One-year Mean Research Articles

Identifying Ontarians with Type 2 Diabetes Mellitus in Administrative Data: A Comparison of Two Case Definitions.

This study compared two previously validated sensitive and specific diabetes case definitions to explore the impact of different classification methods in Ontario ICES administrative data. This study included patients captured by the Ontario Diabetes Database with type 2 diabetes using either the sensitive cohort definition (≥ 2 physician visits for diabetes within 1year or ≥ 1 drug claim for diabetes or ≥ 1 hospitalization with diabetes), or the specific cohort definition (≥ 3 physician visits for diabetes within 1year), between October 1, 2013 to September 30, 2015. Each cohort's demographic and clinical features were described using descriptive analysis. Using sensitive and specific definitions, 1,093,812 and 783,228 patients with type 2 diabetes were identified, respectively. Overall, the demographic and clinical characteristics were similar between cohorts. Patients in the sensitive cohort had mean age of 64.1years and were 52.4% male, compared to 64.8years and 53.6% male in the specific cohort. In the sensitive and specific cohorts respectively, 64.4% and 55.7% of patients reported one-year mean HbA1c of < 7% (53mmol/mol) and 25.3% and 31.5% reported levels between 7.0-8.5% (53-69mmol/mol). Although sample sizes were different between sensitive and specific cohorts, demographic and clinical characteristics were similar.

Does PM 2.5 and PM 10-associated heavy metals affect short-term and long-term survival after out-of-hospital cardiac arrest? Four-year study based on regional registry.

This study aims to investigate the effect of arsenic (As), cadmium (Cd), nickel (Ni) and lead (Pb) suspended on particulate matters (PM) 2.5 and PM 10 taking into account clinical factors on 30-day and one-year survival after out-of-hospital cardiac arrest (OHCA). A retrospective 4-year study that involved patients hospitalized after OHCA. Patients' data were obtained from Emergency Medical Services dispatch cards and the National Health Fund. The concentration of air pollutants was measured by the Environmental Protection Inspectorate in Poland. Among the 948 patients after OHCA, only 225 (23.7%) survived for 30 days, and 153 (16.1%) survived for 1 year. Survivors were more commonly affected by OHCA in urban areas (85 [55.6%] vs. 355 [44.7%]; P=0.013) and had slightly higher one-year mean concentration of As (0.78 vs. 0.77; P=0.01), Cd (0.34 vs. 0.34; P=0.012), and Pb (11.13 vs. 10.20; P=0.015) with no differences in daily mean concentration. Significant differences in mean concentrations of heavy metals and PM 2.5 and PM 10 were observed among different quarters. However, survival analysis revealed no differences in long-term survival between quarters. Heavy metals, PM 2.5, and PM 10 did not affect short-term and long-term survival in multivariable logistic regression. The group of survivors showed slightly higher mean one-year concentrations of As, Cd and Pb, but they also experienced a higher incidence of OHCA in urban areas. There were no differences in long-term survival between patients who suffer OHCA in different quarters. Heavy metals did not independently affect survival.

A Single-Institution 5-Year Retrospective Analysis of Laparoscopic Sleeve Gastrectomy Staple-Line Reinforcement: Bioabsorbable Mesh Versus Oversewing.

Background: Staple-line reinforcement has been used to decrease complications such as staple-line bleeding (SLB) and staple-line leaks (SLLs) in patients undergoing laparoscopic sleeve gastrectomy (SG). There is little data comparing bioabsorbable mesh reinforcement (BMR) with oversewing the staple line (OSL). The aim of our study was to compare BMR with OSL in SG. Materials and Methods: This is a single-institution retrospective analysis comparing risks and benefits of BMR (group a) with those of OSL (group b) for SG staple-line reinforcement between 2015 and 2020. Results: In total, 857 patients were identified. There were 452 (52.74%) in group a and 405 (47.26%) in group b. SLB requiring transfusion occurred in 6 (1.32%) patients in group a and 6 (1.48%) patients in group b, NS (P = .848). Zero SLL was identified in either group. One-year mean direct cost of SG in group a was $7881 compared with $6677 in group b. Conclusion: This retrospective study showed that there was low risk of bleeding or leak with either technique of staple-line reinforcement and there was no significant difference in SLB or leak rate with bioabsorbable mesh versus oversewing. The use of bioabsorbable mesh was more expensive than oversewing.

One-year volume growth of abdominal aortic aneurysms measured by extended field-of-view ultrasound.

Measurement of volume has the potential to detect subtle growth not recognized in the current surveillance paradigm of abdominal aortic aneurysms (AAAs). Currently available three-dimensional ultrasound allows for estimation of AAA volume, but for most patients, the AAA extends beyond the ultrasound field-of-view and only allows visualization of a partial AAA volume. A new extended field-of-view three-dimensional ultrasound protocol (XFoV US) has been found to improve the proportion of patients with visualization of the full AAA volume. To investigate the applicability of the XFoV US protocol in estimating AAA volume growth in follow-up, 86 patients with AAAs were recruited from the surveillance program at a university hospital. All were imaged by XFoV US at baseline and at one-year follow-up. Assessment of full volume, based on visualization of the AAA neck and bifurcation at both baseline and one-year follow-up, was achieved in 67/86 (78%) of patients. One-year mean growth in maximum diameter was 2.8 mm (6%/year), in centerline length 2.9 mm (4%/year), and in volume 15.9 mL (19%/year). In 17/67 (25%) of patients, volume growth was detected in diameter-stable AAAs. Baseline XFoV US volume was associated with one-year AAA volume growth, while, conversely, maximum baseline diameter was not associated with one-year AAA diameter growth. This study concludes that the XFoV US protocol provides a safe and repeatable modality for assessing AAA volume growth, and that AAA volume is a promising predictive measure of AAA growth.

Technique and Early Outcomes for High-Energy Calcaneus Fractures Treated With Staged External Fixation to Combined Open Reduction Internal Fixation and Subtalar Arthrodesis.

(1) To present an effective surgical technique for the treatment of open and high-energy calcaneal fractures with significant soft tissue injuries. (2) To present complications with this technique and to evaluate patient-reported outcomes of staged external fixation followed by delayed reconstruction with open reduction internal fixation (ORIF) and subtalar arthrodesis. Retrospective case series. Level I trauma center. Twelve patients with 13 calcaneus fractures associated with open traumatic wounds (10 patients) or other severe soft tissue injury (ie, fracture blisters) between April 2013 and December 2019. All patients were treated with staged ankle-spanning external fixation and delayed reconstruction with ORIF with subtalar arthrodesis. Patient-Reported Outcomes Measurement Information System (PROMIS) outcomes are presented via the domains of physical function (PF), pain interference (PI), and depression (D) in addition to visual analog score. Complications with the injury and surgical procedure were reported as well. Patients underwent initial stabilization on average 1.3 days (range, 0-12 days) from injury with stage II occurring on average 31.1 days (range, 18-42 days) from external fixation. Mean time to radiographic union was 5.6 months (range, 4-10 months). One-year mean PROMIS outcomes were as follows: PF final average of 37.4 with an average improvement of 12.2 (P < 0.01), PI final average of 62.2 with average improvement of 5.6 (P = 0.01), and D final average of 52.1 with average improvement of 6 (P = 0.12). Mean final visual analog score pain score was 3.6 with an average improvement of 2.25 (P = 0.01). Staged treatment with initial external fixation followed by ORIF and subtalar arthrodesis in the setting of highly comminuted calcaneus fractures with significant soft tissue compromise effectively addresses both bony and soft tissue concerns while providing for positive outcomes postoperatively with regards to pain and function. There were minimal complications noted for this complex injury. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Healthcare utilization and costs associated with a diagnosis of incident atrial fibrillation

Abstract Background Atrial fibrillation (AF) is the most prevalent arrhythmia among adults worldwide and is associated with an increased risk of heart failure, stroke, and death. Prior studies have highlighted the healthcare burden associated with AF; however, contemporary data is lacking. As AF incidence and prevalence continue to increase due to the aging of the population, current estimates are needed for adequate healthcare resource allocation and policy decisions. Purpose The purpose of our study was to examine the healthcare utilization and cost burden associated with a diagnosis of incident AF in the United States (US). Methods Using the 2017–2020 Optum Clinformatics database, an administrative claims data of commercially insured individuals in the US, adult patients with an incident diagnosis of AF were identified. Adults with AF were matched on demographic and comorbid characteristics to those without AF using a propensity score greedy-matching algorithm with a 1:1 case to control ratio. Outcomes including medical services (inpatient admissions, emergency room [ER] visits, outpatients admissions, other services), utilization (all-cause, cardiovascular [CV]-related), and healthcare costs (sum of all medical services and prescription costs; adjusted for medical inflation and reported in 2021 US $) in the one-year post-incident diagnosis of AF were then compared among the matched cohort. Logistic and general linear modeling assessed healthcare utilization and cost outcomes. Results A total of 159,242 matched participants (79,621 AF cases and 79,621 non-AF controls) were identified. Among patients with AF, the mean age was 74 years, and 51% were females. Among the non-AF controls, the mean age was 73 years, and 50% were females. Patients with incident AF had significantly higher all-cause inpatient visits (relative risk [RR] 1.72; 95% confidence interval [CI]: 1.71–1.73), cardiovascular-related inpatient visits (RR 2.42; 95% CI: 2:41–2:44), as well as cardiovascular-related ER visits (RR: 2.36; 95% CI: 2:30–2:42) as compared to non-AF controls in the 1-year following diagnosis (Figure 1). The one-year mean total healthcare costs were $25,006 (95% CI $24,357-$26,912) higher among patients with AF as compared to non-AF controls ($63,031 vs $38,025, p&amp;lt;0.001). Conclusion Patients with AF had significantly higher medical services use than non-AF controls. The higher medical services utilization among the AF cohort translated into a considerably higher economic burden in this cohort. Timely management and treatment remain critical in alleviating the significant financial and health burden imposed by AF on patients, payers, and providers. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Johnson and Johnson

One-Year Mean A1c of > 7% is Associated with Poor Bone Microarchitecture and Strength in Men with Type 2 Diabetes Mellitus.

Type 2 diabetes mellitus (T2DM) is associated with normal or slightly elevated bone mineral density (BMD) but paradoxically increased fracture risk. Although multiple mechanisms have been proposed to explain this observation, one thing is clear from prior studies, T2DM is associated with poor bone quality rather than a defect in bone quantity. The objective of our study is to evaluate the effect of longitudinal glycemic control on bone quality and bone turnover in men with T2DM. This was a secondary analysis of baseline data from 169 male participants, aged 35-65 in 3 clinical trials. Participants were grouped according to the average of all their A1C measurements between 9 and 15months prior to study entry (group 1: no T2DM, group 2: T2DM with A1C ≤ 7%, group 3: T2DM with A1C > 7%). At study entry serum osteocalcin and C-terminal telopeptide of type 1 collagen (CTx) were measured by ELISA, and testosterone and estradiol by liquid-chromatography/mass-spectrometry. Areal BMD, trabecular bone score and body composition were measured by dual-energy X-ray absorptiometry while volumetric BMD, bone microarchitecture, and bone strength were assessed by high-resolution peripheral quantitative computed tomography. At the tibia, trabecular separation was higher and trabecular number was significantly lower in group 3 compared to both groups 2 and 1, even after adjustments for covariates (p = 0.02 for both). Bone strength indices at the tibia such as stiffness and failure load were lowest in group 3, the difference being significant when compared to group 1 (p = 0.01, p = 0.009 respectively) but not to group 2, after adjustments for covariates. Bone turnover markers (osteocalcin and CTx) were significantly lower in group 3 relative to group 1, with CTx also being significantly lower in group 3 compared with group 2 (p < 0.001, p = 0.001 respectively). Poor glycemic control over the course of a year in men with T2DM is associated with poorer bone microarchitecture and strength, and reduced bone turnover. Conversely, good glycemic control in the setting of T2DM appears to attenuate this observed impairment in bone quality.

Glycaemic control is associated with SARS-CoV-2 breakthrough infections in vaccinated patients with type 2 diabetes

Patients with type 2 diabetes (T2D) are characterized by blunted immune responses, which are affected by glycaemic control. Whether glycaemic control influences the response to COVID-19 vaccines and the incidence of SARS-CoV-2 breakthrough infections is unknown. Here we show that poor glycaemic control, assessed as mean HbA1c in the post-vaccination period, is associated with lower immune responses and an increased incidence of SARS-CoV-2 breakthrough infections in T2D patients vaccinated with mRNA-BNT162b2. We report data from a prospective observational study enroling healthcare and educator workers with T2D receiving the mRNA-BNT162b2 vaccine in Campania (Italy) and followed for one year (5 visits, follow-up 346 ± 49 days) after one full vaccination cycle. Considering the 494 subjects completing the study, patients with good glycaemic control (HbA1c one-year mean < 7%) show a higher virus-neutralizing antibody capacity and a better CD4 + T/cytokine response, compared with those with poor control (HbA1c one-year mean ≥ 7%). The one-year mean of HbA1c is linearly associated with the incidence of breakthrough infections (Beta = 0.068; 95% confidence interval [CI], 0.032-0.103; p < 0.001). The comparison of patients with poor and good glycaemic control through Cox regression also show an increased risk for patients with poor control (adjusted hazard ratio [HR], 0.261; 95% CI, 0.097-0.700; p = 0.008). Among other factors, only smoking (HR = 0.290, CI 0.146-0.576 for non-smokers; p < 0.001) and sex (HR = 0.105, CI 0.035-0.317 for females; p < 0.001) are significantly associated with the incidence of breakthrough infections.

Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial

IntroductionThis report evaluates whether health related quality of life (HRQoL) and patient-reported arm morbidity one year after axillary surgery are affected by the omission of axillary lymph node dissection (ALND). MethodsThe ongoing international non-inferiority SENOMAC trial randomizes clinically node-negative breast cancer patients (T1-T3) with 1–2 sentinel lymph node (SLN) macrometastases to completion ALND or no further axillary surgery. For this analysis, the first 1181 patients enrolled in Sweden and Denmark between March 2015, and June 2019, were eligible. Data extraction from the trial database was on November 2020. This report covers the secondary outcomes of the SENOMAC trial: HRQoL and patient-reported arm morbidity. The EORTC QLQ-C30, EORTC QLQ-BR23 and Lymph-ICF questionnaires were completed in the early postoperative phase and at one-year follow-up. Adjusted one-year mean scores and mean differences between the groups are presented corrected for multiple testing. ResultsOverall, 976 questionnaires (501 in the SLN biopsy only group and 475 in the completion ALND group) were analysed, corresponding to a response rate of 82.6%. No significant group differences in overall HRQoL were identified. Participants receiving SLN biopsy only, reported significantly lower symptom scores on the EORTC subscales of pain, arm symptoms and breast symptoms. The Lymph-ICF domain scores of physical function, mental function and mobility activities were significantly in favour of the SLN biopsy only group. ConclusionOne year after surgery, arm morbidity is significantly worse affected by ALND than by SLN biopsy only. The results underline the importance of ongoing attempts to safely de-escalate axillary surgery. Trial registrationThe trial was registered at clinicaltrials.gov prior to initiation (https://clinicaltrials.gov/ct2/show/NCT 02240472).

Impact of limited sample size and follow-up on single event survival extrapolation for health technology assessment: a simulation study

IntroductionExtrapolation of time-to-event data from clinical trials is commonly used in decision models for health technology assessment (HTA). The objective of this study was to assess performance of standard parametric survival analysis techniques for extrapolation of time-to-event data for a single event from clinical trials with limited data due to small samples or short follow-up.MethodsSimulated populations with 50,000 individuals were generated with an exponential hazard rate for the event of interest. A scenario consisted of 5000 repetitions with six sample size groups (30–500 patients) artificially censored after every 10% of events observed. Goodness-of-fit statistics (AIC, BIC) were used to determine the best-fitting among standard parametric distributions (exponential, Weibull, log-normal, log-logistic, generalized gamma, Gompertz). Median survival, one-year survival probability, time horizon (1% survival time, or 99th percentile of survival distribution) and restricted mean survival time (RMST) were compared to population values to assess coverage and error (e.g., mean absolute percentage error).ResultsThe true exponential distribution was correctly identified using goodness-of-fit according to BIC more frequently compared to AIC (average 92% vs 68%). Under-coverage and large errors were observed for all outcomes when distributions were specified by AIC and for time horizon and RMST with BIC. Error in point estimates were found to be strongly associated with sample size and completeness of follow-up. Small samples produced larger average error, even with complete follow-up, than large samples with short follow-up. Correctly specifying the event distribution reduced magnitude of error in larger samples but not in smaller samples.ConclusionsLimited clinical data from small samples, or short follow-up of large samples, produce large error in estimates relevant to HTA regardless of whether the correct distribution is specified. The associated uncertainty in estimated parameters may not capture the true population values. Decision models that base lifetime time horizon on the model’s extrapolated output are not likely to reliably estimate mean survival or its uncertainty. For data with an exponential event distribution, BIC more reliably identified the true distribution than AIC. These findings have important implications for health decision modelling and HTA of novel therapies seeking approval with limited evidence.

Effectiveness of training in guideline-oriented biopsychosocial management of low-back pain in occupational health services - a cluster randomized controlled trial.

Objective:This study aimed to investigate the effectiveness of brief training in the guideline-oriented biopsychosocial management of low-back pain (LBP) in occupational health services using a cluster-randomized design. A small sample of physiotherapists and physicians from the intervention units (N=12) were given three- to seven-day training focusing on the biopsychosocial management of LBP, while professionals in the control units (N=15) received no such training.Methods:Eligible patients with LBP, with or without radicular pain, aged 18–65, were invited to participate. A web-based questionnaire was sent to all recruited patients at baseline, three months and one year. The primary outcome measure was disability (Oswestry Disability Index, ODI) over one year. Between-group differences were analyzed using linear and generalized linear mixed models adjusted for baseline-response delay as well as variables showing between-group imbalance at baseline.Results:The final study sample comprised 234 and 81 patients in the intervention and control groups, respectively at baseline, and 137 and 47 patients, respectively, at one year. At baseline, the mean duration of pain was longer in the intervention group (P=0.017), and pain-related fear concerning physical activity was lower (P=0.012). We observed no significant difference between the groups’ primary outcome measure (adjusted one-year mean difference in the ODI: 2.3; 95% confidence interval -1.0–5.7; P=0.175) or most secondary outcomes.Conclusions:Brief training in guideline-oriented biopsychosocial management of LBP for occupational health professionals did not appear to be effective in reducing patients’ symptom over one-year follow-up compared to treatment as usual.

Long term risk and costs of bleeding in men and women treated with triple antithrombotic therapy-An observational study.

Bleeding is the most common non-ischemic complication in patients with coronary revascularisation procedures, associated with prolonged hospitalisation and increased mortality. Many factors predispose for bleeds in these patients, among those sex. Anyhow, few studies have characterised the population receiving triple antithrombotic therapy (TAT) as well as long term bleeds from a sex perspective. We investigated the one year rate of bleeds in patients receiving TAT, potential sex disparities and premature discontinuation of TAT. We also assessed health care costs in bleeders vs non-bleeders. Three hospitals in the County of Östergötland, Sweden during 2009-2015. All patients discharged with TAT registered in the SWEDEHEART registry. All bleeds receiving medical attention during one-year follow-up were collected by retrieving relevant information about each patient from medical records. Resource use associated with bleeds was assigned unit cost to estimate the health care costs associated with bleeding episodes. Among 272 patients, 156 bleeds occurred post-discharge, of which 28.8% were gastrointestinal. In total 54.4% had at least one bleed during or after the index event and 40.1% bled post discharge of whom 28.7% experienced a TIMI major or minor bleeding. Women discontinued TAT prematurely more often than men (52.9 vs 36.1%, p = 0.01) and bled more (48.6 vs. 37.1%, p = 0.09). One-year mean health care costs were EUR 575 and EUR 5787 in non-bleeding and bleeding patients, respectively. The high bleeding incidence in patients with TAT, especially in women, is a cause of concern. There is a need for an adequately sized randomised, controlled trial to determine a safe but still effective treatment for these patients.

Survival After Hip Fracture: A Comparative Analysis Between a Private and a Public Health Center in Chile.

PurposeThe purpose of the study is to compare the survival after hip fracture in patients older than 50 years after hip fracture between a private and a public health center in Chile. We hypothesize that treatment at a private health center (PRH) may be associated with lower one-year mortality and longer median survival time after hip fracture (adjusted by gender and age) compared to a public health center (PLH).MethodsPRH and PLH patients who were coded with a diagnosis of hip fracture were included in this study. PRH patients were included between 2002 to 2018, and PLH patients were included from 2012 to 2018. One-year mortality was estimated by logistic regression; meanwhile, median survival time was estimated by exponential regression. A survival analysis study was designed and approved by our institutional ethics review board.ResultsA total of 2130 patients were included in the PLH cohort, and a total of 1110 patients were included in the PRH. The one-year mean mortality, adjusted by age and gender, was 0.23 (range: 0.21 to 0.25) in the PLH and 0.16 (range: 0.13 to 0.18) in the PRH cohort. The median survival time, adjusted by age and gender, was 4.2 years (range: 4.1 to 4.4) in the PLH and 6.8 years (range: 6.3 to 7.29) in the PRH cohort.ConclusionPatients older than 50 years treated in a private health center have a higher median survival time and a lower probability of dying one year after a hip fracture.

Efficacy and Safety of Selective Laser Trabeculoplasty among Ethiopian Glaucoma Patients.

Background Selective laser trabeculoplasty (SLT) is a safe and effective treatment modality for lowering intraocular pressure (IOP). Purpose To determine the efficacy and safety of SLT among Ethiopian patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG), and ocular hypertension (OHT). Method A prospective, nonrandomized interventional study was conducted at Menelik II Hospital, Ethiopia. Patients on antiglaucoma medication with uncontrolled IOP and those patients treated for the first time with 360 degrees of SLT were included. Success was defined as an IOP lowering of > 20% from baseline without repeat treatment. Result A total of 95 eyes of 61 patients with a diagnosis of OAG and OHT were enrolled. The diagnosis was POAG in 55 (57.9%) eyes, PXG in 22 (23.2%) eyes, and OHT in 18 (18.9%) eyes. Seventy (73.7%) eyes were on medications, and 25 (26.3%) eyes were treated with laser as primary therapy. The mean (SD) baseline IOP and medication were 24.3 ± 2.5 mmHg and 1.29 ± 1.01, respectively. The one-year mean (SD) IOP reduction was 6.7 ± 4.2 mmHg and medication reduction was 0.26 ± 1.34. The overall IOP reduction at 12 months was 27.6%, and the success rate was 60%. The mean IOP (SD) reduction for patients who were treated for the first time with laser and on antiglaucoma medication was 6.5 ± 3.1 mmHg and 6.8 ± 2.8 mmHg, respectively. Post-SLT, patients experienced transient ocular pain, brow ache, headache, and/or blurring of vision in 31.6%, anterior chamber reaction in 36.8%, and IOP spike ≥ 6 mmHg in 11.6%. Conclusion SLT is an effective and safe treatment modality for OHT, POAG, and PXG among Ethiopian patients either as a first-line treatment or as an adjunct to topical glaucoma treatment.

Incidence of depression in relation to transportation noise exposure and noise annoyance in the SAPALDIA study

Prospective evidence on the risk of depression in relation to transportation noise exposure and noise annoyance is limited and mixed. We aimed to investigate the associations of long-term exposure to source-specific transportation noise and noise annoyance with incidence of depression in the SAPALDIA (Swiss cohort study on air pollution and lung and heart diseases in adults) cohort.We investigated 4,581 SAPALDIA participants without depression in the year 2001/2002. Corresponding one-year mean road, railway and aircraft day-evening-night noise (Lden) was calculated at the most exposed façade of the participants’ residential floors, and transportation noise annoyance was assessed on an 11-point scale. Incident cases of depression were identified in 2010/2011, and comprised participants reporting physician diagnosis, intake of antidepressant medication or having a short form-36 mental health score < 50. We used robust Poisson regressions to estimate the mutually adjusted relative risks (RR) and 95% confidence intervals (CI) of depression, independent of traffic-related air pollution and other potential confounders.Incidence of depression was 11 cases per 1,000 person-years. In single exposure models, we observed positive but in part, statistically non-significant associations (per 10 dB) of road traffic Lden [RR: 1.06 (0.93, 1.22)] and aircraft Lden [RR: 1.19 (0.93, 1.53)], and (per 1-point difference) of noise annoyance [RR: 1.05 (1.02, 1.08)] with depression risk. In multi-exposure model, noise annoyance effect remained unchanged, with weaker effects of road traffic Lden [(RR: 1.02 (0.89, 1.17)] and aircraft Lden [(RR: 1.17 (0.90, 1.50)]. However, there were statistically significant indirect effects of road traffic Lden [(β: 0.02 (0.01, 0.03)] and aircraft Lden [β: 0.01 (0.002, 0.02)] via noise annoyance. There were no associations with railway Lden in the single and multi-exposure models [(RRboth models: 0.88 (0.75, 1.03)]. We made similar findings among 2,885 non-movers, where the effect modification and cumulative risks were more distinct. Noise annoyance effect in non-movers was stronger among the insufficiently active (RR: 1.09; 95%CI: 1.02, 1.17; pinteraction = 0.07) and those with daytime sleepiness [RR: 1.07 (1.02, 1.12); pinteraction = 0.008]. Cumulative risks of Lden in non-movers showed additive tendencies for the linear cumulative risk [(RRper 10dB of combined sources: 1.31 (0.90, 1.91)] and the categorical cumulative risk [(RRtriple- vs. zero-source ≥45 dB: 2.29 (1.02, 5.14)], and remained stable to noise annoyance.Transportation noise level and noise annoyance may jointly and independently influence the risk of depression. Combined long-term exposures to noise level seems to be most detrimental, largely acting via annoyance. The moderation of noise annoyance effect by daytime sleepiness and physical activity further contribute to clarifying the involved mechanisms. More evidence is needed to confirm these findings for effective public health control of depression and noise exposure burden.

Survival Analysis after Hip Fracture in Chile in Patients Over 50 Years Old: A Comparative Analysis between a Private and a Public Health Center

Background: Hip fracture is a frequent pathology in patients over the age of 50. This study aimed to analyze the survival of patients older than 50 years after hip fracture. Treatment at a private health center (PRH) may be associated with lower one-year mortality and longer median survival time after hip fracture (adjusted by gender and age) compared to a public health center (PLH). Methods: A survival analysis study was designed and approved by our institutional ethics review board. PRH and PLH patients who were coded with a diagnosis of hip fracture were included in this study. In the PRH, the corrective operation was performed between 2002 to 2018; in the PLH, the corrective operation was conducted from 2012 to 2018. One-year mortality was estimated by logistic regression; meanwhile, median survival time was estimated by exponential regression. Findings: A total of 2130 patients were included in the PLH cohort, and a total of 1110 patients were included in the PRH. The one-year mean mortality, adjusted by age and gender, was 0·23 (range, 0·21–0·25) in the PLH and 0·16 (range, 0·13–0·18) in the PRH cohort. The median survival time, adjusted by age and gender, was 4·2 years (range, 4·1–4·4) in the PLH and 6·8 years (range, 6·3–7·29) in the PRH cohort. Interpretation: Patients older than age 50 treated in a private health center have a higher median survival time and a lower probability of dying one year after hip fracture. Funding Statement: This study received no funding. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: This study was approved by an institutional ethics review board.

P4635Long term risk and costs of bleeding in men and women treated with triple antithrombotic therapy

Abstract Background Triple antithrombotic therapy (TAT) is known to increase bleeds and its relevance is questioned. No study has observed the long-term risk of bleeding and health care costs from a sex perspective, in a total TAT population. We investigated the rate of all bleeds in patients receiving TAT at index hospitalization and within one year. We explored early discontinuation of TAT and potential sex disparities. We also assessed health care costs related to bleeding complications. Methods All patients discharged with TAT registered in SWEDEHEART in the County of Östergötland 2009–2015 were included. Information about bleeds during one-year follow-up were retrieved from the medical records. All bleeds receiving medical attention were included. Resource use associated with bleeds were assigned unit cost to estimate the health care costs associated with bleeding episodes. Results Among 272 identified patients, 156 bleeds occurred post-discharge, of which 28.8% were gastrointestinal. In total 54.4% had at least one bleed during or after the index event and 40.1% bled post discharge of whom 28.7% experienced a TIMI major or minor bleeding. Women discontinued TAT prematurely more often than men (52.9 vs 36.1%, p=0.01) and bled more (48.6 vs. 37.1%, p=0.09). One-year mean health care costs were EUR 575 and EUR 5787 in non-bleeding and bleeding patients, respectively. Conclusion The very high bleeding incidence in patients with TAT is a cause of concern, especially in women. There is a need for an adequately sized randomized, controlled trial to determine a safe but still effective treatment for these patients.

Ancillary Service Utilization and Impact in Huntington's Disease.

Prior Huntington's disease (HD) studies suggest ancillary services improve motor symptoms, cognition, mood, and quality of life but frequency of use and clinicalcharacteristics are unclear. Describe ancillary service utilization in a cohort of individuals with HD and determine which participant characteristics are associated with ancillary service utilization. Retrospective cross-sectional analysis of Enroll-HD database. Participants were grouped by therapy: physical and/or occupational (PT/OT), psychotherapy and/or counseling (PC), speech and/or swallowing (ST). We performed bivariate comparisons analysis of demographic and disease characteristics between those with/without each therapy and to analyze one-year mean change in assessment scores. Of 4751 participants, 1537 (32.35%) utilized therapies (11.82% PT/OT, 5.33% PC, 3.01% ST, 1.98% all three, 10.21% two therapies). PT/OT participants had worse motor and functional scores: mean UHDRS motor score (41.17 vs. 38.05, p = 0.002), median total functional capacity score (TFC) (8.00 vs. 9.00, p < 0.001). PC participants had worse mood but better cognitive and functional scores: median depression score (7.00 vs. 2.00, p < 0.001), median MMSE (28.00 vs. 26.00, p < 0.001), median TFC (10.00 vs. 8.00, p < 0.001). ST participants had more dysarthria, and worse cognitive and functional scores: dysarthria (32.2% vs. 20.1% p < 0.001), mean correct Symbol Digit Modality Test (16.79 vs. 23.27, p < 0.001), median TFC (6.00 vs. 9.00, p < 0.001). Over one year, PC participants' depression scores improved compared to untreated (- 1.24 vs. - 0.11, p = 0.040). ST participants' depression scores worsened (1.14 vs. - 0.23, p = 0.044). Mean change in TFC was not significant for any therapies. Only 32% of Enroll-HD site participants received ancillary services. Use correlated with expected clinical characteristics, though impact of use remains unclear.

Healthcare resource utilization and costs before and after lacosamide initiation as adjunctive therapy among patients with epilepsy in the United States

ObjectiveThe objective of this study was to evaluate all-cause and epilepsy-specific healthcare resource utilization and costs following lacosamide (LCM) initiation as adjunctive therapy for the treatment of epilepsy. MethodsA noninterventional retrospective database analysis was conducted that examined patients diagnosed as having epilepsy who added LCM to existing antiepileptic drug (AED) therapy between 2009 and 2016 (the first LCM prescription was the index event). This study used a single-case design whereby patients served as their own controls. Patients were further required to have a minimum of 12 months of continuous eligibility before (preindex period) and after (postindex period) their index event. In the 12-month postindex period, the only allowed AED regimen change was the addition of LCM. Demographic and clinical characteristics were measured at index and during the preindex period, respectively. All-cause and epilepsy-specific healthcare resource utilization and costs were measured and compared in the pre- and postindex periods. Paired t- and McNemar's tests were conducted to assess the significant differences between pre- and postindex. Univariate analyses were used to analyze the impact of LCM on specific subpopulations. ResultsThe study sample comprised of 2171 patients: mean (standard deviation [SD]) age: 38.9 (19.3) years; 52.6% female. Just over half (56%) of these patients were on monotherapy before adding LCM. Prior to adding LCM, 28.8% of patients had an epilepsy-specific inpatient (IP) admission, and 35.7% of patients had an all-cause IP admission, compared with 18.2% and 26.1% of patients in the post-LCM period, respectively (both p < 0.0001). Likewise, 35.6% of patients had an epilepsy-specific emergency room (ER) visit, and 50.0% had an all-cause ER visit prior to adding LCM, compared with 23.8% and 42.1% in post-LCM, respectively (both p < 0.0001). After adding LCM, one-year mean [SD] epilepsy-specific IP admission costs decreased by 42.9% ($13,647 [$52,290] to $7788 [$32,321]), and all-cause IP admission costs decreased by 38.6% ($20,654 [$72,716] to $12,688 [$46,120]) (both p < 0.0001). One-year epilepsy-specific mean [SD] ER costs decreased by 35.2% ($691 [$1756] to $448 [$1909]; p < 0.0001), and all-cause ER cost decreased by 17.8% ($1217 [$3014] to $1000 [$2970]; p < 0.01). ConclusionsEpilepsy-related IP hospitalizations and ER visits (indicators of seizures) were significantly reduced in patients with epilepsy 12 months after adding LCM as an adjunctive therapy to existing AED treatment in a real-world setting, leading to reduced healthcare resource utilization and epilepsy costs.

Comparative Effectiveness and Safety of Bariatric Procedures for Weight Loss: A PCORnet Cohort Study.

There has been a dramatic shift in use of bariatric procedures, but little is known about their long-term comparative effectiveness. To compare weight loss and safety among bariatric procedures. Retrospective observational cohort study, January 2005 to September 2015. (ClinicalTrials.gov: NCT02741674). 41 health systems in the National Patient-Centered Clinical Research Network. 65093 patients aged 20 to 79 years with body mass index (BMI) of 35 kg/m2 or greater who had bariatric procedures. 32208 Roux-en-Y gastric bypass (RYGB), 29693 sleeve gastrectomy (SG), and 3192 adjustable gastric banding (AGB) procedures. Estimated percent total weight loss (TWL) at 1, 3, and 5 years; 30-day rates of major adverse events. Total numbers of eligible patients with weight measures at 1, 3, and 5 years were 44978 (84%), 20783 (68%), and 7159 (69%), respectively. Thirty-day rates of major adverse events were 5.0% for RYGB, 2.6% for SG, and 2.9% for AGB. One-year mean TWLs were 31.2% (95% CI, 31.1% to 31.3%) for RYGB, 25.2% (CI, 25.1% to 25.4%) for SG, and 13.7% (CI, 13.3% to 14.0%) for AGB. At 1 year, RYGB patients lost 5.9 (CI, 5.8 to 6.1) percentage points more weight than SG patients and 17.7 (CI, 17.3 to 18.1) percentage points more than AGB patients, and SG patients lost 12.0 (CI, 11.6 to 12.5) percentage points more than AGB patients. Five-year mean TWLs were 25.5% (CI, 25.1% to 25.9%) for RYGB, 18.8% (CI, 18.0% to 19.6%) for SG, and 11.7% (CI, 10.2% to 13.1%) for AGB. Patients with diabetes, those with BMI less than 50 kg/m2, those aged 65 years or older, African American patients, and Hispanic patients lost less weight than patients without those characteristics. Potential unobserved confounding due to nonrandomized design; electronic health record databases had missing outcome data. Adults lost more weight with RYGB than with SG or AGB at 1, 3, and 5 years; however, RYGB had the highest 30-day rate of major adverse events. Small subgroup differences in weight loss outcomes were observed. Patient-Centered Outcomes Research Institute.