Impact of a Nurse-Led Advance Care Planning Intervention on Satisfaction, Health-Related Quality of Life, and Health Care Utilization Among Patients With Severe Respiratory Disease: A Randomized Patient-Preference Trial.

CONTEXT: Previous work has found that facilitated advance care planning (ACP) interventions are effective in increasing ACP uptake among patients with severe respiratory disease. OBJECTIVES: The objective of this study was to investigate whether a nurse-led, facilitated ACP intervention among participants with severe respiratory disease impacts self-reported or clinical outcomes. METHODS: A multicenter, open-label, patient-preference, randomized controlled trial of a nurse-led facilitated ACP intervention was performed. Outcome measures included self-report scales (health care satisfaction and EQ-5D-5L health-related quality of life at three- and six-month follow-up), 12-month mortality, and health care utilization during the final 90 days of life. RESULTS: One hundred forty-nine participants were recruited across two study settings (metropolitan tertiary hospital respiratory department and rural sites) and 106 were allocated to receive the ACP intervention. There was no effect of the intervention on satisfaction with health care, health-related quality of life, or 12-month mortality rates. Among those participants who died during the follow-up period (N = 54), those allocated to the ACP intervention had significantly fewer outpatient consultations (7.51 vs. 13.6, P < 0.001). There were no changes in emergency department attendances, total hospital admissions or length of stay, or home nursing visits. Among those allocated to the ACP intervention, there was a reduced length of stay in acute hospital settings (7.76 vs. 11.5 nights, P < 0.001) and increased length of stay in palliative hospital settings (5.54 vs. 2.08, P < 0.001) during the final 90 days of life. CONCLUSION: A facilitated ACP intervention among patients with severe respiratory disease did not have an impact on satisfaction, health-related quality of life, or 12-month mortality rate. Facilitated ACP may be associated with a different type of health care utilization during the end-of-life period.

Healthy Mothers Healthy Families Workshop Intervention: A Preliminary Investigation of Healthy Lifestyle Changes for Mothers of a Child with a Disability.

Substantial evidence identifies mothers of children with a disability as having a higher risk for compromised health outcomes and lifestyle restrictions secondary to caring responsibilities. Healthy Mothers Healthy Families (HMHF) is an evidence informed health and empowerment group-based workshop program. METHODS: HMHF features health education and lifestyle redesign content. Mixed methods evaluated the program. This paper presents a pretest-postest time series design to evaluate outcomes over 8 months. RESULTS: Mothers reported significant change across 4 time points including participation in healthy activity (p = 0.017), depression, anxiety, stress symptoms (p = 0.017, 0.016, 0.037 respectively) and empowerment (p = 0.009). CONCLUSION: Coupled with qualitative findings, these results suggest that HMHF is effective at improving health and wellbeing outcomes for mothers of children with a disability.

Intravaginal Testosterone Improves Sexual Satisfaction and Vaginal Symptoms Associated With Aromatase Inhibitors.

Context: Intravaginal testosterone (IVT) is a potential treatment of vulvovaginal atrophy (VVA) associated with aromatase inhibitor (AI) use. Objective: To investigate the effects of IVT on sexual satisfaction, vaginal symptoms, and urinary incontinence (UI) associated with AI use. Design: Double-blind, randomized, placebo-controlled trial. Setting: Academic clinical research center. Participants: Postmenopausal women taking an AI with VVA symptoms. Intervention: IVT cream (300 µg per dose) or identical placebo, self-administered daily for 2 weeks and then thrice weekly for 24 weeks. Main Outcomes and Measures: The primary outcome was the change in the sexual satisfaction score on the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal symptoms and responses to the Profile of Female Sexual Function, the Female Sexual Distress Scale-Revised (FSDS-R), and the Questionnaire for UI Diagnosis. Serum sex steroids were measured. Results: A total of 44 women were randomly assigned and 37 provided evaluable data, (mean age 56.4 years, SD 8.8 years). At 26 weeks, the mean between-group difference in the baseline-adjusted change in FSFI satisfaction scores was significantly greater for the IVT group than the placebo group (mean difference 0.73 units; 95% CI, 0.02 to 1.43; P = 0.043). IVT cream resulted in significant improvements, compared with placebo, in FSDS-R scores (P = 0.02), sexual concerns (P < 0.001), sexual responsiveness (P < 0.001), vaginal dryness (P = 0.009), and dyspareunia (P = 0.014). Serum sex steroid levels did not change. Few women had UI symptoms, with no treatment effect. Conclusion: IVT significantly improved sexual satisfaction and reduced dyspareunia in postmenopausal women on AI therapy. The low reporting of UI among women on AI therapy merits further investigation.

The benefits of adding metformin to tamoxifen to protect the endometrium-A randomized placebo-controlled trial.

BACKGROUND: We investigated whether metformin prevents tamoxifen-induced endometrial changes and insulin resistance (IR) after a diagnosis of breast cancer. METHODS: This was a single-centre, randomized, double-blind, placebo-controlled, parallel group trial. Postmenopausal women with hormone receptor-positive breast cancer taking tamoxifen were randomly allocated to metformin 850 mg or identical placebo, twice daily, for 52 weeks. Outcome measures included double endometrial thickness (ET) measured by transvaginal ultrasound, fasting insulin, glucose and IR estimated by the homeostasis model of assessment (HOMA-IR). RESULTS: A total of 112 women were screened and 102 randomized. Results are presented as median (range). The 101 women who took at least one dose of medication were aged 56 (43-72) years, with 5(0.5-28) years postmenopause, and had taken tamoxifen for 28.9 (0-367.4) weeks. The baseline ET was 2.9 mm (1.4-21.9) for the placebo group (n = 52) and 2.5 mm (1.3-14.8) for the metformin group (n = 50). At 52 weeks, the median ET was statistically significantly lower for the metformin (n = 36) than for the placebo group (n = 45) (2.3 mm (1.4-7.8) vs 3.0 (1.2-11.3); P = 0.05). 13.3% allocated to placebo had an ET greater than 4 mm vs 5.7% for metformin (P = 0.26). There was no endometrial atypia or cancer. Compared with placebo, metformin resulted in significantly greater baseline-adjusted reductions in weight (P < 0.001), waist circumference (0.03) and HOMA-IR (P < 0.001). CONCLUSIONS: Metformin appears to inhibit tamoxifen-induced endometrial changes and has favourable metabolic effects. Further research into the adjuvant use of metformin after breast cancer and to prevent EH and cancer is warranted.

Mothers' Experiences of a Women's Health and Empowerment Program for Mothers of a Child with a Disability.

Substantial research identifies mothers of children with a disability as a vulnerable group with compromised health outcomes and restrictions for their own self-care, social, economic and leisure participation. This study investigated perceptions and experiences of mothers following attendance at health education and empowerment workshops (Healthy Mothers Healthy Families). Mixed methods evaluated mothers' experiences. A pragmatic qualitative approach was applied to data analysis of interviews with mothers (N = 19). Four themes emerged: Changes for me; Changes for my family; Wisdom gained; and Worthwhile workshops. Mothers described feeling validated and empowered in this facilitated group intervention and valued education about women's health, tailored research findings, individualised goal setting, time to learn and share with other mothers, and the workshop environment.

Transdermal testosterone improves verbal learning and memory in postmenopausal women not on oestrogen therapy.

OBJECTIVE: The aim of this study was to examine the effects of testosterone on verbal learning and memory in postmenopausal women. DESIGN: Randomized, placebo-controlled trial in which participants were randomized (1:1) to transdermal testosterone gel 300 mcg/day, or identical placebo, for 26 weeks. PATIENTS: Ninety-two postmenopausal women aged 55-65 years, on no systemic sex hormone therapy. MEASUREMENTS: The primary outcome was the score for the International Shopping List Task (ISLT) of CogState. Secondary outcomes included other CogState domains, the Psychological General Well-Being Index (PGWB) and safety variables. RESULTS: Eighty-nine women, median age 60 years, were included in the primary analysis. Testosterone treatment resulted in statistically significantly better performance for the ISLT (improved verbal learning and memory) compared with placebo, adjusted for age and baseline score (mean difference 1·57; 95%CI 0·13, 3·01) P = 0·03). There were no significant differences for other CogState domains or the PGWB scores. At 26 weeks, the median total testosterone was 1·7 nm (interquartile range (IQR) 1·1, 2·4) in the testosterone group and 0·4 nm (IQR 0·3, 0·5) in the placebo group. CONCLUSIONS: The small but statistically significant effect of testosterone treatment on verbal learning and memory in postmenopausal women provides the basis for further clinical trials.

Testosterone improves antidepressant-emergent loss of libido in women: findings from a randomized, double-blind, placebo-controlled trial.

INTRODUCTION: Female sexual dysfunction is a side effect of selective serotonin reuptake inhibitor (SSRI)/serotonin noradrenalin reuptake inhibitor (SNRI) therapy. AIMS: The aim of this study is to investigate the efficacy of transdermal testosterone (TT) as a treatment for SSRI/SNRI-emergent loss of libido. METHODS: This was a double-blind, randomized, placebo-controlled study. Forty-four women, aged 35-55 years, on a stable dose of SSRI or SNRI with treatment-emergent loss of libido were randomly allocated to treatment with a TT patch delivering 300 mcg of testosterone/day or an identical placebo patch (Pl) for 12 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was the change in the Sabbatsberg Sexual Self-rating Scale (SSS) total score over 12 weeks. The 4-week frequency of Satisfactory Sexual Events (SSEs) and the Female Sexual Distress Scale-Revised (FSDS-R) were also measured. RESULTS: At baseline, there were no differences between the treatment groups. At week 12, the change in the SSS score did not differ between the two groups. The increase in the 4-week frequency of SSEs was significantly greater for the TT group than for the Pl group (an increase of 2.3 events vs. 0.1, P = 0.02). The between-group difference in the change in the FSDS-R score approached statistical significance (P = 0.06). The mean total serum testosterone level at 12 weeks in the TT group was 2.1 nmol/L. No women withdrew because of androgenic adverse events. CONCLUSIONS: TT therapy resulted in a significant increase in the number of SSEs compared with Pl therapy in women with SSRI/SNRI-emergent loss of libido. The lack of improvement in the SSS total score may reflect lack of sensitivity of this instrument for the measurement of change in sexual function. This provides the first evidence that TT therapy may be a treatment option for women with SSRI/SNRI-emergent loss of libido who need to remain on their antidepressant therapy.

Continuous-combined oral estradiol/drospirenone has no detrimental effect on cognitive performance and improves estrogen deficiency symptoms in early postmenopausal women: a randomized placebo-controlled trial.

OBJECTIVE: This study aimed to explore the effects of continuous-combined estradiol 1 mg/drospirenone 2 mg (E2D) on cognitive performance in healthy, recently postmenopausal women. METHODS: A 6-month randomized, double-blind, placebo-controlled study was carried out in a university research center. Participants were 23 healthy postmenopausal women aged 49 to 55 years. Cognitive performance was assessed with a computerized cognitive battery administered to all participants on 0, 12, and 26 weeks. Functional magnetic resonance imaging was performed on 13 participants before and after treatment using tasks of verbal fluency and mental rotation. RESULTS: E2D was not associated with an overall effect on cognitive performance. Functional magnetic resonance imaging results showed no difference between the groups for verbal fluency or mental rotation task performance at baseline. The mental rotation task was associated with increased blood oxygen level-dependent signalling in the placebo group in both occipital lobes and in the left superior parietal lobe after 26 weeks (P < 0.05), with no changes over time seen in the treatment group. The total menopausal symptom and sexual function domain scores improved after treatment in women randomized to E2D compared with the placebo group (both P < 0.05). Similarly, systolic blood pressure, weight, and body mass index were significantly lower in women randomized to E2D at 26 weeks (P < 0.05). CONCLUSIONS: E2D has no detrimental effect on cognitive performance in early postmenopausal women. E2D significantly improves menopausal symptoms, sexual function, systolic blood pressure, and weight.

Sex and perimenopause.

BACKGROUND: Sexual difficulties are common across the female lifespan, increasing at midlife. Although changing hormone levels at menopause may contribute to the development of female sexual dysfunction, other factors, including relationship issues; psychological wellbeing; physical wellbeing; and medication use, such as antidepressants, need to be taken into consideration. The most common sexual difficulties reported by women across the perimenopause include dyspareunia, diminished desire, arousal capacity and difficulty in achieving orgasm. OBJECTIVE: This article summarises female sexual dysfunction in the perimenopausal woman, and discusses advice the general practitioner can offer women and possible treatment options. DISCUSSION: Many women experience loss of libido, reduced desire, difficulty in achieving orgasm and dyspareunia during their late reproductive and perimenopausal years. It is important that a woman is assessed in the context of her personal circumstances, partnership status, sexual experiences and cultural expectations. Management options range from informative discussions through to counselling and therapeutic intervention.

Drugs for the treatment of menopausal symptoms.

IMPORTANCE OF THE FIELD: Over the last decade, the management of the menopause has attracted extensive public and professional debate and has become one of the most controversial areas in clinical practice. AREAS COVERED IN THIS REVIEW: This review provides an overview of the field, primarily from a clinical practice perspective. However, as we have incorporated in this 'big-picture' snapshot of the field both conventional and complementary approaches to managing the menopause, it is not an exhaustive review of the literature. WHAT THE READER WILL GAIN: By reviewing menopausal management from the perspective of practicing clinicians, we hope readers will gain insight into decision making processes appropriate for dealing with symptomatic women. TAKE HOME MESSAGE: Although most women do not require pharmacotherapy for menopausal symptoms, many are severely affected by estrogen deficiency at and beyond menopause and, for such women, hormone therapy is important if they are to retain an acceptable quality of life. This article considers the drug treatment of the symptomatic postmenopausal woman and the safety issues related to these medications.

A randomized trial of oral DHEA treatment for sexual function, well-being, and menopausal symptoms in postmenopausal women with low libido.

INTRODUCTION: Dehydroepiandrosterone (DHEA) and its sulfate DHEAS, which are the most abundant steroids in women, decline with age. We have shown association between low sexual function and low circulating DHEAS levels in women. AIM: The aim of this study was to evaluate whether restoration of circulating DHEA levels in postmenopausal women to the levels seen in young individuals improves sexual function. METHODS: Ninety-three postmenopausal women not using concurrent estrogen therapy were enrolled in a 52-week randomized, double-blind, placebo controlled trial and received either DHEA 50 mg or placebo (PL) daily. MAIN OUTCOME MEASURES: Efficacy was assessed through 26 weeks. The main outcome measures were the change in total satisfying sexual events (SSE) and the change in the Sabbatsberg Sexual Self-Rating Scale (SSS) total score. Secondary measures were the Psychological General Well-Being Questionnaire (PGWB), and the Menopause-Specific Quality of Life Questionnaire (MENQOL). Hormonal levels, adverse events (AEs), serious adverse events (SAEs) and clinical labs were evaluated over 52 weeks. RESULTS: Eighty-five participants (91%) were included in the 26-week efficacy analysis. There were no significant differences between the DHEA and PL groups in the change in total SSE per month or the SSS, PGWB, and MENQOL change scores. Overall AE reports and number of withdrawals as a result of AEs were similar in both groups; however more women in the DHEA group experienced androgenic effects of acne and increased hair growth. CONCLUSIONS: In this study treatment of postmenopausal women with low sexual desire with 50 mg/day DHEA resulted in no significant improvements in sexual function over PL therapy over 26 weeks.

The safety of 52 weeks of oral DHEA therapy for postmenopausal women.

OBJECTIVE: The aim of this study was to evaluate the safety of 52 weeks of DHEA 50mg daily oral dose given to postmenopausal women with low libido to improve sexual function. METHOD: 93 postmenopausal women were enrolled in a 52-week randomised, double-blind, placebo-controlled trial and received either DHEA 50mg or placebo (PL) daily. The effects of DHEA versus placebo on lipid profile, insulin-glucose homeostasis and the endomentrium were assessed over 52 weeks. RESULTS: Oral DHEA, 50mg/day, was not associated with any effects on blood lipids or insulin resistance. The pattern of breakthrough bleeding did not substantially differ between the DHEA and PL groups and no significant adverse endometrial effects were apparent. CONCLUSIONS: The use of 50mg oral DHEA did not significantly alter lipid profile, insulin sensitivity or adversely affect the endometrium in postmenopausal women.