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JMIR Formative Research Jun 2024Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the...
BACKGROUND
Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale.
OBJECTIVE
The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success.
METHODS
This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis.
RESULTS
Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated.
CONCLUSIONS
This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.
PubMed: 38935967
DOI: 10.2196/58551 -
PloS One 2024Lameness in dairy cows is an expression of pain most likely originating from a claw disorder, causing impaired animal wellbeing and substantial economic losses for...
Lameness in dairy cows is an expression of pain most likely originating from a claw disorder, causing impaired animal wellbeing and substantial economic losses for farmers. The aim of this study was to investigate the effects of access to pasture, time spent on pasture, and season on farm level lameness prevalence. The survey was part of a cross-sectional observational study, in which farms in three regions of Germany (North, East and South) were visited by study veterinarians. On each farm (total: 659, N: 240, E: 247, S: 172), management data were recorded, and cows were scored for locomotion, according to Sprecher. Median farm-level lameness prevalence (Score 3/5 or higher) was 29.4% (IQR: 18.7% - 42.0%), and 8.2% (IQR: 3.7% - 14.0%) for severe lameness (Score 4/5 or higher). Farm-level lameness prevalence continuously decreased with increasing time spent on pasture (up to approximately 10 hours per cow per day). On farms that did not offer their cows access to pasture lameness prevalence did not show a seasonal variation. On farms where cows had pasture access for up to three hours per day lameness prevalence peaked in autumn. In contrast, on farms offering their cows access to pasture beyond three hours per day the peak of lameness was observed in spring. Our results revealed that even short periods of pasture access of at least two hours per cow and day (on average per year) are beneficial for the locomotion of dairy cows.
Topics: Animals; Lameness, Animal; Cattle; Germany; Prevalence; Cattle Diseases; Cross-Sectional Studies; Dairying; Female; Seasons
PubMed: 38935805
DOI: 10.1371/journal.pone.0305536 -
PloS One 2024Chronic endometritis (CE), an inflammatory condition characterized by plasma cell infiltration within the endometrial stroma, is prevalent among women experiencing... (Observational Study)
Observational Study
Chronic endometritis (CE), an inflammatory condition characterized by plasma cell infiltration within the endometrial stroma, is prevalent among women experiencing unexplained infertility or recurrent miscarriages. CE is traditionally diagnosed by endometrial biopsy using CD138 immunohistochemistry staining. Despite some studies suggesting hysteroscopy as an alternative diagnostic tool, its reliability compared with biopsy remains controversial. This study evaluated the diagnostic accuracy of hysteroscopy for CE by examining endometrial features, such as congestion, micropolyps, edema, and polyps, and comparing these with biopsy-confirmed cases of CE. This retrospective observational study was conducted at Toho University Omori Medical Center between June 2017 and November 2019 and included patients undergoing both hysteroscopy and histopathological examination. Endometrial congestion was identified as the only hysteroscopic finding significantly associated with CE, showing a moderate diagnostic agreement with biopsy results. These findings highlight the importance of further investigating hysteroscopic features of CE and their diagnostic implications and identify endometrial congestion as a potential predictive marker for CE.
Topics: Humans; Female; Endometritis; Hysteroscopy; Adult; Endometrium; Retrospective Studies; Chronic Disease; Biopsy; Middle Aged
PubMed: 38935687
DOI: 10.1371/journal.pone.0303041 -
PLOS Digital Health Jun 2024Study-specific data quality testing is an essential part of minimizing analytic errors, particularly for studies making secondary use of clinical data. We applied a...
Study-specific data quality testing is an essential part of minimizing analytic errors, particularly for studies making secondary use of clinical data. We applied a systematic and reproducible approach for study-specific data quality testing to the analysis plan for PRESERVE, a 15-site, EHR-based observational study of chronic kidney disease in children. This approach integrated widely adopted data quality concepts with healthcare-specific evaluation methods. We implemented two rounds of data quality assessment. The first produced high-level evaluation using aggregate results from a distributed query, focused on cohort identification and main analytic requirements. The second focused on extended testing of row-level data centralized for analysis. We systematized reporting and cataloguing of data quality issues, providing institutional teams with prioritized issues for resolution. We tracked improvements and documented anomalous data for consideration during analyses. The checks we developed identified 115 and 157 data quality issues in the two rounds, involving completeness, data model conformance, cross-variable concordance, consistency, and plausibility, extending traditional data quality approaches to address more complex stratification and temporal patterns. Resolution efforts focused on higher priority issues, given finite study resources. In many cases, institutional teams were able to correct data extraction errors or obtain additional data, avoiding exclusion of 2 institutions entirely and resolving 123 other gaps. Other results identified complexities in measures of kidney function, bearing on the study's outcome definition. Where limitations such as these are intrinsic to clinical data, the study team must account for them in conducting analyses. This study rigorously evaluated fitness of data for intended use. The framework is reusable and built on a strong theoretical underpinning. Significant data quality issues that would have otherwise delayed analyses or made data unusable were addressed. This study highlights the need for teams combining subject-matter and informatics expertise to address data quality when working with real world data.
PubMed: 38935590
DOI: 10.1371/journal.pdig.0000527 -
JAMA Network Open Jun 2024The US has the highest maternal mortality rate among developed countries. The Centers for Disease Control and Prevention deems nearly all of these deaths preventable,... (Observational Study)
Observational Study
IMPORTANCE
The US has the highest maternal mortality rate among developed countries. The Centers for Disease Control and Prevention deems nearly all of these deaths preventable, especially those attributable to mental health conditions. Coordination between US health care and social service systems could help further characterize circumstances and risks associated with perinatal suicide mortality.
OBJECTIVE
To examine contextual and individual precipitating circumstances and risks associated with perinatal suicide.
DESIGN, SETTING, AND PARTICIPANTS
This cross-sectional observational study used a convergent mixed methods design to explore factors contributing to maternal suicides and deaths of undetermined intent (hereinafter, undetermined deaths) identified in National Violent Death Reporting System (NVDRS) data for January 1, 2003, to December 31, 2021. Analyses included decedents who were aged 10 to 50 years and pregnant or post partum at death (collectively, the perinatal group) and demographically matched female decedents who were not pregnant or recently pregnant (nonperinatal group) at death. Analyses were performed between December 2022 and December 2023.
EXPOSURES
Pregnancy status at death (perinatal or nonperinatal).
MAIN OUTCOMES AND MEASURES
The main outcomes included contributing circumstances associated with suicides and undetermined deaths cited in coroner, medical examiner, or law enforcement case narratives. The study examined quantitative differences between groups using a matched analysis and characterized key themes of salient suicide circumstances using qualitative content analysis.
RESULTS
This study included 1150 perinatal decedents identified in the NVDRS: 456 (39.6%) were pregnant at death, 203 (17.7%) were pregnant within 42 days of death, and 491 (42.7%) were pregnant within 43 to 365 days before death, yielding 694 postpartum decedents. The nonperinatal comparison group included 17 655 female decedents aged 10 to 50 years. The mean (SD) age was 29.1 (7.4) years for perinatal decedents and 35.8 (10.8) years for nonperinatal decedents. Compared with matched nonperinatal decedents, perinatal decedents had higher odds of the following identified contributing circumstances: intimate partner problems (IPPs) (odds ratio [OR], 1.45 [95% CI, 1.23-1.72]), recent argument (OR, 1.33 [95% CI, 1.09-1.61]), depressed mood (OR, 1.39 [95% CI, 1.19-1.63]), substance abuse or other abuse (OR, 1.21 [95% CI, 1.03-1.42]), physical health problems (OR, 1.37 [95% CI, 1.09-1.72]), and death of a family member or friend (OR, 1.47 [95% CI, 1.06-2.02]). The findings of the qualitative analysis emphasized the importance of mental health and identified 128 decedents (12.4%) with postpartum depression.
CONCLUSIONS AND RELEVANCE
This study provides insights into complex factors surrounding maternal suicide, and it highlights opportunities for further research to understand long-term consequences of perinatal mental health. These findings also underscore the need for targeted evidence-based interventions and effective policies targeting mental health, substance use, and IPPs to prevent maternal suicide and enhance maternal health outcomes.
Topics: Humans; Female; Pregnancy; Cross-Sectional Studies; Adult; Suicide; United States; Adolescent; Middle Aged; Young Adult; Child; Risk Factors; Maternal Mortality; Perinatal Mortality
PubMed: 38935375
DOI: 10.1001/jamanetworkopen.2024.18887 -
Annals of Intensive Care Jun 2024Previous retrospective research has shown that maintaining prone positioning (PP) for an average of 40 h is associated with an increase of survival rates in intubated...
BACKGROUND
Previous retrospective research has shown that maintaining prone positioning (PP) for an average of 40 h is associated with an increase of survival rates in intubated patients with COVID-19-related acute respiratory distress syndrome (ARDS). This study aims to determine whether a cumulative PP duration of more than 32 h during the first 2 days of intensive care unit (ICU) admission is associated with increased survival compared to a cumulative PP duration of 32 h or less.
METHODS
This study is an ancillary analysis from a previous large international observational study involving intubated patients placed in PP in the first 48 h of ICU admission in 149 ICUs across France, Belgium and Switzerland. Given that PP is recommended for a 16-h daily duration, intensive PP was defined as a cumulated duration of more than 32 h during the first 48 h, whereas standard PP was defined as a duration equal to or less than 32 h. Patients were followed-up for 90 days. The primary outcome was mortality at day 60. An Inverse Probability Censoring Weighting (IPCW) Cox model including a target emulation trial method was used to analyze the data.
RESULTS
Out of 2137 intubated patients, 753 were placed in PP during the first 48 h of ICU admission. The intensive PP group (n = 79) had a median PP duration of 36 h, while standard PP group (n = 674) had a median of 16 h during the first 48 h. Sixty-day mortality rate in the intensive PP group was 39.2% compared to 38.7% in the standard PP group (p = 0.93). Twenty-eight-day and 90-day mortality as well as the ventilator-free days until day 28 were similar in both groups. After IPCW, there was no significant difference in mortality at day 60 between the two-study groups (HR 0.95 [0.52-1.74], p = 0.87 and HR 1.1 [0.77-1.57], p = 0.61 in complete case analysis or in multiple imputation analysis, respectively).
CONCLUSIONS
This secondary analysis of a large multicenter European cohort of intubated patients with ARDS due to COVID-19 found that intensive PP during the first 48 h did not provide a survival benefit compared to standard PP.
PubMed: 38935175
DOI: 10.1186/s13613-024-01340-z -
Annals of Intensive Care Jun 2024EEG reactivity is a predictor for neurological outcome in comatose patients after cardiac arrest (CA); however, its application is limited by variability in stimulus...
BACKGROUND
EEG reactivity is a predictor for neurological outcome in comatose patients after cardiac arrest (CA); however, its application is limited by variability in stimulus types and visual assessment. We aimed to evaluate the prognostic value of the quantitative analysis of EEG reactivity induced by standardized electrical stimulation and for early prognostication in this population.
METHODS
This prospective observational study recruited post-CA comatose patients in Xuanwu Hospital, Capital Medical University (Beijing, China) between January 2016 and June 2023. EEG reactivity to electrical or traditional pain stimulation was randomly performed via visual and quantitative analysis. Neurological outcome within 6 months was dichotomized as good (Cerebral Performance Categories, CPC 1-2) or poor (CPC 3-5).
RESULTS
Fifty-eight post-CA comatose patients were admitted, and 52 patients were included in the final analysis, of which 19 (36.5%) had good outcomes. EEG reactivity induced with the electrical stimulation had superior performance to the traditional pain stimulation for good outcome prediction (quantitative analysis: AUC 0.932 vs. 0.849, p = 0.048). When using the electrical stimulation, the AUC of EEG reactivity to predict good outcome by visual analysis was 0.838, increasing to 0.932 by quantitative analysis (p = 0.039). Comparing to the traditional pain stimulation by visual analysis, the AUC of EEG reactivity for good prognostication by the electrical stimulation with quantitative analysis was significantly improved (0.932 vs. 0.770, p = 0.004).
CONCLUSIONS
EEG reactivity induced by the standardized electrical stimulation in combination with quantitative analysis is a promising formula for post-CA comatose patients, with increased predictive accuracy.
PubMed: 38935167
DOI: 10.1186/s13613-024-01339-6 -
Journal of the American Heart... Jun 2024Anterior-posterior electrode placement is preferred in electrical cardioversion of atrial fibrillation. However, the optimal anterior-posterior electrode position in...
BACKGROUND
Anterior-posterior electrode placement is preferred in electrical cardioversion of atrial fibrillation. However, the optimal anterior-posterior electrode position in relation to the heart is not studied.
METHODS AND RESULTS
We performed a prospective observational study on patients presenting for cardioversion of atrial fibrillation. Electrodes were placed in the anterior-posterior position and shock was delivered in a step-up approach (100 J→200 J→360 J). Fluoroscopic images were obtained, and distances were measured from points A, midanterior electrode; and B, midposterior electrode, to midpoint of the cardiac silhouette. Patients requiring one 100 J shock for cardioversion success (group I) were compared with those requiring >1 shock/100 J (group II). Logistic regression was used to determine the impact of electrode distance on low energy (100 J) cardioversion success. Computed tomography scans from this cohort were analyzed for anatomic landmark correlation to the cardiac silhouette. Of the 87 patients included, 54 (62%) comprised group I and 33 (38%) group II. Group I had significantly lower distances from the mid-cardiac silhouette to points A (5.0±2.4 versus 7.4±3.3 cm; <0.001) and B (7.3±3.0 versus 10.0±3.8 cm; =0.002) compared with group II. On multivariate analysis, higher distances from the mid-cardiac silhouette to point A (odds ratio, 1.33 [95% CI, 1.07-1.70]; =0.01) and B (odds rsatio, 1.24 [95% CI, 1.05-1.50]; =0.01) were independent predictors of low energy (100 J) cardioversion failure. Based on review of computed tomography scans, we suggest that the xiphoid process may be an easy landmark to guide proximity to the myocardium.
CONCLUSIONS
In anterior-posterior electrode placement, closer proximity to the cardiac silhouette predicts successful 100 J cardioversion irrespective of clinical factors.
PubMed: 38934869
DOI: 10.1161/JAHA.123.034817 -
Journal of the American Heart... Jun 2024We aimed to clarify the predictive value of cerebral small-vessel disease and intracranial large artery disease (LAD) observed in magnetic resonance imaging of the brain...
Small-Vessel Disease and Intracranial Large Artery Disease in Brain MRI Predict Dementia and Acute Coronary Syndrome, Respectively: A Prospective, Observational Study in the Population at High Vascular Risk.
BACKGROUND
We aimed to clarify the predictive value of cerebral small-vessel disease and intracranial large artery disease (LAD) observed in magnetic resonance imaging of the brain and magnetic resonance angiography on future vascular events and cognitive impairment.
METHODS AND RESULTS
Data were derived from a Japanese cohort with evidence of cerebral vessel disease on magnetic resonance imaging. This study included 862 participants who underwent magnetic resonance angiography after excluding patients with a modified Rankin Scale score >1 and Mini-Mental State Examination score <24. We evaluated small-vessel disease such as white matter hyperintensities and lacunes in magnetic resonance imaging and LAD with magnetic resonance angiography. Outcomes were incident stroke, dementia, acute coronary syndrome, and all-cause death. Over a median follow-up period of 4.5 years, 54 incident stroke, 39 cases of dementia, and 27 cases of acute coronary syndrome were documented. Both small-vessel disease (white matter hyperintensities and lacunes) and LAD were associated with stroke; however, only white matter hyperintensities were related to dementia. In contrast, only LAD was associated with acute coronary syndrome. Among the 357 patients with no prior history of stroke, coronary or peripheral artery disease, or atrial fibrillation, white matter hyperintensities emerged as the sole predictor of future stroke and dementia, while LAD was the sole predictor of acute coronary syndrome.
CONCLUSIONS
Among cerebral vessels, small-vessel disease could underlie the cognitive impairment while LAD was associated with coronary artery disease as atherosclerotic vessel disease.
PubMed: 38934848
DOI: 10.1161/JAHA.123.033512 -
Indian Journal of Public Health Oct 2023The Saharia tribe of Madhya Pradesh has a very high tuberculosis (TB) burden. However, there is no report of adverse drug reaction (ADR) available in patients receiving... (Observational Study)
Observational Study
Adverse Drug Reaction Patterns of First-line Anti-tubercular Drugs among Saharia Tuberculosis Patients: An Observational Study in Particularly Vulnerable Tribal Group of Madhya Pradesh, India.
The Saharia tribe of Madhya Pradesh has a very high tuberculosis (TB) burden. However, there is no report of adverse drug reaction (ADR) available in patients receiving anti-TB chemotherapy in the community. Reporting and monitoring of ADRs among TB patients is still rare in marginalized communities. An observational prospective study was performed from November 2019 to June 2020 to assess the patterns of ADRs in 250 Saharia TB patients, who were prescribed Category-I daily DOTS (HRZE) by the physician. Both male and female participants equally experienced ADR during the treatment, but relatively more females (92.6%) than males (88.6%) reported ADR during Phase I. Out of 250 patients, 224 patients (89.6%) experienced one or more ADRs in Phase I. The central nervous system-related (75.6%) ADR was mostly reported followed by any gastrointestinal (74.4%), cardiovascular (49.2%) and any dermatological related (44.4%) ADRs. It is paramount to timely monitor and proactively manages ADRs pertaining to anti-TB drug treatment with minimal alteration in the treatment course.
Topics: Humans; India; Male; Female; Antitubercular Agents; Adult; Prospective Studies; Middle Aged; Tuberculosis; Drug-Related Side Effects and Adverse Reactions; Adolescent; Young Adult; Directly Observed Therapy; Aged
PubMed: 38934815
DOI: 10.4103/ijph.ijph_865_22