Sex differences in osteoporosis self-efficacy among community-residing older adults presenting for DXA.

The Osteoporosis Self Efficacy Scale was determined to equivalently measure calcium and exercise beliefs in both sexes. Despite data illustrating men's and women's similar self-efficacy, gender differences in clinical predictors of self-efficacy imply that efforts to improve care must account for more than self-efficacy. INTRODUCTION: To understand the extent to which the Osteoporosis Self Efficacy (OSE) Scale is reliable for both men and women. A secondary objective was to evaluate sex differences in OSE. METHODS: For this cross-sectional study, we analyzed data collected as part of the Patient Activation after DXA Result Notification (PAADRN) pragmatic trial which enrolled 7749 community-residing adults aged 50 and older reporting for bone densitometry. We used univariable methods, item analysis, exploratory and confirmatory factor analyses, and linear regression to evaluate sex differences in OSE responses and measurement. RESULTS: In this sample, the confirmatory factor analysis model for OSE both overall and within groups indicated a poor fit. The sex differences in the measurement model, however, were minor and reflected configural invariance (i.e., constructs were measuring the same things in both men and women), confirming that the OSE was measuring the same constructs in men and women. Men overall had higher exercise self-efficacy and women higher calcium self-efficacy. Overall, education, hip fracture, and self-reported health status predicted exercise self-efficacy whereas prior DXA, self-reported osteoporosis, and history of pharmacotherapy use did not. Predictors of calcium self-efficacy differed by gender. CONCLUSION: The OSE can be used to measure calcium and exercise self-efficacy in all older adults. However, gender differences in clinical predictors of self-efficacy and the lack of an association of prior DXA with self-efficacy imply that interventions to improve self-efficacy may be insufficient to drive significant improvement in rates of osteoporosis evaluation and treatment. TRIAL REGISTRATION: Patient Activation after DXA Result Notification (PAADRN), NCT01507662, https://clinicaltrials.gov/ct2/show/NCT01507662.

Validity, reliability, and responsiveness to change of the "Osteoporosis and You" knowledge scale.

We studied the Osteoporosis and You knowledge scale in 7749 participants enrolled in a clinical trial. Results confirmed its psychometric properties in a diverse audience. Baseline scores were associated with better recall of bone mineral density test results at follow-up; however, the scale was not responsive to knowledge change. INTRODUCTION: The goal of this study was to confirm the measurement properties of the Osteoporosis and You (O&Y) knowledge scale using classic test theory methods in the 7749 men and women participating in the Patient Activation After DXA Result Notification (PAADRN) randomized controlled trial. We hypothesized a simple factor structure that would reflect the four-factor model previously published. METHODS: We conducted psychometric analyses which included item analysis, internal consistency reliability, construct validity using exploratory and confirmatory factor analysis (EFA and CFA), comparing knowledge levels across pre-specified groups, and responsiveness to change. RESULTS: PAADRN participants were predominantly college educated, White females with low bone density, and a moderate level of 10-year fracture risk. EFA revealed four domains closely matching those in two previous reports. While overall scale reliability was minimally acceptable at 0.68, the reliabilities of the domain subscales were unacceptably low (0.59, 0.64, 0.45, and 0.36 for the Biological, Lifestyle, Consequences, and Prevention and Treatment subscales). CFA revealed the data fit the hypothesized model reasonably well with the items loading on their expected latent variable. The scale was not responsive to change, but although not significant, improved knowledge indicated better DXA result recall at 12 and 52 weeks. CONCLUSIONS: In the PAADRN population, the O&Y knowledge scale had psychometric properties similar to those previously reported. Over 12 and 52 weeks, participants did not demonstrate significant changes in knowledge, but those with higher knowledge at baseline were more likely to accurately recall their baseline DXA result.

The cost of a patient activation intervention for achieving successful outcomes: results from the PAADRN randomized controlled trial.

In a large, pragmatic clinical trial, we calculated the costs of achieving four successful patient-centered outcomes using a tailored patient activation DXA result letter accompanied by a bone health brochure. The cost to achieve one successful outcome (e.g., a 0.5 standard deviation improvement in care satisfaction) ranged from $127.41 to $222.75. INTRODUCTION: Pragmatic randomized controlled trials (RCTs) should focus on patient-centered outcomes and report the costs for achieving those outcomes. We calculated per person incremental intervention costs, the number-needed-to-treat (NNT), and incremental per patient costs (cost per NNT) for four patient-centered outcomes in a direct-to-patient bone healthcare intervention. METHODS: The Patient Activation after DXA Result Notification (PAADRN) pragmatic RCT enrolled 7749 patients presenting for DXA at three health centers between February 2012 and August 2014. Interviews occurred at baseline and 52 weeks post-DXA. Intervention subjects received an individually tailored DXA result letter accompanied by an educational bone health brochure 4 weeks post-DXA, while the usual care subjects did not. Outcomes focused on patients (a) correctly identifying their results, (b) contacting their providers, (c) discussing their results with their providers, and (d) satisfaction with their bone healthcare. NNTs were determined using intention-to-treat linear probability models, per person incremental intervention costs were calculated, and costs per NNT were computed. RESULTS: Mean age was 66.6 years old, 83.8% were women, and 75.3% were non-Hispanic whites. The incremental per patient cost (costs per NNT) to increase the ability of a patient to (a) correctly identify their DXA result was $171.07; (b) contact their provider about their DXA result was $222.75; (c) discuss their DXA result with their provider was $193.55; and (d) achieve a 0.5 SD improvement in satisfaction with their bone healthcare was $127.41. CONCLUSION: An individually tailored DXA result letter accompanied by an educational brochure can improve four patient-centered outcomes at a modest cost. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01507662.

The effects of a patient activation intervention on smoking and excessive drinking cessations: results from the PAADRN randomized controlled trial.

Patients may exhibit risky bone health behaviors. In a large pragmatic clinical trial, we tested whether a tailored patient activation DXA result letter accompanied by a bone health brochure led to smoking and excessive drinking cessations. The intervention did not, however, alter these risky bone health behaviors. INTRODUCTION: Besides dual-energy x-ray absorptiometry (DXA) screening and pharmacotherapy when indicated, beneficial bone health behaviors including proper calcium and vitamin D intake and weight-bearing and muscle-strengthening exercise should be encouraged. Similarly, risky bone health behaviors like smoking and excessive drinking should be discouraged. We examined whether a direct-to-patient activation intervention led to smoking and excessive drinking cessations. METHODS: The Patient Activation after DXA Result Notification (PAADRN) pragmatic clinical trial enrolled 7749 patients between February 2012 and August 2014. Interviews occurred at baseline and 12 and 52 weeks later. Intervention subjects were mailed an individually tailored DXA results letter accompanied by a bone health educational brochure 4 weeks post-DXA. Usual care subjects were not sent these materials. Smoking and excessive drinking were assessed by self-report at each interview. Intention-to-treat linear probability models were used. RESULTS: Mean age was 66.6 years, 83.8% were women, and 75.3% were Non-Hispanic-Whites. Smoking was reported at baseline by 7.6% of the intervention group vs. 7.7% of the usual care group (p = 0.873). Excessive drinking was reported at baseline by 6.5% of the intervention group vs. 6.5% of the usual care group (p = 0.968). Intention-to-treat analyses indicated no significant differences between the intervention vs. usual care groups at either 12 or 52 weeks post-DXA (all p values ≥ 0.346). CONCLUSION: An individually tailored DXA result letter accompanied by an educational brochure did not lead to smoking or excessive drinking cessations in patients who received DXA. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01507662.

Predictors of bone mineral density testing among older women on Medicare.

Although dual-energy X-ray absorptiometry (DXA) is recommended for all women ≥65 and is covered by Medicare, 40 % of women on Medicare report never having had a DXA. In a longitudinal cohort of 3492 women followed for two decades, we identified several risk factors that should be targeted to improve DXA testing rates. INTRODUCTION: DXA is used to measure bone mineral density, screen for osteoporosis, and assess fracture risk. DXA is recommended for all women ≥65 years old. Although Medicare covers DXA every 24 months for women, about 40 % report never having had a DXA test, and little is known from prospective cohort studies about which subgroups of women have low use rates and should be targeted for interventions. Our objective was to identify predictors of DXA use in a nationally representative cohort of women on Medicare. METHODS: We used baseline and biennial follow-up survey data (1993-2012) for 3492 women ≥70 years old from the nationally representative closed cohort known as the Survey on Assets and Health Dynamics among the Oldest Old (AHEAD). The survey data for these women were then linked to their Medicare claims (1991-2012), yielding 17,345 person years of observation. DXA tests were identified from the Medicare claims, and Cox proportional hazard regression models were used with both fixed and time-dependent predictors from the survey interviews including demographic characteristics, socioeconomic factors, health status, health habits, and the living environment. RESULTS: DXA use was positively associated with being Hispanic American, better cognition, higher income, having arthritis, using other preventative services, and living in Florida or other southern states. DXA use was negatively associated with age, being African-American, being overweight or obese, having mobility limitations, and smoking. CONCLUSIONS: Interventions to increase DXA use should target the characteristics that were observed here to be negatively associated with such screening.

Patient-activation and guideline-concordant pharmacological treatment after bone density testing: the PAADRN randomized controlled trial.

Patients often do not know or understand their bone density test results, and pharmacological treatment rates are low. In a clinical trial of 7749 patients, we used a tailored patient-activation result letter accompanied by a bone health brochure to improve appropriate pharmacological treatment. Treatment rates, however, did not improve. INTRODUCTION: Patients often do not know or understand their dual-energy x-ray absorptiometry (DXA) test results, which may lead to suboptimal care. We tested whether usual care augmented by a tailored patient-activation DXA result letter accompanied by an educational brochure would improve guideline-concordant pharmacological treatment compared to usual care only. METHODS: We conducted a randomized, controlled, double-blinded, pragmatic clinical trial at three health care centers in the USA. We randomized 7749 patients ≥50 years old and presenting for DXA between February 2012 and August 2014. The primary clinical endpoint at 12 and 52 weeks post-DXA was receiving guideline-concordant pharmacological treatment. We also examined four of the steps along the pathway from DXA testing to that clinical endpoint, including (1) receiving and (2) understanding their DXA results and (3) having subsequent contact with their provider and (4) discussing their results and options. RESULTS: Mean age was 66.6 years, 83.8 % were women, and 75.3 % were non-Hispanic whites. Intention-to-treat analyses revealed that guideline-concordant pharmacological treatment was not improved at either 12 weeks (65.1 vs. 64.3 %, p = 0.506) or 52 weeks (65.2 vs. 63.8 %, p = 0.250) post-DXA, even though patients in the intervention group were more likely (all p < 0.001) to recall receiving their DXA results letter at 12 weeks, correctly identify their results at 12 and 52 weeks, have contact with their provider at 52 weeks, and have discussed their results with their provider at 12 and 52 weeks. CONCLUSION: A tailored DXA result letter and educational brochure failed to improve guideline-concordant care in patients who received DXA.

Impact of the use of an alcohol-based hand sanitizer in the home on reduction in probability of infection by respiratory and enteric viruses.

The goal of this study was to determine the reduction in risk of infection by viruses with the use of an alcohol-based hand sanitizer, used in addition to routine hand washing, in family members in households. A quantitative microbial risk model was used to determine the probability of infection from the concentration of virus on the hands. The model incorporated variation in hand size, frequency of touching orifices (nose, mouth, eyes), and percent transfer to the site of infection, as well as, dose-response for each virus. Data on the occurrence of virus on household members' hands from an intervention study using MS-2 coliphage was used to determine the reduction of viruses on the hands pre- and post-intervention. It was found that the risk of rhinovirus, rotavirus or norovirus infection after the intervention was reduced by 47-98% depending upon the initial concentration of virus on the hands.

Lymphogranuloma venereum detected from the pharynx in four London men who have sex with men.

Lymphogranuloma venereum (LGV) is an established cause of proctitis in men who have sex with men (MSM). Currently in the UK, testing for pharyngeal Chlamydia trachomatis (CT) is not routine, and LGV typing is usually only performed in patients with anorectal symptoms. We report four cases where LGV-associated CT DNA was detected from the pharynx in MSM, demonstrating that nucleic acid amplification testing (NAAT) can be used for detecting and typing pharyngeal CT infection. These cases also highlight other possible routes of infection for LGV, and add to the broad spectrum of clinical presentations associated with this infection.

Genotype/phenotype correlations for coagulation factor XIII: specific normal polymorphisms are associated with high or low factor XIII specific activity.

Factor XIII is a transglutaminase essential for normal hemostasis. We have studied the plasma FXIII levels and FXIII activity in 71 individuals and found these to be normally distributed. FXIII specific activity is also normally distributed. However, we show that FXIII activity is not directly dependent on FXIII levels, and individuals with low FXIII levels may have high FXIII activity and vice versa. We have determined the FXIIIA genotype in these individuals to assess whether the variation observed in FXIII specific activity is dependent on specific polymorphisms in the FXIIIA gene. Our data show that the Leu34 and Leu564 variants give rise to increased FXIII specific activity, while the Phe204 variant results in lower FXIII specific activity. We also report preliminary evidence that the Phe204 polymorphism may be associated with recurrent miscarriage. Overall, we have identified 23 unique FXIIIA genotypes. Certain specific FXIIIA genotypes consistently give rise to high, low, or median FXIII specific activity levels, while others appear to have little or no consistent influence on the FXIII phenotype. These genotype to phenotype relationships are discussed in light of the growing interest in the role of FXIII in clinical problems involving an increased thrombotic tendency.

Commercial sunscreen lotions prevent ultraviolet radiation-induced depletion of epidermal Langerhans cells in Skh-1 and C3H mice.

There is much controversy regarding the ability of sunscreens to prevent ultraviolet (UV)-induced immune suppression. Epidermal Langerhans cells (LC) play a key antigen-presenting role in the afferent limb of the immune system's response to antigens introduced through the skin. It has been suggested that depletion of LC in UV-exposed skin is a critical step toward the induction of immunosuppression by UV radiation. There are a number of disparate reports with inconsistent results concerning the ability of sunscreens to prevent UV-induced depletion of LC. The purpose of this study was to systematically evaluate the ability of sunscreens to prevent UV-induced LC depletion in mice. Epidermal sheets obtained from skin biopsies taken from mice exposed to UV radiation from Kodacel-filtered FS20 sunlamps, which do not emit UV power at wavelengths < 290 nm, were immunoperoxidase stained for LC using a rat monoclonal antibody against mouse Ia (major histocompatibility complex class II antigen). Time course and dose-response curves for LC depletion were generated for Skh-1 and C3H mice. Dose-response curves for acute UV exposure induced depletion of LC in Skh-1 and C3H mice were similar, but not identical. LC density in the skin of Skh-1 mice that received chronic UV exposure (3 days/week for 8 weeks) was reduced by 62% after 2 weeks of exposure, but returned to normal levels by 6 weeks. Five commercial sunscreen lotions with labeled sun protection factors (SPF) of 4, 8, 15, 30 and 45 were tested for their capacity to block UV-induced depletion of LC. LC were depleted approximately 75% in the skin of unprotected or placebo lotion treated Skh-1 mice exposed to UV given on two consecutive days. Conversely, LC depletion was prevented in similarly UV exposed Skh-1 mice protected with a SPF 30 sunscreen. In C3H mice the levels of protection against LC depletion provided by the five sunscreens were proportional to the level of protection predicted by their labeled SPF. Comparisons of dose-response curves showed that significantly higher doses of UV were required for LC depletion and induction of skin edema than for the induction of local suppression of contact hypersensitivity. Thus, at UV doses where sunscreens provide complete protection against immunosuppression of contact hypersensitivity, prevention of LC depletion and skin edema would be expected.

Glucose minimally attenuates scopolamine-but not morphine-induced deficits on a water maze alternation task.

In a previous study, daily injections of glucose, 100 and 250 mg/kg i.p., in Sprague-Dawley rats failed to either facilitate acquisition or to ameliorate scopolamine- or morphine-induced deficits on a water maze alternation task (Means, et al., 1996). The present study demonstrates that daily injections of 1 g/kg minimally ameliorates a scopolamine-induced deficit on the water maze alternation task in Sprague-Dawley rats. However, daily glucose injections of 1, 2 and 4 g/kg failed to improve performance during acquisition or to diminish morphine-induced deficits on the task. The failure of daily administration of glucose to facilitate acquisition or reverse morphine-induced deficits was not due to the daily injection procedure nor to stress elevated glucose levels resulting from exposure to the task. It is suggested that the effects of glucose on memory are task dependent, with facilitation being more easily demonstrated on tasks for which animals have an innate bias to perform the correct response or the ability to acquire in very few trials.

Multiple T cell expansions are found in the blood and synovial fluid of patients with reactive arthritis.

OBJECTIVE: To look for evidence of T lymphocyte expansions in the blood and synovial fluid (SF) of patients with reactive arthritis (ReA). METHODS: Paired peripheral blood and synovial samples from 10 patients with ReA were studied by dual color flow cytometry using T cell receptor (TCR) V beta specific and CD4 or CD8 specific antibodies. Two synovial CD8 expansions were studied by 3 color flow cytometry. Peripheral blood samples from 13 healthy, age matched individuals were studied as controls. RESULTS: Statistically significant expansions were observed in all patients, occurring in blood and SF CD4 and CD8 compartments, but were most common in the synovial CD8 compartment. Expansions studied in further detail displayed an activated "memory" phenotype. A synovial BV22S1/CD8 expansion was seen in 5/6 patients with sexually acquired ReA. CONCLUSION: Multiple T lymphocyte expansions are found in both the blood and SF of patients with ReA. Expansions were most commonly found in the synovial CD8 compartment, where they appeared to express both activation and memory markers. This indicates that T lymphocytes (and in particular cytotoxic T cells) may play a pathogenic role in ReA. These findings are consistent with either an antigen or a superantigen driven response.

Putative analgesic activity of repeated oral doses of vitamin E in the treatment of rheumatoid arthritis. Results of a prospective placebo controlled double blind trial.

OBJECTIVE: Vitamin E, the most potent naturally occurring lipid soluble antioxidant has been suggested to possess both anti-inflammatory and analgesic activity in humans. This double blind and randomised study used a broad spectrum of clinical and laboratory parameters to investigate whether there was any additional anti-inflammatory or analgesic effects, or both, of orally administered alpha-tocopherol in rheumatoid arthritis patients who were already receiving anti-rheumatic drugs. METHODS: Forty two patients were enrolled and treated with alpha-tocopherol (n = 20) at a dose of 600 mg twice a day (2 x 2 capsules) or with placebo (n = 22) for 12 weeks. The following parameters were measured: (1) Three clinical indices of inflammation--the Ritchie articular index, the duration of morning stiffness, and the number of swollen joints; (2) three measures of pain--pain in the morning, pain in the evening, and pain after chosen activity; (3) haematological and biochemical measures of inflammatory activity; (4) assays for the oxidative modification of proteins and lipids. RESULTS: All laboratory measures of inflammatory activity and oxidative modification were unchanged. Furthermore, the clinical indices of inflammation were not influenced by the treatment. However, the pain parameters were significantly decreased after vitamin E treatment when compared with placebo. CONCLUSION: The results provide preliminary evidence that vitamin E may exert a small but significant analgesic activity independent of a peripheral anti-inflammatory effect, but which complements standard anti-inflammatory treatment.

Hydroxyl radical generation by rheumatoid blood and knee joint synovial fluid.

OBJECTIVE: To demonstrate directly that highly reactive hydroxyl radicals (OH.) can be generated in patients with rheumatoid arthritis and contribute to joint damage, and to examine the ability of blood to cause OH. generation. METHODS: The sensitive and specific technique of hydroxylation of aromatic compounds (salicylate and phenylalanine) was used to measure OH.. Synovial fluid and blood from patients with active rheumatoid arthritis were aspirated and immediately added to tubes containing salicylate and phenylalanine as detectors of OH., or to tubes containing saline as a control. Levels of specific products of attack of OH. upon salicylate (2,3- and 2,5-dihydroxybenzoates) and phenylalanine (ortho- and meta-tyrosines) were measured by high performance liquid chromatography. RESULTS: Synovial fluid samples aspirated into saline never contained ortho- or meta-tyrosines or 2,3-dihydroxybenzoate. Of 53 patients examined, synovial fluid and blood from 36 caused formation of ortho- and meta-tyrosines when aspirated into solutions containing phenylalanine. Repeated sampling from three "positive" patients showed consistent evidence of these hydroxylation products. Similarly, of 22 patients examined, synovial fluid and blood from 18 caused formation of 2,3- and 2,5-dihydroxybenzoates when aspirated into salicylate solutions. Further evidence for the role of OH. was provided by inhibition of the hydroxylation by the specific OH. scavengers mannitol and sodium formate. CONCLUSIONS: Aspirated knee joint fluids and blood from rheumatoid arthritis patients can generate OH., consistent with current views on the importance of this radical as a cytotoxic agent in rheumatoid disease. The ability of body fluids to cause OH. formation is not correlated with simple laboratory indices of disease activity, but is reproducible on sequential sampling from the same patients. The mechanism and significance of the phenomenon in rheumatoid arthritis pathology remain to be established.