Question 1

I am interested; what's the next step?

Accepted Answer

Select the Join Us! button above and complete the OtoSurg 1 Site Interest Form.(https://docs.google.com/forms/d/e/1FAIpQLSeAJD4CEp_toaoV1IhK32gu3WGRUMUJPNaZkXxPmO9XMvu6qg/viewform) Dont forget to join our WhatsApp community!(https://chat.whatsapp.com/F4FNVTgc1QPAlbltWXLpww)

If you do not hear from the Recruitment and Publicity Team within 7 days, email us at, otosurg.recruitment@gmail.com.(otosurg.recruitment@gmail.com)

Question 2

What is OtoSurg 1?

Accepted Answer

Oto-Surg 1 is the first-ever international prospective cohort study focused on pediatric tonsillectomy. It brings together collaborators worldwide to better understand the indications, techniques, and outcomes of tonsillectomy across diverse healthcare settings.

Question 3

What are the aims of OtoSurg 1?

Accepted Answer

The primary aims are to:
1. Characterize pediatric tonsillectomy surgical indications and techniques across global WHO regions.
2. Quantify global pediatric 30-day post-tonsillectomy complications and mortality.

The secondary aims are to:
1. Recruit and train a collaborative research network of otolaryngology surgeons and trainees from around the world who will be poised to carry out future research projects.
2. Build the digital infrastructure necessary to support this network sustainably.

Question 4

Why is this study important?

Accepted Answer

Pediatric tonsillectomy is one of the most common surgical procedures worldwide; however, outcomes and practices vary significantly across different WHO regions. By gathering standardized data globally, we aim to identify preventable complications, reduce disparities, and improve surgical care for children everywhere. We also hope this study will lay the foundation for future global otolaryngology-focused outcomes research.

Question 5

Who can participate?

Accepted Answer

Any clinician or trainee who performs pediatric tonsillectomies is eligible to participate, regardless of their country, hospital size, or resource setting. Both high-income and low- and middle-income countries are encouraged to join. So, yes, that means you can participate! We hope you will join us.  
 
Exception: unfortunately, sites in China are excluded due to the Personal Information Protection Law of the People’s Republic of China (PIPL).

Question 6

What are the benefits of participating?

Accepted Answer

By joining, you can 1) become a co-author and contributor to the first-ever prospective global dataset on pediatric tonsillectomy, 2) contribute to research that directly improves patient care and safety, 3) meet other like-minded trainees or surgeons from around the world, and 4) learn more about global health outcomes research.

Question 7

How much time or resources are required?

Accepted Answer

Participation is designed to be easy, stress-free, and feasible even in busy clinical settings. Each center will collect standardized data on a set number of consecutive pediatric tonsillectomy patients over a flexible 60-day data collection period.

Question 8

How will data be collected?

Accepted Answer

Data will be entered into a secure, web-based platform via REDCap. No identifiable patient information will be collected or shared. Each participating site will receive complete guidance on ethics approvals and data security.

Question 9

Who is organizing the study?

Accepted Answer

OtoSurg 1 is led by the Global OHNS Initiative, in collaboration with international leaders in otolaryngology and global surgery research. You can learn more about the Global OHNS Initiative by exploring other sections of our website.

Question 10

How will collaborators be recognized?

Accepted Answer

All collaborators will be listed as PubMed-indexed co-authors on primary study publications, in accordance with collaborative authorship models (e.g., GlobalSurg). More information regarding research equity can be found on the Global OHNS Initiative website under the “Research” tab.

Question 11

Will other sites have access to my data, and/or can I access data from different sites?

Accepted Answer

No. All data will be submitted securely via REDCap and stored centrally through Emory University. Each participating site will have access to its own data but will not have access to data from other sites. Please refer to the data collection agreement for additional details. The data will only be used for the OtoSurg 1 project.

Question 12

Is IRB/Ethics board approval required for my site to participate?

Accepted Answer

Yes. There is a central IRB approved through Emory University to organize this project and house the data in REDCap. However, each participating site must obtain its own institutional research ethics approval or exemption to participate. We have created resources to streamline this process for you, making it as easy as possible. These resources can be found under the “Resources for Partner Sites” tab on the OtoSurg section of the Global OHNS Initiative website.

Question 13

What are the dates this project will take place?

Accepted Answer

The study will begin with recruiting and training participating sites.

• Recruitment, training, and individual site IRB approval will occur over 12 months from October 13, 2025, to October 13, 2026.

• The six-month data collection period will be from October 13, 2026, to April 13, 2027. Individual sites will be able to select any 60-day interval during this data collection window to record and submit their data.

• Data cleaning, preparation, and analysis will occur over four months, from April 13, 2027, to August 13, 2027.

• Manuscript writing, review, and author validations will occur over two months, from August 13, 2027, to October 13, 2027.

• We anticipate submitting the final manuscript in the fall/winter of 2027/2028.

Question 14

How can I learn more details about the study?

Accepted Answer

You can access the study protocol, training materials, and updates through our website, specifically under the "Resources for Partner Sites" tab. Live webinars and Q&A sessions will also be held for interested participants.

Question 15

I have a question that I couldn’t find the answer to on the website. How do I contact the team?

Accepted Answer

You can reach our leadership team through our WhatsApp community (https://chat.whatsapp.com/F4FNVTgc1QPAlbltWXLpww)and via our email address, otosurgohns@gmail.com.(otosurgohns@gmail.com)