Associations of Impulsivity and Risky Decision-Making with E-Cigarette-Related Outcomes Among Adolescents with Congenital Heart Disease: Variable- and Person-Oriented Approaches.

Adolescents with congenital heart disease (CHD) have elevated risk for acquired cardiovascular complications, increasing their vulnerability to e-cigarette-related health harms. Impulsivity and risky decision-making have been associated with adolescent substance use, but the relationships between these factors and e-cigarette-related outcomes among cardiovascular at-risk adolescents with CHD are unknown. This cross-sectional study aimed to (a) determine the associations of impulsivity and risky decision-making with e-cigarette-related outcomes (i.e. susceptibility, ever use, perceptions of harm and addictiveness) via variable-oriented analysis (logistic regression), (b) identify groups of adolescents with similar profiles of impulsivity and risky decision-making via exploratory person-oriented analysis (latent profile analysis; LPA), and (c) examine differences on e-cigarette-related outcomes between profile groups. Adolescents aged 12 to 18 years with CHD (N = 98) completed a survey assessing impulsivity facets (Short UPPS-P) and e-cigarette-related outcomes and were administered a risky decision-making task (Iowa Gambling Task, Version 2; IGT2). In variable-oriented analyses, impulsivity facets (negative urgency, positive urgency, lack of premeditation) but not risky decision-making were associated with e-cigarette susceptibility and ever use. The exploratory LPA identified two groups with similar patterns of responding on the Short UPPS-P and IGT2 labeled "Low Impulsivity" and "High Impulsivity," which were primarily characterized by significant differences in negative and positive urgency. Adolescents in the High Impulsivity group had increased odds of e-cigarette susceptibility but not ever use compared to the Low Impulsivity group. This work indicates that strategies to prevent e-cigarette use among adolescents with CHD may be enhanced by addressing impulsivity, particularly negative and positive urgency.

Age moderates change in disease-related stress among congenital heart disease survivors: a 6-year follow-up.

AIMS: As congenital heart disease (CHD) survivors age, they are confronted with elevated risk of cardiovascular morbidity and increasingly complex disease self-management demands. Given that stress is associated with poor physical and psychosocial outcomes, it is crucial to examine how disease-related stress changes over time in this population. However, this outcome has received little research attention to date. This study aimed to identify demographic and clinical predictors of change in disease-related stress over 6 years among CHD survivors. METHODS AND RESULTS: Congenital heart disease survivors (N = 252, Mage = 25.6 ± 7.1, 52.9% female) completed the first 13 items of the Responses to Stress Questionnaire, adapted for use among CHD survivors, to assess disease-related stressors at study entry (T1) and 6-year follow-up (T2). Age, gender, estimated family income, and New York Heart Association (NYHA) functional class at T1 were entered into mixed linear models to determine their impact on change in disease-related stress. Older age (P < 0.001), lower income (P < 0.001), and presence of functional limitations (NYHA ≥ II) (P < 0.001) predicted greater increases in disease-related stress. When controlling for NYHA, functional class, and income, a significant time by age interaction was identified such that disease-related stress increased over time among those who were adolescents at T1 [b = 4.20, P = 0.010, 95% confidence interval (1.01, 7.40)], but remained stable among young adults. CONCLUSION: The transition from adolescence to adulthood may be a period of increasing disease-related stress. Healthcare providers should consider screening adolescents for elevated disease-related stress during transition education and provide resources to bolster resilience.

The Association of Global and Disease-Related Stress With Susceptibility to and Use of E-Cigarettes and Marijuana Among Adolescents With Congenital Heart Disease.

OBJECTIVE: Adolescents with congenital heart disease (CHD) are exposed to disease-related stressors and have elevated risk for cardiovascular and cognitive complications that are exacerbated by e-cigarettes and marijuana. The aims of this cross-sectional study are to: (1) identify the association between perceived global and disease-related stress and susceptibility to e-cigarettes and marijuana, (2) determine if the association between stress and susceptibility differs by gender, and (3) explore the association between stress and ever use of e-cigarettes and marijuana among adolescents with CHD. METHODS: Adolescents with CHD (N = 98; aged 12-18 years) completed self-report measures of susceptibility to/ever use of e-cigarettes and marijuana and global and disease-related stress. RESULTS: Susceptibility to e-cigarettes and marijuana was reported by 31.3% and 40.2% of adolescents, respectively. Ever use of e-cigarettes and marijuana was reported by 15.3% and 14.3% of adolescents, respectively. Global stress was associated with susceptibility to and ever use of e-cigarettes and marijuana. Disease-related stress was associated with susceptibility to marijuana. Females reported more global and disease-related stress than males, but the association of stress with susceptibility to e-cigarettes and marijuana did not differ by gender. CONCLUSIONS: Susceptibility to e-cigarettes and marijuana is common among adolescents with CHD and is associated with stress. Future work to examine the longitudinal associations between susceptibility, stress, and use of e-cigarettes and marijuana is warranted. Global stress may be an important consideration in the development of strategies to prevent these risky health behaviors among adolescents with CHD.

Ambivalence is associated with decreased physical activity and cardiorespiratory fitness among adolescents with critical congenital heart disease.

BACKGROUND: Adolescents with congenital heart disease (CHD) are insufficiently physically active. Given that increasing physical activity may reduce their cardiovascular risk, it is important to identify correlates of this behavior. Perceived benefits of and barriers to physical activity are associated with physical activity engagement. Existing research has only considered these constructs separately. This population may be ambivalent toward physical activity (i.e., perceive both strong benefits and barriers). The association of ambivalence and physical activity related outcomes is unknown among this at-risk population. OBJECTIVE: Determine the association of ambivalence and sedentary behavior, moderate-to-vigorous physical activity (MVPA), and cardiorespiratory fitness (VO2Peak) among adolescents with CHD. METHODS: The present study is an analysis of data from an eligibility assessment for a randomized clinical trial of an intervention to promote MVPA among adolescents aged 15 to 18 years with moderate or complex CHD. Participants (N = 84) completed a survey assessing perceived benefits and barriers from which ambivalence toward physical activity was calculated, an exercise stress test to measure VO2Peak, and wore an accelerometer for one week to determine their engagement in sedentary behavior and MVPA. Linear regression analyses determined associations between ambivalence and physical activity related outcomes. RESULTS: Greater ambivalence toward physical activity was associated with increased sedentary behavior, decreased MVPA, and reduced VO2Peak, adjusting for demographic and clinical covariates. CONCLUSIONS: Ambivalence is associated with objectively measured physical activity (sedentary behavior, MVPA) and a biomarker of cardiovascular health (VO2Peak). Screening for ambivalence may help clinicians identify those most likely to benefit from physical activity-related education.

Difficulties With Executive Function Are Associated With Risky Health Behaviors Among Young Adult Congenital Heart Defect Survivors.

BACKGROUND: Adults with congenital heart defects (CHDs) have an increased risk for cardiovascular complications, but few are in optimal cardiovascular health. Executive function deficits, which are elevated among CHD survivors, may contribute to engagement in behaviors that increase cardiovascular risk. OBJECTIVE: The aim of this study was to identify the association between executive function and the health risk behaviors of tobacco use, saturated fat intake, and insufficient physical activity among young adults with CHDs. METHODS: Young adults with CHDs completed the Behavior Rating Inventory of Executive Function-Adult Version, which yields composite and 9 individual domain scores (eg, inhibition, working memory). Participants also completed self-report measures of tobacco use, saturated fat intake, and physical activity. Linear and logistic regression models determined the association between executive function and risky health behaviors, adjusting for demographic factors, disease status, and emotional distress. RESULTS: One in 10 young adults with CHDs reported clinically significant difficulties with global executive function. Difficulties with global executive function were associated with increased tobacco use ( P = .018) and greater saturated fat intake ( P = .015) but not insufficient physical activity ( P = .902). Difficulties with inhibition were specifically associated with increased tobacco use ( P = .003) and greater saturated fat intake ( P = .007), and problems with self-monitoring were associated with increased tobacco use ( P = .017). CONCLUSIONS: Executive function difficulties are associated with self-reported engagement in health risk behaviors among young adults with CHDs. Health behavior interventions for adult CHD survivors may require additional modifications that consider executive function problems, particularly difficulties with inhibition.

Gender Differences in Physical Activity Engagement Among Adolescents With Congenital Heart Disease.

OBJECTIVE: The current study aimed to (a) describe moderate-to-vigorous physical activity (MVPA), sedentary behavior (SB), and cardiorespiratory fitness (VO2Peak) via objective assessment among adolescents with congenital heart disease (CHD), (b) examine gender differences on MVPA, SB, VO2Peak, and the Theory of Planned Behavior elements, and (c) identify whether gender moderates the relationships between the Theory of Planned Behavior elements and MVPA, SB, and VO2Peak. METHODS: Adolescent CHD survivors (N = 86; ages 15-18 years) wore an accelerometer to assess MVPA and SB, underwent an exercise stress test to assess VO2Peak, and completed a survey of the Theory of Planned Behavior elements as measured by perceived benefits (attitudes), family/friend support and perceived norms (social norms), and self-efficacy and barriers (perceived behavioral control) to engaging in physical activity. RESULTS: On average, CHD survivors engaged in 22.3 min (SD = 15.3) of MVPA/day and 9 hr of SB/day (M = 565.8, SD = 102.5 min). Females engaged in less MVPA but not more SB had a lower mean VO2Peak, reported lower self-efficacy, and perceived greater barriers than males. In a regression model, barriers explained unique variance in MVPA and VO2Peak, but the relationship between barriers and MVPA/VO2Peak did not vary by gender. Self-efficacy did not explain unique variance in MVPA and VO2Peak when included in a model with gender and barriers. CONCLUSIONS: Family/friend support for physical activity engagement may be an important consideration when developing physical activity interventions for adolescent CHD survivors. The role of gender differences in self-efficacy and perceived barriers on physical activity engagement warrants further investigation.

A Randomized Clinical Trial Demonstrating Feasibility and Preliminary Efficacy of a Videoconference-Delivered Physical Activity Lifestyle Intervention Among Adolescents With a Congenital Heart Defect.

BACKGROUND: Individuals with congenital heart defects are at increased risk for developing further cardiovascular complications, which can be mitigated by increasing physical activity. Given that positive health behaviors begin declining during older adolescence, it is vital to promote lifestyle changes in this population. PURPOSE: The current study aims to (a) determine the feasibility/acceptability of the Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) intervention among adolescents (ages 15-18) with moderate and complex congenital heart defects, and (b) estimate the preliminary efficacy of CHD-PAL for increasing time spent in moderate-to-vigorous physical activity (MVPA) and cardiorespiratory fitness and decreasing sedentary behavior. METHODS: Eligible participants were randomized into either CHD-PAL (eight 30-min videoconferencing sessions over 20 weeks with an interventionist + Fitbit + exercise prescription) or a comparator (Fitbit + exercise prescription). RESULTS: Sixty adolescents were randomized (76% recruitment rate; 94% of participants were retained from baseline to follow-up). Most adolescents (73%) and their parents/guardians (76%) reported that the trial was enjoyable. While there was no effect of arm on change in MVPA, sedentary behavior, or cardiorespiratory fitness for the entire sample, among those who engaged in <21 min of MVPA on average at baseline, adolescents in the CHD-PAL intervention had an increase of 16 min/day of MVPA more than comparators (d = 0.90). CONCLUSIONS: The CHD-PAL intervention warrants examination in a larger trial to establish efficacy among those adolescents with a congenital heart defect who engage in <21 min of MVPA/day and should include follow-up assessments to examine effect durability. CLINICAL TRIALS REGISTRATION: NCT03335475.

Results from the blood donor competence, autonomy, and relatedness enhancement (blood donor CARE) randomized trial.

BACKGROUND: This study aimed to promote competence, autonomy, and relatedness among first-time whole blood donors to enhance intrinsic motivation and increase retention. STUDY DESIGN AND METHODS: Using a full factorial design, first-time donors (N = 2002) were randomly assigned to a no-treatment control condition or to one of seven intervention conditions designed to promote donation competence, autonomy, relatedness, a combination of two (e.g., competence and autonomy), or all three constructs. Participants completed donor motivation measures before the intervention and 6 weeks later, and subsequent donation attempts were assessed for 1 year. RESULTS: There was no significant group difference in the frequency of donation attempts or in the number of days to return. Significant effects of group were observed for 10 of the 12 motivation measures, although follow-up analyses revealed significant differences from the control group were restricted to interventions that included an autonomy component. Path analyses confirmed direct associations between interventions involving autonomy and donor motivation, and indirect mediation of donation attempts via stronger donation intentions and lower donation anxiety. CONCLUSION: Among young, first-time, whole blood donors, brief interventions that include support for donor autonomy were associated with direct effects on donor motivation and indirect, but small, effects on subsequent donation behavior.

The Effect of Psychiatric History on Pain and Related Outcomes Among Living Kidney Donors.

INTRODUCTION: Living donor transplantation of kidneys accounts for one quarter of transplants performed in the United States. Careful screening of psychiatric history is a standard part of the donor evaluation. Little is known about the impact of psychiatric history on post-donation course and pain experience. RESEARCH QUESTION: This study investigated whether psychiatric history was associated with pain and related outcomes among living kidney donors. DESIGN: A retrospective medical record review was conducted of 75 living kidney donors who underwent laparoscopic donor nephrectomy. All donor candidates completed a psychological evaluation and were approved for donation by a multidisciplinary committee. History of psychiatric diagnosis and psychiatric medication use were obtained from donors' psychological evaluation reports. Data on pain and related outcomes (ie, history of prescribed pain medication, post-donation pain, opioid use, length of hospital stay, post-donation emergency department visits), as well as demographic and donation-related characteristics were also abstracted from medical records. RESULTS: Psychiatric history, including current or historical psychiatric diagnosis or psychiatric medication use, in living kidney donors who were evaluated and approved for donation by a transplant psychologist was not associated with greater perceived pain, greater use of opioid pain medication in the post-operative period, longer hospital stays, or more frequent post-donation emergency department visits. DISCUSSION: The findings demonstrate that carefully screened donors with a psychiatric history have comparable pain-related outcomes as donors without a psychiatric history. This study highlights the importance of the pre-donation psychological evaluation in promoting positive postdonation outcomes through careful selection of donor candidates.

Smoking among adult congenital heart disease survivors in the United States: Prevalence and relationship with illness perceptions.

The relationship between smoking and illness perceptions among congenital heart disease (CHD) survivors is unknown. The primary aims of the present study were to compare the smoking prevalence among CHD survivors to a nationally representative U.S. sample and examine the relationship between smoking and illness perceptions. CHD survivors (N = 744) from six U.S. sites participated in the study. The smoking prevalence among CHD survivors (9.3%) was lower than the general population (15.3%). However, 23.3% of CHD survivors with severe functional limitations smoked. Smoking prevalence differed by U.S. region, with a greater proportion of those attending CHD care in the Midwest reporting smoking (11.8%). The illness perception dimensions of Concern and Emotional Response were independently associated with smoking. Differences in illness perceptions enhance our understanding of smoking among CHD survivors and may guide interventions promoting positive health behaviors. The protocol for the study from which the present analyses were conducted was recorded at ClinicalTrials.gov: NCT02150603.

Obesity across the lifespan in congenital heart disease survivors: Prevalence and correlates.

BACKGROUND: Congenital heart disease (CHD) survivors are at risk for cardiovascular comorbidities exacerbated by obesity. OBJECTIVES: Determine relationships between overweight/obesity and medical factors across the lifespan of CHD. METHODS: Lesion severity, weight, blood pressure, cardiac and other comorbidities, and cardiac medications were abstracted from the medical records of 3790 CHD patients, aged ≥6 years, who attended CHD care in the Midwestern U.S. RESULTS: The proportion of patients with overweight/obesity increased across the lifespan, with 73% of adults affected by overweight/obesity. Obesity was more prevalent among patients with moderate lesions (29%). Overweight/obesity was associated with elevated blood pressure across age and lesion severity. Young adults with obesity and simple or moderate lesions had more comorbidities (simple: IRR = 3.1, moderate: IRR = 2.3) and cardiac medications (simple: IRR = 2.2, moderate: IRR = 1.7). CONCLUSIONS: Obesity and its cardiovascular correlates are present across the lifespan for CHD survivors, highlighting the need for early prevention and intervention.

Psychological Needs, Assessment, and Treatment in the Care of Adults with Congenital Heart Disease.

Although the majority of congenital heart disease survivors are thriving, many are at risk for declining emotional well-being as they age. Emotional distress is a risk factor for poorer health outcomes and must be addressed. Primary care and cardiology teams may be the first line of defense in identifying and providing referral resources for symptoms of depression, anxiety, and medical trauma. The current review provides information about commonly used self-report measures of emotional distress to identify symptoms that warrant referral and describes multiple options for addressing these symptoms.

An automated motivational interview promotes donation intention and self-efficacy among experienced whole blood donors.

BACKGROUND: Interventions intended to motivate donors to return can be costly and time consuming. The current study examined the effect of a Web-based automated interview, informed by motivational interviewing and self-determination theory, on donor intention, motivation, and behavior in a sample of highly experienced donors. STUDY DESIGN AND METHODS: Approximately 1 week after donating, 1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female) participated in a study in which they were randomly assigned to either a donor motivational interview (n = 544) or knowledge interview (n = 633). Measures of donor motivation and psychological need support were obtained before the interviews, and again at postinterview assessments conducted approximately 2 days later and 7 weeks later. Blood center records were used to assess repeat donation attempts for 1 year after the interviews. RESULTS: Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up. Among women only, the motivational interview was associated with greater competence and relatedness increases at both follow-up assessments. CONCLUSION: An automated motivational interview appears to be a feasible way to promote donation intention and self-efficacy. Although the observed effects were small among highly experienced donors, we are currently assessing the potential effect of this intervention among less experienced donors.

A motivational interview promotes retention of blood donors with high internal motivation.

BACKGROUND: Based on the hypothesis that self-determined motivation is associated with an increased likelihood of future behavior, the present study examined the ability of a motivational interview to promote internal motivation for giving blood and future donation attempts. STUDY DESIGN AND METHODS: A sample of 484 recent whole-blood and double red blood cell donors (62.4% female; age = 30.2 ± 11.8 years) were randomly assigned to either a telephone-delivered motivational interview or a control call approximately 6 weeks after donating. Several weeks before the call and again 1 week after the call, participants completed the Blood Donor Identity Survey, a multidimensional measure of donor motivation, to derive indices of amotivation, external motivation, and internal motivation to give blood. Repeat donation attempts were tracked using blood center records. RESULTS: Relative to controls, participants in the motivational interview group showed a shift toward more self-determined motivation, as indicated by significant decreases in amotivation (p = 0.01) and significant increases in external (p = 0.009) and internal (p = 0.002) motivation. Furthermore, those with initially high levels of autonomous motivation were more likely to make a donation attempt in the subsequent year if they completed the motivational interview (71.1%) versus the control call (55.1%). CONCLUSION: Motivational interviewing is a potentially useful strategy to enhance retention of existing blood donors, particularly among those who express a greater sense of internal motivation for giving.

A brief motivational interview promotes internal motivation to donate blood among young adults with and without a prior donation history.

BACKGROUND: Recruitment and retention of first-time and repeat donors is essential to maintain a stable blood supply. Recent evidence has shown that promoting internal motivation may be an effective strategy to enhance donation behavior. We tested the efficacy of an in-person motivational interview at increasing internal motivation and intention to donate. STUDY DESIGN AND METHODS: A sample of 219 donors and nondonors (69.4% female; mean ± SD age, 19.2 ± 1.1 years; 52.1% nondonors) were randomly assigned to either a motivational or a knowledge interview. Immediately before and after the interview participants completed a measure of donation intention and the Blood Donor Identity Survey, which is a multidimensional measure of donor motivation. RESULTS: A latent profile analysis revealed three distinct latent classes, which were identified as low internal motivation, mid internal motivation, and high internal motivation. Comparison of change in latent class from pre- to postinterview revealed that a higher proportion of participants in the motivational interview group moved to a more internally motivated class compared to the knowledge interview group (i.e., 34% vs. 4%, respectively). Further, relative to the knowledge interview group, participants in the motivational interview group reported greater increases in intention to donate. CONCLUSION: A brief motivational interview may enhance donation intention and intrinsic motivation among both experienced donors and nondonors alike.

A brief motivational interview with action and coping planning components enhances motivational autonomy among volunteer blood donors.

BACKGROUND: In contrast to standard donor retention strategies (e.g., mailings, phone calls, text messages), we developed a brief telephone interview, based on motivational interviewing principles, that encourages blood donors to reflect upon their unique motivators and barriers for giving. This study examined the effect of this motivational interview, combined with action and coping plan components, on blood donor motivations. STUDY DESIGN AND METHODS: The design was to randomly assign blood donors to receive either a telephone-delivered motivational interview with action and coping plan components or a control call approximately 6 weeks after their most recent donation. Participants completed a series of surveys related to donation motivation approximately 3 weeks before telephone contact (precall baseline) and then repeated these surveys approximately 1 week after telephone contact (postcall). RESULTS: The sample was 63% female, included a majority (52.6%) of first-time blood donors, and had a mean age of 30.0 years (SD, 11.7 years). A series of analyses of variance revealed that, relative to controls (n = 244), donors in the motivational interview group (n = 254) had significantly larger increases in motivational autonomy (p = 0.001), affective attitude (p = 0.004), self-efficacy (p = 0.03), anticipated regret (p = 0.001), and intention (p = < 0.001), as well as larger decreases in donation anxiety (p = 0.01), from precall baseline to postcall assessment. CONCLUSION: This study supports motivational interviewing with action and coping planning as a novel strategy to promote key contributors to donor motivation.

Predictors of post-traumatic psychological growth in the late years after lung transplantation.

BACKGROUND: Although lung transplantation improves quality of life, most psychosocial research focuses on adverse psychological and social functioning outcomes. Positive effects, particularly in the late-term years as physical morbidities increase, have received little attention. We provide the first data on a psychological benefit - post-traumatic growth (PTG) - and we focused on long-term (>5 yr) survivors. METHODS: Among 178 patients from a prospective study of mental health during the first two yr post-transplant, we recontacted survivors 6-11 yr post-transplant. We assessed PTG (i.e., positive psychological change resulting from the transplant) and examined its relationship to other patient characteristics with multivariable regression analyses. RESULTS: Sixty-four patients (86% of survivors) were assessed (M = 8.1 yr post-transplant, SD = 1.2). Mean PTG exceeded the scale's midpoint (M = 38.6, SD = 10.0; scale midpoint = 25). Recipients experiencing greater PTG were female (p = 0.022), less educated (p = 0.014), and had a history of post-transplant panic disorder (p = 0.005), greater friend support (p = 0.048), and better perceived health (p = 0.032). Neither other pre- or post-transplant mood and anxiety disorders nor transplant-related morbidities (acute rejection, bronchiolitis obliterans syndrome) predicted PTG. CONCLUSIONS: PTG exceeded levels observed in other chronic disease populations, suggesting that lung transplantation may uniquely foster positive psychological change in long-term survivors. PTG occurs despite physical and psychiatric morbidities. Whether PTG promotes other positive post-transplant psychosocial outcomes deserves attention.

Prevention of poor psychosocial outcomes in living organ donors: from description to theory-driven intervention development and initial feasibility testing.

CONTEXT: Although some living donors experience psychological, somatic, and interpersonal difficulties after donation, interventions to prevent such outcomes have not been developed or evaluated. OBJECTIVE: To (1) summarize empirical evidence on psychosocial outcomes after donation, (2) describe a theoretical framework to guide development of an intervention to prevent poor outcomes, and (3) describe development and initial evaluation of feasibility and acceptability of the intervention. METHODS: Based on a narrative literature review suggesting that individuals ambivalent about donation are at risk for poor psychosocial outcomes after donation, the intervention targeted this risk factor. Intervention structure and content drew on motivational interviewing principles in order to assist prospective donors to resolve ambivalence. Data were collected on donors' characteristics at our institution to determine whether they constituted a representative population in which to evaluate the intervention. Study participants were then recruited to assess the feasibility and acceptability of the intervention. They were required to have scores greater than 0 on the Simmons Ambivalence Scale (indicating at least some ambivalence about donation). RESULTS: Our population was similar to the national living donor population on most demographic and donation-related characteristics. Eight individuals who had been approved to donate either a kidney or liver segment were enrolled for pilot testing of the intervention. All successfully completed the 2-session telephone-based intervention before scheduled donation surgery. Participants' ratings of acceptability and satisfaction were high. Open-ended comments indicated that the intervention addressed participants' thoughts and concerns about the decision to donate. CONCLUSIONS: The intervention is feasible, acceptable, and appears relevant to donor concerns. A clinical trial to evaluate the efficacy of the intervention is warranted.