Psychometric evaluation of Global Evaluation of Treatment Effectiveness: a tool to assess patients with moderate-to-severe allergic asthma

Lloyd, Andrew; Turk, Florian; Leighton, Trevor; Canonica, Giorgio Walter

doi:10.3111/13696990701478856

Cited by 30 publications

(36 citation statements)

References 13 publications

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“…The PEF was also improved with a mean change from baseline (l/min) of 11.01 (n = 82), 18.38 (n = 66), 32.82 (n = 65), 25.18 (n = 63) and 21.85 (n = 60) at week 16 and months 8, 12, 18 and 24, respectively.…”

Section: Lung Functionmentioning

confidence: 87%

“…Patients were rated on a 5-point scale: 1 -excellent (complete control of asthma), 2 -good (marked improvement), 3 -moderate (discernible, but limited improvement), 4 -poor (no appreciable change), and 5 -worsening (overall deterioration of asthma control). Patients with an ''excellent'' or ''good'' response were considered responders, those with ''moderate'', ''poor'' or ''worsening'' as non-responders [18].…”

Section: Introductionmentioning

confidence: 99%

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Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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A b s t r a c tIntroduction: This was a sub-group analysis of patients with uncontrolled persistent allergic asthma (AA) in the healthcare setting of the Czech Republic, from a global non-interventional, 2-year post-marketing, observational eXpeRience registry. Aim: To evaluate the real-life effectiveness and safety of omalizumab. Material and methods: Patients with uncontrolled persistent AA (currently defined by the Global Initiative for Asthma (GINA) as uncontrolled severe AA) who started omalizumab treatment 15 weeks before inclusion in the registry were analysed for physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms, corticosteroid use, exacerbation rate, asthma control, quality of life, healthcare utilisation and safety during a 24-month observation period. Results: One hundred and fourteen patients from the Czech Republic were enrolled in the eXpeRience registry. A total of 88.9% of the patients were evaluated as responders to omalizumab according to the GETE assessment at week 16. From baseline to month 24: mean change in forced expiratory volume in 1 s (FEV 1 ) was 137 ml and the daily dose of OCS decreased (11.6 mg to 6.4 mg prednisolone equivalent); the percentage of patients with no severe clinically significant exacerbations increased (29.5% to 95.1%); Asthma Control Test scores improved (12.4 to 17.3) and mean total number of days of asthma-related medical healthcare use decreased (6.8 days to 0.4 days). Conclusions: The results of this subgroup analysis support the evidence that add-on omalizumab therapy is effective and well tolerated for management of patients with uncontrolled persistent AA in the Czech Republic. Global evaluation of treatment effectiveness assessment is a reliable predictor of long-term response to omalizumab treatment.

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Section: Lung Functionmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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“…Global evaluation of treatment effectiveness (GETE) is a validated PROM that reflects clinical outcomes and HRQoL in patients with asthma, and has been shown to be positively correlated with clinical indices (except lung function), AQLQ, and HRQoL 42 . The GETE can also be physician-reported, but only patient-reported outcomes were summarized here.…”

Section: Symptom Assessmentmentioning

confidence: 99%

Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials

Corren

Kavati

Ortiz

et al. 2017

Current Medical Research and Opinion

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Objective: Randomized controlled trials (RCTs) have established the safety and efficacy of omalizumab on clinical parameters, and have also evaluated its impact on patient-reported outcomes (PROs). The purpose of this systematic literature review was to review published data based on PRO endpoints in order to determine the benefit of omalizumab as add-on therapy to inhaled corticosteroids in patients with moderate-to-severe persistent allergic asthma. Methods: A systematic literature review was conducted of reference databases and recent conferences. RCTs of add-on omalizumab therapy in adults, adolescents, and children with moderate-to-severe persistent asthma were included. Two researchers independently screened and reviewed articles with regards to inclusion and exclusion criteria for relevant studies. Results: Twenty-six trials met the criteria for inclusion. Of these, PRO measures were included in 19 trials to capture the impact of omalizumab on symptoms, 11 assessed patients for health-related quality-of-life (HRQoL), and four evaluated asthma control. Other PROs related to global evaluation of treatment effectiveness and work productivity. Overall, results demonstrated a significant difference across most PROs in favor of omalizumab add-on therapy vs placebo or comparators. Conclusions: PROs are an integral part of outcome assessment in clinical trials related to asthma. The RCTs reviewed demonstrate that omalizumab treatment improves PROs in patients with moderate-tosevere persistent allergic asthma, particularly symptom control and HRQoL.ARTICLE HISTORY

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“…Recent work has examined the value of avoidance of self-managed asthma exacerbations and exacerbations that required emergency care amongst people with asthma [13]. This study elicited preferences and WTP from 479 asthma patients in the UK, the Netherlands and Spain.…”

Section: Discussionmentioning

confidence: 99%

“…The health state descriptions that were developed were designed to reflect the median and range of symptom burden for each state from patients in the trial. Previous work has demonstrated how the different levels of the GETE reflect tangible and important differences in clinical and quality of life outcomes [13]. The wording from the symptom diary was used in the health states (see ''Appendix'').…”

Section: Development Of Health Statesmentioning

confidence: 99%

Preferences and utilities for the symptoms of moderate to severe allergic asthma

et al. 2007

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The range of utility values (0.71-0.78) demonstrates the severity of moderate to severe allergic asthma. However the spread of scores between complete control of asthma and worsening of asthma was lower than was expected. The community sample placed only a moderate value on the avoidance of all asthma symptoms in the DCE survey. The results suggest that the community sample may not have fully understood the benefits of control over asthma symptoms and the limitations such symptoms can impose on everyday life.

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Psychometric evaluation of Global Evaluation of Treatment Effectiveness: a tool to assess patients with moderate-to-severe allergic asthma

Cited by 30 publications

References 13 publications

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials

Preferences and utilities for the symptoms of moderate to severe allergic asthma

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