| Abstract | Uvod: Upalna bolest crijeva (IBD) predstavlja izražen medicinski i
epidemiološki problem zbog porasta incidencije, učestalih relapsa, ograničavajućih
simptoma te brojnih komplikacija. U pedijatrijskom IBD-u, kvaliteta života ovisna o
zdravlju (HRQOL) je prihvaćna mjera utjecaja bolesti i liječenja na zdravlje. ----- Cilj rada: Lingvistički i psihometrijski validirati specifične HRQOL upitnike,
usporediti HRQOL s nominalnim vrijednostima, ispitati usuglašenost posredničkog i
djetetovog samoizvješća HRQOL-a, istražiti bolest-specifične varijable koje utječu na
HRQOL i testirati prognostičku valjanost specifičnih HRQOL instrumenata. ----- Uzorak i metode: U multicentričnom prospektivnom istraživanju sudjelovalo je
104 pedijatrijska ispitanika i 89 roditelja koristeći generički (PedsQL™) i specifične
upitnike (IMPACT-III (HR) i SHS) koji su međukulturološki adaptirani. Faktorskom
analizom ispitana je struktura IMPACT-III (HR), izračunom Crombachovih α testirana
je pouzdanost, ANOVA-om i Kruskal Wallisovim testom ispitana je diskriminantna
valjanost, a korelacijom s PedsQL™ primjenom Pearsonovih koeficijenata istražena
je konkurentna valjanost. Minimalna klinički vrijedna razlika (MCID) skala IMPACT-III
(HR) analizirana je standardnom pogreškom za aritmetičke sredine. Usuglašenost je
ispitana interklasnim korelacijskim koeficijentom (ICC). Binarni logistički modeli
primjenjeni su za analizu prognostičke valjanosti. ----- Rezultati: Za ukupni rezultat IMPACT-III (HR) α=0,92. Optimalna faktorska
struktura imala je 5 domena: Simptomi, Strepnja, Socijaliziranje, Tjelesna slika i
Zabrinutost za stolicu, s dobrom unutarnjom pouzdanosti (α=0,60-0,89), međutim 2
pitanja su izbačena kako bi se ovo postiglo. Za SHS α=0,74. Diskriminantna
valjanost potvrđena je značajnim razlikama aritmetičkih sredina IMPACT-III (HR)
skala između pacijenata u remisiji i aktivnoj bolesti za ukupni rezultat (P<0,001) i
faktore: Simptomi, Socijaliziranje i Zabrinutost za stolicu (sve P<0,001). Za SHS,
značajna razlika potvrđena je za domene Simptomi (P=0,022) i Funkcioniranje
(P=0,003). Konkurentna valjanost IMPACT-III (HR) i SHS-a pokazala je značajnu i
jaku korelaciju između sukladnih domena. Osjetljivost na promjene dokazana je u
SHS-u za domene Simptoma, Fukcije i Brige (P=0,032; 0,008; 0,021). MCID za skale
IMPACT-III (HR) iznosila je od 4,9-11,4 jedinica. Usporedbom s PedsQL™
rezultatima zdravih vršnjaka, pacijenti u remisiji imali su značajno bolje Emocionalno
funkcioniranje (P<0,01), a ispitanici s aktivnom bolesti su imali značajno lošiji ukupni
rezultat, Tjelesno zdravlje, Socijalno (P<0,05) te Školsko funkcioniranje (P<0,0001).
Usporedbom s PedsQL™ posredničkim izvješćem, suglasnost je bila umjerena do
dobra (ICC=0,581-0,779). Između Crohnove bolesti i ulceroznog kolitisa nađena je
značajna razlika u aritmetičkim sredinama ukupnih IMPACT-III (HR) rezultata
(P=0,019). Hospitalizirani zbog relapsa, kortikosteroidi ili azatioprin u dosadašnjoj
terapiji su povezani sa značajno nižim IMPACT-III (HR) rezultatima (P<0,001;
P=0,047; P=0,008). Negativne promjene faktora Zabrinutost za stolicu povećavaju
šansu porasta razine medikamentoznog liječenja (OR=5,3; 95% CI=1,2-24,2). ----- Zaključak: IMPACT-III (HR) i SHS su pouzdani i valjani instrumenti procjene
HRQOL-a u djece s IBD-om, a skala IMPACT-III (HR) ima prediktivnu vrijednost
budućeg kliničkog ishoda. Kvaliteta života oboljele djece i adolescenata zavisna je o
stupnju aktivnosti bolesti. Spoznaje iz provedenog istraživanja upućuju da mjere
prevencije relapsa i održavanje remisije mogu omogućiti oboljelima jednaku kvalitetu
života kao u vršnjaka. |
| Abstract (english) | Background: With dramatic increase in incidence, life-long and remmiting
course, debilitating symptoms, increased risk of surgery and treatment complications,
Inflammatory bowel diseases (IBD) pose a growing medical and epidemiological
problem. Health-related quality of life (HRQOL) has emerged as informative mean of
assessing the impact of the disease burden on health as well ass determining the
efficacy of medical care. ----- Objectives: To assess the reliability and validity of culturally adapted pediatric
disease-specific HRQOL instruments, to compare HRQOL results of children
suffering from IBD with results of healthy peers, to investigate accordance of selfreport
and proxy reports, to disclose disease-specific variables which greatly
influence patients' HRQOL and to report the prognostic validity of disease-specific
HRQOL questionnaires. ----- Materials and methods: In a multicentric study, 104 children with IBD and 89
parents participated. HRQOL was assessed by generic (PedsQL™) and diseasespecific
(IMPACT-III (HR) and SHS) questionnaires that were previously crosculturally
adapted for use in Croatia. Factor analysis was used to determine optimal
domain structure of IMPACT-III (HR), analysis of Crombac's alpha coefficients to test
internal reliability, ANOVA and Kruskal-Wallis to assess dicriminant validity,
correlation with PedsQL™ using Pearson coefficients to assess concurent validity.
MCID sores were calculated for each IMPACT-III (HR) scale using the standard error
of means. Accordance of self-reports and proxy reports was analysed by interclass
correlation coefficients. Binary logistic models were inmplemented for the prognostic
validty analysis. ----- Results: Cronbach’s alpha for the IMPACT-III (HR) total score was 0.92. The
most robust factor solution was a 5-domain structure: Symptoms, Concerns,
Socializing, Body Image, and Worry about Stool, all of which demonstrated good
internal reliability (α=0.60-0.89), but two items were dropped to achieve this.
Discriminant validity was demonstrated by significant differences (P < 0.001) in mean
IMPACT-III (HR) scores between quiescent and mild or moderate-severe disease
activity groups for total (148 vs. 139 or 125) and following factor scores: Symptoms
(84 vs. 71 or 61), Socializing (91 vs. 83 or 76), and Worry about Stool (significant
only between quiescent and moderate-severe groups, 90 vs. 62, respectively). For
SHS, significant difference in domain scores beetween disease activity groups was
confirmed for Symptoms (P=0.022) and Functinonig (P=0.003). Concurrent validity of
IMPACT-III (HR) or SHS showed significant correlation, which was strongest when
similar domains were compared. Responsivennes to change was showed for
following SHS scales: Symptoms (P=0.032), Functioning (P=0.008), and Worries
(P=0.021). Standard errors of measurement, which represent the MCID for each
scale, were ranging between 4.9-11.4. Patients in remission had comparable HRQOL
scores to healthy peers, with significantly higher scores in emotional functioning
(P<0.01). When conpared to healthy peers, patients with active disease had
significantly worse PedsQL™ scores for Physical Health (P<0.05), Social (P<0.05),
and School Functioning (P<0.0001). In comparison of self and proxy reports,
accordance was moderate to good (ICC=0.581-0.779). Mean total IMPACT-III (HR)
scores significantly differed between Crohn's disease and ulcerative colitis (P=0.019).
Hospitalisations for relapse, previous use of corticosteroids or azathioprine were
were correlated with significantly lower HRQOL scores,P<0.001, P=0.047, P=0.008,
respectively. Drop in HRQOL results of Worry About Stool domain of IMPACT-III
(HR) predicted escalation of medicamentous therapy in next 6-12 months (OR=5.3;
95% CI=1.2-24.2). ----- Conclusion: IMPACT-III (HR) and SHS appear to be useful tool to measure
health-related quality of life in Croatian children with Crohn’s disease and ulcerative
colitis. It seems that induction and maintaince of remission in patients with IBD may
provide HRQOL comparable to the healthy peers. |
