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Nevin Manimala Statistics

Educational inequalities in hypothermia mortality in the Baltic countries and Finland in 2000-15

Eur J Public Health. 2023 Apr 24:ckad062. doi: 10.1093/eurpub/ckad062. Online ahead of print.

ABSTRACT

BACKGROUND: Despite an increased focus on cold-related mortality in recent years, there has been comparatively little research specifically on hypothermia mortality and its associated factors.

METHODS: Educational inequalities in hypothermia mortality among individuals aged 30-74 in the Baltic countries (Estonia, Latvia, Lithuania) and Finland in 2000-15 were examined using data from longitudinal mortality follow-up studies of population censuses (the Baltics) and from a longitudinal register-based population data file (Finland).

RESULTS: Age-standardized mortality rates (ASMRs) were much higher in the Baltic countries than in Finland across the study period. From 2000-07 to 2008-15, overall ASMRs declined in all countries except among Finnish women. Although a strong educational gradient was observed in hypothermia mortality in all countries in 2000-07, inequalities were larger in the Baltic countries. Between 2000-07 and 2008-15, ASMRs declined in all educational groups except for high-educated women in Finland and low-educated women in Lithuania; the changes however were not always statistically significant. The absolute mortality decline was often larger among the low educated resulting in narrowing absolute inequalities (excepting Lithuania), whereas a larger relative decline among the high educated (excepting Finnish women) resulted in a considerable widening of relative inequalities in hypothermia mortality by 2008-15.

CONCLUSION: Although some reduction was observed in absolute educational inequalities in hypothermia mortality in 2000-15, substantial and widening relative inequalities highlight the need for further action in combatting factors behind deaths from excessive cold in socioeconomically disadvantaged groups, including risky alcohol consumption and homelessness.

PMID:37094965 | DOI:10.1093/eurpub/ckad062

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The effect of sample attrition in the EU Statistics on Income and Living Conditions on the estimates of Eurostat’s Healthy Life Years

Eur J Public Health. 2023 Apr 24:ckad069. doi: 10.1093/eurpub/ckad069. Online ahead of print.

ABSTRACT

Eurostat’s official Healthy Life Years (HLY) estimates are based on European Union Statistics on Income and Living Conditions (EU-SILC) cross-sectional data. As EU-SILC has a rotational sample design, the largest part of the samples are longitudinal, health-related attrition constituting a potential source of bias of these estimates. Bland-Altman plots assessing the agreement between pairs of HLY based on total and new rotational, representative samples demonstrated no significant, systematic attrition-related bias. However, the wide limits of agreement indicate considerable uncertainty, larger than accounted for in the confidence intervals of HLY estimates.

PMID:37094944 | DOI:10.1093/eurpub/ckad069

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Optimal concentration of Lugol’s solution for detecting early esophageal carcinoma: A randomized controlled trial

J Gastroenterol Hepatol. 2023 Apr 24. doi: 10.1111/jgh.16190. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Lugol chromoendoscopy is the standard technique to detect an esophageal squamous cell carcinoma (ESCC). However, a high concentration of Lugol’s solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol’s solution to reduce mucosal injury and adverse events without degrading image quality.

METHODS: This was a two-phase double-blind randomized controlled trial. In phase I, 200 eligible patients underwent esophagogastroduodenoscopy and then were randomly (1:1:1:1:1) sprayed with 1.2%, 1.0%, 0.8%, 0.6%, or 0.4% Lugol’s solution. Image quality, gastric mucosal injury, adverse events, and operation satisfaction were compared to investigate the minimal effective concentration. In phase II, 42 cases of endoscopic mucosectomy for early ESCC were included. The patients were randomly assigned (1:1) to the minimal effective (0.6%) or conventional (1.2%) concentration of Lugol’s solution for further comparison of the effectiveness.

RESULTS: In phase I, the gastric mucosal injury was significantly reduced in 0.6% group (P < 0.05). Furthermore, there was no statistical significance in image quality between 0.6% and higher concentrations of Lugol’s solution (P > 0.05, respectively). It also showed that the operation satisfaction decreased in 1.2% group compared with the lower concentration groups (P < 0.05). In phase II, the complete resection rate was 100% in both groups, while 0.6% Lugol’s solution showed higher operation satisfaction (W = 554.500, P = 0.005).

CONCLUSIONS: The study indicates that 0.6% might be the optimal concentration of Lugol’s solution for early detection and delineation of ESCC, considering minimal mucosal injury and satisfied image. The registry of clinical trials: ClinicalTrials.gov (NCT03180944).

PMID:37094943 | DOI:10.1111/jgh.16190

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Nevin Manimala Statistics

Explaining COVID-19 mortality among immigrants in Sweden from a social determinants of health perspective (COVIS): protocol for a national register-based observational study

BMJ Open. 2023 Apr 24;13(4):e070670. doi: 10.1136/bmjopen-2022-070670.

ABSTRACT

INTRODUCTION: Adopting a social determinants of health perspective, this project aims to study how disproportionate COVID-19 mortality among immigrants in Sweden is associated with social factors operating through differential exposure to the virus (eg, by being more likely to work in high-exposure occupations) and differential effects of infection arising from socially patterned, pre-existing health conditions, differential healthcare seeking and inequitable healthcare provision.

METHODS AND ANALYSIS: This observational study will use health (eg, hospitalisations, deaths) and sociodemographic information (eg, occupation, income, social benefits) from Swedish national registers linked using unique identity numbers. The study population includes all adults registered in Sweden in the year before the start of the pandemic (2019), as well as individuals who immigrated to Sweden or turned 18 years of age after the start of the pandemic (2020). Our analyses will primarily cover the period from 31 January 2020 to 31 December 2022, with updates depending on the progression of the pandemic. We will evaluate COVID-19 mortality differences between foreign-born and Swedish-born individuals by examining each mechanism (differential exposure and effects) separately, while considering potential effect modification by country of birth and socioeconomic factors. Planned statistical modelling techniques include mediation analyses, multilevel models, Poisson regression and event history analyses.

ETHICS AND DISSEMINATION: This project has been granted all necessary ethical permissions from the Swedish Ethical Review Authority (Dnr 2022-0048-01) for accessing and analysing deidentified data. The final outputs will primarily be disseminated as scientific articles published in open-access peer-reviewed international journals, as well as press releases and policy briefs.

PMID:37094903 | DOI:10.1136/bmjopen-2022-070670

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Impact assessment of a raw coal ban on maternal and child health outcomes in Ulaanbaatar: a protocol for an interrupted time series study

BMJ Open. 2023 Apr 24;13(4):e061723. doi: 10.1136/bmjopen-2022-061723.

ABSTRACT

INTRODUCTION: Despite a decade of policy actions, Ulaanbaatar’s residents continue to be exposed to extreme levels of air pollution, a major public health concern, especially for vulnerable populations such as pregnant women and children. In May 2019, the Mongolian government implemented a raw coal ban (RCB), prohibiting distribution and use of raw coal in households and small businesses in Ulaanbaatar. Here, we present the protocol for an interrupted time series (ITS; a strong quasi-experimental study design for public health interventions) that aims to assess the effectiveness of this coal ban policy on environmental (air quality) and health (maternal and child) outcomes.

METHODS AND ANALYSIS: Routinely collected data on pregnancy and child respiratory health outcomes between 2016 and 2022 in Ulaanbaatar will be collected retrospectively from the four main hospitals providing maternal and/or paediatric care as well as the National Statistics Office. Hospital admissions data for childhood diarrhoea, an unrelated outcome to air pollution exposure, will be collected to control for unknown or unmeasured coinciding events. Retrospective air pollution data will be collected from the district weather stations and the US Embassy. An ITS analysis will be conducted to determine the RCB intervention impact on these outcomes. Prior to the ITS, we have proposed an impact model based on a framework of five key factors, which were identified through literature search and qualitative research to potentially influence the intervention impact assessment.

ETHICS AND DISSEMINATION: Ethical approval has been obtained via the Ministry of Health, Mongolia (No.445) and University of Birmingham (ERN_21-1403). To inform relevant stakeholders of our findings, key results will be disseminated on both (inter)national and population levels through publications, scientific conferences and community briefings. These findings are aimed to provide evidence for decision-making in coal pollution mitigation strategies in Mongolia and similar settings throughout the world.

PMID:37094900 | DOI:10.1136/bmjopen-2022-061723

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Multidrug chemotherapy, whole-brain radiation and cytarabine therapy for primary central nervous system lymphoma in elderly patients with dose modification based on geriatric assessment: study protocol for a phase II, multicentre, non-randomised study

BMJ Open. 2023 Apr 24;13(4):e071350. doi: 10.1136/bmjopen-2022-071350.

ABSTRACT

INTRODUCTION: Multidrug chemoimmunotherapy with rituximab, high-dose methotrexate, procarbazine and vincristine (R-MPV) is a standard therapy for younger patients with primary central nervous system lymphoma (PCNSL); however, prospective data regarding its use in elderly patients are lacking. This multi-institutional, non-randomised, phase II trial will assess the efficacy and safety of R-MPV and high-dose cytarabine (HD-AraC) for geriatric patients with newly diagnosed PCNSL.

METHODS AND ANALYSIS: Forty-five elderly patients will be included. If R-MPV does not achieve complete response, the patients will undergo reduced-dose, whole-brain radiotherapy comprising 23.4 Gy/13 fractions, followed by local boost radiotherapy comprising 21.6 Gy/12 fractions. After achieving complete response using R-MPV with or without radiotherapy, the patients will undergo two courses of HD-AraC. All patients will undergo baseline geriatric 8 (G8) assessment before HD-AraC and after three, five and seven R-MPV courses. Patients with screening scores of ≥14 points that decrease to <14 points during subsequent treatment, or those with screening scores <14 points that decrease from the baseline during subsequent treatment are considered unfit for R-MPV/HD-AraC. The primary endpoint is overall survival, and the secondary endpoints are progression-free survival, treatment failure-free survival and frequency of adverse events. The results will guide a later phase III trial and provide information about the utility of a geriatric assessment for defining chemotherapy ineligibility.

ETHICS AND DISSEMINATION: This study complies with the latest Declaration of Helsinki. Written informed consent will be obtained. All participants can quit the study without penalty or impact on treatment. The protocol for the study, statistical analysis plan and informed consent form have been approved by the Certified Review Board at Hiroshima University (CRB6180006) (approval number: CRB2018-0011). The study is ongoing within nine tertiary and two secondary hospitals in Japan. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications.

TRIAL REGISTRATION: jRCTs061180093.

PMID:37094899 | DOI:10.1136/bmjopen-2022-071350

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Does doctors’ personality differ from those of patients, the highly educated and other caring professions? An observational study using two nationally representative Australian surveys

BMJ Open. 2023 Apr 24;13(4):e069850. doi: 10.1136/bmjopen-2022-069850.

ABSTRACT

OBJECTIVES: Personality differences between doctors and patients can affect treatment outcomes. We examine these trait disparities, as well as differences across medical specialities.

DESIGN: Retrospective, observational statistical analysis of secondary data.

SETTING: Data from two data sets that are nationally representative of doctors and the general population in Australia.

PARTICIPANTS: We include 23 358 individuals from a representative survey of the general Australian population (with subgroups of 18 705 patients, 1261 highly educated individuals and 5814 working in caring professions) as well as 19 351 doctors from a representative survey of doctors in Australia (with subgroups of 5844 general practitioners, 1776 person-oriented specialists and 3245 technique-oriented specialists).

MAIN OUTCOME MEASURES: Big Five personality traits and locus of control. Measures are standardised by gender, age and being born overseas and weighted to be representative of their population.

RESULTS: Doctors are significantly more agreeable (a: standardised score -0.12, 95% CIs -0.18 to -0.06), conscientious (c: -0.27 to -0.33 to -0.20), extroverted (e: 0.11, 0.04 to 0.17) and neurotic (n: 0.14, CI 0.08 to 0.20) than the general population (a: -0.38 to -0.42 to -0.34, c: -0.96 to -1.00 to -0.91, e: -0.22 to -0.26 to -0.19, n: -1.01 to -1.03 to -0.98) or patients (a: -0.77 to -0.85 to -0.69, c: -1.27 to -1.36 to -1.19, e: -0.24 to -0.31 to -0.18, n: -0.71 to -0.76 to -0.66). Patients (-0.03 to -0.10 to 0.05) are more open than doctors (-0.30 to -0.36 to -0.23). Doctors have a significantly more external locus of control (0.06, 0.00 to 0.13) than the general population (-0.10 to -0.13 to -0.06) but do not differ from patients (-0.04 to -0.11 to 0.03). There are minor differences in personality traits among doctors with different specialities.

CONCLUSIONS: Several personality traits differ between doctors, the population and patients. Awareness about differences can improve doctor-patient communication and allow patients to understand and comply with treatment recommendations.

PMID:37094898 | DOI:10.1136/bmjopen-2022-069850

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Understanding potential participation barriers to improve trial design and outcomes: clinical trial simulation in palmoplantar pustulosis as a case study

BMJ Open. 2023 Apr 24;13(4):e064159. doi: 10.1136/bmjopen-2022-064159.

ABSTRACT

OBJECTIVES: Evaluate the experiences and perceptions of patients participating in a simulated clinical trial and identify ways to enhance future patient-centric trial designs.

DESIGN: International, multicentre, non-interventional, virtual clinical trial visits with patient debriefs and advisory boards.

SETTING: Virtual clinic visits and accompanying advisory boards.

PARTICIPANTS: Nine patients with palmoplantar pustulosis for simulated trial visits; 14 patients and patient representatives for advisory boards.

MAIN OUTCOME MEASURES: Qualitative responses to trial documentation, visit schedule and logistics, and trial design were collected during patient debriefs. Results were discussed at two virtual advisory board meetings.

RESULTS: Patients identified key barriers to participation and potential difficulties encountered when attending trial visits and completing assessments. They also proposed recommendations to overcome these challenges. Patients recognised the need for comprehensive informed consent forms, but recommended use of non-technical language, brevity and additional support to aid understanding. Other trial documentations should be relevant to the disease and include known efficacy and safety of the study drug. Patients were concerned about receiving placebo, stopping existing medications and being unable to receive the study drug after trial completion; therefore, patients and physicians recommended an open-label extension following trial completion. Trial visits were too numerous (n=20) and too long (3-4 hours each); patients recommended improvements to the design to make best use of their time and reduce unnecessary waiting. They also requested financial and logistical support. Patients expressed a desire for study outcomes that matter to them, related to their ability to undertake normal daily activities and not be a burden to others.

CONCLUSIONS: Simulated trials are an innovative method for assessing trial design and acceptance from a patient-centric perspective, enabling specific improvements to be made prior to trial initiation. Incorporation of recommendations from simulated trials could enhance trial recruitment and retention, and optimise trial outcomes and data quality.

PMID:37094891 | DOI:10.1136/bmjopen-2022-064159

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Self-reported sexually transmitted infections among adolescent girls and young women in Mali: analysis of prevalence and predictors

BMJ Open. 2023 Apr 24;13(4):e069226. doi: 10.1136/bmjopen-2022-069226.

ABSTRACT

OBJECTIVE: To examine the prevalence and predictors of self-reported sexually transmitted infections (SR-STIs) among adolescent girls and young women in Mali.

DESIGN: We performed a cross-sectional analysis of data from the Demographic and Health Survey of Mali, which was conducted in 2018. A weighted sample of 2105 adolescent girls and young women aged 15-24 was included. Percentages were used to summarise the results of the prevalence of SR-STIs. We used a multilevel binary logistic regression analysis to examine the predictors of SR-STIs. The results were presented using an adjusted odds ratio (aOR) with 95% confidence interval (CI). Statistical significance was set at p<0.05.

SETTING: Mali.

PARTICIPANTS: Adolescent girls (15-19 years) and young women (20-24 years).

OUTCOME MEASURE: SR-STIs.

RESULTS: The prevalence of SR-STIs among the adolescent girls and young women was 14.1% (95% CI=12.3 to 16.2). Adolescent girls and young women who had ever tested for HIV, those with one parity, those with multiparity, those with two or more sexual partners, those residing in urban areas, and those exposed to mass media were more likely to self-report STIs. However, those residing in Sikasso and Kidal regions were less likely to report STIs.

CONCLUSION: Our study has shown that SR-STIs are prevalent among adolescent girls and young women in Mali. Health authorities in Mali and other stakeholders should formulate and implement policies and programmes that increase health education among adolescent girls and young women and encourage free and easy access to STI prevention and treatment services.

PMID:37094889 | DOI:10.1136/bmjopen-2022-069226

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Anti-interleukin-17 therapies for moderate/severe psoriasis in clinical practice: effectiveness, safety and association with clinical patient factors

Eur J Hosp Pharm. 2023 Apr 24:ejhpharm-2022-003594. doi: 10.1136/ejhpharm-2022-003594. Online ahead of print.

ABSTRACT

OBJECTIVES: Interleukin-17 (IL-17) contributes to the pathogenesis of psoriasis. Secukinumab, ixekizumab, and brodalumab are monoclonal antibodies anti-IL-17 antibodies, approved for the treatment of moderate/severe plaque psoriasis.The aim of the study was to describe the effectiveness and safety of anti-IL-17 agents in moderate/severe plaque psoriasis in clinical practice. We also analysed anti-IL-17 therapies’ survival, dose adjustment, and clinical patients’ factors associated with their effectiveness and safety.

METHODS: A retrospective, longitudinal study was conducted at a tertiary hospital. We included patients with moderate/severe psoriasis treated with anti-IL-17 agents. The effectiveness was evaluated with Psoriasis Area and Severity Index (PASI) score and safety through the adverse drug reactions (ADRs) collected.

RESULTS: 38 patients were studied (median age=47.4 years, 71.0% male). The mean number of biological therapies that patients received was 2.6, and anti-IL-17 therapy was the first biological therapy for 36.8% of patients. The median years in treatment were 2.5 (95% CI 1.95 to 2.98) for secukinumab, 1.2 (95% CI 0.36 to 1.47) for ixekizumab, and 0.7 (IQR 0.71) for brodalumab. The median PASI score after 6 months of treatment was 0 (IQR 0) and 85.3% of patients achieved a PASI of 90 (84.0% with secukinumab, 87.5% with ixekizumab, and 100% with brodalumab). Dose adjustment was associated with the line of treatment (p=0.034 for naïve patients), age (p=0.044 for younger patients), and concomitant pathologies (p=0.015 without more diseases).24 patients suffered from ADRs, mainly infections of the upper respiratory tract, and there were no statistically significant differences between the three therapies.

CONCLUSIONS: Anti-IL-17 agents constitute an effective treatment for patients with moderate/severe plaque psoriasis and for longer. Dose reductions were associated with fewer lines of treatment, younger patients and absence of concomitant pathologies. ADR were minor and similar among the anti-IL-17.

PMID:37094886 | DOI:10.1136/ejhpharm-2022-003594