Nasal valve function is documented in the nasal anatomical worksheet. This sample worksheet documents a patient with mild turbinate hypertrophy, severe left superior and inferior septal deviation, left internal and external nasal valve narrowing, and external nasal valve collapse. Improvement in symptoms was noted with both Cottle and Q-tip maneuvers. This standardized examination permits clinicians to prospectively and efficiently document a complete, scaled, functional nasal examination.
Horstkotte K, Brooks M, Lindsay RW. Creation of an Electronic Data Repository for Patients With Nasal Obstruction Undergoing Functional Rhinoplasty. JAMA Facial Plast Surg. 2016;18(1):73-75. doi:10.1001/jamafacial.2015.1589
Outcomes research for patients with nasal obstruction has been hampered by infrequent objective and quantitative evaluation of nasal function.1 The Nasal Obstruction Symptom Evaluation (NOSE) questionnaire, a validated patient-reported outcomes measure (PROM), allows for prospective evaluation of patients with nasal obstruction.2- 5 However, in practice, PROMs are underused in the field of nasal valve dysfunction, and surgical treatments are still supported only by level 4 evidence.6
Implementation of PROMs in routine clinical practice is hampered by time demands placed on busy clinicians and the inefficiency of paper recording, necessitating subsequent data entry. To address these issues, we created a system that uses electronically administered PROMs and automated data collection. This type of system will be used to determine the relative efficacy of specific surgical techniques on improving nasal obstruction in the context of nasal valve dysfunction. Such a platform will increase research validity and facilitate the creation of best practices across institutions.
REDCap is an electronic data capture platform designed for academic clinical and translational database development,7 which we used to design an integrated system to prospectively collect data from patients undergoing evaluation and surgical treatment for nasal obstruction. This database protocol was approved by the human studies committee at the Massachusetts Eye and Ear Infirmary.
Patients are emailed a secure link to complete an electronic consent form and questionnaires prior to their visit8 (Box). The forms require completion of all fields, and the program performs automatic tabulation of NOSE questionnaire scores on completion of the surveys.
Demographics (Completed by the Clinician or Administrator)
Date of birth
Patient-Reported Outcomes Measures (Completed by the Patient via Email at Home or Web-Based Platform in the Office Prior to Seeing the Clinician and Then at 2, 4, 6, 12, 24, and 36 Months Postoperatively)
Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
Snoring Outcomes Survey (SOS)
EuroQol 5-Dimension 3-Level (EQ-5D-3L)
Nasal History (Completed by the Clinician)
Nasal obstruction (if yes, affected side the left, right, or both)
Nasal steroid use (if yes, did it improve symptoms of nasal obstruction)
History of nasal surgery (if yes, closed nasal reduction, rhinoplasty, septoplasty, sinus surgery, turbinoplasty)
Obstructive sleep apnea (if yes, do you currently use your continuous positive airway pressure machine)
Standardized Nasal Examination (Completed by the Clinician at the Initial Visit and at 2, 4, 6, 12, 24, and 36 Months Postoperatively)
Nasal examination (external nasal examination)
Nasal anatomical worksheet (internal and functional nasal examination)
Standardized Operative Report (Completed by the Clinician on the Day of Surgery)
A detailed standardized nasal history examination is documented on a standardized nasal examination template and Nasal Anatomical Worksheet9 (Figure). Operative information is directly entered into REDCap by the surgeon. The postoperative surveys are completed by the patients via emails that are automatically sent at specific time points after the date of surgery. The event grid within the database efficiently permits one to determine if the forms have been completed at appropriate intervals (Box).
After design and implementation of data collection, we encountered several obstacles to full functionality. Even with a well-developed plan for the electronic database, changes may be needed after implementation requiring dedicated REDCap database support. The concept of this database was that patients would complete the consent and survey forms prior to the visit; however, patients have preferred to complete the surveys at the time of their visit with an iPad (Apple Inc). In fact, of the 572 patients in the database at the time to date, only 2 refused to participate.
Outcomes research is challenging and time consuming but critical to quality improvement. Currently, most clinicians collect data on paper with its inherent difficulties—storage, manpower for data entry, lost data, and inconsistent data collection. Electronic data capture can improve data management by facilitating survey completion, expanding the accuracy and efficiency of data collection, and allowing easy querying and exporting of all data fields.
Herein, we describe our design for a new electronic data capture and storage system for nasal obstruction outcomes research. Large-scale clinical outcomes research will require standardized procedures for data acquisition and storage for use at diverse institutions. To this end, our data collection tool contains a standardized nasal examination, operative details, and outcomes PROMs for patients with nasal obstruction. The ease of use of such systems can also help integrate PROM data collection into daily clinical practice. Internet-based systems such as these are ideal for generalized applicability and multi-institutional research. Without universal standardized data collection tools, we will continue to rely on low-level evidence from anecdotal reports from underpowered studies.
Corresponding Author: Robin W. Lindsay, MD, Division of Facial Plastic and Reconstructive Surgery, Department of Otology and Laryngology, Harvard Medical School/Massachusetts Eye and Ear Infirmary, 243 Charles St, Boston, MA 02114 (email@example.com).
Published Online: November 5, 2015. doi:10.1001/jamafacial.2015.1589.
Author Contributions: Dr Lindsay had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: Lindsay.
Drafting of the manuscript: Lindsay.
Critical revision of the manuscript for important intellectual content: All authors.
Administrative, technical, or material support: All authors.
Study supervision: Lindsay.
Conflict of Interest Disclosures: None reported.
Previous Presentation: This study was presented at the Triological Society Meeting; January 22-24, 2015; San Diego, California.