Evidence map›Paper›PMID 34228217›Full record

ArticleJournal of patient-reported outcomes2021

Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis.

Brandon Becker, Kimberly Raymond, Carol Hawkes, April Mitchell Foster, Andrew Lovley, Cory Saucier, Avery A Rizio, Jakob Bue Bjorner, Mark Kosinski

Open access · goldAbstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
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  9. Assessing sleep and pain among adults with myalgic encephalomyelitis/chronic fatigue syndrome: psychometric evaluation of the PROMIS® sleep and pain short forms.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 4 countries.

Brandon BeckerGlaxoSmithKline, Upper Providence, PA, USA. brandon.becker@bms.com.ORCID http://orcid.org/0000-0002-9232-631X
Kimberly RaymondQualityMetric, Johnston, RI, USA.
Carol HawkesGlaxoSmithKline, London, UK.
April Mitchell FosterQualityMetric, Johnston, RI, USA.
Andrew LovleyQualityMetric, Johnston, RI, USA.
Cory SaucierQualityMetric, Johnston, RI, USA.
Avery A RizioQualityMetric, Johnston, RI, USA.
Jakob Bue BjornerQualityMetric, Copenhagen, Denmark.
Mark KosinskiQualityMetric, Johnston, RI, USA.
GlaxoSmithKline (United Kingdom) · GBProvidence College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health.

methodsA qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance).

resultsThirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation.

conclusionPain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

Indexed as

Cognitive debriefingConcept elicitationContent validityPainPatient-reported outcomePatient-reported outcomes measurement information systemPsychometric evaluationRheumatoid arthritisShort formSleep disturbance

Identifiers

PMID34228217
PMCPMC8260648
OpenAlexW3181687608

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.