A digital intake tool to avert outpatient visits in a FIT-based colorectal cancer screening population: study protocol of a multicentre, prospective non-randomized trial - the DIT-trial.

BACKGROUND: Currently all participants of the Dutch colorectal cancer (CRC) screening program with a positive faecal immunochemical test (FIT) are seen at the outpatient clinic to assess their health status, receive information on colonoscopy and CRC risk, and provide informed consent. However, for many patients this information could probably also safely be exchanged in an online setting, in order to reduce the burden for patients, healthcare system, and environment. In this study we will evaluate if a face-to-face pre-colonoscopy consultation can be replaced by a Digital Intake Tool (DIT) in a CRC screening population. METHODS: This is a prospective multicentre single-arm, non-randomized study with a non-inferiority design. The DIT will triage a total of 1000 participants and inform them about CRC risk, colonoscopy, sedation, and provide bowel preparation instructions. Participants identified as high-risk (i.e., red-triaged) will be contacted by phone or scheduled for an appointment at the outpatient clinic. The primary outcome measure will be adequate bowel preparation rate, defined as the proportion of participants with a Boston Bowel Preparation (BBPS) score ≥ 6. To compare our primary outcome, we will use colonoscopy data from 1000 FIT positive participants who visited the outpatient clinic for pre-colonoscopy consultation. Secondary outcomes will include participation rate, colonoscopy adherence rate, patient experience in terms of satisfaction and anxiety, knowledge transfer, number of outpatient visits that can be averted by the DIT, and cost-effectiveness of the tool. Ethical approval was obtained from the Medical Ethical Committee of the Erasmus Medical Center (MEC-2021-0098). DISCUSSION: This study aims to assess if a face-to-face pre-colonoscopy consultation can be replaced by an eHealth assessment and education tool in a FIT-based CRC screening program. In case favourable results are established, the intervention evaluated in this study could significantly impact CRC screening programs, benefiting both patients and healthcare systems on a (inter)national scale. Additionally, it would enable more personalized care as the DIT can be easily customized and made feasible in other languages, thereby enhancing healthcare accessibility. TRIAL REGISTRATION: Dutch Trial Register: NL9315 , date of registration: March 8th, 2021.

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%). Interviews were audio-recorded, transcribed verbatim and independently coded by 2 researchers in NVivo using thematic analysis. The following 14 themes reflecting donor experiences were found: Satisfaction with donation; Support from social network; Interpersonal stress; Complaints about hospital care; Uncertainty about donor approval; Life on hold between approval and actual donation; Donation requires perseverance and commitment; Recovery took longer than expected; Normalization of the donation; Becoming an advocate for living kidney donation; Satisfaction with anonymity; Ongoing curiosity about outcome or recipient; Importance of anonymous communication; Anonymity is not watertight. The data reinforced that unspecified kidney donation is a positive experience for donors and that they were generally satisfied with the procedures. Most important complaints about the procedure concerned the length of the assessment procedure and the lack of acknowledgment for UKDs from both their recipients and health professionals. Suggestions are made to address the needs of UKDs.

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. Eight hospitals participated in the project. Patients eligible for all kidney replacement therapies (KRT) were invited to participate. Effect outcomes were KRT-knowledge and KRT-communication, and treatment choice. Feasibility, fidelity, and intervention costs were assessed as part of the process evaluation. Three hundred and thirty-two patients completed the intervention. There was a significant increase in KRT-knowledge and KRT-communication among participants. One hundred and twenty-nine out of 332 patients (39%) had LDKT-activity, which was in line with the results of the clinical trials. Protocol adherence, knowledge, and age were correlated with LDKT-activity. This unique implementation study shows that the results in practice are comparable to the previous trials, and show that the intervention can be implemented, while maintaining quality. Results from the project resulted in the uptake of the intervention in standard care. We urge other countries to investigate the uptake of the intervention.

The ELPAT living organ donor Psychosocial Assessment Tool (EPAT): from 'what' to 'how' of psychosocial screening - a pilot study.

Thorough psychosocial screening of donor candidates is required in order to minimize potential negative consequences and to strive for optimal safety within living donation programmes. We aimed to develop an evidence-based tool to standardize the psychosocial screening process. Key concepts of psychosocial screening were used to structure our tool: motivation and decision-making, personal resources, psychopathology, social resources, ethical and legal factors and information and risk processing. We (i) discussed how each item per concept could be measured, (ii) reviewed and rated available validated tools, (iii) where necessary developed new items, (iv) assessed content validity and (v) pilot-tested the new items. The resulting ELPAT living organ donor Psychosocial Assessment Tool (EPAT) consists of a selection of validated questionnaires (28 items in total), a semi-structured interview (43 questions) and a Red Flag Checklist. We outline optimal procedures and conditions for implementing this tool. The EPAT and user manual are available from the authors. Use of this tool will standardize the psychosocial screening procedure ensuring that no psychosocial issues are overlooked and ensure that comparable selection criteria are used and facilitate generation of comparable psychosocial data on living donor candidates.

Exploring Knowledge About Dialysis, Transplantation, and Living Donation Among Patients and Their Living Kidney Donors.

BACKGROUND: In order to make a well-considered decision and give informed consent about renal replacement therapy, potential living kidney donors and recipients should have sufficient understanding of the options and risks. PURPOSE: We aimed to explore knowledge about Dialysis & Transplantation (DT) and Living Donation (LD) among prospective living kidney donors and recipients. METHODS: Eighty-five donors and 81 recipients completed the Rotterdam Renal Replacement Knowledge-Test (R3K-T) 1 day before surgery. The questionnaire was available in various languages. RESULTS: Recipients knew significantly more about DT than donors (p < 0.001); donors knew more about LD than recipients (p < 0.001). A minority of donors (15 %) and recipients (17 %) had a score that was comparable to the knowledge level of the naïve general population. Recipients and donors knew less about DT and LD if their native language was not Dutch. In addition, recipients knew less about DT if they were undergoing pre-emptive transplantation. CONCLUSIONS: We conclude that recipients and donors retain different information. The decision to undergo living donation appears to be not always based on full knowledge of the risks. We recommend that professionals assess knowledge of prospective donors and recipients during the education process using the R3K-T, and extra attention is required for non-native speakers.

Predonation psychosocial evaluation of living kidney and liver donor candidates: a systematic literature review.

Evaluating a person's suitability for living organ donation is crucial, consisting not only of a medical but also of a thorough psychosocial screening. We performed a systematic literature review of guidelines, consensus statements, and protocols on the content and process of psychosocial screening of living kidney and liver donor candidates. We searched PubMed, Embase, CINAHL, and PsycINFO until June 22, 2011, following the PRISMA guidelines, complemented by scrutinizing guidelines databases and references of identified publications. Thirty-four publications were identified, including seven guidelines, six consensus statements, and 21 protocols or programs. Guidelines and consensus statements were inconsistent and lacked concreteness for both their content and process, possibly explaining the observed variability in center-specific evaluation protocols and programs. Overall, recommended screening criteria are not evidence-based and an operational definition of the concept "psychosocial" is missing, causing heterogeneity in terminology. Variation also exists on methods used to psychosocially evaluate potential donors. The scientific basis of predonation psychosocial evaluation needs to be strengthened. There is a need for high-quality prospective psychosocial outcome studies in living donors, a uniform terminology to label psychosocial screening criteria, and validated instruments to identify risk factors.

A psychometric analysis of the Rotterdam Renal Replacement Knowledge-Test (R3K-T) using item response theory.

Knowledge is a prerequisite for promoting well-informed decision-making. Nevertheless, there is no validated and standardized test to assess the level of knowledge among renal patients regarding kidney disease and all treatment options. Therefore, the objective of this study was to investigate the psychometric properties of such a questionnaire for use in research and practice. A 30-item list was validated in four groups: (1) 187 patients on dialysis, (2) 82 patients who were undergoing living donor kidney transplantation the following day, (3) the general population of Dutch residents (n = 515) and (4) North American residents (n = 550). The psychometric properties of the questionnaire were examined using multidimensional item response theory (MIRT). Norm references were also calculated. Five items were found to distort ability estimates (Differential item functioning; DIF). MIRT analyses were subsequently carried out for the remaining 25 items. Almost all items showed good discrimination and difficulty parameters based on the fitted model. Two stable dimensions with 21 items were retrieved for which norm references for the Dutch and North American, dialysis and transplantation groups were calculated. This study resulted in a thorough questionnaire, the Rotterdam renal replacement knowledge-test, which enables reliable testing of patient's knowledge on kidney disease and treatment options in clinic and research.

Multisystemic engagement and nephrology based educational intervention: a randomized controlled trial protocol on the KidneyTteam At Home study.

BACKGROUND: Living donor kidney transplantation (LDKT) is the most successful form of renal replacement therapy in terms of wait time and survival rates. However, we observed a significant inequality in the number of LDKT performed between the Dutch and the non-Dutch patients. The objective of this study is to adapt, implement and test an educational home-based intervention to contribute to the reduction of this inequality. Our aim is to establish this through guided communication together with the social network of the patients in an attempt that well-informed decisions regarding renal replacement therapy can be made: Multisystemic Engagement & Nephrology. This manuscript is a detailed description of the Kidney Team At Home-study protocol. METHODS AND DESIGN: All patients (>18 yrs) that are referred to the pre-transplantation outpatient clinic are eligible to participate in the study. Patients will be randomly assigned to either an experimental or a control group. The control group will continue to receive standard care. The experimental group will receive standard care plus a home-based educational intervention. The intervention consists of two sessions at the patient's home, an initial session with the patient and a second session for which individuals from their social network are invited to take part. Based on the literature and behavioural change theories we hypothesize that reducing hurdles in knowledge, risk perception, subjective norm, self-efficacy, and communication contribute to well-informed decision making and reducing inequality in accessing LDKT programs. A change in these factors is consequently our primary outcome-measure. Based on power calculations, we aim to include 160 patients over a period of two years. DISCUSSION: If we are able to show that this home-based group educational intervention contributes to 1) achieving well-informed decision regarding treatment and 2) reducing the inequality in LDKT, the quality of life of patients will be improved while healthcare costs are reduced. As the intervention is investigated in a random heterogeneous patient group in daily practice, the transfer to clinical practice in other kidney transplant centers should be relatively easy. TRIAL REGISTRATION: Netherlands Trial Register, NTR2730.

Religious attitudes towards living kidney donation among Dutch renal patients.

Terminal kidney patients are faced with lower quality of life, restricted diets and higher morbidity and mortality rates while waiting for deceased donor kidney transplantation. Fortunately, living kidney donation has proven to be a better treatment alternative (e.g. in terms of waiting time and graft survival rates). We observed an inequality in the number of living kidney transplantations performed between the non-European and the European patients in our center. Such inequality has been also observed elsewhere in this field and it has been suggested that this inequality relates to, among other things, attitude differences towards donation based on religious beliefs. In this qualitative research we investigated whether religion might indeed (partly) be the explanation of the inequalities in living donor kidney transplants (LDKT) among non-European patients. Fifty patients participated in focus group discussions and in-depth interviews. The interviews were conducted following the focus group method and analyzed in line with Grounded Theory. The qualitative data analyses were performed in Atlas.ti. We found that religion is not perceived as an obstacle to living donation and that religion actually promotes helping and saving the life of a person. Issues such as integrity of the body were not seen as barriers to LDKT. We observed also that there are still uncertainties and a lack of awareness about the position of religion regarding living organ donation within communities, confusion due to varying interpretations of Holy Scriptures and misconceptions regarding the process of donation. Faith leaders play an important educational role and their opinion is influential. This study has identified modifiable factors which may contribute to the ethnic disparity in our living donation program. We argue that we need to strive for more clarity and awareness regarding the stance of religion on the issue of living donation in the local community. Faith leaders could be key figures in increasing awareness and alleviating uncertainty regarding living donation and transplantation.

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. DESIGN: We invited all unspecified donors who donated a kidney between 2000 and 2016 at our centre to participate in an interview and to complete validated questionnaires. METHODS: We measured positive mental health using the Dutch Mental Health Continuum-Short Form (MHC-SF), psychological complaints using the Symptoms Checklist-90 (SCL-90) and psychiatric diagnoses using the Mini-International Neuropsychiatric Interview (M.I.N.I.) Screen for all donors and the M.I.N.I. Plus on indication. RESULTS: Of the 134 eligible donors, 114 participated (54% female; median age 66 years), a median of 6 years post-donation. Scores on emotional and social well-being subscales of the MHC-SF were significantly higher than in the general population. Psychological symptoms were comparable to the general population. Thirty-two per cent of donors had a current or lifetime psychiatric diagnosis. Psychological symptoms did not significantly change between the pre-donation screening and the post-donation study. CONCLUSIONS: We concluded that, with the appropriate screening, unspecified donation is a safe procedure from a psychological perspective.

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. Third, there is variation in referral rate for transplantation among hospitals. These trends are the result of overutilization of in-center dialysis and that demand for kidney replacement therapy is moderated by suppliers. Current healthcare policy leads to overutilization of in-center dialysis and underutilization of home dialysis and transplantation. This overutilization is the result of supplier-induced demand and leads to suboptimal care for patients and excessive healthcare expenditures. The main drivers of this overutilization are the overcapacity of in-center dialysis beds and the high financial disincentives on empty dialysis beds. Policymakers should address this by reducing dialysis capacity and increasing the capacity of transplantation facilities. This is the first attempt to address the overutilization and the nonalignment of supply and demand by looking at the capacity of in-center dialysis and the financial disincentives for physicians on empty in-center dialysis beds. In our analysis, we conclude that limiting the capacity of in-center dialysis beds is the most effective strategy to better align supply and demand, which will result in better patient outcomes and lower societal costs.

Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study.

BACKGROUND: Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation. METHODS: In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B). RESULTS: In total, 656 pop quizzes were completed (417 in Cohort A, and 239 in Cohort B). The average donor knowledge score was 7.0/25.0 (±3.9, range 0-18) in Cohort A, and 10.5/25.0 (±2.8, range 0-17.5) in Cohort B. Cohort B scored significantly higher on overall knowledge, preparedness, and the individual item scores (p < 0.0001), except for the long-term complications (p = 0.91). CONCLUSIONS: Donor knowledge generally improves during the live donor workup, but it is still quite disappointing. Long-term complications, especially, deserve more attention during living kidney donor education.

Patients' decision-making, experiences and preferences regarding pixantrone treatment in relapsed or refractory diffuse large B-cell lymphoma: study protocol for a longitudinal mixed methods study.

INTRODUCTION: There is a lot of speculation about why and how patients decide to use invasive treatment in an advanced stage of cancer, but the body of research is limited. The present longitudinal qualitative and quantitative study reflects real-life practice of pixantrone use and aims to collect data on patients' considerations for, expectations of and experiences with pixantrone and trajectories in their quality-of-life (QoL) values in a Dutch clinical setting. Hence, two questions emerge. Why do patients choose for this treatment, while the treatment success rate is limited and curation cannot be achieved? And second, once chosen, what conditions would patients like to satisfy and how do they experience the treatment? METHODS AND ANALYSIS: This is a non-interventional longitudinal and multicentre study. Patients are eligible if they are >18 years, have never been treated with pixantrone before, have an Eastern Cooperative Oncology Group performance score ≤2, have a relapsed or refractory diffuse large B-cell lymphoma and have been treated with at least two prior regimens. The decision to treat patients with pixantrone has been taken by the treating physician before patients are asked to participate in the study. If patients refuse study participation after being informed by the investigator, reasons for refusal (if given) will be recorded. Participants will receive at least three interviews accompanied by three QOL questionnaires. Based on the required sample size, we aim to include 20 patients over a period of 2 years. ETHICS AND DISSEMINATION: The Medical Ethical Committee of Erasmus MC, Rotterdam, The Netherlands, has approved this study. The results will be disseminated in peer-reviewed journals and major international conferences. The study is non-interventional and falls therefore not under Medical Research Involving Human Subjects Act (In Dutch: Wet medisch-wetenschappelijk onderzoek met mensen; WMO). Hence, this study is approved to be carried out in the Erasmus MC. Each other participating centre will receive this approval and will separately undergo the ethical approval to be able to participate. In addition to the ethical approval, the participating centres need to obtain written informed consent of their patients. Given the non-interventional nature of this study, a study registration was considered but deemed unnecessary. The study will be conducted in accordance with the Declaration of Helsinki (Tokyo, Venice, Hong Kong and Somerset West amendments). A sequential identification number will be automatically attributed to each patient that has given consent to participate in the study. This number will identify the patient and must be included on all documents. Only the main researcher can link the code to the patient's identity.

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

INTRODUCTION: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. METHODS AND ANALYSIS: The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. RESULTS: Outcome will be published in a scientific journal. TRIAL REGISTRATION NUMBER: NTR5374; Pre-results.

Toward a Conceptualization of the Content of Psychosocial Screening in Living Organ Donors: An Ethical Legal Psychological Aspects of Transplantation Consensus.

BACKGROUND: Across Europe, transplant centers vary in the content of the psychosocial evaluation for eligible living organ donors. To identify whether a common framework underlies this variation in this evaluation, we studied which psychosocial screening items are most commonly used and considered as most important in current psychosocial screening programs of living organ donors. METHODS: A multivariate analytic method, concept mapping, was used to generate a visual representation of the "psychosocial" screening items of living kidney and liver donors. A list of 75 potential screening items was derived from a systematic literature review and sorted and rated for their importance and commonness by multidisciplinary affiliated health care professionals from across Europe. Results were discussed and fine-tuned during a consensus meeting. RESULTS: The analyses resulted in a 6-cluster solution. The following clusters on psychosocial screening items were identified, listed from most to least important: (1) personal resources, (2) motivation and decision making, (3) psychopathology, (4) social resources, (5) ethical and legal factors, and (6) information and risk processing. CONCLUSIONS: We provided a conceptual framework of the essential elements in psychosocial evaluation of living donors which can serve as a uniform basis for the selection of relevant psychosocial evaluation tools, which can be further tested in prospective studies.

Living donor kidney transplantation among ethnic minorities in the Netherlands: a model for breaking the hurdles.

OBJECTIVE: Despite living donor kidney transplantation (LDKT) being the optimal treatment option for patients with end-stage renal disease, we observed a significant inequality in the number of LDKT performed between patients of Dutch versus non-Dutch descent. We conducted a focus group study to explore modifiable hurdles to LDKT. METHODS: Focus group discussions and in-depth interviews were conducted among 50 end-stage renal patients. Analyses were conducted according to 'grounded theory' using Atlas.ti. RESULTS: We found nearly all patients to be in favor of LDKT (96%). However, multiple factors played a role in considering LDKT. Four potentially modifiable hurdles were derived: (1) inadequate patient education, (2) impeding cognitions and emotions, (3) restrictive social influences, and (4) suboptimal communication. With regard to solutions, we found that our patients were open to home-based group education on renal replacement therapy options (88% in favor). CONCLUSION: The study highlights the need for sensitivity and awareness of the influence of cultural factors on decision-making when discussing living donation with culturally diverse populations. PRACTICE IMPLICATIONS: Since the majority of our patients were open to a tailored group education in their own homes, we see this as an opportunity to address factors that influence equality in access to LDKT.

Modifiable factors in access to living-donor kidney transplantation among diverse populations.

BACKGROUND: We have observed a significant inequality in the number of living-donor kidney transplants (LDKT) performed between patients of non-Western European origin and those of Western European origin. The aim of this study was to investigate modifiable factors that could be used as potential targets for an intervention in an attempt to reduce this inequality. METHODS: A questionnaire on knowledge, risk perception, communication, subjective norm, and willingness to accept LDKT was completed by 160 end-stage renal patients who were referred to the pretransplantation outpatient clinic (participation rate of 92%). The questionnaire was available in nine languages. Multivariate analyses of variance were conducted to explore differences between patients with and without a living donor. RESULTS: There were significantly fewer patients of non-Western descent (11 of 82) that brought a living donor to the outpatient clinic than patients of Western descent (38 of 78). After correcting for the unmodifiable sociodemographic factors non-Western descent, low knowledge, little communication about their kidney disease, and low willingness to communicate with individuals from the social network about LDKT were significantly associated with the absence of a living donor. CONCLUSIONS: Knowledge and communication are identified as modifiable factors that are associated with the likelihood of identifying a potential living donor for LDKT. This observation makes knowledge and communication targets for interventions to reduce inequality in access to LDKT.