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dc.contributor.authorHorton, lindsay
dc.contributor.authorRhodes, Jonathan
dc.contributor.authorMenon, David K.
dc.contributor.authorMaas, Andrew I. R.
dc.contributor.authorWilson, Lindsay
dc.contributor.authorAndelic, Nada
dc.contributor.authorAndreassen, Lasse
dc.contributor.authorAnke, Audny Gabriele Wagner
dc.contributor.authorFrisvold, Shirin
dc.contributor.authorHelseth, Eirik
dc.contributor.authorRøe, Cecilie
dc.contributor.authorRøise, Olav
dc.contributor.authorSkandsen, Toril
dc.contributor.authorVik, Anne
dc.contributor.authorÅkerlund, Cecilia
dc.contributor.authorAmrein, Krisztina
dc.contributor.authorAntoni, Anna
dc.contributor.authorAudibert, Gerard
dc.contributor.authorAzouvi, Philippe
dc.contributor.authorAzzolini, Maria luisa
dc.contributor.authorBartels, Ronald
dc.contributor.authorBarzo, Pal
dc.contributor.authorBeauvais, Romuald
dc.contributor.authorBeer, Ronny
dc.contributor.authorBellander, Bo-michael
dc.contributor.authorBelli, Antonio
dc.contributor.authorBenali, Habib
dc.contributor.authorBerardino, Maurizio
dc.contributor.authorBeretta, Luigi
dc.contributor.authorBlaabjerg, Morten
dc.contributor.authorBragge, Peter
dc.contributor.authorBrinck, Vibeke
dc.contributor.authorBrooker, Joanne
dc.contributor.authorBrorsson, Camilla
dc.contributor.authorBuki, Andras
dc.contributor.authorBullinger, Monika
dc.contributor.authorCabeleira, Manuel
dc.contributor.authorCaccioppola, Alessio
dc.contributor.authorCalappi, Emiliana
dc.contributor.authorCalvi, Maria rosa
dc.contributor.authorCameron, Peter
dc.contributor.authorLozano, Guillermo carbayo
dc.contributor.authorCarbonara, Marco
dc.contributor.authorChevallard, Giorgio
dc.contributor.authorChieregato, Arturo
dc.contributor.authorCiterio, Giuseppe
dc.contributor.authorCnossen, Maryse
dc.contributor.authorCoburn, Mark
dc.identifier.citationJAMA Network Open. 2021, 4 (11), .en_US
dc.description.abstractImportance An interview is considered the gold standard method of assessing global functional outcomes in clinical trials among patients with acute traumatic brain injury (TBI). However, several multicenter clinical trials have used questionnaires completed by a patient or caregiver to assess the primary end point. Objective To examine agreement between interview and questionnaire formats for assessing TBI outcomes and to consider whether an interview has advantages. Design, Setting, and Participants This cohort study used data from patients enrolled in the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) project from December 2014 to December 2017. Data were analyzed from December 2020 to April 2021. Included patients were aged 16 years or older with TBI and a clinical indication for computed tomography imaging. Outcome assessments were completed using both an interview and a questionnaire at follow-up 3 and 6 months after injury. Exposures Traumatic brain injury of all severities. Main Outcomes and Measures Ratings on the Glasgow Outcome Scale–Extended (GOSE) administered as a structured interview rated by an investigator and as a questionnaire completed by patients or caregivers and scored centrally were compared, and the strength of agreement was evaluated using weighted κ statistics. Secondary outcomes included comparison of different sections of the GOSE assessments and the association of GOSE ratings with baseline factors and patient-reported mental health, health-related quality of life, and TBI symptoms. Results Among the 3691 eligible individuals in the CENTER-TBI study, both GOSE assessment formats (interview and questionnaire) were completed by 994 individuals (26.9%) at 3 months after TBI (654 [65.8%] male; median age, 53 years [IQR, 33-66 years]) and 628 (17.0%) at 6 months (409 [65.1%] male; median age, 51 years [IQR, 31-64 years]). Outcomes of the 2 assessment methods agreed well at both 3 months (weighted κ, 0.77; 95% CI, 0.73-0.80) and 6 months (weighted κ, 0.82; 95% CI, 0.78-0.86). Furthermore, item-level agreement between the 2 methods was good for sections regarding independence in everyday activities (κ, 0.70-0.79 across both time points) and moderate for sections regarding subjective aspects of functioning such as relationships and symptoms (κ, 0.41-0.51 across both time points). Compared with questionnaires, interviews recorded more problems with work (294 [30.5%] vs 233 [24.2%] at 3 months and 161 [26.8%] vs 136 [22.7%] at 6 months), fewer limitations in social and leisure activities (330 [33.8%] vs 431 [44.1%] at 3 months and 179 [29.7%] vs 219 [36.4%] at 6 months), and more symptoms (524 [53.6%] vs 324 [33.1%] at 3 months and 291 [48.4%] vs 179 [29.8%] at 6 months). Interviewers sometimes assigned an overall rating based on judgment rather than interview scoring rules, particularly for patients with potentially unfavorable TBI outcomes. However, for both formats, correlations with baseline factors (ρ, −0.13 to 0.42) and patient-reported outcomes (ρ, 0.29 to 0.65) were similar in strength. Conclusions and Relevance In this cohort study, GOSE ratings obtained by questionnaire and interview methods were in good agreement. The similarity of associations of the ratings obtained by both GOSE methods with baseline factors and other TBI outcome measures suggests that despite some apparent differences, the core information collected by both interviews and questionnaires was similar. The findings support the use of questionnaires in studies in which this form of contact may offer substantial practical advantages compared with interviews.en_US
dc.publisherAmerican Medical Associationen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.titleQuestionnaires vs Interviews for the Assessment of Global Functional Outcomes After Traumatic Brain Injuryen_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.source.journalJAMA Network Openen_US

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Navngivelse 4.0 Internasjonal
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