Managing cost of care and healthcare utilization in patients using immunoglobulin agents.

The introduction of human immunoglobulin (Ig) therapies 40 years ago reduced the risk of often life-threatening infections for individuals with one of several immune-related conditions known as primary immunodeficiencies. Since then, the use of Ig has expanded to numerous other conditions. However, even though less than 1% of covered lives under Medicare or commercial insurers require Ig, it is in the top 5 drug categories in terms of annual spending. The cost of Ig is directly related to the type of delivery method used and the site of care. Numerous studies attest to the efficacy and cost savings of shifting Ig to the home setting, as well as shifting patients from intravenous Ig (IVIG) to subcutaneous Ig (SCIG). In addition, surveys find that patients with primary immunodeficiencies prefer home delivery, with patient evaluations also finding a preference for SCIG. Payers have numerous options to ensure Ig is used appropriately for the right patient in the right setting. These include formulary management, site-of-care programs, education for providers and patients on the possibility of switching from IVIG to SCIG, preauthorization policies that restrict the use of Ig to certain specialties for specific indications, implementation of evidence-based coverage criteria, and shifting coverage from the medical to the pharmacy benefit.

Review process for IVIg treatment: Lessons learned from INSIGHTS neuropathy study.

BACKGROUND: This project is an effort to understand how orders for IV immunoglobulin (IVIg) are documented and prescribed by physicians, and subsequently, how they are reviewed by insurance companies for the treatment of immune neuropathies. METHODS: A panel of neuromuscular specialists reviewed case records from 248 IVIg-naive patients whose in-home IVIg infusion treatment was submitted to insurance for authorization. After reviewing a case record, 1 panelist was asked to make a diagnosis and to answer several questions about the treatment. A second panelist reviewed the original record and follow-up records that were obtained for reauthorization of additional treatments and was asked to determine whether the patient had responded to the treatment. RESULTS: Our specialists believed that only 32.2% of 248 patients had an immune neuropathy and were appropriate candidates for IVIg therapy, whereas 46.4% had neuropathies that were not immune mediated. Only 15.3% of cases met electrodiagnostic criteria for a demyelinating neuropathy. Our specialists believed that 36.7% of 128 cases with follow-up records had responded to therapy. In cases in which the initial reviewer had predicted that there would be a response to IVIg, the second reviewer found that 54% had responded. This is compared with a 27% response rate when the first reviewer predicted that there would be no response (p = 0.019). CONCLUSIONS: Our expert review finds that the diagnosis of immune neuropathies made by providers, and subsequently approved for IVIg therapy by payers, is incorrect in a large percentage of cases. If payers include an expert in their review process, it would improve patient selection, appropriate use, and continuation of treatment with this expensive therapeutic agent.

Historical Prevalence of Radiological Appendicular Osteoarthritis in Cats (1972-1973).

Interest in feline osteoarthritis has grown recently; this might be due to increased prevalence or increased awareness. This study records the presence of appendicular osteoarthritis in a subset of the United Kingdom cat population in the 1970s and estimates its prevalence. One hundred cats euthanized in 1972-1973 had a series of skeletal radiographic images taken post mortem. Each joint was put into a set with or without osteoarthritis according to the presence or absence of a specified set of radiographic features. Limited historical data were analyzed. The prevalence of osteoarthritis in these cats was 74%. There is no evidence that feline osteoarthritis is a "novel" disease. The prevalence was similar to recent prospective radiological surveys. Recent interest in the condition may have derived from more attention being paid to feline medicine and welfare.

Negative Affect Is Associated With Higher Risk of Incident Cognitive Impairment in Nondepressed Postmenopausal Women.

Background: Positive affect (PA) and negative affect (NA) reflect subjective emotional experiences. Although related to depression and anxiety, these dimensions are distinct constructs representing affective states and patterns. Prior studies suggest that elevated depressive symptoms are associated with risk of mild cognitive impairment (MCI) and probable dementia, but whether affective states are associated with cognitive impairment is still unknown. The present study examined relationships between baseline affective states and cognitive impairment (MCI, probable dementia) in nondepressed women. Method: Baseline PA and NA were assessed in postmenopausal women (N = 2,137; mean age = 73.8 years) from the Women's Health Initiative Study of Cognitive Aging (WHISCA) using the Positive and Negative Affect Schedule (PANAS). Women were followed annually for an average of 11.3 years; those with elevated depressive symptoms at baseline were excluded. Results: Higher NA was associated with a higher risk of MCI and probable dementia, even after adjusting for important covariates including age, education, sociodemographic, lifestyle, and cardiovascular risk factors, global cognition, and hormone therapy assignment at baseline. PA was not significantly associated with either outcome. Conclusions: We present the first evidence to date that greater NA, even in the absence of elevated depressive symptoms, is associated with higher risk of MCI and dementia. This suggests that NA may be an important, measureable and potentially modifiable risk factor for age-related cognitive decline.

Cognitive Function and Changes in Cognitive Function as Predictors of Incident Cardiovascular Disease: The Women's Health Initiative Memory Study.

Background: Cognitive impairment and decline may signal the increased risk of incident cardiovascular disease (CVD). We examined associations of global cognitive function, as measured by the Modified Mini-Mental State Examination (3MS) and changes in 3MS over time, with incident CVD, individual CVD outcomes, CVD death, and all-cause mortality. Methods: A total of 5,596 women (≥ 60) from the Women's Health Initiative Memory Study free of CVD at baseline were followed for an average of 7.1 years. The 3MS was measured at baseline and annually thereafter. Cox proportional hazards regressions were used to model associations between baseline 3MS and changes in 3MS and time to events. Results: In the fully-adjusted models for every 5-point lower baseline 3MS score, the risk was 12% greater for incident CVD, 37% for HF, 35% for CVD death, and 24% for all-cause mortality. No significant relationships were found for coronary heart disease (CHD), angina, stroke/transient ischemic attack (TIA), or coronary revascularization. When change in 3MS was added as a time-varying covariate in the fully-adjusted models, for every 1-point/year greater decline in 3MS, the risk was 4% greater for incident CVD, 10% for CHD, 9% for Stroke/TIA, 17% for CVD death, and 13% for all-cause mortality. Conclusions: In older women free of prevalent CVD at baseline, lower baseline global cognitive function or decline in global cognitive function over time, increased risk of incident CVD, CVD death, and all-cause mortality.

Selecting a polyclonal immune globulin treatment for a patient with primary immune deficiency disease: Role of the clinical pharmacist.

PURPOSE: Considerations for selecting an immune globulin treatment, transitioning patients with primary immune deficiency disease who are receiving long-term treatment between settings of care, and the role of the pharmacist in these endeavors are described. SUMMARY: Numerous immune globulin formulations are commercially available, and these formulations differ in immune globulin concentration, stabilizing additives, trace non-immune globulin proteins, and the manufacturing process, all of which may elicit different adverse reactions in patients. Patients may also exhibit differences in tolerability to the route of administration. The complex process of formulating, establishing, and maintaining an immune globulin treatment regimen requires the participation of the patient and healthcare providers. For patients transitioning between settings of care, particular attention must be paid to any changes to a treatment that has been individualized for a patient. Factors affecting the decision process include medical history, immune globulin formulation characteristics, formulary stock, payer formulary, and patient preference. For patients switching between immune globulin formulations or routes of administration, dosage adjustments of and tolerance to immune globulin may be important considerations. A clinical pharmacist with knowledge of the pharmaceutical suitability of immune globulin formulations can safely facilitate these transitions. CONCLUSION: Selecting a route of administration for and formulation of immune globulin involves the consideration of many factors, including the patient's medical history, formulation characteristics, formulary stock, payer formulary, and patient preference. A pharmacist is essential in helping the patient navigate the decision-making process and in coordinating care and communication among patients, caregivers, and healthcare providers to monitor patient progress and adherence and ensure safe and efficient transitions of care.

Physical Functioning among Women 80 Years of Age and Older With and Without a Cancer History.

BACKGROUND: Females 80 years and older comprise 22% of the total U.S. survivor population, yet the impact of cancer on the physical well-being of women is this age group has not been well characterized. METHODS: We compared women, 80 years of age and older in the Women's Health Initiative extension 2, who did (n = 2,270) and did not (n = 20,272) have an adjudicated history of cancer during Women's Health Initiative enrollment; analyses focused on women >2-years postcancer diagnosis. The physical functioning subscale of the RAND-36 was the primary outcome. Demographic, health-status, and psychosocial covariates were drawn from Women's Health Initiative assessments. Analysis of covariance was used to examine the effect of cancer history on physical function, with and without adjustment for covariates. RESULTS: In adjusted models, women with a history of cancer reported significantly lower mean physical functioning (56.6, standard error [SE] 0.4) than those without a cancer history (58.0, SE 0.1), p = .002. In these models, younger current age, lower body mass index, increased physical activity, higher self-rated health, increased reported happiness, and the absence of noncancer comorbid conditions were all associated with higher physical functioning in both women with and without a history of cancer. CONCLUSIONS: Women older than 80 years of age with a cancer history have only a moderately lower level of physical function than comparably aged women without a cancer history. Factors associated with higher levels of physical functioning were similar in both groups.

Functional Independence in Late-Life: Maintaining Physical Functioning in Older Adulthood Predicts Daily Life Function after Age 80.

BACKGROUND: We examined physical functioning (PF) trajectories (maintaining, slowly declining, and rapidly declining) spanning 15 years in older women aged 65-80 and protective factors that predicted better current levels and less decline in functional independence outcomes after age 80. METHODS: Women's Health Initiative extension participants who met criteria (enrolled in either the clinical trial or observational study cohort, >80 years at the data release cutoff, PF survey data from initial enrollment to age 80, and functional independence survey data after age 80) were included in these analyses (mean [SD] age = 84.0 [1.4] years; N = 10,478). PF was measured with the SF-36 (mean = 4.9 occasions). Functional independence was measured by self-reported level of dependence in basic and instrumental activities of daily living (ADLs and IADLs) (mean = 3.4 and 3.3 occasions). RESULTS: Maintaining consistent PF in older adulthood extends functional independence in ADL and IADL in late-life. Protective factors shared by ADL and IADL include maintaining PF over time, self-reported excellent or very good health, no history of hip fracture after age 55, and no history of cardiovascular disease. Better IADL function is uniquely predicted by a body mass index less than 25 and no depression. Less ADL and IADL decline is predicted by better self-reported health, and less IADL decline is uniquely predicted by having no history of hip fracture after age 55. CONCLUSIONS: Maintaining or improving PF and preventing injury and disease in older adulthood (ages 65-80) has far-reaching implications for improving late-life (after age 80) functional independence.

Correlates of Successful Aging in Racial and Ethnic Minority Women Age 80 Years and Older: Findings from the Women's Health Initiative.

BACKGROUND: Most research has focused on definitions and predictors of successful aging. However, racial/ethnic minorities are often under represented in this research. Given that the U.S. population is aging and becoming more racially diverse, we examined correlates of "successful aging," as defined by physical functioning and overall quality of life (QOL), among racial/ethnic minority women aged 80 years and older in the Women's Health Initiative. METHODS: Participants included 1,924 racial/ethnic minority women (African Americans, Asian/Pacific Islanders, Hispanic/Latinos, and American Indian/Alaskan Natives) 80 years of age and older who are enrolled in the Women's Health Initiative and have physical functioning data after turning 80 years of age. Analysis of covariance was used to examine between and within group differences in physical functioning and selfrated overall QOL for African Americans, Asian/Pacific Islanders, and Hispanic/Latinos. RESULTS: We found no significant differences in physical functioning between racial/ethnic minority groups in adjusted analyses. However, overall QOL was significantly different between racial/ethnic minority groups. Age, recreational physical activity, and overall selfrated health were independent correlates of physical functioning across racial/ethnic minority groups, whereas overall selfrated health was the only consistent correlate of overall QOL across the minority groups for the within minority group comparisons. CONCLUSIONS: Between racial/ethnic minority group differences in physical functioning are largely explained by demographic, psychosocial, behavioral, and health-related variables. We found statistically significant differences in selfrated overall QOL between racial/ethnic minority groups.

Feasibility of self-administered sleep assessment in older women in the Women's Health Initiative (WHI).

PURPOSE: Laboratory-based polysomnography (PSG) is the gold standard assessment of sleep disordered breathing (SDB). In large cohort studies and clinical trials, however, these overnight procedures can be expensive and burdensome to participants, especially older adults. In preparation for a large observational study, we determined the feasibility of self-administering two devices mailed to participants' homes that estimate indices of SDB. METHODS: In two separate studies, older women enrolled in the Women's Health Initiative (WHI) Memory Study extension aged mean (SD) 85.77 (2.98) years who were not using supplemental oxygen and consented to being in the feasibility study completed either an in-home, self-administered overnight sleep assessment using a multi-sensor device that measured oximetry, nasal pressure, chest effort, and snoring (ApneaLink(TM)) (N = 58), or a wrist-worn oximeter (NoninWristOx2(TM)) (N = 33). A follow-up questionnaire assessed the devices' acceptability and important sleep-related exposures. RESULTS: Although the multi-sensor device was assessed only in older women with no cognitive impairment, the proportion of completed interpretable sleep studies was low (54 %) and participants reported needing help to administer the device successfully. In contrast, the wrist-worn device was used in women with either no or mild cognitive impairment (MCI), completion rates were higher (100 %), and women reported being able to administer the device independently. CONCLUSIONS: These studies demonstrated that home-based self-administered assessments of SDB are feasible in older adults with and without cognitive impairment using wrist-worn oximetry. These data support the feasibility of using simple oximetry measurements to provide indices of overnight intermittent hypoxemia in large observational studies and clinical trials.

Global cognitive function before, surrounding, and after ischemic stroke: the role of risk and protective factors varies with time among ischemic stroke survivors.

An estimated 65% of individuals demonstrate multidomain cognitive impairment poststroke, although little is known about the varying role of cognitive risk and protective factors in preischemic, peri-ischemic, and postischemic stroke phases. Longitudinal changes in global cognitive function after ischemic stroke are not well characterized, especially in older adults over age 80. We examined global cognitive function trajectories in these three phases across a mean follow-up of 8.12 (2.30) years in 159 female stroke survivors aged 65-79 at baseline using linear mixed models with change points. In separate models controlling for demographic variables, we tested the interaction of baseline risk and protective factors with stroke phase on global cognitive function. None of the prestroke global cognitive function means or trajectories differed significantly. At the time of ischemic stroke, higher body mass index (BMI), the presence of hypertension (HTN), low optimism, and higher physical function were all associated with significantly greater mean decreases in global cognition (all p's <.0.0001), but were not significantly different from the contrasting level (all p's >0.05). Higher BMI, the presence of HTN, low optimism, and higher physical function were in turn protective of global cognitive decline postischemic stroke (all contrasting p values <.01). Baseline factors may play either a risk or a protective role in global cognitive function depending on the phase of ischemic stroke.

Impact of Type 2 Diabetes and Postmenopausal Hormone Therapy on Incidence of Cognitive Impairment in Older Women.

OBJECTIVE: In older women, higher levels of estrogen may exacerbate the increased risk for cognitive impairment conveyed by diabetes. We examined whether the effect of postmenopausal hormone therapy (HT) on cognitive impairment incidence differs depending on type 2 diabetes. RESEARCH DESIGN AND METHODS: The Women's Health Initiative (WHI) randomized clinical trials assigned women to HT (0.625 mg/day conjugated equine estrogens with or without [i.e., unopposed] 2.5 mg/day medroxyprogesterone acetate) or matching placebo for an average of 4.7-5.9 years. A total of 7,233 women, aged 65-80 years, were classified according to type 2 diabetes status and followed for probable dementia and cognitive impairment (mild cognitive impairment or dementia). RESULTS: Through a maximum of 18 years of follow-up, women with diabetes had increased risk of probable dementia (hazard ratio [HR] 1.54 [95% CI 1.16-2.06]) and cognitive impairment (HR 1.83 [1.50-2.23]). The combination of diabetes and random assignment to HT increased their risk of dementia (HR 2.12 [1.47-3.06]) and cognitive impairment (HR 2.20 [1.70-2.87]) compared with women without these conditions, interaction P = 0.09 and P = 0.08. These interactions appeared to be limited to women assigned to unopposed conjugated equine estrogens. CONCLUSIONS: These analyses provide additional support to a prior report that higher levels of estrogen may exacerbate risks that type 2 diabetes poses for cognitive function in older women. The role estrogen plays in suppressing non-glucose-based energy sources in the brain may explain this interaction.

Driving with Mild Cognitive Impairment or Dementia: Cognitive Test Performance and Proxy Report of Daily Life Function in Older Women.

OBJECTIVES: To investigate associations between proxy report of cognitive and functional limitations and cognitive performance and current or former driving status in older women with mild cognitive impairment (MCI) and all-cause dementia. DESIGN: Cross-sectional data analysis of retrospectively identified older women with adjudicated MCI and all-cause dementia in the Women's Health Initiative Memory Study-Epidemiology of Cognitive Health Outcomes (WHIMS-ECHO). SETTING: Academic medical center. PARTICIPANTS: Women (mean age ± standard deviation 83.7 ± 3.5) adjudicated with MCI or dementia during Year 1, 2, 3, or 4 of the WHIMS-ECHO follow-up period (N = 385). MEASUREMENTS: The telephone-administered cognitive battery included tests of attention, verbal learning and memory, verbal fluency, executive function, working memory, and global cognitive function plus self-report measures of depressive symptomatology. The Dementia Questionnaire (DQ) was administered to a knowledgeable proxy (family member, friend). RESULTS: Sixty percent of women with MCI and 40% of those with dementia are current drivers. Proxy reports of functional limitations in instrumental activities of daily living (IADLs) are associated with current driving status in women with MCI, whereas performance-based cognitive tests are not. In women with dementia, proxy reports of functional limitations in IADLs and performance-based cognitive tests are associated with current driving status, as expected. CONCLUSION: These findings have clinical implications for the importance of evaluating driving concurrently with other instrumental functional abilities in MCI and dementia. Additional work is needed to determine whether proxy report of cognitive and functional impairments should help guide referrals for driving assessment and rehabilitation or counseling for driving transition.

Postmenopausal hormone therapy, type 2 diabetes mellitus, and brain volumes.

OBJECTIVE: To examine whether the effect of postmenopausal hormone therapy (HT) on brain volumes in women aged 65-79 years differs depending on type 2 diabetes status during postintervention follow-up of a randomized controlled clinical trial. METHODS: The Women's Health Initiative randomized clinical trials assigned women to HT (0.625 mg/day conjugated equine estrogens with or without 2.5 mg/day medroxyprogesterone acetate) or placebo for an average of 5.6 years. A total of 1,402 trial participants underwent brain MRI 2.4 years after the trials; these were repeated in 699 women 4.7 years later. General linear models were used to assess the interaction between diabetes status and HT assignment on brain volumes. RESULTS: Women with diabetes at baseline or during follow-up who had been assigned to HT compared to placebo had mean decrement in total brain volume of -18.6 mL (95% confidence interval [CI] -29.6, -7.6). For women without diabetes, this mean decrement was -0.4 (95% CI -3.8, 3.0) (interaction p=0.002). This interaction was evident for total gray matter (p<0.001) and hippocampal (p=0.006) volumes. It was not evident for changes in brain volumes over follow-up or for ischemic lesion volumes and was not influenced by diabetes duration or oral medications. CONCLUSIONS: For women aged 65 years or older who are at increased risk for brain atrophy due to type 2 diabetes, prescription of postmenopausal HT is associated with lower gray matter (total and hippocampal) volumes. Interactions with diabetes and insulin resistance may explain divergent findings on how estrogen influences brain volume among older women.

Depression and frailty in later life: a systematic review.

Frailty and depression are important issues affecting older adults. Depressive syndrome may be difficult to clinically disambiguate from frailty in advanced old age. Current reviews on the topic include studies with wide methodological variation. This review examined the published literature on cross-sectional and longitudinal associations between frailty and depressive symptomatology with either syndrome as the outcome, moderators of this relationship, construct overlap, and related medical and behavioral interventions. Prevalence of both was reported. A systematic review of studies published from 2000 to 2015 was conducted in PubMed, the Cochrane Database of Systematic Reviews, and PsychInfo. Key search terms were "frailty", "frail", "frail elderly", "depressive", "depressive disorder", and "depression". Participants of included studies were ≥ 55 years old and community dwelling. Included studies used an explicit biological definition of frailty based on Fried et al's criteria and a screening measure to identify depressive symptomatology. Fourteen studies met the inclusion/exclusion criteria. The prevalence of depressive symptomatology, frailty, or their co-occurrence was greater than 10% in older adults ≥ 55 years old, and these rates varied widely, but less in large epidemiological studies of incident frailty. The prospective relationship between depressive symptomatology and increased risk of incident frailty was robust, while the opposite relationship was less conclusive. The presence of comorbidities that interact with depressive symptomatology increased incident frailty risk. Measurement variability of depressive symptomatology and inclusion of older adults who are severely depressed, have cognitive impairment or dementia, or stroke may confound the frailty syndrome with single disease outcomes, accounting for a substantial proportion of shared variance in the syndromes. Further study is needed to identify medical and behavioral interventions for frailty and depressive symptomatology that prevent adverse sequelae such as falls, disability, and premature mortality.

Concurrent and longitudinal relationships between cognitive activity, cognitive performance, and brain volume in older adult women.

OBJECTIVES: We investigated (a) cross-sectional associations between cognitive activity, cognitive performance, and MRI measures and (b) longitudinal associations between cognitive activity and change in cognitive performance, using structural equation modeling (SEM). METHOD: Women's Health Initiative Memory Study (WHIMS) Extension participants who continued annual neuropsychological assessments by telephone and completed a concurrent questionnaire of cognitive activities and MRI scans were included (mean age = 81.4 years; N = 393). Cognitive performance was measured by tests of attention, working memory, verbal fluency, executive function, and memory. Cognitive activity was measured by self-reported participation in a variety of cognitive activities (e.g., reading books, playing games, computer activities; N = 11 items) during the previous 12 months. MRI measures included gray and white matter normal and white matter lesion volumes. RESULTS: SEM demonstrated a significant association between cognitive activity and baseline cognitive performance but not change over 2-3 years. Gray and white matter was associated with cognitive performance but not cognitive activity. All effects remained significant after modeling covariates (age, education, depressive symptoms, WHIMS intervention assignment, and intracranial volume). CONCLUSIONS: Cognitive activity benefits current cognitive performance but is not associated with change over 2-3 years. Cognitive activity and MRI volumes are independently associated with cognitive performance, suggesting distinct cognitive and brain reserve constructs.

Long-term effects on cognitive function of postmenopausal hormone therapy prescribed to women aged 50 to 55 years.

IMPORTANCE: Postmenopausal hormone therapy with conjugated equine estrogens (CEEs) may adversely affect older women's cognitive function. It is not known whether this extends to younger women. OBJECTIVE: To test whether prescribing CEE-based hormone therapy to postmenopausal women aged 50 to 55 years has longer-term effects on cognitive function. DESIGN: Trained, masked staff assessed participants with an annual telephone-administered cognitive battery that included measures of global and domain-specific cognitive functions. Cognitive testing was conducted an average of 7.2 years after the trials ended, when women had a mean age of 67.2 years, and repeated 1 year later. Enrollment occurred from 1996 through 1999. SETTING: Forty academic research centers. PARTICIPANTS: The study population comprised 1326 postmenopausal women, who had begun treatment in 2 randomized placebo-controlled clinical trials of hormone therapy when aged 50 to 55 years. INTERVENTION: The clinical trials in which the women had participated had compared 0.625 mg CEE with or without 2.5 mg medroxyprogesterone acetate over a mean of 7.0 years. MAIN OUTCOMES AND MEASURES: The primary outcome was global cognitive function. Secondary outcomes were verbal memory, attention, executive function, verbal fluency, and working memory. RESULTS: Global cognitive function scores from women who had been assigned to CEE-based therapies were similar to those from women assigned to placebo: mean (95% CI) intervention effect of 0.02 (−0.08 to 0.12) standard deviation units (P = .66). Similarly, no overall differences were found for any individual cognitive domain (all P > .15). Prespecified subgroup analyses found some evidence that CEE-based therapies may have adversely affected verbal fluency among women who had prior hysterectomy or prior use of hormone therapy: mean treatment effects of −0.17 (−0.33 to −0.02) and −0.25 (−0.42 to −0.08), respectively; however, this may be a chance finding. CONCLUSIONS AND RELEVANCE: CEE-based therapies produced no overall sustained benefit or risk to cognitive function when administered to postmenopausal women aged 50 to 55 years. We are not able to address whether initiating hormone therapy during menopause and maintaining therapy until any symptoms are passed affects cognitive function, either in the short or longer term. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01124773.

The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y).

The Women's Health Initiative Memory Study-Younger (WHIMS-Y) was designed to assess the effect of prior random assignment to hormone therapy (HT) (conjugated equine estrogen (CEE) alone or CEE plus medroxyprogesterone acetate (MPA)) on global cognitive function in younger middle-aged women relative to placebo. WHIMS-Y was an ancillary study to the Women's Health Initiative (WHI) HT trial and enrolled 1361 women who were aged 50-55 years and postmenopausal at WHI enrollment. WHIMS-Y will examine whether an average of 5.4 years of HT during early menopause has longer term protective effects on global cognitive function and if these effects vary by regimen, time between menopause and study initiation, and prior use of HT. We present the study rationale and design. We describe enrollment, adherence to assigned WHI therapy, and compare risk factor characteristics of the WHIMS-Y cohort at the time of WHI enrollment to similar aged women in the WHI HT who did not enroll in WHIMS-Y. Challenges of WHIMS-Y include lower than expected and differential enrollment. Strengths of WHIMS-Y include balance in baseline risk factors between treatment groups, standardized and masked data collection, and high rates of retention and on-trial adherence and exposure. In addition, the telephone-administered cognitive battery showed adequate construct validity. WHIMS-Y provided an unprecedented chance to examine the hypothesis that HT may have protective effects on cognition in younger postmenopausal women aged 50-55 years. Integrated into the WHI, WHIMS-Y optimized the experience of WHI investigators to ensure high retention and excellent quality assurance across sites. This article is part of a Special Issue entitled Hormone Therapy.

Positive and negative affect, depression, and cognitive processes in the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) Trial.

OBJECTIVES: This study examined the relationship between positive and negative affect, depressive symptoms, and cognitive performance. METHODS: The sample consisted of 1479 non-demented, postmenopausal women (mean age = 67 years) at increased risk of breast cancer enrolled in the National Surgical Adjuvant Breast and Bowel Project's Study of Tamoxifen and Raloxifene. At each annual visit, women completed a standardized neuropsychological battery and self-report measures of affect and depression. Data from three visits were used in linear mixed models for repeated measures using likelihood ratio tests. Separate analyses were performed to relate positive/negative affect and depression to each cognitive measure. RESULTS: Higher positive affect was associated with better letter fluency (p = .006) and category fluency (p < .0001). Higher negative affect was associated with worse global cognitive function (p < .0001), verbal memory (CVLT List B; p = .002), and spatial ability (p < .0001). Depressive symptoms were negatively associated with verbal knowledge (p = .004), figural memory (p < .0001), and verbal memory (p's ≤ .0001). DISCUSSION: Findings are consistent with some prior research demonstrating a link between positive affect and increased verbal fluency and between depressive symptoms and decreased memory. The most novel finding shows that negative affect is related to decreased global cognition and visuospatial ability. Overall, this research in a large, longitudinal sample supports the notion that positive affect is related to increases and negative affect to decreases in performance on distinct cognitive measures.

Building a healthy work environment: a nursing resource team perspective.

Leadership and staff from the London Health Sciences Centre (LHSC) Nursing Resource Team (NRT), including members of their Continuous Quality Improvement (CQI) Council, attended the first Southern Ontario Nursing Resource Team Conference (SONRTC), held March 2012 in Toronto. The SONRTC highlighted healthy work environments (HWEs), noting vast differences among the province's various organizations. Conversely, CQI Council members anecdotally acknowledged similar inconsistencies in HWEs across the various inpatient departments at LHSC. In fact, the mobility of the NRT role allows these nurses to make an unbiased observation about the culture, behaviours and practices of specific units as well as cross-reference departments regarding HWEs. Studies have documented that HWEs have a direct impact on the quality of patient care. Furthermore, the literature supports a relationship between HWEs and nurse job satisfaction. Based on this heightened awareness, the NRT CQI Council aimed to investigate HWEs at LHSC. The American Association of Critical Care Nurses (AACN) Standards for Establishing and Sustaining Healthy Work Environments was adapted in developing a survey for measuring HWEs based on the perceptions of NRT staff. Each of the departments was evaluated in terms of the following indicators: skilled communication, true collaboration, effective decision-making, appropriate staffing, meaningful recognition and authentic leadership (AACN 2005). Ultimately, the Building a Healthy Work Environment: A Nursing Resource Team Perspective survey was employed with NRT nurses at LHSC, and data was collected for use by leadership and staff for creating HWE strategies aimed at improving the quality of patient care.