Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia.

CONTEXT: The multidimensional nature of the fibromyalgia syndrome means that different instruments need to be used to assess the patients' perception of this constellation of physical and psychological symptoms and their impact on their daily lives. Six questionnaires (Multidimensional Fatigue Inventory MFI, Fibromyalgia Impact Questionnaire FIQ, Multiple Ability Self-report Questionnaire MASQ, State-Trait Anxiety Inventory STAI, Beck Depression Inventory-II BDI-II and Patient Global Impression of Change PGIC) were linguistically validated into 12 languages. METHODS: The standardized cross-cultural adaptation process includes the following steps: forward translation, backward translation, and review of the version by a clinician and comprehension tests on subjects in the target country. RESULTS: Regardless of the instruments and dimensions studied, the same translation and cultural adaptation issues arose: (1) an issue that is strictly related to translation, for example, the word "things" was translated as "something"; (2) literal translation is possible but culturally irrelevant, for example the expression "to walk several blocks", which is a completely abstract concept in Europe, was translated as "to walk for more than one kilometre"; (3) the translation needed to be reformulated or the tense needed to be changed for idiomatic reasons. For example, the present perfect does not exist in German and so the present simple was used in the first version. The imperfect was eventually used with adverbs such as "lately". CONCLUSIONS: Linguistic adaptation was completed according to a recognized and rigorous method allowing for the wide-scale use of these patient-reported outcomes instruments in international studies.

Implementation of guidelines for allergic rhinitis in specialist practices. A randomized pragmatic controlled trial.

BACKGROUND: Guidelines for allergic rhinitis are more effective than free-treatment choice in the control of seasonal allergic rhinitis. OBJECTIVE: To validate the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines in the treatment of intermittent and persistent allergic rhinitis induced by pollens. DESIGN: A multicenter, open-label, parallel, pragmatic randomized study compared two therapeutic strategies during a 2-week treatment course. In the first strategy ('guidelines group'), 417 patients were treated according to ARIA with ebastine as oral antihistamine. In the second strategy ('free-choice treatment group'), investigators had a free choice for the treatment of 422 patients. MAIN OUTCOME MEASURES: Quality of life measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), work productivity and daily symptom medication scores. RESULTS: 94.2% patients returned the baseline visit questionnaires and 88.6% returned the posttreatment period questionnaires. RQLQ scores were similar in the two groups at baseline. After treatment, there were improvements in the overall score and in all domains in both treatment groups. According to pragmatic methodology, the improvements show that the guidelines group (-1.70 +/- 1.20) is more effective than the free-choice treatment group (-1.52 +/- 1.22) with a gamma risk of 2%. Individual RQLQ scores, work productivity, and daily symptom scores were significantly improved in the guidelines group by comparison to the free-choice treatment group. CONCLUSION: A treatment based on ARIA guidelines offers patients a significant improvement in comparison to the use of a nonstandardized treatment regimen.

Severity and impairment of allergic rhinitis in patients consulting in primary care.

BACKGROUND: Allergic rhinitis is a disease impairing quality of life, sleep, and work. A new classification for allergic rhinitis, Allergic Rhinitis and its Impact on Asthma (ARIA), has recently been proposed. OBJECTIVE: To study the effect of allergic rhinitis using ARIA definitions to determine severity and duration. METHODS: A total of 3052 patients consulting general practitioners for allergic rhinitis were studied. Patients were classified according to the 4 classes of ARIA. In all patients, quality of life (Rhinoconjunctivitis Quality-of-Life Questionnaire), sleep (Jenkins questionnaire), and work performance (Allergy-Specific Work Productivity and Activity Impairment questionnaire) were assessed. RESULTS: Mild intermittent rhinitis was diagnosed in 11% of the patients, mild persistent rhinitis in 8%, moderate/severe intermittent rhinitis in 35%, and moderate/severe persistent rhinitis in 46%. The severity of rhinitis has more of an effect on quality of life, sleep, daily activities, and work performance than the duration of rhinitis. In moderate/severe rhinitis, more than 80% of patients report impaired activities, as opposed to only 40% with mild rhinitis. CONCLUSION: It seems that the term moderate/severe should be replaced by severe. A study in the general population is necessary, however, to assess the prevalence of the 4 ARIA classes of allergic rhinitis, especially in patients who are not consulting physicians for their symptoms.