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. 2024 Jun;205(2):359-370.
doi: 10.1007/s10549-024-07262-5. Epub 2024 Feb 29.

Development of a core outcome set for breast cancer-related lymphedema: a Delphi study

David Doubblestein  1 , Linda Koehler  2 , Elizabeth Anderson  3 , Nicole Scheiman  4 , Paula Stewart  5 , Mark Schaverien  6 , Jane Armer  3
Affiliations

Development of a core outcome set for breast cancer-related lymphedema: a Delphi study

David Doubblestein et al. Breast Cancer Res Treat. 2024 Jun.

Abstract

Purpose: For breast cancer survivors (BCS) living with breast cancer-related lymphedema (BCRL), what outcome domains (OD) should be measured to assess the burden of the disease and efficacy of interventions? A Core Outcome Set (COS) that promotes standardized measurement of outcomes within the constraints of time influenced by work environments is essential for patients and the multidisciplinary professionals that manage and research BCRL.

Methods: Using Delphi methodology, a multidisciplinary group of BCRL experts (physical and occupational therapists, physicians, researchers, physical therapist assistants, nurses, and massage therapist) completed two waves of online surveys. BCRL expert respondents that completed the first survey (n = 78) had an average of 26.5 years in practice, whereas, respondents who completed the second survey (n = 33) had an average of 24.9 years. ODs were included in the COS when consensus thresholds, ranging from 70% to 80%, were met.

Results: A total of 12 ODs made up the COS. Reaching a minimum consensus of 70%; volume, tissue consistency, pain, patient-reported upper quadrant function, patient-reported health-related quality of life, and upper extremity activity and motor control were recommended at different phases of the BCRL continuum in a time-constrained environment. Joint function, flexibility, strength, sensation, mobility and balance, and fatigue met an 80% consensus to be added when time and resources were not constrained.

Conclusion: The COS developed in this study thoroughly captures the burden of BCRL. Using this COS may reduce selective reporting, inconsistency in clinical use, and variability of reporting across interdisciplinary healthcare fields, which manage or research BCRL.

Keywords: Breast cancer-related lymphedema; Core outcome set; Outcome measures.

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Conflict of interest statement

The authors declare that there is no conflict of interest.

Figures

Fig. 1
Fig. 1
Recommended BCRL outcome domains for non-constrained environments that measure the ICF domain of body structures and functions. BCRL Breast Cancer-Related Lymphedema, ICF International Classification of Disability, Functioning and Health. * Met the minimum consensus threshold of 80%
Fig. 2
Fig. 2
Recommended BCRL outcome domains for non-constrained environments that measure the ICF domain of activities and participation. BCRL Breast Cancer-Related Lymphedema, ICF International Classification of Disability, Functioning and Health, PR Patient-Reported, UE Upper Extremity, AMC Activity and Motor Control, MOB & BAL Mobility and Balance, HRQOL Health-Related Quality of Life, UQF Upper Quadrant Function. * Met the minimum consensus threshold of 80%
Fig. 3
Fig. 3
Recommended outcome domains to assess for each phase of the BCRL continuum. BCRL Breast Cancer-Related Lymphedema, PR Patient-Reported, UQF Upper Quadrant Function, HRQOL Health-Related Quality of Life, MOB & BAL Mobility and Balance, UE Upper Extremity, AMC Activity and Motor Control. Time-constrained outcome measures are also included in the work environments not constrained by time or resources
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