Division of Otolaryngology-Head and Neck Surgery, University of British Columbia, Vancouver, British Columbia, Canada.
NexGen Hearing, Vancouver, British Columbia, Canada.
JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):630-635. doi: 10.1001/jamaoto.2022.0927.
Hearing loss is one of the most common chronic disabilities in older adults, yet reported rates of users' satisfaction with hearing aids are low. Some believe that physicians can provide patients who are pursuing a hearing aid fitting an impartial opinion that will improve hearing aid satisfaction.
To determine whether a physician consultation increased or decreased patients' satisfaction with hearing aids compared with patients undergoing hearing aid fitting with a dispensing audiologist alone.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, parallel-group, standard regimen-controlled, randomized clinical trial was conducted in offices of audiologists, family physicians, and a hospital-based neurotologist in Vancouver, British Columbia, Canada, and recruited participants from July 2016 to December 2020 with a 3-month postintervention follow-up. The final data analysis was conducted on March 25, 2022. Adult first-time hearing aid users with averaged sensorineural hearing losses of more than 25 dB were prospectively allocated by random number generation to control and intervention groups. Participants were excluded from analysis if they did not attend follow-up or complete the study questionnaire.
Control participants were followed up solely by their dispensing audiologist. The intervention group attended a single structured visit with a physician in addition to their audiologist's determined follow-up.
Primary outcome: hearing aid satisfaction 3 months postfitting as measured by the Satisfaction with Amplification in Daily Life (SADL) questionnaire. Secondary outcome: number of returned hearing aids. Prerecruitment null hypothesis: no intergroup difference in postfitting hearing aid satisfaction. Intergroup difference in mean SADL questionnaire scores analyzed by effect size and the Student t test and proportion of returned hearing aids by the Fischer exact test.
A total of 133 participants (mean [SD] age, 70.9 [8.5] years; 64 women [48.1%]) were recruited. Of these, 51 randomized to the control group (mean [SD] age, 71.7 [8.3] years; 28 women [54.9%]) and 42 to the physician intervention (mean [SD] age, 69.9 [7.6] years; 17 women [40.5%]) had results that were analyzed. There was no clinically meaningful intergroup difference in participants' SADL scores (control: mean [SD] score, 5.33 [0.72]; physician consultation: mean [SD] score, 5.35 [0.61]), the mean difference of 0.02 (95% CI, -0.25 to 0.29), or returned hearing aids (control, 1; physician consultation, 0).
The results of this randomized clinical trial suggest that a physician consultation that is focused on hearing change does not alter a patient's satisfaction with hearing aids 3 months postfitting.
ClinicalTrials.gov Identifier: NCT02842905.
听力损失是老年人中最常见的慢性残疾之一,但报告的助听器使用者满意度率却很低。一些人认为,医生可以为正在接受助听器适配的患者提供公正的意见,从而提高助听器的满意度。
确定与仅由听力学家进行助听器适配的患者相比,医生咨询是否会增加或降低患者对助听器的满意度。
设计、地点和参与者:这项多中心、平行组、标准方案对照、随机临床试验在加拿大不列颠哥伦比亚省温哥华的听力学家、家庭医生办公室和医院神经耳科医生处进行,参与者于 2016 年 7 月至 2020 年 12 月期间招募,并在干预后 3 个月进行随访。最终数据分析于 2022 年 3 月 25 日进行。初次使用助听器的成年患者,平均感音神经性听力损失超过 25dB,通过随机数生成被前瞻性分配到对照组和干预组。如果参与者未参加随访或未完成研究问卷,则将其排除在分析之外。
对照组仅由他们的听力学家进行随访。干预组在接受听力学家确定的随访之外,还参加了一次与医生的结构化访问。
主要结果:助听器适配后 3 个月的助听器满意度,采用日常生活中的助听器满意度量表(SADL)进行评估。次要结果:返回的助听器数量。预先招募的零假设:组间助听器适配后满意度无差异。通过效应大小和学生 t 检验分析 SADL 问卷评分的组间差异,通过 Fisher 精确检验分析返回的助听器数量的比例。
共招募了 133 名参与者(平均[标准差]年龄,70.9[8.5]岁;64 名女性[48.1%])。其中,51 名被随机分配到对照组(平均[标准差]年龄,71.7[8.3]岁;28 名女性[54.9%]),42 名被分配到医生干预组(平均[标准差]年龄,69.9[7.6]岁;17 名女性[40.5%]),他们的结果进行了分析。参与者的 SADL 评分在组间没有明显的临床差异(对照组:平均[标准差]评分,5.33[0.72];医生咨询组:平均[标准差]评分,5.35[0.61]),差异均值为 0.02(95%置信区间,-0.25 至 0.29),或返回的助听器数量(对照组,1;医生咨询组,0)。
这项随机临床试验的结果表明,专注于听力变化的医生咨询并不会改变患者在助听器适配后 3 个月对助听器的满意度。
ClinicalTrials.gov 标识符:NCT02842905。