Antihypertensive drug concentration measurement combined with personalized feedback in resistant hypertension: a randomized controlled trial.

BACKGROUND: Adherence to antihypertensive drugs (AHDs) is crucial for controlling blood pressure (BP). We aimed to determine the effectiveness of measuring AHD concentrations using a dried blood spot (DBS) sampling method to identify nonadherence, combined with personalized feedback, in reducing resistant hypertension. METHODS: We conducted a multicenter, randomized, controlled trial (RHYME-RCT, ICTRP NTR6914) in patients with established resistant hypertension. Patients were randomized to receive either an intervention with standard of care (SoC) or SoC alone. SoC consisted of BP measurement and DBS sampling at baseline, 3 months (t3), 6 months (t6), and 12 months (t12); AHD concentrations were measured but not reported in this arm. In the intervention arm, results on AHD concentrations were discussed during a personalized feedback conversation at baseline and t3. Study endpoints included the proportion of patients with RH and AHD adherence at t12. RESULTS: Forty-nine patients were randomized to receive the intervention+SoC, and 51 were randomized to receive SoC alone. The proportion of adherent patients improved from 70.0 to 92.5% in the intervention+SoC arm ( P  = 0.008, n  = 40) and remained the same in the SoC arm (71.4%, n  = 42). The difference in adherence between the arms was statistically significant ( P  = 0.014). The prevalence of resistant hypertension decreased to 75.0% in the intervention+SoC arm ( P  < 0.001, n  = 40) and 59.5% in the SoC arm ( P  < 0.001, n  = 42) at t12; the difference between the arms was statistically nonsignificant ( P  = 0.14). CONCLUSION: Personalized feedback conversations based on DBS-derived AHD concentrations improved AHD adherence but did not reduce the prevalence of RH.

The effect of combining therapeutic drug monitoring of antihypertensive drugs with personalised feedback on adherence and resistant hypertension: the (RHYME-RCT) trial protocol of a multi-centre randomised controlled trial.

BACKGROUND: Adherence to antihypertensive drugs (AHDs) is important for adequate blood pressure control. Not taking these drugs as prescribed is one of the main underlying causes for resistant hypertension (RH), which in turn leads to an increased risk of cardiovascular events, stroke and kidney damage. Therefore, correct identification of patients that are non-adherent to AHDs is crucial to improve clinical outcome. For this goal, therapeutic drug monitoring is the most reliable method. The primary objective of this trial is to investigate whether monitoring of drug concentrations with a dried blood spot (DBS) sampling method combined with personalised feedback leads to a decrease in prevalence of RH after 12 months due to an increase in adherence. Secondary objectives include the difference over time in the number of required AHDs as well as the defined daily dose (DDD). Lastly, the cost-utility of SoC versus the intervention in RH is determined. METHODS: This is a multi-centre single-blinded randomised controlled trial (RHYME-RCT). First, at an eligibility visit, DBS sampling, to monitor drug concentrations in blood, and a 24-h ambulatory blood pressure measurement (24-h ABPM) are performed simultaneously. Patients with a daytime systolic blood pressure (SBP) > 135 and/or diastolic blood pressure (DBP) > 85 mmHg are randomised to SoC or intervention + SoC. The intervention is performed by the treating physician and includes information on drug concentrations and a comprehensive personalised feedback conversation with the use of a communication tool. The follow-up period is one year with visits at 3, 6 and 12 months randomisation and includes 24-h ABPM and DBS sampling. DISCUSSION: This will be the first trial that focusses specifically on patients with RH without taking into account suspicion of non-adherence and it combines monitoring of AHD concentrations to identify non-adherence to AHDs with a comprehensive feedback to improve non-adherence. Furthermore, if this trial shows positive outcomes for the intervention it can be directly implemented in clinical practice, which would be a great improvement in the treatment of RH. TRIAL REGISTRATION: RHYME-RCT is registered in the Dutch Trial Register on 27/12/2017 (NTR6914) and can be found in the International Clinical Trials Registry Platform.

[Proposal for an anonymous reporting code organ trafficking: how transplant professionals can play a role in preventing this trafficking]. / Voorstel voor een anoniem meldpunt orgaanhandel.

Patients travel worldwide to undergo kidney transplantations. Care providers in the Netherlands encounter these patients, both before and after the transplantation. We present the results of a survey that was distributed among Dutch transplant professionals about their experiences with patients who have undergone a kidney transplantation abroad. We propose that care providers should report illegal transplantations. Of the 241 surveyed professionals, 100 treated patients who travelled to a country outside the European Union for a kidney transplant. Thirty-one professionals were certain that patients purchased their kidney, and sixty-five had suspicions that it had been purchased. The majority reported a conflict of duties. Professionals can help prevent organ purchase by detecting and disclosing information about organ trafficking networks. The aim of reporting is two-fold. Firstly, such disclosure can lead to increased knowledge and information about organ trafficking. Secondly, it can support the police and law enforcement agencies to investigate if networks are involved in facilitation of these transplantations. In this manner, those who facilitate organ trafficking can be prosecuted and exploitation of donors can be prevented.

Kidney transplant patients' attitudes towards self-management support: A Q-methodological study.

OBJECTIVE: Kidney transplant recipients face many self-management challenges. We aimed to identify profiles of attitudes towards self-management support (SMS) shortly after kidney transplantation. METHODS: Profiles were generated using Q-methodology: In face-to-face interviews participants rank-ordered opinion statements on aspects of SMS according to agreement. Socio-demographic and medical characteristics were assessed using a questionnaire. By-person factor analysis was used to analyze the rankings and qualitative data was used to support choice of profiles. The resulting factors represent clusters of patients with similar attitudes towards SMS. RESULTS: Forty-three patients (mean age=56; 77% male) participated. Four profiles were identified: (A) transplant-focused and obedient; (B) holistic and collaborative; (C) life-focused and self-determined; and (D) was bipolar. The positive pole (D+) minimalizing and disengaged and the negative pole (D-) coping-focused and needy represent opposing viewpoints within the same profile. Socio-demographic and medical characteristics were not related to profile membership. DISCUSSION: Each profile represents a specific attitude on post-transplant life, responsibility for health and decision-making, SMS needs, and preferences for SMS. PRACTICAL IMPLICATIONS: Patients vary in their attitude, needs and preferences for SMS indicating the necessity of providing personalized support after kidney transplantation. Health professionals should explore patients' SMS needs and adapt support accordingly.

Reporting Organ Trafficking Networks: A Survey-Based Plea to Breach the Secrecy Oath.

Patients travel worldwide to purchase kidneys. Transplant professionals can play a role in identifying kidney purchase. However, due to the tension between their rights and obligations, a lack of understanding and knowledge exists on how to prevent and report purchase. We present the results of a national survey that describes transplant professionals' experiences, attitudes, behaviors, conflicts of duties, legal knowledge and needs for guidelines toward patients who purchase kidneys abroad. Second, we clarify professionals' rights and obligations regarding organ purchase and propose actions that they can take to report purchase. Of the 100/241 (42%) professionals who treated patients who traveled to a country outside the European Union for a kidney transplant, 31 (31%) were certain that patients purchased kidneys. Sixty-five (65%) had suspicions that patients had bought kidneys. The majority reported a conflict of duties. Eighty percent reported a need for guidelines. Professionals can help prevent organ purchase by disclosing information about organ trafficking networks to law enforcement. Such disclosure can support the investigation and prosecution of networks. We offer key components for guidelines on disclosure of these networks.

Mental health among living kidney donors: a prospective comparison with matched controls from the general population.

The impact of living kidney donation on donors' mental health has not been sufficiently nor comprehensively studied. Earlier studies demonstrated that mental health did not change in the majority of donors, however they often lacked a suitable control group and/or had other methodological limitations. Consequently, it remains unclear whether changes in mental health found among a minority of donors reflect normal fluctuations. In this study we matched 135 donors with individuals from the general Dutch population on gender and baseline mental health and compared changes in mental health over time. Mental health was measured using the Brief Symptom Inventory and Mental Health Continuum Short Form. Primary analyses compared baseline and 6 months follow-up. Secondary analyses compared baseline and 9 (controls) or 15 months (donors) follow-up. Primary multilevel regression analyses showed that there was no change in psychological complaints (p = 0.20) and wellbeing (p = 0.10) over time and donors and controls did not differ from one another in changes in psychological complaints (p = 0.48) and wellbeing (p = 0.85). Secondary analyses also revealed no difference in changes between the groups. We concluded that changes in mental health in the short term after donation do not significantly differ from normal fluctuations found in the Dutch general population.

Home-based family intervention increases knowledge, communication and living donation rates: a randomized controlled trial.

Our aim was to develop and test an educational program to support well-informed decision making among patients and their social network regarding living donor kidney transplantation (LDKT). One hundred sixty-three patients who were unable to find a living donor were randomized to standard care or standard care plus home-based education. In the education condition, patients and members of their social network participated in home-based educational meetings and discussed renal replacement therapy options. Patients and invitees completed pre-post self-report questionnaires measuring knowledge, risk perception, communication, self-efficacy and subjective norm. LDKT activities were observed for 6 months postintervention. Patients in the experimental group showed significantly more improvements in knowledge (p < 0.001) and communication (p = 0.012) compared with the control group. The invitees showed pre-post increases in knowledge (p < 0.001), attitude toward discussing renal replacement therapies (p = 0.020), attitude toward donating a kidney (p = 0.023) and willingness to donate a kidney (p = 0.039) and a decrease in risk perception (p = 0.003). Finally, there were significantly more inquiries (29/39 vs. 13/41, p < 0.001), evaluations (25/39 vs. 7/41, p < 0.001) and actual LDKTs (17/39 vs. 4/41, p = 0.003) in the experimental group compared with the control group. Home-based family education supports well-informed decision making and promotes access to LDKT.

A daily diary study on the independent and interactive effects of headache and self-regulatory factors on daily affect among adolescents.

OBJECTIVE: The relationship between recurrent headache and reduced psychological well-being among adolescents has been well documented. Evidence also suggests that headache is associated with greater impediment to successful goal pursuits, which in turn is related to reduced well-being. The aim of this study was to investigate both the independent and interactive effects of headache and self-regulatory processes on daily positive and negative affect. DESIGN AND METHODS: In order to be able to investigate both concurrent and prospective relationships a daily diary design was employed. Independent variables were headache occurrence, daily goal frustration, and strategies to cope with these setbacks. Dependent variables were daily negative and positive affect. Eighty-nine adolescents from the general population aged 13-21 completed an on-line diary for 3 weeks. Data were analysed using multi-level modelling. RESULTS: Negative affect was related to same day headache occurrence, high daily goal frustration, rumination, catastrophizing, other blame, and low coping efficacy beliefs. Furthermore, in the context of headache, coping efficacy appears to buffer the effects of goal frustration on same day negative affect. Negative affect on the next day was predicted by high daily goal frustration, rumination, catastrophizing, and low coping efficacy. In contrast, positive affect was related to no same day headache occurrence; low daily goal frustration, and high acceptance, positive refocusing, and coping efficacy. Positive affect on the following day was related to low daily goal frustration, rumination, and high positive refocusing. CONCLUSIONS: Daily goal frustration and cognitive coping strategies may provide important targets for interventions aimed at adolescent with reduced well-being due to headache.

For love or money? Attitudes toward financial incentives among actual living kidney donors.

Due to lengthening waiting lists for kidney transplantation, a debate has emerged as to whether financial incentives should be used to stimulate living kidney donation. In recent surveys among the general public approximately 25% was in favor of financial incentives while the majority was opposed or undecided. In the present study, we investigated the opinion of living kidney donors regarding financial incentives for living kidney donation. We asked 250 living kidney donors whether they, in retrospect, would have wanted a financial reward for their donation. We also investigated whether they were in favor of using financial incentives in a government-controlled system to stimulate living anonymous donation. Additionally, the type of incentive deemed most appropriate was also investigated. In general almost half (46%) of the study population were positive toward introducing financial incentives for living donors. The majority (78%) was not in favor of any kind of reward for themselves as they had donated out of love for the recipient or out of altruistic principles. Remarkably, 60% of the donors were in favor of a financial incentive for individuals donating anonymously. A reduced premium or free health insurance was the preferred incentive.

Encouraging psychological outcomes after altruistic donation to a stranger.

In a growing number of transplant centers worldwide, altruistic donors are accepted to anonymously donate a kidney to a stranger. An important hesitation to expand these transplantation programs is the fear of evoking psychological distress in the altruistic donor after donation. To what extent this fear is justified has not yet been systematically investigated. In this study, 24 altruistic donors were interviewed on average 2 years after donation. Lifetime mental health history, current psychological complaints, satisfaction with and impact of the donation on well-being, motives for donation, communication with recipient and donation experience were assessed. Altruistic donors report a considerable positive impact of donation on psychological well-being, whereas negative impact was limited. Satisfaction with donation was very high. Although a history of a psychiatric diagnosis was ascertained in almost half of the donors, psychological complaints before and after donation were comparable to national average norm scores. Motives for donation were genuine and the experience of donation generally conformed to their expectations. In conclusion, living kidney donation to a stranger does not appear to exacerbate psychological complaints. Moreover, altruistic donors report considerable satisfaction and personal benefit. The exceptional gift of altruistic donors can contribute toward solving the current organ shortage issue.

Altruistic donor triggered domino-paired kidney donation for unsuccessful couples from the kidney-exchange program.

Between January 2000 and July 2009, 132 individuals inquired about altruistic kidney donation to strangers. These donors were willing to donate to genetically and emotionally unrelated patients. Some altruistic donors wished to donate to a specific person, but most wished to donate anonymously. In domino-paired donation, the altruistic donor donates to the recipient of an incompatible couple; the donor of that couple (domino-donor) donates to another couple or to the waiting list. In contrast to kidney-exchange donation where bilateral matching of couples is required, recipient and donor matching are unlinked in domino-paired donation. This facilitates matching for unsuccessful couples from the kidney-exchange program where blood type O prevails in recipients and is under-represented in donors. Fifty-one altruistic donors (39%) donated their kidney and 35 domino-donors were involved. There were 29 domino procedures, 24 with 1 altruistic donor and 1 domino-donor, 5 with more domino-donors. Eighty-six transplantations were performed. Donor and recipient blood type distribution in the couples limited allocation to blood type non-O waiting list patients. The success rate of domino-paired donation is dependent on the composition of the pool of incompatible pairs, but it offers opportunities for difficult to match pairs that were unsuccessful in the kidney-exchange program.

Goal commitment to finding a partner and satisfaction with life among female singles: the mediating role of rumination.

In this cross-sectional study among 1502 female singles between the ages of 18 and 50, commitment to the goal of finding a partner was negatively related to satisfaction with life. In line with our expectations, this relationship was fully mediated by ruminating about being and remaining single. The relationship between rumination and lower satisfaction with life was stronger in the older age groups. The findings support the notion that rumination is an important mechanism through which goal commitment may negatively influence well-being, and that reducing one's level of commitment to the pursuit of stage-specific life goals may be beneficial when reaching a new developmental stage.