Table of Contents

General health (PROMIS)

The Patient Reported Outcomes Measurement Information System-29 Profile v1.0 (PROMIS-29) (section: diseases & symptoms) is a collection of seven short forms measuring the following seven domains of self-reported health in 4 items each:

  1. depression
  2. anxiety
  3. physical function
  4. pain interference (including a 5th item on pain intensity)
  5. fatigue
  6. sleep disturbance
  7. satisfaction with participation in social roles

The PROMIS-29 for adults was used in Lifelines general assessment 2B and in additional assessment ACTQ.
Underage participants received the 10/8-item PROMIS short forms on fatigue and social roles.

Background

The PROMIS-29 Profile is part of a large system of item banks and instruments that have been validated extensively in the US. Each item bank was developed and validated separately. Subsequently, short forms were developed for each bank, which were combined in the PROMIS-29 Profile.
The short forms that make up the PROMIS Profile Instruments include “high information” items. The selection of items was in part based on item rankings within each domain using two psychometric criteria: (1) maximum interval information, and 2) Computer Adaptive Testing (CAT) simulations.
The PROMIS-29 Profile has been translated into Dutch-Flemish, using a standardized methodology of forward and backward translations. According to the PROMIS standards short forms can be released for use in new languages after a high quality translation.
It is expected that PROMIS instruments (especially PROMIS CATs) will soon become the gold standard world-wide for the measurement of patient-reported health. PROMIS CATs are, however, not yet available for use in the Netherlands because of two reasons:

  1. CAT software and a web-based infrastructure to set up studies using CATs are not yet available. The Dutch-Flemish PROMIS group is working on this.
  2. Reference scores from the Dutch general population are not yet available. These are needed because all PROMIS scores are expressed as T-scores, in which scores have a mean of 50 and a standard deviation of 10 compared with the general population.

Dutch reference scores are to be preferred over US reference scores. The implementation of the PROMIS-29 Profile in Lifelines would help to estimate Dutch reference scores for seven PROMIS item banks (if necessary, using CBS census data for weighting), which will facilitate the implementation of CATs for these banks.

Validation

Content validity of the PROMIS instruments can be considered good because they are based on a clear consensus-based conceptual model and conceptual definitions of all domains, extensive literature search, including consideration of all items from all existing Patient Reported Outcomes, qualitative research, including 79 focus groups with patients from different disease populations, and sophisticated psychometric analyses (Item Response Theory).
Construct validity was supported by moderate to strong correlations with legacy measures (i.e. traditional Patient Reported Outcomes that measure similar constructs) in the general US population. For example, moderate to strong correlations with legacy measures were found for Physical Function (0.88 with HAQ, 0.90 with SF36-PF), Fatigue (0.91 with FACIT, 0.85 with SF-36-VT), Pain Interference (0.84 with BDI Interference), Depression (0.83 with CES-D), and Anxiety (0.80 with MASQ).
Reliability of PROMIS instruments was assessed in the general US population by calculating each item bank’s standard error and reliability coefficients, by T-scores. Reliability (defined here as measurement precision along the continuum) was high for all PROMIS instruments from scores at the mean to 2 or more SD units worse than the mean.
Several studies have shown that the measurement error of PROMIS instruments is smaller than the measurement error of questionnaires measuring comparable constructs (for example PROMIS versus SF-36). These studies were performed in patients with arthritis, depression and patients in a rehabilitation setting.

In 2022, the measurement properties of the Dutch PROMIS-29 v2.1 profile was assessed in Lifelines participants with and without chronic conditions1)

Variables

Questions English Questions Dutch Code Variable Assessment Age
can you do chores like vacuuming or gardening? / physical functioning kunt u klusjes doen zoals stofzuigen of in de tuin werken? / lichamelijk functioneren promis_physical_adu_q_01 promis1 2B ACTQ 18+
can you go up and down stairs at a normal pace? / physical functioning kunt u in een normaal tempo trappen op- en afgaan? / lichamelijk functioneren promis_physical_adu_q_02 promis2 2B ACTQ 18+
are you able to walk for at least 15 minutes? / physical functioning kunt u een wandeling van ten minste 15 minuten maken? / lichamelijk functioneren promis_physical_adu_q_03 promis3 2B ACTQ 18+
are you able to run errands and go shopping? / physical functioning kunt u boodschappen doen en winkelen? / lichamelijk functioneren promis_physical_adu_q_04 promis4 2B ACTQ 18+
i felt anxious / anxiety (please answer for the past 7 days) ik voelde me angstig / angst (geef aub antwoord voor de afgelopen 7 dagen) promis_anxiety_adu_q_05 promis5 2B ACTQ 18+
i found it difficult to focus on something other than my anxiety and concern / anxiety (please answer for the past 7 days) ik vond het moeilijk om me op iets anders dan mijn angst en bezorgdheid te concentreren / angst (geef aub antwoord voor de afgelopen 7 dagen) promis_anxiety_adu_q_06 promis6 2B ACTQ 18+
my worries were more than i could take / anxiety (please answer for the past 7 days) mijn zorgen waren me te veel / angst (geef aub antwoord voor de afgelopen 7 dagen) promis_anxiety_adu_q_07 promis7 2B ACTQ 18+
i felt ill at ease / anxiety (please answer for the past 7 days) ik voelde me slecht op mijn gemak / angst (geef aub antwoord voor de afgelopen 7 dagen) promis_anxiety_adu_q_08 promis8 2B ACTQ 18+
i felt worthless / depression (please answer for the past 7 days) ik voelde me alsof ik niets waard was / depressie (geef aub antwoord voor de afgelopen 7 dagen) promis_depression_adu_q_09 promis9 2B ACTQ 18+
i felt helpless / depression (please answer for the past 7 days) ik voelde me hulpeloos / depressie (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_depression_adu_q_10 promis10 2B ACTQ 18+
i felt depressed / depression (please answer for the past 7 days) ik voelde me depressief / depressie (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_depression_adu_q_11 promis11 2B ACTQ 18+
i felt hopeless / depression (please answer for the past 7 days) ik voelde me zonder hoop / depressie (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_depression_adu_q_12 promis12 2B ACTQ 18+
i suffer from fatigue / fatigue (please answer for the past 7 days) ik heb last van vermoeidheid / vermoeidheid (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_fatigue_adu_q_13 promis13 2B ACTQ 18+
how tired were you, on average? / fatigue (please answer for the past 7 days) hoe vermoeid was u gemiddeld genomen? / vermoeidheid (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_fatigue_adu_q_14 promis14 2B ACTQ 18+
i have difficulty getting starting with things because i am so tired / fatigue (please answer for the past 7 days) het kost me moeite om met dingen te beginnen omdat ik zo moe ben / vermoeidheid (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_fatigue_adu_q_15 promis15 2B ACTQ 18+
how 'worn out' did you feel on average? / fatigue (please answer for the past 7 days) hoe afgepeigerd voelde u zich gemiddeld genomen? / vermoeidheid (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_fatigue_adu_q_16 promis16 2B ACTQ 18+
the quality of my sleep was / sleep disorders (please answer for the past 7 days) de kwaliteit van mijn slaap was… / slaapstoornissen (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_sleep_adu_q_17 promis17 2B ACTQ 18+
my sleep was refreshing / sleep disorders (please answer for the past 7 days) mijn slaap was verkwikkend / slaapstoornissen (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_sleep_adu_q_18 promis18 2B ACTQ 18+
i had a sleeping disorder / sleep disorders (please answer for the past 7 days) ik had een slaapprobleem / slaapstoornissen (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_sleep_adu_q_19 promis19 2B ACTQ 18+
i had difficulty falling asleep / sleep disorders (please answer for the past 7 days) ik had moeite met in slaap vallen / slaapstoornissen (geef a.u.b. antwoord voor de afgelopen 7 dagen) promis_sleep_adu_q_20 promis20 2B ACTQ 18+
i have difficulty engaging in all my normal leisure pursuits with others / ability to participate in social roles and activities ik heb moeite om al mijn gewone vrijetijdsactiviteiten met anderen te doen / vermogen om een aandeel te hebben in sociale rollen en activiteiten promis_social_adu_q_21 promis21 2B ACTQ 18+
i have difficulty doing all the family activities that i want to / ability to participate in social roles and activities ik heb moeite om alle gezins-/ familieactiviteiten te doen die ik wil doen / vermogen om een aandeel te hebben in sociale rollen en activiteiten promis_social_adu_q_22 promis22 2B ACTQ 18+
i have difficulty doing all my normal work (including work at home) / ability to participate in social roles and activities ik heb moeite om al mijn gewone werk (inclusief werk thuis) te doen / vermogen om een aandeel te hebben in sociale rollen en activiteiten promis_social_adu_q_23 promis23 2B ACTQ 18+
i have difficulty doing all the activities with friends that i want to / ability to participate in social roles and activities ik heb moeite om alle activiteiten met vrienden te doen die ik wil doen / vermogen om een aandeel te hebben in sociale rollen en activiteiten promis_social_adu_q_24 promis24 2B ACTQ 18+
to what extent did pain hamper you in your daily activities? / limitations due to pain (please answer for the past 7 days) in welke mate belemmerde pijn u bij uw dagelijkse activiteiten? / belemmeringen door pijn (geef aub antwoord voor de afgelopen 7 dagen) promis_pain_adu_q_25 promis25 2B ACTQ 18+
to what extent did pain hamper you in your work in and around the house? / limitations due to pain (please answer for the past 7 days) in welke mate belemmerde pijn u bij werk in en om het huis? / belemmeringen door pijn (geef aub antwoord voor de afgelopen 7 dagen) promis_pain_adu_q_26 promis26 2B ACTQ 18+
to what extent did pain hamper you in your ability to participate in social activities? / limitations due to pain (please answer for the past 7 days) in welke mate belemmerde pijn uw vermogen om deel te nemen aan sociale activiteiten? / belemmeringen door pijn (geef aub antwoord voor de afgelopen 7 dagen) promis_pain_adu_q_27 promis27 2B ACTQ 18+
to what extent did pain hamper you in your household chores? / limitations due to pain (please answer for the past 7 days) in welke mate belemmerde pijn u bij uw huishoudelijke klusjes? / belemmeringen door pijn (geef aub antwoord voor de afgelopen 7 dagen) promis_pain_adu_q_28 promis28 2B ACTQ 18+
how would you rate the pain you feel, on average? / pain intensity (please provide answer for the past 7 days) hoe zou u gemiddeld uw pijn beoordelen? / pijnintensiteit (geef aub antwoord voor de afgelopen 7 dagen) promis_pain_adu_q_29 promis29 2B ACTQ 18+
1)
Elsman E.B. et al. (2022) Measurement properties of the Dutch PROMIS-29 v2.1 profile in people with and without chronic conditions; Quality of Life Research 176[1]