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Regional versus general anesthesia for total hip and knee arthroplasty: a nationwide retrospective cohort study

Reg Anesth Pain Med. 2024 Apr 30:rapm-2024-105440. doi: 10.1136/rapm-2024-105440. Online ahead of print.

ABSTRACT

INTRODUCTION: We aimed to determine whether regional anesthesia (RA) has any advantages over general anesthesia (GA) in total joint arthroplasty (TJA) in terms of mortality and postoperative complications.

METHODS: This population-based retrospective cohort study included data of adults who underwent total knee or hip arthroplasty under RA or GA between 2016 and 2021 from the National Health Insurance Service of South Korea. RA included spinal or epidural anesthesia or a combination of both. Endpoints were 30-day mortality, 90-day mortality, and postoperative complications. Propensity score (PS) matching was used for statistical analysis.

RESULTS: We included 517 960 patients (RA, n=380 698; GA, n=137 262) who underwent TJA. After PS matching, 186 590 patients (93 295 in each group) were included in the final analysis. In the logistic regression analyses using the PS-matched cohort, the RA group compared with the GA group showed 31% (OR: 0.69; 95% CI, 0.60 to 0.80; p<0.001) and 22% (OR: 0.78; 95% CI, 0.72 to 0.85; p<0.001) lower 30-day and 90-day mortality rates, respectively. However, the total postoperative complication rate did not differ significantly between the two groups (p=0.105).

CONCLUSION: RA compared with GA was associated with improved 30-day and 90-day survival outcomes in patients who underwent TJA. However, the postoperative complication rate did not differ significantly. Therefore, our results should be interpreted with caution, and more well-designed future studies are needed to clarify the most appropriate type of anesthesia for TJA.

PMID:38688686 | DOI:10.1136/rapm-2024-105440

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Do athletic ECG changes predict athletic performance in Gurkha recruits?

BMJ Mil Health. 2024 Apr 30:e002576. doi: 10.1136/military-2023-002576. Online ahead of print.

ABSTRACT

INTRODUCTION: ECG changes are associated with regular long-term intensive exercise due to electrical manifestations of increased vagal tone, increased ventricular wall thickness and enlarged chamber size. The aim of this study was to further understand the relationship of athletic ECG changes and athletic performance in an athletic population.

METHODS: A retrospective cohort study was performed in 195 Nepali civilian males undergoing selection to the Gurkhas. V̇O2max (maximal oxygen consumption) was estimated from a 1.5-mile run time using Cooper’s formula and correlated with athletic ECG adaptations. Variables were explored with univariable and multivariable linear regression.

RESULTS: The median number of athletic changes on ECG was 2 (IQR 1-2). There was no significant correlation (p=0.46) between the number of ECG adaptations and the degree of cardiovascular fitness by estimated V̇O2max (estV̇O2max). We found a negligible but significant correlation between the presence of inferior T wave inversion (TWI) and estV̇O2max (R2=0.03, p=0.02). The multivariable-fitted regression model was: estV̇O2max~Intercept+presence of RVH (right ventricular hypertrophy) voltage criteria+absence of sinus arrhythmia+T wave axis+inferior TWI. The overall regression was statistically significant: R2=0.10, F(df=4, df=189)=[5.4], p=0.0004). All variables in the multivariable model significantly predicted estV̇O2max (p<0.04).

CONCLUSION: ECG changes of athleticism negligibly predict and differentiate athletic performance in our athletic population. The most predictive ECG markers being voltage criteria for left ventricular hypertrophy and RVH. Markers of increased vagal tone were not predictive. TWI, being a marker for disease, was also a marker for athletic performance in this cohort. The number of athletic ECG adaptations did not predict increased athletic performance.

PMID:38688679 | DOI:10.1136/military-2023-002576

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Relation between pre-existing quality management measures and prevention and containment of COVID-19 outbreaks in 159 nursing homes in Tuscany: a mixed methods study

BMJ Open Qual. 2024 Apr 30;13(2):e002560. doi: 10.1136/bmjoq-2023-002560.

ABSTRACT

BACKGROUND: Nursing homes were often the focus of COVID-19 outbreaks. Many factors are known to influence the ability of a nursing home to prevent and contain a COVID-19 outbreak. The role of an organisation’s quality management prior to the pandemic is not yet clear. In the Italian region of Tuscany nursing home performance indicators have been regularly collected since before the pandemic, providing the opportunity to better understand this relationship.

OBJECTIVES: To test if there is a difference in the results achieved by nursing homes in Tuscany on 13 quality management indicators, when grouped by severity of COVID-19 outbreaks; and to better understand how these indicators may be related to the ability to control COVID-19 outbreaks, from the perspective of nursing homes.

METHODS: We used a mixed methods sequential explanatory design. Based on regional and national databases, 159 nursing homes in Tuscany were divided into four groups by outbreak severity. We tested the significance of the differences between the groups with respect to 13 quality management indicators. The potential relation of these indicators to COVID-19 outbreaks was discussed with 29 managers and other nursing homes’ staff through four group interviews.

RESULTS: The quantitative analysis showed significant differences between the groups of nursing homes for 3 of the 13 indicators. From the perspective of nursing homes, the indicators might not be good at capturing important aspects of the ability to control COVID-19 outbreaks. For example, while staffing availability is seen as essential, the staff-to-bed ratio does not capture the turn-over of staff and temporary absences due to positive COVID-19 testing of staff.

CONCLUSIONS: Though currently collected indicators are key for overall performance monitoring and improvement, further refinement of the set of quality management indicators is needed to clarify the relationship with nursing homes’ ability to control COVID-19 outbreaks.

PMID:38688676 | DOI:10.1136/bmjoq-2023-002560

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Repurposing of dextromethorphan as an adjunct therapy in patients with major depressive disorder: a randomised, group sequential adaptive design, controlled clinical trial protocol

BMJ Open. 2024 Apr 30;14(4):e080500. doi: 10.1136/bmjopen-2023-080500.

ABSTRACT

BACKGROUND: Therapeutic latency, lack of efficacy and adverse drug reactions are the major concerns in current antidepressant therapies. To overcome these treatment hurdles, add-on therapy to conventional antidepressant medications may lead to better therapeutic outcomes. The present randomised controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD).

METHODS AND ANALYSIS: A randomised, double-blind, add-on, placebo-controlled, group sequential design clinical trial will be conducted on patients with MDD who will be randomly assigned to the control and the test group in a 1:1 ratio. Patients in the test group will get dextromethorphan 30 mg once daily, whereas patients in the control group will receive a placebo once daily as an add-on to ongoing SSRI treatment for 8 weeks. All patients will be evaluated for the primary outcome (change in the Montgomery-Åsberg Depression Rating Scale score) and secondary outcomes (treatment response rate, remission rate, Clinical Global Impression, serum brain-derived neurotrophic factor, serum dextromethorphan and treatment-emergent adverse events) over the period of 8 weeks. Intention-to-treat analysis will be done for all parameters using suitable statistical tools.

ETHICS AND DISSEMINATION: This study was approved by the Institutional Ethics Committee of All India Institute of Medical Sciences, Bhubaneswar, India, and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s ethical guidelines for biomedical research on human subjects (2017). Written informed consent will be obtained from the participants before recruitment. The results of this study will be published in peer-reviewed publications.

TRIAL REGISTRATION NUMBER: NCT05181527.

PMID:38688675 | DOI:10.1136/bmjopen-2023-080500

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Life skills and reproductive health empowerment intervention for newly married women and their families to reduce unintended pregnancy in India: protocol for the TARANG cluster randomised controlled trial

BMJ Open. 2024 Apr 30;14(4):e086778. doi: 10.1136/bmjopen-2024-086778.

ABSTRACT

INTRODUCTION: In South Asia, younger women have high rates of unmet need for family planning and low empowerment. Life skills interventions can equip young women with agency, but the effectiveness of these interventions in reproductive and sexual autonomy and contraception has not been examined.

METHODS AND ANALYSIS: A two-arm, parallel, cluster randomised controlled trial will evaluate the impact of TARANG (Transforming Actions for Reaching and Nurturing Gender Equity and Empowerment), a life skills and reproductive health empowerment group-based intervention for newly married women, compared with usual services in the community in rural and tribal Rajasthan, India. TARANG will also provide light-touch sessions to husbands and mothers-in-law of newly married women. We will test the impact of TARANG in 80 village clusters among 800 eligible households comprising newly married women aged 18-25 years who are at risk of pregnancy but do not want a pregnancy within 1 year at the time of enrolment, their husbands and mothers-in-law who consent to participate. Women in the intervention villages will receive 14 sessions over a 6-month period, while husbands and mothers-in-law will receive 1 and 4 sessions (respectively) each. Three rounds of surveys will be collected over 18 months. Control villages will receive the intervention after the endline surveys. Primary outcomes include rate of unintended pregnancy and modern contraceptive use. We plan to start recruitment of participants and data collection in April 2024. We will estimate unadjusted and adjusted intention-to-treat effects using survival analysis and mixed models.

ETHICS AND DISSEMINATION: Study protocols have been reviewed and approved by the human subjects review boards at the University of California, San Francisco, and the Centre for Media Studies, India (IRB00006230) and ACE Independent Ethics Committee, Bangalore (NET0062022). Results will be disseminated in international peer-reviewed journals and conferences, to stakeholders including local government and non-governmental organisations, and directly to the communities and individuals that participated in the intervention.

TRIAL REGISTRATION NUMBER: NCT06024616.

PMID:38688674 | DOI:10.1136/bmjopen-2024-086778

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Social inequality in prevalence of NCD risk factors: a cross-sectional analysis from the population-based Tromsø Study 2015-2016

BMJ Open. 2024 Apr 30;14(4):e080611. doi: 10.1136/bmjopen-2023-080611.

ABSTRACT

OBJECTIVE: We aimed to examine associations between educational level, serving as an indicator of socioeconomic position, and prevalence of WHO-established leading behavioural and biological risk factors for non-communicable diseases (NCDs), in middle-aged to older women and men.

DESIGN: Population-based cross-sectional study.

SETTING: All inhabitants of the municipality of Tromsø, Norway, aged ≥40 years, were invited to the seventh survey (2015-2016) of the Tromsø Study; an ongoing population-based cohort study.

PARTICIPANTS: Of the 32 591 invited; 65% attended, and a total of 21 069 women (53%) and men aged 40-99 years were included in our study.

OUTCOME MEASURES: We assessed associations between educational level and NCD behavioural and biological risk factors: daily smoking, physical inactivity (sedentary in leisure time), insufficient fruit/vegetable intake (<5 units/day), harmful alcohol use (>10 g/day in women, >20 g/day in men), hypertension, obesity, intermediate hyperglycaemia and hypercholesterolaemia. These were expressed as odds ratios (OR) per unit decrease in educational level, with 95% CIs, in women and men.

RESULTS: In women (results were not significantly different in men), we observed statistically significant associations between lower educational levels and higher odds of daily smoking (OR 1.69; 95% CI 1.60 to 1.78), physical inactivity (OR 1.38; 95% CI 1.31 to 1.46), insufficient fruit/vegetable intake (OR 1.54, 95% CI 1.43 to 1.66), hypertension (OR 1.25; 95% CI 1.20 to 1.30), obesity (OR 1.23; 95% CI 1.18 to 1.29), intermediate hyperglycaemia (OR 1.12; 95% CI 1.06 to 1.19), and hypercholesterolaemia (OR 1.07; 95% CI 1.03 to 1.12), and lower odds of harmful alcohol use (OR 0.75; 95% CI 0.72 to 0.78).

CONCLUSION: We found statistically significant educational gradients in women and men for all WHO-established leading NCD risk factors within a Nordic middle-aged to older general population. The prevalence of all risk factors increased at lower educational levels, except for harmful alcohol use, which increased at higher educational levels.

PMID:38688673 | DOI:10.1136/bmjopen-2023-080611

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Appropriateness of prescribing profiles and intake adherence to non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: analysis of a retrospective longitudinal study using real-world data from Northern Portugal (AF-React Study)

BMJ Open. 2024 Apr 30;14(4):e076108. doi: 10.1136/bmjopen-2023-076108.

ABSTRACT

OBJECTIVES: This study aimed to assess the appropriateness of prescribing profiles and intake adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF).

DESIGN: Retrospective longitudinal study.

SETTING: The study was conducted in the Regional Health Administration of Northern Portugal.

PARTICIPANTS: The authors selected a database of 21 854 patients with prescriptions for NOACs between January 2016 and December 2018 and were classified with AF until December 2018.

OUTCOME MEASURES: The appropriate dosage of NOAC for patients with AF divided into three categories: contraindicated, inconsistent and consistent, based on the 2020 European Society of Cardiology guidelines for AF.

RESULTS: Dabigatran had a lower percentage of guideline-consistent doses (n=1657, 50.1%) than other drugs such as rivaroxaban (n=4737, 81.6%), apixaban (n=3830, 78.7%) and edoxaban (n=436, 82.1%). Most patients with an inconsistent dose were prescribed a lower dose than recommended based on their glomerular filtration rate (GFR). Among patients younger than 75 years with GFR >60 mL/min, 59.8% (n=10 028) had an adequate GFR range, while 27.8% (n=7166) of GFR measurements from patients older than 75 years old and 29.4% (n=913) of GFR measurements from patients younger than 75 years with GFR <60 mL/min were within an adequate time range. Adherence to NOACs varied across different drugs, with 59.1% (n=540) adhering to edoxaban, 56.3% (n=5443) to rivaroxaban, 55.3% (n=3143) to dabigatran and 53.3% (n=4211) to apixaban.

CONCLUSIONS: Dabigatran had the lowest percentage of guideline-consistent doses. Patients younger than 75 years with GFR >60 mL/min had the highest percentage with an adequate GFR range, while other groups who require closer GFR monitoring had lower percentages within an adequate GFR range. Adherence to NOACs differed among different drugs, with greater adherence to treatment with edoxaban and less adherence to apixaban.

PMID:38688672 | DOI:10.1136/bmjopen-2023-076108

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Effect of visual impairment on subjective cognitive decline in older adults: a cross-sectional study in China

BMJ Open. 2024 Apr 30;14(4):e072626. doi: 10.1136/bmjopen-2023-072626.

ABSTRACT

OBJECTIVE: People with visual impairment have more functional limitations associated with subjective cognitive decline (SCD), and those with SCD are extremely susceptible to transitioning to irreversible cognitive impairment. This study aimed to explore if visual impairment is a significant predictor of SCD compared with other socioeconomic and health factors associated with SCD.

DESIGN: Cross-sectional study.

SETTING AND PARTICIPANTS: The investigation aimed to assess the factors influencing SCD among 428 participants aged 60 and above in Zhaoyuan, China.

PRIMARY OUTCOME MEASURES: The primary outcome variable was SCD, measured by the Chinese version of SCD questionnaire. Multiple logistic regression and propensity score matching (PSM) were used to analyse the influence of visual impairment on the subjective cognition of the elderly.32.2% of the elderly were experiencing SCD. Older adults with SCD showed a higher prevalence of visual impairment (72.5%) than the elderly without SCD (58.6%) (P=0.006). Multivariate logistic regression analysis showed that bad self-reported health status, lack of physical exercise and visual impairment were the risk factors for SCD in older adults, while more than 9 years of education was a protective factor. In addition, PSM model showed that after eliminating the dominant biases caused by the individual observable heterogeneity of older adults with and without visual impairment, the risk of SCD in the elderly with visual impairment was increased by 13.6%-14.5% and the difference was statistically significant (P<0.05).

CONCLUSIONS: It was found that older adults experiencing visual impairments are at an elevated risk of developing SCD compared with their counterparts without such impairments. Additionally, visual impairment remains a significant risk factor for SCD in the elderly, even adjusting for potential biases arising from individual observable heterogeneity.

PMID:38688669 | DOI:10.1136/bmjopen-2023-072626

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Risk of cardiovascular diseases among young adults: a cross-sectional study in Malaysia

BMJ Open. 2024 Apr 30;14(4):e084454. doi: 10.1136/bmjopen-2024-084454.

ABSTRACT

BACKGROUND: Cardiovascular disease (CVD) is the major cause of mortality worldwide. Recent studies showed that there is increasing CVD incidence at younger ages. Therefore, this study aimed to estimate the risk of CVD and its associated factors among young adults.

METHODS: A cross-sectional study was conducted among university students in Selangor, Malaysia, using a self-administered questionnaire along with anthropometric measurements. The sample size was calculated using a single proportion formula. The CVD risk was calculated using the non-laboratory-based Inter-Heart Modifiable Risk Score (IHMRS). Participants aged 18 years and above, with no CVD history, were recruited using a convenience sampling method between February and May 2022. CVD risk was classified as low (scores between 0 and 9 points), moderate (scores between 10 and 15 points) and high (scores between 16 and 48 points). The factors associated with the CVD risk were identified using χ2 analysis.

RESULTS: A total of 241 participants were included in this study. The median age was 28 years and the majority were females (75.1%). The IHMRS revealed that 46.5%, 44.4% and 9% of the respondents have low, moderate and high CVD risk, respectively. The CVD risk associated factors were education, the history of heart attacks among parents, feeling sad or depressed for 2 weeks or more in a row, having several episodes/permanent stress, expose to secondhand smoke and consuming meat and poultry more than two times daily.

CONCLUSIONS: This study found that more than 50% of study participants had moderate to high risk of CVD. Family history and lifestyle factors are the most likely determinants of CVD risk among the young age group. These findings support the development and implementation of targeted prevention programmes as well as provide useful information for action planning and policymaking to curb the disease in the future.

PMID:38688667 | DOI:10.1136/bmjopen-2024-084454

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Time-to-onset Analysis of Rhabdomyolysis due to Different Proton Pump Inhibitors Using a Pharmacovigilance Database

In Vivo. 2024 May-Jun;38(3):1285-1291. doi: 10.21873/invivo.13567.

ABSTRACT

BACKGROUND/AIM: Recent research has increasingly demonstrated an association between proton pump inhibitors (PPIs) and serious adverse events. This study aimed to evaluate the association between PPI and rhabdomyolysis (RM), examining its time-to-onset profiles using the Japanese Adverse Drug Event Report (JADER) database.

PATIENTS AND METHODS: Data spanning from April 2004 to March 2022 were used. The association between PPIs and RM was evaluated using the reporting odds ratio (ROR), adjusted for sex and age. Subsequent analyses were conducted after excluding cases involving concomitant use of statins or fibrates. Furthermore, the onset time of RM and Weibull distribution parameters were calculated to evaluate the expression profile of RM, and the outcomes were examined.

RESULTS: RM was associated with the use of esomeprazole, omeprazole, and rabeprazole, even in the absence of concomitant statin or fibrate use. The median time to RM onset varied among PPIs, ranging from 6.5 to 127 d. The Weibull distribution parameters indicated that the hazard types of nearly all orally administered PPIs were classified as early failure or close to random failure. Regarding outcomes, cases of death were reported for all PPIs except vonoprazan.

CONCLUSION: The findings suggest the need for vigilant monitoring of RM during PPI administration, particularly in the early stages, considering the varying onset times.

PMID:38688634 | DOI:10.21873/invivo.13567