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Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials. To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type. Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334). Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type. Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT. Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. [ABSTRACT FROM AUTHOR]

This article discusses the validation of predictive models for identifying clinical deterioration in acute care cardiology wards. The study evaluates the performance of a predictive analytics tool called CoMET, which was developed before the COVID-19 pandemic and tested during the pandemic. The results show that the models had good performance and accurately predicted clinical deterioration events. The study also found that the models performed better than other existing models and showed differences in performance based on biological sex. The authors suggest further research is needed to determine the impact of these models on clinical care. [Extracted from the article]

Background: Low-intensity shockwave therapy for erectile dysfunction is emerging as a promising treatment option. Aim: This randomized sham-controlled crossover trial assessed the efficacy of low-intensity shockwave therapy in the treatment of erectile dysfunction. Methods: Thirty-three participants with organic erectile dysfunction were enrolled and randomized to shockwave therapy (n = 17) or sham (n = 16). The sham group was allowed to cross over to receive shockwave therapy after 1 month. Outcomes: Primary outcomes were the changes in Sexual Health Inventory for Men (SHIM) score and Erection Hardness Score at 1 month following shockwave therapy vs sham, and secondary outcomes were erectile function measurements at 1, 3, and 6 months following shockwave therapy. Results: At 1 month, mean SHIM scores were significantly increased in the shockwave therapy arm as compared with the sham arm (+3.0 vs −0.7, P = .024). Participants at 6 months posttreatment (n = 33) showed a mean increase of 5.5 points vs baseline (P < .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score <3, 68% improved to a score ≥3 at 6 months. When compared with baseline, the entire cohort demonstrated significant increases in erectile function outcomes at 1, 3, and 6 months after treatment. Clinical Implications: In this randomized sham-controlled crossover trial, we showed that 54.6% of participants with organic erectile dysfunction met the minimal clinically important difference in SHIM scores after treatment with low-intensity shockwave therapy. Strengths and Limitations: Strengths of this study include a sham-controlled group that crossed over to treatment. Limitations include a modest sample size at a single institution. Conclusions: Low-intensity shockwave therapy improves erectile function in men with erectile dysfunction as compared with sham treatment, which persists even 6 months after treatment. Clinical Trial Registration: ClinicalTrials.gov NCT04434352. [ABSTRACT FROM AUTHOR]

In observational studies, the time origin of interest for time-to-event analysis is often unknown, such as the time of disease onset. Existing approaches to estimating the time origins are commonly built on extrapolating a parametric longitudinal model, which rely on rigid assumptions that can lead to biased inferences. In this paper, we introduce a flexible semiparametric curve registration model. It assumes the longitudinal trajectories follow a flexible common shape function with person-specific disease progression pattern characterized by a random curve registration function, which is further used to model the unknown time origin as a random start time. This random time is used as a link to jointly model the longitudinal and survival data where the unknown time origins are integrated out in the joint likelihood function, which facilitates unbiased and consistent estimation. Since the disease progression pattern naturally predicts time-to-event, we further propose a new functional survival model using the registration function as a predictor of the time-to-event. The asymptotic consistency and semiparametric efficiency of the proposed models are proved. Simulation studies and two real data applications demonstrate the effectiveness of this new approach. for this article are available online. [ABSTRACT FROM AUTHOR]

Rationale: Immature control of breathing is associated with apnea, periodic breathing, intermittent hypoxemia, and bradycardia in extremely preterm infants. However, it is not clear if such events independently predict worse respiratory outcome. Objectives: To determine if analysis of cardiorespiratory monitoring data can predict unfavorable respiratory outcomes at 40 weeks postmenstrual age (PMA) and other outcomes, such as bronchopulmonary dysplasia at 36 weeks PMA. Methods: The Prematurity-related Ventilatory Control (PreVent) study was an observational multicenter prospective cohort study including infants born at,29 weeks of gestation with continuous cardiorespiratory monitoring. The primary outcome was either “favorable” (alive and previously discharged or inpatient and off respiratory medications/O2/support at 40 wk PMA) or “unfavorable” (either deceased or inpatient/previously discharged on respiratory medications/O2/support at 40 wk PMA). Measurements and Main Results: A total of 717 infants were evaluated (median birth weight, 850 g; gestation, 26.4 wk), 53.7% of whom had a favorable outcome and 46.3% of whom had an unfavorable outcome. Physiologic data predicted unfavorable outcome, with accuracy improving with advancing age (area under the curve, 0.79 at Day 7, 0.85 at Day 28 and 32 wk PMA). The physiologic variable that contributed most to prediction was intermittent hypoxemia with oxygen saturation as measured by pulse oximetry,90%. Models with clinical data alone or combining physiologic and clinical data also had good accuracy, with areas under the curve of 0.84–0.85 at Days 7 and 14 and 0.86–0.88 at Day 28 and 32 weeks PMA. Intermittent hypoxemia with oxygen saturation as measured by pulse oximetry,80% was the major physiologic predictor of severe bronchopulmonary dysplasia and death or mechanical ventilation at 40 weeks PMA. Conclusions: Physiologic data are independently associated with unfavorable respiratory outcome in extremely preterm infants. [ABSTRACT FROM AUTHOR]

Aim: This descriptive cross-sectional study estimates the frequencies and kinds of potential developmental disabilities (DD) and behavior problems (BP) among children in grades R and 1 who attend a primary public school in rural Western Cape Province, South Africa. Methods: Data were collected on 174 children aged 5.1-8.8 years using the "Ten Question Screener" (10QS) and the "Developmental Behaviors Checklist-Short form." Results: For the entire sample, 42% (n = 73) screened positive for 1 or more possible DD on the 10SQ. Twenty-one percent (n = 36) screened positive for one or more possible DDs. Thirty-six percent (n = 63) of the sample scored above the cutoff for a behavioral problem that may be clinically significant. For this group the proportion of females (n = 36, 39%) was slightly higher than males (n = 28, 35%). Conclusion: The percent of possible DDs and BP among children in grades R and 1 is higher than the number of learners with special needs reported by the Principal for the entire school (18.7%). The findings from this study suggest that there may be more learners than formally designated who have special educational needs that may benefit from special educational programs (e.g. speech, occupational, language, etc.). There may be a need for expanded remedial educational and behavioral services in this school and elsewhere in the district. (Contains 3 tables.)

This study examined the association between sexual relationship power, intimate partner violence, and condom use among African American and Hispanic urban girls. In this sample of 56 sexually active girls, 50% did not use condoms consistently and therefore were at higher risk for acquiring HIV or sexually transmitted diseases (STDs). Teens who experienced more intimate partner violence had a significantly higher likelihood of inconsistent condom use and therefore a greater risk for HIV/STDs. Girls' sense of sexual control in their relationships was not directly associated with inconsistent condom use but was inversely related to verbal and emotional abuse. Interventions aimed at reducing HIV/STD risk for adolescent girls need to address patterns of dominance and control in adolescent relationships as well as multiple forms of partner violence. This suggests the need for multilevel intervention approaches that promote girls' agency and multiple ways to keep girls safe from perpetrators of partner abuse. (Contains 2 tables and 3 figures.)