[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659392":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":19,"studyPopulation":20,"armGroups":21,"interventions":28,"overallOfficials":35,"centralContacts":39,"locations":47,"responsibleParty":60,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":16,"enrollmentInfo":78,"targetDuration":16,"studyType":81,"phases":16,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":92,"whyStopped":16,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of the West of England","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Steroid PRO","The Steroid PRO is a 15-item, valid and reliable scale for measuring the impact of glucocorticoid therapy in people with rheumatic diseases. The fifteen items are grouped into four domains (Social impact, Impact on Appearance, Psychological Impact and Treatment Concerns). The Steroid PRO responses options are presented across a 5-item Likert scale, with a numerical value attributed to the response:\n\n* Never (0)\n* Rarely (1)\n* Sometimes (2)\n* Often (3)\n* Always (4)\n\nTypically, each item or domain in the Steroid PRO is assigned a numerical value or score based on the response options provided. These scores may reflect the severity, frequency, or impact of symptoms, side effects, or other aspects of steroid therapy on the patient's well-being. The four subscales plus a total score can be used.","Baseline (completed once during each focus group).",{"measure":14,"description":15,"timeFrame":12},"EQ-5D-5L","The EQ-5D-5L is a short questionnaire used to understand how a person's health affects their quality of life. The questionnaire asks people to rate themselves across 5 areas of daily life: mobility (moving around), self-care (washing, dressing), usual activities (work, study, housework), pain or discomfort, and anxiety or depression. Each area has 5 levels (1 = no problems, 5 = extreme problems). A respondent selects one level for each area, producing a 5 digit code (e.g., 12345). There is also a Visual Analogue Scale where respondents rate their overall health today with 0 = worst imaginable health and 100 = best imaginable health.",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":6,"timePerspective":18,"maskingInfo":16},"CROSS_SECTIONAL","Glucocorticoids, also known as steroids, are used in inflammatory rheumatic conditions such as rheumatoid arthritis, giant cell arteritis and lupus. They work quickly by controlling active inflammation and improving symptoms. Steroids do have adverse effects, including increased blood pressure, diabetes, infection and osteoporosis. They also impact peoples' mood, sleep and lead to weight gain.\n\nNewer treatments are available, but they are usually more expensive than steroids. Economic evaluations weigh up different costs of treatment, including the costs of side effects. They are used to decide whether new treatments are 'cost-effective' enough for the NHS. At present, only some of the costs of steroids are considered, usually those directly related to healthcare. We would like to consider the broader costs to patients and society, and the impact on peoples' health-related quality of life.\n\nThis project will be overseen by a steering committee of clinicians, researchers, patient partners and charity representatives (including Vasculitis UK), health-economists, and PPIE experts. The project will include focus groups with people who have rheumatological conditions and have used steroids in the last three years. The focus groups will explore the full range of costs related to steroids. We will use open-ended questions and follow a framework used in economic evaluations. We will also ask people to give their thoughts on a general patient reported outcome (PRO) questionnaire (called the EQ5D) and a steroid-specific questionnaire (the Steroid PRO). One focus group will be held face to face in Leeds, and two will be held online so that people from across the UK can join. We will ask participants to consent to us recording and writing out the focus group data. The data will be anonymised for analysis by a researcher. We will submit the final report for publication. A lay summary will be circulated to participants and patient groups. This work will inform the next stages of our research to properly capture the full economic impact of steroids.","Patients will be purposively sampled to include a spectrum of participants with a range of different inflammatory rheumatic conditions (including Rheumatoid Arthritis, Lupus, Giant Cell Arteritis) and demographics (including age, gender, ethnic group).",[22],{"label":23,"type":16,"description":24,"interventionNames":25},"Patients with inflammatory rheumatic conditions.","Patients will be purposively sampled to include a spectrum of participants with a range of inflammatory rheumatic conditions and demographics.",[26,27],"Other: This is a qualitative focus group study therefore no interventions planned","Behavioral: This is a qualitative focus group study therefore no interventions planned",[29,32],{"type":6,"name":30,"description":30,"armGroupLabels":31,"otherNames":16},"This is a qualitative focus group study therefore no interventions planned",[23],{"type":33,"name":30,"description":30,"armGroupLabels":34,"otherNames":16},"BEHAVIORAL",[23],[36],{"name":37,"affiliation":5,"role":38},"Joanna C Robson","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":16,"email":43},"CONTACT","0044117-342-7418","jo.robson@uwe.ac.uk",{"name":45,"role":41,"phone":16,"phoneExt":16,"email":46},"Christine A Silverthorne","chris.silverthorne@uwe.ac.uk",[48],{"facility":49,"status":16,"city":50,"state":16,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":16},"University of the West of England \u002F Bristol Royal Infirmary","Bristol","BS2 8HW","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-2.59665,51.45523,{"lat":58,"lon":57},{"type":61,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[63,66],{"name":64,"class":65},"UK Musculoskeletal Translational Research Collaboration (MSK TRC)","UNKNOWN",{"name":67,"class":6},"University of Leeds","100659392","health-economic-impact-of-steroids-100659392",false,"NCT07863245","Health Economic Impact of Steroids","Health Economic Impact of Steroids: Exploration and Measurement of the Impact of Glucocorticoids in Patients With Inflammatory Rheumatic Conditions","HEIST","Inclusion Criteria:\n\n1. People who have an inflammatory rheumatic condition.\n2. People who are aged 18 years or older.\n3. Have the capacity to give informed consent.\n4. Have a good understanding of spoken and written English to be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.\n5. Received treatment with intravenous or oral glucocorticoids for an inflammatory rheumatic condition within the previous three years.\n\nExclusion Criteria:\n\n1. People who do not have an inflammatory rheumatic condition.\n2. People who are less than 18 years of age.\n3. Do not have the capacity to give informed consent.\n4. Have insufficient understanding of spoken and written English be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.\n5. Either have never taken steroids or not taken steroids within the last three years as part of the treatment plan for their rheumatological condition.\n6. Membership of the steering committee.","ALL","18 Years",{"count":79,"type":80},24,"ESTIMATED","OBSERVATIONAL","Three focus groups will be conducted with patients who have an inflammatory rheumatic condition and have been treated with steroids in the last three years to discuss the impact of steroids on their quality of life, the financial costs to them and costs to the NHS and social care. We will also ask people to give their thoughts on a general patient reported outcome (PRO) questionnaire (the EQ5D) and a steroid-specific questionnaire (the Steroid PRO).",[84],"Rheumatic Conditions",[86,87,88,89,90,91],"Glucocorticoids","Steroids","Rheumatology","Patient","Health-related quality of life","Health economic impact","NOT_YET_RECRUITING","2026-10-01",{"date":95,"type":96},"2026-10-07","ACTUAL",{"date":98,"type":80},"2026-09-15",{"date":100,"type":80},"2027-03-30",{"name":5,"class":6},1]