Follow-up study of consumer-decides OTC model (Humes et al., 2019)

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.Trial Registration: Clinicaltrials.gov: NCT01788432; https://clinicaltrials.gov/ct2/show/NCT01788423 Supplemental Material S1. Complete protocol manual. Supplemental Material S2. Data collection forms. Humes, L. E., Kinney, D. L., Main, A. K., & Rogers, S. E. (2019). A follow-up clinical trial evaluating the consumer-decides service delivery model. American Journal of Audiology. Advance online publication. https://doi.org/10.1044/2018_AJA-18-0082

研究目标：本研究的两项主要目标包括：一是复制先前针对老年人选择助听器的消费者决定（CD）方法的临床试验，作为柜台（OTC）干预的潜在模型，通过减少对参与者前端筛查的依赖，并扩大设备中频率增益特性的范围；二是若参与者选择允许，评估CD方法相对于基于CD的安慰剂设备的有效性。研究设计：本研究的方案为一项单中心、前瞻性、双盲临床试验。在典型的4至5周试验期结束后，收集了结果指标。为复制和比较目的，还包含了一个为期4周的基于听力学最佳实践的附加随访试验。研究环境：通过报纸和社区传单招募了来自普通社区的老年人参与大学研究诊所的试验。参与者：参与者为54至78岁的成年轻度至中度听力受损者。41名参与者作为志愿者样本登记，其中40人完成了干预。干预措施：所有参与者都接受了相同的双边高端数字迷你耳背式助听器。CD参与者通过OTC型模型自行选择预编程的助听器。参与者可选择的3种设备中，其中一种被编程为无功能增益的安慰剂设备。主要和次要结果指标：主要结果指标是66项自我报告的助听器效益概览（Cox & Alexander，1990）。次要结果指标是连接语音测试（Cox，Alexander，& Gilmore，1987）效益。还获得了助听器效益和使用的其他指标。结果：基于41名（41名中的40名）完成研究的参与者数据的方案分析进行了。从这一后续CD（CD2）队列的助听器结果积极，总体上与原始CD队列相似。与基于CD的安慰剂对照组相比，CD服务交付模型有效，观察到了中等效果量。大约一半的CD2组可能在试验后购买助听器，这与原始CD队列的结果相似。32名选择完成可选4周AB试验的CD2参与者，其结果显著改善。对于这个主要未经筛选的样本，更多听力健康的人寻求放大，其中许多人（35%）选择了双耳的安慰剂设备。结论：CD服务交付的前期积极结果在一种更加灵活的参与者招募方法中得到了复制。CD方法再次被发现是有效的。在随后的AB服务交付随访中观察到显著更好的结果，这也复制了先前的研究发现。包括使用类似CD方法进行助听器自我选择的OTC模型在内的有效模型，可能会提高数百万老年助听器的可及性和可负担性。向消费者提供有关最佳干预路径的前端指导，从在线自我筛查听力到全面的听力学评估，似乎对于优化OTC方法的成功至关重要。临床试验注册：Clinicaltrials.gov：NCT01788432；https://clinicaltrials.gov/ct2/show/NCT01788423 补充材料S1：完整的方案手册。补充材料S2：数据收集表格。Humes, L. E.，Kinney, D. L.，Main, A. K.，& Rogers, S. E. (2019). 评估消费者决定服务交付模型的后续临床试验。美国听力学杂志。提前在线发表。https://doi.org/10.1044/2018_AJA-18-0082