Category: Statistics

Int Urogynecol J. 2022 May 19. doi: 10.1007/s00192-022-05228-z. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Overactive bladder (OAB) and urinary incontinence (UI) are prevalent in older women. We investigated relations of toileting behaviors and urinary urge cues to OAB and UI in women ≥ 65 years. We tested mediation hypotheses that toileting behaviors lead to higher sensitivity to urinary urge cues (the mediator), which leads to both OAB and UI.

METHODS: An e-panel was recruited to respond to an electronic survey that included demographic information, Urinary Cues Scale version 2, Toileting Behaviors-Women’s Elimination Behaviors (TB-WEB) scale, and the International Consultation on Incontinence Questionnaire Short Forms for Urinary Incontinence (ICIQ-SF-UI) and Overactive Bladder (ICIQ-SF-OAB). Descriptive statistics were conducted; correlation matrices were created to explore relationships among major variables. Regression analyses were conducted to test our mediation hypotheses.

RESULTS: There were 338 respondents with average age 70.9 (SD + 5.55) years. Most were white, overweight or obese, and had UI. Urinary urge cues fully mediated the relationship of TB-WEB with OAB. Urinary urge cues partially mediated the relationship of TB-WEB with UI; the direct effect of toileting behaviors on UI remained significant. Age and body mass index had significant partial correlations with UI but not with OAB.

DISCUSSION: Toileting behaviors appear to contribute to sensitivity to urinary cues, which are related to both OAB and UI. Toileting behaviors have indirect effects on OAB and both indirect and direct effects on UI. Interventions to change toileting behaviors and extinguish urinary cues are needed.

CONCLUSIONS: Behavioral and conditioning factors contribute to UI in older women.

PMID:35588320 | DOI:10.1007/s00192-022-05228-z

Biomark Med. 2022 May 19. doi: 10.2217/bmm-2021-1014. Online ahead of print.

ABSTRACT

Aims: To evaluate BRAK and APRIL in serum samples from healthy patients and an ovarian tumor group and analyze their effective value as biomarkers. Materials & methods: BRAK and APRIL were measured in 197 serum samples including 34 healthy controls, 48 patients with benign ovarian cysts and 115 patients with ovarian cancer, and the best statistical cutoff values were calculated. Then, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value for selected cutoff points were assessed. Results: The healthy control group had statistically significant higher BRAK and lower APRIL than the ovarian tumor group. BRAK was excellent for differentiating healthy patients from patients with ovarian tumors, showing area under the receiver operating characteristic curve 0.983, 98.16% sensitivity and 100% specificity. When BRAK was combined with APRIL and CA-125, it also played a role in distinguishing benign cysts from malignancies with area under the curve 0.864, 81.74% sensitivity and 79.17% specificity. Conclusions: BRAK and APRIL are good candidates for ovarian tumor biomarkers.

PMID:35588310 | DOI:10.2217/bmm-2021-1014

Transfusion. 2022 May 19. doi: 10.1111/trf.16934. Online ahead of print.

ABSTRACT

BACKGROUND: The therapeutic benefit of convalescent plasma (CP) therapy to treat COVID-19 may derive from neutralising antibodies (nAbs) to SARS-CoV-2. To investigate effects of antigenic variation on neutralisation potency of CP, we compared nAb titres against prototype and recently emerging strains of SARS-CoV-2, including Delta and Omicron, in CP donors previously infected with SARS-CoV-2 before and after immunisation.

METHODS AND MATERIALS: Samples were assayed from previously SARS-CoV-2 infected donors before (n=17) and after one (n=43) or two (n=71) doses of Astra-Zeneca or Pfizer vaccinations. Ab titres against Wuhan/wild type (WT), Alpha, Beta and Delta SARS-CoV-2 strains were determined by live virus microneutralization assay while titres to Omicron used a focus reduction neutralisation test. Anti-spike antibody was assayed by Elecsys anti-SARS-CoV-2 quantitative spike assay (Roche).

RESULTS: Unvaccinated donors showed a geometric mean titre (GMT) of 148 against WT, 80 against Alpha but mostly failed to neutralise Beta, Delta and Omicron strains. Contrastingly, high GMTs were observed in vaccinated donors against all SARS-CoV-2 strains after one vaccine dose (WT:703; Alpha:692; Beta:187; Delta:215; Omicron:434). By ROC analysis, reactivity in the Roche quantitative Elecsys spike assay of 20,000 U/ml was highly predictive of donations with nAb titres of ≥1:640 against Delta (90% sensitivity; 97% specificity) and ≥1:320 against Omicron (89% sensitivity; 81% specifciity) DISCUSSION: Vaccination of previously infected CP donors induced high levels of broadly neutralising antibodies against circulating antigenic variants of SARS-CoV-2. High titre donations could be reliably identified by automated quantitative anti-spike antibody assay, enabling large-scale pre- selection of high-titre convalescent plasma.

PMID:35588314 | DOI:10.1111/trf.16934

J Med Virol. 2022 May 19. doi: 10.1002/jmv.27871. Online ahead of print.

ABSTRACT

OBJECTIVE: To provide a comparative meta-analysis and systematic review of the risk and clinical outcomes of COVID-19 infection between fully vaccinated and unvaccinated groups.

METHODS: Eighteen studies of COVID-19 infections in fully vaccinated (“breakthrough infections”) and unvaccinated individuals were reviewed from Medline/PubMed, Scopus, Embase, and Web of Science databases. The meta-analysis examined the summary effects and between-study heterogeneity regarding differences in the risk of infection, hospitalization, treatments, and mortality between vaccinated and unvaccinated individuals.

RESULTS: The overall risk of infection was lower for the fully vaccinated compared to that of the unvaccinated (relative risk[RR] 0.20, 95% CI 0.19-0.21), especially for variants other than Delta (Delta: RR 0.29, 95% CI 0.13-0.65; other variants: RR 0.06, 95% CI 0.04-0.08). The risk of asymptomatic infection was not statistically significantly different between fully vaccinated and unvaccinated (RR 0.56, 95% CI 0.27-1.19). There were neither statistically significant differences in risk of hospitalization (RR 1.06, 95% CI 0.38-2.93), invasive mechanical ventilation (RR 1.65 ,95% CI 0.90-3.06), or mortality (RR 1.19, 95% CI 0.79-1.78). Conversely, the risk of supplemental oxygen during hospitalization was significantly higher for the unvaccinated (RR 1.40, 95% CI 1.08-1.82).

CONCLUSIONS: Unvaccinated people were more vulnerable to COVID-19 infection than fully vaccinated for all variants. Once infected, there were no statistically significant differences in the risk of hospitalization, invasive mechanical ventilation, or mortality. Still, unvaccinated showed an increased need for oxygen supplementation. Further prospective analysis, including patients’ risk factors, COVID-19 variants, and the utilized treatment strategies, would be warranted. This article is protected by copyright. All rights reserved.

PMID:35588301 | DOI:10.1002/jmv.27871

JMIR Form Res. 2022 May 19;6(5):e34906. doi: 10.2196/34906.

ABSTRACT

BACKGROUND: Innovative digital technology systems that support and monitor real-time medication intake are now available commercially; however, there is limited knowledge of the use of such technology in patients’ homes. One such smart medication dispenser, spencer, provides alerts to patients to take their medications and allows for tracking and reporting real-time medication adherence data.

OBJECTIVE: The objectives of this study were to examine the use of a smart medication dispenser as a medication adherence and self-management support tool for community dwelling adults over a 6-month period, in addition to usability, usefulness, satisfaction, and impact on caregiver support.

METHODS: This prospective, observational study invited community-dwelling adults aged 45 years and older taking at least one chronic medication and their caregivers to use this smart medication dispenser for their medication administration for 6 months. Adherence was defined as a dose intake within 2 hours post scheduled time. Real-time adherence data were collected using the smart medication dispenser and the AdhereNet platform. Usability, usefulness, and satisfaction were measured using the System Usability Scale and the Usefulness, Satisfaction, and Ease of Use questionnaire, respectively. Caregiver burden was measured on a visual analog scale at baseline and at the end of the 6-month study period.

RESULTS: A total of 58 participants were recruited, of which 55% (32/58) were female with a mean age of 66.36 (SD 11.28; range 48-90) years. Eleven caregiver participants were recruited, of whom 91% (10/11) were female. The average monthly adherence over 6 months was 98% (SD 3.1%; range 76.5%-100%). The average System Usability score was 85.74 (n=47; SD 12.7; range 47.5-100). Of the 46 participants who provided data, 44 (96%) rated the product as easy, 43 (93%) as simple to use, and 43 (93%) were satisfied with the product. Caregiver burden prior to and following smart medication dispenser use for 6 months was found to be statistically significantly different (P<.001; CI 2.11-5.98).

CONCLUSIONS: Smart medication adherence products such as spencer, when connected and clinically monitored, can be a useful solution for medication management and have the potential to improve caregiver burden.

PMID:35587371 | DOI:10.2196/34906

J Med Internet Res. 2022 May 19;24(5):e36431. doi: 10.2196/36431.

ABSTRACT

BACKGROUND: Exposure and response prevention, a type of cognitive-behavioral therapy, is an effective first-line treatment for obsessive-compulsive disorder (OCD). Despite extensive evidence of the efficacy of exposure and response prevention (ERP) from clinical studies and in real-world samples, it is still underused as a treatment. This is likely due to the limits to access to care that include the availability of adequately trained therapists, as well as geographical location, time, and cost barriers. To address these, NOCD created a digital behavioral health treatment for OCD using ERP delivered via video teletherapy and with technology-assisted elements including app-based therapy tools and between-session therapist messaging.

OBJECTIVE: We examined treatment outcomes in a large naturalistic sample of 3552 adults with a primary OCD diagnosis who received NOCD treatment.

METHODS: The treatment model consisted of twice-weekly, live, face-to-face video teletherapy ERP for 3 weeks, followed by 6 weeks of once-weekly brief video teletherapy check-ins for 30 minutes. Assessments were conducted at baseline, at midpoint after completion of 3 weeks of twice-weekly sessions, and at the end of 6 weeks of brief check-ins (endpoint). Longitudinal assessments were also obtained at 3, 6, 9, and 12 months after endpoint.

RESULTS: Treatment resulted in clinically and statistically significant improvements, with a 43.4% mean reduction in obsessive-compulsive symptoms (g=1.0; 95% CI 0.93 to 1.03) and a 62.9% response rate. Treatment also resulted in a 44.2% mean reduction in depression, a 47.8% mean reduction in anxiety, and a 37.3% mean reduction in stress symptoms. Quality of life improved by a mean of 22.7%. Reduction in OCD symptoms and response rates were similar for those with mild, moderate, or severe symptoms. The mean duration of treatment was 11.5 (SD 4.0) weeks, and the mean total therapist time was 10.6 (SD 1.1) hours. Improvements were maintained at 3, 6, 9, and 12 months.

CONCLUSIONS: In this sample, representing the largest reported treated cohort of patients with OCD to date, video teletherapy treatment demonstrated effectiveness in reducing obsessive-compulsive and comorbid symptoms and improved quality of life. Further, it achieved meaningful results in less than half the total therapist time compared with standard once-weekly outpatient treatment, an efficiency that represents substantial monetary and time savings. The effect size was large and similar to studies of in-person ERP. This technology-assisted remote treatment is readily accessible for patients, offering an advancement in the field in the dissemination of effective evidence-based care for OCD.

PMID:35587365 | DOI:10.2196/36431

J Vis. 2022 May 3;22(6):7. doi: 10.1167/jov.22.6.7.

ABSTRACT

Natural scenes contain several statistical regularities despite their superficially diverse appearances (e.g., mountains, rainforests, deserts). First, they exhibit a unique distribution of luminance intensities decreasing across spatial frequency, known as the 1/fα amplitude spectrum (α ≈ 1). Additionally, natural scenes share consistent geometric properties, comprising similar densities of structure across multiple scales-a property classifying them as fractal (e.g., how the branching patterns of rivers and trees appear similar irrespective of scale). These two properties are intimately related and correlate strongly in natural scenes. However, research using thresholded noise images suggests that spatially, the human visual system is preferentially tuned to natural scene structure more so than 1/fα spectra. It is currently unclear whether this dependency on natural geometry extends to the temporal domain. We used a psychophysics task to measure discrimination sensitivity toward two types of synthetic noise movies: gray scale and thresholded (N = 60). Each movie type shared the same geometric properties (measured fractal D), but substantially differing spectral properties (measured α). In both space and time, we observe a characteristic dependency on stimulus structure across movie types, with sensitivity peaking for stimuli with natural geometry despite having altered 1/fα spectra. Although only measured behaviorally, our findings may imply that the neural processes underlying this tuning have developed to be sensitive to the most stable signal in our natural environment-structure (e.g., the structural properties of a tree are consistent from morning to night despite illumination changes across time points).

PMID:35587355 | DOI:10.1167/jov.22.6.7

JAMA Netw Open. 2022 May 2;5(5):e2212939. doi: 10.1001/jamanetworkopen.2022.12939.

ABSTRACT

IMPORTANCE: Amitriptyline is an established medication used off-label for the treatment of fibromyalgia, but pregabalin, duloxetine, and milnacipran are the only pharmacological agents approved by the US Food and Drug Administration (FDA) to treat fibromyalgia.

OBJECTIVE: To investigate the comparative effectiveness and acceptability associated with pharmacological treatment options for fibromyalgia.

DATA SOURCES: Searches of PubMed/MEDLINE, Cochrane Library, Embase, and Clinicaltrials.gov were conducted on November 20, 2018, and updated on July 29, 2020.

STUDY SELECTION: Randomized clinical trials (RCTs) comparing amitriptyline or any FDA-approved doses of investigated drugs.

DATA EXTRACTION AND SYNTHESIS: This study follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. Four independent reviewers extracted data using a standardized data extraction sheet and assessed quality of RCTs. A random-effects bayesian network meta-analysis (NMA) was conducted. Data were analyzed from August 2020 to January 2021.

MAIN OUTCOMES AND MEASURES: Comparative effectiveness and acceptability (defined as discontinuation of treatment owing to adverse drug reactions) associated with amitriptyline (off-label), pregabalin, duloxetine, and milnacipran (on-label) in reducing fibromyalgia symptoms. The following doses were compared: 60-mg and 120-mg duloxetine; 150-mg, 300-mg, 450-mg, and 600-mg pregabalin; 100-mg and 200-mg milnacipran; and amitriptyline. Effect sizes are reported as standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with 95% credible intervals (95% CrIs). Findings were considered statistically significant when the 95% CrI did not include the null value (0 for SMD and 1 for OR). Relative treatment ranking using the surface under the cumulative ranking curve (SUCRA) was also evaluated.

RESULTS: A total of 36 studies (11 930 patients) were included. The mean (SD) age of patients was 48.4 (10.4) years, and 11 261 patients (94.4%) were women. Compared with placebo, amitriptyline was associated with reduced sleep disturbances (SMD, -0.97; 95% CrI, -1.10 to -0.83), fatigue (SMD, -0.64; 95% CrI, -0.75 to -0.53), and improved quality of life (SMD, -0.80; 95% CrI, -0.94 to -0.65). Duloxetine 120 mg was associated with the highest improvement in pain (SMD, -0.33; 95% CrI, -0.36 to -0.30) and depression (SMD, -0.25; 95% CrI, -0.32 to -0.17) vs placebo. All treatments were associated with inferior acceptability (higher dropout rate) than placebo, except amitriptyline (OR, 0.78; 95% CrI, 0.31 to 1.66). According to the SUCRA-based relative ranking of treatments, duloxetine 120 mg was associated with higher efficacy for treating pain and depression, while amitriptyline was associated with higher efficacy for improving sleep, fatigue, and overall quality of life.

CONCLUSIONS AND RELEVANCE: These findings suggest that clinicians should consider how treatments could be tailored to individual symptoms, weighing the benefits and acceptability, when prescribing medications to patients with fibromyalgia.

PMID:35587348 | DOI:10.1001/jamanetworkopen.2022.12939

JAMA Netw Open. 2022 May 2;5(5):e2212964. doi: 10.1001/jamanetworkopen.2022.12964.

ABSTRACT

IMPORTANCE: Increased bystander cardiopulmonary resuscitation (CPR) is essential to improve survival after cardiac arrest. Although most studies focus on technical CPR skills, the randomized Lowlands Saves Lives trial prespecified a follow-up survey on other important aspects that affect the widespread performance of CPR.

OBJECTIVE: To investigate bystander willingness to perform CPR on a stranger, theoretical knowledge retention, and dissemination of CPR awareness 6 months after undergoing short face-to-face and virtual reality (VR) CPR trainings.

DESIGN, SETTING, AND PARTICIPANTS: A prespecified 6-month posttraining survey was conducted among 320 participants in the Lowlands Saves Lives trial, a randomized comparison between 20-minute face-to-face, instructor-led CPR training and VR training. Participants were recruited at the Lowlands music festival, with a designated area to conduct scientific projects (August 16-18, 2019; the Netherlands). Statistical analysis was performed from March 1, 2020, to July 31, 2021.

INTERVENTIONS: Two standardized 20-minute protocols on CPR and automated external defibrillator use: instructor-led face-to-face training using CPR manikins or VR training using the Resuscitation Council (UK)-endorsed Lifesaver VR smartphone application and a pillow to practice compressions.

MAIN OUTCOMES AND MEASURES: Primary outcomes were willingness to perform CPR on a stranger, theoretical knowledge retention, and dissemination of CPR awareness as reported by the entire cohort. As secondary analyses, the results of the 2 training modalities were compared.

RESULTS: Of 381 participants, 320 consented to this follow-up survey; 188 participants (115 women [61%]; median age, 26 years [IQR, 22-32 years]) completed the entire survey and were accordingly included in the secondary analysis. The overall proportion of participants willing to perform CPR on a stranger was 77% (144 of 188): 81% (79 of 97) among face-to-face participants and 71% (65 of 91) among VR participants (P = .02); 103 participants (55%) reported feeling scared to perform CPR (P = .91). Regarding theoretical knowledge retention, a median of 7 (IQR, 6-8) of 9 questions were answered correctly in both groups (P = .81). Regarding dissemination of CPR awareness, 65% of participants (123 of 188) told at least 1 to 10 family members or friends about the importance of CPR, and 15% (29 of 188) had participated in certified, instructor-led training at the time of the survey, without differences between groups.

CONCLUSIONS AND RELEVANCE: In this 6-month posttraining survey, young adult participants of short CPR training modules reported high willingness (77%) to perform CPR on a stranger, with slightly higher rates for face-to-face than for VR participants. Theoretical knowledge retention was good, and the high dissemination of awareness suggests that these novel CPR training modules staged at a public event are promising sensitizers for involvement in CPR, although further challenges include mitigating the fear of performing CPR.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04013633.

PMID:35587346 | DOI:10.1001/jamanetworkopen.2022.12964

JAMA Netw Open. 2022 May 2;5(5):e2212957. doi: 10.1001/jamanetworkopen.2022.12957.

ABSTRACT

IMPORTANCE: The number of extreme heat events is increasing because of climate change. Previous studies showing an association between extreme heat and higher mortality rates generally have been limited to urban areas, and whether there is heterogeneity across different populations is not well studied; understanding whether this association varies across different communities, particularly minoritized racial and ethnic groups, may allow for more targeted mitigation efforts.

OBJECTIVE: To the assess the association between extreme heat and all-cause mortality rates in the US.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study involved a longitudinal analysis of the association between the number of extreme heat days in summer months from 2008 to 2017 (obtained from the Centers for Disease Control and Prevention’s Environmental Public Health Tracking Program) and county-level all-cause mortality rates (obtained from the National Center for Health Statistics), using a linear fixed-effects model across all counties in the contiguous US among adults aged 20 years and older. Data analysis was performed from September 2021 to March 2022.

EXPOSURES: The number of extreme heat days per month. Extreme heat was identified if the maximum heat index was greater than or equal to 90 °F (32.2 °C) and in the 99th percentile of the maximum heat index in the baseline period (1979 to 2007).

MAIN OUTCOMES AND MEASURES: County-level, age-adjusted, all-cause mortality rates.

RESULTS: There were 219 495 240 adults aged 20 years and older residing in the contiguous US in 2008, of whom 113 294 043 (51.6%) were female and 38 542 838 (17.6%) were older than 65 years. From 2008 to 2017, the median (IQR) number of extreme heat days during summer months in all 3108 counties in the contiguous US was 89 (61-122) days. After accounting for time-invariant confounding, secular time trends, and time-varying environmental and economic measures, each additional extreme heat day in a month was associated with 0.07 additional death per 100 000 adults (95% CI, 0.03-0.10 death per 100 000 adults; P = .001). In subgroup analyses, greater increases in mortality rates were found for older vs younger adults (0.19 death per 100 000 individuals; 95% CI, 0.04-0.34 death per 100 000 individuals), male vs female adults (0.12 death per 100 000 individuals; 95% CI, 0.05-0.18 death per 100 000 individuals), and non-Hispanic Black vs non-Hispanic White adults (0.11 death per 100 000 individuals; 95% CI, 0.02-0.20 death per 100 000 individuals).

CONCLUSIONS AND RELEVANCE: These findings suggest that from 2008 to 2017, extreme heat was associated with higher all-cause mortality in the contiguous US, with a greater increase noted among older adults, men, and non-Hispanic Black individuals. Without mitigation, the projected increase in extreme heat due to climate change may widen health disparities between groups.

PMID:35587347 | DOI:10.1001/jamanetworkopen.2022.12957