Call for an Evidence-Based Consensus on Outcome Reporting in Tinnitus Intervention Studies

Londero, Alain; Hall, Deborah A.

doi:10.3389/fmed.2017.00042

Cited by 22 publications

(14 citation statements)

References 31 publications

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“…There is a strong movement toward applying appropriate outcome measures, especially in the context of clinical trials (Williamson et al, 2012). The Tinnitus Research Initiative also has prioritized creating appropriate outcome measures for tinnitus (Langguth et al, 2007), and concerns about this issue continue to be raised (Londero and Hall, 2017). A systematic review indicated that the outcome domains most frequently used in the clinical trials of tinnitus relate to the tinnitus percept, the impact of tinnitus, other co-occurring complains, health-related quality of life, and body structures and functions (Hall et al, 2016).…”

Section: Study Implicationsmentioning

confidence: 99%

Problems and Life Effects Experienced by Tinnitus Research Study Volunteers: An Exploratory Study Using the ICF Classification

et al. 2018

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Tinnitus is one of the most distressing hearing-related symptoms. It is often associated with a range of physiological and psychological complications, such as depression, anxiety, and insomnia. Hence, approaching tinnitus from a biopsychological perspective may be more appropriate than from purely a biomedical model.The present study was aimed at determining the relationship between tinnitus and the problems and life effects experienced by UK-based tinnitus research study volunteers. Open-ended questions were used. Responses were classified using the International Classification of Functioning, Disability and Health (ICF) framework to understand the impact of tinnitus in a multidimensional manner using a biopsychosocial perspective.A cross-sectional survey design was used.Study sample included a sample of 240 adults with tinnitus who were interested in undertaking an Internet-based intervention for tinnitus.The data were collated using two open-ended questions. The first focused on problems related to having tinnitus and the second to life effects as a result of tinnitus. Responses were analyzed using a simplified content analysis approach to link concepts to ICF categories in accordance with established linking rules. A Wilcoxon signed-rank test was performed to compare the number of responses between the two questions.There were 764 responses related to problems identified, 797 responses associated with life effects due to tinnitus, and 37 responses that did not fit into any ICF category. No significant differences were observed in the number of responses between the two questions. In addition, no significant association between the number of responses reported and demographic variables was found. Most of the problems and life effects experienced by tinnitus sufferers were related to body function, followed by activity limitations, and participation restrictions. Only a few responses were related to environmental and personal factors. The most frequent responses related to body function involved “emotional functions” (b152), “sleep functions” (b134), “hearing functions” (b230), “sustaining attention” (b1400), and “energy level” (b1300). For activity limitations and participation restrictions they were “communicating with—receiving—spoken messages” (d310), “socialization” (d9205), “handling stress and other psychological demands” (d240), and “recreation and leisure” (d920). The most frequently occurring responses related to environmental factors were “sound intensity” (e2500), “sound quality” (e2501), and “general products and technology for communication” (e1250). “Coping styles” was the most frequently occurring personal factor.The study highlights the use of open-ended questions in gathering useful information about the impact of tinnitus. The responses coded to ICF show that tinnitus impacts many domains, not only particularly body function, but also activity limitations and participation restrictions. The results demonstrate the heterogeneous nature of the impact of tinnitus on people affected.

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Section: Study Implicationsmentioning

confidence: 99%

Problems and Life Effects Experienced by Tinnitus Research Study Volunteers: An Exploratory Study Using the ICF Classification

et al. 2018

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“…Therefore, in order to be productive, it appears mandatory for healthcare providers to gain knowledge on consensual and patient-centered evaluations [Williamson et al, 2012;Black, 2013]. Obtaining an exhaustive and accurate insight on patients' symptoms may pave the way DOI: 10.1159/000504741 for a better understanding into the "structural properties" of ST/HA subgroups of patients, appropriate assessment and outcome instruments also fitting the patients' needs [Hall et al, 2019], and ultimately the development of efficient consensual therapeutic strategies [Londero and Hall, 2017;. This is why a systematic quantitative study of tinnitus patients' verbatim would be meaningful and informative.…”

Section: Introductionmentioning

confidence: 99%

Assessing the Heterogeneity of Complaints Related to Tinnitus and Hyperacusis from an Unsupervised Machine Learning Approach: An Exploratory Study

2020

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Introduction: Subjective tinnitus (ST) and hyperacusis (HA) are common auditory symptoms that may become incapacitating in a subgroup of patients who thereby seek medical advice. Both conditions can result from many different mechanisms, and as a consequence, patients may report a vast repertoire of associated symptoms and comorbidities that can reduce dramatically the quality of life and even lead to suicide attempts in the most severe cases. The present exploratory study is aimed at investigating patients’ symptoms and complaints using an in-depth statistical analysis of patients’ natural narratives in a real-life environment in which, thanks to the anonymization of contributions and the peer-to-peer interaction, it is supposed that the wording used is totally free of any self-limitation and self-censorship. Methods: We applied a purely statistical, non-supervised machine learning approach to the analysis of patients’ verbatim exchanged on an Internet forum. After automated data extraction, the dataset has been preprocessed in order to make it suitable for statistical analysis. We used a variant of the Latent Dirichlet Allocation (LDA) algorithm to reveal clusters of symptoms and complaints of HA patients (topics). The probability of distribution of words within a topic uniquely characterizes it. The convergence of the log-likelihood of the LDA-model has been reached after 2,000 iterations. Several statistical parameters have been tested for topic modeling and word relevance factor within each topic. Results: Despite a rather small dataset, this exploratory study demonstrates that patients’ free speeches available on the Internet constitute a valuable material for machine learning and statistical analysis aimed at categorizing ST/HA complaints. The LDA model with K = 15 topics seems to be the most relevant in terms of relative weights and correlations with the capability to individualizing subgroups of patients displaying specific characteristics. The study of the relevance factor may be useful to unveil weak but important signals that are present in patients’ narratives. Discussion/Conclusion: We claim that the LDA non-supervised approach would permit to gain knowledge on the patterns of ST- and HA-related complaints and on patients’ centered domains of interest. The merits and limitations of the LDA algorithms are compared with other natural language processing methods and with more conventional methods of qualitative analysis of patients’ output. Future directions and research topics emerging from this innovative algorithmic analysis are proposed.

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“…For tinnitus, the outcome domains and measurement instruments reported in clinical trials are numerous and diverse (Hall et al, 2016), and this precludes comparisons across interventions, as well as pooling the evidence for one type of intervention across studies (e.g., Martinez-Devesa, Perera, Theodoulou, & Waddell, 2010). One of the biggest barriers to good clinical trial design in tinnitus is the insufficient evidence base for choosing which outcomes should be assessed in clinical trials (e.g., Landgrebe et al, 2012;Londero & Hall, 2017;Tyler, Oleson, Noble, Coelho, & Ji, 2007). The current diversity and lack of agreed standards impedes the ability to confidently select the most valid and best performing measurement instrument for quantifying expected treatment-related change for a tinnitus intervention (see Prinsen et al, 2018;Terwee et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

et al. 2019

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Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints (''outcome domains''). For tinnitus, there is no common standard. The Core Outcome Measures in Tinnitus International Delphi (COMiT'ID) study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention that is being evaluated in the clinical trial and to demonstrate that the COMiT'ID recommendations are robust. The COMiT'ID study used an online three-round Delphi method with three separate surveys for sound-, psychology-, and pharmacology-based interventions. Survey data were analyzed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the health-care practitioners), and across health-care users with varying tinnitus duration. There were few dissenting voices, and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.

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Call for an Evidence-Based Consensus on Outcome Reporting in Tinnitus Intervention Studies

Cited by 22 publications

References 31 publications

Problems and Life Effects Experienced by Tinnitus Research Study Volunteers: An Exploratory Study Using the ICF Classification

Problems and Life Effects Experienced by Tinnitus Research Study Volunteers: An Exploratory Study Using the ICF Classification

Assessing the Heterogeneity of Complaints Related to Tinnitus and Hyperacusis from an Unsupervised Machine Learning Approach: An Exploratory Study

One Size Does Not Fit All: Developing Common Standards for Outcomes in Early-Phase Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

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