Publications

PURPOSE

Patient participation in cancer clinical trials is imperative to the advancement of medical science. Physicians play an important role in recruitment by discussing clinical trials with their cancer patients. Patient-physician discussion is influenced by many factors relating to the physician, the patient, and the healthcare system.

METHODS

Physicians selected from the 2008-2009 American Medical Association Physician Masterfile who practiced in California, Florida, Illinois, or New York and specialized in medical oncology, surgery, or radiation oncology were surveyed about their attitudes and practices with respect to breast cancer clinical trials. Practice types were categorized according to the classifications provided by the American College of Surgeons, and clinical trial and practice addresses were geocoded.

RESULTS

Surveys were completed by 706 of 1,534 eligible physicians (46 %). Medical oncologists were more likely than surgical or radiation oncologists to discuss the possibility, benefits, and risks of clinical trial enrollment with their breast cancer patients. Physicians who spent the most time in patient care were least likely to discuss clinical trials with their patients. Distance from a physician's practice to the nearest clinical trial site was inversely associated with referral and recruitment. Perceived barriers to clinical trial participation were associated with greater referral activity suggesting that physicians who were more involved in trials were also more likely to understand barriers to participation.

CONCLUSIONS

Multilevel interventions may be successful at increasing participation of women in clinical trials.

BACKGROUND

The purpose of this study was to evaluate trends in awareness of cardiovascular disease (CVD) risk among women between 1997 and 2012 by racial/ethnic and age groups, as well as knowledge of CVD symptoms and preventive behaviors/barriers.

METHODS AND RESULTS

A study of awareness of CVD was conducted by the American Heart Association in 2012 among US women >25 years of age identified through random-digit dialing (n=1205) and Harris Poll Online (n=1227), similar to prior American Heart Association national surveys. Standardized questions on awareness were given to all women; additional questions about preventive behaviors/barriers were given online. Data were weighted, and results were compared with triennial surveys since 1997. Between 1997 and 2012, the rate of awareness of CVD as the leading cause of death nearly doubled (56% versus 30%; P<0.001). The rate of awareness among black and Hispanic women in 2012 (36% and 34%, respectively) was similar to that of white women in 1997 (33%). In 1997, women were more likely to cite cancer than CVD as the leading killer (35% versus 30%), but in 2012, the trend reversed (24% versus 56%). Awareness of atypical symptoms of CVD has improved since 1997 but remains low. The most common reasons why women took preventive action were to improve health and to feel better, not to live longer.

CONCLUSIONS

Awareness of CVD among women has improved in the past 15 years, but a significant racial/ethnic minority gap persists. Continued effort is needed to reach at-risk populations. These data should inform public health campaigns to focus on evidenced-based strategies to prevent CVD and to help target messages that resonate and motivate women to take action.

OBJECTIVE

To evaluate the reliability and validity of a standardized measure of healthcare personnel (HCP) influenza vaccination.

SETTING

Acute care hospitals, long-term care facilities, ambulatory surgery centers, physician practices, and dialysis centers from 3 US jurisdictions.

PARTICIPANTS

Staff from 96 healthcare facilities randomly sampled from 234 facilities that completed pilot testing to assess the feasibility of the measure.

METHODS

Reliability was assessed by comparing agreement between facility staff and project staff on the classification of HCP numerator (vaccinated at facility, vaccinated elsewhere, contraindicated, declined) and denominator (employees, credentialed nonemployees, other nonemployees) categories. To assess validity, facility staff completed a series of case studies to evaluate how closely classification of HCP groups aligned with the measure's specifications. In a modified Delphi process, experts rated face validity of the proposed measure elements on a Likert-type scale.

RESULTS

Percent agreement was high for HCP vaccinated at the facility (99%) and elsewhere (95%) and was lower for HCP who declined vaccination (64%) or were medically contraindicated (64%). While agreement was high (more than 90%) for all denominator categories, many facilities' staff excluded nonemployees for whom numerator and denominator status was difficult to determine. Validity was lowest for credentialed and other nonemployees.

CONCLUSIONS

The standardized measure of HCP influenza vaccination yields reproducible results for employees vaccinated at the facility and elsewhere. Adhering to true medical contraindications and tracking declinations should improve reliability. Difficulties in establishing denominators and determining vaccination status for credentialed and other nonemployees challenged the measure's validity and prompted revision to include a more limited group of nonemployees.

A variety of foreign "invaders" such as viruses, bacteria and other particulates e.g., cigarette smoke, are inhaled, deposit on the airway surface and invade the "host." Mucins produced by the surface airway epithelium and by the submucosal glands are secreted into the airway lumen. Deposited particulates adhere to the mucus and are cleared via mucociliary transport and via cough. Mucins are major constituents of mucus, which is important in the clearance of inhaled materials. Normally, secreted mucus is cleared without symptoms or interference with lung function. However, in obstructive airway diseases such as COPD, asthma, and cystic fibrosis, excessive mucus is produced. Because of the prominence of mucous hypersecretion as a cause of cough, this discussion focuses on mechanisms regulating normal production of mucins and the mechanisms underlying exaggerated mucin secretion in chronic obstructive airway diseases. Mucins are produced by airway epithelial cells via a cascade of signals (the Epidermal Growth Factor Cascade) and secreted on the luminal epithelial surface, often in response to the deposition of inhaled irritants. Normally, only minimal amounts of mucins are secreted, which assist in clearance of the inhaled particulates. However, in disease, additional pathways are induced via positive feedback systems, which lead to mucous hypersecretion. In the large conducting airways, where cough receptors are concentrated, mucous hypersecretion causes stimulation of neural receptors that result in cough. However, in small airways (e.g., bronchioles), because of their small diameters, mucous hypersecretion leads to plugging of the airways. Because there are so many small airways, their plugging is difficult to detect early, and this locus is known as a "silent zone." In chronic obstructive airway diseases, plugging of small airways may persist and increase over time, finally resulting in severe airway obstruction. Different obstructive airway diseases induce inflammatory signaling (including mucous hypersecretion) via different stimuli, but often via similar signaling pathways. Application of present knowledge of signaling that occurs with mucous hypersecretion can lead to novel therapies for hypersecretion and cough induced in conducting airways and could prevent plugging in small airways that can lead to clinical deterioration and death.

Quantification of minimal residual disease (MRD) following allogeneic hematopoietic cell transplantation (allo-HCT) predicts post-transplant relapse in patients with chronic lymphocytic leukemia (CLL). We utilized an MRD-quantification method that amplifies immunoglobulin heavy chain (IGH) loci using consensus V and J segment primers followed by high-throughput sequencing (HTS), enabling quantification with a detection limit of one CLL cell per million mononuclear cells. Using this IGH-HTS approach, we analyzed MRD patterns in over 400 samples from 40 CLL patients who underwent reduced-intensity allo-HCT. Nine patients relapsed within 12 months post-HCT. Of the 31 patients in remission at 12 months post-HCT, disease-free survival was 86% in patients with MRD <10(-4) and 20% in those with MRD ≥10(-4) (relapse hazard ratio (HR) 9.0; 95% confidence interval (CI) 2.5-32; P<0.0001), with median follow-up of 36 months. Additionally, MRD predicted relapse at other time points, including 9, 18 and 24 months post-HCT. MRD doubling time <12 months with disease burden ≥10(-5) was associated with relapse within 12 months of MRD assessment in 50% of patients, and within 24 months in 90% of patients. This IGH-HTS method may facilitate routine MRD quantification in clinical trials.