There are many reasons why a patient may be made inactive on the kidney transplant waiting list, including psychosocial or financial issues or medical comorbidities. This has important implications for a patient’s overall morbidity and mortality. Sensitization, as measured by calculated plasma reactive antibodies (cPRA), also affects likelihood of transplant. Recently, a new “Kidney Allocation System” was implemented, the priorities of which were to increase transplant rates in individuals who are highly sensitized and to improve access to underserved populations. In this retrospective cohort study, 42,558 first-time registrants (2014-2016) identified through the Organ Procurement and Transplantation Network kidney transplant database were followed up to determine whether activity status changes differ among races/ethnicities and levels or sensitization, and if these differences are associated with transplant probability after implementation of the Kidney Allocation System. Researchers found that in patients in the calculated plasma reactive antibody categories of 0% to 79% cPRA, there was no significant difference in transplant probability among races/ethnicities. However, with cPRA between 80% and 89%, white race was associated with an increase in transplant probability (HR 1.8, 95% CI 1.4 to 2.2). Similarly, white patients with a cPRA of 90% or greater were more likely to receive transplantation than black individuals with the same cPRA levels (HR 2.4, 95% CI 2.1 to 2.8). Additionally, white individuals were more likely to have the issues that made them inactive resolved, as compared to both Hispanic patients (HR 1.2, 95% CI 1.17 to 1.3) and black patients (HR 1.4, 95% CI 1.3 to 1.4). Investigators therefore concluded that, with the Kidney Allocation System, in highly sensitized populations, black patients continue to have less access to transplant, as compared to white patients. Additionally, both Hispanic and black individuals are less likely to be activated after being made inactive, as compared to white patients.
In areas of Pakistan affected by recent conflict, epidemiological studies have shown a high prevalence of psychological distress in women. In the setting of conflict with poor access to care, as well as role restrictions, there is a large population of women that are particularly vulnerable to anxiety and depression. As such, there is a need for culturally-appropriate and scalable psychological interventions in these settings. The WHO recommends a range of interventions for non-specialized healthcare settings, including cognitive behavioral therapy (CBT), interpersonal therapy, and stress management delivered in individual or group formats. In this cluster randomized controlled trial, individuals from 34 community clusters in rural Swat, Pakistan were randomized 1:1 to receive either a group intervention, including five sessions facilitated by non-specialists that teach behavioral strategies, or usual care to establish the effectiveness of this new WHO group intervention in a conflict-affected setting. Women between the ages of 18 and 60 years were eligible if they scored at least 3 on the General Health Questionnaire-12 and at least 17 on the WHO Disability Assessment Schedule (n=712). Researchers found that the intervention arm had a significantly lower mean Hospital Anxiety and Depression Scale (HADS) score at 3 months, with an adjusted mean difference of -4.53 (95% CI -7.13 to -1.92, p=0.0007). Both HADS depression and anxiety scores, when taken alone, were also significantly lower in the treatment arm. No adverse events were noted. Investigators concluded that this group intervention administered by female non-specialists resulted in significantly lower depression and anxiety symptoms at 3 months in a post-conflict setting, as compared to standard care.
Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injection Regimens in Children and Young People at Diagnosis of Type 1 Diabetes: Pragmatic Randomized Controlled Trial and Economic Evaluation
Multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) are two forms of intensive insulin regimens utilized by patients with type 1 diabetes. Here, MDI and CSII are compared in terms of their safety, efficacy, and cost in the first year after a diagnosis of type 1 diabetes. This randomized controlled trial and economic evaluation enrolled 294 patients across multiple centers in England and Wales. Patients with a new diagnosis of type 1 diabetes between the ages of 7 months and 15 years were randomized to receive either MDI or CSII within 14 days of diagnosis. Titration occurred according to local clinical practice. Researchers found that glycated hemoglobin (HbA1c) at 1 year was not significantly different between the CSII and MDI arms (mean difference 2.4 mmol/mol, 95% CI -0.4 to 5.3, p=0.09). Additionally, there was no significant difference in the proportion of patients achieving a HbA1c less than 58 mmol/mol. Parents reported an improvement in quality of life scores with CSII, as compared to MDI, however, children did not. Additionally, CSII was more expensive by $2,474 per year (95% CI $2,116 to $2,792) and was not associated with a significant difference in incremental cost per quality adjusted life year (difference -0.006, 95% CI -0.031 to 0.018). Investigators therefore concluded that there was no glycemic control benefit to CSII, as compared to MDI, in the first year after a diagnosis of type 1 diabetes, despite it being more expensive.
Effect of a Multifaceted Quality Improvement Intervention on the Prescription of Evidence-Based Treatment in Patients at High Cardiovascular Risk in Brazil: The BRIDGE Cardiovascular Prevention Cluster Randomized Clinical Trial
In low and middle-income countries, the implementation of evidence-based therapies for cardiovascular disease, including the use of statins, antiplatelet therapy and anti-hypertensive medications, remains a challenge, despite high associated morbidity and mortality. In this cluster randomized controlled trial, 1619 patients with established atherosclerotic disease from 40 public and private outpatient clinics (clusters) in Brazil were randomized to receive either a multifaceted quality improvement intervention, including educational materials, feedback reports, and case management or routine care, to evaluate whether such an intervention can improve the prescription of evidence-based therapies. Researchers found that patients who received the intervention were more likely to receive evidence-based medications, as 73.5% of patients received them versus 58.7% of patients receiving usual care (OR 2.30, 95% CI 1.14 to 4.65). Additionally, smokers in the intervention group were more likely to receive smoking cessation education, as compared to those in the usual care group (51.9% vs 18.2%, OR 11.24, 95% CI 2.20 to 57.43). However, no differences were observed in diabetic, hypertensive, or hyperlipidemic control. Mortality rate was also not significantly different for the intervention group when compared with the control arm (2.6% vs. 3.4%, HR 0.76, 95% CI 0.43 to 1.34). In this Brazilian population with known atherosclerotic disease, a multimodal quality improvement intervention resulted in an increased proportion of patients receiving evidence-based therapies for cardiovascular disease, including smoking cessation education although outcomes at 1-2 years were unaffected.
Pembrolizumab Versus Chemotherapy for Previously Untreated, PD-L1-Expressing, Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (KEYNOTE-042): a Randomized, Open-Label, Controlled, Phase 3 Trial
Pembrolizumab is a monoclonal antibody against programmed cell death protein 1 (PD-1). Previous studies have shown that pembrolizumab is effective in prolonging survival in advanced non-small-cell lung cancer (NSCLC) with a PD1-ligand (PD-L1) tumor proportion score (TPS) of 50% or greater. In this randomized, open-label, phase 3 study, pembrolizumab was investigated for its efficacy in prolonging survival in locally advanced or metastatic NSCLC with a PD-L1 TPS of 1% or greater. Patients were included in the study if they had previously untreated locally advanced or metastatic NSCLC, expressed PD-L1 as above, had an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1, and did not have a sensitizing EGFR mutation or ALK translocation (n=1,274). They were randomized to receive either pembrolizumab (200 mg every 3 weeks for up to 35 cycles) or the investigator’s choice of platinum-based chemotherapy (4-6 cycles). Analysis was performed on three separate groups, those with PD-L1 TPS of 50% or greater, 20% or greater, and 1% or greater. Researchers found that pembrolizumab prolonged overall survival in all three analyses, as compared to chemotherapy, yielding a hazard ratio for death of 0.69 in those with 50% or greater PD-L1 TPS (95% CI 0.56 to 0.85, p=0.0003), 0.77 in those with 20% or greater PD-L1 TPS (95% CI 0.64 to 0.92, p=0.0020), and 0.81 in those with 1% or greater PD-L1 TPS (95% CI 0.71 to 0.93, p=0.0018). Treatment-related adverse events that were grade 3 or higher were significantly less common in the pembrolizumab group (18%), as compared to the chemotherapy group (41%). Similar treatment-related death rates occurred. Investigators therefore concluded that pembrolizumab is an effective first-line therapy in patients with metastatic or locally advanced NSCLC with greater than 1% PD-L1 TPS who do not have other sensitizing mutations or translocations.
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