Introduction

Rhinoseptoplasty is one of the most frequent and challenging procedures in aesthetic surgery. Commonly, rhinoplasty surgeons have to address both function and form even in solo aesthetic rhinoplasty. In many situations, rhinoplasty patients complain about both functional and aesthetic issues. Self-perception in aesthetic surgery plays a crucial role in medical planning, and the surgeon’s awareness of this is of utmost importance. In this perspective, a validated quantification instrument can help physicians to plan the surgical treatment to meet patient’s requirements.

Patient-related outcomes measures (PROMs) are intended to be validated, replicable and informative instruments to better understand patients’ pre- and post-operative conditions. Although different types of questionnaires already exist in the literature and clinical practice, only a few of them are directly targeted to rhinoseptoplasty patients. Moreover, they usually only address one single domain at a time, the cosmetic or functional one, yet both are important to assess in all rhinoplasty patients [1].

To date, Italian rhinoplasty surgeons may rely only on the validated version of the Nasal Obstruction Symptom Evaluation (I-NOSE) [2] scale or on Italian SNOT-22 [3] to assess the solely patient-reported nasal function. On the other hand, the cosmetic domain is addressed by FACE-Q [4], but even this test is vitiated by the exclusive inquiry of the aesthetic part [5]. Only the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) is characterized by combinatory exploration of the two fundamental domains, containing an obstructive and a cosmetic scale. In its original version [6], SCHNOS questionnaire is characterized by high internal consistency, displaying an excellent Cronbach α for both domains. Exploratory factor analysis has demonstrated the unidimensionality and the high validity of this tool. Furthermore, the composite SCHNOS obstructive scale shows a very good correlation with the NOSE questionnaire; therefore, it may be administered without the NOSE scale to assess the nasal obstruction [6]. Given the good correlation to specific psychiatric screening tools, it also demonstrated a potential role in preoperative screening of rhinoplasty patients for body dysmorphic disorders [7], considered crucial in aesthetic surgery. Moreover, SCHNOS showed optimal discrimination between different subgroups of patients (pre- and post-operative conditions, cosmetic or functional rhinoplasty, and non-rhinoplasty patients) with a high potential in following the natural history of patients who undergo rhinoplasty, as reported by Kandathil et al. [8] The original SCHNOS has been already validated in Spanish [9], French [10], Turkish [11], Arabic [12], Persian [13] and others. All these translations are endowed with high internal consistency, reliability and validity as the original one. However, at present, a validated Italian version does not exist.

This study aimed to translate and validate the Standardized Cosmesis and Health Nasal Outcomes Survey in the Italian language [6, 8].

Material and Methods

The present study protocol was approved by the Institutional Review Board, at the clinical research centre where it has been conducted, as a prospective observational study (Protocol number: Rhinoplasty2020; decision number: 38/INT/2020). It was carried out between 1 May 2020 and 1 May 2021.

Italian translation and cultural adaptation of the SCHNOS was conducted in a two-phase validation process (translational phase and psychometric validation phase), with respect to the International Society for Pharmacoeconomics and Outcomes Research guidelines (Fig. 1) [14].

Fig. 1
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Translation process according to International guidelines

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Translation Process

The first phase consisted of a multistep translation and adaptation process. First of all, a forward translation from English to Italian was made by two independent Italian-native, fluent English speakers, experts in the Otorhinolaryngology field. The two translations were analysed and reconciled in a preliminary Italian version by an ENT experts’ team to merge concepts, respecting the original meaning. Subsequently, a back-translation from the Italian preliminary version to English was performed by another independent, bilingual translator, unaware of the original SCHNOS questionnaire. The latter version was sent to the senior author who verified that concepts from the original questionnaire were respected and preserved, without any discrepancy in the meaning.

Ten Italian-native rhinoplasty patients were therefore interviewed, during a 15-min consultation, by two authors, who reviewed with the patients each item, taking written notes of eventual ambiguities and comprehension issues, and verified acceptability of the translation. Moreover, patients were asked to verbalize each sentence to assess understandability and outline the eventual necessity of clarification. Cultural adaptation and modifications were made based on the interviews’ results. To review the latter version, five additional interviews were conducted. A final version of the Italian SCHNOS was then approved.

Psychometric Validation

A total of 411 consecutive outpatients presenting at the Otorhinolaryngology clinic for the first or follow-up consultations were enrolled, after the explanation of the methods and purpose of the study. Among these, 253 were included in the rhinoplasty group, given their preoperative (n= 92) or post-operative condition (n= 161). One-hundred fifty-eight patients, presenting for non-nasal complain (neither nasal deformity nor nasal obstruction), were enrolled in the control group. All individuals were native Italian speakers, literate and above 18 years of age. The population in study was interviewed on general data (gender, age, comorbidities, etc.). Controls’ exclusion criteria were any allergic/systemic disease, any previous sinonasal surgery, congenital facial anomaly, nasal pathology detected during physical examination and sleep apnoea/snoring. General exclusion criteria for all individuals were as follows: head/facial trauma within the last 3 months, adenoid hypertrophy, previous neoplastic sinonasal disease and inflammatory/infectious disease during the study period. Patients’ characteristics are reported in Table 1. All patients gave their informed consent to participate in the study, and the Italian SCHNOS was administered on the day of consultation.

Table 1 Sample characteristics
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In order to assess the reproducibility of the obtained scores, 53 patients from the entire cohort (28 rhinoplasty patients and 25 non-rhinoplasty patients) were then enrolled in a “test–retest” group. They were contacted two weeks later by phone calls and asked to answer the questionnaire again, and data were recorded.

Statistical Analysis

The estimates were reported as means, standard deviations (SDs), medians, interquartile ranges (IRQs) and percentages, when appropriate.

Internal Consistency

To measure the internal consistency of the SCHNOS-O and the SCHNOS-C, the Cronbach’s alpha was calculated along with a one-sided (lower) 95% confidence limit (95% CL). The alpha ≥ 0.9 was considered excellent, ≥0.8 was good, ≥0.7 was acceptable, ≥0.6 was questionable, ≥0.5 was poor, and <0.5 was unacceptable. Several additional alpha-related estimates were reported: item–test correlations, item–rest correlations, average interitem covariances and alphas with one item removed at a time.

Test–Retest Reliability

To investigate the correlations between repeated measures, the Spearman correlation coefficient was calculated along with 95% confidence interval (95 CI). The correlation coefficient of <0.19 was considered very weak, 0.20 to 0.39 as weak, 0.40 to 0.59 as moderate, 0.60 to 0.79 as strong and 0.80 to 1.0 as a very strong correlation.

Difference Between Cases and Controls

The two-sample Wilcoxon rank-sum (Mann–Whitney) test was applied to investigate whether the first responses given by patients were significantly different from the first responses given by healthy controls. The significance level of all the two-tailed p-values was set at <=0.05.

Exploratory Factor Analysis

The exploratory factor analysis (EFA) was conducted on the estimates obtained from all 411 respondents and included both quantitative (unrotated principal factors and parallel analysis) and graphical analyses (scree plot along with a parallel analysis line). The cutoff for retaining was set at eigenvalues ≥1.0 (Kaiser rule).

All the analyses were carried out using Stata/IC Statistical Software: Release 16. College Station (StataCorp LP, TX, USA).

Results

Forward and Back-Translation

Differences in the choice of words and syntactic order were depicted in the two independent Italian translations of SCHNOS. The two versions were then reconciled and merged by the authors in a preliminary version, discussing the opportunity of selecting literally translated items versus more commonly used medical syntaxis. Back-translation, although minimal discrepancies, was evaluated as consistent with the original version, keeping intact the meaning of the questionnaire. Forward translations, preliminary version and back-translation with authors’ comments are reported in Table 2.

Table 2 Reconciliation of forward translations and evaluation of back-translation.
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Cognitive Interviews

Ten rhinoplasty patients (mean age 37 ± 11.9) were selected to be equally distributed according to gender (F:M = 1:1) and preoperative (no. 5) and post-operative condition (no. 5), belonging to different socioeconomic and cultural contexts. All patients accepted to participate (a 100% response rate). Cognitive interviews, conducted by two of the authors, highlighted a good overall comprehension of the questionnaire. However, some adjustments were made to simplify the self-administration of the Italian SCHNOS.

Within the introduction, the words “mese” (original: month) and “problema” (original: problem) were underlined in order to focus the patient’s attention on them, as reported in the updated version of the original SCHNOS [8]. In fact, 4 over 10 patients asked the authors whether the questions were related to the current condition, and these were interpreted as inattention’s mistakes. On the other hand, 2 patients required a revision of a given score during the questionnaire since they did not focus on the “negative impact” of the item, as explicated by the use of “problem”, on the answer.

Two patients asked for clarifications on item no.3, particularly referred to a slight overlap with item no. 1, so authors decided to add in the final version of the Italian SCHNOS “sintomi infiammatori” in brackets (literally: inflammatory symptoms) to sentence no. 3, to better focus patient’s attention on nasal congestive state.

Some patients pointed out redundancy and overlapping of items nos. 9 and 10. According to the original version, the authors decided to keep both items but better specify the ninth one adding in brackets “considerando le proporzioni” (literally: considering the proportion).

The most challenging item was the no. 7, as many patients were very confused about its meaning, at least before reading item no. 8. Although the optimal results obtained in back-translation (Table 2), Italian speakers usually use “naso dritto” (literally: straight nose) to describe both the frontal and the profile projection. Consequently, five out of ten patients enrolled in the cognitive interviews hardly understood the meaning of straightness, referring the assigned score to the straightness of the nose on the profile view, usually affects by humps’ presence. For this reason, the authors agreed on adding in brackets “in asse sul piano frontale” in the final version (literally: in axis on the frontal view) to specify the point of view.

The final version of the Italian SCHNOS, was further administered to 5 rhinoplasty patients, who did not detect these previously identified issues (Fig. 2).

Fig. 2
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Structures and scoring formulas of English and Italian versions of SCHNOS

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Sample Characteristics

Of the 411 respondents, 281 (32%) were women (Table 1). The average age was 33.6 (11.3) years. The average SCHNOS-O score was 31.3 (28.8) points, and the SCHNOS-C was 22.3 (27.8) points.

Psychometric Validation

Reliability

The Cronbach’s alpha was excellent for both the SCHNOS-O (0.90, 95% CL 0.88) and the SCHNOS-C (0.94, 95% CL 0.94) scores (Table 3). For the entire SCHNOS, the alpha was 0.93 (95% CL 0.92). All the items demonstrated good or acceptable item–test and item–rest correlations. Also, excluding one item at a time did not substantially improve alpha for either the SCHNOS-O or the SCHNOS-C.

Table 3 Internal consistency of the SCHNOS.
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All the correlations between repeated measures were moderate to very strong (Table 4). For all the items as well as for the SCHNOS-O and the SCHNOS-C scores, there were significant differences between cases and controls with p<0.0001 (Mann–Whitney U test).

Table 4 Test–retest validity of the SCHNOS
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Validity

The exploratory factor analysis demonstrated unidimensionality of both the SCHNOS-O and the SCHNOS-C scores. For the SCHNOS-O, the single factor retained with eigenvalue 2.68 (Tables 5 and 6 and Fig. 3). Respectively, for the SCHNOS-C, a single factor exceeded the cutoff level with eigenvalue 4.47.

Table 5 Exploratory factor analysis—item loadings
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Table 6 Parallel analysis
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Fig. 3
figure 3

Scree plot of exploratory factor analysis of the SCHNOS-O and the SCHNOS-C

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Discussion

The original version of the SCHNOS was successfully translated adapted and validated into Italian. This study resulted in a coherent and reliable Italian version of the original questionnaire. Based on the international guidelines, we meticulously followed the multistep process of forward translation, back-translation and cognitive interviewing deemed necessary to obtain a valid clinical instrument. In this study, given their paramount importance, respect for the original conception and syntaxis, and adaptation to an Italian targeted population were achieved.

The Italian SCHNOS showed to be a reliable tool, given the high internal consistency in both obstructive and cosmetic domains, with excellent values of Cronbach’s alpha, being very similar to the original version [6]. According to the other versions of SCHNOS [6, 11], all the items were deemed essential to the considerable consistency of the Italian translation. The validity of this version has been proved by the positive and significant correlation of items and the unidimensionality of each domain. Moreover, the scale exhibited good discrimination between rhinoplasty and non-rhinoplasty patients, as generally requested for PROMs. The results obtained in the test–retest phase demonstrated the high reproducibility of this instrument, in line with the other translations of the questionnaire. In fact, the participants included in this group answered in a positively correlated manner in the 2-week interval for both the obstructive domain and cosmetic domain.

These data suggest a promising role of the Italian SCHNOS even in comparative analysis of pre- and post-surgical conditions, as already done for English speakers [8]. Moreover, the possibility of self-administration and the good understandability of the scale permits eventual on-demand data collection through online survey dissemination, as already experienced by authors [15], even in non-clinical settings. Therefore, this scale allows a more regular follow-up and outcomes reports after surgery.

Different gender distributions in the rhinoplasty and non-rhinoplasty patients may affect the generalization of our results. In fact, larger proportions of women were included in the rhinoplasty group compared to controls. This could be explained by the consecutiveness of our recruitment process. Moreover, in our experience, cosmetic rhinoplasty is usually more requested among the female Italian population. A recent review has highlighted that women generally have inferior Patient-reported outcomes related to satisfaction after medical or surgical treatment [16]. Further studies may investigate whether gender should affect SCHNOS results. However, the great strength of this study is given by the large sample in the psychometric validation phase, compared to smaller cohorts included in previous translations of the SCHNOS. In this perspective, the Italian translation of SCHNOS represents a good, standardized instrument for rhinoplasty surgeons not only for a clinical purpose but also indispensable to share and compare personal results in scientific publications.

Conclusions

We successfully generated an Italian version of the SCHNOS questionnaire, which is a valid and reliable instrument to evaluate obstructive and cosmetic outcomes in rhinoplasty patients. We hope that this will provide an additional tool for the clinician in the evaluation of Italian-speaking rhinoplasty patients.