CARD (Comfort Ask Relax Distract) for school-based immunizations in Calgary, Canada: a pragmatic cluster trial.

ABSTRACT: School-based immunizations are fear-inducing events for many students and contribute to vaccine hesitancy. We developed an immunization delivery framework called the CARD (Comfort Ask Relax Distract) system that incorporates evidence-based interventions to improve the experience (eg, reduce fear, pain, dizziness). We evaluated CARD in grades 6 and 9 students in Calgary, Canada. In this pragmatic, hybrid, effectiveness-implementation, cluster trial, we randomized 8 Community Health Centres providing regional immunization services to CARD or control (usual care). In the CARD group, public health staff educated students about CARD and planned processes to reduce fear cues and support student coping choices during immunization. Students self-reported fear, pain, and dizziness during immunization using a 0-10 numerical rating scale; staff recorded procedure details, including vaccines administered, fainting episodes, and coping strategies used. Staff participated in focus groups afterward. Altogether, 8839 children from 105 schools in the 2019 to 2020 school calendar year were included. Fear was lower for CARD (mean = 3.6 [SD = 3.1] vs control 4.1 [3.2]; mean difference = -0.5; 95% confidence interval = -0.74 to -0.21; P < 0.001). Effectiveness persisted after stratification by student gender (male and female) and grade level (grade 6 and grade 9). Other symptoms did not differ. Compared with control, CARD students used peers, privacy, muscle tension, and topical anesthetics more; verbal distraction, deep breathing, and adult support were used less frequently ( P < 0.05, all analyses). Immunization rate did not differ. Staff reported positive to neutral attitudes about CARD. In summary, this pragmatic trial demonstrated that CARD improved the immunization experiences of students at school.

Experiences of community pharmacists administering COVID-19 vaccinations: A qualitative study.

Background: Throughout the COVID-19 pandemic, community pharmacists have played an important role in the provision of patient care, including the delivery of COVID-19 vaccines. The additional workload and related demands arising from these extended services might affect worklife burnout. This qualitative study explored the experiences of Canadian community pharmacists in providing COVID-19 vaccines during the COVID-19 pandemic. Methods: Eighteen community pharmacists across 10 provinces were asked about vaccination processes and perceptions about their role in separate, virtual semistructured interviews. Interviews were transcribed verbatim and analyzed using a deductive approach using the Areas of Worklife Burnout framework, with pharmacists' self-reported descriptions of their activities summarized using the Association of Faculties of Pharmacy of Canada's (AFPC) professional competencies framework. Results: Participants identified aspects of their role that were rewarding and challenging. Some challenges included lack of control, increased workload, inadequate communication, unfair treatment and conflicting values. They described being able to meet challenges and demonstrating resiliency via adaptability, developing communities and valuing their contribution to ending the COVID-19 pandemic. Self-identified AFPC competencies contributing to their ability to manage their worklife included care-provider, professional, leader-manager, collaborator and scholar. Conclusion: Pharmacists accepted their additional responsibility of managing COVID-19 vaccines during the COVID-19 pandemic. However, they expressed some challenges with this role. To ensure sustainability of these services, prioritizing adequate resources, work processes and efficient communication with all relevant stakeholder groups, including public health, government and corporate leaders, is recommended for the future. Can Pharm J (Ott) 2023;156(Suppl):xx-xx.

Integration of CARD (Comfort Ask Relax Distract) for COVID-19 community pharmacy vaccination in children: Effect on implementation outcomes.

Introduction: Community pharmacists report that providing vaccinations can be challenging, particularly if the vaccine recipient is a child, because of heightened levels of fear. The objective of this study was to determine acceptability and feasibility of the CARD (Comfort Ask Relax Distract) system as a vaccination delivery framework for children receiving COVID-19 vaccinations in a community pharmacy setting. CARD incorporates evidence-based interventions that reduce fear and immunization stress-related responses in vaccine recipients and was demonstrated to be effective and feasible in other vaccination settings providing vaccinations to children and adults. Methods: This mixed-methods study involved 5 independent pharmacies (with 6 vaccinators) offering COVID-19 vaccinations to children between 5 and 11 years of age. Vaccinating staff and implementation leads from the pharmacy organization participated in a small-scale CARD implementation project (before-and-after design). Afterwards, they filled in quantitative surveys and provided qualitative feedback about their perceptions and experiences in focus group discussions. Qualitative data were analyzed deductively, using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted between January 16 and March 20, 2022. Across both quantitative and qualitative measures, vaccinating staff reported positive attitudes about CARD and alignment with their professional roles. They reported that CARD reduced children's fear and improved the vaccination experiences in children and parents and for themselves. Vaccinators reported increased confidence due to CARD. They reported compatibility of CARD interventions within their practice and that it was time neutral. They maintained use of some interventions after the study. They also provided suggestions and shared concerns about fidelity and future feasibility of continuing various components of the program. Conclusion: CARD was demonstrated to be acceptable and feasible by vaccinators performing vaccinations in children in community pharmacies.

Community pharmacists' perceptions of the CARD (Comfort Ask Relax Distract) system for use during vaccinations.

Introduction: We explored Canadian community pharmacists' perceptions of the CARD (Comfort Ask Relax Distract) system, a vaccine delivery framework that integrates evidence-based interventions that reduce immunization stress-related responses (ISRRs). The objective was to introduce CARD to pharmacists and obtain their feedback to guide future implementation efforts for community pharmacy-based vaccinations. Methods: Eighteen pharmacists across all provinces participated in one-on-one moderated virtual interviews. A semistructured interview guide was used to guide the discussion and included questions about experiences with coronavirus disease 2019 (COVID-19) vaccine administration and perceptions of CARD as a framework for vaccination delivery in the pharmacy. In this report, we focus on feedback about CARD. Interviews were audio-recorded and transcribed verbatim and deductively coded using the Consolidated Framework for Implementation Research (CFIR). Results: The study was conducted from May 28 to August 16, 2021. Pharmacists' responses were categorized in 3 CFIR domains: intervention characteristics, inner setting and characteristics of individuals. Overall, pharmacists were receptive towards CARD and thought it filled a current gap in practice, particularly for childhood vaccinations. Pharmacists reported learning techniques to make vaccinations more comfortable for their clients. They provided feedback on how specific interventions could be adapted for their practice (e.g., dissemination of client-directed education via appointment booking portals, provision of distraction items in waiting and vaccinating spaces). Discussion: This study provided preliminary evidence that pharmacists found CARD acceptable and appropriate for community pharmacy-based vaccinations. The data collected from this study were used to inform a small-scale implementation project with CARD during COVID-19 vaccine administration in children aged 5 to 11 years.

CARD (Comfort Ask Relax Distract) for community pharmacy vaccinations in children: Effect on immunization stress-related responses and satisfaction.

Introduction: CARD (Comfort Ask Relax Distract) is a vaccine delivery program demonstrated to reduce pain, fear and associated immunization stress-related responses (ISRR) in children undergoing vaccinations at school. This study evaluated CARD's clinical impact when integrated into community pharmacy-based pediatric vaccinations. Methods: This was a before-and-after CARD implementation study in 5 independent pharmacies offering COVID-19 vaccinations to children aged 5-11 years. No changes were made to practices in the "before" phase. CARD interventions were integrated in the "after" phase (e.g., children prepared a coping plan using a checklist, distraction toolkits were placed in waiting and vaccination spaces, vaccinations were performed with privacy, needles were obscured). Children self-reported ISRR, including fear, pain and dizziness during vaccination, and both children and parents/caregivers (herein, parents) compared the child's experience to their last needle (better, same, worse). In the "after" phase, parents and children reported how much CARD helped (not at all, a little bit, a moderate amount, a lot). Results: The study was conducted between January 16 and March 20, 2022. Altogether, 152 children participated (71 before and 81 after CARD); demographic characteristics did not differ. Children's self-reported fear was lower after CARD, when assessed continuously (2.5 vs 3.7 out of 10; p = 0.02) or dichotomously, using a cut-off of 0 vs >0 (58% vs 80%; p = 0.01). Pain was lower when assessed dichotomously (<2 vs ≥2; p = 0.03). There was no difference in dizziness. After CARD, children and parents reported more positive experiences compared to the child's last needle (p = 0.01, both analyses) and more children and parents reported that distraction and child participation in the process were helpful (p < 0.001, both analyses). Overall, 92% of children and 91% of parents said CARD helped. Conclusion: CARD reduced children's fear and improved vaccination experiences for children and parents when integrated in community pharmacy-based vaccinations.

Prevalence of pain and fear as barriers to vaccination in children - Systematic review and meta-analysis.

BACKGROUND: Injection-related pain and fear are common adverse reactions in children undergoing vaccination and influence vaccine acceptance. Despite the large body of literature on sources of vaccine non-compliance, there is no estimate of the prevalence of pain and fear as contributing factors. The objective was to estimate the prevalence of injection pain or fear of needles as barriers to childhood (i.e., 0-18 years) vaccination. METHODS: Four databases were searched from inception for relevant English and French articles until August 2021. In addition, the references of recent systematic reviews and all articles included in the review were hand searched. Article screening and data extractions were performed in duplicate. Studies were included if they reported on injection-related pain or fear of needles in children (0-18 years) using a checklist/closed-ended question(s). Results were stratified by respondent (parents or children), type of pediatric population (general or under-vaccinated), and relative importance of barrier (pain or needle fear as primary reason or any reason for under-vaccination). Prevalence rates of pain or needle fear were combined using a random effects model. Quality of included studies was assessed using the Joanna Briggs Institute critical appraisal checklist for prevalence data. Quality across studies was assessed using GRADE. RESULTS: There were 26 studies with 45 prevalence estimates published between 1995 and 2021. For parent reports (of children) and children self-reported reasons for non-compliance, prevalence rates of pain or needle fear ranged from 5 to 13% in a general population and 8 to 28% in an under-vaccinated population, with a substantial variation in the prevalence estimates. There was no difference between category of respondent or relative importance on pain or needle fear prevalence rate. A regression model demonstrated an overall prevalence rate of pain or needle fear as an obstacle to vaccination of 8% in the general population and 18.3% in the under-vaccinated population. All evidence was very low in quality. CONCLUSION: This is the first review to systematically quantify the prevalence and therefore, importance, of pain and needle fear as obstacles to vaccination in children around the world. Pain from injection or fear of needles were demonstrated to be sufficiently prevalent as barriers to vaccination in children to warrant attention. Addressing pain and fear has the potential to significantly improve vaccination acceptance.

Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial.

BACKGROUND: The CARD (Comfort Ask Relax Distract) system is a vaccine delivery framework that integrates evidence-based interventions to reduce stress-related responses and improve the vaccination experience for children undergoing vaccinations at school. In preliminary studies, CARD was acceptable and effective. The objective was to evaluate CARD in a large, pragmatic trial to confirm its effectiveness in real-world settings. METHODS: Hybrid effectiveness-implementation cluster randomized trial in schools receiving vaccination services from Wellington-Dufferin-Guelph Public Health. Forty schools with grade 7 students (12 years old) were randomized to CARD and control (n = 20/group). Nurses in CARD schools planned clinics with principals and educated students about CARD ahead of time. Principals disseminated information to staff and parents and sent reminders. Vaccination day processes minimized fear and facilitated student self-selected coping strategies. Nurses in control schools followed usual practices, which excluded principal meetings, education, reminders, and systematic integration of fear-reducing or child-selected coping strategies. Outcomes included stress-related symptoms (fear - primary outcome, pain, dizziness, fainting, post-vaccination reactions), use of coping interventions, vaccination uptake, attitudes and implementation outcomes (acceptability, appropriateness, feasibility, fidelity). RESULTS: Altogether, 1919 students were included. Fear and pain were lower in CARD schools: OR 0.65 (95% CI 0.47-0.90) and OR 0.62 (95% CI 0.50-0.77), respectively. No students fainted in CARD schools compared to 0.8% in control (p = 0.02). Dizziness and post-vaccination reactions did not differ. Student-led coping interventions were used more frequently in CARD schools. Vaccination uptake was 76.1% in CARD schools and 72.5% in control schools (OR 1.13 (95% CI 0.85-1.50)). Staff and students had positive attitudes about CARD and implementation outcomes; however, recommendations were made to improve fidelity. DISCUSSION: CARD reduced stress-related responses in students undergoing vaccinations at school and was positively received by students and public health staff. CARD is recommended to improve the quality of vaccination delivery services. TRIAL REGISTRATION: NCT03966300.

Establishing a core outcome measure for pain in patients with autosomal dominant polycystic kidney disease: a consensus workshop report.

BACKGROUND: Pain is the highest prioritized patient-reported outcome in people with autosomal dominant polycystic kidney disease (ADPKD) but remains infrequently and inconsistently measured in clinical trials and poorly managed in clinical settings. A recently completed systematic review of pain in ADPKD identified 26 different outcome measures. None of these measures were considered appropriate as a core outcome measure due to the lack of patient-important dimensions, inadequate content, relatively long duration of completion time and limited evidence to support psychometric robustness. METHODS: We convened an international Standardized Outcomes in Nephrology-Polycystic Kidney Disease consensus workshop involving 21 patients/caregivers and 40 health professionals (clinicians, nurses, researchers, policy makers and industry representatives) from 18 countries to discuss the identification or development of a core outcome measure for pain. RESULTS: Four themes were identified highlighting fundamental issues for the measurement of pain in ADPKD: distressing and disrupting life participation; variability and ambiguity in defining pain; stigma, frustration and adaptation to pain; and ensuring validity and feasibility of pain measures. CONCLUSIONS: Existing measures were found to be insufficient in capturing pain as a core outcome and there was consensus on the need for a new validated measure that is simple, succinct and addresses the impact of pain on life participation. This measure will facilitate the appropriate prioritization of pain in all trials and guide clinical decision making in people with ADPKD.

A Focus Group Study of Self-Management in Patients With Glomerular Disease.

INTRODUCTION: Patients with glomerular disease experience symptoms that impair their physical and mental health while managing their treatments, diet, appointments and monitoring general and specific indicators of health and their illness. We sought to describe the perspectives of patients and their care partners on self-management in glomerular disease. METHODS: We conducted 16 focus groups involving adult patients with glomerular disease (n = 101) and their care partners (n = 34) in Australia, Hong Kong, the United Kingdom, and United States. Transcripts were analyzed thematically. RESULTS: We identified the following 4 themes: empowered in autonomy (gaining confidence through understanding, taking ownership of disease and treatment, learning a positive health approach); overwhelmed by compounding treatment burdens (financially undermined and depleted, demoralized by side effects and harms, frustrated by fragmented and inflexible care, fear of possible drug harms); striving for stability and normalcy (making personal sacrifices, maximizing life participation, attentiveness to bodily signs, avoiding precarious health states, integrating medicines into routines); and necessity of health-sustaining relationships (buoyed by social support, fulfilling meaningful responsibilities, sharing and normalizing experiences, seeking a trusting and respectful alliance). CONCLUSION: Patients with glomerular disease and their care partners value their capacity for autonomy and disease ownership, stability of their health, and relationships that support self-management. Strategies directed at strengthening these factors may increase self-efficacy and improve the care and outcomes for patients with glomerular disease.

A Core Outcome Set for Trials in Glomerular Disease: A Report of the Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) Stakeholder Workshops.

BACKGROUND AND OBJECTIVES: Outcomes reported in trials in adults with glomerular disease are often selected with minimal patient input, are heterogeneous, and may not be relevant for clinical decision making. The Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) initiative aimed to establish a core outcome set to help ensure that outcomes of critical importance to patients, care partners, and clinicians are consistently reported. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: We convened two 1.5-hour workshops in Melbourne, Australia, and Washington, DC, United States. Attendees were identified purposively with 50 patients/care partners and 88 health professionals from 19 countries; 51% were female. Patients and care partners were from the United States, Australia, and Canada, and had experience of a glomerular disease with systemic features (n=9), kidney-limited nephrotic disease (n=9), or other kidney-limited glomerular disease (n=8). Attendees reviewed the results of the SONG-GD Delphi survey and aims of the workshop and then discussed potential core outcomes and their implementation in trials among moderated breakout groups of eight to 12 people from diverse backgrounds. Transcripts of discussions were analyzed thematically. RESULTS: Three themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (i.e., applicable across diverse populations and settings). The fourth theme, preparedness for implementation, included engaging with funders and regulators, establishing reliable and validated measures, and leveraging existing endorsements for patient-reported outcomes. CONCLUSIONS: Workshop themes demonstrated support for kidney function, disease activity, death, life participation, and cardiovascular disease, and these were established as the core outcomes for trials in adults with glomerular disease. Future work is needed to establish the core measures for each domain, with funders and regulators central to the uptake of the core outcome set in trials.

Development of an international Delphi survey to establish core outcome domains for trials in adults with glomerular disease.

Outcomes relevant to treatment decision-making are inconsistently reported in trials involving glomerular disease. Here, we sought to establish a consensus-derived set of critically important outcomes designed to be reported in all future trials by using an online, international two-round Delphi survey in English. To develop this, patients with glomerular disease, caregivers and health professionals aged 18 years and older rated the importance of outcomes using a Likert scale and a Best-Worst scale. The absolute and relative importance was assessed and comments were analyzed thematically. Of 1198 participants who completed Round 1, 734 were patients/caregivers while 464 were health care professionals from 59 countries. Of 700 participants that completed Round 2, 412 were patients/caregivers and 288 were health care professionals. Need for dialysis or transplant, kidney function, death, cardiovascular disease, remission-relapse and life participation were the most important outcomes to patients/caregivers and health professionals. Patients/caregivers rated patient-reported outcomes higher while health care professionals rated hospitalization, death and remission/relapse higher. Four themes explained the reasons for their priorities: confronting death and compounded suffering, focusing on specific targets in glomerular disease, preserving meaning in life, and fostering self-management. Thus, consistent reporting of these critically important outcomes in all trials involving glomerular disease is hoped to improve patient-centered decision-making.

Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial.

BACKGROUND: Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada. METHODS: In a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student's choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™. RESULTS: Nine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation. CONCLUSION: While most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov ( NCT03948633 ); Submitted April 24, 2019.

Establishing a Core Outcome Set for Autosomal Dominant Polycystic Kidney Disease: Report of the Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Consensus Workshop.

The omission of outcomes that are of relevance to patients, clinicians, and regulators across trials in autosomal dominant polycystic kidney disease (ADPKD) limits shared decision making. The Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Initiative convened an international consensus workshop on October 25, 2018, to discuss the identification and implementation of a potential core outcome set for all ADPKD trials. This article summarizes the discussion from the workshops and the SONG-PKD core outcome set. Key stakeholders including 11 patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, and researchers) attended the workshop. Four themes emerged: "Relevance of trajectory and impact of kidney function" included concerns about a patient's prognosis and uncertainty of when they may need to commence kidney replacement therapy and the lack of an early prognostic marker to inform long-term decisions; "Discerning and defining pain specific to ADPKD" highlighted the challenges in determining the origin of pain, adapting to the chronicity and repeated episodes of pain, the need to place emphasis on pain management, and to have a validated measure for pain; "Highlighting ADPKD consequences" encompassed cyst-related complications and reflected patient's knowledge because of family history and the hereditary nature of ADPKD; and "Risk for life-threatening but rare consequences" such as cerebral aneurysm meant considering both frequency and severity of the outcome. Kidney function, mortality, cardiovascular disease, and pain were established as the core outcomes for ADPKD.

'A sword of Damocles': patient and caregiver beliefs, attitudes and perspectives on presymptomatic testing for autosomal dominant polycystic kidney disease: a focus group study.

BACKGROUND AND OBJECTIVES: Presymptomatic testing is available for early diagnosis of hereditary autosomal dominant polycystic kidney disease (ADPKD). However, the complex ethical and psychosocial implications can make decision-making challenging and require an understanding of patients' values, goals and priorities. This study aims to describe patient and caregiver beliefs and expectations regarding presymptomatic testing for ADPKD. DESIGN, SETTING AND PARTICIPANTS: 154 participants (120 patients and 34 caregivers) aged 18 years and over from eight centres in Australia, France and Korea participated in 17 focus groups. Transcripts were analysed thematically. RESULTS: We identified five themes: avoiding financial disadvantage (insecurity in the inability to obtain life insurance, limited work opportunities, financial burden); futility in uncertainty (erratic and diverse manifestations of disease limiting utility, taking preventive actions in vain, daunted by perplexity of results, unaware of risk of inheriting ADPKD); lacking autonomy and support in decisions (overwhelmed by ambiguous information, medicalising family planning, family pressures); seizing control of well-being (gaining confidence in early detection, allowing preparation for the future, reassurance in family resilience); and anticipating impact on quality of life (reassured by lack of symptoms, judging value of life with ADPKD). CONCLUSIONS: For patients with ADPKD, presymptomatic testing provides an opportunity to take ownership of their health through family planning and preventive measures. However, these decisions can be wrought with tensions and uncertainty about prognostic implications, and the psychosocial and financial burden of testing. Healthcare professionals should focus on genetic counselling, mental health and providing education to patients' families to support informed decision-making. Policymakers should consider the cost burden and risk of discrimination when informing government policies. Finally, patients are recommended to focus on self-care from an early age.

Student Feedback to Tailor the CARD™ System for Improving the Immunization Experience at School.

Increasing the comfort of vaccine delivery at school is needed to improve the immunization experience for students. We created the CARD™ (C-Comfort, A-Ask, R-Relax and D-Distract) system to address this clinical care gap. Originally designed for grade 7 students, this study examined the perceptions of grade 9 students of CARD™. Grade 9 students who had experience with school-based immunizations, either as recipients or onlookers (n = 7; 100% females 14 years old) participated. Students answered pre-post surveys, reviewed CARD™ educational materials and participated in a semi-structured focus group discussion. The Consolidated Framework for Implementation Research (CFIR) was used as the framework for analysis of qualitative data. Participants reported positive perceptions of CARD™ educational materials and that CARD™ could fit into the school immunization process. CARD™ improved knowledge about effective coping interventions and was recommended for education of both nurses and students. The results provide preliminary evidence that CARD™ is acceptable and appropriate for implementation in grade 9 school-based immunizations.

Establishing core outcome domains in pediatric kidney disease: report of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-KIDS) consensus workshops.

Trials in children with chronic kidney disease do not consistently report outcomes that are critically important to patients and caregivers. This can diminish the relevance and reliability of evidence for decision making, limiting the implementation of results into practice and policy. As part of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-Kids) initiative, we convened 2 consensus workshops in San Diego, California (7 patients, 24 caregivers, 43 health professionals) and Melbourne, Australia (7 patients, 23 caregivers, 49 health professionals). This report summarizes the discussions on the identification and implementation of the SONG-Kids core outcomes set. Four themes were identified; survival and life participation are common high priority goals, capturing the whole child and family, ensuring broad relevance across the patient journey, and requiring feasible and valid measures. Stakeholders supported the inclusion of mortality, infection, life participation, and kidney function as the core outcomes domains for children with chronic kidney disease.

Developing Consensus-Based Outcome Domains for Trials in Children and Adolescents With CKD: An International Delphi Survey.

RATIONALE & OBJECTIVE: The inconsistency in outcomes reported and lack of patient-reported outcomes across trials in children with chronic kidney disease (CKD) limits shared decision making. As part of the Standardized Outcomes in Nephrology (SONG)-Kids initiative, we aimed to generate a consensus-based prioritized list of critically important outcomes to be reported in all trials in children with CKD. STUDY DESIGN: An online 2-round Delphi survey in English, French, and Hindi languages. SETTINGS & PARTICIPANTS: Patients (aged 8-21 years), caregivers/family, and health care professionals (HCPs) rated the importance of outcomes using a 9-point Likert scale (7-9 indicating critical importance) and completed a Best-Worst Scale. ANALYTICAL APPROACH: We assessed the absolute and relative importance of outcomes. Comments were analyzed thematically. RESULTS: 557 participants (72 [13%] patients, 132 [24%] caregivers, and 353 [63%] HCPs) from 48 countries completed round 1 and 312 (56%) participants (28 [40%] patients, 64 [46%] caregivers, and 220 [56%] HCPs) completed round 2. Five outcomes were common in the top 10 for each group: mortality, kidney function, life participation, blood pressure, and infection. Caregivers and HCPs rated cardiovascular disease higher than patients. Patients gave lower ratings to all outcomes compared with caregivers/HCPs except they rated life participation (round 2 mean difference, 0.1), academic performance (0.1), mobility (0.4), and ability to travel (0.4) higher than caregivers and rated ability to travel (0.4) higher than HCPs. We identified 3 themes: alleviating disease and treatment burden, focusing on the whole child, and resolving fluctuating and conflicting goals. LIMITATIONS: Most participants completed the survey in English. CONCLUSIONS: Mortality, life participation, kidney function, and blood pressure were consistently highly prioritized by patients, caregivers, and HCPs. Patients gave higher priority to some lifestyle-related outcomes compared with caregivers/HCPs. Establishing critically important outcomes for all trials in children with CKD may improve consistent reporting of survival, kidney health, and clinical and life impact outcomes that are meaningful for decision making.

Identifying Outcomes Important to Patients with Glomerular Disease and Their Caregivers.

BACKGROUND AND OBJECTIVES: Shared decision making in patients with glomerular disease remains challenging because outcomes important to patients remain largely unknown. We aimed to identify and prioritize outcomes important to patients and caregivers and to describe reasons for their choices. DESIGN: , setting, participants, & measurementsWe purposively sampled adult patients with glomerular disease and their caregivers from Australia, Hong Kong, the United Kingdom, and the United States. Participants identified, discussed, and ranked outcomes in focus groups using the nominal group technique; a relative importance score (between zero and one) was calculated. Qualitative data were analyzed thematically. RESULTS: Across 16 focus groups, 134 participants (range, 19-85 years old; 51% women), including 101 patients and 33 caregivers, identified 58 outcomes. The ten highest-ranked outcomes were kidney function (importance score of 0.42), mortality (0.29), need for dialysis or transplant (0.22), life participation (0.18), fatigue (0.17), anxiety (0.13), family impact (0.12), infection and immunity (0.12), ability to work (0.11), and BP (0.11). Three themes explained the reasons for these rankings: constraining day-to-day experience, impaired agency and control over health, and threats to future health and family. CONCLUSIONS: Patients with glomerular disease and their caregivers highly prioritize kidney health and survival, but they also prioritize life participation, fatigue, anxiety, and family impact.

Core Outcome Domains for Trials in Autosomal Dominant Polycystic Kidney Disease: An International Delphi Survey.

RATIONALE & OBJECTIVE: Outcomes reported in trials involving patients with autosomal dominant polycystic kidney disease (ADPKD) are heterogeneous and rarely include patient-reported outcomes. We aimed to identify critically important consensus-based core outcome domains to be reported in trials in ADPKD. STUDY DESIGN: An international 2-round online Delphi survey was conducted in English, French, and Korean languages. SETTING & PARTICIPANTS: Patients/caregivers and health professionals completed a 9-point Likert scale (7-9 indicating critical importance) and a Best-Worst Scale. ANALYTICAL APPROACH: The absolute and relative importance of outcomes were assessed. Comments were analyzed thematically. RESULTS: 1,014 participants (603 [60%] patients/caregivers, 411 [40%] health professionals) from 56 countries completed round 1, and 713 (70%) completed round 2. The prioritized outcomes were kidney function (importance score, 8.6), end-stage kidney disease (8.6), death (7.9), blood pressure (7.9), kidney cyst size/growth (7.8), and cerebral aneurysm (7.7). Kidney cyst-related pain was the highest rated patient-reported outcome by both stakeholder groups. Seven themes explained the prioritization of outcomes: protecting life and health, directly encountering life-threatening and debilitating consequences, specificity to ADPKD, optimizing and extending quality of life, hidden suffering, destroying self-confidence, and lost opportunities. LIMITATIONS: Study design precluded involvement from those without access to internet or limited computer literacy. CONCLUSIONS: Kidney function, end-stage kidney disease, and death were the most important outcomes to patients, caregivers, and health professionals. Kidney cyst-related pain was the highest rated patient-reported outcome. Consistent reporting of these top prioritized outcomes may strengthen the value of trials in ADPKD for decision making.