Proton Shell Gaps in N=28 Nuclei from the First Complete Spectroscopy Study with FRIB Decay Station Initiator.

The first complete measurement of the β-decay strength distribution of _{17}^{45}Cl_{28} was performed at the Facility for Rare Isotope Beams (FRIB) with the FRIB Decay Station Initiator during the second FRIB experiment. The measurement involved the detection of neutrons and γ rays in two focal planes of the FRIB Decay Station Initiator in a single experiment for the first time. This enabled an analytical consistency in extracting the β-decay strength distribution over the large range of excitation energies, including neutron unbound states.

Observation of New Isotopes in the Fragmentation of ^{198}Pt at FRIB.

Five previously unknown isotopes (^{182,183}Tm, ^{186,187}Yb, ^{190}Lu) were produced, separated, and identified for the first time at the Facility for Rare Isotope Beams (FRIB) using the Advanced Rare Isotope Separator (ARIS). The new isotopes were formed through the interaction of a ^{198}Pt beam with a carbon target at an energy of 186  MeV/u and with a primary beam power of 1.5 kW.

Discovery of ^{39}Na.

The new isotope ^{39}Na, the most neutron-rich sodium nucleus observed so far, was discovered at the RIKEN Nishina Center Radioactive Isotope Beam Factory using the projectile fragmentation of an intense ^{48}Ca beam at 345  MeV/nucleon on a beryllium target. Projectile fragments were separated and identified in flight with the large-acceptance two-stage separator BigRIPS. Nine ^{39}Na events have been unambiguously observed in this work and clearly establish the particle stability of ^{39}Na.

Using the PAI-A to Classify Juvenile Offenders by Adjudicated Offenses.

To improve understanding and treatment of criminal behavior, researchers have developed typologies of juvenile offenders, primarily focusing on personality traits and criminal history to classify according to type of offense committed. Existing literature has examined underlying personality characteristics found in different subcategories of criminal offenses in juveniles; however, few studies have employed the Personality Assessment Inventory-Adolescent (PAI-A), instead choosing the MMPI-A. A typical classification model of juvenile offenses categorizes offenses into: Interpersonal, Property, and Drug/Alcohol-related charges, to further study within-group differences.

Location of the Neutron Dripline at Fluorine and Neon.

A search for the heaviest isotopes of fluorine, neon, and sodium was conducted by fragmentation of an intense ^{48}Ca beam at 345  MeV/nucleon with a 20-mm-thick beryllium target and identification of isotopes in the large-acceptance separator BigRIPS at the RIKEN Radioactive Isotope Beam Factory. No events were observed for ^{32,33}F, ^{35,36}Ne, and ^{38}Na and only one event for ^{39}Na after extensive running. Comparison with predicted yields excludes the existence of bound states of these unobserved isotopes with high confidence levels.

Discovery of ^{60}Ca and Implications For the Stability of ^{70}Ca.

The discovery of the important neutron-rich nucleus _{20}^{60}Ca_{40} and seven others near the limits of nuclear stability is reported from the fragmentation of a 345  MeV/u ^{70}Zn projectile beam on ^{9}Be targets at the radioactive ion-beam factory of the RIKEN Nishina Center. The produced fragments were analyzed and unambiguously identified using the BigRIPS two-stage in-flight separator. The eight new neutron-rich nuclei discovered, ^{47}P, ^{49}S, ^{52}Cl, ^{54}Ar, ^{57}K, ^{59,60}Ca, and ^{62}Sc, are the most neutron-rich isotopes of the respective elements.

Assessing United States Patient and Dermatologist Experiences with Severe Chronic Hand Eczema.

Objective: Patients with severe chronic hand eczema often have persistent symptoms that interfere with daily activities, social functioning, and employment. Many patients are refractory to topical corticosteroids. This survey-based study was performed to characterize treatment experiences, impact on productivity, and quality of life of patients with severe chronic hand eczema; understand dermatologists' severe chronic hand eczema treatment patterns.

Systematic review and network meta-analysis of the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants among patients with nonvalvular atrial fibrillation and CHADS2 score ⩾ 2.

Background: The nonvitamin K antagonist oral anticoagulants pivotal clinical trials for stroke prevention in atrial fibrillation have important differences in trial designs and baseline patient characteristics.

Objective: We sought to evaluate the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants in the management of stroke prevention in atrial fibrillation by adjusting for differences in baseline stroke risk and the length of follow-up among the four phase 3 randomized controlled trials.

Methods: We conducted a systematic literature review of randomized controlled trials evaluating the nonvitamin K antagonist oral anticoagulants for stroke prevention in atrial fibrillation and performed a network meta-analysis using data from ENGAGE AF-TIMI 48, RE-LY, ROCKET-AF, and ARISTOTLE, with warfarin as a common comparator.

Randomized controlled trials in relapsed/refractory chronic lymphocytic leukemia: a systematic review and meta-analysis.

This systematic literature review with meta-analysis was conducted on the clinical efficacy and safety of interventions used in the treatment of chronic lymphocytic leukemia (CLL). We systematically searched databases (PubMed, Cochrane Library, and Embase; 1997 to August 2, 2012), conference abstracts, bibliographic reference lists, recent reviews, and Clinicaltrials.gov.

Q-TWiST analysis comparing ipilimumab/dacarbazine vs placebo/dacarbazine for patients with stage III/IV melanoma.

Background: Study CA184024 was a multinational, randomised, double-blind, phase 3 study comparing ipilimumab/dacarbazine (DTIC) vs placebo/DTIC in patients with untreated stage III/IV melanoma, which showed that ipilimumab significantly improves survival in patients with metastatic melanoma. The objective of this analysis was to compare the quality-adjusted survival experience among patients in this trial.

Methods: Survival time was partitioned into health states: toxicity, time before progression without toxicity, and relapse until death or end of follow-up.

Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology.

Overall survival (OS) is the gold standard in measuring the treatment effect of new drug therapies for cancer. However, practical factors may preclude the collection of unconfounded OS data, and surrogate endpoints are often used instead. Meta-analyses have been widely used for the validation of surrogate endpoints, specifically in oncology.

The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years.

The Osteosarcoma Surveillance Study, an ongoing 15-year surveillance study initiated in 2003, is a postmarketing commitment to the United States (US) Food and Drug Administration to evaluate a potential association between teriparatide, rhPTH(1-34), a recombinant human parathyroid hormone analog (self-injectable medication to treat osteoporosis), and development of osteosarcoma in response to a finding from preclinical (animal) studies. Incident cases of primary osteosarcoma diagnosed in adults (aged ≥40 years) on or after January 1, 2003, are identified through population-based state, regional, and comprehensive cancer center registries in the US. Information on possible prior treatment with teriparatide, on demographics, and on risk factors is ascertained by patient or proxy telephone interview after patient consent.

Single-pill vs free-equivalent combination therapies for hypertension: a meta-analysis of health care costs and adherence.

This meta-analysis compares health care resource use costs, adherence, and persistence between groups of patients taking antihypertensives as single-pill combinations (SPCs) vs free-equivalent components (FEC) based on a structured review of published studies. The search yielded 12 retrospective database studies included in analyses. The mean difference in combined total annual all-cause and hypertension-related health care costs was $1357 (95% confidence interval [CI], $778-$1935) lower in favor of SPC than FEC groups.

Meta-analysis of the association between progression-free survival and overall survival in metastatic colorectal cancer.

Purpose: The validity of progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in metastatic colorectal cancer (mCRC) trials has been studied, primarily in first-line treatment. The relationship between PFS and OS has not been well studied in later lines of treatment.

Methods: We conducted a systematic literature review of mCRC phase 2 and 3 clinical trials that reported OS and PFS (or time-to-progression [TTP]) data.

Quality-adjusted survival analysis of first-line treatment of hormone-receptor-positive HER2+ metastatic breast cancer with letrozole alone or in combination with lapatinib.

Aim: Compare first-line lapatinib plus letrozole (L + Let) versus letrozole monotherapy (Let) in hormone-receptor-positive HER2 + metastatic breast cancer, employing Q-TWiST (quality-adjusted time without symptoms and toxicity) analysis to account for differences in progression times, with offsets for the impact of adverse events during the treatment period.

Methods: The area under survival curves for each treatment group was partitioned into distinct health states of varying utility: toxicity (TOX), time without toxicity or disease progression (TWiST), and the period following disease progression until death or end of follow-up (REL). The utility-weighted sum of the mean health state durations was derived for each group.

A Q-TWiST analysis comparing panitumumab plus best supportive care (BSC) with BSC alone in patients with wild-type KRAS metastatic colorectal cancer.

Background: Panitumumab+best supportive care (BSC) significantly improved progression-free survival (PFS) vs BSC alone in patients with chemo-refractory wild-type KRAS metastatic colorectal cancer (mCRC). We applied the quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) analysis to provide an integrated measure of clinical benefit, with the objective of comparing quality-adjusted survival between the two arms. As the trial design allowed patients on BSC alone to receive panitumumab after disease progression, which confounded overall survival (OS), the focus of this analysis was on PFS.

Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer.

Background: Progression-free survival (PFS) was significantly longer for the lapatinib plus trastuzumab (L+T) arm than for L alone in a phase III, randomized, open-label study of women with human epidermal growth factor receptor 2 positive metastatic breast cancer who had documented progression on at least one T-containing regimen in the metastatic setting. This analysis focused on impact of treatments on health-related quality of life (HRQOL).

Methods: HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire.

Urgency as an Endpoint in Irritable Bowel Syndrome.

Background: The choice of endpoints is crucial for proper evaluation of agents in clinical trials of irritable bowel syndrome (IBS). In a recently published draft guidance for IBS from the United States Food and Drug Administration (FDA), urgency was not considered an appropriate primary endpoint. The FDA's position is that it is not clear how patients with diarrhea-predominant IBS (D-IBS) "define or describe urgency".

Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

Background: Sigmoidoscopy/colonoscopy is usually performed prior to enrollment into clinical trials of irritable bowel syndrome (IBS). Two main reasons are to rule out alternative diagnoses and to ensure that colitis is not present. However, the possible impact of a recent versus remote colon procedure on symptoms in IBS trials has not been evaluated.

Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib.

Background: A phase III trial compared lapatinib plus letrozole (L + Let) with letrozole plus placebo (Let) as first-line therapy for hormone receptor (HR)(+) metastatic breast cancer (MBC) patients. The primary endpoint of progression-free survival (PFS) in patients whose tumors were human epidermal growth factor receptor (HER)-2(+) was significantly longer for L + Let than for Let (8.2 months versus 3 months; p = .

Impact of lapatinib monotherapy on QOL and pain symptoms in patients with HER2+ relapsed or refractory inflammatory breast cancer.

Objective: EGF103009 (ClinicalTrials.gov identifier: NCT00105950) was a phase 2, open-label, multicenter study that showed lapatinib monotherapy to be clinically active in women with relapsed or refractory HER2+ (ErbB2+) inflammatory breast cancer that progressed following prior therapy with anthracyclines, taxanes, and trastuzumab. The objective of the present study was to assess the impact of lapatinib on quality of life (QOL) and pain symptoms in these patients.

Impact of waist circumference difference on health-care cost among overweight and obese subjects: the PROCEED cohort.

Objective: To estimate the incremental effect of waist circumference (WC) on health-care costs among overweight and obese subjects after adjusting for body mass index (BMI).

Methods: A prospective study. The subjects were members of Internet panels in the United States (US) and Germany.

Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer.

Background: In a phase 3 randomized, multicenter, double-blind, placebo-controlled study, first-line therapy with lapatinib plus paclitaxel significantly improved clinical outcomes based on a pre-planned analysis of ErbB2+ metastatic breast cancer patients (GSK Study #EGF30001; ClinicalTrials.gov identifier: NCT00075270). Patients with ErbB2- or untested did not significantly benefit.