Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

OBJECTIVE: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects. METHODS: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome. RESULTS: A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice. CONCLUSIONS: We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.

Correlations among Core Outcomes in Menopause-recommended vasomotor symptom outcomes in MsFLASH trials.

OBJECTIVE: This study aimed to advance understanding of vasomotor symptom (VMS) outcomes measurement using pooled data from three Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) trials. METHODS: Participants self-reported VMS frequency, severity, and bother using daily diaries; completed standardized measures of VMS interference, insomnia severity, and sleep quality/disturbance; and completed four treatment satisfaction items. Analyses included descriptive statistics, Pearson correlations (baseline pooled sample, posttreatment pooled sample, posttreatment placebo only), t tests, and analysis of variance. RESULTS: Participants were mostly postmenopausal (82.9%) and a mean of 54.5 years old. VMS frequency was fairly correlated with severity, bother, and interference for pooled baseline and placebo posttreatment samples ( r values = 0.21-0.39, P values < 0.001) and moderately correlated with severity, bother, and interference for pooled posttreatment ( r values = 0.40-0.44, P values < 0.001). VMS severity, bother, and interference were moderately correlated ( r values = 0.37-0.48, P values < 0.001), with one exception. VMS severity and bother were strongly correlated ( r values = 0.90-0.92, P values < 0.001). VMS interference was moderately correlated with insomnia ( r values = 0.45-0.54, P values < 0.001) and fairly to moderately correlated with sleep quality/disturbance ( r values = 0.31-0.44, P values < 0.001). Other VMS outcomes were weakly to fairly correlated with insomnia ( r values = 0.07-0.33, P values < 0.001 to < 0.05) and sleep quality/disturbance ( r values = 0.06-0.26, P values < 0.001 to > 0.05). Greater improvement in VMS and sleep over time was associated with higher treatment satisfaction ( P values < 0.001). CONCLUSIONS: This pooled analysis advances understanding of VMS outcomes measurement and has implications for selecting measures and creating future research.

Palpitations and Co-Occurring Menopausal Symptoms in Women Prior to Breast Cancer Surgery.

OBJECTIVES: To determine the occurrence rate of palpitations in women prior to breast cancer surgery and evaluate for differences in demographic and clinical characteristics and menopausal symptoms in patients with and without palpitations. SAMPLE & SETTING: Presurgery data on palpitations and menopausal symptoms from 398 patients who underwent breast cancer surgery were analyzed. METHODS & VARIABLES: The Menopausal Symptoms Scale was used to evaluate the occurrence, severity, and distress of 46 symptoms, including palpitations. Parametric and nonparametric tests were used to evaluate for differences between patients with and without palpitations. RESULTS: Women with palpitations had lower annual income, lower functional status, higher comorbidity burden, and higher rates of back pain than women without palpitations. Women with palpitations had twice the number of menopausal symptoms and had higher occurrence rates for 39 of the 45 menopausal symptoms. They reported significantly higher severity scores for difficulty concentrating, dizziness, swollen hands/feet, and wake during the night, and higher distress scores for anxiety, hot flashes, swollen hands/feet, and wake during the night. IMPLICATIONS FOR NURSING: Clinicians should perform routine assessments of palpitations and make appropriate referrals to a cardiologist.

"Quick flutter skip": midlife women's descriptions of palpitations.

OBJECTIVE: The objective of this study is to describe peri- and postmenopausal women's experiences of palpitations (quality, frequency, severity, distress, duration and temporal pattern, aura, associated symptoms, and aggravating/alleviating factors) and related healthcare experiences. METHODS: Qualitative descriptive methods were used. Semistructured interviews were conducted with women who reported palpitations and were enrolled in a larger case-control pilot study comparing electrocardiographic results between women with and without palpitations. Authors analyzed women's narratives using standard content analytic procedures. RESULTS: Fourteen participants (mean age, 54.5 y [SD = 4.8 y]; range, 46-62 y; 79% postmenopausal) completed interviews. The interviews revealed that women (a) often had difficulty describing their palpitations until prompted by the interviewer; (b) experienced noteworthy variations in the quality and other dimensions of their palpitations; (c) had a wide variety of healthcare experiences related to their palpitations, including not reporting their symptoms to providers, having providers dismiss their symptoms, and having providers be aware of their symptoms and provide diagnostic tests; and (d) at times, created worst case scenarios (downward shifts) under which they would seek treatment for their palpitations, thus enabling them to minimize their symptoms and avoid healthcare. CONCLUSION: This study advances understanding of how women describe their palpitations and related healthcare experiences. Findings could have implications for building research and clinical tools to guide assessment, communication, and/or education for patients and/or providers about palpitations and for developing and testing behavioral interventions to address this poorly understood symptom in peri- and postmenopausal women.

Patients with palpitations experience a higher symptom burden prior to breast cancer surgery.

PURPOSE: Anxiety, depression, sleep disturbance, fatigue, cognitive dysfunction, and pain are common symptoms reported by patients with breast cancer. Recent evidence suggests that palpitations, a feeling of the heart racing or pounding, may be equally common. Study purpose was to compare the severity and clinically meaningful occurrence rates of common symptoms and quality of life (QOL) outcomes between patients with breast cancer who did and did not report palpitations prior to surgery. METHODS: Patients (n = 398) were classified as having or not having palpitations using a single item from the Menopausal Symptoms Scale. Valid and reliable measures were used to assess state and trait anxiety, depression, sleep disturbance, fatigue, energy, cognitive function, breast symptoms, and QOL. Between group differences were evaluated using parametric and non-parametric tests. RESULTS: Patients with palpitations (15.1%) reported significantly higher severity scores for state and trait anxiety, depression, sleep disturbance, and fatigue as well as significant decrements in energy and cognitive function (all p < .05). A higher percentage of these patients had clinically meaningful levels of state anxiety, depression, sleep disturbance and decrements in cognitive function (all p < .05). Except for spiritual well-being, QOL scores were lower in the palpitations group (all p < .001). CONCLUSION: Findings support the need for routine assessment of palpitations and management of multiple symptoms in women prior to breast cancer surgery.

Pain and Associated Factors in Nursing Home Residents.

BACKGROUND: Understanding factors associated with risk of pain allows residents and clinicians to plan care and set priorities, however, factors associated with pain in nursing home residents has not been conclusively studied. AIM: To evaluate the association between pain and nursing home (NH) resident demographic and clinical characteristics. DESIGN: Retrospective analysis of Minimum Data Set 3.0 records of nursing home residents residing in 44 Indiana NHs between September 27, 2011 and December 27, 2019 (N = 9,060). RESULTS: Pain prevalence in this sample of NH residents was 23.7%. Of those with pain, 28.0% experienced moderate to severe/frequent pain and 54.6% experienced persistent pain. Risk factors for moderate to severe/frequent pain include female sex; living in a rural setting; intact, mildly, or moderately impaired cognition; arthritis; contracture; anxiety; and depression. In contrast, stroke and Alzheimer's disease and Alzheimer's-disease related dementias (AD/ADRD) were associated with decreased risk of reporting moderate to severe/frequent pain, likely representing both the under-assessment and under-reporting of pain among cognitively impaired NH residents. Risk factors for persistent pain included age <70, Black race, living in a rural location, intact cognition, contracture, and depression. CONCLUSIONS: Pain remains a pressing problem for NH residents. In this study, we identified demographic and clinical factors associated with moderate to severe frequent pain and persistent pain. Residents with a diagnosis of AD/ADRD were less likely to report pain, likely representing the difficulty of evaluating pain in these residents. It is important to note that those with cognitive impairment may not experience any less pain, but assessment and reporting difficulties may make them appear to have less pain. Knowledge of factors associated with pain for NH residents has the potential for improving the ability to predict, prevent, and provide better pain care in NH residents.

Pain trajectories of nursing home residents.

BACKGROUND: Understanding changes in nursing home (NH) resident pain over time would provide a more informed perspective, allowing opportunities to alter the course of illness, plan care, and set priorities. Therefore, the purpose of this analysis was to identify and characterize clinically meaningful, dynamic pain trajectories in NH residents. METHODS: Retrospective longitudinal analysis of NH resident pain scores with a length of stay >100 days (N = 4864). Group-based trajectory modeling was applied to Minimum Data Set 3.0 assessments to identify pain trajectories. Trajectories were then characterized using unadjusted and adjusted cross-sectional associations between residents' demographic and clinical characteristics and their pain trajectory. RESULTS: We identified four distinct trajectories: (1) consistent pain absence (48.9%), (2) decreasing-increasing pain presence (21.8%), (3) increasing-decreasing pain presence (15.3%), and (4) persistent pain presence (14.0%). Demographics of younger age and living in a rural area were associated with the persistent pain presence trajectory. Clinical variables of obesity and intact cognition were associated with being in the persistent pain presence trajectory. A smaller proportion of residents with moderately or severely impaired cognition were in any of the trajectory groups with pain. CONCLUSIONS: We identified and characterized four pain trajectories among NH residents, including persistent pain presence which was associated with demographic characteristics (younger, female, rural) and clinical factors (obese, fracture, contracture). Moreover, residents with a diagnosis of Alzheimer's disease or dementia were less likely to be in any of the three trajectories with pain, likely representing the difficulty in evaluating pain in these residents. It is important that NH staff understand, recognize, and respond to the factors associated with the identified pain trajectories to improve mitigation of potentially persistent pain (e.g., hip fracture, contracture) or improve proxy pain assessment skills for residents at risk for under reporting of pain (e.g., Alzheimer's Disease).

A Pilot Study of Associations Between the Occurrence of Palpitations and Cytokine Gene Variations in Women Prior to Breast Cancer Surgery.

OBJECTIVES: Palpitations are common and have a negative impact on women's quality of life. While evidence suggests that inflammatory mechanisms may play a role in the development of palpitations, no studies have evaluated for this association in patients with breast cancer who report palpitations prior to surgery. The purpose of this pilot study was to evaluate for associations between the occurrence of palpitations and single nucleotide polymorphisms (SNPs) in genes for pro- and anti-inflammatory cytokines, their receptors, and transcriptional regulators. METHODS: Patients were recruited prior to surgery and completed a self-report questionnaire on the occurrence of palpitations. Genotyping of SNPs in cytokine genes was performed using a custom array. Multiple logistic regression analyses were done to identify associations between the occurrence of palpitations and SNPs in fifteen candidate genes. RESULTS: Of the 82 SNPs evaluated in the bivariate analyses, eleven SNPs in 6 genes were associated with the occurrence of palpitations. After controlling for functional status, the occurrence of back pain, and self-reported and genomic estimates of race/ethnicity, 3 SNPs in 3 different genes (i.e., interleukin (IL) 1-beta (IL1B) rs1143643, IL10 rs3024505, IL13 rs1295686) were associated with the occurrence of palpitations prior to surgery (all p ≤ .038). CONCLUSIONS: While these preliminary findings warrant replication, they suggest that inflammatory mechanisms may contribute to the subjective sensation of palpitations in women prior to breast cancer surgery.

Palpitations across the menopause transition in SWAN: trajectories, characteristics, and associations with subclinical cardiovascular disease.

OBJECTIVE: Our objectives were to identify trajectories of palpitations over the menopause transition, characterize them, and examine associations with subclinical cardiovascular disease (CVD). METHODS: We analyzed the following data from the multisite, multiethnic SWAN (Study of Women Across the Nation): reported palpitations occurrence over time; baseline sociodemographic, reproductive, medication, and health-related factors; and follow-up visit subclinical CVD (carotid atherosclerosis, vascular stiffness). Trajectories of palpitations (n = 3,276), their characteristics, and their associations with subclinical CVD (n = 1,559) were identified using group-based trajectory modeling and linear and logistic regression models. RESULTS: Three trajectories emerged: high probability of palpitations in perimenopause to early postmenopause diminishing in late postmenopause (15.9% of women), moderate probability of palpitations in perimenopause to early postmenopause diminishing in late postmenopause (34.3%), and sustained low probability of palpitations (49.8%). In the fully adjusted multivariable model, the high probability group had a more adverse reproductive and health-related profile at baseline (higher gravidity, early perimenopause, vasomotor symptoms, poorer overall health, higher depressive symptoms, higher perceived stress, greater sleep problems, higher blood pressure). In fully adjusted multivariable models, palpitation trajectories were not related to atherosclerosis or arterial stiffness. CONCLUSIONS: Distinct patterns of palpitations emerged, with a substantial portion of women having palpitations during the perimenopause and early postmenopause. Palpitations were not associated with subclinical CVD. Findings can help identify women at risk of palpitations during the menopause transition who may need symptom relief.

Communication Between Registered Nurses and Family Members of Intensive Care Unit Patients.

BACKGROUND: Effective communication between intensive care unit patients and their families and nurses promotes relationship-centered care and improves nurses' ability to meet patient and family needs. However, communication with these patients is challenging because of their critical illness. Families often become surrogate decision makers for adult intensive care unit patients. OBJECTIVE: To systematically assess available evidence on communication between adult intensive care unit patients and their families and nurses as the initial step in developing nursing strategies to strengthen communication skills. METHODS: In this integrative review, the method of Whittemore and Knafl was used to synthesize findings from qualitative and quantitative (descriptive and experimental) research. RESULTS: The review revealed a variety of research designs, measurement tools, and types of interventions. The qualitative findings suggest that nurses can strengthen relationship-centered care by regularly updating patients' families and providing information that can assist with decision-making. The quantitative findings suggest that nurses should be mindful of family members' needs for assurance, comfort, and support. Providing information on patient status can help alleviate family concerns. CONCLUSIONS: Improved communication between patients and families and intensive care unit nurses is essential to strengthen relationship-centered care. Additional research is needed to better understand the communication needs of adult patients and their families in the intensive care unit.

Prevalence and Factors Associated with Pain in Nursing Home Residents: A Systematic Review of the Literature.

OBJECTIVES: To describe the pain prevalence in nursing home (NH) residents and the factors associated with the experience of pain. DESIGN: Systematic review of descriptive studies. SETTING AND PARTICIPANTS: Three electronic databases were searched from 2010 to September 2020 in English. Descriptive studies that examined pain in NH residents, reported pain prevalence, and/or associated factors were included. Studies that focused exclusively on a specific disease or type of care such as cancer or hospice were excluded. METHODS: Two reviewers independently screened, selected, extracted data, and assessed risk of bias from included studies; narrative synthesis was performed. The review was guided by the Biopsychosocial Model of Chronic Pain for Older Adults. RESULTS: Twenty-six studies met our inclusion criteria. Overall, the prevalence of current pain ranged from 22.2% to 85.0%, the prevalence of persistent pain ranged from 19.5% to 58.5%, and the prevalence of chronic pain ranged from 55.9% to 58.1%. A variety of pain scales were used reporting higher pain prevalence for those using self-report measures (31.8% to 78.8%) or proxy measures (29.5% to 85.0%) compared with using chart review (22.2% to 29.3%) as the source of pain information. The studies reviewed provide support that certain diseases and clinical conditions are associated with pain. Impairment in activities of daily living (ADL) (12 studies), cognition (9 studies), depression (9 studies), and arthritis (9 studies) are the most widely studied factors, whereas depression, ADL impairment, arthritis, dementia, and cognitive impairment present the strongest association with pain. CONCLUSION AND IMPLICATIONS: This review highlights the complexities of pain in NH residents and has implications for both clinical practice and future research. Understanding the factors that underlie the experience of pain, such as depression, is useful for clinicians evaluating pain and tailoring management therapies. In addition, the gaps in knowledge uncovered in this review are important areas for future research.

Correlates of palpitations during menopause: A scoping review.

OBJECTIVE: Palpitations during peri- and post-menopause are common. It is unclear what variables are related to palpitations in peri- and post-menopausal women. The purpose of this scoping review was to summarize potential correlates of palpitations in women transitioning through menopause. METHODS: The review followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Authors included English-language, full-length, peer-reviewed, cross-sectional research articles on palpitations in menopausal women published through December 18, 2021, from PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and PsycINFO searches. Following de-duplication, screening of titles and abstracts, and review of full-texts, independent reviewers extracted data on variables studied in relationship to palpitations from 84 articles and resolved discrepancies. Authors extracted data on (1) demographic, clinical, biomarker, and symptom/quality of life variables and (2) data analysis method (bivariate, multivariate). Authors classified each variable as a likely, unlikely, or unclear correlate of palpitations. RESULTS: Articles were diverse in region of origin, sample sizes, and variables assessed in relationship to palpitations. Evidence for any one variable was sparse. Likely correlates of palpitations included race/ethnicity, lower physical activity, worse vasomotor symptoms (VMSs), worse sleep, and worse quality of life. Unlikely correlates included age, employment, education, marital status, socioeconomic status, comorbidities, body mass index, and sexual difficulties. Unclear correlates due to equivocal evidence were menopausal status, smoking, and depression. Unclear correlates due to insufficient evidence (less than three articles) included all of the assessed biomarkers, anxiety, and stress. CONCLUSION: Likely correlates were identified including race/ethnicity, physical activity, VMS, sleep, and quality of life. However, additional research is needed to better understand potential correlates of palpitations.

Mechanisms of pelvic floor muscle training for managing urinary incontinence in women: a scoping review.

BACKGROUND: Pelvic floor muscle training is recommended as first line treatment for urinary incontinence in women based on three proposed theorized mechanisms: 'Enhanced Pelvic Floor Muscle Strength,' 'Maximized Awareness of Timing,' and 'Strengthened Core Muscles'. The purpose of this scoping review was to systematically map evidence for and against theorized mechanisms through which pelvic floor muscle training interventions work to reduce urinary incontinence in women. METHODS: The scoping review is based upon a comprehensive search of relevant literature published from 1990 to 2020 in PubMed, CINAHL, PsycINFO, ClinialTrials.gov, reference lists from review articles, and hand searches of articles by known researchers in the field. We included English-language, peer-reviewed articles on pelvic floor muscle training as an intervention for adult women if they provided empirical evidence to testing the theorized intervention mechanisms. Two independent reviewers screened articles for inclusion and extracted data to describe details of each study (author, year, country, design, sampling), measures of pelvic floor muscle strength and urinary incontinence, statistical analysis of linkage between changes in the measures, and pelvic floor muscle training regimens. Data were summarized to facilitate the integration of diverse evidence to draw conclusions on supporting or refuting the three proposed theorized mechanisms for managing urinary incontinence in women. RESULTS: Of the 278 articles identified with the search, 13 (4.7%) met inclusion criteria. There was weak to no evidence for the mechanism of enhanced pelvic floor muscle strength, equivocal support for maximized awareness of timing, and no evidence for strengthened core muscles. CONCLUSIONS: This review revealed extremely limited data supporting the proposed theorized mechanisms underlying pelvic floor muscle training programs to manage urinary incontinence in women. Such evidence is needed to help women and clinicians understand how, why and when a woman benefits from pelvic floor muscle training. Future studies should specifically state and report statistical analysis that relates the theorized mechanisms to the training outcomes observed.

Toward a better measure of midlife sexual function: pooled analyses in nearly 1,000 women participating in MsFLASH randomized trials.

OBJECTIVE: Evaluate appropriateness of the current Female Sexual Function Index (FSFI)-19 value of <26.6 to designate female sexual dysfunction (FSD) in postmenopausal women, using the Female Sexual Distress-Revised (FSDS-R) scale to measure distress. METHODS: Participant-level data containing standardized measures from five completed Menopause Strategies: Finding Lasting Answers for Symptoms and Health trials was pooled. Baseline characteristics and FSFI-19 scores were compared across trials (F-test, homogeneity). FSFI-19 score associations with the FSDS-R were described. Receiver operating characteristic (ROC) curves were plotted to illustrate the choice of optimal FSFI-19 value to predict sexual distress. ROC curves were also estimated adjusting for trial number, clinical center, age, education, race, smoking, and BMI. RESULTS: Nine hundred ninety eight women (79.2% postmenopausal), mean age 55.9 (SD 4.8) had complete FSFI-19, FSDS-R, and covariate data. Baseline mean FSFI-19 score among all participants and sexually active participants was 18.7 (SD 9.5) and 22.0 (SD 7.2), respectively. There was a consistent pattern across the trials of inverse association between poorer sexual function (FSFI-19) and greater sexual distress. Based on the ROC curve showing the likelihood of FSDS-R frequent or greater distress according to cut points of FSFI, the optimal cut point for FSD was FSFI-19 <21 for all participants. This cut point corresponded to sensitivity 87.2% (95% CI, 83.4-91.0), specificity 57.9% (95% CI, 54.3-61.6) and adjusted area under the ROC curve 78.8% (95% CI, 75.8-81.8). CONCLUSIONS: A new FSFI-19 cut point of ≥21 should be considered to describe normal sexual function in periand postmenopausal women as opposed to the standard cut point of >26.6. VIDEO SUMMARY: http://links.lww.com/MENO/A915.

Attitudinal and social predictors of adherence to oral endocrine therapy: A psychometrically-informed model.

There is a need for a psychometrically-informed model identifying attitudinal and social factors explaining adherence to oral endocrine therapy (OET) for women with hormone receptor positive breast cancer. This study tested a model with variables selected by stringent psychometric criteria, including attitudes about benefit and burden, patient-practitioner alliance and confusion, and positive and negative interpersonal interactions. Self-report scales were completed by 150 current or past OET users. Fourteen correlations and six mediated pathways implied by the model were tested. All hypothesized associations were significant. This preliminary study suggests the model is a valuable framework for OET adherence research and intervention.

A study of Indiana University Health's spirit of inquiry and innovation during COVID.

BACKGROUND: COVID-19 has required nursing innovations to meet patient care needs not previously encountered. PURPOSE: The purpose of this study was to describe nursing innovations conceived, implemented, and desired during the first COVID-19 surge. METHODS: The investigators invited registered nurses employed across 16 Midwest hospitals (6,207) to complete the survey. Respondents provided demographics and written descriptions of innovations they conceived, witnessed, and desired. Investigators analyzed text responses using standard content analytic procedures and summarized quantitative demographics using percentages. FINDINGS: Nurses reported seven types of innovations that would (a) improve personal protective equipment (PPE), (b) limit the need to repeatedly don and doff PPE, (c) ensure safer practice, (d) conserve and access supplies, (e) provide patient and family education and support, (f) make team member communication more efficient, and (g) improve peer support. DISCUSSION: Nurses are in a unique position to generate innovative solutions to meet patient care needs under adverse and rapidly changing situations.