Tag: pubmed

JMIR Form Res. 2023 Nov 14;7:e48637. doi: 10.2196/48637.

ABSTRACT

BACKGROUND: Working pregnant women often need to adjust their physically demanding jobs for a healthy pregnancy. However, uncertainty about the extent of these adjustments can hinder their effectiveness. To address this, we developed the Job Adjustment mobile app, which allows users to input job and health details to generate a variety of personalized action plans. As this is the first version of the app, assessing its feasibility and usability is crucial.

OBJECTIVE: This study aims to verify the feasibility and usability of the Job Adjustment mobile app.

METHODS: A longitudinal observational study was conducted on pregnant Japanese women who were allowed to use the app anytime from 12 to 34 weeks of gestation; they received reminder emails every 2 weeks encouraging app use. A questionnaire was administered before app use and at 20 and 32 weeks of gestation. Feasibility was evaluated across 4 domains: implementation, demand, acceptability, and adverse events. Implementation was evaluated based on 3 parameters: dropout rate, initial reminder email receipt rate, and adherence rate (measured as pregnant women who used the app at intervals of 2.5 weeks or less). Demand was measured by intervals between use and intervals between log-in, and participants answered 15 questions to assess acceptability. Adverse events were assessed by analyzing the degree of anxiety related to work. Demographic data were analyzed to determine any statistically significant differences in intervals between uses. Usability was evaluated using the System Usability Scale.

RESULTS: The analysis included 66 pregnant women, and 61% (n=40) of them were multipara. The dropout rate, adherence rate, and initial reminder email receipt rate were 18% (13/71), 44% (29/66), and 79% (52/66) respectively. The median intervals between use and intervals between log-in were 2.94 (IQR 2.00-5.13) weeks and 2.28 (IQR 1.81-4.00) weeks, respectively. Overall, 60% (35/58) to 90% (52/58) of the participants responded positively to all 15 questions assessing acceptability, and no anxiety regarding work was recorded. The mean System Usability Scale score was 66.1 points. Multipara women had significantly longer intervals between app use compared to primipara women (P=.01).

CONCLUSIONS: The results demonstrated acceptable levels of feasibility and usability of the app. However, the low adherence rates, especially among multipara women, suggest the need for modifications to reduce the time burden of the app. Further research should explore more effective and acceptable intervals between use and timing, involving a larger sample and accounting for diverse characteristics of pregnant women.

TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000042943; https://tinyurl.com/ydrchfas.

PMID:37962945 | DOI:10.2196/48637

JMIR Res Protoc. 2023 Nov 14;12:e52565. doi: 10.2196/52565.

ABSTRACT

BACKGROUND: Mycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. The current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant Mgenitalium or strains with unknown resistance profiles. However, it is unclear whether sitafloxacin, a 4th-generation fluoroquinolone antibiotic, is effective against resistant strains.

OBJECTIVE: This study aims to assess and compare the efficacy and safety of sitafloxacin- and moxifloxacin-based treatment regimens for managing Mgenitalium infections.

METHODS: We will conduct this randomized controlled trial at multiple centers in Japan. Eligible participants include adults aged 18 years or older with a confirmed Mgenitalium infection, as determined through the nucleic acid amplification test. Patients will be randomly assigned using a stratified approach based on the treatment facility and infection site. The interventions comprise oral sitafloxacin (200 mg) daily for 7 days (with optional pretreatment of oral doxycycline, 200 mg, daily for up to 7 days), with a control group receiving oral doxycycline (200 mg) daily for 7 days followed by moxifloxacin (400 mg) daily for another 7 days. The primary outcome is the treatment success rate with a superiority margin of 10%, as confirmed through the nucleic acid amplification test. Secondary outcomes encompass changes in the bacterial load at the urogenital or rectal sites and the emergence of posttreatment-resistant mutant strains.

RESULTS: Enrollment commenced in June 2023 and will conclude in December 2024, with findings anticipated by 2025. The expected success rates fall within the range of 80% for sitafloxacin and 42% for moxifloxacin against Mgenitalium carrying the G248T (S83I) mutation, based on previous studies. Accordingly, with a 5% significance level (2-sided) and 80% statistical power, we aim to recruit 50 participants per group, factoring in a 10% expected dropout rate.

CONCLUSIONS: This study will provide valuable insights into the efficacy and safety of sitafloxacin- versus moxifloxacin-based sequential therapy in treating Mgenitalium infections. These findings have the potential to influence clinical guidelines, favoring more effective therapeutic choices. The multicenter approach enhances the robustness of this study. However, a limitation is the potential insufficiency of statistical power to detect posttreatment-resistant mutant strains in each group, rendering posttreatment-resistance mutations a notable concern. In the future, we may need to increase the sample size to enhance power.

TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCTs031230111); https://jrct.niph.go.jp/en-latest-detail/jRCTs031230111.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52565.

PMID:37962941 | DOI:10.2196/52565

JMIR Res Protoc. 2023 Nov 14;12:e48925. doi: 10.2196/48925.

ABSTRACT

BACKGROUND: Only 5% of the molecules tested in oncology phase 1 trials reach the market after an average of 7.5 years of waiting and at a cost of tens of millions of dollars. To reduce the cost and shorten the time of discovery of new treatments, “drug repurposing” (research with molecules already approved for another indication) and the use of secondary data (not collected for the purpose of research) have been proposed. Due to advances in informatics in clinical care, secondary data can, in some cases, be of equal quality to primary data generated through prospective studies.

OBJECTIVE: The objective of this study is to identify drugs currently marketed for other indications that may have an effect on the prognosis of patients with cancer.

METHODS: We plan to monitor a cohort of patients with high-lethality cancers treated in the public health system of Catalonia between 2006 and 2012, retrospectively, for survival for 5 years after diagnosis or until death. A control cohort, comprising people without cancer, will also be retrospectively monitored for 5 years. The following study variables will be extracted from different population databases: type of cancer (patients with cancer cohort), date and cause of death, pharmacological treatment, sex, age, and place of residence. During the first stage of statistical analysis of the patients with cancer cohort, the drugs consumed by the long-term survivors (alive at 5 years) will be compared with those consumed by nonsurvivors. In the second stage, the survival associated with the consumption of each relevant drug will be analyzed. For the analyses, groups will be matched for potentially confounding variables, and multivariate analyses will be performed to adjust for residual confounding variables if necessary. The control cohort will be used to verify whether the associations found are exclusive to patients with cancer or whether they also occur in patients without cancer.

RESULTS: We anticipate discovering multiple significant associations between commonly used drugs and the survival outcomes of patients with cancer. We expect to publish the initial results in the first half of 2024.

CONCLUSIONS: This retrospective study may identify several commonly used drugs as candidates for repurposing in the treatment of various cancers. All analyses are considered exploratory; therefore, the results will have to be confirmed in subsequent clinical trials. However, the results of this study may accelerate drug discovery in oncology.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48925.

PMID:37962929 | DOI:10.2196/48925

JMIR Form Res. 2023 Nov 14;7:e51752. doi: 10.2196/51752.

ABSTRACT

BACKGROUND: There has been a growth surge in the use of social media among individuals today. The widespread adoption of these platforms, coupled with their engaging features, presents a unique opportunity for the dissemination of health advocacy information. Social media is known as a powerful tool used to share health policy and advocacy efforts and disseminate health information to digital community members and networks. Yet, there is still a gap in the full exploitation of this powerful instrument, among health care professionals, for health advocacy campaigns.

OBJECTIVE: This paper aims to describe the process of mobilizing social media platforms such as Twitter (rebranded to X Corp in 2023) for health advocacy of the digital community. Additionally, it aims to share the lessons and insights gained during this digital health advocacy engagement process.

METHODS: We performed a comprehensive review of Twitter analytical data to examine the impact of our social media posts. We then consolidated these analytic reports with our meeting logs to describe our systematic, iterative, and collaborative design process to implement social media efforts and generate key lessons learned.

RESULTS: Our review of monthly Twitter analytical reports and regular team meeting logs revealed several themes for successful and less successful practices in relation to our social media-based health advocacy efforts. The successful practices noted by the team included using personable, picture-based tweets; using a series of posts on a particular topic rather than an isolated post; leveraging team members’ and partners’ collaborations in shared posts; incorporating hashtags in tweets; using a balanced mix of texts and graphics in posts; using inclusive (nondestigmatizing) languages in tweeted posts; and use of polls to share tweets. Among the many lessons learned, we also experienced limitations including a lack of comprehensive statistics on Twitter usage for health care-related purposes such as health advocacy and limits in collating the estimates of the actual impact made on the intended digital community members by our posts.

CONCLUSIONS: Twitter has been successfully used in promoting health advocacy content, and the social media team aims to explore other social media platforms that have a wider reach than Twitter. We will continue making necessary adjustments in strategies, techniques, and styles to engage the audience as we expand onto new platforms like Instagram and TikTok for health advocacy promotions.

PMID:37962914 | DOI:10.2196/51752

Kidney360. 2023 Nov 14. doi: 10.34067/KID.0000000000000301. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic resulted in an unprecedented shift in the delivery of outpatient medical care, including the rapid transition of services from in-person to telehealth. We adapted an evidence-based personalized health planning group visit care model traditionally offered in-person to telehealth to support the care of patients with type 2 diabetes mellitus (T2D) and chronic kidney disease (CKD). Despite the need to leverage telehealth technologies to better support self-management for patients with CKD, scant evidence exists on how to do so.

METHODS: We conducted prospective adaptations of in-person evidence-based group visit model for telehealth delivery for patients with CKD and T2D. Intervention adaptations are reported using the Framework for Reporting Adaptations and Modifications (FRAME) taxonomy. The adapted virtual group visit care model was pilot tested among adults with T2D and stage 3b or 4 CKD. Feasibility outcomes included recruitment, attendance, satisfaction, and self-reported goal progress. Clinical outcomes were evaluated using Wilcoxon signed rank tests and included hemoglobin A1C (HbA1c), diastolic and systolic blood pressure, body mass index, and estimated glomerular filtration rate.

RESULTS: Adaptation areas included outreach, visit format, educational materials design and access, staffing, and patient engagement strategies. 39% (43) of patients (110) contacted verbalized interest, and 58% (25) of those participated. 72% completed >6 group sessions. 68% of patients reported completing one or more health goals, with nutrition and physical activity being the most common. We observed a statistically significant improvement in HbA1c (p = 0.0176) six months post-program participation.

CONCLUSIONS: Adapting evidence-based interventions for telehealth delivery is challenging due to the risk of altering an intervention’s core components responsible for observed benefits. We adapted an in-person group visit model for the care of T2D and CKD for telehealth delivery. The telehealth approach was feasible and preliminary data suggested it improved relevant health and patient-recorded outcomes up to six months post-program completion. The approaches used here may be applicable to the adaptation of other clinical programs for telehealth delivery.

PMID:37962910 | DOI:10.34067/KID.0000000000000301

ACS Appl Mater Interfaces. 2023 Nov 14. doi: 10.1021/acsami.3c13956. Online ahead of print.

ABSTRACT

Memristive devices, known for their nonvolatile resistive switching, are promising components for next-generation neuromorphic computing systems, which mimic the brain’s neural architecture. Specifically, these devices are well-suited for functioning as artificial synapses due to their analogue tunability and low energy consumption. However, the improvement of their performance and reliability remains a pressing challenge. In this study, we report the development and comprehensive characterization of memristive devices based on a parylene-MoO_x (PPX-Mo) nanocomposite layer, which exhibit improved characteristics over their parylene-based counterparts: lower switching voltage and energy, smaller dispersion, and better resistive plasticity. A robust statistical analysis identified the optimal synthesis parameters for these devices, providing valuable insights for future device optimization. The most probable resistive switching mechanism of the devices is proposed. By successfully integrating these memristors into a neuromorphic computing model and showcasing their scalability in crossbar geometry, we demonstrate their potential as functional artificial synapses. The results obtained from this study can be useful for the development of hardware-brain-inspired computational systems.

PMID:37962902 | DOI:10.1021/acsami.3c13956

JMIR Mhealth Uhealth. 2023 Nov 3;11:e44703. doi: 10.2196/44703.

ABSTRACT

BACKGROUND: Hearing disability in preschool children can delay or impact oral communication and social skills. Provision of hearing screening tests by standard audiometry in low- to middle-income countries is problematic due to a lack of pediatric audiologists, standard hearing equipment, and standard soundproof rooms. Therefore, an innovative hearing screening tool that is easily accessible and inexpensive such as a mobile app should be considered. Headphones have been a crucial part of hearing screenings. Audiometric headphones, which serve as the reference standard, have been used in most studies. However, since audiometric headphones are not accessible in rural areas, we hypothesized that generic headphones can also be used in hearing screenings.

OBJECTIVE: This study aimed to determine the sensitivity, specificity, κ coefficiency, and time consumption of the PASS-Pro (Preschool Audiometry Screening System-Pro) app when using TDH39 headphones, Beyerdynamic DT 770 PRO headphones, and generic earmuff headphones compared to standard conditioned play audiometry.

METHODS: We recruited preschool children aged 4 to 5 years to participate in this study. The children received 3 PASS-Pro screening tests using different types of headphones in a quiet room and 1 standard conditioned play audiometry in a soundproof room. All tests were administered in random order. The agreement coefficient, sensitivity, specificity, and mean test duration were determined.

RESULTS: A total of 44 children participated in this study. For mild hearing loss screening, the κ coefficients between standard conditioned play audiometry and the PASS-Pro app using TDH39 headphones, Beyerdynamic DT 770 PRO headphones, and generic earmuff headphones were 0.195, 0.290, and 0.261 (P=.02, P=.002, and P=.004), respectively. The sensitivity for all headphones was 50% and the specificity was more than 88%. For moderate hearing loss screening, the κ coefficients were 0.206, 0.272, and 0.235 (all Ps=.001), respectively. The sensitivity for all headphones was 100% and the specificity was more than 92%. There were no statistical differences in sensitivity and specificity between the reference headphone (TDH39), Beyerdynamic DT 770 PRO headphone, and generic earmuff headphones (all Ps >.05). The PASS-Pro app used significantly less time to carry out hearing tests than conditioned play audiometry (P<.001).

CONCLUSIONS: The PASS-Pro app, used with generic headphones, is effective for conducting hearing screening tests in preschool children with high sensitivity and specificity.

PMID:37962900 | DOI:10.2196/44703

JAMA Netw Open. 2023 Nov 1;6(11):e2343290. doi: 10.1001/jamanetworkopen.2023.43290.

ABSTRACT

IMPORTANCE: Clinical trial data have called into question the efficacy of thiazide diuretics for the prevention of kidney stones.

OBJECTIVE: To identify whether there is an association between genetic proxies of thiazide diuretics and the risk of kidney stones.

DESIGN, SETTING, AND PARTICIPANTS: This genetic association study undertook a mendelian randomization analysis of derived exposures and outcomes from genome-wide association study summary statistics. Genetic proxies of thiazide diuretics were derived from the International Consortium for Blood Pressure. Kidney stone cases and controls were derived from the Million Veteran Program, UK Biobank, and the FinnGen study. These cross-sectional designs do not report a duration of follow-up. Data analysis was performed in May 2023.

EXPOSURE: Genetic proxies of thiazide diuretics were genetic variants in the thiazide-sensitive sodium chloride cotransporter gene associated with systolic blood pressure. Genetic proxies of β-blockers and systolic blood pressure served as negative controls.

MAIN OUTCOMES AND MEASURES: The main outcome was the odds of kidney stones. The secondary outcomes were serum laboratory values relevant to the treatment of kidney stones.

RESULTS: The main analysis included up to 1 079 657 individuals, including 50 832 kidney stone cases and 1 028 825 controls. In a meta-analysis of all cohorts, genetic proxies of thiazide diuretics were associated with a lower odds of kidney stones (OR, 0.85; 95% CI, 0.81-0.89; P < .001). Genetic proxies of β-blockers (OR, 1.02; 95% CI, 0.96-1.07; P = .52) and systolic blood pressure (OR, 1.00; 95% CI, 1.00-1.01; P = .49) were not associated with kidney stones. Genetic proxies of thiazide diuretics were associated with higher serum calcium (β [SE], 0.051 [0.0092]; P < .001) and total cholesterol (β [SE], 0.065 [0.015]; P < .001), but lower serum potassium (β [SE], -0.073 [0.022]; P < .001).

CONCLUSIONS AND RELEVANCE: In this genetic association study, genetic proxies of thiazide diuretics were associated with reduced kidney stone risk. This finding reflects a drug effect over the course of a lifetime, unconstrained by the limited follow-up period of clinical trials.

PMID:37962888 | DOI:10.1001/jamanetworkopen.2023.43290

JAMA Netw Open. 2023 Nov 1;6(11):e2343318. doi: 10.1001/jamanetworkopen.2023.43318.

ABSTRACT

IMPORTANCE: Severe respiratory disease declined during the COVID-19 pandemic, partially due to decreased circulation of respiratory pathogens. However, the outcomes of children with higher risk have not been described using population-based data.

OBJECTIVE: To compare respiratory-related hospitalizations, intensive care unit (ICU) admissions, and mortality during the pandemic vs prepandemic, among children with medical complexity (CMC) and without medical complexity (non-CMC).

DESIGN, SETTING, AND PARTICIPANTS: This population-based repeated cross-sectional study used Canadian health administrative data of children aged younger than 18 years in community and pediatric hospitals during a pandemic period (April 1, 2020, to February 28, 2022) compared with a 3-year prepandemic period (April 1, 2017, to March 31, 2020). The pandemic period was analyzed separately for year 1 (April 1, 2020, to March 31, 2021) and year 2 (April 1, 2021, to February 28, 2022). Statistical analysis was performed from October 2022 to April 2023.

MAIN OUTCOMES AND MEASURES: Respiratory-related hospitalizations, ICU admissions, and mortality before and during the pandemic among CMC and non-CMC.

RESULTS: A total of 139 078 respiratory hospitalizations (29 461 respiratory hospitalizations for CMC and 109 617 for non-CMC) occurred during the study period. Among CMC, there were fewer respiratory hospitalizations in both 2020 (rate ratio [RR], 0.44 [95% CI, 0.42-0.46]) and 2021 (RR, 0.55 [95% CI, 0.51-0.62]) compared with the prepandemic period. Among non-CMC, there was an even larger relative reduction in respiratory hospitalizations in 2020 (RR, 0.18 [95% CI, 0.17-0.19]) and a similar reduction in 2021 (RR, 0.55 [95% CI, 0.54-0.56]), compared with the prepandemic period. Reductions in ICU admissions for respiratory illness followed a similar pattern for CMC (2020: RR, 0.56 [95% CI, 0.53-0.59]; 2021: RR, 0.66 [95% CI, 0.63-0.70]) and non-CMC (2020: RR, 0.22 [95% CI, 0.20-0.24]; RR, 0.65 [95% CI, 0.61-0.69]). In-hospital mortality for these conditions decreased among CMC in both 2020 (RR, 0.63 [95% CI, 0.51-0.77]) and 2021 (RR, 0.72 [95% CI, 0.59-0.87]).

CONCLUSIONS AND RELEVANCE: This cross-sectional study found a substantial decrease in severe respiratory disease resulting in hospitalizations, ICU admissions, and mortality during the first 2 years of the pandemic compared with the 3 prepandemic years. These findings suggest that future evaluations of the effect of public health interventions aimed at reducing circulating respiratory pathogens during nonpandemic periods of increased respiratory illness may be warranted.

PMID:37962886 | DOI:10.1001/jamanetworkopen.2023.43318

JAMA Netw Open. 2023 Nov 1;6(11):e2343425. doi: 10.1001/jamanetworkopen.2023.43425.

ABSTRACT

IMPORTANCE: Industry involvement is prominent in influential clinical trials, and commitments to transparency of trials are highly variable.

OBJECTIVE: To evaluate the modes of industry involvement and the transparency features of the most cited recent clinical trials across medicine.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was a meta-research assessment including randomized and nonrandomized clinical trials published in 2019 or later. The 600 trials of any type of disease or setting that attracted highest number of citations in Scopus as of December 2022 were selected for analysis. Data were analyzed from March to September 2023.

MAIN OUTCOMES AND MEASURES: Outcomes of interest were industry involvement (sponsor, author, and analyst) and transparency (protocols, statistical analysis plans, and data and code availability).

RESULTS: Among 600 trials with a median (IQR) sample size of 415 (124-1046) participants assessed, 409 (68.2%) had industry funding and 303 (50.5%) were exclusively industry-funded. A total of 354 trials (59.0%) had industry authors, with 280 trials (46.6%) involving industry analysts and 125 trials (20.8%) analyzed exclusively by industry analysts. Among industry-funded trials, 364 (89.0%) reached conclusions favoring the sponsor. Most trials (478 trials [79.7%]) provided a data availability statement, and most indicated intention to share the data, but only 16 trials (2.7%) had data already readily available to others. More than three-quarters of trials had full protocols (482 trials [82.0%]) or statistical analysis plans (446 trials [74.3%]) available, but only 27 trials (4.5%) explicitly mentioned sharing analysis code (8 readily available; 19 on request). Randomized trials were more likely than nonrandomized studies to involve only industry analysts (107 trials [22.9%] vs 18 trials [13.6%]; P = .02) and to have full protocols (405 studies [86.5%] vs 87 studies [65.9%]; P < .001) and statistical analysis plans (373 studies [79.7%] vs 73 studies [55.3%]; P < .001) available. Almost all nonrandomized industry-funded studies (90 of 92 studies [97.8%]) favored the sponsor. Among industry-funded trials, exclusive industry funding (odds ratio, 2.9; 95% CI, 1.5-5.4) and industry-affiliated authors (odds ratio, 2.9; 95% CI, 1.5-5.6) were associated with favorable conclusions for the sponsor.

CONCLUSIONS AND RELEVANCE: This cross-sectional study illustrates how industry involvement in the most influential clinical trials was prominent not only for funding, but also authorship and provision of analysts and was associated with conclusions favoring the sponsor. While most influential trials reported that they planned to share data and make both protocols and statistical analysis plans available, raw data and code were rarely readily available.

PMID:37962883 | DOI:10.1001/jamanetworkopen.2023.43425