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Concept: Subgroup

102

Meningiomas are the most common primary intracranial tumors in adults. Identification of SMO and AKT1 mutations in meningiomas has raised the hope for targeted therapies. It would be useful to know the precise frequency of these mutations in anatomical subgroups and clarify their prognostic value.

Concepts: DNA, Cancer, Mutation, Evolution, Brain tumor, Subgroup, Coset, Nigel Godrich

25

Purposes of this study were to identify subgroups of patients with distinct trajectories for morning and evening fatigue, evaluate for differences in demographic and clinical characteristics among these subgroups, and compare and contrast the predictors of subgroup membership for morning and evening fatigue.

Concepts: Subgroup, Normal subgroup

25

Psychotropic dose equivalence is an important concept when estimating the approximate psychotropic doses patients receive, and deciding the approximate titration dose when switching from one psychotropic agent to another. It is also useful from a research viewpoint when defining and extracting specific subgroups of subjects. Unification of various agents into a single standard agent facilitates easier analytical comparisons. On the basis of differences in psychopharmacological prescription features, those of available psychotropic agents and their approved doses, and racial differences between Japan and other countries, psychotropic dose equivalency tables designed specifically for Japanese patients have been widely used in Japan since 1998. Here we introduce dose equivalency tables for (1) antipsychotics, (2) antiparkinsonian agents, (3) antidepressants, and (4) anxiolytics, sedatives and hypnotics available in Japan. Equivalent doses for the therapeutic effects of individual psychotropic compounds were determined principally on the basis of randomized controlled trials conducted in Japan, and consensus among dose equivalency tables reported previously by psychopharmacological experts. Since these tables are intended to merely suggest approximate standard values, physicians should use them with discretion.

Concepts: Therapeutic effect, Pharmacology, Randomized controlled trial, Subgroup, Titration, Equivalence, Equivalence relation, Diphenhydramine

24

Sexual and gender minority (SGM) youth are disproportionately affected by suicide-related thoughts and behaviors relative to their heterosexual and/or non-transgender peers. Theory and empirical evidence suggest that there are unique factors that contribute to this elevated risk, with distinguishable differences among SGM subgroups. Although SGM youth suicide prevention research is in its nascence, initial findings indicate that interventions, which focus on family support and acceptance may be beneficial. It is critical that we develop and test tailored interventions for SGM youth at risk for suicide, with specific attention to subgroup differences and reductions in suicide-related thoughts and behaviors as outcomes.

Concepts: Scientific method, Psychology, Critical thinking, Sociology, Empiricism, Subgroup, Empirical research, Suicide prevention

20

Purpose:To determine whether intravenous low-osmolality iodinated contrast material is associated with post-computed tomography (CT) acute kidney injury (AKI).Materials and Methods:Institutional review board approval was obtained and patient consent waived for this HIPAA-compliant retrospective study. CT examinations performed over a 10-year period in adult inpatients with sufficient serum creatinine (SCr) data were identified. A one-to-one propensity-matched matched cohort analysis with multivariate analysis of effects was performed with post-CT AKI as the primary outcome measure (10 121 unenhanced and 10 121 intravenous contrast-enhanced CT examinations in 20 242 patients). Propensity matching was performed with respect to likelihood of patient receiving intravenous contrast material (36 tested covariates). The primary endpoint was post-CT AKI by using Acute Kidney Injury Network SCr criteria; the secondary endpoint was post-CT AKI by using traditional SCr criteria for contrast material-induced nephrotoxicity (CIN; SCr increase ≥0.5 mg/dL [44.20μmol/L] or ≥25%). Multivariate subgroup threshold analysis was performed (SCr <1.5 [<132.60 μmol/L]; ≥1.5 to ≥2.0 mg/dL [≥132.60 to ≥176.80 μmol/L]) and adjusted for assigned propensity scores.Results:Intravenous low-osmolality iodinated contrast material had a significant effect on the development of post-CT AKI for patients with pre-CT SCr levels of 1.6 mg/dL (141.44 μmol/L) or greater (odds ratio, 1.45; 95% confidence interval [CI]: 1.11, 1.89;P = .007). This effect strengthened as pre-CT SCr increased. Patients with stable SCr less than 1.5 mg/dL (132.60 μmol/L) were not at risk for developing CIN (P = .25, power > 95%). Both endpoints demonstrated similar results (eg, SCr ≥1.6 mg/dL [141.44 μmol/L] by using traditional CIN criteria: odds ratio, 1.64; 95% CI: 1.18, 2.28; P = .003). Post-CT AKI was prevalent in both the unenhanced and contrast-enhanced CT subgroups, and it increased with increases in pre-CT SCr. Many risk factors contributed to development of post-CT AKI, regardless of iodinated contrast material.Conclusion:Intravenous low-osmolality iodinated contrast material is a nephrotoxic risk factor, but not in patients with a stable SCr level less than 1.5 mg/dL. Many factors other than contrast material can affect post-CT AKI rates.© RSNA, 2013.

Concepts: Epidemiology, Patient, Medical statistics, Risk, Multivariate statistics, Acute kidney injury, Subgroup, Radiocontrast

11

Background Venetoclax inhibits BCL2, an antiapoptotic protein that is pathologically overexpressed and that is central to the survival of chronic lymphocytic leukemia cells. We evaluated the efficacy of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Methods In this randomized, open-label, phase 3 trial, we randomly assigned 389 patients to receive venetoclax for up to 2 years (from day 1 of cycle 1) plus rituximab for the first 6 months (venetoclax-rituximab group) or bendamustine plus rituximab for 6 months (bendamustine-rituximab group). The trial design did not include crossover to venetoclax plus rituximab for patients in the bendamustine-rituximab group in whom progression occurred. The primary end point was investigator-assessed progression-free survival. Results After a median follow-up period of 23.8 months, the rate of investigator-assessed progression-free survival was significantly higher in the venetoclax-rituximab group (32 events of progression or death in 194 patients) than in the bendamustine-rituximab group (114 events in 195 patients); the 2-year rates of progression-free survival were 84.9% and 36.3%, respectively (hazard ratio for progression or death, 0.17; 95% confidence interval [CI], 0.11 to 0.25; P<0.001 by the stratified log-rank test). The benefit was maintained across all clinical and biologic subgroups, including the subgroup of patients with chromosome 17p deletion; the 2-year rate of progression-free survival among patients with chromosome 17p deletion was 81.5% in the venetoclax-rituximab group versus 27.8% in the bendamustine-rituximab group (hazard ratio, 0.13; 95% CI, 0.05 to 0.29), and the 2-year rate among those without chromosome 17p deletion was 85.9% versus 41.0% (hazard ratio, 0.19; 95% CI, 0.12 to 0.32). The benefit of venetoclax plus rituximab over bendamustine plus rituximab was confirmed by an independent review committee assessment of progression-free survival and other secondary efficacy end points. The rate of grade 3 or 4 neutropenia was higher in the venetoclax-rituximab group than in the bendamustine-rituximab group, but the rates of grade 3 or 4 febrile neutropenia and infections or infestations were lower with venetoclax than with bendamustine. The rate of grade 3 or 4 tumor lysis syndrome in the venetoclax-rituximab group was 3.1% (6 of 194 patients). Conclusions Among patients with relapsed or refractory chronic lymphocytic leukemia, venetoclax plus rituximab resulted in significantly higher rates of progression-free survival than bendamustine plus rituximab. (Funded by Genentech and AbbVie; ClinicalTrials.gov number, NCT02005471 .).

Concepts: Clinical trial, Cancer, Oncology, Chemotherapy, Hematology, Leukemia, Blood disorders, Subgroup

9

To evaluate the effectiveness of oral glucosamine in subgroups of people with hip or knee osteoarthritis (OA) based on baseline pain severity, body mass index (BMI), sex, structural abnormalities and presence of inflammation using individual patient data.

Concepts: Obesity, Mass, Rheumatoid arthritis, Osteoarthritis, Body mass index, Subgroup, Normal subgroup, Cyclic group

6

A subgroup of individuals becomes entrenched in a “revolving door” involving corrections, health, and social welfare services. Little research has investigated the numbers of people that are in frequent contact with multiple public agencies, the costs associated with these encounters, or the characteristics of the people concerned. The present study used linked administrative data to examine offenders who were also very frequent users of health and social services. We investigated the magnitude and distribution of costs attributable to different categories of service for those in the top 10 % of sentences to either community or custodial settings. We hypothesized that the members of these subgroups would be significantly more likely to have substance use and other mental disorders than other members of the offender population.

Concepts: Sociology, Distribution, Mental disorder, Mental illness, Subgroup, Welfare economics, Insanity defense, Social welfare function

5

In the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in pre-specified subgroups of patients aged ≥65 and <65 years.

Concepts: Head and neck anatomy, Head and neck, Cancer, Lung cancer, Carcinoma, Squamous cell carcinoma, Squamous epithelium, Subgroup

5

Body mass index (BMI) can be used to group individuals in terms of their height and weight as obese. However, such a distinction fails to account for the variation within this group across other factors such as health, demographic and behavioural characteristics. The study aims to examine the existence of subgroups of obese individuals.

Concepts: Cancer, Nutrition, Obesity, Mass, Body mass index, Subgroup, Body shape, Normal subgroup