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
Objectives The 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). Initial...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e089225.full |
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| author | Shaney L Barratt Emma Dures Mwidimi Ndosi Michelle Sharp Sebastian E Sattui Jill Dawson Susan M Goodman Sarah L Mackie Tom Creed Catherine L Hill Joanna C Robson Pamela Richards Susan Bridgewater Christine A Silverthorne Jen Orme Anne-Marie T Sweeney Elizabeth Arthurs Genevieve Osborne Giles Dunhill Richard P Ramonell Timothy Patton |
| author_facet | Shaney L Barratt Emma Dures Mwidimi Ndosi Michelle Sharp Sebastian E Sattui Jill Dawson Susan M Goodman Sarah L Mackie Tom Creed Catherine L Hill Joanna C Robson Pamela Richards Susan Bridgewater Christine A Silverthorne Jen Orme Anne-Marie T Sweeney Elizabeth Arthurs Genevieve Osborne Giles Dunhill Richard P Ramonell Timothy Patton |
| author_sort | Shaney L Barratt |
| collection | DOAJ |
| description | Objectives The 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.Design Qualitative study with semistructured cognitive interview methods.Setting Online or face-to-face interviews with participants from seven departments across three secondary care hospitals in the UK and USA.Participants Inclusion 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.Results Purposive 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.Conclusions The 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. |
| format | Article |
| id | doaj-art-96bbbde88129410fbbd83999b6d844e1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-96bbbde88129410fbbd83999b6d844e12025-02-06T03:25:09ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-089225Impact 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 conditionsShaney L Barratt0Emma Dures1Mwidimi Ndosi2Michelle Sharp3Sebastian E Sattui4Jill Dawson5Susan M Goodman6Sarah L Mackie7Tom Creed8Catherine L Hill9Joanna C Robson10Pamela Richards11Susan Bridgewater12Christine A Silverthorne13Jen Orme14Anne-Marie T Sweeney15Elizabeth Arthurs16Genevieve Osborne17Giles Dunhill18Richard P Ramonell19Timothy Patton20North Bristol NHS Foundation Trust, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKJohns Hopkins University School of Medicine, Baltimore, Maryland, USAUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USANuffield Department of Population Health, University of Oxford, Oxford, UKWeill Cornell Medicine, New York City, New York, USALeeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UKGastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UKThe University of Adelaide, Adelaide, South Australia, AustraliaCenter for Health and Clinical Research, University of the West of England, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKGastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UKDermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UKDermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UKDivision of Pulmonary Allergy Critical Care and Sleep Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania, USAObjectives The 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.Design Qualitative study with semistructured cognitive interview methods.Setting Online or face-to-face interviews with participants from seven departments across three secondary care hospitals in the UK and USA.Participants Inclusion 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.Results Purposive 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.Conclusions The 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.https://bmjopen.bmj.com/content/15/2/e089225.full |
| spellingShingle | Shaney L Barratt Emma Dures Mwidimi Ndosi Michelle Sharp Sebastian E Sattui Jill Dawson Susan M Goodman Sarah L Mackie Tom Creed Catherine L Hill Joanna C Robson Pamela Richards Susan Bridgewater Christine A Silverthorne Jen Orme Anne-Marie T Sweeney Elizabeth Arthurs Genevieve Osborne Giles Dunhill Richard P Ramonell Timothy Patton 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/2/e089225.full |
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