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Reporting characteristics of allergic rhinitis trials registered on ClinicalTrials.gov and in publications (CROSBI ID 729742)

Prilog sa skupa u zborniku | sažetak izlaganja sa skupa | međunarodna recenzija

Paladin, Ivan ; Pranić, Shelly Reporting characteristics of allergic rhinitis trials registered on ClinicalTrials.gov and in publications. Cape Town: World Conferences on Research Integrity, 2022

Podaci o odgovornosti

Paladin, Ivan ; Pranić, Shelly

engleski

Reporting characteristics of allergic rhinitis trials registered on ClinicalTrials.gov and in publications

Objective: Data from randomized controlled trials (RCTs) on Allergic rhinitis (AR) should be complete and consistent throughout multiple sources to ensure accurate evidence-based information so our aim was to determine whether there were discrepancies in the reported data from AR trials. Method: This cross-sectional study retrospectively analyzed completed RCTs on AR for completeness, informativeness and major changes to World Health Organization Trial Registration Data Set items as well as completeness of results data in ClinicalTrials.gov and corresponding publications. Results: Omitted items were present in 79 (97.5%) of the 81 trials at initial registration, 67 (82.7%) at last registration, and in 21 (58.3%) of the 36 publications. All 81 trials between first and last registration and all 36 publications had major changes in registration items. Trials that started during or after first registration had less complete registration and more major changes to registration items, χ2=4.101, P=.04 ; χ2=13.711, P=.008, respectively. Major changes in outcomes as the most important were predominantly, changed methodological details in both primary and secondary outcomes between first and last registration as well as in publications although primary outcome changes in ClinicalTrials.gov and in publications included the addition of new outcomes and changes to existing ones. Uninformative reporting of analyzed items was present in both ClinicalTrials.gov and publications. We found that industry-sponsored compared to non-industry funded trials had a statistically significant shorter duration (χ2=6.496, P=.01), more major changes to registration items (χ2=10.192, P=.04) and higher publication rate (χ2=13.558, P<.001). Completeness of results in ClinicalTrials.gov and publications was poor, mostly due to ommited All-cause mortality. Conclusion: Discrepancies in data elements of AR trials are common in both ClinicalTrials.gov and subsequent publications. To ensure a transparency of data reporting from AR trials, multiple stakeholders should be involved to ensure the accuracy and completeness of AR trial data to notice discrepancies before publication.

Allergic rhinitis ; Randomized Controlled Trial ; Trial Registration Data Set ; ClinicalTrials.gov ; Completeness ; Informativeness

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Podaci o prilogu

WCRI2022-164

2022.

objavljeno

Podaci o matičnoj publikaciji

Cape Town: World Conferences on Research Integrity

0-000-00000-0

0000-000X

Podaci o skupu

7th World Conference on Research Integrity

poster

29.05.2022-01.06.2022

Cape Town, Južnoafrička Republika

Povezanost rada

Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje), Integrativna bioetika (prirodne, tehničke, biomedicina i zdravstvo, biotehničke, društvene, humanističke znanosti), Kliničke medicinske znanosti