A Systematic Review of Adherence to Oral Antineoplastic Therapies.

BACKGROUND: Oral antineoplastic therapies not only improve survival but also reduce the burden of care for patients. Yet patients and clinicians face new challenges in managing adherence to these oral therapies. We conducted a systematic literature review to assess rates and correlates of adherence to oral antineoplastic therapies and interventions aimed at improving adherence. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a comprehensive literature search of the Ovid MEDLINE database from January 1, 2003 to June 30, 2015, using relevant terminology for oral antineoplastic agents. We included observational, database, and intervention studies. At least two researchers evaluated each paper to ensure accuracy of results and determine risk of bias. RESULTS: We identified 927 records from the search and screened 214 abstracts. After conducting a full-text review of 167 papers, we included in the final sample 51 papers on rates/correlates of adherence to oral antineoplastic therapy and 12 papers on intervention studies to improve adherence. Rates of adherence varied widely, from 46% to 100%, depending on patient sample, medication type, follow-up period, assessment measure, and calculation of adherence. Of the intervention studies, only 1 of the randomized trials and 2 of the cohort studies showed benefit regarding adherence, with the majority suffering high risk of bias. CONCLUSIONS: Although no reliable estimate of adherence to oral antineoplastic therapies can be gleaned from the literature, a substantial proportion of patients struggle to adhere to these medications as prescribed. The few intervention studies for adherence have notable methodological concerns, thereby limiting the evidence to guide practice in promoting medication adherence among patients with cancer.

Measuring Coping Behavior in Liver Transplant Candidates: A Psychometric Analysis of the Brief COPE.

Liver transplant candidates must cope with significant physiological and psychological challenges. The Brief COPE is a frequently used measure of coping behavior; however, knowledge of the scale's factor structure and construct validity is limited with regard to liver transplant candidates. This study assessed the validity of the Brief COPE in 120 liver transplant candidates using exploratory factor analysis. Results revealed a 6-factor solution, only 2 of which were consistent with the original scale assignments. Construct validity of the 6 Brief COPE scales yielded in this study was demonstrated. The results indicate that the Brief COPE is valid, reliable, and can be meaningfully interpreted in liver transplant patients. Future research should confirm this factor structure and examine its predictive validity prior to widespread use among liver transplant patients. Suggestions are presented for enhancing the care of transplant candidates by promoting the use of adaptive coping mechanisms to manage distress.

Acceptability and feasibility of a culturally tailored Internet-delivered intervention to promote blood donation in Blacks.

INTRODUCTION: A pilot test of a computer-tailored intervention designed to promote blood donation among Blacks was conducted. METHOD: Intervention content, based on the transtheoretical model, offered participants individually and culturally tailored information on blood donation with emphasis on need specific to race (e.g., sickle-cell disease). Black adults (N = 150) with a diversity of blood donation experience were recruited from a blood center and a survey recruitment website. Posttest assessment included a 14-item evaluation and transtheoretical model questions. RESULTS: Participants rated the program positively (81.3% to 98.7% of participants agreeing or strongly agreeing with evaluation items). For example, 98.7% of respondents reported that the program gave sound advice and that personal feedback was easily understood, and 87.3% felt the program was designed for people like themselves. Ninety-five percent of participants reported that they would recommend the program to others. There were no significant differences in ratings based on demographics. Qualitative responses support program acceptability. Furthermore, pre- and postprogram assessments indicated an increase in intention to donate, t(149) = 3.56, p = .001, d = .29. DISCUSSION: With acceptability and feasibility confirmed, the next steps are to test efficacy and cost-effectiveness for use to increase blood donation, particularly in priority populations.

Your Path to Transplant: a randomized controlled trial of a tailored computer education intervention to increase living donor kidney transplant.

BACKGROUND: Because of the deceased donor organ shortage, more kidney patients are considering whether to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although Blacks and Hispanics are 3.4 and 1.5 times more likely, respectively, to develop end stage renal disease (ESRD) than Whites, they are less likely to receive LDKTs. To address this disparity, a new randomized controlled trial (RCT) will assess whether Black, Hispanic, and White transplant patients' knowledge, readiness to pursue LDKT, and receipt of LDKTs can be increased when they participate in the Your Path to Transplant (YPT) computer-tailored intervention. METHODS/DESIGN: Nine hundred Black, Hispanic, and White ESRD patients presenting for transplant evaluation at University of California, Los Angeles Kidney and Pancreas Transplant Program (UCLA-KPTP) will be randomly assigned to one of two education conditions, YPT or Usual Care Control Education (UC). As they undergo transplant evaluation, patients in the YPT condition will receive individually-tailored telephonic coaching sessions, feedback reports, video and print transplant education resources, and assistance with reducing any known socioeconomic barriers to LDKT. Patients receiving UC will only receive transplant education provided by UCLA-KPTP. Changes in transplant knowledge, readiness, pros and cons, and self-efficacy to pursue LDKT will be assessed prior to presenting at the transplant center (baseline), during transplant evaluation, and 4- and 8-months post-baseline, while completion of transplant evaluation and receipt of LDKTs will be assessed at 18-months post-baseline. The RCT will determine, compared to UC, whether Black, Hispanic, and White patients receiving YPT increase in their readiness to pursue LDKT and transplant knowledge, and become more likely to complete transplant medical evaluation and pursue LDKT. It will also examine how known patient, family, and healthcare system barriers to LDKT act alone and in combination with YPT to affect patients' transplant decision-making and behavior. Statistical analyses will be performed under an intent-to-treat approach. DISCUSSION: At the conclusion of the study, we will have assessed the effectiveness of an innovative and cost-effective YPT intervention that could be utilized to tailor LDKT discussion and education based on the needs of individual patients of different races in many healthcare settings. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02181114.

Measuring the processes of change for increasing blood donation in black adults.

BACKGROUND: Blacks have significantly lower blood donation rates than whites. Many views, experiences, and behaviors associated with blood donation are unique to black culture. Evidence suggests that culturally tailored health promotion programs help with increasing black blood donation. To be effective, tailored interventions should be based on valid and reliable measures. The Transtheoretical Model's (TTM) Processes of Change (POC) construct provides an assessment of participants' covert and overt activities and experiences in blood donation. This study describes development and validation of POC for increasing blood donation tailored to blacks. STUDY DESIGN AND METHODS: Cross-sectional measure development with online survey dissemination was used in 566 blacks in the Northeastern United States. Factor analytic structural modeling procedures were used to examine validity of the POC measure. Blood donation POC were examined in participants representing a range of blood donation history and intentions (nondonors, sometimes donors, regular donors) based on an established algorithm. RESULTS: Confirmatory analyses replicated the theoretically expected structure of POC scales which is a 10-factor, fully correlated best-fit model. Expected POC patterns by Stages of Change based on theoretical and empirical predictions were confirmed. The range of effect sizes for 10 POC were η(2) = 0.04 to 0.25, indicating that TTM POC are strong strategies in blood donation decision making for blacks and can be applied to interventions to increase blood donation for a minority population. CONCLUSION: POC measure was internally and externally valid in a sample of blacks. Interventions can utilize the POC measure to guide stage-matched interventions to encourage use of relevant experiential and behavioral strategies to increase blood donation.

Treated individuals who progress to action or maintenance for one behavior are more likely to make similar progress on another behavior: coaction results of a pooled data analysis of three trials.

OBJECTIVE: This study compared, in treatment and control groups, the phenomena of coaction, which is the probability that taking effective action on one behavior is related to taking effective action on a second behavior. METHODS: Pooled data from three randomized trials of Transtheoretical Model (TTM) tailored interventions (n=9461), completed in the U.S. in 1999, were analyzed to assess coaction in three behavior pairs (diet and sun protection, diet and smoking, and sun protection and smoking). Odds ratios (ORs) compared the likelihood of taking action on a second behavior compared to taking action on only one behavior. RESULTS: Across behavior pairs, at 12 and 24 months, the ORs for the treatment group were greater on an absolute basis than for the control group, with two being significant. The combined ORs at 12 and 24 months, respectively, were 1.63 and 1.85 for treatment and 1.20 and 1.10 for control. CONCLUSIONS: The results of this study with addictive, energy balance and appearance-related behaviors were consistent with results found in three studies applying TTM tailoring to energy balance behaviors. Across studies, there was more coaction within the treatment group. Future research should identify predictors of coaction in more multiple behavior change interventions.

Mutuality and heart failure self-care in patients and their informal caregivers.

BACKGROUND: Heart failure is a progressive condition characterized by frequent hospitalizations for exacerbated symptoms. Informal family caregivers may help patients improve self-care, which may in turn reduce hospitalizations. However, little is known about how mutuality, defined as the quality of the patient-caregiver relationship, and caregiver burden affect self-care. OBJECTIVE: This study examines the associations among mutuality, patient self-care confidence (beliefs in abilities to engage in self-care behaviors) and maintenance (behaviors such as medication adherence, activity, and low salt intake), caregiver confidence in and maintenance of patient care, and caregiver perceived burden. METHODS: This study used cross-sectional baseline data from a multi-site randomized clinical trial of a symptom and psychosocial care intervention. Patient-caregiver dyads ( N=99) completed self-report surveys of mutuality and self-care confidence and maintenance, and caregivers completed a measure of caregiver burden. Path analysis, with actor (effects within a person) partner (effects across the dyad) interdependence model paths and regression models were used to examine the associations among mutuality, caregiver burden, and self-care. RESULTS: The majority of patients ( M age=66, 21% female) and caregivers ( M age=57, 81% female) were spouses (60%). The path model demonstrated significant actor effects; patients and caregivers with better mutuality were more confident in patient self-care ( p<.05). Partner effects were not significant. Regression models indicated that caregivers with greater mutuality reported less perceived burden ( p<.01). CONCLUSIONS: Mutuality in patient-caregiver dyads is associated with patient self-care and caregiver burden and may be an important intervention target to improve self-care and reduce hospitalizations.

Motivation for HPV Vaccination Among Young Adult Men: Validation of TTM Decisional Balance and Self-Efficacy Constructs.

PURPOSE: In the United States, 36% of human papillomavirus (HPV)-related cancers occur among men. HPV vaccination can substantially reduce the risk of HPV infection; however, the vast majority of men are unvaccinated. This study developed and validated transtheoretical model-based measures for HPV vaccination in young adult men. DESIGN: Cross-sectional measurement development. SETTING: Online survey of young adult men. SUBJECTS: Three hundred twenty-nine mostly college-attending men, ages 18 to 26. MEASURES: Stage of change, decisional balance (pros/cons), and self-efficacy. ANALYSIS: The sample was randomly split into halves for exploratory principal components analysis (PCA), followed by confirmatory factor analyses (CFA) to test measurement models. Multivariate analyses examined relationships between scales. RESULTS: For decisional balance, PCA revealed two uncorrelated five-item factors (pros α = .78; cons α = .83). For the self-efficacy scale, PCA revealed a single-factor solution (α = .83). CFA confirmed that the two-factor uncorrelated model for decisional balance and a single-factor model for self-efficacy. Follow-up analyses of variance supported the theoretically predicted relationships between stage of change, pros, and self-efficacy. CONCLUSION: This study resulted in reliable and valid measures of pros and self-efficacy for HPV vaccination that can be used in future clinical research.

Measuring kidney patients' motivation to pursue living donor kidney transplant: development of stage of change, decisional balance and self-efficacy measures.

While educational interventions to increase patient motivation to pursue living donor kidney transplant have shown success in increasing living donor kidney transplant rates, there are no validated, theoretically consistent measures of Stage of Change, a measure of readiness to pursue living donor kidney transplant; Decisional Balance, a weighted assessment of living donor kidney transplant's advantages/disadvantages; and Self-Efficacy, a measure of belief that patients can pursue living donor kidney transplant in difficult circumstances. This study developed and validated measures of these three constructs. In two independent samples of kidney patients (N 1 = 279 and N 2 = 204), results showed good psychometric properties and support for their use in the assessment of living donor kidney transplant interventions.

Measuring coping behavior in patients with major burn injuries: a psychometric evaluation of the BCOPE.

Burn injuries involve significant physiological, psychological, and social challenges with which individuals must cope. Although the brief COPE (BCOPE) is frequently used, knowledge of its factor structure and construct validity is limited, thus limiting confidence with interpreting results. This study assessed psychometric properties of the BCOPE in hospitalized patients with burn injury. Participants had a major burn injury (n = 362). Measures assessed coping behavior and physical, psychological, and social functioning. Exploratory factorial analysis was conducted to evaluate patterns of coping strategies. To assess construct validity, the BCOPE scale scores were correlated with the distress measures across time points. Exploratory factorial analysis revealed seven factors accounting for 51% of total variance. The pattern matrix indicated four items loaded onto factor 1 (active coping = 0.47-0.80) and four onto factor 2 (avoidant coping = 0.59-0.73). The remaining factors were consistent with original scale assignments reported by Carver (Int J Behav Med 1997;4:92-100). Construct validity of BCOPE scales (active and avoidant) was demonstrated by their association with the Davidson trauma scale, short form-12, and satisfaction with appearance scale. The results indicate that the BCOPE is valid, reliable, and can be meaningfully interpreted. Research using these factors may improve knowledge about interrelationships among stress, coping, and outcome, thus building the evidence base for managing distress in this population.

Peritraumatic heart rate and posttraumatic stress disorder in patients with severe burns.

OBJECTIVE: Previous studies have suggested a link between heart rate (HR) following trauma and the development of posttraumatic stress disorder (PTSD). This study expands on previous work by evaluating HR in burn patients followed longitudinally for symptoms of acute stress disorder (ASD) and PTSD. METHOD: Data were collected from consecutive patients admitted to the Johns Hopkins Burn Center, Baltimore, Maryland, between 1997 and 2002. Patients completed the Stanford Acute Stress Reaction Questionnaire (n = 157) to assess symptoms of ASD. The Davidson Trauma Scale was completed at 1 (n = 145), 6 (n = 106), 12 (n = 94), and 24 (n = 66) months postdischarge to assess symptoms of PTSD. Heart rate in the ambulance, emergency room, and burn unit were obtained by retrospective medical chart review. RESULTS: Pearson correlations revealed a significant relationship between HR in the ambulance (r = 0.32, P = .016) and burn unit (r = 0.30, P = .001) and ASD scores at baseline. Heart rate in the ambulance was related to PTSD avoidance cluster scores at 1, 6, 12, and 24 months. In women, HR in the ambulance was correlated with PTSD scores at 6 (r = 0.65, P = .005) and 12 (r = 0.78, P = .005) months. When covariates (gender, ß-blockers, Brief Symptom Inventory Global Severity Index score) were included in multivariate linear regression analyses, ambulance HR was associated with ASD and PTSD scores at baseline and 1 month, and the interaction of ambulance HR and gender was associated with PTSD scores at 6 and 12 months. Multivariate logistic regression results were similar at baseline and 12 months, which included an HR association yet no interaction at 6 months and a marginal interaction at 1 month. CONCLUSIONS: While peritraumatic HR is most robustly associated with PTSD symptom severity, HR on admission to burn unit also predicts the development of ASD. Gender and avoidance symptoms appear particularly salient in this relationship, and these factors may aid in the identification of subgroups for which HR serves as a biomarker for PTSD. Future work may identify endophenotypic measures of increased risk for PTSD, targeting subgroups for early intervention.

Growth curve trajectories of distress in burn patients.

Psychological adjustment after a major burn injury is a significant concern to providers and patients alike. Although efforts have been made to identify associated risk factors, little is known about heterogeneity in the levels or trajectories of adjustment in this population. This study used a novel application of Growth Mixture Modeling to identify subgroups of patients based on their longitudinal self-reported distress using the Brief Symptom Inventory (BSI). Data were drawn from the database of the Burn Model Systems project, a prospective, multisite, cohort study of major burn injury survivors. The BSI was used to assess symptoms in-hospital and at 6, 12, and 24 months postburn. Participants' T scores on the BSIs Global Severity Index provided a continuous measure of psychological distress. Analyses were conducted using participants' Global Severity Index T scores to discern distinct classes of respondents with similar trajectories across the 2-year follow-up. Results from the Growth Mixture Modeling analysis produced an ordered four-class model of psychological recovery from a major burn. Groups represented the equivalent of high, subthreshold, mild, and minimal symptom severity. Covariates significantly affected the intercept and slope of each class, as well as prediction of group assignment. These analyses demonstrate differences between individual recoveries after a major burn. Psychological distress symptoms remain largely stable over time and highlight the psychological vulnerability of this patient population.