Acute and chronic fatigue in nurses providing direct patient care and in non-direct care roles: A cross-sectional analysis.

Nurses are at risk for work-related fatigue, which can impact their health, well-being, and job readiness. The purpose of this study was to examine the levels, types, and factors associated with fatigue in registered nurses (RNs) in direct patient care (DCRNs) and in non-direct patient care (non-DCRNs) roles. A cross-sectional survey was administered to 313 RNs. Measures included: Multidimensional Fatigue Symptom Inventory, Occupational Fatigue Exhaustion Recovery, Brief COPE, PROMIS® Global Sleep Disturbance, and Job Content Questionnaire. Acute fatigue levels in RNs were similar to those in diseased populations, and nearly 50% reported moderate/high levels of chronic fatigue. DCRNs reported higher levels of acute and chronic fatigue than non-DCRNs, but the differences were small and disappeared when accounting for other factors associated with fatigue including sleep disturbance, job strain, workplace support, maladaptive coping, and especially intershift recovery, which accounted for 20%-41% of fatigue variability. This study suggests that it may not be only nurses providing direct patient care who are at risk for acute and chronic fatigue. Intershift recovery may be particularly important in alleviating acute and chronic fatigue in nurses.

Factors influencing loneliness in cancer caregivers: A longitudinal study.

OBJECTIVE: To describe levels of loneliness in cancer caregivers over a 6 month time period, and to examine factors that influence changes in loneliness in caregivers over time. METHODS: Prospective, repeated measures design was utilized to examine levels of loneliness and factors that influence loneliness in 129 family caregivers of individuals undergoing cancer treatment at three time points over a 6 month period. Measures included: PROMIS global health and sleep disturbance; NIH Toolbox loneliness, self-efficacy and perceived stress; Family Care Inventory mutuality scale; and Caregiver Reaction Assessment. RESULTS: Approximately one third (30.2%, n = 39) of the caregivers had high levels of loneliness, and levels of loneliness did not change over the three time points (P = .985). For any given time point, caregivers who were not married (P = .008), not working (P = .027), with worse mental health (P = .015), more perceived-stress (P < .0001), and more caregiver burden (P = .003) reported higher levels of loneliness. CONCLUSION: This study provides guidance for clinicians attempting to identify at-risk caregivers by confirming the findings of previous research that caregivers with higher burden, stress and in poor mental health are at increased risk for loneliness. This study provides preliminary evidence that continuing to work during the caregiving trajectory may be beneficial to caregivers by reducing levels of loneliness. Future research is needed to confirm these findings and to examine novel interventions to reduce loneliness in cancer caregivers.

Fatigue predicts impaired social adjustment in survivors of allogeneic hematopoietic cell transplantation (HCT).

PURPOSE: The aim of this study is to examine social adjustment to illness and to identify factors related to social adjustment in allogeneic hematopoietic cell transplantation (HCT) survivors. METHODS: Cross-sectional data were drawn from a longitudinal study of patients ≥ 3 years after their first HCT. The five subscales of the Psychosocial Adjustment to Illness Scale (PAIS) that reflect social adjustment, specifically vocational environment (VE); domestic environment (DE); sexual relationships (SEX); extended family relationships (ER); and social environment (SE) were examined in this analysis. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) measured cancer-related fatigue. RESULTS: Subjects (N = 171) were a median of 5.19 years from HCT (range 3-16). The most impaired dimension of social adjustment was ER with 38% of participants reaching clinically relevant (score ≥ 62) levels of social maladjustment. Unmarried and unemployed participants had lower levels of social adjustment in VE (p < .001 and p < .001, respectively) and DE (p = .004 and p = .006, respectively). Survivors with some college had poorer SEX adjustment than those with less or more education (p < .005). Hispanics reported lower adjustment with respect to ER adjustment (p = .002). Participants with higher fatigue had poorer adjustment in all five dimensions (p < .001). CONCLUSIONS: Although the majority of survivors are well adjusted, subgroups may experience significant poor social adjustment. Specifically, survivors with fatigue are at risk to experience lower levels of social adjustment. Development of effective rehabilitation strategies to improve affected areas of social health is warranted, and all HCT survivors should be screened periodically for social maladjustment and provided with resources and referrals.

Nurses and health-promoting self-care: Do we practice what we preach?

AIMS: To examine the health-promoting behaviours performed by registered nurses (RNs), as well as workplace factors that influence participation in those behaviours. BACKGROUND: Nurses have high levels of overweight/obesity and may not be engaging in health-promoting self-care. METHODS: A cross-sectional Web-based survey collected information from 335 RNs regarding their physical activity, sedentariness and fruit/vegetable consumption. RESULTS: More than half were overweight (34.1%) or obese (23.4%), and 80.1% were "sedentary" (≥3 hr sitting/day), particularly those working outside of direct patient care in management, research and education. Only 47.2% consumed 5+ servings of fruits/vegetables daily. Nurses who enjoyed their jobs (higher levels of compassion satisfaction) reported higher levels of physical activity (p = 0.03) and fruit/vegetable consumption (p = 0.02). CONCLUSION: RNs who work outside of direct patient care might be at increased risk for sedentariness and obesity. RNs who enjoy their jobs may experience less stress and have more energy to exercise and to prepare/consume healthy meals. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse managers should practice self-care by engaging in exercise, proper nutrition and demonstrating work-life balance, both to protect their own health and to serve as role models for RNs in direct patient care.

Documenting stress in caregivers of transplantation patients: initial evidence of HPA dysregulation.

There is growing evidence linking caregiver stress with an increased risk for morbidity and mortality. While the emotional and practical burden experienced by caregivers is well established, the physiological changes that may affect the caregiver's health are less understood. This study sought to compare self-reported stress, anxiety and depression along with neuroendocrine and immune markers of stress among adult caregivers of allogeneic hematopoietic stem cell transplantation patients during the acute transplant recovery period to matched non-caregivers controls. Biomarkers and self-reported data were collected at three points during the patient's HSCT: (1) before transplant, (2) after initial transplantation discharge (±7 days) and (3) 6 weeks after initial transplantation discharge. Mixed linear modeling was used to examine differences by group and time. Twenty-one caregivers and 20 controls completed all study procedures. The majority of caregivers were female (57% or 57.1%) and married (95.2%), with a mean age of 52 ± 11.4 years. Caregiver perceived stress, anxiety and depression scores were significantly higher than controls (p < 0.001) with effect sizes (ES) ranging from 1.37 to 1.80 and they did not change over time (p > 0.05) for either group. Caregivers had significantly lower serum cortisol levels than controls at both discharge (p = 0.013; ES = 0.81) and 6 weeks after discharge (p = 0.028; ES = 0.72) but exhibited no significant relationship between self-reported stress and serum cortisol. In addition, caregivers showed a significant inverse relationship between stress and epinephrine levels (r(s)=-0.654, p = 0.021). These findings support the evidence of the caregiving experience being stressful. The counter-intuitive relationship between cortisol and epinephrine might suggest dysregulation of the HPA axis and central nervous system but additional research on the physiological impact of caregiving is warranted.

Spiritual Well-Being in Hispanic and Non-Hispanic Survivors of Allogeneic Hematopoietic Stem Cell Transplantation.

Research suggests that spiritual well-being positively contributes to quality of life during and following cancer treatment. This relationship has not been well-described in ethnically diverse survivors of allogeneic transplantation.  This study compares spiritual well-being and quality of life of Hispanic (n = 69) and non-Hispanic (n = 102) survivors. Hispanic participants were significantly younger and reported significantly greater spiritual well-being than non-Hispanic survivors. Survivors with higher spiritual well-being had significantly better quality of life. Meaning and Peace significantly predicted quality of life. Although Hispanic survivors report greater spiritual well-being, Meaning and Peace, irrespective of ethnicity, have a salutary effect on quality of life.

Symptom distress predicts long-term health and well-being in allogeneic stem cell transplantation survivors.

The number of survivors after allogeneic hematopoietic stem cell transplantation (HSCT) continues to increase, yet their survivorship experience has not been fully characterized. This study examines the health status and health-related quality of life (HRQL) of HSCT survivors. The aims of the study were to: (1) explore the baseline and change over time in these health outcomes, and (2) characterize subgroups experiencing adverse outcomes. In this longitudinal study, adults who survived >3 years from date of allogeneic HSCT completed a series of patient-reported outcome measures annually, including measures of health status, HRQL, and symptoms. Data were analyzed using hierarchical linear modeling. Subjects (N = 171) were on average 44 (±13.5) years of age and primarily male (62.6%); 40% were Hispanic. Mean scores for physical and mental health and HRQL were preserved relative to population norms. Hierarchical linear modeling revealed no significant change in the mean trajectories of these outcomes, although significant between-individual variability was observed. When controlling for demographic and clinical factors, physical symptom distress negatively affected all outcomes. The impact of symptom distress on physical health varied based on time since HSCT; impairment in physical health was greatest in survivors experiencing high symptom distress and who were within the first decade post transplantation. Extended treatment with systemic immunosuppressive therapy also predicted inferior physical health. These findings suggest that patient-centered outcomes are preserved relative to normative values and are generally stable after allogeneic HSCT, although survivors with persistent symptoms and those receiving systemic immunosuppression experience impairments in health status and HRQL.

Professional quality of life, sleep disturbance and health among nurses: A mediation analysis.

AIMS: This study aimed to examine sleep disturbance as a mediator of the relationship between professional quality of life (compassion satisfaction, burnout, secondary traumatic stress) and health (physical and mental health) in nurses. DESIGN: Descriptive, cross-sectional study. METHODS: Three hundred eighteen Registered Nurses completed a web-based survey at the National Institutes of Health Clinical Center in the United States. Mediation analyses were conducted to test hypothesized relationships. RESULTS: Nurses with higher levels of compassion satisfaction reported lower levels of sleep disturbance and better physical/mental health. Burnout and secondary traumatic stress were negatively associated with physical/mental health and positively associated with sleep disturbance. Sleep disturbance fully or partially mediated the relationships between professional quality of life and physical/mental health among nurses.

Effects of a yoga-based stress reduction intervention on stress, psychological outcomes and cardiometabolic biomarkers in cancer caregivers: A randomized controlled trial.

Caregiving stress is a risk factor for cardiometabolic disease. Therefore, integrating cardiometabolic biomarkers into caregiving research provides a more comprehensive assessment of an individual's health and response to an intervention. The objective of this study was to examine the effects of a yoga-based stress reduction intervention on stress, psychological outcomes, and cardiometabolic biomarkers in cancer caregivers. This prospective randomized controlled trial enrolled family caregivers of adult patients who underwent an allogeneic HSCT at the National Institutes of Health (NIH) Clinical Center. All subjects received usual care education. Participants in the intervention group received an Iyengar yoga intervention self-administered over six weeks using an audio recording file. The primary outcome was perceived stress (measured using the NIH toolbox Perceived Stress). The secondary outcomes were psychological factors (depression and anxiety measured using PROMIS® Depression and Anxiety), and cardiometabolic biomarkers measured by nuclear magnetic resonance spectroscopy. A total of 50 family caregivers (mean [SD] age, 44.9 [15.2] years; 42 [84.0%] women) were randomized, 25 to the intervention group and 25 to the control group. No group differences were noted in stress, depression, and anxiety. Significant interaction effects between group and time were found in large TRL-P (F(1,43) = 10.16, p = 0.003) and LP-IR (F(1,42) = 4.28, p = 0.045). Post-hoc analyses revealed that the levels of large TRL-P (mean difference = 1.68, CI = [0.86, 2.51], p< .001) and LP-IR (mean difference = 5.67, CI = [1.15, 10.18], p = 0.015) significantly increased over time in the control group but while remained stable in the intervention group (mean difference = -0.15, CI = [-0.96, 0.66], p = 0.718; mean difference = -0.81, CI = [-5.22, 3.61], p = 0.714, respectively). Even when perceptions of psychological distress remain unchanged, incorporating gentle yoga poses and breathing exercises may reduce the risk of cardiometabolic disease in caregivers by inhibiting the development of insulin resistance. Standard lipids of cardiometabolic risk do not appear to be robust enough to detect short-term early changes of cardiometabolic risk in caregivers. Trial registration: ClinicalTrials.gov Identifier: NCT02257853.

Distress screening in allogeneic hematopoietic stem cell (HSCT) caregivers and patients.

UNLABELLED: Family caregivers of allogeneic hematopoietic stem cell transplant (HSCT) patients are at risk for experiencing significant psychological distress yet screening caregivers has not been well studied. OBJECTIVE: This analysis explored the psychometric characteristics of the Distress Thermometer (DT) by examining its relationship, sensitivity, and specificity relative to the Brief Symptom Inventory 18 (BSI-18) and the Multidimensional Fatigue Symptom Inventory (MFSI) in a sample of allogeneic HSCT caregivers and patients. METHODS: Longitudinal data were drawn from an ongoing intervention study for HSCT caregivers and patients. Data from one hundred and fifty-six English-speaking adults where patients (n = 65) were receiving their first allogeneic HSCT with at least one adult caregiver (n = 91) were eligible for this analysis. Study questionnaires were administered at baseline, initial discharge, and 6 weeks following discharge. RESULTS: Construct validity was supported by significant relationships (p<0.001) between the DT and the BSI-18 GSI and the MFSI-Emotional subscales for caregivers and patients. The diagnostic utility of the DT for patients was good (AUC = 0.85±0.05, p = 0.001), while for caregivers it was poor (AUC = 0.61±0.08, p = 0.28). A DT cut point of 5 was supported for patients (sensitivity = 1.0, specificity = 0.68), while for caregivers there was less confidence (sensitivity = 0.70, specificity = 0.52). Caregivers and patients reporting a higher number of problems had a greater level of distress (p<0.001). CONCLUSIONS: These findings support the validity of the DT in screening for distress in HSCT caregivers and patients. Although the diagnostic utility of the DT for HSCT caregivers may be limited, understanding factors associated with distress can guide practice for this understudied population.

Function, adjustment, quality of life and symptoms (FAQS) in allogeneic hematopoietic stem cell transplantation (HSCT) survivors: a study protocol.

BACKGROUND: The population of survivors following allogeneic HSCT continues to increase, and yet their experiences of recovery and long-term survivorship have not been fully characterized. This paper presents a study protocol examining over time the functional status, psychosocial adjustment, health-related quality of life, and symptom experience of survivors who have undergone allogeneic transplantation. The aims of the study are to: 1) explore the patterns of change in these health outcomes during the survivorship phase; 2) characterize subgroups of survivors experiencing adverse outcomes; and 3) examine relationships among outcomes and demographic and clinical factors (such as age, graft-versus-host disease (GVHD), and disease relapse). METHODS: In this longitudinal observational study, adults who survive a minimum of 3 years from date of allogeneic transplantation complete a series of questionnaires annually. Demographic and clinical data are collected along with a series of patient-reported outcome measures, specifically: 1) Medical Outcomes Study SF- 36; 2) Functional Assessment of Chronic Illness Therapy (FACIT) - General, 3) FACIT-Fatigue; 4) FACIT- Spiritual; 5) Psychosocial Adjustment to Illness Scale; 6) Rotterdam Symptom Checklist-Revised; and 7) Pittsburgh Sleep Quality Index. CONCLUSIONS: This study will provide multidimensional patient-reported outcomes data to expand the understanding of the survivorship experience across the trajectory of allogeneic transplantation recovery. There are a number of inherent challenges in recruiting and retaining a diverse and representative sample of long-term transplant survivors. Study results will contribute to an understanding of outcomes experienced by transplant survivors, including those with chronic GVHD, malignant disease relapse, and other late effects following allogeneic transplantation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00128960.

Symptom Clusters and Influencing Factors in Family Caregivers of Individuals With Cancer.

BACKGROUND: A symptom cluster is a group of 2 or more symptoms that occur together and are related to each other. Although family caregivers of individuals with cancer experience multiple concurrent symptoms, the majority of symptom research has focused on assessing and managing individual, isolated symptoms. OBJECTIVE: The study purpose was to investigate symptom clusters in cancer caregivers and to explore factors that influence symptom clusters. METHODS: Cluster analysis was performed using cross-sectional survey data from 129 family caregivers of individuals receiving cancer treatment at the National Institutes of Health Clinical Center. PROMIS (Patient-Reported Outcomes Measurement Information System) measures of 5 common symptoms in caregivers (fatigue, sleep disturbance, depression, anxiety, impaired cognition) were used to identify symptom clusters. RESULTS: Two symptom cluster groups were identified: low symptom burden (n = 106, 82.2%) and high symptom burden (n = 23, 17.8%). Individuals who reported higher levels of caregiving burden (impact on health subscale) (ß = 1.31, P = .005) and loneliness (ß = 0.18, P = .024) were significantly more likely to be in the high symptom burden group. CONCLUSIONS: This study provides evidence that 5 key symptoms among cancer caregivers appear to cluster into 2 groups, those with low symptom burden and those with high symptom burden. Caregiving burden (impact of health) and loneliness were significant factors differentiating symptom cluster membership. IMPLICATIONS FOR PRACTICE: Identifying symptom clusters may lead to better prevention and treatment strategies that target symptoms in cancer caregivers. Identifying factors that place a group at high risk of symptom burden can be used to guide individualized and tailored interventions.

Factors That Influence Health-Promoting Behaviors in Cancer Caregivers.

OBJECTIVES: To describe cancer caregivers' participation in health-promoting behaviors and to identify factors influencing participation. SAMPLE & SETTING: 129 informal cancer caregivers at the National Institutes of Health Clinical Center. METHODS & VARIABLES: Cross-sectional survey methodology using Health-Promoting Lifestyle Profile-II (HPLP-II), PROMIS® Global Physical Health, NIH Toolbox Stress and Self-Efficacy, Caregiver Reaction Assessment, and Family Care Inventory Mutuality subscale. RESULTS: Caregivers reported the highest HPLP-II subscale scores for spirituality and interpersonal relationships and the lowest for physical activity. Caregivers who were older, with lower body mass indices, in better physical health, and with higher self-efficacy and mutuality participated in more health-promoting behaviors. Sixty percent of the caregivers reported that they exercised less since becoming a caregiver, and 47% reported that their diet was worse. IMPLICATIONS FOR NURSING: Future research is needed to examine novel interventions to increase health-promoting activities in cancer caregivers, and these interventions might be strengthened by including components that focus on increasing self-efficacy and/or improving the strength of the relationship between the caregiver and care recipient.

Enhancing the cancer caregiving experience: Building resilience through role adjustment and mutuality.

PURPOSE: The purpose of this study was to explore the dyadic experience of caring for a family member with cancer. Particular attention was given to examine the relationship between dyadic perceptions of role adjustment and mutuality as facilitators in resilience for posttreatment cancer patients and family caregivers. METHOD: For this convergent parallel, mixed-methods study using grounded theory methodologies, 12 dyads were recruited from the National Institutes of Health Clinical Center in Bethesda, Maryland, USA. Qualitative data collection focused on social interactions between cancer patients and their family caregivers to better understand and describe how post-treatment patients and caregivers create mutuality in their relationships, how they describe the processes of role-adjustment, and how these processes facilitate dyadic resiliency. Quantitative data collected through electronic survey included the Family Caregiving Inventory (FCI) for Mutuality Scale, Neuro QoL Ability to Participate in Social Roles and Activities, and Satisfaction with Social Roles and Activities-Short Forms, and Mental Health Continuum-Short Form (MHC). RESULTS: Eleven participants were spouses. Twenty-two self-reported as Caucasian. The sample ranged from 35 to 71 years of age (Caregiver M = 53.7, Patient M = 54.3). Most of the caregivers were female (n = 8; 66.7%) and most of the patients were male (n = 9; 75%). Qualitative interview data illuminated two primary psychosocial processes relating to resilience, role adjustment and mutuality, as key facilitators for transformation and growth within dyadic partnerships coping with the challenges of cancer treatment and cancer caregiving. The FCI-mutuality score for patients (M = 3.65 ±â€¯0.47) and caregivers (M = 3.45 ±â€¯0.42) reflected an average level of relationship quality. Relative to participation in, and satisfaction with social roles and activities, patients (M = 50.66 ±â€¯7.70, M = 48.81 ±â€¯6.64, respectively) and caregivers (M = 50.69 ±â€¯8.6, M = 51.9 ±â€¯8.75, respectively) reported scores that were similar to the US General Population (M = 50 ±â€¯10). CONCLUSIONS: New patterns of role adjustment and mutuality can assist with making meaning and finding benefit, and these patterns contribute to dyadic resilience when moving through a cancer experience. There are few interventions that target the function of the dyad, yet the emergent model identified in this paper provides a direction for future dyadic research. By developing interventions at a dyadic level, providers have the potential to encourage dyadic resilience and sustain partnerships from cancer treatment into survivorship.

Factors That Influence Health-Promoting Self-care in Registered Nurses: Barriers and Facilitators.

Nurses are instrumental in the battle against lifestyle-related diseases, yet nurses may not be participating in their own health-promoting self-care. This study used qualitative content analysis of survey responses to explore nurses' perceptions regarding barriers and facilitators to health-promoting behaviors such as exercise, healthy eating, and participation in stress reduction activities. Seven themes emerged: lack of time/overwork, lack of resources/facilities, fatigue, outside commitments, "unhealthy" food culture, supportive versus unsupportive individuals, and positive versus negative role models. Institutional, interpersonal, and intrapersonal changes are needed to adequately address barriers to nurses' participation in health-promoting behaviors.

Hematopoietic Stem Cell Transplantation Recipient and Caregiver Factors Affecting Length of Stay and Readmission.

PURPOSE/OBJECTIVES: To evaluate the contributions of patient and caregiver factors to length of stay (LOS) and 30-day readmission status for recipients of allogeneic hematopoietic stem cell transplantation (HSCT).
. DESIGN: Secondary data analysis from a phase 2 clinical trial.
. SETTING: National Institutes of Health Clinical Center in Bethesda, Maryland.
. SAMPLE: 68 dyads (N = 136) comprised of patients receiving HSCT and their caregivers. 
. METHODS: Multiple linear regression and logistic regression analyses were used to investigate associations between caregiver and patient factors and outcomes.
. MAIN RESEARCH VARIABLES: Patients' initial LOS, 30-day readmission, and demographic and disease characteristics; caregiver demographic factors, health problems, psychological distress, burden, and self-efficacy. 
. FINDINGS: Twenty-five patients were readmitted within 30 days after hospital discharge following their initial hospitalization for HSCT. LOS was 34% longer for patients with infection than patients without infection. Patients with grade 2 or greater acute graft-versus-host disease (GVHD) stayed longer compared to patients with no or mild acute GVHD. Patients who had nonspousal caregivers stayed longer than patients with spousal caregivers. Infection was significantly related to readmission.
. CONCLUSIONS: Knowledge regarding factors associated with increased LOS and 30-day readmission can help nurses and transplantation team members anticipate the healthcare needs of patients receiving HSCT, improve outcomes, and decrease the use of expensive health services. 
. IMPLICATIONS FOR NURSING: Educating patients and caregivers on infection prevention is critically important to reduce LOS and 30-day readmission after HSCT.

Cardiometabolic risk factors and health behaviors in family caregivers.

The purpose of this study was to compare components of cardiometabolic risk and health behaviors of 20 family caregivers of allogeneic hematopoietic stem cell transplant patients to those of age, gender, and race/ethnicity-matched controls. A prospective, repeated measures design was used to compare cardiometabolic risk and health behaviors in caregivers and controls at three time-points: pre-transplantation, discharge, and six weeks post-discharge. Measures included components of metabolic syndrome, Reynolds Risk Score, NMR serum lipoprotein particle analyses, and the Health-Promoting Lifestyle Profile II (HPLP-II). Mixed-model repeated measure analyses were used. There were no between or within group differences in LDL cholesterol, HDL cholesterol, and triglycerides. There was a significant interaction effect between time and role in large VLDL concentration (VLDL-P) (F (2, 76) = 4.36, p = .016), with the trajectory of large VLDL-P increasing over time in caregivers while remaining stable in controls. Within caregivers, VLDL particle size (VLDL-Z) was significantly larger at time-point three compared to time-points one (p = .015) and two (p = .048), and VLDL-Z was significantly larger in caregivers than in controls at time point three (p = .012). HPLP-II scores were lower in caregivers than controls at all time-points (p < .01). These findings suggest that caregiving may have a bigger impact on triglycerides than on other lipids, and it is through this pathway that caregivers may be at increased cardiometabolic risk. More sensitive measurement methods, such as NMR lipoprotein particle analyses, may be able to detect early changes in cardiometabolic risk.

Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings.

A problem-solving education intervention in caregivers and patients during allogeneic hematopoietic stem cell transplantation.

The aim of this study was to determine the effect of problem-solving education on self-efficacy and distress in informal caregivers of allogeneic hematopoietic stem cell transplantation patients. Patient/caregiver teams attended three 1-hour problem-solving education sessions to help cope with problems during hematopoietic stem cell transplantation. Primary measures included the Cancer Self-Efficacy Scale-transplant and Brief Symptom Inventory-18. Active caregivers reported improvements in self-efficacy (p < 0.05) and distress (p < 0.01) post-problem-solving education; caregiver responders also reported better health outcomes such as fatigue. The effect of problem-solving education on self-efficacy and distress in hematopoietic stem cell transplantation caregivers supports its inclusion in future interventions to meet the multifaceted needs of this population.