Duration of frontline therapy and impact on clinical outcomes in newly diagnosed multiple myeloma patients not receiving frontline stem cell transplant.

BACKGROUND: Extended first-line therapy (1LT) has improved clinical outcomes in newly diagnosed multiple myeloma (NDMM). This retrospective study of NDMM patients evaluated the relationship between dose-attenuation of 1LT and duration of therapy (DOT) and DOT on outcomes. METHODS: Adults with NDMM not undergoing stem cell transplant (SCT) from January 1, 2012 toMarch 31, 2018 from the Integrated Oncology Network were included; 300 were randomly selected for chart review. 1LT DOT, time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS) were estimated using Kaplan-Meier analysis. Marginal structural models evaluated relationships between DOT and TTNT, PFS, and OS at 2 years accounting for confounders and survival bias from the time-dependent nature of DOT. RESULTS: Of 300 chart-reviewed patients, 93 were excluded for incomplete data or meeting exclusion criteria. Among 207 NDMM patients, median age was 74 years; 146 (70.5%) did not receive dose-attenuation during 1LT. Patients with short DOT were older, frailer, with a higher comorbidity burden, and a significantly lower proportion had an Eastern Cooperative Oncology Group PS = 0. As DOT increased, more patients underwent dose-attenuation (p < 0.0001). The median 1LT DOT was 20.9 (95% confidence interval [CI]: 13.9, 26.4) versus 4.2 months (95% CI: 3.2, 4.9) for patients receiving versus not receiving dose-attenuation, respectively (p < 0.0001). After accounting for survival bias, confounder-adjusted TTNT was prolonged with each additional month of 1LT (odds ratio [OR]: 0.76 [95% CI: 0.75, 0.78]); likelihoods of risks of disease progression (OR: 0.87 [95% CI: 0.86, 0.88]) and death at 2 years (OR: 0.72 [95% CI: 0.70, 0.74]) were reduced with each month of 1LT (p < 0.0001 for all outcomes). CONCLUSIONS: Dose-attenuated 1LT was associated with longer DOT among patients with non-SCT NDMM. Each additional month of 1LT was associated with a reduced adjusted likelihood of disease progression and death at 2 years. Dose-attenuation of 1LT can extend DOT; longer DOT may improve clinical outcomes

Management of hepatocellular carcinoma from diagnosis in routine clinical practice

AIM: To assess real-world management of patients diagnosed with hepatocellular carcinoma (HCC) within an integrated delivery network. MATERIALS & METHODS: A retrospective cohort analysis of adults newly diagnosed with HCC from January 2014 to March 2019. Overall survival and treatment journey were assessed over the entire available follow-up period per patient. RESULTS: Of the 462 patients, 85% had ≥1 treatment. The 24-month overall survival rate (95% CI) from first treatment was 77% (72-82%). Majority of Child-Pugh class A (71%) and B (60%) patients received locoregional therapy first. Half (53.6%) of the patients with liver transplantation first were Child-Pugh class C patients. Sorafenib was the predominant systemic therapy. CONCLUSION: This integrated delivery network data analysis offers a comprehensive insight into the real-world management of HCC

Current recommendations on the selection of measures for well-being

Measures of well-being have proliferated over the past decades. Very little guidance has been available as to which measures to use in what contexts. This paper provides a series of recommendations, based on the present state of knowledge and the existing measures available, of what measures might be preferred in which contexts. The recommendations came out of an interdisciplinary workshop on the measurement of well-being. The recommendations are shaped around the number of items that can be included in a survey, and also based on the differing potential contexts and purposes of data collection such as, for example, government surveys, or multi-use cohort studies, or studies specifically about psychological well-being. The recommendations are not intended to be definitive, but to stimulate discussion and refinement, and to provide guidance to those relatively new to the study of well-being

A brief CBT intervention for depersonalisation/derealisation in psychosis:study protocol for a feasibility randomised controlled trial

BACKGROUND: Depersonalisation is the experience of being detached or disconnected from one’s experience. Studies suggest that clinically significant levels of depersonalisation are common in individuals who have psychotic symptoms and are associated with increased impairment. However, to date, there have been no studies that have investigated an intervention designed to target clinically significant depersonalisation in such patient groups. This study aims to determine the feasibility and acceptability of a brief intervention targeting clinically significant depersonalisation in those who also have current psychotic symptoms. METHODS/DESIGN: The feasibility of delivering six sessions of cognitive behavioural therapy for depersonalisation in psychosis patients will be evaluated using a single-blinded randomised controlled trial with a treatment as usual control condition. Participants will be assessed at baseline and then randomised to either the treatment or control arm. Participants randomised to the treatment arm will be offered six sessions of individual cognitive behavioural therapy delivered over a maximum of 10 weeks. Therapy will focus on an individualised shared formulation of depersonalisation experiences and behavioural, cognitive, emotional regulation and thinking process strategies to decrease distress associated with depersonalisation. Participants will be assessed again at a 10-week (post-randomisation) follow-up assessment. The primary outcomes of interest will be those assessing the feasibility and acceptability of the intervention including rates of referral, eligibility and acceptance to participate; attendance at therapy sessions and completion of homework tasks; satisfaction with the intervention; maintenance of blinding; and therapist competence. Secondary outcomes will be data on clinical outcome measures of depersonalisation and positive symptoms of psychosis, anxiety, depression and post-traumatic stress. DISCUSSION: This study will determine the feasibility of delivering six sessions of cognitive behavioural therapy for individuals with current psychotic symptoms who also experience clinically significant levels of depersonalisation. The results will provide information to inform a larger randomised trial to assess intervention efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT0242754

Venous thromboembolism after orthopedic surgery: Implications of the choice for prophylaxis

Abstract Introduction: Venous thromboembolism (VTE) is an important cause of morbidity and mortality following major orthopedic surgeries. In clinical trials, fondaparinux and low molecular weight heparins have been shown to be more effective than unfractionated heparin (UFH) in preventing VTE. We retrospectively analyzed a large hospital discharge database to assess the occurrence of clinically detected VTE as a function of the injectable antithrombotic agent used for VTE prophylaxis in orthopedic surgery. Methods: The Premier's Perspective database, representing over 500 hospitals across the US, was utilized to identify patients receiving dalteparin, enoxaparin, fondaparinux, or UFH following hip or knee replacement or hip fracture surgery between January 2003 and March 2005. The primary outcome was the proportion of patients in each cohort with a VTE, while secondary outcomes included VTE occurrence during index hospitalization, and proportion of patients with a VTEassociated hospital readmission

Clinical and economic outcomes associated with the use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium bromide 18 mcg as initial maintenance treatment for chronic obstructive pulmonary disease in managed care

<p><b>Aims:</b> To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US.</p> <p><b>Methods:</b> A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]). The analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs.</p> <p><b>Results:</b> Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs$2,352 [±3,721], <i>p</i> = .057). There was no difference between cohorts for COPD-related medical costs (<i>p</i> = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], <i>p</i> < .001). There were no statistically significant differences in the rate or number of exacerbations between the matched cohorts.</p> <p><b>Limitations:</b> While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present.</p> <p><b>Conclusions:</b> Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.</p