Steps in Measure Development
PROMIS measures are developed using rigorous qualitative and quantitative methods.
Comprehensive Literature Searches
We conduct comprehensive literature searches yielding hundreds of potential items. This supports content validity (i.e., the assurance that each measure represents all facets of a domain).
Focus Groups
To ensure comprehensive coverage of the domain, we conduct focus groups with relevant participants and do thematic analyses of the discussion. Next, we complete an item-review process to eliminate items that are redundant, confusing, or poorly written.
Cognitive Interviews
We conduct cognitive interviews. Multiple individuals with diverse characteristics (e.g., gender, race, ethnicity, literacy level) review each candidate item and share feedback on the language, clarity, and relevance of the items.
Translatability Assessment
Translations experts review and revise items to minimize ambiguities and use words, grammar, and concepts that translate well in other languages and cultures (e.g., replace idiomatic expressions, jargon, and non-universal units of measurement).
Large Scale Testing
We collect responses to candidate items from large samples of relevant participants (both community and clinical samples), usually via computer administration.
Psychometric Analysis
We use techniques from both classical test theory (CTT) and item response theory (IRT) during psychometric testing. Data from large samples confirm the factor structure of the domain and allow for analyses at the item and bank level (see Reeve et al, 2007) with an update from Hansen et al, 2014).
Centering on a Reference Population
A measure’s T-score is set so that 50 is the average (or mean) of a relevant group of people. That group represents the reference population (e.g., general population, kids with a painful condition).
Validity Studies
Researchers conduct validity studies to determine the degree to which an instrument measures what it is intended to measure and captures change.
Translation
Calibration Samples
To develop PROMIS measures, we administer candidate items to large samples of people. These groups are called calibration samples. The purpose of a calibration sample is to estimate item parameters (item characteristics such as difficulty and discrimination) using an item response theory model. The following tables list who comprised the calibration sample (e.g., general population, clinical sample) for each PROMIS measure. The calibration sample for a domain applies to all types of measures (e.g., computer adaptive tests, short forms). Note that the calibration sample is sometimes different from the centering sample. Learn more about centering samples at Reference Populations.
| Measure Domain | Calibration Sample |
|---|---|
| Ability to Participate in Social Roles and Activities (v2.0) | General population |
| Alcohol – Alcohol Use | General population + Clinical sample |
| Alcohol – Negative Consequences | General population + Clinical sample |
| Alcohol – Negative Expectancies | General population + Clinical sample |
| Alcohol – Positive Consequences | General population + Clinical sample |
| Alcohol – Positive Expectancies | General population + Clinical sample |
| Anger | General population |
| Anxiety | General Population |
| Anxiety (PROMIS-Cancer) | Hybrid* |
| Cognitive Function | General Population |
| Cognitive Function – Abilities | General Population |
| Companionship | General population |
| Depression | General population |
| Depression (PROMIS-Cancer) | Hybrid* |
| Dyspnea – Activity Motivation | N/A – Uncalibrated item pool |
| Dyspnea – Activity Requirements | N/A – Uncalibrated item pool |
| Dyspnea – Airborne Exposure | N/A – Uncalibrated item pool |
| Dyspnea – Assistive Devices | N/A – Uncalibrated item pool |
| Dyspnea – Characteristics | N/A – Uncalibrated item pool |
| Dyspnea – Emotional Response | N/A – Uncalibrated item pool |
| Dyspnea – Functional Limitations | COPD Sample |
| Dyspnea – Severity | COPD Sample |
| Dyspnea – Task Avoidance | N/A – Uncalibrated item pool |
| Dyspnea – Time Extension | N/A – Uncalibrated item pool |
| Emotional Support | General population |
| Fatigue | General population |
| Fatigue (PROMIS-Cancer) | General population |
| Gastrointestinal – Belly Pain | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Gastrointestinal – Bowel Incontinence | N/A – Uncalibrated item pool |
| Gastrointestinal – Constipation | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Gastrointestinal – Diarrhea | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Gastrointestinal – Disrupted Swallowing | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Gastrointestinal – Gas and Bloating | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Gastrointestinal – Gastroesophageal Reflux | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Gastrointestinal – Nausea and Vomiting | GI Sample (clinical sample + general population who reported at least 1 GI symptom) |
| Global Mental | General population |
| Global Physical | General population |
| Informational Support | General population |
| Instrumental Support | General population |
| Itch – Activity & Clothing | Clinical sample |
| Itch – Interference | Clinical sample |
| Itch – Mood & Sleep | Clinical sample |
| Itch – Quality | Clinical sample |
| Itch – Scratching Behavior | Clinical sample |
| Itch – Severity | Clinical sample |
| Itch – Triggers | Clinical sample |
| Life Satisfaction | General population |
| Meaning and Purpose | General population |
| Medication Adherence | N/A |
| Mobility | General population |
| Pain – Behavior | General population + Clinical sample |
| Pain – Interference | General population + Clinical sample |
| Pain Interference (PROMIS-Cancer) | Hybrid* |
| Pain Intensity | General population + clinical sample |
| Pain Quality – Neuropathic Pain | Clinical sample with painful conditions |
| Pain Quality – Nociceptive Pain | Clinical sample with painful conditions |
| Physical Function | General population |
| Physical Function (PROMIS-Cancer) | Hybrid* |
| Physical Function for Samples with Mobility Aid Users | Clinical Sample |
| Positive Affect | General population |
| Psychosocial Illness Impact – Negative | Clinical sample (cancer) |
| Psychosocial Illness Impact – Positive | Clinical sample (cancer) |
| Satisfaction with Participation in Discretionary Social Activities (v1.0) | General population |
| Satisfaction with Participation in Social Roles (v1.0) | General population |
| Satisfaction with Social Roles and Activities (v2.0) | General population |
| Self-Efficacy – General | General population |
| Self-Efficacy – Manage Daily Activities | Clinical sample |
| Self-Efficacy – Manage Emotions | Clinical sample |
| Self-Efficacy – Manage Meds/Treatment | Clinical sample |
| Self-Efficacy – Manage Social Interactions | Clinical sample |
| Self-Efficacy – Manage Symptoms | Clinical sample |
| Sexual Function and Satisfaction: Anal Discomfort with Sexual Activity (for Sexually Active People) | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Bother Regarding Sexual Function (Male and Female measures) | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Erectile Function (for Sexually Active Men) | Sexually active men from the general population and men with sexual dysfunction |
| Sexual Function and Satisfaction: Factors Interfering with Sexual Satisfaction | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Interest in Sexual Activity | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Oral Discomfort with Sexual Activity (for Sexually Active People) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Oral Dryness with Sexual Activity (for Sexually Active People) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Orgasm – Ability (for Sexually Active People) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Orgasm – Pleasure (for Sexually Active People) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Satisfaction with Sex Life | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Screeners | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Sexual Activities (Male and Female measures) | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Therapeutic Aids for Sexual Activity (Male and Female measures) | N/A – Uncalibrated item pool |
| Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity (for Sexually Active Women) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Vaginal Lubrication for Sexual Activity (for Sexually Active Women) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Vulvar Discomfort with Sexual Activity – Clitoral (for Sexually Active Women) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sexual Function and Satisfaction: Vulvar Discomfort with Sexual Activity – Labial (for Sexually Active Women) | Sexually active adults from the general population and adults with sexual dysfunction |
| Sleep Disturbance | General population + Clinical sample |
| Sleep-Related Impairment | General population + Clinical sample |
| Smoking – Coping Expectancies | Clinical sample (smokers drawn from the general population) |
| Smoking – Emotional/Sensory Expectancies | Clinical sample (smokers drawn from the general population) |
| Smoking – Negative Health Expectancies | Clinical sample (smokers drawn from the general population) |
| Smoking – Negative Psychosocial Expectancies | Clinical sample (smokers drawn from the general population) |
| Smoking – Nicotine Dependence | Clinical sample (smokers drawn from the general population) |
| Smoking – Social Motivations | Clinical sample (smokers drawn from the general population) |
| Social Isolation | General population |
| Substance Use – Appeal | Clinical and non-clinical substance users |
| Substance Use – Prescription Pain Medication Misuse | Participants who reported possession of a prescription for pain medication and potential misuse of such a medication |
| Substance Use – Severity | Clinical and non-clinical substance users |
| Upper Extremity | General population |
* Hybrid: items that did not have differential item functioning (DIF) between general population and cancer patients used the PROMIS parameters. DIF items used cancer-based parameters. All items included in fatigue item bank did not have DIF, and thus all used PROMIS parameters.
| Measure Domain | Calibration Sample |
|---|---|
| Anger (v3.0) | General population |
| Anxiety (v3.0) | General population |
| Asthma Impact | Clinical sample |
| Cognitive Function | General population |
| Depression (v3.0) | General population |
| Family Relationships | General population |
| Fatigue (v3.0) | General population |
| Global Health | General population |
| Itch (PIQ-C) | Clinical sample (Children with skin conditions) |
| Life Satisfaction | General population |
| Meaning and Purpose | General population |
| Mobility (v3.0) | General population |
| Pain – Behavior (v3.0) | General population |
| Pain – Interference (v3.0) | General population |
| Pain Quality – Affective (v3.0) | General population |
| Pain Quality – Sensory (v3.0) | General population |
| Pain Quality (v3.0) | General population |
| Peer Relationships (v3.0) | General population |
| Physical Activity | General population |
| Physical Stress Experience | General population |
| Positive Affect | General population |
| Psychological Stress Experiences | General population |
| Sleep Disturbance | General population |
| Sleep-Related Impairment | General population |
| Stigma | Clinical sample (Children with chronic conditions) |
| Stigma – Skin | Clinical sample (Children with chronic conditions) |
| Strength Impact | General population |
| Upper Extremity (v3.0) | General population |
| Measure Domain | Calibration Sample |
|---|---|
| Anger (v3.0) | General population |
| Anxiety (v3.0) | General population |
| Asthma Impact | Clinical sample |
| Cognitive Function | General population |
| Depression (v3.0) | General population |
| Family Relationships | General population |
| Fatigue (v3.0) | General population |
| Global Health | General population |
| Itch | Clinical sample (Parents of children with skin conditions) |
| Life Satisfaction | General population |
| Meaning and Purpose | General population |
| Mobility (v3.0) | General population |
| Pain – Behavior (v3.0) | General population |
| Pain – Interference (v3.0) | General population |
| Peer Relationships (v3.0) | General population |
| Physical Activity | General population |
| Physical Stress Experience | General population |
| Positive Affect | General population |
| Psychological Stress Experiences | General population |
| Sleep Disturbance | General population |
| Sleep-Related Impairment | General population |
| Stigma | Clinical sample (Parents of children with chronic conditions) |
| Stigma – Skin | Clinical sample (Parents of children with chronic conditions) |
| Strength Impact | General population |
| Upper Extremity (v3.0) | General population |
| Measure Domain | Calibration Sample |
|---|---|
| Anger/Irritability | General population |
| Anxiety | General population |
| Depressive Symptoms | General population |
| Engagement – Curiosity | General population |
| Engagement – Persistence | General population |
| Global Health | General population |
| Physical Activity | General population |
| Positive Affect | General population |
| Self-Regulation – Flexibility | General population |
| Self-Regulation – Frustration Tolerance | General population |
| Sleep Health | General population |
| Social Relationships (Child-Caregiver, Family, Peer) | General population |
PROMIS Translation Methodology
PROMIS, Neuro-QoL and NIH Toolbox patient-reported outcome (PRO) measures use the FACIT Translation Methodology (see Eremenco et al, 2005). It consists of an iterative process of:
- forward and back-translation
- multiple reviews
- harmonization across languages
- cognitive debriefing with a sample of the target population.
This approach to translation is universal, which means we aim for language versions that are appropriate for more than one country, rather than country-specific versions of each language.
Descriptions of consensus-based best practices in translation methods are available (See Eremenco et al, 2018 for PRO measures and McKown et al, 2020 for observer-reported outcome, clinician-reported outcome, and performance outcome measures).
If you are interested in creating a new translation of a PROMIS measure, view Make New Translations.
PROMIS Standards for Measure Creation
- Read about the PROMIS Instrument Development and Validation Scientific Standards.
- For additional information on PROMIS instrument development, see a presentation on PROMIS Instrument Development and Psychometric Evaluation Scientific Standards. This presentation describes a set of standards that serve as the scientific foundation and guidance for the development and evaluation of PROMIS item banks and instruments.
Last updated Aug 3, 2026
Last updated: September 14, 2026