Int. J. Oral Maxillofac. Surg. 2011; 40: 926930 doi:10.1016/j.ijom.2011.04.001, available online at http://www.sciencedirect.

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Clinical Paper Orthognathic Surgery

The clinical relevance of orthognathic surgery on quality of life

C. Murphy, G. Kearns, D. Sleeman, M. Cronin, P. F. Allen: The clinical relevance of orthognathic surgery on quality of life. Int. J. Oral Maxillofac. Surg. 2011; 40: 926 930. # 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Abstract. The aim of orthognathic surgery is to produce a more aesthetic facial skeletal appearance, and improve jaw function. This prospective study, aimed to evaluate the impact of orthognathic surgery on quality of life for patients with dentofacial deformity, and whether it was clinically meaningful. 62 consecutive patients were recruited (27 male, 35 female) aged 1838 years. Baseline data were collected using a validated health status measure (Orthognathic Quality of Life Questionnaire (OQLQ)) and a visual analogue scale (VAS). Postoperative questionnaires (OQLQ, VAS) and a Global Transition Scale (GTS) were completed at 6 months after completion of treatment and compared with pre-treatment scores. Following surgery, there was a signicant (p < 0.05, paired t test) improvement in OQLQ scores for each domain. The proportion of patients reporting a moderate or large improvement was: facial appearance (93%), chewing function (64%), comfort (60%) and speech (32%). Clinical relevance of change scores was reported in terms of effect sizes, and the largest effect was on facial aesthetics. The clinical impact was moderate on social aspects of deformity and oral function and a small effect on awareness of facial deformity. This research reafrms that orthognathic surgery has positive effects on quality of life.

C. Murphy1, G. Kearns2, D. Sleeman1, M. Cronin3, P. F. Allen1

1 Department of Oral and Maxillofacial Surgery, Cork University Dental Hospital, Ireland; 2Department of Oral and Maxillofacial Surgery, Mid-Western Regional Hospital Limerick, Ireland; 3Department of Statistics University College Cork, Ireland

Key words: orthognathic surgery; quality of life. Accepted for publication 8 April 2011 Available online 26 May 2011

The evaluation of quality of life using health status measures is increasing in the assessment of healthcare outcomes1,21. It has been recognized that objective measures alone do not fully capture the impact of a condition on daily living, and subjective assessment of the impact of disease or condition is also required. Orthognathic surgery is carried out to correct dentofacial deformity. This involves pre-surgical orthodontics with xed appliances for alignment and level0901-5027/090926 + 05 $36.00/0

ling of the dental arches. Surgery is then carried out to reposition the jaws, resulting in a more harmonious facial skeleton. Many studies show that patients benet psychologically and have improved facial and dental aesthetics and improved function after treatment8,10,11,14,15,19,20,22. The assessment of quality of life impact after orthognathic surgery is difcult to measure objectively as the patients life is neither extended nor is a disease cured in the conventional understanding of

healthcare1. Health related quality of life (HRQoL) is multifactorial, and any model constructed to quantify this should include, physical, social and psychological domains, as suggested by CAMILLERI-BREN3 NAN & STEELE . Generic health, generic oral health and condition-specic measures have been used to assess the impact of orthognathic surgery. The generic health questionnaire may be used to compare the outcomes with those of other conditions, but the lack of condition specicity can

# 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Clinical relevance of orthognathic surgery on quality of life

mean that generic instruments are not able to address issues relevant to people with facial deformity. For instance, LEE et al.16 found the 36 item Short Form Health Survey (SF-36) to be insensitive and unable to detect differences in quality of life between those with and without dentofacial deformities. The development of a condition-specic measure was undertaken to generate a specic measure that could focus on a particular condition and population and be potentially more responsive to small, but clinically important, changes in health6,7. CUNNINGHAM et al.6 noted that patients with severe dentofacial deformity had not been studied in this way and previous reports relied on generic questionnaires that were less likely to detect specic changes in a specic population. The Orthognathic Quality of Life Questionnaire (OQLQ) was developed using several sources for item derivation, including a literature review, and unstructured interviews with clinicians and patients6,7. The items were divided into four domains: social aspects of deformity, facial aesthetics, oral function and awareness of facial deformity. CUNNINGHAM et al.6 have tested the validity of OQLQ by using the SF-36 questionnaire and a visual analogue scale (VAS) for comparison. A number of recent reports have used the OQLQ to evaluate the impact of orthognathic surgery on quality of life. In a casecontrol study of 154 Chinese patients, LEE et al.16 showed that facial deformity affects many aspects of patients lives and the OQLQ was able to detect this. In a follow up publication, 36 of these patients received orthognathic surgery and reported signicant improvement in quality of life15. In a study of German patients using the OQLQ, BOCK et al.2 conrmed the ndings of LEE et al. that facial deformity had signicant negative impacts on quality of life. Each of these reports suggests that the OQLQ has good measurement properties and is suitable as an outcome measure for facial deformity and its management using orthognathic surgery. Measurement of change is central to evaluating the impact of treatment in healthcare, and is usually reported in terms of statistical signicance. In some cases, pre-/post-treatment change scores may be statistically signicant but not necessarily clinically signicant or meaningful to the patients who experience that change. Interpretability of a health status measure has been dened as the degree to which one can assign qualitative meaning that is, clinical or commonly understood connotations to quantitative scores18. A commonly used approach to determine the clinical meaning of scores is to calculate the effect sizes. An effect size is a distribution based measure of change, and COHEN4 has suggested benchmarks to indicate the size of change that has occurred following a clinical intervention. He has suggested that an effect size of 0.2 is equivalent to a small change, 0.30.7 as a moderate and >0.8 as a large pre-/posttreatment change. None of the previous studies have used self reported global transition scores to give an indication of the clinical relevance of orthognathic surgery, nor have they attempted to quantify the clinical relevance of change. The aim of this study was to evaluate the impact of orthognathic surgery on the quality of life of patients with facial deformity, and, to determine if the OQLQ is able to detect clinically important change in patients undergoing surgery to correct dentofacial deformity.
Material and methods

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The study protocol was reviewed and approved by the Clinical Research Ethics committee of the Cork Teaching Hospitals. Patients attending for consultation in orthognathic surgery between June 2006 and July 2008 in Cork and Limerick maxillofacial surgery units were asked to participate. In this prospective study, 62 consecutive patients (27 male, 35 female) with congenital deformities in the maxilla, mandible or both, agreed to participate in the study. All of the patients had congenital disharmony, and none of them had symptoms associated with syndromes. The age range was 1838 years (mean 21.6 years). Patients were recruited having commenced orthodontic treatment, and whilst awaiting surgical treatment. Data were collected at two stages: during the orthodontic phase of treatment, prior to surgical intervention; and 6 months after surgical treatment. The measures used to assess quality of life were the OQLQ, a VAS and, a Global Transition Scale (GTS). Patients completed the OQLQ and VAS prior to treatment, and the post-treatment questionnaire 6 months post-surgery. The GTS was included in the post-treatment questionnaire, and used to determine the concurrent validity of the pre- and post-treatment change score for the OQLQ. The OQLQ contains 22 statements relating to 4 domains: appearance; function; social aspects of deformity; and awareness of deformity. Respondents are

asked to indicate their level of agreement with statements such as I dont like eating in public places. These responses are rated on a Likert scale scoring system, with response possibilities ranging from 1 (it bothers you a little) to 4 (it bothers you signicantly). Summary scores for each domain were calculated by summing response codes within domains pre- and postoperatively and then compared to detect change. Higher scores indicate higher levels of concern in relation to each domain, lower scores indicate less concern and better quality of life. A VAS was also incorporated into the pre- and post-treatment questionnaires. Patients were asked to indicate their level of satisfaction with treatment on a 100 mm scale ranging from 0 to 100, 0 being poor satisfaction level and 100 being the best possible outcome. The preoperative VAS was rated on satisfaction with treatment up to the point of surgery. The postoperative VAS was rated on satisfaction with postsurgery period and outcomes of treatment. In addition, a GTS was incorporated in the post-treatment questionnaire to provide an anchor based measure of change against which the condition-specic scale can be measured. In this questionnaire, patients rated the impact of surgery on appearance, chewing, oral comfort and speech. As recommended by JUNIPER et al.13, these transition variables were scored on 15-point scale (Table 1). In addition to descriptive statistics, pretreatment domain scores were compared with post-treatment scores using paired t tests (SAS1 Version 9.1) at a 5% level of signicance. Effect sizes for each domain were calculated by subtracting the mean post-treatment score from the mean pretreatment score and dividing by the stanTable 1. Global Transition Scale response possibilities. Code 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Response A very great deal worse A great deal worse A good deal worse Moderately worse Somewhat worse A little worse Almost the same, hardly any worse at all No change Almost the same, hardly any better at all A little better Somewhat better Moderately better A good deal better A great deal better A very great deal better

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condence in public. There was also a signicant improvement in function for the study population. This may reect improvement for such groups with significant reverse overjets or anterior open bites. The clinical relevance of these effects varied, and it would appear, as one could reasonable expect, that the largest impact was on appearance. The impact of orthognathic surgery on social and functional domains was important, but more moderate than its impact on perception of appearance. There could be a number of explanations for this, including the variation in patient personality and the age range of the sample. A further possibility is that signicant facial appearance change is immediate and dramatic, and thus the most obvious impact following surgery. Such a signicant facial appearance change may make some patients cautious about engaging in social interaction in the immediate aftermath of surgery, and thus moderate the impact on these domains. It is possible that this may improve with time as the patient becomes more condent with social interaction post-surgery. This nding is of relevance when explaining the possible benets to patients with facial deformity in advance of surgery. The majority of studies previously carried out were retrospective and showed a similar correlation with the present results1417 The longitudinal studies carried out by KIYAK et al.14 and CUNNINGHAM et al.5 also revealed high satisfaction rates. The results from this prospective study compare favourably, as the majority of patients reported improved perception of appearance, function and self condence. The GTS was completed by patients postoperatively to measure the effect of surgery on appearance, chewing, speech and oral comfort. It also allowed the construct validity of the OQLQ to be tested. Perceived chewing ability improved for most patients, with 56% of the sample reporting moderate or large improvement as a result of surgery. A signicant similar picture emerged for the impact of surgery on appearance, with 81% of the sample reporting a moderate or large change. A

Table 2. Comparison of mean pre-/post-treatment OQLQ scores (by domain) and VAS scores (n = 52). Domain, N = 52 Aesthetics Awareness Social Function VAS (N = 41)
*

Mean pre (S.D.) 12.21 6.90 10.42 7.46 79.22 (5.87) (4.80) (8.33) (5.99) (18.42)

Mean post (S.D.) 7.00 5.73 7.19 5.69 87.56 (5.64) (4.19) (8.32) (5.77) (15.50)

Mean difference 5.21 1.17 3.23 1.77 8.34 (6.19) (3.93) (8.18) (6.00) (20.94)

P-value 0.0001* 0.0363* 0.0063* 0.0384* 0.0*

Statistically signicant p < 0.05, paired t tests.

dard deviation of the pre-treatment score. Using the Global Transition Scale, the proportion of patients who reported no change, minor improvement, moderate improvement, large improvement and deterioration were calculated. Also, following JUNIPER et al.13, the magnitude of change in the four domains assessed was dened as follows: 7, 8 or 9 was considered as no change; 10 or 11 was considered as a small change that denes the minimally important difference; 12 or 13 was considered moderately changed; 14 or 15 was considered a large change; and 1, 2, 3, 4, 5 or 6 was considered a deterioration.
Results

There were 62 participants in the study of whom 52 completed postoperative questionnaires. 10 subjects (5 male, 5 female) were lost to follow-up, but there were no characteristic differences between these patients and those who completed the follow-up questionnaires. For the remaining 52 patients, the most common skeletal classication was class 3 (n = 32). This was corrected by mandibular setback or bimaxillary surgery. 16 patients had surgery to correct class 2 malocclusion, 4 patients had surgery to correct class 1 malocclusion. All of the patients in the study, except one (female, age 36 years), had pre-surgical orthodontic treatment to optimize treatment outcome. Mean length of time for pre-surgical orthodontics was 24 months. The mean pre-/post-treatment difference was found to be statistically signicant for all domains of the OQLQ at the 5% level of signicance (Table 2). In

terms of clinical signicance, the effects sizes were: appearance 0.9; function 0.4; social aspects of deformity 0.4, and awareness of deformity 0.2. This indicates that the impact on appearance was large, with moderate impacts on social aspects of deformity and function. The impact on awareness of deformity was clinically important, but the effect was small. The preoperative VAS scores are high, which may be attributed to the fact that patients are satised with orthodontic treatment and surgical consultations. The mean difference in VAS is statistically signicant as shown in Table 2. In terms of the post-treatment GTS, details of the change in scores for each category are shown in Table 3. Overall, the most patients reported improvement in all four domains. The level of reported improvement varied from minor improvement to large improvement. Orthognathic surgery appears to have the biggest impact on appearance and chewing, followed by comfort. Its impact on speech is much less, and unlikely to be clinically meaningful (32 patients reported no change in this domain).
Discussion

The analysis of change in quality of life was carried out using the OQLQ. This condition-specic questionnaire was constructed to tap into the various areas of concern for patients and show if there was a quantiable change as result of surgery. The mean difference score in each domain showed a statistically signicant change, and this may reect areas of improvement in relation to appearance and psychological benets such as having improved self

Table 3. Global rating of post-treatment change, by domain, reported as proportion (percentage) of sample (n = 52) in each change category. Domain Global transition rating Deterioration (1, 2, 3, 4, 5, 6) Appearance Chewing Comfort Speech 0 4 8 2 (0%) (7.5%) (15%) (4%) No change (7, 8, 9) 4 15 13 32 (7%) (29%) (25%) (62%) Minor improvement (10, 11) 6 4 8 4 (12%) (7.5%) (15%) (7%) Moderate improvement (12, 13) 18 13 11 5 (35%) (25%) (22%) (10%) Large improvement (14, 15) 24 16 12 8 (46%) (31%) (23%) (15%)

Clinical relevance of orthognathic surgery on quality of life

signicant proportion of patients cite function and appearance as their motivation for treatment. FINLAY et al.9 suggested that facial appearance was cited by 52% of patients as the most important reason for undergoing surgery, whilst 31% cited function as the most important reason. These results are similar to those found by WILMOTT et al.23 which also suggested gures of 56% citing aesthetics and 32% citing difculty chewing. One of the possible benets of GTS is that it captures information about people who did not improve or deteriorated post-surgery. The results in the present study suggest that 7% of patients reported a deterioration in function. This may be attributed to the fact that some patients had not completed post-surgery orthodontics at the time of post-treatment evaluation. 15% of the sample reported a deterioration in comfort following surgery, which is potentially related to surgical side-effects such as altered sensation. To determine whether this is a transient effect would require a longer follow-up period. The results suggest that orthognathic surgery has a limited impact on speech. A small proportion of patients reported improved speech and this may be due to improved occlusal harmony and improved lip competence. Surgery is not aimed at correcting speech, but improvements in this area are considered an added benet from surgery. The GTS also reported deterioration in a small percentage of patients in chewing, comfort and speech components, which may be due to the timing of follow-up as patients are still readjusting to post-surgical changes. The authors would not anticipate these ndings to be signicant in the long term. These results reafrm those obtained using the OQLQ and may be used to show its responsiveness as a condition-specic tool. As highlighted in a recent systematic review12, variations in study design and lack of uniformity of approach in assessing psychosocial constructs have obscured the true nature of the impact of orthognathic surgery. The items in the OQLQ may be considered representative of areas of interest for these patients, but the GTS would be recommended for use alongside OQLQ in future longitudinal studies. In addition, it may ultimately be used to determine the minimally important clinical difference for the OQLQ measure. The patients main point of dissatisfaction was the length of treatment and occasional cancellation of surgery. Length of treatment time presurgery was 23 months, which, which should be considered satisfactory when one takes into account the waiting time for surgery once orthodontic treatment is completed. A small number of patients required orthodontics for more than 4 years; this was due to a change in the treatment plan from orthodontics only to combined surgery and orthodontics. This may be avoided in the future by early recognition of deformity beyond the scope of orthodontics. It may also indicate that early referral of patients to a multidisciplinary clinic would be desirable. This is close to an acceptable time frame as orthodontic treatment may often take 18 months to 2 years for standard xed appliance therapy. A number of patients were treated for 3 4 years, owing to alteration of treatment plans or waiting for hospital beds once orthodontic decompensation was completed. One patient had pre-surgical orthodontics for 108 months due to changing treatment plans. In conclusion, combined orthodontics and orthognathic surgery is a reliable treatment modality with signicant positive effects. This is the rst longitudinal study carried out in an Irish population with dentofacial deformity. Overall the research shows a positive impact on the patients facial appearance and oral function and found social advantages such as improved self condence.
Funding

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None.
Competing interests

None declared.
Ethical approval

Ethical approval was granted from Ethics Research committee at Mid Western Regional Hospital Limerick and Cork University Hospital.
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