Otolaryngology–Head and Neck Surgery (2010) 143, 361-366

ORIGINAL RESEARCH–HEAD AND NECK SURGERY

Development and preliminary validation of the Lip

Reanimation Outcomes Questionnaire

John R. de Almeida, MD, Ashlin J. Alexander, MD, Mark G. Shrime, MD,Ralph W. Gilbert, MD, FRCSC, and David P. Goldstein, MD, FRCSC,

Toronto, Ontario, Canada

No sponsorships or competing interests have been disclosed forthis article.

ABSTRACT

OBJECTIVE: Lip paralysis is associated with eating, speaking,and appearance impairments. The lip reanimation outcome ques-tionnaire is designed to assess these functional impairments afterlip reanimation.STUDY DESIGN: Cross-sectional validation study.SETTING: Tertiary care academic center.SUBJECTS AND METHODS: Patients who underwent lipreanimation and control subjects. A disease-specific instrumentwas created by systematic literature review and expert opinion.The 15-item patient completed subscale was administered to 20 lipreanimation patients. Photographs of 19 patients and three controlsubjects were taken in four poses and rated by six raters (2surgeons, 2 residents, and 2 novices) by the use of a external ratersubscale, and reliability was determined by the use of intraclasscorrelation coefficients (ICC). Content and construct validity wereassessed.RESULTS: Internal consistency (ICC range 0.813-0.915 foreach domain), test�retest reliability (ICC range 0.616-0.981 foreach item) for the patient completed subscale, and interrater (ICC �0.852) and interlevel reliability (ICC � 0.929) for the externalrater subscale were substantial to excellent. The content validityindex was 0.87. Construct validity was demonstrated by poorerscores in patients with transected nerves versus intact nerves forappearance (P � 0.04) and oral competence (P � 0.011). Photo-graphs of control patients had lower asymmetry scores (P �0.001), and the instrument detected greater asymmetry in patientswith progressively more exaggerated smile (P � 0.001).CONCLUSION: The lip reanimation outcome questionnaire haspromising reliability and validity in this preliminary study, butadditional psychometric testing with larger samples is requiredbefore the survey can be recommended for clinical use.

© 2010 American Academy of Otolaryngology–Head and NeckSurgery Foundation. All rights reserved.

Paralysis of the lip muscles caused by facial nerve injurycan lead to difficulties with eating and drinking, speak-

ing, and nonverbal communication; it can also have a neg-

Received February 19, 2010; revised May 9, 2010; accepted May 13, 2010.

0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Necdoi:10.1016/j.otohns.2010.05.015

ative impact on appearance and quality of life.1-4 Injury tothe marginal mandibular branch can occur in isolation dur-ing neck dissection or submandibular gland excision, or asa consequence of damage to the main trunk of the facialnerve. Paralysis of the lip depressors can then result inasymmetry that is exaggerated during smiling.5

Several surgical reanimation techniques, both static anddynamic, have been described to address both functionaland cosmetic impairments.6-11 Facial nerve grading scales,12,13

although good at measuring movement and symmetry, arenot ideal to measure disability, and facial disability ques-tionnaires, like the Facial Disability Index and Facial Clini-metric Evaluation scale, provide a measure of gross facialdysfunction but are not specific for lip dysfunction.1,14 Wereport the development and validation of the Lip Reanima-tion Outcomes Questionnaire (LROQ), an instrument de-signed to measure changes in outcomes related to lip paral-ysis after reanimation surgery.

Methods

Item GenerationItems for the LROQ were developed by the use of a com-posite strategy. A systematic review was performed by theuse of MEDLINE (to August 2009), relevant bibliographies,and expert opinion (D.P.G., R.W.G.) to identify pertinentstudies and items. Keywords and medical subject headingsdelimiting the search included facial and lip paralysis, sur-gical reconstructive procedures, facial reanimation, qualityof life, questionnaires, outcomes, and patient satisfaction.Included studies involved: 1) patients with unilateral lipparesis/paralysis, and 2) any functional outcome measuredby means of a disease-specific scale or questionnaire (val-idated or not).

Items for the LROQ were then created by the use of bothitems from included studies and items deemed relevant byexperts (D.P.G., R.W.G). Two subscales, one completed bypatients and one completed by external rater(s), were included.For the patient-rated subscale, items were divided into preop-

k Surgery Foundation. All rights reserved.

362 Otolaryngology–Head and Neck Surgery, Vol 143, No 3, September 2010

erative and postoperative and used a seven-category Likertscale. Preoperative items related to impairments before surgeryand contained three anchors: 1 corresponded with no difficultyat all, 4 corresponded with some difficulty, and 7 correspondedwith extreme difficulty. Postoperative items related to changescompared with before surgery and contained three anchors: 1corresponded with much worse, 4 corresponded with nochange, and 7 corresponded with much better. The final itemassesses the patient’s own subjective feeling of symmetry. Thisitem was constructed by the use of a 10-cm visual analoguescale with “very asymmetric” and “perfect symmetry” as theend anchors.

For the external rater subscale, items included subjectiverating of lip symmetry on the basis of four photographs: one atrest and three in different positions of smile as previouslydescribed.15 The three smile positions include a “Mona Lisa”smile, a “canine” smile, and a “full mouth” smile. Each itemused a seven-category Likert scale with four anchors: 1 corre-sponded with no asymmetry, 3 corresponded with mild asym-metry, 5 corresponded with moderate asymmetry, and 7 cor-responded with severe asymmetry.

PatientsResearch ethics approval was granted from the ResearchEthics Board at the University Health Network in Toronto,Canada, before the commencement of the study, and in-formed consent was obtained from each patient enrolled inthe study. The inclusion criteria for involvement in the studywere as follows: 1) having undergone a reconstructive/reanimation procedure for unilateral lip paresis/paralysis atthe University Health Network between 2001 and 2009; 2)being able to provide informed consent; and 3) being able tocomplete the questionnaire in English. Palliative patientsand patients with bilateral lip paresis/paralysis were ex-cluded from the study. Information regarding age, gender,histopathological diagnosis, primary tumor site, reason forlip paresis/paralysis, method of reanimation/reconstruction,and duration of follow-up were collected.

Reliability TestingTwenty patients were asked to complete the 15-item patientrated subscale on two separate occasions separated by 14days. Only 10 patients completed the same questionnaire 14days later. This time point was chosen to ensure that patientswould not recall their previous responses, and we assumedno change in their functional status in the interim. Internalconsistency (�) and test�retest reliability were computed.Four standardized photographs were taken with a digitalsingle lens reflex camera (Fuji FinePix S9000; FujifilmUSA Inc., Valhalla, NY) in the four positions delineatedpreviously. The external rater subscale was then completedby six raters (2 head and neck surgeons, 2 otolaryngologyresident trainees, 2 novice observers) for 19 patients andthree control subjects. One patient refused to have photo-graphs taken. Interrater, interlevel, and internal consistency

were computed.

Reliability coefficients range from 0 to 1, and were ratedas excellent if between 0.8 and 1.0, substantial if between0.60 and 0.79, moderate if between 0.40 and 0.59, fair ifbetween 0.20 and 0.39, and poor if between 0 and 0.19, asadapted from Landis et al.16 Reliability coefficients werecalculated with intraclass correlation (ICC) statistics andgeneralizability theory17 by the use of G-String (v.2.0;McMaster University, Hamilton, Ontario, Canada) fromvariance estimates calculated with UrGENOVA (Universityof Iowa, Iowa City, IA).

Validity TestingValidity was assessed using both content validity and con-struct validity. Content validity, the determination of therepresentativeness or relevance of items of the question-naire, was applied at the developmental stage and subse-quently assessed in the judgment stage as previously de-scribed.18 At the developmental stage, experts (M.G.S.,D.P.G., R.W.G.) were involved in identification of contentdomains (appearance, oral competence, speech, symmetry).Each item was subsequently judged by experts on a scalefrom 1 to 4; 1 corresponding with no relevance and 4corresponding with very relevant. The content validity in-dex (CVI) for each item was computed as the proportion ofexperts rating each item 3 or 4.19 The CVI for the instru-ment was computed as the proportion of items in the ques-tionnaire on which all experts agreed on content validity.

Construct validity was assessed testing three a prioriconstructs/hypotheses:

1) Lip dysfunction is commensurate with the extent ofnerve injury, and patients who have had loss of integrityof the nerve/sheath (transected nerves), either by intra-operative injury or sacrifice of the nerve with or withoutnerve grafting, are likely to have worse outcomes thanthose with an intact nerve sheath.

2) Patient with lip dysfunction and reanimation will havepoorer scores than control patients.

3) Asymmetry will be more apparent with progressivelygreater voluntary lip muscle movement as the result ofunopposed lip elevation. Therefore, the “full mouth”smile will elicit more asymmetry than the “canine”smile, the “Mona Lisa” smile, and the rest position.

Construct validity was tested by the use of an independentsample Mann-Whitney U test (nonparametric) to comparemeans of scores of patients for construct 1 and 2, andKruskal-Wallis analysis of variance for construct 3. Analpha level of 0.05 was chosen for all analyses. Statisticaltests for assessment of validity were performed by the use ofSPSS (v.17.0; SPSS Inc., Chicago, IL).

Results

Item GenerationA search for relevant studies revealed 432 studies, of which

six met inclusion criteria and had disease-specific items

363de Almeida et al Development and preliminary validation of the . . .

relevant to lip dysfunction (Fig 1).1,10,14,15,20,21 Furtheritems were generated on the basis of expert opinion. Twosubscales, consisting of a 15-item patient rated subscale anda four-item external rater subscale, were created (Fig 2).The patient-rated subscale consisted of items relating topreoperative disability and questions relating to changesince the operation. Items belong to the following domains:appearance (items 1-4, 8-11), oral competence (items 5-6,12-13), speech (items 7, 14), and symmetry (item 15).

PatientsTwenty patients were included in the study, comprising 10men and 10 women. Nineteen patients and three controlpatients were photographed. The mean age (SD) was 63.2years (17.6 years) and median age was 65.5 years. The meanduration of follow-up (SD) was 31.5 months (26.4 months).The most common histopathological diagnosis was squa-mous cell carcinoma (60%), and pleomorphic adenoma wassecond most common (10%). Other tumors include oneeach of basal cell carcinoma, adenoid cystic, adenocarci-noma, small cell carcinoma, osteosarcoma, and angiosar-coma. The most common tumor site was the parotid gland(40%), with buccal mucosa (15%), mandible (10%), tongue(10%), floor of mouth (10%), and other sites occupying theremaining sites (15%). Mechanism of lip paralysis includediatrogenic injury (45%), nerve sacrifice for oncologic rea-sons (40%), lip resections for oncologic reasons (10%), andiatrogenic nerve transection (5%). Mechanisms of lip rean-imation included tendon suspension from mid-lip to com-

Figure 1 Systematic review flow diagram showing includedstudies and reasons for exclusions.

missure (45%), static sling from commissure to zygoma

(40%), cable grafting (20%), and primary reanastamosis(5%).

ReliabilityFor the patient-related subscale, internal consistencies for alldomains (ICC range, 0.813-0.915) (Table 1) were excellent,and test�retest reliability coefficients were substantial to ex-cellent for all items (ICC range, 0.616-0.981) (Table 2).

For the external rater subscale, interrater (ICC � 0.852)and interlevel reliability (ICC � 0.929) were excellent. Theinternal consistency between the four poses was substantial(ICC � 0.736) but demonstrated even stronger internalconsistency when assessing only the three smile poses (ICC �0.774) (Table 3).

Content ValidityCVI for all items was 1.0, except for item 4 (“Did your lippull to the non-paralyzed side before your operation”; CVI �0.33) and item 12 (“How do you feel about your ability tohold solids/liquids in your mouth”; CVI � 0.67). The CVIfor the overall questionnaire was 0.87.

Construct ValidityTo test the first construct/hypothesis, mean postoperativeappearance, oral competence, speech, and symmetry scores

Figure 2 Lip Reanimation Outcomes Questionnaire.

364 Otolaryngology–Head and Neck Surgery, Vol 143, No 3, September 2010

were compared between patients who have had preservationof the nerve sheath versus those who have not (nerve sac-rificed or iatrogenically transected) (Fig 3). Scores weresignificantly poorer for patients who had violated nervesheaths in both appearance (2.9 � 1.5 vs 4.5 � 1.5; meandifference � 1.6, 95% confidence interval [95% CI] 0.14-3.01, P � 0.04) and oral competence (2.4 � 1.5 vs 4.5 � 1.6;mean difference � 2.1; 95% CI 0.66-3.54, P � 0.011). Scoresfor speech (3.2 � 1.3 vs 4.5 � 1.6; mean difference � 1.2;95% CI �0.14 to 2.6, P � 0.074) and symmetry (2.7 � 2.3 vs4.3 � 2.8; mean difference � 1.6; 95% CI �0.93 to 3.90, P �0.17) also were poorer but did not reach statistical significance.

To test the second hypothesis, mean scores of externalraters were significantly better for control patients (n � 3)than for patients with lip reanimation for paralysis (n � 19;P � 0.001) (Fig 4). To test the third hypothesis, mean scoresof each external rater item were compared. All items hadsignificantly different mean scores; with a significant dif-

Table 1

Internal consistencies for various domains of the patient-ra

Domain Item

Preoperative appearance 1-4Preoperative swallowing 5-6Preoperative speech 7Postoperative appearance 8-11Postoperative swallowing 12-13Postoperative speech 14Symmetry 15

CI, confidence interval; NA, not applicable.

Table 2

Test�retest reliability coefficients for patient rated

subscale of the Lip Reanimation Outcomes

Questionnaire

ItemTest�retest reliability

(n � 10) 95% CI

1 0.882 0.596-09692 0.699 0.168-0.9163 0.902 0.657-0.9754 0.941 0.783-0.9855 0.981 0.925-0.9956 0.885 0.606-0.9707 0.900 0.649-0.9748 0.786 0.350-0.9429 0.928 0.740-0.982

10 0.976 0.913-0.99311 0.828 0.450-0.95412 0.808 0.400-0.94813 0.897 0.697-0.97314 0.817 0.424-0.95115 0.616 0.022-0.888

CI, confidence interval.

ference in mean ranks using the Kruskal-Wallis test (P �0.001) (Fig 4).

Discussion

The LROQ is a measurement instrument designed to assessthe burden of functional impairments caused by lip paralysisand also the extent of change after lip reanimation. Thepatient-rated and external rater subscales provide both self-reported functional information and an assessment of ap-pearance. This new instrument comprises content validitems suggested by experts and also those borne out in otherinstruments in the literature.

Previous measurement instruments have been created forassessing facial disability, such as the Facial DisabilityIndex and the Facial Disability Index and Facial ClinimetricEvaluation questionnaires.1,14 Both of these instruments arevalidated and contain items relevant to lip dysfunction.However, lip-related items comprise only a subset of allfacial morbidity. An instrument designed to assess only lipdysfunction will have a stronger discriminative ability be-cause the signal-to-noise ratio is greater.22 Furthermore,both of these instruments are designed to evaluate facial

Table 3

Reliability coefficients of the external rater subscale

of the Lip Reanimation Outcomes Questionnaire

Reliability coefficient

Intraclasscorrelationcoefficient 95% CI

Interrater reliability (6 raters) 0.852 0.807-0.891Interlevel reliability (3 levels:

surgeon, resident, novice) 0.929 0.900-0.950Internal consistency

(all 4 poses) 0.736 0.572-0.864Internal consistency (3 smile

poses, excludes restingpose) 0.774 0.602-0.890

CI, confidence interval.

bscale of the Lip Reanimation Outcomes Questionnaire

Internal consistency (�),n � 20 95% CI

0.821 0.687-0.9150.915 0.799-0.966NA nil

0.871 0.767-0.9400.813 0.729-0.952NA nilNA nil

ted su

365de Almeida et al Development and preliminary validation of the . . .

disability as a state at one point in time. Thus, to evaluatechange after a surgical reconstructive procedure would re-quire prospective administration. The LROQ has items re-lating to preoperative morbidity and changes after reanima-tion. It is thus useful for studies with a retrospective orcross-sectional design. However, the LROQ will be modi-fied in a future study for prospective administration. Suchmodifications would enable one to assess and detect stabil-ity over time. Other instruments have been created with onlyitems related to lip dysfunction, but these have not under-gone psychometric evaluation,10,15,20,21 have relatively fewitems,15 and are designed for ablative procedures, not rean-imation.20

We evaluated the LROQ for psychometric properties anddemonstrated sound reliability and validity. The patientrated subscale demonstrated substantial to excellent internalconsistency in the appearance and oral competence do-mains, and the test�retest reliability for all items appear tohave good reliability although certain items demonstratewide CIs. The symmetry item showed the pooresttest�retest reliability, likely because it was designed as avisual analogue scale. The authors of previous studies23,24

have shown that visual analogue scales may be more diffi-cult to comprehend and may have poorer test�retest reli-ability particularly in populations with literacy problems.

The interrater and interlevel reliability of the externalrater subscale were both excellent, suggesting that this sub-scale can be used by novices and experts alike without

Figure 3 Construct validity demonstrating differences in post-operative appearance and oral competence scores in patients withviolated versus intact nerve sheaths (error bars represent standarddeviation).

compromising its ability to measure appearance. The inter-

nal consistency of the four ratings was substantial. Thisfinding is likely because of the fact that each smile poserequires progressively more use of the lip elevators, thusexaggerating any smile deficits. It stands to reason then that“full mouth” smile will not be internally consistent with theat rest pose. This finding is supported by a greater internalconsistency of the three smile poses alone and also byconstruct three, which demonstrates progressively highermean scores of asymmetry with more exaggerated smiles.

The LROQ also demonstrated both content and constructvalidity. The CVI for the entire instrument was 0.87 on ascale from 0 to 1.0 as rated by three experts. Constructvalidity was demonstrated by showing poorer postoperativescores for appearance and oral competence in patients whohave had nerve transections either for oncologic reasons oriatrogenic reasons. Seddon25 and Sunderland26 have bothdemonstrated poor facial recovery in transected nerves de-spite nerve repair. We failed to show a statistical differencein the speech and symmetry domains postoperatively be-tween patients who had nerve transections versus those whodid not. Generation of speech is a complex process requiringphonation, articulation, and other processes. As such, lipparalysis our instrument was not capable of detecting sig-nificant changes in speech scores.

We further demonstrated construct validity by showingbetter scores in individuals with normal facial functioncompared to those with lip paralysis followed by reanima-

Figure 4 Construct validity demonstrating differences betweencontrol patients and patients with reanimated lips as well as moreasymmetry in patients with progressively exaggerated smiles

(error bars represent standard deviation).

366 Otolaryngology–Head and Neck Surgery, Vol 143, No 3, September 2010

tion. Scores also reflected progressively more asymmetrywith each more exaggerated smile. This suggests that theexternal reviewer subscale was sensitive to detectingchanges in smile symmetry due to more excessive imbal-ance of lip elevators to depressors.

This study was limited in that it was a small study andcross-sectional in nature. For the first seven items, patientswere asked to recall morbidity preoperatively, thus introducingan element of recall bias. The size of the study also precludedconfirmatory factor analysis that would provide more informa-tion on items and the domains to which they belong. Further-more, certain reliability coefficients and validity statistics haverather large CIs. These large CIs suggest that the true reliabilityand validity may be poor, which is indeed a limitation to thestudy. Future larger validation studies are needed to betterestablish psychometric properties.

Acknowledgments

Dr. de Almeida would like to thank the Albert and Temmy Lattner Familyfor graduate studies funding in conjunction with Dr. Jeremy Freeman andthe Samuel Lunenfeld Research Institute at Mount Sinai Hospital, Toronto,Ontario, Canada.

Author Information

From the Department of Otolaryngology–Head and Neck Surgery, PrincessMargaret Hospital/University Health Network, University of Toronto, To-ronto, Ontario, Canada.

Corresponding author: Dr. John de Almeida, Wharton Head and NeckCentre 3-952, 610 University Avenue, Toronto, ON M5G 2M9.

E-mail address: john.dealmeida@utoronto.ca.

This project was selected for presentation at the American Association forFacial Plastics and Reconstructive Surgery Annual Meeting, San Diego,CA, October 1, 2009.

Author Contributions

John R. de Almeida, design of study, drafting, and final approval; AshlinJ. Alexander, design of study, drafting, and final approval; Mark G.Shrime, design of study, drafting, and final approval; Ralph W. Gilbert,design of study, drafting, and final approval; David P. Goldstein, design ofstudy, drafting, and final approval.

Disclosures

Competing interests: None.

Sponsorships: None.

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