal–new-born unit at a military medical center designed and implemented an evidence-based practice change from infant sponge baths shortly after birth to delayed immersion baths. An analysis of newborn temperature data showed that newborns who received delayed immersion baths were less likely to be hypothermic than those who received a sponge bath shortly after birth. Furthermore, parents reported that they liked participating in bathing their newborns and that they felt prepared to bathe them at home.

Purpose To perform a prospective trial testing the feasibility and utility of acquiring activity data as a measure of health status during concurrent chemoradiotherapy. Methods and Materials Ambulatory patients who were planned for treatment with concurrent chemoradiotherapy with curative intent for cancers of the head and neck, lung, or gastrointestinal tract were provided with activity monitors before treatment initiation. Patients were asked to wear the devices continuously throughout the radiation therapy course. Step count data were downloaded weekly during radiation therapy and 2 and 4 weeks after radiation therapy completion. The primary objective was to demonstrate feasibility, defined as collection of step counts for 80% of the days during study subjects' radiation therapy courses. Secondary objectives included establishing step count as a dynamic predictor of unplanned hospitalization risk. Results Thirty-eight enrolled patients were treated with concurrent chemoradiotherapy. Primary diagnoses included head and neck cancer (n=11), lung cancer (n=13), and a variety of gastrointestinal cancers (n=14). Step data were collected for 1524 of 1613 days (94%) during patients' radiation therapy courses. Fourteen patients were hospitalized during radiation therapy or within 4 weeks of radiation therapy completion. Cox regression modeling demonstrated a significant association between recent step counts (3-day average) and hospitalization risk, with a 38% reduction in the risk of hospitalization for every 1000 steps taken each day (hazard ratio 0.62, 95% confidence interval 0.46-0.83, P =.002). Inferior quality of life scores and impaired performance status were not associated with increased hospitalization risk. Conclusion Continuous activity monitoring during concurrent chemoradiotherapy is feasible and well-tolerated. Step counts may serve as powerful, objective, and dynamic indicators of hospitalization risk.

Purpose Durable continuous flow left ventricular assist devices (LVADs) operate at a fixed speed set by the clinician. Within Momentum 3, a large multicenter clinical trial of a magnetically levitated centrifugal LVAD, we sought to characterize pump speeds utilized, identify clinical variables associated with speed selection, and determine if early speed setting was independently associated with major adverse events. Methods Momentum 3 was a prospective randomized clinical trial comparing the HeartMate II and HeartMate 3 (HM3) in advanced heart failure. Multivariate linear regression analyses were used to identify baseline clinical factors associated with HM3 speed setting at implant and discharge. The negative binomial model was used to determine if pump speed at implant or discharge from the index hospitalization was independently associated with a composite endpoint of death, transplant for pump thrombosis, and the occurrence of hemocompatibility related adverse events: bleeding due to surgical or non-surgical causes, any stroke, suspected or confirmed pump thrombosis or peripheral arterial thromboembolism. Results There were 514 patients implanted with the HM3 that had speed data available for analysis. Median speed at implant was lower than all other time points through 180 days (Figure). Baseline clinical variables independently associated with higher pump speed at implant were increasing body surface area (BSA, p=0.003) and left ventricular end diastolic diameter (LVEDD, p=0.008), and at hospital discharge were BSA (p Conclusion Within the Momentum 3 clinical trial, HM3 speed was significantly lower at implant compared to other time points up to 180 days. Younger age, male gender, larger BSA and LVEDD were associated with higher pump speeds. Early HM3 speed was not independently associated with adverse events.

Background Collaborations between community health and academic partners hold promise for improving community health through research. Objectives To develop, implement, and evaluate a partnership to build capacity for community-based research. Methods Development of the partnership was based on a participatory model that aimed to nurture strong infrastructure, clear communication, and trust between partners. Research training was individualized to assessed needs. Methods of evaluation included online surveys of partnership members comparing years 1 and 2 and appreciative inquiry (AI) interviews in year 3.Results and Lessons Learned: Course corrections from year 1 responses were implemented, and reflected in improvements on the second survey. Interviews highlighted mutual benefits of infrastructure developed in partnership; threats to sustainability were identified. Lessons learned included the importance of early course correction based on feedback, opportunities for communication, and building trust and a shared language. Conclusions Partnerships develop through commitment and trust. Routine assessments and course correction may enable productive research partnerships.

Background: Emergency contraception (EC) has the potential to play a vital role in preventing unintended pregnancies after unprotected sexual intercourse or contraceptive failure. Residenc...

PURPOSE: As we begin to leverage Big Data in health care settings and particularly in assessing patient-reported outcomes, there is a need for novel analytics to address unique challenges. One such challenge is in coding transcribed interview data, typically free-text entries of statements made during a face-to-face interview. Latent Dirichlet Allocation (LDA) offers statistical rigor and consistency in automating the interpretation of patients’ expressed concerns and coping strategies. METHODS: LDA was applied to interview data collected as part of a prospective, longitudinal study of QOL in N = 211 patients undergoing radical cystectomy and urinary diversion for bladder cancer. LDA analyzed personal goal statements to extract the latent topics and themes, stratified by time, and on things patients wanted to accomplish and prevent. Model comparison metrics determined the number of topics to extract. RESULTS: LDA extracted seven latent topics. Prior to surgery, patients’ priorities were primarily in cancer surgery and recovery. Six months after the surgery, they were replaced by goals on regaining a sense of normalcy, to resume work, to enjoy life more fully, and to appreciate friends and family more. LDA model parameters showed changing priorities, e.g., immediate concerns on surgery and resuming employment decreased post-surgery and were replaced by concerns over cancer recurrence and a desire to remain healthy and strong. CONCLUSIONS: Novel Big Data analytics such as LDA offer the possibility of summarizing personal goals without the need for conventional fixed-length measures and resource-intensive qualitative data coding.

Diagnostic criteria for provoked vestibulodynia (PVD) rely on mucosal pain in the vulvar vestibule, with less emphasis on pain from pelvic floor muscles. It is unknown how psychosocial variables associated with PVD are differentially associated with mucosal versus muscle pain. Analysis of data from the National Vulvodynia Registry (n = 202) revealed several factors associated with increased mucosal pain: pain duration (P = .043), the McGill sensory subscore (P = .0086) and the Gracely pain scale (P.001). Increased mucosal pain was also associated with decreased arousal (P = .036). On the other hand, factors significantly associated with greater muscle pain included number of comorbid pain conditions (P = .001), decreased intercourse frequency post PVD onset (P = .02) and higher scores on the McGill sensory (P = .0001) and affective (P = .0002) subscores, the Gracely pain scale (P = .0012), and state anxiety (P.001). Sexual function was also significantly impacted by high pelvic floor muscular pain, with lower scores for arousal (P = .046), orgasm (P = .0014) and satisfaction (P = .013), and higher pain (P = .01). Significant differences in the relationship between muscle and mucosal pain for pain duration (P = .005), McGill affective score (P = .001), orgasm (P = .049), change in intercourse frequency (P = .027), and state anxiety (P = .030) suggest the possibility of mucosal or muscle pain predominant PVD subtypes. PERSPECTIVE: Patients with higher pelvic floor muscle pain scores than mucosal pain scores may represent different subgroups or characteristics of patients with provoked vestibulodynia. This research highlights the importance of assessment of the pelvic floor muscles in addition to the cotton swab test of the vestibule.

Primary dysmenorrhea (PD; menstrual pain without an underlying medical condition) is associated with enhanced pain sensitivity and temporal summation (TS) in adult women, which may reflect the presence of central pain processes. Research in this area has been limited by focusing on only adult populations and incomplete assessments of central sensitization. The current study explored both excitatory and inhibitory measures of pain processing in girls and young adult women with and without PD. Thirty-two young women with PD and 34 healthy controls underwent laboratory pain testing during each of 3 menstrual cycle phases (menstrual, ovulatory, and midluteal), which included measures of pain tolerance and threshold, TS, and conditioned pain modulation. Results indicated enhanced pain sensitivity in young women with PD as measured by heat pain tolerance and Average Pain50 (P50), compared with healthy controls. These group differences were evident at all phases of the menstrual cycle. No group differences in cold pain tolerance, TS, or conditioned pain modulation were evident at any phase of the menstrual cycle. These data suggest some evidence of central sensitization in young women with PD, although no evidence of enhanced excitatory or deficient inhibitory mechanisms were observed. Future research should focus on identifying other potential phenotypes for PD to determine those at risk of developing other pain problems.

e22512 Background: Differences in breast cancer screening exist between the NYC neighborhoods of East Harlem (EH) and Central Harlem (CH), and the Upper East Side (UES). Here we assess the relationship between six cancer beliefs and breast cancer screening among women in these neighborhoods. Methods: We include women aged ≥40 who responded to the Community Cancer Needs Survey between 2018-2019 and were eligible to undergo screening mammography within 2 years (“recommended screening”). All estimates use weighted data generated using raking techniques. We compared categorical variables using Chi-square tests & estimated odds ratios (OR) and 95% confidence intervals (CI) from logistic regression model associating beliefs and reported mammography receipt (results and covariates listed in Table). For each belief, we compared women who reported “agree” (combined strongly or somewhat agree) to those who “disagree” (combined strongly or somewhat disagree). Results: Of the weighted sample of 76,610 (41.3% CH, 34.4% EH, and 24.3% UES) women eligible to undergo screening mammography, 75.1%, 81.2%, and 90.3% of women in CH, EH, and UES, respectively reported recommended screening. There was no difference by neighborhood in prolonged (>2 years ago) screening intervals: 10.6% in CH, 7.9% in EH, and 9.8% in the UES, while never use was reported by 11.3% in CH, 7.6% in EH, and none in the UES (p=

e18649 Background: Molecular biomarker testing is integral to NSCLC cancer care, but adoption and testing practices in the community are varied and often suboptimal. Testing practices, such as standard testing protocols and results turnaround time (TAT), impact timely treatment decisions. We examined adoption and testing practices for guideline recommended NSCLC biomarkers among National Cancer Institute Community Research Program (NCORP) sites. The study was conducted in collaboration with Wake Forest NCORP Research Base. Methods: An online survey was administered to onsite labs affiliated with NCORP sites April 2019 – June 2020. We assessed testing practices for 7 NCCN recommended biomarkers, including 3 with category 1 recommendation (EGFR, ALK, PD-L1) and 4 with category 2 recommendations (BRAF, ROS1, MET, RET). Guideline concordant result TAT was defined as return of EGFR and ALK results in ≤ 10 days (Lindeman 2018) (see Table for other outcomes). We used proportions, including two-sided Fischer exact tests, to compare outcomes by site characteristics (safety net, practice size). Results: The survey response rate was 69% (58/85). All responding labs offered testing for category 1 biomarkers (EGFR, ALK and PD-L1); only 10% conducted these tests in-house (Table). The majority of labs also tested for category 2 biomarkers (67%). TAT varied, with most labs returning results in ≤ 10 days for EGFR and ALK (69%, but only a minority meet this TAT for all biomarkers. Larger practice size (> 1400 new cancer cases a year) was associated with in-house testing of EGFR, ALK, PD-L1 (p=0.03) and having standard testing protocols (p

Cancer care is highly complex and suffers from fragmentation and lack of coordination across provider specialties and clinical domains. As a result, patients often find that they must coordinate care on their own. Coordinated delivery teams may address these challenges and improve quality of cancer care. Task interdependence is a core principle of rigorous teamwork and is essential to addressing the complexity of cancer care, which is highly interdependent across specialties and modalities. We examined challenges faced by a patient with early-stage breast cancer that resulted from difficulties in understanding and managing task interdependence across clinical domains involved in this patient’s care. We used team science supported by the project management discipline to discuss how various task interdependence aspects can be recognized, deliberately designed, and systematically managed to prevent care breakdowns. This case highlights how effective task interdependence management facilitated by project management methods could markedly improve the course of a patient’s care. This work informs efforts of cancer centers and practices to redesign cancer care delivery through innovative, practical, and patient-centered approaches to management of task interdependence in cancer care. Future patient-reported outcomes research will help to determine optimal ways to engage patients, including those who are medically underserved, in managing task interdependence in their own care.

To evaluate self-administration of vaginal lidocaine gel to decrease pain with intrauterine device (IUD) insertion in nulliparous women.In this randomized, double-blind, placebo-controlled trial, women self-administered 2% lidocaine or placebo vaginal gel 5 minutes before IUD insertion. The primary outcome was change in pain from baseline to IUD insertion on a 100-mm visual analog scale. We also assessed pain after speculum insertion, tenaculum placement, uterine sounding, and 5 minutes after IUD insertion. Secondary outcomes included patient acceptability, ease of IUD insertion, and need for pain medication for up to 7 days.From July 2012 to May 2013, 59 women were randomized; 30 received lidocaine gel and 29 placebo. Baseline demographics, including age, race, and body mass index, were similar. There was no difference in median change in pain during IUD insertion in women receiving lidocaine (61 mm [interquartile range 53-71]) compared with placebo (69 mm [interquartile range 63-80], P=.06). Women receiving lidocaine experienced less pain with tenaculum placement (32 mm [interquartile range 18-54]) compared with placebo (56 mm [interquartile range 26-75], P=.02). Most (76%) women were satisfied with their IUD insertion experience and 86% would probably or definitely recommend an IUD to a friend. Thirty-four percent of women required pain medication for at least 3 days after IUD insertion.For nulliparous women, self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, but does decrease pain with tenaculum placement.ClinicalTrials.gov, http://clinicaltrials.gov, NCT01534520.

Whilst professional bodies such as the Royal College and the American College of Obstetricians and Gynecologists have well-established standards for audit of management for most gynaecology disorders, such standards for premenstrual disorders (PMDs) have yet to be developed. The International Society of Premenstrual Disorders (ISPMD) has already published three consensus papers on PMDs covering areas that include definition, classification/quantification, clinical trial design and management (American College Obstetricians and Gynecologists 2011; Brown et al. in Cochrane Database Syst Rev 2:CD001396, 2009; Dickerson et al. in Am Fam Physician 67(8):1743-1752, 2003). In this fourth consensus of ISPMD, we aim to create a set of auditable standards for the clinical management of PMDs. All members of the original ISPMD consensus group were invited to submit one or more auditable standards to be eligible in the inclusion of the consensus. Ninety-five percent of members (18/19) responded with at least one auditable standard. A total of 66 auditable standards were received, which were returned to all group members who then ranked the standards in order of priority, before the results were collated. Proposed standards related to the diagnosis of PMDs identified the importance of obtaining an accurate history, that a symptom diary should be kept for 2 months prior to diagnosis and that symptom reporting demonstrates symptoms in the premenstrual phase of the menstrual cycle and relieved by menstruation. Regarding treatment, the most important standards were the use of selective serotonin reuptake inhibitors (SSRIs) as a first line treatment, an evidence-based approach to treatment and that SSRI side effects are properly explained to patients. A set of comprehensive standards to be used in the diagnosis and treatment of PMD has been established, for which PMD management can be audited against for standardised and improved care.

To examine associations between radiation therapy (RT) noncompliance and clinical outcomes.We reviewed all patients who completed courses of external beam RT with curative intent in our department from the years 2007 to 2012 for cancers of the head and neck, breast, lung, cervix, uterus, or rectum. Patients who missed 2 or more scheduled RT appointments (excluding planned treatment breaks) were deemed noncompliant. Univariate, multivariable, and propensity-matched analyses were performed to examine associations between RT noncompliance and clinical outcomes.Of 1227 patients, 266 (21.7%) were noncompliant. With median follow-up of 50.9 months, 108 recurrences (8.8%) and 228 deaths (18.6%) occurred. In univariate analyses, RT noncompliance was associated with increased recurrence risk (5-year cumulative incidence 16% vs 7%, P.001), inferior recurrence-free survival (5-year actuarial rate 63% vs 79%, P.001), and inferior overall survival (5-year actuarial rate 72% vs 83%, P.001). In multivariable analyses that were adjusted for disease site and stage, comorbidity score, gender, ethnicity, race, and socioeconomic status (SES), RT noncompliance was associated with inferior recurrence, recurrence-free survival, and overall survival rates. Propensity score-matched models yielded results nearly identical to those seen in univariate analyses. Low SES was associated with RT noncompliance and was associated with inferior clinical outcomes in univariate analyses, but SES was not associated with inferior outcomes in multivariable models.For cancer patients being treated with curative intent, RT noncompliance is associated with inferior clinical outcomes. The magnitudes of these effects demonstrate that RT noncompliance can serve as a behavioral biomarker to identify high-risk patients who require additional interventions. Treatment compliance may mediate the associations that have been observed linking SES and clinical outcomes.

573 Background: We previously proposed a 4R care delivery model which enables patients and care teams to manage timing and sequence of interdependent, time sensitive care with a novel multimodality 4R Care Sequence plan (NCI ASCO Teams Project; Trosman, JOP 2016). We report final results of a program which tested 4R at 10 US centers (4 academic and 6 non-academic) from 2016 to 2019. Methods: 4R Sequences were provided to stage 0-III breast cancer patients (4R cohort, N = 422) at participating centers. Analyses of clinical and patient-reported data compared the 4R cohort to a historical control cohort of patients who received care pre-4R at the same centers (N = 466). Results: We significantly improved 5 guideline recommended referral metrics and 4 referral completion metrics indicating receipt of care by patients who were referred (Table). Although significantly increased, referrals to dental visit and smoking cessation before treatment remained low (< 20% and < 10% respectively). Patient survey comments indicated that insufficient lead time to quit smoking or obtain fertility consult before cancer treatment was a key barrier for completing these referrals. Conclusions: 4R markedly improved referral and receipt of interdependent guideline recommended breast cancer care for most metrics. Future 4R program should optimize the timing of referrals within the 4R Care Sequence to allow sufficient time for smoking cessation and fertility care before treatment initiation. [Table: see text]

Background Cancer frequently occurs with other chronic diseases, and this poses serious care coordination challenges during patients’ active cancer treatment (ACT) and contributes to disparities in health outcomes. There is limited research addressing pre-existing chronic comorbidity (PCC) management during ACT. This study aimed to examine oncologists’ approach for PCC management during ACT. Methods Oncologists in the National Cancer Institute’s Community Oncology Research Program (NCORP) were surveyed about their approach in managing PCC. The Likert scale survey was piloted-tested, IRB-approved, and administered to oncologists. In December 2018, NCORP network oncologists were sent an email invitation to complete the online survey. Pearson chi-square test was used to identify differences in oncologists’ management approach of PCC. Results Among the 375 respondents of the ongoing survey, 45.6% practiced primarily as medical oncologists, 37.3% as hematology, surgical, or radiation oncologists, and 17.1% as other oncology specialists. Approximately 70% of oncologists reported that >50% of their patients had ≥ 1 PCC. When asked about the three most challenging PCC to manage, 23.3% cited diabetes, 19.5% cited heart disease, and 57.1% cited another PCC. Medical oncologists were more likely to cite diabetes first (77.5%) and less likely (22.5%) to cite heart disease first compared to other specialists (p=0.004). Co-management with patients’ PCP was the most common management approach for diabetes among medical oncologists (42.2%) compared to those of other specialties (15.0%) while referral to other physicians was the most common approach among those of other specialties (50.0%) compared to medical oncologists (22.5%) (p=0.002). Consultation and referral were the most common management approaches for heart disease across oncology specialties. Conclusion Oncologists face significant challenges to manage patients’ PCC during ACT. These results indicate that the medical oncologist is more likely to co-manage diabetes with patients’ PCP compared to other oncology specialists, but heart disease was seldom co-managed. Greater collaboration between oncology and non-oncology specialists is needed for effective management of PCC during ACT to ensure complete and coordinated care and to reduce disparities in health outcomes for these patients. Citation Format: Dudith Pierre-Victor, Iman K. Martin, Brenda Adjei, Mary Shaw-Ridley, Bruce Rapkin, Marjorie Good, Diane ST. Germain, Bernard Parker, Worta McCaskill-Stevens. Oncologists’ approach in managing pre-existing chronic comorbidities during patients’ active cancer treatment [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr D079.

e19211 Background: We previously proposed a 4R model of teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence plan, including a novel visual feature describing timing and sequence of care. We report final results of a program which tested 4R at 5 safety net and 5 non safety net US centers from 2016 to 2019. Methods: Patients with stage 0-III breast cancer received 4R plans (4R Cohort). We surveyed 4R cohort and a historical control cohort of patients receiving care at same centers pre-4R. We assessed the usefulness of 4R to the 4R cohort and the impact on pSM in 4R cohort compared to historical cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control). 4R significantly increased the composite pSM score and 5 of 7 pSM metrics vs control (Table). The increase was not influenced by patient age, stage or whether treated at safety net site. pSM scores increased in 4R vs control cohort to a similar extent for patients < 65 years old (74% vs 51%, p = .0001) as for patients ≥ 65 years old (78% vs 57%, p = .0002). pSM improved similarly for patients with stage 0 or I breast cancer (77% vs 56%, p = .0001) as for patients with stage II or III breast cancer (72% vs 54%, p = .0001). Safety net patients showed pSM increase (77% vs 51%, p = .0001) similar to non safety net patients (74% vs 58%, p = .0002). Within the 4R cohort, 80% found 4R useful for organizing care and 70% found the novel visual feature useful to manage care timing and sequence. Usefulness was similar for age groups and stages, but higher for safety net than non safety net patients (88% vs 74%, p = .0008). Conclusions: 4R markedly improved patient self-management in early breast cancer across age groups and cancer stages, but further enhancements are needed to benefit as many patients as possible. 4R benefits in safety net setting indicate that 4R may reduce disparities. [Table: see text]

e24176 Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .

There is no established salvage regimen for pediatric patients with relapsed nasopharyngeal carcinoma (NPC) and outcomes are dismal. We performed a multicenter retrospective review to determine outcomes after first salvage therapy for pediatric patients with relapsed NPC. Fourteen patients were treated with varied regimens. Two of the 14 patients received oxaliplatin-containing regimens and achieved a long-term complete response. Although definitive recommendations cannot be made based on outcomes for 14 patients who received varied regimens, we discuss justification for an oxaliplatin-containing regimen in combination with gemcitabine as a reasonable choice for first-line salvage therapy for pediatric patients with relapsed NPC.

We found that patients with cancer who completed a large presurgical battery of patient-reported outcomes questionnaires and interviews experienced minimal response burden. OBJECTIVE: Patient response burden is often raised as a human subjects concern in consideration of the length or complexity of patient-reported outcome (PRO) instruments used in oncology. We sought to quantify patient response burden and identify its predictive factors. METHODS: Data were collected pre-surgically during a prospective trial that employed a comprehensive symptom and health-related quality of life (HRQoL) PRO assessment. A subset of patients also completed HRQoL interviews. Response burden was captured using an internally developed 6-item instrument. Demographics, clinical characteristics, and HRQoL were examined as potential predictors using hierarchical regression. Response burden was used to predict participant drop-out at the first follow-up interval. RESULTS: A total of 275 patients (mean age=67.5, 23.6% female) completed surveys (n=126) or surveys in addition to interviews (n=149). Patients experienced low response burden (M(SD)=12.19(11.65)). Repetitive questions were identified by 60 patients (21.8%), whereas 31.6% indicated additional information should be gathered; 35 patients (12.7%) identified repetitive questions and expressed a desire for additional items. Low self-reported cognitive function was a significant predictor of higher response burden (β; = −0.20; t(270) = −3.38; p = 0.01; Model Adjusted R(2) = 0.04). Response burden was not a significant predictor of study drop-out. CONCLUSIONS: Despite completing a large battery of PRO measures and interviews, patients reported minimal response burden, with nearly one third expressing that more questions should have been asked. Patients with lower cognitive function are more likely to report higher response burden when completing PRO measures. Further examination of patient characteristics related to response burden may reveal useful pathways for tailoring patient-centered interventions.

This study aimed to identify the essential parts of the Quality of Life (QOL) Appraisal Profile that capture the most important differences in the ways that people with multiple sclerosis respond to patient-reported outcome (PRO) measures. This process will enable the eventual development of a more practical, less resource-intensive version of the QOL Appraisal Profile to facilitate its use in clinical research and practice. This is a secondary analysis of longitudinal PRO data (n = 859) of participants in the North American Research Committee on Multiple Sclerosis registry. Following the Rapkin and Schwartz (Health Qual Life Outcomes 2(1):14, 2004) model, we computed a “standard QOL model,” and then multivariate analysis of variance (MANOVA) and discriminant function (DF) analysis to identify patterns of appraisal measures associated with group differences in response to each QOL outcome. The “standard QOL model” explains a moderate amount of variance (i.e., 15–17 %) in physical functioning and disease-specific disability, and very little variance in mental health functioning. The MANOVAs identified the appraisal variables that mattered by PRO, and the DF analysis included 10–16 of the 83 potential appraisal variables in two DFs per outcome that distinguished groups with better, average, and worse expected scores, as well as groups with better-than-expected, as-expected, and worse-than-expected scores. The dominant appraisal parameters were more similar between the generic and disease-specific measure of physical functioning and disability, respectively, than between the mental health measure and the former two measures. The practical implications of this work all revolve around a fundamental recommendation: Whenever one measures QOL, one should measure appraisal.

BackgroundDifficulties in regulating emotions are linked to the core symptoms of premenstrual dysphoric disorder (PMDD). We therefore investigated the neural substrates of emotion-regulation problems in women with PMDD.MethodsOn the basis of self-evaluations over 2 months on the Daily Record of Severity of Problems, eligible participants were assigned to two groups: PMDD and control (18 per group). Functional magnetic resonance imaging (fMRI) and a well-validated task were used to assess brain function during emotion regulation. Participants were tested twice, once during the follicular (asymptomatic) and once in the late luteal (symptomatic) phase of the menstrual cycle.ResultsWomen with PMDD gave higher ratings of negative affect in the luteal phase than in the follicular phase, and compared with healthy control participants during the luteal phase. A region-of-interest fMRI analysis indicated that during the late luteal phase, women with PMDD had hypoactivation in right dorsolateral prefrontal cortex (dlPFC) during all conditions of the emotion-regulation task, not only in the contrast that isolated emotion regulation. An exploratory whole-brain, voxel-wise analysis showed that women with PMDD had less activation in the precentral gyrus during the luteal phase than the follicular phase, and less activation in the postcentral gyrus compared with control participants.ConclusionsDuring the luteal phase of the menstrual cycle, women with PMDD experience difficulty regulating emotions. Hypoactivation in the right dlPFC may contribute to this problem, but may be related more generally to other affective symptoms of PMDD. Hypofunction in the right pre- and postcentral gyri warrants additional study.

Background Vulvodynia is a poorly characterized condition with multiple treatment options that have been described as largely ineffective in research settings. Aim To describe treatment patterns in women enrolled in the National Vulvodynia Registry and determine if there is an association between selected treatments and patient-reported outcomes such as pain, sexual function, and psychological distress after 6 months of treatment. Methods Participants completed questionnaires on general medical history and patient-reported outcomes using the short-form McGill Pain Questionnaire, the Female Sexual Function Index, the Short Form-12 quality-of-life questionnaire, the Coping Strategies Questionnaire, and the State-Trait Anxiety Inventory. The evaluation also included pain sensitivity assessment of the vaginal mucosa using a cotton-tipped applicator and the vaginal muscles using a single-digit. In this prospective cohort study, all measurements were collected at baseline and again at 6 months after treatment. Outcomes Type of treatment, number of treatments, self-reported pain intensity, dyspareunia, and pain-related psychological distress measures are reported at baseline and 6 months. Results Of 344 women enrolled, 282 received treatment; 78 different treatments were identified and categorized by type (eg, topical, oral, physical therapy) and number. The most commonly used treatments were topical (85%, n = 241), physical therapy (52%, n = 147), and oral medications (45%, n = 128). Notably, 73% of participants received ≥2 treatments. There was no association between type or number of treatments and patient characteristics. At 6 months, women reported improvements in general pain (P = .001), pain during intercourse (P = .001), catastrophizing (P = .000), and anxiety (P = .000). The Short Form-12 quality-of-life questionnaire showed improvements in physical limitations (P = .024), emotional limitations (P = .003), well-being (P = .025), and social function (P = .010). However, all domains of the Female Sexual Function Index indicated worsening in sexual function (P = .000) except for pain. Clinical Translation Multi-modal treatments were most commonly used in clinical practice and improvements in patient-reported outcomes such as quality of life, distress, and pain were noted; however, participants who returned at 6 months continued to report poor sexual function. Conclusions Strengths include a prospective and long-term study design that evaluated women in clinical settings. Limitations include a high rate of loss to follow-up for certain measures and inability to evaluate efficacy of individual treatments. In a setting where women were receiving highly specialized care, we found wide variation in the type and number of treatments used to treat vulvodynia. Despite this heterogeneity in treatment selection, women reported significant improvements in all study measures except sexual function.

Environmental conditions during sexual maturation impact sexual signal expression, but little is known about how individual histories of changing environmental conditions affect the intensity of male sexual advertisement. We investigated the effects of shifting dietary nutrient composition (protein vs. carbohydrates) in male Nauphoeta cinerea cockroaches on consumption, final lipid reserves, and sex pheromone levels subsequent to completing sexual maturation on a specific diet, at high and low concentration of dietary nutrients. Consumption, lipid reserves, and sex pheromone levels were highly affected by dietary nutrient composition with higher values on carbohydrate- biased diet, and males had significantly higher and lower levels of consumption, lipid reserves, and sex pheromones when shifted to a carbohydrate-biased and a protein-biased diet, respectively, compared with males maintained on either initial diet throughout the experiment. Males shifted to a carbohydrate-biased diet at high nutrient concentration fully recouped their sex pheromone levels, attaining levels that were not significantly lower than those in males maintained on carbohydrate-biased diet at high nutrient concentration throughout the experiment. Our study shows that male sexual display in N. cinerea is plastic and highly affected by present as well as previous dietary conditions. Signaling of adaptive quality through male sex pheromones can therefore vary dynamically within the early adult life of a male in response to the nutritional composition of food that is available to ingest. This contrasts morphological sexual traits in arthropods that are affected during development and are fixed at adulthood.