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Nevin Manimala Statistics

Implementation and Evaluation of a Gait Training Assistant for the Use of Crutches: Usability Study

JMIR Hum Factors. 2024 Aug 16;11:e51898. doi: 10.2196/51898.

ABSTRACT

BACKGROUND: Surgical procedures on the lower extremities often require weight-bearing on crutches as part of the rehabilitation process. Orthopedic elective procedures enable patients to learn the correct use of crutches in a controlled preoperative setting. Digital assistance systems can safely circumvent a shortage of skilled staff and any contact restrictions that may be necessary.

OBJECTIVE: The usability of a newly developed gait training assistant (GTA) for the use of crutches will be evaluated. An intervention group trained to use crutches by the digital trainer will be compared with a control group trained to use crutches conventionally by a physiotherapist.

METHODS: As part of the development and implementation of a novel GTA, 14 patients learned to walk with crutches by completing specific exercises while receiving live feedback. Their movements were detected by a depth sensor and evaluated in real time. Specific parameters (step length, synchronous movement, crutch angle, and crutch distance to the feet) were compared with a control group (n=14) trained to use crutches by physiotherapists. The intervention group was also assessed by a physiotherapist. At the end of the study, the patients completed questionnaires to evaluate the usability of the system (Brooke’s System Usability Scale score) and patient satisfaction.

RESULTS: All patients trained by the novel GTA were able to use crutches correctly. The intervention group showed significantly better values for crutch angle (mean -6.3°, SD 3.5° vs mean -12.4°, SD 4.5°; P<.001) and crutch position (mean 3.3, SD 5.1 cm vs mean -8.5, SD 4.9 cm; P=.02). Both groups reported that they felt confident in the use of crutches, were able to follow the instructions, and enjoyed the training. Even though the majority (12/14, 86%) preferred physical therapy over a purely digital approach, most participants enjoyed using the system (13/14, 93%) and were interested in trying out other digital assistants (11/14, 79%). The usability of the GTA was rated above average by the majority (9/14, 64%) of the patients.

CONCLUSIONS: The newly designed GTA is a safe method of teaching the use of crutches and is statistically superior to training by a physiotherapist. Even if patients prefer interaction with a physiotherapist over a purely digital approach, digital devices provide a safe and motivating opportunity to learn the essential locomotor skills for rehabilitation.

PMID:39150759 | DOI:10.2196/51898

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Nevin Manimala Statistics

Discussion of sound propagation through the turbulent Martian atmosphere and implications for inference of turbulence spectra

J Acoust Soc Am. 2024 Aug 1;156(2):1165-1170. doi: 10.1121/10.0028166.

ABSTRACT

Chide et al. [J. Acoust. Soc. Am. 155, 420-435 (2024)] provide a first attempt to infer the spectrum of temperature fluctuations on Mars from experimental data on the variances of travel-time and log-amplitude fluctuations recorded by the microphone on board the Perseverance rover. However, the theoretical formulations that were used to interpret the travel-time data have limitations. In addition to explaining those issues, this article also outlines approaches for predicting statistical characteristics of acoustic signals in the Martian atmosphere. In particular, the experimentally observed dependence of the travel-time variance on the propagation range can be attributed to ground-blocking of buoyantly produced turbulent velocity fluctuations and the non-Markov character of phase fluctuations.

PMID:39150737 | DOI:10.1121/10.0028166

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Nevin Manimala Statistics

Drug Prices After Patent Expirations in High-Income Countries and Implications for Cost-Effectiveness Analyses

JAMA Health Forum. 2024 Aug 2;5(8):e242530. doi: 10.1001/jamahealthforum.2024.2530.

ABSTRACT

IMPORTANCE: Understanding how patent expirations affect drug prices is crucial because price changes directly inform accurate cost-effectiveness assessments. This study investigates the association between patent expirations and drug prices in 8 high-income countries and evaluates how the changes affect cost-effectiveness assessments.

OBJECTIVE: To analyze how the expiration of drug patents is associated with drug price changes and to assess the implications of these price changes for cost-effectiveness evaluations.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study performed an event study design using data from 8 high-income countries to assess the association between patent expiration and drug prices, and created a simulation model to understand the implications for cost-effectiveness analyses. The simulation cost-effectiveness model analyzed the implications of including or ignoring postpatent price dynamics.

EXPOSURE: Drug patent expiration.

MAIN OUTCOMES AND MEASURES: Change in drug prices and differences in incremental cost-effectiveness ratios when considering vs ignoring postpatent price dynamics.

RESULTS: The sample comprised 505 drugs undergoing patent expiration in Australia, Canada, France, Germany, Japan, Switzerland, UK, and US. Price decreases were statistically significant over the 8 years after patent expiration, with the fastest price declines observed in the US: 32% (95% CI, 24%-39%) in year 1 after patent expiration and 82% (95% CI, 71%-89%) in the 8 years after patent expiration. Estimates for other nations ranged from a decrease of 64% in Australia to 18% in Switzerland in the 8 years after expiration. The cost-effectiveness simulation model indicated that not accounting for generic entry into the market may produce biased incremental cost-effectiveness ratios of 40% to -40%, depending on the scenario.

CONCLUSIONS AND RELEVANCE: The findings of this cohort study demonstrate that drug prices were reduced substantially after patent expirations in high-income countries. Therefore, incorporating information on patent status and pricing dynamics in cost-effectiveness assessment analyses is necessary for producing accurate economic evaluations of new drugs.

PMID:39150730 | DOI:10.1001/jamahealthforum.2024.2530

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Nevin Manimala Statistics

Personality, Social Factors, Brain Functioning, Familial Risk, and Trajectories of Alcohol Misuse in Adolescence

JAMA Netw Open. 2024 Aug 1;7(8):e2425114. doi: 10.1001/jamanetworkopen.2024.25114.

ABSTRACT

IMPORTANCE: The development of an alcohol use disorder in adolescence is associated with increased risk of future alcohol dependence. The differential associations of risk factors with alcohol use over the course of 8 years are important for preventive measures.

OBJECTIVE: To determine the differential associations of risk-taking aspects of personality, social factors, brain functioning, and familial risk with hazardous alcohol use in adolescents over the course of 8 years.

DESIGN, SETTING, AND PARTICIPANTS: The IMAGEN multicenter longitudinal cohort study included adolescents recruited from European schools in Germany, the UK, France, and Ireland from January 2008 to January 2019. Eligible participants included those with available neuropsychological, self-report, imaging, and genetic data at baseline. Adolescents who were ineligible for magnetic resonance imaging or had serious medical conditions were excluded. Data analysis was conducted from July 2021 to September 2022.

EXPOSURE: Personality testing, psychosocial factors, brain functioning, and familial risk of alcohol misuse.

MAIN OUTCOME AND MEASURES: Hazardous alcohol use as measured with the Alcohol Use Disorders Identification Test scores, a main planned outcome of the IMAGEN study. Alcohol misuse trajectories at ages 14, 16, 19, and 22 years were modeled using latent growth curve models.

RESULTS: A total of 2240 adolescents (1110 female [49.6%] and 1130 male [50.4%]) were included in the study. There was a significant negative association of psychosocial resources (β = -0.29; SE = 0.03; P < .001) with the general risk of alcohol misuse as well as a significant positive association of the risk-taking aspects of personality with the intercept (β = 0.19; SE = 0.04; P < .001). Furthermore, there were significant positive associations of the social domain (β = 0.13; SE = 0.02; P < .001) and the personality domain (β = 0.07; SE = 0.02; P < .001) with trajectories of alcohol misuse development over time (slope). Family history of substance misuse was negatively associated with general risk of alcohol misuse (β = -0.04; SE = 0.02; P = .045) and its development over time (β = -0.03; SE = 0.01; P = .01). Brain functioning showed no significant association with intercept or slope of alcohol misuse in the model.

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest known risk factors of adolescent drinking may contribute differentially to future alcohol misuse. This approach may inform more individualized preventive interventions.

PMID:39150713 | DOI:10.1001/jamanetworkopen.2024.25114

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Hospital-Skilled Nursing Facility Integration and Participation in a Bundled Payment Initiative

JAMA Netw Open. 2024 Aug 1;7(8):e2425627. doi: 10.1001/jamanetworkopen.2024.25627.

ABSTRACT

IMPORTANCE: Reduced institutional postacute care has been associated with savings in alternative payment models. However, organizations may avoid voluntary participation if participation could threaten their own revenues.

OBJECTIVE: To characterize the association between hospital-skilled nursing facility (SNF) integration and participation in Medicare’s Bundled Payments for Care Improvement Advanced (BPCI-A) program.

DESIGN, SETTING, AND PARTICIPANTS: This is a cross-sectional analysis of hospital participation in BPCI-A beginning with its launch in 2018. Each SNF-integrated hospital was matched with 2 nonintegrated hospitals for each of 4 episode-specific analyses. Fifteen hospital-level variables were used for matching: beds, case mix index, days, area SNF beds, metropolitan location, ownership, region, system membership, and teaching status. Hospitals were also matched on episode-specific volume, target price, and the interaction of target price and case mix. Episode-specific logistic models were estimated regressing hospital participation on integration and the previously listed variables. The marginal effect of integration on participation was then calculated. Analysis took place from August 2022 to May 2024.

EXPOSURE: Hospital-SNF integration, as defined by common ownership and referral patterns and identified using cost reports, Medicare claims, and Provider Enrollment, Chain, and Ownership System records. Additional sources included records of target prices and participation, the Area Health Resources File, and the Compendium of US Health Systems.

MAIN OUTCOMES AND MEASURES: Participation in BPCI-A.

RESULTS: In total, 1524 hospitals met criteria for inclusion in the hip and femur (HFP) analysis, 1825 were included in the major joint replacement of the lower extremity (MJRLE) analysis, 2018 were included in the sepsis analysis, and 1564, were included in the stroke-specific analysis. Across episodes, 191 HFP-eligible hospitals (12.5% of HFP-eligible hospitals), 302 MJRLE-eligible hospitals (16.5%), 327 sepsis-eligible hospitals (16.2%), and 185 sepsis-eligible hospitals (11.8%) were SNF integrated. In total, 79 hospitals (5.2%) participated in the HFP episode, 128 (7.0%) participated in the MJRLE episode, 204 (10.1%) participated in the sepsis episode, and 141 (9.0%) participated in the stroke episode. Integration was associated with a 4.7-percentage point decrease (95% CI, 2.4 to 6.9 percentage points) in participation in the MJRLE episode. There was no association between integration and participation for HFP (0.5-percentage point increase in participation moving from nonintegrated to integrated; 95% CI, -2.9 to 3.8 percentage points), sepsis (1.0-percentage point increase; 95% CI, -2.2 to 4.2 percentage points), and stroke (0.3-percentage point decrease; 95% CI, -3.1 to 3.8 percentage points).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, there was an uneven association between hospital-SNF integration and participation in Medicare’s BPCI-A program. Other factors may be more consistent determinants of selection into voluntary payment reform.

PMID:39150712 | DOI:10.1001/jamanetworkopen.2024.25627

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Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial

JAMA Netw Open. 2024 Aug 1;7(8):e2427691. doi: 10.1001/jamanetworkopen.2024.27691.

ABSTRACT

IMPORTANCE: Delirium is common among older hospitalized adults. In addition to presenting immediate management issues, delirium can increase the long-term risk of dementia, institutionalization, and mortality. Delirium is associated with disrupted sleep, and prior studies suggest that some specific sleep-promoting agents may reduce delirium.

OBJECTIVE: To evaluate the orexin receptor antagonist suvorexant for reducing delirium in older adults at high risk for delirium after hospitalization.

DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled, phase 3 randomized clinical trial was conducted at 50 hospitals in Japan between October 22, 2020, and December 23, 2022. The study population included Japanese adults aged 65 to 90 years who were at high risk for delirium (mild cognitive impairment or mild dementia, history of delirium at prior hospitalization, or both) and had been hospitalized for acute disease or elective surgery. Data analysis was performed between January 23 and March 13, 2023.

INTERVENTION: Participants were randomized 1:1 to suvorexant (15 mg) or placebo taken at bedtime for up to 7 days while in the hospital.

MAIN OUTCOMES AND MEASURES: Delirium, the primary end point, was diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria while participants were hospitalized. The treatment difference in the proportion of participants with delirium was analyzed.

RESULTS: This study included 203 participants: 101 were treated with suvorexant (mean [SD] age, 81.5 [4.5]; years; 52 men [51.5%] and 49 women [48.5%]) and 102 received placebo (mean [SD] age, 82.0 [4.9] years; 45 men [44.1%] and 57 women [55.9%]). There were 17 participants with delirium (16.8%) in the suvorexant group compared with 27 (26.5%) in the placebo group (difference, -8.7% [95% CI, -20.1% to 2.6%]; P = .13). Adverse events were similar between the 2 groups.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of suvorexant in older adults at high risk for delirium after hospitalization, fewer participants taking suvorexant had delirium compared with placebo, but the difference was not statistically significant. Further studies are needed to determine whether suvorexant may be useful for reducing delirium, particularly delirium with a hyperactive component, in this population.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04571944.

PMID:39150711 | DOI:10.1001/jamanetworkopen.2024.27691

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Perceived Parental Distraction by Technology and Mental Health Among Emerging Adolescents

JAMA Netw Open. 2024 Aug 1;7(8):e2428261. doi: 10.1001/jamanetworkopen.2024.28261.

ABSTRACT

IMPORTANCE: The digital phenomenon termed technoference refers to interruptions in routine social interactions due to technology use. Technoference may negatively affect parents’ attention to cues necessary for supporting children’s mental health.

OBJECTIVE: To explore whether there are directional prospective associations between perceived parental technoference and emerging adolescents’ mental health symptoms (anxiety, depression, inattention, and hyperactivity).

DESIGN, SETTING, AND PARTICIPANTS: This cohort study assessed a general population of mothers and emerging adolescents in Calgary, Alberta, Canada. Women were recruited during pregnancy between May 3, 2008, and December 13, 2010, with convenience sampling and repeated follow-up; eligible women were 18 years or older, spoke English, had a gestational age of at least 24 weeks, and received local prenatal care. Data collection for the present study took place when emerging adolescents were aged 9 (May 20 to July 15, 2020), 10 (March 4 to April 30, 2021), and 11 (November 22, 2021, to January 17, 2022) years. Mothers provided consent for their child to participate, and emerging adolescents provided assent. Data were analyzed from December 1 to 31, 2023, using random-intercept cross-lagged panel models.

EXPOSURE: Perceived parental technoference.

MAIN OUTCOMES AND MEASURES: Emerging adolescents completed questionnaires about their perception of parental technoference and their mental health symptoms (depression, anxiety, hyperactivity, and inattention) at the 3 study times. This study did not rely on statistical significance, but instead on the magnitude of effect sizes to determine meaningful effects.

RESULTS: Participants included 1303 emerging adolescents (mean [SD] age, 9.7 [0.8] years at time 1; of the 1028 reporting information, 529 [51.5%] were girls). Cross-sectional associations indicated correlations between perceptions of parental technoference and emerging adolescents’ mental health (r range, 0.17-0.19). Higher levels of anxiety at 9 and 10 years of age were prospectively associated with higher parental technoference scores at 10 (β = 0.11 [95% CI, -0.05 to 0.26]) and 11 (β = 0.12 [95% CI, 0.001-0.24]) years of age, with small magnitudes of effect size. Higher parental technoference scores at 9 and 10 years of age were prospectively associated with higher hyperactivity at 10 (β = 0.07 [95% CI, -0.07 to 0.22]) and 11 (β = 0.11 [95% CI, -0.02 to 0.24]) years of age and inattention at 11 years of age (β = 0.12 [95% CI, 0.001-0.24]), with small magnitudes of effect size. No gender differences were identified.

CONCLUSIONS AND RELEVANCE: In this 3-wave longitudinal birth cohort study, perceived parental technoference was associated with emerging adolescents’ mental health. The findings speak to the need to discuss digital technology use and mental health with parents and emerging adolescents as a part of routine care.

PMID:39150710 | DOI:10.1001/jamanetworkopen.2024.28261

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Abiraterone or Enzalutamide for Patients With Metastatic Castration-Resistant Prostate Cancer

JAMA Netw Open. 2024 Aug 1;7(8):e2428444. doi: 10.1001/jamanetworkopen.2024.28444.

ABSTRACT

IMPORTANCE: Abiraterone acetate and enzalutamide are recommended as preferred treatments for metastatic castration-resistant prostate cancer (mCRPC), but differences in their relative efficacy are unclear due to a lack of head-to-head clinical trials. Clear guidance is needed for making informed mCRPC therapeutic choices.

OBJECTIVE: To compare clinical outcomes in patients with mCRPC treated with abiraterone acetate or enzalutamide.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, multicenter cohort study included patients with mCRPC in the US Department of Veterans Affairs health care system who initiated treatment with abiraterone acetate or enzalutamide between January 1, 2014, and October 30, 2022.

EXPOSURES: Abiraterone acetate or enzalutamide.

MAIN OUTCOMES AND MEASURES: The study used inverse probability of treatment weighting to balance baseline characteristics between patients initiating abiraterone acetate or enzalutamide and evaluated restricted mean survival time (RMST) differences in overall survival (OS), prostate cancer-specific survival (PCS), time to next treatment switching or death (TTS), and time to prostate-specific antigen (PSA) response (TTR) at different time points after treatment initiation.

RESULTS: The study included 5779 patients (median age, 74.42 years [IQR, 68.94-82.14 years]). Median follow-up was between 38 and 60 months. Patients initiating enzalutamide on average had longer OS than those initiating abiraterone acetate, with RMSTs of 24.29 months (95% CI, 23.58-24.99 months) and 23.38 months (95% CI, 22.85-23.92 months), respectively, and a difference in RMST of 0.90 months (95% CI, 0.02-1.79 months) at 4 years. Similarly, TTS and TTR were improved in patients initiating enzalutamide, with an RMST at 4 years of 1.95 months (95% CI, 0.92-2.99 months) longer for TTS and 3.57 months (95% CI, 1.76-5.38 months) shorter for TTR. For PCS, the RMST at 2 years was 0.48 months (95% CI, 0.01-0.95 months) longer. An examination of subgroups identified that enzalutamide initiation was associated with longer RMST in OS among patients without prior docetaxel treatment (1.14 months; 95% CI, 0.19-2.10 months) and in those with PSA doubling time of 3 months or longer (2.23 months; 95% CI, 0.81-3.66 months) but not among patients with prior docetaxel (-0.25 months; 95% CI, -2.59 to 2.09 months) or with PSA doubling time of less than 3 months (0.05 months; 95% CI, -1.05 to 1.15 months).

CONCLUSIONS AND RELEVANCE: In this cohort study of patients with mCRPC, initiation of enzalutamide was associated with small but statistically significant improvements in OS, PCS, TTS, and TTR compared with initiation of abiraterone acetate. The improvements were more prominent in short-term outcomes, including TTS and TTR, and in patient subgroups without prior docetaxel or with PSA doubling time longer than 3 months.

PMID:39150709 | DOI:10.1001/jamanetworkopen.2024.28444

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Emergency Allotments in SNAP and Food Hardship Among Households With Children

JAMA Netw Open. 2024 Aug 1;7(8):e2428680. doi: 10.1001/jamanetworkopen.2024.28680.

ABSTRACT

IMPORTANCE: Households with children and minoritized racial and ethnic groups experience a disproportionate burden of food hardship. During the COVID-19 pandemic, the US federal government implemented emergency allotments in the Supplemental Nutrition Assistance Program (SNAP), increasing the amount of food purchasing assistance received by many participating households.

OBJECTIVE: To examine the association of implementing emergency allotments in SNAP with food hardship among households with children overall and for households with Black, Hispanic, and White children by comparing income-eligible households that did and did not participate in SNAP.

DESIGN, SETTING, AND PARTICIPANTS: This ecologic cross-sectional study used 2016-2022 National Survey of Children’s Health data and a difference-in-differences approach to compare changes in the risk of food hardship from before implementation of emergency allotments in SNAP (2016-2019) to during implementation (2020-2022). Households with children younger than 18 years and incomes 130% or less of the federal poverty level (FPL) in all 50 states and Washington, DC, were included.

EXPOSURE: Implementation of emergency allotments in SNAP.

MAIN OUTCOME AND MEASURES: The primary outcome was caregiver report of household food hardship during the past 12 months.

RESULTS: Of 44 753 households with incomes 130% or less of the FPL, a weighted 23.4% had Black children, 56.7% had White children, and 19.9% had children of other races. More than one-third of households (37.8%) had Hispanic children, and 31.8% had young children aged 0 to 5 years. The percentage of households that experienced food hardship decreased from 2016 to 2021 (from 62.9% to 48.2% among SNAP-participating households and from 44.3% to 38.9% among income-eligible nonparticipating households) but increased in 2022 (to 58.0% among SNAP-participating households and to 47.5% among nonparticipating households). Adjusting for confounders, implementing emergency allotments in SNAP was associated with a decreased risk of food hardship among SNAP-participating compared with nonparticipating households (risk ratio [RR], 0.88; 95% CI, 0.81-0.96). Implementing emergency allotments in SNAP was associated with a decreased risk of food hardship among SNAP-participating households with Hispanic (RR, 0.86; 95% CI, 0.72-1.02) and White (RR, 0.85; 95% CI, 0.76-0.94) children compared with nonparticipating households but not among households with Black children (RR, 1.04; 95% CI, 0.87-1.23).

CONCLUSIONS AND RELEVANCE: In this ecologic cross-sectional study, implementing emergency allotments in SNAP was associated with a decreased risk of food hardship among households with children. Efforts are needed to ensure that all populations benefit from economic policies.

PMID:39150708 | DOI:10.1001/jamanetworkopen.2024.28680

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Carbohydrate quality indices and lung cancer risk: a case-control study from Iran

Eur J Cancer Prev. 2024 Jul 31. doi: 10.1097/CEJ.0000000000000913. Online ahead of print.

ABSTRACT

Considering that carbohydrates play an important role in supplying the body with energy and exhibit diverse mechanisms that can either prevent or stimulate cancer, we hypothesize that the quality of carbohydrate intake may be associated with cancer risk, including lung cancer. This hospital-based case-control study was conducted on 135 newly diagnosed lung cancer patients, and 237 healthy age- and sex-matched hospitalized controls. We used a valid and reliable 148-item Food Frequency Questionnaire to collect the dietary intake of subjects. Multivariate logistic regression was used to estimate the association between carbohydrate quality indices and the odds of lung cancer. After adjustment for confounding variables, the high glycemic index appears to be an increased risk factor for lung cancer [odds ratio (OR) = 2.51, 95% confidence interval (CI): 1.28-4.91]. No statistically significant association was found between glycemic load and lung cancer (OR = 2.51, 95% CI: 0.98-6.43). In contrast, the carbohydrate quality index (OR = 0.23, 95% CI: 0.11-0.48) and low-carbohydrate diet score (OR = 0.17, 95% CI: 0.08-0.36), were associated with a decrease in the risk of lung cancer. In summary, our study showed that a high glycemic index is a risk factor for lung cancer, however carbohydrate quality index and low-carbohydrate diet score is a dietary approach to reduce the risk of lung cancer.

PMID:39150686 | DOI:10.1097/CEJ.0000000000000913