PURPOSE:Universal newborn hearing screening allows early identification of hearing loss; however, some families face difficulties accessing diagnostic audiology. This study aimed to investigate audiologists' opinions regarding implementing a teleaudiology infant diagnostic audiology service in Victoria, Australia, a region where traditional access barriers persist despite high follow-up rates. METHOD:Nine experienced infant diagnostic audiologists participated in three focus groups. Prompt questions, based on the Capability, Opportunity, Motivation-Behaviour model of behavior change, explored clinician-identified barriers and facilitators to teleaudiology implementation. Thematic analysis was used to analyze audiologists' opinions of the proposed model. RESULTS:Audiologists identified that teleaudiology infant diagnostic services may introduce a barrier trade-off; while teleaudiology had the capacity to reduce barriers to service access for some families, it may introduce additional challenges compared to in-person testing. Three main barriers or areas of concern regarding a teleaudiology model of infant diagnostic services were identified: communication and support concerns, risk of error, and financial and motivational concerns. Participants proposed a training model, where experienced clinicians could support and upskill less experienced audiologists acting as in-person facilitators of the service, to address both service delivery and workforce development needs. CONCLUSIONS:A teleaudiology model of infant diagnostic assessments in Victoria has the potential to improve accessibility if facilitator training, effective family communication, and resource management are prioritized to ensure service quality is not impacted. A proposed training model offers a novel approach to use teleaudiology to maintain service access, as well as improve workforce experience in underserviced areas.

OBJECTIVE:Untreated hearing loss is associated with significant negative physical, psychological, cognitive, and financial sequelae. Hearing aid (HA) take-up and use are low. Current studies have explained limited variance in HA take-up and use. This focus group study used an applied theoretical framework of human behaviour (Theoretical Domains Framework) to investigate barriers and enablers to HA take-up and use by older adults to identify top potentially modifiable barriers and enablers that could be addressed with behavioural interventions. DESIGN:Data on barriers and enablers to HA take-up and use was obtained through online focus groups with older adults with hearing loss. STUDY SAMPLES:Participants were 19 adult HA users and 12 non-users in Australia with diagnosed hearing loss recruited from two rural and one large metropolitan audiology clinic/s. RESULTS:The perceived effectiveness of HAs, the influence of others, the ability to adapt to HAs, the relative importance of hearing loss, and the perceived need for HAs were all identified as both top potentially modifiable barriers and enablers to HA take-up and use. CONCLUSIONS:These top barriers and enablers to HA take-up and use will be addressed through theory-informed behavioural interventions in a further study to improve HA take-up and use.

PURPOSE:Early diagnosis is crucial for infants with hearing loss, but access to specialized services can be challenging for some families. This study piloted a student-facilitated teleaudiology model for infant diagnostics and investigated caregiver opinions of this service in Victoria, Australia. METHOD:Eight families with infants under 6 months old participated in either in-person or teleaudiology appointments, followed by interviews with caregivers to explore their experiences. Thematic analysis was used to analyze interview data. RESULTS:Four main themes emerged: (a) improved accessibility of appointments; (b) effective rapport building and communication, with concerns for supporting challenging scenarios; (c) varying perceptions of facilitator involvement; and (d) level of concern influencing family preferences for appointment type. Caregivers reported positive experiences with teleaudiology, citing improved convenience and reduced travel time as major benefits. However, some expressed concerns about the provision of adequate emotional support in complex cases via telehealth and some impacts of having student facilitators on caregiver confidence in the results. CONCLUSIONS:While a student-facilitated teleaudiology service could improve access to infant diagnostic audiology, family preferences and appointment complexity should be considered when offering this option. Future research should explore the feasibility of this service with a larger sample size. SUPPLEMENTAL MATERIAL:https://doi.org/10.23641/asha.32144953.

Abstract BACKGROUND Though evidence indicates that treating hearing loss with hearing aids (HAs) could reduce dementia risk, the effects on biomarkers of Alzheimer's disease and related dementias (ADRD) remain unknown. METHODS Observational data from Aspirin in Reducing Events in the Elderly (ASPREE) study participants without dementia and with hearing problems were used. We emulated two target trials to estimate the effect of (1) new HA prescription and (2) the frequency of HA use on plasma ADRD biomarkers after 7 years using targeted maximum likelihood estimation, with multiple imputation for missing data. RESULTS There was a median of 2842 individuals (mean 75 years, 48% female) across imputed datasets, and 735 new HA prescriptions. Estimated treatment effects were close to null for phosphorylated tau181, neurofilament light chain, glial fibrillary acidic protein, and amyloid beta 42/40. There was little evidence of effect modification (e.g., by apolipoprotein E ε4 genotype). DISCUSSION In older people with hearing loss, HA prescription and frequency of use had minimal association with levels of ADRD biomarkers.

Background/Objectives: Localization deficit is often said to be a symptom of Auditory Processing Disorder (APD). However, no clinically viable assessment of localization ability has been developed to date. The current study presents pilot data for a new assessment of absolute auditory localization using headphones. Methods: Speech phrases encoded with non-individualized head-related transfer functions (HRTF) using real-time digital processing were presented to two cohorts of participants with normal hearing. Variations in the simulated environment (anechoic and reverberant) and signal to noise ratio (SNR) were made to assess each of these factors’ influences on localization performance. Experiment 1 assessed 30 young adults aged 21–33 years old and Experiment 2 assessed 28 young adults aged 21–29 years old. All participants had hearing thresholds better than 20 dB HL. Results: Participants performed the localization task with a moderate degree of accuracy (Experiment 1: Mean RMS error = 25.9°; Experiment 2: Mean RMS error 27.2°). Front–back errors (FBEs) were evident, contributing to an average RMS error that was notably elevated when compared to similar free-field tasks. There was no statistically significant influence from the simulated environment or SNR on performance. Conclusions: An exploration of test viability in the pediatric and APD-positive populations is warranted alongside further correction for FBEs; however, the potential for future clinical implementation of this measure of absolute auditory localization is encouraging.

Background:Promising evidence indicates that treating hearing loss with hearing aids (HAs) could reduce dementia risk. We extend this evidence by investigating the effect of HAs on plasma biomarkers of Alzheimer's disease and related dementias (ADRD). Methods:We emulated two target trials using observational data from Australian participants of the ASPREE study. Eligible participants had self-reported hearing problems, no past HA use, and were dementia-free. HA prescriptions and frequency of HA use were measured by questionnaire. Phosphorylated-tau181 (pTau181), neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), and amyloid-β (Aβ) 42/40 were measured after approximately 6-8 years. We estimated the effect of new HA prescription (first target trial) and the frequency of HA use (second target trial) using targeted maximum likelihood estimation, with multiple imputation for missing data. Results:Across imputed datasets, a median of 2842 eligible individuals were included (mean age 75 years, 48% female), with a median of 735 receiving a new HA prescription. Among survivors, the estimated mean differences comparing HA prescription and no HA prescription were 1.8 pg/mL (95% CI: -0.6, 4.1), 0.1 pg/mL (-7.8, 8.0), -2.2 pg/mL (-14.5, 10.1), and -0.7 (-2.6, 1.2) for the concentrations of pTau181, NfL, GFAP, and (Aβ42 × 1000)/Aβ40, respectively. Mean differences did not differ substantially across levels of potential baseline effect modifiers, including APOE-ε4 genotype and cognition. Conclusion:In community-dwelling older people with hearing loss and no dementia, we found minimal effects of HA prescription and frequency of HA use on plasma ADRD biomarkers after a 7-year follow-up.

ObjectiveCurrent studies have explained only a small proportion of variance in hearing aid (HA) uptake and use. This novel study applied theoretical frameworks of human behaviour to develop surveys to identify further barriers and enablers that could be addressed with behavioural interventions.DesignData on hearing healthcare decisions/behaviours and/or acceptability of interventions was extracted from an ongoing systematic review of barriers and enablers to uptake and use of hearing interventions conducted by some of the authors. Two surveys, one each for HA users and non-users, were administered primarily online.Study sampleRespondents were 38 adult HA users and 48 non-users in Australia with diagnosed hearing loss recruited across three metropolitan/rural audiology clinics.ResultsSurvey responses yielded 5 barriers and 7 enablers not previously identified. Barriers included other health concerns being more important, and lack of knowledge about HAs and trust in service providers. Enablers included the input of others, and the beliefs that HAs are easy to manage and that HAs would make people feel good about themselves.ConclusionsApplying behavioural frameworks to identify barriers and enablers to hearing aid uptake and use resulted in identification of influences not previously reported. These should be addressed with behavioural interventions.

BackgroundWith an aging population, the prevalence of hearing loss and dementia are increasing rapidly. Hearing loss is currently considered the largest potentially modifiable risk factor for dementia. The effect of hearing interventions on cognitive function should therefore be investigated, as if effective, these may be successfully implemented to modify cognitive outcomes for older adults with hearing loss.MethodsThis prospective longitudinal observational cohort study compared outcomes of a convenience sample of prospectively recruited first-time hearing aid users without dementia from an audiology center with those of community-living older adults participating in a large prospective longitudinal cohort study with/without hearing loss and/or hearing aids. All participants were assessed at baseline, 18 months, and 36 months using the same measures.ResultsParticipants were 160 audiology clinic patients (48.8% female patient; mean age 73.5 years) with mild–severe hearing loss, fitted with hearing aids at baseline, and 102 participants of the Australian Imaging, Biomarkers and Lifestyle Flagship Study of Aging (AIBL) (55.9% female patient; mean age 74.5 years). 18- and 36-month outcomes of subsets of the first participants to reach these points and complete the cognition assessment to date are compared. Primary comparative analysis showed cognitive stability for the hearing aid group while the AIBL group declined on working memory, visual attention, and psychomotor function. There was a non-significant trend for decline in visual learning for the AIBL group versus no decline for the hearing aid group. The hearing aid group showed significant decline on only 1 subtest and at a significantly slower rate than for the AIBL participants (p < 0.05). When education effects on cognitive trajectory were controlled, the HA group still performed significantly better on visual attention and psychomotor function (lower educated participants only) compared to the AIBL group but not on working memory or visual learning. Physical activity had no effect on cognitive performance trajectory.ConclusionHearing aid users demonstrated significantly better cognitive performance to 3 years post-fitting, suggesting that hearing intervention may delay cognitive decline/dementia onset in older adults. Further studies using appropriate measures of cognition, hearing, and device use, with longer follow-up, are required.

Background: Universal newborn hearing screening programs allow for early identification of congenital hearing loss. However, some families experience difficulties accessing diagnostic audiology services following a refer screen result.Methods: This study aimed to assess the opinions of families who had experienced infant diagnostic audiology assessments regarding a telehealth option for these appointments within Victoria, Australia. Families who attended in-person infant diagnostic audiology appointments were sent a questionnaire exploring their experiences of the service and their opinion regarding a proposed telehealth option for infant diagnostic audiology (50 responses received). These results were also compared to those of families who were surveyed following testing in 2020, where the audiologist conducted the appointment remotely to comply with COVID-19-related social distancing recommendations at the time (10 responses received).Results: There were not significant differences between the duration or number of appointments, perceived understanding of results, or concerns regarding a tele-audiology model between families who experienced face-to-face and tele-audiology infant diagnostic audiology appointments. Opinions of infant diagnostic audiology appointments utilizing telehealth technology were largely positive, and minimal technological difficulties were identified.Conclusion: Overall positive attitudes of many families with infant diagnostic appointment experiences toward a tele-audiology option of this service suggest that offering a telehealth model of appointments may be an appropriate model to improve service access for families requiring infant diagnostic audiology in Victoria.

Objective: With our aging population, an increasing number of older adults with hearing loss have cognitive decline. Hearing care practitioners have an important role in supporting healthy aging and should be knowledgeable about cognitive decline and associated management strategies to maximize successful hearing intervention.Methods: A review of current research and expert opinion.Results: This article outlines the association between hearing loss and cognitive decline/dementia, hypothesized mechanisms underlying this, and considers current research into the effects of hearing intervention on cognitive decline. Cognition into old age, cognitive impairment, dementia, and how to recognize cognitive decline that is not part of normal aging are described. Screening of older asymptomatic adults for cognitive decline and practical suggestions for the delivery of person-centered hearing care are discussed. Holistic management goals, personhood, and person-centered care in hearing care management are considered for older adults with normal cognitive aging through to dementia. A case study illustrates important skills and potential management methods. Prevention strategies for managing hearing and cognitive health and function through to older age, and strategies to maximize successful hearing aid use are provided.Conclusion: This article provides evidence-based recommendations for hearing care professionals supporting older clients to maximize well-being through the cognitive trajectory.

Objectives: Hearing loss is highly prevalent in older adults and is independently associated with accelerated cognitive decline. Cochlear implants are usually the only effective treatment for people with severe-profound hearing loss, who have the highest risk of cognitive decline and dementia, however, very few receive them. Current evidence of the effects of cochlear implant use on cognitive decline/dementia outcomes is limited and unclear. This study aimed to investigate the effect of cochlear implant use on longitudinal cognitive performance, as this intervention may be an effective method of modifying cognitive outcomes for older adults with significant hearing loss. Methods: This prospective longitudinal observational study investigated cognitive performance in a convenience sample of older adults (mean age 74 years) with cochlear implants over 4.5 years post-implantation, comparing this with that of community-living adults with untreated hearing loss/normal hearing over 3 years (Australian Imaging, Biomarker and Lifestyle Flagship Study of Ageing; AIBL). All participants were assessed at 18-month intervals from baseline using the same measures. Panel regression was used to compare cognitive trajectories. Results: Cochlear implant users demonstrated significantly improved performance in executive function and working memory, as well as stability in attention, psychomotor function, and visual learning at 4.5-year follow-up. Comparatively, AIBL participants showed significantly greater worsening performance per year in attention and psychomotor function, and stability in working memory and visual learning at 3-year follow-up. Conclusions: Cochlear implant use may delay cognitive decline and/or improve cognitive performance in older adults with severe-profound hearing loss, providing proof-of-concept evidence of the positive effects of hearing intervention on cognitive performance in older adults with hearing loss.

Hearing loss has been identified as the largest potentially modifiable risk factor for dementia and affects 50% adults aged 50-64 years, and 70% aged 70 years and older. The quality of evidence the effect of hearing aid use on cognition in older adults is currently poor due to methodological limitations. Few studies have objectively studied these outcomes beyond 6-12 months. This prospective longitudinal observational cohort study investigated the effects of hearing aid use on cognitive performance in older adults over 3 years. 183 first-time hearing aid users aged 60 years and older with mild to severe hearing loss were assessed using gold standard measures before hearing aid fitting, with subsets of this group re-assessed after 18 and 36 months as they reached these timepoints. Outcomes for the treatment group were compared with those of participants of a large longitudinal cohort study of community-living older adults (AIBL) using the same measures. Objective assessment measures included cognitive function, hearing loss, hearing aid use, genetic phenotyping, and speech perception. Subjective measures included hearing disability, mood, quality of life, social isolation, and loneliness. The treatment group showed good hearing aid compliance, significant improvement in speech perception (quiet and noise) and decreased self-reported listening disability despite further significant hearing loss over the 3-year follow-up. There was significant improvement in cognitive performance from baseline for the treatment group versus the comparative group for working memory, attention, psychomotor function, and visual learning. Comparatively, AIBL participants showed statistically significant decline across all cognitive functions. Older adults with untreated hearing loss are expected to decline cognitively at 2-5 times the rate of adults without hearing loss. Comparatively, cognitive performance in treated participants in this study instead improved after 3 years of hearing aid use, while the comparative group declined. These results suggest that treatment of hearing loss with hearing aids may delay cognitive decline.

Hearing loss is highly prevalent in older adults and has been identified as the largest single potentially modifiable risk factor for dementia. Although hearing aids are a successful treatment for hearing loss, it is unknown whether their use can delay the onset of cognitive decline or improve cognitive function. Less than 20% of adults who would benefit from hearing aids actually using them. Results at 18‐ and 36‐months post‐hearing aid fitting in this prospective Australian longitudinal study will be presented.

BACKGROUND:Hearing loss is independently associated with a faster rate of cognitive decline in older adults and has been identified as a modifiable risk factor for dementia. The mechanism for this association is unknown, and there has been limited exploration of potential casual pathology. OBJECTIVE:Our objective was to investigate whether there was an association between degree of audiometrically measured hearing loss (HL) and brain amyloid-β (Aβ) in a pre-clinical sample. METHODS:Participants of the Australian Imaging and Biomarker Longitudinal Study (AIBL; n = 143) underwent positron emission tomography (PET) imaging and objective measurement of hearing thresholds within 5 years of imaging, as well as cognitive assessment within 2 years of imaging in this observational cohort study. RESULTS:With one exception, study participants who had cognitive assessments within 2 years of their PET imaging (n = 113) were classified as having normal cognition. There was no association between cognitive scores and degree of hearing loss, or between cognitive scores and Aβ load. No association between HL and Aβ load was found once age was controlled for. As previously reported, positive Apolipoprotein E4 (APOE4) carrier status increased the risk of being Aβ positive (p = 0.002). CONCLUSION:Degree of HL was not associated with positive Aβ status.

While there is a growing level of demand for accountability and documentation of services provided to students who are Deaf or Hard of Hearing (DHH), there is a paucity of evidence on the nature of such support; who (personnel), what (content), and how (delivery). This study describes Teacher of the Deaf (ToD) perspectives on current classroom student support practices across a range of contemporary service delivery models in Victoria, Australia. Maximum variation sampling was used to identify 10 Victorian ToDs; each completed a one-hour semi-structured interview, which focused on an interview topic guide associated with typical practice: pathways to teaching; role of the profession; professional development; role in the classroom; goal setting; professional identity; and one open-ended question regarding wishes for the future. Qualitative content analysis generated six categories from these interviews: scope of practice; content of teaching/support; goal setting; service delivery; communication; and accountability. Three recommendations to improve future service delivery for students who are DHH included: standardisation of goal setting/assessment tools; improved shared language between all student support personnel, students and parents; and implementation of agreed rubrics to determine frequency of service with consistent definitions of decision-making criteria for tiered service delivery.

Purpose: To extend our knowledge about factors influencing early vocabulary development for infants with cochlear implants (CIs), we investigated the impact of positive parenting behaviors (PPBs) from the Indicator of Parent Child Interaction, used in parent?child interactions during everyday activities. Method: Implantation age for the sample recruited from CI clinics in Australia ranged from 6 to 10 months for 22 children and from 11 to 21 months for 11 children. Three observation sessions at three monthly intervals were coded for use of PPBs. Children?s productive vocabulary, based on the MacArthur?Bates Communicative Development Inventories parent checklist, was collected approximately 6 and 9 months later. A repeated-measures negative binomial generalized linear mixed-effects model was used to investigate associations between the total PPBs per session, covariates (maternal education, gender, and time since implant), and the number of words produced. In follow-up analyses with the PPBs entered separately, variable selection was used to retain only those deemed informative, based on the Akaike information criterion. Results: As early as Session 1, associations between the PPBs and vocabulary were identified. Time since implant had a positive effect. For different sessions, specific PPBs (descriptive language, follows child?s lead, and acceptance and warmth) were identified as important contributors. Conclusions: Complementing previous findings, valuable information was identified about parenting behaviors that are likely to impact positively the early vocabulary of infants with CIs. Of importance is providing parents with information and training in skills that have the potential to help create optimal contexts for promoting their child?s early vocabulary development.

Purpose The purpose of this study was to explore the effects of hearing, cognition, and personal factors on hearing aid (HA) uptake, use, and benefit. Method Eighty-five older adults aged 60-80 years (M = 70.23, SD = 5.17) participated in the study. Hearing was assessed using pure-tone audiometry and the Listening in Spatialised Noise-Sentences test. Cognition was measured using the Cogstate Brief Battery and the Cogstate Groton Maze Learning task. Personal demographics were recorded from participants' answers on a series of take-home questionnaires. HA benefit and use was subjectively reported at 3 and 6 months post HA fitting for those who chose to use HAs. Results Stepwise-regression and mixed-effects models indicated that stronger psychomotor function predicted greater reported use of HAs at 3 and 6 months post HA fitting. Greater family interaction scores also predicted greater HA use at 3 months after fitting. Participants who chose to be fitted with HAs had significantly poorer self-reported health and poorer audiometric thresholds. Poorer hearing was also significantly related with greater reported HA benefit. Conclusions A combination of cognitive, psychosocial factors and hearing impacted HA outcomes for the older Australians in this study. Self-reported HA use was significantly greater in participants with better psychomotor function. Furthermore, those with poorer self-reported health were more likely to choose to use HAs. These factors should be considered in audiological rehabilitation to best maximize patient HA outcomes.

AbstractBackgroundHearing loss is associated with accelerated cognitive decline in older adults, and has been identified as a modifiable risk factor for dementia. Although hearing aids are a successful treatment for hearing loss, it is unknown whether hearing aid use can delay the onset of cognitive decline or improve cognitive function in older adults with hearing loss. This prospective longitudinal study is investigating the effect of hearing aid use on cognitive decline and addresses many of the methodological limitations of previous studies.MethodPatients are recruited from the University of Melbourne Academic Hearing Aids Audiology Clinic and assessed before and every 18 months after hearing aid fitting. When numbers are sufficient, results will be compared with those of a control group of approximately 400 participants of a cohort study of ageing in older adults. Assessments include cognitive function (visually presented computerised assessment battery), hearing, speech perception, quality of life, activity, diet, loneliness and isolation, anxiety, depression, medical health and genetic risk.ResultAt baseline, multiple linear regression for 98 participants (62‐82 years), controlling for age, gender, cardiovascular conditions, education, and working/retired, with mean better ear PTA 31dB showed hearing loss and age predicted significantly poorer executive function, while tertiary education predicted significantly better executive function and visual learning. At 18‐month follow up, results for a subset of participants showed significant improvements in speech perception, listening disability and quality of life. Group mean scores across the cognitive assessment battery showed no significant decline and executive function was significantly improved. There was either clinically significant improvement or stability for executive function for over 97% of the subset, and for females for working memory, visual learning and visual attention, despite significantly greater hearing loss over this period.ConclusionDespite a small initial sample size, hearing loss, age and education significantly predicted baseline cognitive function. At 18‐month follow up, the majority of participants had either remained stable or demonstrated a meaningful clinical improvement in cognitive function, with significant group mean improvements for executive function and working memory. Treatment of hearing loss with hearing aids may delay cognitive decline. These are initial results, and further follow up is required.

Objectives: Previous research has investigated whether the apolipoprotein E ( APOE ) ϵ4 allele, which is associated with an increased risk of cognitive decline, is also associated with hearing loss in older people. Results of the very limited research to date are conflicting, and sample sizes for all but one study were small. The present study aimed to investigate whether there is an association between the APOE ϵ4 allele and hearing loss in a large, population-based sample of community-dwelling older adults. Design: Cross-sectional audiometric data on hearing levels and APOE genotypes for 2006 participants (aged 55 to 85 years) of the Hunter Community Study were analyzed using multiple linear regression to examine the association between APOE ϵ4 carrier status and the 4-frequency pure-tone average (0.5 to 4 kHz) in the better hearing ear, and also across individual frequencies in the better ear. Results: Observed and expected APOE allele frequency distributions did not differ significantly overall from established general population allele frequency distributions. Unadjusted modeling using better ear pure-tone average showed a statistically significant association between APOE ϵ4 allele status (0, 1, 2 copies) and reduced hearing loss, but when the model was adjusted for age, this was no longer statistically significant. Across individual hearing frequencies, unadjusted regression modeling showed APOE ϵ4 status was significantly associated with a reduction in mean hearing thresholds at 1 and 2 kHz, but again this effect was no longer statistically significant after adjusting for age. Conclusions: The results of this study did not provide any evidence of a statistically significant association between APOE ϵ4 allele status and hearing loss for older adults. Further investigation of the effect of homozygous carrier status on hearing thresholds is required.

Hearing loss is a modifiable risk factor for dementia in older adults. Whether hearing aid use can delay the onset of cognitive decline is unknown. Participants in this study (aged 62-82 years) were assessed before and 18 months after hearing aid fitting on hearing, cognitive function, speech perception, quality of life, physical activity, loneliness, isolation, mood, and medical health. At baseline, multiple linear regression showed hearing loss and age predicted significantly poorer executive function performance, while tertiary education predicted significantly higher executive function and visual learning performance. At 18 months after hearing aid fitting, speech perception in quiet, self-reported listening disability and quality of life had significantly improved. Group mean scores across the cognitive test battery showed no significant decline, and executive function significantly improved. Reliable Change Index scores also showed either clinically significant improvement or stability in executive function for 97.3% of participants, and for females for working memory, visual attention and visual learning. Relative stability and clinically and statistically significant improvement in cognition were seen in this participant group after 18 months of hearing aid use, suggesting that treatment of hearing loss with hearing aids may delay cognitive decline. Given the small sample size, further follow up is required.