Feasibility and acceptability of the ShareD dEciSIon making for patients with kidney failuRE to improve end-of-life care intervention: A pilot multicentre randomised controlled trial.

Background: Kidney failure is associated with a high disease burden and high mortality rates. National and international guidelines recommend health professionals involve patients with kidney failure in making decisions about end-of-life care, but implementation of these conversations within kidney services varies. We developed the DESIRE (ShareD dEciSIon-making for patients with kidney failuRE to improve end-of-life care) intervention from our studies investigating multiple decision maker needs and experiences of end-of-life care in kidney services. The DESIRE intervention's three components are a training programme for health professionals, a patient decision aid, and a kidney service consultation held to facilitate shared decision-making conversations about planning end-of-life care. Objectives: To assess the feasibility and acceptability of integrating the DESIRE intervention within kidney services. Design: A pilot study using a multicentre randomised controlled design. Setting: Four Danish nephrology departments. Participants: Patients with kidney failure who were 75 years of age or above, their relatives, and health professionals. Methods: Patients were randomised to either the intervention or usual care. Feasibility data regarding delivering the intervention, the trial design, and outcome measures were collected through questionnaires and audio recordings at four points in time: before, during, post, and 3 months after the intervention. Acceptability data were collected through semi-structured interviews with patients and relatives, as well as a focus group with health professionals post the intervention. Results: Twenty-seven patients out of the 32 planned were randomised either to the intervention (n= 14) or usual care (n= 13). In addition, four relatives and 12 health professionals participated. Follow-up was completed by 81 % (n= 22) of patient participants. We found that both feasibility and acceptability data suggested health professionals improved their decision support and shared decision-making skills via the training. Patient and relative participants experienced the intervention as supporting a shared decision-making process; from audio recordings, we showed health professionals were able to support proactively decision-making about end-of-life care within these consultations. All stakeholders perceived the intervention to be effective in promoting shared decision-making and relevant for supporting end-of-life care planning. Conclusions: Participant feedback indicated that the DESIRE intervention can be integrated into practice to support patients, relatives, and health professionals in planning end-of-life care alongside the management of worsening kidney failure. Minimising exhaustion and enhancing engagement with the intervention should be a focus for subsequent refinement of the intervention. Registration: The study has been registered at ClinicalTrials.gov with the identifier: NCT05842772. Date of first recruitment: March 20, 2023.

Involvement of patients in the research process.

Healthcare research emphasises involvement of patients in the research process, recognizing that this can enhance the relevance, quality, and implementation of research. This article highlights the need for more systematic planning to successfully involve patients in research projects and provides guidance on key aspects that researchers should consider in the planning of involving patients in research. The article accentuates the importance of establishing clear frameworks and guidelines to promote transparency and facilitate implementation.

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.

Have a vital end-user been overlooked? Developing a shared decision intervention for patients with potential pancreatic cancer regarding the choice of surgery.

Objective: To develop a patient decision aid facilitating shared decision making for patients with potential pancreatic cancer deciding about no treatment, surgical or medical treatment. Methods: Based on a user-centred design by Wittemann et al., we developed a shared decision making intervention in three phases: 1) Understanding decision needs 2) Development of a patient decision aid (PtDA) based on a generic template 3) Assessment of the intervention from interviews with patients (n = 11), relatives (n = 11), nurses (n = 4) and surgeons (n = 2) analysed with thematic analysis, and measuring patients' perceptions of choice of options with the Decisional Conflict Scale. Results: Results showed varying experiences with the use of the PtDA, with surgeons not finding PtDA useful as it was impractical and constraining with patients' conversations. There was no difference in patients' perceptions in choosing options for those being presented vs those patients not being presented for the PtDA. Conclusion: The format and structure of the PtDA was not feasible for the surgeons as fundamental users in the present clinic. Innovation: This study highlights the urgent need to consider clinical context before introducing a predefined tool and shows the importance of a multistakeholder approach. Research should focus on finding means to successful implement shared decision making.

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.

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.

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.

Determinants of practice for providing decision coaching to facilitate informed values-based decision-making: protocol for a mixed-methods systematic review.

INTRODUCTION: Decision coaching is a non-directive approach to support patients to prepare for making health decisions. It is used to facilitate patients' involvement in informed values-based decision-making and use of evidence-based health information. A recent systematic review revealed low certainty evidence for its effectiveness with and without evidence-based information. However, there may be opportunities to improve the study and use of decision coaching in clinical practice by systematically investigating its determinants of practice. We aim to conduct a systematic review to identify and synthesise the determinants of practice for providing decision coaching to facilitate patient involvement in decision-making from multiple perspectives that influence its use. METHODS AND ANALYSIS: We will conduct a mixed-methods systematic review guided by the Cochrane' Handbook of Systematic Reviews. We will include studies reporting determinants of practice influencing decision coaching with or without evidence-based patient information with adults making a health decision for themselves or a family member. Systematic literature searches will be conducted in Medline, EMBASE, Cochrane CENTRAL and PsycINFO via Ovid and CINAHL via EBSCO including quantitative, qualitative and mixed-methods study designs. Additionally, experts in the field will be contacted.Two reviewers will independently screen and extract data. We will synthesise determinants using deductive and inductive qualitative content analysis and a coding frame developed specifically for this review based on a taxonomy of barriers and enablers of shared decision-making mapped onto the major domains of the Consolidated Framework for Implementation Research. We will assess the quality of included studies using the Mixed Methods Appraisal Tool. ETHICS AND DISSEMINATION: Ethical approval is not required as this systematic review involves only previously published literature. The results will be published in a peer-reviewed journal, presented at scientific conferences and disseminated to relevant consumer groups. PROSPERO REGISTRATION NUMBER: CRD42022338299.

Decision aids to assist patients and professionals in choosing the right treatment for kidney failure.

Background: Kidney services vary in the way they involve people with kidney failure (PwKF) in treatment decisions as management needs change. We discuss how decision-science applications support proactively PwKF to make informed decisions between treatment options with kidney professionals. Methods: A conceptual review of findings about decision making and use of decision aids in kidney services, synthesized with reference to: the Making Informed Decisions-Individually and Together (MIND-IT) multiple stakeholder decision makers framework; and the Medical Research Council-Complex Intervention Development and Evaluation research framework. Results: This schema represents the different types of decision aids that support PwKF and professional reasoning as they manage kidney disease individually and together; adjustments at micro, meso and macro levels supports integration in practice. Conclusion: Innovating services to meet clinical guidelines on enhancing shared decision making processes means enabling all stakeholders to use decision aids to meet their goals within kidney pathways at individual, service and organizational levels.

Dietary app for patients with kidney disease: Qualitative evaluation of a prototype.

BACKGROUND: Individual dietary recommendations change as loss of kidney function progresses. Adopting these recommendations in everyday life poses major challenges for patients. Individualising dietary counselling is crucial to easy accessibility. AIM: To investigate patients' needs with regard to a dietary app for patients with chronic kidney disease, patients', and health professionals' immediate responses to such a dietary app and suggestions for improvement and further development of a prototype. DESIGN: A prototype of the dietary app has been developed and demonstrates how all information it provides can be tailored to the individual patient according to stage of disease, anthropometrics, and phosphate and potassium levels. A qualitative evaluation of the prototype was conducted using the Consolidated Criteria for Reporting Qualitative Research checklist for reporting. APPROACH: Seven individual interviews and four focus groups were analysed using interpretive description. PARTICIPANTS: Individual interviews with seven patients who have stage 4 or 5 chronic kidney disease and are not on dialysis, and four focus groups: one with participants from the individual interviews, one with six patients on haemodialysis, one with 13 kidney dieticians and one with seven health professionals. FINDINGS: Both patients and healthcare professionals were positive about the app. Individualisation is necessary for the app to work in practice. The patients reported access to a diet diary and recipes as important elements. CONCLUSION: There is a need to improve the tools we use today to enhance patient adherence to dietary recommendations. The development of an app for individual dietary counselling could be a useful solution.

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.

Person-specific evidence has the ability to mobilize relational capacity: A four-step grounded theory developed in people with long-term health conditions.

Person-specific evidence was developed as a grounded theory by analyzing 20 selected case descriptions from interventions using the guided self-determination method with people with various long-term health conditions. It explains the mechanisms of mobilizing relational capacity by including person-specific evidence in shared decision-making. Person-specific self-insight was the first step, achieved as individuals completed reflection sheets enabling them to clarify their personal values and identify actions or omissions related to self-management challenges. This step paved the way for sharing these insights and challenges in a relationship with a supportive health professional, who could then rely on person-specific evidence instead of assumptions or a narrow disease perspective for shared decision-making. Trust in the evidence encouraged the supportive health professional to transfer it to the interdisciplinary team. Person-specific evidence then enhanced the ability of team members to apply general evidence in a meaningful way. The increased openness achieved by individuals through these steps enabled them to eventually share their new self-insights in daily life with other people, decreasing loneliness they experienced in self-management. Relational capacity, the core of the theory, is mobilized in both people with long-term health conditions and healthcare professionals. Further research on person-specific evidence and relational capacity in healthcare is recommended.

The experiences of patients with amyotrophic lateral sclerosis of their decision-making processes to invasive home mechanical ventilation-A qualitative study.

AIM: To explore and gain knowledge of the experiences and needs among patients with amyotrophic lateral sclerosis (ALS) of their decision-making processes whether to choose invasive home mechanical ventilation or not. DESIGN: A qualitative study. METHODS: A phenomenological-hermeneutic approach influenced by Ricoeur's interpretation theory was used. Seven patients with ALS were interviewed. The Consolidated Criteria for Reporting Qualitative Research checklist was used for reporting. RESULTS: Three themes were evident in patients' accounts of the decision-making process: (1) being taken care of directly after receiving the diagnosis, (2) living in uncertainty about what the future would bring and (3) doubt causing patients with ALS to change their minds. Patients with ALS were burdened with everyday life challenging decision-making processes about future treatment and doubt caused patients to change their minds about their future treatment. It is necessary to support patients in their decision-making processes using shared decision-making. PATIENT OR PUBLIC CONTRIBUTION: No Patient or Public Contribution.

The phenomenon of urinary tract infection experienced by women with a kidney transplant.

BACKGROUND: Urinary tract infection is the most common infection among people with a kidney transplant and increases the risk of graft rejection. Women have a higher risk. A literature search did not identify any description of the phenomenon of urinary tract infection experienced by women with a kidney transplant. OBJECTIVE: To examine how women with a kidney transplant experienced the phenomenon of a urinary tract infection. DESIGN: A qualitative study with a phenomenological approach. APPROACH: Eight individual semistructured interviews based on van Manen's four lifeworld existentials and analysed using systematic text condensation. PARTICIPANTS: Women with a kidney transplant and recently been admitted to the hospital due to a urinary tract infection. FINDINGS: We identified four themes: (1) Feeling both typical and atypical symptoms; (2) Becoming aware of the body and trying her best to prevent urinary tract infection; (3) Having a urinary tract infection is a dual experience, both good and bad; (4) Support from relatives. CONCLUSION: The urinary tract infection symptoms pathway varied between participants but also between individual episodes of incidents among each participant. Participants felt secure when they experienced a common symptom pattern, but a new symptom pattern made them insecure. Together with their relatives, they experienced a urinary tract infection as a disruption of their everyday life and it decreased their experiences of happiness. They experienced to be supported by relatives but also by healthcare professionals, but needed more information on how to prevent, observe and react to a urinary tract infection in the future.

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.

Decision coaching for people with kidney failure: A case study.

BACKGROUND: Little is known about the usefulness of decision coaching for people with kidney failure facing decisions about end-of-life care. OBJECTIVES: To investigate experiences of people with kidney failure who received decision coaching for end-of-life care decisions. DESIGN: We conducted a prospective case study bound by time (September to December 2021), location (one nephrology department), and guided by the Ottawa Decision Support Framework. PARTICIPANTS: Adults with kidney failure facing end-of-life care decisions. MEASUREMENTS: A nurse trained in decision coaching screened for unmet decisional needs with the SURE test and provided decision coaching using the Ottawa Personal Decision Guide. Postcoaching, the participants were rescreened using the SURE test and interviewed to explore their experience with decision coaching. Change in SURE test findings was analysed descriptively and systematic text condensation was used for the analysis of interviews. Recorded decision coaching sessions underwent content analysis using the Decision Support Analysis Tool. RESULTS: Decision coaching was provided to four adults with kidney failure. Median pre-SURE test score was 2.5 (range 2-4) and posttest score was 3 (range 3-4), indicating a decrease in decisional needs. Participants described that decision coaching provided an overview of features of options to consider, identified remaining decisional needs for further discussion with relatives and health professionals and clarified next steps. Median Decision Support Analysis Tool score was 9 (range 8-9). CONCLUSIONS: After decision coaching, results suggest that the participants experienced fewer decisional needs and seemed clearer about the next steps in the decision making process.

Live music during haemodialysis: A multiple methods randomised controlled pilot study.

BACKGROUND: Fatigue is an immense problem among patients undergoing haemodialysis and is associated with anxiety and depression. Live music used in different hospital settings has shown promising effects, but the feasibility and potential effectiveness of live music during haemodialysis are unknown. OBJECTIVES: To evaluate the feasibility, the participants' musical experience and potential effectiveness of live music on patients' levels of fatigue, relaxation, anxiety, depression, treatment satisfaction and work engagement among nurses. DESIGN: A pilot randomised controlled trial evaluated with a multiple methods design. PARTICIPANTS: Two clusters of 12 patients were each randomised to receive either 30 min of live music once a week during haemodialysis or usual care over a period of 6 weeks. MEASUREMENTS: The primary outcome was patients' immediate fatigue. Other outcomes were patients' long-term and post-dialysis fatigue, relaxation, anxiety, depression, treatment satisfaction and work engagement among nurses. Observations and semi-structured interviews with patients, nurses and musicians were conducted to gain an in-depth understanding of the musical experience as well as feasibility. RESULTS: The study was feasible and detected significant differences on immediate fatigue (p < 0.001) and anxiety (p < 0.012) in the intervention group compared to controls. Among 17 nurses, a significant difference was found in Dedication (p < 0.024). Furthermore, live music gave patients an uplifting experience, bringing joy and relaxation and the nurses experienced a sense of quietness in a stressful day. CONCLUSIONS: Providing live music performed by professional musicians in a haemodialysis setting is feasible and showed a significant effect on immediate fatigue and anxiety compared to controls.

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.

Understanding how and under what circumstances decision coaching works for people making healthcare decisions: a realist review.

BACKGROUND: Decision coaching is non-directive support delivered by a trained healthcare provider to help people prepare to actively participate in making healthcare decisions. This study aimed to understand how and under what circumstances decision coaching works for people making healthcare decisions. METHODS: We followed the realist review methodology for this study. This study was built on a Cochrane systematic review of the effectiveness of decision coaching interventions for people facing healthcare decisions. It involved six iterative steps: (1) develop the initial program theory; (2) search for evidence; (3) select, appraise, and prioritize studies; (4) extract and organize data; (5) synthesize evidence; and (6) consult stakeholders and draw conclusions. RESULTS: We developed an initial program theory based on decision coaching theories and stakeholder feedback. Of the 2594 citations screened, we prioritized 27 papers for synthesis based on their relevance rating. To refine the program theory, we identified 12 context-mechanism-outcome (CMO) configurations. Essential mechanisms for decision coaching to be initiated include decision coaches', patients', and clinicians' commitments to patients' involvement in decision making and decision coaches' knowledge and skills (four CMOs). CMOs during decision coaching are related to the patient (i.e., willing to confide, perceiving their decisional needs are recognized, acquiring knowledge, feeling supported), and the patient-decision coach interaction (i.e., exchanging information, sharing a common understanding of patient's values) (five CMOs). After decision coaching, the patient's progress in making or implementing a values-based preferred decision can be facilitated by the decision coach's advocacy for the patient, and the patient's deliberation upon options (two CMOs). Leadership support enables decision coaches to have access to essential resources to fulfill their role (one CMOs). DISCUSSION: In the refined program theory, decision coaching works when there is strong leadership support and commitment from decision coaches, clinicians, and patients. Decision coaches need to be capable in coaching, encourage patients' participation, build a trusting relationship with patients, and act as a liaison between patients and clinicians to facilitate patients' progress in making or implementing an informed values-based preferred option. More empirical studies, especially qualitative and process evaluation studies, are needed to further refine the program theory.