Effects of High Anxiety Scores on Surgical and Overall Treatment Plan in Patients with Breast Cancer Treated with Neoadjuvant Therapy.

BACKGROUND: Patients with newly diagnosed breast cancer and high levels of anxiety often pursue more aggressive surgical interventions. The neoadjuvant treatment (NAT) setting could provide a window of opportunity to address patients' anxiety. However, the impact of anxiety on surgical decisions in the setting of NAT for breast cancer has not been previously studied. MATERIALS AND METHODS: A prospective database of patients with breast cancer treated with NAT at BC Cancer was used to identify patients treated with NAT and subsequent surgical resection. Patients with bilateral breast cancer or BRCA mutations or those referred to the hereditary cancer program were excluded. An anxiety score of 0-3 was assigned based on responses to the Edmonton Symptom Assessment System and Psychosocial Screen for Cancer. Clinicopathological information and treatment data were retrieved and cross-referenced between the low-anxiety (scores 0-1) and high-anxiety (scores 2-3) cohorts. RESULTS: From 2012 to 2016, 203 patients met eligibility criteria. Of these, 93 patients (45.8%) had low anxiety and 110 patients (54.2%) had high anxiety. Overall, 161 patients (79.3%) had locally advanced cancers; no differences in stage, grade, or biomarkers were found between the low- and high-anxiety cohorts. Patients with high self-reported anxiety at initial consultation were younger (mean 56 years vs. 60 years; p = .011) and more likely to undergo mastectomy for breast-conserving surgery-eligible disease and bilateral mastectomy for unilateral disease compared with those with low anxiety (37.3% vs. 18.3%; likelihood ratio 9.15; p = .002). No significant differences in treatment timelines were identified between the two cohorts. CONCLUSION: Patients with high anxiety at initial consultation were nine times more likely to undergo aggressive surgery compared with patients with low anxiety. These findings underscore the need for early identification of patients who may benefit from tailored supportive and educational services to address sources of anxiety and knowledge gaps. IMPLICATIONS FOR PRACTICE: The prevalence of anxiety among women with newly diagnosed breast cancer is being increasingly acknowledged. However, health care providers have not fully appreciated the impact of anxiety on the surgical management of patients with early-stage breast cancer. This study highlights the importance of self-reported anxiety on surgical management. The preoperative period provides a unique window of opportunity to address sources of anxiety and provide targeted educational materials over a period of 4-6 months, which may ultimately lead to less aggressive surgery when it is not needed.

Telephone-Based Progressive Tinnitus Management for Persons With and Without Traumatic Brain Injury: A Randomized Controlled Trial.

OBJECTIVES: This randomized controlled trial evaluated the efficacy of delivering coping skills education from Progressive Tinnitus Management (PTM) by telephone (Tele-PTM). The trial followed a previous pilot study that showed positive results for Tele-PTM. DESIGN: Participants included individuals with bothersome tinnitus (N = 205) located anywhere within the United States. A special emphasis was given to including individuals who had experienced one or more traumatic brain injuries (TBIs). Participants were randomized to either Tele-PTM intervention or 6-month wait-list control (WLC). The Tele-PTM intervention involved five telephone appointments-two led by an audiologist (teaching how to use therapeutic sound) and three by a psychologist (teaching coping skills derived from cognitive-behavioral therapy). It was hypothesized that Tele-PTM would be more effective than WLC in reducing functional effects of tinnitus as measured with the Tinnitus Functional Index. Additional outcome measures included the Self-Efficacy for Managing Reactions to Tinnitus questionnaire and the Hospital Anxiety and Depression Scale. The effect of Tele-PTM on outcomes was estimated using linear mixed models. RESULTS: Overall results showed convincingly that the Tele-PTM group had significantly better outcomes than the WLC group. These results were consistent across all outcome measures, indicating not only a reduction of tinnitus functional distress but also increased self-efficacy. Improvements in measures of anxiety and depression were also observed. Tele-PTM participants in all TBI categories showed significant improvement. CONCLUSIONS: Results provide strong support for use of Tele-PTM methodology for persons with bothersome tinnitus, regardless of whether the person also has TBI symptoms. The effect size for Tele-PTM was high for the primary outcome measure, the Tinnitus Functional Index, and all other outcome measures showed significant improvement. Combined with our previous pilot study, the Tele-PTM method is validated for potential nationwide provision of tinnitus services.

The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus.

OBJECTIVES: Chronic subjective tinnitus is a prevalent condition that causes significant distress to millions of Americans. Effective tinnitus treatments are urgently needed, but evaluating them is hampered by the lack of standardized measures that are validated for both intake assessment and evaluation of treatment outcomes. This work was designed to develop a new self-report questionnaire, the Tinnitus Functional Index (TFI), that would have documented validity both for scaling the severity and negative impact of tinnitus for use in intake assessment and for measuring treatment-related changes in tinnitus (responsiveness) and that would provide comprehensive coverage of multiple tinnitus severity domains. DESIGN: To use preexisting knowledge concerning tinnitus-related problems, an Item Selection Panel (17 expert judges) surveyed the content (175 items) of nine widely used tinnitus questionnaires. From those items, the Panel identified 13 separate domains of tinnitus distress and selected 70 items most likely to be responsive to treatment effects. Eliminating redundant items while retaining good content validity and adding new items to achieve the recommended minimum of 3 to 4 items per domain yielded 43 items, which were then used for constructing TFI Prototype 1.Prototype 1 was tested at five clinics. The 326 participants included consecutive patients receiving tinnitus treatment who provided informed consent-constituting a convenience sample. Construct validity of Prototype 1 as an outcome measure was evaluated by measuring responsiveness of the overall scale and its individual items at 3 and 6 mo follow-up with 65 and 42 participants, respectively. Using a predetermined list of criteria, the 30 best-functioning items were selected for constructing TFI Prototype 2.Prototype 2 was tested at four clinics with 347 participants, including 155 and 86 who provided 3 and 6 mo follow-up data, respectively. Analyses were the same as for Prototype 1. Results were used to select the 25 best-functioning items for the final TFI. RESULTS: Both prototypes and the final TFI displayed strong measurement properties, with few missing data, high validity for scaling of tinnitus severity, and good reliability. All TFI versions exhibited the same eight factors characterizing tinnitus severity and negative impact. Responsiveness, evaluated by computing effect sizes for responses at follow-up, was satisfactory in all TFI versions.In the final TFI, Cronbach's alpha was 0.97 and test-retest reliability 0.78. Convergent validity (r = 0.86 with Tinnitus Handicap Inventory [THI]; r = 0.75 with Visual Analog Scale [VAS]) and discriminant validity (r = 0.56 with Beck Depression Inventory-Primary Care [BDI-PC]) were good. The final TFI was successful at detecting improvement from the initial clinic visit to 3 mo with moderate to large effect sizes and from initial to 6 mo with large effect sizes. Effect sizes for the TFI were generally larger than those obtained for the VAS and THI. After careful evaluation, a 13-point reduction was considered a preliminary criterion for meaningful reduction in TFI outcome scores. CONCLUSIONS: The TFI should be useful in both clinical and research settings because of its responsiveness to treatment-related change, validity for scaling the overall severity of tinnitus, and comprehensive coverage of multiple domains of tinnitus severity.

Sound Tolerance Conditions (Hyperacusis, Misophonia, Noise Sensitivity, and Phonophobia): Definitions and Clinical Management.

Purpose: For some people, exposure to everyday sounds presents a significant problem. The purpose of this tutorial was to define and differentiate between the various sound tolerance conditions and to review some options for their clinical management. METHOD: We informally reviewed the literature regarding sound tolerance conditions. The terminology and definitions provided are mostly consistent with how these terms are defined. However, many inconsistencies are noted. Methods of assessment and treatment also differ, and different methodologies are briefly described. RESULTS: Hyperacusis describes physical discomfort or pain when any sound reaches a certain level of loudness that would be tolerable for most people. Misophonia refers to intense emotional reactions to certain sounds (often body sounds such as chewing and sniffing) that are not influenced by the perceived loudness of those sounds. Noise sensitivity refers to increased reactivity to sounds that may include general discomfort (annoyance or feeling overwhelmed) due to a perceived noisy environment, regardless of its loudness. Phonophobia, as addressed in the audiology profession, describes anticipatory fear of sound. Phonophobia is an emotional response such as anxiety and avoidance of sound due to the "fear" that sound(s) may occur that will cause a comorbid condition to get worse (e.g., tinnitus) or the sound itself will result in discomfort or pain. (Note that phonophobia is a term used by neurologists to describe "migraineur phonophobia"-a different condition not addressed herein.) Conclusions: The literature addresses sound tolerance conditions but reveals many inconsistencies, indicating lack of consensus in the field. When doing an assessment for decreased sound tolerance, it is important to define any terms used so that the patient and all health care professionals involved in the care of the patient are aligned with the goals of the treatment plan. Treatment generally involves gradual and systematic sound desensitization and counseling. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.20164130.

Principles and application of educational counseling used in progressive audiologic tinnitus management.

Exposure to loud sounds is a common cause and exacerbater of tinnitus - a troubling auditory symptom that affects millions of people worldwide. Clinical research at the National Center for Rehabilitative Auditory Research has resulted in a clinical model of tinnitus management referred to as Progressive Audiologic Tinnitus Management (PATM). The model involves five hierarchical levels of management: Triage, Audiologic Evaluation, Group Education, Tinnitus Evaluation, and Individualized Management. Counseling by audiologists and, as needed, mental health providers, is a key component of PATM. This style of counseling focuses less on didactic informational counseling; instead, counseling is used for facilitating patients' learning to adjust to the disturbing auditory symptom by successfully employing tools from two powerful skillsets for self-management of chronic tinnitus - the therapeutic uses of sound and techniques from cognitive-behavioral psychology. This article provides an overview of the methods of counseling used with PATM and provides details concerning the overarching principles of collaborative adult learning that are believed to be most important in facilitating self-management by patients who complain of tinnitus.

Using therapeutic sound with progressive audiologic tinnitus management.

Management of tinnitus generally involves educational counseling, stress reduction, and/or the use of therapeutic sound. This article focuses on therapeutic sound, which can involve three objectives: (a) producing a sense of relief from tinnitus-associated stress (using soothing sound); (b) passively diverting attention away from tinnitus by reducing contrast between tinnitus and the acoustic environment (using background sound); and (c) actively diverting attention away from tinnitus (using interesting sound). Each of these goals can be accomplished using three different types of sound-broadly categorized as environmental sound, music, and speech-resulting in nine combinations of uses of sound and types of sound to manage tinnitus. The authors explain the uses and types of sound, how they can be combined, and how the different combinations are used with Progressive Audiologic Tinnitus Management. They also describe how sound is used with other sound-based methods of tinnitus management (Tinnitus Masking, Tinnitus Retraining Therapy, and Neuromonics).

The role of audiologic evaluation in progressive audiologic tinnitus management.

Progressive Audiologic Tinnitus Management (PATM) is based on the premise that tinnitus is managed most efficiently using a hierarchy of clinical services that address different levels of need. PATM includes five levels of management: (a) triage; (b) audiologic evaluation; (c) group education; (d) tinnitus evaluation; and (e) individualized management. This article provides an overview of PATM and focuses on the procedures that make up the Level 2 Audiologic Evaluation. The evaluation is conducted to assess the potential need for medical, audiologic (hearing loss, tinnitus, hyperacusis), and/or mental health services. The Tinnitus Handicap Inventory, Hearing Handicap Inventory, and Tinnitus and Hearing Survey are used to differentiate effects of tinnitus and hearing loss. If indicated, patients are interviewed with the Tinnitus-Impact Screening Interview. Patients requiring amplification receive hearing aids. Often, management of hearing loss at Level 2 addresses any problems that were attributed to the tinnitus, which obviates further tinnitus-specific intervention.

A Randomized Controlled Trial to Evaluate Approaches to Auditory Rehabilitation for Blast-Exposed Veterans with Normal or Near-Normal Hearing Who Report Hearing Problems in Difficult Listening Situations.

BACKGROUND: Blast exposure is a major source of injury among Service members in the Iraq and Afghanistan conflicts. Many of these blast-exposed veterans report hearing-related problems such as difficulties understanding speech in noise and rapid speech, and following instructions and long conversations that are disproportionate to their measured peripheral hearing sensitivity. Evidence is mounting that these complaints result from damage to the central auditory processing system. PURPOSE: To evaluate the effectiveness of audiological rehabilitative interventions for blast-exposed veterans with normal or near-normal peripheral hearing and functional hearing difficulties. RESEARCH DESIGN: A randomized controlled trial with four intervention arms. STUDY SAMPLE: Ninety-nine blast-exposed veterans with normal or near-normal peripheral hearing who reported functional hearing difficulties. INTERVENTION: Four interventions were compared: compensatory communication strategies (CCS) education, CCS and use of a personal frequency modulation system (FM + CCS), CCS and use of an auditory training program (AT + CCS), and use of all three interventions combined (FM + AT + CCS). DATA COLLECTION AND ANALYSIS: All participants tested before, and immediately following an 8-week intervention period. The primary outcome measures upon which the study was powered assessed speech understanding in noise and self-reported psychosocial impacts of the intervention. In addition, auditory temporal processing, auditory working memory, allocation of attention, and hearing and cognitive self-report outcomes were assessed. RESULTS: Use of FM + CCS resulted in significant benefit for speech understanding in noise and self-reported hearing benefits, and FM + AT + CCS provided more self-reported cognitive benefits than FM + CCS, AT + CCS, or CCS. Further, individuals liked and reported using the FM system, but there was poor adherence to and high attrition among individuals assigned to receive AT. CONCLUSIONS: It is concluded that a FM system (or remote microphone via Bluetooth system) is an effective intervention for blast-exposed veterans with normal or near-normal hearing and functional hearing difficulties and should be routinely considered as an intervention approach for this population when possible.

Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used With Progressive Tinnitus Management.

Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention involved 5 group workshops: 2 led by an audiologist (teaching how to use sound as therapy) and 3 by a psychologist (teaching coping skills derived from cognitive behavioral therapy). It was hypothesized that PTM would be more effective than wait-list control in reducing functional effects of tinnitus and that there would be no differences in effectiveness between sites. Results: At both sites, a statistically significant improvement in mean Tinnitus Functional Index scores was seen at 6 months for the PTM group. Combined data across sites revealed a statistically significant improvement in Tinnitus Functional Index relative to wait-list control. The effect size for PTM using the Tinnitus Functional Index was 0.36 (small). Conclusions: Results suggest that PTM is effective at reducing tinnitus-related functional distress in clinical settings. Although effect sizes were small, they provide evidence of clinical effectiveness of PTM in the absence of stringent research-related inclusion criteria and with a relatively small number of sessions of cognitive behavioral therapy.

Auditory difficulties in blast-exposed Veterans with clinically normal hearing.

UNLABELLED: Vast numbers of blast-injured Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn personnel report postconcussive symptoms that include headache, dizziness, poor memory, and difficulty concentrating. In addition, many report hearing problems, such as difficulty understanding speech in noise, yet have no measureable peripheral auditory deficits. In this article, self-report and performance-based measures were used to assess 99 blast-exposed Veterans. All participants reported auditory problems in difficult listening situations but had clinically normal hearing. Participants' scores on self-report questionnaires of auditory difficulties were more similar to scores of older individuals with hearing impairment than to those of younger individuals with normal hearing. Participants showed deficits relative to published normative data on a number of performance-based tests that have demonstrated sensitivity to auditory processing deficits. There were several measures on which more than the expected number of participants (15.9%) performed one or more standard deviations below the mean. These were assessments of speech understanding in noise, binaural processing, temporal resolution, and speech segregation. Performance was not universally poor, with approximately 53% of participants performing abnormally on between 3 and 6 of the 10 measures. We concluded that participants exhibited task-specific deficits that add to the evidence suggesting that blast injury results in damage to the central auditory system. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov; Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury (mTBI); NCT00930774; https://clinicaltrials.gov/ct2/show/NCT00930774?term=NCT00930774&rank=1.

Development of a progressive audiologic tinnitus management program for Veterans with tinnitus.

Tinnitus is the most prevalent service-connected disability awarded to Veterans. However, clinical protocols for management of tinnitus have been inconsistent across Department of Veterans Affairs (VA) medical centers. A study was funded to develop and pilot test a protocol to provide tinnitus services consistently across VA audiology clinics. Drawing on a series of prior VA and external research projects, a clinical model was formulated, supporting materials in multimedia were developed, and a pilot study was conducted. Five hierarchical levels of care were defined and labeled the Progressive Audiologic Tinnitus Management (PATM) model. The model facilitates access to medical services for tinnitus and includes detailed protocols for evaluation, education, and counseling of patients. Patients at each level of care have the option to "progress" to the next level of PATM if further services are required. Clinical procedures were defined for each level and materials were produced for audiologists and patients. The PATM model was then piloted with clinical patients at the James A. Haley Veterans' Hospital (JAHVH) in Tampa, Florida. Throughout the pilot study, feedback from patients and clinicians was carefully noted. Training materials for audiologists, incorporation of the protocol into clinic activities, and patient outcomes were evaluated. The model was implemented within the JAHVH Audiology Clinic and to assist Veterans with tinnitus management. The most notable finding was how little tinnitus-specific intervention was required for the majority of patients. This finding supports a clinical model that offers stepped-care ("progressive") levels of care until tinnitus management is achieved by the patient.

Pilot study to develop telehealth tinnitus management for persons with and without traumatic brain injury.

Tinnitus, or "ringing in the ears," affects 10%-15% of adults; cases can be problematic and require lifelong management. Many people who have experienced traumatic brain injury (TBI) also experience tinnitus. We developed Progressive Tinnitus Management (PTM), which uses education and counseling to help patients learn how to self-manage their reactions to tinnitus. We adapted PTM by delivering the intervention via telephone and by adding cognitive-behavioral therapy. A pilot study was conducted to evaluate the feasibility and potential efficacy of this approach for individuals with and without TBI. Participants with clinically significant tinnitus were recruited into three groups: probable symptomatic mild TBI (n = 15), moderate to severe TBI (n = 9), and no symptomatic TBI (n = 12). Participants received telephone counseling (six sessions over 6 months) by an audiologist and a psychologist. Questionnaires were completed at baseline, 12 weeks, and 24 weeks. All groups showed trends reflecting improvement in self-perceived functional limitations due to tinnitus. A follow-up randomized clinical study is underway.

Dual sensory impairment (DSI) in traumatic brain injury (TBI)--An emerging interdisciplinary challenge.

The present review characterizes dual sensory impairment (DSI) as co-existing auditory and visual deficits in TBI that can be peripherally or centrally based. Current research investigating DSI in the military population, along with applicable research which focuses on unimodal deficits, is considered. Due to the heterogenous nature of TBI lesions, an important challenge that the clinician faces is ruling out the influence of multiple sensory deficits and/or the influence of cognitive processes on diagnosis and rehabilitation of the patient. Treatment options for DSI involve remediation of the sensory deficits via existing sensory aids or training exercises.

Auditory and vestibular dysfunction associated with blast-related traumatic brain injury.

The dramatic escalation of blast exposure in military deployments has created an unprecedented amount of traumatic brain injury (TBI) and associated auditory impairment. Auditory dysfunction has become the most prevalent individual service-connected disability, with compensation totaling more than 1 billion dollars annually. Impairment due to blast can include peripheral hearing loss, central auditory processing deficits, vestibular impairment, and tinnitus. These deficits are particularly challenging in the TBI population, as symptoms can be mistaken for posttraumatic stress disorder, mental-health issues, and cognitive deficits. In addition, comorbid factors such as attention, cognition, neuronal loss, noise toxicity, etc., can confound assessment, causing misdiagnosis. Furthermore, some auditory impairments, such as sensorineural hearing loss, will continue to progress with age, unlike many other injuries. In the TBI population, significant clinical challenges are the accurate differentiation of auditory and vestibular impairments from multiple, many times overlapping, symptoms and the development of multidisciplinary rehabilitation strategies to improve treatment outcomes and quality of life for these patients.

Auditory and visual impairments in patients with blast-related traumatic brain injury: Effect of dual sensory impairment on Functional Independence Measure.

The frequencies of hearing impairment (HI), vision impairment (VI), or dual (hearing and vision) sensory impairment (DSI) in patients with blast-related traumatic brain injury (TBI) and their effects on functional recovery are not well documented. In this preliminary study of 175 patients admitted to a Polytrauma Rehabilitation Center, we completed hearing and vision examinations and obtained Functional Independence Measure (FIM) scores at admission and discharge for 62 patients with blast-related TBI. We diagnosed HI only, VI only, and DSI in 19%, 34%, and 32% of patients, respectively. Only 15% of the patients had no sensory impairment in either auditory or visual modality. An analysis of variance showed a group difference for the total and motor FIM scores at discharge (p < 0.04). Regression model analyses demonstrated that DSI significantly contributed to reduced gain in total ( t = -2.25) and motor ( t = -2.50) FIM scores ( p < 0.05). Understanding the long-term consequences of sensory impairments in the functional recovery of patients with blast-related TBI requires further research.