Tombers, Nicole M.

OBJECTIVE The minimal important difference (MID) and minimal important change (MIC) are two metrics that bridge the gap between statistical significance and clinical relevance and are critical to managing clinical decisions and conducting clinical research. The objective of this study was to define MIDs to evaluate cross-sectional differences among groups and to define MICs to evaluate longitudinal within-patient changes for the Mayo Clinic Vestibular Schwannoma Quality of Life (VSQOL) Index. METHODS Anchor-based methods were used to define MIDs and MICs for the VSQOL Index domain scores, which range from 0 to 100 points, for a national cohort of 1050 patients with sporadic vestibular schwannoma, 644 of whom completed the VSQOL Index twice approximately 1 year apart. RESULTS The median of the MID estimates for the VSQOL Index domains were: hearing problems (17, IQR 12.5–21); dizziness and imbalance (21, IQR 18–23); pain, discomfort, and tinnitus (19.5, IQR 15–23.5); problems with face or eyes (18, IQR 17–28); impact on physical, emotional, and social well-being (19.5, IQR 14.5–23.5); difficulty with thinking and memory (23.5, IQR 18.5–28.5); global quality of life (12, IQR 8–16); and satisfaction or regret (13.5, IQR 7–17). MIC estimates for the hearing problems and satisfaction and regret domains were not obtained because the correlations between these domain scores and their associated anchors were not sufficiently strong. The MIC estimates (minimum and maximum) for the remaining domains were: dizziness and imbalance (7.2 and 8.3); pain, discomfort, and tinnitus (8.3 and 8.5); problems with face or eyes (7.0 and 7.4); impact on physical, emotional, and social well-being (2.1 and 8.0); and difficulty with thinking and memory (12.9 and 15.0). The median of the MIC estimates for global quality of life was 5.2 (IQR 3.7–5.6). CONCLUSIONS The MIDs and MICs reported herein provide a framework to interpret quality-of-life benefit or harm cross-sectionally among groups and longitudinally within patients. Moving forward, these values should be considered when interpreting studies using the VSQOL Index to assess disease-specific quality of life in patients with sporadic vestibular schwannoma.

Objective: The Complete Cochlear Implant Care (CCIC) model is a highly coordinated care delivery model reducing and condensing in-person visits for cochlear implant (CI) patients, leveraging telehealth and remote programming. Clinical, quality-of-life, implementation, patient experience, and financial outcomes of the clinical trial are reported. Study design: Prospective, nonrandomized, 2-arm clinical trial Setting: Tertiary referral CI center Patients: Adult CI candidates Interventions: Cochlear implantation Main outcome measures: Speech perception, quality of life, implementation, patient experience, and financial outcomes for both CCIC and traditional care delivery models. Results: Patients participating in the traditional and CCIC delivery models demonstrated 12-month postoperative speech perception scores comparable to nationally reported outcomes (CNC 61% and 72% and AzBio in quiet 75% and 87% for traditional and CCIC cohorts, respectively). Quality-of-life evaluation using the CIQOL-10 demonstrated similar 12-month postoperative scores between groups (52 and 54 for traditional and CCIC cohorts, respectively). The CI Patient Experience Survey demonstrated high satisfaction outcomes in ease of communication, preparedness for surgery, and overall care in both cohorts. Implementation analysis of the CCIC model revealed perceived benefits from staff and clinicians; however, support for expansion of the program was contingent upon the availability of app-based or web-based remote programming technology. Finally, financial analysis revealed decreased out-of-pocket costs for CCIC patients. Conclusion: The CCIC model has the potential to dramatically streamline hearing health care delivery and reduce out-of-pocket costs for CI recipients. Clinical outcomes between cohorts were comparable in this feasibility study; however, a sufficiently powered trial is required to definitively comment on clinical outcomes with the new care delivery model.

To address the limitations of existing instruments, the authors developed the Vestibular Schwannoma Quality of Life (VSQOL) Index. The Index captures the multifaceted impacts of vestibular schwannoma (VS) on daily life across eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. Initially developed in English, this digital supplement of the Journal of Neurosurgery presents translations of the VSQOL Index to Simplified Chinese, Spanish, Japanese, Arabic, French, and Norwegian. These translations aim to improve access to VS quality of life (QOL) research globally with enhanced racial, ethnic, and geographic representation. The goal is to comprehensively evaluate the impact of VS diagnosis and management on well-being and QOL by offering the VSQOL Index in patients’ native, or first-learned, languages. The English version and these translations may be used for noncommercial research, clinical, or educational purposes without written permission from the authors. Investigators interested in translating the VSQOL Index to other languages should contact the corresponding author for translation methodology instructions.

The authors developed a new disease-specific patient-reported outcome measure to capture the multifaceted impacts of vestibular schwannoma on daily life, the Vestibular Schwannoma Quality of Life (VSQOL) Index, which contains 40 items grouped into eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. 1 The VSQOL Index was developed in English, although the availability of this instrument in other languages can improve access to quality of life (QOL) research worldwide with enhanced racial, ethnic, and geographic representation. The authors partnered with FACITtrans, a component of the Functional Assessment of Chronic Illness Therapy (FACIT) group with more than 25 years of experience in translation, cultural adaptation, and linguistic validation of patient-reported outcome measures, to translate the VSQOL Index to Norwegian using a rigorous translation methodology. 2–5 The translation of the VSQOL Index presented at the end of this article may be used for noncommercial research, clinical, or educational purposes without seeking written permission from the authors. By providing a suite of translations in this digital supplement of the Journal of Neurosurgery , the authors hope to increase the reach and breadth of vestibular schwannoma QOL research and facilitate international collaborations.

The authors developed a new disease-specific patient-reported outcome measure to capture the multifaceted impacts of vestibular schwannoma on daily life, the Vestibular Schwannoma Quality of Life (VSQOL) Index, which contains 40 items grouped into eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. 1 The VSQOL Index was developed in English, although the availability of this instrument in other languages can improve access to quality of life (QOL) research worldwide with enhanced racial, ethnic, and geographic representation. The authors partnered with FACITtrans, a component of the Functional Assessment of Chronic Illness Therapy (FACIT) group with more than 25 years of experience in translation, cultural adaptation, and linguistic validation of patient-reported outcome measures, to translate the VSQOL Index to French using a rigorous translation methodology. 2–5 The translation of the VSQOL Index presented at the end of this article may be used for noncommercial research, clinical, or educational purposes without seeking written permission from the authors. By providing a suite of translations in this digital supplement of the Journal of Neurosurgery , the authors hope to increase the reach and breadth of QOL research and facilitate international collaborations.

The authors developed a new disease-specific patient-reported outcome measure to capture the multifaceted impacts of vestibular schwannoma on daily life, the Vestibular Schwannoma Quality of Life (VSQOL) Index, which contains 40 items grouped into eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. 1 The VSQOL Index was developed in English, although the availability of this instrument in other languages can improve access to quality of life (QOL) research worldwide with enhanced racial, ethnic, and geographic representation. The authors partnered with FACITtrans, a component of the Functional Assessment of Chronic Illness Therapy (FACIT) group with more than 25 years of experience in translation, cultural adaptation, and linguistic validation of patient-reported outcome measures, to translate the VSQOL Index to Simplified Chinese using a rigorous translation methodology. 2–5 The translation of the VSQOL Index presented at the end of this article may be used for noncommercial research, clinical, or educational purposes without seeking written permission from the authors. By providing a suite of translations in this digital supplement of the Journal of Neurosurgery , the authors hope to increase the reach and breadth of QOL research and facilitate international collaborations.

The authors developed a new disease-specific patient-reported outcome measure to capture the multifaceted impacts of vestibular schwannoma on daily life, the Vestibular Schwannoma Quality of Life (VSQOL) Index, which contains 40 items grouped into eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. 1 The VSQOL Index was developed in English, although the availability of this instrument in other languages can improve access to quality of life (QOL) research worldwide with enhanced racial, ethnic, and geographic representation. The authors partnered with FACITtrans, a component of the Functional Assessment of Chronic Illness Therapy (FACIT) group with more than 25 years of experience in translation, cultural adaptation, and linguistic validation of patient-reported outcome measures, to translate the VSQOL Index to Arabic using a rigorous translation methodology. 2–5 The translation of the VSQOL Index presented at the end of this article may be used for noncommercial research, clinical, or educational purposes without seeking written permission from the authors. By providing a suite of translations in this digital supplement of the Journal of Neurosurgery , the authors hope to increase the reach and breadth of QOL research and facilitate international collaborations.

The authors developed a new disease-specific patient-reported outcome measure to capture the multifaceted impacts of vestibular schwannoma on daily life, the Vestibular Schwannoma Quality of Life (VSQOL) Index, which contains 40 items grouped into eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. 1 The VSQOL Index was developed in English, although the availability of this instrument in other languages can improve access to quality of life (QOL) research worldwide with enhanced racial, ethnic, and geographic representation. The authors partnered with FACITtrans, a component of the Functional Assessment of Chronic Illness Therapy (FACIT) group with more than 25 years of experience in translation, cultural adaptation, and linguistic validation of patient-reported outcome measures, to translate the VSQOL Index to Spanish using a rigorous translation methodology. 2–5 The translation of the VSQOL Index presented at the end of this article may be used for noncommercial research, clinical, or educational purposes without seeking written permission from the authors. By providing a suite of translations in this digital supplement of the Journal of Neurosurgery , the authors hope to increase the reach and breadth of QOL research and facilitate international collaborations.

The authors developed a new disease-specific patient-reported outcome measure to capture the multifaceted impacts of vestibular schwannoma on daily life, the Vestibular Schwannoma Quality of Life (VSQOL) Index, which contains 40 items grouped into eight categories: hearing problems; dizziness and imbalance; pain, discomfort, and tinnitus; problems with face or eyes; impact on physical, emotional, and social well-being; difficulty with thinking and memory; satisfaction or regret; and impact on employment. 1 The VSQOL Index was developed in English, although the availability of this instrument in other languages can improve access to quality of life (QOL) research worldwide with enhanced racial, ethnic, and geographic representation. The authors partnered with FACITtrans, a component of the Functional Assessment of Chronic Illness Therapy (FACIT) group with more than 25 years of experience in translation, cultural adaptation, and linguistic validation of patient-reported outcome measures, to translate the VSQOL Index to Japanese using a rigorous translation methodology. 2–5 The translation of the VSQOL Index presented at the end of this article may be used for noncommercial research, clinical, or educational purposes without seeking written permission from the authors. By providing a suite of translations in this digital supplement of the Journal of Neurosurgery , the authors hope to increase the reach and breadth of QOL research and facilitate international collaborations.

Objective To compare differences in sporadic vestibular schwannoma (VS)–associated patient-reported symptom scores among patients receiving observation, microsurgery, or radiosurgery. Study Design Prospective longitudinal survey. Setting Tertiary referral center and the national Acoustic Neuroma Association. Patients Adults with sporadic VS. Intervention Observation, microsurgery, or radiosurgery. Main Outcome Measure Baseline and follow-up surveys on patient-reported severity of tinnitus, dizziness/imbalance, and headaches scored on a 10-point numeric scale, with higher scores indicating more severe symptoms; changes of 2 or more points from baseline were considered clinically important. Results A total of 455 patients were eligible for study with a mean (SD) follow-up of 4.5 (2.4) years, including 122 (27%) managed with observation, 226 (50%) undergoing microsurgery, and 107 (23%) undergoing radiosurgery. Changes in tinnitus severity scores differed significantly among management groups (p = 0.006), with severity scores increasing significantly in the radiosurgery (+0.8, p = 0.005) group but not in the observation (+0.2, p = 0.5) or microsurgery (−0.2, p = 0.18) groups. The changes in dizziness/imbalance and headache severity scores did not differ significantly among management groups. When comparing clinically important improvements (decrease of 2 or more points), the microsurgery and observation cohorts had a greater proportion of patients experiencing a clinically important improvement in tinnitus compared with the radiosurgery cohort; no other clinically important changes were significantly different among management groups. Conclusions In this prospective study of 455 patients comparing patient-reported symptoms after VS management, radiosurgery was associated with worsening tinnitus severity scores overall and resulted in fewer patients reporting clinically important improvements in tinnitus compared with observation and microsurgery. As there was substantial variability in the effect of management modality on changes in symptom severity scores, possible treatment effects on subjective symptoms, including tinnitus, dizziness/imbalance, and headache, should not be used in isolation to inform clinical decision-making for management of sporadic VS.