Shared decision making for patients with kidney failure to improve end-of-life care: Development of the DESIRE intervention.

AIM: To describe the development of a shared decision making intervention for planning end-of-life care for patients with kidney failure, their relatives and health professionals in kidney services. BACKGROUND: End-of-life care conversations within standard disease management consultations are challenging for patients with kidney failure, their relatives and health professionals. End-of-life care planning is about making difficult decisions in advance, which is why health professionals need shared decision making skills to be able to initiate end-of-life conversations. Health professionals report needing more skills to raise the issue of end-of-life care options within consultations and patients want to be able to discuss issues important to them about future care plans. METHODS: The development design was guided by the UK Medical Research Council's framework and a user-centred approach was applied. Four workshops were conducted with end users. The Template for Intervention Description and Replication for Population Health and Policy interventions was used to shape which questions needed to be answered through the workshops and to present the intervention. The International Patient Decision Aid Standards (IPDAS) criteria set the standards to be achieved. RESULTS: Areas considered significant to a shared decision making intervention were training of health professionals, conversations about end-of-life care, planning and evaluation of the decisions, reporting decisions in health records and repetition of consultation. The development process went through 14 iterations. CONCLUSION: An intervention named DESIRE was developed that comprises: (1) a training programme for health professionals; (2) shared decision making conversations; and (3) a patient decision aid. The intervention met 30 out of 33 IPDAS criteria. IMPLICATIONS FOR PRACTICE: DESIRE is intended to support shared decision making about planning end-of-life care among patients with kidney failure, their relatives and health professionals. The study provides important tools for the stakeholders engaged that can be used within different models of care. IMPACT: What problem did the study address? International guidelines recommend health professionals involve patients with kidney failure in making decisions about end-of-life care, but there is variation in how this is implemented within and across kidney services. Furthermore, patients, relatives and health professionals find it challenging to initiate conversations about end-of-life care. What were the main findings? The study resulted in the development of a complex intervention, called DESIRE, about shared decision making and planning end-of-life care for patients with kidney failure, their relatives and health professionals in kidney services, including a training programme for health professionals, shared decision making conversations and a patient decision aid. Where and on whom will the research have an impact? The research contributes a shared decision making intervention to patients in the later stage of kidney failure, their relatives and health professionals. We believe that the DESIRE intervention could be introduced during consultations with health professionals at an earlier stage of the patient's illness trajectory, as well as being applied to other chronic diseases. REPORTING METHOD: This intervention development research is reported according to the GUIDance for the rEporting of intervention Development (GUIDED) checklist and the DEVELOPTOOLS Reporting Checklist. PATIENT OR PUBLIC CONTRIBUTION: Patients, relatives and health professionals have been involved throughout the research process as part of the research team and advisory board. For this study, the advisory board has particularly contributed to the development process of the DESIRE intervention by actively participating in the four workshops, in the iterations between the workshops and in the preparation of the manuscript.

Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study.

OBJECTIVES: Traditional potassium (K+) binders for treating hyperkalaemia are unpalatable and poorly tolerated. Newer K+ binders are reportedly better tolerated; however, no published data describe their palatability, a determinant of long-term adherence. This study evaluated the palatability of and preference for three K+ binders: sodium and calcium polystyrene sulfonate (S/CPS), sodium zirconium cyclosilicate (SZC) and calcium patiromer sorbitex (patiromer). DESIGN: Phase 4, randomised, participant-blinded, cross-over study. Participants were randomised to one of six taste sequences and, using a 'sip and spit' approach, tasted each K+ binder before completing a survey. SETTING: 17 centres across the USA, Canada and European Union. PARTICIPANTS: 144 participants with chronic kidney disease, hyperkalaemia and no recent use of K+ binders. MAIN OUTCOME MEASURES: For the primary (USA) and key secondary (Canada and European Union) endpoints, participants rated palatability attributes (taste, texture, smell and mouthfeel) and willingness to take each K+ binder on a scale of 0-10 (rational evaluation). Feelings about each attribute, and the idea of taking the product once daily, were evaluated using a non-verbal, visual measure of emotional response. Finally, participants ranked the K+ binders according to palatability. RESULTS: In each region, SZC and patiromer outperformed S/CPS on overall palatability (a composite of taste, texture, smell and mouthfeel), based on rational evaluation and emotional response. Taking the product once daily was more appealing for SZC and patiromer, creating greater receptivity than the idea of taking S/CPS. The emotional response to mouthfeel had the strongest influence on feelings about taking each product. In each region, a numerically greater proportion of participants ranked SZC as the most preferred K+ binder versus patiromer or S/CPS. CONCLUSIONS: Preference for more palatable K+ binders such as SZC and patiromer may provide an opportunity to improve adherence to long-term treatment of hyperkalaemia. TRIAL REGISTRATION NUMBER: NCT04566653.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Patient decision aids are interventions designed to support people making health decisions. At a minimum, patient decision aids make the decision explicit, provide evidence-based information about the options and associated benefits/harms, and help clarify personal values for features of options. This is an update of a Cochrane review that was first published in 2003 and last updated in 2017. OBJECTIVES: To assess the effects of patient decision aids in adults considering treatment or screening decisions using an integrated knowledge translation approach. SEARCH METHODS: We conducted the updated search for the period of 2015 (last search date) to March 2022 in CENTRAL, MEDLINE, Embase, PsycINFO, EBSCO, and grey literature. The cumulative search covers database origins to March 2022. SELECTION CRITERIA: We included published randomized controlled trials comparing patient decision aids to usual care. Usual care was defined as general information, risk assessment, clinical practice guideline summaries for health consumers, placebo intervention (e.g. information on another topic), or no intervention. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations for inclusion, extracted intervention and outcome data, and assessed risk of bias using the Cochrane risk of bias tool. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made (informed values-based choice congruence) and the decision-making process, such as knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision-making, and adverse events. Secondary outcomes were choice, confidence in decision-making, adherence to the chosen option, preference-linked health outcomes, and impact on the healthcare system (e.g. consultation length). We pooled results using mean differences (MDs) and risk ratios (RRs) with 95% confidence intervals (CIs), applying a random-effects model. We conducted a subgroup analysis of 105 studies that were included in the previous review version compared to those published since that update (n = 104 studies). We used Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to assess the certainty of the evidence. MAIN RESULTS: This update added 104 new studies for a total of 209 studies involving 107,698 participants. The patient decision aids focused on 71 different decisions. The most common decisions were about cardiovascular treatments (n = 22 studies), cancer screening (n = 17 studies colorectal, 15 prostate, 12 breast), cancer treatments (e.g. 15 breast, 11 prostate), mental health treatments (n = 10 studies), and joint replacement surgery (n = 9 studies). When assessing risk of bias in the included studies, we rated two items as mostly unclear (selective reporting: 100 studies; blinding of participants/personnel: 161 studies), due to inadequate reporting. Of the 209 included studies, 34 had at least one item rated as high risk of bias. There was moderate-certainty evidence that patient decision aids probably increase the congruence between informed values and care choices compared to usual care (RR 1.75, 95% CI 1.44 to 2.13; 21 studies, 9377 participants). Regarding attributes related to the decision-making process and compared to usual care, there was high-certainty evidence that patient decision aids result in improved participants' knowledge (MD 11.90/100, 95% CI 10.60 to 13.19; 107 studies, 25,492 participants), accuracy of risk perceptions (RR 1.94, 95% CI 1.61 to 2.34; 25 studies, 7796 participants), and decreased decisional conflict related to feeling uninformed (MD -10.02, 95% CI -12.31 to -7.74; 58 studies, 12,104 participants), indecision about personal values (MD -7.86, 95% CI -9.69 to -6.02; 55 studies, 11,880 participants), and proportion of people who were passive in decision-making (clinician-controlled) (RR 0.72, 95% CI 0.59 to 0.88; 21 studies, 4348 participants). For adverse outcomes, there was high-certainty evidence that there was no difference in decision regret between the patient decision aid and usual care groups (MD -1.23, 95% CI -3.05 to 0.59; 22 studies, 3707 participants). Of note, there was no difference in the length of consultation when patient decision aids were used in preparation for the consultation (MD -2.97 minutes, 95% CI -7.84 to 1.90; 5 studies, 420 participants). When patient decision aids were used during the consultation with the clinician, the length of consultation was 1.5 minutes longer (MD 1.50 minutes, 95% CI 0.79 to 2.20; 8 studies, 2702 participants). We found the same direction of effect when we compared results for patient decision aid studies reported in the previous update compared to studies conducted since 2015. AUTHORS' CONCLUSIONS: Compared to usual care, across a wide variety of decisions, patient decision aids probably helped more adults reach informed values-congruent choices. They led to large increases in knowledge, accurate risk perceptions, and an active role in decision-making. Our updated review also found that patient decision aids increased patients' feeling informed and clear about their personal values. There was no difference in decision regret between people using decision aids versus those receiving usual care. Further studies are needed to assess the impact of patient decision aids on adherence and downstream effects on cost and resource use.

Decisional needs in people with kidney failure, their relatives and health professionals about end-of-life care options: A qualitative interview study.

AIM: To investigate the decisional needs in Denmark of people with kidney failure, relatives, and health professionals when planning end-of-life care. DESIGN: A qualitative interview study. METHODS: Individual semi-structured interviews were carried out with people with kidney failure, relatives and health professionals from November 2021 to June 2022. Malterud's systematic text condensation was used to analyse transcripts. RESULTS: A total of 13 patients, 10 relatives, and 12 health professionals were interviewed. Overall, four concepts were agreed on: (1) Talking about end of life is difficult, (2) Patients and relatives need more knowledge and information, (3) Health professionals need more tools and training, and (4) Experiencing busyness as a barrier to conversations about end of life. CONCLUSION: People with kidney failure, relatives, and health professionals shared certain decisional needs while also having some different decisional needs about end-of-life care. To meet these various needs, end-of-life conversations should be systematic and organized according to the patients' needs and wishes. IMPACT: Non-systematic end-of-life care decision-making processes limit patients' involvement. Patients and relatives need more knowledge about end-of-life care, and health professionals need more competences and time to discuss decisional needs. A shared decision-making intervention for people with kidney failure when making end-of-life care decisions will be developed. REPORTING METHOD: This empirical qualitative research is reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist. PATIENT OR PUBLIC CONTRIBUTION: Patients, relatives, and health professionals have been involved throughout the research process as part of the research team and advisory board. The patients are people with kidney failure and the relatives are relatives of a person with kidney failure. For this study, the advisory board has particularly contributed to the validation of the invitation letter for participation, the interview guides and the preparation of the manuscript.

Recommendations for successful involvement of patient partners in complex intervention research: a collaborative learning process.

BACKGROUND: Patient and public involvement in health-related research is a new discipline in Denmark. In 2021, a national conference titled 'Patient and Public Involvement in Complex Intervention Research' provided a forum for discussion between patient partners, researchers and clinicians on involving patients as partners in complex intervention research. METHODS: We aimed to describe specific challenges to and initiatives for patient partner involvement in order to develop recommendations for creating successful partnerships in complex intervention research. Through a collaborative learning process, 140 researchers identified the most important challenges for them in patient partner involvement and potential initiatives to improve such involvement. At a subsequent workshop, four patient partners identified the challenges and initiatives from their perspective as patient partners. They also gave feedback on the challenges and initiatives suggested by the researchers and helped shape three recommendations for practice. Three of the patient partners were involved in writing this paper. RESULTS: The five most important challenges identified by researchers were time, recruitment, ethics, power and inequality. Between four and seven initiatives to overcome these challenges were suggested. The three most important challenges identified by patient partners were communication, when you get information that is hard to handle and recruitment. They suggested three to four initiatives for improvement. Patient partners confirmed the importance of all the researcher identified challenges when presented with them, they also provided additional comments on the researchers' initiatives. This led to the formation of recommendations for involving patient partners. CONCLUSIONS: A collaborative learning process was shown to be a suitable method for patient partner involvement. Consistency was seen between the challenges and initiatives identified by researchers and patient partners. Based on these observations, three recommendations were developed: (1) create specific programmes that aim to involve all kind of patients (including but limited to vulnerable patients) as patient partners, (2) produce ethical guidelines for the involvement of patient partners, and (3) develop a national strategy for patient partner involvement. To build on these recommendations, a joint workshop with both researchers and patient partners is needed.

Involving patients in complex intervention research is new in Denmark, so there is a need to work out how to do it properly. In 2021, a national conference about this was arranged. There, two workshops were held with 70 complex intervention researchers in each. In the workshops, challenges and steps needed to bring patient partners into complex intervention research were identified. Later, a similar workshop was organized with four patient partners. Their views were similar to what was concluded at the earlier workshops. All challenges and steps to overcome these were discussed between patients and researchers at the last workshop. This resulted in the development of three recommendations to successfully involve patient partners into complex intervention research: (1) create programmes to involve patients who might otherwise be missed as patient partners, (2) produce ethical guidelines for involving patient partners in complex intervention research, and (3) develop a national plan for involving in patient partners.

Patient involvement interventions for patients with kidney failure making end-of-life care decisions: a scoping review.

OBJECTIVE: The objective of this review was to investigate and map empirical evidence of patient involvement interventions to support patients with kidney failure making end-of-life care decisions in kidney services. INTRODUCTION: Clinical guidance integrating end-of-life care within kidney failure management pathways varies. Advance care planning interventions aimed at involving patients with kidney failure in their end-of-life care planning are established in some countries. However, there is limited evidence of the other types of patient involvement interventions integrated within services to support patients with kidney failure in making decisions about their end-of-life care. INCLUSION CRITERIA: This scoping review included studies exploring patient involvement interventions evaluated for patients with kidney failure considering end-of-life care, their relatives, and/or health professionals in kidney services. Studies of children under the age of 18 years were excluded. METHODS: The review was informed by JBI methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review guidelines. MEDLINE, Scopus, Embase, and CINAHL were searched for full-text studies in English, Danish, German, Norwegian, or Swedish. Two independent reviewers assessed the literature against the inclusion criteria. A relational analysis framework was used to synthesize the data extracted from the included studies, and to investigate and map different patient involvement interventions. RESULTS: The search identified 1628 articles, of which 33 articles met the inclusion criteria. A total of 23 interventions were described. Interventions targeted patients (n=3); health professionals (n=8); patients and health professionals (n=5); and patients, relatives, and health professionals (n=7). Intervention components included patient resources (eg, information, patient decision aids), consultation resources (eg, advance care planning, shared decision-making), and practitioner resources (eg, communication training). Patient involvement interventions were delivered within hospital-based kidney services. CONCLUSIONS: The review identified several ways to support patients with kidney failure to be involved in end-of-life care decisions. Future interventions may benefit from adopting a complex intervention framework to engage multiple stakeholders in the research and design of an intervention for shared decision-making between patients with kidney failure, their relatives, and health professionals about integrating end-of-life care options into their kidney disease management pathway.

Coordinating efforts to optimize next-generation kidney replacement therapies: the European Kidney Health Alliance Work Group 'Breakthrough Innovation'.

Chronic kidney disease (CKD) is one of the fastest growing health problems, set to become the fifth global death cause by 2040. Factors contributing to this fast growth include increased survival from other diseases (cancer, cardiovascular disease, diabetes, etc.), population aging, lack of early CKD diagnosis tools, insufficient CKD awareness within healthcare systems, limited therapeutic armamentarium to prevent CKD progression and limitations of currently available kidney replacement therapies (KRTs). The European Kidney Health Alliance (EKHA) and the American Association of Kidney Patients joined forces within the Decade of the KidneyTM framework to address these issues. We report on the rationale and vision of the EKHA Work Group 'Breakthrough Innovation' which aims to disrupt the existing innovation paradox on KRT. We discuss how the concepts of international technological roadmapping and coopetition may leverage breakthrough KRT technologies, and present a map of the kidney innovation playing field, driven by patient advocacy groups.

The value of partnership in patient-driven as well as in researcher-driven projects.

Patient involvement in health research is rarely driven solely by patients, who could be considered to have the highest degree of investment in such research. In the Kidney Connect project, the patients have been the driving force. This commentary considers the following questions: How did we, as patients, lead the work as the driving force in the project? What went well and what did not go so well from our perspective? How did the project compare with work driven by researchers? We argue that projects driven solely by either patients or researchers each have their own limitations. Projects driven solely by patients have some limitations in their robustness, rigour, and likelihood of publication. Nevertheless, a project driven solely by patients has been able to produce findings that are broadly comparable to a project driven solely by researchers that employed methods ensuring robustness and rigour. We suggest collaboration between patients and researchers also for projects driven by patients.

Health research often uses patients as either participants or partners. Patients running the research is less common, even though the outcomes might be more important to patients than to anyone else. A medical company started the Kidney Connect project, but invited patients to drive it. The main driving role was planning and conducting data collection and analysis of data for the project. In this commentary, patient representatives describe how they led the project's work, what went well and what did not go so well for patients. It then compares the project's results with those from similar work that involved patients as partners but had only researchers in charge. We found that certain things can limit research that is run only by patients, but it has similar results to a project with only researchers in charge.

Shared decision-making and planning end-of-life care for patients with end-stage kidney disease: a protocol for developing and testing a complex intervention.

BACKGROUND: Internationally, it has been stressed that advance care planning integrated within kidney services can lead to more patients being involved in decisions for end-of-life care. In Denmark, there is no systematic approach to advance care planning and end-of-life care interventions within kidney services. A shared decision-making intervention for planning end-of-life care may support more effective treatment management between patients with end-stage kidney disease, their relatives and the health professionals. The purpose of this research is to find evidence to design a shared decision-making intervention and test its acceptability to patients with end-stage kidney disease, their relatives, and health professionals in Danish kidney services. METHODS: This research project will be conducted from November 2020 to November 2023 and is structured according to the UK Medical Research Council framework for complex intervention design and evaluation research. The development phase research includes mixed method surveys. First, a systematic literature review synthesising primary empirical evidence of patient-involvement interventions for patients with end-stage kidney disease making end-of-life care decisions will be conducted. Second, interview methods will be carried out with patients with end-stage kidney disease, relatives, and health professionals to identify experiences of involvement in decision-making and decisional needs when planning end-of-life care. Findings will inform the co-design of the shared decision-making intervention using an iterative process with our multiple-stakeholder steering committee. A pilot test across five kidney units assessing if the shared decision-making intervention is acceptable and feasible to patients, relatives, and health professionals providing services to support delivery of care in kidney services. DISCUSSION: This research will provide evidence informing the content and design of a shared decision-making intervention supporting patient-professional planning of end-of-life care for patients with end-stage kidney disease, and assessing its acceptability and feasibility when integrated within Danish kidney units. This research is the first step to innovating the involvement of patients in end-of-life care planning with kidney professionals.

Mapping the empirical evidence on patient involvement interventions in patients with end-stage kidney disease making end-of-life care decisions: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to investigate and map existing empirical evidence on patient involvement interventions helping patients with end-stage kidney disease to make end-of-life care decisions about kidney services. INTRODUCTION: Patients with end-stage kidney disease have a high disease burden and mortality rate. Despite this, kidney services differ in how they offer and integrate end-of-life care, if it is offered at all. Some countries have established advance care planning protocols to encourage patient involvement when offering end-of-life care options as part of end-stage kidney disease care. However, there is a limited understanding of the components of patient involvement interventions designed to support patients with end-stage kidney disease making decisions about end-of-life care. INCLUSION CRITERIA: The review will consider studies on patient involvement interventions concerning end-of-life care decisions for patients with end-stage kidney disease. A broad definition of patient involvement interventions will be used. Studies on interventions that do not involve patients or relatives will be excluded. The review will focus on interventions applied to kidney health care and other services, such as community-based health care. METHODS: MEDLINE, Embase, Scopus, and CINAHL will be searched. The literature will be screened for inclusion by two independent reviewers. Data synthesis will be conducted through relational analysis investigating patient involvement interventions and relevant information in line with the review objective and questions. Data will be extracted and listed in the data extraction instruments, accompanied by a narrative summary describing how the results relate to the review objective.

Father of Artificial Organs - The story of medical pioneer Willem J. Kolff (1911-2009).

This biography of serial inventor and medical doctor Willem J. ("Pim") Kolff is written by scientific/historical journalist Herman Broers. The book provides an objective and multi-perspective account of the life and work of Dr. Kolff, who put an undisputed mark on the history of organ-replacement devices by secretly inventing the first clinically functioning hemodialysis machine (in a Nazi-occupied Holland) and later in the United States leading the team that realized the first implantable fully artificial heart. Besides offering a solid historical account, the book also describes the present revival of innovation in the artificial kidney field and contains valuable lessons for a broad variety of readers. Suitable for an audience ranging from medical professionals interested in technology & technologists interested in medicine, to patients & their families, as well as policy makers & research funding parties. The review of this scientific/historic book was composed using the recommendations of Gupta for book reviews of scientific and technical books. Additionally, the reviewer team, composed of a biomedical engineer, a dialysis patient, and a nephrologist, tried to distil some lessons that may be learned from the book.

Involvement of patients with chronic kidney disease in research: A case study.

BACKGROUND: Knowledge about best practices of patient involvement in research among patients with chronic kidney disease is sparse, with little information about barriers to and facilitators of this process. The purpose of this study is to evaluate the process and outcomes of patient involvement in a particular chronic kidney disease research project. OBJECTIVES: To describe how patients with chronic kidney disease were involved in the research; to explain what occurred when patients with chronic kidney disease were involved; to identify facilitators of and barriers to patient involvement in research. PARTICIPANTS: Two patients with chronic kidney disease who have both been involved in a previous research project. MEASUREMENTS: A retrospective embedded case study of patient involvement in research with the shared decision-making and dialysis choice project inspired by Yin (2012, Case Study Methods), using document analysis and semistructured individual interviews. Data were analysed with specific research questions in mind. RESULTS: Two patients participated in four research meetings covering all substudies of a research project and all six phases of the research process. Eight facilitators and barriers were identified. CONCLUSIONS: Patients with chronic kidney disease were involved in all the six phases of the research process but were more highly involved in some phases than others. Important facilitators of patient involvement in chronic kidney disease research include working as a team, being a part of the process, and being prepared for the work. Important barriers to patient involvement include patient vulnerability and uremic symptoms, both of which must be taken into account.