10.14639/0392-100X-N1291
Objective. Normative values of patient-reported outcome instruments are needed to iden- tify good candidates for rhinoplasty. Rhinoplasty Outcome Evaluation (ROE) and Func- tional Rhinoplasty Outcome Inventory-17 (FROI-17) are disease-specific questionnaires that evaluate quality of life in patients undergoing rhinoplasty.Methods. The reference cohort contained 1,000 participants, selected from a non-probabil- ity panel. Normative ROE and FROI-17 scores from this reference cohort were compared with ROE and FROI-17 scores from a patient cohort before (n = 104) and 6 (n = 55) and 12 months (n = 32) after septorhinoplasty.Results. Mean FROI-17 scores (± SD) were: overall score, 20.8 ± 17; nasal symptoms,&nbsp;16.8 ± 7; general symptoms, 24.8 ± 22; and self-confidence, 16.4 ± 21. The ROE total score was 73.1 ± 16. Normative values differed significantly from the preoperative ROE and FROI-17 scores of septorhinoplasty patients (p &lt; 0.01). Except for the FROI-17 gen- eral score at 12 months postoperatively (p = 0.004), there were no significant differences between normative ROE/FROI-17 and septorhinoplasty scores postoperatively, indicating that they returned to normalcy.Conclusions. Normative scores for ROE and FROI-17 provide a reference point from&nbsp;which to identify patients who are most likely to benefit from rhinoplasty.
text/xml
1827-675X
1291
en
Karim Zaoui
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
rhinoplasty
How to predict the outcome of septorhinoplasty? A normative study of ROE and FROI-17 scores
Text.Serial.Journal
https://www.actaitalica.it/
41
Rhinology
2021-09-14
2020-12-02
2021-09-15
2021-09-15
327-335
1
Karim Zaoui
2021/09/14
10.14639/0392-100X-N1291
327
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Heidelberg, Heidelberg, Germany
1827-675X
rhinoplasty
en
335
How to predict the outcome of septorhinoplasty? A normative study of ROE and FROI-17 scores
https://www.actaitalica.it/article/download/1291/652
41
ACTA OTORHINOLARYNGOLOGICA ITALICA 2021;41:327-335; doi: 10.14639/0392-100X-N1291




Rhinology


How to predict the outcome of septorhinoplasty?
A normative study of ROE and FROI-17 scores
Prevedere l’esito della settorinoplastica? Valori di riferimento per i questionari ROE
e FROI-17
Michaela Plath1, Matthias Sand2, Carlo Cavaliere3, Peter K. Plinkert1, Ingo Baumann1, Karim Zaoui1
1
 Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Heidelberg, Heidelberg, Germany; 2 GESIS-
Leibniz-Institute for the Social Sciences, Mannheim, Germany; 3 Department of Oral and Maxillofacial Sciences, Sapienza University
of Rome, Italy


SUMMARY
Objective. Normative values of patient-reported outcome instruments are needed to iden-
tify good candidates for rhinoplasty. Rhinoplasty Outcome Evaluation (ROE) and Func-
tional Rhinoplasty Outcome Inventory-17 (FROI-17) are disease-specific questionnaires
that evaluate quality of life in patients undergoing rhinoplasty.
Methods. The reference cohort contained 1,000 participants, selected from a non-probabil-
ity panel. Normative ROE and FROI-17 scores from this reference cohort were compared
with ROE and FROI-17 scores from a patient cohort before (n = 104) and 6 (n = 55) and 12
months (n = 32) after septorhinoplasty.
Results. Mean FROI-17 scores (± SD) were: overall score, 20.8 ± 17; nasal symptoms,                 Received: December 2, 2020
16.8 ± 7; general symptoms, 24.8 ± 22; and self-confidence, 16.4 ± 21. The ROE total                Accepted: January 24, 2021
score was 73.1 ± 16. Normative values differed significantly from the preoperative ROE
and FROI-17 scores of septorhinoplasty patients (p < 0.01). Except for the FROI-17 gen-             Correspondence
eral score at 12 months postoperatively (p = 0.004), there were no significant differences          Karim Zaoui
between normative ROE/FROI-17 and septorhinoplasty scores postoperatively, indicating               Department of Otorhinolaryngology, Head and
that they returned to normalcy.                                                                     Neck Surgery, University Hospital Heidelberg,
Conclusions. Normative scores for ROE and FROI-17 provide a reference point from                    Ruprecht-Karls-University, Im Neuenheimer Feld
which to identify patients who are most likely to benefit from rhinoplasty.                         400, D-69120 Heidelberg, Germany
                                                                                                    Tel. +49-(0)6221-56 39510
KEY WORDS: normative score, patient-reported outcome measures, rhinoplasty outcome                  E-mail: karim.zaoui@med.uni-heidelberg.de
evaluation, functional rhinoplasty outcome inventory-17, rhinoplasty
                                                                                                    Funding
                                                                                                    None.
RIASSUNTO
Obiettivo. L’identificazione dei valori di riferimento per i questionari di autovalutazione
permette di selezionare i candidati migliori per la rinoplastica. Il Rhinoplasty Outcome            Conflict of interest
                                                                                                    The Authors declare no conflict of interest.
Evaluation (ROE) e il Functional Rhinoplasty Outcome Inventory-17 (FROI-17) sono que-
stionari che valutano la qualità della vita dei pazienti sottoposti a rinoplastica.
Metodi. 1000 volontari sani sono stati reclutati come popolazione di riferimento. I valori            How to cite this article: Plath M, Sand M,
standard del ROE e del FROI-17 sono stati poi confrontati con i valori rilevati in un gruppo          Cavaliere C, et al. How to predict the out-
di pazienti prima dell’intervento di rinosettoplatica (n = 104) e dopo 6 (n = 55) e 12 mesi           come of septorhinoplasty? A normative study
(n = 32).                                                                                             of ROE and FROI-17 scores. Acta Otorhi-
Risultati. I valori medi del FROI-17 (± SD) sono: punteggio totale 20,8 ± 17; sintomi                 nolaryngol Ital 2021;41:327-335. https://doi.
                                                                                                      org/10.14639/0392-100X-N1291
nasali 16,8 ± 7; sintomi generali 24,8 ± 22; autostima 16,4 ± 21. Il punteggio totale del
ROE è 73,1 ± 16. I valori standard si sono rivelati significativamente diversi dai valori
                                                                                                    © Società Italiana di Otorinolaringoiatria
del ROE e del FROI-17 dei pazienti pre-intervento (p < 0,01). Ad eccezione del punteggio            e Chirurgia Cervico-Facciale
totale del FROI-17 a 12 mesi (p = 0,004), non si sono evidenziate differenze significative
tra i valori standard e i punteggi dichiarati dai pazienti a 6 e a 12 mesi, a indicare il ritorno                  OPEN ACCESS
alla normalità.
Conclusioni. La standardizzazione del ROE e del FROI-17 è utile a identificare i pazienti           This is an open access article distributed in accordance with
                                                                                                    the CC-BY-NC-ND (Creative Commons Attribution-Non-
con maggiori probabilità di beneficiare della rinoplastica.                                         Commercial-NoDerivatives 4.0 International) license. The
                                                                                                    article can be used by giving appropriate credit and mentio-
PAROLE CHIAVE: standardizzazione dei questionari, questionari di autovalutazione dei                ning the license, but only for non-commercial purposes and
pazienti, rhinoplasty outcome evaluation, functional rhinoplasty outcome inventory-17,              only in the original version. For further information: https://
rinoplastica                                                                                        creativecommons.org/licenses/by-nc-nd/4.0/deed.en




                                                                                                                                                            327
M. Plath et al.




Introduction                                                       into account but not quoted for. Participants consented to
                                                                   their data being collected.
Rhinoplasty is a popular cosmetic surgical procedure and
                                                                   Data from the reference cohort (n = 1,000) were compared
was the fifth most common operation in 2013 1. Facial
                                                                   with data from a patient cohort before septorhinoplasty
symmetry and proportions are important determinants of
                                                                   (n = 104) and 6 (n = 55/54) and 12 months (n = 32/31) after
attractiveness 2, and the nose is a vital part of a person’s ap-
                                                                   surgery at Department of Ear, Nose and Throat, Head and
pearance and identity 3. Male gender, young age, minimal
                                                                   Neck Surgery, University of Heidelberg, Germany between
deformities, and unrealistic expectations of the surgical re-
                                                                   January 2010 and March 2011.
sults all reduce satisfaction after facial cosmetic surgery 4.
                                                                   The Ethics Committee of the Medical Faculty at the Univer-
Furthermore, patients with body dysmorphic disorders
                                                                   sity of Heidelberg granted permission to conduct the study
are almost never fully satisfied with rhinoplasty results 5.
                                                                   (Project No. 409/2006) according to the Declaration of
Patient-reported outcome measures are relevant because
                                                                   Helsinki on biomedical research involving human subjects.
patient satisfaction and improved quality of life (QoL) are
                                                                   Informed consent was obtained from all patients. Patients
predominant factors for rhinosurgical success 3,6. Many
                                                                   were evaluated during an outpatient examination (usually
studies have described that patients benefit physically and
                                                                   one day before the surgery). They were asked to fill out
psychologically from rhinoplasty and that QoL increases
                                                                   questionnaires including FROI-17 and ROE. Surgery was
after rhinoplasty 7. Patient-reported outcome measures
                                                                   performed by one of the authors. With the request to an-
in rhinoplasty research are very diverse 8-10. The Rhinoplas-
                                                                   swer the questionnaire again, patients were contacted by
ty Outcome Evaluation (ROE) is the most used QoL ques-
                                                                   mail at 6 months and 1 year after surgery. One hundred and
tionnaire (70.6%) 3, and focuses on aesthetic outcomes 11,
                                                                   four septorhinoplasty patients were enrolled in this study
while the Functional Rhinoplasty Outcome Inventory 17
                                                                   (53 women, 51 men). After 6 months, 52.4% remained (55
(FROI-17) evaluates functional and aesthetic outcomes 8.
                                                                   FROI-17/54 ROE answers), and after 12 months 30.3% (31
There are still no normative scores for the ROE and
                                                                   FROI-17/32 ROE answers) remained. Since this follow-up
FROI-17 questionnaires. It is not yet known how the QoL
                                                                   required a high degree of compliance, patients who did not
of patients undergoing septorhinoplasty compares with that
of a control population. This limits our ability to determine      respond were contacted by telephone. Due to the young
the impact of septorhinoplasty on individuals.                     and mobile septorhinoplasty patient collective, interest in
Normative scores of the generic and internationally ap-            participation in the study was decreased.
proved instrument, the short form survey 36 (SF-36), for
German participants were published in 2005 12. In 2017,            Recruitment process
normative scores were also published for the breast sur-           The reference cohort (n = 1,000) was recruited by September
gery-specific and validated patient-reported outcome ques-         2018 using the Respondi panel, an international organiza-
tionnaire, BREAST-Q 13. Both are useful interpretive tools         tion for standardisation (ISO)-certified online access panel
for clinicians and researchers.                                    for market and social science research. Due to the nature of
The main aim of our study was to provide the first norma-          a cohort derived from the general public, that sample size
tive values for the ROE and FROI-17 questionnaires as a            was decided on to ensure a small sampling error and small-
decision-making tool after septorhinoplasty by perform-            er confidence intervals, since the occurrence of participants
ing a systematic prospective study on 1,000 healthy par-           with low (or high) QoL-measures was expected to be less
ticipants and comparing these normative values with ROE            pronounced than in the clinical cohort. The programming
and FROI-17 scores of septorhinoplasty patients before and         of the questionnaire, quota conditions and quota sizes were
after surgery.                                                     programmed by Respondi. Participants were divided into
                                                                   groups in the panel based on the master data information.
                                                                   Before finalising the questionnaire, an internal test run was
Materials and methods                                              conducted. On the first day of recruitment, only 200 partici-
                                                                   pants were invited for a first data check after which other
Patient cohort                                                     participants received reporting access. Sociodemographic
1,000 German individuals were recruited via a non-proba-           questions were asked first. Study participants answered 59
bilistic online panel. The subset of this panel used for this      questions, including two disease-specific questionnaires
study was quoted to relevant population distributions of the       (FROI-17 and ROE), by online access within a mean time
German Microcensus (an annual 1% probability sample of             of approximately 7 min and 16 sec (arithmetic mean). Raw
the German population) 14. Relevant parameters were age,           data were cleansed and converted into a labeled SPSS data-
gender, region and education. Migration was also taken             set before checking that questions were complete and rel-



328
                                                                                                        Normative scores of ROE and FROI-17




evant quotas were distributed. Test groups were screened to         Table I. Demographic characteristics of the study population (n = 1000).
make sure the correct questions had been asked. Statistical          Characteristic                                    Reference cohort
analysis was conducted by GESIS (Leibniz Institute for So-                                                                (n = 1000)
cial Sciences).                                                      Age (years)                                          44.3 ± 14.2
                                                                                                                         (range:18-69)
Disease-specific questionnaires (ROE and FROI-17)                    Gender
ROE and FROI-17 are validated and reliable disease-spe-                Male                                                500 (50%)
cific instruments for measuring QoL after septorhinoplasty.            Female                                              500 (50%)
The ROE has six questions, each one with five answers,               Marital status
from zero (worst) to four (best). The sum of the scores is             Single                                             411 (41.1%)
then converted into a percentage with a lower score indi-              Married                                            424 (42.4%)
cating less satisfaction. The FROI-17 includes 17 items.               Separated/divorced                                 138 (13.8%)
Responses are rated zero (no problem) to five (worst pos-              Widowed                                             27 (2.7%)
sible). The overall score is then converted into a percentage        Residence (state)
with a lower score indicating more satisfaction 7,15.                  Baden-Wurttemberg                                   71 (7.1%)
                                                                       Bavaria                                            137 (13.7%)
Statistical analysis                                                   Berlin                                              27 (2.7%)
Data were analysed using the statistical software R (version           Brandenburg                                         25 (2.5%)
3.4.1). Absolute, relative and joint distributions were created        Bremen                                              18 (1.8%)
for the indices and sociodemographic variables. The five indi-         Hamburg                                             57 (5.7%)
ces (ROE, FROI-17, and the three FROI-17 sub-indices) were             Hesse                                               91 (9.1%)
tested for independence of sociodemographic characteristics
                                                                       Mecklenburg-Vorpommern                              18 (1.8%)
using the Pearson’s chi-squared test. A significant p-value
                                                                       Lower Saxony                                        93 (9.3%)
(e.g. α ≤ 0.05) rejected the null hypothesis that variables are
                                                                       North Rhine-Westphalia                             161 (16.1%)
independently distributed, and supported a relationship (not
                                                                       Rhineland                                           82 (8.2%)
necessarily linear) between variables. In this case, p values
                                                                       Saarland                                            33 (3.3%)
were calculated via Monte Carlo statistic 16. Correlation be-
                                                                       Saxony                                              52 (5.2%)
tween the FROI indices and the ROE were also assessed.
The (linear) influence of sociodemographic variables was               Saxony-Anhalt                                       28 (2.8%)
tested via generalised regression. For metric variables, the           Schleswig-Holstein                                  67 (6.7%)
published coefficients relate to the slope by which a value            Thuringia                                           40 (4.0%)
increases. For non-metric variables (most sociodemograph-            Country of birth
ics), model.matrix is used. The coefficients show the incre-           Germany                                            958 (95.8%)
ment of increase, when deviating from baseline (first level of         EU country                                          19 (1.9%)
a variable; e.g., if male gender is the baseline, the coefficient      Non-EU country                                      23 (2.3%)
for the FROI overall index increases by 3.3 if the participant       Graduation
is female). Aside from the coefficients, residual standard er-         No degree                                            10 (10%)
rors, Student’s t-statistics and p values are also reported.           Certificate of Secondary Education                  300 (30%)
The calculated indices of the reference cohort were com-               General Certificate                                 340 (34%)
pared with those in the patient cohort before and 6 and 12             of Secondary Education
months after septorhinoplasty. Comparisons were made us-               High school diploma                                 350 (35%)
ing a Student’s t-test for unequal variances, and p values           Employment
are reported. If the p value was not significant, the null hy-         On leave/temporarily released                       24 (2.4%)
pothesis that there is no difference between the variables             Not working or no longer working                   292 (29.2%)
was rejected.                                                          Employed occasionally or by the hour                71 (7.1%)
                                                                       Part-time employment                               154 (15.4%)
Results                                                                Full-time employment                               459 (45.9%)
                                                                     Household member                                      2.5 ± 2.4
The reference cohort of 1,000 participants included 500
males and 500 females with an average age of 44.3 ± 14.2
years (Tab. I). Since participants belong to a non-probabil-



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M. Plath et al.




istic open access panel with quoted parameters and a fixed                      before septorhinoplasty (p < 0.01). There were no signifi-
sample size, the response rate is not reported. Participants                    cant differences between the normative ROE and FROI-17
were sampled from an existing (opt-in) access panel until a                     scores and those of septorhinoplasty patients at 6 and 12
particular quota was filled.                                                    months after surgery to the reference cohort, except for
We also recruited a cohort of patients undergoing septorhi-                     the FROI-17 general score at 12 months after surgery
noplasty in our department. At the time of surgery patients                     (p = 0.004; Tab. III). However, the substantial loss of par-
were on average 28.8 ± 11.5 years old. The demographic                          ticipants especially after 12 months, may have impacted
and clinical data are shown in Table II.                                        the estimator’s variance. Such an increase in variance could
The normative ROE and FROI-17 scores differed sig-                              also explain the lack of significance.
nificantly from the ROE and FROE-17 scores of patients                          Concerning the impact of sociodemographic factors on the


Table II. Demographic characteristics of septorhinoplasty patients before, 6 and 12 months after surgery.
 Characteristic                                                     Preoperative                      6 months            12 months
                                                                      (n = 104)                        (n = 55)            (n = 32)
 Age (years)                                                       28.8 ± 11.5                      29.4 ± 11.5           29.0 ± 12.8
                                                                (range: 16.4-65.6)               (range: 17.4-64.2)    (range: 16.4-64.2)
 Gender
   Male                                                                50%                             38%                   35%
   Female                                                              50%                             62%                   65%
 Marital status
   Married                                                            26.7%                           24.4%                 24.1%
   Separated/divorced                                                 71.3%                           73.3%                 69.0%
   Widowed                                                             2%                              2.2%                  6.9%
 Graduation
   Certificate of Secondary Education                                 28.7%                           17.8%                 31.0%
   General Certificate of Secondary Education                         27.7%                           28.9%                 24.1%
   High school diploma                                                43.6%                           53.3%                 44.8%
 Employment
   Employed/Self-Employed                                             46.5%                           48.9%                 41.4%
   Retired                                                             4.0%                            4.4%                  6.9%
   Homemaker                                                           3.0%                            0.0%                  3.4%
   Student                                                            19.8%                           20.0%                 31.0%
   Unemployed                                                          9.0%                            6.7%                  3.4%
   Other                                                              17.8%                           20.0%                 13.8%
 Smoking status
   Currently                                                          31.7%                           31.1%                 20.7%
   Former                                                             18.8%                           22.2%                 31.0%
   Never                                                              49.5%                           46.7%                 48.3%
 Subjective description of the shape of the nose
   Too large
   • no                                                               52.5%                           54.5%                 58.6%
   • indifferent                                                      23.8%                           15.9%                 31.0%
   • yes                                                              23.8%                           29.5%                 10.3%
   Too small
   • no                                                               97.0%                           97.7%                 93.1%
   • yes                                                               3.0%                            2.3%                  6.9%



                                                                                                                                 continues   u



330
                                                                                                                      Normative scores of ROE and FROI-17




Table II. Demographic characteristics of septorhinoplasty patients before, 6 and 12 months after surgery (follows).
 Characteristic                                                     Preoperative                      6 months                       12 months
                                                                      (n = 104)                        (n = 55)                       (n = 32)
   Too long
   • no                                                                70.3%                              75%                          72.4%
   • indifferent                                                       13.9%                             11.4%                         13.8%
   • yes                                                               15.8%                             13.6%                         13.8%
   Too short
   • no                                                                95.1%                             97.0%                         97.0%
   • yes                                                                4.9%                              3.0%                          3.0%
   Too wide
   • no                                                                64.4%                             79.6%
   • indifferent                                                       18.8%                              9.1%                          NA
   • yes                                                               16.8%                             11.3%
   Crooked nose
   • no                                                                43.6%                             43.6%                         43.6%
   • indifferent                                                       17.8%                             17.8%                         17.8%
   • yes                                                               38.6%                             38.6%                         38.6%
   Nasal bumps
   • no                                                                40.6%                             40.6%
   • indifferent                                                       14.9%                             14.9%                          NA
   • yes                                                               44.6%                             44.6%
   Nose tip too clumsy
   • no                                                                74.3%                             74.3%
   • indifferent                                                       11.9%                             11.9%                          NA
   • yes                                                               13.9%                             13.9%
   Nose tip too pinted
   • no                                                                91.1%
   • indifferent                                                        5.0%                               NA                           NA
   • yes                                                                4.0%
   Nose tip bent
   • no                                                                73.3%                             72.2%
   • indifferent                                                       11.9%                             20.9%                          NA
   • yes                                                               14.9%                              7.0%



functional and aesthetic septorhinoplasty outcomes, age                           tion) (p < 0.01). Marital status, residence state, education
and female gender significantly affected the FROI overall                         level and employment status had no effect on the ROE or
and self-confidence scores (p < 0.05), whereas no variables                       FROI-17 scores. A migration background only affected the
influenced the nasal symptom score (p > 0.05; Fig. 1). Fe-                        FROI overall score (p = 0.037).
male participants (n = 500) had higher FROI-17 scores (Fig.                       For most variables, the chi-square test after Pearson showed
1B) and lower ROE (Fig. 2B) scores, and the overall (22.4                         that the null hypothesis that variables are independently
vs 19.1), general (27 vs 22.7), and self-confidence (19.8 vs                      distributed cannot be rejected, except for the joint distribu-
13.1) FROI-17 scores were significantly different between                         tion of ROE and age as well as FROI confidence and age.
males and females (p < 0.01; Fig. 1B, Tab. IV).
Only age significantly influenced the FROI-17 (Fig. 1A)
and ROE (Fig. 2A) scores (p < 0.01). Participants older
                                                                                  Discussion
than 50 years had lower FROI-17 scores (negative lin-                             Measuring QoL after plastic surgery has become more im-
ear relation) and higher ROE scores (positive linear rela-                        portant in recent years 7,8,11. In a systematic literature search



                                                                                                                                                    331
M. Plath et al.




Table III. Comparison of ROE and FROI-17 scores between the reference cohort and the patient cohort before and 6 and 12 months after septorhinoplasty.
 Disease-specific     Reference cohort           Preoperative                          6 months                            12 months
                                                                      p-value                              p-value                             p-value
 questionnaires           (n = 1000)          (n = 102 F/101R)                      (n = 55 F/54 R)                      (n = 31 F/32 R)
 FROI-17 Index               Mean           SD             Mean              SD                      Mean            SD                       Mean           SD
 Overall score               20.8          17.1            32.3             17.5    < 0.01           18.3           15.0       0.3            17.2          16.4    0.25
 Nasal score                 16.8          16.6            31.7             17.0    < 0.01           16.9           14.1       1.0            17.2          15.0    0.88
 General score               24.8          21.5            33.0             22.8    < 0.01           20.2           19.3       0.1            14.9          17.3   < 0.01
 Self-confidence             16.4          21.1            31.5             27.2    < 0.01           14.4           17.5       0.5            13.8          19.3    0.45

 ROE Index                    73.1         15.9             39.7            15.1    < 0.01            72.4          18.6       0.8             68.5         17.8    0.16
Higher ROE scores and lower FROI-17 scores indicate higher levels of satisfaction. Values are presented as mean ± standard deviation. F: FROI-17; R: ROE.



with the terms “Rhinoplasty” and “Quality of Life” using                                   frequently used QoL questionnaire (70.6%) by focusing on
PubMed/MEDLINE, Google Scholar and Cochrane data-                                          prospective study design, a significant cohort size (at least
bases, the authors concluded that the ROE was the most                                     50 patients) and a follow-up period of at least 6 months
                                                                                           after rhinoplasty. They further reported that the measure-
                                                                                           ment of both satisfaction of appearance and physical func-
                                                                                           tion of the nose makes the ROE score, FROI-17 and the
                                                                                           novel Standardized Cosmetics and Health Nasal Outcomes
                                                                                           Survey (SCHNOS) more eligible for functional and cos-
                                                                                           metic rhinoplasty than QoL questionnaires with general
                                                                                           functional and/or aesthetic components 3. Since septorhi-
                                                                                           noplasty addresses functional and aesthetic impairments of
                                                                                           the nose 8, we specially selected the ROE and the FROI-17
                                                                                           as validated patient-reported outcome measures (PROMs)
                                                                                           and not generic instruments (e.g. Short-Form Health Sur-
                                                                                           vey (SF-36) questionnaire 17 or non-rhinoplasty-specific
                                                                                           questionnaires (e.g. FACE-Q) 9.
                                                                                           Rhinoplasty belongs to aesthetic surgeries with low levels
                                                                                           of satisfaction 18; therefore, identifying patients who are
                                                                                           most likely to benefit from the surgery is fundamental for
                                                                                           a successful outcome. Identifying patients who can benefit
                                                                                           most from rhinoplasty could be simplified by comparing
                                                                                           the ROE and FROI-17 scores with normative values by
                                                                                           predicting which results will be satisfactory. In addition,
                                                                                           rhinoplasty outcomes could be compared between the old
                                                                                           and new federal states in Germany as well between Ger-




Figure 1. Forest plots showing the association between FROI-17 scores and                  Figure 2. Forest plots showing the association between ROE scores and age
age (A) and gender (B). The questionnaire score is plotted on the y-axis, and              (A) and gender (B). The questionnaire score is plotted on the y-axis, and the
the frequency of score responses on the x-axis.                                            frequency of score responses on the x-axis.



332
                                                                                                           Normative scores of ROE and FROI-17




Table IV. Normative ROE and FROI-17 scores from the reference cohort (n = 1000).
 Disease-specific                         All                   Female                 Male             < 50 years           > 50 years
 questionnaires                       (n = 1000)               (n = 500)             (n = 500)           (n = 619)            (n = 381)
 FROI-17
 Overall score                              20.8 ± 17.1       22.4 ± 17.1           19.1 ± 17.0         22.0 ± 17.6          18.7 ± 16.1
 Nasal symptoms                             16.8 ± 16.6       17.3 ± 16.8           16.3 ± 16.4         17.7 ± 16.9          15.3 ± 16.0
 General symptoms                           24.8 ± 21.5        27 ± 21.6            22.7 ± 21.3          25.9 ± 22           23.1 ± 20.7
 Self confidence                            16.4 ± 21.1       19.8 ± 22.6           13.1 ± 19.0         19.3 ± 22.7          11.7 ± 17.4
 ROE                                        73.1 ± 15.9       72.5 ± 16.6           73.6 ± 15.1         71.1 ± 16.5          76.3 ± 14.3
Values are presented as mean ± standard deviation.



many and other industrialised countries, such as the United                  may decrease after surgery was received. In addition, soci-
States. Alsaraf et al. performed a prospective pilot study                   odemographic characteristics such as the participants’ age
of 78 patients treated in three cosmetic surgery centres in                  or mobility may also play a role.
the United States and concluded that patient-reported out-                   We observed that age has a significant influence on the
come measures are useful to assess cosmetic facial plas-                     functional and aesthetic outcomes of rhinoplasty. Partici-
tic surgery outcomes and provide the surgeon with a more                     pants older than 50 years had lower FROI-17 scores and
objective means of comparing treatment options 11. Self-                     higher ROE scores, indicating higher levels of satisfac-
administered questionnaires can be completed quickly and                     tion. This finding is supported by the results of Litner et
are less expansive, but can be influenced by response shift                  al. 22 and Bulut et al. 7, who argued that mental impairment
bias 19.                                                                     affects the physical health of young, healthy individuals.
In this study, the FROI-17 scores (overall score, nasal                      Older people are more accepting of who they are and how
symptoms, general symptoms, and self-confidence) and                         they look, and thus are better able to adapt to their new fa-
ROE index revealed significantly more functional impair-                     cial appearance and functional disabilities. Contrary to our
ment before rhinoplasty than after rhinoplasty. Herruer et                   findings, previous studies reported that younger patients
al. (2018) showed that patients seeking rhinoplasty have                     were more satisfied with their QoL following rhinoplasty
more distress associated with self-consciousness of ap-                      than patients older than 35-40 years. This may be because
pearance than the general unconcerned population 20. In                      patients become less satisfied with their facial appearance
the present study, we did not find significant differences                   as they age, e.g., because of facial lines, loss of cheek full-
in aesthetic and functional burden between the reference                     ness, and bags under the eyes 23. However, it is difficult to
cohort and postoperative patient cohort, except for the                      compare age-related findings between studies because the
FROI-17 general score which was significantly lower in the                   age limits are different. In our opinion, being older than 40
patient cohort 12 months after rhinoplasty (14.9 vs 24.8;                    does not fall under the definition of old.
p = 0.004). These findings suggest that rhinoplasty has gen-                 Female gender also affected the normative FROI-17 gen-
eral benefits. Oedema following rhinoplasty can mask the                     eral and self-confidence scores of the reference cohort.
final result for up to 12 months and can adversely affect                    Female participants had higher FROI-17 scores and lower
patient satisfaction 7,11,21. Although we lost almost 70% of                 ROE scores, indicating lower levels of satisfaction. This
our septorhinoplasty patients to follow-up at 12 months, we                  may be because females pay more attention to their facial
have decided to include these data precisely to take into                    appearance. In addition, their self-image and body satis-
account the long times obtaining a restitutio ad integrum.                   faction are negatively affected by unrealistic beauty stand-
The limit of this comparison is the consistent dropout at                    ards and demands to hide outer imperfections imposed by
12 months that can lead to an increase in the estimator’s                    social media 24. Global QoL instruments like the SF-36
variance. However, the aim of this study was not to com-                     have shown that women have poorer health scores than
pare groups, but rather establish normative values for the                   men across eight domains 25. Rohrich et al. (2003) also
ROE and FROI-17 questionnaires in a European reference                       argued that male patients have less understanding of their
cohort as a fundamental help for rhinosurgeons in quali-                     health – in this case nose deformity – than women do 26.
tatively monitoring their own performance and treatment                      A weakness of our study is that the sample was a non-prob-
results. Reasons for this dropout rate might be the lack of                  abilistic quota sample, so that the data is more suited to
participants’ interest due to the setting for the clinical co-               descriptive analysis; inference cannot be calculated. There-
hort, since it may be expected that interest in such a study                 fore, we have to assume that FROI and ROE scores are



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M. Plath et al.




independently distributed between those that opt-in and      Ethical considerations
those that do not. We assumed that the decision to par-
                                                             The Ethics Committee of the Medical Faculty at the Uni-
ticipate in the Respondi panel was not correlated to any-
                                                             versity of Heidelberg granted permission to conduct the
thing that may affect the FROI and ROE scores. We con-
                                                             study (Project No. 409/2006) according to the Declaration
sidered this reference cohort to be a “healthy” cohort in
                                                             of Helsinki on biomedical research involving human sub-
contrast to our patient cohort of individuals undergoing
                                                             jects.
rhinoplastic surgery. Thus, the medical history of facial
trauma or nasal surgery was not queried. We observed
differences in all index scores between these cohorts.       References
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