NN&I Article on SONG-HD Initiative shows disparity between patients and medical professionals on desired outcomes by David L. Rosenbloom

SONG-HD Initiative shows disparity between patients and medical professionals on desired outcomes

A new international consortium of medical professionals, academic researchers, and dialysis patients and their care partners has determined that treatment outcomes most sought by patients are not supported by the bulk of medical research done in the nephrology field.

The SONG-HD (Standardized Outcomes in Nephrology—Hemodialysis) survey project is the first time patient preference in research outcomes has been considered on a large, international scale and given equal consideration with those of medical professionals. The study involved 1,181 participants from 73 countries over three rounds of a Delphi study where patients, caregivers, and health professionals ranked desired outcomes on a 9-point Likert scale. Twenty desired health outcomes were charted in the final results.1

Table 1 and the accompanying chart (Fig. 3) from the SONG-HD report shows that with few exceptions, patients and health professional are far apart in understanding what outcomes matter most.2

What outcomes are important to dialysis patients?

In hemodialysis, biochemical markers such as serum phosphorus, calcium, and parathyroid hormone levels are commonly reported but are not strongly and consistently associated with mortality, cardiovascular disease or quality of life. Hemodialysis patients and their caregivers prioritize outcomes relevant to their well-being and quality of lifestyle, factors usually absent as outcomes reported in clinical trials. These priorities often include empowerment, independence, social acceptance, concerns for family and care partners, normality, free time from dialysis, and freedom to travel. 3-7

At the start of the SONG-HD Initiative, the consortium reviewed research outcomes over the last 15 years. This period had an alarming growth in the number of new dialysis patients, which in turn led to a plethora of studies. The Cochrane Renal Group Specialized Register shows that from 2004 to 2014, there were 1,500 randomized, controlled trials in hemodialysis.8Yet there has been very limited improvement in clinical, quality-of-life, and mortality outcomes for dialysis patients.9-10 

In 2014, the Lancet reported that 85% of the $240 billion expended on health research in 2010 was wasted because of problems in the design, conduct, analysis and reporting of research, much of which ignored patient’s non-medical needs.11

Chronic kidney disease is all about loss and the life-changing deprivations kidney dialysis brings. Today, CKD is a leading contributor of mortality and morbidity the world over 12-14 and its standard form of treatment, 3-times-per-week in-center dialysis, has proven to be inadequate to rehabilitate people with kidney failure. Patients on dialysis have an annual mortality rate 15-100 times higher than that of the general population.15-18 And studies consistently show that dialysis patients report a significant loss in quality of life, even greater than people with metastatic cancer and other chronic diseases.19-20

SONG is designed to help establish consensus on a prescribed list of dialysis outcomes most desired by health care professionals and patients, to which future randomized trials and other research on dialysis should adhere. It is based on the precept that patient-centered care involves shared decision making, which takes into account patients’ priorities and values as well as the biomedical goals of the clinician.

The initiative takes its cue from the success of the Outcome Measures in Rheumatology (OMERACT) initiative which began in 1992. OMERACT outcomes have improved the reporting and relevance of outcomes in rheumatology trials and its methodology has been applied successfully in cancer, middle ear infection, eczema, and chronic pain. Both the World Health Organization and the U.S. Food and Drug Administration have endorsed OMERACT outcomes. In 2010, the international Core Outcome Measures in Effectiveness Trials (COMET) organization was launched to facilitate the development and application of core outcome sets.21-29

Core outcome sets represent the minimum that should be measured and reported in all clinical trials for a specific condition. While they are not meant to be definitive, the intention is that the core outcomes be collected and reported to allow the results of trials and other studies to be compared, contrasted, and combined as appropriate; researchers are at liberty to collect and explore other outcomes. A core outcome set does not exist for CKD.

Phases of the initiative

SONG-HD is a five-phase, multi-method project that includes systematic reviews, focus groups, semi-structured interviews, Delphi surveys with best-worst/choice experiments, and a consensus workshop.

In Phase 1, SONG-HD reviewed 265 research trials published in Cochrane, involving 19,393 patients on hemodialysis. In those trials, 1,507 different outcomes were reported with a mean of 12 outcomes per trial. Biochemical outcomes were most frequently reported (e.g. phosphorus, calcium, hemoglobin, parathyroid hormone measurements).30

In Phase 2, 58 hemodialysis patients and 24 care partners from 11 dialysis units in Sydney and Melbourne, Australia, and Calgary, Canada identified, defined, and ranked outcomes they considered important. The top 10 were:

1) Fatigue/energy

2) Resilience/coping

3) Ability to travel

4) Dialysis-free time

5) Impact on family

6) Ability to work

7) Sleep

8) Anxiety/stress

9) Drop in blood pressure

10) Lack of appetite

In interviews with participants in Phase 3, patients spoke openly about not fully understanding the biomedical markers so valued by nephrologists, like potassium and phosphate levels or clearance formulas. Instead, they wanted to maintain as normal a life as possible while on dialysis. Mortality was not high on their list of priorities as they live with death daily; they were more concerned about the quality of the life left to them than their longevity.31

Phase 4: The Delphi survey

The Delphi method, developed at the beginning of the Cold War to forecast the impact of technology on warfare, is based on the principle that decisions from a structured group of individuals are more accurate than those from unstructured groups.32

In a typical Delphi survey, participants are asked to give their opinions over several rounds, until a consensus emerges. The mean (average) or median scores of the final rounds determine the results. All participants remain anonymous, even after completion of the final report, to prevent the personality or reputation of some participants from dominating others. Arguably, anonymity also frees participants from their personal biases, allows free expression of opinions, encourages open critique, and facilitates admission of errors when revising earlier judgments.33-35

Approximately 200+ patients and caregivers, along with more than 1,100 health professionals (nephrologists, surgeons, nurses, allied health care professionals, researchers, policy makers and people from industry), took part in the three rounds of the SONG-HD Delphi survey. There was a similar proportion of males and females, and a wide range of ages (18 years to over 81 years). Round 1 participants were from 73 countries and began by ranking 34 desired HD outcomes on a scale of 1 (least important) to 9 (critical). In Round 2, five outcomes with medians <7 were excluded, leaving 29 to rank. In Round 3, nine outcomes with a median <7 were excluded, leaving 20 to rank. Outcomes that were removed are still important—but not of critical importance to both patients and health professionals.36

Core outcomes

Consensus was defined a priority based on the OMERACT definition using proportion scores. However, because most participants rated all outcomes in round 3 as critically important with scores of 7 to 9, these criteria resulted in a list of 16 outcomes, which exceeded the recommended 3 to 5 outcomes for a core outcome set. Therefore, the definition and threshold for “consensus in” were revised to determine a maximum of 5 core outcomes to be considered for the core outcome set.

The highest priority outcomes shared among patients/caregivers and health professionals were 1) vascular access problems, 2) dialysis adequacy, 3) fatigue, 4) cardiovascular disease, and 5) mortality. Frequently reported biochemical outcomes in HD trials, such as phosphate, calcium, and parathyroid hormone levels, were consistently rated to be of lower importance by both stakeholder groups.37

Consensus workshops were held with Delphi participants to further define “fatigue”—the condition that occurs after in-center dialysis treatment session.

Future SONG projects

SONG-HD is first focusing on hemodialysis, since it is the main dialysis modality worldwide. The SONG Initiative is now working to develop core outcomes across the CKD treatment spectrum, including kidney transplantation (SONG-Tx), childhood CKD (SONG-Kids), polycystic kidney disease (SONG-PKD), and peritoneal dialysis (PD).


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It has been Nichole Jefferson‘s personal mission to tell her story and promote awareness. She was diagnosed with end-stage renal disease (ESRD) in October 2003. At that time, not only was she unaware of what that meant; she also did not know she was a high-risk factor for developing the disease.
After the initial shock of the diagnosis, she decided peritoneal dialysis (PD) was the best option and utilized PD for a few years until she needed to switch to hemodialysis.
She received a kidney transplant from a deceased donor on June 12, 2008, but at the time, she didn’t realize it was simply another form of treatment and not a cure. Today, Nichole is waiting for a new transplant.
Nichole has worked with many advocacy groups on Capitol Hill and has provided her personal experience with ESRD to leaders in the field of nephrology. She tries to express the feelings of those who are unable or unwilling to speak for themselves.