Clinical Translation and Implementation of a Bioartificial Pancreas Therapy: A Qualitative Study Exploring the Perspectives of People With Type 1 Diabetes.

Background: The development of a hybrid beta-cell replacement approach, referred to as a personalized, transplantable bioartificial pancreas (BAP), holds promise to treat type 1 diabetes (T1D). This interview study aimed to explore patients' expectations, needs, concerns, and considerations when considering to undergo a BAP transplantation.

Research Design And Methods: Semistructured interviews were conducted with 24 participants diagnosed with T1D.

Living Kidney Donation: A Narrative Review of Mid- and Long-term Psychosocial Outcomes.

Living kidney donors make a significant contribution to alleviating the organ shortage. The aim of this article is to provide an overview of mid- and long-term (≥12 mo) living donor psychosocial outcomes and highlight areas that have been understudied and should be immediately addressed in both research and clinical practice. We conducted a narrative review by searching 3 databases.

Removing the physician from the equation: Patient-controlled, home-based therapeutic drug self-monitoring of tacrolimus.

The dosing of tacrolimus, which forms the backbone of immunosuppressive therapy after kidney transplantation, is complex. This is due to its variable pharmacokinetics (both between and within individual patients), narrow therapeutic index, and the severe consequences of over- and underexposure, which may cause toxicity and rejection, respectively. Tacrolimus is, therefore, routinely dosed by means of therapeutic drug monitoring (TDM).

Clinical Translation of Bio-Artificial Pancreas Therapies: Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations.

The field of regenerative medicine offers potential therapies for Type 1 Diabetes, whereby metabolically active cellular components are combined with synthetic medical devices. These therapies are sometimes referred to as "bioartificial pancreases." For these emerging and rapidly developing therapies to be clinically translated to patients, researchers must overcome not just scientific hurdles, but also navigate complex legal, ethical and psychosocial issues.

The self-regulation skills instrument in transplantation (SSIt): Development and measurement properties of a self-report self-management instrument.

Objective: To develop a self-management instrument for organ transplant recipients that incorporates self-regulations skills and to determine its measurement properties.

Methods: The instrument includes concepts from social cognitive models: problem awareness, attitude, self-efficacy, motivation, social support, goal setting, goal pursuit, skills and goal affect. The measurement properties were evaluated based on the COSMIN guidelines.

Counselling on Conceiving: Attitudes and Factors Influencing Advice of Professionals in Transplantation.

Pregnancy after kidney transplantation (KT) conveys risks of adverse pregnancy outcomes (APO). Little is known about performance of pre-pregnancy counselling after KT. This study investigated perceptions of risk, attitudes towards pregnancy and factors influencing advice given at pre-pregnancy counselling after KT.

Twenty Years of Unspecified Kidney Donation: Unspecified Donors Looking Back on Their Donation Experiences.

The Netherlands was the first European country to implement unspecified kidney donation in 2000. This qualitative study aimed to evaluate the experiences of unspecified kidney donors (UKDs) in our transplant institute to improve the care for this valuable group of donors. We conducted semi-structured interviews with 106 UKDs who donated between 2000-2016 (response rate 84%).

Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.

Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recipients.

Induced demand in kidney replacement therapy.

There are three notable aspects of the current kidney replacement therapy program. First, the number of patients on home dialysis has dropped substantially over the last decades. Second, the rate of transplantation has stabilized in recent years.

Organoids: a systematic review of ethical issues.

Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitro miniature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral.

Relinquishing Anonymity in Living Donor Kidney Transplantation: Lessons Learned From the UK Policy for Anonymous Donors.

Anonymous living donor kidney transplantation (LDKT) is performed in many countries and policies on anonymity differ. The UK is the only European country with a conditional policy, allowing pairs to break anonymity post-transplant. There is little evidence on how contact after anonymous LDKT is experienced.

Nurse-led self-management support after organ transplantation-protocol of a multicentre, stepped-wedge randomized controlled trial.

Background: Recipients of an organ transplantation face a number of challenges and often need to change their health behaviour. Good self-management skills are essential for optimal clinical outcomes. However, few interventions are available to support post-transplant self-management.

Introducing the importance and difficulties of a three-step approach to improve nonadherence to antihypertensive drugs: a case series.

Nonadherence to antihypertensive drugs is an important reason for not reaching blood pressure goals. A possible method to improve nonadherence involves three essential steps: identification of nonadherent patients (step 1), determination of underlying causes (step 2) and a personalized solution (step 3). We present three unique cases to show the importance and difficulties of this three-step approach.

A dynamic Markov model to assess the cost-effectiveness of the Kidney Team at Home intervention in The Netherlands.

Objectives: The Kidney Team at Home program is an educational intervention aimed at patients with chronic kidney disease to assist them in their choice for kidney replacement therapy. Previous studies have shown that the intervention results in an increase in knowledge and communication on kidney replacement therapy, and eventually in an increase in the number of living donor kidney transplantations. The study assesses the cost-effectiveness of the intervention compared to standard care.

EXPloring attitudes and factors influencing reproductive Choices in kidney Transplant patients (The EXPECT-study).

Pregnancy can have risks after kidney transplantation (KT). This mixed-methods study aimed to identify the percentage of women getting pregnant after KT and explore motives for and against pregnancy together with psychosocial and medical factors involved in decision making. Furthermore, experiences of pregnancy and child-raising were explored.

Is simplification of immunosuppressive medication a way to promote medication adherence of kidney transplant recipients? Findings from a randomized controlled trial.

After kidney transplantation, a strict immunosuppressive medication regimen is necessary for graft survival. However, nonadherence to medication has been shown to occur early after transplantation and to increase over time. Weaning the recipient off dual therapy onto monotherapy in order to reduce immunosuppressive burden may also be a way to promote adherence, although little is known about the impact of such a regimen on fear of rejection.

Implementation of the kidney team at home intervention: Evaluating generalizability, implementation process, and effects.

Research has shown that a home-based educational intervention for patients with chronic kidney disease results in better knowledge and communication, and more living donor kidney transplantations (LDKT). Implementation research in the field of renal care is almost nonexistent. The aims of this study were (1) to demonstrate generalizability, (2) evaluate the implementation process, and (3) to assess the relationship of intervention effects on LDKT-activity.

Positive and negative aspects of mental health after unspecified living kidney donation: A cohort study.

Objectives: Unspecified donors give a kidney to a stranger with end-stage kidney failure. There has been little research on the long-term impact of unspecified donation on mental health outcomes. The aim of this study was to assess the positive and negative aspects of mental health among unspecified donors.

Exploring health literacy and self-management after kidney transplantation: A prospective cohort study.

Objective: Investigate the influence of health literacy and self-management on complications, kidney function and graft failure after kidney transplantation.

Methods: We included patients who received a kidney transplant between May 2012 and May 2013 and monitored outcomes until December 2018. Health literacy was measured using the Newest Vital Sign and self-management using the Partner in Health scale (before discharge, and after 6 and 12 months).

Self-Determination Theory to observe healthcare professionals' counselling in chronic care encounters: Development of the COUNSEL-CCE tool.

Objective: To develop and psychometrically evaluate an observation tool to rate healthcare professionals' engagement in need-supportive and need-thwarting counselling in chronic care encounters.

Methods: The observation tool was developed through three stages (January 2018 - June 2019). First, a set of items was developed according to essential components of need-supportive and need-thwarting counselling as identified in Self-Determination Theory.

Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol.

Background: After kidney transplantation non-adherence and inadequate self-management undermine clinical outcomes and quality of life. Both have been demonstrated to be substantial in all age groups. However, interventions promoting adherence and self-management among kidney transplant recipients that have proven to be effective are scarce.

Global Kidney Exchange: opportunity or exploitation? An ELPAT/ESOT appraisal.

This paper addresses ethical, legal, and psychosocial aspects of Global Kidney Exchange (GKE). Concerns have been raised that GKE violates the nonpayment principle, exploits donors in low- and middle-income countries, and detracts from the aim of self-sufficiency. We review the arguments for and against GKE.