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Everyday People Sing a Simple Song

Establishing a Core Outcome for Life Participation

Aala, Amtul, MD1; Brennan, Daniel C., MD, FACP2

doi: 10.1097/TP.0000000000002477

1 Department of Medicine, Division of Nephrology, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA.

2 The Johns Hopkins University School of Medicine, Baltimore, MD.

Received 11 September 2018. Revision received 1 October 2018.

Accepted 3 October 2018.

A.A. participated in literature search on Life participation and SONG-Tx articles, writing of the article, and data analysis. D.B. participated in the writing of the article and data analysis.

The authors declare no conflicts of interest.

D.B. was funded by NIH NIDDK U01AI063594, R01DK102981, and U01DK116042.

Correspondence: Daniel C. Brennan, MD, FACP, The Johns Hopkins University School of Medicine Medical Director, The Comprehensive Transplant Center, The Johns Hopkins Hospital, Carnegie 668A, 600 N. Wolfe St., Baltimore, MD 21287. (

Several studies in transplantation have reported patient centered outcomes to help improve long-term kidney transplant recipient care, with the hope of standardizing these outcomes for all future studies. 1 These are mostly found to be short term, often inconsistent, and incomplete. There is lack of uniformity in reporting these outcomes in clinical trials, which hinders shared decision making. Physicians, caregivers, and patients have an interest in what is reported to guide treatment and develop clinic guidelines. Acknowledging this need, several consensus guidelines have been developed recently, including Clinical Data Interchange Standards Consortium 2016 and Standardized Outcomes in Nephrology—Transplantation 2016.

Standardized Outcomes in Nephrology-Transplantation (SONG-Tx) Outcomes is a global initiative to develop a core outcome set for trials in kidney transplantation.2,3 Initiated in 2015, this was a 3-phase process; first phase was a systematic review of various clinical studies, second phase was to use a Delphi survey with an international multistakeholder panel (patients, caregivers, clinicians, researchers, policy makers, members from industry) which developed a consensus-based prioritized list of outcome domains; followed by the third phase, using a consensus workshop to review and finalize these core outcome sets. The top 10 ranked outcomes overall were kidney rejection leading to graft loss, kidney function, damage to other organs, cancer (all), diabetes, skin cancer, cardiovascular disease, infection, weight gain, and excessive appetite, and the top 5 psychosocial or physical symptoms were impact on family, depression, impact on work, gastrointestinal problem, and concentration and memory. Potential outcomes for the Delphi survey were also extrapolated from a systematic review of qualitative studies on the motivations, challenges, and attitudes to self-management in kidney transplant recipients. Although “Life participation” then established by Delphi survey as “patient’s ability to work” was included as a core outcome for standardization, its scope was not well elaborated.

Studies that have evaluated life participation in kidney transplant recipients have used varying definitions in the past.4-6 In this recent SONG-Tx publication in this issue of Transplantation, Ju et al7 propose a new definition/standard set, to the core life participation outcome measure, with the hope for use in all trials in kidney transplantation in the future.

The investigators of the most recent SONG-Tx reviewed preliminary analysis of 271 studies in kidney transplantation reporting on 34 different measures (ie, questionnaires) that have been used to assess life participation. For feasibility, the investigators included a simple core outcome with a focus on life participation that asks a maximum of 3 questions. Kidney transplant recipients, caregivers, and health professionals from 8 countries were preassigned to 6 breakout groups to ensure diversity of participation. The workshop program and background materials were sent to all attendees and collaborators 2 weeks before the workshop. Each group had a facilitator who moderated the discussion. To prompt discussion, the facilitator provided 3 questions as proposed measures (EuroQol-5D Usual Activities8—life participant subscale, and a question each on severity and frequency of limitation in life participation), Short Form-36 (daily activities subscale), and the Kidney Disease Quality of Life-Short Form. Sessions were audiotaped and transcribed. The groups reconvened to provide a brief summary in the final plenary session and later in the form of comments and feedback 2 weeks after the workshop. All transcripts were imported into HyperRESEARCH software for qualitative data management, and thematic analysis was used to summarize the discussion.

The outcome measure for life participation was reported as 4 different themes: (a) returning to normality; (b) recognizing the diverse meaning and activities of “life”; (c) capturing vulnerability and fluctuations posttransplant; and (d) having a scientifically rigorous, feasible, and meaningful measure.

The first 2 themes included the content to be recorded in a measure, and the last 2 themes were related to the application of the outcome measure. These themes were derived from the discussions with the idea that these will contribute to content validity of the outcome measure.

This report has various strengths; we need to recognize how much work has been put into this workshop overall by the multidisciplinary teams. The discussions arising from this workshop determine that patients conceptualize life participation based on their own background and priorities, proposing that measures assessing life participation need to be outlined so as to be appropriately comprehensive and consistent. A novel approach by the investigators is to remove the distinction between nonmandatory and mandatory tasks to make the outcome measure less granular. Another thoughtful concept is to consider a longer period of recall, which was recommended to capture fluctuations in recipient’s level of life participation, particularly in the first year after transplant, which will help avoid bias. It is multicenter and international in its approach and included wide variety of individuals; patients, caregivers, and professionals. The investigators realize that validation studies are necessary to ensure that the measure is appropriate for the population in which it is being used and can be modified accordingly.9,10 The outcome measure will be made more feasible for use in future studies.

This report has some limitations; no children were included in the workshop discussions. Also, there is no consensus on the total recall period. It remains unclear if these measures capture “life participation” as hypothesized by kidney transplant recipients.

Life participation has been made much simpler yet effective by the SONG investigators in the recent workshop, just like Sly and the Family Stone’s hit in the 1960s “Everyday people (A-Side) Sing a Simple Song” (B-Side).11 Recognizing that our “everyday people” include: (1) our vast end-stage renal disease community; (2) the broad spectrum of kidney transplant recipients; and finally, (3) the broad team of physicians, social workers, dialysis nurses, coordinators, and industry personnel involved in the SONG-Tx workshops. It is important to realize that establishing a valid outcome measure for life participation will not only improve the dependability but also uniformity in the assessment of life in kidney transplantation for our “everyday people.” This will also help in improving clinical decision-making process in kidney transplant recipients. The SONG-Tx process is a much needed and useful method for developing consensus in transplantation.

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