[Assessment of patient-reported outcomes by questionnaires in patients with Moderate and severe chronic obstructive pulmonary disease treated with glycopyrroniUm in the reaL lifE setTing in Hungary (AMULET)].

Abstract:

:Introduction: Chronic obstructive pulmonary disease (COPD) is a multifactorial disorder, therefore, airflow limitation alone does not reflect the full burden of COPD. In Hungary, no national data are available yet about the results obtained with the different COPD questionnaires in daily patient care, and about difficulties of questionnaires for patients. Aim and method: The aim of the study was to evaluate patient-reported outcomes with guideline-suggested questionnaires (CCQ, CAT, mMRC, EQ-5D-5L) in patients treated with glycopyrronium-bromide (therapy naïve, add-on combination or switch from another therapy) in the real life setting during 16 weeks treatment. This study was open-label, multi-centre, non-interventional, observational. Results: 527 patients were enrolled in the study (mean age: 63.8 ± 9.64 years, mean FEV1: 59.8 ± 15.12%). In all of the groups, the CCQ mean scores, all of the CCQ subscores, CAT and mMRC scores significantly decreased from visit 1 to visit 3. The EQ-5D-5L index and VAS scores increased significantly between visits. According to investigators' opinion, the CAT test reflects the patient's condition better (84.7%) than CCQ or mMRC; also, from the patient's point of view, CAT was simpler and easier to understand (83.2%). There was a positive, statistically significant correlation between CCQ and CAT (rs = 0.711, p<0.001), between CCQ and mMRC (rs = 0.524, p<0.001) and between CAT and mMRC scores at visit 3 (rs = 0.475, p<0.001). Conclusion: Our results suggest that the CAT test may be simpler and easier to understand for patients. Also, according to investigators' opinion, CAT reflects the patient's condition better, so CAT appears to be the most promising tool in COPD evaluation. Orv Hetil. 2020; 161(8): 295-305. :Absztrakt: Bevezetés: A krónikus obstruktív tüdőbetegség (COPD) sok szervrendszert érint, ezért a légúti áramlás korlátozottságának mértéke önmagában nem tükrözi a COPD teljes betegségterhét. Magyarországon nincsenek a járóbeteg-ellátásban alkalmazott COPD-kérdőívekről országos adatok, így arról sem, hogy a betegek mennyire találják könnyűnek vagy nehéznek a kitöltést. Célkitűzés és módszer: A vizsgálat célkitűzése az egészségi állapotra vonatkozó, beteg által kitöltött, irányelvek javasolta kérdőívek (CCQ, CAT, mMRC, EQ-5D-5L) eredményeinek értékelése olyan COPD-s betegeknél, akik a mindennapos betegellátásban, 16 hetes kezelési szakaszban glikopirrónium-bromid-terápiát kaptak (korábban terápiában nem részesültek, vagy kiegészítő kombinációban más hörgőtágítókkal kapták, vagy váltás történt egyéb terápiáról). A vizsgálat nyílt elrendezésű, multicentrikus, beavatkozással nem járó, megfigyeléses volt. Eredmények: A vizsgálatba vont 527 beteg átlagéletkora 63,8 ± 9,64 év, az átlagos FEV1 59,8 ± 15,12% volt. Az első és az utolsó vizit között, mindhárom kezelési csoportban, klinikailag jelentősen csökkentek a CCQ-átlagpontszámok, az összes CCQ-alpontszám, a CAT- és az mMRC-pontszámok, növekedtek ugyanakkor az EQ-5D-5L- és a VAS-pontszámok. A vizsgálók szerint a CAT-teszt jobban tükrözte a betegek állapotát (84,7%), mint a CCQ vagy az mMRC. A betegek szerint is a CAT-teszt a legegyszerűbb és a legkönnyebben érthető (83,2%). Az utolsó viziten szignifikáns különbség volt a CCQ- és a CAT- (rs = 0,711, p<0,001), a CCQ- és az mMRC- (rs = 0,524, p<0,001), illetve a CAT- és az mMRC- (rs = 0,475, p<0,001) pontszámok között. Következtetés: Eredményeink azt igazolták, hogy a CAT-teszt a legkönnyebben érthető a betegeknek, és a vizsgálóorvosok szerint is a CAT tükrözte a legjobban betegeik állapotát, így a CAT-teszt tűnik a legígéretesebb eszköznek a COPD tüneteinek értékelésében. Orv Hetil. 2020; 161(8): 295–305.

journal_name

Orv Hetil

journal_title

Orvosi hetilap

authors

Tamási L,Speer G,AMULET vizsgálóorvosai: .

doi

10.1556/650.2020.31661

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

295-305

issue

8

eissn

0030-6002

issn

1788-6120

journal_volume

161

pub_type

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