Author: Christine Adler
First Examiner (Aalen University): Prof. Dr. Anna Nagl
Second Examiner (Pacific University): Prof. Dr. Hannu Laukkanen
Submission Date: August 31, 2025
Purpose of the Master’s Thesis:
The paper version of the Brain Injury Vision Symptom Survey (BIVSS) was validated in the U.S. in 2016 and subsequently widely adopted for mild to moderate traumatic brain injury (mTBI). It was later modified into unvalidated electronic formats by various providers. A limited 2024 pilot study suggested few differences in results between the paper version and an online electronic format. The main aim of this master’s thesis is to expand upon the pilot study’s reliability investigation and extend it to different countries. Another objective is to investigate the impact of cultural and linguistic factors on results from BIVSS translations into other languages. Related aims include exploring scoring variability within the 8-BIVSS symptom subcategories across different countries and for different causes of acquired brain injury.
Methods:
Healthcare providers from North America, Europe, and Asia collaborated to help complete this international multicenter study. Subjects aged 18–70 with trauma-induced ABI and non-trauma-induced ABI were recruited. Prior to data collection, the BIVSS was translated into 8 different languages using the multistep “forward-backward translation” protocol. The BIVSS questionnaire was converted to an electronic online format on the Qualtrics platform. Participants completed the BIVSS twice, approximately one month apart—once on paper and once online, or vice versa.
The BIVSS questionnaire is a 28-item quality-of-life survey with 8 subcategories: visual acuity, visual comfort, double vision, light sensitivity, dry eyes, depth perception, peripheral vision, and reading. Visual symptoms are rated on a Likert scale from 0 = never to 4 = always. The cutoff score is ≥ 32. Patients whose symptoms exceed this cutoff score are at high risk for significant visual problems related to mTBI.
Study protocol methods differed slightly between Asia, North America, and Europe due to anonymization rules and data protection regulations. Responses to both questionnaires were summarized in an Excel table and analyzed using SPSS. A regression line and a Bland-Altmann plot were generated. The paired t-test (95% CI, p 0.05) was used to test the two formats for significant differences. The TOST test (with CI = 90%) was used to test the equivalence of the paper-based and online formats. This was performed twice: the first time with an equivalence margin of 0.2 SD, and the second time with 0.5 SD. The other targets could only be represented with diagrams due to the limited number of participants.
Results:
125 participants from the United States, Canada, Spain, the Philippines, and Luxembourg. Participants from Israel, China, and Poland also took part. Only 38 participants (~30%) completed the required protocol and were included in the data analysis. The mean difference between electronic and paper formats was M = 1.76 points (+/-8.67 SD). The Bland-Altmann scatter plot difference score was within the tolerance range [15.24; -18.76]. The paired t-test, p = 0.218 [95% CI; p > 0.05] showed no significant differences between the two formats, with an equivalence margin of 0.2 SD = 0 ± 1.74 points and a 90% CI [-4.1367; 0.6104]. In contrast, the TOST test failed (p-values [0.5081; 0.0088]). The TOST test indicated equivalence between the paper and online formats with an equivalence margin of 0.5X SD = ± 4.34 points. The two p-values [0.0377; 0.0001] fell within the 90% CI. Statistically meaningful conclusions could not be drawn regarding the other objectives due to the limited dataset.
Conclusions:
In clinical practice, the electronic and paper formats of the BIVSS can be considered equivalent in most cases. When readministering the BIVSS to a patient, it is recommended to use the same format for follow-up. When the patient’s total BIVSS score is close to 32 points, sticking with the same format reduces the risk of potential misdiagnosis. Due to the small dataset, no further extrapolative conclusions could be drawn. Further research is recommended to explore potential variables related to language, non-traumatic ABI, and BIVSS symptom subcategories.
Keywords: Traumatic Brain Injury (TBI); Acquired Brain Injury (ABI); Brain Injury Vision Symptom Survey (BIVSS); International; Translation