Acceptability of a novel vaginal microbicide during a safety trial among low-risk women

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.     

Shoulder magnetic resonance imaging findings in manual wheelchair users with spinal cord injury

Objective: To investigate the prevalence of rotator cuff and long head of the biceps pathologies in manual wheelchair (MWC) users with spinal cord injury (SCI).Design: Cross-sectional study.Setting: Outpatient clinic at a tertiary medical center.Participants: Forty-four adult MWC users with SCI (36 men and 8 women) with an average age (SD) of 42 (13) years. SCI levels ranged from C6 to L1; complete and incomplete SCI.Outcome Measures: Participants’ demographic and anthropometric information, presence of shoulder pain, Wheelchair User’s Pain Index (WUSPI) scores, and magnetic resonance imaging findings of shoulder pathologies including tendinopathy, tendon tears, and muscle atrophy.Results: Fifty-nine percent of the participants reported some shoulder pain. The prevalence of any tendinopathy across the rotator cuff and the long head of biceps tendon was 98%. The prevalence of tendinopathy in the supraspinatus was 86%, infraspinatus was 91%, subscapularis was 75%, and biceps was 57%. The majority of tendinopathies had mild or moderate severity. The prevalence of any tears was 68%. The prevalence of tendon tears in the supraspinatus was 48%, infraspinatus was 36%, subscapularis was 43%, and biceps was 12%. The majority of the tears were partial-thickness tears. Participants without tendon tears were significantly younger (P < 0.001) and had been wheelchair user for a significantly shorter time (P = 0.005) than those with tendon tears.Conclusion: Mild and moderate shoulder tendinopathy and partial-thickness tendon tears were highly prevalent in MWC users with SCI. Additionally, the findings of this study suggest that strategies for monitoring shoulder pathologies in this population should not be overly reliant on patient-reported pain, but perhaps more concerned with years of wheelchair use and age.     

ASO Visual Abstract: Impact of Endocrine Therapy Adherence on Outcomes in Elderly Women With Early-Stage Breast Cancer Undergoing Lumpectomy Without Radiotherapy

Annals of Surgical Oncology -     

Determinants of outcome in elderly patients with positive sentinel lymph nodes

Background

Older women are less likely to receive standard of care treatment for breast cancer.

Methods

We examined variables that affected the outcome of elderly patients ≥70 years old among 1,470 patients with invasive cancer with positive sentinel lymph nodes (SLNs).

Results

Elderly patients were less likely to undergo mastectomy, completion axillary node dissection (ALND), adjuvant chemotherapy, and radiotherapy (RT) following breast-conserving therapy (BCT) compared with patients <70 years old. The 5-year risk of disease progression and cumulative incidence of breast cancer–specific deaths were not significantly different for both groups. On multivariate analysis, hormone receptor–negative status, number of metastatic lymph nodes, high nuclear grade, and tumor size were the factors independently associated with increased risk of disease progression.

Conclusions

Tumor factors were the primary determinants of breast cancer outcomes in our cohort. Elderly patients are less likely to receive aggressive surgical interventions and adjuvant therapy because of perceived life expectancy.     

A population-based study of geriatric trauma in a rural state

BACKGROUND: Urban geriatric trauma patients are known to die more often than their younger counterparts. Little is known of the fate of geriatric trauma patients in a rural environment where delays to definitive treatment are frequent. We hypothesized that rural trauma patients would do worse than their urban counterparts because of prolonged delays to definitive care. METHODS: Five-year retrospective analysis of all trauma deaths occurring within a rural state and retrospective outcome analysis of trauma patients admitted to a tertiary care facility who were less than 55 years old (defined as young) and 55 or more years old (defined as old). Outcome analysis was performed comparing old and young rural hospitalized patients to the Major Trauma Outcome Study data set collected in major urban trauma centers. RESULTS: Of the total trauma deaths in the state, 32.5% were old. Old patients were less likely to die at the scene of the injury than were their younger counterparts (R2 = 0.84, p < 0.001). Hospitalized old patients had a significantly higher mean Revised Trauma Score and a significantly lower Injury Severity Score, a higher complication rate, and a higher mortality rate than did hospitalized young patients. The young group had a significantly better survival (W = 0.59, Z = -3.49, p = 0.0001) than the MTOS data set, but the old group had a significantly worse survival (W = -1.8, Z = -3.49, p = 0.001). CONCLUSION: In a rural environment, old trauma patients die more commonly in the hospital than their younger counterparts, who die more commonly at the scene. Old trauma patients who die in the hospital were less severely injured than their younger counterparts who died in the hospital. Old patients admitted to this rural trauma center have a significantly worse survival than their urban counterparts despite the fact that young rural trauma patients do significantly better than their urban counterparts. Understanding the demographics of rural geriatric trauma may be useful in allocating resources in rural trauma system design. It must be understood that despite relatively low injury severity and physiologic stability, there is a significant potential for rural geriatric trauma patients to do poorly.     

The dilemma of DCIS

The increasingly frequent diagnosis of ductal carcinoma in situ (DCIS) presents a major clinical dilemma. Our inability to predict which DCIS will progress to invasive cancer or the time interval in which recurrent DCIS or invasive cancer will occur has resulted in treatments ranging from mastectomy to excision and observation being offered to patients. Four randomized trials have demonstrated that the use of radiation reduces the risk of local recurrence by about 50% in women with DCIS. Prospective attempts to duplicate retrospective findings that wide excision results in high rates of local control have been unsuccessful. Patient attitudes towards risks and benefits of treatment are an important component of treatment choice in the absence of predictors of biologic behavior.     

Variation in susceptibility to atherosclerosis among inbred strains of mice

The effect of short-term exercise withdrawal on plasma lipoproteins, apoprotein A-I (Apo A-I), and lecithin:cholesterol acyltransferase (LCAT) was studied in moderately trained lifestyle exercisers. Eight endurance-trained men, age 18-45 years (means = 29 years), withdrew from aerobic activity for 6 weeks, while an age and fitness-matched control group (n = 9) maintained normal exercise habits. A baseline period that included two blood samplings preceded the detraining intervention. Plasma total cholesterol (TCHOL), HDL cholesterol (HDL-C) and triglyceride (TG) levels were determined weekly. Other blood variables (HDL2-C, HDL3-C, Apo A-I, and LCAT), % fat, and aerobic capacity (VO2max) were measured pre-, mid-, and post-experiment. A two-way repeated measures analysis of variance (ANOVA) indicated that the 6-week exercise withdrawal period failed to elicit significant mean changes in any blood variable, % fat, or VO2max. Therefore, a short-term layoff from aerobic activity by moderately trained, chronic exercisers generally does not adversely affect the blood lipoprotein profile or aerobic capacity.