Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey
Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core...
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| Published in | American journal of kidney diseases Vol. 70; no. 4; pp. 464 - 475 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.10.2017
Elsevier |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis.
In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents’ scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated.
1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3.
Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10.
Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively).
The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection.
Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions. |
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| AbstractList | Background Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. Study Design In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents’ scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. Setting & Participants 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3. Outcomes & Measurements Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10. Results Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). Limitations The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. Conclusions Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions. BACKGROUND: Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. STUDY DESIGN: In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. SETTING & PARTICIPANTS: 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round~3. OUTCOMES & MEASUREMENTS: Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score~≥q 8, mean score~≥q 7.5, proportion rating the outcome as critically important~≥q 75%, and median score in the forced ranking question~<~10. RESULTS: Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). LIMITATIONS: The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. CONCLUSIONS: Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions. Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis. In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents’ scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated. 1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3. Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10. Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively). The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection. Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions. Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis.BACKGROUNDSurvival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis.In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated.STUDY DESIGNIn a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated.1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3.SETTING & PARTICIPANTS1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3.Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10.OUTCOMES & MEASUREMENTSOutcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10.Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively).RESULTSPatients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively).The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection.LIMITATIONSThe Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection.Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.CONCLUSIONSPatients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions. |
| Author | Craig, Jonathan C. Howell, Martin Mandayam, Sreedhar Johnson, David W. Pollock, Carol Tugwell, Peter Crowe, Sally Winkelmayer, Wolfgang C. Agar, John Evangelidis, Nicole Polkinghorne, Kevan R. Youssouf, Sajeda Tam-Tham, Helen Ju, Angela Tentori, Francesca Kerr, Peter G. Tong, Allison Sautenet, Benedicte Howard, Kirsten Harris, David C. Hemmelgarn, Brenda Gallagher, Martin Van Biesen, Wim O’Donoghue, Donal Rifkin, Dena E. Hawley, Carmel Manns, Braden McDonald, Stephen P. Harris, Tess Wheeler, David C. |
| Author_xml | – sequence: 1 givenname: Nicole orcidid: 0000-0001-9184-680X surname: Evangelidis fullname: Evangelidis, Nicole email: nicole.evangelidis@sydney.edu.au organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia – sequence: 2 givenname: Allison surname: Tong fullname: Tong, Allison organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia – sequence: 3 givenname: Braden surname: Manns fullname: Manns, Braden organization: Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada – sequence: 4 givenname: Brenda surname: Hemmelgarn fullname: Hemmelgarn, Brenda organization: Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada – sequence: 5 givenname: David C. surname: Wheeler fullname: Wheeler, David C. organization: Centre for Nephrology, University College London, London, United Kingdom – sequence: 6 givenname: Peter surname: Tugwell fullname: Tugwell, Peter organization: Department of Medicine, University of Ottawa, Ottawa, Canada – sequence: 7 givenname: Sally surname: Crowe fullname: Crowe, Sally organization: Crowe Associates, Oxon, United Kingdom – sequence: 8 givenname: Tess surname: Harris fullname: Harris, Tess organization: PKD International, Geneva, Switzerland – sequence: 9 givenname: Wim surname: Van Biesen fullname: Van Biesen, Wim organization: Renal Division, Ghent University Hospital, Ghent, Belgium – sequence: 10 givenname: Wolfgang C. surname: Winkelmayer fullname: Winkelmayer, Wolfgang C. organization: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX – sequence: 11 givenname: Benedicte surname: Sautenet fullname: Sautenet, Benedicte organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia – sequence: 12 givenname: Donal surname: O’Donoghue fullname: O’Donoghue, Donal organization: Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom – sequence: 13 givenname: Helen surname: Tam-Tham fullname: Tam-Tham, Helen organization: Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada – sequence: 14 givenname: Sajeda surname: Youssouf fullname: Youssouf, Sajeda organization: Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom – sequence: 15 givenname: Sreedhar surname: Mandayam fullname: Mandayam, Sreedhar organization: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX – sequence: 16 givenname: Angela surname: Ju fullname: Ju, Angela organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia – sequence: 17 givenname: Carmel surname: Hawley fullname: Hawley, Carmel organization: Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital – sequence: 18 givenname: Carol surname: Pollock fullname: Pollock, Carol organization: Renal Division, Kolling Institute, Sydney, Australia – sequence: 19 givenname: David C. surname: Harris fullname: Harris, David C. organization: Centre for Transplantation and Renal Research, The Westmead Institute for Medical Research, University of Sydney, Westmead, New South Wales, Australia – sequence: 20 givenname: David W. surname: Johnson fullname: Johnson, David W. organization: Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital – sequence: 21 givenname: Dena E. surname: Rifkin fullname: Rifkin, Dena E. organization: Division of Nephrology, University of California, San Diego, CA – sequence: 22 givenname: Francesca surname: Tentori fullname: Tentori, Francesca organization: Arbor Research Collaborative for Health, Ann Arbor, MI – sequence: 23 givenname: John surname: Agar fullname: Agar, John organization: University Hospital Geelong, Geelong, Australia – sequence: 24 givenname: Kevan R. surname: Polkinghorne fullname: Polkinghorne, Kevan R. organization: Monash Medical Centre and Monash University, Clayton, Australia – sequence: 25 givenname: Martin surname: Gallagher fullname: Gallagher, Martin organization: Concord Clinical School, The University of Sydney, Sydney, Australia – sequence: 26 givenname: Peter G. surname: Kerr fullname: Kerr, Peter G. organization: Monash Medical Centre and Monash University, Clayton, Australia – sequence: 27 givenname: Stephen P. surname: McDonald fullname: McDonald, Stephen P. organization: Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia – sequence: 28 givenname: Kirsten surname: Howard fullname: Howard, Kirsten organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia – sequence: 29 givenname: Martin surname: Howell fullname: Howell, Martin organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia – sequence: 30 givenname: Jonathan C. surname: Craig fullname: Craig, Jonathan C. organization: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28238554$$D View this record in MEDLINE/PubMed https://hal.science/hal-03158138$$DView record in HAL |
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| Keywords | Delphi survey well-being surrogate end points Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) core outcome set research priorities vascular access problems Hemodialysis (HD) outcome domains lifestyle-related outcomes trials patient-centered care outcomes mortality quality of life dialysis adequacy cardiovascular disease (CVD) biochemical end point Humans Middle Aged Male Outcome Assessment Young Adult Delphi Technique Adult Female Clinical Trials as Topic International Cooperation Health Care Adolescent Aged Renal Dialysis |
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| Title | Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey |
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