Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA<sup>2</sup>LEN taskforce position paper

Braido, Fulvio; Bousquet, P.; Brzoza, Zenon; Canonica, Giorgio Walter; Compalati, Enrico; Fiocchi, Alessandro; Fokkens, Wytske J.; Wijk, Roy Gerth van; Grutta, Stefania La; Lombardi, Carlo; Maurer, Marcus; Pinto, Ana; Ridolo, Erminia; Senna, Gianenrico; Terreehorst, Ingrid; Todo-Bom, Ana; Bousquet, Jean; Zuberbier, Torsten; Baiardini, Ilaria

doi:10.1111/j.1398-9995.2010.02383.x

Cited by 63 publications

(49 citation statements)

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“…Some of these measures have already been validated. Moreover, certain tools for patient-reported outcomes and their practical use in clinical trials have been reported in the GA 2 LEN recommendations (93). Under these recommendations, the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ; 94) as well as the RQLQ, as disease-specific questionnaires, assess the disease from the patients' perspectives.…”

Section: Discussionmentioning

confidence: 99%

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Pfaar

Démoly

Wijk

et al. 2014

Allergy

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382

442

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Background: Allergen immunotherapy (AIT) has been thoroughly documented in randomized controlled trials (RCTs). It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy (SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints. Methods: As elaborated by a Task Force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) Immunotherapy Interest Group, this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis. Results: Based on a thorough literature review, the TF members have outlined recommendations for nine domains of clinical outcome measures. As the primary outcome, the TF recommends a homogeneous combined symptom and medication score (CSMS) as a simple and standardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner. All outcomes, grouped into nine domains, are reviewed. Conclusion: A standardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required. The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis.

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Section: Discussionmentioning

confidence: 99%

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Pfaar

Démoly

Wijk

et al. 2014

Allergy

Self Cite

382

442

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“…HRQoL is a broad-ranging concept incorporating, in a complex way, the person’s physical and mental health, level of independence, social relationships, well-being and satisfaction [10,11]. Due to its multidimensional nature, HRQoL can be approached from different angles.…”

Section: Introductionmentioning

confidence: 99%

Chronic Obstructive Pulmonary Disease Patient Well-Being and Its Relationship with Clinical and Patient-Reported Outcomes: A Real-Life Observational Study

Braido

Baiardini²,

Balestracci³

et al. 2011

Respiration

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Background: Quality of life is an umbrella concept that refers to all aspects of a person’s life, including health status and well-being. While health status measure focuses on the impact of the disease on physical functioning, well-being represents the self-representation of the emotional states related to the disease itself. Objectives: The objective of this study was to evaluate the psychological well-being and its determining factors in a real-life chronic obstructive pulmonary disease (COPD) population and to evaluate if patients with a different well-being differ in illness perception, health status and alexithymia. Methods: Psychological well-being (Psychological General Well-Being Index), health status (SF-36), illness perception (Illness Perception Questionnaire), alexithymia (Toronto Alexithymia Scale), as well as clinical parameters were assessed in COPD out-patients. Results: One hundred and sixty-four patients, with a mean forced expiratory volume in 1 s of 58.5%, were recruited. Forty percent of them had a moderately/severely impaired well-being, not correlated with forced expiratory volume in 1 s and the Charlson index value but significantly with the Medical Research Council score (p = 0.0001) that appeared to be the dominant factor. Patients with impaired well-being showed a different illness perception in terms of correct identification of symptoms, disease consequences, emotional representation and confidence in treatment compared with those having a positive well-being. The latter presented a lower alexithymia prevalence and a better health status. Conclusions: In order to minimize the disease-negative effects on patients’ lives, assessment of well-being and its determining factors, as well as planning specific behavioural, educational and therapeutic interventions seem to be relevant and useful.

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“…[22][23][24] Essentially, researchers interested in developing versions for their country/language are invited to participate in the process, which is described in detail at http://caratnetwork.org, a dedicated website which also contains a web tool to help researchers follow the stipulated protocol.…”

Section: Cross-cultural Adaptationsmentioning

confidence: 99%

Control of Allergic Rhinitis and Asthma Test (CARAT): dissemination and applications in primary care

Azevedo¹,

Sousa

Bousquet³

et al. 2013

Primary Care Respiratory Journal

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Asthma frequently occurs in association with allergic rhinitis and a combined management approach has been suggested. The Control of Allergic Rhinitis and Asthma Test (CARAT) is the first questionnaire to assess control of both diseases concurrently. However, to have an impact on healthcare it needs to be disseminated and adopted. In this paper we discuss the dissemination of CARAT in different countries and its possible applications in primary care. At present, the adaptation of CARAT for use in different languages and cultures is being led by volunteer researchers and clinicians in 15 countries. Website and smartphone applications have been developed, and a free open model of distribution was adopted to contribute to the dissemination of CARAT. Examples of dissemination activities include distribution of leaflets and posters, educational sessions on the use of the questionnaire in the follow-up of patients, development of

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Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA²LEN taskforce position paper

Cited by 63 publications

References 100 publications

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Chronic Obstructive Pulmonary Disease Patient Well-Being and Its Relationship with Clinical and Patient-Reported Outcomes: A Real-Life Observational Study

Control of Allergic Rhinitis and Asthma Test (CARAT): dissemination and applications in primary care

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Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA2LEN taskforce position paper

Cited by 63 publications

References 100 publications

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Chronic Obstructive Pulmonary Disease Patient Well-Being and Its Relationship with Clinical and Patient-Reported Outcomes: A Real-Life Observational Study

Control of Allergic Rhinitis and Asthma Test (CARAT): dissemination and applications in primary care

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Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA²LEN taskforce position paper