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URMC / Center for Health + Technology / Our Expertise / CHeT Outcomes

Health Indexes (PROs and CROs)

Powering Research with Disease-specific Results

The CHeT Outcomes team develops and validates disease-specific patient-reported outcome measures (PROs) and caregiver-reported measures for use in therapeutic trials and FDA drug-labeling claims. Our instruments are designed to measure how patients feel and function, improve trial sensitivity, and help sponsors reduce sample size and cost.

Our highly sensitive Health Indexes measure how a specific disease affects daily life, as reported by patients (PRO) and caregivers (CRO or ObsRO). Our 250+ disease-specific instruments (and over 2500 subscales) help researchers and clinicians understand symptoms, function, and quality-of-life from the patient’s perspective — beyond what traditional clinical measures capture.

Our 5 Pivotal Studies

Our disease-specific instruments have demonstrated superior responsiveness in detecting clinically relevant changes in patient conditions compared to traditional measures.

Learn More About Our 5 Pivotal Studies

Measure What Matters Most

Contact Our Team Apply for Licensing

Uses of Disease-specific Health Indexes

  • Pharmaceutical sponsored clinical trials
  • Academic center initiated clinical trials
  • Government funded clinical trials
  • Foundation initiated research and registries

Advantages of Disease-specific Health Indexes 

  • Higher relevance and content validity for target populations
  • Lower burden to patients and caregivers
  • Strong correlation to functional capabilities
  • Ability to lower sample size requirements
  • Ability to emphasize relevant symptomatic themes of a specific population while excluding non-relevant issues
  • Increased sensitivity to detect small, but clinically relevant changes in disease-specific health
  • Better suited to measure disease progression or therapeutic gain over time compared to generic outcome measures

Our Health Indexes

We develop these measures for both adults and children, including Health Indexes for the following conditions:

 

About CHeT Outcomes

Our team includes experts in epidemiology, biostatistics, qualitative research, patient advocacy, language, computer programming, outcomes research, and medicine. Together, we create surveys and assessments that patients and caregivers can use to report symptoms and quality-of-life concerns.

All of our COAs align with FDA Patient-Focused Drug Development guidance to measure what matters to patients. Health Indexes are clear about what is being measured, help to appropriately evaluate the effectiveness, tolerability, and safety of treatments, and allow studies to avoid misleading claims. By selecting disease-specific outcome measures, study design teams can ensure selected measures are fit-for-purpose, addressing the meaningful aspects of health (MAH), concepts of interest (COI), and best support context of use (COU) including the interpretation of the endpoint results in a medical product development program.

Our group will collaborate with you to develop and fully validate a disease-specific outcome measure for any disease or provide consultation regarding outcome measure selection, use, optimization, and analysis. If you would like more information about how you can obtain a license to use our health indexes in your study, please contact HealthIndexes@URMC.Rochester.edu.

Frequently Asked Questions (FAQs)

We offer Health Indexes for a broad range of diseases, including neurological, neuromuscular, genetic, and rare conditions. View the full list here.
Our Health Indexes are developed by a multidisciplinary team that includes epidemiologists, biostatisticians, qualitative researchers, patient advocates, linguists, computer scientists, outcomes specialists, and physicians. Patients and caregivers are engaged throughout development to ensure each instrument reflects real-world experience.
Health Indexes are used to track symptoms, monitor treatment impact, and support regulatory-grade evidence for therapeutic trials. They can inform drug-labeling claims, compare baseline and follow-up status, and help assess how well a therapy is improving a patient’s daily function or quality of life.
Yes. Our development process follows current regulatory-guidance standards (e.g., FDA guidance for patient-focused outcome measures) and rigorous psychometric validation. This ensures that the instruments are reliable, responsive, and appropriate for regulatory submission and high-quality research.
Most Health Indexes are designed for independent completion by patients. For pediatric populations or adults who require assistance, caregiver-reported versions (ObsRO) are also available — so patients or caregivers can complete them in person or remotely.
Completion time varies by disease and instrument length. Full instruments typically take about 10–20 minutes, while short-form versions (when available) may take only a few minutes. Short forms are useful for research requiring minimal participant burden, but full versions are recommended for regulatory studies.
Yes. We offer both paper and secure electronic (e-PRO) formats. We can work with study teams to integrate instruments into web- or app-based platforms for remote or decentralized trials.
Many of our Health Indexes are available in multiple languages. We also support certified translations and cross-cultural validation for international studies or culturally diverse populations. If you need a language not yet supported, our team can often coordinate translation and validation. 
To protect the validity and reliability of the instrument, we do not permit changing the wording or order of questions. If a study requires a tailored or purpose-fit version, we encourage you to contact us — we may be able to help with a custom adaptation while maintaining psychometric integrity. 
Yes — in many cases, individual subscales can be used independently. During development, each subscale is validated separately as well as in combination. If your study only needs certain domains (e.g., fatigue, mobility, pain), we can advise which subscales are appropriate to use alone.
Please complete our online licensing request form or email our team at HealthIndexes@URMC.Rochester.edu. Licensing fees vary depending on study type, number of participants, and intended use. Once we receive your request, we will work with you to determine the appropriate license and provide next steps.