The Tinnitus Retraining Therapy Trial's Standard of Care Control Condition: Rationale and Description of a Patient-Centered Protocol.
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SUBMITTER: Erdman SA
PROVIDER: S-EPMC6808311 | biostudies-literature | 2019 Sep
REPOSITORIES: biostudies-literature
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The Tinnitus Retraining Therapy Trial's Standard of Care Control Condition: Rationale and Description of a Patient-Centered Protocol.
Erdman Sue Ann SA Scherer Roberta W RW Sierra-Irizarry Benigno B Formby Craig C
American journal of audiology 20190819 3
Purpose The selection and design of control conditions are critical factors in minimizing the influence of unwanted variables in randomized controlled trials (RCTs). This article describes the rationale, design, and content of a standard of care control condition in a Phase III RCT of tinnitus retraining therapy. Method Existing tinnitus practices at military hospitals were identified and aligned with the American Speech-Language-Hearing Association's (2006) preferred practice patterns for tinni ...[more]
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Project description:Importance:Tinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, tinnitus. Objective:To compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life. Design, Setting, and Participants:A randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat. Interventions:Central randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC. Main Outcomes and Measures:The primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS). Results:Among the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%). Conclusions and Relevance:There were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus. Trial Registration:ClinicalTrials.gov identifier: NCT01177137.
| S-EPMC6547112 | biostudies-literature
Project description:Subjective tinnitus is the perception of sound in the absence of a corresponding external sound for which there is no known medical etiology. For a minority of individuals with tinnitus, the condition impacts their ability to lead a normal lifestyle and is severely debilitating. There is no known cure for tinnitus, so current therapy focuses on reducing the effect of tinnitus on the patient's quality of life. Tinnitus retraining therapy (TRT) uses nonpsychiatric tinnitus-specific educational counseling and sound therapy in a habituation-based protocol to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, the tinnitus, with the ultimate goal of reducing the tinnitus impact on the patient's quality of life. Some studies support the efficacy of TRT, but no trial to date has compared TRT with the current standard of care or evaluated the separate contributions of TRT counseling and sound therapy. The Tinnitus Retraining Therapy Trial (TRTT) is a randomized, double-blind, placebo-controlled, multicenter trial for individuals with intolerable tinnitus.The TRTT is enrolling active-duty and retired military personnel and their dependents with functionally adequate hearing sensitivity and severe tinnitus at US Air Force, Navy, and Army medical centers. Eligible study participants are randomized to TRT, partial TRT, or standard care to determine the efficacy of TRT and its components (TRT counseling and sound therapy). The primary outcome is change in score on the Tinnitus Questionnaire assessed longitudinally between baseline and follow-up (3, 6, 12, and 18 months following treatment). Secondary outcomes include subscale score changes in the Tinnitus Questionnaire, overall and subscale score changes in the Tinnitus Functional Index and Tinnitus Handicap Inventory, and change in the visual analog scale of the TRT Interview Form. Audiological outcomes include tinnitus pitch and loudness match and measures of loudness discomfort levels. The incidence of depression as a safety measure is assessed at each visit using the Beck Depression Inventory Fast Screen.Clinicaltrials.gov NCT01177137.
| S-EPMC4210573 | biostudies-literature
Project description:BackgroundTreatment fidelity, defined as ensuring that the recipient receives the intended intervention, is a critical component for accurate estimation of treatment efficacy. Ensuring fidelity and protocol adherence in behavioral trials requires careful planning during the design phase and implementation during the trial. The Tinnitus Retraining Therapy Trial (TRTT) randomized individuals with severe tinnitus to tinnitus retraining therapy (TRT, comprised of tinnitus-specific educational counseling (TC) and sound therapy (ST) using conventional sound generators (SGs)); Partial TRT (TC and placebo SGs); or standard of care (SOC), using a patient-centered care approach. Study audiologists administered both types of counseling in the TRTT, creating a challenge for managing protocol adherence.MethodsWe developed methods to enhance treatment fidelity including training, competency assessment, scripts, visual aids, and fidelity monitoring. Protocol monitors identified critical topics and content to be addressed for each type of counseling session, prepared corresponding scripts, and developed training aids and treatment-specific checklists covering those topics. Study audiologists' competency assessment required submission and review by the protocol monitors of an audiotape of one TC and one SOC counseling session. Treatment-specific aids included scripts, a 3-D model of the ear, handouts, and for TC, an illustrated flip-chart with talking points that followed the scripted content. During the trial, audiologists completed treatment-specific checklists during each counseling session, indicating topics covered/discussed and submitted audiotapes of counseling sessions. Protocol monitors reviewed audiotapes using corresponding treatment-specific checklists. Results for individual checklist items were tabulated and proportions calculated.ResultsTwenty-five audiologists were certified for TC and/or SOC counseling and 24 completed at least one counseling session. Adherence to each of 33 critical items on the TC checklist as assessed by the protocol monitor ranged from 70 to 100% across 37 counseling sessions (median 97%), with no difference between adherence for TRT (median, 97%) and partial TRT (median, 100%). Adherence to each of 44 critical items on the SOC checklist across 30 SOC counseling sessions ranged from 42 to 100% (median, 87.5%).ConclusionThe TRTT used multiple methods to address treatment fidelity. The close adherence to each treatment type was critical for evaluating the efficacy of the study interventions in this randomized trial.Trial registrationclinicaltrials.gov NCT01177137 . Registered on 5 August 2010.
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Project description:Currently, there still is no treatment that eliminates tinnitus in all patients. Recent studies have shown that Tinnitus Retraining Therapy (TRT) significantly improves quality of life for tinnitus patients. Also, several studies have reported that transcranial Direct Current Stimulation (tDCS) has a positive effect on attention, working memory, long-term memory and other cognitive processes. The aim of this randomised placebo-controlled double-blind study is to evaluate the added effect of tDCS to TRT in chronic tinnitus patients. To our knowledge, this is the first study to combine both methods.Patients with chronic, non-pulsatile tinnitus will be randomised in two treatment groups: TRT and real tDCS versus TRT and sham tDCS. Evaluations will take place at baseline before therapy starts, at the end of the TRT and 3 months after therapy starts. The Tinnitus Functional Index will be used as the primary outcome measurement. Secondary outcome measurements will be the Visual Analogue Scale of Loudness, Hospital Anxiety and Depression Scale (HADS), Hyperacusis Questionnaire, psychoacoustic measurements and Event-related potential (ERP).To our knowledge this is the first study to combine TRT and tDCS. The objective is to evaluate whether tDCS can provide faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily lives. The advantage of the study is that it is double-blind and placebo-controlled.The present study protocol was registered on 31 October 2014 at Clinicaltrials.gov: NCT02285803 .
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Project description:BackgroundLiving with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse (SCN) is usually performed after surgery to support the adaptation process. In the present paper, we describe a new model of ostomy care, where a clinical feedback system (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We also present a plan for evaluating patients experience with the CFS and their clinical outcomes.MethodsIn this study, we include patients who had recently performed colostomy, ileostomy, or urostomy surgery. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (HRQoL), as well as patient experiences and satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores are instantly analysed and graphically presented for use during the consultation and the patient and the SCN can discuss the findings. Patient experiences and satisfaction with care will be measured with the Generic Short Patient Experiences Questionnaire. Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and HRQoL with the Short Form 36.DiscussionThis study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.Trial registerClinicalTrials.gov Registration Number: NCT03841071. Date 18. February 2019 retrospectively registered.
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Project description:BackgroundAlthough severe asthma can be life-threatening, many patients are unaware they have this condition.ObjectivesPatient Understanding Leading to Assessment for a Severe Asthma Referral (PULSAR) is a novel, multidisciplinary working group aiming to develop and disseminate a global, patient-centered description of severe asthma to improve patient understanding of severe asthma and effect a change in patient behavior whereby patients are encouraged to visit their healthcare professional, when appropriate.MethodsCurrent definitions from patient organization websites, asthma guidelines, and medication information for key asthma drugs were assessed and informed a multidisciplinary working group, convened to identify common concepts and terminology used to define severe asthma. A patient-centered description of severe asthma and patient checklist were drafted based on working-group discussions and reviewed by an external behavioral scientist for patient understanding and relevance. These were tested using an online US/Canadian survey.ResultsThe patient-centered description of severe asthma and patient checklist were reviewed and re-drafted by the authors. The text was simplified following the behavioral-scientist review. The survey (n?=?153) included 105 patients with severe asthma. Of those with severe asthma, 92.2% of patients reported that the description was consistent with their experiences of severe asthma and 92.6% of patients reported that the PULSAR initiative would encourage them to visit their healthcare provider.ConclusionA patient-centered description of severe asthma has been developed and tested using patients with severe asthma; this description will allow patients to assess whether they might have severe asthma and prompt them to visit their healthcare provider, if appropriate.
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Project description:This paper argues that "functional," "medically unexplained," or "somatoform" symptoms and disorders necessarily require a patient-centered approach from the clinicians. In the first part, I address the multiple causes of the patients' suffering and I analyze the unease of the doctors faced with these disorders. I emphasize the iatrogenic role of medical investigations and the frequent failure in attempting to reassure the patients. I stress the difficulties in finding the right terms and concepts, despite overabundant nosological categories, to give a full account of psychosomatic complexity. Finally, I discuss the moral dimension attached to assigning a symptom, at times arbitrarily, to a psychogenic origin. The following part presents a brief reminder of the patient-centered approach (PCA) in medicine. In the last part, I aim to explain why and how patient-centered medicine should be applied in the context of functional disorders. First, because PCA focuses on the patients' experience of illness rather than the disease from the medical point of view, which is, indeed, absent. Second, because PCA is the only way to avoid sterile attribution conflicts. Last, because PCA allows doctors and patients to collaboratively create plausible and non-stigmatizing explanations for the symptoms, which paves the way toward effective management.
| S-EPMC8110699 | biostudies-literature
Project description:IntroductionFollowing a cancer diagnosis, patients and their caregivers face crucial decisions regarding goals of care and treatment, which have consequences that can persist throughout their cancer journey. To foster informed and value-driven treatment choices, evidence-based information on outcomes relevant to patients is needed. Traditionally, clinical studies have largely focused on a few concrete and easily measurable outcomes such as survival, disease progression and immediate treatment toxicities. These outcomes do not capture other important factors that patients consider when making treatment decisions. Patient-centred outcomes (PCOs) reflect the patients' individual values, preferences, needs and circumstances that are essential to directing meaningful and informed healthcare discussions. Often, however, these outcomes are not included in research protocols in a standardised and practical fashion. This scoping review will summarise the existing literature on PCOs in gastrointestinal (GI) cancer care as well as the tools used to assess these outcomes. A comprehensive list of these PCOs will be generated for future efforts to develop a core outcome set.Methods and analysisThis scoping review will follow Arksey and O'Malley's expanded framework for scoping reviews. We will systematically search Medline, Embase, CINAHL, Cochrane Library and APA PsycINFO databases for studies examining PCOs in the context of GI cancer. We will include studies published in or after the year 2000 up to the date of the final searches, with no language restrictions. Studies involving adult patients with GI cancers and discussion of any PCOs will be included. Opinion pieces, protocols, case reports and abstracts will be excluded. Two authors will independently perform two rounds of screening to select studies for inclusion. The data from full texts will be extracted, charted and summarised both quantitatively and qualitatively.Ethics and disseminationNo ethics approval is required for this scoping review. Results will be disseminated through scientific publication and presentation at relevant conferences.
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Project description:BACKGROUND:Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. METHODS/DESIGN:Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the "RP intervention" or "standard care control" groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child's electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. DISCUSSION:This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. TRIAL REGISTRATION:Restrospective Clinical Trial Registration: NCT03482908 . Registered March 29, 2018.
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Project description:The selection of a control condition in a randomized controlled trial (RCT) is critical in determining the effect of the experimental treatment. While the use of a placebo pill can be an ideal control in pharmaceutical trials, RCTs of behavioral interventions present unique challenges in the selection and implementation of the appropriate control condition. Investigators must not only consider the control condition's ability to protect against threats to internal validity and its plausibility as a possible intervention, but must also carefully implement the control condition so it does not introduce bias from either the investigators or the participants. The purpose of this paper is to provide the rationale for the use of a health education intervention (HEI) as the control condition in the CTN-0037 Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) trial. In this paper, we will describe the careful design of the HEI to ensure proper implementation and discuss alternative control conditions considered.
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