Background Patients with chronic kidney disease are often requested to engage in self-monitoring sodium (i.e. salt) intake, but it is currently unknown how self-monitoring would empower them. This... Show moreBackground Patients with chronic kidney disease are often requested to engage in self-monitoring sodium (i.e. salt) intake, but it is currently unknown how self-monitoring would empower them. This study aims to assess: (1) how frequent self-monitoring tools are being used during low-sodium diet self-management interventions; (2) whether self-efficacy (i.e. trust in own capability to manage the chronic disease) is associated with self-monitoring frequency; and (3) whether higher self-monitoring frequency is associated with an improvement in self-efficacy over time.Method Data from two multicenter randomized controlled trials (ESMO [n = 151] and SUBLIME [n = 99]) among adult Dutch patients with chronic kidney disease (eGFR >= 20-25 mL/min/1.73 m(2)) were used. In both studies, routine care was compared to a 3-month low-sodium diet self-management intervention with several self-monitoring tools (online food diary, home blood pressure monitor, and urinary sodium measurement device [only ESMO]). Data was collected on usage frequency of self-monitoring tools. Frequencies during the interventions were compared between low and high baseline self-efficacy groups using the Mann-Whitney U test and T-test and associated with changes in self-efficacy during the interventions using Spearman correlation coefficients.Results Large variations in self-monitoring frequency were observed. In both interventions, usage of self-monitoring tools was highest during the first month with sharp drops thereafter. The online food diary was the most frequently used tool. In the ESMO intervention, low baseline self-efficacy was associated with a higher usage frequency of self-monitoring tools. This finding was not confirmed in the SUBLIME intervention. No significant associations were found between usage frequency of self-monitoring tools and changes in self-efficacy over time.Conclusion Patients with low self-efficacy might benefit most from frequent usage of self-monitoring tools when sufficient guidance and support is provided. Show less
Healthcare is shifting towards a more person-centred approach, aiming at a personalised treatment that fits the patient’s preferences and needs. The use of patient-reported outcome measures (PROMs... Show moreHealthcare is shifting towards a more person-centred approach, aiming at a personalised treatment that fits the patient’s preferences and needs. The use of patient-reported outcome measures (PROMs) to systematically assess outcomes such as health-related quality of life and symptom burden can facilitate the process of adapting to what is important to the patient. But, how to integrate PROMs into a routine care setting and how to use PROMs to achieve this personalised treatment? This dissertation provides insight into and practical knowledge of the implementation and use of PROMs in routine nephrology care. Research was performed within the different steps for implementation of PROMs into routine care, including the selection of PROMs, pilot testing PROMs, and nationwide implementation and use of PROMs, using a broad variety of quantitative and qualitative research methods. The use of PROMs was investigated both at individual patient level and at population level, with the potential to facilitate personalised treatment and evaluation of healthcare quality. Patients and healthcare professionals considered the PROM-results relevant additional information in routine practice, complementary to traditional clinical measures. In addition, discussing individual PROM results proved to be of great added value and directly applicable in routine care. Show less
Horst, D.E.M. van der; Engels, N.; Hendrikx, J.; Dorpel, M.A. van den; Pieterse, A.H.; Stiggelbout, A.M.; ... ; Bos, W.J.W. 2023
IntroductionGuidelines on chronic kidney disease (CKD) recommend that nephrologists use clinical prediction models (CPMs). However, the actual use of CPMs seems limited in clinical practice. We... Show moreIntroductionGuidelines on chronic kidney disease (CKD) recommend that nephrologists use clinical prediction models (CPMs). However, the actual use of CPMs seems limited in clinical practice. We conducted a national survey study to evaluate: 1) to what extent CPMs are used in Dutch CKD practice, 2) patients' and nephrologists' needs and preferences regarding predictions in CKD, and 3) determinants that may affect the adoption of CPMs in clinical practice.MethodsWe conducted semi-structured interviews with CKD patients to inform the development of two online surveys; one for CKD patients and one for nephrologists. Survey participants were recruited through the Dutch Kidney Patient Association and the Dutch Federation of Nephrology.ResultsA total of 126 patients and 50 nephrologists responded to the surveys. Most patients (89%) reported they had discussed predictions with their nephrologists. They most frequently discussed predictions regarded CKD progression: when they were expected to need kidney replacement therapy (KRT) (n = 81), and how rapidly their kidney function was expected to decline (n = 68). Half of the nephrologists (52%) reported to use CPMs in clinical practice, in particular CPMs predicting the risk of cardiovascular disease. Almost all nephrologists (98%) reported discussing expected CKD trajectories with their patients; even those that did not use CPMs (42%). The majority of patients (61%) and nephrologists (84%) chose a CPM predicting when patients would need KRT in the future as the most important prediction. However, a small portion of patients indicated they did not want to be informed on predictions regarding CKD progression at all (10-15%). Nephrologists not using CPMs (42%) reported they did not know CPMs they could use or felt that they had insufficient knowledge regarding CPMs. According to the nephrologists, the most important determinants for the adoption of CPMs in clinical practice were: 1) understandability for patients, 2) integration as standard of care, 3) the clinical relevance.ConclusionEven though the majority of patients in Dutch CKD practice reported discussing predictions with their nephrologists, CPMs are infrequently used for this purpose. Both patients and nephrologists considered a CPM predicting CKD progression most important to discuss. Increasing awareness about existing CPMs that predict CKD progression may result in increased adoption in clinical practice. When using CPMs regarding CKD progression, nephrologists should ask whether patients want to hear predictions beforehand, since individual patients' preferences vary. Show less
For people with chronic kidney disease (CKD), adhering to a range of self-management tasks—such as healthy eating, frequent physical activity, and non-smoking—is crucial. However, changing health... Show moreFor people with chronic kidney disease (CKD), adhering to a range of self-management tasks—such as healthy eating, frequent physical activity, and non-smoking—is crucial. However, changing health behaviors is difficult. To support patients in doing so, an eHealth care pathway was developed and evaluated. The results provide different insights into patients' priorities and care needs. Many individuals with CKD experience problems in self-management, which can be hindered by many different barriers of which a common one is psychological distress. Therefore, personalized interventions are needed with screening and treatment of both psychological distress and suboptimal self-management, tailored to the specific barriers and needs of the individual patient. The E-GOAL eHealth care pathway is an example of such a personalized intervention, combining cognitive behavioral therapy with self-management support. Patients were enthusiastic about the eHealth care pathway. However, in a randomized study, the intervention was not effective in reducing psychological distress compared with regular care only. Patients did experience improvements in areas of functioning and self-management that they prioritized themselves. These mixed results show that interventions could be implemented that are person-tailored, with personalized outcomes that reflect individually meaningful treatment goals and improvements for every patient. Show less
Shen, H.X.; Kleij, R. van der; Boog, P.J.M. van der; Wang, W.J.; Song, X.Y.; Li, Z.Y.; ... ; Chavannes, N. 2022
Background: A growing body of evidence supports the potential effectiveness of electronic health (eHealth) self management interventions in improving disease self-management skills and health... Show moreBackground: A growing body of evidence supports the potential effectiveness of electronic health (eHealth) self management interventions in improving disease self-management skills and health outcomes of patients suffering from chronic kidney disease (CKD). However, current research on CKD eHealth self-management interventions has almost exclusively focused on high-income, western countries. Objective: To inform the adaptation of a tailored eHealth self-management intervention for patients with CKD in China based on the Dutch Medical Dashboard (MD) intervention, we examined the perceptions, attitudes and needs of Chinese patients with CKD and health care professionals (HCPs) towards eHealth based (self -management) interventions in general and the Dutch MD intervention in specific. Methods: We conducted a basic interpretive, cross-sectional qualitative study comprising semi-structured interviews with 11 patients with CKD and 10 HCPs, and 2 focus group discussions with 9 patients with CKD. This study was conducted in the First Affiliated Hospital of Zhengzhou University in China. Data collection continued until data saturation was reached. All data were transcribed verbatim and analyzed using a framework approach. Results: Three themes emerged: (1) experience with eHealth in CKD (self-management), (2) needs for supporting CKD self-management with the use of eHealth, and (3) adaptation and implementation of the Dutch MD intervention in China. Both patients and HCPs had experience with and solely mentioned eHealth to 'inform, monitor and track' as potentially relevant interventions to support CKD self-management, not those to support 'interaction' and 'data utilization'. Factors reported to influence the implementation of CKD eHealth self-management interventions included information barriers (i.e. quality and consistency of the disease-related information obtained via eHealth), perceived trustworthiness and safety of eHealth sources, clinical compatibility and complexity of eHealth, time constraints and eHealth literacy. Moreover, patients and HCPs expressed that eHealth interventions should support CKD self-management by improving the access to reliable and relevant disease related knowledge and optimizing the timeliness and quality of patient and HCPs interactions. Finally, suggestions to adaptation and implementation of the Dutch MD intervention in China were mainly related to improving the intervention functionalities and content of MD such as addressing the complexity of the platform and compatibility with HCPs' workflows. Conclusions: The identified perceptions, attitudes and needs towards eHealth self-management interventions in Chinese settings should be considered by researchers and intervention developers to adapt a tailored eHealth self management intervention for patients with CKD in China. In more detail, future research needs to engage in co creation processes with vulnerable groups during eHealth development and implementation, increase eHealth literacy and credibility of eHealth (information resource), ensure eHealth to be easy to use and well-integrated into HCPs' workflows. Show less
Shen, H.X.; Kleij, R. van der; Boog, P.J.M. van der; Wang, W.J.; Song, X.Y.; Li, Z.Y.; ... ; Chavannes, N. 2022
BackgroundA growing body of evidence supports the potential effectiveness of electronic health (eHealth) self-management interventions in improving disease self-management skills and health... Show moreBackgroundA growing body of evidence supports the potential effectiveness of electronic health (eHealth) self-management interventions in improving disease self-management skills and health outcomes of patients suffering from chronic kidney disease (CKD). However, current research on CKD eHealth self-management interventions has almost exclusively focused on high-income, western countries.ObjectiveTo inform the adaptation of a tailored eHealth self-management intervention for patients with CKD in China based on the Dutch Medical Dashboard (MD) intervention, we examined the perceptions, attitudes and needs of Chinese patients with CKD and health care professionals (HCPs) towards eHealth based (self-management) interventions in general and the Dutch MD intervention in specific.MethodsWe conducted a basic interpretive, cross-sectional qualitative study comprising semi-structured interviews with 11 patients with CKD and 10 HCPs, and 2 focus group discussions with 9 patients with CKD. This study was conducted in the First Affiliated Hospital of Zhengzhou University in China. Data collection continued until data saturation was reached. All data were transcribed verbatim and analyzed using a framework approach.ResultsThree themes emerged: (1) experience with eHealth in CKD (self-management), (2) needs for supporting CKD self-management with the use of eHealth, and (3) adaptation and implementation of the Dutch MD intervention in China. Both patients and HCPs had experience with and solely mentioned eHealth to ‘inform, monitor and track’ as potentially relevant interventions to support CKD self-management, not those to support ‘interaction’ and ‘data utilization’. Factors reported to influence the implementation of CKD eHealth self-management interventions included information barriers (i.e. quality and consistency of the disease-related information obtained via eHealth), perceived trustworthiness and safety of eHealth sources, clinical compatibility and complexity of eHealth, time constraints and eHealth literacy. Moreover, patients and HCPs expressed that eHealth interventions should support CKD self-management by improving the access to reliable and relevant disease related knowledge and optimizing the timeliness and quality of patient and HCPs interactions. Finally, suggestions to adaptation and implementation of the Dutch MD intervention in China were mainly related to improving the intervention functionalities and content of MD such as addressing the complexity of the platform and compatibility with HCPs’ workflows.ConclusionsThe identified perceptions, attitudes and needs towards eHealth self-management interventions in Chinese settings should be considered by researchers and intervention developers to adapt a tailored eHealth self-management intervention for patients with CKD in China. In more detail, future research needs to engage in co-creation processes with vulnerable groups during eHealth development and implementation, increase eHealth literacy and credibility of eHealth (information resource), ensure eHealth to be easy to use and well-integrated into HCPs’ workflows. Show less
Shen, H.X.; Kleij, R. van der; Boog, P.J.M. van der; Wang, W.J.; Song, X.Y.; Li, Z.Y.; ... ; Chavannes, N. 2022
BackgroundA growing body of evidence supports the potential effectiveness of electronic health (eHealth) self-management interventions in improving disease self-management skills and health... Show moreBackgroundA growing body of evidence supports the potential effectiveness of electronic health (eHealth) self-management interventions in improving disease self-management skills and health outcomes of patients suffering from chronic kidney disease (CKD). However, current research on CKD eHealth self-management interventions has almost exclusively focused on high-income, western countries.ObjectiveTo inform the adaptation of a tailored eHealth self-management intervention for patients with CKD in China based on the Dutch Medical Dashboard (MD) intervention, we examined the perceptions, attitudes and needs of Chinese patients with CKD and health care professionals (HCPs) towards eHealth based (self-management) interventions in general and the Dutch MD intervention in specific.MethodsWe conducted a basic interpretive, cross-sectional qualitative study comprising semi-structured interviews with 11 patients with CKD and 10 HCPs, and 2 focus group discussions with 9 patients with CKD. This study was conducted in the First Affiliated Hospital of Zhengzhou University in China. Data collection continued until data saturation was reached. All data were transcribed verbatim and analyzed using a framework approach.ResultsThree themes emerged: (1) experience with eHealth in CKD (self-management), (2) needs for supporting CKD self-management with the use of eHealth, and (3) adaptation and implementation of the Dutch MD intervention in China. Both patients and HCPs had experience with and solely mentioned eHealth to ‘inform, monitor and track’ as potentially relevant interventions to support CKD self-management, not those to support ‘interaction’ and ‘data utilization’. Factors reported to influence the implementation of CKD eHealth self-management interventions included information barriers (i.e. quality and consistency of the disease-related information obtained via eHealth), perceived trustworthiness and safety of eHealth sources, clinical compatibility and complexity of eHealth, time constraints and eHealth literacy. Moreover, patients and HCPs expressed that eHealth interventions should support CKD self-management by improving the access to reliable and relevant disease related knowledge and optimizing the timeliness and quality of patient and HCPs interactions. Finally, suggestions to adaptation and implementation of the Dutch MD intervention in China were mainly related to improving the intervention functionalities and content of MD such as addressing the complexity of the platform and compatibility with HCPs’ workflows.ConclusionsThe identified perceptions, attitudes and needs towards eHealth self-management interventions in Chinese settings should be considered by researchers and intervention developers to adapt a tailored eHealth self-management intervention for patients with CKD in China. In more detail, future research needs to engage in co-creation processes with vulnerable groups during eHealth development and implementation, increase eHealth literacy and credibility of eHealth (information resource), ensure eHealth to be easy to use and well-integrated into HCPs’ workflows. Show less
Janse, R.J.; Fu, E.L.; Dahlstrom, U.; Benson, L.; Lindholm, B.; Diepen, M. van; ... ; Savarese, G. 2022
Aim Half of heart failure (HF) patients have chronic kidney disease (CKD) complicating their pharmacological management. We evaluated physicians' and patients' patterns of use of evidence-based... Show moreAim Half of heart failure (HF) patients have chronic kidney disease (CKD) complicating their pharmacological management. We evaluated physicians' and patients' patterns of use of evidence-based medical therapies in HF across CKD stages.Methods and results We studied HF patients with reduced (HFrEF) and mildly reduced (HFmrEF) ejection fraction enrolled in the Swedish Heart Failure Registry in 2009-2018. We investigated the likelihood of physicians to prescribe guideline-recommended therapies to patients with CKD, and of patients to fill the prescriptions within 90 days of incident HF (initiating therapy), to adhere (proportion of days covered >= 80%) and persist (continued use) on these treatments during the first year of therapy. We identified 31 668 patients with HFrEF (median age 74 years, 46% CKD). The proportions receiving a prescription for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (ACEi/ARB/ARNi) were 96%, 92%, 86%, and 68%, for estimated glomerular filtration rate (eGFR) >= 60, 45-59, 30-44, and <30 ml/min/1.73m(2), respectively; for beta-blockers 94%, 93%, 92%, and 92%, for mineralocorticoid receptor antagonists (MRAs) 45%, 44%, 37%, 24%; and for triple therapy (combination of ACEi/ARB/ARNi+ beta-blockers+ MRA) 38%, 35%, 28%, and 15%. Patients with CKD were less likely to initiate these medications, and less likely to adhere to and persist on ACEi/ARB/ARNi, MRA, and triple therapy. Among stoppers, CKD patients were less likely to restart these medications. Results were consistent after multivariable adjustment and in patients with HFmrEF (n = 15114).Conclusions Patients with HF and CKD are less likely to be prescribed and to fill prescriptions for evidence-based therapies, showing lower adherence and persistence, even at eGFR categories where these therapies are recommended and have shown efficacy in clinical trials.[GRAPHICS]. Show less
Engels, N.; Nat, P.B. van der; Ankersmid, J.W.; Prick, J.C.M.; Parent, E.; The, R.; ... ; Dorpel, M.A. van den 2022
Background: Patient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients' risk perception, and help patients... Show moreBackground: Patient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients' risk perception, and help patients make decisions congruent with their expectations and values. Our aim was to develop an online PtDA to support kidney failure treatment modality decision-making, that: 1) provides patients with real-world outcome information, and 2) facilitates SDM in clinical practice. Methods: The International Patient Decision Aids Standards (IPDAS) development process model was complemented with a user-centred and convergent mixed-methods approach. Rapid prototyping was used to develop the PtDA with a multidisciplinary steering group in an iterative process of co-creation. The results of an exploratory evidence review and a needs-assessment among patients, caregivers, and clinicians were used to develop the PtDA. Seven Dutch teaching hospitals and two national Dutch outcome registries provided real-world data on selected outcomes for all kidney failure treatment modalities. Alpha and beta testing were performed to assess the prototype and finalise development. An implementation strategy was developed to guide implementation of the PtDA in clinical practice. Results: The 'Kidney Failure Decision Aid' consists of three components designed to help patients and clinicians engage in SDM: 1) a paper hand-out sheet, 2) an interactive website, and 3) a personal summary sheet. A 'patients-like-me' infographic was developed to visualise survival probabilities for each treatment modality on the website. Other treatment outcomes were incorporated as event rates (e.g. hospitalisation rates) or explained in text (e.g. the flexibility of each treatment modality). No major revisions were needed after alpha and beta testing. During beta testing, some patients ignored the survival probabilities because they considered these too confronting. Nonetheless, patients agreed that every patient has the right to choose whether they want to view this information. Patients and clinicians believed that the PtDA would help patients make informed decisions, and that it would support values- and preferences-based decision-making. Implementation of the PtDA has started in October 2020. Conclusions: The 'Kidney Failure Decision Aid' was designed to facilitate SDM in clinical practice and contains real-world outcome information on all kidney failure treatment modalities. It is currently being investigated for its effects on SDM in a clinical trial. Show less
In part 1 of the thesis Predicting Outcomes in Patients with Kidney Disease, key differences between etiological and prediction research are explored and it is shown that observational research... Show moreIn part 1 of the thesis Predicting Outcomes in Patients with Kidney Disease, key differences between etiological and prediction research are explored and it is shown that observational research often conflates etiology and prediction which leads to incorrect causal conclusions. A framework for the external validation of prognostic models is provided and it is shown how competing events can be dealt with when externally validating a time-to-event prognostic model. These results are applicable to many clinical research fields, including nephrology as exemplified in part 2. Within the six applied chapters in part 2, prediction models for various adverse outcomes in patients with advanced kidney disease are identified, validated and developed. The thesis provides a broad overview of prognostic model applications in patients with chronic kidney disease, including comprehensive external validation studies for kidney failure prediction models, mortality prediction models and graft failure prediction models. Models to predict mortality on conservative care and dialysis and models to predict adverse outcomes after kidney transplantation were developed and validated. These results may improve shared decision-making processes and individualized medicine for patients with kidney disease. Show less
Background Prospective cohort studies are challenging to deliver, with one of the main difficulties lying in retention of participants. The need to socially distance during the COVID-19 pandemic... Show moreBackground Prospective cohort studies are challenging to deliver, with one of the main difficulties lying in retention of participants. The need to socially distance during the COVID-19 pandemic has added to this challenge. The pre-COVID-19 adaptation of the European Quality (EQUAL) study in the UK to a remote form of follow-up for efficiency provides lessons for those who are considering changing their study design. Methods The EQUAL study is an international prospective cohort study of patients >= 65 years of age with advanced chronic kidney disease. Initially, patients were invited to complete a questionnaire (SF-36, Dialysis Symptom Index and Renal Treatment Satisfaction Questionnaire) at research clinics every 3-6 months, known as "traditional follow-up" (TFU). In 2018, all living patients were invited to switch to "efficient follow-up" (EFU), which used an abbreviated questionnaire consisting of SF-12 and Dialysis Symptom Index. These were administered centrally by post. Response rates were calculated using returned questionnaires as a proportion of surviving invitees, and error rates presented as the average percentage of unanswered questions or unclear answers, of total questions in returned questionnaires. Response and error rates were calculated 6-monthly in TFU to allow comparisons with EFU. Results Of the 504 patients initially recruited, 236 were still alive at the time of conversion to EFU; 111 of these (47%) consented to the change in follow-up. In those who consented, median TFU was 34 months, ranging from 0 to 42 months. Their response rates fell steadily from 88% (98/111) at month 0 of TFU, to 20% (3/15) at month 42. The response rate for the first EFU questionnaire was 60% (59/99) of those alive from TFU. With this improvement in response rates, the first EFU also lowered errors to baseline levels seen in early follow-up, after having almost trebled throughout traditional follow-up. Conclusions Overall, this study demonstrates that administration of shorter follow-up questionnaires by post rather than in person does not negatively impact patient response or error rates. These results may be reassuring for researchers who are trying to limit face-to-face contact with patients during the COVID-19 pandemic. Show less
Background: COVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) stages G4-G5, on dialysis or after kidney transplantation (kidney replacement... Show moreBackground: COVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) stages G4-G5, on dialysis or after kidney transplantation (kidney replacement therapy, KRT). SARS-CoV-2 vaccine trials do not elucidate if SARS-CoV-2 vaccination is effective in these patients. Vaccination against other viruses is known to be less effective in kidney patients. Our objective is to assess the efficacy and safety of various types of SARS-CoV-2 vaccinations in patients with CKD stages G4-G5 or on KRT. Methods: In this national prospective observational cohort study we will follow patients with CKD stages G4-G5 or on KRT (n = 12,000) after SARS-CoV-2 vaccination according to the Dutch vaccination program. Blood will be drawn for antibody response measurements at day 28 and month 6 after completion of vaccination. Patient characteristics and outcomes will be extracted from registration data and questionnaires during 2 years of follow-up. Results will be compared with a control group of non-vaccinated patients. The level of antibody response to vaccination will be assessed in subgroups to predict protection against COVID-19 breakthrough infection. Results: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19 after vaccination. Secondary endpoints are the antibody based immune response at 28 days after vaccination, the durability of this response at 6 months after vaccination, mortality and (serious) adverse events. Conclusion: This study will fulfil the lack of knowledge on efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages G4-G5 or on KRT. Current knowledge about this subject. COVID-19 has devastating impact on patients with CKD stages G4-G5, on dialysis or after kidney transplantation.. Effective SARS-CoV-2 vaccination is very important in these vulnerable patient groups.. Recent studies on vaccination in these patient groups are small short-term studies with surrogate endpoints. Contribution of this study. Assessment of incidence and course of COVID-19 after various types of SARS-CoV-2 vaccination during a twoyear follow-up period in not only patients on dialysis or kidney transplant recipients, but also in patients with CKD stages G4-G5.. Quantitative analysis of antibody response after SARS-CoV-2 vaccination and its relationship with incidence and course of COVID-19 in patients with CKD stages G4-G5, on dialysis or after kidney transplantation compared with a control group.. Monitoring of (serious) adverse events and development of anti-HLA antibodies. Impact on practice or policy. Publication of the study design contributes to harmonization of SARS-CoV-2 vaccine study methodology in kidney patients at high-risk for severe COVID-19.. Data on efficacy of SARS-CoV-2 vaccination in patients with CKD will provide guidance for future vaccination policy. Show less
This thesis investigates the effectiveness and safety of treatments in patients with cardiovascular and kidney disease. Routinely collected healthcare data provide an immense opportunity to... Show moreThis thesis investigates the effectiveness and safety of treatments in patients with cardiovascular and kidney disease. Routinely collected healthcare data provide an immense opportunity to investigate such questions in populations underrepresented in clinical trials, such as patients with advanced chronic kidney disease (CKD).The first part of this thesis deals with how to appropriately use routinely collected data to answer causal questions. It illustrates what study designs eliminate commonly occurring biases, namely immortal time and prevalent user bias, and how to use propensity scores to correctly adjust for confounding in the setting of time-fixed and time-varying treatments.The second part investigates the effectiveness and safety of various treatments. For instance, the effectiveness of beta-blockers in patients with heart failure and advanced CKD is investigated. Renin-angiotensin system inhibitors (RASi) are an especially widely used medication class in CKD patients. The relationship between the magnitude of renal function decline - which is commonly observed after initiation of these drugs - with mortality and cardiorenal outcomes is investigated. In addition, comparative effectiveness study of RASi and calcium channel blockers among patients with advanced CKD is performed. In the last two chapters, a target trial is explicitly emulated to investigate the effect of stopping or continuing RASi and the optimal timing to start dialysis in patients with advanced chronic kidney disease. Show less
Chronic kidney disease (CKD) poses a major challenge to public health. China, a middle-income country, is the largest country globally with a current population of 1.4 billion. China accounts for... Show moreChronic kidney disease (CKD) poses a major challenge to public health. China, a middle-income country, is the largest country globally with a current population of 1.4 billion. China accounts for around one fifth of the global burden of CKD. Hence, eHealth self-management interventions are a great potential to Chinese populations. An extensively studied CKD self-management eHealth intervention is the Dutch ‘Medical Dashboard (MD)’. It has been demonstrated effective in decreasing the burden of CKD. To aim of this thesis is to inform the adaptation and evaluation of a tailored CKD self-management eHealth intervention in China based on the Dutch MD intervention. Specific characteristics and needs (e.g. facilitators and barriers) in Chinese settings need to be addressed to optimize the implementation of CKD self-management eHealth intervention. Emphasis should be placed on addressing the existing paternalistic patient-HCP relationship, stakeholder involvement in the development and implementation process, adjusting eHealth design features to fit the clinical workflows, and providing the needed support and training. This thesis is a vital step towards the design and implementation of a tailored eHealth solution to improve health outcomes of patients with CKD and address the high burden of CKD in China. Show less
The main objective of this thesis was to determine the value of dialysis and conservative care for older patients with advanced chronic kidney disease. To do so, we compared a combination of... Show moreThe main objective of this thesis was to determine the value of dialysis and conservative care for older patients with advanced chronic kidney disease. To do so, we compared a combination of patient-relevant outcomes and treatment costs in a cohort of older patients (≥70 years old) who chose either dialysis or conservative care after a shared decision-making process. Overall, we observed that older patients who chose dialysis lived longer compared with older patients who chose conservative care. There was, however, little or no significant survival advantage in patients aged ≥80 years old and patients aged ≥70 years old with severe comorbidity who chose dialysis over conservative care, while similar outcomes on quality of life and symptoms were observed between both patient groups, and lower treatment burden and treatment costs were observed in patients who chose conservative care. Therefore, we conclude that conservative care is a viable treatment alternative to dialysis in selected older patients. In clinical practice, conservative care needs to become available and openly discussed as one of the possible treatment pathways for advanced chronic kidney disease in older patients. Moreover, a shift towards a person-centered process of shared decision-making is needed that aims to focus on all that matters to the patient as person, in order to come to a treatment plan that fits best with the patient. Show less
As the population is aging worldwide, and in spite of all preventive efforts, age-related diseases are increasingly prevalent, such as cardiovascular diseases and cognitive impairment. Different... Show moreAs the population is aging worldwide, and in spite of all preventive efforts, age-related diseases are increasingly prevalent, such as cardiovascular diseases and cognitive impairment. Different vascular risk factors, both the ‘traditional’ modifiable factors, such as hypertension or diabetes, and non-modifiable factors, such as age or gender, can lead to different kind of intertwined micro- and macrovascular diseases in various or multiple simultaneous organs. There is a growing need for knowledge regarding the interplay between different (co)morbidities, the relation of (co)morbidities with the various underlying pathophysiological mechanisms and treatment options of these (co)morbidities. Therefore, the aims of this thesis were to identify patients at high cardiovascular risk and to optimize treatment for these patients. We further unravelled the complexity of various interacting (poly) vascular diseases, ultimately leading to an increased risk of not only cognitive impairment, but also MACE including death. Identification of these patients and better understanding of the interplay and underlying mechanisms of these diseases is the first step towards preventive strategies. Treating these high risk patients can be a therapeutic challenge, but there is growing knowledge regarding both established and evolving therapies to optimize efficacy and efficiency. Show less
Jong, Y. de; Fu, E.L.; Diepen, M. van; Trevisan, M.; Szummer, K.; Dekker, F.W.; ... ; Ocak, G. 2021
Aims The increasing prevalence of ischaemic stroke (IS) can partly be explained by the likewise growing number of patients with chronic kidney disease (CKD). Risk scores have been developed to... Show moreAims The increasing prevalence of ischaemic stroke (IS) can partly be explained by the likewise growing number of patients with chronic kidney disease (CKD). Risk scores have been developed to identify high-risk patients, allowing for personalized anticoagulation therapy. However, predictive performance in CKD is unclear. The aim of this study is to validate six commonly used risk scores for IS in atrial fibrillation (AF) patients across the spectrum of kidney function.Methods and results Overall, 36 004 subjects with newly diagnosed AF from SCREAM (Stockholm CREAtinine Measurements), a healthcare utilization cohort of Stockholm residents, were included. Predictive performance of the AFI, CHADS(2), Modified CHADS(2), CHA(2)DS(2)-VASc, ATRIA, and GARFIELD-AF risk scores was evaluated across three strata of kidney function: normal kidney function [estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m(2)], mild CKD (eGFR 30-60 mL/min/1.73 m(2)), and advanced CKD (eGFR <30 mL/min/1.73 m(2)). Predictive performance was assessed by discrimination and calibration. During 1.9 years, 3069 (8.5%) patients suffered an IS. Discrimination was dependent on eGFR: the median c-statistic in normal eGFR was 0.75 (range 0.68-0.78), but decreased to 0.68 (0.58-0.73) and 0.68 (0.55-0.74) for mild and advanced CKD, respectively. Calibration was reasonable and largely independent of eGFR. The Modified CHADS(2) score showed good performance across kidney function strata, both for discrimination [c-statistic: 0.78 (95% confidence interval 0.77-0.79), 0.73 (0.71-0.74) and 0.74 (0.69-0.79), respectively] and calibration.Conclusion In the most clinically relevant stages of CKD, predictive performance of the majority of risk scores was poor, increasing the risk of misclassification and thus of over- or undertreatment. The Modified CHADS2 score performed good and consistently across all kidney function strata, and should therefore be preferred for risk estimation in AF patients. Show less
Shen, H.X.; Kleij, R. van der; Boog, P.J.M. van der; Song, X.Y.; Wang, W.J.; Zhang, T.T.; ... ; Chavannes, N. 2020
Background: Chronic kidney disease (CKD) is a significant public health concern. In patients with CKD, interventions that support disease self-management have shown to improve health status and... Show moreBackground: Chronic kidney disease (CKD) is a significant public health concern. In patients with CKD, interventions that support disease self-management have shown to improve health status and quality of life. At the moment, the use of electronic health (eHealth) technology in self-management interventions is becoming more and more popular. Evidence suggests that eHealth-based self-management interventions can improve health-related outcomes of patients with CKD. However, knowledge of the implementation and effectiveness of such interventions in general, and in China in specific, is still limited. This study protocol aims to develop and tailor the evidence-based Dutch 'Medical Dashboard' eHealth self-management intervention for patients suffering from CKD in China and evaluate its implementation process and effectiveness.Methods: To develop and tailor a Medical Dashboard intervention for the Chinese context, we will use an Intervention Mapping (IM) approach. A literature review and mixed-method study will first be conducted to examine the needs, beliefs, perceptions of patients with CKD and care providers towards disease (self-management) and eHealth (self-management) interventions (IM step 1). Based on the results of step 1, we will specify outcomes, performance objectives, and determinants, select theory-based methods and practical strategies. Knowledge obtained from prior results and insights from stakeholders will be combined to tailor the core interventions components of the 'Medical Dashboard' self-management intervention to the Chinese context (IM step 2-5). Then, an intervention and implementation plan will be developed. Finally, a 9-month hybrid type 2 trial design will be employed to investigate the effectiveness of the intervention using a cluster randomized controlled trial with two parallel arms, and the implementation integrity (fidelity) and determinants of implementation (IM step 6).Discussion: Our study will result in the delivery of a culturally tailored, standardized eHealth self-management intervention for patients with CKD in China, which has the potential to optimize patients' self-management skills and improve health status and quality of life. Moreover, it will inform future research on the tailoring and translation of evidence-based eHealth self-management interventions in various contexts. Show less
Faria, B.; Costa, M.G. da; Lima, C.; Willems, L.; Brandwijk, R.; Berger, S.P.; ... ; Poppelaars, F. 2020
Introduction Various studies have reported the importance of complement regulators in preventing mesothelial damage during peritoneal dialysis (PD). Its assessment, however, is limited in clinical... Show moreIntroduction Various studies have reported the importance of complement regulators in preventing mesothelial damage during peritoneal dialysis (PD). Its assessment, however, is limited in clinical practice due to the lack of easy access to the peritoneal membrane. Recently, a soluble form of the complement regulatory protein CD59 (sCD59) has been described. We therefore aimed to investigate the role of sCD59 in PD.Methods Plasma sCD59 was measured in 48 PD patients, 41 hemodialysis patients, 15 non-dialysis patients with chronic kidney disease and 14 healthy controls by ELISA (Hycult; HK374-02). Additionally, sCD59 and sC5b-9 were assessed in the peritoneal dialysate.Results sCD59 and sC5b-9 were detectable in the peritoneal dialysate of all patients, and marginally correlated (r = 0.27, P = 0.06). Plasma sCD59 levels were significantly higher in PD patients than in patients with chronic kidney disease and healthy controls, but did not differ from hemodialysis patients. During follow-up, 19% of PD patients developed peritoneal membrane failure and 27% of PD patients developed loss of residual renal function. In adjusted models, increased sCD59 levels in the dialysate (HR 3.44, 95% CI 1.04-11.40, P = 0.04) and in plasma (HR 1.08, 95% CI 1.01-1.17, P = 0.04) were independently associated with the occurrence of peritoneal membrane failure. Higher plasma levels of sCD59 were also associated with loss of residual renal function (HR 1.10, 95% CI 1.04-1.17, P < 0.001).Conclusions Our study suggests that sCD59 has potential as a biomarker to predict peritoneal membrane function and loss of residual renal function in PD, thereby offering a tool to improve patient management. Show less
Aims Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin... Show moreAims Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide similar benefit across a range of renal function. We determined whether effects of the PCSK9 inhibitor alirocumab to reduce cardiovascular events and death after ACS are influenced by renal function.Methods and results ODYSSEY OUTCOMES compared alirocumab with placebo in patients with recent ACS and dyslipidaemia despite intensive statin treatment. Estimated glomerular filtration rate (eGFR) <30mL/min/1.73 m(2) was exclusionary. In 18 918 patients, baseline eGFR was 82.8 +/- 17.6 mL/min/1.73 m(2), and low-density lipoprotein cholesterol (LDL-C) was 92 +/- 31 mg/dL. At 36 months, alirocumab decreased LDL-C by 48.5% vs. placebo but did not affect eGFR (P = 0.65). Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non -fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization) with fewer deaths. There was no interaction between continuous eGFR and treatment on the primary outcome or death (P = 0.14 and 0.59, respectively). Alirocumab reduced primary outcomes in patients with eGFR >= 90 mUmin/1.73 m(2) (n = 7470; hazard ratio 0.784, 95% confidence interval 0.670-0.919; P= 0.003) and 60 to <90 (n = 9326; 0.833, 0.731-0.949; P=0.006), but not in those with eGFR< 60 (n = 2122; 0.974, 0.805-1.178; P= 0.784). Adverse events other than local injection -site reactions were similar in both groups across all categories of eGFR.Conclusions In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m(2). Show less
