Objectives: This study investigated whether physical and cognitivefunctioning predicts developing difficulties in basic or instrumental activitiesof daily living (ADL/IADL), and whether country-level factors moderated theassociations. Methods: 69,227 adults aged 50+ from 19 countrieswere followed for up to 14 years. Cox regression and meta-regression analyseswere used. Results: Higher grip strength was associated with a 45%lower risk of developing ADL limitations and a 47% lower risk of IADLlimitations. The corresponding values were 22% and 23% for peak flow, 20% and23% for word recall, and 20% and 24% for temporal orientation. The associationswere similar and statistically significant in most countries, but someassociations were weaker in countries with lower GDP and lower service coverage.Discussion: Good physical and cognitive functional capacityprotects from ADL and IADL limitations consistently across Western countries.The associations may be stronger in countries with more resources. Activities of daily living (ADL) are activities needed to live independently in thecommunity. These activities are classified into basic ADL and instrumentalactivities of daily living (IADL) . ADLs arThe prevalence of difficulties in ADL and IADL increases with age and are typicallyfirst seen in more complex activities captured by IADL . Both ADFurthermore, disability is not solely a result of the individual’s characteristics,as the environment has a major effect especially on the experience of disability. DifficuDisability is an outcome of the interaction between individual functional capacityand the environment . The envIn addition, the moderator role of country-level environmental factors on theassociation between functional capacity and disability is not clear. Both economicsituation and service access may moderate the role of individual characteristics. Astudy focusing on within-country regional differences showed that individualcharacteristics have a larger role in end-of-life well-being in areas with higherunemployment and poor service access . A countThe purpose of this study was to investigate whether physical and cognitiveperformance predict difficulties in ADL and IADL similarly across Western countries.This work contributes to existing knowledge of the association between functionalcapacity and ADL/IADL limitations by providing a large longitudinal cross-nationalcomparison based on harmonized measures across 17 European countries, Israel, andthe US This study further contributes to this research area by comparing thepredictive value of four functional capacity indicators  on two outcomes (ADL and IADL limitations)and investigates country-level differences and country-level moderators of theassociation between functional capacity and ADL/IADL limitations.Based on past research e.g., , we expeData were from two large aging studies, the Survey of Health, Ageing andRetirement in Europe (SHARE)  and thehttp://www.share-project.org/home0.html). The SHARE study wasreviewed and approved by the Ethics Committee of the University of Mannheim inwaves 2 and 4 and from wave 4 onwards by the Ethics Council of the Max PlanckSociety. All participants provided written informed consent.To maximize the number of included countries and harmonized measures betweenSHARE and HRS and have a long enough follow-up, waves 2  and 4  were used as abaseline for SHARE. 15 countries  participated in wave 2 and 4 more countries  were included in wave 4. Ireland did notparticipate in later SHARE waves and thus was excluded from the present sample.Follow-up information from all available waves was utilized: wave 4 (for thosewith baseline in wave 2), wave 5 , 6 , 7 , and 8. Release 8.0.0. was used . Data arhttps://hrs.isr.umich.edu/about). Ethical approval for the HRSwas obtained from the University of Michigan Institutional Review Board. Allparticipants provided either oral (interviews) or written informed consent.In HRS, waves 8 (2006) and 9 (2008) were used as the baseline. Physicalmeasurements were conducted for a random one-half of the sample in 2006 and in2008 for the other half of the sample. These two samples were combined as thebaseline. These measurements were introduced in 2004 but were not used forbaseline because they were only available for a small random subsample.Follow-up information from all available waves was utilized: wave 9 (for thosewith baseline in wave 8), wave 10 (2010), 11 (2012), 12 (2014), 13 (2016), 14(2018), and 15 (2020). The public release data are available for registeredusers  and 1 = Normal temporal orientation (All four questions answeredcorrectly).Cognitive functioning was assessed by memory performance  and temporal orientation. In the all test, particigrip strength andpeak flow. Grip strength was measuredusing a handheld dynamometer twice from both hands, alternating between hands , depression, chronicdiseases, education, marital status, height, and weight. Depression was abinary variable (0 = No and 1 = Yes) that indicated elevated depressivesymptoms on the cut-point for the EURO-D scale in SHARE   and theGross domestic product (GDP) per capita, health expenditure (% of GDP), theUHC service coverage index (SDG 3.8.1.) indicators on service capacity andaccess, and geographic area were used as country-level indicators. GDP andhealth expenditure from the baseline year 2006 and service capacity andaccess from the year 2010 (available only every 5 years) were collected fromthe World Bank. GDP per capita is a country’s GDP divided by its totalpopulation and is an indicator of national wealth. Health expenditure as ashare of GDP is the ratio of spending on health care goods and servicescompared to total spending in the economy. UHC SDG index indicates theaverage coverage of four essential health service areas needed by mostpopulations: reproductive, maternal, newborn, and child health, infectiousdiseases, non-communicable diseases, and service capacity and access . The ser2-test to compare the participants with and without follow-upinformation. Binary logistic regression analyses were used to test whetherphysical and cognitive performance at baseline predicted the likelihood ofavailable follow-up information after adjusting for gender.Attrition analysis was performed using independent samples t-test andxCox regression hazard models were used to test whether physical and cognitiveperformance at baseline predicted incidence of difficulties in ADL or IADL overup to 14 years of follow-up in each country. Identical analyses for difficultiesin ADL and IADL as an outcome were conducted and the predictors  were tested in separatemodels. Time was coded in years from the baseline assessment asyear-to-incidence in difficulties in ADL or IADL. For participants who did notdevelop difficulties during the follow-up, cases were censored at their lastavailable assessment. For participants who died during the follow-up and had theend-of-life/exit interview available that indicated the absence of difficultiesbefore death, cases were censored at their year of death. Z-scores for gripstrength, peak flow, and word recall separately for each country were calculatedand used in cox regression to facilitate interpretation of hazard ratios.The proportional hazard assumption was checked with Kaplan–Meier plots andinteraction terms between time and predictors in time-dependent covariate Coxregression models. As the incidence of both ADL and IADL exponentially increaseswith age, age violated the assumption. Thus, all Cox regression models werestratified by age group  to allow separate baselinehazard functions to be fitted within different age strata. The associations ofthe predictors were still modeled as a single set of common effects acrossstrata. All Cox regression models were adjusted for baseline age, gender,education, marital status, depressive symptoms, and chronic diseases. The modelswith grip strength were also adjusted with weight and height, and models withpeak flow with height.2 wasused as an indicator of heterogeneity with values below 30 indicating low andvalues above 50 indicating notably heterogeneity  werecombined using random-effects meta-analysis to estimate the overall effect.Forest plots were used to visualize results. Random-effects meta-regression wasused to assess the country-level moderators  and were tested in separate models toavoid multicollinearity. Dummy-coded variables for geographic area  were used in the meta-regression. Iogeneity .AdditioIBM SPSS Statistics Version 26 was used for descriptive statistics and Coxregression and Stata Version 16 was used for the meta-analysis.Descriptive statistics are in Supplementary Tables S1-S3 separately for each country. Theavailability of follow-up information was on average 83.3% (range 60.1–97.6%) forADL and 82.5% (range 60.6–97.5%) for IADL. In general, follow-up information wasavailable from older and less educated participants, and women were more likely tohave available follow-up information on ADL and IADL than men (Table S1). These differences were not consistent across countries.After adjusting for gender (Table S2 and S3), participants with better functional capacitytended to have available follow-up information on both ADL and IADL. Theseassociations were not consistent across countries and functional capacityindicators.The results of attrition analysis are shown in Supplementary table S4 for ADL and in Supplementary table S5 for IADL. Weaker grip strength and peak flow,worse word recall performance, and poor temporal orientation were associated withdeveloping difficulties in ADL and IADL over the follow-up in most countries and themeta-analysis. One positive SD from the mean grip strength was associated with a 45%lower risk of developing ADL difficulties and a 47% lower risk of developing IADLdifficulties during the follow-up. The corresponding values were 22% and 23% forpeak flow and 20% and 23% for word recall. Participants with poor temporalorientation at baseline had a 20% higher risk of developing difficulties in ADL anda 24% higher risk of developing difficulties in IADL during the follow-up.The results of Cox regression analyses and meta-analyses are reported in Grip strength had a statistically significant association with ADL and IADL in 18/19countries. The proportions were similar for peak flow (14/19 with ADL and 16/19 withIADL) and word recall . The association with temporalorientation was less consistent between countries and was statistically significantfor only 8/19 countries for ADL and 6/19 countries for IADL. The pattern ofassociations was similar across countries  and 3 wi2 statistics suggested low heterogeneity for the association betweentemporal orientation and ADL (I2 = 0%) and IADL (I2 = 8.0%)and moderate heterogeneity for the association between grip strength and ADL(I2 = 32.1%). All other associations had notable heterogeneity: gripstrength and IADL I2 = 73.1%, peak flow and ADL I2 = 86.7%,peak flow and IADL I2 = 71.5%, word recall and ADL I2 = 69.7%,and word recall and IADL I2 = 61.4%. As Greece was an outlier withnonsignificant associations between all predictors and ADL and IADL difficulties,sensitivity analyses without Greece were performed. The results of meta-analysisremained the same (Supplementary tables S4 and S5): associations of physical andcognitive indicators with ADL and IADL limitations were just slightly stronger andI2 suggested slightly lower heterogeneity between countries.The Ip > .05, Supplementary Table S6).Moderation analyses showed some country-level moderator effects . ServiceSupplementary Table S7). The moderator effect of service capacityand access on the associations between grip strength and IADL , peak flow and ADL , peak flow and IADL , and wordrecall and ADL  were not statisticallysignificant after exclusion of Greece. The moderator effects of service capacity andaccess and GDP on the association between word recall and IADL (shown in Supplementary figure S1) as well as the moderator effect of northernEurope on the associations between grip strength and ADL and temporal orientationand ADL remained statistically significant. In addition, some new moderator effectswere found when Greece was excluded. Health expenditure  had a statistically significant moderator effect on theassociation between word recall and IADL and service capacity and access on theassociation between temporal orientation and ADL . These effects suggested stronger associations in countries withhigher health expenditure and higher service capacity and access. In addition to theabove-mentioned stronger associations in northern European countries that were foundwith the whole sample including Greece, geographic area moderated the associationbetween word recall and IADL when Greece was excluded: the predictive value of wordrecall was weaker in eastern European countries compared to others .Sensitivity analyses without Greece showed that most moderator effects of servicecapacity and access were not statistically significant after the exclusion of Greece compared to other countries. This finding mayindicate that in countries with better financial resources and formal services, theexperience of limitations in daily activities is a more direct outcome of limitedfunctional capacity. In the other words, the larger discrepancy between functionalcapacity and limitations in daily activities in countries with the less favorableenvironment may indicate the role of environmental challenges in the experience ofdisability .The moderator results also suggested some geographic differences that were not asclearly explained by GDP and service capacity and access. The associations betweengrip strength and temporal orientation and ADL limitations were stronger in northernEurope countries, namely, Denmark and Sweden, compared to other countries. Denmarkand Sweden have both Nordic welfare state models with tax-funded health care systemsand good service coverage . Older aSince differences between countries were small, which suggested a relativelyconsistent role of functional capacity in developing ADL and IADL limitations,practical implications likely generalize across Western countries. A key policypriority should be preventive actions that focus on lifestyle factors throughout thelife course, as they play a major role in later life functional capacity .In addiThe major strength of this study is the large sample size of middle-aged and olderadults from 19 countries, which permitted the generalization of findings todifferent Western countries. The present study appears to have the largest samplesize and number of countries compared with previous studies that addressed thisquestion. The use of harmonized sister-studies SHARE and HRS with similar methodsprovides the opportunity for country-level comparisons. Even thoughperformance-based measures of functional capacity are not free of measurement error,the use of standardized protocols to assess functional capacity provides explicitindicators for country-level comparisons.Both SHARE and HRS samples are representative of their target population aged 50 andolder . SpecifiEven though the whole samples of SHARE and HRS are representative of the populationaged 50 and older, the sample used in the present study is not likely to becompletely representative. First, 12–16% of participants were excluded from theanalysis due to difficulties in ADL or IADL at baseline, and thus, the most disabledparticipants were excluded from the present study (as the focus was on thedevelopment of new limitations). Second, the attrition analysis suggested that, evenwithin this healthier sample without ADL/IADL limitations at the baseline,participants with poorer functional capacity at baseline were more likely to dropout of the study. These selection and attrition biases may lead to underestimationof the impact of functional capacity on developing ADL and IADL limitations. Despitethese limitations, the samples used in the present study are likely to be morediverse and representative compared to convenience samples.This study has some other limitations as well. The samples collected in each countryhave different demographic statistics, and participations rates, recruitmentstrategies, and mortality varied between countries. There were differences also inthe amount of follow-up information varying from losing only ∼2.5% of the HRS sampledue to missing follow-up information on ADL or IADL to losing almost 40% of thesample in Germany and Hungary. These differences in attrition likely explain a largepart of the variation in incidence rates between countries. With separate analysesfor each country adjusted by demographics, the differences between samples shouldnot substantially bias estimates.Difficulties in ADL and IADL were assessed as a binary variable that indicateddifficulty in any ADL or IADL activity. Focusing on separate activities or thenumber of difficulties may reveal different insights. In addition, there are micro-and meso-level environmental factors that may affect the experience of disability,such as accessibility, usability, living arrangements, and social support . This stIn conclusion, the results from SHARE and HRS provided strong evidence for anassociation between functional capacity and ADL and IADL limitations amongmiddle-aged and older adults in Europe, Israel, and the US. The results wereconsistent across different functional capacity indicators, across outcomes (ADL andIADL limitations), and across countries. Good functional capacity is an importantresource for maintaining independence in daily activities, regardless of country ofresidence.Click here for additional data file.Supplemental Material for Functional Capacity and Difficulties in Activities ofDaily Living From a Cross-National Perspective by Tiia Kekäläinen, MartinaLuchetti, Angelina Sutin, and Antonio Terracciano in Journal of Aging andHealth.


The cartilage-conduction hearing aid (CC-HA) is a new hearing device that is suitable for use in patients with conductive hearing loss. It has been 5 years since the introduction of the CC-HA. Although the number of users has increased, the CC-HA is not yet widely known. This study examines the effects of CC-HA on patients with conductive hearing loss and investigates factors that affect the willingness to use the device by comparing purchasers and non-purchasers of CC-HA in patients with unilateral conductive hearing loss. Eight patients had bilateral conductive hearing loss, and 35 had unilateral conductive hearing loss. Each patient underwent sound field tests and speech audiometry, and the effects of the CC-HA were compared with those of conventional bone conduction hearing aids (BC-HA). In patients with bilateral conductive hearing loss, the CC-HA was non-inferior to BC-HA. The CC-HA improved the hearing thresholds and speech recognition in patients with unilateral conductive hearing loss. Moreover, in patients with unilateral conductive hearing loss, experiencing the effect of wearing the CC-HA under conditions such as putting noise in the better ear could affect patients’ willingness to use the CC-HA. It has long been postulated that auditory sound conduction is facilitated solely through two pathways: air conduction (AC) via the ear canal and bone conduction (BC) through the skull. However, in 2004, Hosoi  discoverThree sound conduction pathways are now believed to exist from the CC transducer to the inner ear: the vibration of the ear cartilage produces air-conducted sound in the external auditory canal, which reaches the tympanic membrane; it is referred to as “cartilage AC”. Vibrations of the otocardium generate vibrations in the temporal bone, which are transmitted to the inner ear, which is known as “cartilage BC”. The CC transducer vibrates the air surrounding it, and the resulting air-conducted sound enters the external auditory canal through its entrance and reaches the tympanic membrane. This is called “direct AC”. These three pathways have been previously described ,3.The concept of CC has been utilized in the development of products such as hearing aids, smartphones, and earphones . SpecifiConventional sound conduction methods for hearing aids typically rely on air conduction. A condition that is difficult to manage with an air-conduction hearing aid (AC-HA) is aural atresia . In such cases, the use of AC-HA can be difficult or ineffective due to the closed outer ear. In these patients, bone-conduction hearing aids (BC-HA), implantable bone-conduction hearing aids , and middle ear implants (VSB) have been employed. BC-HA is bone conductive; therefore, sound conduction is not significantly affected even if the ear canal is closed. However, a headband must be used to attach the transducer to the bone to achieve optimal hearing. However, prolonged use is challenging because of local pain, indentation, redness, and erosion caused by headband fixation, which is also aesthetically unappealing. BAHA, BONEBRIDGE, and VSB can address the limitations of bone-anchored hearing aids because they are surgically implanted. However, the requirement for surgery is a significant drawback ,9,10. ThNishimura et al.  reportedIt has been 5 years since the introduction of the CC-HA, and although the efficacy of the CC-HA, such as those mentioned above, has been reported, it is not yet widely used worldwide. In this study, we examined the effect of wearing the CC-HA on patients with conductive hearing loss at our hospital who had a hearing aid trial with the CC-HA.Participants included eight patients with bilateral conductive hearing loss and 35 patients with unilateral conductive hearing loss who underwent a hearing aid trial with the CC-HA at our hospital  over a period of 5 years from December 2017 to December 2022. Among patients with bilateral conductive hearing loss, we included patients who were using BC-HAs as their conventional hearing aid and excluded patients who were not using BC-HAs. Patients with bilateral conductive hearing loss were 6–27 years of age (median 13 years) and consisted of two males and six females, whereas those with unilateral conductive hearing loss were 4–64 years old (median 15 years), consisting of 20 males and 15 females. Among the patients with bilateral conductive hearing loss, six had microtia, and two had external auditory canal stenosis or atresia with a normal concha. Of the patients with unilateral conductive hearing loss, 30 had microtia, three had external auditory canal stenosis or atresia with a normal concha, one had a middle ear malformation, and one had undergone surgery for external auditory canal cancer.For the hearing aid trial, from December 2017 to October 2020, HB-J1CC  was used, and from October 2020, HB-A2CC, a new model of the same device, was used. The transducers selected were ear-chip-embedded or simple types according to the ear condition. Since HB-J1CC does not have a child lock function, it was said to be suitable for ages 3 and up. However, the HB-A2CC was equipped with a child lock function to prevent the accidental swallowing of the battery, allowing for its use from a younger age.Simple pure-tone audiometry, sound field tests, and speech audiometry were performed in patients with bilateral conductive hearing loss. Regarding speech audiometry, two patients did not consent to participate, and speech audiometry was not performed. For the sound field test and speech audiometry, the test results obtained when using conventional BC-HA were compared with those obtained using the CC-HA. For patients with unilateral conductive hearing loss, we performed simple pure-tone audiometry, sound field tests, and speech audiometry. Similar to the method described by Akasaka et al.  to examit-test and a chi-squared test were used for statistical analyses. Analyses were performed using Microsoft 365 Excel , and statistical significance was set at p < 0.05.Welch’s We revealed the purpose and content of the survey to the participants and ensured the protection of privacy. This study was approved by the Ethics Committee of Sapporo Medical University in an official letter on 27 February 2023 (Protocol number: 342-232).The clinical characteristics of the study participants are summarized in p = 0.054); however, SRS tended to be better in the purchase group than in the non-purchase group when noise was produced in the good ear (good ear c.In this study, we first examined whether the test results differed between BC-HAs and CC-HAs in patients with bilateral conductive hearing loss. We did not observe a significant difference, and the average results of the sound field test and speech audiometry both improved slightly; therefore, CC-HA was shown to be non-inferior to BC-HA. Although not included in this study, there was one patient with bilateral conductive hearing loss who used an AC-HA as a conventional hearing aid, and CC-HA was as effective as the AC-HA in both sound field testing and speech audiometry. Although patients with bilateral conductive hearing loss were classified into purchase and non-purchase groups to compare the test results, there was only one non-purchaser; therefore, statistical analysis could not be performed. Further studies with more participants are needed to examine whether differences between CC-Has and BC-Has affect their willingness to use CC-HAs. Other differences between the BC-HA and the CC-HA may be perceived as comfort when wearing hearing aids. In fact, some patients who experienced wearing the BC-HA commented that after wearing the CC-HA for a while, skin pain and feelings of pressure were improved. Alternatively, some patients chose to wear the CC-HA with a simple transducer rather than the ear-chip-embedded transducer and felt that it was troublesome to stick them on. Furthermore, BC-HAs were often only worn in one ear for aesthetic reasons because if they were worn in both ears, the crimping feeling became stronger. In contrast, CC-HAs are often worn on both ears for comfort. Reeder et al.  reportedNext, we investigated whether the binaural hearing effect of wearing CC-HA improved speech recognition in patients with unilateral conductive hearing loss. First, we compared SRS with and without CC-HA at a sound pressure 10 dB lower than the sound pressure at which the highest SRSs were obtained without a hearing aid. As a result, an improvement in the SRS was observed when wearing CC-HA. This result was similar to the result of the study reported by Akasaka et al. , who exaIn addition, the economic situation may also influence the willingness to wear CC-HAs because of their high cost. When introducing CC-HAs to patients, it is important to provide appropriate information not only about their effect on hearing but also about the comfort and aesthetics of CC-HAs, as well as the cost of purchasing CC-HAs and the available subsidies.The limitations of this study included the low number of non-purchasers, which resulted in an imbalance between purchasers and non-purchasers. In particular, there was only one non-purchaser among the patients with bilateral conductive hearing loss, which was considerably low. It is not possible to perform a statistical analysis separating the CC-HA purchasers and non-purchasers. The acquisition of additional participants was, therefore, necessary. Additionally, because of the low number of non-purchasers, it was thought that patients who were not proactive in purchasing were not very cooperative in examinations, and there were cases where data could not be obtained, suggesting the presence of selection bias. Furthermore, there were many young patients with microtia at our hospital. As a result, confounding factors such as the presence or absence of subsidies for purchases may have been at play.This study examined the effectiveness of CC-HA in patients with bi- and unilateral conductive hearing loss and investigated the predictive factors that lead to their willingness to wear CC-HA. The results indicate that CC-HA was non-inferior to BC-HA in patients with bilateral conductive hearing loss, and its usefulness was demonstrated in patients with unilateral conductive hearing loss. In patients with unilateral conductive hearing loss, good results on speech audiometry while wearing CC-HA with noise in the good ear may influence their willingness to wear CC-HA.


Population-based research has consistently shown that people with hearing loss are at greater risk of cognitive impairment. We aimed to explore the cross-sectional association of both subjective and objective hearing measures with global and domain-specific cognitive function. We also examined the influence of hearing aid use on the relationship.n = 1,105, 52% women) of 70-year-olds that were representative of the inhabitants of the city of Gothenburg, Sweden completed a detailed cognitive examination, pure-tone audiometry, and a questionnaire regarding perceived hearing problems. A subsample  also completed a test of speech-recognition-in-noise (SPRIN). Multiple linear regression analyses were conducted to explore the association of hearing with cognitive function, adjusting for sex, education, cardiovascular factors, and tinnitus.A population-based sample , the better ear SPRIN score , but not with the self-reported hearing measure . Both verbally loaded and nonverbally loaded tasks, testing a variety of cognitive domains, contributed to the association. Hearing aid users had better global cognitive function than nonusers with equivalent hearing ability. The difference was only significant in the mild hearing loss category.In a population-based sample of 70-year-old persons without dementia, poorer hearing was associated with poorer global and domain-specific cognitive function, but only when hearing function was measured objectively and not when self-reported. The speech-in-noise measure showed the strongest association. This highlights the importance of including standardized hearing tests and controlling for hearing status in epidemiological geriatric research. More research is needed on the role that hearing aid use plays in relation to age-related cognitive declines. Hearing loss and dementia are two prevalent health conditions in advancing age that have serious negative effects on the lives of affected individuals as well as their families. Both conditions have been demonstrated to affect numerous domains of healthy aging, including social engagement, mental well-being, and daily functioning . In addiIn the present study, we aimed to investigate the cross-sectional association between hearing and cognitive function in a representative sample of mainly community dwelling 70-year-old persons without dementia, using data from the most recent cycle of the Gothenburg H70 Birth Cohort Study 2014-2016. Additionally, we aimed to clarify whether different measures of hearing − pure-tone audiometry, speech-recognition-in-noise (SPRIN) audiometry, and self-reported hearing problems − yield different magnitudes of associations. We hypothesized that the speech-in-noise task and the self-report measure would show a stronger association with cognitive function than pure-tone audiometry would, given the fact that these involve central auditory function.n = 251, response rate 82%) completed an extended audiological evaluation, which among other things involved a test of SPRIN. Further information about the methodologies of the main investigation [n = 23). No further exclusion criteria were used in order to obtain a representative sample with a range of differing hearing and cognitive abilities. There were several different reasons for nonresponse. Importantly, 46 participants had not performed pure-tone audiometry, since this test was not included during domiciliary visits. Further reasons included being too tired, time constraints, or that the participant declined. The final sample consisted of 1,105 participants (52% women) and the subsample consisted of 247 participants (54% women). Procedure: the main investigation took place in the Neuropsychiatric Clinic at the Sahlgrenska University Hospital and lasted for a full day, including breakfast and lunch. Participants could also choose to perform the tests over 2 days. Specially trained research nurses administered most of the assessments. However, a mental health nurse, a psychiatrist, or a medical doctor conducted some of the cognitive tests. Moreover, the extended audiological examination (performed on a subsample) was conducted in a research facility within the Audiology Department at the University of Gothenburg by audiologists.The data used in the present study come from the Gothenburg H70 Birth Cohort Study, which is an ongoing prospective multidisciplinary study that examines the health and determinants of health in age-homogeneous representative samples of the older population in Gothenburg, Western Sweden. Gothenburg is the second largest city in Sweden with a population of 579,281 persons in 2019. During 2014-2016, a new birth cohort of 70-year-old persons born in 1944 was examined. All residents of Gothenburg that were aged 70 years at the time of invitation and born on dates ending in 0, 2, 5, or 8 were eligible for participation. A total of 1,203 persons responded  and completed a detailed test battery covering a large range of health domains, including a hearing assessment (pure-tone audiometry and a questionnaire on perceived hearing problems), as well as a comprehensive cognitive evaluation. In addition, a systematically selected subsample  [Dureman and Sälde [The cognitive test battery was designed to cover a wide range of cognitive abilities and included tasks from the DAS-COG)  as well nd Sälde  psychomend Sälde . Raw teshearing index based on five items was selected to represent self-reported hearing problems. This index has been described and validated against pure-tone audiometry in a previous study [How is your hearing?”. Three response categories were possible: “Fine, no problems,” “Slightly impaired,” or “Significantly impaired.” The remaining four questions concerned perceived hearing problems in the following situations: conversations with one other person; conversations in a group; listening to the television; and hearing the doorbell. Three response categories were available for all four items: “No problems,” “Slight problems,” and “Significant problems.” A score of 0, 1, or 2 points were given for each item, yielding a possible score of 0–10, where 10 indicated significant problems in all situations, etc. In addition, participants were also asked about the presence of tinnitus (of any degree) and hearing aid use.Self-reported hearing was examined with a 10-item questionnaire that has been included in the H70 Study since its beginning. The questionnaire was given to all participants of the study during a general health interview conducted by one of the nurses. The questions were designed to measure hearing-related problems in a number of situations. For the purpose of the present study, a us study . The firPure-tone air conduction thresholds were measured in a quiet office with an Entomed SA 202IV audiometer and Sennheiser HDA200 circumaural headphones, using an automated computerized test procedure. Ambient noise levels were measured and found to be within the tolerance values specified in ISO 8253-1:2010, Tables A test of SPRIN  was compAs part of the main investigation, data regarding various health parameters were collected. Systolic and diastolic blood pressure was recorded in the right arm with the participant in sitting position, after 5 min of rest. Hypertension was defined as a systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg, and/or current treatment with antihypertensive drugs. Cardiovascular disease (past or present) was diagnosed if any of the following were present: angina pectoris (self-reported or presence of chest pain according to the ROSE questionnaire), myocardial infarction (self-reported or presence of major or moderate Q-waves on the ECG), or heart failure (self-reported). For more information regarding these health variables, see Rydberg Sterner et al. .2 tests. Nonresponders refer to participants in the birth cohort that were not selected for the study samples (due to not having available cognitive and/or hearing data). Multiple linear regression was used to study the associations between global and domain-specific cognitive function and three different measures of hearing. Since the objective was to compare the extent to which each parameter explained the variance in the outcome variable, the standardized regression coefficients (β) were used. The 95% confidence interval (CI) of the β coefficients were calculated and used to evaluate statistically significant differences between regression coefficients. The main dependent variable, global cognitive function, was examined with a histogram and a normal Q-Q plot and was found to be normally distributed, both in the main sample and in the subsample. Three models were created, in which the following explanatory variables were used: model 1 − the pure-tone average (PTA4) in the better hearing ear; model 2 − the SPRIN score in the better hearing ear, defined as the ear with the lowest (in dB HL) PTA4; model 3 − self-reported hearing index on a continuous scale. All three models were adjusted for years of education (continuous variable) and sex, hypertension, cardiovascular disease, and tinnitus . In secondary analyses, we adjusted model 2 for PTA4 and created a model with all three hearing measures added simultaneously. Additionally, we performed the regression analyses for men and women separately. The significance of each model was tested with ANOVA and the assumptions of homoscedasticity and independence were ascertained by plotting standardized residuals against predicted scores, and by normality analysis of the residuals. Based on the Collinearity Diagnostics in SPSS, collinearity between the independent variables was only moderate  and was therefore not assumed to affect the results. The significance level for all analyses was set at p < 0.05 and missing data were excluded listwise.Statistical analysis was performed using the R studio version 1.2 and SPSS for Windows version 25. Comparisons between the total sample and the subsample, and between responders and nonresponders were performed using χn = 247) did not differ significantly from the sample, except concerning educational attainment, where the subsample were slightly more highly educated . Additionally, the participants of the present study did not differ significantly from the remainder of the birth cohort, with regard to the abovementioned characteristics.Demographic and general health characteristics of the sample are presented in Table www.karger.com/doi/10.1159/000527930). Global cognitive scores were available in 99% of the participants and were normally distributed in the sample, with even distribution among different hearing loss categories . Moreover, 4% of female and 9% of male participants scored <−1 SD from the mean, and 0.3%  and 1.7%  scored < −1.5 SD from the mean, which are commonly used criteria for possible mild cognitive impairment. Hearing loss in the better hearing ear was present in 25% of the sample, of which 20% had mild degree (PTA4 = 21–40 dB HL) and 5% had moderate degree (PTA4 = 41–60 dB HL). Only two participants had severe degree (>60 dB HL). Furthermore, 31% of the sample reported having tinnitus, and 13% reported using hearing aids . A strong correlation was also found between the self-reported hearing index and the PTA4 in the better hearing ear , whereas a moderate correlation was found between the hearing index and the SPRIN score .Detailed descriptive characteristics of all hearing and cognitive variables are available in the online supplementary Material . In additional analyses, model 2 (using SPRIN as the main explanatory variable) was adjusted for PTA4, but this did not alter the regression coefficient for SPRIN. When adding all three hearing measures simultaneously in a model (not in any table), only SPRIN remained a significant predictor . Due to possible issues with collinearity, these models are not presented in any table.Significant associations were found between the objective hearing measures − PTA4  and SPRIN  − and global cognitive function, adjusting for sex, educational attainment, hypertension, cardiovascular disease, and tinnitus (see Table p = 0.043). Reporting tinnitus was not associated with global cognitive function in the bivariate analysis  and only weakly in models that included PTA4 and self-reported hearing loss. Being female was associated with higher global cognitive function , an effect which remained in the models with PTA4 and self-reported hearing loss as main explanatory variables, but interestingly not in the model that included SPRIN  were significantly associated with worse scores in all cognitive domains , except for visual memory in the case of PTA4, and visual and working memory in the case of SPRIN Table . The strIn this population-based sample of 70-year-old individuals free from dementia, poorer hearing function was independently associated with worse global and domain-specific cognitive function, in line with previous research , 31. FurContrary to our findings, self-reported hearing loss − assessed with a variety of different questions  − has been shown to correlate with cognitive function in previous research  and has model 2 in Table Moreover, in a meta-analysis  of experWhether or not hearing aid use can mitigate the effect of hearing loss on cognitive performance, and progression of cognitive decline, is an essential question that has been addressed in numerous studies with mixed results , 19, 37.n = 2, 0.18%) and none with profound hearing loss in the sample, which may be an effect of improved hearing status in this birth cohort in comparison to previous generations [The design of the Gothenburg H70 Birth Cohort Study offers unique opportunities to study multiple aspects of health and its determinants in age-homogeneous samples of older people, allowing for comprehensive descriptions of the relationship between various age-related health entities at specific stages in the aging process. Using age-homogeneous samples has been shown to be an advantage in cross-sectional analyses, since age-related variables may appear more correlated than they truly are when samples contain mixed ages . Here, werations . Second,erations . HoweverMoreover, in the endeavor of achieving representativeness, the sample and subsample studied in the present study included persons who did not have Swedish as their first language. There is a possibility that this may have affected the results, both in terms of speech-in-noise performance and in the more verbally loaded cognitive tasks. Additionally, considering the effect of the visual status of the participants could have enhanced the conclusions on how sensory and cognitive functions interact. Finally, the present analysis was cross-sectional and it is not possible to assess the direction of the relationship between hearing and cognition. Although there is evidence to support that hearing loss precedes cognitive decline, it is certainly possible that poor cognitive abilities lead to worse hearing outcomes as well.In all, these results highlight the importance of considering hearing loss as a risk factor of cognitive impairment, as recognized in the Lancet report by Livingston et al. . In spitObjectively assessed hearing function, using pure-tone audiometry and SPRIN testing, is independently associated with global and domain-specific cognitive function in early old age. Self-reported hearing loss, on the other hand, may be too insensitive a measure to study the relationship. Hearing aid users had better cognitive scores among persons with mild hearing loss. However, more research is needed to study the role of hearing aid use in relation to age-related cognitive declines.Written informed consent was obtained from all participants or their relatives. The Regional Ethical Review Board in Gothenburg reviewed and approved the study protocols of the main investigation (reg. no. 869-13) and the substudy (reg. no. 976-13).The authors have no conflicts of interest to declare.This study was supported by grants from Rune och Ulla Amlövs Stiftelse (2016-105), Felix Neuberghs Stiftelse (2020-0218), Foundation Agneta Prytz-Folke and Gösta Folke (2013-0613), Region Västra Götaland (2014-0601), The Swedish Research Council , Swedish Research Council for Health, Working Life and Welfare , the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (ALF 716681), Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse, Swedish Alzheimer Foundation, Hjärnfonden, Eivind och Elsa K:son Sylvans Stiftelse, Stiftelsen Söderström-Königska Sjukhemmet, Stiftelsen för Gamla Tjänarinnor, Handlanden Hjalmar Svenssons Forskningsfond, and Stiftelsen Professor Bror Gadelius Minnesfond. None of the funding sources had any role or input into the design and conduct of the study or approval of the manuscript.Maria Hoff and Johan Skoog conceived the design and analyzed the data. Maria Hoff performed the literature review and wrote the first draft of the article. Maria Hoff, Tomas Tengstrand, Johan Skoog, and Timothy Hadarsson Bodin collected the data. Ulf Rosenhall, Ingmar Skoog, and André Sadeghi contributed to the design, analysis, and interpretation of findings, and supervised the research project. All authors revised the first draft and approved the final version of the manuscript.All data generated or analyzed during this study are included in this article and/or its supplementary material files. Further inquiries can be directed to the corresponding author (M.H.).Supplementary dataClick here for additional data file.Supplementary dataClick here for additional data file.


Background: With the removal of many barriers to direct-to-consumer telehealth during the COVID-19 pandemic, which resulted in a historic surge in the adoption of telehealth into ongoing practice, health systems must now identify the most efficient and effective way to sustain these visits. The Medical University of South Carolina Center for Telehealth developed a Telehealth Centralized Support team as part of a strategy to mature the support infrastructure for the continued large-scale use of outpatient virtual care. The team was deployed as the Center for Telehealth rolled out a new ambulatory telehealth software platform to monitor clinical activity, support patient registration and virtual rooming, and ensure successful visit completion. Methods: A multi-method, program-evaluation approach was used to describe the development and composition of the Telehealth Centralized Support Team in its first 18 months utilizing the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. Results: In the first 18 months of the Telehealth Centralized Support team, over 75,000 visits were scheduled, with over 1500 providers serving over 46,000 unique patients. The team was successfully deployed over a large part of the clinical enterprise and has been well received across the health system. It has proven to be a scalable model to support enterprise-level virtual health care delivery. Conclusions: While further research is needed to evaluate the long-term program outcomes, the results of its early implementation suggest great promise for improved telehealth patient and provider satisfaction, the more equitable delivery of virtual services, and more cost-effective means for supporting virtual care. The COVID-19 pandemic brought the removal of many barriers to direct-to-consumer telehealth, resulting in a historic surge in telehealth adoption. While volumes have declined since the early months of the pandemic, health systems continue to provide a significant percentage of care virtually. According to FAIRHealth, rates of telehealth have remained stable, around 5% of all claims throughout 2021 and 2022, which is significantly greater than pre-pandemic levels  1,2,3]..3]. ThesWith telehealth here to stay, healthcare organizations are now faced with numerous challenges as they develop care delivery models to support long term telehealth activity. First, although telehealth has the potential to expand access with fewer practice expenses , the worSeveral institutions have explored creative solutions to address these challenges. These have included volunteer medical students helping patients with low technology literacy prepare for telehealth visits ; recruitCentralized pools of virtual staff supporting enterprise-wide outpatient telehealth may prove to be a solution to this challenge. In late 2021, the Center for Telehealth (Center) at the Medical University of South Carolina (MUSC) developed a Telehealth Centralized Support (TCS) team. The team was deployed as MUSC rolled out a new ambulatory telehealth software platform to monitor clinical activity, support patient registration and virtual rooming, and ensure successful visit completion. Using a multi-method program-evaluation approach, this report shares early findings from the 18 months of operations including the roles and responsibilities of TCS team members, staffing ratios, communication procedures, and evolving workflows. The goal is to disseminate a promising model for health systems to support large volumes of telehealth more efficiently and equitably.The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework was used to evaluate and describe the development and composition of TCS in its first 18 months . RE-AIM We used a multi-method approach, with data sources including both qualitative and quantitative data. The project was submitted to the Quality Improvement Program Evaluation Self-Certification Tool sponsored by MUSC’s Institutional Review Board (IRB) ; the proThe TCS is housed within the Health System’s Center for Telehealth. The Center for Telehealth has over 15 years of experience providing telehealth, offering over 100 unique telehealth services to over 280 sites across South Carolina. Care settings include over 45 hospitals, over 90 schools, and over 100 community clinics and other facilities. The TCS team was developed in response to pressing patient and provider needs that resulted from the rapid expansion of direct-to-patient telehealth video visits across ambulatory specialties during the pandemic. Like in-person patients, telehealth patients still require standard registration and medication reconciliation typically handled by frontline staff. Additionally, they face the added challenge of needing to navigate the telehealth platform on their personal device to begin visits. Prior to TCS, each department handled virtual patient registration differently, sometimes utilizing existing registration staff but often relying on the provider themselves to educate and problem solve with a patient, resulting in an inconsistent and inefficient process for patients and providers alike.The virtual TCS team includes an interprofessional team of Certified Medical Assistants, Licensed Practical Nurses, and is overseen by a TCS manager at the Center. The primary goal of the TCS team is to ensure the success of patients and clinicians using telehealth for outpatient visits and to serve as a virtual clinical support to the provider. The current team’s structure that is outlined below is an optimization and maturation of the original, smaller-scale team, which included two individuals who started each day with a morning huddle and often turned to an “all-hands-on-deck” approach as described by a TCS team member to meet the needs of the patients and providers.The roles of the TCS staff were established to support patient clinical intake following standard enterprise protocols, patient education, and technical support. For clinics engaged with the TCS model, the TCS team provides at least one audio call to each telehealth patient up to one business day prior to the patient’s telehealth visit. The purpose of the audio call is to complete the pre-visit required intake and to communicate what the patient can expect to experience from the video platform. The pre-visit required intake, which varies by specialty, can include medication reconciliation, questionnaires, and patient-reported vital signs . The TCS team members make three attempts to reach each patient. If the TCS team member cannot reach the patient, they note this in the patient’s chart in the electronic medical record (EMR) so that the provider can decide if they would like to see the patient or if the visit must be rescheduled. Additionally, the TCS team provides support during each visit by troubleshooting technology as needed based on patient and provider needs.A full description of each of the roles and team responsibilities are outlined in The front-line work of TCS is carried out by CMAs, organized into four sub-teams defined by clinical specialties with oversight from two charge LPNs. The team is led by a TCS Clinical Manager who reports to the Director of Operations and Nursing in the Center. Additional ad hoc, specialized wraparound support is offered by the Center’s Manager of Clinical Development and Implementation, Telehealth Education Coordinator, Virtual Solutions Director, and technical support team as well as the health system’s Quality and Safety Manager. The organizational structure is depicted in In the current state, TCS supports nearly all adult and pediatric primary care and specialty clinics across the MUSC Charleston campus and surrounding clinics. TCS also provides a lighter form of support focused mainly on resolving connection problems to providers affiliated with MUSC Health’s Regional Health Network, a recent expansion of the MUSC Health system to new regions in South Carolina. One current exclusion is for psychiatry which does not participate due to its large volume of virtual visits relative to in person visits and robust departmental virtual visit procedures. Additional exceptions include multi-specialty clinics with complex virtual visit workflows. Staffing ratios have fluctuated since the launch of TCS based on the onboarding of new specialties, hiring permanent TCS care team members, and obtaining additional CMA and LPN support through contracting with a staffing agency. The center used a staffing agency to help scale the team quickly while the team waited on the hospital system’s approval of the permanent TCS positions. As the center received approvals to hire TCS team members, the positions were posted, and the center has in turn hired approximately 90% of the TCS team members that were brought on through the staffing agency. The team has grown to 14 team members over the past 18 months, each supporting at least 30–40 visits per day and collectively 400–500 visits daily. Each CMA is responsible for different clinics as explained by one TCS team member, “As we continue to grow and with this last expansion, we did a staffing optimization to where we said we need to separate out into some group that way clinics know who they’re dedicated people are to go to for communication purpose, and we’re making sure that we’re having a smaller set of patients… you know, for each group to concentrate on”.An essential element to the work of TCS are the Microsoft Teams asynchronous chat threads to support communication with the providers and clinical staff, and through the patients via the pre-visit phone calls.Communication between TCS and the clinic staff are organized across the enterprise in over 150 separate asynchronous chat threads via Microsoft Teams. Additionally, a common phone number for clinic staff to call the TCS was established, though the clinic staff use the Microsoft Teams chat function most often. Each clinic has a unique chat thread, typically including participating providers, the lead nurse, and the lead patient registrar as described by a TCS team member “… there are a lot of areas [specialties] that the providers do not want to be a part of the chat. So, we kind of pivoted as we were going to the clinics to do training. We would capture their lead nurse or any lead registration folks or anybody that we knew would be watching the chats to help us communicate with the providers if they’re there in person especially… so it kind of pivoted more… to the clinic level”.Provider use of the TCS communication threads is variable in the current state. In hybrid in-person and telehealth clinics, the providers commonly rely on their local support staff to communicate with the TCS team as described by a TCS team member, “[In] a hybrid setting, [they] have a nurse usually at their elbow that they can grab onto and utilize”. Providers who are not working in the clinic and seeing only telehealth patients on a given day use the chat function regularly as their remote clinical and administrative support as described by a TCS team member “…the providers who have a block [virtual] schedule that work from home use TCS as their clinical staff. They are more…vocal in the chats because they don’t have anyone else to help them”. The most common reason for using the Microsoft Teams asynchronous chat thread is an outreach from the provider when the patient is not in the visit as expected.One current limitation is the inability of the TCS team to route the patient for rescheduling without further provider or clinic office staff engagement. A second challenge of the chat function is that the amount of chat traffic occurring in a single thread can be distracting, particularly for providers with infrequent virtual visits. Establishing provider-specific chat capabilities for the TCS team has proven challenging due to the volume of participating providers.As noted previously, a major component of patient communication is the pre-visit telephone call TCS conducts with patients to conduct intake paperwork and orient the patient to the video visit. This is typically conducted the day prior to the visit or the morning of for a few clinics.During the visit itself, TCS is regularly monitoring the telehealth technology platform dashboard of patient statuses in the TCS triage workflow to determine whether any additional patient outreach is needed. Sometimes, TCS will contact a patient via audio call if a provider is running late. Most commonly, patient outreach during a visit occurs due to a patient not having arrived to the virtual visit during the scheduled appointment. When this occurs, a TCS team member will contact the patient via an audio call and assist them in connecting to the visit. If the patient is not able to be reached or is unable to connect to the visit, the TCS team member will share with the provider or clinic staff that the visit needs to be rescheduled due to the patient not being available or not being able to make the connection in time. Patient experience data suggested this type support was critical. For example, one patient noted in their post-visit survey, “[the provider] was able to see us but we couldn’t hear so we did it over the phone after several attempts to get it correct”.In the 18 months since the launch of TCS in October of 2021, over 75,000 visits were completed with support from the team and using the new telehealth platform, with over 1500 providers serving over 46,000 unique patients. Of note, providers have had some difficulties moving to the new telehealth platform with patient triage features, as providers have become used to sending links from unintegrated solutions and relaxed oversight on compliance requirements set forth at the beginning of the COVID-19 pandemic. However, virtual visits supported by TCS have lower rates of visit loss , as compared to virtual visits not receiving support from the TCS team, as seen in To maintain high quality care in a post-pandemic world of elevated virtual care use, forward-leaning health systems must provide cost-efficient support infrastructure for virtual visits. While digital automations and patient self-directed portal use have the potential to improve virtual visit experience, innovations in the use of human workforce remain essential components of virtual care growth strategies. The TCS staffing approach has been successfully deployed over a large part of the MUSC clinical enterprise within the 18 months of operations. TCS has been well received across the health system and has become increasingly relied upon during this transition period of technology and workflow conversions related to the expiration of the Public Health Emergency.The TCS model exemplifies the broader move in healthcare toward “systemness”, i.e., efforts made toward streamlining workflows, creating a more consistent patient experience, and leveraging centralized resources across multiple and varied departments within a health system ,28. SuchImportantly, investment in virtual visit support models, like TCS, can help mitigate the telehealth equity concerns raised during the pandemic. Dedicated telehealth support staff and flexible telehealth workflows that can adapt to patient needs have both been identified as components that can support health equity in telehealth . Others Although successful, opportunities for improvement are considerable in the areas of communication, staffing, workflow, and technology. Currently, providers and clinic staff receive messages that they do not need through the asynchronous chat. The team is exploring opportunities for more focused communication so that providers only receive messages that are directed to them. Additionally, contract workers were initially used to build out the TCS team; however, hiring team members onto the TCS team permanently has supported retention and decreased re-training effort needs. In the area of workflow specifically, the process for re-scheduling patient appointments for those unable to connect has been identified as a challenge, as the TCS team does not have scheduling rights in the EMR. This is intentional as the center aims to ensure the TCS roles and responsibilities remain focused. Plans are underway to identify a more streamlined approach to inform clinics when a patient needs to be rescheduled.In the area of technology, patient portal use, telehealth platform automations, and targeted digital literacy risk scoring are ongoing initiatives that have not yet been launched during the 18 months of operations. Having established a core workforce and set of procedures to support high-volume video visit use, we hope to deploy predictive analytics on digital literacy to further gain workforce efficiencies and develop additional interventions to further reduce digital care disparities. Another opportunity is increased coordination with other automations across the MUSC system to avoid messaging fatigue to the patient, as one TCS member put it: “TCS as a whole is greatly appreciated by the patients. The barrage of communication from MUSC is not”. Finally, additional layered technological interventions on our roadmap include leveraging medical record data and artificial intelligence to customize visit experiences as well as combining technology and human interventions in the post-visit space to help patients navigate their post-care follow-up and prescribed care pathways.In summary, challenges associated with communication between TCS, the providers, and patients are present due to the complexity of a core team messaging with many disparate clinical service lines. Workflow adjustments and automations remain a consistent focus for quality improvement. Additionally, while technical difficulties are mitigated with the dedicated support, they remain a significant challenge and ongoing demand that limits the expansion of duties for the support team. Conversely, planned platform enhancements, enhanced digital literacy risk assessments and other innovations may benefit in their deployment due to the experience of the centralized team. An additional area of opportunity for improvement is the post-visit portion of the workflow, for which care coordination and patient messaging optimizations are needed.This project has several limitations. First, we are only able to assess the first year and a half of data and are unable to assess the long-term program outcomes currently. However, as many health systems are struggling with these issues, there are valuable lessons learned from both this model and its implementation. Second, this is an examination of one health system’s program. The results and processes may not be fully generalizable to other settings and regions, but other systems may adapt our workflows to meet their individual needs.Future areas of research will focus on the cost savings of TCS staffing as compared to both previous departmental support for telehealth and more traditional in-person support staffing. Additionally, we intend to examine the accuracy of digital risk scoring in predicting patient support needs and the impact of the TCS model on patient and provider satisfaction.Finally, despite opportunities for continued improvement on workflow automations, communication methods, technology enhancements, and provider education, TCS is largely seen as a success among the MUSC enterprise due to its ability to support enterprise-level virtual health more efficiently. While further research is needed to fully evaluate the TCS model, the results of its early implementation suggest great promise for improved telehealth patient and provider satisfaction, more equitable delivery of virtual services, and more cost-effective means for supporting virtual care.


Borrelia burgdorferi sensu stricto, is a major lipoprotein surface-expressed during early-phase human infections. Antibodies to OspC are used in serological diagnoses. This study explored the hypothesis that serological test sensitivity decreases as genetic similarity of ospC major groups (MGs) of infecting strains, and ospC A (the MG in the strain B31 used to prepare antigen for serodiagnosis assays) decreases. We used a previously published microarray dataset to compare serological reactivity to ospC A (measured as pixel intensity) versus reactivity to 22 other ospC MGs, within a population of 55 patients diagnosed by two-tier serological testing using B. burgdorferi s.s. strain B31 as antigen, in which the ospC MG is OspC A. The difference in reactivity of sera to ospC A and reactivity to each of the other 22 ospC MGs (termed ‘reactivity difference’) was the outcome variable in regression analysis in which genetic distance of the ospC MGs from ospC A was the explanatory variable. Genetic distance was computed for the whole ospC sequence, and 9 subsections, from Neighbour Joining phylogenetic trees of the 23 ospC MGs. Regression analysis was conducted using genetic distance for the full ospC sequence, and the subsections individually. There was a significant association between the reactivity difference and genetic distance of ospC MGs from ospC A: increased genetic distance reduced reactivity to OspC A. No single ospC subsection sequence fully explained the relationship between genetic distance and reactivity difference. An analysis of single nucleotide polymorphisms supported a biological explanation via specific amino acid modifications likely to change protein binding affinity. This adds support to the hypothesis that genetic diversity of B. burgdorferi s.s.  may impact serological diagnostic test performance. Further prospective studies are necessary to explore the clinical implications of these findings.The outer surface protein C (OspC) of the agent of Lyme disease,  Results of a WB for IgM antibodies are used for diagnosis in early infection and results of a WB for IgG antibodies are used during the later stages of the disease [Borrelia burgdorferi sensu stricto is a diverse bacterium [Until recently, a two-tier testing approach, combining an initial enzyme-immuno assay (EIA) followed by a Western immunoblot (WB) has been recommended for serological diagnosis of Lyme disease in North America . If the  disease . For bot disease , 3. Howe disease . With lo disease ) 60% to  disease , and eli disease . Most re disease  and Healacterium  and its acterium . If so, B. burgdorferi infection of mammals [B. burgdorferi s.s. in North America [https://pubmlst.org/). Nevertheless, strain typing by ospC MGs has robust associations with typing by MLST and whole genomes, and these taxonomic groupings may be associated with ecological drivers of selection including reservoir host associations [B. burgdorferi there is limited cross-immunity following infection with different strains when strain typing is based on ospC MGs [OspC is a protein essential for the early stages of  mammals , and is  mammals . OspC se America . Strain ciations , 15, 16.ospC MGs , 18, andospC MGs , 20.B. burgdorferi on serological assays using an in-depth look at the diversity of OspC and, from a previous study, possible impacts on WB signals. In particular we explore if antibodies raised against an infecting strain bind with lower affinity to the OspC A of the B31 strain used as antigen in the WB [Here we explore the possible effects of genetic diversity of n the WB ; the genn the WB .We explored the genetic distance of the different ospC sequences of 82 whole genomes from North America, from ospC A of the B31 strain. Using the combined ospC sequence data and WB band intensity data in  we testeIxodes scapularis) collected by drag sampling in three Canadian regions: southeastern Manitoba, northwestern Ontario and Nova Scotia [https://www.ncbi.nlm.nih.gov/) through the BioProject accession number: PRJNA416494. Additional strains download from Genbank were PAli (NZ_CP019845.1), PAbe (NZ_CP019917.1), MM1 (NZ_CP031398.1), 297 (NC_018983.1), B31 (NC_001903.1), 118a (NC_012261.1), 156a (NC_011853.1), 29805 (NC_012513.1), 72a (NC_011974.1), 94a (NC_012263.1), Bol26 (NC_012512.1), CA-11-2A (NC_012157.1), JD1 (NC_017395.1), N40 (NC_017401.1), WI91-23 (NC_012151.1), ZS7 (NC_011724.1), B331 (NZ_CP017202.1) and B31_NRZ (NZ_CP019755.1).Of the strains used in this study for phylogenetic analysis, 64 were isolated from host-seeking ticks , which ribed in  in an inTo explore the relatedness of ospC sequences that may underly differences in reactivity of sera, a number of phylogenetic analyses were conducted. First, a Bayesian maximum likelihood (ML) phylogenetic tree was built using 64 sequences published in a previous study  and 113 Second, the nucleotide sequences of the 23 ospC MGs used by . Third, https://www.r-project.org/) [For the 22 ospC MGs in the array of , the genct.org/) . Most inct.org/) . The mulct.org/) , 28 undeThe outcome variable was the difference in reactivity to ospC A and reactivity to the other 22 ospC MGs (termed reactivity difference). The null hypothesis is that any variations in reactivity difference would be random, and unrelated to the genetic distance between an ospC MG and ospC A. The alternative hypothesis is that the reactivity difference increases with genetic distance, suggesting that the sensitivity of the serological test decreases/increases  with the genetic distance of infecting strains from the B31 strain. Therefore, if the null hypothesis is rejected, then the associations between genetic distance  and reactivity difference would signal a possible impact of genetic diversity on serological test sensitivity, at least in terms of responses to OspC.To test these hypotheses, regression models were developed in Stata V15.1 . Differehttps://www.geneious.com/). The multiple nucleotide sequences and protein sequence alignments of the 23 ospC MGs were obtained using MAFFT v7.450 [The importance of ospC diversity for immune responses is well known . HoweverT v7.450 , 28 provThe global phylogenetic tree of the ospC MGs using 177 nucleotide sequences of 47 ospC MGs revealed that the 23 ospC MGs used by [However, when restricting phylogenetic analysis of the 23 ospC MGs using only the sequences of the N-terminus and the highly conserved region of the C-terminus , the analysis showed 9 phylogenetic groups for the first subsection  and 3 phThe α2L4 fragment is highly diverse showing 22 different genotypes where 5 ospC MGs form 2 clear clades corresponding to 2 phylogenetic groups, and 17 others  were gathered in the same phylogenetic group .The α3L5 fragment is also highly diverse with 22 different genotypes which were clustered into 6 clear clades corresponding to 6 phylogenetic groups .The α4L6 and α5 helices form, respectively, 8 and 7 phylogenetic groups Figs  and 7A.The two β-strands connected by loops L1, L2, L3 (L1β1L2β2L3) created 6 phylogenetic groups forming distinct clades .When investigating the relationship between the reactivity difference and the genetic distance of ospC A to the other 22 ospC MGs by linear regression, using the whole sequence length, there was a significant negative relationship   . Except For the N-terminus, there was a significant positive linear relationship with the reactivity difference but this relationship was complex , with quFor the C-terminus and pepC10 fragments, here was a significant quadratic relationship between genetic distance and reactivity difference  there were 10 SNPs Fig 1 in  includinB. burgdorferi, and it’s expression is required to establish infection in a mammalian host after a tick bite [B. burgdorferi to escape the host immune system [The outer surface protein C is a major virulence factor of ick bite , 37. Theick bite , 39. Accick bite  may be oe system . This ine system . Therefoe system  to exploe system , the higB. burgdorferi strains carrying different ospC MGs naturally co-infecting the same host displayed immunological distinctness, which means that in natural infections, the host immune system react differently to different ospC MGs. However, by an in-depth investigation of the relationship between local nucleotide sequence identity and antibody response intensity, it appears that this relationship is more complex for the subsection sequences mostly used to design epitopes targeted during the two-step EIA and the EIA-WB two-tier diagnostic tests  [We demonstrated in this in-silico study that there is a significant association between the genetic diversity of the ospC gene and the difference in immunoreactivity to OspC A and to other OspC MG proteins within an infected population who had been diagnosed using serological assays that employed OspC A as antigen; i.e. the null hypothesis of statistical models was rejected. This result is consistent with Di and colleagues , which r region) . These r region) , 44, sup region)  demonstr region) , 46, 47  region)  indicate region) , we inve region) .B. burgdorferi. Indeed, in trees constructed for the three subsections L1β1L2β2L3, α3L5 and α5, the B, E, F and K ospC MGs occur within the most distant clades to ospC A, and perhaps including MGs from these clades could be considered in the development of serodiagnosis using OspC antigen. Di and colleagues [Investigating regions of the OspC protein other than the extremities allowed identification of three zones significantly and linearly associated with the decrease of the intensity signal of the antibody response of OspC: the α-helices, 3 (connected by the loop 5) and 5, and the 2 β-strands . The α-helix 3, with helix 4, forms a lattice zone on the protein surface which might be involved in protein-protein or protein-ligand binding  allowinglleagues  proposedlleagues  and geneThe investigation of single nucleotide polymorphisms (SNPs) in this study identified nine substitutions and one deletion within three fragments showing a linear relationship between genetic distance and reactivity difference. This supports the idea that exploring phylogeny of the ospC MGs (by genetic distance and clade structure) is meaningful in terms of amino acid changes that can cause conformational modifications in the protein structure or physicochemical alterations that could affect antibody binding in vitro and in vivo . For exaB. burgdorferi, and genetic distance from the antigen used in diagnostic kits, can play in the serodiagnosis of Lyme disease when this is based on the OspC antigen. However, this observation needs to be confirmed using experimental studies. Further prospective investigations are needed to investigate strain-diversity-related factors that affect antibody binding of ospC MGs, and any consequent impacts on performance of serodiagnostic assays for Lyme disease.The deletion in the β-strand 1 at position 85 resulting in removal of an asparagine amino acid recontributing to the distinction of three clades  from clade 1 of ospC A within the L1β1L2β2L3 fragment. Asparagine residues are often found in protein structural subsections and can participate in hydrogen bonding interactions that help stabilize the protein’s secondary structure, including β-strands . The remS1 File(DOCX)Click here for additional data file.


Head position at any point in time plays a fundamental role in shaping the auditory information that reaches a listener, information that continuously changes as the head moves and reorients to different listening situations. The connection between hearing science and the kinesthetics of head movement has gained interest due to technological advances that have increased the feasibility of providing behavioral and biological feedback to assistive listening devices that can interpret movement patterns that reflect listening intent. Increasing evidence also shows that the negative impact of hearing deficits on mobility, gait, and balance may be mitigated by prosthetic hearing device intervention. Better understanding of the relationships between head movement, full body kinetics, and hearing health, should lead to improved signal processing strategies across a range of assistive and augmented hearing devices. The purpose of this review is to introduce the wider hearing community to the kinesiology of head movement and to place it in the context of hearing and communication with the goal of expanding the field of ecologically-specific listener behavior. Hearing aids and other assistive listening devices are on the cusp of major innovative leaps due to technical advances in machine learning, power sources, microchip miniaturization, increased capacity for online signal processing, and translational advances in the fields of auditory and cognitive neuroscience. Prosthetic hearing devices, are also uniquely positioned to capture key kinesthetic information due to their location on the head, providing great potential for capturing user intention based on head-movement as a listener interacts with the acoustic environment. Current hearing aid technologies typically rely on acoustic cues alone to determine which sound-features to amplify and which to suppress or modify . This apIn recent years, more attention has been paid toward individual variability in auditory perceptual abilities with the expectation that tailored approaches resulting from “precision audiology” will improve hearing health outcomes . From thWith the inclusion of inertial sensors  in modern premium hearing aids, the devices are now capable of monitoring not just the acoustic environment but also the physical interaction of the listener with that environment . ImportaStudies of body language usually fall within the scope of fields such as social psychology, while investigations of the mechanical nature of head and body movements are common in the fields of kinesiology, physical therapy, occupational therapy, and exercise science. In an effort to combine information learned from across these disciplines to advance hearing enhancement technology, we review the relevant literature in the hopes that providing a resource that touches on a wide range of relevant head movement and balance literature will provide context, and promote advancement and communication between research, clinical practice, and the hearing device industry. This review is organized into five main focal areas: (1) the fundamental physics of head movement, (2) head movement during active listening (3) head movement during communication, (4) head-body interactions, and (5) the prospects of device intervention to benefit hearing and balance outcomes.Many methodologies have been used over the years to study head movement, some with remarkable ingenuity e.g., . A full To understand the connection between head kinematics and acoustic cues used in hearing, it is important to begin with the physical properties of the human head. The human head weighs up to 5.5 kg (12 lb) and has a circumference of approximately 60 cm (24 in), with average weight and circumference depending on age, height, and sex . Head siHead size also dictates the location of the center of mass . The FraIn addition to the standard axes of translation: x , y (left to right), and z , there are three axes of rotation, each associated with one of the standard dimensions. The yaw axis rotates along the z-dimension  characteyaw axis of rotation, is around ±80° with the majority of maximal ranges reported between ±60° and ±80°  is −90° and executing an extension motion (moving head to back) is +101°  the initial movement, described by high velocity and imprecise change in position toward a target position; and (2) the final movement, which is slower, but more precise than the initial movement  rotating around a point such as the center of mass ; howeverheard, but only some are listened to. To expressly measure active listening, research paradigms typically require an explicit participant-response to measure their perception, such as repeating back a word in noise or selecting between options in a discrimination task. A distinction can be drawn however, between measures of perception that are intuitive to put into words such as repeating back a sentence, vs. absolute measures or quality of a sound, such as of the speed of a sound-source or the distance or physical shape of an auditory object. In nearly all naturally occurring environments there exist a variety of sound sources. Some of these sound sources are important while others can be safely ignored. Nevertheless, all sounds are transduced and refined to some degree at the auditory periphery, beyond which the central auditory processing system determines which sound sources require active attention . In otheThe ability to localize sound requires complex integration of interaural differences in time (ITD) and sound level (ILD) in combination with spectral cues specific to the individuals’ head-related transfer function (HRTF). Age-related hearing-loss followed by the introduction of hearing devices, fundamentally disrupts these spatial cues and the head-movement strategies the central auditory system relies upon for sound localization and auditory stream segregation .In the vast majority of sound-booth or anechoic chamber sound-localization testing paradigms, participants begin with their head fixed at 0° azimuth and indicate their perception of sound location following stimulus presentation . ParticiWhen instructed to orient their head to a sound source, similar patterns of movement were observed for both normal-hearing listeners and those with hearing-loss, but with different degrees of localization accuracy. In listening environments with a target-talker and masker-talker at a different azimuth, studies show that rather than pointing the head directly at the target-talker, the most beneficial head orientation is midway between the target and masker . For larOne general conclusion from surveying the head movement literature, is that in experimental settings, unprompted listener head movement is heavily influenced by the context of the experiment and the directions provided by the experimenter. When listeners were explicitly instructed to explore their listening environment or if a visual representation of the talkers’ face was presented, head movement increased and performance on the speech in noise task significantly improved . Grange In many listening environments, the presence of inanimate objects such as walls and objects create reflections and echoes. Listeners rely on these cues to create an internal acoustic-representation of their environment and configuration of objects relative to their physical location . OutsideWhen asked to judge the distance of a sound, a dichotomy in perception is observed as near-sounds tend to be overestimated and far-sounds underestimated, with a transition point related to room characteristics . The cueIn a study of distance perception that investigated the effects of training with various reaching strategies, and touches on the discussion above concerning subject-response paradigms, Echolocation, though typically associated with blind individuals and extreme examples in the animal kingdom, is a localization ability well documented in sighted, relatively untrained human listeners as well . In its Performance of echolocators improves with concurrent movement of the head and body. Early research showed that blind as well as sighted (blindfolded) individuals were both able to walk down a hallway and accurately stop before encountering a flat reflective surface . RosenblAdditional factors that influence echolocation include distance to and orientation of reflective objects , the freIn a complex acoustic scene, detection of and orientation to novel or relevant sound sources often requires multiple systems working in concert, including peripheral auditory processing , central auditory processing , and fine-motor processing . The timing of behavioral responses  to new sounds therefore, can shed light on normally functioning or impaired functioning of these systems, and changes to the temporal course of behavior as a result of intervention may provide evidence of successful treatment options.Numerous studies have shown that hearing deficits lead to slower and less accurate sound localization, as measured by head movements to source locations and ability to identify the speaker . For exaHead movements in communication settings comprise a variety of head movement patterns with a correspondingly wide range of culturally specific meaning and interpretation. For most western cultures, the most common communicative head movements are “nods” and “shaking,” both of which involve oscillations along the rotational axes , though “Turn” and “tilt” head movements are also described with similar frequency of occurrence in communication environments, with each motion leading to a different pattern of movement around the pitch, yaw, and roll axes of rotations. Together, all of these movements affect the nature of the sound received by the ear in a manner that depends on the axis upon which the head is rotating and the frequency of the head movement . For exaEach of these movements has the potential to convey meaning on their own or in combination with vocalization . Over thHead movement between conversational partners has also been shown to provide nuance to observers. For example, observers were able to identify whether interactions were between friends or strangers with a higher success rate when presented head and face movements compared to body movement, indicating that head movement communicates familiarity between talkers . ObserveWhile listening to speech stimuli, individuals generally orient their head in azimuth to the direction of the target, but often with a systematic offset between head angle and location of the talker. Movements in the yaw domain have a linear relationship to target angle or talker, quantified by a slope of approximately 0.6, representing a consistent “undershoot” of head turns . In multMovement along the yaw axis is prominently involved in active listening strategies and non-verbal communication. There are two very similar types of movements, one described as an orienting, non-cyclical head-turn along the yaw-axis of rotation, with slight movement on the roll axis . The othHead shaking has a similar potential for increasing spatial information and serves as a means of non-verbal communication. The nuances that carry specific meaning in head movements can be difficult to study due to challenges in systematically defining and annotating specific behaviors across multiple observers . AvailabMovement along the pitch axis of rotation can take the form of a single downward (flexion) or upward motion (extension) made in the context of several activities, but in the field of active attention is naturally suited to surveying the external environment along the vertical dimension. Periodic pitch movements are often characterized as a “nod” in the context of communication. This motion is defined as repeated sinusoidal oscillations along the pitch axis combined with little movement along yaw and roll axes . Nods nanot observed at low frequencies for yaw and roll  plane  plane , indepenw) plane . When low) plane . These rw) plane .During a loss of balance, an individual must correct their head orientation by making a corrective movement in the form of a step to regain balance, thus allowing the individual to reorient their posture and regain their balance. The ability of a person to regain balance depends, in part, on the time it takes to step and the velocity of the head . Head veTo discuss the relationship between standing balance and hearing, a brief background on theories of standing balance is helpful. Current understanding is that the postural stability needed for balance involves integration of multiple sensory  and proprioceptive modalities that work in tandem with the motor system in a feedback and feedforward relationship. Experiments examining the relative contributions of different sensory systems indicate a weighted distribution that shifts as available sensory information changes . For exaStudies have also demonstrated the use of auditory cues in the environment to reduce sway . Easton It must be noted that in addition to studies that did not show an effect of auditory stimuli to reduce sway  a numberAs individuals age, sensory and proprioceptive systems begin to decline and their utility for providing feedback to the motor system is compromised. In order to maintain competency in daily life individuals compensate via reallocation of cognitive resources , often mDuring activities that involve full body movement such as gait, the head is used for balance. Normal gait in this context refers to the gait of non-pathological, healthy adults at an average walking speed. In steady state, or controlled balanced walking, a person requires coordinated control of the trunk movements and neck muscles to maintain the head’s center of mass . The heaAdditionally, during gait the head moves in repeated side-to-side and front-to-back oscillations . These hThe gait cycle is divided into different stages, based upon the location of the person’s feet and body. Each stage focuses on the path of motion of one leg since the other leg will mirror the movement . As illuDuring the gait cycle, there are two cycles of head acceleration corresponding to the movements of the left and right foot. These cycles of acceleration correspond to the moment the foot contacts the floor and the upward swing upon the foots’ release. Thus, head movement during the gait cycle can be divided into the contact phase of the foot and the foot release . The effN > 1,000), gait speed was significantly slower in individuals with hearing loss, characterized by an estimate that a 25 dB shift in hearing loss was equivalent to approximately 12 additional years of age  for spatially separated targets . In low-In general, the strongest directional effect in modern hearing aids can be found directly in front of the listener due to more aggressive microphone strategies at the front. However, studies have shown that the angle of greatest “head-turn advantage” for most people is 30° , with thUnderstanding how the head is involved in stabilization and balance is important for anticipating and monitoring falls. Many individuals with hearing-loss over the age of 65 years are also at risk of falls resulting in injury . Thus, iN = 829) and those with greater hearing loss , showed that participants with bilateral caloric areflexia (severe vestibular impairment), had a modified gait cycle including increased stride time and decreased stride length when implant users had their devices turned on or were listening to music through the device, compared to the devices turned off (N = 13) and cochlear implant users (N = 12), with their devices turned on or turned off, and failed to find significant differences between the two conditions. The authors of that study did however note that a subset of individuals exhibited marked improvement in balance metrics with devices on. These studies, and in the context of multiple studies that have shown improved standing balance in the presence of auditory cues, support the hypothesis that some individuals more than others use auditory cues for spatial awareness which can contribute to improved balance, and individuals with that listening profile are most likely to see a benefit with the use of hearing devices.One study with cochlear implant users showed a benefit on postural stability when devices were turn on compared to off , but therned off . ConversTo further understand the utility of those perceptual abilities, studies of balance and hearing aid use is an area where an individualized approach might factor into future clinical decisions. That is, if aids are known to influence balance, either negatively or positively for an individual, knowing the specific factors that contribute to this outcome could be taken into consideration before fitting aids to certain at-risk populations. Finally, whereas hearing aids may provide more natural awareness of the environment and possibly mitigate fall risk, they may also play a critical role in alerting others of falls or warn the user of imminent falls. Current devices have the capability to monitor movements such as step counts, falls, or sudden impacts with the use of inertial sensors . To furtThe above sections have outlined the fundamental kinematics of head movement, relationship to between head movement and active listening and spatial awareness, communication, head-body interactions, and reviewed movement differences for individuals with hearing-loss. As continued investigation builds the knowledge base connecting head movement patterns to optimized hearing strategies, the translation to listening devices will grow. Devices, specifically hearing aids and cochlear implants, situated with bilateral point sources co-located with the ears, are well positioned to provide the necessary biometric feedback. It is realistic to speculate that future devices will have the capacity to register head movement relative to instrument-identified target location, to provide a running computation of degree and direction of alignment or misalignment with target sources that can quickly adapt to the listeners environment. This process will require dynamic signal processing by the device in response to changes in head position, target location, and importantly, the ability to accurately target primary acoustic features. Such devices will also need to operate with a fundamental knowledge of conversational dynamics to determine if body or acoustic changes warrant change to target focus. From a macro-perspective, advances in this direction will require a shift in perspective from current validation measures that focus almost exclusively on tests of speech reception to more varied measures that investigate perception of spatial awareness.All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.This work was partially supported by Sonova Corporation in Stäfa Switzerland, University of South Florida School of Aging Studies, and Auditory and Speech Sciences Laboratory. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.