"What matters to you?": The relevance of patient priorities in dialysis care for assessment and clinical practice.

BACKGROUND: Dialysis patients are confronted with numerous, complex problems, which make it difficult to identify individual patient's most prominent problems. The objectives of this study were to (1) identify dialysis patients' most prominent problems from a patient perspective and (2) to calculate disease-specific norms for questionnaires measuring these problems. METHODS: One hundred seventy-five patients treated with hemodialysis or peritoneal dialysis completed a priority list on several domains of functioning (e.g., physical health, mental health, social functioning, and daily activities) and a set of matching questionnaires assessing patient functioning on these domains. Patient priorities were assessed by calculating the importance ranking of each domain on the priority list. Subsequently, disease-specific norm scores were calculated for all questionnaires, both for the overall sample and stratified by patient characteristics. RESULTS: Fatigue was listed as patients' most prominent problem. Priorities differed between male and female patients, younger and older patients, and home and center dialysis patients, which was also reflected in their scores on the corresponding domains of functioning. Therefore, next to general norm scores, we calculated corrections to the general norms to take account of patient characteristics (i.e., sex, age, and dialysis type). CONCLUSIONS: Results highlight the importance of having attention for the specific priorities and needs of each individual patient. Adequate disease-specific, norm-based assessment is not only necessary for diagnostic procedures but is an essential element of patient-centered care: It will help to better understand and respect individual patient needs and tailor treatment accordingly.

The Personalized Priority and Progress Questionnaire (PPPQ): A personalized instrument for quality of life and self-management for use in clinical trials and practice.

PURPOSE: The aim of this study was to develop and validate a brief personalized instrument that (1) defines patients' priorities for improvement, (2) measures progress in prioritized quality of life (QoL) and self-management outcomes, and (3) is applicable in both clinical practice and clinical trials. METHODS: The instrument was developed based on the literature on personalized assessment and patient priorities, feedback by clinicians, and six cognitive interviews with patients with chronic kidney disease. The resulting questionnaire, the Personalized Priority and Progress Questionnaire (PPPQ), contains a baseline and follow-op measurement. The baseline measurement assesses functioning on QoL (8 items) and self-management (5 items). The final item evaluates patients' priorities for improvement. The follow-up measurement assesses progress in QoL and self-management. A personalized progress score can be calculated indicating the amount of progress on the QoL or self-management domain that is prioritized by the individual patient. Psychometric properties of the PPPQ were evaluated among patients with chronic kidney disease (n = 121) and patients with kidney failure treated with dialysis (n = 22). RESULTS: The PPPQ showed to be a feasible instrument that is easy and quick to complete. Regarding the construct validity, small to large correlations were found between the items and existing validated questionnaires measuring related constructs. CONCLUSION: The PPPQ proved to be a feasible and valid instrument. The PPPQ can be adapted to match diverse populations and could be a useful tool both in clinical practice (e.g., to identify priorities and tailor treatment) and clinical trials (e.g., to evaluate the effectiveness of personalized interventions).

Personal Genomes in Practice: Exploring Citizen and Healthcare Professionals' Perspectives on Personalized Genomic Medicine and Personal Health Data Spaces Using a Mixed-Methods Design.

Ongoing health challenges, such as the increased global burden of chronic disease, are increasingly answered by calls for personalized approaches to healthcare. Genomic medicine, a vital component of these personalization strategies, is applied in risk assessment, prevention, prognostication, and therapeutic targeting. However, several practical, ethical, and technological challenges remain. Across Europe, Personal Health Data Space (PHDS) projects are under development aiming to establish patient-centered, interoperable data ecosystems balancing data access, control, and use for individual citizens to complement the research and commercial focus of the European Health Data Space provisions. The current study explores healthcare users' and health care professionals' perspectives on personalized genomic medicine and PHDS solutions, in casu the Personal Genetic Locker (PGL). A mixed-methods design was used, including surveys, interviews, and focus groups. Several meta-themes were generated from the data: (i) participants were interested in genomic information; (ii) participants valued data control, robust infrastructure, and sharing data with non-commercial stakeholders; (iii) autonomy was a central concern for all participants; (iv) institutional and interpersonal trust were highly significant for genomic medicine; and (v) participants encouraged the implementation of PHDSs since PHDSs were thought to promote the use of genomic data and enhance patients' control over their data. To conclude, we formulated several facilitators to implement genomic medicine in healthcare based on the perspectives of a diverse set of stakeholders.

E-HEalth treatment in Long-term Dialysis (E-HELD): study protocol for a multicenter randomized controlled trial evaluating personalized Internet-based cognitive-behavioral therapy in dialysis patients.

BACKGROUND: Kidney failure and dialysis treatment have a large impact on a patient's life. Patients experience numerous, complex symptoms and usually have multiple comorbid conditions. Despite the multitude of problems, patients often have priorities for improvement of specific aspects of their functioning, which would be helpful for clinicians to become informed of. This highlights a clear need for patient-centered care in this particular patient group, with routine screening as a vital element to timely recognize symptoms and tailored treatment to match individual patients' needs and priorities. By also providing feedback on patient's screening results to the patient itself, the patient is empowered to actively take control in one's mostly uncontrollable disease process. The current paper describes the study design of a multicenter randomized controlled trial evaluating the effectiveness of the "E-HEealth treatment in Long-term Dialysis" (E-HELD) intervention. This therapist-guided Internet-based cognitive-behavioral therapy (ICBT) intervention is focused on and personalized to the myriad of problems that dialysis patients experience and prioritize. METHODS: After a screening procedure on adjustment problems, 130 eligible dialysis patients will be randomized to care as usual or the E-HELD intervention. Patients will complete questionnaires on distress (primary outcome measure), several domains of functioning (e.g., physical, psychological, social), potential predictors and mediators of treatment success, and the cost-effectiveness of the intervention, at baseline, 6-month follow-up, and 12-month follow-up. In addition, to take account of the personalized character of the intervention, the Personalized Priority and Progress Questionnaire (PPPQ) will be administered which is a personalized instrument to identify, prioritize, and monitor individual problems over time. DISCUSSION: The present study design will provide insight in the effectiveness of tailored ICBT in patients with kidney failure who are treated with dialysis. When proven effective, the screening procedure and the subsequent ICBT intervention could be implemented in routine care to detect, support, and treat patients struggling with adjustment problems. TRIAL REGISTRATION: NL63422.058.17 [Registry ID: METC-LDD] NL7160 [Netherlands Trial Register; registered on 16 July 2018].

Detecting and Treating Psychosocial and Lifestyle-Related Difficulties in Chronic Disease: Development and Treatment Protocol of the E-GOAL eHealth Care Pathway.

Many patients with lifestyle-related chronic diseases find it difficult to adhere to a healthy and active lifestyle, often due to psychosocial difficulties. The aim of the current study was to develop an eHealth care pathway aimed at detecting and treating psychosocial and lifestyle-related difficulties that fits the needs and preferences of individual patients across various lifestyle-related chronic diseases. Each intervention component was developed by (1) developing initial versions based on scientific evidence and/or the Behavior Change Wheel; (2) co-creation: acquiring feedback from patients and health professionals; and (3) refining to address users' needs. In the final eHealth care pathway, patients complete brief online screening questionnaires to detect psychosocial and lifestyle-related difficulties, i.e., increased-risk profiles. Scores are visualized in personal profile charts. Patients with increased-risk profiles receive complementary questionnaires to tailor a 3-month guided web-based cognitive behavioral therapy intervention to their priorities and goals. Progress is assessed with the screening tool. This systematic development process with a theory-based framework and co-creation methods resulted in a personalized eHealth care pathway that aids patients to overcome psychosocial barriers and adopt a healthy lifestyle. Prior to implementation in healthcare, randomized controlled trials will be conducted to evaluate its cost-effectiveness and effectiveness on psychosocial, lifestyle, and health-related outcomes.

Predicting health-related quality of life in dialysis patients: Factors related to negative outcome expectancies and social support.

OBJECTIVES: Dialysis patients report a low health-related quality of life (HRQOL) due to high disease burden and far-reaching consequences of dialysis treatment. This study examined several cognitive-behavioral and social factors, with a focus on negative outcome expectancies, that might be relevant for HRQOL in end-stage kidney disease (ESKD) patients treated with dialysis. METHODS: Patients treated with hemodialysis or peritoneal dialysis were recruited from Dutch hospitals and dialysis centers. Patients completed self-report questionnaires at baseline (n = 175) and six months follow-up (n = 130). Multiple regression analyses were performed. RESULTS: Higher scores on factors related to negative outcome expectancies at baseline, especially helplessness and worrying, and less perceived social support were significantly related to worse HRQOL six months later. When controlling for baseline HRQOL, besides sex and comorbidity, helplessness remained significantly predictive of worse HRQOL six months later, indicating that helplessness is associated with changes in HRQOL over time. CONCLUSIONS: Negative outcome expectancies and social support are relevant markers for HRQOL and/or changes in HRQOL over time. PRACTICE IMPLICATIONS: Negative outcome expectancies could be prevented or diminished by enhanced treatment information, an improved patient-clinician relationship, and interventions that promote adaptive and realistic expectations. Additionally, increasing supportive social relationships could be a relevant treatment focus.

Using Personal Genomic Data within Primary Care: A Bioinformatics Approach to Pharmacogenomics.

One application of personalized medicine is the tailoring of medication to the individual, so that the medication will have the highest chance of success. In order to individualize medication, one must have a complete inventory of all current pharmaceutical compounds (a detailed formulary) combined with pharmacogenetic datasets, the genetic makeup of the patient, their (medical) family history and other health-related data. For healthcare professionals to make the best use of this information, it must be visualized in a way that makes the most medically relevant data accessible for their decision-making. Similarly, to enable bioinformatics analysis of these data, it must be prepared and provided through an interface for controlled computational analysis. Due to the high degree of personal information gathered for such initiatives, privacy-sensitive implementation choices and ethical standards are paramount. The Personal Genetic Locker project provides an approach to enable the use of personal genomic data in primary care. In this paper, we provide a description of the Personal Genetic Locker project and show its utility through a use case based on open standards, which is illustrated by the 4MedBox system.