Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.

BACKGROUND: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance. OBJECTIVE: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines. METHODS: Eight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements. RESULTS: Due to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites. CONCLUSIONS: The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.

Obstetric violence is a misnomer.

The term "obstetric violence" has been used in the legislative language of several countries to protect mothers from abuse during pregnancy. Subsequently, it has been expanded to include a spectrum of obstetric procedures, such as induction of labor, episiotomy, and cesarean delivery, and has surfaced in the peer-reviewed literature. The term "obstetric violence" can be seen as quite strong and emotionally charged, which may lead to misunderstandings or misconceptions. It might be interpreted as implying a deliberate act of violence by healthcare providers when mistreatment can sometimes result from systemic issues, lack of training, or misunderstandings rather than intentional violence. "Obstetric mistreatment" is a more comprehensive term that can encompass a broader range of behaviors and actions. "Violence" generally refers to the intentional use of physical force to cause harm, injury, or damage to another person (eg, physical assault, domestic violence, street fights, or acts of terrorism), whereas "mistreatment" is a more general term and refers to the abuse, harm, or control exerted over another person (such as nonconsensual medical procedures, verbal abuse, disrespect, discrimination and stigmatization, or neglect, to name a few examples). There may be cases where unprofessional personnel may commit mistreatment and violence against pregnant patients, but as obstetrics is dedicated to the health and well-being of pregnant and fetal patients, mistreatment of obstetric patients should never be an intended component of professional obstetric care. It is necessary to move beyond the term "obstetric violence" in discourse and acknowledge and address the structural dimensions of abusive reproductive practices. Similarly, we do not use the term "psychiatric violence" for appropriately used professional procedures in psychiatry, such as electroshock therapy, or use the term "neurosurgical violence" when drilling a burr hole. There is an ongoing need to raise awareness about the potential mistreatment of obstetric patients within the context of abuse against women in general. Using the term "mistreatment in healthcare" instead of the more limited term "obstetric violence" is more appropriate and applies to all specialties when there is unprofessional abuse and mistreatment, such as biased care, neglect, emotional abuse (verbal), or physical abuse, including performing procedures that are unnecessary, unindicated, or without informed patient consent. Healthcare providers must promote unbiased, respectful, and patient-centered professional care; provide an ethical framework for all healthcare personnel; and work toward systemic change to prevent any mistreatment or abuse in our specialty.

Addressing challenges related to the professional practice of abortion post-Roe.

The landmark Roe vs Wade Supreme Court decision in 1973 established a constitutional right to abortion. In June 2022, the Dobbs vs Jackson Women's Health Organization Supreme Court decision brought an end to the established professional practice of abortion throughout the United States. Rights-based reductionism and zealotry threaten the professional practice of abortion. Rights-based reductionism is generally the view that moral or ethical issues can be reduced exclusively to matters of rights. In relation to abortion, there are 2 opposing forms of rights-based reductionism, namely fetal rights reductionism, which emphasizes the rights for the fetus while disregarding the rights and autonomy of the pregnant patient, and pregnant patient rights reductionism, which supports unlimited abortion without regards for the fetus. The 2 positions are irreconcilable. This article provides historical examples of the destructive nature of zealotry, which is characterized by extreme devotion to one's beliefs and an intolerant stance to opposing viewpoints, and of the importance of enlightenment to limit zealotry. This article then explores the professional responsibility model as a clinically ethically sound approach to overcome the clashing forms of rights-based reductionism and zealotry and to address the professional practice of abortion. The professional responsibility model refers to the ethical and professional obligations that obstetricians and other healthcare providers have toward pregnant patients, fetuses, and the society at large. It provides a more balanced and nuanced approach to the abortion debate, avoiding the pitfalls of reductionism and zealotry, and allows both the rights of the woman and the obligations to pregnant and fetal patients to be considered alongside broader ethical, medical, and societal implications. Constructive and respectful dialogue is crucial in addressing diverse perspectives and finding common ground. Embracing the professional responsibility model enables professionals to manage abortion responsibly, thereby prioritizing patients' interests and navigating between absolutist viewpoints to find balanced ethical solutions.

Association of Maternal Comorbidity Burden With Cesarean Birth Rate Among Nulliparous, Term, Singleton, Vertex Pregnancies.

IMPORTANCE: Cesarean birth rate among nulliparous, term, singleton, vertex (NTSV) pregnancies is a standard quality measure in obstetrical care. There are limited data on how the number and type of preexisting conditions affect mode of delivery among primigravidae, and it is also uncertain how maternal comorbidity burden differs across racial and ethnic groups and whether this helps to explain disparities in the NTSV cesarean birth rate. OBJECTIVE: To determine the association between obstetric comorbidity index (OB-CMI) score and cesarean delivery among NTSV pregnancies and to evaluate whether disparities in mode of delivery exist based on race and ethnicity group after adjusting for covariate factors. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study of deliveries between January 2019 and December 2021 took place across 7 hospitals within a large academic health system in New York and included all NTSV pregnancies identified in the electronic medical record system. Exclusion criteria were fetal demise and contraindication to labor. EXPOSURE: The OB-CMI score. Covariate factors assessed included race and ethnicity group (American Indian or Alaska Native, Asian or Pacific Islander, Hispanic, non-Hispanic Black, non-Hispanic White, other or multiracial, and declined or unknown), public health insurance, and preferred language. MAIN OUTCOME AND MEASURES: Cesarean delivery. RESULTS: A total of 30 253 patients (mean [SD] age, 29.8 [5.4] years; 100% female) were included. Non-Hispanic White patients constituted the largest race and ethnicity group (43.7%), followed by Hispanic patients (16.2%), Asian or Pacific Islander patients (14.6%), and non-Hispanic Black patients (12.2%). The overall NTSV cesarean birth rate was 28.5% (n = 8632); the rate increased from 22.1% among patients with an OB-CMI score of 0 to greater than 55.0% when OB-CMI scores were 7 or higher. On multivariable mixed-effects logistic regression modeling, there was a statistically significant association between OB-CMI score group and cesarean delivery; each successive OB-CMI score group had an increased risk. Patients with an OB-CMI score of 4 or higher had more than 3 times greater odds of a cesarean birth (adjusted odds ratio, 3.14; 95% CI, 2.90-3.40) than those with an OB-CMI score of 0. Compared with non-Hispanic White patients, nearly all other race and ethnicity groups were at increased risk for cesarean delivery, and non-Hispanic Black patients were at highest risk (adjusted odds ratio, 1.43; 95% CI, 1.31-1.55). CONCLUSIONS AND RELEVANCE: In this cross-sectional study of patients with NTSV pregnancies, OB-CMI score was positively associated with cesarean birth. Racial and ethnic disparities in this metric were observed. Although differences in the prevalence of preexisting conditions were seen across groups, this did not fully explain variation in cesarean delivery rates, suggesting that unmeasured clinical or nonclinical factors may have influenced the outcome.

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device.

OBJECTIVE: To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)-cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management. METHODS: Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success , defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony). RESULTS: In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported. CONCLUSION: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04995887.

Vacuum-Induced Hemorrhage Control versus Uterine Balloon Tamponade for Postpartum Hemorrhage.

OBJECTIVE: To compare maternal outcomes of uterine balloon tamponade (UBT) versus an intrauterine vacuum-induced hemorrhage control device (VHD) for the management of primary postpartum hemorrhage (PPH). METHODS: Retrospective cohort of all patients with PPH due to uterine atony treated with an intrauterine device within a university health system from January 2019 to June 2021. The primary outcome of massive transfusion, defined as PPH requiring transfusion of ≥4 units of packed red blood cells (PRBC), was compared between 2 groups: UBT (n = 78) versus VHD (n = 36). Statistical analysis included the use of chi-squared and Wilcoxon rank sum tests with statistical significance set at P < 0.05. RESULTS: Baseline characteristics were similar between the 2 groups. The proportion of patients who received ≥4 units of PRBC was significantly lower in the VHD group compared to the UBT group (2.8% vs. 20.5%, P = <0.01). The proportion of patients who were transfused ≥2 units of PRBC and median estimated blood loss (EBL) were also both significantly lower in the VHD group compared to the UBT group (36.1% vs. 57.7%, P = < 0.01, and 1 500 mL vs. 1 875 mL, P = 0.02, respectively). Rates of other secondary outcomes were similar between the 2 groups. CONCLUSION: Our data suggest that the use of intrauterine VHD in the management of PPH is associated with a lower number of massive transfusions and EBL compared to UBT. Randomized controlled trials are needed before drawing definitive conclusions on which device is more effective in this setting.

Vortex Formation Time is a Novel Measure for Early Detection of Diastolic Abnormalities in Adolescents with Hypertension.

Pediatric hypertension (HTN) has demonstrated an upward trend in recent years. Adolescent HTN has been linked to adult HTN, cardiovascular disease, and other health conditions. Thus, it is essential that HTN and its associated cardiac abnormalities be diagnosed and treated early to minimize lifelong adverse effects. In this study, we evaluated whether vortex formation time (VFT), a validated echocardiogram measure of left ventricular diastolic dysfunction, correlated with ambulatory blood pressure monitoring (ABPM) and HTN in adolescents. Echocardiogram data including systolic and diastolic function indices and ABPM data from 2015 to 2022 in adolescents age 13-21 years were analyzed retrospectively. We found that VFT was significantly lower in adolescents with HTN compared to those without HTN (3.69 ± 1.39 vs. 4.50 ± 1.73, p = 0.02). Standard echocardiographic indices of systolic and diastolic function were similar between the two groups, except indexed left atrial volume. Higher overall systolic blood pressure (SBP) (ß = - 0.01, CI - 0.02, - 2.2 × 10-3, p = 0.02), mean wake SBP (ß = - 0.01, CI - 0.02, - 9.4 × 10-4, p = 0.03), and mean sleep SBP (ß = - 0.01, CI - 0.02, - 1.2 × 10-3, p = 0.03) were significantly associated with lower VFT. This study demonstrates that VFT correlates to ABPM data and can be used a novel diagnostic measure in adolescents with HTN.

Information, Motivation, Behavioral Skills Model in Youth Newly Starting Antiretroviral Treatment.

An understanding of adherence among youth newly starting antiretroviral therapy (ART) is critical but understudied. The information-motivation-behavioral skills (IMB) model is often used to understand health behaviors, but has rarely been studied in youth with HIV. In a multi-site sample of 153 youth newly starting ART, structural equation modeling was utilized to test this model. The model was generally supported with information and behavioral skills directly related to the decision to adhere, while motivation was indirectly related through behavioral skills. Results suggest that interventions focusing on improving IMB constructs for medication adherence are important for preventing non-adherence in youth newly starting ART.

RESUMEN: El entendimiento de la adherencia en jóvenes que recién comienzan ART es fundamental, pero se ha estudiado poco. El modelo de información-motivación-habilidades conductuales (IMB, por sus siglas en inglés) se usa a menudo para comprender los comportamientos de salud, pero rara vez se ha estudiado en jóvenes que viven con el VIH. En una muestra de múltiples sitios de 153 jóvenes que recién comenzaban ART, se utilizó el análisis de ecuaciones estructurales para probar este modelo. En general, el modelo fue apoyado con información y habilidades conductuales directamente relacionadas con la decisión de adherirse, mientras que la motivación se relacionó indirectamente a través de las habilidades conductuales. Los resultados sugieren que las intervenciones que se enfocan en mejorar los aspectos del modelo IMB para la adherencia al medicamento son importantes para prevenir la falta de adherencia en los jóvenes que recién comienzan ART.

Hidden in plain sight in the delivery room - the Apgar score is biased.

OBJECTIVES: The objective of this study was to compare the maximum 5-min Apgar score of 10 among different U.S. races and Hispanic ethnicity. METHODS: Retrospective population-based cohort study from the National Center for Health Statistics (NCHS), and Division of Vital Statistics natality online database. We included only deliveries where the race and Hispanic ethnicity of the father and mother were listed as either Black, White, Chinese, or Asian Indian and as Hispanic or Latino origin or other. Proportions of 5-Minute Apgar scores of 10 were compared among different races and Hispanic ethnicity for six groups each for mother and father: Non-Hispanic or Latino White, Hispanic or Latino White, Non-Hispanic or Latino Black, Hispanic or Latino Black, Chinese, and Asian Indian. RESULTS: The study population consists of 9,710,066 mothers and 8,138,475 fathers from the US natality birth data 2016-2019. Black newborns had a less than 50% chance of having a 5-min Apgar score of 10 when compared to white newborns (OR 0.47 for Black mother and Black father; p<0.001). White babies (non-Hispanic and Hispanic) had the highest proportion of Apgar scores of 10 across all races and ethnicities. CONCLUSIONS: The Apgar score introduces a bias by systematically lowering the score in people of color. Embedding skin color scoring into basic data and decisions of health care propagates race-based medicine. By removing the skin color portion of the Apgar score and with it's racial and ethnic bias, we will provide more accuracy and equity when evaluating newborn babies worldwide.

Electrophysiological phenotypes of suicidality predict prolonged response to oral ketamine treatment.

Oral ketamine has shown to be a rapid-acting antidepressant and a potential treatment option for suicidality, however, repeated doses are often required. Objective markers of prolonged treatment response are needed to help individuals and clinicians make informed treatment decisions. This secondary analysis sought to identify objective electrophysiological predictors of both prolonged response and dose sensitivity to low-dose oral ketamine in people with chronic suicidality. Individuals with a Beck Scale for Suicide Ideation total score (BSS) ≥ 6 (N = 29) completed a six-week ketamine treatment, pre-treatment electroencephalography and follow-up assessment of suicidality (four weeks from the final ketamine dose). Prolonged response was observed in 52% of participants (follow-up BSS reduced by 50% or ≤6); nearly half were prolonged non-responders. There was decisive evidence for a predictive Bayesian linear regression model with follow-up BSS score as the response variable and pre-treatment auditory evoked power bands as predictors (theta, alpha and beta frequencies, BF10 = 17,948, R2 = 0.70). A Bayesian one-way ANOVA indicated strong evidence for a model of positive association between auditory evoked power and ketamine dose sensitivity (theta-alpha BF+0 = 108, effect size δ = 1.3, 95% CI 0.5-2.1; high-beta BF+0 = 7.4, δ = 0.8, 95% CI 0.1-1.6). Given auditory evoked power may index serotonin neurotransmission, these results suggest that a prolonged response to ketamine may, in part, be mediated by pre-treatment serotonergic functioning. In addition, the observed beta power differences may arise from GABAergic functioning. These suicidality phenotypes, identifiable by pre-treatment electrophysiology, may aid diagnosis, treatment selection and prediction of prolonged treatment outcome.

White matter connectivity in neonates at risk of stuttering: Preliminary data.

BACKGROUND: Developmental stuttering is thought to be underpinned by structural impairments in the brain. The only way to support the claim that these are causal is to determine if they are present before onset. MATERIALS AND METHODS: Magnetic resonance imaging (MRI) was conducted on 18 neonates, aged 8-18 weeks, 6 of whom were determined to be genetically at risk of stuttering. RESULTS: With tract-based spatial statistics (TBSS) analysis, no statistically significant differences were found between the at-risk group and the control group. However, fractional anisotropy (FA), mean diffusivity (MD), and radial diffusivity (RD) in the corpus callosum of the at-risk group were lower (uncorrected) than in the control group. Automated Fiber Quantification (AFQ) yielded lower FA in the at-risk group than in the control group in the medial section of the callosum forceps minor. DISCUSSION: The findings, albeit with a small number of participants, support the proposition that reduced integrity of white matter in the corpus callosum has a causal role in developmental stuttering. Longitudinal research to determine if children with this impairment at birth later start to stutter is needed to confirm this. The left arcuate fasciculus is thought to develop as speech develops, which likely explains why there were no abnormal findings in this area in our at-risk neonates so soon after birth. This is the first study to investigate the brains of children before the onset of stuttering, and the findings warrant further research.

Oral ketamine reduces the experience of stress in people with chronic suicidality.

BACKGROUND: Stress is prevalent in people experiencing suicidality and is a major contributor to the development of mental disorders. Evidence suggests ketamine shows capacity to reverse stress-induced brain changes. Though stress and ketamine have been explored individually for suicidality, this study is the first to examine ketamine treatment for self-reported stress in adults with chronic suicidality, building on pre-clinical evidence of ketamine's capacity to normalize stress-induced responses and contributing to our understanding of oral ketamine in clinical populations. METHODS: Thirty two adult participants (22-72 years; 17 female) with chronic suicidality completed 6 weeks of active treatment, receiving low (0.5 mg/kg - 3.0 mg/kg) doses of oral ketamine once per week, with a 4-week follow-up phase, to assess the effect of ketamine on their perceived stress. Stress was measured via self-report utilizing the Depression Anxiety Stress Scale-21(DASS-21), and analysed at pre-treatment (week 0), post-treatment (week 6) and at follow-up (week 10). RESULTS: Repeated measures ANOVA showed a significant reduction in stress (p<.001) post-treatment and Reliable Change Index calculations confirmed this to be clinically significant. Furthermore, those classified as 'prolonged responders' demonstrated a sustained reduction in stress at follow-up (i.e. after 4 weeks of nil ketamine). LIMITATIONS: Small sample size, open label design, expectancy, secondary analysis CONCLUSIONS: Ketamine showed the capacity to produce a robust and sustained improvement in stress symptoms, in people with chronic suicidality. Future larger, controlled studies examining treatment suitability in a range of stress related disorders are warranted.

Student characteristics and substance use as predictors of self-reported HIV testing: the youth risk behavior survey (YRBS) 2013-2015.

Many adolescents and young adults (AYAs; ages 13-24) are unaware of their HIV status despite participating in behavior that places them at risk for contracting HIV. This study examined possible predictors of self-reported HIV testing for high school students (grades 9-12) who completed the Youth Risk Behavior Survey (YRBS). Three sex-stratified, stepwise multivariable logistic models were used to estimate odds of having received a HIV test being associated with student characteristics and substance use. The likelihood of being tested for HIV was associated with students who were a racial/ethnic minority and age 18 and older. HIV testing was also associated with male students who reported same sex partners (males) or same sex partners (males) and different sex partners (females). Female students who reported same sex partners (females) and different sex partners (males) were more likely to have been tested for HIV. Male and female students were more likely to have been tested for HIV if they reported illicit drug and/or marijuana use, while prescription drug use was also associated with HIV testing for female students. Knowledge of the predictors of HIV testing for adolescents can guide efforts for the effective scale up of testing for this vulnerable population.

The Risk of Readmission after Early Postpartum Discharge during the COVID-19 Pandemic.

OBJECTIVE: To determine whether early postpartum discharge during the coronavirus disease 2019 (COVID-19) pandemic was associated with a change in the odds of maternal postpartum readmissions. STUDY DESIGN: This is a retrospective analysis of uncomplicated postpartum low-risk women in seven obstetrical units within a large New York health system. We compared the rate of postpartum readmissions within 6 weeks of delivery between two groups: low-risk women who had early postpartum discharge as part of our protocol during the COVID-19 pandemic (April 1-June 15, 2020) and similar low-risk patients with routine postpartum discharge from the same study centers 1 year prior. Statistical analysis included the use of Wilcoxon's rank-sum and chi-squared tests, Nelson-Aalen cumulative hazard curves, and multivariate logistic regression. RESULTS: Of the 8,206 patients included, 4,038 (49.2%) were patients who had early postpartum discharge during the COVID-19 pandemic and 4,168 (50.8%) were patients with routine postpartum discharge prior to the COVID-19 pandemic. The rates of postpartum readmissions after vaginal delivery (1.0 vs. 0.9%; adjusted odds ratio [OR]: 0.75, 95% confidence interval [CI]: 0.39-1.45) and cesarean delivery (1.5 vs. 1.9%; adjusted OR: 0.65, 95% CI: 0.29-1.45) were similar between the two groups. Demographic risk factors for postpartum readmission included Medicaid insurance and obesity. CONCLUSION: Early postpartum discharge during the COVID-19 pandemic was associated with no change in the odds of maternal postpartum readmissions after low-risk vaginal or cesarean deliveries. Early postpartum discharge for low-risk patients to shorten hospital length of stay should be considered in the face of public health crises. KEY POINTS: · Early postpartum discharge was not associated with an increase in odds of hospital readmissions after vaginal delivery.. · Early postpartum discharge was not associated with an increase in odds of hospital readmissions after cesarean delivery.. · Early postpartum discharge for low-risk patients should be considered during a public health crisis..

Relationships between reduction in symptoms and restoration of function and wellbeing: Outcomes of the Oral Ketamine Trial on Suicidality (OKTOS).

Recovery of functioning is integral to successful treatment outcomes in depressive illness. Optimal antidepressant treatment results in both symptomatic remission and functional recovery. Oral ketamine rapidly reduces suicidality and depression; however, reports of functional and wellbeing outcomes are lacking. This study examines participants' social and occupational functioning and wellbeing outcomes in the Oral Ketamine Trial on Suicidality (OKTOS). Thirty adults with chronic suicidality participated in the trial over 10 weeks. Functional recovery and wellbeing were assessed using the Social and Occupational Functioning Scale (SOFAS) and World Health Organization Well-Being Index (WHO-5). Suicidality and depressive symptoms were assessed using the Beck Scale for Suicidal ideation (BSS) and Montgomery-Asberg Depression Rating Scale (MADRS). Relationships between the four treatment outcomes were analysed. Forty-three percent of participants achieved healthy function (SOFAS ≥ 80) and 27% reported healthy wellbeing (WHO-5 > 60%) at the four-week post-treatment follow-up. Wellbeing was revealed as the data-derived treatment endpoint for the sample. Effect sizes for functioning and wellbeing outcomes were smaller than for suicidality and depression outcomes. Results suggest that reduction in depressive symptoms and suicidal ideation may be necessary but not sufficient for full restoration of function and wellbeing in antisuicidal and antidepressant therapy, including clinical trials.

Measures of Psychological Impacts of Stuttering in Young School-Age Children: A Systematic Review.

Purpose Recent research has shown that some school-age children who stutter may have speech-related anxiety. Given this, speech-language pathologists require robust measures to assess the psychological effects of stuttering during the school-age years. Accordingly, this systematic review aimed to explore available measures for assessing the psychological impacts of stuttering in young school-age children and to examine their measurement properties. Method The systematic search protocol was registered with PROSPERO (ID: 163181). Seven online databases, in addition to manual searching and screening of reference lists, were used to identify appropriate measures for the population of children who stutter aged 7-12 years. The first two authors independently assessed the measures using the quality appraisal tool described by Terwee et al. (2007). Results Despite the comprehensive search strategy, only six measures were identified for quality appraisal. No assessment tool was found to possess adequate measurement properties for the eight assessed domains: content validity, internal consistency, construct validity, reproducibility, reliability, responsiveness, floor and ceiling effects, and interpretability. No measure had clear evidence of responsiveness to clinical change. Based on the criterion defined by the Terwee et al. (2007) appraisal tool, the Communication Attitude Test and the Overall Assessment of the Speaker's Experience of Stuttering for School-Age Children received the highest number of ratings in support of their measurement properties. Conclusions The results highlight a lack of available measures in this domain and poor practices in developing and testing measurement instruments. To ensure that clinicians and researchers are equipped with sound measures to meet the mental health needs of this vulnerable population, further research to establish resources is needed.

Utilizing Alternative Testing Technology for Human Immunodeficiency Virus (HIV) in the COVID era.

PURPOSE OF REVIEW: With the onset of the Coronavirus disease 2019 (COVID-19) pandemic, in-person human immunodeficiency virus (HIV) testing is no longer easily accessible. Therefore, alternative testing technologies must be considered and implemented on a large scale to continue prevention efforts. This review seeks to describe the benefits of utilizing at-home HIV testing technologies, traditionally deemed an alternative form of testing. RECENT FINDINGS: Utilizing at-home testing technology during the COVID-19 pandemic overcomes novel and previously identified barriers to HIV testing. SUMMARY: Ensuring access to HIV testing is imperative to long-term prevention goals. With the Ending the HIV Epidemic (EHE) initiative in the USA targeting achievement by 2030, obstacles to HIV testing must be addressed to ensure its success. Implementing alternative testing technology more broadly allows for continued prevention efforts for HIV in light of COVID era restrictions.