The Role of Patient Reported Outcomes in Capturing the “Invisible” Symptoms of Lipedema

Introduction

The “invisible” symptoms of Lipedema pose challenges to research and treatment. Patients experience a variety of symptoms that are not easily measured clinically, such as pain, fatigue, and muscle pain. The inability to capture these experienced symptoms precisely and consistently can make it difficult for researchers and clinicians to track and gather data, which can contribute to the challenge of both understanding and diagnosing the disease, and comparing data across studies.

One tool that can be used to better catalog and understand Lipedema symptoms is Patient Reported Outcome Measures (PROMs). PROMs are a type of survey that collects independent patient reports on health, symptoms, quality of life, or other status related to a condition or treatment. The most immediately beneficial PROMs are previously-validated PROMs—meaning that researchers have already taken the steps necessary to demonstrate that the PROM’s measurement scale is accurately and consistently capturing what it should. The alternative is to develop a Lipedema-specific validated PROM, but doing so will take significant time and resources. In either case, it is critical to use patient-centered tools, like validated PROMs, when trying to learn about and treat under-researched and lesser understood conditions like Lipedema. Incorporating validated PROMs in research and clinical settings is a key resource for improving how we prevent and treat Lipedema.

Using Validated PROMs in Lipedema Research and Treatment

PROMs are widely used by researchers because these standardized surveys reduce interpreter bias and translate the subjective experiences of patients into quantifiable data. For example, one commonly used PROM is the RAND-36, which measures health-related Quality of Life across eight domains (e.g., pain, energy and fatigue, physical functioning, emotional well-being) (1). RAND-36 has been used in clinical studies across a wide variety of conditions, including Lipedema. These studies have found that women with Lipedema report a lower health-related Quality of Life (hrQoL) than the general female population across all domains, but particularly in physical functioning and pain (1, 2). These studies demonstrate that PROMs are a tool that can likely be used to improve both the quality and quantity of Lipedema research and provide a richer understanding of the Lipedema patient experience.

Validated PROMs can also be used to compare the symptoms of Lipedema to the symptoms of other chronic conditions for which Lipedema is often mistaken. In one study, researchers used standard and disease-specific PROMs to study lymphedema and Lipedema patients. They found significant differences between the two conditions, particularly in the pain and physical function domains (3). A later study by the same research group analyzed standard and pain-specific PROMs completed by Lipedema and fibromyalgia patients. Although the two conditions have many similar symptoms, Lipedema patients had higher social and emotional function scores as well as lower pain levels than those with fibromyalgia (4). While further research is necessary, these studies suggest that PROMs could be useful in differentiating Lipedema from common misdiagnoses and in reducing delayed and incorrect diagnoses that undermine research, clinical treatment, and patient experience. 

Developing Lipedema-specific PROMs

Some research questions may be so specific to Lipedema that they cannot be answered using currently validated PROMs. In these cases, it may be worth developing and validating Lipedema specific instruments. Developing these measures will be time-intensive and require considerable financial and workforce resources. Yet investing resources in PROM development has the potential to be of considerable benefit to the field. One notable benefit of disease-specific PROMs is their ability to capture data points unique to Lipedema patients, such as fat texture and fibrosis, leg heaviness, bruising, etc. Another key advantage of disease-specific PROMs is their potential to capture the experiences of patients with that disease more sensitively than general PROMs do. This sensitivity means that disease-specific PROMs can enable comparisons between different groups of people with the same condition, which can help researchers study the impact of potential treatments.

One area where a Lipedema-specific PROM may be particularly useful is in measuring pain and physical function. These two domains contribute to health-related Quality of Life, which is measured on previously validated PROMs, but they do not contribute equally for Lipedema and other conditions. Studies have suggested that even among patients with similar physical functioning scores, those scores are less associated with overall mental health for Lipedema patients than for lymphedema patients (4). By contrast, pain scores contribute to depression in Lipedema patients similarly to patients with many other—but not all—chronic pain conditions (3). These results suggest that a Lipedema-specific PROM could more sensitively measure the domain of pain, which strongly affects patient experience, and could more sensitively distinguish the specific elements of physical functioning that most affect patients. Such measures would ultimately help assess the impact of treatments that affect these domains.

The Importance of Lipedema Patients in PROM Development

The participation and perspectives of Lipedema patients are critical at all phases of research—including PROM development. Patients must be engaged in developing and implementing novel PROMs to ensure that these measures capture the nuances of living with Lipedema and reflect the diverse experiences of the Lipedema patient population. PROMs that reflect these experiences can more accurately measure treatment outcomes that matter to people living with Lipedema, enabling us to use those measures to better assess the tradeoffs of specific treatments’ risks and benefits. Patients who are engaged in developing PROMs can also help play important roles in other aspects of Lipedema research, such as recruiting participants for studies. This engagement can help mitigate mistrust often seen between healthcare professionals and Lipedema patients (5, 6). We are hopeful researchers and clinicians will begin to invest time and attention in creating Lipedema-specific PROMs and will work closely with patients when doing so.

Researchers and Clinicians – Help Us Innovate!

The use of already validated PROMs will be crucial in Lipedema research wherever possible. These PROMs are a reliable way of gathering comparable data for many conditions and therefore can be a helpful tool for characterizing what is unique about Lipedema patient experiences and treatment effects. Yet for the rapidly growing Lipedema research community, novel measures may also be important to answer Lipedema-specific research questions. Using best practices of PROM validation, we’ll be well positioned to use existing and new measures to better understand the experience of Lipedema patients.

  1. Falck, J., Rolander, B., Nygårdh, A., Jonasson, L.-L., & Mårtensson, J. (2022). Women with lipoedema: a national survey on their health, health-related quality of life, and sense of coherence. BMC Women’s Health, 22(1), 457. https://doi.org/10.1186/s12905-022-02022-3

  2. Romeijn, J. R. M., de Rooij, M. J. M., Janssen, L., & Martens, H. (2018). Exploration of Patient Characteristics and Quality of Life in Patients with Lipoedema Using a Survey. Dermatology and Therapy, 8(2), 303–311. https://doi.org/10.1007/s13555-018-0241-6

  3. Angst, F., Lehmann, S., Aeschlimann, A., Sandòr, P. S., & Wagner, S. (2020). Cross-sectional validity and specificity of comprehensive measurement in lymphedema and lipedema of the lower extremity: a comparison of five outcome instruments. Health and Quality of Life Outcomes, 18(1), 245. https://doi.org/10.1186/s12955-020-01488-9

  4. Angst, F., Benz, T., Lehmann, S., Sandor, P., & Wagner, S. (2021). Common and Contrasting Characteristics of the Chronic Soft-Tissue Pain Conditions Fibromyalgia and Lipedema. Journal of Pain Research, Volume 14, 2931–2941. https://doi.org/10.2147/JPR.S315736

  5. Melander, C., Juuso, P., & Olsson, M. (2021). Women’s experiences of living with lipedema. Health Care for Women International, 1–16. https://doi.org/10.1080/07399332.2021.1932894

  6. Fetzer, A., & Fetzer, S. (2014). Lipoedema UK BIg Survey 2014 research report. https://www.lipoedema.co.uk/wp-content/uploads/2016/04/UK-Big-Surey-version-web.pdf