Emma O'Lone1,2, Martin Howell1,2, Andrea K Viecelli3,4, Jonathan C Craig5, Allison Tong1,2, Benedicte Sautenet6,7,8, William G Herrington9, Charles A Herzog10, Tazeen H Jafar11,12,13, Meg Jardine14,15, Vera Krane16, Adeera Levin17, Jolanta Malyszko18, Michael V Rocco19, Giovanni Strippoli1,2,20,21,22, Marcello Tonelli23, Angela Yee-Moon Wang24, Christoph Wanner16, Faiez Zannad25, Wolfgang C Winkelmayer26, David C Wheeler27. 1. Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia. 2. Centre for Kidney Research, Children's Hospital at Westmead, Sydney, NSW, Australia. 3. Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. 4. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia. 5. College of Medicine and Health, Flinders University, Adelaide, SA, Australia. 6. Department of Nephrology and Clinical Immunology, Tours University, Tours, France. 7. Department of Nephrology-Hypertension, Dialysis, Renal Transplantation, Tours Hospital, Tours, France. 8. INSERM U1246, Tours, France. 9. Nuffield Department of Population Health, University of Oxford, Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Oxford, UK. 10. Department of Medicine, Division of Cardiology, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USA. 11. Program in Health Services and Systems Research, Duke-NUS Graduate Medical School, Singapore. 12. Department of Renal Medicine, Singapore General Hospital, Singapore. 13. Department of Medicine, Section of Nephrology, Aga Khan University, Karachi, Pakistan. 14. George Institute for Global Health, Sydney, NSW, Australia. 15. Concord Repatriation General Hospital, Sydney, NSW, Australia. 16. Department of Medicine I, Division of Nephrology, University Hospital, Würzburg, Germany. 17. Division of Nephrology, University of British Columbia, Vancouver, BC, Canada. 18. Department of Nephrology, Dialysis and Internal Medicine Warsaw Medical University, Warsaw, Poland. 19. Wake Forest School of Medicine, Section on Nephrology, Winston-Salem, NC, USA. 20. Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 21. Medical Scientific Office, Diaverum Sweden AB, Lund, Sweden. 22. Diaverum Academy, Bari, Italy. 23. Department of Medicine, Division of Nephrology, University of Calgary, Calgary, AB, Canada. 24. Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, PR China. 25. Université de Lorraine, Inserm CIC 1433 and INI-CRCT, CHU, Nancy, France. 26. Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX, USA. 27. Department of Renal Medicine, University College London, London, UK.
Abstract
BACKGROUND: Cardiovascular disease (CVD) is a major contributor to morbidity and mortality in people on hemodialysis (HD). Cardiovascular outcomes are reported infrequently and inconsistently across trials in HD. This study aimed to identify the priorities of patients/caregivers and health professionals (HPs) for CVD outcomes to be incorporated into a core outcome set reported in all HD trials. METHODS: In an international online survey, participants rated the absolute importance of 10 cardiovascular outcomes (derived from a systematic review) on a 9-point Likert scale, with 7-9 being critically important. The relative importance was determined using a best-worst scale. Likert means, medians and proportions and best-worst preference scores were calculated for each outcome. Comments were thematically analyzed. RESULTS: Participants included 127 (19%) patients/caregivers and 549 (81%) HPs from 53 countries, of whom 530 (78%) completed the survey in English and 146 (22%) in Chinese. All but one cardiovascular outcome ('valve replacement') was rated as critically important (Likert 7-9) by all participants; 'sudden cardiac death', 'heart attack', 'stroke' and 'heart failure' were all rated at the top by patients/caregivers (median Likert score 9). Patients/caregivers ranked the same four outcomes as the most important outcomes with mean preference scores of 6.2 (95% confidence interval 4.8-7.5), 5.9 (4.6-7.2), 5.3 (4.0-6.6) and 4.9 (3.6-6.3), respectively. The same four outcomes were ranked most highly by HPs. We identified five themes underpinning the prioritization of outcomes: 'clinical equipoise and potential for intervention', 'specific or attributable to HD', 'severity or impact on the quality of life', 'strengthen knowledge and education', and 'inextricably linked burden and risk'. CONCLUSIONS: Patients and HPs believe that all cardiovascular outcomes are of critical importance but consistently identify sudden cardiac death, myocardial infarction, stroke and heart failure as the most important outcomes to be measured in all HD trials.
BACKGROUND:Cardiovascular disease (CVD) is a major contributor to morbidity and mortality in people on hemodialysis (HD). Cardiovascular outcomes are reported infrequently and inconsistently across trials in HD. This study aimed to identify the priorities of patients/caregivers and health professionals (HPs) for CVD outcomes to be incorporated into a core outcome set reported in all HD trials. METHODS: In an international online survey, participants rated the absolute importance of 10 cardiovascular outcomes (derived from a systematic review) on a 9-point Likert scale, with 7-9 being critically important. The relative importance was determined using a best-worst scale. Likert means, medians and proportions and best-worst preference scores were calculated for each outcome. Comments were thematically analyzed. RESULTS:Participants included 127 (19%) patients/caregivers and 549 (81%) HPs from 53 countries, of whom 530 (78%) completed the survey in English and 146 (22%) in Chinese. All but one cardiovascular outcome ('valve replacement') was rated as critically important (Likert 7-9) by all participants; 'sudden cardiac death', 'heart attack', 'stroke' and 'heart failure' were all rated at the top by patients/caregivers (median Likert score 9). Patients/caregivers ranked the same four outcomes as the most important outcomes with mean preference scores of 6.2 (95% confidence interval 4.8-7.5), 5.9 (4.6-7.2), 5.3 (4.0-6.6) and 4.9 (3.6-6.3), respectively. The same four outcomes were ranked most highly by HPs. We identified five themes underpinning the prioritization of outcomes: 'clinical equipoise and potential for intervention', 'specific or attributable to HD', 'severity or impact on the quality of life', 'strengthen knowledge and education', and 'inextricably linked burden and risk'. CONCLUSIONS:Patients and HPs believe that all cardiovascular outcomes are of critical importance but consistently identify sudden cardiac death, myocardial infarction, stroke and heart failure as the most important outcomes to be measured in all HD trials.
Authors: Erica Musgrove; Loretta Gasparini; Katie McBain; Susan A Clifford; Simon A Carter; Helena Teede; Melissa Wake Journal: Pediatr Res Date: 2021-12-17 Impact factor: 3.953