In response to Laser versus conventional fenestration in stapedotomy for otosclerosis: A systematic review Short-running title: Reply: Letter to the editor
Inge Wegner MD1,2; Digna M.A. Kamalski MD1,2; Rinze A. Tange MD, PhD1,2; Wilko Grolman MD, PhD1,2
1) Department of Otorhinolaryngology – Head and Neck Surgery, University Medical Center Utrecht, the Netherlands 2) Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands
Corresponding author: I. Wegner, MD Department of Otorhinolaryngology – Head and Neck Surgery; G05.129 University Medical Center Utrecht, Heidelberglaan 100 3584 CX Utrecht The Netherlands Tel: +31 88 7556644 Fax: +31 30 2541922 Email: [email protected]
Financial relationships:
None reported
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/lary.24629 The American Laryngological, Rhinological and Otological Society, Inc.
The Laryngoscope
Potential conflicts of interest:
None reported
Reply: Letter to the editor We would like to thank the authors for taking the time to address several important issues regarding our paper on laser versus conventional fenestration in stapedotomy. We agree with the authors that some considerations need to be taken into account when interpreting the findings of our systematic review1. The authors once more stress that no uniform definition of sensorineural hearing loss is used in the included studies and pure-tone audiometric frequencies that were used differ. The difference in pure-tone audiometric frequencies is one of several heterogeneities discussed in our paper, alongside differences in approach to type and settings of the laser, the conventional fenestration technique and follow-up duration.
Regarding one of the other remarks that were raised in the letter: the paper written by the author’s group2 was neither included nor shortlisted. Quite a few years ago Dr. Matthew Yung had the great idea to start an international otological database to be able to gather important surgical data quicker and facilitate research. He contacted many esteemed surgeons to join this Common Otology Database (COD). In the initial idea he proposed that apart from entering the data into the COD, independent auditors were needed for site visits to go through the records for say verification or “regular external validation” as he calls it.3 The paper written by van Rompaey et al. was excluded during the screening process for several reasons. First, no mention was made of the type of laser that was used for laser fenestration, nor was there any mention of the laser settings that were used. Standardization of treatment was not achieved: different types of lasers and surgical techniques were used in the 20 different tertiary-referral centers from which data were collected. Second, the results of 608 surgically treated cases of otosclerosis, with at least 3 months of follow-up, performed in 20 tertiary-referral otologic centers (the benchmark group), over a 5-
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year period were included. This means that on average 6 patients were included per center per year for analysis (608 patients / 20 centers / 5 years = 6 patients/center/year). Since usually far more than 6 otosclerosis patients are surgically treated in tertiary-referral centers, selection bias is most likely an issue. Third, it is possible to enter patient data after the date of the actual surgical procedure was performed in the online Common Otology Database (COD) (tested on January 22nd, 2014). This being the case, the preoperative data could be submitted in the postoperative phase by the surgeon resulting in the inherent risk of becoming a retrospective database and, again, selective reporting cannot be excluded. The need for external data validation during site visits becomes important at this point, as proposed by Yung in 2005. A full disclosure of the participating sites and numbers per site and audit validation dates in the publication would have resulted in including it in our rapid systematic review.
We agree that there is no evidence supporting superiority of one of both techniques, which is also the conclusion of our review1. In lack of high quality and consistent evidence, decisions regarding which method to use are based on expert opinion instead. We prefer the use of laser in stapedotomy when available, taken into account a theoretical risk of both footplate fracture and mechanical trauma.
References 1. Wegner I, Kamalski DM, Tange RA, et al. Laser versus conventional fenestration in stapedotomy for otosclerosis: A systematic review. Laryngoscope. 2013 Nov 11. doi: 10.1002/lary.24514. [Epub ahead of print].
The American Laryngological, Rhinological and Otological Society, Inc.
The Laryngoscope
2. Van Rompaey V, Yung M, Claes J, et al. Prospective Effectiveness of Stapes Surgery for Otosclerosis in a Multicenter Audit Setting: Feasibility of the Common Otology Database as a Benchmark Database. Otol Neurotol. 2009;30:1101-1110. 3. Yung M, Gjuric M, Haeusler R, et al. An international otology database. Otol Neurotol. 2005;26:1087-1092.
The American Laryngological, Rhinological and Otological Society, Inc.
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Inge Wegner MD1,2; Digna M.A. Kamalski MD1,2; Rinze A. Tange MD, PhD1,2; Wilko Grolman MD, PhD1,2
1) Department of Otorhinolaryngology – Head and Neck Surgery, University Medical Center Utrecht, the Netherlands 2) Brain Center Rudolf Magnus, University Medical Center Utrecht, the Netherlands
Corresponding author: I. Wegner, MD Department of Otorhinolaryngology – Head and Neck Surgery; G05.129 University Medical Center Utrecht, Heidelberglaan 100 3584 CX Utrecht The Netherlands Tel: +31 88 7556644 Fax: +31 30 2541922 Email: [email protected]
Financial relationships:
None reported
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/lary.24629 The American Laryngological, Rhinological and Otological Society, Inc.
The Laryngoscope
Potential conflicts of interest:
None reported
Reply: Letter to the editor We would like to thank the authors for taking the time to address several important issues regarding our paper on laser versus conventional fenestration in stapedotomy. We agree with the authors that some considerations need to be taken into account when interpreting the findings of our systematic review1. The authors once more stress that no uniform definition of sensorineural hearing loss is used in the included studies and pure-tone audiometric frequencies that were used differ. The difference in pure-tone audiometric frequencies is one of several heterogeneities discussed in our paper, alongside differences in approach to type and settings of the laser, the conventional fenestration technique and follow-up duration.
Regarding one of the other remarks that were raised in the letter: the paper written by the author’s group2 was neither included nor shortlisted. Quite a few years ago Dr. Matthew Yung had the great idea to start an international otological database to be able to gather important surgical data quicker and facilitate research. He contacted many esteemed surgeons to join this Common Otology Database (COD). In the initial idea he proposed that apart from entering the data into the COD, independent auditors were needed for site visits to go through the records for say verification or “regular external validation” as he calls it.3 The paper written by van Rompaey et al. was excluded during the screening process for several reasons. First, no mention was made of the type of laser that was used for laser fenestration, nor was there any mention of the laser settings that were used. Standardization of treatment was not achieved: different types of lasers and surgical techniques were used in the 20 different tertiary-referral centers from which data were collected. Second, the results of 608 surgically treated cases of otosclerosis, with at least 3 months of follow-up, performed in 20 tertiary-referral otologic centers (the benchmark group), over a 5-
The American Laryngological, Rhinological and Otological Society, Inc.
Page 2 of 4
Page 3 of 4
The Laryngoscope
year period were included. This means that on average 6 patients were included per center per year for analysis (608 patients / 20 centers / 5 years = 6 patients/center/year). Since usually far more than 6 otosclerosis patients are surgically treated in tertiary-referral centers, selection bias is most likely an issue. Third, it is possible to enter patient data after the date of the actual surgical procedure was performed in the online Common Otology Database (COD) (tested on January 22nd, 2014). This being the case, the preoperative data could be submitted in the postoperative phase by the surgeon resulting in the inherent risk of becoming a retrospective database and, again, selective reporting cannot be excluded. The need for external data validation during site visits becomes important at this point, as proposed by Yung in 2005. A full disclosure of the participating sites and numbers per site and audit validation dates in the publication would have resulted in including it in our rapid systematic review.
We agree that there is no evidence supporting superiority of one of both techniques, which is also the conclusion of our review1. In lack of high quality and consistent evidence, decisions regarding which method to use are based on expert opinion instead. We prefer the use of laser in stapedotomy when available, taken into account a theoretical risk of both footplate fracture and mechanical trauma.
References 1. Wegner I, Kamalski DM, Tange RA, et al. Laser versus conventional fenestration in stapedotomy for otosclerosis: A systematic review. Laryngoscope. 2013 Nov 11. doi: 10.1002/lary.24514. [Epub ahead of print].
The American Laryngological, Rhinological and Otological Society, Inc.
The Laryngoscope
2. Van Rompaey V, Yung M, Claes J, et al. Prospective Effectiveness of Stapes Surgery for Otosclerosis in a Multicenter Audit Setting: Feasibility of the Common Otology Database as a Benchmark Database. Otol Neurotol. 2009;30:1101-1110. 3. Yung M, Gjuric M, Haeusler R, et al. An international otology database. Otol Neurotol. 2005;26:1087-1092.
The American Laryngological, Rhinological and Otological Society, Inc.
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