A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Mode
A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Mode
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DOI：
10.1044/2018_aja-18-0082
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发表时间：
2019-03-01
影响因子：
1.8
通讯作者：
Rogers, Sara E.
中科院分区：
文献类型：
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作者：
Humes, Larry E.;Kinney, Dana L.;Rogers, Sara E.
目标：有两个主要目标。主要目的是复制之前的临床试验，即消费者决定（CD）方法选择老年人助听器作为非处方（OTC）干预的潜在模型，使用较少的参与者前端筛选和更广泛的设备频率增益特性。第二个目标，只有可行的，如果参与者的选择允许，是评估CD的方法相对于CD为基础的安慰剂device.Design的有效性：本研究的设计是一个单一的网站，前瞻性，双盲临床试验。在典型的4- 5周试验期后获得结果指标。一个可选的后续4周的听力学为基础的（AB）的最佳实践的试验也包括复制和comparatives.Setting：老年人从一般社区通过报纸和社区传单招募参加在大学的研究clinics.Participants：参与者是成年人，年龄在54-78岁，轻度-中度听力损失。41名参与者作为志愿者样本登记; 40人完成了intervention. Interventions（s）：所有参与者都接受了双侧安装的相同高端数字微型耳后助听器。CD参与者通过OTC类型的模型自行选择他们自己的预编程助听器。参与者可以选择的3个设备之一被编程为安慰剂设备，没有functionalgain.Primary和Secondary结局测量：主要结局测量是66项自我报告的助听器效益概况（考克斯和亚历山大，1990）。次要结果测量是连接语音测试（考克斯，亚历山大，和吉尔摩，1987）的好处。助听器的好处和使用的其他措施也gained.Results：每协议分析的基础上的数据从40（41）参与者谁完成了研究。该随访CD（CD 2）队列的助听器结局是积极的，通常与原始CD队列相同。CD服务提供模式相对于基于CD的安慰剂对照是有效的，观察到中等效应量。大约一半的CD 2组在试验后可能会购买助听器，与原始CD队列的结果相似。选择完成可选的4周AB试验的32名CD 2参与者的结局显著改善。对于这个大部分未筛选的样本，更多的人与健康的听力寻求放大，这些人中的许多人（35%）选择安慰剂设备的两个ears.Conclusions：CD服务提供之前的积极成果已被复制在一个限制较少的参与者招募的方法。裁谈会的做法再次被证明是有效的。在随后的AB服务提供随访后观察到明显更好的结果，也复制了以前的研究结果。有效的OTC模型，包括使用类似CD方法进行助听器自我选择的模型，可能会增加数百万老年人助听器的可及性和可负担性。对消费者进行关于最佳干预途径的前端指导，从在线听力自我筛查到完整的听力学评估，似乎对优化OTC方法的成功至关重要。
Objectives: There were 2 main objectives. The primary objective was to replicate a prior clinical trial of a consumer-decides (CD) approach to selecting hearing aids in older adults as a potential model for over-the-counter (OTC) intervention using less front-end screening of participants and a wider range of frequency-gain characteristics in the devices. The 2nd objective, only feasible if participant choices allowed, was to evaluate the efficacy of the CD approach relative to a CD-based placebo device.Design: The design of this study is a single-site, prospective, double-blind clinical trial. Outcome measures were obtained after a typical 4- to 5-week trial period. An optional follow-up of a 4-week audiology-based (AB) best practices trial was also included for replication and comparison purposes.Setting: Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic.Participants: Participants were adults, aged 54-78 years, with mild-moderate hearing loss. Forty-one participants enrolled as a volunteer sample; 40 completed the intervention.Intervention(s): All participants received the same high-end digital mini-behind-the-ear hearing aids fitted bilaterally. CD participants self-selected their own preprogrammed hearing aids via an OTC-type model. One of the 3 devices from which participants could choose was programmed to be a placebo device with no functional gain.Primary and Secondary Outcome Measures: The primary outcome measure is the 66-item self-report Profile of Hearing Aid Benefit (Cox & Alexander, 1990). The secondary outcome measure is the Connected Speech Test (Cox, Alexander, & Gilmore, 1987) benefit. Additional measures of hearing aid benefit and usage were also obtained.Results: Per-protocol analyses based on the data from the 40 (of 41) participants who completed the study were performed. Hearing aid outcomes from this follow-up CD (CD2) cohort were positive and generally the same as for the original CD cohort. CD service delivery model was efficacious relative to CD-based placebo control, with medium effect sizes observed. Approximately half of the CD2 group was likely to purchase hearing aids after the trial, similar to findings for the original CD cohort. Outcomes improved significantly for the 32 CD2 participants who elected to complete the optional 4-week AB trial. For this largely unscreened sample, more individuals with healthy hearing sought amplification, and many of these individuals (35%) chose placebo devices for both ears.Conclusions: Prior positive outcomes for CD service delivery have been replicated in a less restrictive approach to participant recruitment. The CD approach was again found to be efficacious. Significantly better outcomes were observed after subsequent AB service delivery follow-up, also replicating prior findings. Efficacious OTC models, including those using similar CD approaches to hearing aid self-selection, may increase accessibility and affordability of hearing aids for millions of older adults. Front-end guidance to consumers regarding the best path to intervention, ranging from self-screening of hearing online to a full audiologic assessment, appears to be critical to optimize the success of OTC approaches.