Monitoring Visits Research Articles

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial

Background Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ‘Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial’, a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors. Methods This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James’s Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. Results The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. Conclusion This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. Registration ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019

Therapeutic Hydroxychloroquine Blood Levels Are Associated With Fewer Hospitalizations and Possible Reduction of Health Disparities in Lupus.

Nonadherence to receiving hydroxychloroquine (HCQ) is associated with a three-fold higher risk of lupus-related hospitalization. Monitoring HCQ blood levels could improve adherence to receiving HCQ and efficacy. Yet, HCQ level monitoring is not routinely done partially due to cost and coverage concerns. To establish HCQ level monitoring cost-effectiveness, we reported the following: (1) risk of acute care by HCQ blood levels, and (2) cost of HCQ monitoring versus acute care visits. HCQ blood levels were measured during routine lupus visits. HCQ levels were categorized as follows: (1) subtherapeutic (<750 ng/mL), (2) therapeutic (750-1,200 ng/mL), or (3) supratherapeutic (>1,200 ng/mL). All lupus-related acute care visits (emergency room visits/hospitalizations) after the index clinic visit until next follow-up were abstracted. In our primary analysis, we examined associations between HCQ levels and time to first acute care visit in all patients and subgroups with higher rates of acute care. A total of 39 lupus-related acute care visits were observed in 181 patients. Therapeutic HCQ blood levels were associated with 66% lower rates of acute care. In our cohort, two groups, Black or Hispanic patients and those with public insurance, faced three to four times higher rates of acute care. Levels within 750 to 1,200 ng/mL were associated with 95% lower rates of acute care use in subgroups with higher acute care use. HCQ blood levels within 750 to 1,200 ng/mL are associated with lower rates of acute care in all patients with lupus, including groups with higher rates of acute care. Future clinical trials should establish the causal association between HCQ level monitoring and acute care in patients with lupus.

Exploring Nonspecialist Preparedness to Deliver an Evidence-Based, Family Strengthening Intervention in Rwanda: A Qualitative Study.

Families in low- and middle-income countries (LMICs) face significant mental health and psychosocial care gaps. In recent years, researchers and practitioners have addressed these gaps by task-sharing evidence-based mental health and psychosocial support (MHPSS) interventions to nonspecialist community providers. Supervision and training approaches are intended to prepare nonspecialists to deliver evidence-based interventions with quality. However, there is still little research exploring nonspecialist experiences with training and supervision and how, if at all, their training and supervision experiences result in fidelity and competence in delivering the intervention. This qualitative study uses data from a cluster-randomized trial of a family strengthening and violence prevention program in Rwanda, known as Sugira Muryango. In semi-structured interviews, the nonspecialists provided examples of using skills such as rapport-building, empathy, and active listening to deliver Sugira Muryango effectively. Because nonspecialists were serving in their own communities, they found that it was easier to earn trust with friends and neighbors, and this facilitated effective delivery of Sugira Muryango. Nonspecialists discussed how training, monthly supervision, in-person monitoring visits, and the use of the manual and audio recorders equipped them to deliver Sugira Muryango with quality. Nonspecialists also provided examples of barriers to quality of delivery, including supervisor lack of availability, delayed compensation, and technology issues. Preparedness was consistent across gender; however, nonspecialists serving in a better-resourced district had previous experiences delivering evidence-based interventions and felt more prepared at the beginning of Sugira Muryango.

Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial.

HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention. The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing. Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. DERR1-10.2196/56587.

Caregiver Experience Survey of Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Introduction: Diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) require frequent anti-vascular endothelial growth factor (VEGF) treatment and monitoring visits. We aimed to understand the burden of treatment on caregivers. Methods: This multinational, noninterventional study used a cross-sectional survey of adult patients with DME or nAMD treated with anti-VEGF injections in the USA, Canada, France, Italy, Spain, and the UK. The survey assessed caregivers’ sociodemographic characteristics, patient relationships, patients’ clinical history and treatment experiences, caregivers’ experiences, and the Caregiver Reaction Assessment of caregiving burden. Results: Caregivers for patients with DME (n = 30) and nAMD (n = 95) completed surveys. Mean ± standard deviation (SD) age was 64.0 ± 13.4 years, and most were female (71.2%), white (70.4%), married (66.4%), and from Europe (67.2%). Most were caring for their mother/father or partner/spouse (85.6%). Mean ± SD length of time as a caregiver was 9.1 ± 10.0 years. Caregivers estimated they provided support for 4.2 ± 2.9 days/week and 6.0 ± 7.1 h/day on average. Nearly half of caregivers (45.6%) reported some impairment in daily activities, and more than two-thirds (70.5%) of working caregivers (n = 44) reported work absenteeism due to anti-VEGF treatment/monitoring appointments. At least one treatment barrier was reported by 66.7% and 50.5% of caregivers of patients with DME and nAMD, respectively, which were related to coronavirus disease 2019- (38.4%), clinic- (18.4%), social-/health- (13.6%), treatment- (10.4%), or financial-related factors (4.8%). Caregiver Reaction Assessment scores indicated mild-to-moderate burden, with higher caregiver schedule disruption scores associated with an increasing number of anti-VEGF treatment/monitoring visits among DME caregivers (r = 0.61). Conclusion: Caregivers devote substantial time to caregiving, leading to schedule disruptions and absenteeism for some working caregivers. Positive and negative impacts on caregiver mental health were reported.

EMPOWERING B40 WOMEN IN MALAYSIA: A SOCIOECONOMIC IMPACT ASSESSMENT OF THE ECER-SURI@HOME PROGRAM

Women can be categorised as one of the marginalised and disadvantaged groups in Malaysia. With the COVID-19 pandemic that has hit Malaysia over the past three years, the vulnerability of Malaysian women in aspects of mental health and limited or inflexible occupations has increased. ECER-Suri@Home is a socioeconomic development program designed for women in ECER, especially housewives and single mothers with mobility constraints, to engage in home-based businesses, such as tenun and songket weaving, as a means to help them earn regular additional income. This study aims to assess the socioeconomic impact of the ECER-Suri@Home program on the participants and explore how the monitoring practice used can influence the sustainability of the program in empowering the wellbeing of B40 women in Terengganu. This study employed quantitative and qualitative approaches in data collection by distributing questionnaires to the program’s participants and in-depth interviews with several key informants from ECERDC and Yayasan Pembangunan Keluarga Terengganu. The outcome of this study revealed that this program has had a high impact on the economic status of the participants. The monthly monitoring visit has increased the productivity and quality of the tenun songket produced by the participants; however, this program would not be sustainable for the next cohort due to the difficulty in finding suitable participants.

Scanning amplicons with CRISPR-Dx detects endangered amphibians in environmental DNA.

More efficient methods for extensive biodiversity monitoring are required to support rapid measures to address the biodiversity crisis. While environmental DNA (eDNA) metabarcoding and quantitative PCR (qPCR) methods offer advantages over traditional monitoring approaches, their large-scale application is limited by the time and labour required for developing assays and/or for analysis. CRISPR (clustered regularly interspaced short palindromic repeats) diagnostic technologies (Dx) may overcome some of these limitations, but they have been used solely with species-specific primers, restricting their versatility for biodiversity monitoring. Here, we demonstrate the feasibility of designing species-specific CRISPR-Dx assays in silico within a short metabarcoding fragment using a general primer set, a methodology we term 'ampliscanning', for 18 of the 22 amphibian species in Switzerland. We sub-selected nine species, including three classified as regionally endangered, to test the methodology using eDNA sampled from ponds at nine sites. We compared the ampliscanning detections to data from traditional monitoring at these sites. Ampliscanning was successful at detecting target species with different prevalences across the landscape. With only one visit, we detected more species per site than three traditional monitoring visits (visual and acoustic detections by trained experts), in particular more elusive species and previously undocumented but expected populations. Ampliscanning detected 25 species/site combinations compared to 12 with traditional monitoring. Sensitivity analyses showed that larger numbers of field visits and PCR replicates are more important for reliable detection than many technical replicates at the CRISPR-Dx assay level. Given the reduced sampling and analysis effort, our results highlight the benefits of eDNA and CRISPR-Dx combined with universal primers for large-scale monitoring of multiple endangered species across landscapes to inform conservation measures.

Addressing healthcare vulnerabilities in nursing homes : Insights from human rights monitoring in two Austrian provinces.

Current demographic changes bear challenges for national care systems due to higher life expectancy of older citizens. Largely cut off from society, nursing home residents are at risk for violence, neglect, and other potential human rights violations. This study aimed to investigate healthcare vulnerabilities in nursing homes and evaluate the Austrian National Preventive Mechanism (NPM). Between 2017 and 2019, 55 monitoring visits were conducted in 32 nursing homes. Study outcomes from two Austrian provinces included data on infrastructure, occupancy, staffing, resident's demographics and medical conditions, as well as measures related to the functioning of the NPM. Accessibility with mobility aids was sufficient in 87%, but assistance for persons with visual or hearing impairments solely in 20-40% of the institutions. An understaffing with nursing assistants (-5.2 full-time equivalents in Carinthia) and home helpers (-1.6 in Carinthia and Styria) was present. Less than 20% of the personnel received advanced training related to dementia and neuropsychiatric care. While 50% of the residents were diagnosed with apsychiatric disorder, approximately 36% received support from an appointed legal guardian. Of the monitoring visits 58.1% were conducted due to anonymous complaints and urgent referrals. The median processing times of the NPM and the provincial governments exceeded 250 days. Human rights monitoring reveals critical aspects in nursing home care, including insufficient accessibility, understaffing and inadequate training. Although the authorities' handling times hinder prompt responses, the NPM may foster systemic improvements and accountability within nursing homes.

Remote blood pressure management for postpartum hypertension: a cost-effectiveness analysis

Recognizing the importance of close follow-up after hypertensive disorders of pregnancy, many centers have initiated programs to support postpartum remote blood pressure management. This study aimed to evaluate the cost-effectiveness of remote blood pressure management to determine the scalability of these programmatic interventions. This was a cost-effectiveness analysis of using remote blood pressure management vs usual care to manage postpartum hypertension. The modeled remote blood pressure management included provision of a home blood pressure monitor, guidance on warning symptoms, instructions on blood pressure self-monitoring twice daily, and clinical staff to manage population-level blood pressures as appropriate. Usual care was defined as guidance on warning symptoms and recommendations for 1 outpatient visit for blood pressure monitoring within a week after discharge. This study designed a Markov model that ran over fourteen 1-day cycles to reflect the initial 2 weeks after delivery when most emergency department visits and readmissions occur and remote blood pressure management is clinically anticipated to be most impactful. Parameter values for the base-case scenario were derived from both internal data and literature review. Quality-adjusted life-years were calculated over the first year after delivery and reflected the short-term morbidities associated with hypertensive disorders of pregnancy that, for most birthing people, resolve by 2 weeks after delivery. Sensitivity analyses were performed to assess the strength and validity of the model. The primary outcome was the incremental cost-effectiveness ratio, which was defined as the cost needed to gain 1 quality-adjusted life-year. The secondary outcome was incremental cost per readmission averted. Analyses were performed from a societal perspective. In the base-case scenario, remote blood pressure management was the dominant strategy (ie, cost less, higher quality-adjusted life-years). In univariate sensitivity analyses, the most cost-effective strategy shifted to usual care when the cost of readmission fell below $2987.92 and the rate of reported severe range blood pressure with a response in remote blood pressure management was <1%. Assuming a willingness to pay of $100,000 per quality-adjusted life-year, using remote blood pressure management was cost-effective in 99.28% of simulations in a Monte Carlo analysis. Using readmissions averted as a secondary effectiveness outcome, the incremental cost per readmission averted was $145.00. Remote blood pressure management for postpartum hypertension is cost saving and has better outcomes than usual care. Our data can be used to inform future dissemination of and support funding for remote blood pressure management programs.

Deployment of attractive targeted sugar baits in western Zambia: installation, monitoring, removal, and disposal procedures during a Phase III cluster randomized controlled trial

BackgroundAttractive Targeted Sugar Baits (ATSBs) offer a complementary vector control strategy to interventions targeting blood feeding or larval control by attacking the sugar feeding behaviour of adult mosquitoes using an attract-and-kill approach. Western Zambia was the first location to receive and deploy ATSB Sarabi version 1.2 stations in a Phase III cluster randomized controlled trial. This paper describes ATSB station installation, monitoring, removal, and disposal, quantifies ATSB station coverage, and reports major reasons for ATSB station replacement.MethodsATSB stations were deployed during two annual transmission seasons, through scheduled installation and removal campaigns. During deployment, monitoring was conducted per protocol to maintain high coverage of the ATSB stations in good condition. Routine monitoring visits during the trial captured details on ATSB station damage necessitating replacement following pre-defined replacement criteria. Annual cross-sectional household surveys measured ATSB station coverage during peak malaria transmission.ResultsA total of 67,945 ATSB stations were installed in Year 1 (41,695 initially installed+ 26,250 installed during monitoring) and 69,494 ATSB stations were installed in Year 2 (41,982 initially installed+ 27,512 installed during monitoring) across 35 intervention clusters to maintain high coverage of two ATSB stations in good condition per eligible household structure. The primary reasons for ATSB station replacement due to damage were holes/tears and presence of mold. Cross-sectional household surveys documented high coverage of ATSB stations across Year 1 and Year 2 with 93.1% of eligible structures having ≥ 2 ATSB stations in any condition.DiscussionATSB station deployment and monitoring efforts were conducted in the context of a controlled cRCT to assess potential product efficacy. Damage to ATSB stations during deployment required replacement of a subset of stations. High coverage of eligible structures was maintained over the two-year study despite replacement requirements. Additional research is needed to better understand the impact of damage on ATSB station effectiveness under programmatic conditions, including thresholds of threats to physical integrity and biological deterioration on product efficacy.ConclusionsOptimizing ATSB stations to address causes of damage and conducting implementation research to inform optimal delivery and cost-effective deployment will be important to facilitate scale-up of ATSB interventions.

Genome-wide DNA methylation profiles and breast cancer among World Trade Center survivors.

Increased incidence of cancer has been reported among World Trade Center (WTC)-exposed persons. Aberrant DNA methylation is a hallmark of cancer development. To date, only a few small studies have investigated the relationship between WTC exposure and DNA methylation. The main objective of this study was to assess the DNA methylation profiles of WTC-exposed community members who remained cancer free and those who developed breast cancer. WTC-exposed women were selected from the WTC Environmental Health Center clinic, with peripheral blood collected during routine clinical monitoring visits. The reference group was selected from the NYU Women's Health Study, a prospective cohort study with blood samples collected before 9 November 2001. The Infinium MethylationEPIC array was used for global DNA methylation profiling, with adjustments for cell type composition and other confounders. Annotated probes were used for biological pathway and network analysis. A total of 64 WTC-exposed (32 cancer free and 32 with breast cancer) and 32 WTC-unexposed (16 cancer free and 16 with prediagnostic breast cancer) participants were included. Hypermethylated cytosine-phosphate-guanine probe sites (defined as β > 0.8) were more common among WTC-exposed versus unexposed participants (14.3% vs. 4.5%, respectively, among the top 5000 cytosine-phosphate-guanine sites). Cancer-related pathways (e.g., human papillomavirus infection, cGMP-PKG) were overrepresented in WTC-exposed groups (breast cancer patients and cancer-free subjects). Compared to the unexposed breast cancer patients, 47 epigenetically dysregulated genes were identified among WTC-exposed breast cancers. These genes formed a network, including Wnt/β-catenin signaling genes WNT4 and TCF7L2, and dysregulation of these genes contributes to cancer immune evasion. WTC exposure likely impacts DNA methylation and may predispose exposed individuals toward cancer development, possibly through an immune-mediated mechanism.

Comparison of QT interval readings between smartwatch ECG combined with artificial intelligence and 12-lead ECG in subjects hospitalized for antiarrhythmic drug initiation and follow-up

Abstract Background/Introduction Class III antiarrhythmic drugs (AADs) are effective for the maintenance of sinus rhythm (SR) in subjects with atrial fibrillation (AF). However, several require initial hospitalization for QT interval monitoring using the 12-lead ECG. Purpose The purpose of this study was to evaluate the feasibility of using a smartwatch single lead ECG combined with a deep learning algorithm for routine QT interval determination in the context of AAD initiation. Methods A deep learning model was developed using smartwatch and Holter ECG recordings to estimate corrected QT intervals. To evaluate the performance of this model, we carried out a prospective study on subjects hospitalized for initiation of sotalol and/or dofetilide. Subjects recorded near simultaneous (maximal 2 minutes apart) smartwatch ECGs (Apple Watch Series 6) and 12-lead ECG (Mac 5500 HD ECG or GE Carescape B450) right before and 2-3 hours after drug administration twice a day for 2-3 days. Blinded double annotation followed by adjudication of disagreement provided a reference heart rhythm (NSR or AF) and QTc interval. The tangent method was used for QTc interval determination. Bland-Altman analysis was performed to assess the agreement between QTc measures. Results Fifty subjects (mean age 67.4±10.9 years, 64% male) were enrolled in the study from February 2022 to October 2022. Out of 386 monitoring visits, 321 near simultaneous pairs of ECGs were collected with a mean delay of +15.0±41.1s for the smartwatch ECG compared to the 12-lead ECG. Overall, a mean QTcF reference value of 419.9±34.0 ms was observed (435.2±38.4 ms for QTcB, r=0.83 between annotators[BL2] ). Among the 139 pairs with 12-lead ECG found in NSR, we observed a mean QTcF difference of +19.7 ms and limits of agreements equal to -21.5 ms and 60.8 ms, with AI-facilitated measurement. In comparison, a mean QTcF difference of +22.5 ms and limits of agreements equal to -23.8 ms and 68.8 ms were observed for manual readings of smartwatch ECGs instead. Conclusion(s): Our findings suggest that a smartwatch ECG deep learning approach can estimate the QT interval with a fair agreement compared to standard 12-lead monitoring during AAD initiation. This measurement method appears to be at least as accurate as manual measurements on smartwatch ECGs. With further validation, the smartwatch-based automatic detection of QT interval prolongation, could be used for a faster, safe, and extended outpatient QT interval monitoring.Bland-Altman plots

#1381 Economic evaluation of an integrated care program versus conventional care for chronic kidney disease patients in rural communities of Thailand

Abstract Background and Aims This study evaluates an integrated care program for chronic kidney disease (CKD), which has demonstrated effectiveness in delaying kidney function decline in the rural population of Thailand. Efficacy of the program was initially established through the ESCORT-1 study, a cluster-randomized controlled trial (doi: 10.1186/s12882-016-0414-4), and further demonstrated the effectiveness by the larger-scale prospective cohort study, ESCORT-2 (doi: 10.1111/nep.13849). The aim of this study is to assess the cost-effectiveness of incorporating this program into Thailand's public health benefit package, with the goal of establishing it as a model for similar rural areas in resource-limited settings. Method Following the Thailand's guideline for health technology assessment, a cost-utility analysis utilizing data from the ESCORT studies, local databases, and literatures. The integrated care program was tailored to primary healthcare system by using preexisting workforces. It involved a collaboration between Multi-Disciplinary Care Teams (MDCT) at district hospitals and Community Care Network (CCN) teams at Sub-District Health Centers (SDHC). The MDCT, comprising general practitioners, CKD nurse managers, pharmacists, a nutritionist, and a physical therapist, provided key patient education on diet, medication adherence, exercise, and avoiding certain medications and herbal remedies. The CCN teams, including community nurses and village health volunteers, conducted home visits for health monitoring and lifestyle guidance. Both MDCT and CCN personnel received training in CKD care based on the NKF-K/DOQI and KDIGO Clinical Practice Guidelines. A decision-analytic Markov model and Monte-Carlo simulation were applied to quantify and compare the lifetime costs and quality-adjusted life years (QALY) outcomes of the intervention and conventional-care from a societal perspective considering both direct and indirect costs. The analysis included extensive sensitivity analyses, incorporating a probabilistic model and scenario-analyses based on patient ages, CKD stages, and varying program efficacy. Additionally, a budget impact analysis from the payer's perspective assessed the financial impact and affordability over a five-year period. Results The integrated care program was found to dominate conventional care. The results indicated an incremental cost-effectiveness of (-)278,000 Thai Baht (∼7,267 EUR) per QALY for the base case analysis. Probabilistic analysis demonstrated consistent outcomes, with the integrated care program being cost-effective at almost 100% of the time during analysis at the 160,000 Thai Baht (∼4,182 EUR) willingness-to-pay threshold (Fig. 1). These results are driven by significant cost savings due to reduced time and overall costs in dialysis before death. The program is most cost-effective when provided early to patients, in terms of both age and CKD stages (Fig. 2). The budget impact analysis showed that introducing the intervention could save the payer 184 billion Thai Baht (4.76 billion EUR) over five years. (The exchange rate; 1 Thai Baht = 38.26 EUR) Conclusion The integrated care program for patients with stage 3-4 CKD is cost-effective and suitable for inclusion in Thailand's health benefit package, mainly due to its significant cost savings and enhanced health outcomes. The program's design, focusing on sustainability and feasibility by utilizing existing workforces, positions it as a viable model for similar economic and healthcare contexts, especially in resource-limited countries.

Gender differences in obstructive sleep apnea syndrome: a pilot study

PurposeOSAS is a syndrome that often presents clinically differently between men and women. The aim of this study was to assess the clinical presentation, nocturnal home sleep cardiorespiratory monitoring and therapeutic adherence to CPAP in both sexes to identify the most frequent patterns.MethodsData from the first visit, the nocturnal home sleep cardiorespiratory monitoring and follow-up visit of 74 OSA patients were collected. Exclusion criteria included other respiratory and/or neuromuscular diseases (including Obesity hypoventilation syndrome) and other non-respiratory sleep disorders.ResultsMen were older and had a higher supine AHI and ODI compared to women. In addition, BMI and age correlated positively with AHI in males. Women had a higher hypopneas frequency and better therapeutic adherence to CPAP.ConclusionsMen were associated with a higher AHI when sleeping in the supine position and this may be useful to look for new therapeutic options in combination with or as an alternative to CPAP. BMI correlated positively with AHI in men and this should be considered to stimulate weight loss as the main treatment to reduce the number of apneas/hypopneas, as men also had less therapeutic adherence to CPAP in our study. Females presented a significantly higher frequency of hypopneas than men, as well as a lower number of desaturation events per hour (ODI): these differences in the nocturnal home sleep cardiorespiratory monitoring could reflect different pathophysiological mechanisms of OSAS onset between the two sexes, which should be investigated in future scientific studies.

Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy

BackgroundHypertensive disorders of pregnancy are a main cause of maternal morbidity and mortality in the United States and worldwide, and it is estimated that approximately 60% of maternal deaths in the United States occur during the postpartum period. The utilization of telehealth modalities such as home blood pressure monitoring has shown improvement in blood pressure control and adherence with follow up visits. Our study sought to determine if standardized education improved patient hypertension knowledge and if this when combined with home blood pressure telemonitoring increased participants’ postpartum self-blood pressure monitoring and postpartum visit attendance.MethodsThis is an Institutional Review Board approved prospective cohort study conducted at the University of Mississippi Medical Center. Women with a hypertensive disorder of pregnancy who met the inclusion criteria and provided written informed consent to participate were enrolled. Participants received a baseline pre-education questionnaire designed to assess their knowledge of their hypertensive diagnosis, hypertension management, and postpartum preeclampsia (PreE). Participants then received standard education, a blood pressure monitor, and were scheduled a follow-up visit during the first 10 days following discharge. Remote home blood pressure monitoring was performed via text messages and voice calls for 6-weeks postpartum. At the conclusion of the study, participants repeated their original questionnaire.Results250 women provided informed consent to participate in the study and were included in this analysis. Relative to the baseline survey, there was a significant increase (p = 0.0001) in the percentage of correct responses. There was not an association between study engagement and percentage of correct responses on end of study questionnaire (p = 0.33) or postpartum visit attendance (p = 0.69). Maternal age was found to drive study engagement, even when adjusted for community-level distress (p = 0.03) and maternal race (p = 0.0002).ConclusionImplementing a standardized postpartum education session was associated with improvement in patient’s knowledge. Further studies are needed with more longitudinal follow up to assess if this program would also result in improved long-term outcomes and decreased hospital readmission rates.Trial registrationNCT04570124.

A discrete approximation method for modeling interval-censored multistate data.

Many longitudinal studies are designed to monitor participants for major events related to the progression of diseases. Data arising from such longitudinal studies are usually subject to interval censoring since the events are only known to occur between two monitoring visits. In this work, we propose a new method to handle interval-censored multistate data within a proportional hazards model framework where the hazard rate of events is modeled by a nonparametric function of time and the covariates affect the hazard rate proportionally. The main idea of this method is to simplify the likelihood functions of a discrete-time multistate model through an approximation and the application of data augmentation techniques, where the assumed presence of censored information facilitates a simpler parameterization. Then the expectation-maximization algorithm is used to estimate the parameters in the model. The performance of the proposed method is evaluated by numerical studies. Finally, the method is employed to analyze a dataset on tracking the advancement of coronary allograft vasculopathy following heart transplantation.

The effect of chimney fitted improved stove on kitchen fine particulate matter (PM2.5) concentrations in rural Ethiopia: Evidence from a randomized controlled trial

BackgroundMillions of Ethiopian people cook with biomass fuels using traditional stoves, releasing harmful pollutants and contributing to a significant public health crisis. Improved stoves offer a potential escape route, but their effectiveness needs close scrutiny. This study delves into the impact of chimney-fitted stoves on kitchen PM2.5 concentrations in rural Ethiopian households. MethodWe conducted a randomized controlled trial with 86 households equally divided (1:1 ratio) between intervention and control groups. The 24-h average kitchen PM2.5 concentrations was measured using Particle and Temperature Sensor (PATS+) at baseline and after intervention. All relevant sociodemographic and cooking related characteristics were collected at baseline and dynamic characteristics were updated during air monitoring visits. Three distinct statistical models, including independent sample t-tests, paired sample t-tests and one-way analysis of variance were used to analyze the data using Statistical Package for the Social Sciences (SPSS) software for Windows (v 24.0). ResultAt baseline, the average 24-h kitchen PM2.5 concentrations were 482 μg/m3 (95% CI: 408, 557) for the control and 405 μg/m3 (95% CI: 318, 492) for the intervention groups. Despite remaining elevated at 449 μg/m3 (95% CI: 401, 496) in the control group, PM2.5 concentrations reduced to 104 μg/m3 (95% CI: 90,118) in the intervention group, indicating a statistically significant difference (t = 6.97, p < 0.001). All three statistical analyses delivered remarkably consistent results, estimating a PM2.5 reductions of 74% with the before-and-after approach, 76% when comparing groups, and 74% for difference in difference analysis. Beyond the overall reduction, homes with primary school completed women, larger kitchens, smaller family size, and those specifically baking Injera (the traditional energy-intensive staple food), witnessed even greater drops in PM2.5 levels. ConclusionPregnant women in our study encountered dangerously high PM2.5 exposures in their kitchens. While the intervention achieved a significant PM2.5 reductions, unfortunately remained above the WHO's safe limit, highlighting the need for further interventions.

Understanding Loss to Follow-Up in AMD Patients Receiving VEGF Inhibitor Therapy: Associated Factors and Underlying Reasons.

In patients with wet age-related macular degeneration (AMD), loss to follow-up (LTFU) leads to unplanned interruptions in therapy and the risk of visual loss. This retrospective and prospective case-control cohort study compared AMD patients with (LTFU YES) and without (LTFU NO) LTFU during anti-VEGF treatment over 12 years. LTFU was defined as missing any treatment or monitoring visits, or not scheduling follow-ups for six months. Significant differences between LTFU NO (n = 298) and LTFU YES (n = 174) groups were age, treatment phase, baseline and final best-corrected visual acuity (BCVA), type of anti-VEGF drug, treatment switch, commuting distance, and escort during commuting. A multivariate logistic regression analysis identified the need for an escort during the commuting and treatment phase as the only significant difference. The four most common reasons for LTFU were general health worsening (21.8%), patient-missed appointments (16.7%), COVID-19-related issues (14.9%), and treatment dissatisfaction (8.6%). The factors associated with increased LTFU rates were older age, inactive treatment phase, lower baseline and final BCVA, bevacizumab treatment, monotherapy, longer travelling distance, and commuting with an escort. According to the multivariate logistic regression analysis, only the escort during the commuting and treatment phases was significant. These findings could direct research to explore social support in treatment adherence and highlight the importance of treatment phases in practice.

Caregiver use of MUAC tapes in South Sudan: a three-group prospective comparison.

Nutrition program modifications occurred globally in response to the COVID-19 pandemic. Within community management of acute malnutrition (CMAM), community screenings for acute malnutrition were replaced by caregivers monitoring child mid-upper arm circumference (MUAC), but questions remain about different MUAC tapes' performance and acceptability for caregiver use. The study was conducted in Central Equatoria and Warrap States, South Sudan, between March 2022 and January 2023. A three-group prospective non-randomized design was used to compare the performance of three MUAC tapes (UNICEF 2009, UNICEF 2020, and GOAL MAMI) used by caregivers. The primary outcome was the false negative rate (i.e., the proportion of children not identified as wasted by the caregiver but classified as wasted by enumerators). Caregivers with children aged 5-53 months were assigned to and trained on the use of 1 of the 3 tapes and followed for 8 months, including three monitoring visits and baseline/endline surveys. Of the 2,893 enrolled children, 2,401 (83.0%) completed baseline, endline, and two or more monitoring visits. Only 3.7% of children were identified as wasted by caregivers and 3.8% by study team measurement. Cumulative measurement agreement between caregivers and enumerators was similar by tape. False negative and false positive rates were both <0.5% overall and similar among the tapes. There were differences in training needs and durability between the tapes, but all three were acceptable and performed equally well. Caregiver measurement of child MUAC is feasible in South Sudan. The three MUAC tapes were acceptable, and caregivers could measure accurately with minimal support. All tapes performed similarly and are appropriate for use in Family MUAC programs in South Sudan. There were indications that the UNICEF 2020 tape may be less durable; the GOAL MAMI tape has the added benefit of being suitable for assessments of infants <6 months of age.

Ideal frozen embryo transfer regime.

This review aims to compare evidence on four criteria (embryo implantation, obstetric outcomes, patient convenience, and IVF-unit efficiency) by analyzing published research on different endometrial preparation methods for frozen embryo transfer (FET). While the artificial-FET cycle provides advantages in scheduling and implantation, it falls short in ensuring optimal obstetric outcomes. In contrast, natural-FET ensures embryo implantation conditions if ovulation is correctly identified. Supplementing with exogenous progesterone shields against low corpus luteum progesterone secretion, crucial for positive obstetric outcomes. In mNC-FET, ovulation is hCG-triggered, closely resembling natural cycles and reducing monitoring visits for enhanced patient convenience.Letrozole is a recommended option for anovulatory patients, preserving endometrial thickness. It is cost-effective, less likely to induce multifollicular development than gonadotropins, and better tolerated.In a novel approach, the natural-proliferative-phase-FET initiates progesterone in an unmediated ovulatory cycle at 7 mm endometrial thickness, combining the benefits of a natural proliferative endometrium with the convenience of scheduled artificial cycles. The artificial cycle offers scheduling advantages, but may compromise obstetric outcomes. Natural FET relies on accurate ovulation timing for successful implantation. mNC-FET simplifies the process using hCG induction, minimizing clinic visits for improved convenience. Letrozole is highlighted as a cost-effective and well tolerated option in anovulatory patients. A recent innovative approach combines elements of natural and artificial cycles, showing promise for FET procedures.