- Research Article
2
- 10.1016/j.cct.2025.107866
Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.
- May 01, 2025
- Contemporary clinical trials
- Lesley H Curtis + 13 more +13
Publications from 2021 to 2026
Showing 10 of 106 papers
Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.
An agent-based model of COVID- 19 in the food industry for assessing public health and economic impacts of infection control strategies
The COVID- 19 pandemic exposed challenges of balancing public health and economic goals of infection control in essential industries like food production. To enhance decision-making during future outbreaks, we developed a customizable agent-based model (FInd CoV Control) that predicts and counterfactually compares COVID- 19 transmission in a food production operation under various interventions. The model tracks the number of infections as well as economic outcomes (e.g., number of unavailable workers, direct expenses, production losses). The results revealed strong tradeoffs between public health and economic impacts of interventions. Temperature screening and virus testing protect public health but have substantial economic downsides. Vaccination, while inexpensive, is too slow as a reactive strategy. Intensive physical distancing and biosafety interventions prove cost-effective. The variability and bimodality in predicted impacts of counterfactual interventions, explained by the chance effects and early stochastic infection die-off, caution against relying on single-operation real-world data for decision-making. These findings underscore the need for a proactive infrastructure capable of rapidly developing integrated infection-economic mechanistic models for the essential industries to guide infection control, policy-making, and socially acceptable decisions.
Read moreInterpretation of WFAS standard: general requirements for the risk control in the safe use of acupuncture
The international standard “General Requirements for the Risk Control in the Safe Use of Acupuncture” drafted by the Institute of Acupuncture and Moxibustion of the China Academy of Chinese Medical Sciences has been officially released by the World Federation of Acupuncture-Moxibustion Societies (WFAS). As the first general international standard in the field of acupuncture safety standards, in order to avoid the repetition of common problems, this standard specifies the basic requirements for the safe use of acupuncture, defines terms with common characteristics that are easily confused in the field of acupuncture safety, clarifies the scope and level of acupuncture risks, sorts out the sources of acupuncture risks, and formulates control processes and control measures for acupuncture risks, and lays the foundation for the establishment of subsequent related standards for specific needles. In order to help the developers of standards related to the safe use of acupuncture needles to better understand and apply this standard, this paper provides an in-depth interpretation of the development process and content of this standard. At the same time, it analyses the terminology definition process of this standard, the current research status of acupuncture risk and the sources of different types of acupuncture risk and corresponding control measures. This can provide a professional reference for the developers of subsequent related standards for specific needles and help promote the safe use of acupuncture techniques worldwide.
Read moreA Guide to a Healthier Planet 3
Letter by Mayer Regarding Article, "Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants".
Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults.
Estimating Future Surface Water Availability Through an Integrated Climate‐Hydrology‐Management Modeling Framework at a Basin Scale Under CMIP6 Scenarios
Abstract Climate change and increasing water demand due to population growth pose serious threats to surface water availability. The biggest challenge in addressing these threats is the gap between climate science and water management practices. Local water planning often lacks the integration of climate change information, especially with regard to its impacts on surface water storage and evaporation as well as the associated uncertainties. Using Texas as an example, state and regional water planning relies on the use of reservoir “Firm Yield” (FY)—an important metric that quantifies surface water availability. However, this existing planning methodology does not account for the impacts of climate change on future inflows and on reservoir evaporation. To bridge this knowledge gap, an integrated climate‐hydrology‐management (CHM) modeling framework was developed, which is generally applicable to river basins with geographical, hydrological, and water right settings similar to those in Texas. The framework leverages the advantages of two modeling approaches—the Distributed Hydrology Soil Vegetation Model (DHSVM) and Water Availability Modeling (WAM). Additionally, the Double Bias Correction Constructed Analogues method is utilized to downscale and incorporate Coupled Model Intercomparison Project Phase 6 GCMs. Finally, the DHSVM simulated naturalized streamflow and reservoir evaporation rate are input to WAM to simulate reservoir FY. A new term—“Ratio of Firm Yield” (RFY)—is created to compare how much FY changes under different climate scenarios. The results indicate that climate change has a significant impact on surface water availability by increasing reservoir evaporation, altering the seasonal pattern of naturalized streamflow, and reducing FY.
Read moreClinician Perspectives on Barriers and Enablers to Implementing an Inpatient Oncology Early Warning System: A Mixed-Methods Study.
To elicit end-user and stakeholder perceptions regarding design and implementation of an inpatient clinical deterioration early warning system (EWS) for oncology patients to better fit routine clinical practices and enhance clinical impact. In an explanatory-sequential mixed-methods study, we evaluated a stakeholder-informed oncology early warning system (OncEWS) using surveys and semistructured interviews. Stakeholders were physicians, advanced practice providers (APPs), and nurses. For qualitative data, we used grounded theory and thematic content analysis via the constant comparative method to identify determinants of OncEWS implementation. Survey respondents generally agreed that an oncology-focused EWS could add value beyond clinical judgment, with nurses endorsing this notion significantly more strongly than other clinicians (nurse: median 5 on a 6-point scale [6 = strongly agree], interquartile range 4-5; doctors/advanced practice providers: 4 [4-5]; P = .005). However, some respondents would not trust an EWS to identify risk accurately (n = 36 [42%] somewhat or very concerned), while others were concerned that institutional culture would not embrace such an EWS (n = 17 [28%]).Interviews highlighted important aspects of the EWS and the local context that might facilitate implementation, including (1) a model tailored to the subtleties of oncology patients, (2) transparent model information, and (3) nursing-centric workflows. Interviewees raised the importance of sepsis as a common and high-risk deterioration syndrome. Stakeholders prioritized maximizing the degree to which the OncEWS is understandable, informative, actionable, and workflow-complementary, and perceived these factors to be key for translation into clinical benefit.
Read moreReaching Ambulatory Older Adults with Educational Tools: Comparative Efficacy and Cost of Varied Outreach Modalities in Primary Care
BackgroundProviding patients with access to health information that can be obtained outside of an office visit is an important part of education, yet little is known about the effectiveness of outreach modalities to connect older adults to online educational tools. The objective was to identify the effectiveness and cost of outreach modalities providing online information about advance care planning (ACP) for older adults.MethodsSix different outreach modalities were utilized to connect patients to online educational tools (ACP video decision aids). Participants were 13,582 patients aged 65 and older of 185 primary care providers with appointments over a 30-month period within a large health system in the greater New York City area. Main outcome measures were number of online video views and costs per outreach for each modality.Key ResultsThere were 1150 video views for 21,407 remote outreach events. Text messages, sent to the largest volume of patients (8869), had the highest outcome rate (9.6%) and were the most economical ($0.09). Characterization of phone calls demonstrated 21.7% engagement in the topic of ACP but resulted in minimal video views (<1%) and incurred the highest cost per outreach ($2.88). In-office handouts had negligible results (<1%).ConclusionsText was the most cost-effective modality to connect older adults to an online educational tool in this pragmatic trial, though overall efficacy of all modalities was low.
Read moreEarly neurological development and nutritional status in Mexican socially deprived contexts
Early childhood development (ECD) is a critical stage in the intergenerational process of human development. Targeted interventions depend on accurate and up-to-date ECD measurements. This paper presents estimates for the nutritional and neurodevelopmental status of socially marginalized children in Mexico. We performed a cross-sectional study based on data collected in 2019–2020 during home visits to 1,176 children aged 0–38 months across 24 highly marginalized locations in Oaxaca. We assessed nutritional status according to the World Health Organization 2006 child-growth standards and ECD status using the Child Development Evaluation Test, 2nd Edition. We stratified results by sex. Prevalence of stunting was 5.3 percentage points (p.p.) higher (p = 0.023) in males (25.3%; 95% CI: 20.2%, 31.1%) compared to females (20.0%; 95% CI: 15.0%, 26.1%). Overall prevalence rates stood at 5.7% (95% CI: 4.0%, 8.1%) for underweight, 1.5% (95% CI: 0.9%, 2.7%) for wasting and 3.6% (95% CI: 2.3%, 5.7%) for overweight/obesity, with no significant differences by sex. Prevalence of normal development was 8.3 p.p. lower (p = 0.001) in males (39.3%; 95% CI: 34.5%, 44.4%) compared to females (47.6%; 95% CI: 41.6%, 53.6%). By development area, the highest prevalence of suboptimal outcomes among children with developmental lag or at risk of delay was observed in their gross motor and language skills: 24.1% (95% CI: 20.0%, 28.8%) and 38.6% (95% CI: 34.0%, 43.3%), respectively. The largest difference between the sexes was found in the language area. Our results show that childhood development strategies have been insufficient thus far in the studied population. Programs specifically designed to prevent ECD lags and bridge inequality gaps are urgently needed.Trial registration: ClinicalTrials.gov ID: NCT04210362.
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