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Seo C, Hu S, King-Kallimanis BL, Chang AE, Regnault A, Miller AS, Kaur MN. Understanding data visualization techniques in qualitative studies used to develop and validate patient-reported outcome measures: a targeted literature review. Qual Life Res 2025:10.1007/s11136-025-03964-5. [PMID: 40279025 DOI: 10.1007/s11136-025-03964-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/24/2025] [Indexed: 04/26/2025]
Abstract
PURPOSE Qualitative data that reflects patients' experiences are the foundation of any patient-reported outcome measure (PROM) development and validation study; however, there is limited understanding of the type of data visualization techniques that facilitate communication of this data. The goal of this targeted literature review was to investigate data visualization methods that have been used in published PROM development and validation literature to report qualitative results. METHODS A literature search in OVID via MEDLINE was conducted among the top 10 non-disease-specific journals publishing PROM qualitative development and validation studies. Studies that reported qualitative methods to develop/validate a PROM and included data visualization in the form of tables or figures were included. Article characteristics and data visualization types were extracted. RESULTS A total of 185 articles were included in data extraction. Most articles (n = 109, 59.1%) included figures (n = 172, average 2 relevant figures per article) in the form of hierarchy/flowcharts (n = 124, 72.1%) and bar charts (n = 29, 16.9%). Information reported in figures included depiction of conceptual frameworks (n = 112, 65.1%) and concept frequency (n = 40, 24.4%). Most articles (n = 152, 81.7%) included tables (n = 307, average 2 relevant tables per article). Information reported in tables included concept frequency (n = 133, 43.3%) and cognitive debriefing and revisions (n = 91, 29.6%). CONCLUSION Data visualization techniques used to report qualitative results in the identified PROM qualitative development and validation studies were heterogeneous, and many studies did not utilize any data visualization techniques. This study will inform the development of guidance for using data visualizations to report qualitative PROM research.
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Affiliation(s)
- Caroline Seo
- BioPharmaceuticals Medical Evidence, AstraZeneca, Gaithersburg, MD, USA.
| | - Sophia Hu
- Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
| | | | - Ashley E Chang
- Division of Plastic Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA
| | | | - Amitai S Miller
- Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
| | - Manraj N Kaur
- Patient-Reported Outcomes, Value, and Experience (PROVE) Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
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Sabater Cabrera E, Trennery C, Jones AM, Griffiths N, Foley E, Hamill MM, Schwarz M. Real-Life Experiences of Herpes Simplex Virus Type 2 Genital Herpes in the United States: A Structured Literature Review and Qualitative Concept Elicitation Study. Infect Dis Ther 2025:10.1007/s40121-025-01118-1. [PMID: 40234344 DOI: 10.1007/s40121-025-01118-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Accepted: 02/20/2025] [Indexed: 04/17/2025] Open
Abstract
INTRODUCTION Research on real-life experiences of herpes simplex virus type 2 (HSV-2) genital herpes (GH) is scarce. This study primarily aimed to characterize the signs/symptoms and impacts of Ý (HRQoL) of people living with HSV-2 GH in the United States. The secondary aim was to map the identified signs/symptoms and impact concepts onto existing patient-reported outcome (PRO) measures to assess PRO coverage. METHODS A structured literature review and concept elicitation (CE) interviews were conducted based on predefined eligibility criteria. The literature search was conducted across three digital databases and publicly available online resources. The CE interviews were conducted among three participant groups with a confirmed HSV-2 GH diagnosis. A conceptual model was developed based on signs/symptoms and HRQoL impact concepts, identified from the literature review and CE interviews. Key concepts from the model were mapped onto three existing PRO instruments [Herpes Symptoms Checklist (HSC), Herpes Outbreak Impact Questionnaire (HOIQ), and Recurrent Genital Herpes Quality of Life questionnaire (RGHQoL)] to assess concept coverage. RESULTS Overall, 26 records were included in the literature review and 30 participants were recruited for CE interviews. The final conceptual model included 35 signs/symptoms and 59 impact concepts categorized among 6 and 9 domains, respectively. Most frequently reported signs/symptoms were itching, sores/lesions/blisters, and body pain. Sores/lesions/blisters were reported as most bothersome. Most frequently reported impact concepts were anxiety and worry, concerns about disclosing diagnosis, and loss of self-esteem/confidence. Conceptual mapping revealed that, when used together, existing PRO instruments provided comprehensive coverage of most concepts (HSC 83%, HOIQ 56%, and RGHQoL 50% of domains covered, respectively). CONCLUSIONS Participants experienced a range of signs/symptoms and HRQoL impacts. Existing PRO measures provided comprehensive coverage of recurrent HSV-2 GH specific concepts for the domains they measured.
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Affiliation(s)
| | - Claire Trennery
- GSK, Av. Fleming 20, 1300, Wavre, Belgium
- Patient Centered Outcomes, Adelphi Values Ltd., Bollington, UK
| | - Amy M Jones
- Patient Centered Outcomes, Adelphi Values Ltd., Bollington, UK
| | | | - Elizabeth Foley
- Department of Sexual Health, Solent NHS Trust, Southampton, UK
- School of Medicine, University of Southampton, Southampton, UK
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Sweeney AMT, Bridgewater S, Orme J, Sattui SE, Sharp M, Richards P, Silverthorne CA, Arthurs E, Creed T, Osborne G, Dunhill G, Dawson J, Dures E, Barratt SL, Ramonell RP, Patton T, Goodman SM, Hill CL, Mackie SL, Ndosi M, Robson JC. 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 2025; 15:e089225. [PMID: 39909511 PMCID: PMC11800201 DOI: 10.1136/bmjopen-2024-089225] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2024] [Accepted: 01/20/2025] [Indexed: 02/07/2025] Open
Abstract
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.
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Affiliation(s)
- Anne-Marie T Sweeney
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Center for Health and Clinical Research, University of the West of England, Bristol, UK
| | - Susan Bridgewater
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Center for Health and Clinical Research, University of the West of England, Bristol, UK
| | - Jen Orme
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Center for Health and Clinical Research, University of the West of England, Bristol, UK
| | | | - Michelle Sharp
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Pamela Richards
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Christine A Silverthorne
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Center for Health and Clinical Research, University of the West of England, Bristol, UK
| | - Elizabeth Arthurs
- Gastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK
| | - Tom Creed
- Gastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK
| | - Genevieve Osborne
- Dermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK
| | - Giles Dunhill
- Dermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK
| | - Jill Dawson
- Nuffield Department of Population Health, University of Oxford, Oxford, UK
| | - Emma Dures
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- University of the West of England, Bristol, UK
| | | | - Richard P Ramonell
- Division of Pulmonary Allergy Critical Care and Sleep Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
| | - Timothy Patton
- Department of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
| | | | - Catherine L Hill
- The University of Adelaide, Adelaide, South Australia, Australia
- Department of Rheumatology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
| | - Sarah L Mackie
- Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
| | - Mwidimi Ndosi
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Center for Health and Clinical Research, University of the West of England, Bristol, UK
| | - Joanna C Robson
- University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Center for Health and Clinical Research, University of the West of England, Bristol, UK
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Ryan GW, Goulding M, Mejia Agudelo D, Simms S, Spano M, Arenas J, Becker S, Radu S, Lemon SC, Rosal M, Pbert L, Trivedi M. Advancing Equitable Participation in Pediatric Clinical Trials Through Cognitive Interviewing. Pediatrics 2025; 155:e2024068666. [PMID: 39714047 DOI: 10.1542/peds.2024-068666] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/06/2024] [Accepted: 10/14/2024] [Indexed: 12/24/2024] Open
Affiliation(s)
- Grace W Ryan
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts
| | - Melissa Goulding
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts
| | - Deicy Mejia Agudelo
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
| | - Stephanie Simms
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
| | - Michelle Spano
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
| | - Juliana Arenas
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
| | - Sarah Becker
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
| | - Sonia Radu
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
| | - Stephenie C Lemon
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts
| | - Milagros Rosal
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts
| | - Lori Pbert
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts
| | - Michelle Trivedi
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts
- Division of Pulmonary Medicine, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
- Child Health Equity Center, Department of Pediatrics, University of Massachusetts Chan Medical School, UMass Memorial Children's Medical Center, Worcester, Massachusetts
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Louis G, Pétré B, Sousa-Pinto B, Bousquet J, Van Ganse É, Schleich F, Louis R. When patient-reported respiratory symptoms shed light on pathophysiology in adult asthma: a cross-sectional study. Sci Rep 2024; 14:29997. [PMID: 39623071 PMCID: PMC11612149 DOI: 10.1038/s41598-024-81745-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2024] [Accepted: 11/28/2024] [Indexed: 12/06/2024] Open
Abstract
While studies have demonstrated the impact of asthma symptoms on quality of life, very few studies have investigated the relationship between detailed asthma symptoms, as reported by the patient, and lung function and inflammation. A cross-sectional study was conducted on treated (ICS/LABA) adult (> 18 years) asthma patients recruited from the Liege University Hospital Asthma Clinic (Belgium) between 2018 and 2023 (n = 505). The intensity of asthma symptoms (dyspnea, wheezing, chest tightness, cough, and airway secretion) was measured using five-point Likert scales (5 expressing the greatest intensity). Multiple linear regression models including all independent variables were carried out to evaluate whether lung function and inflammatory parameters were independently associated with distinct symptoms. Cough associated with female gender (p < 0.05), smoking (p < 0.01), low FeNO (p < 0.05) and FEV1% pred. (p < 0.05), and high blood and sputum eosinophils (p < 0.05 for both). Airway secretion associated with smoking (p < 0.05). Chest tightness associated with young age (p < 0.001), female gender (p < 0.05) and low FEV1% pred. (p < 0.01). Dyspnea associated with female gender (p < 0.001), high BMI (p < 0.05), low FEV1% pred. (p < 0.0001) and high FEV1/FVC % (p < 0.01). Wheezing associated with young age (p < 0.01), high BMI (p < 0.05), smoking (p < 0.01), low FEV1% pred. (p < 0.0001) and high FEV1/FVC % (p < 0.05). Different respiratory symptoms are associated with distinct demographic, functional and inflammatory features paving the way for personalized therapeutic interventions.
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Affiliation(s)
- Gilles Louis
- Department of Public Health, University of Liège, Liège, Belgium.
- Department of Pneumology, GIGAI3, University of Liège, Liège, Belgium.
| | - Benoit Pétré
- Department of Public Health, University of Liège, Liège, Belgium
| | - Bernardo Sousa-Pinto
- Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Jean Bousquet
- University Hospital Montpellier, Montpellier, France
| | | | - Florence Schleich
- Department of Pneumology, GIGAI3, University of Liège, Liège, Belgium
| | - Renaud Louis
- Department of Pneumology, GIGAI3, University of Liège, Liège, Belgium
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Mosnaim G, Carrasquel M, Snedden M, Oppenheimer J, Lang D, Rathkopf M. Patient-Reported Outcomes in Asthma. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE 2024; 12:2562-2572. [PMID: 38796101 DOI: 10.1016/j.jaip.2024.04.061] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/22/2024] [Revised: 04/11/2024] [Accepted: 04/19/2024] [Indexed: 05/28/2024]
Abstract
Food and Drug Administration's Center for Drug Evaluation and Research defines patient-reported outcomes as "any report of the status of a patient's health condition, health behavior, or experience with healthcare that comes directly form the patient, without interpretation of the patient's response by a clinician or anyone else." Validated patient-reported outcome measures are used extensively in pediatric and adult asthma across clinical and research settings to assess the impact of treatments on patient outcomes over time. This work aims to review some of the most commonly used asthma patient-reported outcomes across the following criteria: validity, reliability, responsiveness, time to complete, ease of administration, target population, recall period, scoring method, availability in different languages, use in clinical practice or research settings, licensing requirements, and cost of use.
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Affiliation(s)
- Giselle Mosnaim
- Division of Allergy & Immunology, Department of Medicine, Endeavor Health, Glenview, Ill.
| | - Michelle Carrasquel
- Division of Allergy & Immunology, Department of Medicine, Endeavor Health, Glenview, Ill
| | - Madeline Snedden
- Division of Allergy & Immunology, Department of Medicine, Endeavor Health, Glenview, Ill
| | - John Oppenheimer
- Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ
| | - David Lang
- Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio
| | - Melinda Rathkopf
- Department of Pediatrics, Emory University School of Medicine, Atlanta, Ga
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Bridgewater S, Ndosi M, Dawson J, Richards P, Silverthorne C, Dures E, Goodman SM, Hill C, Mackie SL, Robson JC. Validation of a new glucocorticoid-specific Patient-Reported Outcome Questionnaire (the Steroid PRO). Ann Rheum Dis 2024; 83:394-400. [PMID: 37949468 PMCID: PMC10894813 DOI: 10.1136/ard-2023-224946] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2023] [Accepted: 10/24/2023] [Indexed: 11/12/2023]
Abstract
OBJECTIVES Glucocorticoids used in the treatment of inflammatory rheumatic conditions can impact on health-related quality of life. An underpinning qualitative study developed a long-list of candidate items for a treatment-specific patient-reported outcome (PRO) measure. The objective of this paper is to determine scale structure and psychometric properties of the Steroid PRO. METHODS A cross-sectional survey of adults from the UK, USA, Australia and New Zealand, taking glucocorticoids for a rheumatic disease. Initial survey collected demographics, clinical information, 40 Steroid PRO candidate items and EuroQol-5 Dimensions- 5 levels (EQ-5D-5L). Follow-up, 3-5 days later, collected Steroid PRO candidate items and a condition-change ('transition') question. Analysis included Rasch measurement model, exploratory factor analysis (EFA), and hypothesis testing for discriminative validity, convergence validity and test-retest reliability. RESULTS Total responses 946: UK n=743 (79%); USA n=139 (15%); Australia/New Zealand n=64 (7%); mean age 57.6 (SD=13.6); 833 (88%) women. Participants with inflammatory arthritis n=197 (21%), connective tissue disease and/or vasculitis n=402 (42%), giant cell arteritis and/or polymyalgia rheumatica n=347 (37%). Twenty-five items were removed due to lack of fit to Rasch model. Of the remaining items, EFA suggested four subscales: Social impact (4 items); Impact on appearance (3 items); Psychological impact (5 items); Treatment concerns (3 items). Rasch modelling supported a four-subscale structure and total score, confirming construct validity and reliability. Hypothesis testing confirmed discriminant and convergence validity. Intraclass correlation coefficient (total score) was 0.809 demonstrating excellent (test-retest) reliability. CONCLUSIONS The Steroid PRO is a 15-item, valid and reliable scale for measuring the impact of glucocorticoid therapy in people with rheumatic diseases.
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Affiliation(s)
- Susan Bridgewater
- School of Health and Social Wellbeing, University of the West of England, Bristol, UK
- Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Mwidimi Ndosi
- School of Health and Social Wellbeing, University of the West of England, Bristol, UK
- Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Jill Dawson
- Nuffield Department of Population Health, University of Oxford, Oxford, UK
| | - Pamela Richards
- School of Health and Social Wellbeing, University of the West of England, Bristol, UK
- Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Christine Silverthorne
- School of Health and Social Wellbeing, University of the West of England, Bristol, UK
- Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Emma Dures
- School of Health and Social Wellbeing, University of the West of England, Bristol, UK
- Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Susan M Goodman
- Rheumatology Department, Hospital for Special Surgery, New York, New York, USA
| | - Catherine Hill
- Rheumatology Department, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia
- Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
| | - Sarah L Mackie
- Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
| | - Joanna C Robson
- School of Health and Social Wellbeing, University of the West of England, Bristol, UK
- Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
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Bridgewater S, Shepherd MA, Dawson J, Richards P, Silverthorne C, Ndosi M, Almeida C, Black RJ, Cheah JTL, Dures E, Ghosh N, Hoon EA, Lyne S, Navarro-Millan I, Pearce-Fisher D, Ruediger C, Tieu J, Yip K, Mackie SL, Goodman S, Hill C, Robson JC. Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure. Rheumatology (Oxford) 2023; 62:3565-3575. [PMID: 36840642 PMCID: PMC10629780 DOI: 10.1093/rheumatology/kead081] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2022] [Revised: 02/01/2023] [Accepted: 02/07/2023] [Indexed: 02/26/2023] Open
Abstract
OBJECTIVES Glucocorticoids (GCs) ('steroids') are used to treat rheumatic diseases but adverse effects are common. We aimed to explore the impact of GC therapy on health-related quality of life (HRQoL), to inform the development of a treatment-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS Semi-structured qualitative interviews were conducted with patients from the UK, USA and Australia, treated for a rheumatic condition with GCs in the last 2 years. Purposive sampling was used to select participants with a range of demographic and disease features. An initial conceptual framework informed interview prompts and cues. Interviews elicited GC-related physical and psychological symptoms and salient aspects of HRQoL in relation to GC therapy. Interview data were analysed inductively to develop initial individual themes and domains. Candidate questionnaire items were developed and refined. RESULTS Sixty semi-structured qualitative interviews were conducted (UK n = 34, USA n = 10, Australia n = 16). The mean age was 58 years; 39/60 were female; and 18 rheumatic diseases were represented. Some 126 individual themes were identified and organized into six domains: physical symptoms; psychological symptoms; psychological impact of steroids; impact of steroids on participation; impact of steroids on relationships; and benefits of steroids. Candidate questionnaire items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews and linguistic translatability assessment, informing a draft questionnaire. CONCLUSION We describe an international qualitative study to develop candidate items for a treatment-specific PROM for patients with rheumatic diseases. A future survey will enable the validation of a final version of the PROM.
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Affiliation(s)
- Susan Bridgewater
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Michael A Shepherd
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Jill Dawson
- Department of Population Health (HSRU), University of Oxford, Oxford, UK
| | - Pamela Richards
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Christine Silverthorne
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Mwidimi Ndosi
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Celia Almeida
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Rachel J Black
- Discipline of Medicine, The University of Adelaide, Adelaide, Australia
- Rheumatology Department, Royal Adelaide Hospital, Adelaide, Australia
- Department of Rheumatology, The Queen Elizabeth Hospital, Adelaide, Australia
| | - Jonathan T L Cheah
- Department of Medicine, Division of Rheumatology, University of Massachusetts Medical School, Worcester, MA, USA
| | - Emma Dures
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
| | - Nilasha Ghosh
- Division of Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, USA
| | - Elizabeth A Hoon
- Discipline of General Practice, The University of Adelaide, Adelaide, Australia
- School of Public Health, The University of Adelaide, Adelaide, Australia
| | - Suellen Lyne
- Discipline of Medicine, The University of Adelaide, Adelaide, Australia
- Department of Rheumatology, The Queen Elizabeth Hospital, Adelaide, Australia
| | - Iris Navarro-Millan
- Department of Medicine, Division of Rheumatology, University of Massachusetts Medical School, Worcester, MA, USA
- Division of General Internal Medicine, Weill Cornell Medicine, New York, NY, USA
| | - Diyu Pearce-Fisher
- Division of Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, USA
| | - Carlee Ruediger
- Department of Rheumatology, The Queen Elizabeth Hospital, Adelaide, Australia
| | - Joanna Tieu
- Department of Rheumatology, The Queen Elizabeth Hospital, Adelaide, Australia
- Rheumatology Unit, Lyell McEwin Hospital, Adelaide, Australia
| | - Kevin Yip
- Division of Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, USA
| | - Sarah L Mackie
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Susan Goodman
- Division of Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, USA
| | - Catherine Hill
- Discipline of Medicine, The University of Adelaide, Adelaide, Australia
- Rheumatology Department, Royal Adelaide Hospital, Adelaide, Australia
- Department of Rheumatology, The Queen Elizabeth Hospital, Adelaide, Australia
| | - Joanna C Robson
- Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England—UWE Bristol, Bristol, UK
- Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
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Bradley H, Trennery C, Jones AM, Lydon A, White F, Williams-Hall R, Arbuckle R, Tomaszewski E, Shih VH, Haughney J, Eisen A, Winders T, Coons SJ, Eremenco S. Assessing asthma symptoms in children: qualitative research supporting the development of the Pediatric Asthma Diary-Child (PAD-C) and Pediatric Asthma Diary-Observer (PAD-O). J Patient Rep Outcomes 2023; 7:104. [PMID: 37863864 PMCID: PMC10589163 DOI: 10.1186/s41687-023-00639-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/03/2023] [Accepted: 09/26/2023] [Indexed: 10/22/2023] Open
Abstract
BACKGROUND Pediatric asthma has been identified by regulators, clinicians, clinical trial sponsors, and caregivers as an area in need of novel fit-for-purpose clinical outcome assessments (COAs) developed in accordance with the U.S. Food and Drug Administration's (FDA's) regulatory guidance for evaluating clinical benefit in treatment trials. To address this gap, the Patient-Reported Outcome (PRO) Consortium's Pediatric Asthma Working Group has continued development of 2 COAs to assess asthma signs and symptoms in pediatric asthma clinical trials to support efficacy endpoints: a PRO measure, the Pediatric Asthma Diary-Child (PAD-C) for children 8-11 years old (y.o.) and an observer-reported outcome measure, the Pediatric Asthma Diary-Observer (PAD-O) for caregivers of children 4-11 y.o. This qualitative research aimed to generate evidence regarding the content validity of the PAD-C and PAD-O. METHODS Semi-structured combined concept elicitation and cognitive interviews were conducted with a diverse sample of U.S. participants (15 children 8-11 y.o. and 30 caregivers of children 4-11 y.o.). All children had clinician-diagnosed mild to severe asthma. Interviews explored the experience of pediatric asthma and assessed the understanding and relevance of both measures. Interviews were conducted across 3 iterative rounds to allow for modifications. RESULTS Concept elicitation findings demonstrated that the core sign/symptom and impact concepts assessed in the PAD-C (cough, hard to breathe, out of breath, wheezing, chest tightness, and nighttime awakenings/symptoms) and PAD-O (cough, difficulty breathing, short of breath, wheezing, and nighttime awakenings/signs) correspond to those most frequently reported by participants; concept saturation was achieved. All PAD-C and PAD-O instructions and core items were well understood and considered relevant by most participants. Feedback from participants, the Pediatric Asthma Working Group, advisory panel, and FDA supported modifications to the measures, including addition of 1 new item to both measures and removal of 1 caregiver item. CONCLUSIONS Findings provide strong support for the content validity of both measures. The cross-sectional measurement properties of both measures and their user experience and feasibility in electronic format will be assessed in a future quantitative pilot study with qualitative exit interviews, intended to support the reliability, construct validity, final content, and, ultimately, FDA qualification of the measures.
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Affiliation(s)
| | | | - Amy M Jones
- Adelphi Values Ltd, Bollington, Cheshire, UK
| | - Aoife Lydon
- Adelphi Values Ltd, Bollington, Cheshire, UK
| | | | | | | | | | | | - John Haughney
- NHS Greater Glasgow and Clyde R&I, Queen Elizabeth University Hospital, Glasgow, UK
| | | | - Tonya Winders
- Global Allergy and Airways Patient Platform, Vienna, Austria
| | - Stephen Joel Coons
- Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA
| | - Sonya Eremenco
- Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA
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10
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Tomaszewski EL, Atkinson MJ, Janson C, Karlsson N, Make B, Price D, Reddel HK, Vogelmeier CF, Müllerová H, Jones PW. Chronic Airways Assessment Test: psychometric properties in patients with asthma and/or COPD. Respir Res 2023; 24:106. [PMID: 37031164 PMCID: PMC10082977 DOI: 10.1186/s12931-023-02394-6] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/30/2022] [Accepted: 03/10/2023] [Indexed: 04/10/2023] Open
Abstract
BACKGROUND No short patient-reported outcome (PRO) instruments assess overall health status across different obstructive lung diseases. Thus, the wording of the introduction to the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) was modified to permit use in asthma and/or COPD. This tool is called the Chronic Airways Assessment Test (CAAT). METHODS The psychometric properties of the CAAT were evaluated using baseline data from the NOVELTY study (NCT02760329) in patients with physician-assigned asthma, asthma + COPD or COPD. Analyses included exploratory/confirmatory factor analyses, differential item functioning and analysis of construct validity. Responses to the CAAT and CAT were compared in patients with asthma + COPD and those with COPD. RESULTS CAAT items were internally consistent (Cronbach's alpha: > 0.7) within each diagnostic group (n = 510). Models for structural and measurement invariance were strong. Tests of differential item functioning showed small differences between asthma and COPD in individual items, but these were not consistent in direction and had minimal overall impact on the total score. The CAAT and CAT were highly consistent when assessed in all NOVELTY patients who completed both (N = 277, Pearson's correlation coefficient: 0.90). Like the CAT itself, CAAT scores correlated moderately (0.4-0.7) to strongly (> 0.7) with other PRO measures and weakly (< 0.4) with spirometry measures. CONCLUSIONS CAAT scores appear to reflect the same health impairment across asthma and COPD, making the CAAT an appropriate PRO instrument for patients with asthma and/or COPD. Its brevity makes it suitable for use in clinical studies and routine clinical practice. TRIAL REGISTRATION NCT02760329.
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Affiliation(s)
- Erin L Tomaszewski
- BioPharmaceuticals Medical, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, USA.
| | | | - Christer Janson
- Department of Medical Sciences: Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden
| | | | - Barry Make
- National Jewish Health and University of Colorado Denver, Denver, CO, USA
| | - David Price
- Observational and Pragmatic Research Institute, Singapore, Singapore
- Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
| | - Helen K Reddel
- The Woolcock Institute of Medical Research, The University of Sydney, Sydney, NSW, Australia
| | - Claus F Vogelmeier
- Department of Medicine, Pulmonary and Critical Care Medicine, German Center for Lung Research (DZL), University of Marburg, Marburg, Germany
| | | | - Paul W Jones
- Global Respiratory Franchise, GlaxoSmithKline, Brentford, Middlesex, UK
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11
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Sousa-Pinto B, Jácome C, Pereira AM, Regateiro FS, Almeida R, Czarlewski W, Kulus M, Shamji MH, Boulet LP, Bonini M, Brussino L, Canonica GW, Cruz AA, Gemicioglu B, Haahtela T, Kupczyk M, Kvedariene V, Larenas-Linnemann D, Louis R, Niedoszytko M, Pham-Thi N, Puggioni F, Romantowski J, Sastre J, Scichilone N, Taborda-Barata L, Ventura MT, Vieira RJ, Agache I, Bedbrook A, Bergmann KC, Amaral R, Azevedo LF, Bosnic-Anticevich S, Brusselle G, Buhl R, Cecchi L, Charpin D, Loureiro CC, de Blay F, Del Giacco S, Devillier P, Jassem E, Joos G, Jutel M, Klimek L, Kuna P, Laune D, Luna Pech J, Makela M, Morais-Almeida M, Nadif R, Neffen HE, Ohta K, Papadopoulos NG, Papi A, Pétré B, Pfaar O, Yeverino DR, Cordeiro CR, Roche N, Sá-Sousa A, Samolinski B, Sheikh A, Ulrik CS, Usmani OS, Valiulis A, Vandenplas O, Vieira-Marques P, Yorgancioglu A, Zuberbier T, Anto JM, Fonseca JA, Bousquet J. Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study. Lancet Digit Health 2023; 5:e227-e238. [PMID: 36872189 DOI: 10.1016/s2589-7500(23)00020-1] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2022] [Revised: 01/23/2023] [Accepted: 01/24/2023] [Indexed: 03/06/2023]
Abstract
BACKGROUND Validated questionnaires are used to assess asthma control over the past 1-4 weeks from reporting. However, they do not adequately capture asthma control in patients with fluctuating symptoms. Using the Mobile Airways Sentinel Network for airway diseases (MASK-air) app, we developed and validated an electronic daily asthma control score (e-DASTHMA). METHODS We used MASK-air data (freely available to users in 27 countries) to develop and assess different daily control scores for asthma. Data-driven control scores were developed based on asthma symptoms reported by a visual analogue scale (VAS) and self-reported asthma medication use. We included the daily monitoring data from all MASK-air users aged 16-90 years (or older than 13 years to 90 years in countries with a lower age of digital consent) who had used the app in at least 3 different calendar months and had reported at least 1 day of asthma medication use. For each score, we assessed construct validity, test-retest reliability, responsiveness, and accuracy. We used VASs on dyspnoea and work disturbance, EQ-5D-VAS, Control of Allergic Rhinitis and Asthma Test (CARAT), CARAT asthma, and Work Productivity and Activity Impairment: Allergy Specific (WPAI:AS) questionnaires as comparators. We performed an internal validation using MASK-air data from Jan 1 to Oct 12, 2022, and an external validation using a cohort of patients with physician-diagnosed asthma (the INSPIRERS cohort) who had had their diagnosis and control (Global Initiative for Asthma [GINA] classification) of asthma ascertained by a physician. FINDINGS We studied 135 635 days of MASK-air data from 1662 users from May 21, 2015, to Dec 31, 2021. The scores were strongly correlated with VAS dyspnoea (Spearman correlation coefficient range 0·68-0·82) and moderately correlated with work comparators and quality-of-life-related comparators (for WPAI:AS work, we observed Spearman correlation coefficients of 0·59-0·68). They also displayed high test-retest reliability (intraclass correlation coefficients range 0·79-0·95) and moderate-to-high responsiveness (correlation coefficient range 0·69-0·79; effect size measures range 0·57-0·99 in the comparison with VAS dyspnoea). The best-performing score displayed a strong correlation with the effect of asthma on work and school activities in the INSPIRERS cohort (Spearman correlation coefficients 0·70; 95% CI 0·61-0·78) and good accuracy for the identification of patients with uncontrolled or partly controlled asthma according to GINA (area under the receiver operating curve 0·73; 95% CI 0·68-0·78). INTERPRETATION e-DASTHMA is a good tool for the daily assessment of asthma control. This tool can be used as an endpoint in clinical trials as well as in clinical practice to assess fluctuations in asthma control and guide treatment optimisation. FUNDING None.
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Affiliation(s)
- Bernardo Sousa-Pinto
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Cristina Jácome
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Ana Margarida Pereira
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal; Patient Centred Innovation and Technology, Centro de Investigação em Tecnologias e Serviços de Saúde, Centre for Health Technology and Services Research, University of Porto, Porto, Portugal
| | - Frederico S Regateiro
- Allergy and Clinical Immunology Unit, Centro Hospitalar e Universitário de Coimbra, Coimbra and Institute of Immunology, and Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal
| | - Rute Almeida
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | | | - Marek Kulus
- Department of Pediatric Respiratory Diseases and Allergology, Medical University of Warsaw, Warsaw, Poland
| | - Mohamed H Shamji
- National Heart and Lung Institute, Imperial College & National Institutes for Health Imperial Biomedical Research Centre, London, UK
| | | | - Matteo Bonini
- Department of Cardiovascular and Respiratory Sciences, Università Cattolica del Sacro Cuore, Rome, Italy; Department of Neurological, Ear, Nose, and Throat, and Thoracic Sciences, Fondazione Policlinico Universitario A Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; National Heart and Lung Institute, Imperial College London, London, UK
| | - Luisa Brussino
- Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino & Mauriziano Hospital, Torino, Italy
| | - G Walter Canonica
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy
| | - Alvaro A Cruz
- Fundaçao ProAR, Federal University of Bahia and Global Alliance Against Chronic Respiratory Diseases and WHO Planning Group, Salvador, Bahia, Brazil
| | - Bilun Gemicioglu
- Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Türkiye
| | - Tari Haahtela
- Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Maciej Kupczyk
- Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
| | - Violeta Kvedariene
- Institute of Biomedical Sciences, Department of Pathology and Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
| | - Desirée Larenas-Linnemann
- Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico
| | - Renaud Louis
- Department of Pulmonary Medicine, Centre Hospitalier Universitaire Liege, and GIGA Infection, Immunity, Inflammation Laboratories research group, University of Liege, Liege, Belgium
| | - Marek Niedoszytko
- Department of Allergology, Medical University of Gdańsk, Gdansk, Poland
| | - Nhân Pham-Thi
- Institut de Recherche bio-Médicale des Armées, Bretigny sur Orge, France; École Polytechnique de Palaiseau, Palaiseau, France; Université Paris Cité, Paris, France
| | - Francesca Puggioni
- Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy
| | - Jan Romantowski
- Department of Allergology, Medical University of Gdańsk, Gdansk, Poland
| | - Joaquin Sastre
- Allergy Service, Fundacion Jimenez Diaz, Faculty of Medicine Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain
| | | | - Luis Taborda-Barata
- University of Beira Interior Air, Clinical & Experimental Lung Centre and Centro de Investigação em Ciências da Saúde-University of Beira Interior Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal; Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal
| | - Maria Teresa Ventura
- Unit of Geriatric Immunoallergology, University of Bari Medical School, Bari, Italy
| | - Rafael José Vieira
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Ioana Agache
- Faculty of Medicine, Transylvania University Brasov, Brasov, Romania
| | - Anna Bedbrook
- Allergic Rhinitis and its Impact on Asthma, Montpellier, France
| | - Karl C Bergmann
- Institute of Allergology, Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, Berlin, Germany
| | - Rita Amaral
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Luís Filipe Azevedo
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Sinthia Bosnic-Anticevich
- Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, The University of Sydney, and Sydney Local Health District, Sydney, NSW, Australia
| | - Guy Brusselle
- Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium
| | - Roland Buhl
- Department of Pulmonary Medicine, Mainz University Hospital, Mainz, Germany
| | - Lorenzo Cecchi
- Struttura Organizzativa Semplice Allergology and Clinical Immunology Unita Sanitaria Locale, Toscana Centro, Prato, Italy
| | - Denis Charpin
- Clinique des Bronches, Allergie et Sommeil, Hôpital Nord, Marseille, France
| | - Claudia Chaves Loureiro
- Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
| | - Frédéric de Blay
- Allergy Division, Chest Disease Department, University Hospital of Strasbourg, Strasbourg, France; Federation of Translational Medicine, University of Strasbourg, Strasbourg, France
| | - Stefano Del Giacco
- Department of Medical Sciences and Public Health and Unit of Allergy and Clinical Immunology, University Hospital Duilio Casula, University of Cagliari, Cagliari, Italy
| | - Philippe Devillier
- Virologie et Immunologie Moléculaires Suresnes, Unités Mixtes de Recherche 0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France
| | - Ewa Jassem
- Medical University of Gdańsk, Department of Pneumonology, Gdansk, Poland
| | - Guy Joos
- Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium
| | - Marek Jutel
- Department of Clinical Immunology, Wrocław Medical University, Wroclaw, Poland; All-Medicine Medical Research Institute, Wroclaw, Poland
| | - Ludger Klimek
- Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany
| | - Piotr Kuna
- Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
| | | | | | - Mika Makela
- Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | | | - Rachel Nadif
- Université Paris-Saclay, Université Versailles-St Quentin, Université Paris-Sud, Paris, France; Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, Villejuif, France
| | - Hugo E Neffen
- Center of Allergy, Immunology and Respiratory Diseases, Santa Fe, Argentina
| | - Ken Ohta
- National Hospital Organization, Tokyo National Hospital, Tokyo, Japan; JATA Fukujuji Hospital, Tokyo, Japan
| | | | - Alberto Papi
- Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy
| | - Benoit Pétré
- Department of Public Health, University of Liege, Liege, Belgium
| | - Oliver Pfaar
- Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
| | - Daniela Rivero Yeverino
- Allergy and Clinical Immunology Department, Hospital Universitario de Puebla, Puebla, Mexico
| | | | - Nicolas Roche
- Pneumologie, Assistance Publique - Hôpitaux de Paris, Centre Université de Paris Cité, Hôpital Cochin, Paris, France
| | - Ana Sá-Sousa
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal; Patient Centred Innovation and Technology, Centro de Investigação em Tecnologias e Serviços de Saúde, Centre for Health Technology and Services Research, University of Porto, Porto, Portugal
| | - Boleslaw Samolinski
- Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland
| | - Aziz Sheikh
- Usher Institute, The University of Edinburgh, Edinburgh, UK
| | - Charlotte Suppli Ulrik
- Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Omar S Usmani
- National Heart and Lung Institute, Imperial College London, London, UK; Royal Brompton Hospital, Airways Disease Section, London, UK
| | - Arunas Valiulis
- Institute of Clinical Medicine and Institute of Health Sciences and Medical Faculty of Vilnius University, Vilnius, Lithuania
| | - Olivier Vandenplas
- Department of Chest Medicine, Centre Hospitalier Universitaire UCL, Namur, Belgium; Université Catholique de Louvain, Yvoir, Belgium
| | - Pedro Vieira-Marques
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Arzu Yorgancioglu
- Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Türkiye
| | - Torsten Zuberbier
- Institute of Allergology, Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, Berlin, Germany
| | - Josep M Anto
- ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain; Universitat Pompeu Fabra, Barcelona, Spain; Centro de Investigación Biomédica en Red Epidemiología y Salud Pública, Barcelona, Spain
| | - João A Fonseca
- MEDicina da Comunidade, Informação e Decisão em Saúde, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal; Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde, Health Research Network, MEDCIDS, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Jean Bousquet
- Institute of Allergology, Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology, Berlin, Germany; Inserm, Equipe d'Epidémiologie Respiratoire Intégrative, Villejuif, France; University Hospital Montpellier, Montpellier, France.
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12
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Louis G, Schleich F, Guillaume M, Kirkove D, Nekoee Zahrei H, Donneau AF, Henket M, Paulus V, Guissard F, Louis R, Pétré B. Development and validation of a predictive model combining patient-reported outcome measures, spirometry and exhaled nitric oxide fraction for asthma diagnosis. ERJ Open Res 2023; 9:00451-2022. [PMID: 36755965 PMCID: PMC9900444 DOI: 10.1183/23120541.00451-2022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2022] [Accepted: 10/30/2022] [Indexed: 11/27/2022] Open
Abstract
Introduction Although asthma is a common disease, its diagnosis remains a challenge in clinical practice with both over- and underdiagnosis. Here, we performed a prospective observational study investigating the value of symptom intensity scales alone or combined with spirometry and exhaled nitric oxide fraction (F ENO) to aid in asthma diagnosis. Methods Over a 38-month period we recruited 303 untreated patients complaining of symptoms suggestive of asthma (wheezing, dyspnoea, cough, sputum production and chest tightness). The whole cohort was split into a training cohort (n=166) for patients recruited during odd months and a validation cohort (n=137) for patients recruited during even months. Asthma was diagnosed either by a positive reversibility test (≥12% and ≥200 mL in forced expiratory volume in 1 s (FEV1)) and/or a positive bronchial challenge test (provocative concentration of methacholine causing a 20% fall in FEV1 ≤8 mg·mL-1). In order to assess the diagnostic performance of symptoms, spirometric indices and F ENO, we performed receiver operating characteristic curve analysis and multivariable logistic regression to identify the independent factors associated with asthma in the training cohort. Then, the derived predictive models were applied to the validation cohort. Results 63% of patients in the derivation cohort and 58% of patients in the validation cohort were diagnosed as being asthmatic. After logistic regression, wheezing was the only symptom to be significantly associated with asthma. Similarly, FEV1 (% pred), FEV1/forced vital capacity (%) and F ENO were significantly associated with asthma. A predictive model combining these four parameters yielded an area under the curve of 0.76 (95% CI 0.66-0.84) in the training cohort and 0.73 (95% CI 0.65-0.82) when applied to the validation cohort. Conclusion Combining a wheezing intensity scale with spirometry and F ENO may help in improving asthma diagnosis accuracy in clinical practice.
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Affiliation(s)
- Gilles Louis
- Department of Public Health, University of Liège, Liege, Belgium,Corresponding author: Gilles Louis ()
| | - Florence Schleich
- Department of Pneumology, GIGAI3, University of Liège, Liege, Belgium
| | | | - Delphine Kirkove
- Department of Public Health, University of Liège, Liege, Belgium
| | | | | | - Monique Henket
- Department of Pneumology, GIGAI3, University of Liège, Liege, Belgium
| | - Virginie Paulus
- Department of Pneumology, GIGAI3, University of Liège, Liege, Belgium
| | | | - Renaud Louis
- Department of Pneumology, GIGAI3, University of Liège, Liege, Belgium
| | - Benoit Pétré
- Department of Public Health, University of Liège, Liege, Belgium
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Tabberer M, Wells JR, Chandler D, Abetz-Webb L, Zhang S, Meeraus W, Fowler A, Slade D. Patient experience of moderate asthma attacks: qualitative research in the USA and Germany. J Patient Rep Outcomes 2022; 6:117. [PMID: 36414789 PMCID: PMC9681943 DOI: 10.1186/s41687-022-00506-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2021] [Accepted: 09/05/2022] [Indexed: 11/24/2022] Open
Abstract
BACKGROUND There is limited information available on the impact of moderate asthma exacerbations, often called "asthma attacks" (i.e., those not requiring hospitalisation or treatment with systemic corticosteroids) on patients' lives. This multi-country qualitative study explored the patient experience of these events. METHODS Semi-structured concept elicitation interviews were conducted in the USA and Germany with adult patients with asthma who had experienced a moderate asthma exacerbation in the prior 30 days. Physicians with experience in managing patients with asthma were also interviewed. Interviews explored patients' experience of symptoms and impact of moderate exacerbations and associated exacerbation triggers and treatment patterns. Physicians were also asked about their interpretation of a clinical definition and treatment of a moderate exacerbation. RESULTS Twenty-eight patient (n = 20 in the USA, n = 8 in Germany) and six physician (n = 3 in the USA, n = 3 in Germany) interviews were conducted. During their moderate exacerbation, all patients reported experiencing shortness of breath, which many considered to be severe and the most bothersome symptom. Wheezing was also reported by all patients and considered severe by two thirds of patients. Most patients also reported coughing and chest tightness. All or almost all patients reported that moderate exacerbation caused fatigue/tiredness and impacted their physical functioning, emotional functioning, activities of daily living and work/school life. Most patients reported using rescue or maintenance inhalers to alleviate symptoms of the exacerbation. Conceptual saturation (i.e., the point at which no new concepts are likely to emerge with continued data collection) was achieved. Findings were used to develop a patient-focused conceptual model of the experience of moderate asthma exacerbations, outlining concepts related to triggers, symptoms, impact, and treatment from the patient perspective. Physician data was consistent with patient reports and complemented the conceptual model. CONCLUSIONS Findings from concept elicitation interviews highlight the increased frequency, duration and severity of asthma symptoms and increased rescue medication use during moderate asthma exacerbations compared with the typical daily asthma experience, which have a substantial impact on patients' lives.
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Affiliation(s)
| | - Jane R Wells
- Patient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK
| | - Dale Chandler
- Patient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK
| | - Linda Abetz-Webb
- Patient-Centred Outcomes Assessments Ltd, Bollington, Cheshire, UK
| | - Shiyuan Zhang
- GSK Collegeville, 1250 S. Collegeville Rd, Collegeville, PA, 19426, USA.
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14
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Louis R, Satia I, Ojanguren I, Schleich F, Bonini M, Tonia T, Rigau D, Ten Brinke A, Buhl R, Loukides S, Kocks JWH, Boulet LP, Bourdin A, Coleman C, Needham K, Thomas M, Idzko M, Papi A, Porsbjerg C, Schuermans D, Soriano JB, Usmani OS. European Respiratory Society guidelines for the diagnosis of asthma in adults. Eur Respir J 2022; 60:2101585. [PMID: 35169025 DOI: 10.1183/13993003.01585-2021] [Citation(s) in RCA: 108] [Impact Index Per Article: 36.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2021] [Accepted: 01/10/2022] [Indexed: 12/20/2022]
Abstract
Although asthma is very common, affecting 5-10% of the population, the diagnosis of asthma in adults remains a challenge in the real world, which results in both over- and under-diagnosis. A taskforce was set up by the European Respiratory Society to systematically review the literature on the diagnostic accuracy of tests used to diagnose asthma in adult patients and provide recommendations for clinical practice.The taskforce defined eight Population, Index, Comparator and Outcome questions that were assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. The taskforce utilised the outcomes to develop an evidence-based diagnostic algorithm, with recommendations for a pragmatic guideline for everyday practice that was directed by real-life patient experiences.The taskforce supports the initial use of spirometry followed by bronchodilator reversibility testing (if airway obstruction is present). If initial spirometry fails to show obstruction, further tests should be performed in the following order: exhaled nitric oxide fraction, peak expiratory flow variability, or, in secondary care, bronchial challenge. We present the thresholds for each test that are compatible with a diagnosis of asthma in the presence of current symptoms.The taskforce reinforces spirometry as a priority and recognises the value of measuring blood eosinophils and serum immunoglobulin E to phenotype the patient. Measuring gas trapping by body plethysmography in patients with preserved forced expiratory volume in 1 s/forced vital capacity ratio deserves further attention. The taskforce draws attention to the difficulty of making a correct diagnosis in patients already receiving inhaled corticosteroids; the comorbidities that may obscure diagnosis; the importance of phenotyping; and the necessity of considering the patient experience in the diagnostic process.
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Affiliation(s)
- Renaud Louis
- Dept of Pneumology, CHU Liege, GIGA I Research Group, University of Liege, Liege, Belgium
- Taskforce chair
| | - Imran Satia
- Division of Respirology, McMaster University, Hamilton, ON, Canada
- These authors contributed equally
| | - Inigo Ojanguren
- Servei de Pneumologia, Hospital Universitari Vall d'Hebron, Universitat Autònomona de Barcelona (UAB); Vall d'Hebron Institut de Recerca (VHIR); CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain
- These authors contributed equally
| | - Florence Schleich
- Dept of Pulmonary Medicine, University of Liege, Liège, Belgium
- These authors contributed equally
| | - Matteo Bonini
- Sapienza University of Rome, Rome, Italy
- These authors contributed equally
| | - Thomy Tonia
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
| | - David Rigau
- Iberoamerican Cochrane Centre, Barcelona, Spain
| | - Anne Ten Brinke
- Pulmonology, Medical Center Leeuwarden, Leeuwarden, The Netherlands
| | - Roland Buhl
- Pulmonary Dept, Mainz University Hospital, Mainz, Germany
| | | | | | - Louis-Philippe Boulet
- Pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, Quebec, QC, Canada
| | | | | | | | - Mike Thomas
- Primary Care and Population Sciences Division, University of Southampton, Southampton, UK
| | - Marco Idzko
- Dept of Respiratory Medicine, Medical University of Vienna, Vienna, Austria
| | - Alberto Papi
- Respiratory Medicine, University of Ferrara, Ferrara, Italy
| | - Celeste Porsbjerg
- Respiratory Medicine, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark
| | - Daniel Schuermans
- Respiratory Division, Academic Hospital UZBrussel, Brussels, Belgium
| | - Joan B Soriano
- Universidad Autónoma de Madrid, Hospital Universitario de la Princesa, Madrid, Spain
| | - Omar S Usmani
- National Heart and Lung Institute, Imperial College London, London, UK
- Taskforce co-chair
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15
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Padró C, Gutiérrez D, Moreno F, Parra A, Rial MJ, Lleonart R, Torán‐Barona C, Justicia JL, Roger A. Effectiveness and safety of a microcrystalline tyrosine‐adjuvanted
Dermatophagoides pteronyssinus
allergoid immunotherapy in adult patients with allergic asthma and rhinitis: A real‐life prospective observational study. Immun Inflamm Dis 2022; 10:e585. [PMID: 35478444 PMCID: PMC9017636 DOI: 10.1002/iid3.585] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2021] [Accepted: 11/18/2021] [Indexed: 11/27/2022] Open
Abstract
Introduction Although clinical trials have shown the efficacy and safety of allergen‐specific immunotherapy (AIT) in the treatment of allergic asthma, there is a need for real‐life studies. We aimed to assess the effectiveness and safety of a microcrystalline tyrosine‐adjuvanted Dermatophagoides pteronyssinus allergoid (Acarovac Plus®) in patients with house dust mite (HDM)‐induced allergic asthma in a real‐life study. Methods A subanalysis of a multicenter, prospective, observational, real‐life study. Patients with rhinitis and allergic asthma caused by HDMs were assessed before AIT with Acarovac Plus® and at 6 and 12 months after this treatment. Assessment parameters were percentage of days with asthma symptoms, percentage of days on asthma medication, classification of asthma according to Spanish guidelines for the management of asthma, asthma‐related quality of life (quality of life in adults with asthma questionnaire [QLAAQ]), perception of symptoms (visual analog scale [VAS]), and treatment satisfaction (treatment satisfaction questionnaire for medication [TSQM]). Safety was assessed by the number and severity of adverse reactions. Results This subanalysis included 55 patients. Treatment with Acarovac Plus® showed significant differences in the analyzed variables when the baseline visit was compared with the 12‐month visit: reduction of the mean (SD) percentage of days with asthma symptoms (23.9 [9.2] vs. 5.1 [12.8]; p = .002), of the mean [SD] percentage of days on asthma medication (67.6 [42.9] vs. 45.1 [46.8]; p = .002), and of the percentage of patients with persistent asthma (78.2% vs. 38.9%; p = .009). Acarovac Plus® significantly improved asthma‐related quality of life, as shown by a decrease of 1.39 points in QLAAQ score at 12 months (p < .001), and in the subjective perception of symptoms on the VAS (−3.50, p < .0001). Patients showed high treatment satisfaction according to the TSQM, and it was well tolerated. No serious adverse events were reported. Conclusions Acarovac Plus® was effective and safe for the treatment of patients with HDM‐induced allergic asthma in a real‐life study.
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Affiliation(s)
- Clara Padró
- Allergy Section Hospital Universitari Germans Trias i Pujol Badalona Spain
| | - Diego Gutiérrez
- Clínica Médico Asistencial Virgen del Rosario Algeciras Spain
| | | | - Antonio Parra
- Allergy Department Complexo Hospitalario Universitario A Coruña A Coruña Spain
| | - Manuel J. Rial
- Allergy Department Complexo Hospitalario Universitario A Coruña A Coruña Spain
| | - Ramón Lleonart
- Allergy Unit Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Spain
| | | | | | - Albert Roger
- Allergy Section Hospital Universitari Germans Trias i Pujol Badalona Spain
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16
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Gater A, Nelsen L, Coon CD, Eremenco S, O'Quinn S, Khan AH, Eckert L, Staunton H, Bonner N, Hall R, Krishnan JA, Stoloff S, Schatz M, Haughney J, Coons SJ. Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD): Measurement Properties of Novel Patient-Reported Symptom Measures. THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE 2022; 10:1249-1259. [PMID: 34896298 DOI: 10.1016/j.jaip.2021.11.026] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/23/2021] [Revised: 10/27/2021] [Accepted: 11/17/2021] [Indexed: 11/25/2022]
Abstract
BACKGROUND The Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescents. OBJECTIVE To determine scoring and evaluate the measurement properties of the ADSD/ANSD. METHODS Adolescents (12-17 years) and adults (18+ years) with asthma completed draft 8-item electronic versions of the ADSD/ANSD for 10 days alongside the Adult Asthma Symptom Daily Scales (AASDS) and a Patient Global Impression of Severity (PGIS). Using classical and modern psychometric methods, initial analyses evaluated the performance of ADSD/ANSD items to inform scoring. Subsequent analyses evaluated the reliability and validity of ADSD/ANSD scores. RESULTS A demographically and clinically diverse sample (n = 130 adolescents; n = 89 adults) was recruited. Item performance was generally strong. However, items assessing chest pressure and mucus/phlegm demonstrated redundancy and poorer performance and were removed. Principal-components analysis, confirmatory factor analysis, and item response theory supported combining items to form 6-item total ADSD/ANSD scores. Internal consistency (α = 0.94-0.95) and test-retest reliability (intraclass correlation coefficient = 0.86-0.95) were strong. Strong correlations (r = 0.72-0.80) were observed between ADSD scores and AASDS items assessing asthma symptom frequency, bother, and impact on activities. Significant differences (P < .001) in mean ADSD/ANSD scores were observed between groups categorized by asthma severity (PGIS), asthma control, inhaler use, nebulizer use, activity limitations, and nighttime awakenings. CONCLUSIONS The ADSD/ANSD items and scores demonstrated strong reliability and validity. Implementation of the measures in interventional studies will enable the evaluation of responsiveness and meaningful within-patient change.
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Affiliation(s)
- Adam Gater
- Adelphi Values Ltd, Bollington, Cheshire, United Kingdom.
| | | | | | - Sonya Eremenco
- Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, Ariz
| | | | | | | | - Hannah Staunton
- Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
| | - Nicola Bonner
- Adelphi Values Ltd, Bollington, Cheshire, United Kingdom
| | - Rebecca Hall
- Adelphi Values Ltd, Bollington, Cheshire, United Kingdom
| | | | | | - Michael Schatz
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital, San Diego, Calif
| | - John Haughney
- Queen Elizabeth University Hospital, Glasgow, United Kingdom
| | - Stephen Joel Coons
- Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, Ariz
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17
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Mukuria C, Connell J, Carlton J, Peasgood T, Scope A, Clowes M, Rand S, Jones K, Brazier J. Qualitative Review on Domains of Quality of Life Important for Patients, Social Care Users, and Informal Carers to Inform the Development of the EQ-HWB. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2022; 25:492-511. [PMID: 35365298 DOI: 10.1016/j.jval.2021.11.1371] [Citation(s) in RCA: 21] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/16/2021] [Revised: 10/25/2021] [Accepted: 11/23/2021] [Indexed: 06/14/2023]
Abstract
OBJECTIVES To identify the themes to inform the content of a new generic measure, the EQ-HWB (EQ Health and Wellbeing), that can be used in economic evaluation across health, social care, and public health, based on the views of users and beneficiaries of these services including informal carers. METHODS A qualitative review was undertaken. Systematic and citation searches were undertaken focusing on qualitative evidence of the impact on quality of life from reviews for selected health conditions, informal carers, social care users, and primary qualitative work used in the development of selected measures. A subset of studies was included in the review. Framework analysis and synthesis were undertaken based on a conceptual model. RESULTS A total of 42 reviews and 24 primary studies were selected for inclusion in the review. Extraction and synthesis resulted in 7 high-level themes (with subthemes): (1) feelings and emotions (sadness, anxiety, hope, frustration, safety, guilt/shame); (2) cognition (concentration, memory, confusion, thinking clearly); (3) self-identity (dignity/respect, self-esteem); (4) "coping, autonomy, and control" relationships; (5) social connections (loneliness, social engagement, stigma, support, friendship, belonging, burden); (6) physical sensations (pain, discomfort, sleep, fatigue); and (7) activity (self-care, meaningful activities, mobility, communication, hearing, vision). Apart from physical sensations, most of the other themes and subthemes were relevant across both health and social care, including for informal carers. CONCLUSIONS The findings from this broad review identified themes that go beyond health and that are relevant to patients, informal carers, and social care users. The themes and subthemes informed the domains for the EQ-HWB.
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Affiliation(s)
- Clara Mukuria
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK.
| | - Janice Connell
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
| | - Jill Carlton
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
| | - Tessa Peasgood
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
| | - Alison Scope
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
| | - Mark Clowes
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
| | - Stacey Rand
- Personal Social Services Research Unit (PSSRU), University of Kent, Canterbury, England, UK
| | - Karen Jones
- Personal Social Services Research Unit (PSSRU), University of Kent, Canterbury, England, UK
| | - John Brazier
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
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18
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Van Oorschot D, McGirr A, Goulet P, Koochaki P, Pratiwadi R, Shah S, Curran D. A Cross-Sectional Concept Elicitation Study to Understand the Impact of Herpes Zoster on Patients' Health-Related Quality of Life. Infect Dis Ther 2022; 11:501-516. [PMID: 34994924 PMCID: PMC8847496 DOI: 10.1007/s40121-021-00581-w] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2021] [Accepted: 12/06/2021] [Indexed: 12/03/2022] Open
Abstract
Introduction After a chickenpox infection, the varicella zoster virus lies dormant in nerve cells and can be reactivated in later life to cause herpes zoster (HZ), also called shingles, a painful rash that may result in persistent postherpetic neuralgia (PHN). Treatment options are limited, and HZ/PHN may have substantial negative effects on health-related quality of life (HRQoL). This qualitative cross-sectional study explored the subjective patient experience and impact on HRQoL of HZ and PHN in adults aged ≥ 50 years in Canada. Methods Patients were eligible for the study if they were aged at least 50 years and had been diagnosed with HZ by a healthcare practitioner 7–60 days earlier for HZ patients and 90–365 days earlier for PHN patients. Eligible patients were invited to participate in concept elicitation interviews by telephone. Data from the interviews were transcribed and analyzed to identify key concepts related to symptoms and impacts on the patients’ lives. Results A total of 32 patients participated, with a mean age of 61 years. Most (72%) were female. The most common symptoms reported were rash (n = 32), pain (n = 31), fatigue (n = 26), and itchiness (n = 20). The most commonly reported HRQoL domains affected were emotional functioning (n = 31), activities of daily living (n = 31), sleep (n = 29), physical functioning (n = 25) and hobbies (n = 21). A conceptual model was developed to summarize these symptoms and impacts. Conclusion HZ negatively affected many dimensions of patients’ HRQoL, particularly during the acute phase of illness. This qualitative study helps to broaden understanding of the subjective patient experience of HZ. Graphical Abstract ![]()
Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00581-w.
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Affiliation(s)
| | | | | | - Patricia Koochaki
- Mapi Group, Health Research and Commercialization ICON Plc, Cincinnati, OH, USA
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19
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de Charras YL, Ramírez-Rigo MV, Bertin DE. Prediction of the particle size distribution of the aerosol generated by a pressurized metered-dose inhaler. POWDER TECHNOL 2022. [DOI: 10.1016/j.powtec.2022.117151] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
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20
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Tabberer M, von Maltzahn R, Bacci ED, Karn H, Hsieh R, Howell TA, Bailes Z, Fowler A, Lee L, Murray LT. Measuring respiratory symptoms in moderate/severe asthma: evaluation of a respiratory symptom tool, the E-RS®: COPD in asthma populations. J Patient Rep Outcomes 2021; 5:104. [PMID: 34632556 PMCID: PMC8502721 DOI: 10.1186/s41687-021-00338-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2020] [Accepted: 06/30/2021] [Indexed: 11/23/2022] Open
Abstract
BACKGROUND Symptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) tool may be relevant to patients with asthma. The purpose of this study was to evaluate content validity and psychometric performance of the E-RS: COPD in moderate/severe asthma patients. METHODS Content validity of the E-RS: COPD was evaluated in patients with moderate/severe asthma using concept elicitation and cognitive debriefing interviews. Secondary analyses using data from two clinical trials in patients with moderate/severe asthma evaluated the factor structure of the E-RS: COPD plus two supplementary items (wheeze; shortness of breath with strenuous physical activity) and assessed psychometric properties of the tool, which will be referred to as E-RS®: Asthma when used in asthma populations. RESULTS Qualitative interviews (N = 25) achieved concept saturation for asthma respiratory symptoms. Concepts in the E-RS: COPD were relevant to patients and instructions were understood. Most patients (19/25; 76%) reported experiencing all concepts in the E-RS: COPD; no patients indicated missing symptoms. Secondary analyses of clinical trial data supported the original factor structure (RS-Total and three symptom-specific subscales). The two supplemental items did not fit with this factor structure and were not retained. RS-Total and subscale score reliability was high (internal consistency [α] > 0.70). Validity was demonstrated through significant (P < 0.0001) relationships with the St George's Respiratory Questionnaire (SGRQ) and Asthma Symptom Severity scale. E-RS: Asthma was responsive to change when evaluated using SGRQ, Patient Global Impression of Change and Asthma Quality of Life Questionnaire as anchors (P < 0.0001). Clinically meaningful change thresholds were also identified (RS-Total: - 2.0 units). CONCLUSIONS The E-RS: Asthma is reliable and responsive for evaluating respiratory symptoms in patients with moderate/severe asthma.
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Affiliation(s)
- Maggie Tabberer
- GSK House, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
| | | | - Elizabeth D Bacci
- Evidera, Patient-Centered Research, 615 2nd Avenue, Seattle, WA, 98104, USA
| | - Hayley Karn
- Evidera, Patient-Centered Research, 201 Talgarth Road, London, W6 8BJ, UK
| | - Ray Hsieh
- Evidera, Patient-Centered Research, 7101 Wisconsin Avenue, Bethesda, MD, 20814, USA
| | - Timothy A Howell
- Evidera, Patient-Centered Research, 7101 Wisconsin Avenue, Bethesda, MD, 20814, USA
| | - Zelie Bailes
- GSK House, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK
| | - Andrew Fowler
- GSK House, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK
| | - Laurie Lee
- GSK, 1250 S Collegeville Road, Collegeville, PA, 19426, USA
| | - Lindsey T Murray
- Evidera, Patient-Centered Research, 7101 Wisconsin Avenue, Bethesda, MD, 20814, USA
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21
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Karlsson N, Atkinson MJ, Müllerová H, Alacqua M, Keen C, Hughes R, Janson C, Make B, Price D, Reddel HK. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD. ERJ Open Res 2021; 7:00828-2020. [PMID: 33569501 PMCID: PMC7861031 DOI: 10.1183/23120541.00828-2020] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2020] [Accepted: 11/13/2020] [Indexed: 12/26/2022] Open
Abstract
Background The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD). Methods Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (ClinicalTrials.gov: NCT02760329). The total sample (n=1530) comprised three randomly selected samples (n=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD and COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses. Results For the total sample, the mean±sd RSQ score was 5.6±4.3 (range 0–16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's α=0.76–0.80). All items had high factor loadings and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the θ score range of –2.0 to 2.8, with discrimination coefficients for individual items being high to very high (1.7–2.6). Strong convergent correlations were observed between the RSQ and the St George's Respiratory Questionnaire (0.77, p<0.001). Conclusions The RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies. The Respiratory Symptoms Questionnaire is a new, short, diagnosis-agnostic measure of respiratory symptoms. Validation in the NOVELTY study indicates that it is suitable for assessing respiratory symptoms in patients with asthma and/or COPD.https://bit.ly/36Nw7eU
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Affiliation(s)
| | | | | | | | | | - Rod Hughes
- BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK
| | - Christer Janson
- Dept of Medical Sciences: Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden
| | - Barry Make
- National Jewish Health and University of Colorado Denver, Denver, CO, USA
| | - David Price
- Observational and Pragmatic Research Institute, Singapore, Singapore.,Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
| | - Helen K Reddel
- Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia
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22
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Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A structured review evaluating content validity of the Asthma Control Test, and its consistency with U.S. guidelines and patient expectations for asthma control. J Asthma 2020; 59:628-637. [PMID: 33377411 DOI: 10.1080/02770903.2020.1861624] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
OBJECTIVE To assess whether the content of the Asthma Control Test (ACT) served as a valid measure of asthma control (i.e., content validity) by mapping ACT items to the National Heart, Lung and Blood Institute (NHLBI) guideline asthma control definitions, and to language used by patients to describe their asthma. DATA SOURCES PubMed and EMBASE databases were used for a structured literature analysis. STUDY SELECTIONS Full-text, English-language articles that reported findings from qualitative studies conducted in adults, focusing on patient descriptors of asthma symptoms, impacts, or severity, were included. Pediatric studies, studies conducted in patients without asthma, and studies that did not contain qualitative data were excluded. RESULTS ACT items reflected all domains of asthma impairment described in the NHLBI guidelines, except pulmonary function. Following the literature review, 28 full-text publications were identified that included patient descriptors that could be mapped to ACT items. For example, per ACT Item 1, patients described having trouble at work, school, and completing household chores; and, per ACT Item 2, patients used the phrase "short of breath" to describe asthma-associated symptoms. CONCLUSION ACT item content corresponded well with the NHLBI guideline definitions of the impairment domain of asthma control (focused on asthma symptoms and impact), and we identified numerous examples in the literature indicating that ACT concepts and item content mirror the language patients use when discussing asthma symptoms and impact, and their degree of asthma control. This provides further evidence to support content validity of the ACT as a measure of asthma control.
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Affiliation(s)
- Linda M Nelsen
- Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA
| | | | | | | | - Michael Schatz
- Department of Allergy, Kaiser Permanente Medical Center, San Diego, CA, USA
| | - Richard H Stanford
- US Value Evidence and Outcomes, GlaxoSmithKline plc., Research Triangle Park, NC, USA (at the time of study)
| | - Henrik Svedsater
- Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, MDX, UK
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23
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Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma 2020; 58:1518-1527. [PMID: 32718193 DOI: 10.1080/02770903.2020.1802746] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVE Acute exacerbations contribute significantly to the morbidity of asthma. Recent studies have shown that early detection and treatment of asthma exacerbations leads to improved outcomes. We aimed to develop a machine learning algorithm to detect severe asthma exacerbations using easily available daily monitoring data. METHODS We analyzed daily peak expiratory flow and symptom scores recorded by participants in the SAKURA study (NCT00839800), an international multicentre randomized controlled trial comparing budesonide/formoterol as maintenance and reliever therapy versus budesonide/formoterol maintenance plus terbutaline as reliever, in adults with persistent asthma. The dataset consisted of 728,535 records of daily monitoring data in 2010 patients, with 576 severe exacerbation events. Data post-processing techniques included normalization, standardization, calculation of differences or slopes over time and the use of smoothing filters. Principal components analysis was used to reduce the large number of derived variables to a smaller number of linearly independent components. Logistic regression, decision tree, naïve Bayes, and perceptron algorithms were evaluated. Model accuracy was assessed using stratified cross-validation. The primary outcome was the detection of exacerbations on the same day or up to three days in the future. RESULTS The best model used logistic regression with input variables derived from post-processed data using principal components analysis. This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations. CONCLUSION Asthma exacerbations may be detected using machine learning algorithms applied to daily self-monitoring of peak expiratory flow and asthma symptoms.
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Affiliation(s)
- Olivier Zhang
- Department of Computer Engineering (INFO), INSA Rennes, Rennes, France
| | | | - Sherif Gonem
- Department of Respiratory Medicine, Nottingham City Hospital, Nottingham, UK.,Department of Respiratory Science, University of Leicester, Leicester, UK
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Choy DF, Arron JR. Beyond type 2 cytokines in asthma - new insights from old clinical trials. Expert Opin Ther Targets 2020; 24:463-475. [PMID: 32223656 DOI: 10.1080/14728222.2020.1744567] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Introduction: Human asthma is a heterogeneous disorder on molecular, pathological, and clinical levels. The paradigm of asthma as an allergic process driven by type 2 cytokines and mediators has led to targeted biologic therapies resulting in some clinical benefit in patient subsets. However, some patient subsets and clinical manifestations do not benefit from these interventions, thus redefining unmet needs. Clinical studies of type 2 directed therapies have identified new targets under investigation in clinical development; these include epithelial alarmins, non-type 2 cytokines, cytokine receptor signaling, mast cells and neuroinflammation.Areas covered: We consider lessons learned concerning asthma pathogenesis from observational studies and clinical trials of biologic agents that target type 2 mediators. We also provide a perspective on emerging therapeutic hypotheses to target processes independent of or orthogonal to type 2 inflammation in asthma.Expert opinion: Type 2 inflammation is continuous, not discrete, and is likely a modifier of underlying dysregulated airway physiology. Non-type 2 inflammatory mediators (e.g., IL17, IL6, IFNs), microbiome, alarmins (e.g., TSLP, IL33), mast cells and sensory neurons may represent orthogonal targets to type 2 mediators. There is a need to better match targets and outcome measures in biologically defined patient populations to appropriately test hypotheses in the clinic.
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Castner J, Jungquist CR, Mammen MJ, Pender JJ, Licata O, Sethi S. Prediction model development of women's daily asthma control using fitness tracker sleep disruption. Heart Lung 2020; 49:548-555. [PMID: 32089295 DOI: 10.1016/j.hrtlng.2020.01.013] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2019] [Revised: 01/12/2020] [Accepted: 01/22/2020] [Indexed: 01/04/2023]
Abstract
BACKGROUND Night-time wakening with asthma symptoms is an important indicator of disease control and severity, with no gold-standard objective measurement. OBJECTIVE The study objective was to use fitness tracker sleep data to develop predictive models of daily disease control-related asthma-specific wakening and FEV1 in working-aged women with poorly controlled asthma. METHODS A repeated measures panel design included data from 43 women with poorly controlled asthma. Two components of asthma control were the primary outcomes, measured daily as (1) self-reported asthma-specific wakening and (2) self-administered spirometry to measure FEV1. Data were analyzed using generalized linear mixed models. RESULTS Our models demonstrated predictive value (AUC=0.77) for asthma-specific night-time wakening and good predictive value (AUC=0.83) for daily FEV1. CONCLUSIONS: Fitness tracker sleep efficiency and wake counts demonstrate clinical utility as predictive of asthma-specific night-time wakening and daily FEV1. Fitness tracker sleep data demonstrated predictive capability for daily asthma outcomes.
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Affiliation(s)
- Jessica Castner
- The Rockefeller Heilbrunn Family Center for Research Nursing Nurse Scholar, New York, NY, USA; University at Buffalo, Buffalo, NY, USA; Castner Incorporated, Grand Island, NY 14072, USA.
| | | | - Manoj J Mammen
- Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA
| | - John J Pender
- University at Buffalo School of Nursing Graduate, Buffalo, NY, USA
| | - Olivia Licata
- Department of Biomedical Engineering & Department of Materials Design and Innovation, University at Buffalo School of Engineering and Applied Sciences, Buffalo, NY, USA
| | - Sanjay Sethi
- Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA
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Chan TC, Hu TH, Chu YH, Hwang JS. Assessing effects of personal behaviors and environmental exposure on asthma episodes: a diary-based approach. BMC Pulm Med 2019; 19:231. [PMID: 31791294 PMCID: PMC6889623 DOI: 10.1186/s12890-019-0998-0] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2019] [Accepted: 11/15/2019] [Indexed: 12/18/2022] Open
Abstract
Background Quantifying the effects of personal health behaviors and environmental exposure on asthma flare-ups is a challenge. Most studies have focused on monitoring the symptoms and drug usage for relieving symptoms. In this study, we emphasize the need to understand how personal and environmental conditions are related to the occurrence of asthma symptoms. Methods We designed an online health diary platform to collect personal health behaviors from children, their parents and other adults with any allergic diseases including asthma, allergic rhinitis, atopic dermatitis and allergic conjunctivitis. The participants used mobile devices or computers to record their daily health-related activities such as sleep, exercise, diet, perception of air quality and temperature, and asthma symptoms. The participants also recorded secondhand smoke exposure and the time of activities, which were combined with ambient air quality measurements for calculating personal air pollution exposure. A generalized linear mixed model was used to estimate the effects of the factors. Results During the study period (January 2017–June 2017, and October 2017–September 2018), 132 participants provided 25,016 diary entries, and 84 participants had experienced asthma symptoms in 1458 diary entries. The results showed some different risk factors for the minors and adults. For minors, high-intensity exercise, contact with persons with influenza-like illness (ILI) and the perception of hot temperature and bad indoor air quality were associated with the occurrence of asthma episodes. The identified risk factors for the adult participants included having dehumidifiers at home, exposure to secondhand smoke, having bad sleep quality, contact with persons with ILI, not eating fruit and seafood, perceiving cold temperature, bad quality of indoor and outdoor air, and exposure to high concentration of ozone. Conclusions The revealed personal risk factors and perceptions of air quality and temperature may provide guidance on behavioral change for people susceptible to asthma to help control acute onset and severe exacerbation of asthma flare-ups.
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Affiliation(s)
- Ta-Chien Chan
- Research Center for Humanities and Social Sciences, Academia Sinica, 128 Academia Road, Section 2, Taipei, Taiwan
| | - Tsuey-Hwa Hu
- Institute of Statistical Science, Academia Sinica, 128 Academia Road, Section 2, Taipei, Taiwan
| | - Yen-Hua Chu
- Institute of Statistical Science, Academia Sinica, 128 Academia Road, Section 2, Taipei, Taiwan
| | - Jing-Shiang Hwang
- Institute of Statistical Science, Academia Sinica, 128 Academia Road, Section 2, Taipei, Taiwan.
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Zhu LY, Ni ZH, Luo XM, Wang XB. Advance of antioxidants in asthma treatment. World J Respirol 2017; 7:17-28. [DOI: 10.5320/wjr.v7.i1.17] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/02/2016] [Revised: 11/23/2016] [Accepted: 01/14/2017] [Indexed: 02/07/2023] Open
Abstract
Asthma is an allergic disease, characterized as a recurrent airflow limitation, airway hyperreactivity, and chronic inflammation, involving a variety of cells and cytokines. Reactive oxygen species have been proven to play an important role in asthma. The pathogenesis of oxidative stress in asthma involves an imbalance between oxidant and antioxidant systems that is caused by environment pollutants or endogenous reactive oxygen species from inflammation cells. There is growing evidence that antioxidant treatments that include vitamins and food supplements have been shown to ameliorate this oxidative stress while improving the symptoms and decreasing the severity of asthma. In this review, we summarize recent studies that are related to the mechanisms and biomarkers of oxidative stress, antioxidant treatments in asthma.
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Zhang Q, Lamichhane R, Diggs LA. Disparities in emergency department visits in American children with asthma: 2006-2010. J Asthma 2016; 54:679-686. [PMID: 27880053 DOI: 10.1080/02770903.2016.1263315] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
OBJECTIVE This article was to examine the trends in emergency department (ED) visits for asthma among American children in 2006-2010 across sociodemographic factors, parental smoking status, and children's body weight status. METHODS We analyzed 5,535 children aged 2-17 years with current asthma in the Asthma Call-Back Survey in 2006-2010. Multivariate log binomial regression was used to examine the disparities of ED visits by demographics, socioeconomic status, parental smoking status, children's body weight status, and the level of asthma control. We controlled for average state-level air pollutants. Prevalence ratios (PRs) and 95% confidence intervals (CIs) were reported. RESULTS Minority children with current asthma had higher risks of ED visits compared with white children in 2009 and 2010, e.g., the PR (95% CI) for black children in 2009 was 3.64 (1.79, 7.41). Children who had current asthma and more highly educated parents experienced a higher risk of ED visits in 2007 (PRs [95% CI] = 2.15 [1.02, 4.53] and 2.97 [1.29, 6.83] for children with some college or college-graduated parents), but not significant in other years. Children with uncontrolled asthma were significantly more likely to visit the ED in 2008 (PRs [95% CI] = 2.79 [1.44, 5.41] and 6.96 [3.55, 13.64] for not-well-controlled and very poorly controlled children with asthma). CONCLUSIONS Minority children with current asthma or children with uncontrolled asthma were more likely to visit EDs for asthma treatment. However, the disparities in ED visits across sociodemographics, health status, or asthma control vary in scale and significance across time. More research is needed to explain these differences.
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Affiliation(s)
- Qi Zhang
- a School of Community and Environmental Health, Old Dominion University , Norfolk , VA , USA
| | - Rajan Lamichhane
- b Department of Mathematics , Texas A&M University-Kingsville , Kingsville , TX , USA
| | - Leigh Ann Diggs
- a School of Community and Environmental Health, Old Dominion University , Norfolk , VA , USA
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