- Email: [email protected]
Reply to: Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population
Hearing Research xxx (2016) 1
Contents lists available at ScienceDirect
Hearing Research journal homepage: www.elsevier.com/locate/heares
Letter to the Editor
Reply to: Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population
As a co-author of the original Tinnitus Functional Index (TFI) article (Meikle et al., 2012), I was bemused by Fackrell et al.’s recent article in Hearing Research. The authors exerted some degree of effort to fill 15½ pages of this journal with small font text in an attempt to analyze the psychometric properties of the TFI. Unfortunately, their flawed methodology renders some of the article's conclusions invalid. For example, Fackrell et al., in press conducted a retrospective analysis of data collected from 294 participants in a “randomized controlled trial of a novel tinnitus device”. Although the “device” is not named in the article, the Clinicaltrials.gov web site reveals it to be Acoustic Coordinated Reset (CR) Neuromodulation. One disturbing fact about Fackrell et al.’s report is they do not present any outcomes of the clinical trial. Instead, they analyze baseline data and test-retest data for a subset of 44 participants who completed the TFI twice within 15 days. One of the most disturbing aspects of this report is its claims regarding the “responsiveness of the TFI” because no post-interventional data are presented. Despite this lack of pre- and post-treatment comparisons, Fackrell et al. speculate that “The global TFI score may be poorly responsive to treatment-related change in a research population”. Based on the test-retest data of 44 participants, the authors propose a “Smallest Detectable Change” score of at least 22.4 points for this tinnitus assessment instrument. Given that the 44 participants had a baseline TFI score of 45.3, a decrease of 22.4 points would represent a change of >49%. I think we can all agree that a 49% change in tinnitus severity from baseline would be significant in most cases. However, the goal of outcomes assessment is not to identify the greatest possible change, but instead to identify the least amount of change that is clinically significant. In the original TFI article (Meikle et al., 2012), we speculated conservatively that a change of 13 points (or 24%, given the mean baseline score of 54) would be clinically significant. A recent report of transcranial magnetic stimulation (TMS) treatment for tinnitus suggests that a smaller change in TFI score (7e8 points) post-treatment was clinically significant for that study population (Folmer et al., 2015). In fact, the “Smallest Detectable Change” in TFI score that corresponds to clinically significant improvement is not yet known. Additional research involving a variety of tinnitus interventionseand
correlations with other outcome measures e is needed to address the question. Given the heterogeneity of tinnitus populations and the great variety of interventions available, there might be more than one correct answer regarding the Smallest Detectable Change in TFI. In any case, it is a shame that Fackrell et al. did not allow their own assertion, “the single most important factor for clinical trials is the assessment of outcome”, to influence the study design of this report. In the future, they should base their conclusions about questionnaire responsiveness on actual outcome data, instead of speculations extrapolated from baseline data.
References Fackrell K., Hall D.A., Barry J.G. and Hoare D.J., Psychometric properties of the Tinnitus Functional Index (TFI): assessment in a UK research volunteer population.Hear. Res. (in press) Folmer, R.L., Theodoroff, S.M., Casiana, L., Shi, Y., Griest, S., Vachhani, J., 2015. Repetitive transcranial magnetic stimulation treatment for chronic tinnitus: a randomized clinical trial. JAMA Otolaryngol. Head. Neck Surg. 141 (8), 716e722. Meikle, M.B., Henry, J.A., Griest, S.E., Stewart, B.J., Abrams, H.B., McArdle, R., Myers, P.J., Newman, C.W., Sandridge, S., Turk, D.C., Folmer, R.L., Frederick, E.J., House, J.W., Jacobson, G.P., Kinney, S.E., Martin, W.H., Nagler, S.M., Reich, G.E., Searchfield, G., Sweetow, R., Vernon, J.A., 2012. The Tinnitus Functional Index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 33 (2), 153e176.
Robert L. Folmer* National Center for Rehabilitative Auditory Research, Portland VA Medical Center, Portland, OR, USA Department of Otolaryngology, Oregon Health & Science University, Portland, OR, USA *
National Center for Rehabilitative Auditory Research, Portland VA Medical Center, 3710 S.W. U.S. Veterans Hospital Road (NCRAR), Portland, OR, 97239, USA. E-mail address: [email protected]. 6 November 2015 Available online xxx
DOI of original article: http://dx.doi.org/10.1016/j.heares.2015.09.009. http://dx.doi.org/10.1016/j.heares.2016.02.011 0378-5955/Published by Elsevier B.V.
Please cite this article in press as: Folmer, R.L.Reply to: Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population, Hearing Research (2016), http://dx.doi.org/10.1016/j.heares.2016.02.011
Contents lists available at ScienceDirect
Hearing Research journal homepage: www.elsevier.com/locate/heares
Letter to the Editor
Reply to: Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population
As a co-author of the original Tinnitus Functional Index (TFI) article (Meikle et al., 2012), I was bemused by Fackrell et al.’s recent article in Hearing Research. The authors exerted some degree of effort to fill 15½ pages of this journal with small font text in an attempt to analyze the psychometric properties of the TFI. Unfortunately, their flawed methodology renders some of the article's conclusions invalid. For example, Fackrell et al., in press conducted a retrospective analysis of data collected from 294 participants in a “randomized controlled trial of a novel tinnitus device”. Although the “device” is not named in the article, the Clinicaltrials.gov web site reveals it to be Acoustic Coordinated Reset (CR) Neuromodulation. One disturbing fact about Fackrell et al.’s report is they do not present any outcomes of the clinical trial. Instead, they analyze baseline data and test-retest data for a subset of 44 participants who completed the TFI twice within 15 days. One of the most disturbing aspects of this report is its claims regarding the “responsiveness of the TFI” because no post-interventional data are presented. Despite this lack of pre- and post-treatment comparisons, Fackrell et al. speculate that “The global TFI score may be poorly responsive to treatment-related change in a research population”. Based on the test-retest data of 44 participants, the authors propose a “Smallest Detectable Change” score of at least 22.4 points for this tinnitus assessment instrument. Given that the 44 participants had a baseline TFI score of 45.3, a decrease of 22.4 points would represent a change of >49%. I think we can all agree that a 49% change in tinnitus severity from baseline would be significant in most cases. However, the goal of outcomes assessment is not to identify the greatest possible change, but instead to identify the least amount of change that is clinically significant. In the original TFI article (Meikle et al., 2012), we speculated conservatively that a change of 13 points (or 24%, given the mean baseline score of 54) would be clinically significant. A recent report of transcranial magnetic stimulation (TMS) treatment for tinnitus suggests that a smaller change in TFI score (7e8 points) post-treatment was clinically significant for that study population (Folmer et al., 2015). In fact, the “Smallest Detectable Change” in TFI score that corresponds to clinically significant improvement is not yet known. Additional research involving a variety of tinnitus interventionseand
correlations with other outcome measures e is needed to address the question. Given the heterogeneity of tinnitus populations and the great variety of interventions available, there might be more than one correct answer regarding the Smallest Detectable Change in TFI. In any case, it is a shame that Fackrell et al. did not allow their own assertion, “the single most important factor for clinical trials is the assessment of outcome”, to influence the study design of this report. In the future, they should base their conclusions about questionnaire responsiveness on actual outcome data, instead of speculations extrapolated from baseline data.
References Fackrell K., Hall D.A., Barry J.G. and Hoare D.J., Psychometric properties of the Tinnitus Functional Index (TFI): assessment in a UK research volunteer population.Hear. Res. (in press) Folmer, R.L., Theodoroff, S.M., Casiana, L., Shi, Y., Griest, S., Vachhani, J., 2015. Repetitive transcranial magnetic stimulation treatment for chronic tinnitus: a randomized clinical trial. JAMA Otolaryngol. Head. Neck Surg. 141 (8), 716e722. Meikle, M.B., Henry, J.A., Griest, S.E., Stewart, B.J., Abrams, H.B., McArdle, R., Myers, P.J., Newman, C.W., Sandridge, S., Turk, D.C., Folmer, R.L., Frederick, E.J., House, J.W., Jacobson, G.P., Kinney, S.E., Martin, W.H., Nagler, S.M., Reich, G.E., Searchfield, G., Sweetow, R., Vernon, J.A., 2012. The Tinnitus Functional Index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 33 (2), 153e176.
Robert L. Folmer* National Center for Rehabilitative Auditory Research, Portland VA Medical Center, Portland, OR, USA Department of Otolaryngology, Oregon Health & Science University, Portland, OR, USA *
National Center for Rehabilitative Auditory Research, Portland VA Medical Center, 3710 S.W. U.S. Veterans Hospital Road (NCRAR), Portland, OR, 97239, USA. E-mail address: [email protected]. 6 November 2015 Available online xxx
DOI of original article: http://dx.doi.org/10.1016/j.heares.2015.09.009. http://dx.doi.org/10.1016/j.heares.2016.02.011 0378-5955/Published by Elsevier B.V.
Please cite this article in press as: Folmer, R.L.Reply to: Psychometric properties of the Tinnitus Functional Index (TFI): Assessment in a UK research volunteer population, Hearing Research (2016), http://dx.doi.org/10.1016/j.heares.2016.02.011