|Year : 2014 | Volume
| Issue : 1 | Page : 35-41
Adapting quality assurance principles to open structure rhinoplasty Ahmed Elguindy
Department of Otolaryngology and Head & Neck Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt
|Date of Submission||10-Nov-2013|
|Date of Acceptance||23-Nov-2013|
|Date of Web Publication||7-Apr-2014|
Department of Otolaryngology and Head & Neck Surgery, Faculty of Medicine, Tanta University, 2 Omar Ibn Abdelaziz Street, PO Box 527, Tanta 31211
Rhinoplasty is a pursuit for perfection, and every esthetic surgeon strives for excellence.
The aim of the study was to evaluate the methodology and outcomes of open structure rhinoplasty after adapting quality assurance (QA) principles during planning, surgery, and follow-up.
Participants and methods
QA principles were adapted to a prospective cohort study conducted in a tertiary care center on 72 patients undergoing open structure rhinoplasty, starting with a surgeon recognizant of the nasal esthetic and functional standards (quality defining). Patient's esthetic and functional variants were analyzed and deformities were identified (quality measuring). Patient's objectives were checked against surgery limitations to realize expectations. Quality improvement required effective selection of techniques and efficient sequencing of steps. The results were checked against patient's expectations and satisfaction, and against conformance to the esthetic and functional standards.
In all, 90.6% of the surgeries met patient's expectations, whereas 92.2% fulfilled patient's satisfaction. 85.9% of patients conformed to esthetic measures and 93.7% to functional parameters.
Adapting QA principles to open rhinoplasty allowed standardization of methodology and better assessment of operation outcomes in a precise and accurate manner. It enhances education through a progressive procedure, starting with defining norms, analyzing variants, identifying deformities, realizing demands, recognizing limitations, virtualizing possible result, reaching agreement, selecting technique, sequencing steps, performing a safe surgery, and ending with achieving preset goals effectively and efficiently with better patient's quality of life.
Keywords: Rhinoplasty, quality assurance, outcomes research, esthetic surgery
|How to cite this article:|
Elguindy A. Adapting quality assurance principles to open structure rhinoplasty Ahmed Elguindy. Tanta Med J 2014;42:35-41
| Introduction|| |
Rhinoplasty is the most challenging, commonly performed procedure of facial plastic surgery. Successful rhinoplasty requires detailed understanding of the nasal anatomy and physiology to produce a functional and esthetically pleasing nose. In the past, surgeons used reductive techniques to decrease the size and alter the shape of the underlying cartilage and bone at the expense of the stability and function of nasal framework. Over the last 25 years, rhinoplasty has undergone significant changes. With expansion of knowledge and practice, surgeons have recently focused more on repositioning and restructuring existing tissues to ensure long-term cosmetic results while respecting and optimizing nasal airway function.
Rhinoplasty is a pursuit for perfection, and every esthetic surgeon strives for excellence. Quality assurance (QA) broadly means conformance to standards, meeting customer's expectations, and fulfilling consumer's satisfaction . The author, as a manager of Quality Assurance Unit in his Medical School and as an instructor of Higher Education Quality Improvement for many years, felt that adopting and adapting the QA principles in his open structure rhinoplasties might help in the achievement of preoperative goals in a predictable and controllable manner and improve the quality of life (QOL) of his patients.
This prospective cohort study was conducted to evaluate the methodology and outcomes of open structure rhinoplasty after adapting QA principles during planning, surgery, and follow-up.
| Participants and methods|| |
This prospective cohort study was conducted on a consecutive series of 72 patients undergoing open structure rhinoplasty at Otolaryngology and Head & Neck surgery Department, Tanta University Hospitals, during the period from February 2010 to June 2011. The indications were cosmetic demand with or without associated functional request. The inclusion criteria were patients above 18 years presenting with twisted nose, dorsal hump, or tip deformities. The exclusion criteria were acute nasal trauma or fracture in the past 3 months, revision surgery after prior septoplasty or rhinoplasty, adenoid hypertrophy, craniofacial anomalies (e.g. cleft palate), chronic sinusitis, or sinonasal masses. Written informed consent was signed by the patient. The study protocol was approved by both institutional and regional ethics committees.
The QA principles were adapted starting with the QA triangle; the first angle is quality defining (QD) that means a surgeon recognizant of the nasal esthetic and functional standards. The second angle is quality measuring (QM) that necessitated analyzing patient's anatomic and functional variants and identifying present deformities and deviations before operation. Patient's objectives were checked against surgery limitations to realize expectations, aided by preoperative digital imaging. Quality improvement (QI) is the third angle that is applied through four steps [Figure 1]; after identifying the problem (Identify) and understanding its causes (Analyze), the objectives or changes needed to improve the problem is hypothesized (Develop), and tested (Test/Implement) through the PDSA cycle where the surgical steps are planned, performed, studied, modified, or implemented. QI integrates two main activities: effective selection of the techniques (What is performed or content) and efficient sequencing of the steps (How is it performed or process).
All patients were operated upon by the author. The operation was performed under general anesthesia. Under the operative microscope, an inverted V-shaped midcolumellar incision was made and the skin-soft tissue envelope was elevated [Figure 2]. The surgical manipulations involving the nasal septum varied from the classical septoplasty, extracorporeal septoplasty, and caudal septum relocation to harvesting septal cartilage graft. Nasal dorsum height was reduced, if needed, by osteotomes, rasps, or electric drills [Figure 3]. Nasal dorsum width was then reduced, if needed, by medial or lateral (and sometimes intermediate) osteotomies, which may be external or internal [Figure 4]. Thereafter, alar cartilages were resized, reshaped, and repositioned [Figure 5], if needed. Internal nasal valve narrowing was treated by spreader grafts and/or septoplasty and turbinate reduction. The skin flap was redraped, and the incision was closed. Finally, alar base narrowing, if needed, was performed by wedge resection. After executing all the surgical steps, splints/dressings were applied. Follow-up visits were arranged every week in the first 2 months and then every month for 1 year.
Following QA concepts, the results were checked against meeting patient's expectations and fulfilling patient's satisfaction, and against conformance to the esthetic nasal measures and functional clinical parameters. Patient's expectation was measured by comparing preoperative virtual image with the postoperative real one on a scale  from 1 to 4, where 1 = identical, 2 = similar, 3 = approximate, and 4 = poor. Patient's satisfaction was measured by preoperative and postoperative evaluation with the Rhinoplasty Outcome Evaluation (ROE) scale  that is a standardized validated procedure-specific QOL questionnaire. The ROE instrument is structured of six items; each is scored on a 0-4 scale, with 0 representing the most negative response and 4 representing the most positive response. Dividing the total score for each instrument by 24 and multiplying by 100 yields the scaled instrument score. The range is 0-100, with 0 representing the least patient satisfaction and 100 representing the highest patient satisfaction. Conformance to the standards was evaluated for nasal form and function through measuring facial symmetry and nasal esthetic angles and assessing the nasal septum and nasal valve. For evaluation of facial symmetry, A-P photographs were taken for the patients preoperatively and postoperatively in the standardized position. A straight line is drawn between the pupils, and the center point between the medial canthi is marked. From this point, a straight midline vertical line is dropped intersecting the nasal dorsum, tip, columellar base, nasal spine, philtrum, upper incisors, and menton. Patient with a twisted nose was evaluated postoperatively as corrected, worsened deviation, or residual deviation. The A-P photographs were also used to assess the width of the alar base, which should approximate the intercanthal distance. Patients undergoing dorsal hump reduction were assessed by analysis of the profile photographs before and after surgery. Nasal hump reduction was considered successful, if the surgery results in acceptable refinement of the dorsal profile. Generally, the contour of the dorsal profile should be relatively straight with slight convexity at the rhinion in male patients, whereas a slight concavity is desirable in female patients. Evaluation of tip rotation and projection was assessed by analysis of the profile view. Tip projection was evaluated by measuring the nasofacial (NFA) angle and the Goode ratio (GR). The nasal tip rotation was evaluated by measuring the nasolabial angle (NLA) and the tip rotation angle (RA). Evaluation of the shape and position of the nasal septum was carried out by anterior rhinoscopy. The severity of deviation was scored on a four-point scale of none, mild, moderate, and severe grades . Mild deviations were defined as occluding up to one-third of the lumen, moderate deviations occluding between one-third and two-third of the lumen, and severe deviations occluding more than two-third of the nasal cavity lumen. Nasal valve was assessed on both sides by digital imaging analysis of video endoscopy. Data from preoperative and postoperative evaluations were then analyzed to evaluate the responsiveness to change. A paired Student's t-test was used to compare the preoperative and postoperative scores. A P value of less than 0.001 was considered statistically significant.
| Results|| |
A total of 72 patients met the inclusion and exclusion criteria; 64 of them completed the follow-up period, and hence were enrolled in the study. The characteristics of the patients are summarized in [Table 1]. [Table 2] shows the surgical procedures performed in the study population. The follow-up period ranged from 7 to 16 months (mean ± SD, 9.03 ± 2.01 months).
On comparing preoperative virtual image with the postoperative real one to evaluate patient's expectations, 58 patients (90.6%) rated the results as identical (34 patients) or similar (24 patients), whereas the results were rated approximate by three patients and poor by three.
Analysis of the distribution of the difference between the preoperative and postoperative ROE scores showed that the mean preoperative ROE score (± SD) was 31.6 ± 8.5, the mean postoperative ROE score (± SD) was 86.64 ± 8.65. The median difference (± SD) was -55.04 ± 9.29. Statistical analysis of the ROE score differences showed significant improvement in the postoperative state compared with the preoperative state (P<0.001). In all, 92.2% of the study population was satisfied to variable degrees.
A total of 57 patients had septal deviation; the deviation was severe in seven patients, moderate in 41, and mild in nine patients. Postoperative evaluation revealed residual mild deviation in three patients, whereas the remaining patients had corrected nasal septum. Nasal valve narrowing was treated by spreader grafts with or without septoplasty in 28 patients, of which 27 had successful results. Digital image analysis of video endoscopy of the valve before and after surgery showed that the mean difference (± SD) between them was 14.33 ± 12.77° on the right side and 11.59 ± 11° on the left side (P < 0.001). Sixty patients (93.7%) had a patent airway with straight midline septum and adequate nasal valve.
Analysis of A-P photographs of patients with twisted noses showed correction of the deviation in 51 patients, whereas residual deviation or asymmetry was reported in four patients, and no patient had worsened deviation. Thirty-five patients had deformities of the nasal tip. Of the 21 patients who had wide alar base, acceptable narrowing of the alar base was achieved by tip remodeling only in 13 patients and by alar base wedge resection in five patients, whereas inadequate narrowing was reported in three patients.
Of the 25 patients who had dorsal hump, acceptable refinement of the dorsal profile was achieved in 23 patients, whereas inadequate hump reduction was reported in two patients, and they were planned for future profile refinement. Of the 29 patients who were indicated for nasal tip repositioning, the postoperative values of NLA, RA, NFA, and GR of 25 patients were within the normal range. Over-rotation was reported in two patients and underprojection was reported in two patients. Of the 64 patients enrolled in the study, 55 (85.9%) conformed to esthetic measures as evaluated by facial symmetry and anthropometric assessment.
| Discussion|| |
The three core QA activities are QD, QM, and QI. The three activities form the three angles of what is called a QA triangle. QD means developing expectations or standards of quality. Standards are defined as explicit statement of expected quality of an activity and are developed in accordance with the quality dimensions .
QM means quantifying the current level of performance according to the defined standards. QM is inextricably linked to QD, as the indicators necessary for QM are derived from the standards defined by QD. QM is a process of regular collection and analysis of core set of indicators and includes the use of existing data or collection of new data to identify the areas for improvement, which is the first step in QI ,.
QI involves applying measures to close the gap between current (as determined by QM and defined by indicators) and expected (as determined by QD and defined by the standards) levels of quality. QI framework addresses what is performed (content or effectiveness) and how is it performed (process or efficiency) ,.
QI follows the scientific method; the first step is 'identify' to determine what to improve, the second step is 'analyze' to understand the problem, and the third step is 'develop' that uses the information from the previous steps to provide a hypothesis about what changes will solve the problem. In the last step, 'test/implement', the hypothesis is tested to see if the proposed intervention yields the expected improvement or needs to be modified through the Plan, Do, Study, and Act (PDSA) cycle .
The concept of QA triangle was adapted in our study. The first angle, which is QD, means a surgeon recognizant of the nasal esthetic and functional standards. The assessment of beauty no more depends only on the personal taste; however, it can now be objectively evaluated by measurement of the proportions, symmetry, angles, and lines using facial analysis. A beautiful face is divided into three equal horizontal thirds and five equal vertical fifths. The width of the eye, the intercanthal distance, and the alar base width, each should equal a fifth of the total face width. Symmetry should be present when comparing the two halves of a beautiful face. Facial analysis also includes measurement of nasal tip rotation and projection. Two lines are important to standardize the assessment: Frankfort horizontal and facial lines. Preserving or restoring nasal function means patent airway that primarily necessitates a straight midline septum and adequate nasal valve. The second angle (QM) necessitates listening to client's needs, analyzing patient's anatomic and functional variants, and identifying present deformities before operation. Patient's objectives were checked against surgery limitations and possible result is virtualized to the patient by preoperative digital imaging to realize expectations, aided by preoperative digital imaging. QI is the third angle in which, after identifying the deformity (identify) and understanding its causes (analyze), the objectives or changes needed to improve the problem is hypothesized (develop) and tested (test/implement) through the PDSA cycle where the surgical steps are planned, performed, studied, modified, or implemented. QI integrates 'what is performed' or the content with 'how is it performed' or the process through effective selection of techniques and efficient sequencing of steps [Figure 6].
Facial plastic surgery strives for quality, and quality in its broad term means conforming to standards (a surgeon's perspective), meeting patient's expectations, and fulfilling patient's satisfaction (patient's perspectives), which are as follows.
Conformance to standards: It was evaluated for nasal form and function through measuring facial symmetry and nasal esthetic angles and assessing airway patency by examination of the nasal septum and nasal valve. Nasal septum was assessed for the shape and position by rhinoscopy. The severity of deviation was scored on a four-point scale of none, mild, moderate, and severe grades. A total of 57 patients had variable degrees of septal deviation. The operative objective was to get a straight midline septum. Residual postoperative mild deviation was observed in three patients, whereas the other 54 patients (85.3%) had corrected septal deviation. Boyce and Eccles  found that the investigator's subjective assessment of septal deviation had a high sensitivity at around 100% but had a lower specificity (30%) compared with the objective measurements using rhinospirometer.
Improving or correcting the nasal valve angle has been an active area of interest for surgeons who perform functional rhinoplasties . Examination by anterior rhinoscopy and Cottle's maneuver is subject to examiner's variability, and therefore lack objectivity . Keck et al.  used digital image analysis of video endoscopic images to study the valve area before and after nasal surgery. Digital image analysis of video endoscopy of our patients showed significant widening of the valve angle postoperatively. Sixty patients (93.7%) had a patent airway with straight midline septum and adequate nasal valve.
Facial symmetry measures were used to evaluate the esthetic outcome after surgery objectively. Jang et al.  evaluated the outcome of rhinoplasty performed upon 75 patients with dorsum deviated as related to the facial midline; the deviation was corrected in 67 patients (89.3%). In our study, the anteroposterior preoperative photographs of patients were studied. Fifty-five patients had the dorsum twisted and asymmetric as related to a vertical line dropped from the center point between the pupils. The deviation was corrected by surgery in 51 patients (92.7%).
Analysis of the profile view of the photographs was carried out to evaluate the dorsal height and the tip position. Of the 25 patients who had dorsal hump, acceptable refinement of the dorsal profile was achieved in 23 (92%) patients, whereas inadequate hump reduction was reported in two patients, and they were planned for future profile refinement.
In our study, 29 patients had surgical repositioning of the tip. The nasal tip rotation was objectively evaluated by the NLA and the rotation RA, the projection of the tip by the GR and NFA. The mean increase in the value of the NLA was 6.11°, RA was 4.16°, NFA was 2.46°, and GR was 0.06 (P < 0.001). Twenty-five patients (86.2%) had their values within the normal range. Over-rotation was reported in two patients (6.9%) and underprojection was reported in two patients (6.9%). Of the 64 patients enrolled in the study, 55 (85.9%) conformed to esthetic measures as evaluated by facial symmetry and anthropometric assessment.
Meeting patient's expectations: The esthetic patient has usually a high level of expectation from surgery, and the best way to meet his expectation is by virtualizing the possible surgical results to him in a preoperative digital image. The outcomes are measured on a scale from 1 to 4, where 1 = identical, 2 = similar, 3 = approximate, and 4 = poor. A total of 58 patients (90.6%) rated the results as identical (34 patients) or similar (24 patients). Mόhlbauer and Holm  compared the virtual results with the surgical results on a scale from 1 to 4 in 120 patients with corrective rhinoplasty and found that ˜70% of the surgical results was rated identical or similar by the authors versus 80% by the patients.
Fulfilling patient's satisfaction: Esthetic surgery involves taking a healthy person and making that person sick before treating him or her. Thus, ultimate improvement in QOL and self-esteem are the reasons for which patients seek surgery . This well being is intimately related not only to the physical health of the patient (as related to the facial form and function), but also to the individual's mental or emotional satisfaction and social consequences (as related to family, friends, and colleagues) in addition to functionality (or her/his ability to perform daily activities) as well .
Alsarraf  identified the key aspects that constitute patient's satisfaction after rhinoplasty, and developed and validated the ROE instrument. In a case series of 26 patients, Alsarraf et al.  used ROE to evaluate the esthetic improvement after rhinoplasty and found an average increase in patient's satisfaction after surgery of 44.5, from a mean preoperative score of 38.8 to a postoperative score of 83.3. We also used ROE instrument for esthetic evaluation after rhinoplasty. Our average postoperative score was 86.64 and our average increase in patient's satisfaction was 35.04. In all, 92.2% of our study population was satisfied to variable degrees.
| Conclusion|| |
Adopting and adapting QA principles to open structure rhinoplasty enhances education and learning through better defining of the norms (QD), analysis of esthetic and functional variants, addressing esthetic and functional deviations (QM), and planning for the operation through proper selection of techniques and customized sequencing of steps (QI) to achieve preoperative goals effectively and efficiently with better patient's QOL.
| Acknowledgements|| |
Conflicts of interest
There are no conflicts of interest.
| References|| |
|1.||Ozeki K, Asaka T. Handbook of quality tools: the Japanese approach. New York, NY, USA: Productivity press; 1990. |
|2.||Mühlbauer W, Holm C. Computer imaging and surgical reality in aesthetic rhinoplasty. Plast Reconstr Surg 2005; 115:2098-2104. |
|3.||Alsarraf R, Murakami CS, Larrabee WF, Johnson CM. Measuring cosmetic facial plastic surgery outcomes: a pilot study. Arch Facial Plast Surg 2001; 3:198-201. |
|4.||Boyce JM, Eccles R. Assessment of subjective scales for selection of patients for nasal septal surgery. Clin Otolaryngol 2006; 31: 297-302. |
|5.||Massaoud R, Askov K, Reinke J, Franco LM, Bornstein T, Knebel E, MacAulay C. A modern paradigm for improving healthcare quality. Bethesda, MD, USA: Quality Assurance Project; 2001. |
|6.||Donabedian A. Explorations in quality assessment and monitoring. Ann Arbor, MI: Health Administration Press; 1980. Vol. 3. |
|7.||Miller Franco L, Newman J, Murphy G, Mariani E. Achieving quality through problem-solving and process improvement. 2nd ed. Bethesda, MD, USA: Quality Assurance Project; 1997. |
|8.||Poetker DM, Rhee JS, Mocan BO, Michel MA. Computed tomography technique for evaluation of the nasal valve. Arch Facial Plast Surg 2004; 6:240-243. |
|9.||Rhee JS, Poetker DM, Smith TL, Bustillo A, Burzynski M, Davis RE. Nasal valve surgery improves disease-specific quality of life. Laryngoscope 2005; 115:437-440. |
|10.||Keck T, Leiacker R, Kuhnemann S, Lindemann J Rozsasi A, Wantia N. Video-endoscopy and digital image analysis of the nasal valve area. Eur Arch Otorhinolaryngol 2006; 263:675-679. |
|11.||Jang Y,Wang JH, Lee BJ. Classification of the deviated nose and its treatment. Arch Otolaryngol Head Neck Surg 2008; 134:311-315. |
|12.||Stewart MG, Porter JP. Outcomes research and facial plastic surgery. Facial Plast Surg 2002; 18:73-76. |
|13.||Alsarraf R. Outcomes instruments in facial plastic surgery. Facial Plast Surg 2002; 18:77-86. |
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2]