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Response to “Complications associated with arthroscopic rotator cuff tear repair: definition of a core event set by Delphi consensus process”
ARTICLE IN PRESS J Shoulder Elbow Surg (2017) ■■, ■■
www.elsevier.com/locate/ymse
Response to “Complications associated with arthroscopic rotator cuff tear repair: definition of a core event set by Delphi consensus process” Our recent publications on complications and negative events associated with arthroscopic rotator cuff tear repair (ARCR)1,2 generated some confusion about the nature of our proposal and the terminology used. We think there is a misunderstanding that requires clarification. We highlighted the need for standardization in the way in which complications are documented and reported in orthopedic surgery. Our overall objective was to propose a solution toward this standardization, which requires a structured stepwise approach and international consensus. The title of our most recent publication in this Journal includes the word complication, yet the aforementioned objective was not to define this term. We aimed to develop, by consensus, a structured list of negative (untoward) events relevant in the course of ARCR (ie, the proposed term core event set [CES]), which should be considered for systematic documentation in practice and research. We agree that some of these events may be perceived as “inherent in the procedure” (eg, edema) or a “failure to cure” (eg, recurrent tears) as suggested; however, this is an interpretation the consensus panel did not make. The event of “edema” included in the CES (ie, requiring additional treatment) may not be inherent to ARCR. Whether all or part of the identified events are complications or not is a different matter that can (or probably should) be addressed in a follow-up project, which first requires the successful consensus of a general definition of surgical complication in orthopedics. In addition, it was neither our objective to define all individual terms proposed nor to collect clinical data and to make inferences on the occurrence rate of these events in the target population. Therefore, in what sense should we understand the word “cautious” when our work is based on a consensus decision made by 84 experienced surgeons? It is certainly possible that another panel may have proposed a different event list. Consequently, we consider the current CES as one achievement that requires further evaluation and development, notably by defining selected event terms (eg, stiffness), field testing, and incorporating the patient’s perspective. We believe that the current development provides not only an initial, standardized event list for documenting ARCR patients but also a general framework to facilitate similar
development for other indications or interventions in orthopedics. In a parallel project to define a CES in shoulder arthroplasty, this framework was approved by 90% of the 89 surgeon participants in a first Delphi survey. This is very supportive as we all move toward the standardization of complication or adverse event reporting in orthopedics.
Disclaimer Support for this research was provided by the Schulthess Clinic. The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article. Laurent Audigé, PhD Research and Development, Schulthess Clinic, Zürich, Switzerland Upper Extremities, Schulthess Clinic, Zürich, Switzerland. E-mail address: [email protected] Holger Durchholz, MD Klinik Gut St Moritz, St Moritz, Switzerland Research and Development, Schulthess Clinic, Zürich, Switzerland
References 1. Audigé L, Blum R, Müller AM, Flury M, Durchholz H. Complications following arthroscopic rotator cuff tear repair: a systematic review of terms and definitions with focus on shoulder stiffness. Orthop J Sports Med 2015;3:2325967115587861. http://dx.doi.org/10.1177/2325967115587861 2. Audigé L, Flury M, Müller AM; ARCR CES Consensus Panel, Durchholz H. Complications associated with arthroscopic rotator cuff tear repair: definition of a core event set by Delphi consensus process. J Shoulder Elbow Surg 2016;25:1907-17. http://dx.doi.org/10.1016/j.jse.2016.04.036
1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. http://dx.doi.org/10.1016/j.jse.2017.02.007
www.elsevier.com/locate/ymse
Response to “Complications associated with arthroscopic rotator cuff tear repair: definition of a core event set by Delphi consensus process” Our recent publications on complications and negative events associated with arthroscopic rotator cuff tear repair (ARCR)1,2 generated some confusion about the nature of our proposal and the terminology used. We think there is a misunderstanding that requires clarification. We highlighted the need for standardization in the way in which complications are documented and reported in orthopedic surgery. Our overall objective was to propose a solution toward this standardization, which requires a structured stepwise approach and international consensus. The title of our most recent publication in this Journal includes the word complication, yet the aforementioned objective was not to define this term. We aimed to develop, by consensus, a structured list of negative (untoward) events relevant in the course of ARCR (ie, the proposed term core event set [CES]), which should be considered for systematic documentation in practice and research. We agree that some of these events may be perceived as “inherent in the procedure” (eg, edema) or a “failure to cure” (eg, recurrent tears) as suggested; however, this is an interpretation the consensus panel did not make. The event of “edema” included in the CES (ie, requiring additional treatment) may not be inherent to ARCR. Whether all or part of the identified events are complications or not is a different matter that can (or probably should) be addressed in a follow-up project, which first requires the successful consensus of a general definition of surgical complication in orthopedics. In addition, it was neither our objective to define all individual terms proposed nor to collect clinical data and to make inferences on the occurrence rate of these events in the target population. Therefore, in what sense should we understand the word “cautious” when our work is based on a consensus decision made by 84 experienced surgeons? It is certainly possible that another panel may have proposed a different event list. Consequently, we consider the current CES as one achievement that requires further evaluation and development, notably by defining selected event terms (eg, stiffness), field testing, and incorporating the patient’s perspective. We believe that the current development provides not only an initial, standardized event list for documenting ARCR patients but also a general framework to facilitate similar
development for other indications or interventions in orthopedics. In a parallel project to define a CES in shoulder arthroplasty, this framework was approved by 90% of the 89 surgeon participants in a first Delphi survey. This is very supportive as we all move toward the standardization of complication or adverse event reporting in orthopedics.
Disclaimer Support for this research was provided by the Schulthess Clinic. The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article. Laurent Audigé, PhD Research and Development, Schulthess Clinic, Zürich, Switzerland Upper Extremities, Schulthess Clinic, Zürich, Switzerland. E-mail address: [email protected] Holger Durchholz, MD Klinik Gut St Moritz, St Moritz, Switzerland Research and Development, Schulthess Clinic, Zürich, Switzerland
References 1. Audigé L, Blum R, Müller AM, Flury M, Durchholz H. Complications following arthroscopic rotator cuff tear repair: a systematic review of terms and definitions with focus on shoulder stiffness. Orthop J Sports Med 2015;3:2325967115587861. http://dx.doi.org/10.1177/2325967115587861 2. Audigé L, Flury M, Müller AM; ARCR CES Consensus Panel, Durchholz H. Complications associated with arthroscopic rotator cuff tear repair: definition of a core event set by Delphi consensus process. J Shoulder Elbow Surg 2016;25:1907-17. http://dx.doi.org/10.1016/j.jse.2016.04.036
1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. http://dx.doi.org/10.1016/j.jse.2017.02.007