LF Common Case Report Form (CCRF)

Advancing Lipedema Research Through Standardization

The Lipedema Foundation’s Common Case Report Form (CCRF) represents an important step in strengthening the research infrastructure for Lipedema.

Developed through international collaboration and broad stakeholder engagement, the CCRF is a unified, publicly available framework designed to improve data quality, reproducibility, and comparability across studies. By supporting more consistent data collection, it helps researchers generate findings that can be meaningfully compared and evaluated.

The CCRF is organized into Core, Supplemental–Highly Recommended, Supplemental, and Exploratory classifications. This structure allows for standardization of essential data elements while maintaining flexibility for different research designs and clinical settings. The Exploratory version of the CCRF is the full CCRF and it is recommended that researchers use the most inclusive version of the CCRF as it feasible for their study design.

By enabling consistent and transparent data collection, the CCRF supports:

  • Cross-study comparison

  • More rigorous diagnostic research

  • Stronger foundations for evidence generation

As adoption expands in 2026 and beyond, this shared framework is expected to facilitate meta-analyses, support more consistent diagnostic research, and strengthen the evidence base informing future advances in treatment, policy, and patient care.

 

Steps involved in CCRF development:

  • Began with a rough list of elements to collect from Box 4 (page 24) of the Lipedema Research Roadmap (included input from > 60 stakeholders)

  • Created a Common Data Element (CDE) database, pulled from as many published sources as possible

  • Reviewed with trusted clinicians, researchers, and patients

  • Configured in REDCap Cloud and did extensive internal and external user testing 

  • Piloted the CCRF at an LF Biobank recruitment event in March 2025 at the FDRS conference in Atlanta, with 74 participants and 3 diagnosing clinicians

  • Engaged an external biostatistician to analyze pilot data and recommend CCRF CDE refinements 

  • Categorizing the CDEs into four categories: Core, Supplemental - Highly Recommended, Supplemental, and Exploratory with input from our Scientific Advisory Committee.

 

CCRF Classifications

  • This is the CCRF in its entirety. This classification includes the Core, Supplemental Highly Recommended, Supplemental, and Exploratory Common Data Elements.

    Exploratory Data Elements are Defined as:

    Definition:
    Data elements that are emerging, experimental, or do not yet have a clear link to Lipedema. These elements may represent novel assessments, biomarkers, or patient-reported outcomes not yet validated with Lipedema populations. Exploratory items can inform hypothesis generation and future standardization but are not yet recommended for routine use.

    Total Number of CDE’s: 682

    • 120 Clinical Form (~18 min to complete)

    • 562 Participant Form (~45 min to complete

  • This classification includes the Core, Supplemental Highly Recommended, and Supplemental Common Data Elements.

    Supplemental Data Elements are Defined as:

    Data elements that may add scientific or clinical value but are not critical to diagnosis or characterization in all studies. These are useful in specific research aims or contexts, such as exploring specifics (such as triggers) for disease onset or worsening, treatment outcomes, quality of life, or comorbid conditions.

    Total Number of CDEs: 618

    • 89 Clinical Form (~13 min to complete)

    • 529 Participant Form (~42 min to complete

  • This classification includes the Core and Supplemental Highly Recommended Common Data Elements.

    Supplemental Highly Recommended Data Elements are Defined as:

    Data elements that are not required for a basic diagnosis of Lipedema but are strongly recommended for comprehensive characterization of the condition and/or samples. These elements provide important context about subpopulations/subtypes and foundational understanding of disease onset, worsening (progression or exacerbation), severity, or impact and are widely applicable across most Lipedema studies.

    Total Number of CDEs: 424

    • 89 Clinical Form (~13 min to complete

    • 335 Participant Form (~19 min to complete

  • This classification includes the Core Common Data Elements. This is the minimum CCRF which should be used in Lipedema research.

    Supplemental Highly Recommended Data Elements are Defined as:

    Common data elements related to the diagnosis of Lipedema include items essential for identifying, confirming, or differentiating Lipedema, as well as those providing clinically relevant information for diagnosis. Core elements include clinically assessed items such as Lipedema diagnosis for research purposes, Lipedema stage, anthropometric measurements, presence of edema, and palpable findings of nodularity or fibrosis. Participant-reported items that support diagnosis are also included, such as pain or discomfort in affected areas, common comorbidities, current medications and supplements, surgical history, menstrual status, family history, and basic demographics. This classification addresses areas of clinical disagreement and research gaps, facilitating data collection for cross-study and cross-geography comparisons to enhance understanding.

    Total Number of CDEs: 288

    • 86 Clinical Form (~13 min to complete

    • 202 Participant Form (~16 min to complete

Exploratory - Complete CCRF (Start Here)
Supplemental CCRF
Supplemental Highly Recommended CCRF
Core CCRF
 

CCRF Data Dictionaries

The data dictionary versions of the CCRF are detailed references that defines each question on the form: what it means, how responses should be recorded, and how the data is structured behind the scenes. Data dictionaries serve as a “rulebook” to ensure every question is interpreted consistently and the data can be used reliably.

 

  • At this stage in our field’s development, clinicians and investigators do not always agree on precise diagnostic criteria. We expect that variation across countries and groups will persist for some time. This is expected and acceptable, as long as teams collect and report data in comparable ways. 

    Consistent capture of diagnostic factors, comorbidities, and other data will allow the field to:

    • Assess the applicability of findings from individual studies

    • Compare results across studies

    • Conduct rigorous meta-analyses

    • Conduct retrospective analyses to understand which factors matter most for diagnosis

    • Identify and classify meaningful subtypes