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1.  Hearing Instruments for Unilateral Severe-to-Profound Sensorineural Hearing Loss in Adults: A Systematic Review and Meta-Analysis 
Ear and Hearing  2016;37(5):495-507.
A systematic review of the literature and meta-analysis was conducted to assess the nature and quality of the evidence for the use of hearing instruments in adults with a unilateral severe to profound sensorineural hearing loss.
The PubMed, EMBASE, MEDLINE, Cochrane, CINAHL, and DARE databases were searched with no restrictions on language. The search included articles from the start of each database until February 11, 2015. Studies were included that (a) assessed the impact of any form of hearing instrument, including devices that reroute signals between the ears or restore aspects of hearing to a deaf ear, in adults with a sensorineural severe to profound loss in one ear and normal or near-normal hearing in the other ear; (b) compared different devices or compared a device with placebo or the unaided condition; (c) measured outcomes in terms of speech perception, spatial listening, or quality of life; (d) were prospective controlled or observational studies. Studies that met prospectively defined criteria were subjected to random effects meta-analyses.
Twenty-seven studies reported in 30 articles were included. The evidence was graded as low-to-moderate quality having been obtained primarily from observational before-after comparisons. The meta-analysis identified statistically significant benefits to speech perception in noise for devices that rerouted the speech signals of interest from the worse ear to the better ear using either air or bone conduction (mean benefit, 2.5 dB). However, these devices also degraded speech understanding significantly and to a similar extent (mean deficit, 3.1 dB) when noise was rerouted to the better ear. Data on the effects of cochlear implantation on speech perception could not be pooled as the prospectively defined criteria for meta-analysis were not met. Inconsistency in the assessment of outcomes relating to sound localization also precluded the synthesis of evidence across studies. Evidence for the relative efficacy of different devices was sparse but a statistically significant advantage was observed for rerouting speech signals using abutment-mounted bone conduction devices when compared with outcomes after preoperative trials of air conduction devices when speech and noise were colocated (mean benefit, 1.5 dB). Patients reported significant improvements in hearing-related quality of life with both rerouting devices and following cochlear implantation. Only two studies measured health-related quality of life and findings were inconclusive.
Devices that reroute sounds from an ear with a severe to profound hearing loss to an ear with minimal hearing loss may improve speech perception in noise when signals of interest are located toward the impaired ear. However, the same device may also degrade speech perception as all signals are rerouted indiscriminately, including noise. Although the restoration of functional hearing in both ears through cochlear implantation could be expected to provide benefits to speech perception, the inability to synthesize evidence across existing studies means that such a conclusion cannot yet be made. For the same reason, it remains unclear whether cochlear implantation can improve the ability to localize sounds despite restoring bilateral input. Prospective controlled studies that measure outcomes consistently and control for selection and observation biases are required to improve the quality of the evidence for the provision of hearing instruments to patients with unilateral deafness and to support any future recommendations for the clinical management of these patients.
Adults with a unilateral severe-to-profound sensorineural hearing loss report difficulties with listening in many everyday situations. Current hearing instruments attempt to alleviate these difficulties either by rerouting sounds from the impaired ear to the non-impaired ear or by restoring hearing in the impaired ear. A systematic review and meta-analysis evaluated the evidence for their use. The evidence was of low-to-moderate quality. Meta-analyses found benefits to speech perception in noise and reductions in listening difficulty. Controlled trials are needed to provide higher-quality evidence for hearing instrument use in unilateral deafness and to support recommendations for the clinical management of these patients.
Supplemental Digital Content is available in the text.
PMCID: PMC4998125  PMID: 27232073
Air conduction; Bone conduction; Cochlear implantation; Contralateral routing of signals; Localization; Meta-analysis; Quality of life; Re-routing devices; Restorative devices; Single-sided deafness; Speech perception; Systematic review; Unilateral deafness; Unilateral hearing loss
2.  Consensus on Hearing Aid Candidature and Fitting for Mild Hearing Loss, With and Without Tinnitus: Delphi Review 
Ear and Hearing  2015;36(4):417-429.
In many countries including the United Kingdom, hearing aids are a first line of audiologic intervention for many people with tinnitus and aidable hearing loss. Nevertheless, there is a lack of high quality evidence to support that they are of benefit for tinnitus, and wide variability in their use in clinical practice especially for people with mild hearing loss. The aim of this study was to identify a consensus among a sample of UK clinicians on the criteria for hearing aid candidature and clinical practice in fitting hearing aids specifically for mild hearing loss with and without tinnitus. This will allow professionals to establish clinical benchmarks and to gauge their practice with that used elsewhere.
The Delphi technique, a systematic methodology that seeks consensus amongst experts through consultation using a series of iterative questionnaires, was used. A three-round Delphi survey explored clinical consensus among a panel of 29 UK hearing professionals. The authors measured panel agreement on 115 statements covering: (i) general factors affecting the decision to fit hearing aids, (ii) protocol-driven factors affecting the decision to fit hearing aids, (iii) general practice, and (iv) clinical observations. Consensus was defined as a priori ≥70% agreement across the panel.
Consensus was reached for 58 of the 115 statements. The broad areas of consensus were around factors important to consider when fitting hearing aids; hearing aid technology/features offered; and important clinical assessment to verify hearing aid fit (agreement of 70% or more). For patients with mild hearing loss, the greatest priority was given by clinicians to patient-centered criteria for fitting hearing aids: hearing difficulties, motivation to wear hearing aids, and impact of hearing loss on quality of life (chosen as top five by at least 64% of panelists). Objective measures were given a lower priority: degree of hearing loss and shape of the audiogram (chosen as top five by less than half of panelists). Areas where consensus was not reached were related to the use of questionnaires to predict and verify hearing aid benefit for both hearing and tinnitus; audiometric criteria for fitting hearing aids; and safety of using loud sounds when verifying hearing aid fitting when the patient has tinnitus (agreement of <70%).
The authors identified practices that are considered important when recommending or fitting hearing aid for a patient with tinnitus. More importantly perhaps, they identified practical issues where there are divided opinions. Their findings inform the design of clinical trials and open up debate on the potential impact of practice differences on patient outcomes.
This study identified areas of consensus among 29 United Kingdom hearing professionals on the criteria for hearing aid candidature and clinical practice in fitting devices for mild hearing loss with and without tinnitus. Consensus was strong for factors important to consider when fitting hearing aids, hearing aid technology/features offered, and important clinical assessment to verify hearing aid fit. The results will inform the design of clinical trials and open up debate on the potential impact of practice differences on patient outcomes.
PMCID: PMC4478070  PMID: 25587668
Delphi review; Hearing aids; Mild hearing loss; Tinnitus
3.  Gameplay as a Source of Intrinsic Motivation in a Randomized Controlled Trial of Auditory Training for Tinnitus 
PLoS ONE  2014;9(9):e107430.
Previous studies of frequency discrimination training (FDT) for tinnitus used repetitive task-based training programmes relying on extrinsic factors to motivate participation. Studies reported limited improvement in tinnitus symptoms.
To evaluate FDT exploiting intrinsic motivations by integrating training with computer-gameplay.
Sixty participants were randomly assigned to train on either a conventional task-based training, or one of two interactive game-based training platforms over six weeks. Outcomes included assessment of motivation, tinnitus handicap, and performance on tests of attention.
Participants reported greater intrinsic motivation to train on the interactive game-based platforms, yet compliance of all three groups was similar (∼70%) and changes in self-reported tinnitus severity were not significant. There was no difference between groups in terms of change in tinnitus severity or performance on measures of attention.
FDT can be integrated within an intrinsically motivating game. Whilst this may improve participant experience, in this instance it did not translate to additional compliance or therapeutic benefit.
Trial Registration NCT02095262
PMCID: PMC4162598  PMID: 25215617
4.  Effect of Insulin Glargine and n-3FA on Carotid Intima-Media Thickness in People With Dysglycemia at High Risk for Cardiovascular Events 
Diabetes Care  2013;36(9):2466-2474.
To evaluate the effects of insulin glargine and n-3 polyunsaturated fatty acid (n-3FA) supplements on carotid intima-media thickness (CIMT).
We enrolled 1,184 people with cardiovascular (CV) disease and/or CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or early type 2 diabetes in a randomized multicenter 2 × 2 factorial design trial. Participants received open-label insulin glargine (targeting fasting glucose levels ≤5.3 mmol/L [95 mg/dL]) or standard glycemic care and double-blind therapy with a 1-g capsule of n-3FA or placebo. The primary trial outcome was the annualized rate of change in maximum CIMT for the common carotid, bifurcation, and internal carotid artery segments. Secondary outcomes were the annualized rates of change in maximum CIMT for the common carotid and the common carotid plus bifurcation, respectively. Baseline followed by annual ultrasounds were obtained during a median follow-up of 4.9 years.
Compared with standard care, insulin glargine reduced the primary CIMT outcome, but the difference was not statistically significant (difference = 0.0030 ± 0.0021 mm/year; P = 0.145) and significantly reduced the secondary CIMT outcomes (differences of 0.0033 ± 0.0017 mm/year [P = 0.049] and 0.0045 ± 0.0021 mm/year [P = 0.032], respectively). There were no differences in the primary and secondary outcomes between the n-3FA supplement and placebo groups.
In people with CV disease and/or CV risk factors and dysglycemia, insulin glargine used to target normoglycemia modestly reduced CIMT progression, whereas daily supplementation with n-3FA had no effect on CIMT progression.
PMCID: PMC3747889  PMID: 23564916
5.  Heart Rate Variability During Caregiving and Sleep after Massage Therapy in Preterm Infants 
Early human development  2013;89(8):525-529.
Preterm birth impairs the infant’s stress response due to interruption of autonomic nervous system (ANS) development. Preterm infants demonstrate a prolonged and aberrant sympathetic response to stressors. ANS development may be promoted by massage therapy (MT), which has been shown to improve stress response in preterm infants.
To compare preterm infant ANS function and stress response during sleep and caregiving epochs, as measured by heart rate variability (HRV), after two weeks of twice-daily MT.
Study Design
A subset of participants from a larger randomized, masked, controlled trial was used.
Twenty-one infants (8 males, 13 females) from a larger study of 37 medically stable preterm infants were studied. Infants were receiving full volume enteral feedings with a mean post-menstrual age of 31.4 (MT) and 30.9 (Control) weeks.
Outcome Measures
Low to High frequency (LF:HF) ratio of HRV was the outcome of interest.
There was a significant group x time x sex interaction effect (p <.05). Male Control infants demonstrated a significant decline in LF:HF ratio from baseline to the second caregiving epoch, suggesting decreased mobilization of sympathetic nervous system response when exposed to stressors. Male MT infants demonstrated increased LF:HF ratio during caregiving and decreased LF:HF ratio during sleep epochs, suggesting improved ANS function, although this was not statistically significant. LF:HF ratio was similar in female MT and female Control infants during caregiving and sleep.
Control males had decreased HRV compared to MT males. There was no difference in HRV between MT and Control females.
PMCID: PMC3647010  PMID: 23361061
6.  Massage Improves Growth Quality by Decreasing Body Fat Deposition in Male Preterm Infants 
The Journal of pediatrics  2012;162(3):490-495.
To assess the effect of massage on weight gain and body fat deposition in preterm infants.
Study design
Preterm infants (29–32 wk) were randomized to Massage (n=22, 12F/10M) or Control (n=22, 12F/10M). Treatment was masked with Massage or Control administered twice-daily by licensed massage therapists (6 d/wk for 4 wk). Body weight (g), length (cm), ponderal index (PI g/cm3), body circumferences (cm), skinfold thickness (triceps TSF, mid-thigh MTSF, and subscapular SSF; mm) were measured. Circulating IGF-1, leptin, and adiponectin were determined by ELISA. Daily dietary intake was collected.
Energy and protein intake as well as increase in weight (g/kg/d), length, and body circumferences were similar. Massage male infants had smaller PI, TSF, MTSF, and SSF, and increases over time than Control male infants (p<0.05). Massage female infants had larger SSF increase than Control females (p<0.05). Circulating adiponectin increased over time in Control male infants (group X time X sex interaction, p<0.01) and was correlated to PI (r=0.39, p<0.01).
Twice daily massage did not promote greater weight gain in preterm infants. Massage did, however, limit body fat deposition in male preterm infants. Massage decreased circulating adiponectin over time in male infants with higher adiponectin concentrations associated with increased body fat. These findings suggest that massage may improve body fat deposition, and in turn growth quality, of preterm infants in a sex-specific manner.
PMCID: PMC3549027  PMID: 23062248
preterm infant; infant massage; growth; growth quality; body fat; IGF-1; adiponectin; leptin
7.  Overcoming Autopsy Barriers in Pediatric Cancer Research 
Pediatric blood & cancer  2012;60(2):204-209.
More than 13,000 children annually in the United States and Canada under the age of 20 will be diagnosed with cancer at a mortality approaching twenty percent [1,2]. Tumor samples obtained by autopsy provide an innovative way to study tumor progression, potentially aiding in the discovery of new treatments and increased survival rates. The purpose of this study was to identify barriers to autopsies and develop guidelines for requesting autopsies for research purposes.
Families of children treated for childhood cancer were referred by patient advocacy groups and surveyed about attitudes and experiences with research autopsies. From 60 interviews, barriers to autopsy and tumor banking were identified. An additional 14 interviews were conducted with medical and scientific experts.
Ninety-three percent of parents of deceased children did or would have consented to a research autopsy if presented with the option; however, only half of these families were given the opportunity to donate autopsy tissue for research. The most significant barriers were the physicians’ reluctance to ask a grieving family and lack of awareness about research opportunities.
The value of donating tumor samples to research via an autopsy should be promoted to all groups managing pediatric cancer patients. Not only does autopsy tumor banking offer a potentially important medical and scientific impact, but the opportunity to contribute this Legacy Gift of autopsy tumor tissue also creates a positive outlet for the grieving family. Taking these findings into account, our multidisciplinary team has developed a curriculum addressing key barriers.
PMCID: PMC3522778  PMID: 23015377
Autopsy; childhood; cancer; research; end-of-life care
8.  Predicate Structures, Gesture, and Simultaneity in the Representation of Action in British Sign Language: Evidence From Deaf Children and Adults 
British Sign Language (BSL) signers use a variety of structures, such as constructed action (CA), depicting constructions (DCs), or lexical verbs, to represent action and other verbal meanings. This study examines the use of these verbal predicate structures and their gestural counterparts, both separately and simultaneously, in narratives by deaf children with various levels of exposure to BSL (ages 5;1 to 7;5) and deaf adult native BSL signers. Results reveal that all groups used the same types of predicative structures, including children with minimal BSL exposure. However, adults used CA, DCs, and/or lexical signs simultaneously more frequently than children. These results suggest that simultaneous use of CA with lexical and depicting predicates is more complex than the use of these predicate structures alone and thus may take deaf children more time to master.
PMCID: PMC3943391  PMID: 23670881
9.  An evaluation of the content and quality of tinnitus information on websites preferred by General Practitioners 
Tinnitus is a prevalent and complex medical complaint often co-morbid with stress, anxiety, insomnia, depression, and cognitive or communication difficulties. Its chronicity places a major burden on primary and secondary healthcare services. In our recent national survey of General Practitioners (GPs) from across England, many reported that their awareness of tinnitus was limited and as a result were dissatisfied with the service they currently provide. GPs identified 10 online sources of information they currently use in clinical practice, but welcomed further concise and accurate information on tinnitus assessment and management. The purpose of this study was to assess the content, reliability, and quality of the information related to primary care tinnitus assessment and management on these 10 websites.
Tinnitus related content on each website was assessed using a summative content analysis approach. Reliability and quality of the information was assessed using the DISCERN questionnaire.
Quality of information was rated using the validated DISCERN questionnaire. Significant inter-rater reliability was confirmed by Kendall’s coefficient of concordance (Wt) which ranged from 0.48 to 0.92 across websites. The website Map of Medicine achieved the highest overall DISCERN score. However, for information on treatment choice, the British Tinnitus Association was rated best. Content analysis revealed that all websites lacked a number of details relating to either tinnitus assessment or management options.
No single website provides comprehensive information for GPs on tinnitus assessment and management and so GPs may need to refer to more than one if they want to maximise their coverage of the topic. From those preferred by GPs we recommend several specific websites as the current ‘best’ sources. Our findings should guide healthcare website providers to improve the quality and inclusiveness of the information they publish on tinnitus. In the case of one website, our preliminary findings are already doing so. Such developments will in turn help facilitate best practice in primary care.
PMCID: PMC3439701  PMID: 22788751
World wide web; Education; Good practice guidelines; Tinnitus management
10.  Prenatal Flutamide Enhances Survival in a Myogenic Mouse Model of Spinal Bulbar Muscular Atrophy 
Neuro-Degenerative Diseases  2010;8(1-2):25-34.
Spinal bulbar muscular atrophy (SBMA) is caused by a CAG repeat expansion mutation in the androgen receptor (AR) gene, and mutant AR is presumed to act in motoneurons to cause SBMA. However, we found that mice overexpressing wild-type (wt) AR solely in skeletal muscle fibers display the same androgen-dependent disease phenotype as when mutant AR is broadly expressed, challenging the assumptions that only an expanded AR can induce disease and that SBMA is strictly neurogenic. We have previously reported that AR toxicity was ligand dependent in our model, and that very few transgenic (tg) males survived beyond birth.
We tested whether the AR antagonist flutamide could block perinatal toxicity. tg males were treated prenatally with flutamide and assessed for survival and motor behavior in adulthood.
Prenatal treatment with flutamide rescued tg male pups from perinatal death, and, as adults, such perinatally rescued tg males showed an SBMA phenotype that was comparable to that of previously described untreated tg males. Moreover, tg males carrying a mutant endogenous allele for AR – the testicular feminization mutation (tfm) – and thus having functional AR only in muscle fibers nevertheless displayed the same androgen-dependent disease phenotype as adults.
These mice represent an excellent model to study the myogenic contribution to SBMA as they display many of the core features of disease as other mouse models. These data demonstrate that AR acting exclusively in muscle fibers is sufficient to induce SBMA symptoms and that flutamide is protective perinatally.
PMCID: PMC3030474  PMID: 20689246
Polyglutamine; Neuromuscular disease; Androgen; Transgenic mice
11.  Health Literacy and Depression in the Context of Home Visitation 
Maternal and Child Health Journal  2011;16(7):1500-1508.
We explored health literacy in parents as an underlying construct that develops through social interaction and reflection and involves an array of skills that enable a parent to manage personal and child health and healthcare. We hypothesized that depression impairs health literacy and impedes efforts to promote health literacy through home visitation. We analyzed an AHRQ/NIH database of 2,572 parent/child dyads compiled in a 2006–2008 quasi-experimental six-site nationwide study using multiple waves of measurement and a matched comparison group. Cohort families participated in home visitation programs augmented to develop parents’ reflective skills. Visitors monitored depression, health- and healthcare-related practices, and surrounding family conditions at baseline and 6-month intervals for up to 36 months using the Life Skills Progression instrument. We examined differences in initial depression ratings for demographic subgroups and explored patterns of change in health literacy among depressed versus not-depressed parents. Correlation analysis showed that at each of four assessments better depression scores were consistently and positively correlated with use of information and services (r = 21–22, P < .001) and with self-management of personal and child health (r = 42–49, P < .001). Overall, parents made significant improvements in health literacy (P < .001). As expected, depressed parents demonstrated lower baseline health literacy scores than not-depressed parents; however, they achieved greater gains (P < .001). While depression is linked with lower parental health literacy, after 1 year of enhanced home visitation, vulnerable parents were better able to manage personal and family health and healthcare, especially if depressed. Enhanced home visitation could be an effective channel to develop health literacy as a life skill, and to improve depression.
PMCID: PMC3443343  PMID: 22120425
Health literacy; Depression; Community health services; Home visitation
12.  Tinnitus referral pathways within the National Health Service in England: a survey of their perceived effectiveness among audiology staff 
In the UK, audiology services deliver the majority of tinnitus patient care, but not all patients experience the same level of service. In 2009, the Department of Health released a Good Practice Guide to inform commissioners about key aspects of a quality tinnitus service in order to promote equity of tinnitus patient care in UK primary care, audiology, and in specialist multi-disciplinary centres. The purpose of the present research was to evaluate utilisation and opinions on pathways for the referral of tinnitus patients to and from English Audiology Departments.
We surveyed all audiology staff engaged in providing tinnitus services across England. A 36-item questionnaire was mailed to 351 clinicians in all 163 National Health Service (NHS) Trusts identified as having a tinnitus service. 138 clinicians responded. The results presented here describe experiences and opinions of the current patient pathways to and from the audiology tinnitus service.
The most common referral pathway was from general practice to a hospital-based Ear, Nose & Throat department and from there to a hospital-based audiology department (64%). Respondents considered the NHS tinnitus referral process to be generally effective (67%), but expressed needs for improving GP referral and patients' access to services. 'Open access' to the audiology clinic was rarely an option for patients (9%), nor was the opportunity to access specialist counselling provided by clinical psychology (35%). To decrease the number of inappropriate referrals, 40% of respondents called for greater awareness by referrers about the audiology tinnitus service.
Respondents in the present survey were generally satisfied with the tinnitus referral system. However, they highlighted some potential targets for service improvement including 1] faster and more appropriate referral from GPs, to be achieved through education on tinnitus referral criteria, 2] improved access to psychological services through audiologist training, and 3] ongoing support from tinnitus support groups, national charities, or open access to the tinnitus clinic for existing patients.
PMCID: PMC3144449  PMID: 21733188
13.  Design and Implementation of an Application and Associated Services to Support Interdisciplinary Medication Reconciliation Efforts at an Integrated Healthcare Delivery Network 
Confusion about patients’ medication regimens during the hospital admission and discharge process accounts for many preventable and serious medication errors. Many organizations have begun to redesign their clinical processes to address this patient safety concern. Partners HealthCare, an integrated delivery network in Boston, Massachusetts, has answered this interdisciplinary challenge by leveraging its multiple outpatient electronic medical records (EMR) and inpatient computerized provider order entry (CPOE) systems to facilitate the process of medication reconciliation. This manuscript describes the design of a novel application and the associated services that aggregate medication data from EMR and CPOE systems so that clinicians can efficiently generate an accurate pre-admission medication list. Information collected with the use of this application subsequently supports the writing of admission and discharge orders by physicians, performance of admission assessment by nurses, and reconciliation of inpatient orders by pharmacists. Results from early pilot testing suggest that this new medication reconciliation process is well accepted by clinicians and has significant potential to prevent medication errors during transitions of care.
PMCID: PMC1656965  PMID: 17114640
14.  Designing an Electronic Medication Reconciliation System 
Unintended medication discrepancies at hospital admission and discharge potentially harm patients. Explicit medication reconciliation (MR) can prevent unintended discrepancies among care settings and is mandated by JCAHO for 2005. Enterprise-wide, we are linking pre-admission and discharge medication lists in our outpatient electronic health records (EHR) with our inpatient order entry applications (OE) - currently not interoperable - to support MR and inform the development of comprehensive MR among hospitalized patients.
PMCID: PMC1560872  PMID: 16779263
Public Health Reports  1991;106(6):733-734.
PMCID: PMC1580319  PMID: 19313230

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