Distinct Longitudinal Trajectories of Symptom Burden Predict Clinical Outcomes in End-Stage Liver Disease.

OBJECTIVES: Little has been reported about the clinical relevance and trajectories of symptoms in end-stage liver disease (ESLD). The purpose of this prospective study was to identify trajectories of change in symptom burden over the course of 12 months in adults with ESLD. METHODS: Patients were recruited from hepatology clinics at two health care systems. Validated measures were used to assess physical and psychological symptoms. Latent growth mixture modeling and survival and growth modeling were used to analyze the survey data. RESULTS: Data were available for 192 patients (mean age 56.5±11.1 years, 64.1% male, mean MELD-3.0 19.2±5.1, ETOH as primary etiology 33.9%, ascites 88.5%, encephalopathy 70.8%); there were 38 deaths and 39 liver transplantations over 12 months. Two symptom trajectories were identified: 62 patients (32.3%) had high and unmitigated symptoms, and 130 (67.7%) had lower and improving symptoms. Patients with high and unmitigated symptoms had twice the hazard of all-cause mortality (sHR 2.53, 95% CI: 1.32-4.83), and had worse physical (p<0.001) and mental quality of life (p=0.012) compared with patients with lower and improving symptoms. Symptom trajectories were not associated with MELD 3.0 scores (p=0.395). Female gender, social support, and level of religiosity were significant predictors of symptom trajectories (p<0.05 for all). CONCLUSIONS: There appears to be two distinct phenotypes of symptom experience in patients with ESLD that is independent of disease severity and associated with gender, social support, religiosity, and mortality. Identifying patients with high symptom burden can help optimize their care.

Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study.

BACKGROUND: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe the creation of 5 self-reported 4-item short forms and the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation. METHODS: Using a cross-sectional sample of patients (n = 620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created 5 4-item short forms: Satisfaction with Treatment, ventricular assist device (VAD) Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item profile. Analyses included intercorrelations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity. RESULTS: The 620 patients were mean age = 57 years, 78% male, 70% White, and 56% on destination therapy LVADs. Intercorrelations among the 5 4-item measures were low to moderate (≤0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were ≥0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the 5 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures. CONCLUSIONS: Our 5 4-item short forms are reliable and valid and may be used individually or together as a 20-item profile to assess adjustment and HRQOL in patients who undergo LVAD implantation.

Body listening in the link between symptoms and self-care management in cardiovascular disease: A cross-sectional correlational descriptive study.

OBJECTIVE: The aim of this study was to quantify relationships among symptoms, interoceptive sensibility (i.e. the conscious level of sensing, interpreting and integrating signals from the body), and self-care management behaviors (i.e. the response to symptoms when they occur) among adults with cardiovascular disease. We hypothesized that better interoceptive sensibility would increase the positive behavior-driving effects of symptoms on self-care management. METHODS: Adult patients with cardiovascular disease who experienced recent symptoms were recruited to participate in this cross-sectional correlational descriptive study. Patient-Reported Outcomes Measurement Information System measures were used to capture dyspnea, pain interference, fatigue, sleep disturbances, nausea and vomiting, anxiety and depressive symptoms. Interoceptive sensibility was measured using the Multidimensional Assessment of Interoceptive Awareness Version 2. The Self-Care of Chronic Illness Inventory was used to measure self-care management. Network analysis was used to identify domains of interoceptive sensibility that were most central. Linear regression with interaction terms was used to test the moderating effect of interoceptive sensibility on the relationship between symptoms and self-care management. RESULTS: The age of participants in the sample (n = 387) ranged from 18 to 88 years, a slight majority (53.5 %) were female, and a majority were Caucasian (66.4 %) or African American (32.0 %). Hypertension was the most common disorder (n = 238 (61.5 %)), followed by rhythm disorders (n = 124 (32.0 %)), coronary artery disease (n = 94 (24.3 %)), heart failure (n = 89 (23.0 %)), valve disease (n = 69 (17.8 %)), stroke (n = 62 (16.0 %)) and peripheral vascular disease (n = 49 (12.7 %)). Based on network analysis, body listening (i.e. active listening to the body for insights) was the most central interoceptive domain, and distracting (i.e. tendency to ignore or distract oneself from sensations of discomfort) was the least central. Noticing (i.e. greater awareness of body sensations), distracting, and body listening were significant in moderating relationships between dyspnea, sleep disturbances and anxiety and the outcome of self-care management behaviors (all p < 0.001). Better noticing and body listening were associated with better self-care management across symptoms, whereas ignoring or distracting oneself from discomfort was associated with worse self-care management behaviors. CONCLUSION: Among adults with cardiovascular disease, interventions designed to augment the identified interoceptive sensibility domains like body listening, and mitigate the tendency to ignore or distract oneself from discomfort may support adults with cardiovascular disease through the development of future interventions that optimize patient behaviors in response to symptoms when they occur.

Self-care trajectories of patients with coronary heart disease: a longitudinal, observational study.

AIMS: To determine if distinct trajectories of coronary heart disease (CHD) self-care behaviours could be identified, linked to differences in quality of life (QoL), and predicted based on baseline characteristics. METHODS AND RESULTS: A secondary analysis of a prospective, longitudinal, observational study. Patients with CHD answered questionnaires at study enrolment and six months later: Self-Care of Coronary Heart Disease Inventory (three subscales: maintenance, management and confidence, scored 0-100, higher score = better self-care), Hospital Anxiety and Depression Scale, 12-Item Short Form Survey, 16-Item European Health Literacy Survey Questionnaire, CHD Education Questionnaire. Latent growth mixture modelling was used to identify distinct self-care trajectories over time.On average, patients (n = 430, mean age 64.3 ± 8.9, 79% male) reported inadequate self-care (maintenance 61.6 ± 15.4, management 53.5 ± 18.5) at enrolment. Two distinct trajectories of self-care behaviours were identified: First, an "inadequate-and-worsening" (IN-WORSE) trajectory (57.2%), characterised by inadequate self-care, improvement in maintenance (4.0 ± 14.5-point improvement, p < 0.001) and worsening of management over time (6.3 ± 24.4-point worsening, p = 0.005). Second, an "inadequate-but-maintaining" (IN-MAIN) trajectory (42.8%), characterised by inadequate self-care, improvement in maintenance (5.0 ± 16.2-point improvement, p < 0.001) and stability in management over time (0.8 ± 21.9-point worsening, p = 0.713). In comparison, patients in the IN-WORSE trajectory had less favourable characteristics (including lower health literacy, knowledge, confidence) and significantly lower QoL. Not attending rehabilitation (OR 2.175; CI 1.020-4.637, p = 0.044) and older age (OR 0.959; CI 0.924-0.994, p = 0.024) predicted (IN-WORSE) trajectory inclusion. CONCLUSION: Two self-care trajectories were identified, both suboptimal. Rehabilitation predicted membership in the more favorable trajectory and some positive characteristics were identified among patients in that group. Therefore, interventions supporting these factors may benefit patients' self-care and QoL.

The role of nurse-patient mutuality on self-care behaviours in patients with chronic illness.

AIM: To examine the role of nurse-patient mutuality on three self-care behaviours in chronic illness patients. DESIGN: A cross-sectional multi-centre study was conducted. METHODS: Mutuality was measured with the Nurse-Patient Mutuality in Chronic Illness scale which has the dimensions of developing and going beyond, being a point of reference and deciding and sharing care, and self-care was measured with the Self-care of Chronic Illness Inventory (SC-CII). Multivariable linear regression analyses were used to assess the contribution of three dimensions of mutuality on self-care maintenance, monitoring and management behaviours controlling for patient gender, age, education, number of medications, and presence of a family caregiver. RESULTS: The sample included 465 inpatients and outpatients with at least one chronic illness. The three dimensions of mutuality had different roles in their influence on the three dimensions of self-care. Developing and going beyond was significantly associated with self-care maintenance and self-care monitoring behaviours. Point of reference was significantly associated with self-care maintenance behaviour. Deciding and sharing care was significantly associated with self-care monitoring and self-care management behaviours. CONCLUSION: The mutuality between nurse and patient may be a novel area of research to support and improve patient self-care behaviours with implications for clinical practice and education. IMPLICATION FOR PROFESSION AND PATIENT CARE: Mutuality between nurse and patient increases patient engagement, symptom recognition, decision-making process and patient-centred approach favouring the development of self-care behaviours. IMPACT: Mutuality between nurse and patient is a new concept and its association with the patient outcomes could bring relevance to the nursing profession. Self-care behaviours are important in the management of chronic diseases, but are difficult to perform. Mutuality between nurse and patient influences the three different behaviours of self-care in chronic illness, for this reason it is important to increase the level of mutuality in this dyad. REPORTING METHOD: STROBE checklist for cross-sectional studies was followed in this study. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the sample of the study.

Classes and predictors of reversal in male patients with congenital hypogonadotropic hypogonadism: a cross-sectional study of six international referral centres.

BACKGROUND: Although some male patients with congenital hypogonadotropic hypogonadism (CHH) undergo spontaneous reversal following treatment, predictors of reversal remain elusive. We aimed to assemble the largest cohort of male patients with CHH reversal to date and identify distinct classes of reversal. METHODS: This multicentre cross-sectional study was conducted in six international CHH referral centres in Brazil, Finland, France, Italy, the UK, and the USA. Adult men with CHH (ie, absent or incomplete spontaneous puberty by age 18 years, low serum testosterone concentrations, and no identifiable cause of hypothalamic-pituitary-gonadal [HPG] axis dysfunction) were eligible for inclusion. CHH reversal was defined as spontaneous recovery of HPG axis function off treatment. Centres provided common data elements on patient phenotype, clinical assessment, and genetics using a structured, harmonised data collection form developed by COST Action BM1105. Latent class mixture modelling (LCMM) was applied to establish whether at least two distinct classes of reversal could be identified and differentially predicted, and results were compared with a cohort of patients without CHH reversal to identify potential predictors of reversal. The primary outcome was the presence of at least two distinct classes of reversal. FINDINGS: A total of 87 male patients with CHH reversal and 108 without CHH reversal were included in the analyses. LCMM identified two distinct reversal classes (75 [86%] in class 1 and 12 [14%] in class 2) on the basis of mean testicular volume, micropenis, and serum follicle-stimulating hormone (FSH) concentration. Classification probabilities were robust (0·998 for class 1 and 0·838 for class 2) and modelling uncertainty was low (entropy 0·90). Compared with class 1, patients in class 2 had significantly larger testicular volume (p<0·0001), no micropenis, and higher serum FSH concentrations (p=0·041), consistent with the Pasqualini syndrome (fertile eunuch) subtype of CHH. Patients without CHH reversal were more likely to have anosmia (p=0·016), cryptorchidism (p=0·0012), complete absence of puberty (testicular volume <4 cm³; p=0·0016), and two or more rare genetic variants (ie, oligogenicity; p=0·0001). Among patients who underwent genetic testing, no patients (of 75) with CHH reversal had a rare pathogenic ANOS1 variant compared with ten (11%) of 95 patients without CHH reversal. Individuals with CHH reversal had a significantly higher rate of rare variants in GNRHR than did those without reversal (nine [12%] of 75 vs three [3%] of 95; p=0·025). INTERPRETATION: Applying LCMM to a large cohort of male patients with CHH reversal uncovered two distinct classes of reversal. Genetic investigation combined with careful clinical phenotyping could help surveillance of reversal after withdrawing treatment, representing the first tailored management approach for male patients with this rare endocrine disorder. FUNDING: National Institutes of Health National Center for Advancing Translational Sciences; Ministry of Health, Rome, Italy; Ministry of University, Rome, Italy; National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; and the Josiah Macy Jr Foundation. TRANSLATION: For the Italian translation of the abstract see Supplementary Materials section.

Informal Family Care Partner Well-Being Is Diminished in End-Stage Liver Disease.

BACKGROUND: Chronic liver disease is a significant global neglected public health problem. End-stage liver disease is associated with substantial symptom complexity, disability, and care needs that require assistance from informal family care partners. Research on these care partners' caregiver burden or strain, symptoms, and quality of life is sparse and has not focused on these variables as co-occurring or in the context of the quality of the relationship care partners have with the patients. OBJECTIVES: The purpose of this study was to provide a collective presentation of patterns and determinants of well-being as measured by caregiver strain, depression, sleep, and quality of life in a cohort of informal family care partners for adult outpatients with end-stage liver disease. METHODS: Care partners (aged >18 years) were recruited from two liver clinics within two tertiary healthcare systems and invited to complete a cross-sectional survey. They completed the Multidimensional Caregiver Strain Index, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Short Form Health Survey, and Mutuality Scale. Descriptive statistics and latent class mixture modeling were used to analyze these data. RESULTS: The sample was predominantly female and White. The well-being of care partners was diminished. Three distinct classes of well-being were identified: mildly diminished (53.2%), moderately diminished (39.0%), and severely diminished (7.8%). Those at a greater risk of worse well-being were younger and spouses and had poorer relationship quality with the patients. DISCUSSION: To improve the well-being of care partners in moderately and severely diminished classes, assessing and addressing caregiver strain and co-occurring symptoms is essential. Addressing the strain and symptoms has the potential to maintain or optimize care partners' ability to provide care to patients. Future researchers should include longitudinal and dyadic studies to examine how patients' disease progression and symptoms may affect family care partners' well-being and vice versa.

Symptom characteristics, perceived causal attributions, and contextual factors influencing self-care behaviors: An ecological daily assessment study of adults with chronic illness.

OBJECTIVE: Insights into how symptoms influence self-care can guide patient education and improve symptom control. This study examined symptom characteristics, causal attributions, and contextual factors influencing self-care of adults with arthritis, asthma, chronic obstructive pulmonary disease, diabetes, or heart failure. METHODS: Adults (n = 81) with a symptomatic chronic illness participated in a longitudinal observational study. Using Ecological Daily Assessment, participants described one symptom twice daily for two weeks, rating its frequency, severity, bothersomeness, duration, causes, and self-care. RESULTS: The most frequent symptoms were fatigue and shortness of breath. Pain, fatigue, and joint stiffness were the most severe and bothersome. Most participants engaged in active self-care, but those with fatigue and pain engaged in passive self-care (i.e., rest or do nothing), especially when symptoms were infrequent, mild, somewhat bothersome, and fleeting. In people using passive self-care, thoughts, feelings, and the desire to conceal symptoms from others interfered with self-care. CONCLUSION: Most adults with a chronic illness take an active role in managing their symptoms but some conceal or ignore symptoms until the frequency, severity, bothersomeness, or duration increases. PRACTICE IMPLICATIONS: When patients report symptoms, asking about self-care behaviors may reveal inaction or ineffective approaches. A discussion of active self-care options may improve symptom control.

Sympathetic dysfunction is associated with worse fatigue and early and subtle symptoms in heart failure: an exploratory sex-stratified analysis.

AIMS: Physical symptoms impact patients with heart failure (HF) despite treatment advancements; however, our understanding of the pathogenic mechanisms underlying HF symptoms remains limited, including sex differences therein. The objective of this study was to quantify associations between sympathetic markers [norepinephrine (NE) and 3,4-dihydroxyphenylglycol (DHPG)] and physical symptoms in patients with HF and to explore sex differences in these associations. METHODS AND RESULTS: We performed a secondary analysis of combined data from two studies: outpatients with HF (n = 111), and patients prior to left ventricular assist device implantation (n = 38). Physical symptoms were measured with the Heart Failure Somatic Perception Scale (HFSPS) dyspnoea and early/subtle symptom subscales and the Functional Assessment in Chronic Illness Therapy Fatigue Scale (FACIT-F) to capture dyspnoea, early symptoms of decompensation, and fatigue. Norepinephrine and DHPG were measured with high-performance liquid chromatography with electrochemical detection. Multivariate linear regression was used to quantify associations between symptoms and sympathetic markers. The sample (n = 149) was 60.8 ± 15.7 years, 41% women, and 71% non-ischaemic aetiology. Increased plasma NE and NE:DHPG ratio were associated with worse FACIT-F scores (P = 0.043 and P = 0.013, respectively). Increased plasma NE:DHPG ratio was associated with worse HFSPS early/subtle symptoms (P = 0.025). In sex-stratified analyses, increased NE:DHPG ratio was associated with worse FACIT-F scores (P = 0.011) and HFSPS early/subtle scores (P = 0.022) among women but not men. CONCLUSION: In patients with HF, sympathetic dysfunction is associated with worse fatigue and early/subtle physical symptoms with associations stronger in women than men.

Identification of Fatigue Subtypes and Their Correlates in Prevalent Heart Failure: A Secondary Analysis of the Atherosclerosis Risk in Communities Study.

BACKGROUND: Among patients with heart failure (HF), fatigue is common and linked to quality of life and functional status. Fatigue is hypothesized to manifest as multiple types, with general and exertional components. Unique subtypes of fatigue in HF may require differential assessment and treatment to improve outcomes. We conducted this study to identify fatigue subtypes in persons with prevalent HF in the ARIC study (Atherosclerosis Risk in Communities) and describe the distribution of characteristics across subtypes. METHODS: We performed a cross-sectional analysis of 1065 participants with prevalent HF at ARIC visit 5 (2011-2013). We measured exertional fatigue using the Modified Medical Research Council Breathlessness scale and general fatigue using the Patient Reported Outcomes Measurement Information System fatigue scale. We used latent class analysis to identify subtypes of fatigue. Number of classes was determined using model fit statistics, and classes were interpreted and assigned fatigue severity rating based on the conditional probability of endorsing survey items given class. We compared characteristics across classes using multinomial regression. RESULTS: Overall, participants were 54% female and 38% Black with a mean age of 77. We identified 4 latent classes (fatigue subtypes): (1) high general/high exertional fatigue (18%), (2) high general/low exertional fatigue (27%), (3) moderate general/moderate exertional fatigue (20%), and (4) low/no general and exertional fatigue (35%). Female sex, Black race, lower education level, higher body mass index, increased depressive symptoms, and higher prevalence of diabetes were associated with higher levels of general and exertional fatigue. CONCLUSIONS: We identified unique subtypes of fatigue in patients with HF who have not been previously described. Within subtype, general and exertional fatigue were mostly concordant in severity, and exertional fatigue only occurred in conjunction with general fatigue, not alone. Further understanding these fatigue types and their relationships to outcomes may enhance our understanding of the symptom experience and inform prognostication and secondary prevention efforts for persons with HF.

Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study.

BACKGROUND: Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device adjustment and health-related quality of life (HRQOL). METHODS: Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n = 620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n = 154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n = 466]). We constructed 5 item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity. RESULTS: Of 620 participants, 56% (n = 345) were implanted as destination therapy, 51% (n = 316) were <12 months post-implantation, mean age = 57.3 years, 78% (n = 485) male, 70% (n = 433) White, 58% (n = 353) married/partnered, and 58% (n = 357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators. CONCLUSIONS: These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions.

Patterns of self-care decision-making and associated factors: A cross-sectional observational study.

OBJECTIVE: The aim of this study was to identify for the first time patterns of self-care decision-making (i.e. the extent to which participants viewed contextual factors influencing decisions about symptoms) and associated factors among community-dwelling adults with chronic illness. METHODS: This was a secondary analysis of data collected during the development and psychometric evaluation of the 27-item Self-Care Decisions Inventory that is based on Naturalistic Decision-Making (n = 430, average age = 54.9 ±â€¯16.2 years, 70.2 % female, 87.0 % Caucasian, average number of chronic conditions = 3.6 ±â€¯2.8). Latent class mixture modeling was used to identify patterns among contextual factors that influence self-care decision-making under the domains of external, urgency, uncertainty, cognitive/affective, waiting/cue competition, and concealment. Multivariate multinomial regression was used to identify additional socio-demographic, clinical, and self-care behavior factors that were different across the patterns of self-care decision-making. RESULTS: Three patterns of self-care decision-making were identified in a cohort of 430 adults. A 'maintainers' pattern (48.1 %) consisted of adults with limited contextual influences on self-care decision-making except for urgency. A 'highly uncertain' pattern (23.0 %) consisted of adults whose self-care decision-making was largely driven by uncertainty about the cause or meaning of the symptom. A 'distressed concealers' pattern (28.8 %) consisted of adults whose self-care decision-making was highly influenced by external factors, cognitive/affective factors and concealment. Age, education, financial security and specific symptoms were significantly different across the three patterns in multivariate models. CONCLUSION: Adults living with chronic illness vary in the extent to which contextual factors influence decisions they make about symptoms, and would therefore benefit from different interventions.

Predictors of Fertility-Awareness-Based Method Use Among Women Trying to Conceive and Women Contemplating Pregnancy.

BACKGROUND: Fertility-awareness-based methods have been linked to shorter time to conception; however, little is known about the predictors of fertility-awareness-based method use among women who are currently or will soon be trying to conceive. OBJECTIVES: The aim of this study was to identify predictors of fertility-awareness-based methods use among women trying to conceive or contemplating pregnancy within the next year. METHODS: Women participating in the Nurses' Health Study 3 were asked if they were trying to become pregnant or contemplating pregnancy and whether they are using fertility-awareness-based methods. Multivariable negative binomial regression was used to identify predictors for a number of fertility-awareness-based methods used. RESULTS: Among the 23,418 women asked about pregnancy intention since 2015, 955 were trying to conceive, and 2,282 were contemplating pregnancy within the next year. The three most used fertility-awareness-based methods among women trying to conceive were menstrual cycle tracking, ovulation prediction kits, and cervical mucus monitoring. Among women contemplating pregnancy, the three most commonly used methods were menstrual cycle tracking, cervical mucus monitoring, and basal body temperature monitoring. The ongoing duration of pregnancy attempts and gravidity were associated with the number of methods used among women actively trying to conceive. When compared with women who were trying for 2 months or less, the number of methods was 29% higher when trying for 3-5 months, 45% higher when trying for 6-12 months, and 38% higher when trying for more than 1 year. Compared with nulligravid women, the number of methods was lower for women with a history of two or more pregnancies. Among women contemplating pregnancy, those who were married or in a domestic partnership used more fertility-awareness-based methods than unpartnered women. No other significant predictors of fertility-awareness-based method use were identified. DISCUSSION: Duration of ongoing pregnancy attempt and gravidity were the only significant predictors for the number of fertility-awareness-based methods used among women actively trying to conceive, whereas partnership was the only significant predictor of the number of fertility-awareness-based methods among women contemplating pregnancy.

Sex differences in the impact of physical frailty on outcomes in heart failure.

BACKGROUND: Physical frailty is strongly related to adverse outcomes in heart failure (HF), and women are more likely to be physically frail than men; however, it is unknown if this sex difference affects outcomes. OBJECTIVES: To determine if there are sex differences in the associations between physical frailty and health-related quality of life (HRQOL) and clinical outcomes in HF. METHODS: We conducted a prospective study of adults with HF. Physical frailty was assessed using the Frailty Phenotype Criteria. HRQOL was assessed using the Minnesota Living with HF Questionnaire. One-year clinical events (all-cause death or cardiovascular hospitalization or emergency department visit) were ascertained. We used generalized linear modeling to quantify associations between physical frailty and HRQOL, and Cox proportional hazards modeling to quantify associations between physical frailty and clinical events, adjusting for Seattle HF Model scores. RESULTS: The sample (n = 115) was 63.5 ± 15.7 years old and 49% women. Physical frailty was associated with significantly worse total HRQOL among women (p = 0.005) but not men (p = 0.141). Physical frailty was associated with worse physical HRQOL among both women (p < 0.001) and men (p = 0.043). There was a 46% higher clinical event risk for every one-point increase in physical frailty score among men (p = 0.047) but not women (p = 0.361). CONCLUSIONS: Physical frailty is associated with worse overall HRQOL among women and higher clinical event risk among men, indicating a need to better understand contributors to sex-specific health differences associated with physical frailty in HF.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Person with Heart Failure and Care Partner Dyads: Current Knowledge, Challenges, and Future Directions: State-of-the-Art Review.

Over the past decade, there has been substantial growth in heart failure (HF) research that focuses on persons with HF and their care partners (family members or other close friends that provide unpaid support) as an interdependent team, or care dyad. In this state-of-the-art review, we use a dyadic lens to identify and summarize current research on HF care dyads, from qualitative studies, to nonexperimental quantitative studies, to randomized controlled trials. Although much work has been done, this literature is younger and less well-developed than care dyad literatures from other conditions (eg, cancer, Alzheimer's disease). We discuss the substantial challenges and limitations in this body of work, with an eye toward addressing common issues that impact rigor. We also look toward future directions, and discuss the promise dyadic research holds for improving patient, care partner, and relationship health.

Self-Management and Glycemic Targets in Adult Haitian Immigrants With Type 2 Diabetes: Research Protocol.

BACKGROUND: Type 2 diabetes (T2D) is a chronic condition affecting more than 34.2 million U.S. adults, and people of African descent have a disproportionate burden. Haitian immigrants' unique cultural and biological factors put them at elevated risk for T2D-related complications. Despite prior research highlighting the success of multimethod approaches to T2D self-management behaviors on glycemic targets, a dearth of studies have used these methods to improve diabetes self-management in this marginalized population. OBJECTIVES: This article describes a repeated-measures design protocol of a going study about self-management behaviors among adult Haitian immigrants with T2D and characterizing their barriers to T2D self-management. METHODS: We will enroll 100 Haitian immigrants aged 18-64 years who have lived with T2D for at least 1 year. Using multiple recruitment methods and Research Electronic Data Capture, subjective and objective data on T2D self-management practices, glucose variability via continuous glucose monitor, and a comprehensive view of physical activity via actigraphy are collected. RESULTS: Data analysis will follow a two-part approach mirroring the two primary study objectives. DISCUSSION: Findings from the study will guide the development and testing of a culturally tailored diabetes self-management education program that will contribute essential information about best practices for this population and break barriers that may impede research on unique individuals and subsequent effective self-management.

Dyadic Archetypes of Patient Self-Care and Caregiver Contribution to Self-Care in Dyads With Multiple Chronic Conditions: An Observational Study.

Self-care of multiple chronic conditions (MCCs) and caregiver contribution to self-care have been theorized as dyadic. However, the different dyadic archetypes are still unknown. This cross-sectional study aimed to identify dyadic archetypes related to how in patient-caregiver dyads manage the patient's MCCs and to describe other ways in which the dyadic archetypes differ. A sample of 340 MCCs patient-caregiver dyads was enrolled in outpatient and community settings. Patients had a mean age of 76.7 (±7.3) years and were mostly female (54.5%). Caregivers had a mean age of 54.6 (±15.1) years and were mostly female (71.5%). Four dyadic archetypes were observed: "autonomous," "compensatory," "balanced," and "complementary" care. Clinical programs should consider the different characteristics of dyads to support self-care.

Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

BACKGROUND: A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. METHODS: Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. RESULTS: Participants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5). CONCLUSIONS: The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.