Participants' and physiotherapists' views on the delivery of a randomised controlled feasibility trial investigating a bespoke dynamic elastomeric fabric orthosis for women with chronic pelvic girdle

Cochlear implants (CIs) provide access to sound for individuals with moderate-to-profound sensorineural hearing loss and typically result in significant improvements in outcome domains of both speech recognition and quality of life (QOL). However, outcomes vary widely across patients, and the association between speech-recognition performance and hearing-related QOL using patient-reported outcome measures (PROMs) is inconsistent. Nevertheless, CI candidacy criteria and assessments of outcomes continue to rely heavily on speech-recognition abilities, which may not adequately represent everyday communication difficulties. A growing emphasis on PROMs aligns with evolving FDA guidance and clinical trial design standards, where PROMs are recognized as primary endpoints to capture real-world impact of interventions. Although CI candidacy is still frequently determined using speech recognition in quiet (eg, CNC words, AzBio sentences), many CI centers now incorporate testing in noise to better reflect real-world listening challenges. Some patients demonstrate borderline candidacy performance in quiet—such as CNC word recognition around 50% to 60%—yet meet candidacy criteria when tested using sentences in noise. These “borderline” candidates who only qualify in noise fall into a gray zone, and there is less evidence describing their postoperative CI benefits compared with “traditional” CI candidates who qualify in quiet. In one study, Schauwecker et al. reported that there was a significant difference in the proportions of borderline versus traditional CI candidates who demonstrated improvements in speech recognition in the CI-only testing condition, but not in their bilateral best-aided (“everyday listening”) condition. Although the findings of that study suggest that everyday listening speech-recognition benefits are similar between groups, the degree to which borderline CI candidates improve in their perceived real-world communication abilities and QOL after implantation remains unclear. This topic is clinically important, as demonstrated by a large multicenter study using a registry (n=1611) with data from 12 clinical sites across 9 states. That study, which is now almost a decade old, showed that even then up to one-third of adult CI candidates qualified only in noise (10% at +10 dB signal-to-noise ratio, SNR; 27% at +5 dB SNR). Although that study found overall postoperative improvements in speech recognition and self-reported outcomes, approximately one-quarter of patients did not demonstrate meaningful gains. Direct comparison between noise-qualified and quiet-qualified (borderline vs. traditional) candidates was not performed, underscoring the need to clarify how these groups differ in real-world CI benefits. Unlike speech-recognition measures in the booth, PROMs capture broader domains of communication, engagement, and well-being, offering a more patient-centered assessment of benefits. However, patient-reported QOL outcomes in borderline CI candidates remain poorly characterized. For example, Schauwecker et al. demonstrated that borderline CI candidates achieved smaller CI-only gains but equivalent everyday listening speech recognition, and the groups showed comparable final scores on patient-reported QOL. However, that study did not consider the impact of baseline QOL on post-CI QOL changes. Thus, one objective of this study is to investigate whether QOL changes differ between borderline and traditional CI recipients, using the Cochlear Implant Quality of Life (CIQOL), a validated CI-specific PROM.