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Date: 10/21/2022
To: "Jacqueline M.K. Wong"
From: "The Green Journal" [email protected] Subject: Your Submission ONG-22-1637
RE: Manuscript Number ONG-22-1637
The Elephant in the OR: A Call to Action for Ergonomic Surgical Devices Designed for Diverse Surgeon End-Users Dear Dr. Wong:
Thank you for sending us your work for consideration for publication in Obstetrics & Gynecology. Your manuscript has been reviewed by the Editorial Board and by special expert referees. The Editors would like to invite you to submit a revised version for further consideration.
If you wish to revise your manuscript, please read the following comments submitted by the reviewers and Editors. Each point raised requires a response, by either revising your manuscript or making a clear argument as to why no revision is needed in the cover letter.
To facilitate our review, we prefer that the cover letter you submit with your revised manuscript include each reviewer and Editor comment below, followed by your response. That is, a point-by-point response is required to each of the EDITOR COMMENTS (if applicable), REVIEWER COMMENTS, and STATISTICAL EDITOR COMMENTS (if applicable) below.
The revised manuscript should indicate the position of all changes made. Please use the "track changes" feature in your document (do not use strikethrough or underline formatting).
Your submission will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by 11/11/2022, we will assume you wish to withdraw the manuscript from further consideration.
EDITOR COMMENTS:
Please note the following:
* Please change the article type to Personal Perspective, and delete the current abstract. It is not needed for the different article type.
* Help us reduce the number of queries we add to your manuscript after it is revised by reading the Revision Checklist at https://journals.lww.com/greenjournal/Documents/RevisionChecklist_Authors.pdf and making the applicable edits to your manuscript.
REVIEWER COMMENTS:
Reviewer #1: Review of Manuscript ONG-22-1637 "The elephant in the OR: A call to action for ergonomic surgical devices designed for diverse surgeon end users"
Ain interesting current commentary that calls into question the true ergonomic benefits of laparoscopic instrumentation has been submitted. As noted by the authors, perhaps one size does not fit alone when it comes to laparoscopic
instrumentation across surgeons. The authors note that much of the lack of true ergonomics may impact female surgeons more than their male counterparts, although they provide an asterisk to explain their gender terminology selection. I have the following questions and comments.
Title - Not a big fan of using an idiom in a title but defer to the editors.
Précis - None provided.
Abstract - None
View Letter
1 of 3 11/14/2022, 12:13 PM
Introduction -
Is there Gyn specific literature that addresses issues with some of the more common laparoscopic instrumentation used?
Line 28 - What about the powered laparoscopic staplers which are seemingly more commonly stocked in hospitals?
Line 29 - In the future please remove phrases or words that have a strike through.
Line 50 - What was done with the issue of trigger force?
Line 72 - Is there an estimate, based on surgeon glove size, the potential number of "sizes" of instrumentation that may be needed - say small, medium and large? Moreover, while not the purpose of this commentary, what if a trainee surgeon needed to use a "smaller' instrument and the attending physician needed to use a "larger" instrument, how do health economics then impact charges for the institution and a patient?
Reviewer #2:
ONG-22-1637
The Elephant in the OR: A Call to Action for Ergonomic Surgical Devices Designed for Diverse Surgeon End-Users The author/authors nicely describe the repercussions of the use of "one size fits all" surgical devices and instruments.
Specifically, the authors reference multiple studies describing the frequency and extent of work-related musculoskeletal disorders attributed to the mismatch between instrument/device design and surgeon hand size. I have several
observations and questions for the authors.
-The authors list six call to action measures at the conclusion of the commentary. Action one calls for surgical societies and device companies to form partnerships to promote research on surgeon ergonomics. Most of the studies referenced in the manuscript are based on questionnaires with self-reported outcomes and low response rates. From a research
standpoint, how would the authors propose to distinguish the ergonomic impact of a particular device from other ergonomic factors such as table height, degree of Trendelenburg positioning, duration of the procedure and patient size?
Action two suggests developing a platform for reporting ergonomic-related injuries of employed surgeons to the Occupational Safety and Health Administration (OSHA). Do the authors consider an ergonomic-related injury to be an employer responsibility or manufacturer responsibility?
Actions three, four and five involve a call for design, manufacturing, regulation and purchasing of devices for a diverse group of end-users. From a practical standpoint, would having an instrument/device designed for a specific end-user be cost prohibitive? For many cases of minimally invasive surgery, the primary surgeon is assisted by a co-surgeon, resident physician, or surgical assistant. As an example, would a five-foot one-inch attending physician operating with a six-foot one-inch resident physician share the same laparoscopic grasper, needle driver and scissor? Will the institution be expected to provide two sets of instruments based on the physical characteristics of two different surgeons?
Very clearly, having instruments optimized to specific surgeon characteristics would be ideal. However, as gynecologic surgeons we deal with multiple factors that may contribute to work-related musculoskeletal disorders such as operating tables that don't reach optimal height, vaginal surgery that requires assistants to maintain abnormal posture,
hyperextended knees because of leaning over morbidly obese patients during laparotomy, holding a laparoscopic camera in a stable position for hours, etc. What role does the education play helping surgeons reduce injury to themselves in the operating room? Do the authors see robotic techniques as a solution to minimize some of the mechanical or ergonomic factors surgeons face?
Reviewer #3: This commentary covers an important topic that is relevant to readers of this journal. The authors support their points and recommendations with an organized outline and well thought out call to action. Although there is gendered language throughout the manuscript, the authors do provide an appropriate clarification at the end of the prose to explain why this was included. The authors could consider including some type of clarification statement about the gendered language at the beginning of the article in some way to make it more clear, particularly given the focus of the article is about inclusion and equity.
3 11/14/2022, 12:13 PM
-- Sincerely,
Jason D. Wright, MD Editor-in-Chief
The Editors of Obstetrics & Gynecology
__________________________________________________
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View Letter
3 11/14/2022, 12:13 PM
Dear Dr. Wright and Journal Reviewers,
We are very grateful for your comments and review of our paper, entitled “The Elephant in the OR: A Call to Action for Ergonomic Surgical Devices Designed for Diverse Surgeon End-Users.”
We believe that your reviewers’ valuable feedback has helped to make this manuscript stronger. We are pleased to submit this revised version of the manuscript, in which we have addressed the reviewers’ comments fully and have edited the manuscript accordingly.
Thank you again for your consideration.
Jackie Wong Louise King Erin Carey Kelly Wright Cara King Rosanne Kho
________________________________________________________________________
EDITOR COMMENTS:
Please note the following:
* Please change the article type to Personal Perspective, and delete the current abstract. It is not needed for the different article type.
- This has been edited accordingly.
* Help us reduce the number of queries we add to your manuscript after it is revised by reading the Revision Checklist
at https://urldefense.com/v3/ https://journals.lww.com/greenjournal/Documents/RevisionC hecklist Authors.pdf ;!!Mi0JBg!P6cyIV2WQlMc7uEle 9j1iq0jZQ75lQHW7kaItI84VmARyAvOH nxU3fuhEUmjoYpcg4EllQZYanaxO1A$ and making the applicable edits to your manuscript.
- Noted and followed.
REVIEWER COMMENTS:
Reviewer #1: Review of Manuscript ONG-22-1637 "The elephant in the OR: A call to action for ergonomic surgical devices designed for diverse surgeon end users"
Ain interesting current commentary that calls into question the true ergonomic benefits of
laparoscopic instrumentation has been submitted. As noted by the authors, perhaps one size
does not fit alone when it comes to laparoscopic instrumentation across surgeons. The authors
note that much of the lack of true ergonomics may impact female surgeons more than their
male counterparts, although they provide an asterisk to explain their gender terminology selection. I have the following questions and comments.
Title - Not a big fan of using an idiom in a title but defer to the editors.
- Revised accordingly to: “A call to action for ergonomic surgical devices designed for diverse surgeon end users"
Précis - None provided.
Abstract - None Introduction -
Is there Gyn specific literature that addresses issues with some of the more common laparoscopic instrumentation used?
- There is newly published literature available regarding gynecologic surgeons’ ergonomic outcomes from use of various laparoscopic advanced energy devices. This information has been added to the updated manuscript accordingly [lines 18-20].
Line 28 - What about the powered laparoscopic staplers which are seemingly more commonly stocked in hospitals?
- We agree that the introduction of powered laparoscopic staplers was an important
innovation to help alleviate the large ergonomic strain caused by manual stapler use. This has been added to the manuscript and edited accordingly [lines 79-81].
Line 29 - In the future please remove phrases or words that have a strike through.
- Edited accordingly.
Line 50 - What was done with the issue of trigger force?
- We have cited this example based on peer-reviewed research demonstrating that female soldiers were most affected by task failure from pistol firing, with reduction in both trigger weights and handle span suggested as the two most likely interventions to improve pistol ergonomics for women soldiers. It is unknown to the authors whether future research on trigger force requirements related to soldier pistol firing were subsequently conducted and whether this changed military practice.
Line 72 - Is there an estimate, based on surgeon glove size, the potential number of "sizes" of instrumentation that may be needed - say small, medium and large? Moreover, while not the purpose of this commentary, what if a trainee surgeon needed to use a "smaller' instrument and the attending physician needed to use a "larger" instrument, how do health economics then impact charges for the institution and a patient?
- This is such an impactful question that gets to the heart of the issue of laparoscopic
instrument ergonomics: what population(s) of surgeons will be able to have their tools fit
their hands and needs? We would argue, in line with the recommendations of ergonomic and
human factors engineers, that ideal laparoscopic instrumentation is actually size- and gender-
acquisition and economically feasible. We have edited the manuscript accordingly to reflect this sentiment [lines 81-84].
We would also gently suggest that this comment reflects ableism albeit unintentionally.
Advocates for persons with disabilities frequently note that many access issues are simply design issues. As an example, regulations that required ramps for persons in wheelchairs in the end afford able bodied-persons with two options - ramp and stairs. An alternative used in some designs is no stairs at all. Those who are fully ambulatory can still easily use the ramp and while that might take them slightly more time, it decreases the incidence of falls.
Similarly, as manufacturers study optimal sizes for instruments they may opt to only create smaller handpieces that works for the largest number of variable hand sizes and those with larger hands will be able to use those smaller instruments but may have to adapt. This is a necessary step towards equity. The costs and charges need not be increased or passed on as suggested by the question if all involved commit to finding optimal instrument sizing for users.
Reviewer #2:
ONG-22-1637
The Elephant in the OR: A Call to Action for Ergonomic Surgical Devices Designed for Diverse Surgeon End-Users
The author/authors nicely describe the repercussions of the use of "one size fits all" surgical devices and instruments. Specifically, the authors reference multiple studies describing the frequency and extent of work-related musculoskeletal disorders attributed to the mismatch between instrument/device design and surgeon hand size. I have several observations and questions for the authors.
-The authors list six call to action measures at the conclusion of the commentary. Action one calls for surgical societies and device companies to form partnerships to promote research on surgeon ergonomics. Most of the studies referenced in the manuscript are based on
questionnaires with self-reported outcomes and low response rates. From a research
standpoint, how would the authors propose to distinguish the ergonomic impact of a particular device from other ergonomic factors such as table height, degree of Trendelenburg positioning, duration of the procedure and patient size?
-There remain many necessary steps in research ahead before we fully understand how the surgeon, patient, device, and environmental factors and their interactions together all create an ultimate ergonomic experience for surgeons. The authors have conducted separate
research into the specific ergonomic factors related intrinsically to certain laparoscopic
devices, which has been recently published and added to the manuscript accordingly [lines
18-20]. Briefly, this research involved an ergonomic simulation in which a static ergonomic
position was maintained while the surgeon performed rapid, repetitive movements with various advanced energy laparoscopic devices.
Intersectionality is also frequently an issue in discrimination. Here the intersectionality
implicates multiple companies, which is interesting. We would assert that the companies that manufacture gloves, instruments, and tables – and the hospitals that purchase them – are charged with addressing these issues as well. It is the duty of those causing known and established harm to conduct studies to determine how to rectify the issues, not the duty of those who suffer the discriminatory effects, to do so.
Action two suggests developing a platform for reporting ergonomic-related injuries of employed surgeons to the Occupational Safety and Health Administration (OSHA). Do the authors consider an ergonomic-related injury to be an employer responsibility or manufacturer responsibility?
-We have edited the manuscript to expand upon the question here of the role of OSHA in the reporting of surgeon injuries. OSHA has an existing mandate under the Occupational Safety and Health Act General Duty Clause, Section 5(a)(1) to promote the ergonomic safety of employees, and so through this federal policy, ergonomic-related injuries are considered an employer responsibility. Ultimately, OSHA, the FDA, and the consumer product liability commission and various state laws consider it the responsibility of both the manufacturer and employer. [lines 104-110].
Actions three, four and five involve a call for design, manufacturing, regulation and purchasing of devices for a diverse group of end-users. From a practical standpoint, would having an instrument/device designed for a specific end-user be cost prohibitive? For many cases of minimally invasive surgery, the primary surgeon is assisted by a co-surgeon, resident physician, or surgical assistant. As an example, would a five-foot one-inch attending physician operating with a six-foot one-inch resident physician share the same laparoscopic grasper, needle driver and scissor? Will the institution be expected to provide two sets of instruments based on the physical characteristics of two different surgeons?
-Reviewer #1 had a similar thoughtful question, and we have included our response again here below:
This is such an impactful question that gets to the heart of the issue of laparoscopic instrument ergonomics: what population(s) of surgeons will be able to have their tools fit their hands and needs? We would argue, in line with the recommendations of ergonomic and human factors engineers, that ideal laparoscopic instrumentation is actually size- and gender- neutral, and instead is able to accommodate a large range of hand sizes and strengths. This is likely to achieve ideal surgeon comfort while remaining practical for hospital supply chain acquisition and economically feasible. We have edited the manuscript accordingly to reflect this sentiment [lines 81-84].
Very clearly, having instruments optimized to specific surgeon characteristics would be
ideal. However, as gynecologic surgeons we deal with multiple factors that may contribute to
work-related musculoskeletal disorders such as operating tables that don't reach optimal
laparoscopic camera in a stable position for hours, etc. What role does the education play helping surgeons reduce injury to themselves in the operating room? Do the authors see robotic techniques as a solution to minimize some of the mechanical or ergonomic factors surgeons face?
-We believe strongly that continued education, research, and advocacy remain essential to the acknowledgement, understanding, and optimization of surgeon ergonomics. The value of research and education is exemplified in particular in our call to action measure 1 [lines 120- 121]. These questions belie how much surgeon ergonomic safety a culture issue. Surgeons are likely educated enough to know that there must be solutions available, but they don't have the purchase power or agency to create solutions. So, it is the duty of companies and hospitals to protect surgeons from injury. This is similar to our burnout issue. It is not a matter of lack of resiliency or lack of knowledge re mental health that causes burnout in physicians and high suicide rates. It is a failure of those in leadership to create systems and work environments that are conducive to flourishing.
Robotic assisted techniques have classically been posed as a solution to poor laparoscopic ergonomics, however robotic surgery has its own ergonomic limitations as well. This includes nonoptimal robot console design for small users, which can lead to feet not resting flat on the floor and excessive lower back muscle engagement. Use of a robotic system also tends to worsen ergonomic issues for those at the bedside who have to work around the robotic arms.
Transferring greater ergonomic risk to scrub techs, assistants, and PAs also does not represent an ideal direction.
Reviewer #3: This commentary covers an important topic that is relevant to readers of this journal. The authors support their points and recommendations with an organized outline and well thought out call to action. Although there is gendered language throughout the
manuscript, the authors do provide an appropriate clarification at the end of the prose to explain why this was included. The authors could consider including some type of clarification statement about the gendered language at the beginning of the article in some way to make it more clear, particularly given the focus of the article is about inclusion and equity.
-We agree that a particular focus on sex/gender inclusiveness is both relevant and important in this article. We have changed the asterisk position alerting to the presence of a clarification statement regarding this gendered language to be immediately following the first mention of surgeon sex in this article accordingly [line 20].
-- Sincerely,
Jason D. Wright, MD Editor-in-Chief
The Editors of Obstetrics & Gynecology
