Category: Nevin Manimala

BMJ Open. 2023 Jun 28;13(6):e068183. doi: 10.1136/bmjopen-2022-068183.

ABSTRACT

OBJECTIVE: To assess differences in acute ischaemic stroke (AIS) in-hospital mortality between referral stroke hospitals and provide evidence on the association of those differences with the overtime adoption of effective reperfusion therapies.

DESIGN: Retrospective, longitudinal observational study using administrative data for virtually all hospital admissions from 2003 to 2015.

SETTING: Thirty-seven referral stroke hospitals in the Spanish National Health System.

PARTICIPANTS: Patients aged 18 years and older with a hospital episode with an admission diagnosis of AIS in any referral stroke hospital (196 099 admissions). MAIN ENDPOINTS: (1) Hospital variation in 30-day in-hospital mortality measured in terms of the intraclass correlation coefficient (ICC); and (2) the difference in mortality between the hospital of treatment and the trend of utilisation of reperfusion therapies (including intravenous fibrinolysis and endovascular mechanical thrombectomy) in terms of median OR (MOR).

RESULTS: Adjusted 30-day AIS in-hospital mortality decreased over the study period. Adjusted in-hospital mortality after AIS rates varied from 6.66% to 16.01% between hospitals. Beyond differences in patient characteristics, the relative contribution of the hospital of treatment was higher in the case of patients undergoing reperfusion therapies (ICC=0.031 (95% Bayesian credible interval (BCI)=0.017 to 0.057)) than in the case of those who did not (ICC=0.016 (95% BCI=0.010 to 0.026)). Using the MOR, the difference in risk of death was as high as 46% between the hospital with the highest risk and the hospital with the lowest risk of patients undergoing reperfusion therapy (MOR 1.46 (95% BCI 1.32 to 1.68)); in patients not undergoing any reperfusion therapy, the risk was 31% higher (MOR 1.31 (95% BCI 1.24 to 1.41)).

CONCLUSIONS: In the referral stroke hospitals of the Spanish National Health System, the overall adjusted in-hospital mortality decreased between 2003 and 2015. However, between-hospital variations in mortality persisted.

PMID:37380213 | DOI:10.1136/bmjopen-2022-068183

BMJ. 2023 Jun 28;381:e075230. doi: 10.1136/bmj-2023-075230.

ABSTRACT

OBJECTIVE: To investigate whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events.

DESIGN: Randomised, double blind, placebo controlled trial of monthly vitamin D (the D-Health Trial). Computer generated permuted block randomisation was used to allocate treatments.

SETTING: Australia from 2014 to 2020.

PARTICIPANTS: 21 315 participants aged 60-84 years at enrolment. Exclusion criteria were self-reported hypercalcaemia, hyperparathyroidism, kidney stones, osteomalacia, sarcoidosis, taking >500 IU/day supplemental vitamin D, or unable to give consent because of language or cognitive impairment.

INTERVENTION: 60 000 IU/month vitamin D₃ (n=10 662) or placebo (n=10 653) taken orally for up to five years. 16 882 participants completed the intervention period: placebo 8270 (77.6%); vitamin D 8552 (80.2%).

MAIN OUTCOME MEASURES: The main outcome for this analysis was the occurrence of a major cardiovascular event, including myocardial infarction, stroke, and coronary revascularisation, determined through linkage with administrative datasets. Each event was analysed separately as secondary outcomes. Flexible parametric survival models were used to estimate hazard ratios and 95% confidence intervals.

RESULTS: 21 302 people were included in the analysis. The median intervention period was five years. 1336 participants experienced a major cardiovascular event (placebo 699 (6.6%); vitamin D 637 (6.0%)). The rate of major cardiovascular events was lower in the vitamin D group than in the placebo group (hazard ratio 0.91, 95% confidence interval 0.81 to 1.01), especially among those who were taking cardiovascular drugs at baseline (0.84, 0.74 to 0.97; P for interaction=0.12), although the P value for interaction was not significant (<0.05). Overall, the difference in standardised cause specific cumulative incidence at five years was -5.8 events per 1000 participants (95% confidence interval -12.2 to 0.5 per 1000 participants), resulting in a number needed to treat to avoid one major cardiovascular event of 172. The rate of myocardial infarction (hazard ratio 0.81, 95% confidence interval 0.67 to 0.98) and coronary revascularisation (0.89, 0.78 to 1.01) was lower in the vitamin D group, but there was no difference in the rate of stroke (0.99, 0.80 to 1.23).

CONCLUSIONS: Vitamin D supplementation might reduce the incidence of major cardiovascular events, although the absolute risk difference was small and the confidence interval was consistent with a null finding. These findings could prompt further evaluation of the role of vitamin D supplementation, particularly in people taking drugs for prevention or treatment of cardiovascular disease.

TRIAL REGISTRATION: ACTRN12613000743763.

PMID:37380191 | DOI:10.1136/bmj-2023-075230

J Am Vet Med Assoc. 2023 Jun 28:1-7. doi: 10.2460/javma.23.04.0217. Online ahead of print.

ABSTRACT

OBJECTIVE: To estimate the incidence of and identify patient risk factors for an acute adverse event in dogs after administration of a sustained-release injectable heartworm preventive product.

ANIMALS: Canine patients that received the injectable heartworm preventive product during routine preventive care visits.

METHODS: Retrospective analysis of electronic medical records of canine visits within a large network of primary care veterinary clinics in which the product was administered from January 1, 2016, through December 31, 2020. Visits during which vaccination(s) were also administered were excluded from analysis. Identification of acute adverse events was based on diagnostic entries and other clinical presentations suggestive of an adverse event within 3 days of product administration. Data were analyzed using mixed-effects logistic regression.

RESULTS: In the 5-year study period, 1,399,289 visits with 694,030 dogs led to an incidence estimate of approximately 14.3 events/10,000 doses. Regression analysis found younger dogs and 7 breeds (relative to mixed-breed dogs) to have statistically significant greater odds of an event.

CLINICAL RELEVANCE: Understanding of incidence and patient risk factors provides veterinary professionals and dog owners more information when deciding on heartworm preventive options for their dog when considering risk for adverse event in dogs of certain ages or breeds.

PMID:37380165 | DOI:10.2460/javma.23.04.0217

J Arthroplasty. 2023 Jun 26:S0883-5403(23)00674-5. doi: 10.1016/j.arth.2023.06.036. Online ahead of print.

ABSTRACT

BACKGROUND: Patient-reported antibiotic allergy often leads to different prophylactic antibiotic regimens. The aim of the present study was to compare causative bacteria and their antibiotic resistance profiles in patients developing a periprosthetic joint infection (PJI) based on preoperative prophylactic antibiotic regimens in primary total hip (THA) and primary total and unicompartmental knee arthroplasty (TKA/UKA).

METHODS: We reviewed all cases of PJI occurring after primary THA and primary TKA/UKA, between 2011 and 2020 in a tertiary referral hospital. The standard preoperative prophylactic antibiotic for primary joint arthroplasty was cefuroxime and recommended second-line agent was clindamycin. Patients were divided by the replaced joint and analyzed independently. The PJI-causative bacteria and their antibiotic susceptibility were collected from the microbiological database.

RESULTS: In the THA group, culture-positive PJI was detected in 61 of 3,123 (2.0%) cefuroxime-administered cases and 6 of 206 (2.9%) non-cefuroxime-administered cases. In the TKA/UKA group, culture positive PJI was identified in 21 of 2455 (0.9%) cefuroxime-administered cases and in 3 of 211 (1.4%) non-cefuroxime administered cases. The most commonly isolated bacteria in both groups were coagulase negative staphylococci (CNS). There were no statistically significant differences of pathogen spectrum depending on the preoperative antibiotic regimen detected. Antibiotic resistance of isolated bacteria was significantly different in 4 of 27 (14.8%) analyzed antibiotics in THA and in 3 of 22 (13.6%) analyzed antibiotics in TKA/UKA. In all cohorts, a high occurrence of oxacillin-resistant CNS (50.0 to 100.0%) and clindamycin-resistant CNS (56.3 to 100.0%) has been observed.

CONCLUSIONS: The use of the second-line antibiotic did not influence the pathogen spectrum or antibiotic resistance. However, an alarmingly high proportion of CNS strains was resistant to clindamycin.

PMID:37380142 | DOI:10.1016/j.arth.2023.06.036

J Arthroplasty. 2023 Jun 26:S0883-5403(23)00671-X. doi: 10.1016/j.arth.2023.06.033. Online ahead of print.

ABSTRACT

BACKGROUND: Prosthetic joint infection(PJI) is a devastating complication of total hip arthroplasty (THA). This study aimed to determine if the anterior surgical approach (AP) influenced the incidence of early PJI in THA compared to posterior approach (PP).

METHODS: Record linkage was performed between state-wide hospitalization data and a national joint replacement registry to identify unilateral THA performed via the AP or PP. Complete data on 12,605 AP and 25,569 PP THAs were obtained. Propensity score matching (PSM) was undertaken to match covariates between the two approaches. Outcomes were the 90-day PJI hospital readmission rate (using narrow and broad definitions) and 90-day PJI revision rate (defined as component removal or exchange).

RESULTS: The raw PJI readmission rate for AP was lower than PP (0.8 vs 1.1%, respectively). In the PSM analysis, there was no statistically significant difference in PJI readmission rate between approaches using narrow or broad definition of PJI readmission. In terms of revision for infection, both methods showed AP had a significantly lower rate than PP, with an adjusted Odds Ratio (OR) of 0.47 (95% Confidence Interval (CI) 0.30, 0.75) for the 1:1 nearest neighbor method and 0.50 (95%CI 0.32, 0.77) for the subclassification method.

CONCLUSIONS: After addressing known confounders, there was no significant difference in the 90-day hospital readmission rate for hip PJI between approaches. There was a significantly reduced 90-day PJI revision rate for AP. The difference in revision may reflect differences in the surgical management of PJI between hip approaches rather than a difference in the underlying rate of infection.

PMID:37380141 | DOI:10.1016/j.arth.2023.06.033

Arch Phys Med Rehabil. 2023 Jun 26:S0003-9993(23)00364-7. doi: 10.1016/j.apmr.2023.06.007. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate physical activity levels of individuals with ataxia and correlate fitness to ataxia severity.

DESIGN: Observational study SETTING: : Outpatient ataxia clinic in a large, tertiary, urban hospital in the US.

PARTICIPANTS: Individuals with cerebellar ataxia (n=42).

INTERVENTION: Not applicable.

MAIN OUTCOME MEASURE: Participants were classified as sedentary or physically active using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Maximal oxygen consumption (VO₂max) as an indicator of fitness level was measured, and ataxia severity was determined by the Scale for the Assessment and Rating of Ataxia (SARA). Mixed effect models were used to correlate ataxia severity to fitness levels.

RESULTS: Most participants (28 out of 42) lived sedentary lifestyles, and these individuals had poor fitness levels (only 67.3% of their predicted measure). The main barriers to physical activity included lack of energy, lack of time, and fear of falling. There were no differences in age, sex, disease type, disease duration, ataxia severity, fatigue level, and medication use between sedentary and active groups. Measures of VO₂max, maximal work, maximal heart rate, and anerobic threshold demonstrated statistically significant differences between groups whereas maximal respiratory rate and expired ventilation/carbon dioxide production were similar between groups. When adjusting for age, sex, functional mobility status, and disease duration, ataxia severity was inversely correlated with fitness level in the sedentary group. There was no relationship between ataxia severity and fitness level in the fourteen individuals who were physically active.

CONCLUSIONS: Lower fitness levels were associated with more ataxia symptoms in the sedentary group. This relationship was not seen in individuals who were more active. Given the poor health outcomes associated with low fitness, physical activity should be encouraged in this population.

PMID:37380120 | DOI:10.1016/j.apmr.2023.06.007

J Clin Epidemiol. 2023 Jun 26:S0895-4356(23)00160-9. doi: 10.1016/j.jclinepi.2023.06.013. Online ahead of print.

ABSTRACT

OBJECTIVE: To synthesise the current literature on the use of surrogate endpoints, including definitions, acceptability, and limitations of surrogate endpoints, and guidance for their design/reporting, into trial reporting items.

STUDY DESIGN AND SETTING: Literature was identified through searching bibliographic databases (until March 1^st, 2022) and grey literature sources (until May 27^th, 2022). Data were thematically analysed into four categories: (1) definitions, (2) acceptability, (3) limitations and challenges, and (4) guidance, and synthesised into reporting guidance items.

RESULTS: After screening, 90 documents were included: 79% (n=71) had data on definitions, 77% (n=69) on acceptability, 72% (n=65) on limitations and challenges, and 61% (n=55) on guidance. Data were synthesised into 17 potential trial reporting items: explicit statements on the use of surrogate endpoint(s) and justification for their use (items 1-6); methodological considerations, including whether sample size calculations were informed by surrogate validity (items 7-9); reporting of results for composite outcomes containing a surrogate endpoint (item 10); discussion and interpretation of findings (items 11-14); plans for confirmatory studies, collecting data on the surrogate endpoint and target outcome, and data sharing (items 15-16); and informing trial participants about using surrogate endpoints (item 17).

CONCLUSION: The review identified and synthesised items on the use of surrogate endpoints in trials; these will inform the development of the SPIRIT-SURROGATE and CONSORT-SURROGATE extensions.

PMID:37380118 | DOI:10.1016/j.jclinepi.2023.06.013

J Affect Disord. 2023 Jun 26:S0165-0327(23)00796-6. doi: 10.1016/j.jad.2023.06.030. Online ahead of print.

ABSTRACT

OBJECTIVES: Evaluate differences in sustained attention (SAT) and associated neurofunctional profiles between bipolar disorder type I (BD), attention-deficit/hyperactivity disorder (ADHD), and healthy comparison (HC) youth.

METHODS: Adolescent participants, aged 12-17 years, with BD (n = 30) and ADHD (n = 28) and HC adolescents (n = 26) underwent structural and functional magnetic resonance imaging (fMRI) while completing a modified Continuous Performance Task-Identical Pairs task. Attentional load was modifying in this task using three levels of image distortion (0 %, 25 % and 50 % image distortion). Task related fMRI activation and performance measures: perceptual sensitivity index (PSI); response bias (RB) and response time (RT); were calculated and compared between groups.

RESULTS: BD participants displayed lower perceptual sensitivity index (0 % p = 0.012; 25 % p = 0.015; 50 % p = 0.036) and higher values of response bias across levels of distortion (0 % p = 0.002, 25 % p = 0.001, and 50 % p = 0.008) as compared to HC. No statistically significant differences were observed for PSI and RB between BD and ADHD groups. No difference in RT were detected. Between-group and within-group differences in task related fMRI measures were detected in several clusters. In a region of interest (ROI) analysis of these clusters comparing BD and ADHD confirmed differences between these two groups.

CONCLUSIONS: Compared with HC, BD participants displayed SAT deficits. Increased attentional load revealed that BD participants had lower activation in brain regions associated with performance and integration of neural processes in SAT. ROI analysis between BD and ADHD participants shows that the differences were likely not attributable to ADHD comorbidity, suggesting SAT deficits were distinct to the BD group.

PMID:37380109 | DOI:10.1016/j.jad.2023.06.030

J Heart Lung Transplant. 2023 Jun 26:S1053-2498(23)01920-4. doi: 10.1016/j.healun.2023.06.013. Online ahead of print.

ABSTRACT

BACKGROUND: Reasons for women’s increased probability to experience adverse events (AEs) after left ventricular assist device (LVAD) implantation compared with men’s remain uncertain. We explored the role of psychosocial risk in the experience of AEs in women and men.

METHODS: INTERMACS patients receiving a primary continuous-flow LVAD between 7/2006 and 12/2017, median follow-up 13.6 months, were included (n=20123, 21.3% women). Time-to-event was calculated with cumulative incidence functions for 10 types of AEs separately (e.g., infection, device malfunction), each time accounting for the competing outcomes death, heart transplant and device explant due to recovery. Event-specific Cox proportional hazard models were run with a binary psychosocial risk variable (including: substance abuse, psychiatric diagnoses, limited social support, limited cognition, repeated noncompliance), controlled for covariates.

RESULTS: Psychosocial risk was more prevalent in men than in women (21.4% vs. 17.5%, p <.001). Seven out of ten AEs were more likely in women than in men (e.g., infection 44.5% vs. 39.2%, p <.001). The association of psychosocial risk with each AE was either stronger in women than in men (e.g., device malfunction HR_adj 1.29, 95% CI [1.06-1.56] vs. HR_adj 1.10, 95% CI [0.97-1.25]; rehospitalization HR_adj 1.15, 95% CI [1.02-1.29] vs. HR_adj 1.03, 95% CI [0.97-1.10]) or similar between sexes.

CONCLUSIONS: Independent of clinical parameters, the presence of psychosocial risk is associated with increases in AEs. This suggests that early modification of psychosocial risk factors may have the potential to lower the risk for AEs in this patient population.

PMID:37380090 | DOI:10.1016/j.healun.2023.06.013

Am J Prev Med. 2023 Jun 26:S0749-3797(23)00277-5. doi: 10.1016/j.amepre.2023.06.014. Online ahead of print.

ABSTRACT

INTRODUCTION: This study examines the association between prior incarceration and health insurance status and whether living in a state adopting the Affordable Care Act (ACA) Medicaid expansion moderates this relationship.

METHODS: Data are from the National Longitudinal Study of Adolescent to Adult Health (Wave I [1993-1994]; Wave IV [2008] and Wave V [2016-2018]; n = 8,965). Multiple logistic regression with multiplicative interaction terms were performed to assess the relationship between previous incarceration and ACA Medicaid expansion on (a) being insured and (b) being on public health insurance. Analyses were performed in 2023.

RESULTS: Findings demonstrate a positive and statistically significant interaction in the association between previous incarceration and living in a state with ACA Medicaid expansion on having public health insurance (OR = 2.402; 95% CI = 1.257, 4.588).

CONCLUSIONS: The ACA Medicaid expansion was associated with a greater likelihood of public health insurance coverage for formerly incarcerated persons in the United States. These findings suggest that Medicaid expansion could be critical in improving health insurance coverage among formerly incarcerated individuals who are a population that is more likely to be uninsured.

PMID:37380089 | DOI:10.1016/j.amepre.2023.06.014