Proportion Of Tests Research Articles

Assessing medical students’ beliefs about the opioid crisis and their post-graduation plans: a cross-sectional study

BackgroundThe number of deaths in the United States attributed to overdose was 70,237 in 2017 and 67,367 in 2018. Approximately 67.7% and 69.5%, respectively, of these deaths involved the use of opioids. Moreover, different specialties of physicians often have different experiences and encounters with people involved with opioids. To investigate medical students’ beliefs about the opioid crisis and their post-graduation plans from two medical schools in the United States.Methods312 students from one medical school with three campuses were surveyed on their experiences, beliefs, and the impacts that the opioid crisis has had on their lives and their medical training. T-tests compared the difference in confidence and expectations to treat people with opioid addiction. Qualitative data was also analyzed from participants’ comments pertaining to the opioid crisis. A proportion test was performed to compare the percentage of students pursuing primary care for those immediately impacted by opioids. P < 0.05 defined statistical significance for all statistical tests performed in this study.ResultsApproximately 39.7% of medical students surveyed were planning to pursue primary care, and 60.3% were planning to pursue any of the other specialties. The two-sample proportion test did not show a statistically significant difference in the percentage of students pursuing primary care for those immediately impacted and those not (P = 0.9, α = 0.05). The t-test comparing the expectation to treat people with opioid addiction did not show a statistically significant difference between students (P = 0.9, α = 0.05). Students wanting to pursue specialties outside of primary care were significantly more confident in treating people with opioid addiction (P < 0.01, α = 0.05).ConclusionThis study was conducted to identify the differences in perspective of medical students planning to pursue varying specialties. The findings of this study show a disparity in confidence levels for treating people with opioid use disorder between specialties. The knowledge gained in this study can help to inform medical school curriculum design to ensure that all students feel confident and prepared to treat those with opioid use disorder.

Reduced left-without-being-seen rates and impact on disparities after guest services ambassadors implementation.

The rate of patients who leave without being seen (LWBS) from an emergency department (ED) is a common measurement of quality, operational efficiency, and patient satisfaction. We hypothesized that adding a nonclinical staff role, guest service ambassadors (GSA), to the ED waiting room would decrease LWBS rates and reduce existing differences by race, ethnicity, sex, and primary language for ED patients. We conducted an observational cohort study at a quaternary care academic ED in the Midwestern United States with approximately 60,000 annual visits between April and December 2022. GSAs were trained to guide patients and visitors through the check-in process and help manage the waiting room. LWBS rates were compared between pre- and postimplementation periods using logistic regression. Using two-sample proportion tests, subgroup analyses were performed to assess differences according to race, ethnicity, sex, and primary language. We analyzed 50,507 ED visits including 9798 during periods of GSA coverage. GSA presence was associated with a reduction in LWBS rate from 3.4% to 2.0% (absolute risk reduction [ARR] of 1.4%, χ2 = 17.357, p < 0.001) with an adjusted odds ratio (OR) of 0.65 (95% confidence interval [CI] 0.49-0.85). There was a greater reduction in LWBS for Black, Indigenous, and people of color (BIPOC) patients compared to White patients (BIPOC ARR 1.8%, 95% CI 0.39%-3.14%; White ARR 1.2%, 95% CI 0.48%-1.94%). There was a reduction in LBWS rates for both males and females (female ARR 1.7%, 95% CI 0.80%-2.63%; male ARR 1.0%, 95% CI 0.06%-1.90%). The reduction in LWBS for patients speaking a language other than English and requiring interpreter services did not meet statistical significance (ARR 1.4%, 95% CI -1.04% to 3.85%). Although some disparities remain, our study suggests that GSAs may provide an effective strategy to reduce the overall LWBS rate and reduce disparities across diverse demographic groups including BIPOC and female patients.

Large language models generating synthetic clinical datasets: a feasibility and comparative analysis with real-world perioperative data

BackgroundClinical data is instrumental to medical research, machine learning (ML) model development, and advancing surgical care, but access is often constrained by privacy regulations and missing data. Synthetic data offers a promising solution to preserve privacy while enabling broader data access. Recent advances in large language models (LLMs) provide an opportunity to generate synthetic data with reduced reliance on domain expertise, computational resources, and pre-training.ObjectiveThis study aims to assess the feasibility of generating realistic tabular clinical data with OpenAI’s GPT-4o using zero-shot prompting, and evaluate the fidelity of LLM-generated data by comparing its statistical properties to the Vital Signs DataBase (VitalDB), a real-world open-source perioperative dataset.MethodsIn Phase 1, GPT-4o was prompted to generate a dataset with qualitative descriptions of 13 clinical parameters. The resultant data was assessed for general errors, plausibility of outputs, and cross-verification of related parameters. In Phase 2, GPT-4o was prompted to generate a dataset using descriptive statistics of the VitalDB dataset. Fidelity was assessed using two-sample t-tests, two-sample proportion tests, and 95% confidence interval (CI) overlap.ResultsIn Phase 1, GPT-4o generated a complete and structured dataset comprising 6,166 case files. The dataset was plausible in range and correctly calculated body mass index for all case files based on respective heights and weights. Statistical comparison between the LLM-generated datasets and VitalDB revealed that Phase 2 data achieved significant fidelity. Phase 2 data demonstrated statistical similarity in 12/13 (92.31%) parameters, whereby no statistically significant differences were observed in 6/6 (100.0%) categorical/binary and 6/7 (85.71%) continuous parameters. Overlap of 95% CIs were observed in 6/7 (85.71%) continuous parameters.ConclusionZero-shot prompting with GPT-4o can generate realistic tabular synthetic datasets, which can replicate key statistical properties of real-world perioperative data. This study highlights the potential of LLMs as a novel and accessible modality for synthetic data generation, which may address critical barriers in clinical data access and eliminate the need for technical expertise, extensive computational resources, and pre-training. Further research is warranted to enhance fidelity and investigate the use of LLMs to amplify and augment datasets, preserve multivariate relationships, and train robust ML models.

A Study on Proportionality

The core of proportionality is about adjusting the rational relationship between means and ends, seeking a balance between benefits and harms. This study discusses the application of Proportionality Analysis (PA), which is a structured test of proportionality created by The German Federal Constitutional Court and now used by almost all the world, from a comparative legal perspective, introducing the sub-tests of proportionality: legitimacy, suitability, necessity, and balancing tests, and illustrates its application through examples from four jurisdictions: Germany, Canada, Taiwan, and Hong Kong. For China, although proportionality is not explicitly included in the constitutional text, it is effectively applied through constitutional interpretation and judicial practice. PA is becoming integrated into China's constitutional review system. With increased emphasis on human rights protection, the application of PA is expected to expand in China.

Prophylactic Laser Retinopexy and Scleral Buckle Placement for Retinal Detachment Prevention in Pierson Syndrome: A Retrospective, Case Series Study.

To report the impact of prophylactic 360° laser retinopexy and scleral buckle placement for retinal detachment (RD) prophylaxis in patients affected by Pierson syndrome (PS). This retrospective case series included 11 PS patients (2015-2024), analyzing demographic data, ophthalmological exams, and genetic testing. Prophylactic interventions were compared with post-RD surgical interventions based on RD occurrence and timing. A one-sample proportion test evaluated outcome differences. This study of 11 PS patients evaluated the effectiveness of prophylactic 360° laser retinopexy and scleral buckle (SB) placement. Ten patients carried the LAMB2 c.440A>G mutation and had associated findings of thyroid and renal disease. All retinal detachments (RDs) were combined tractional retinal detachment (TRD) and rhegmatogenous retinal detachment (RRD) due to posterior tears. Eight eyes with TRD-RRD were actively treated with laser retinopexy and SB; six (75%) experienced re-detachments. In contrast, seven eyes with TRD-RRD were treated prophylactically, with 86.6% of eyes treated with laser retinopexy and 100% of those receiving additional SB placement maintaining retinal integrity over an average follow-up of 3.4 years. Prophylactically treated eyes had significantly fewer RD recurrences compared to those treated surgically after RD onset (p < 0.01), highlighting the benefits of early combined intervention in PS. This study's results suggest a potential role for prophylactic laser retinopexy and subsequent scleral buckle placement to prevent RD among patients with a confirmed diagnosis of Pierson syndrome.

593. Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of the Safety of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine

Abstract Background Better influenza vaccines are needed, not just for seasonal strains but for future pandemic viruses. BPL-1357 is a whole-virus, β-propiolactone-inactivated vaccine containing four wild-type, low-pathogenicity avian influenza viruses (H1N9, H3N8, H5N1, and H7N3). In mice and ferrets, BPL-1357 provided robust protection against challenge with a diverse set of influenza A viruses, including completely heterosubtypic strains. Methods A phase 1, randomized, placebo-controlled, double-blinded, study was performed in volunteers 18 to 55 years of age using a single dose-level of vaccine given twice 28-days apart, either intramuscularly (IM) or intranasally (IN). Forty-five participants were block randomized (1:1:1) to receive IM BPL-1357 and IN placebo (IM group), IM placebo and IN BPL-1357 (IN group), or IM placebo and IN placebo (placebo group). Adverse events (AEs) were solicited using a questionnaire for 7 days after each vaccination and volunteers had medical follow-up for 182 days after the second vaccine (V2D182). Solicited AEs were presented visually as proportions. AEs were compared using tests of proportions at day 28 (V2D28) and V2D182. Results Forty-five participants were enrolled between June 27, 2022 and November 9, 2022 and randomized into each group (n=15,15,15). Two participants (placebo group) delayed or missed their second dose because they developed COVID-19. No serious AEs were observed. Most AEs were mild. Injection site pain was the most common AE, which occurred in 87%/67% of the IM group after each vaccine dose respectively, but only in 33%/0% of the IN group, and 13%/21% of the placebo group. Other AEs, such as fatigue and headache, were similarly observed across the three groups. There was a severe AE possibly related to the IN vaccine (fever 39-40°C) which occurred after the first dose, but not the second. When comparing intervention-related AEs, only injection site pain was found to occur more frequently in the combined IM+IN group relative to placebo. Conclusion BPL-1357 was safe and well-tolerated. Pain at the injection site was commonly seen in the IM group, though was mostly mild. Other AEs were similar in frequency between vaccine and placebo groups. Further work to determine the immunogenicity and efficacy of BPL-1357 is underway. Disclosures All Authors: No reported disclosures

P-1376. Impact of COVID-19 and Mpox on Inpatient Screening of STIs

Abstract Background Sexually transmitted infections (STIs) continue to pose a considerable public health challenge, with a notable uptick in STI rates over the last few years. Access to care, both inpatient and outpatient, was disrupted during COVID-19 with a subsequent increase in STIs reported in many areas, followed by additional strain on services with the emergence of Mpox in Oregon. Abbreviations: sexually transmitted infection (STI) STIs include chlamydia, gonorrhea, syphilis, human immunodeficiency virus (HIV), and hepatitis C Methods We conducted a retrospective cohort of hospitalized patients at the Oregon Health &amp; Science University (OHSU) Internal Medicine and Family Medicine services to evaluate STI screening and diagnoses (including chlamydia, gonorrhea, HIV, HCV and syphilis) across distinct periods: pre-COVID-19 pandemic (1/1/2018-2/29/2020), during the COVID-19 pandemic (3/1/2020-7/31/2022), and amidst the Mpox surge (8/1/2022-3/1/2023). We calculated the proportion screened, percent positivity by time and compared proportions between our pre-designated periods using the two-sample test of equal proportions. Results During the study period, 5802 patients were admitted to OHSU. Most were White (4705, 81.1%), non-Hispanic (5308, 91.5%) and Female sex (3600, 62.1%). In total, 2151 (37%) were screened for one or more STIs. HIV and syphilis were the most frequently screened STIs at 15.0% and 33.1%. The highest proportion of STI screenings were among those 25-44 years at 40.9% with the highest percent positivity in those 55-64 years at 34.0%. There was a statistically significant increase in proportion screened for all STIs (see Table 2), along with percent positivity for syphilis (P&amp;lt;0.01) between pre-COVID-19 and COVID-19 period, however this trend did not consistently continue after emergence of Mpox. Conclusion The proportion of inpatient STI screening is low for patients admitted to internal medicine and family medicine services with percent positivity by age ranging from 5.9-34.0%. We observed an overall increase in proportion screened during the COVID-19 period. Disclosures All Authors: No reported disclosures

P-1194. Comparison of COVID-19 inpatient burden in hospitalized children age &amp;lt; 5 years, by SARS-CoV-2 variant

Abstract Background COVID-19 disease severity has fluctuated with emergence of variants. To investigate disease severity in children, we analyzed clinical resource utilization among children hospitalized for COVID-19 during different variant periods in the United States. Methods We constructed a cohort of children age &amp;lt; 5 years hospitalized for COVID-19 (ICD-10-CM code U07.1 “COVID-19”) using PINC AI Healthcare Data, a hospital-based real world data source from the United States. Hospitalizations in pre-Delta (April - June 2021), Delta (July - December 2021) or Omicron (January 2022 – July 2023) variant periods were included. We examined pre-existing conditions, hospitalization length of stay (LOS), supplemental oxygen (O2), admission to and number of days in the intensive care unit (ICU) and receipt of invasive mechanical ventilation (IMV). P-values for 3-way comparisons were calculated using Chi-square tests for proportions and Kruskal-Wallis for medians. Results Of 10,316 children hospitalized for COVID-19, the majority occurred in the Omicron period (n=7,767, 75%) followed by Delta (2,241; 22%) and pre-Delta (308; 3%) periods (Table 1). The age, sex, race and ethnicity distribution of cases was similar between Delta and Omicron eras. Rheumatologic and other inflammatory conditions were more prevalent during pre-Delta; otherwise, the prevalence of pre-existing health conditions was generally similar across each variant wave (Table 2). Among the following outcomes, there were no significant differences across the variants: supplemental O2 (13% pre-Delta, 16% Delta, 18% Omicron, p = 0.06), LOS (median 2 days), proportion requiring ICU care (20-21%, p = 0.77), days in ICU care (median 1 pre-Delta, 2 Delta and Omicron) and proportion requiring IMV (6-8%, p = 0.35) (Table 3). Deaths were more common in the Delta (0.9%) than pre-Delta (0.7%) or Omicron (0.4%) eras. Conclusion Similar disease severity was observed among children age &amp;lt; 5 years hospitalized for COVID-19 during pre-Delta, Delta and Omicron periods. Although in-hospital death was more common with Delta, Omicron led to increased hospitalizations, highlighting the importance of continued preventative measures to prevent SARS-CoV-2 infection in children, including routine immunization. Disclosures Kathleen M. Andersen, PhD MSc, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds (Public Company) Thomas M. Porter, MPH, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds (Public Company) Maya Reimbaeva, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds (Public Company) Maria McColgan, MD, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds (Public Company) Santiago M.C. Lopez, MD, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds (Public Company)

Concurrent Validity and Reliability of In-Person and Supervised Remote STEADI Fall Risk Assessment in Community-Dwelling Older Adults.

Physical therapists play a vital role in preventing and managing falls in older adults. With advancements in digital health and technology, community fall prevention programs need to adopt valid and reliable telehealth-based assessments. The purpose of this study was to evaluate the validity and reliability of the telehealth-based timed up and go (TUG) test, 30-second chair stand test (30s-CST), and four-stage (4-stage) balance test as functional components of the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) fall risk assessment. This cross-sectional study was conducted using a convenience sample of community-dwelling older adults. The TUG, 30s-CST, and 4-stage balance test were administered in random order in 1 session in the participant's own environment. Performance was scored concurrently by an in-person and synchronous telehealth rater. The video recordings of the performances were scored by an asynchronous telehealth rater on days 1 and 30 for inter- and intra-rater reliability. Additionally, participants performed the TUG test twice, using the distance measured by the participant and the distance measured by the in-person rater. To establish the validity of telehealth-based STEADI fall risk assessments, the Intraclass Correlation Coefficient (ICC), Pearson correlation coefficient, and 95% limits of agreement were derived. Inter- and intra-rater reliability were established by calculating ICC using a 2-way mixed model. Bland-Altman plots were created for nonsignificant proportional bias tests. Thirty community-dwelling older adults participated. Based on the STEADI algorithm, 13 participants were classified as having a moderate fall risk. A comparison of in-person and synchronous telehealth ratings showed excellent ICCs (0.97-0.99) and relationships (r=0.94-0.98). Bland-Altman plots were created for all tests except for the 30s-CST (t=-2.168, P =.04). All tests had good to excellent inter-rater reliability (ICC=0.84-1.00) and intra-rater reliability (0.77-1.00). No adverse events were reported. This study suggests that telehealth-administered functional tests in the STEADI fall risk assessment are valid and reliable when technology, environment, camera view, and angle are optimally managed.

Fear of childbirth and psychiatric disorders decrease the likelihood of subsequent births: a retrospective register-based cohort study

BackgroundMirroring other developed countries globally, the birth rate has decreased in Finland in recent years. The effects of a fear of childbirth (FOC) and psychiatric disorders on the likelihood of having more than one child remain relatively unstudied. This study aims to assess the influence of FOC, psychiatric disorders, and the mode of first delivery on the likelihood of the second birth among primiparous women.MethodsData were collected from the Medical Birth Register, the Hospital Discharge Register, and Statistics Finland census data. We used the t-test to compare continuous variables and the chi-square test or test for relative proportions to compare categorical variables. We calculated the hazard ratios (HRs) and 95% confidence intervals (CIs) using the Cox regression analysis.ResultsAltogether, 317 219 women delivering their first child in 2006–2016 met the inclusion criteria, 216 521 of whom (68.3%) had their second birth during that time. A total of 11 108 (3.5%) of women were diagnosed with FOC during their first pregnancy, 34 381 (10.8%) women were diagnosed with a psychiatric disorder before or during their first pregnancy and 10 331 (3.3%) women received a new diagnosis of a psychiatric condition following the first birth. Between 2006–2021, the second child was born to 47.5% of women with FOC (n = 5276), 56.8% of women with a psychiatric disorder before or during their first pregnancy (n = 19 540), 53.4% of women receiving a psychiatric diagnosis after their first delivery (n = 5514) and 70.2% of women without either of these diagnoses (n = 191 572). Women with FOC had a 22% lower likelihood of the second birth [aHR 0.78 (95% CI 0.76–0.80)] compared to women without FOC. A psychiatric disorder before or during the first pregnancy decreased the likelihood of the second birth by 28% [aHR 0.72 (95% CI 0.71–0.73)] and by 51% (aHR 0.49 (95% CI 0.48–0.50)] with a psychiatric disorder following a first birth compared with women without a diagnosed psychiatric disorder. Among all women, a caesarean section as the mode of a first delivery reduced the likelihood of the second birth.ConclusionFOC and psychiatric disorders are associated with a low birthrate following the first delivery. Caesarean section as the mode of delivery decreases the likelihood of the second birth among women with FOC and psychiatric disorders.

P0622 Total emulsifier intake, but not ultra-processed food consumption is higher in patients with Inflammatory Bowel Disease compared to healthy controls

Abstract Background Ultra-processed food (UPF) intake, which often contains emulsifiers that might affect the intestinal barrier, has been linked to inflammatory bowel disease (IBD) incidence and progression.1 Here, we assessed intake of UPFs, emulsifiers and macronutrients in patients with IBD and healthy controls. Methods Dietary intake was cross-sectionally calculated from Food Frequency Questionnaires (FFQs) and food logs. Two 24-hour dietary recalls in IBD patients attending the infusion unit were compared to two prospective logs from healthy controls from the FOAM study.2 Kruskal Wallis with post-hoc Dunn test was used for continuous data, and Fisher exact test for proportions, with Bonferroni correction for multiple testing. Results We included 186 subjects (Table 1). Assessing food logs, UPF intake was similar in all groups, yet emulsifier intake was higher in UC and CD compared to controls (p=0.03 and p=0.0004, resp). Compared to controls, higher intakes of E402 (UC p=0.02, CD p=0.002), E411 (both p=0.01), E471 (UC p=0.02, CD p=0.0009), as well as carrageenan E407 (UC p=0.001, CD p=0.002), and xanthan gum E415 (UC p=0.03, CD p=0.01) were seen (Fig 1). Intake of E476 was higher in CD compared to controls (p=0.02), while intake of guar gum E412 was higher in UC compared to controls (p=0.02). The proportion of non-consumers of E402 was higher in controls (100%) compared to IBD (CD 83%, UC 67%, p=0.03). Sugar intake was higher in UC (p=0.004) compared to controls. When comparing FFQs, a higher intake of deli meat in CD was seen, compared to UC (p=0.04). Compared to controls, soft drink (UC p=0.0005, CD p=0.001), meat (UC p=0.02, CD p=0.04), and butter intake (UC p=0.03, CD p= 0.005) was higher in IBD. However, intake of breakfast cereals (UC p=6e-13, CD p=1e-10), legumes (UC p=2e-04, CD p=1e-05), meat substitutes (UC 6e-04, CD p=0.02), whole grain pasta and rice (UC p=2e-6, CD p=4e-5), and fibre (UC p=0.01, CD p=0.002) was lower in UC and CD. Coffee (p=0.03), potato (p=0.01), deli meat (p=3e-04), and sodium intake (p=0.02) was higher in CD patients than controls, while nut and seed intake was lower (p=3e-04). For UC, polysaccharide intake was lower in UC than controls (p=0.007). There was no correlation between C-reactive protein and intake of UPFs, emulsifiers, macronutrients or total energy intake (p&amp;gt;0.1). Conclusion We show higher intakes of emulsifiers in patients with IBD compared to controls, while UPF intake was comparable. The concomitant increased intake of specific emulsifiers such as carrageenan and guar gum that have previously been associated with disruption of the intestinal barrier, warrant further investigation into their role in the propagation and maintenance of gut inflammation.

A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV

BackgroundDespite efforts to promote optimal breastfeeding practices, the practice of exclusive breastfeeding is low in South Africa. We conducted a trial to determine whether text messaging plus motivational interviewing prolonged exclusive breastfeeding during the first six months of life and improved child health outcomes.MethodsWe conducted a randomized parallel group-controlled trial between July 2022 and May 2024, at a secondary-level healthcare facility. Mothers living with HIV, 18 years or older, initiating breastfeeding, on combination antiretroviral therapy (cART) and their infants were enrolled. The primary endpoint was exclusive breastfeeding from birth through week 24, based on the consecutive 24-hour food recall interviews. We compared differences in exclusive breastfeeding rates using a proportion test. Mothers who completely stopped breastfeeding were asked an open-ended question on reasons for stopping breastfeeding.ResultsUsing block randomization mother-child pairs (n = 276) were randomly allocated to receive intervention (n = 138) or standard infant feeding counselling (n = 138), of whom 105 and 101 mother-child pairs in the intervention group and standard care group, respectively, completed all four study visits. Exclusive breastfeeding rate at 24 weeks in the intervention group was 6% (6/105) and 7% (7/101) in the standard care group, rate difference − 1% (95% CI -6–4%). Sixty-two of 276 mothers completely stopped breastfeeding, of whom 25% (34/138) and 20% (28) were in the intervention group and standard care group, respectively. The most common reasons for stopping breastfeeding were the mother needing to return to work or look for work, 66% (n = 41). We also found that early breastfeeding cessation increased risk of child hospitalization or death compared to any form of breastfeeding to week 24, 10% (5/48) versus 3% (5/158), p = 0.055.ConclusionsWe found no effect of the intervention on exclusive breastfeeding rates. Early cessation of breastfeeding was prevalent and maternal employment characteristics are important social determinants of breastfeeding behaviour. There is need for further research evaluating the effect of interventions that include financial incentives on breastfeeding practices among socioeconomically disadvantaged mothers. HIV services should reliably offer cART, consistently monitor viral load, and support mothers cART adherence, in settings where mixed feeding is common.Trial registrationThe trial was registered on ClinicalTrials.gov (NCT05063240) and Pan African Clinical Trial Registries (PACTR202110870407786) before recruitment of the first subject.

Effectiveness of HPV vaccination in reducing infection among young Brazilian women

BackgroundGlobally, cervical cancer is an increasing public health issue, and vaccination against HPV has proven to be an effective strategy to reduce this neoplasia. The purpose of this study was to assess the effectiveness of the quadrivalent vaccine in reducing the prevalence and incidence of HPV infection in women, aged 18 to 24 years old, in the cities of Ouro Preto and Mariana, Minas Gerais, Brazil.MethodsA concurrent cohort study was performed, with an initial follow-up of 12 to 18 months. The selected young women were interviewed and divided into two groups: vaccinated and unvaccinated. Participants underwent a Pap smear and cervical sample collection for HPV detection, genotyping performed by PCR-RFLP, type-specific PCR, and using the PapilloCheck®. The prevalence of HPV infection was analyzed using the compare proportions test. Poisson and Cox multivariate regression models were used to estimate vaccine effectiveness.ResultsThere was no significant difference in the overall prevalence of HPV infection between vaccinated and unvaccinated groups (23.6% vs. 18.7%; p = 0.364). However, the prevalence of infection by HPV 6/11, 16 and 18 types in vaccinated young women (1.1%) was lower than in unvaccinated ones (7.5%; p = 0.030). Regarding non-vaccine types, a higher prevalence was identified among vaccinated women (22.5% vs. 11.2%; p = 0.018). The overall incidence of HPV infection was 15.75/100 young women/year in non-immunized women compared to 9.12/100 young women/year among those immunized. The effectiveness of the vaccine was 64.0%, regardless of the viral type, and no vaccinated woman was detected with the specific vaccine HPV-type in follow-up. HPV33/45, related to cross-protection, were detected in 12.3% of vaccinated women and 1.2% of unvaccinated ones (p < 0.001) at baseline. These viral types were identified at follow-up in 2.03/100 young women/year of vaccinated participants and 4.24/100 young women/year of unvaccinated ones.ConclusionsThe results showed that the quadrivalent HPV vaccine was effective in reducing the prevalence of vaccine-type HPV and the incidence of infection by any HPV type. Public health policies must encourage vaccination to prevent HPV infection. However, surveillance of HPV infection should be continued to assess the prevalence of different genotypes and the impact of the vaccination program.

Balancing the right to health and commercial speech: the approach of Argentina's Supreme Court.

Noncommunicable diseases (NCDs) cause significant human and economic costs globally. Each year, 17 million people die from an NCD before age 70. The burden of NCDs is associated with socioenvironmental, cultural factors and social behavior, including modifiable risk factors like tobacco use, unhealthy diets, physical inactivity and alcohol consumption. NCDs can be prevented if healthy environments are guaranteed by the promotion of effective public policies that control the behavior of the tobacco, food and alcohol industries. The regulation of marketing strategies of unhealthy products, and even its ban, has been demonstrated as an effective measure to protect the right to health and promote human rights. However, companies that produce and commercialize these ultra-processed food products argue that protecting measures restricting marketing violate their constitutional right to freedom of speech, among others. Regarding tobacco product marketing activities, the Supreme Court of Justice of Argentina has ruled that it is afforded less constitutional protection than political speech and could be restricted to protect public health and human rights. This article examines the tobacco marketing case and, using an analytical framework argues that the proportionality test used by the Supreme Court could indeed be applied to ultra-processed food products. It is concluded that a complete ban on ultra-processed food product marketing would be constitutionally valid.

Ambiguity in robotic surgical instruction: lessons from remote and in-person simulation.

The rise of robotic surgery has been accompanied by numerous educational challenges as surgeons and trainees learn skills unique to the robotic platform. Remote instruction is a solution to provide surgeons ongoing education when in-person teaching is not feasible. However, surgical instruction faces challenges from unclear communication. We aimed to describe, examine, and compare ambiguities in remote and in-person robotic instruction. We designed a simulation scenario in which a standardized learner performed tasks in robotic surgery while making pre-scripted errors. Instructors provided remote or in-person instruction to the standardized learner. We applied tools from discourse analysis to transcribe sessions, identify instructional instances, classify ambiguities, and select passages for further review. We used tests of proportions to compare ambiguities between the settings. We conducted four simulation sessions, including two remote and two in-person sessions, and identified 206 instructional instances. Within these, we found 964 occurrences of three common semantic ambiguities, or ambiguities arising from words alone. Instructors used visual tools - thus employing multimodality - to clarify semantic ambiguities in 32% of instructional instances. We identified a similar degree of referential ambiguity, or ambiguity for which context from multimodality did not provide clarifying information, during remote (60%) and in-person (48%) instructional instances (p = 0.08). We described, examined, and compared ambiguities in remote and in-person instruction for simulated robotic surgery. Based on the high prevalence of ambiguity in both settings, we recommend that robotic instructors decrease referential ambiguity. To do so, instructors can reduce semantic ambiguity, harness multimodality, or both.

Train-the-Educator: Boosting Knowledge and Confidence for Conducting Substance Use Prevention Education.

School-based substance use prevention is important, yet many educators are not trained in the curriculums. The purpose of this study was to assess changes in educators' knowledge about substances and confidence in delivering drug education before and after participating in educator trainings, as well as overall perceptions of the trainings, for three curriculums: tobacco, cannabis, and all drugs prevention. We conducted one-arm pre-post analyses evaluating educators' changes in knowledge about products and confidence to deliver curriculums. A total of 1064, 648, and 171 educators participated in the trainings and completed surveys (June 2021-November 2023) about drug knowledge (closed-ended, three items for tobacco, five for cannabis), confidence to deliver curriculums (Likert, four items for all trainings), and perceptions of the trainings (open-ended, four items for all trainings). Paired-sample t-tests and McNemar tests of paired proportions were conducted for the matched sample. Two coders double-coded open-ended responses to identify key themes. The training for tobacco was associated with pre-post improvements on all knowledge questions (p's ≤ 0.001). Trainings for all three curriculums were associated with pre-post improvements for all confidence questions (p's < 0.007). Participants qualitatively reported wanting longer trainings with more in-depth content and navigation of materials. Our findings suggest that trainings are a promising method that may improve the knowledge and confidence of educators who deliver drug education curriculums. Educator trainings will likely benefit from detailed content on various substances, interactive activities, and show educators how to tailor curriculums based on their students' specific needs.

Sickle Cell Disease in the Islands of Zanzibar: Patients' Characteristics, Management, and Clinical Outcomes.

This study aimed to describe Sickle Cell Disease (SCD) phenotypes, sociodemographic characteristics, healthcare, and clinical outcomes of patients with SCD attending Mnazi Mmoja Hospital (MMH) in Zanzibar. Individuals who visited MMH between September 2021 and December 2022 and were known or suspected to have SCD were enrolled in the clinic. Sociodemographic characteristics and clinical features were documented, and laboratory tests were performed. A two-sample test of proportions was used to ascertain the significance of differences in the distribution of clinical outcomes between the follow-up visits. A total of 724 patients with SCD were enrolled: 367 (50.7%) were male, and 357 (49.3%) were female. Most patients-713 (98.5%) in total-were homozygous (Hb SS), 9 (1.2%) had the Hb SC phenotype, and 2 (0.3%) had HbS β+ thalassemia. The majority of patients were aged 13 years and below-520 (71.8%) in total-and most did not have health insurance-582 (80.4%) in total. While all patients received folic acid, only a quarter received pneumococcal prophylaxis and hydroxyurea. Attendance at the third visit was associated with a reduced frequency of self-reported episodes of pain (24 patients [4.3%] vs. 11 patients [1.9%]). The population of patients with SCD in Zanzibar mostly comprised children who were Hb SS. Basic care services are still suboptimal, although they are associated with better outcomes when present. Thorough evaluation of SCD prevalence in Zanzibar through newborn screening programs is warranted.

The Significant Effects of Threshold Selection for Advancing Nitrogen Use Efficiency in Whole Genome of Bread Wheat.

Currently in wheat breeding, genome wide association studies (GWAS) have successfully revealed the genetic basis of complex traits such as nitrogen use efficiency (NUE) and its biological processes. In the GWAS model, thresholding is common strategy to indicate deviation of expected range of p-value(s), and it can be used to find the distribution of true positive associations under or over of test statistics. Therefore, the threshold plays a critical role to identify reliable and significant associations in wide genome, while the proportion of false positive results is relatively low. The problem of multiple comparisons arises when a statistical analysis involves multiple simultaneous statistical tests, each of them has the potential to be a discovery. There are several ways to address this problem, including the family-wise error rate and false discovery rate (FDR), raw and adjusted p-value(s), consideration of threshold coherence and consonance, and the properties of proportional hypothesis tests in the threshold definition. We encountered some limitations in the definition of FDR threshold, particularly in the upper bounds of linear and nonlinear approaches. We emphasize that empirical null distributions based on permutation test can be useful when the assumption of linear or parametric FDR approaches do not hold. Nevertheless, we believe that it is necessary to utilize modern statistical optimization techniques to evaluate the stability and performance of our results and to select significant FDR threshold. By incorporating the neural network algorithm, it is possible to improve the reliability of FDR threshold and increase the probability of identifying true genetic associations while minimizing the risk of false positives in GWAS results.

Analysis of Bilateral and Unilateral Data: A Comparative Review of Model-Based and MLE-Based Methods for the Homogeneity Test of Proportions

In many medical comparative studies, subjects may provide either bilateral or unilateral data. While numerous testing procedures have been proposed for bilateral data that account for the intra-class correlation between paired organs of the same individual, few studies have thoroughly explored combined correlated bilateral and unilateral data. Ma and Wang (2021) introduced three test procedures based on the maximum likelihood estimation (MLE) algorithm for general g groups. In this article, we employ a model-based approach that treats the measurements from both eyes of each subject as repeated observations. We then compare this approach with Ma and Wang’s Score test procedure. Monte Carlo simulations demonstrate that the MLE-based Score test offers certain advantages under specific conditions. However, this model-based method lacks an explicit form for the test statistic, limiting its potential for further development of an exact test.

Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell ComboTM stent vs. Biolimus eluting absorbable polymer coated BioMatrix AlphaTM stent in patients undergoing percutaneous coronary intervention. Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) XI trial: SORT-OUT XI Trial Design.

The biodegradable polymer BioMatrix Alpha™ stent contains biolimus A9 drug which is sirolimus derivative increase in lipophicity. The biodegradable polymer sirolimus eluting Combo™ stent is a dual-therapy sirolimus-eluting and CD34+ antobody coated stent capturing endothelial progenitor cells (EPCs). The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 BioMatrix Alpha ™ stent is noninferior to the biodegradable polymer sirolimus eluting Combo™ stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI). The SORT OUT XI study was a randomized, multicenter, single blinded, all-comer, 2-arm, noninferiority trial comparing the biodegradable polymer biolimus A9 BioMatrix Alpha™ stent to the biodegradable polymer sirolimus eluting Combo™ stent in three Danish University Hospitals in Western Denmark. The composite primary endpoint was target lesion failure (TLF) within 12 months. TLF was defined as composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization. Clinically driven event detection was used and no planned follow up was performed. With a sample size of 1,564 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority with a predetermined noninferiority margin of 2.1%. The trial ran from August 14, 2019 to March 19, 2023. A total of 3141 patients were enrolled and randomized 1:1 to Combo™ stent (n=1,573) and BioMatrix Alpha™ stent (n=1,568). Conclusion The SORT OUT XI trial will assess if the biolimus A9 eluting BioMAtrix Alpha™ stent is noninferior to the dual-therapy Combo™ stent with respect to target lesion failure. (ClinicalTrials.gov NCT03952273).