Markodimitraki Laura M, Stegeman Inge, Thomeer Hans G X M
Department of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, Netherlands.
Front Neurosci. 2022 Apr 29;16:830768. doi: 10.3389/fnins.2022.830768. eCollection 2022.
Surgical success of cochlear implantation is usually measured through speech perception and quality of life questionnaires. Although these questionnaires cover a broad spectrum of domains, they do not evaluate the consciousness of wearing a cochlear implant (CI) and how this impacts the daily life of patients. To evaluate this concept we aimed to develop and validate a standardized patient reported outcome measure (PROM) for use in cochlear implant users.
Development and evaluation of the COchlear iMPlant AwareneSS (COMPASS) questionnaire was realized following the COSMIN guidelines in three phases: (1) item generation, (2) qualitative pilot study to ensure relevance, comprehensiveness, comprehensibility, and face validity, and (3) quantitative survey study for the assessment of reliability (test-retest) with 54 participants.
Nine domains of CI awareness were identified through literature research and interviews with experts and patients. These resulted in the formulation of 18 items which were tested with a pilot study, after which 3 items were deleted. The final 15-item COMPASS questionnaire proved to have good validity and satisfactory reliability. The intraclass correlation coefficient calculated for items with continuous variables ranged from 0.66 to 0.89 with seven out of eight items scoring above the acceptable level of 0.7. The Cohen's kappa calculated for items with nominal variables ranged from -0.4 to 0.78 with 11 (sub)items out of 15 scoring above fair to good agreement. Measurement error analysis for items with continuous variables showed a mean difference of -2.18 to 0.22. The calculated 95% limits of agreement for these items revealed no statistically significant difference between the two administered questionnaires. For items with nominal variables, the percentages of agreement calculated, ranged between 0 and 95%, and 83.3 and 96.6% for positive and negative agreement, respectively.
The COMPASS questionnaire is a valid and reliable PROM for evaluating the cochlear implant awareness, and it can be easily used in routine clinical practice.
人工耳蜗植入手术的成功通常通过言语感知和生活质量问卷来衡量。尽管这些问卷涵盖了广泛的领域，但它们并未评估佩戴人工耳蜗（CI）的意识以及这对患者日常生活的影响。为了评估这一概念，我们旨在开发并验证一种用于人工耳蜗使用者的标准化患者报告结局测量指标（PROM）。
按照COSMIN指南分三个阶段开展人工耳蜗植入意识（COMPASS）问卷的开发与评估：（1）条目生成；（2）定性预试验研究，以确保相关性、全面性、可理解性和表面效度；（3）定量调查研究，对54名参与者进行可靠性评估（重测）。
通过文献研究以及对专家和患者的访谈，确定了人工耳蜗植入意识的九个领域。由此制定了18个条目，并在预试验研究中进行了测试，之后删除了3个条目。最终的15条目COMPASS问卷被证明具有良好的效度和令人满意的信度。对具有连续变量的条目计算的组内相关系数范围为0.66至0.89，八项条目中有七项得分高于可接受水平0.7。对具有名义变量的条目计算的科恩kappa系数范围为-0.4至0.78，15项（子）条目中有11项得分在一般至良好一致性之上。对具有连续变量的条目进行的测量误差分析显示平均差异为-2.18至0.22。对这些条目计算的95%一致性界限显示，两次发放的问卷之间无统计学显著差异。对于具有名义变量的条目，计算的一致性百分比范围为0%至95%，积极一致性和消极一致性分别为83.3%和96.6%。
COMPASS问卷是一种用于评估人工耳蜗植入意识的有效且可靠的PROM，可轻松用于常规临床实践。
