Lessons learned from community-based minority health care serving system participation in an NIH clinical trial

To address the historically low rate of minority participation in clinical trials, the NIH and others have provided incentives to increase the diversity of patients and study sites involved in NIH-funded research. An example of the efforts to achieve this aim was the creation of the Partnerships Program to Reduce Cardiovascular Health Disparities," whereby a health care system that serves a predominantly minority patient population partners with a research-intensive medical center that has a track record of NIH-supported research. In the city of Baltimore, Maryland, the Bon Secours Baltimore Health System partnered with the University of Maryland and was awarded 1 of 7 U01 partnerships within cardiovascular health. This commentary describes the qualitative experiences of the participating physicians and not a quantitative analysis of the study data or findings. It describes the lessons learned by Bon Secours that can address patient and physician barriers to clinical trial participation. Based upon the views of participating physicians, it is easiest to engage physicians when there is a supportive principal investigator and appropriate infrastructure to do research. Patient recruitment requires cultural competence and sensitivity, and using minority physicians, nurses, and staff may greatly assist in building the trust that is necessary for patients to be willing to participate in research. Clarity of the study's purpose and aims at the outset is critical, and reinforcement with educational sessions helped with physician and patient retention throughout the study.     

Therapy Insight: fertility in women after cancer treatment

Cancer is the second-commonest cause of death in women under 40 years of age in Western Europe and the US. The survival of cancer patients has, nevertheless, improved during the past two decades. During this period, and especially during the last decade, there have been ground-breaking advances in the optimization of the quality of life of patients treated for cancer, in particular by the development of fertility-enhancing and fertility-preserving procedures in young patients treated for cancer. Surgery, chemotherapy and radiation therapy affect the fertility potential of women in different ways. Surgery to remove the uterus and ovaries has a direct impact on fertility. Radiation therapy (external or brachytherapy) can affect ovarian and also uterine function. Different drugs used in chemotherapy can directly influence ovarian function. Some markers have now been evaluated that are predictive of the potential toxic injury to the gonads and uterus. Various procedures have been proposed to preserve the fertility potential in women before anticancer treatment begins or after the tumor is treated; however, such optimization of management should only be undertaken if it does not have a deleterious effect on the survival of the patient.     

American College of Sports Medicine position stand. The female athlete triad

The female athlete triad (Triad) refers to the interrelationships among energy availability, menstrual function, and bone mineral density, which may have clinical manifestations including eating disorders, functional hypothalamic amenorrhea, and osteoporosis. With proper nutrition, these same relationships promote robust health. Athletes are distributed along a spectrum between health and disease, and those at the pathological end may not exhibit all these clinical conditions simultaneously. Energy availability is defined as dietary energy intake minus exercise energy expenditure. Low energy availability appears to be the factor that impairs reproductive and skeletal health in the Triad, and it may be inadvertent, intentional, or psychopathological. Most effects appear to occur below an energy availability of 30 kcal.kg(-1) of fat-free mass per day. Restrictive eating behaviors practiced by girls and women in sports or physical activities that emphasize leanness are of special concern. For prevention and early intervention, education of athletes, parents, coaches, trainers, judges, and administrators is a priority. Athletes should be assessed for the Triad at the preparticipation physical and/or annual health screening exam, and whenever an athlete presents with any of the Triad's clinical conditions. Sport administrators should also consider rule changes to discourage unhealthy weight loss practices. A multidisciplinary treatment team should include a physician or other health-care professional, a registered dietitian, and, for athletes with eating disorders, a mental health practitioner. Additional valuable team members may include a certified athletic trainer, an exercise physiologist, and the athlete's coach, parents and other family members. The first aim of treatment for any Triad component is to increase energy availability by increasing energy intake and/or reducing exercise energy expenditure. Nutrition counseling and monitoring are sufficient interventions for many athletes, but eating disorders warrant psychotherapy. Athletes with eating disorders should be required to meet established criteria to continue exercising, and their training and competition may need to be modified. No pharmacological agent adequately restores bone loss or corrects metabolic abnormalities that impair health and performance in athletes with functional hypothalamic amenorrhea.     

Evaluation of the topical anti-inflammatory activity of ginger dry extracts from solutions and plasters

In this study the skin permeation and the topical anti-inflammatory properties of ginger extracts were investigated. A commercial ginger dry extract (DE) and a gingerols-enriched dry extract (EDE) were evaluated for their in vivo topical anti-inflammatory activity by inhibition of Croton oil-induced ear oedema in mice. Furthermore, the feasibility of an anti-inflammatory plaster containing DE or EDE was evaluated. Since the in vivo activity was evaluated in mice, the ex vivo skin permeation study was performed by using mouse skin or human epidermis. The DE from the acetonic solution exerted a dose-dependent topical anti-inflammatory activity (ID (50) = 142 microg/cm (2)), not far from that of the potent reference substance indomethacin (ID (50) = 93 microg/cm (2)). Similarly, the EDE induced a dose-dependent oedema reduction though its potency (ID (50) = 181 microg/cm (2)) was slightly lower than that of DE. Increase of the 6-gingerol concentration in the extract did not improve the anti-inflammatory activity. The medicated plasters, containing 1 mg/cm (2) of the commercial DE or EDE, had good technological characteristics and exerted a significant antiphlogistic effect, too. By using the plaster containing EDE, the 6-gingerol amount that permeated through human epidermis was 6.9 microg/cm (2) while the amount that passed through mouse skin was 22.1 microg/cm (2). Nevertheless, the amounts of 6-gingerol permeated through human epidermis and mouse skin in the early period (8h) were comparable (p > 0.3). This preliminary result suggests that the anti-inflammatory effect observed in mice could also be exerted in humans.     

Relationship Between Literacy, Knowledge, Self-Care Behaviors, and Heart Failure-Related Quality of Life Among Patients With Heart Failure

BACKGROUND

We sought to examine the relationship between literacy and heart failure-related quality of life (HFQOL), and to explore whether literacy-related differences in knowledge, self-efficacy and/or self-care behavior explained the relationship.

METHODS

We recruited patients with symptomatic heart failure (HF) from four academic medical centers. Patients completed the short version of the Test of Functional Health Literacy in Adults (TOFHLA) and questions on HF-related knowledge, HF-related self-efficacy, and self-care behaviors. We assessed HFQOL with the Heart Failure Symptom Scale (HFSS) (range 0?C100), with higher scores denoting better quality of life. We used bivariate (t-tests and chi-square) and multivariate linear regression analyses to estimate the associations between literacy and HF knowledge, self-efficacy, self-care behaviors, and HFQOL, controlling for demographic characteristics. Structural equation modeling was conducted to assess whether general HF knowledge, salt knowledge, self-care behaviors, and self-efficacy mediated the relationship between literacy and HFQOL.

RESULTS

We enrolled 605 patients with mean age of 60.7 years; 52% were male; 38% were African-American and 16% Latino; 26% had less than a high school education; and 67% had annual incomes under $25,000. Overall, 37% had low literacy (marginal or inadequate on TOFHLA). Patients with adequate literacy had higher general HF knowledge than those with low literacy (mean 6.6 vs. 5.5, adjusted difference 0.63, p?p?p?p?CONCLUSION Low literacy was associated with worse HFQOL and lower HF-related knowledge, self-efficacy, and self-care behaviors, but differences in knowledge, self-efficacy and self-care did not explain the relationship between low literacy and worse HFQOL.     

Hemolysis parameters of St. Jude Medical: Hemodynamic Plus and Regent valves in aortic position

BACKGROUND: Elevated plasma lactate dehydrogenase (LDH) concentration may reflect hemolysis due to mechanical heart valve dysfunction. Thus, knowledge of LDH levels in patients with properly working prostheses is required. Because hemolysis parameters for the SJM Hemodynamic Plus (HP) and Regent series are currently not available, the purpose of our study was to determine these data. METHODS: At 12-19 months follow-up after isolated aortic valve replacement with SJM HP(R) or Regent prostheses, we examined 102 patients by transthoracic echocardiography and determined plasma LDH, haptoglobin, bilirubin and hemoglobin. RESULTS: Five patients with properly working prostheses were excluded because of increased LDH due to non-cardiac reasons. In four patients with paravalvular leakage, LDH was 244, 307, 446 and 628 U/l, respectively. In patients with properly working prostheses, LDH was 287+/-52 (range: 163-374) U/l for HP(R) (n=33) and 274+/-48 (151-386) U/l for Regent valves (n=60, p=0.2). Haptoglobin was <1g/l in all patients; in 91% of HP and 75% of Regent valves, haptoglobin was below detection limit. Bilirubin and hemoglobin as well as red blood cell count (RBC) were normal in all patients except for five patients with renal anemia, two patients with paravalvular leakage and four patients with macrocytosis due to alcohol abuse. There was no correlation between LDH and transvalvular gradient (r=-0.02) or valve size (r=0.25). CONCLUSIONS: In patients with SJM HP(R) or Regent valves in aortic position, LDH values > 400 U/l indicate valvular dysfunction or leakage if non-cardiac causes for hemolysis are excluded. However, paravalvular leakage can be present without substantially increased LDH. Haptoglobin has no diagnostic value as it is almost always markedly reduced. Hemolysis does not correlate with transvalvular gradient or prosthesis size.