Citations

Abstract Introduction: While effective Brief Tobacco Interventions (BTIs) are available for cigarette smoking and smokeless tobacco, given the changing prevalence of tobacco and nicotine containing products (TNCPs), there is a need for interventions targeting a broader range of TNCPs (eg, cigarettes, smokeless tobacco, electronic cigarettes, and hookah). The purpose of the current investigation was to evaluate the efficacy of a BTI, a 40-minute intervention designed to intervene on four TNCPs in a sample of US military personnel during an 11-week period of involuntary tobacco abstinence, for reducing intentions to use TNCPs and increasing perceptions of harm of TNCPs. Methods: The BTI was administered to 1055 Airmen enrolled in Technical Training in the US Air Force. Assessments of perceived harm and intentions to use nine TNCPs (cigarettes, smokeless tobacco, snus, cigars, cigarillos, pipe, e-cigarettes, roll your own cigarettes, and hookah), were assessed at pretest and posttest (immediately following the BTI). Results: Significant increases in perceived harm were observed across all nine TNCPs (all P < .0001) for both users and nonusers. Intentions to use TNCPs were significantly reduced for most products but mainly among users. Conclusions: Results suggested that a BTI shows promise for impacting TNCP use in a military population. Further research should evaluate the behavioral outcomes (tobacco use) as a result of the intervention. Implications: Given that there are 220 000 new trainees in the military every year, the public health implications of an effective BTI targeting the most commonly used TNCPs for military trainees is considerable.

Hodgkin lymphoma is a rare lymphoid malignancy affecting ∼9,200 new patients in the United States annually. Progress in the management of this disease over the past 50 years has been remarkable and the prognosis of this malignancy has changed from a uniformly fatal process to one in which the vast majority of patients are expected to be cured. This remarkable progress has been due to the use of combination approaches incorporating chemotherapy and radiation therapy, and now more recently antibody‐drug conjugates and immune checkpoint inhibitors. The goal for the future is to develop treatment combinations that successfully treat all patients and markedly decrease the long‐term side effects. Am. J. Hematol. 91:109–112, 2016. © 2015 Wiley Periodicals, Inc.

Objectives To determine the incidence and 1‐year outcomes of an elderly population with perioperative atrial arrhythmia (PAA) within 7 days of hip fracture surgery. Design Retrospective cohort study. Setting The Rochester Epidemiology Project (REP). Participants Elderly adults consecutive undergoing hip fracture repair from 1988 to 2002 in Olmsted County, Minnesota (N = 1,088, mean age 84.0 ± 7.4, 80.2% female). Measurements Baseline clinical variables were analyzed in relation to survival using Cox proportional hazards methods for comparison. Results Sixty‐one participants (5.6%) developed PAA within the first 7 days. During 1 year of follow‐up, 239 (22%) participants died. PAA was associated with greater mortality (45% vs 21%; hazard ratio (HR) = 2.8, 95% confidence interval (CI) = 1.9–4.2). Other mortality risk factors were male sex (HR = 2.0, 95% CI = 1.5–2.6), congestive heart failure (HR = 2.1, 95% CI = 1.7–2.8), chronic renal insufficiency (HR = 2.0, 95% CI = 1.5–2.8), dementia (HR = 2.9, 95% CI = 2.2–3.7), and American Society of Anesthesiologists risk Class III, IV, or V (HR = 3.3, 95% CI = 1.9–5.9). Conclusion Elderly adults undergoing hip fracture surgery who develop PAA within 7 days have significantly higher 1‐year mortality than those who do not. Further studies are indicated to determine whether prevention of PAA will reduce mortality in this population.

Objectives To determine the proportion of nursing home ( NH ) residents ( NHR ) with overactive bladder ( OAB ) or urinary incontinence ( UI ) with potential pharmacodynamic contraindications to antimuscarinic treatment because of concomitant anticholinergic medications or acetylcholinesterase inhibitors ( AC h EI s) and nonpharmacological limitations to antimuscarinic treatment. Design Cross‐sectional retrospective analysis. Setting U.S. skilled nursing facilities. Participants Nursing home residents with a diagnosis of OAB or UI . Measurements Linked and deidentified pharmacy claims and Minimum Data Set ( MDS ) 3.0 records (October 1, 2010 to September 30, 2012). Results Of NHR s, 71.3% received at least one anticholinergic medication. Medications that can cause or worsen UI were used commonly. AC h EI s and antimuscarinic treatment were prescribed concurrently in 24% of NHR s with OAB or UI . NHR s with OAB or UI were more likely to have concurrent moderate to severe cognitive impairment ( MSCI ) (70.1%) than those without (29.9%) ( P < .001). NHR s with or without OAB or UI and with MSCI were more likely to be treated with an anticholinergic medication than those without MSCI ( P = .001). When NHR s with MSCI , severe mobility impairment ( SMI ), and anticholinergic medication and AC h EI use were excluded, only a small proportion of NHR s were potential candidates for antimuscarinic treatment (6.6% with OAB or UI , 6.2% with UI ). Conclusions This study advances understanding of the challenges in prescribing antimuscarinic treatment safely and appropriately in elderly NHR s with a high prevalence of drug interactions, underlying MSCI , and SMI .

Purpose Phase II clinical trials inform go/no-go decisions for proceeding to phase III trials, and appropriate end points in phase II trials are critical for facilitating this decision. Phase II solid tumor trials have traditionally used end points such as tumor response defined by Response Evaluation Criteria for Solid Tumors (RECIST). We previously reported that absolute and relative changes in tumor measurements demonstrated potential, but not convincing, improvement over RECIST to predict overall survival (OS). We have evaluated the metrics by using additional measures of clinical utility and data from phase III trials. Methods Resampling methods were used to assess the clinical utility of metrics to predict phase III outcomes from simulated phase II trials. In all, 2,000 phase II trials were simulated from four actual phase III trials (two positive for OS and two negative for OS). Cox models for three metrics landmarked at 12 weeks and adjusted for baseline tumor burden were fit for each phase II trial: absolute changes, relative changes, and RECIST. Clinical utility was assessed by positive predictive value and negative predictive value, that is, the probability of a positive or negative phase II trial predicting an effective or ineffective phase III conclusion, by prediction error, and by concordance index (c-index). Results Absolute and relative change metrics had higher positive predictive value and negative predictive value than RECIST in five of six treatment comparisons and lower prediction error curves in all six. However, differences were negligible. No statistically significant difference in c-index across metrics was found. Conclusion The absolute and relative change metrics are not meaningfully better than RECIST in predicting OS.

Purpose Patients with metastatic rhabdomyosarcoma (RMS), except those younger than 10 years with embryonal RMS, have an estimated long-term event-free survival (EFS) of less than 20%. The main goal of this study was to improve outcome of patients with metastatic RMS by dose intensification with interval compression, use of the most active agents determined in phase II window studies, and use of irinotecan as a radiation sensitizer. Patients and Methods Patients with metastatic RMS received 54 weeks of therapy: blocks of therapy with vincristine/irinotecan (weeks 1 to 6, 20 to 25, and 47 to 52), interval compression with vincristine/doxorubicin/cyclophosphamide alternating with etoposide/ifosfamide (weeks 7 to 19 and 26 to 34), and vincristine/dactinomycin/cyclophosphamide (weeks 38 to 46). Radiation therapy occurred at weeks 20 to 25 (primary) but was also permitted at weeks 1 to 6 (for intracranial or paraspinal extension) and weeks 47 to 52 (for extensive metastatic sites). Results One hundred nine eligible patients were enrolled, with a median follow-up of surviving patients of 3.8 years (3-year EFS for all patients, 38% [95% CI, 29% to 48%]; survival, 56% [95% CI, 46% to 66%]). Patients with one or no Oberlin risk factor (age > 10 years or < 1 year, unfavorable primary site of disease, ≥ three metastatic sites, and bone or bone marrow involvement) had a 3-year EFS of 69% (95% CI, 52% to 82%); high-risk patients with two or more risk factors had a 3-year EFS of 20% (95% CI, 11% to 30%). Toxicity was similar to that on prior RMS studies. Conclusion Patients with metastatic RMS with one or no Oberlin risk factor had an improved 3-year EFS of 69% on ARST0431 compared with an historical cohort from pooled European and US studies; those with two or more risk factors have a dismal prognosis, and new approaches are needed for this very-high-risk group.

Purpose In recent retrospective analyses of early-stage colorectal cancer (CRC), low and high body mass index (BMI) scores were associated with worsened outcomes. Whether BMI is a prognostic or predictive factor in metastatic CRC (mCRC) is unclear. Patients and Methods Individual data from 21,149 patients enrolled onto 25 first-line mCRC trials during 1997 to 2012 were pooled. We assessed both prognostic and predictive effects of BMI on overall survival and progression-free survival, and we accounted for patient and tumor characteristics and therapy type (targeted v nontargeted). Results BMI was prognostic for overall survival (P < .001) and progression-free survival (P < .001), with an L-shaped pattern. That is, risk of progression and/or death was greatest for low BMI; risk decreased as BMI increased to approximately 28 kg/m 2 , and then it plateaued. Relative to obese patients, patients with a BMI of 18.5 kg/m 2 had a 27% increased risk of having a PFS event (95% CI, 20% to 34%) and a 50% increased risk of death (95% CI, 43% to 56%). Low BMI was associated with poorer survival for men than women (interaction P < .001). BMI was not predictive of treatment effect. Conclusion Low BMI is associated with an increased risk of progression and death among the patients enrolled on the mCRC trials, with no increased risk for elevated BMI, in contrast to the adjuvant setting. Possible explanations include negative effects related to cancer cachexia in patients with low BMI, increased drug delivery or selection bias in patients with high BMI, and potential for an interaction between BMI and molecular signaling pathways.

Abstract Posterior cruciate ligament (PCL) injuries account for nearly 20% of knee ligament injuries. PCL injuries can occur in isolation or, more commonly, in the setting of multiligamentous knee injuries. Isolated PCL disruptions are commonly treated nonoperatively; however, symptomatic grade III injuries, as well as PCL injuries found in multiligamentous injuries, are frequently treated surgically. Several reconstructive techniques exist for the treatment of PCL deficiency without a clear optimal approach. We describe our preferred operative technique to reconstruct the PCL using an all‐inside arthroscopic approach with a quadrupled tibialis anterior or peroneus longus allograft with both tibial and femoral suspensory fixation. Technique Video video See video under supplementary data.