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Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P < 0.001) and sustained (39.7% to 51.4%, P < 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P < 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU Toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Cyanobacterial phytoplankton blooms are more prevalent in the freshwater Sacramento-San Joaquin Delta (Delta) since the late 1990s, including blooms driven by overgrowths of potentially toxigenic organisms of the genus Microcystis. Data from 2014 to 2021 were used to show how flow dynamics, water temperature, and water clarity drive occurrence of Microcystis. We used a Microcystis bloom in the central Delta from 2021 as a case study for how novel monitoring tools can track blooms in real-time and be used post hoc to evaluate the effects of management actions.Microcystis was detected throughout the Delta in all but the highest-flow years, and bloom incidence and severity increased during drier years. In the South Delta, Franks Tract, lower San Joaquin River, and Old River regions, where blooms are most prevalent, higher water temperatures and clarities combined with lower exports from state and federal water projects were the best explanatory factors for the occurrence of Microcystis blooms. Nutrient concentrations were lower in summer than in winter, but only became limiting at high phytoplankton concentrations.We used satellite data and in situ continuous monitoring of flow, phytoplankton communities, and water quality to track hydro-biogeochemical conditions during the 2021 case study Microcystis bloom in the Central Delta. We did not find evidence that changes to Delta outflow regulatory standards contributed to this bloom, but changes in flow caused by a salinity barrier placed in west False River may have exacerbated the bloom. The frequency and severity of droughts are expected to increase in the future as a result of climate change, and our study demonstrates how continued monitoring of cyanotoxins, water quality, and phytoplankton communities could help improve management of cyanobacterial blooms in the Delta and other estuaries.

Multi-year droughts are ever-present and transformational features of California’s Mediterranean climate and can fundamentally affect the water quality and the ecosystem responses of the San Francisco Estuary and the Sacramento–San Joaquin Delta. This study assessed data collected by long-term monitoring programs over the past 46 water years (1975–2021) to evaluate how water quality in the estuary changes during multi-year droughts. Data were aggregated by region (South-Central Delta, North Delta, confluence, Suisun Bay, and Suisun Marsh) and season, then differences between multi-year drought periods, multi-year wet periods, and neutral periods were compared using generalized linear models. We found that multi-year drought periods altered multiple physical and chemical parameters in the estuary, increasing water temperature, salinity, water clarity, and nutrient levels. This trend was consistent across regions and seasons, with few exceptions. Increases in these parameters during drought periods were likely caused by reduced Delta inflows that intensified in each successive dry year because of reduced precipitation and managed estuarine inflows and outflows. Drought periods did not substantially affect tidal velocities within the estuary, which remained mostly consistent across wet and drought periods. Trends in chlorophyll concentrations during drought periods were more nuanced with higher concentrations occurring in the South-Central Delta region and during the winter and spring. Together, these results characterized drought in the estuary as warm, clear, high in nutrients, with patchy phytoplankton blooms (as indexed by chlorophyll), all of which have implications for higher trophic levels. Considering that droughts are expected to increase in frequency and intensity in California with climate change, understanding the effects of multi-year droughts on the water quality conditions of the estuary can help inform water management decisions.

Droughts have major effects on estuaries because freshwater entry is one of the defining features of an estuary, and freshwater flow is an important variable that determines the interannual change in the environment. In the upper San Francisco Estuary (the Sacramento–San Joaquin Delta, Suisun Bay, and Suisun Marsh), the Mediterranean climate includes frequent multi-year droughts. To assess ecosystem responses to droughts in the upper estuary, the Interagency Ecological Program Drought Synthesis Team assembled a set of flow, water quality, chlorophyll, zooplankton, and fish data from 1975 to 2021 to test for differences between multi-year droughts and multi-year wet periods and tested for linear relationships between each variable and the Sacramento Valley Hydrologic Index (see definitions and relationships as outlined in Appendix A). Our models showed droughts decreased Delta outflow, project exports, zooplankton in Suisun Bay, and some fish species. We also found that droughts increased water clarity, salinity, nutrients, chlorophyll in the South Delta, zooplankton in the South Delta, and water residence time. Although our analyses only tested correlations, we hypothesized that most of the food-web responses could be traced to increased residence time, decreased transport rates, or both. However, some responses may have been caused by secondary effects, including shifts in salinity gradients, regional changes in water quality, or differences in top-down effects of increased predation and grazing rates. With increased frequency of droughts in the future, this increasingly low-outflow, warming, clearing estuary—which is invaded by non-native species and has low pelagic fish production—is rapidly becoming the new “normal.”

Background and objective: Elevated intrarenal pressure (IRP) may increase the risk of complications in patients undergoing ureteroscopy. As there is limited clarity on a threshold value for high IRP, how to manage high IRP, or which patients are at greater risk of complications due to high IRP, we used the Delphi methodology to understand expert opinion in this area. Methods: The Delphi process comprised two online surveys and an in-person meeting. During the in-person meeting, areas of disagreement and consensus were explored. Consensus statements were developed and voted on to determine the level of consensus. The study was granted a waiver by HML IRB Research and Ethics (reference number 2193). Key findings and limitations: The pan-European panel started with 12 and ended with 11 experienced endourologists. Eleven consensus statements were developed. The statements cover topics such as the definition of high IRP, complications linked to high IRP, and patient risk factors for these complications. After anonymous voting, consensus was achieved for all the statements. Two had a strong level and nine had a moderate level of agreement. There was no consensus on an IRP threshold, although the majority would be concerned for patient safety at a pressure above 61–80 cm H2O. Conclusions and clinical implications: Any IRP above normal physiological levels should be considered high. High IRP during ureteroscopy is a concern for patient safety. It is important to understand links between high IRP, patient characteristics, and complications. We call for additional research to better understand these risks and to inform refinements to clinical practice. Patient summary: A group of experts were asked their opinion on pressure within the kidney (intrarenal pressure, IRP) during a procedure called ureteroscopy (URS), when a narrow telescope is passed through the bladder and into the tube connected to the kidney. Statements that the panel agreed on were developed. These statements show that there is a concern about high IRP during URS as it may be linked to a higher risk of complications for the patient. More research is needed to better understand high IRP and its link to patient outcomes.

Objective This study reports on food insecurity (FI) amidst the COVID-19 pandemic. Participants and methods College students in four regions of the US completed the two-item validated Hunger Vital Sign™ screening tool on Qualtrics. Results FI increased significantly after March 2020 among US students (worry about food running out: 25% to 35%; food did not last: 17% to 21%) with significant regional increase in the Midwest and South. An adjusted multivariable logistic regression model indicated students that ran out of food were significantly at greater odds of experiencing hardship with paying bills (AOR: 5.59, 95% CI =3.90-8.06). Conclusions The findings identified an increase in the prevalence of FI among college students during the pandemic. Suggestions of how to address FI are discussed.

Abstract Weight loss during feed deprivation is correlated with feed conversion efficiency (FCR) in several fish species, suggesting weight loss could be used to indirectly select for improved feed conversion. Trials were conducted to determine relationships among weight loss and FCR with Delta Select and Delta Control line channel catfish fingerlings. Weight loss was measured for 79 Delta Select line families and 20 Delta Control line families in replicate feed deprivation trials. Weight loss was higher for Delta Controls than Delta Selects. The 10 Delta Select families with the highest weight loss, 10 Delta Select families with the lowest weight loss, and 10 random Delta Control families were used in a feeding trial. Initial weight, final weight, percent weight gain, and percent feed consumption were similar among Delta Select groups but higher than the Delta Control's. Feed conversion and survival were similar for all groups. Fish from the feeding trial were used in a third feed deprivation trial. Family means for weight loss were positively correlated across three feed deprivation trials but not correlated with feed conversion indicating selection for weight‐loss would not improve feed conversion. The faster growth of Delta Select catfish is as a result of increased feed consumption.

While older adults account for a disproportionate amount of healthcare spending, they are often underrepresented in clinical research needed to guide clinical care. The purpose of this perspective is to make readers aware of new data on age at enrollment for participants included in National Institutes of Health (NIH)-funded clinical research. We highlight key findings of relevance to general internal medicine and suggest ways readers could support the inclusion of older adults in clinical research. Data from the NIH Research Inclusion Statistics Report show that there were 881,385 participants enrolled in all NIH-funded clinical research in 2021, of whom 170,110 (19%) were 65 years and older. However, on average, studies included a far lower percentage of older adults. Additionally, there were many conditions for which overall enrollment rates for older adults were lower than would be expected. For example, while 10% of participants in studies related to diabetes were ≥ 65 years old, older individuals represent 43% of all prevalent diabetes in the USA. Researchers should work with clinicians to advocate for older adults and ensure their participation in clinical research. Best practices and resources for overcoming common barriers to the inclusion of older adults in research could also be disseminated.

Abstract The Delta Select channel catfish strain (DS) was developed by selection for increased growth and carcass yield. Progeny from DS and the Delta Control (DC) strain (a randomly bred strain from the same base population as DS) were compared in three trials. Trial 1: unvaccinated ~1‐year‐old fingerlings from each strain reared communally in 0.4‐ha ponds. Trial 2: vaccinated ~ 1‐year‐old fingerlings from each strain grown in separate replicated 0.4‐ha ponds and fish in about half the ponds were given an ESC vaccine‐booster at 13 months post‐hatch. Trial 3: same procedures as Trial 2, except fish were raised in replicate 0.04‐ha ponds with no vaccine‐booster. In Trial 1 DS were larger at stocking, larger at harvest, and had higher carcass yield than DC; in Trial 2 DS were larger at harvest, had better survival and higher production/ha than DC. Vaccine‐booster had no effect on fish growth or survival. DS and DC were not different for any traits in Trial 3. Although outcome varied among trials, the overall results indicated a vaccine booster did not affect growth or survival, DS strain fingerlings grew faster than DC fingerling, and DS had higher carcass yield than DC strain fish when reared communally.

Introduction Self-harm and suicide are major contributors to the global burden of disease and people in custodial settings are at a markedly increased risk of these adverse outcomes. Contactless monitoring technology is emerging as a possible solution to prevent self-harm and suicide by detecting and predicting vulnerabilities among people at increased risk in custodial settings in realtime, however no reviews to date have synthesized the evidence base, in the custodial context, regarding (a) the extent to which this technology has been implemented; and (b) the acceptability and feasibility of its application among custodial staff, specifically in relation to maintaining the wellbeing and safety of both incarcerated people and custodial professionals.Methods and analysis Our scoping review will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. We searched key electronic health and social science databases (MEDLINE, PubMed, Scopus, Web of Science, ProQuest and Google Scholar) on 5 February 2024 for peer-reviewed studies, which report on the use of contactless monitoring in custodial settings. Any type of study design was eligible, and the publication format was not limited. We included quantitative peer-reviewed journal articles, all types of reviews (narrative, systematic and meta-analysis) and did not apply study eligibility restrictions on country of origin. We will also search grey literature. Inclusion of publications will be restricted to the English language.Ethics and dissemination This review does not require institutional ethics review or approval as it is a review of studies that have already been granted relevant ethics approval. Our dissemination strategy includes a peer-reviewed publication and presentations at relevant national and international academic conferences. A plain language summary will be distributed through consumers and professional networks.

BackgroundAdolescent and adult obesity continues to be a public health epidemic in the United States. Despite the popularity of mHealth apps with gamification among adolescents, there are insufficient studies to evaluate the efficacy of gamified mHealth apps and financial incentives to motivate sustained health behavior change in adolescents or their adult caregivers. ObjectiveThis study aims to evaluate the effectiveness of gamification techniques and financial incentives used in the novel “CommitFit” mHealth app to motivate health behavior change and improve various mental and physical health metrics in adolescents and their caregivers. MethodsThis study is a 3-month randomized controlled trial (RCT) with 30 adolescents (aged 13-15 years) and their adult caregivers (N=60). It evaluates “CommitFit,” which uses gamification including points and leaderboards to motivate logging and achievement of self-selected health behavior goals (eg, more water, sleep, physical activity, fruits, or vegetables or fewer sugary beverages). The RCT had three arms, each with 10 dyads: (1) CommitFit-only users; (2) CommitFit$, where adolescents were paid US $0.05 for each point they earned; and (3) waitlist control. Intervention dyads used the app for 3 months and had the option to use it for the fourth month without prompts or extra financial incentives. User analytic software was used to evaluate the frequency of user logs and goal achievement. Monthly surveys evaluated self-reported change in the 5 CommitFit health behaviors. Changes in BMI and blood pressure were evaluated for all participants at 3 clinical visits. Mental health, gamification, and behavior economics surveys were completed during the clinical visits. ResultsRecruitment began in August 2023 and was completed in 10 weeks. The research team successfully recruited and enrolled 30 dyads. Researchers emailed and called 89 caregivers on a physician-approved adolescent patient list, a 33% recruitment rate. Data collection and analysis will be conducted in the spring and summer of 2024. The results of this study are anticipated to be published between late 2024 and early 2025. ConclusionsThis RCT will expand knowledge of the effectiveness of gamification techniques, financial incentives, and mHealth apps to motivate sustained health behavior change among adolescents and caregivers. These results may offer new opportunities to caregivers, health insurers, health care systems, and clinicians to motivate health behavior change in adolescents and caregivers, with the ultimate goal of preventing or reducing obesity and obesity-related diseases. Additional gamification, mental health surveys, and app user analytics included in the study may provide further insight into the characteristics of adolescents or caregivers who would benefit the most from using a gamified mHealth app like CommitFit. International Registered Report Identifier (IRRID)DERR1-10.2196/63505

BackgroundAlthough the incidence of acute myocardial infarction (AMI) is rising in sub-Saharan Africa, the uptake of evidence-based care for the diagnosis and treatment of AMI is limited throughout the region. In Tanzania, studies have revealed common misdiagnosis of AMI, infrequent administration of aspirin, and high short-term mortality rates following AMI. ObjectiveThis study aims to evaluate the implementation and efficacy outcomes of an intervention, the Multicomponent Intervention to Improve Acute Myocardial Infarction Care (MIMIC), which was developed to improve the delivery of evidence-based AMI care in Tanzania. MethodsThis single-arm pilot trial will be conducted in the emergency department (ED) at a referral hospital in northern Tanzania. The MIMIC intervention will be implemented by the ED staff for 1 year. Approximately 400 adults presenting to the ED with possible AMI symptoms will be enrolled, and research assistants will observe their care. Thirty days later, a follow-up survey will be administered to assess mortality and medication use. The primary outcome will be the acceptability of the MIMIC intervention, which will be measured by the Acceptability of Intervention Measurement (AIM) instrument. Acceptability will further be assessed via in-depth interviews with key stakeholders. Secondary implementation outcomes will include feasibility and fidelity. Secondary efficacy outcomes will include the following: the proportion of participants who receive electrocardiogram and cardiac biomarker testing, the proportion of participants with AMI who receive aspirin, 30-day mortality among participants with AMI, and the proportion of participants with AMI taking aspirin 30 days following enrollment. ResultsImplementation of MIMIC began on September 1, 2023. Enrollment is expected to be completed by September 1, 2024, and the first results are expected to be published by December 31, 2024. ConclusionsThis study will be the first to evaluate an intervention for improving AMI care in sub-Saharan Africa. If MIMIC is found to be acceptable, the findings from this study will inform a future cluster-randomized trial to assess effectiveness and scalability. Trial RegistrationClinicalTrials.gov NCT04563546; https://clinicaltrials.gov/study/NCT04563546 International Registered Report Identifier (IRRID)DERR1-10.2196/59917

BackgroundChildhood and adolescent obesity are persistent public health issues in the United States. Childhood obesity Electronic Health Record (EHR) tools strengthen provider-patient relationships and improve outcomes, but there are currently limited EHR tools that are linked to adolescent mHealth apps. This study is part of a larger study entitled, CommitFit, which features both an adolescent-targeted mobile health application (mHealth app) and an ambulatory EHR tool. The CommitFit mHealth app was designed to be paired with the CommitFit EHR tool for integration into clinical spaces for shared decision-making with patients and clinicians.ObjectivesThe objective of this sub-study was to identify the functional and design needs and preferences of healthcare clinicians and professionals for the development of the CommitFit EHR tool, specifically as it relates to childhood and adolescent obesity management.MethodsWe utilized a user-centered design process with a mixed-method approach. Focus groups were used to assess current in-clinic practices, deficits, and general beliefs and preferences regarding the management of childhood and adolescent obesity. A pre- and post-focus group survey helped assess the perception of the design and functionality of the CommitFit EHR tool and other obesity clinic needs. Iterative design development of the CommitFit EHR tool occurred throughout the process.ResultsA total of 12 healthcare providers participated throughout the three focus group sessions. Two themes emerged regarding EHR design: (1) Functional Needs, including Enhancing Clinical Practices and Workflow, and (2) Visualization, including Colors and Graphs. Responses from the surveys (n = 52) further reflect the need for Functionality and User-Interface Design by clinicians. Clinicians want the CommitFit EHR tool to enhance in-clinic adolescent lifestyle counseling, be easy to use, and presentable to adolescent patients and their caregivers. Additionally, we found that clinicians preferred colors and graphs that improved readability and usability. During each step of feedback from focus group sessions and the survey, the design of the CommitFit EHR tool was updated and co-developed by clinicians in an iterative user-centered design process.ConclusionMore research is needed to explore clinician actual user analytics for the CommitFit EHR tool to evaluate real-time workflow, design, and function needs. The effectiveness of the CommitFit mHealth and EHR tool as a weight management intervention needs to be evaluated in the future.

BackgroundSickle Cell Disease (SCD) is a progressive genetic disease that causes organ damage and reduces longevity. Hydroxyurea is an underutilized evidence-based medication that reduces complications and improves survival in SCD. In a multi-site clinical trial, part of the NIH-funded Sickle Cell Disease Implementation Consortium (SCDIC), we evaluate the implementation of a multi-level and multi-component mobile health (mHealth) patient and provider intervention to target the determinants and context of low hydroxyurea use. Given the complexity of the intervention and contextual variability in its implementation, we combined different behavioral and implementation theories, models, and frameworks to facilitate the evaluation of the intervention implementation. In this report, we describe engagement with stakeholders, planning of the implementation process, and final analytical plan to evaluate the implementation outcomes.MethodsDuring 19 meetings, a 16-member multidisciplinary SCDIC implementation team created, conceived, and implemented a project that utilized Intervention Mapping to guide designing an intervention and its evaluation plan. The process included five steps: (1) needs assessment of low hydroxyurea utilization, (2) conceptual framework development, (3) intervention design process, (4) selection of models and frameworks, and (5) designing evaluation of the intervention implementation.ResultsBehavioral theories guided the needs assessment and the design of the multi-level mHealth intervention. In designing the evaluation approach, we combined two implementation frameworks to best account for the contextual complexity at the organizational, provider, and patient levels: (1) the Consolidated Framework for Implementation Research (CFIR) that details barriers and facilitators to implementing the mHealth intervention at multiple levels (users, organization, intervention characteristics, broader community), and (2) the Technology Acceptance Model (TAM), a conceptual model specific for explaining the intent to use new information technology (including mHealth). The Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework was used to measure the outcomes.DiscussionOur research project can serve as a case study of a potential approach to combining different models/frameworks to help organize and plan the evaluation of interventions to increase medication adherence. The description of our process may serve as a blueprint for future studies developing and testing new strategies to foster evidence-based treatments for individuals living with SCD.