A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC.

PURPOSE: Opportunities exist for patients with metastatic breast cancer (MBC) to engage in shared decision-making (SDM). Presenting patient-reported data, including patient treatment preferences, to oncologists before or during a treatment plan decision may improve patient engagement in treatment decisions. METHODS: This randomized controlled trial evaluated the standard-of-care treatment planning process vs. a novel treatment planning process focused on SDM, which included oncologist review of patient-reported treatment preferences, prior to or during treatment decisions among women with MBC. The primary outcome was patient perception of shared decision-making. Secondary outcomes included patient activation, treatment satisfaction, physician perception of treatment decision-making, and use of treatment plans. RESULTS: Among the 109 evaluable patients from December 2018 to June 2022, 28% were Black and 12% lived in a highly disadvantaged neighborhood. Although not reaching statistical significance, patients in the intervention arm perceived SDM more often than patients in the control arm (63% vs. 59%; Cramer's V = 0.05; OR 1.19; 95% CI 0.55-2.57). Among patients in the intervention arm, 31% were at the highest level of patient activation compared to 19% of those in the control arm (V = 0.18). In 82% of decisions, the oncologist agreed that the patient-reported data helped them engage in SDM. In 45% of decision, they reported changing management due to patient-reported data. CONCLUSIONS: Oncologist engagement in the treatment planning process, with oncologist review of patient-reported data, is a promising approach to improve patient participation in treatment decisions which should be tested in larger studies. TRIAL REGISTRATION: NCT03806738.

A 2-Year Longitudinal Randomized Control Trial of Speed of Processing Cognitive Training in Aging Adults with HIV-Associated Neurocognitive Disorder: Results of the Think Fast Study.

Nearly 40% of people with HIV (PWH) experience HIV-associated Neurocognitive Disorder (HAND). In this 3-group efficacy study, 216 PWH 40 + years with HAND or borderline HAND were randomized to either: (1) 10 h of SOP training (n = 70); (2) 20 h of SOP training (n = 73), or (3) 10 h of Internet navigation training (n = 73; contact control group). Participants were administered a measure of SOP [i.e., the Useful Field of View Test (UFOV®)] at baseline, at posttest immediately after training, and at year 1 and year 2 follow up. Intent-to-treat linear mixed-effect models with subject-specific intercept and slope were fitted to estimate between-group mean differences at the follow-up time-points. At the post-intervention time-point, small beneficial SOP training effects were observed for the 10-h group in UFOV® total (d = 0.28, p = 0.002). Effects were of larger magnitude for the 20-h group in these same outcomes [UFOV® total (d = 0.43, p < 0.001)]. These results indicated better benefit with more training. No intervention effect was observed at year 1. At year 2, beneficial effects of small magnitude were observed again in the 10-h group [UFOV® total (d = 0.22, p = 0.253)] with larger small-to-moderate magnitude in the 20-h group [UFOV® total (d = 0.32, p = 0.104)]. This study suggests that SOP training can improve a key indicator of this cognitive performance and that treatment gains are small-to-moderate over a two-year period. Prior literature suggests slower SOP is predictive of impairment in everyday functioning in older PWH; such an approach could potentially improve everyday functioning in PWH.

Cerca del 40% de las personas viviendo con VIH (PVV) experimentan Trastorno Neurocognitivo Asociado al VIH (HAND, por sus siglas en inglés). En este estudio de eficacia de 3 grupos, se aleatorizó a 216 PVV mayores de 40 años de edad con HAND o HAND límite a: (1) 10 horas de entrenamiento en velocidad de procesamiento (SOP, por sus siglas en inglés) (n = 70); (2) 20 horas de entrenamiento SOP (n = 73), o (3) 10 horas de entrenamiento en navegación por Internet (n = 73; grupo control de contacto). Se administró una medida de SOP a los participantes [la Prueba de Campo de Visión Útil (UFOV®)] al inicio, inmediatamente después del entrenamiento, y en el seguimiento de año 1 y año 2. Los datos se analizaron bajo el principio de intención de tratar, utilizando modelos lineales de efectos mixtos para estimar las diferencias promedio entre grupos en los puntos de seguimiento. En el punto de tiempo de post- entrenamiento, se observaron pequeños efectos beneficiosos del entrenamiento SOP para el grupo de 10 horas en el puntaje total de UFOV® (d = 0.28, p = 0.002). Para esta misma medida, los efectos fueron de mayor magnitud en el grupo de 20 horas [UFOV® total (d = 0.43, p < 0.001)]. Estos resultados indicaron un mayor beneficio con más entrenamiento. No se observó ningún efecto de intervención en el año 1. En el año 2, se observaron efectos beneficiosos de pequeña magnitud nuevamente en el grupo de 10 horas [UFOV® total (d = 0.22, p = 0.253)] y en el grupo de 20 horas [UFOV® total (d = 0.32, p = 0.104)] con una magnitud pequeña a moderada). Este estudio confirma que el entrenamiento SOP puede mejorar un indicador clave de este rendimiento cognitivo y que las ganancias del tratamiento son pequeñas a moderadas durante un período de dos años. La literatura previa sugiere que una SOP más lenta es predictiva de deterioro en el funcionamiento diario en PVV mayores; tal enfoque podría mejorar potencialmente el funcionamiento diario en PVV.

Effect of prior treatments on post-CDK 4/6 inhibitor survival in hormone receptor-positive breast cancer.

PURPOSE: Multiple treatment options exist for patients with metastatic breast cancer (MBC). However, limited information is available on the impact of prior treatment duration and class on survival outcome for novel therapies, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ HER2-) MBC. METHODS: This study used a nationwide, de-identified electronic health record-derived database to identify women with HR+ HER2- MBC who received at least one CDK 4/6i between 2011 and 2020. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated for the association between prior duration and class of cancer treatment (both early-stage and metastatic) and prior CDK 4/6i survival as well as for those with multiple CDK 4/6i. RESULTS: Of 5363 patients, the median survival from first CDK 4/6 inhibitor administration was 3.3 years. When compared to patients with no prior treatments, patients with < 1 year of prior treatment duration had a 30% increased hazard of death (HR, 1.30; 95% CI 1.15-1.46), those with 1 to < 3 years a 68% increased hazard of death (HR 1.68; 95% CI 1.49-1.88), and those with 3 or more years a 55% increased hazard of death (HR 1.55; 95% CI 1.36, 1.76). Patients who received prior therapy (endocrine or chemotherapy) before their CDK 4/6i had worse outcomes than those who received no prior therapy. Similar results were seen when comparing patients in the metastatic setting alone. Finally, patients who received a different CDK 4/6i after their first saw a lower hazard of death compared to patients who received subsequent endocrine or chemotherapy after their first CDK 4/6i. CONCLUSION: Prior treatment duration and class are associated with a decreased overall survival after CDK 4/6 inhibitor administration. This highlights the importance for clinicians to consider prior treatment and duration in treatment decision-making and for trialists to stratify by these factors when randomizing patients or reporting results of future studies.

Family caregiver roles and challenges in assisting patients with cancer treatment decision-making: Analysis of data from a national survey.

BACKGROUND: We aimed to describe the roles and challenges of family caregivers involved in patients' cancer treatment decision-making. METHODS: Family caregiver-reported data were analyzed from a national survey conducted in the United States by CancerCare® (2/2021-7/2021). Four select-all-that-apply caregiver roles were explored: (1) observer (patient as primary decision-maker); (2) primary decision-maker; (3) shared decision-maker with patient and (4) decision delegated to healthcare team. Roles were compared across five treatment decisions: where to get treatment, the treatment plan, second opinions, beginning treatment and stopping treatment. Ten challenges faced by caregivers (e.g., information, cost, treatment understanding) were then examined. χ2 and regression analyses were used to assess associations between roles, decision areas, challenges and caregiver sociodemographics. RESULTS: Of 2703 caregiver respondents, 87.6% reported involvement in patient decisions about cancer treatment, including 1661 who responded to a subsection further detailing their roles and challenges with specific treatment decisions. Amongst these 1661 caregivers, 22.2% reported an observing role, 21.3% a primary decision-making role, 53.9% a shared decision-making role and 18.1% a role delegating decisions to the healthcare team. Most caregivers (60.4%) faced ≥1 challenge, the most frequent being not knowing how treatments would affect the patient's physical condition (24.8%) and quality of life (23.2%). In multivariable models, being Hispanic/Latino/a was the strongest predictor of facing at least one challenge (b = -0.581, Wald = 10.69, p < .01). CONCLUSIONS: Most caregivers were involved in patients' cancer treatment decisions. The major challenge was not understanding how treatments would impact patients' physical health and quality of life. Challenges may be more commonly faced by Hispanic/Latino/a caregivers. PATIENT OR PUBLIC CONTRIBUTION: The CancerCare® survey was developed in partnership with caregiving services and research experts to describe the role of cancer family caregivers in patient decision-making and assess their needs for support. All survey items were reviewed by a CancerCare advisory board that included five professional patient advocates and piloted by a CancerCare social worker and other staff who provide counselling to cancer caregivers.

The Subjective Component of the Dutch Objective Burden Inventory: A Psychometric Analysis.

BACKGROUND: The reliability and validity of the subjective component of the Dutch Objective Burden Inventory (DOBI) are unknown. OBJECTIVE: The validity and reliability of the subjective component of the DOBI were examined in caregivers of individuals with heart failure, using the original 38- and a 24-item version. METHODS: In an online cross-sectional investigation, confirmatory factor analysis was used to examine factorial validity. In examining convergent validity, corrected item-dimension correlations assessed item performance and associations between subjective subscale scores and the Bakas Caregiving Outcomes Scale. Cronbach's α examined internal consistency. RESULTS: The original 4-factor solution was retained and both the original and shorter versions of the subjective component of the DOBI supported adequate construct validity and internal consistency. CONCLUSIONS: Both the 38- and 24-item forms of the subjective DOBI supported construct validity and reliability. Further studies examining the usefulness of both versions are needed in carers of individuals with more severe HF.

Using item response theory to develop a shortened practice environment scale of the nursing work index.

The 31-item Practice Environment Scale of the Nursing Work Index (PES-NWI) has been frequently used globally to measure the nurse work environment. However, due to its length and subsequent respondent burden, a more parsimonious version of the PES-NWI may be desirable. Item response theory (IRT) is a statistical technique that assists in decreasing the number of items in an instrument without sacrificing reliability and validity. Two separate samples of nurses in the United States (one called the "internal data source" and the other called "external data source"; sample sizes = 843 and 722, respectively) were analyzed. The internal data source was randomly split into training (n = 531) and validating data sets (n = 312), while a separate whole external data source was used as the final validating data set. Using IRT with training data, we removed nine items; two additional items were removed based on recommendations from a previous study. Confirmatory factor analyses supported the validity of the measurement model with the 20-item of PES-NWI in both internal and external validation data sources. The correlations among subscales between 31- and 20-item versions were high magnitude for five subscales in both validation data sets (τ = 0.84-0.89). Ultimately, we identified a 20-item version of the PES-NWI which demonstrated adequate validity and reliability properties while decreasing data collection burden yet maintaining a similar factor structure to the original instrument. Additional research may be necessary to update the items themselves on the PES-NWI.

Associations between geography, decision-making style, and interest in cancer clinical trial participation.

BACKGROUND: Clinical trials offer novel treatments, which are essential to high quality cancer care. Patients living in rural areas are often underrepresented in clinical trials due to several factors. This study evaluated the association between rurality and interest in clinical trial participation, change in interest, and treatment decision-making style preference. METHODS: This cohort study included patients with cancer receiving oncology care at the University of Alabama at Birmingham from 2017 to 2019. Associations between treatment decision-making preference and the interaction between rurality and area deprivation were analyzed using multinomial logistic regression. Initial interest in clinical trial participation and change in interest were analyzed using modified Poisson regressions with robust standard errors. Initial interest model was stratified by Area Deprivation Index (ADI; higher vs. lower disadvantaged). RESULTS: In adjusted models, patients in rural versus urban areas had similar initial interest in clinical trials, both those in higher (40% vs. 50%) and lower disadvantaged settings (54% vs. 62%). Additionally, rural versus urban patients had similar change of clinical trial interest for both those who changed from uninterested-to-interested (31% vs. 26%) and interested-to-uninterested (47% vs. 42%). CONCLUSION: This study compares the interest in clinical trial participation among patients living in rural and urban settings. Lack of interest may be secondary to barriers that patients in rural areas face (e.g., transportation, financial, access). Most rural patients prefer a shared treatment decision-making style, which should be considered when identifying interventions to increase enrollment of underserved rural patients in clinical trials.

A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial.

BACKGROUND: The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). METHODS: This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. RESULTS: Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. CONCLUSIONS: The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. LAY SUMMARY: To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Nurse Burnout Syndrome and Work Environment Impact Patient Safety Grade.

BACKGROUND: Burnout impacts nurses' health as well as brain structures and functions including cognitive function, which could lead to work performance and patient safety issues. Yet, few organization-level factors related to patient safety have been identified. PURPOSE: This study examined nurse-reported patient safety grade and its relationship to both burnout and the nursing work environment. METHODS: A cross-sectional electronic survey was conducted among nurses (N = 928) in acute care Alabama hospitals. RESULTS: In multilevel ordinal mixed-effects models with nurses nested within hospitals, all burnout dimensions of the Copenhagen Burnout Inventory (OR for +1 SD ranging 0.63-0.78; P < .05) and work environment (OR for +1 SD ranging 4.35-4.89; P < .001) were related to the outcome of patient safety grade after controlling for nurse characteristics. CONCLUSIONS: Results indicate that health care organizations may reduce negative patient safety ratings by reducing nurse burnout and improving the work environment at the organization level.

Quantifying treatment preferences and their association with financial toxicity in women with breast cancer.

BACKGROUND: The objective of the current study was to understand treatment preferences and their association with financial toxicity in Patient Advocate Foundation clients with breast cancer. METHODS: This choice-based conjoint analysis used data from a nationwide sample of women with breast cancer who received assistance from the Patient Advocate Foundation. Choice sets created from 13 attributes of 3 levels each elicited patient preferences and trade-offs. Latent class analysis segmented respondents into distinct preference archetypes. The Comprehensive Score for Financial Toxicity (COST) tool captured financial toxicity. Adjusted generalized linear models estimated COST score differences by preference archetype. RESULTS: Of 220 respondents (for a response rate of 10%), the median age was 58 years (interquartile range, 49-66 years); 28% of respondents were Black, indigenous, or people of color; and approximately 60% had household incomes <$40,000. The majority of respondents were diagnosed with early-stage cancer (91%), 38% had recurrent disease, and 61% were receiving treatment. Treatment choice was most affected by preferences related to affordability and impact on activities of daily living. Two distinct treatment preference archetypes emerged. The "cost-prioritizing group" (75% of respondents) was most concerned about affordability, impact on activities of daily living, and burdening care partners. The "functional independence-prioritizing group" (25% of respondents) was most concerned about their ability to work, physical side effects, and interference with life events. COST scores were found to be similar between the archetypes in adjusted models (cost-prioritizing group COST score, 12 [95% confidence interval, 9-14]; and functional independence-prioritizing COST score, 11 [95% confidence interval, 9-13]). CONCLUSIONS: Patients with breast cancer prioritized affordability or maintaining functional independence when making treatment decisions. Because of this variability, preference evaluation during treatment decision making could optimize patients' treatment experiences.

Clinical trial representativeness and treatment intensity in a real-world sample of women with early stage breast cancer.

PURPOSE: The extent to which evidence-based treatments are applied to populations not well represented in early stage breast cancer (EBC) trials remains unknown. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. METHODS: This retrospective cohort study used real-world data to evaluate the intensity (high or low) of EBC chemotherapy by patient characteristics (age, race and ethnicity, presence of comorbidity) denoting clinical trial representation status (well represented, underrepresented, unrepresented) for patients diagnosed from 2011 to 2020. Odds ratios (OR) from a logistic regression model was used to evaluate the association between receipt of high-intensity chemotherapy and clinical trial representation status characteristics adjusting for cancer stage and subtype. RESULTS: Of 970 patients with EBC, 41% were characterized as well represented, 45% as underrepresented, and 13% as unrepresented in clinical trials. In adjusted models, patients aged ≥ 70 versus 45-69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26-0.60), while those aged < 45 versus 45-69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10-3.01). In predicted estimates, the proportion of patients receiving a high-intensity treatment was 87% for patients aged < 45, 79% for patients aged 45-69, and 60% for patients aged ≥ 70. CONCLUSION: 59% of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity. Widening clinical trial eligibility criteria should be considered to better understand survival outcomes, toxicity effects, and ultimately make evidence-based treatment decisions using a more diverse sample.

Can Individualized-Targeted Computerized Cognitive Training Benefit Adults with HIV-Associated Neurocognitive Disorder? The Training on Purpose Study (TOPS).

Half of people with HIV (PWH) have HIV-associated neurocognitive disorder (HAND). This study examined whether cognition can be improved using a framework targeting impaired individual cognitive domains in PWH with HAND. In this two-group pre-post experimental design study, 88 adults with HAND were randomized to either: (1) a no-contact control group (n = 40) or (2) the Individualized-Targeted Cognitive Training group (n = 48). Baseline cognitive performance was assessed on eight cognitive domains. A theoretical framework was used to determine the two cognitive domains selected for training. With priority on speed of processing (SOP) and attention impairments, participants received SOP and/or attention training if such impairments were detected; if not, participants were assigned to cognitive training in one/two of the least impaired cognitive domains contributing to their HAND diagnosis. Global cognitive score was slightly improved following training (p = 0.256; d = - 0.21), but it was not significant. Significant improvements were observed on SOP following training in that domain (SOP; d = - 0.88; p = 0.011). SOP training also improved functioning in other cognitive domains. This individualized cognitive intervention did not change HAND status, but it did result in improved SOP, in turn yielding improvement in other cognitive domains.

A Pilot Study of Nicotine Replacement Therapy Sampling and Selection to Increase Medication Adherence in Low-Income Smokers.

INTRODUCTION: Adherence to smoking cessation medications remains suboptimal, particularly among low-income smokers. Guided, experiential sampling of nicotine replacement therapies (NRTs) may increase NRT adherence and smoking cessation over gold standard counseling plus NRT. The present pilot study aimed to examine feasibility, acceptability, and preliminary efficacy of a novel experiential intervention. AIMS AND METHODS: This pilot randomized controlled trial (N = 83) compared gold standard smoking cessation treatment (four weekly sessions of behavioral counseling followed by self-selected combination NRT in week 5) to a novel experiential approach (ie, In Vivo; four weekly sessions of sampling each short form of NRT-gum, lozenge, inhaler, nasal spray-in-session while wearing the nicotine patch followed by NRT selection in week 5). Both groups received 8 weeks of nicotine patch plus their selected additional short form NRT for smoking cessation followed by a 1-month assessment. RESULTS: Screening and enrollment rates supported feasibility. In Vivo was comparable in acceptability with the gold standard of care intervention; however, there was greater attrition in the In Vivo group compared with the gold standard of care group. Results suggested higher medication adherence and improvements in smoking behavior in the In Vivo intervention; with generally small-to-medium effect sizes. CONCLUSIONS: This experiential approach to sampling NRT is feasible and acceptable to low-income people who smoke. This intervention may increase adherence and reduce harmful smoking behavior but needs to be tested on a larger scale. IMPLICATIONS: Medication adherence remains a significant impediment to the successful smoking cessation. The results of this study suggest that guided sampling of NRT products improves adherence among low-income smokers. Additionally, this approach yielded greater improvements in smoking behavior compared with gold standard smoking cessation treatment. This intervention shows promise as a feasible smoking cessation treatment for low-income smokers.

Resilience, preparedness, and distress among family caregivers of patients with advanced cancer.

OBJECTIVE: Resilience has been proposed as a primary factor in how many family caregivers of patients with advanced cancer are able to resist psychological strain and perform effectively in the role while bearing a high load of caregiving tasks. To evaluate this hypothesis, we examined whether self-perceived resilience is associated with distress (anxiety and depressive symptoms), caregiver preparedness, and readiness for surrogate decision-making among a racially diverse sample of family caregivers of patients with newly diagnosed advanced cancer. METHODS: Secondary analysis of baseline data from two small-scale, pilot clinical trials that both recruited family caregivers of patients with newly diagnosed advanced cancer. Using multivariable linear regression, we analyzed relationships of resilience as a predictor of mood, caregiving preparedness, and readiness for surrogate decision-making, controlling for sociodemographics. RESULTS: Caregiver participants (N = 112) were mean 56 years of age and mostly female (76%), the patient's spouse/partner (52%), and White (56%) or African-American/Black (43%). After controlling for demographics, standardized results indicated that higher resilience was relevantly associated with higher caregiver preparedness (beta = .46, p < .001), higher readiness for surrogate decision-making (beta = .20, p < .05) and lower anxiety (beta = - .19, p < .05), and depressive symptoms (beta = - .20, p < .05). CONCLUSIONS: These results suggest that resilience may be critical to caregivers' abilities to manage stress, be effective sources of support to patients, and feel ready to make future medical decisions on behalf of patients. Future work should explore and clinicians should consider whether resilience can be enhanced in cancer caregivers to optimize their well-being and ability to perform in the caregiving and surrogate decision-making roles.

Examining the relationship between nutrition, quality of life, and depression in hemodialysis patients.

PURPOSE: Lifestyle changes associated with end-stage renal disease may be a factor in depression and quality of life (QOL) for patients receiving hemodialysis. This cross-sectional study examined the relationship between nutritional status, QOL, and depression in 124 hemodialysis patients. METHODS: Nutritional markers included serum albumin, normalized protein catabolic rate (nPCR), body mass index (BMI), body fat percentage, and daily protein intake. Physical and Mental dimension scores of the Kidney Disease QOL-Short Form (KDQOL-SF), and the Center for Epidemiological Studies of Depression (CESD) survey were used to measure QOL and depression, respectively. Data were analyzed using regression analyses. Measures of effect size were used for interpretation. RESULTS: Nutritional status indicators explained a moderate amount of the variability of the Physical dimension of QOL (crude R2 = .14, covariate-adjusted ΔR2 = .06) but had weak explanatory ability for the Mental dimension of QOL (crude R2 = .05, covariate-adjusted ΔR2 = .02) and CESD (crude R2 = .02, covariate-adjusted ΔR2 = .005). Additional findings suggested the presence of non-linear relationships between protein intake and both the Physical and Mental QOL dimension scores. Longer dialysis vintage was also correlated with lower psychosocial patient outcomes. CONCLUSION: While nutritional status is an important element in predicting hemodialysis patient outcomes, its relationship to depression and QOL, in this sample, demonstrated only moderate explanatory ability. However, dialysis vintage and level of education had a significant relationship with depression and QOL. These findings suggest that patients with longer dialysis vintage and limited health literacy require unique plans of care. Future studies aimed at understanding the interrelationships between non-modifiable patient characteristics and psychosocial outcomes are imperative.

Inclusion of Effect Size Measures and Clinical Relevance in Research Papers.

BACKGROUND: There are multiple issues that arise when researchers focus on and only report "statistical significance" of study findings. An important element that is often not included in reports is a discussion of clinical relevance. OBJECTIVES: The authors address issues related to significance, the use of effect sizes, confidence or credible intervals, and the inclusion of clinical relevance in reports of research findings. METHODS: Measures of magnitude, precision, and relevance such as effect sizes, confidence intervals (CIs), and clinically relevant effects are described in detail. In addition, recommendations for reporting and evaluating effect sizes and CIs are included. Example scenarios are presented to illustrate the interplay of statistical significance and clinical relevance. RESULTS: There are several issues that may arise when significance is the focus of clinical research reporting. One issue is the lack of attention to nonsignificant findings in published works although findings show clinical relevance. Another issue is that significance is interpreted as clinical relevance. As well, clinically relevant results from small-sample studies are often not considered for publication, and thus, findings might not be available for meta-analysis. DISCUSSION: Findings in research reports should address effect sizes and clinical relevance and significance. Failure to publish clinically relevant effects and CIs may preclude the inclusion of clinically relevant studies in systematic reviews and meta-analyses, thereby limiting the advancement of evidence-based practice. Several accessible resources for researchers to generate, report, and evaluate measures of magnitude, precision, and relevance are included in this article.

Psychometric properties of Copenhagen Burnout Inventory among nurses.

Worldwide, nurses have been reporting high levels of burnout. Given the high prevalence of nurse burnout, measurements of burnout need to be carefully considered for their validity and reliability. Our research team used a relatively new instrument to measure burnout among nurses: the Copenhagen Burnout Inventory (CBI). This 19-item instrument measures burnout in three dimensions: Personal, Work-related, and Client-related Burnout. However, the psychometric properties of the CBI have not been examined in nurses. Thus, the purpose of this study was to determine the psychometric properties of the CBI in a state-wide survey of inpatient staff nurses. A total of 928 registered nurses working in Alabama-area hospitals (N = 42 hospitals) participated in this study. Confirmatory factor analysis resulted in an adequate fit to the data and supported construct validity. As evidence of convergent validity, the CBI was moderately to highly correlated with measures of the overall work environment, job satisfaction, and intent to leave, in the anticipated directions. The Cronbach's alphas for Personal Burnout, Work-related Burnout, and Client-related Burnout were 0.91, 0.89, and 0.92, respectively, demonstrating excellent internal consistency reliability for the subscales. Based on our data, the CBI demonstrates adequate validity and reliability for measuring burnout among frontline nurses. As nurses provide care to the most vulnerable patients in healthcare systems, their psychological well-being is important due to the impact on quality of care on patient outcomes. The availability of the CBI on its website allows nurses, nurse managers, and researchers to evaluate burnout in a variety of nursing populations with no licensing costs.

Weight Gain and Blood Pressure in Toddlers Born Very Preterm.

BACKGROUND: Preterm birth is a risk factor for elevated blood pressure in childhood and the development of hypertension and cardiometabolic disease in adulthood; however, mechanisms for the development of both are poorly understood. Rapid weight gain early in childhood may serve as a driver directly and indirectly through cortisol levels found to be elevated in early childhood in individuals born preterm. OBJECTIVES: The objective of this pilot study was to examine the effect sizes of the relationships between weight gain and blood pressure in toddlers born very preterm. A secondary aim was to note any mediating effect of cortisol on the relationships between weight gain and blood pressure. METHODS: A cross-sectional design with a convenience sample of 36 toddlers who were born very preterm was used to examine the relationships between postnatal weight gain, cortisol, and blood pressure at follow-up. RESULTS: Many of the participants experienced rapid weight gain in the first 12 months of life. Mean systolic and diastolic readings were 94 and 56.6, respectively. Diastolic blood pressure readings were obtained from 23 participants, and the majority were elevated. Weight gain was associated with diastolic blood pressure with a medium effect size. A mediating role with cortisol was not supported. DISCUSSION: Although findings need to be validated in a larger sample, the blood pressure elevations in this sample were alarming. If readings continue to amplify as these children age, the fact that elevations are already present during the toddler period could indicate more significant cardiovascular disease in adulthood for this population. Rapid weight gain in early life may be a driver for elevated blood pressure even during early childhood in individuals born preterm.

Psychosocial Factors Related to Adverse Outcomes in Heart Failure Caregivers: A Structural Equation Modeling Analysis.

BACKGROUND: Heart failure (HF) caregivers experience increased demands and burden. Social support and problem solving may influence the effect of these variables on caregiver outcomes. OBJECTIVE: The aim of this study was to examine whether social support and problem solving mediate relationships among caregiver demands and burden, self-care, depression, and life changes in heart failure caregivers. METHODS: Using a cross-sectional, exploratory design, heart failure caregivers (n = 530) completed online questionnaires on caregiver demands and burden, social support, problem solving, depression, self-care, and life changes. Path analysis examined a hypothesized mediating role of social support and problem solving in the relationships among caregiver demands and burden and caregiver outcomes. The analysis included (1) a model-development phase (n = 329) to make data-based decisions on measurement indicators and model structure and (2) a confirmatory phase (n = 201) to provide unbiased inference on the model structure resulting from the initial phase. RESULTS: Participants were 41.39 (±10.38) years old and primarily white (78.3%) men (50.9%) caring for a spouse (44.9%). Per the magnitudes of the estimated path coefficients, social support mediated the relationship between caregiver burden and depression but did not relevantly mediate the relationship between caregiver burden and self-care or caregiver life changes. In the presence of social support as a parallel mediator, problem solving was not a relevant mediator between caregiver burden and demands and caregiver outcomes. CONCLUSIONS: Social support mediates the effects of caregiver burden on depression but has little effect on self-care or life changes. In the presence of social support, problem solving does not mediate the effects of caregiver demands and burden on caregiver outcomes.