Category: Statistics

JAMA Netw Open. 2024 Jul 1;7(7):e2422281. doi: 10.1001/jamanetworkopen.2024.22281.

ABSTRACT

IMPORTANCE: Acute urinary retention (UR) is common, yet variations in diagnosis and management can lead to inappropriate catheterization and harm.

OBJECTIVE: To develop an algorithm for screening and management of UR among adult inpatients.

DESIGN, SETTING, AND PARTICIPANTS: In this mixed-methods study using the RAND/UCLA Appropriateness Method and qualitative interviews, an 11-member multidisciplinary expert panel of nurses and physicians from across the US used a formal multi-round process from March to May 2015 to rate 107 clinical scenarios involving diagnosis and management of adult UR in postoperative and medical inpatients. The panel ratings informed the first algorithm draft. Semistructured interviews were conducted from October 2020 to May 2021 with 33 frontline clinicians-nurses and surgeons from 5 Michigan hospitals-to gather feedback and inform algorithm refinements.

MAIN OUTCOMES AND MEASURES: Panelists categorized scenarios assessing when to use bladder scanners, catheterization at various scanned bladder volumes, and choice of catheterization modalities as appropriate, inappropriate, or uncertain. Next, qualitative methods were used to understand the perceived need, usability, and potential algorithm uses.

RESULTS: The 11-member expert panel (10 men and 1 woman) used the RAND/UCLA Appropriateness Method to develop a UR algorithm including the following: (1) bladder scanners were preferred over catheterization for UR diagnosis in symptomatic patients or starting as soon as 3 hours since last void if asymptomatic, (2) bladder scanner volumes appropriate to prompt catheterization were 300 mL or greater in symptomatic patients and 500 mL or greater in asymptomatic patients, and (3) intermittent was preferred to indwelling catheterization for managing lower bladder volumes. Interview findings were organized into 3 domains (perceived need, feedback on algorithm, and implementation suggestions). The 33 frontline clinicians (9 men and 24 women) who reviewed the algorithm reported that an evidence-based protocol (1) was needed and could be helpful to clinicians, (2) should be simple and graphically appealing to improve rapid clinician review, and (3) should be integrated within the electronic medical record and prominently displayed in hospital units to increase awareness. The draft algorithm was iteratively refined based on stakeholder feedback.

CONCLUSIONS AND RELEVANCE: In this study using a systematic, multidisciplinary, evidence- and expert opinion-based approach, a UR evaluation and catheterization algorithm was developed to improve patient safety by increasing appropriate use of bladder scanners and catheterization. This algorithm addresses the need for practical guidance to manage UR among adult inpatients.

PMID:39012634 | DOI:10.1001/jamanetworkopen.2024.22281

JAMA Netw Open. 2024 Jul 1;7(7):e2422399. doi: 10.1001/jamanetworkopen.2024.22399.

ABSTRACT

IMPORTANCE: Virtual patient-physician communications have increased since 2020 and negatively impacted primary care physician (PCP) well-being. Generative artificial intelligence (GenAI) drafts of patient messages could potentially reduce health care professional (HCP) workload and improve communication quality, but only if the drafts are considered useful.

OBJECTIVES: To assess PCPs’ perceptions of GenAI drafts and to examine linguistic characteristics associated with equity and perceived empathy.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional quality improvement study tested the hypothesis that PCPs’ ratings of GenAI drafts (created using the electronic health record [EHR] standard prompts) would be equivalent to HCP-generated responses on 3 dimensions. The study was conducted at NYU Langone Health using private patient-HCP communications at 3 internal medicine practices piloting GenAI.

EXPOSURES: Randomly assigned patient messages coupled with either an HCP message or the draft GenAI response.

MAIN OUTCOMES AND MEASURES: PCPs rated responses’ information content quality (eg, relevance), using a Likert scale, communication quality (eg, verbosity), using a Likert scale, and whether they would use the draft or start anew (usable vs unusable). Branching logic further probed for empathy, personalization, and professionalism of responses. Computational linguistics methods assessed content differences in HCP vs GenAI responses, focusing on equity and empathy.

RESULTS: A total of 16 PCPs (8 [50.0%] female) reviewed 344 messages (175 GenAI drafted; 169 HCP drafted). Both GenAI and HCP responses were rated favorably. GenAI responses were rated higher for communication style than HCP responses (mean [SD], 3.70 [1.15] vs 3.38 [1.20]; P = .01, U = 12 568.5) but were similar to HCPs on information content (mean [SD], 3.53 [1.26] vs 3.41 [1.27]; P = .37; U = 13 981.0) and usable draft proportion (mean [SD], 0.69 [0.48] vs 0.65 [0.47], P = .49, t = -0.6842). Usable GenAI responses were considered more empathetic than usable HCP responses (32 of 86 [37.2%] vs 13 of 79 [16.5%]; difference, 125.5%), possibly attributable to more subjective (mean [SD], 0.54 [0.16] vs 0.31 [0.23]; P < .001; difference, 74.2%) and positive (mean [SD] polarity, 0.21 [0.14] vs 0.13 [0.25]; P = .02; difference, 61.5%) language; they were also numerically longer (mean [SD] word count, 90.5 [32.0] vs 65.4 [62.6]; difference, 38.4%), but the difference was not statistically significant (P = .07) and more linguistically complex (mean [SD] score, 125.2 [47.8] vs 95.4 [58.8]; P = .002; difference, 31.2%).

CONCLUSIONS: In this cross-sectional study of PCP perceptions of an EHR-integrated GenAI chatbot, GenAI was found to communicate information better and with more empathy than HCPs, highlighting its potential to enhance patient-HCP communication. However, GenAI drafts were less readable than HCPs’, a significant concern for patients with low health or English literacy.

PMID:39012633 | DOI:10.1001/jamanetworkopen.2024.22399

JAMA Netw Open. 2024 Jul 1;7(7):e2422406. doi: 10.1001/jamanetworkopen.2024.22406.

ABSTRACT

IMPORTANCE: Hepatitis C can be cured with direct-acting antivirals (DAAs), but Medicaid programs have implemented fibrosis, sobriety, and prescriber restrictions to control costs. Although restrictions are easing, understanding their association with hepatitis C treatment rates is crucial to inform policies that increase access to lifesaving treatment.

OBJECTIVE: To estimate the association of jurisdictional (50 states and Washington, DC) DAA restrictions and Medicaid expansion with the number of Medicaid recipients with filled prescriptions for DAAs.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used publicly available Medicaid documents and claims data from January 1, 2014, to December 31, 2021, to compare the number of unique Medicaid recipients treated with DAAs in each jurisdiction year with Medicaid expansion status and categories of fibrosis, sobriety, and prescriber restrictions. Medicaid recipients from all 50 states and Washington, DC, during the study period were included. Multilevel Poisson regression was used to estimate the association between Medicaid expansion and DAA restrictive policies on jurisdictional Medicaid DAA prescription fills. Data were analyzed initially from August 15 to November 15, 2023, and subsequently from April 15 to May 9, 2024.

EXPOSURES: Jurisdictional Medicaid expansion status and fibrosis, sobriety, and prescriber DAA restrictions.

MAIN OUTCOMES AND MEASURES: Number of people treated with DAAs per 100 000 Medicaid recipients per year.

RESULTS: A total of 381 373 Medicaid recipients filled DAA prescriptions during the study period (57.3% aged 45-64 years; 58.7% men; 15.2% non-Hispanic Black and 52.2% non-Hispanic White). Medicaid nonexpansion jurisdictions had fewer filled DAA prescriptions per 100 000 Medicaid recipients per year than expansion jurisdictions (38.6 vs 86.6; adjusted relative risk [ARR], 0.56 [95% CI, 0.52-0.61]). Jurisdictions with F3 to F4 (34.0 per 100 000 Medicaid recipients per year; ARR, 0.39 [95% CI, 0.37-0.66]) or F1 to F2 fibrosis restrictions (61.9 per 100 000 Medicaid recipients per year; ARR, 0.62 [95% CI, 0.59-0.66]) had lower treatment rates than jurisdictions without fibrosis restrictions (94.8 per 100 000 Medicaid recipients per year). Compared with no sobriety restrictions (113.5 per 100 000 Medicaid recipients per year), 6 to 12 months of sobriety (38.3 per 100 000 Medicaid recipients per year; ARR, 0.65 [95% CI, 0.61-0.71]) and screening and counseling requirements (84.7 per 100 000 Medicaid recipients per year; ARR, 0.87 [95% CI, 0.83-0.92]) were associated with reduced treatment rates, while 1 to 5 months of sobriety was not statistically significantly different. Compared with no prescriber restrictions (97.8 per 100 000 Medicaid recipients per year), specialist consult restrictions was associated with increased treatment (66.2 per 100 000 Medicaid recipients per year; ARR, 1.05 [95% CI, 1.00-1.10]), while specialist required restrictions were not statistically significant.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, Medicaid nonexpansion status, fibrosis, and sobriety restrictions were associated with a reduction in the number of people with Medicaid who were treated for hepatitis C. Removing DAA restrictions might facilitate treatment of more people diagnosed with hepatitis C.

PMID:39012632 | DOI:10.1001/jamanetworkopen.2024.22406

JAMA Netw Open. 2024 Jul 1;7(7):e2422513. doi: 10.1001/jamanetworkopen.2024.22513.

ABSTRACT

IMPORTANCE: The Ministry of Health, Labour, and Welfare (MHLW) of Japan aggregates human papillomavirus (HPV) vaccination data across Japan for each fiscal year (FY) by age at vaccination. Birth FY (BFY)-specific vaccination coverage remains unknown.

OBJECTIVE: To calculate the BFY-specific vaccination coverage for each FY and the cumulative first-dose coverage for each BFY in Japan, to understand the generation-specific vaccination coverage, and to estimate the cumulative first-dose coverage of each BFY that would be achieved by FY 2028 vs World Health Organization (WHO) targets.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, MHLW-published national age-specific HPV vaccination numbers and demographic data for female individuals were used to calculate the BFY-specific first-dose coverage for each FY and the BFY-specific cumulative first-dose coverage. It was assumed that the BFYs 2007 to 2012 vaccination coverage in FY 2023 to 2028 would remain the same as the vaccination coverage of the same grade in FY 2022 to estimate the cumulative first-dose coverage that would be achieved by FY 2028. Data analysis was performed from December 2023 to January 2024.

EXPOSURE: Two MHLW policy changes were the government’s suspension of proactive recommendation for HPV vaccination in June 2013 and the government’s resumption of proactive recommendation for HPV vaccination in April 2022.

MAIN OUTCOMES AND MEASURES: The primary outcome was generation-specific vaccination coverage among female individuals born in BFYs 1994 to 2010 in FYs 2010 to 2022, calculated using reconfigured published data.

RESULTS: In this study of vaccination data for 9 414 620 female individuals, the generation-specific vaccination coverage was 71.96% for the vaccination generation (BFYs 1994-1999), 4.62% for the vaccine-suspension generation (BFYs 2000-2003), 16.16% for the generation that received information individually (BFYs 2004-2009), and 2.83% for the vaccine-resumed generation (BFY 2010). HPV routine vaccination coverage was extremely low in BFYs 2000 to 2010 (0.84%-25.21%) vs BFYs 1994 to 1999 (53.31%-79.47%). The cumulative first-dose coverage that was estimated to be achieved in the vaccine-resumed generation by FY 2028 plateaued at 43.16%.

CONCLUSIONS AND RELEVANCE: Even after the resumption of MHLW’s proactive recommendations, HPV vaccination coverage has only minimally recovered in Japan. The cumulative first-dose coverage that was estimated to be achieved in the vaccine-resumed generation by FY 2028 is below the WHO target. These findings reveal that stronger cervical cancer control measures are required, particularly for the vaccine-resumed generation, which will plateau at approximately one-half the WHO target values.

PMID:39012629 | DOI:10.1001/jamanetworkopen.2024.22513

Qual Life Res. 2024 Jul 16. doi: 10.1007/s11136-024-03735-8. Online ahead of print.

ABSTRACT

OBJECTIVES: To describe the health-related quality of life (HRQoL), estimate the associated health state utility values (HSUVs) and explore factors associated with HRQoL of patients with anxiety and/or depression in a resource-limited hospital setting.

METHODS: A cross-sectional survey involving 462 participants was conducted in a hospital setting. The Amharic version of the EQ-5D-5 L assessed HRQoL, while the GAD-7 and PHQ-9 measured severity of anxiety and depression symptoms respectively. HSUVs were analysed based on clinical and demographic profiles; mean differences were compared using t-tests and one-way ANOVA; Scheffe’s post hoc comparisons and effect sizes (Cohen’s d statistic) were used to assess the magnitude of group differences. Factors associated with HRQoL were explored using regression analysis.

RESULTS: The mean HSUV was 0.87 (SD = 0.17) and the EQ VAS was 71.4 (SD = 19.1). Patients with both anxiety and depression scored significantly lower (HSUV = 0.83 [0.16], EQ VAS = 64.4 [17.9]) compared to those with either anxiety only (HSUV = 0.88 [0.17], EQ VAS = 75.3 [17.9]) or depression only (HSUV = 0.89 [0.18], EQ VAS 74.4 [19.7]). Males had slightly higher mean scores than females, while those aged 18-35 years demonstrated the highest scores on both the EQ-5D-5 L and EQ VAS. Older age (β=-0.002), higher PHQ-9 scores (β=-0.008) and comorbid hypertension (β=-0.07) associated with lower HSUVs. Lower EQ VAS scores were associated with being female (β=-4.4), having comorbid hypertension (β=-7.4) and higher PHQ-9 scores (β=-0.86), while a positive association was found with having ‘more than enough’ income (β = 11.8).

CONCLUSIONS: Older age, severity or co-diagnosis of anxiety or depression and comorbid conditions were associated with lower HRQoL, highlighting the need for better interventions to improve the HRQoL of patients with anxiety and depression in Ethiopia.

PMID:39012559 | DOI:10.1007/s11136-024-03735-8

J Cancer Educ. 2024 Jul 16. doi: 10.1007/s13187-024-02472-3. Online ahead of print.

ABSTRACT

Breast cancer remains a significant global health challenge, particularly in low- and middle-income countries where disparities in healthcare exacerbate the disease burden. The Breast Cancer Comprehensive Center at the National Cancer Institute, Cairo University, has implemented integrated patient navigation and education programs aimed at enhancing patient outcomes and healthcare quality. This study evaluated the effectiveness of these programs involving 2202 participants over 12 months. The methodology included systematic data collection, material preparation, and the application of tailored educational strategies to facilitate the patient’s journey from diagnosis to treatment. The study utilized three-phased patient navigation assistance to provide comprehensive support. The programs significantly improved patient satisfaction, with over 90% of participants reporting high levels of contentment with the services received. Key improvements included enhanced understanding of breast cancer (including risk factors, symptoms, importance of seeking early care, and treatment options), reduction in patient anxiety, improved treatment adherence, and streamlined diagnostic and treatment processes. Notably, the use of audio-visual educational tools effectively bridged the literacy gap among patients. The integration of patient navigation and education systems at BCCC-NCI has proven to be a highly effective model for improving breast cancer care. This model not only enhances patient understanding and treatment compliance but also facilitates a more efficient healthcare process. The study underscores the potential for replicating this approach in similar healthcare settings globally, suggesting that such integrations can significantly improve cancer care outcomes.

PMID:39012556 | DOI:10.1007/s13187-024-02472-3

Clin Drug Investig. 2024 Jul 16. doi: 10.1007/s40261-024-01382-y. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: The estimated prevalence of atopic dermatitis (AD) among adolescents (12-17 years of age) is about 14.8%. AD compromises sleep quality and may be associated with poor scholastic performance, mood disruptions, low self-esteem, and difficulty in building social relationships. Upadacitinib was recently approved by the European Medicines Agency for the treatment of moderate-to-severe AD in patients aged ≥ 12 years who are candidates for systemic treatment. The aim of this real-world study was to determine the effectiveness in disease control and safety of upadacitinib in adolescents aged 12-17 years with moderate-to-severe AD.

METHODS: This is a retrospective study in adolescents with moderate-to-severe AD treated with upadacitinib 15 mg between July 2022 and February 2024 at six Italian dermatological referral centres. The primary endpoint was to analyse the evolution of the response in terms of absolute Eczema Area and Severity Index (EASI) value, as well as the percentage of patients achieving 75% and 90% improvement in EASI (EASI75 and EASI90) from baseline to weeks (W) 4, 16, 24, and 52. Secondary endpoints included the assessment of treatment efficacy in terms of Numerical Rating Scale (NRS) for pruritus (P-NRS) and sleep (S-NRS), Children’s Dermatology Life Quality Index (c-DLQI), and safety.

RESULTS: Thirty-six patients [males: 18 (50%)] were evaluated. A statistically significant improvement of EASI was observed at each timepoint, as stated by a mean percentage reduction from baseline of 72.2% at W4, 82.7% at W16, of 86.4% at W24 (n = 34) and of 92.7% at W52 (n = 18) (p < 0.0001). At W4, 21/36 (58.3%) achieved EASI75 and 12/36 (33.3%) EASI90. At W16, 29/36 (80.5%) achieved EASI75 and 19/36 (52.8%) EASI90. At W24, 32/34 (94.1%) reached EASI75 and 24/34 (70.6%) EASI90. Finally, at W52 all the assessed patients (n = 18) maintained EASI75 and 14/18 (77.7%) reached EASI90. Likewise, a statistically significant reduction of c-DLQI, P-NRS and S-NRS was observed at each timepoint.

CONCLUSION: Our real-world experience seems to confirm the efficacy and safety of upadacitinib for the long-term treatment of moderate-to-severe AD in adolescents.

PMID:39012535 | DOI:10.1007/s40261-024-01382-y

Environ Sci Pollut Res Int. 2024 Jul 16. doi: 10.1007/s11356-024-34242-5. Online ahead of print.

ABSTRACT

The patterns of the potentially toxic elements (PTEs: Cr, Fe, Ni, Cu, Zn, As, Mo, Pb, Hg) distribution in soils were studied together with the health risk assessment in the area of ore mineralization, past gold activity, and tailing effects of the Sarala gold-ore group located in the Republic of Khakassia, Russia. High PTE concentrations were found in soils with the presence of potential negative impact on human health based on the following: local background investigation, according to statistics; geochemical, environmental, and human health risk calculations; and comparative analysis using international and local reference, such as continental crust, clarke, and permissible concentrations. Sources of PTE soil enrichment and pollution were statistically identified in ascending order of degree: geogenic (local background) < geogenic-technogenic (sites with geological exploration traces – trenches) < technogenic (waste tailings). The main pollutants are Hg and As which showed moderate to significant ecological risk. Negative impact of Cr on soils was found. The pollution degree and toxicity (moderate to significant) of other PTEs increase in the location of ore mineralization zone with exploration trenches and waste tailings. Arsenic poses a carcinogenic risk to adults and children upon contact with polluted soils and non-carcinogenic effect on children in areas affected by tailings and ore mineralization zone. The non-carcinogenic effect of Fe on children was found in soils of all sites. The results provide useful information regarding the studied PTEs and their impact on the environment and human health. Such information can be helpful for the state-level decision-making process when addressing solutions for contaminated areas.

PMID:39012531 | DOI:10.1007/s11356-024-34242-5

Clin Res Cardiol. 2024 Jul 16. doi: 10.1007/s00392-024-02486-3. Online ahead of print.

ABSTRACT

BACKGROUND: Leaflet thrombosis (LT) is a multifaceted and underexplored condition that can manifest following transcatheter aortic valve implantation (TAVI). The objective of this study was to formulate a prediction model based on laboratory assessments and clinical parameters, providing additional guidance and insight into this relatively unexplored aspect of post-TAVI complications.

METHODS: The present study was an observational prospective hypothesis-generating study, including 101 patients who underwent TAVI and a screening for LT (the primary endpoint) by multidetector computed tomography (MDCT). All images were acquired on a third-generation dual-source CT system. Levels of von Willebrand factor (vWF) activity, hemoglobin (Hb), and lactate dehydrogenase (LDH) were measured among other parameters. A predictive score utilizing binary logistic regression, Kaplan-Meier time-to-event analysis, and receiver operating characteristics (ROC) analysis was established.

RESULTS: LT (11 subclinical and 2 clinical) was detected in 13 of 101 patients (13%) after a median time to screening by MDCT of 105 days (IQR, 98-129 days). Elevated levels of vWF activity (> 188%) pre-TAVI, decreased Hb values (< 11.9 g/dL), as well as increased levels of LDH (> 312 U/L) post-TAVI and absence of oral anticoagulation (OAC) were found in patients with subsequent LT formation as compared to patients without LT. The established EFFORT score ranged from – 1 to 3 points, with an increased probability for LT development in patients with ≥ 2 points (85.7% of LT cases) vs < 2 points (14.3% of LT cases; p < 0.001). Achieving an EFFORT score of ≥ 2 points was found to be significantly associated with a 10.8 times higher likelihood of developing an LT (p = 0.001). The EFFORT score has an excellent c-statistic (area under the curve (AUC) = 0.89; 95% CI 0.74-1.00; p = 0.001) and a high negative predictive value (98%).

CONCLUSION: An EFFORT score might be a helpful tool to predict LT development and could be used in risk assessment, if validated in confirmatory studies. Therefore, the score has the potential to guide the stratification of individuals for the planning of subsequent MDCT screenings.

PMID:39012508 | DOI:10.1007/s00392-024-02486-3

Pediatr Surg Int. 2024 Jul 16;40(1):192. doi: 10.1007/s00383-024-05772-3.

ABSTRACT

INTRODUCTION: Trauma is the leading cause of paediatric mortality and morbidity. Stay-home regulations for coronavirus disease 2019 (COVID-19) reportedly changed trauma severity, yet data from Hong Kong were lacking. This study examined Hong Kong’s spectrum of paediatric trauma and addressed knowledge gaps concerning epidemiological changes during COVID-19.

METHODS: Children with traumatic injuries who attended a tertiary trauma centre from January 2010 to March 2022 were included in this retrospective, cross-sectional study. We analysed demographic and clinical data and conducted unadjusted bivariate analyses of injury patterns before and after the pandemic.

RESULTS: In total, 725 children attended the Accident and Emergency Department due to trauma, 585 before and 140 during COVID-19. The male-to-female ratio was 1.84:1. The 90-day trauma-related mortality was 0.7%. The overall Injury Severity Score was 3.52 ± 5.95. The paediatric trauma incidence was similar before and after social-distancing policies (both 5.8 cases monthly). Gender, ISS distribution, intensive care unit stay length, and hospital stay length values were similar (p > 0.05). Trauma call activation (8.4% vs. 5.7%, p = 0.002) and road traffic accidents (10.6% vs. 5.7%, p = 0.009) significantly decreased, yet younger-patient injuries (< 10 years old; 85.7% vs. 71%, p < 0.001), burns (28% vs. 45.7%, p < 0.001), and domestic injuries (65.5% vs. 85.7%, p < 0.001) significantly increased. No significant self-harm, assault, or abuse increases were found.

CONCLUSIONS: The paediatric trauma incidences were similar before and during the pandemic. However, domestic and burn injuries significantly increased, highlighting the importance of injury prevention.

PMID:39012503 | DOI:10.1007/s00383-024-05772-3