A Review of Meaningful Change Thresholds for EORTC QLQ-C30 and FACT-G Within Oncology.

OBJECTIVES: This literature review provides an overview of meaningful change thresholds for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and the Functional Assessment of Cancer Therapy - General (FACT-G) used across hematological cancers and solid tumors (melanoma, lung, bladder, and prostate). METHODS: Embase, MEDLINE, and PubMed were searched to identify relevant oncology publications from 2016 to 2021. Label claims from the US Food and Drug Administration and the European Medicines Agency for 7 recently approved drugs (pembrolizumab, atezolizumab, glasdegib, gilteritinib, tisagenlecleucel, axicabtagene ciloleucel, and daratumumab plus hyaluronidase-fihj) were reviewed. RESULTS: Publications providing guidance on meaningful change thresholds for the QLQ-C30 displayed a growing trend away from broad "legacy" thresholds of 10 points for all QLQ-C30 scales), toward deriving "contemporary" thresholds (eg, subscale specific, population specific). Contemporary publications generally provide guidance on selecting thresholds for specific scales that account for improved or worsening thresholds (eg, QLQ-C30 subscales). This trend was not clear for FACT-G, with less new guidance available. Most clinical trials used in regulatory label submissions have used thresholds of 10 points for the QLQ-C30 subscales and 3 to 7 points for the FACT-G total score. Despite the availability of more recent guidelines, contemporary meaningful change thresholds seem slow to emerge in the published literature and regulatory labels. CONCLUSIONS: Trialists should consider using contemporary thresholds, rather than legacy thresholds, for QLQ-C30 endpoints. Thresholds derived for a similar patient-population should be used where available. Further work is required to provide these across a broader range of cancer sites.

The executive disruption model of tinnitus distress: Model validation in two independent datasets using factor score regression.

This study presents the executive disruption model (EDM) of tinnitus distress and subsequently validates it statistically using two independent datasets (the Construction Dataset: n = 96 and the Validation Dataset: n = 200). The conceptual EDM was first operationalised as a structural causal model (construction phase). Then multiple regression was used to examine the effect of executive functioning on tinnitus-related distress (validation phase), adjusting for the additional contributions of hearing threshold and psychological distress. For both datasets, executive functioning negatively predicted tinnitus distress score by a similar amount (the Construction Dataset: ß = -3.50, p = 0.13 and the Validation Dataset: ß = -3.71, p = 0.02). Theoretical implications and applications of the EDM are subsequently discussed; these include the predictive nature of executive functioning in the development of distressing tinnitus, and the clinical utility of the EDM.

Associations Between Subjective Tinnitus and Cognitive Performance: Systematic Review and Meta-Analyses.

Tinnitus is the perception of sound in the absence of a corresponding external sound source, and bothersome tinnitus has been linked to poorer cognitive performance. This review comprehensively quantifies the association between tinnitus and different domains of cognitive performance. The review protocol was preregistered and published in a peer-reviewed journal. The review and analyses were reported according to Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. Peer-reviewed literature was searched using electronic databases to find studies featuring participants with tinnitus who had undertaken measures of cognitive performance. Studies were assessed for quality and categorized according to an established cognitive framework. Random-effects meta-analyses were performed on various cognitive domains with potential moderator variables assessed where possible. Thirty-eight records were included in the analysis from a total of 1,863 participants. Analyses showed that tinnitus is associated with poorer executive function, processing speed, general short-term memory, and general learning and retrieval. Narrow cognitive domains of Inhibition and Shifting (within executive function) and learning and retrieval (within general learning and retrieval) were also associated with tinnitus.

Evidence for an Association Between Hearing Impairment and Disrupted Sleep: Scoping Review.

Purpose Hearing impairment (HI) is the most common sensory impairment and may negatively impact sleep through reduced auditory input. Factors associated with HI such as anxiety regarding communication in daily life may also adversely impact an individual's sleep. Here, research on the relationship between HI and sleep disruption was catalogued using scoping review methodology. Method A systematic strategy was employed to search various electronic databases. This review is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses Scoping Review Extension. Results Sixteen records met inclusion criteria. Studies have investigated sleep in HI as a primary aim in noise-exposed workers or large surveys in older participants. Experimental and quasi-experimental studies report alterations to sleep architecture of potential neuroplastic origins. Studies reporting sleep as a secondary aim generally report poorer sleep in HI participants. Conclusions This scoping review has catalogued evidence that altered or negatively impacted sleep may be associated with HI. Potential confounding factors, mechanisms, and considerations for future research are discussed. Supplemental Material https://doi.org/10.23641/asha.9968369.

Association between subjective tinnitus and cognitive performance: protocol for systematic review and meta-analysis.

INTRODUCTION: Subjective tinnitus is very common and has a number of comorbid associations including depression, sleep disturbance and concentration difficulties. Concentration difficulties may be observable in people with tinnitus through poorer behavioural performance in tasks thought to measure specific cognitive domains such as attention and memory (ie, cognitive performance). Several reviews have discussed the association between tinnitus and cognition; however, none to date have investigated the association between tinnitus and cognitive performance through meta-analysis with reference to an established theoretical taxonomy. Furthermore, there has been little overlap between sets of studies that have been included in previous reviews, potentially contributing to the typically mixed findings that are reported. METHODS AND ANALYSIS: This systematic review aims to comprehensively review the literature using an established theoretical taxonomy and quantitatively synthesise relevant data to determine associations between subjective tinnitus and cognitive performance. Methods are reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. All study designs will be eligible for inclusion with no date restrictions on searches. Studies eligible for inclusion must contain adult participants (≥18 years) with subjective tinnitus and a behavioural measure of cognitive performance. Meta-analysis will be reported via correlation for the association between tinnitus and cognitive performance. ETHICS AND DISSEMINATION: No ethical issues are foreseen. Findings will be reported in a student thesis, at national and international , ear, nose and throat/audiology conferences and by peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42018085528.