Jacobs Institute of Women's Health
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Analysis of Long-term Follow-up of a Randomized Clinical Trial With Departures From Assigned Treatments: Estimation of Metformin Effects on Diabetes and Its Complications in the Diabetes Prevention Program Outcomes Study
No full textThe Diabetes Prevention Program (DPP) was a 3-year randomized clinical trial (RCT) with evaluation of lifestyle and metformin interventions compared with placebo for diabetes prevention in high-risk adults. Both interventions significantly reduced diabetes incidence, prompting the long-term Diabetes Prevention Program Outcomes Study (DPPOS) to assess the progression of diabetes and its complications over 22 years. During follow-up, departures from the original metformin or placebo assignment occurred primarily because of development of diabetes that, by protocol, was managed by clinicians outside the study, after participants developed diabetes with HbA1c ≥7.0%. Diabetes development led to changes in metformin treatment and addition of other glucose-lowering therapies. Using statistical methods designed to estimate intervention effects despite these deviations, we consistently found that metformin reduced diabetes incidence. However, using these methods to evaluate whether use of metformin for prediabetes confers continued benefits after diabetes diagnosis did not substantially change the conclusions from those of the simpler intention-to-treat analysis that did not account for treatment changes. All of the analytic methods used resulted in similar metformin effect estimates with 95% CIs for hazard ratios including 1.0 (no effect) for all outcomes except for diabetes incidence. Elucidating metformin\u27s long-term role in mitigating diabetes-related complications beyond its effects on diabetes prevention is challenging
Multicenter Expanded Access Protocol for Research Through Access to Trehalose in People With Amyotrophic Lateral Sclerosis
No full textINTRODUCTION/AIMS: Expanded access protocols (EAPs) allow individuals ineligible for clinical trials to receive investigational products. EAP data can be collected in parallel to randomized clinical trials (RCTs) and serve as a source of evidence in clinical practice. Here, we present the results of a National Institutes of Health (NIH)-funded EAP for amyotrophic lateral sclerosis (ALS). METHODS: Participants received trehalose, a drug studied in a parallel RCT, for up to 24 weeks; clinical and biomarker data were collected throughout the study. RESULTS: Seventy participants were enrolled at 20 study centers across the United States. Treatment with trehalose did not affect the levels of neurofilament light chain [estimated flat slope per month was -0.005, SE = 0.0078; 95% CI (-0.021, 0.011)] or disease progression [estimated least square mean change of the ALS Functional Rating Scale-Revised total score and slow vital capacity (percent predicted) from baseline to Week 24 were -5.6 (0.67); 95% CI (-7.0, -4.3) and -4.53 (4.308); 95% CI (-13.55, 4.48)], respectively. No unexpected treatment-related risks were identified. Serious adverse events were deemed not related to trehalose (20 occurrences in 13 [18.6%] participants with eight deaths). DISCUSSION: This EAP establishes a framework for implementing multi-center EAPs that complement data collected from RCTs. Additional NIH-funded EAPs are currently underway. Data and additional serum samples collected in this study are available to the research community for further study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05597436
Trends in vaccination coverage and equity in the Democratic Republic of the Congo from 2017 to 2023
No full textINTRODUCTION: Several routine immunization (RI) strengthening efforts have been implemented in the Democratic Republic of the Congo (DRC) in the last decade. However, there has been no assessment of national or provincial-level trends in inequalities in RI coverage since the implementation of these programs. In this analysis, we aimed to describe trends in childhood vaccination coverage and inequalities from 2017 to 2023 at the national and provincial levels and to compare these trends among groups of provinces where two initiatives have been in place: the Mashako plan and a provincial level public-private partnership using a memorandum of understanding (MOU) approach. MATERIALS AND METHODS: We used population-based surveys including the Multiple Indicator Cluster Survey (MICS) - Palu 2017-2018 survey and four annual vaccination coverage surveys conducted from 2020 through 2023. We described vaccination coverage (three doses of pentavalent vaccine (Penta3) and at least one dose of a measles containing vaccine (MCV1)) and assessed relative and absolute inequalities in vaccination coverage by maternal education and household wealth at each time point. Analyses were conducted at the national level and within two groups of provinces: those initially included in the Mashako plan in 2018 and those initially included in the MOU approach. Inequality estimates were pooled across province groups using a random effects DerSimonian and Laird estimator for meta-analysis. RESULTS: From 2017 to 2023, national Penta3 coverage increased by 9.9 percentage points (47.7 % to 57.6 %) while MCV1 declined by 6.7 percentage points (58.9 % to 52.2 %). As of 2023, substantial wealth and education-related inequalities in childhood vaccination coverage remained: at the national level, children from wealthier households were 2.23 times more likely to receive Penta3 compared to children from poorest households (95 % Confidence Interval (CI) 2.16-2.31). Between 2017 and 2023, absolute and relative wealth-related inequalities appear to have declined, but differences were not statistically significant. Education-related inequalities have improved less than wealth-related inequalities. Though differences were often not statistically significant, reductions in inequalities were generally larger in provinces initially included in the Mashako plan and the MOU approach than in provinces not initially included in either initiative. Initial improvements in coverage and inequality between 2017 and 2020-2021 have largely stagnated at the national and sub-national levels in 2022 and 2023. DISCUSSION: Efforts remain needed to reach RI coverage and equity targets in the DRC. Routine monitoring of inequalities in RI coverage should be performed regularly to track progress. A more explicit equity focus in RI strengthening initiatives in the DRC may be necessary to accelerate progress in reducing existing inequalities
Comprehensibility in Measurement of Neurobehavioral Function in Disorders of Consciousness: Integrating Data Visualization and Change Indices for the Coma/Near-Coma Scale
No full textOBJECTIVES: To apply a person-centered measurement principle, comprehensibility, to the reporting of Coma/Near-Coma Scale (CNC-8), a measure of neurobehavioral function (NBF) for patients with disorders of consciousness. We developed Rasch equal-interval measures and change indices on a 0-100 equal-interval scale to support comprehensibility and applied data visualization techniques to enhance transparency for interpreting change in CNC-8 measures over time. DESIGN: Secondary data set using the partial credit Rasch Measurement Model and a case example. SETTING: Post-acute care rehabilitation. PARTICIPANTS: Participants (n=40) with disorders of consciousness (DoC) following a severe brain injury. INTERVENTIONS: None. MAIN OUTCOME MEASURE: CNC-8. RESULTS: We transformed CNC-8 raw total scores to 0-100 equal-interval measures so that lower values indicated less NBF and higher values indicated more NBF. Indices of responsiveness, including minimal detectable change (MDC) = 15 units and conditional minimal detectable change (cMDC) ranged from 16-62 units. CONCLUSIONS: cMDCs provide a more precise method for examining NBF change; however, without an electronic approach to data visualization, a single MDC is easier and quicker to apply in clinical practice. Relationship to PCM principle(s): Person-centered measurement emphasizes the need for assessment results that are comprehensible to all relevant parties, including clinicians and family care partners. Integration of Rasch equal-interval measures, change indices, and modern data visualization techniques can facilitate comprehensibility of interpreting CNC-8 assessment results in real time at the bedside
Validating the Anal Sex Stigma Scale among Black Sexual Minority Men Living with HIV
No full textAnal sex stigma substantially affects sexual minority men (SMM), particularly regarding sexual roles and the implications of identifying as a top or bottom. The intersection of negative perceptions regarding race, sexuality, and health status could intensify anal sex stigma effects among Black SMM living with HIV. However, there are few validated tools to measure this form of stigma among this demographic. Therefore, this study tested the psychometric properties of the Anal Sex Stigma Scale (ASSS) among 650 Black SMM living with HIV. Using exploratory and confirmatory factor analyses, a two-factor model was generated: Self & Provider Anal Sex Stigma and Peer & Knowledge-Based Anal Sex Stigma. Both subscales showed excellent internal consistency (Cronbach\u27s α \u3e 0.90). Results revealed a strong correlation between higher anal sex stigma and negative mental health outcomes, including internalized homophobia, depression, and HIV stigma, as well as lower social support and LGBT community connectedness. Findings suggest that the ASSS is a reliable measure to assess anal sex stigma among Black SMM living with HIV and provide novel insights into how it manifests in this population
Evaluating p53 protein overexpression as a predictive marker of malignant progression in Barrett\u27s oesophagus
No full textMultidimensional Experiences of Gender Among US Adolescents-Beyond the Transgender-Cisgender Binary
No full textInteragency Collaboration for Patient-Centered Antibacterial Drug Development
No full textThis manuscript presents key advances of the Antibacterial Resistance Leadership Group (ARLG) Innovations Task Force, a collaboration focused on improving endpoints for registrational trials of antibacterial drugs, including health-related quality-of-life measures, for common acute infections. This group includes members from the United States Food and Drug Administration, National Institutes of Health, academia, industry, and patient representatives to amplify patient voices and ensure that the endpoints are meaningful to how patients feel, function, and survive
Amputations and Avulsion Injuries due to Human/Equine Interaction
No full textIntroductionAmputations and avulsion injuries due to horse-associated activity are rare, yet they can result in significant impairment. The purpose of this study was to further investigate such injuries using a national emergency department database.MethodsThe US National Electronic Injury Surveillance System (NEISS) was used to identify horse-associated amputation and avulsion injuries occurring between 2000-2023. Demographic data of age, sex, and injury details were collected.ResultsThere were 34,091 emergency department visits for equine-associated injuries, with 120 (0.35%) due to amputations/avulsions; 53 (44%) patients sustained amputations, and 67 patients (56%) sustained avulsions. The average age was 37 (SD = 21 years). There were 78 female and 42 male patients. The most common mechanism of injury was riding the horse, with further details not specified (31%), followed by equipment issues (19%), bucked/thrown/kicked off the horse (15%), falling off the horse (11%), and others (6%). A rope/chain was involved in 29 patients (24%). There were 55 amputations involving the finger (40), thumb (13), and others (2). Rope-related injuries were more commonly involved in those sustaining amputations versus avulsions (42% vs 10%, P \u3c .001). Males had more rope-associated injuries (36% vs 18%, P = .043).ConclusionsThis is the largest study to date of amputations and/or avulsions due to horse-associated injuries. There were multiple mechanisms of injury, with ropes involved in one-quarter. This baseline data can be useful for evaluating the effectiveness of future prevention programs
Differences in Patient and Parent Preferences for Prognostic Communication Across Disease Milestones in Advanced Childhood Cancer
No full textBACKGROUND: Navigating prognostic communication is challenging for clinicians caring for adolescents and young adults (AYAs) with poor-prognosis cancer. Presently, little is known about how AYA and parent preferences for prognostic disclosure evolve over time. This study explored communication preferences at key illness milestones of disease progression to inform individualized, person-centered approaches to optimize prognostic disclosure. PROCEDURE: Sixty-five participants, including 25 AYAs aged 12-25 years and 40 parents, were recruited at distinct illness timepoints-diagnosis, relapse/progression, Phase I/II trial enrollment, and bereavement-to participate in semi-structured interviews about their preferences for timing, style, and content of prognostic communication. Rapid analysis was conducted to generate and compare themes across timepoints. RESULTS: Preferences for early, ongoing, and repeated prognostic discussions were increasingly reported by AYAs and parents at advancing illness milestones, with bereaved parents particularly emphasizing the value of early disclosure in retrospect. Parents of living AYAs, though not bereaved parents, advised oncologists to consider excluding AYAs from prognostic conversations-a view rarely shared by AYAs themselves. AYAs and parents preferred oncologist-led communication and also advocated for the inclusion of multidisciplinary clinicians. CONCLUSIONS: These findings highlight the dynamic nature of prognostic communication preferences across the illness trajectory and key variances between AYA and parents\u27 preferences. Early and serial prognostic conversations are welcomed by many AYAs and parents, and multidisciplinary support may enhance communication satisfaction, particularly as preferences shift over time. Future research will investigate longitudinal interventions that recognize evolving communication preferences to personalize prognostic disclosure across pediatric cancer care