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1. The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA‐AD™): a clinical outcome measure for the severity of atopic dermatitis

Author

Simpson, Eric L, Bissonnette, Robert, Paller, Amy S, King, Brett, Silverberg, Jonathan I, Reich, Kristian, Thyssen, Jacob P, Doll, Helen, Sun, Luna, DeLozier, Amy M, Nunes, Fabio P, and Eichenfield, Lawrence F

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Adult, Azetidines, Clinical Trials, Phase III as Topic, Dermatitis, Atopic, Humans, Outcome Assessment, Health Care, Purines, Pyrazoles, Reproducibility of Results, Severity of Illness Index, Sulfonamides, Oncology and Carcinogenesis, Dermatology & Venereal Diseases, Clinical sciences
Abstract

BackgroundThe validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) is a standardized severity assessment for use in clinical trials and registries for atopic dermatitis (AD).ObjectivesTo investigate the reliability, validity, responsiveness and within-patient meaningful change of the vIGA-AD.MethodsData were analysed from adult patients with moderate-to-severe AD in the BREEZE-AD1 (N = 624 patients; NCT03334396), BREEZE-AD2 (N = 615; NCT03334422) and BREEZE-AD5 (N = 440; NCT03435081) phase III baricitinib clinical studies.ResultsAcross studies, test-retest reliability for stable patients showed moderate-to-good agreement [range of Kappa values for Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD), 0·516-0·639; for Eczema Area and Severity Index (EASI), 0·658-0·778]. Moderate-to-large correlations between vIGA-AD and EASI or body surface area (range at baseline, 0·497-0·736; Week 16, 0·716-0·893) supported convergent validity. Known-groups validity was demonstrated vs. EASI and PGI-S-AD (vIGA-AD for severe vs. moderate EASI categories at baseline, P

Published
2022

2. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis

Author

Silverberg, Jonathan I, DeLozier, Amy, Sun, Luna, Thyssen, Jacob P, Kim, Brian, Yosipovitch, Gil, Nunes, Fabio P, Gugiu, P Cristian, Doll, Helen A, and Eichenfield, Lawrence F

Subjects
Health Services and Systems, Public Health, Health Sciences, Pain Research, Neurosciences, Clinical Research, Chronic Pain, Adult, Dermatitis, Atopic, Humans, Pain, Psychometrics, Quality of Life, Reproducibility of Results, Severity of Illness Index, Sleep, Atopic dermatitis, Atopic dermatitis sleep scale, Convergent-divergent validity, Itch NRS, Numeric rating scale, Patient-reported outcome, Psychometric, Reliability, Responsiveness, Skin pain NRS, Validity, Public Health and Health Services, Health Policy & Services, Health services and systems, Public health
Abstract

BackgroundThe Itch Numeric Rating Scale (NRS), Skin Pain NRS, and Atopic Dermatitis Sleep Scale (ADSS) are self-administered patient-reported outcome (PRO) instruments developed to assess symptoms in patients with atopic dermatitis (AD). The objective of this study was to evaluate the psychometric properties (reliability, validity, and responsiveness) and interpretability thresholds of these PROs using data from three pivotal Phase 3 studies in adults.MethodsBREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 evaluated the safety and efficacy of baricitinib in adults with moderate-to-severe AD. Clinician-reported outcomes and other PROs commonly assessed in patients with AD were used to estimate meaningful changes and evaluate test-retest reliability, convergent and divergent validity, known-groups validity, responsiveness, and meaningful change thresholds (MCTs) of the Itch NRS, Skin Pain NRS, and ADSS.ResultsThe test-retest reliability of the Itch NRS, Skin Pain NRS, and ADSS was evidenced by generally large intraclass correlation coefficients (> 0.7) in stable groups of patients between baseline and Week 1 and Weeks 4 and 8. Moderate-to-large correlations (r > 0.4) at baseline and Week 16 were generally observed between each measure and other PROs measuring the same concept, supporting convergent validity. Small-to-moderate correlations with clinician-reported outcomes demonstrated divergent validity. Each instrument was able to distinguish between known groups of disease severity as assessed using other indicators of AD severity. The responsiveness of the Itch NRS, Skin Pain NRS, and ADSS scales was demonstrated through significant differences in their change scores from baseline to Week 16 between categories of change in another PRO also from baseline to Week 16. Thresholds for interpreting meaningful change were estimated as - 4.0 for the 0-10 Itch and Skin Pain NRS items; - 1.25 for the 0-4 ADSS Items 1 and 3 and; - 1.50 for the 0-29 ADSS Item 2, these equivalent to moderate degrees of change.ConclusionsResults of this study demonstrate that the psychometric properties of the Itch NRS, Skin Pain NRS, and ADSS are good to excellent. These findings support the use of these instruments in daily assessment of AD symptoms in adults with moderate-to-severe AD. Trial registration ClinicalTrials.gov numbers: NCT03334396, NCT03334422, and NCT03435081.

Published
2021

15. Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial

Author

Whole System Demonstrator evaluation team, Henderson, Catherine, Knapp, Martin, Fernández, José-Luis, Beecham, Jennifer, Hirani, Shashivadan P, Cartwright, Martin, Rixon, Lorna, Beynon, Michelle, Rogers, Anne, Bower, Peter, Doll, Helen, Fitzpatrick, Ray, Steventon, Adam, Bardsley, Martin, Hendy, Jane, and Newman, Stanton P

Published
2013

16. Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial

Author

Whole Systems Demonstrator evaluation team, Cartwright, Martin, Hirani, Shashivadan P, Rixon, Lorna, Beynon, Michelle, Doll, Helen, Bower, Peter, Bardsley, Martin, Steventon, Adam, Knapp, Martin, Henderson, Catherine, Rogers, Anne, Sanders, Caroline, Fitzpatrick, Ray, Barlow, James, and Newman, Stanton P

Published
2013

27. Additional file 1 of Concept confirmation of the Treatment Administration Satisfaction Questionnaire (TASQ) in rare paroxysmal nocturnal hemoglobinuria

Author

Doll, Helen, Coşkun, Ufuk, Hartford, Chris, and Tomazos, Ioannis

Abstract

Additional file 1 : Supplementary Material. Treatment Administration Satisfaction Questionnaire – Intravenous (TASQ-IV). Treatment Administration Satisfaction Questionnaire – Subcutaneous (TASQ-SC). Supplementary Table 1 Participant eligibility criteria. Supplementary Table 2 Participant opinions about the TASQ-IV instructions. Supplementary Table 3 Participant-suggested changes to TASQ-IV instructions. Supplementary Table 4 Participant-suggested changes to TASQ-IV items. Supplementary Table 5 Gaps and participant suggestions for change for TASQ-IV measure overall. Supplementary Table 6 Participant-suggested changes to TASQ-SC instructions.

Published
2021
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33. Trends In Referral Patterns [with Reply]

Author

Dunbar, James A., Vincent, D. Susan, Meikle, Joyce N., Dunbar, Ann P., Jones, Patricia A., Perrett, Kevin, Smith, R. A., Coulter, Angela, Bradlow, Jean, Stewart-Brown, Sarah, and Doll, Helen

Published
1996

34. The effect of telecare on the quality of life and psychological well-being of elderly recipients of social care over a 12-month period: the Whole Systems Demonstrator cluster randomised trial

Author

Beynon, Michelle, Hirani, Shashivadan Parbat, Cartwright, Martin, Rixon, Lorna, Doll, Helen, Henderson, Catherine, Bardsley, Martin, Steventon, Adam, Knapp, Martin, Rogers, Anne, Bower, Peter, Sanders, Caroline, Fitzpatrick, Ray, Hendy, Jane, and Newman, Stanton Peter

Published
2014
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35. The prevalence of mental disorders among the homeless in Western countries: systematic review and meta-regression analysis

Author

Fazel, Seena, Khosla, Vivek, Doll, Helen, and Geddes, John

Subjects
Homeless persons -- Health aspects -- Demographic aspects -- Surveys, Prevalence studies (Epidemiology) -- Methods -- Surveys -- Health aspects, Mental illness -- Risk factors -- Diagnosis -- Care and treatment -- Surveys, Biological sciences
Abstract

Background There are well over a million homeless people in Western Europe and North America, but reliable estimates of the prevalence of major mental disorders among this population are lacking. We undertook a systematic review of surveys of such disorders in homeless people. Methods and Findings We searched for surveys of the prevalence of psychotic illness, major depression, alcohol and drug dependence, and personality disorder that were based on interviews of samples of unselected homeless people. We searched bibliographic indexes, scanned reference lists, and corresponded with authors. We explored potential sources of any observed heterogeneity in the estimates by meta-regression analysis, including geographical region, sample size, and diagnostic method. Twenty-nine eligible surveys provided estimates obtained from 5,684 homeless individuals from seven countries. Substantial heterogeneity was observed in prevalence estimates for mental disorders among the studies (all Cochran's [chi square] significant at p < 0.001 and all [I.sup.2] > 85%). The most common mental disorders were alcohol dependence, which ranged from 8.1% to 58.5%, and drug dependence, which ranged from 4.5% to 54.2%. For psychotic illness, the prevalence ranged from 2.8% to 42.3%, with similar findings for major depression. The prevalence of alcohol dependence was found to have increased over recent decades. Conclusions Homeless people in Western countries are substantially more likely to have alcohol and drug dependence than the age-matched general population in those countries, and the prevalences of psychotic illnesses and personality disorders are higher. Models of psychiatric and social care that can best meet these mental health needs requires further investigation., Introduction Around 380,000 individuals in the United Kingdom [1] and 740,000 individuals in the United States [2] are reported to be homeless at any given time. Although most live in [...]

Published
2008

37. The Parkinson's Disease Questionnaire (PDQ-39): evidence for a method of imputing missing data

Author

Jenkinson, Crispin, Heffernan, Catherine, Doll, Helen, and Fitzpatrick, Ray

Subjects
Aged patients -- Care and treatment, Aged patients -- Research, Parkinson's disease -- Research, Parkinson's disease -- Care and treatment, Parkinson's disease -- Diagnosis, Psychiatric patients -- Research, Psychiatric patients -- Care and treatment, Health, Psychology and mental health, Seniors, Social sciences
Published
2006

39. Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial

Author

Cartwright, Martin, Hirani, Shashivadan P, Rixon, Lorna, Beynon, Michelle, Doll, Helen, Bower, Peter, Bardsley, Martin, Steventon, Adam, Knapp, Martin, Henderson, Catherine, Rogers, Anne, Sanders, Caroline, Fitzpatrick, Ray, Barlow, James, and Newman, Stanton P

Published
2013
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41. Correction to: Evaluating the Impact and Benefits of Fluticasone Furoate/Vilanterol in Individuals with Asthma or COPD: A Mixed-Methods Analysis of Patient Experiences

Author

Svedsater, Henrik, Doll, Helen A., Macey, Jake, Miles, Gail, Bradshaw, Lisa, and Vanya, Magdalena

Subjects
Adult, Male, Correction, General Medicine, Middle Aged, Chlorobenzenes, Asthma, Drug Administration Schedule, Bronchodilator Agents, Androstadienes, Drug Combinations, Pulmonary Disease, Chronic Obstructive, Treatment Outcome, Double-Blind Method, Forced Expiratory Volume, Surveys and Questionnaires, Administration, Inhalation, Humans, Female, Pharmacology (medical), Benzyl Alcohols, Aged
Abstract

This study evaluated patients' experiences with fluticasone furoate/vilanterol (FF/VI) combination therapy in UK patients with asthma or chronic obstructive pulmonary disease (COPD).Participants aged ≥ 18 years, with self-reported, physician-diagnosed asthma or COPD (≥ 1 year) who had been receiving FF/VI (≥ 3 months) were recruited from UK primary care. This two-phase, mixed-methods study consisted of a semi-structured, telephone-interview phase (qualitative) and a self-completed online/paper-survey phase (quantitative).The telephone-interview phase included 50 individuals [asthma, n = 25; COPD, n = 25; mean age (SD) 56.7 years (13.3); 50% female]. Of these, 21 with asthma reported that their condition was stable/well controlled and 13 with COPD felt their condition was manageable. Most participants found FF/VI easy to use (asthma, 25; COPD, 23), easy to integrate into their daily routine (asthma, 25; COPD, 24), and able to control symptoms for ≥ 24 h (asthma, 14; COPD, 16). During the survey phase, 199 individuals were recruited [asthma, n = 100; COPD, n = 99; mean age (SD) 63.6 years (15.1); 59.3% female]. Most participants were satisfied/very satisfied with the efficacy of FF/VI in terms of all-day symptom relief (asthma, 84%; COPD, 75%) and found FF/VI easy/very easy to fit into their daily routine (asthma, 99%; COPD, 96%), easy/very easy to use (asthma, 97%; COPD, 92%), and convenient/very convenient to take as instructed (asthma, 95%; COPD, 93%). Significantly more individuals with asthma (87% versus 46%, P 0.001) and numerically more individuals with COPD (84% versus 76%, P = 0.055) were satisfied/very satisfied with FF/VI compared with their most recent previous maintenance medication.The majority of individuals in this study had confidence in FF/VI and were satisfied or very satisfied with various key attributes of the treatment.GSK study HO-15-15503/204888.GSK.

Published
2021

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