Quality standards in respiratory real-life effectiveness research: the REal Life EVidence AssessmeNt Tool (RELEVANT): report from the Respiratory Effectiveness Group—European Academy of Allergy and Clinical Immunology Task Force

Roche, Nicolás; Campbell, Jonathan D.; Krishnan, Jerry A.; Chisholm, Alison; Bjermer, Leif; Thomas, Mike; Ganse, Éric Van; Berge, Maarten van den; Christoff, George; Quint, Jennifer K; Papadopoulos, Nikolaos G.; Price, David

doi:10.1186/s13601-019-0255-x

Cited by 22 publications

(37 citation statements)

References 99 publications

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“… 29 , 31 That is why “real-life experience” and “real patient” representation have been powerful elements of recent data, and the validity of RCTs should be assessed to inform guideline development. 32 A lack of representative participants impacts guidelines, which base their recommendations on clinical evidence and application to clinical practice. 31 Steps must be taken to broaden the inclusion criteria of RCTs to represent wider asthma populations.…”

Section: Resultsmentioning

confidence: 99%

Perspectives on decisions for treatment and care in severe asthma

Winders¹,

Máspero²,

Callan

et al. 2021

World Allergy Organization Journal

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Background Severe asthma is a subtype of asthma that can be hard to control, resulting in an exceptional impact on an individual's quality of life. The aim of this review article is to explore the misalignment of perceptions of severe asthma among different stakeholders to identify how to reduce burden and improve delivery of care. Results The misalignment of perspectives is best reflected in randomised controlled trials (RCTs) in asthma treatments, which are often designed for regulatory approval with a focus on exacerbations with no direct input from the individuals that the treatments are designed for. Based on a literature review and the clinical experience of the authors to overcome this disparity, the goals of people with severe asthma need to be incorporated throughout their care, from study design to the day-to-day management of their condition. Improved education for individuals and their support network will provide them with resources and knowledge so that they can effectively communicate their needs to other stakeholders involved in their care. Conclusion/recommendation A collaborative effort from all stakeholders is essential to ensure efficient management of asthma and a reduction in asthma burden on individuals and society.

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Section: Resultsmentioning

confidence: 99%

Perspectives on decisions for treatment and care in severe asthma

Winders¹,

Máspero²,

Callan

et al. 2021

World Allergy Organization Journal

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“…The RELEVANT criteria were considered in the design and reporting of this study [26 ]. RELEVANT is a recently developed tool by Respiratory Effectiveness Group (REG) and EAACI, designed to evaluate the quality of real‐life studies and whether they may be used in guidelines.…”

Section: Methodsmentioning

confidence: 99%

Effect of nasal irrigation on allergic rhinitis control in children; complementarity between CARAT and MASK outcomes

Mitsias

Dimou

Lakoumentas

et al. 2020

Clin Transl Allergy

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Background: Nasal irrigations (NI) are increasingly used as an over-the-counter adjunctive treatment for allergic rhinitis (AR), but clinical studies on their effectiveness are limited.Methods: An open-label, controlled, non-randomized, real-life study was conducted to evaluate the effectiveness of NI with a new hypertonic solution as add-on treatment for AR. Children and adolescents with AR were prescribed symptomatic treatment. The active group also received an additional sea-water NI solution supplemented with algae extracts. The primary endpoint was symptom control, assessed by the control of allergic rhinitis and asthma test (CARAT) questionnaires. Moreover, the MASK/Allergy Diary was used to track symptoms and daily medication use that were combined in a novel total symptom/medication score (TSMS). Results:We assessed 76 patients. Overall, there was a significant improvement of CARAT results (median Z-score change of 1.1 in the active/NI group vs. 0.4 in the control group; p = 0.035). Among patients > 12 years old (n = 51), there was a significant improvement in CARAT10 results among participants receiving NI (21.0 to 25.5; p < 0.001), but not in the regular treatment group (21.5 to 24.0; p = 0.100). For children < 12 years old (n = 25), the ΝΙ group had significantly improved symptom control (CARATKids results: 5.0 to 2.0; p = 0.002), in contrast to the control group (4.0 to 2.5; p = 0.057). MASK data on allergic symptoms were comparable between groups. However, the NI group had lower TSMS, more days with < 20% symptoms and fewer days using symptomatic treatment (26.9% vs. 43.5%; p = 0.005). Conclusion:Addition of NI with a sea-water solution to regular treatment improved AR symptom control. CARAT questionnaires and MASK application can be useful outcome tools in real-life studies. Active (n: 55) Control (n: 23) p-value * Percentage (%) of days on treatment 0.005 Median (25-75 percentile) 26.9 (19.1-40.7) 43.5 (31.0-61.2) Medication score a 0.006 Median (25-75 percentile) 16.7 (10.7-25.0) 25.7 (17.3-35.7)

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“…These include the CONSORT statement extension for pragmatic trials [18], STROBE statement for observational studies in epidemiology [19], EMA-ENCePP checklist for pharmacoepidemiology and pharmacovigilance studies [20], UNLOCK initiative on quality criteria and minimal datasets requirements for observational studies [21], PRISMA for meta-analyses [22] and StaRI standards for implementation trials [23]. Recently, the REG has developed, tested and released the REal Life EVidence AssessmeNt Tool (RELEVANT) to assess the quality of real-life comparative effectiveness research [24,25]. This tool relies on previously established quality standards proposed by REG and others [4,26,27] and is expected to facilitate both study design and appraisal.…”

Section: We Knowmentioning

confidence: 99%