Tag: statistics

J Neurointerv Surg. 2023 Jun 28:jnis-2023-020170. doi: 10.1136/jnis-2023-020170. Online ahead of print.

ABSTRACT

BACKGROUND: Melphalan, which is poorly soluble at room temperature, is widely used for the treatment of retinoblastoma by selective ophthalmic artery infusion. Evomela, a propylene glycol-free formulation of melphalan with improved solubility and stability, has recently been used as an alternative.To compare the safety and efficacy of Evomela with standard-formulation melphalan (SFM) in the treatment of retinoblastoma by selective ophthalmic artery infusion.

METHODS: We performed a retrospective case-control study of patients with retinoblastoma undergoing selective ophthalmic artery infusion with SFM or Evomela at a single institution. Cycle-specific percent tumor regression (CSPTR) was estimated by comparing photos obtained during pretreatment examination under anesthesia (EUA) with those obtained during post-treatment EUA 3-4 weeks later. CSPTR, ocular salvage rates, complication rates, operation times (unadjusted and adjusted for difficulty of ophthalmic artery catheterization), and intraprocedural dose expiration rates were compared between Evomela- and SFM-treated groups. Univariate and multivariate analyses were performed.

RESULTS: Ninety-seven operations (melphalan: 45; Evomela: 52) for 23 patients with 27 retinoblastomas were studied. The ocular salvage rate was 79% in the SFM-treated group and 69% in the Evomela-treated group. Multivariate regression controlling for tumor grade, patient age, and treatment history revealed no significant differences in ocular salvage rate, CSPTR, complication rates, or operation times. Although the dose expiration rate was higher for the SFM-treated group, the difference was not statistically significant. Notably, there were no ocular or cerebral ischemic complications.

CONCLUSION: Evomela has non-inferior safety and efficacy relative to SFM when used for the treatment of retinoblastoma by selective ophthalmic artery infusion.

PMID:37380354 | DOI:10.1136/jnis-2023-020170

Jpn J Nurs Sci. 2023 Jun 28:e12549. doi: 10.1111/jjns.12549. Online ahead of print.

ABSTRACT

AIM: This study aimed to determine the effect of an attachment-based intervention program (ABIP) on attachment, prenatal expectation and stress levels in pregnant women.

METHODS: This randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The study sample consisted of a total of 154 pregnant women (77 experimental, 77 control) at 28-38 weeks of gestation. The ABIP was applied to the pregnant women in the experimental group for 5-7 days. The ABIP included five interventions: (1) perceiving/counting fetal movements; (2) music therapy; (3) preparation for the baby; (4) writing notes/letters to the baby; and (5) watching images of the fetus/pregnancy.

RESULTS: After the ABIP, pregnant women in the experimental group had higher prenatal maternal attachment and prenatal positive expectation mean scores than those in the control group, and the difference between them was statistically significant in favor of those in the experimental group (P < .001). In addition, pregnant women in the experimental group had lower prenatal negative expectation and prenatal distress mean scores than those in the control group, and the difference between them was statistically significant in favor of those in the experimental group (P < .001).

CONCLUSIONS: The results of this study suggest that ABIP is a unique and pioneering program to increase maternal-antenatal attachment and prenatal positive expectations and reducing prenatal negative expectations and distress through diverse interventions. However, further research is required to assess the effectiveness of ABIP on maternal-fetal attachment, prenatal maternal expectations, and prenatal distress.

PMID:37380333 | DOI:10.1111/jjns.12549

Am J Pharm Educ. 2023 Jul;87(7):100086. doi: 10.1016/j.ajpe.2023.100086. Epub 2023 May 9.

ABSTRACT

OBJECTIVE: The objective of the study was to assess the level of pharmacy student well-being during the first 2 years of their didactic education utilizing the Well-being Index (WBI) and 5 Gears assessment.

METHODS: WBI and 5 Gears data were tracked monthly for first- and second-year students enrolled at the Medical University of South Carolina College of Pharmacy from September 2019 to March 2022. Data were collected through monthly RedCap surveys, then de-identified and separated into 4 study cohorts (A-D). Data were analyzed using descriptive statistics.

RESULTS: Responses from 279 students were evaluated. WBI ratings showed variance across the first and second professional years of the program. Students also reported fluctuations in WBI throughout academic years, most often correlating with major events (scheduled breaks, COVID-19 pandemic). Similarly, the 5 Gears assessments results also changed throughout the study period, including variance within and between each academic year.

CONCLUSION: Incorporating well-being assessments into the co-curriculum has allowed us to identify when students are struggling with their well-being, provide tools and resources to help enhance their well-being, and opportunities to discuss struggles with their peers. Colleges of Pharmacy must incorporate holistic approaches to address all aspects of well-being, including consideration of how the curriculum is impacting the student experience as well as institutional approaches to well-being.

PMID:37380261 | DOI:10.1016/j.ajpe.2023.100086

JACC Cardiovasc Interv. 2023 Jun 26;16(12):1448-1459. doi: 10.1016/j.jcin.2023.03.023.

ABSTRACT

BACKGROUND: Little is known regarding the risk of cerebrovascular events (CVE) in patients with heart failure and severe secondary mitral regurgitation treated with transcatheter edge-to-edge repair (TEER).

OBJECTIVES: The study sought to examine the incidence, predictors, timing, and prognostic impact of CVE (stroke or transient ischemic attack) in the COAPT (Cardiovascular Outcomes Assessment of the Mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.

METHODS: A total of 614 patients with heart failure and severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) vs GDMT alone.

RESULTS: At 4-year follow-up, 50 CVEs occurred in 48 (7.8%) of the 614 total patients enrolled in the COAPT trial; Kaplan-Meier event rates were 12.3% in the TEER group and 10.2 in the GDMT alone group (P = 0.91). Within 30 days of randomization, CVE occurred in 2 (0.7%) patients randomized to TEER and 0% randomized to GDMT (P = 0.15). Baseline renal dysfunction and diabetes were independently associated with increased risk of CVE, while baseline anticoagulation was associated with a reduction of CVE. A significant interaction was present between treatment group and anticoagulation such that TEER compared with GDMT alone was associated with a reduced risk of CVE among patients with anticoagulation (adjusted HR: 0.24; 95% CI: 0.08-0.73) compared with an increased risk of CVE in patients without anticoagulation (adjusted HR: 2.27; 95% CI: 1.08-4.81; P_interaction = 0.001). CVE was an independent predictor of death within 30 days after the event (HR: 14.37; 95% CI: 7.61, 27.14; P < 0.0001).

CONCLUSIONS: In the COAPT trial, the 4-year rate of CVE was similar after TEER or GDMT alone. CVE was strongly associated with mortality. Whether anticoagulation is effective at reducing CVE risk after TEER warrants further study. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT); NCT01626079).

PMID:37380226 | DOI:10.1016/j.jcin.2023.03.023

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