Evaluating the Quality and Safety of In-Office Rhinologic Procedures: A YO-IFOS Pilot Study

: The primary objective of this pilot study was to identify which aspects of in-office rhinologic procedures (IORPs) warrant further attention and investigation in the future. The secondary objectives were to survey which IORPs are most common and to identify needs for education and training. A cross-sectional study was carried out following the Consensus-Based Checklist for Reporting of Survey Studies (CROSS). The survey collected demographic, organizational, quality, and safety aspects of IORPs and was electronically distributed to YO-IFOS members across five continents. A total of 194 surgeons completed the survey, and 172 respondents (88%) performed IORPs. Ninety-nine responders (51.5%) worked in an academic setting. Common procedures included powered polypectomy (48, 28.4%) and turbinate reduction (93, 54.1%). The main concerns were about patients’ tolerance (116, 76.3%) and about the safety of the procedure (102, 67.1%). The most important barriers to the diffusion of IORPs are concerns about the tolerance and safety of these procedures. It would be convenient to establish protocols for this type of procedure to ensure the greatest patient comfort based on evidence.


Introduction
Rhinological procedures performed in-office are increasingly popular due to their distinct advantages over traditional surgery.When appropriately selected, these procedures can avoid general anesthesia, reduce costs and waiting times, and expedite care while delivering comparable benefits [1].However, ensuring patient comfort, safety, and optimal outcomes requires careful consideration of technical and logistical aspects [2].
The scope of office-based rhinologic practices has expanded to include procedures like inferior turbinoplasty, endoscopic sinus surgery techniques, septoplasty, and various types of rhinoplasty and septorhinoplasty [7].IORPs are generally considered safe, with a reported complication rate of 2.5% in a series of 315 procedures [3].The COVID-19 pandemic has further increased the demand for office-based surgeries due to longer surgical wait times [8].This pilot study sought to identify which aspects of IORPs deserve more attention, to gather information on IORP quality and safety concerns, and to address educational and training needs.

Materials and Methods
The study protocol was reviewed and approved by the hospital's ethics committee (Ethical Committee, Hospital Universitario Marques de Valdecilla, Santander, Spain) and by the institutional review board (Code 2021.376).This survey was designed by collaborators of the Rhinology section of the Young Otolaryngologists of International Federation of Oto-rhino-laryngological Societies (YO-IFOS) group.

Target Population and Method
A cross-sectional study was carried out following the most recent guidelines for reporting of surveys (Consensus-Based Checklist for Reporting of Survey Studies, CROSS) [9].The eligibility criteria were board-certified otolaryngologists, whether or not they perform IORPs.An English survey adapted from Lee et al. [1] was electronically distributed through the YO-IFOS mailing list.The anonymous questionnaire was generated using the free software Google Forms (Google Inc., Mountain View, CA, USA).A single-use link that permitted access and the compilation of the survey was sent via e-mail and was open from March to May 2022 for a total of twelve weeks.

Survey Structure
This questionnaire included the following sections: (1) demographic information, (2) aspects related to the location and scope of work, (3) type of rhinological procedures performed in the office, (4) aspects related to training for these procedures and aspects related to personnel and their emergency training, (5) quality and safety aspects related to patient screening, selection, and monitoring, and (6) rationale for choosing to perform these procedures in the office setting versus the operating room (OR).Some questions included multiple choice answers; other questions included "select all that apply" options; and others allowed free-text answers to open-ended questions.
The main variables examined were years of experience, fellowship training, work setting and involvement of the resident or trainee in these procedures, and rationale for choosing to perform these procedures in the office versus the operating room.
The full questionnaire is available in Supplementary Materials.

Statistical Analysis
A formal descriptive analysis was performed.Calculation of the mean, median, or mode for continuous variables and percentages for categorical variables was performed.Categorical variables are presented as the means of absolute and relative frequencies, and numerical variables are presented as the mean (standard deviation) or median (25th and 75th percentiles).Categorical variables were analyzed with the chi-square test, and the numerical variables were analyzed with the Mann-Whitney U test or the Kruskall-Wallis test.Analysis of variance and Fisher's exact test were used where appropriate.A p-value of less than 0.05 was considered statistically significant.The analysis was performed with StataCorp.2021.(Stata Statistical Software: Release 17. College Station, TX, USA: StataCorp LLC).

Results
A total of 194 otolaryngologists from 26 countries across five continents responded to the survey (see Figure 1).The mean age of respondents was 46 years (SD 11.9).Among them, 83 (42.8%) were rhinologists, while 111 (57.2%) practiced general ENT or other subspecialties.Additionally, 40.2% had completed fellowship training in rhinology and skull base surgery.Table 1 summarizes the demographic information.

In-Office Rhinology Procedures (IORPs)
A total of 172 respondents (88.6%) performed IORPs.Common procedures under topical/local anesthesia outside the OR included turbinate reduction (54.1%) and polypectomy (55.2%) (see Table 2).On average, nine in-office polypectomies were performed annually, with a mode of five.

In-Office Rhinology Procedures (IORPs)
A total of 172 respondents (88.6%) performed IORPs.Common procedures under topical/local anesthesia outside the OR included turbinate reduction (54.1%) and polypectomy (55.2%) (see Table 2).On average, nine in-office polypectomies were performed annually, with a mode of five.IORPs were more commonly performed in academic settings than in private practice (92.1% vs. 64.7%,p < 0.001).Within private practice, these procedures were more often performed in a hospital setting, although this difference was not statistically significant (p = 0.10).Vitals were monitored by 57.5% of respondents during and after the procedures.A total of 60.2% never used sedation or pre-medication, while 31.6%used it for anxious patients, and 8.2% used it routinely.

Human Resources, Facilities, and Education
Human resources included an assistant or nursing staff in 79.9% of cases.Otolaryngology trainees were present in 63.4% of procedures.The main practice setting was academic (51.5%), with procedures typically performed in a clinic within the hospital (82%).Nonacademic groups accounted for 34.3%, and solo practices 13%.

Patient Screening/Monitoring
Exclusion criteria included intolerance to nasal endoscopy, significant anxiety, and bleeding disorders.Other criteria were unfavorable anatomy, lesions too bulky for inoffice procedures, uncontrolled hypertension, and lidocaine allergy.Eighty-two percent of respondents advised patients to discontinue anticoagulation medication before IORPs after consulting the prescribing physician.

Procedure and Emergency Equipment
In 71.6% of cases, staff had training for emergencies like CPR or ACLS.There were no significant differences in emergency equipment availability between rhinologists and other subspecialties, or between those who performed IORPs and those who did not (see Tables 3 and 4).The main concerns in performing IORPs were patient tolerance and safety.The primary advantages were avoiding general anesthesia risks and reducing surgical wait times (see Figures 2 and 3).

Discussion
Office-based rhinology is gaining traction among American Rhinologic Society (ARS) members, with increased adoption across various practice settings [1].This trend, however, is not fully understood in other parts of the world [5,6].
Recent research explores the use of office-based rhinology for managing chronic rhinosinusitis with nasal polyposis, simple polypectomy [5], steroid-eluting stents [10], and inferior turbinate reduction [11].Despite small patient numbers, these studies report favorable outcomes for IORPs.Other applications include the drainage of mucoceles [12], balloon dilation of the frontal sinus ostium [13,14], and the reopening of failed dacryocystorhinostomies using powered instruments like microdebriders and lasers [15,16].Additionally, posterior nasal nerve (PNN) ablation for chronic rhinitis has shown promise as a minimally invasive option [17].Generally, patients tolerate IORPs well, reporting low pain and anxiety levels [18].
In-office rhinological procedures (IORPs) are becoming more prevalent due to advancements in medical technology and the benefits they offer in terms of patient convenience, cost effectiveness, and resource utilization.However, they present several challenges that need to be carefully managed to ensure patient safety and procedural success.
Participants in this study had varied experience levels and practice settings [1,19,20], commonly performing nasal polypectomy and turbinate reduction/turbinoplasty.Many had residents or trainees involved in these procedures.Key concerns for IORPs were patient tolerance and procedure safety.Benefits include avoiding general anesthesia, reducing surgical wait times, lowering costs, and speeding up recovery [21][22][23][24].Ensuring respectful staff communication is crucial for minimizing patient anxiety.
Selecting appropriate patients for IORPs is crucial.Not all patients are suitable candidates for these procedures due to various factors such as the severity of their condition, anatomical considerations, and overall health status.Proper patient evaluation and selection are essential to minimize risks and ensure the best outcomes.
Effective anesthesia management is a significant challenge of IORPs.Unlike in traditional operating rooms where general anesthesia is commonly used, in-office procedures often rely on local anesthesia.This requires precise administration to ensure adequate pain control while minimizing risks.
Establishing evidence-based protocols or guidelines for IORPs is advisable to ensure patient comfort and safety.Future research should focus on assessing the effectiveness of various protocols and anesthetic regimens, especially as advanced procedures like hybrid balloon sinus dilation become more common in office settings.For instance, incorporating the maxillary nerve block has shown to enhance anesthesia coverage and reduce complications.Various anesthetic regimens involving oral sedation, topical tetracaine gel, and intranasal local infiltrative anesthesia have shown variable effectiveness [25].
Most participants advised discontinuing anticoagulation medication before IORPs, though NSAIDs were generally not a contraindication.Perioperative bridging with heparin should only be dictated by the patient's condition, not by the procedure itself [26].In a recent study, thirty-five patients underwent in-office balloon sinus ostial dilation while on antiplatelet and/or anticoagulant therapy.None of the patients experienced significant bleeding events postoperatively and only two patients needed absorbable nasal packing for persistent bleeding immediately post procedure [27].
Even minor in-office procedures can encounter complications.Ensuring that emergency equipment and trained staff are available to handle issues such as allergic reactions, excessive bleeding, or cardio-respiratory arrest is vital.Minimally invasive procedures can still lead to complications such as the trigemino-cardiac reflex (TCR), necessitating quick and effective response protocols [3,6].
A comparison with previous surveys revealed a lower percentage of participants performing polypectomies and balloon sinuplasty, potentially due to evolving practices and the availability of new treatments [1,28,29].While IORPs offer cost savings by avoiding operating room expenses and reducing surgical wait times, there are economic and logistical challenges.These include securing appropriate reimbursement, investing in necessary equipment, and managing the logistics of performing surgical procedures in an office setting.In some regions, lack of reimbursement for certain in-office procedures like balloon sinuplasty can hinder their adoption.
There is a need for standardized protocols to guide IORPs.This includes guidelines on patient preparation, anesthesia administration, procedural steps, and post-procedural care.Standardized protocols help ensure consistency in patient care, enhance safety, and improve outcomes across different practice settings.
The skill and experience of the medical practitioners performing IORPs are crucial.As these procedures are integrated into practice, ensuring that otolaryngologists receive adequate training is essential.This includes understanding the nuances of in-office procedures, managing complications, and using specialized equipment effectively.
The shift towards office-based procedures in otorhinolaryngology reflects advancements in technology and procedural techniques, offering patient convenience, cost effectiveness, and reduced healthcare resource utilization [30].It aligns with the broader trend towards patient-centered care, emphasizing personalized treatment plans and enhanced patient engagement.However, it also presents challenges in patient selection, procedural safety, and perioperative management.Ongoing research and quality improvement initiatives are essential to evaluate the safety, efficacy, and long-term outcomes of office-based procedures.In order to strengthen the level of evidence for these procedures, we simply need more studies to be added to the currently scant body of literature.For example, a 2024 paper from Canada presented an impressive report of 1208 patients who underwent IORPs, namely turbinoplasties (35%), FESS (26%), septoplasties (15%), nasal fracture reductions (7%), and other procedures.The authors reported that 1.1% of the procedures were aborted prior to completion, and the post-operative complication rate was 3.2% [31].Hopefully, new studies from other institutions will appear in the next few years, which would make a summary or meta-analysis of the outcomes of IORPs more feasible.
This study has several limitations, including a small and potentially biased sample, and the lack of a detailed assessment of procedure volume and practice patterns.Despite these limitations, it provides a preliminary understanding of IORP practices and highlights the need for standardization and further research to address safety and tolerability concerns.Future studies should explore detailed monitoring protocols and best practices to facilitate wider adoption of IORPs.

Conclusions
This study highlights the preliminary findings on office-based rhinology practices.The small and unrepresentative sample limits the generalizability of the results.However, it provides a first step in understanding the quality and safety concerns of IORPs and identifying areas for future research.Standardizing best practices and conducting further studies on patient outcomes and procedural safety will help broaden the adoption of IORPs and address current barriers.

Figure 2 .
Figure 2. Reasons for performing rhinologic procedures in an in-office setting.Figure 2. Reasons for performing rhinologic procedures in an in-office setting.

Figure 2 .
Figure 2. Reasons for performing rhinologic procedures in an in-office setting.Figure 2. Reasons for performing rhinologic procedures in an in-office setting.

Figure 2 .
Figure 2. Reasons for performing rhinologic procedures in an in-office setting.

Figure 3 .
Figure 3. Reasons for not performing rhinologic procedures in an in-office setting.Figure 3. Reasons for not performing rhinologic procedures in an in-office setting.

Figure 3 .
Figure 3. Reasons for not performing rhinologic procedures in an in-office setting.Figure 3. Reasons for not performing rhinologic procedures in an in-office setting.

Table 2 .
Which of these rhinologic procedures do you perform in-office under topical/local anesthesia with or without sedation?

Table 1 .
Demographic information.Range and standard deviation are shown where applicable.
* Rhinology practice vs. another subspecialty or general ENT.

Table 2 .
Which of these rhinologic procedures do you perform in-office under topical/local anesthesia with or without sedation?

Table 3 .
Surgical and emergency equipment.