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ArticleBMJ open2025

Impact of glucocorticoids on patients' quality of life: a qualitative study assessing face validity and feasibility of the Steroid PRO in patients with inflammatory gastroenterology, respiratory and dermatology conditions.

Anne-Marie T Sweeney, Susan Bridgewater, Jen Orme, Sebastian E Sattui, Michelle Sharp, Pamela Richards, Christine A Silverthorne, Elizabeth Arthurs, Tom Creed, Genevieve Osborne and 11 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06314451 (Cross-condition Validation of the Patient Reported Outcome Measure for Patients Receiving Glucocorticoids), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT06314451 unknown statusnot on this map

Cross-condition Validation of the Patient Reported Outcome Measure for Patients Receiving Glucocorticoids (the Steroid PRO)

TypeobservationalSponsorUniversity of the West of EnglandRan2022 to 2024Enrolled60ConditionsInflammatory Disease, Immune System Disorder, Gastrointestinal Diseases, Dermatologic DiseaseArmsCognitive Interview
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

21 authors.

Anne-Marie T SweeneyUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Susan BridgewaterUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Jen OrmeUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Sebastian E SattuiUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Michelle SharpJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Pamela RichardsUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Christine A SilverthorneUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.ORCID http://orcid.org/0000-0001-8145-2305
Elizabeth ArthursGastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK.
Tom CreedGastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK.
Genevieve OsborneDermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK.
Giles DunhillDermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK.
Jill DawsonNuffield Department of Population Health, University of Oxford, Oxford, UK.
Emma DuresUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Shaney L BarrattNorth Bristol NHS Foundation Trust, Bristol, UK.ORCID http://orcid.org/0000-0003-3067-7349
Richard P RamonellDivision of Pulmonary Allergy Critical Care and Sleep Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Timothy PattonDepartment of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Susan M GoodmanWeill Cornell Medicine, New York City, New York, USA.
Catherine L HillThe University of Adelaide, Adelaide, South Australia, Australia.
Sarah L MackieLeeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Mwidimi NdosiUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.ORCID http://orcid.org/0000-0002-7764-3173
Joanna C RobsonUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK Jo.Robson@uwe.ac.uk.ORCID http://orcid.org/0000-0002-7939-5978

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe Steroid PRO is a treatment-specific patient-reported outcome questionnaire which measures the impact of glucocorticoids on health-related quality of life. It has 15 items grouped into 4 domains (Social impact, Impact on Appearance, Psychological Impact and Treatment Concerns). Initially developed and validated in rheumatic diseases, the Steroid PRO demonstrates potential for broader application in patients with other inflammatory conditions. The objective of this study was to assess face validity, content validity and feasibility of the Steroid PRO in (1) patients treated with glucocorticoids for inflammatory respiratory, dermatological and gastroenterological conditions and (2) clinicians working within these specialties in the UK and USA.

designQualitative study with semistructured cognitive interview methods.

settingOnline or face-to-face interviews with participants from seven departments across three secondary care hospitals in the UK and USA.

participantsInclusion criteria: (1) Adult patients with inflammatory respiratory, gastroenterological and dermatological conditions treated with glucocorticoids and (2) healthcare professionals (HCPs) working in respiratory, dermatology and gastroenterology departments in the UK and USA.

resultsPurposive sampling to ensure a range of patient and HCP participants. A total of 42 patient participants were recruited, from respiratory/pulmonology (n=14, 33.3%), dermatology (n=13, 31.0%) and gastroenterology (n=15, 35.8%) medical departments; 32 in the UK and 10 from the USA. Mean age 48.2 years (range 22-71) and 19 (45.2%) were female. Patient participants had a range of inflammatory lung, skin and bowel conditions, with a spectrum of demographics and patterns of glucocorticoid use. 14 HCPs participated from the UK (9) and USA (5). Face validity: 97% (30/31) patients and 100% (14/14) HCPs reported the Steroid PRO was 'relevant or very relevant' to them and their disease. FEASIBILITY: 97% (30/31) patients and 100% (14/14) HCPs reported the Steroid PRO was 'easy or very easy to complete'. Patients reported that the four domains of the Steroid PRO had relevance to them and that it was validating to see their concerns represented: 'It's obvious you guys know what you're talking about-these are my issues. It's very validating when you realise it's not just you. These problems are real and they matter.… These are not questions my doctor asks me about. Doctors never ask about psychosocial aspects. It would be really great if they used this' (female patient with asthma). Patients and clinicians felt the Steroid PRO would be suitable for use in clinical practice within their specialties and would aid in understanding of the impact of glucocorticoids.

conclusionsThe Steroid PRO demonstrated face validity and content validity for assessing the impact of glucocorticoids in patients with inflammatory respiratory, gastroenterological and dermatological conditions. Additionally, the feasibility of using the Steroid PRO with both patients and HCPs has been established. Future work should include quantitative testing of the Steroid PRO as an outcome measure within clinical trials in these conditions. TRIAL REGISTRATION NUMBER: NCT06314451.

Indexed as

Gastrointestinal DiseasesGlucocorticoidsPatient Reported Outcome MeasuresQuality of LifeRespiratory Tract DiseasesSkin DiseasesAdultAgedFeasibility StudiesFemaleHumansMaleMiddle AgedQualitative ResearchReproducibility of ResultsSurveys and QuestionnairesGlucocorticoidsAsthmaDermatologyEczemaGastroenterologyQUALITATIVE RESEARCH

Identifiers

PMID39909511
PMCPMC11800201

What OpenQuestion holds

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Registered trials

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.