Inverse Probability Of Treatment Research Articles

Risk of major adverse cardiovascular events in rural vs urban settings among patients with erectile dysfunction: a propensity-weighted retrospective cohort study of 430 621 men.

The relationship between erectile dysfunction (ED) and cardiovascular (CV) events has been postulated, with ED being characterized as a potential harbinger of CV disease. Location of residence is another important consideration, as the impact of rural residence has been associated with worse health outcomes. To investigate whether men from rural settings with ED are associated with a higher risk of major adverse CV events (MACEs). A propensity-weighted retrospective cohort study was conducted with provincial health administrative databases. ED was defined as having at least 2 ED prescriptions filled within 1 year. MACE was defined as the first hospitalization for an episode of acute myocardial infarction, heart failure, or stroke that resulted in a hospital visit >24hours. We classified study groups into ED urban, ED rural, no ED urban, and no ED rural. A multiple logistic regression model was used to determine the propensity score. Stabilized inverse propensity treatment weighting was then applied to the propensity score. A Cox proportional hazard model was used to examine our primary outcome of time to a MACE. The median time to a MACE was 2731, 2635, 2441, and 2508days for ED urban (n = 32 341), ED rural (n = 18 025), no ED rural (n = 146 358), and no ED urban (n = 233 897), respectively. The cohort with ED had a higher proportion of a MACE at 8.94% (n = 4503), as opposed to 4.58% (n = 17 416) for the group without ED. As compared with no ED urban, no ED rural was associated with higher risks of a MACE in stabilized time-varying comodels based on inverse probability treatment weighting (hazard ratio, 1.06-1.08). ED rural was associated with significantly higher risks of a MACE vs no ED rural, with the strength of the effect estimates increasing over time (hazard ratio, 1.10-1.74). Findings highlight the need for physicians treating patients with ED to address CV risk factors for primary and secondary prevention of CV diseases. This is the most extensive retrospective study demonstrating that ED is an independent risk factor for MACE. Due to limitations in data, we were unable to assess certain comorbidities, including obesity and smoking. Our study confirms that ED is an independent risk factor for MACE. Rural men had a higher risk of MACE, with an even higher risk among those who reside rurally and are diagnosed with ED.

Comparative Effectiveness of Natalizumab, Fingolimod, and Injectable Therapies in Pediatric-Onset Multiple Sclerosis: A Registry-Based Study.

Patients with pediatric-onset multiple sclerosis (POMS) typically experience higher levels of inflammation with more frequent relapses, and though patients with POMS usually recover from relapses better than adults, patients with POMS reach irreversible disability at a younger age than adult-onset patients. There have been few randomized, placebo-controlled clinical trials of multiple sclerosis (MS) disease-modifying therapies (DMTs) in patients with POMS, and most available data are based on observational studies of off-label use of DMTs approved for adults. We assessed the effectiveness of natalizumab compared with fingolimod using injectable platform therapies as a reference in pediatric patients in the global MSBase registry. This retrospective study included patients with POMS who initiated treatment with an injectable DMT, natalizumab, or fingolimod between January 1, 2006, and May 3, 2021. Patients were matched using inverse probability treatment weighting. The primary outcome was time to first relapse from index therapy initiation. Secondary study outcomes included annualized relapse rate; proportions of relapse-free patients at 1, 2, and 5 years; time to treatment discontinuation; and times to 24-week confirmed disability worsening and confirmed disability improvement. A total of 1,218 patients with POMS were included in this analysis. Patients treated with fingolimod had a significantly lower risk of relapse than patients treated with injectable DMTs (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.29-0.83; p = 0.008). After adjustment for prior DMT experience in the unmatched sample, patients treated with natalizumab had a significantly lower risk of relapse than patients treated either with injectable DMTs (HR, 0.15; 95% CI 0.07-0.31; p < 0.001) or fingolimod (HR, 0.37; 95% CI 0.14-1.00; p = 0.049). The adjusted secondary study outcomes were generally consistent with the primary outcome or with previous observations. The findings in the inverse probability treatment weighting-adjusted patient populations were confirmed in multiple sensitivity analyses. Our analyses of relapse risk suggest that natalizumab is more effective than fingolimod in the control of relapses in this population with high rates of new inflammatory activity, consistent with previous studies of natalizumab and fingolimod in adult-onset patients and POMS. In addition, both fingolimod and natalizumab were more effective than first-line injectable therapies. This study provides Class II evidence that patients with POMS treated with natalizumab had a lower risk of relapse than those with fingolimod.

The safety, feasibility and oncological outcomes of laparoscopic completion total gastrectomy for remnant gastric cancer: a prospective study with 3-year follow-up (FUGES-004 study).

The efficacy of laparoscopic completion total gastrectomy (LCTG) for remnant gastric cancer (RGC) remains controversial. The primary outcome was postoperative morbidity within 30 days after surgery. Secondary outcomes included 3-year disease-free survival (DFS), 3-year overall survival (OS), and recurrence. Inverse probability treatment weighted (IPTW) was used to balance the baseline between LCTG and OCTG. Final analysis included 46 patients with RGC who underwent LCTG at the FJMUUH between June 2016 and June 2020. The historical control group comprised of 160 patients who underwent open completion total gastrectomy (OCTG) in the six tertiary teaching hospitals from CRGC-01 study. After IPTW, no significant difference was observed between the LCTG and OCTG groups in terms of incidence (LCTG vs. OCTG: 28.0% vs. 35.0%, P=0.379) or severity of complications within 30 days after surgery. Compared with OCTG, LCTG resulted in better short-term outcomes and faster postoperative recovery. However, the textbook outcome rate was comparable between the two groups (45.9% vs. 32.8%, P=0.107). Additionally, the 3-year DFS and 3-year OS of LCTG were comparable to those of OCTG (DFS: log-rank P=0.173; OS: log-rank P=0.319). No significant differences in recurrence type, mean recurrence time, or 3-year cumulative hazard of recurrence were observed between the two groups (all P>0.05). Subgroup analyses and concurrent comparisons demonstrated similar trends. This prospective study suggested that LCTG was non-inferior to OCTG in both short- and long-term outcomes. In experienced centers, LCTG may be considered as a viable treatment option for RGC.

Rates of Recurrent Intestinal Metaplasia and Dysplasia After Successful Endoscopic Therapy of Barrett's Neoplasia by EMR vs ESD and Ablation: A Large North American Multicenter Cohort.

Endoscopic eradication therapy (EET) combining endoscopic resection (ER) with endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) followed by ablation is the standard of care for the treatment of dysplastic Barrett's esophagus (BE). We have previously shown comparable rates of complete remission of intestinal metaplasia (CRIM) with both approaches. However, data comparing recurrence after CRIM are lacking. We compared rates of recurrence after CRIM with both techniques in a multicenter cohort. Patients undergoing EET achieving CRIM at 3 academic institutions were included. Demographic and clinical data were abstracted. Outcomes included rates and predictors of any BE and dysplastic BE recurrence in the two groups. Cox proportional hazards models and inverse probability treatment weighting (IPTW) analysis were utilized for analysis. 621 patients (514 EMR, 107 ESD) achieving CRIM were included in the recurrence analysis. The incidence of any BE (15.7, 5.7 per 100 patient years) and dysplastic BE recurrence (7.3, 5.3 per 100 patient-years) were comparable in the EMR and ESD groups, respectively. On multivariable analyses, the chances of BE recurrence were not influenced by ER technique (HR, 0.87; 95% CI, 0.51-1.49; p= 0.62), which was also confirmed by IPTW analysis (ESD vs EMR: HR, 0.98; 95% CI, 0.56-1.73; p= 0.94). BE length, lesion size, and history of cigarette smoking were independent predictors of BE recurrence. Patients with BE dysplasia/neoplasia achieving CRIM, initially treated with EMR/ablation had comparable recurrence rates to ESD/ablation. Randomized trials are needed to confirm these outcomes between the two ER techniques.

Impact of informal caregiving on depressive symptoms among a national cohort of men

BackgroundThere is evidence that unpaid caregiving can have negative effects on the mental health of female caregivers; however, evidence of impacts on male caregivers is limited. This study addressed this...

Do end-of-life outcomes differ by assisted living memory-care designation?

Residential care/assisted living (RC/AL) is an increasingly common place of end-of-life care for persons with Alzheimer's disease and related dementia (ADRD), who have unique care needs as their health declines. Approximately 22% of RC/ALs provide specialized memory care (memory-care RC/AL). Understanding how end-of-life outcomes differ by memory care among residents with ADRD could facilitate aging/dying in place for this population. The objective of this paper is to examine if end-of-life outcomes (i.e., mortality, hospice use, and number of days receiving hospice in the last month of life) differ between residents with ADRD who moved to memory-care RC/AL, compared with residents with ADRD who moved to RC/AL without memory care (general RC/AL). Prospective cohort of 15,152 fee-for-service Medicare beneficiaries with ADRD who moved to large RC/AL (> = 25 beds) between 2016 and 2018. We used inverse probability treatment weighting to account for observable differences between memory-care and general RC/AL residents. Two-part models estimated the difference by memory care in the number of days receiving hospice care in the last months of life among RC/AL decedents. The unadjusted mortality rates were 13.4% in general RC/AL and 15.8% in memory-care RC/AL with an adjusted difference of 1.3 percentage points higher mortality among memory-care RC/AL residents (p = 0.04). Hospice use was 8% and 10.6% among general and memory-care RC/AL residents, respectively, with an adjusted difference of 1.4 percentage points (p = 0.01) higher in memory care. Two-part models showed that decedents in memory-care RC/AL spent about 1.4 more days receiving hospice care in the last month of life (p = 0.02). We find a higher mortality rate and higher rate of hospice use among memory-care RC/AL residents. These findings suggest that memory care may attract residents closer to the end of life and/or promote hospice use at the end of life.

Impact of neoadjuvant chemotherapy on short-term outcomes after simple and complex minimally invasive minor hepatectomy for colorectal liver metastases: A propensity-score matched and coarsened exact matched study

BackgroundIn the last three decades, minimally invasive liver resection has been replacing conventional open approach in liver surgery. More recently, developments in neoadjuvant chemotherapy have led to increased multidisciplinary management of colorectal liver metastases with both medical and surgical treatment modalities. However, the impact of neoadjuvant chemotherapy on the surgical outcomes of minimally invasive liver resections remains poorly understood. MethodsA multicenter, international, database of 4998 minimally invasive minor hepatectomy for colorectal liver metastases was used to compare surgical outcomes in patients who received neoadjuvant chemotherapy with surgery alone. To correct for baseline imbalance, propensity score matching, coarsened exact matching and inverse probability treatment weighting were performed. Results2546 patients met the inclusion criteria. After propensity score matching there were 759 patients in both groups and 383 patients in both groups after coarsened exact matching. Baseline characteristics were equal after both matching strategies. Neoadjuvant chemotherapy was not associated with statistically significant worse surgical outcomes of minimally invasive minor hepatectomy. ConclusionNeoadjuvant chemotherapy had no statistically significant impact on short-term surgical outcomes after simple and complex minimally invasive minor hepatectomy for colorectal liver metastases.

Cost consequence analysis of adding semaglutide to treatment regimen for patients with Type II diabetes in Saudi Arabia

IntroductionSemaglutide, a Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA), is often prescribed for managing type 2 diabetes, particularly in cases unresponsive to other hypoglycemic agents. Despite its popularity, the real-world efficacy and cost-effectiveness of Semaglutide relative to other treatments remain understudied. ObjectiveThis study aimed to examine the direct medical cost and consequences of adding Semaglutide to the treatment regimen for patients with type 2 diabetes in Saudi Arabia. MethodsWe conducted a single-center, retrospective review of Electronic Medical Records (EMRs) for adults with type 2 diabetes. Patients who had been on Semaglutide for at least three months were matched with those receiving alternative hypoglycemic therapies. Exclusions were made for patients with cancer, incomplete EMRs, or lacking prescription data. Investigated outcomes included changes in HbA1C levels and weight, and the direct costs comprised medications, clinic visits, and emergency care. Baseline adjustments were made through inverse probability treatment weighting, and uncertainty was assessed via bootstrapping with 10,000 replications. ResultsOut of 350 patients meeting the criteria, 116 were on Semaglutide. Predominantly females (62%), the cohort had an average age of 60 and a disease duration of 22 years. The difference in HbA1C (%) reductions between Semaglutide and non-Semaglutide users over 3,6, and 12 months were 0.154 (95% CI: –0.452-0.483), –0.031(95% CI: –0.754-0.239), –0.16(95% CI: –1.425-0.840), respectively. Semaglutide users did experience modest weight reductions ranging from 0.42 kg to 1.16 kg. The annual additional direct medical cost for Semaglutide was USD 4,086.82 (95% CI: $3,710.85 - $4,294.99). ConclusionAlthough Semaglutide induced modest weight reductions, it did not offer significant advantages in lowering HbA1C levels compared to other hypoglycemic treatments. These findings suggest the need for further research involving larger and more diverse cohorts to corroborate these findings.

Association between tranexamic acid administration and mortality based on the trauma phenotype: a retrospective analysis of a nationwide trauma registry in Japan

BackgroundIn trauma systems, criteria for individualised and optimised administration of tranexamic acid (TXA), an antifibrinolytic, are yet to be established. This study used nationwide cohort data from Japan to evaluate the association between TXA and in-hospital mortality among all patients with blunt trauma based on clinical phenotypes (trauma phenotypes).MethodsA retrospective analysis was conducted using data from the Japan Trauma Data Bank (JTDB) spanning 2019 to 2021.ResultsOf 80,463 patients with trauma registered in the JTDB, 53,703 met the inclusion criteria, and 8046 (15.0%) received TXA treatment. The patients were categorised into eight trauma phenotypes. After adjusting with inverse probability treatment weighting, in-hospital mortality of the following trauma phenotypes significantly reduced with TXA administration: trauma phenotype 1 (odds ratio [OR] 0.68 [95% confidence interval [CI] 0.57–0.81]), trauma phenotype 2 (OR 0.73 [0.66–0.81]), trauma phenotype 6 (OR 0.52 [0.39–0.70]), and trauma phenotype 8 (OR 0.67 [0.60–0.75]). Conversely, trauma phenotypes 3 (OR 2.62 [1.98–3.47]) and 4 (OR 1.39 [1.11–1.74]) exhibited a significant increase in in-hospital mortality.ConclusionsThis is the first study to evaluate the association between TXA administration and survival outcomes based on clinical phenotypes. We found an association between trauma phenotypes and in-hospital mortality, indicating that treatment with TXA could potentially influence this relationship. Further studies are needed to assess the usefulness of these phenotypes.Graphical abstract

Social Disadvantage and Multimorbidity Including Oral Conditions in the United States.

Existing studies on multimorbidity have largely excluded oral diseases in multimorbidity prevalence estimates. The reason behind this is somewhat unclear, as chronic oral conditions are highly prevalent, affecting over half the global population. To address this gap, we examined the relationship between social disadvantage and multimorbidity, stratifying by the inclusion and exclusion of oral conditions. For participants aged 30 y and over (n = 3,693), cross-sectional analysis was carried out using the US National Health and Nutrition Survey (2013-2014). Multimorbidity was defined as having 2 or more chronic conditions. Five medical conditions were examined: diabetes, asthma, arthritis, cardiovascular disease, and depression, as well as 4 oral health conditions: caries, periodontal disease, number of teeth, and edentulousness. Education and income poverty ratio were selected as measures of social disadvantage. Multimorbidity prevalence estimates according to social disadvantage were analyzed on an absolute and relative scale using inverse probability treatment weighting (IPTW), adjusting for age, sex, and ethnicity. The inclusion of oral health conditions in the assessment of multimorbidity increased the overall prevalence of multimorbidity from 20.8% to 53.4%. Findings from IPTW analysis demonstrated clear social gradients for multimorbidity estimates stratified by the exclusion of oral conditions. Upon inclusion of oral conditions, the prevalence of multimorbidity was higher across all social groups for both education and income. Stratifying by the inclusion of oral conditions, the mean probability of multimorbidity was 27% (95% confidence interval [CI], 23%-30%) higher in the low-education group compared to the high-education group. Similarly, the mean probability of multimorbidity was 44% (95% CI, 40%-48%) higher in the low-income group. On a relative scale, low education was associated with a 1.52 times (95% CI, 1.44-1.61) higher prevalence of multimorbidity compared to high education. Low income was associated with a 2.18 (95% CI, 1.99-2.39) higher prevalence of multimorbidity. This novel study strongly supports the impact of chronic oral conditions on multimorbidity prevalence estimates.

Autologous cell salvage in off-pump coronary artery bypass surgery reduces post-operative complications: a retrospective weighted-matching analysis.

Blood transfusion plays a crucial role in coronary artery bypass grafting (CABG). The choice between autologouscell saver (CS) and allogenic blood transfusion (ABT) has been a continuous debate in the medical community, especially within cardiac surgery. This study aimed to assess the outcomes of off-pump CABG (OPCAB) surgery in patients receiving blood solely via cell salvage compared to those receiving ABT or a combination of ABT and CS perioperatively. A total of 414 patients who underwent isolated OPCAB surgery at our cardiovascular clinic were analyzed. Among them, 250 patients (60.4%) received blood via CS alone, while 164 patients (39.6%) received either ABT or a mix of ABT and CS. Stabilized inverse probability treatment weighted (IPTW) matching technique ensured balance in baseline covariates. We found no significant differences in 30-day mortality rates between the CS and ABT groups. The CS group displayed significantly lower rates of overall complications, encompassing stroke, acute kidney injury, atrial fibrillation, and pulmonary complications. Rates of sepsis, readmission, gastrointestinal complications, heparin-induced thrombosis, and deep venous thrombosis were comparable between the two groups. However, in contrast to the ABT group,the CS group exhibited significantly shorter median lengths of hospital stay (LOHS), ICU stay, andventilation time, along with higher rates of discharge to homerather than acute care facilities. Our data suggest that autologous blood transfusion via CS results in fewer perioperative complications and faster recovery following OPCAB procedures as compared to ABT.

Preterm Birth Following Active Surveillance vs Loop Excision for Cervical Intraepithelial Neoplasia Grade 2

Active surveillance for cervical intraepithelial neoplasia grade 2 (CIN2) is being implemented in many high-income countries due to the association of excisional treatment with preterm birth. However, it is unknown whether active surveillance results in lower risk of preterm birth given that cervical dysplasia itself is associated with higher risk of preterm birth. To compare the preterm birth risk between women with CIN2 undergoing active surveillance or immediate loop electrosurgical excision procedure (LEEP). This historical population-based cohort study included women with a first-time diagnosis of CIN2 and a subsequent singleton birth from 1998 to 2018 in Denmark. Women with prior CIN grade 3 or greater or LEEP were excluded. Data were collected from 4 Danish health care registries. Analyses were conducted from October 2022 to June 2023. Women were categorized into active surveillance (cervical biopsy and/or cytology) or immediate LEEP based on their first cervical sample after CIN2 diagnosis. The active surveillance group was further subdivided based on whether a delayed LEEP was performed within 28 months from CIN2 diagnosis. Risk of preterm birth (<37 + 0 weeks) was assessed and relative risks (RRs) were calculated using modified Poisson regression. Analyses used inverse probability treatment weighting of the propensity scores to adjust for age, parity, calendar year, index cytology, and smoking. A total of 10 537 women with CIN2 and a singleton birth were identified; 4430 (42%) underwent active surveillance and 6107 (58%) were treated with immediate LEEP. For both groups, most were aged 23 to 29 years at CIN2 diagnosis (3125 [70%] and 3907 [64%], respectively). Overall, 869 births (8.2%) were preterm. The risk of preterm birth was comparable between active surveillance and immediate LEEP (RR, 1.03; 95% CI, 0.90-1.18). However, for women undergoing delayed LEEP after active surveillance (1539 of the active surveillance group [35%]), the risk of preterm birth was higher than for women treated with immediate LEEP (RR, 1.29; 95% CI, 1.08-1.55). In this cohort study of women with CIN2, the risk of preterm birth was comparable between active surveillance and immediate LEEP. However, delayed LEEP was associated with 30% higher risk of preterm birth than immediate LEEP. Thus, risk stratification at CIN2 diagnosis is important to identify women with increased risk of delayed LEEP.

Adjuvant Ovarian Function Suppression in Premenopausal Hormone Receptor–Positive Breast Cancer

Few oncology studies have assessed the effectiveness of adjuvant ovarian function suppression (OFS) in observational settings for premenopausal hormone receptor-positive breast cancer. Target trial emulation is increasingly used for estimating treatment outcomes in observational cohorts. To describe hormone therapy and OFS treatment patterns (aim 1), examine the association between adding OFS to tamoxifen (TAM) or aromatase inhibitor (AI) and survival (aim 2), and examine the association between duration of hormone treatment (TAM or AI) plus OFS (H-OFS) and survival (aim 3). This population-based cohort study included all premenopausal, early-stage breast cancer diagnoses between 2010 and 2020 in Alberta, Canada. Target trial emulation was conducted. Eligibility criteria were directly modeled after the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Participants were followed up for a maximum of 5 years. Data were analyzed from July 2022 through March 2023. For aim 2, exposures were receiving the following baseline treatments for 2 years: AI + OFS (AI-OFS), TAM + OFS (T-OFS), and TAM alone. For aim 3, exposures were a 2-year or greater and a less than 2-year duration of H-OFS. Recurrence-free survival was the primary outcome of interest. Marginal structural Cox models with inverse probability treatment and censoring weights were used to estimate hazard ratios (HRs), adjusted for baseline and time-varying confounding variables. Among 3434 female patients with premenopausal, early-stage breast cancer diagnoses (median [IQR] age, 45 [40-48] years), 2647 individuals satisfied SOFT and TEXT eligibility criteria. There were 2260 patients who initiated TAM, 232 patients who initiated T-OFS, and 155 patients who initiated AI-OFS; 192 patients received H-OFS for 2 or more years, and 195 patients received H-OFS for less than 2 years. The 5-year recurrence risks were not significantly lower in AI-OFS vs TAM (HR, 0.76; 95% CI, 0.38-1.33) or T-OFS vs TAM (HR, 0.87; 95% CI, 0.50-1.45) groups. Patients receiving H-OFS for 2 or more years had significantly better 5-year recurrence-free survival compared with those receiving H-OFS for less than 2 years (HR, 0.69; 95% CI, 0.54-0.90). This study found no significant reductions in recurrence risk for AI-OFS and T-OFS compared with TAM alone. H-OFS duration for at least 2 years was associated with significantly improved recurrence-free survival.

Preoperative DLco and FEV1 are correlated with postoperative pulmonary complications in patients after esophagectomy

Limited information is available regarding the association between preoperative lung function and postoperative pulmonary complications (PPCs) in patients with esophageal cancer who undergo esophagectomy. This is a retrospective cohort study. Patients were classified into low and high lung function groups by the cutoff of the lowest fifth quintile of forced expiratory volume in 1 s (FEV1) %predicted (%pred) and diffusing capacity of the carbon monoxide (DLco) %pred. The PPCs compromised of atelectasis requiring bronchoscopic intervention, pneumonia, and acute lung injury/acute respiratory distress syndrome. Modified multivariable-adjusted Poisson regression model using robust error variances and inverse probability treatment weighting (IPTW) were used to assess the relative risk (RR) for the PPCs. A joint effect model considered FEV1%pred and DLco %pred together for the estimation of RR for the PPCs. Of 810 patients with esophageal cancer who underwent esophagectomy, 159 (19.6%) developed PPCs. The adjusted RR for PPCs in the low FEV1 group relative to high FEV1 group was 1.48 (95% confidence interval [CI] = 1.09–2.00) and 1.98 (95% CI = 1.46–2.68) in the low DLco group relative to the high DLco group. A joint effect model showed adjusted RR of PPCs was highest in patients with low DLco and low FEV1 followed by low DLco and high FEV1, high DLco and low FEV1, and high DLco and high FEV1 (Reference). Results were consistent with the IPTW. Reduced preoperative lung function (FEV1 and DLco) is associated with post-esophagectomy PPCs. The risk was further strengthened when both values decreased together.

Association of oral disease-modifying agents and their adherence trajectories with annual relapses in multiple sclerosis

BackgroundReal-world effectiveness can vary across oral disease-modifying agents (DMAs) and their adherence trajectories in patients with multiple sclerosis (MS). However, previous studies have not considered longitudinal adherence patterns while evaluating oral DMAs. ObjectivesThis study aimed to evaluate the association of oral DMAs and their adherence trajectories with annualized relapse rate (ARR) in patients with MS. MethodsThis retrospective observational cohort study based on the 2015–2019 MarketScan Commercial Claims and Encounters Database involved continuous enrolled adults (18–64 years) with ≥1 MS diagnosis (ICD-9/10-CM:340/G35) and ≥ 1 oral DMA prescription. Patients were grouped into incident fingolimod (FIN), teriflunomide (TER), and dimethyl fumarate (DMF) users based on the index DMA with a one-year washout period. Annual DMA adherence trajectories based on the monthly Proportion of Days Covered (PDC) one year after treatment initiation were identified using Group-Based Trajectory Modeling (GBTM). The validated claims-based ARR was evaluated during the one-year follow-up period using generalized boosted model-based inverse probability treatment weights with negative binomial regression model. ResultsThe study cohort consisted of 994 MS patients who initiated with FIN (23.0%), TER (22.3%), and DMF (54.7%) during the study period. GBTM grouped eligible patients into three adherence trajectories: complete adherers (59.2%), slow decliners (23.8%), and rapid decliners (17.0%). The proportion of complete adherers varied across the oral DMAs (FIN: 67.1%, TER: 55.4%, and DMF: 57.4%). The negative binomial regression modeling revealed that, while there was no difference in ARR across the three DMAs, rapid decliners (adjusted incidence rate ratio[aIRR]: 1.6, 95% CI: 1.1–2.4) had a higher rate of relapses compared to completely adherent patients. The type of oral DMAs did not moderate the relationship between ARR and the adherence trajectory groups. ConclusionsAdherence trajectories classified as rapid decliners were associated with a higher ARR than complete adherers after adjusting for their type of oral DMAs. Longitudinal medication adherence patterns are critical in reducing relapse rates in MS.

Initial renal replacement therapy (RRT) modality associates with 90-day postdischarge RRT dependence in critically ill AKI survivors

PurposeReal-world comparison of RRT modality on RRT dependence at 90 days postdischarge among ICU patients discharged alive after RRT for acute kidney injury (AKI). MethodsUsing claims-linked to US hospital discharge data (Premier PINC AI Healthcare Database [PHD]), we compared continuous renal replacement therapy (CRRT) vs. intermittent hemodialysis (IHD) for AKI in adult ICU patients discharged alive from January 1, 2018 to June 30, 2021. RRT dependence at 90 days postdischarge was defined as ≥2 RRT treatments in the last 8 days. Between-group differences were balanced using inverse probability treatment weighting (IPTW). ResultsOf 34,804 patients, 3804 patients (from 382 hospitals) had claims coverage for days 83–90 postdischarge. Compared to IHD-treated patients (n = 2740), CRRT-treated patients (n = 1064) were younger; had more admission to large teaching hospitals, surgery, sepsis, shock, mechanical ventilation, but lower prevalence of comorbidities (p < 0.05 for all). Compared to IHD-treated patients, CRRT-treated patients had lower RRT dependence at hospital discharge (26.5% vs. 29.8%, p = 0.04) and lower RRT dependence at 90 days postdischarge (4.9% vs. 7.4% p = 0.006) with weighted adjusted OR (95% CI): 0.68 (0.47–0.97), p = 0.03. Results persisted in sensitivity analyses including patients who died during days 1–90 postdischarge (n = 112) or excluding patients from hospitals with IHD patients only (n = 335), or when excluding patients who switched RRT modalities (n = 451). ConclusionsAdjusted for potential confounders, the odds of RRT dependence at 90 days postdischarge among survivors of RRT for AKI was 30% lower for those treated first with CRRT vs. IHD, overall and in several sensitivity analyses. SummaryCritically ill patients in intensive care units (ICU) may develop acute kidney injury (AKI) that requires renal replacement therapy (RRT) to temporarily replace the injured kidney function of cleaning the blood. Two main types of RRT in the ICU are called continuous renal replacement therapy (CRRT), which is performed almost continuously, i.e., for >18 h per day, and intermittent hemodialysis (IHD), which is a more rapid RRT that is usually completed in a little bit over 6 h, several times per week. The slower CRRT may be gentler on the kidneys and is more likely to be used in the sickest patients, who may not be able to tolerate IHD. We conducted a data-analysis study to evaluate whether long-term effects on kidney function (assessed by ongoing need for RRT, i.e., RRT dependence) differ depending on use of CRRT vs. IHD. In a very large US linked hospital-discharge/claims database we found that among ICU patients discharge alive after RRT for AKI, fewer CRRT-treated patients had RRT dependence at hospital discharge (26.5% vs. 29.8%, p = 0.04) and at 90 days after discharge (4.9% vs. 7.4% p = 0.006). In adjusted models, RRT dependence at 90 days postdischarge was >30% lower for CRRT than IHD-treated patients. These results from a non-randomized study suggest that among survivors of RRT for AKI, CRRT may result in less RRT dependence 90 days after hospital discharge.

Comparing ocrelizumab to interferon/glatiramer acetate in people with multiple sclerosis over age 60

BackgroundOngoing controversy exists regarding optimal management of disease modifying therapy (DMT) in older people with multiple sclerosis (pwMS). There is concern that the lower relapse rate, combined with a higher...

AcumenTM hypotension prediction index guidance for prevention and treatment of hypotension in noncardiac surgery: a prospective, single-arm, multicenter trial

BackgroundIntraoperative hypotension is common during noncardiac surgery and is associated with postoperative myocardial infarction, acute kidney injury, stroke, and severe infection. The Hypotension Prediction Index software is an algorithm based on arterial waveform analysis that alerts clinicians of the patient’s likelihood of experiencing a future hypotensive event, defined as mean arterial pressure < 65 mmHg for at least 1 min.MethodsTwo analyses included (1) a prospective, single-arm trial, with continuous blood pressure measurements from study monitors, compared to a historical comparison cohort. (2) A post hoc analysis of a subset of trial participants versus a propensity score-weighted contemporaneous comparison group, using external data from the Multicenter Perioperative Outcomes Group (MPOG). The trial included 485 subjects in 11 sites; 406 were in the final effectiveness analysis. The post hoc analysis included 457 trial participants and 15,796 comparison patients. Patients were eligible if aged 18 years or older, American Society of Anesthesiologists (ASA) physical status 3 or 4, and scheduled for moderate- to high-risk noncardiac surgery expected to last at least 3 h. Measurements: minutes of mean arterial pressure (MAP) below 65 mmHg and area under MAP < 65 mmHg.ResultsAnalysis 1: Trial subjects (n = 406) experienced a mean of 9 ± 13 min of MAP below 65 mmHg, compared with the MPOG historical control mean of 25 ± 41 min, a 65% reduction (p < 0.001). Subjects with at least one episode of hypotension (n = 293) had a mean of 12 ± 14 min of MAP below 65 mmHg compared with the MPOG historical control mean of 28 ± 43 min, a 58% reduction (p< 0.001). Analysis 2: In the post hoc inverse probability treatment weighting model, patients in the trial demonstrated a 35% reduction in minutes of hypotension compared to a contemporaneous comparison group [exponentiated coefficient: − 0.35 (95%CI − 0.43, − 0.27); p < 0.001].ConclusionsThe use of prediction software for blood pressure management was associated with a clinically meaningful reduction in the duration of intraoperative hypotension. Further studies must investigate whether predictive algorithms to prevent hypotension can reduce adverse outcomes.Trial registrationClinical trial number: NCT03805217. Registry URL: https://clinicaltrials.gov/ct2/show/NCT03805217. Principal investigator: Xiaodong Bao, MD, PhD. Date of registration: January 15, 2019.

Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System

ObjectivesBiosimilar-originator equivalence has been demonstrated in phase 3 trials in a few indications of infliximab, etanercept and adalimumab. The objective of our study was to compare the persistence and safety...

Propofol vs etomidate for induction prior to invasive mechanical ventilation in patients with acute myocardial infarction

BackgroundPatients with acute myocardial infarction (AMI) requiring invasive mechanical ventilation (IMV) have a high mortality. However, little is known regarding the impact of induction agents, used prior to IMV, on clinical outcomes in this population. We assessed for the association between induction agent and mortality in patients with AMI requiring IMV. MethodsWe compared clinical outcomes between those receiving propofol compared to etomidate for induction among adults with AMI between October 2015 and December 2019 using the Vizient® Clinical Data Base, a multicenter, US national database. We used inverse probability treatment weighting (IPTW) to assess for the association between induction agent and in-hospital mortality. ResultsWe identified 5,147 patients, 1,386 (26.9%) of received propofol and 3,761 (73.1%) received etomidate for IMV induction. The mean (SD) age was 66.1 (12.4) years, 33.0% were women, and 51.6% and 39.8% presented with STEMI and cardiogenic shock, respectively. Patients in the propofol group were more likely to require pre-intubation vasoactive medication and mechanical circulatory support (both, P<0.05). Utilization of propofol was associated with lower mortality compared to etomidate (32.3 vs. 36.1%, P=0.01). After propensity weighting, propofol use remained associated with lower mortality (weighted mean difference -4.7%; 95% Confidence interval: -7.6% to -1.8%, P=0.002). Total cost, ventilator days, and length of stay were higher in the propofol group (all, P<0.001). ConclusionsInduction with propofol, compared with etomidate, was associated with lower mortality for patients with AMI requiring IMV. Randomized trials are needed to determine the optimal induction agent for this critically ill patient population.