Development and preliminary validation of the Lip Reanimation Outcomes Questionnaire

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  • ORIGINAL RESEARCHHEAD AND NECK SURGERY

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    studegicofIncluded studies involved: 1) patients with unilateral lipparesis/paralysis, and 2) any functional outcome measured

    OtolaryngologyHead and Neck Surgery (2010) 143, 361-366

    019doiore the survey can be recommended for clinical use.

    2010 American Academy of OtolaryngologyHead and Neckrgery Foundation. All rights reserved.

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

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

    by 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-

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

    4-5998/$36.00 2010 American Academy of OtolaryngologyHead and Neck Surgery Foundation. All rights reserved.evelopment and prelimineanimation Outcomes Qu

    hn R. de Almeida, MD, Ashlin J. Alalph W. Gilbert, MD, FRCSC, and Davronto, Ontario, Canadasponsorships or competing interests have been disclosed for

    s article.

    STRACT

    JECTIVE: Lip paralysis is associated with eating, speaking,appearance impairments. The lip reanimation outcome ques-

    nnaire is designed to assess these functional impairments afterreanimation.UDY DESIGN: Cross-sectional validation study.TTING: Tertiary care academic center.BJECTS AND METHODS: Patients who underwent lipnimation and control subjects. A disease-specific instruments created by systematic literature review and expert opinion.e 15-item patient completed subscale was administered to 20 lipnimation patients. Photographs of 19 patients and three controljects were taken in four poses and rated by six raters (2geons, 2 residents, and 2 novices) by the use of a external raterscale, and reliability was determined by the use of intraclassrelation coefficients (ICC). Content and construct validity wereessed.SULTS: Internal consistency (ICC range 0.813-0.915 forh domain), testretest reliability (ICC range 0.616-0.981 forh item) for the patient completed subscale, and interrater (ICC 52) and interlevel reliability (ICC 0.929) for the externaler subscale were substantial to excellent. The content validityex was 0.87. Construct validity was demonstrated by poorerres in patients with transected nerves versus intact nerves forearance (P 0.04) and oral competence (P 0.011). Photo-phs of control patients had lower asymmetry scores (P 01), and the instrument detected greater asymmetry in patientsth progressively more exaggerated smile (P 0.001).NCLUSION: The lip reanimation outcome questionnaire hasmising reliability and validity in this preliminary study, but:10.1016/j.otohns.2010.05.015y validation of the Liptionnaire

    nder, MD, Mark G. Shrime, MD,P. Goldstein, MD, FRCSC,

    ve impact on appearance and quality of life.1-4 Injury tomarginal mandibular branch can occur in isolation dur-neck dissection or submandibular gland excision, or as

    onsequence of damage to the main trunk of the facialrve. Paralysis of the lip depressors can then result inmmetry that is exaggerated during smiling.5Several surgical reanimation techniques, both static andnamic, have been described to address both functional

    cosmetic impairments.6-11 Facial nerve grading scales,12,13hough good at measuring movement and symmetry, aret ideal to measure disability, and facial disability ques-nnaires, like the Facial Disability Index and Facial Clini-tric Evaluation scale, provide a measure of gross facialsfunction but are not specific for lip dysfunction.1,14 Weort the development and validation of the Lip Reanima-n Outcomes Questionnaire (LROQ), an instrument de-ned to measure changes in outcomes related to lip paral-

    is after reanimation surgery.

    ethods

    m Generationms for the LROQ were developed by the use of a com-site strategy. A systematic review was performed by thee of MEDLINE (to August 2009), relevant bibliographies,d expert opinion (D.P.G., R.W.G.) to identify pertinentdies and items. Keywords and medical subject headingslimiting the search included facial and lip paralysis, sur-al reconstructive procedures, facial reanimation, qualitylife, questionnaires, outcomes, and patient satisfaction.

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    362 OtolaryngologyHead and Neck Surgery, Vol 143, No 3, September 2010tive and postoperative and used a seven-category Likertle. Preoperative items related to impairments before surgery

    d contained three anchors: 1 corresponded with no difficultyall, 4 corresponded with some difficulty, and 7 correspondedth extreme difficulty. Postoperative items related to changesmpared with before surgery and contained three anchors: 1rresponded with much worse, 4 corresponded with noange, and 7 corresponded with much better. The final itemesses the patients own subjective feeling of symmetry. Thism was constructed by the use of a 10-cm visual analoguele with very asymmetric and perfect symmetry as the

    d anchors.For the external rater subscale, items included subjectiveing of lip symmetry on the basis of four photographs: one att and three in different positions of smile as previouslyscribed.15 The three smile positions include a Mona Lisaile, a canine smile, and a full mouth smile. Each itemd a seven-category Likert scale with four anchors: 1 corre-nded with no asymmetry, 3 corresponded with mild asym-try, 5 corresponded with moderate asymmetry, and 7 cor-ponded with severe asymmetry.

    tientssearch ethics approval was granted from the Researchhics Board at the University Health Network in Toronto,nada, before the commencement of the study, and in-med consent was obtained from each patient enrolled instudy. The inclusion criteria for involvement in the study

    re as follows: 1) having undergone a reconstructive/nimation procedure for unilateral lip paresis/paralysis atUniversity Health Network between 2001 and 2009; 2)

    ing able to provide informed consent; and 3) being able tomplete the questionnaire in English. Palliative patientsd patients with bilateral lip paresis/paralysis were ex-ded from the study. Information regarding age, gender,topathological diagnosis, primary tumor site, reason forparesis/paralysis, method of reanimation/reconstruction,

    d duration of follow-up were collected.

    liability Testingenty patients were asked to complete the 15-item patient

    ed subscale on two separate occasions separated by 14ys. Only 10 patients completed the same questionnaire 14ys later. This time point was chosen to ensure that patientsuld not recall their previous responses, and we assumedchange in their functional status in the interim. Internal

    nsistency () and testretest reliability were computed.ur standardized photographs were taken with a digitalgle lens reflex camera (Fuji FinePix S9000; FujifilmA Inc., Valhalla, NY) in the four positions delineatedviously. The external rater subscale was then completedsix raters (2 head and neck surgeons, 2 otolaryngologyident trainees, 2 novice observers) for 19 patients andee control subjects. One patient refused to have photo-

    phs taken. Interrater, interlevel, and internal consistencyre computed.

    AsixReliability coefficients range from 0 to 1, and were ratedexcellent if between 0.8 and 1.0, substantial if between0 and 0.79, moderate if between 0.40 and 0.59, fair if

    tween 0.20 and 0.39, and poor if between 0 and 0.19, asapted from Landis et al.16 Reliability coefficients werelculated with intraclass correlation (ICC) statistics andneralizability theory17 by the use of G-String (v.2.0;cMaster University, Hamilton, Ontario, Canada) fromriance estimates calculated with UrGENOVA (UniversityIowa, Iowa City, IA).

    lidity Testinglidity was assessed using both content validity and con-uct validity. Content validity, the determination of theresentativeness or relevance of items of the question-

    ire, was applied at the developmental stage and subse-ently assessed in the judgment stage as previously de-ibed.18 At the developmental stage, experts (M.G.S.,P.G., R.W.G.) were involved in identification of contentmains (appearance, oral competence, speech, symmetry).ch item was subsequently judged by experts on a scalem 1 to 4; 1 corresponding with no relevance and 4rresponding with very relevant. The content validity in-x (CVI) for each item was computed as the proportion ofperts rating each item 3 or 4.19 The CVI for the instru-nt was computed as the proportion of items in the ques-nnaire on which all experts agreed on content validity.Construct validity was assessed testing three a priori

    nstructs/hypotheses:

    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.Patient with lip dysfunction and reanimation will havepoorer scores than control patients.Asymmetry will be more apparent with progressivelygreater voluntary lip muscle movement as the result ofunopposed lip elevation. Therefore, the full mouthsmile will elicit more asymmetry than the caninesmile, the Mona Lisa smile, and the rest position.

    nstruct validity was tested by the use of an independentple Mann-Whitney U test (nonparametric) to compare

    ans of scores of patients for construct 1 and 2, anduskal-Wallis analysis of variance for construct 3. Anha level of 0.05 was chosen for all analyses. Statisticalts for assessment of validity were performed by the use ofSS (v.17.0; SPSS Inc., Chicago, IL).

    sults

    m Generation

    search for relevant studies revealed 432 studies, of which

    met inclusion criteria and had disease-specific items

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    363de Almeida et al Development and preliminary validation of the . . .evant to lip dysfunction (Fig 1).1,10,14,15,20,21 Furtherms were generated on the basis of expert opinion. Twobscales, consisting of a 15-item patient rated subscale andour-item external rater subscale, were created (Fig 2).e patient-rated subscale consisted of items relating tooperative disability and questions relating to changece the operation. Items belong to the following domains:pearance (items 1-4, 8-11), oral competence (items 5-6,-13), speech (items 7, 14), and symmetry (item 15).

    tientsenty patients were included in the study, comprising 10n and 10 women. Nineteen patients and three control

    tients were photographed. The mean age (SD) was 63.2ars (17.6 years) and median age was 65.5 years. The meanration of follow-up (SD) was 31.5 months (26.4 months).e most common histopathological diagnosis was squa-us cell carcinoma (60%), and pleomorphic adenoma wasond most common (10%). Other tumors include one

    ch of basal cell carcinoma, adenoid cystic, adenocarci-ma, small cell carcinoma, osteosarcoma, and angiosar-ma. The most common tumor site was the parotid gland%), with buccal mucosa (15%), mandible (10%), tongue%), floor of mouth (10%), and other sites occupying theaining sites (15%). Mechanism of lip paralysis included

    rogenic injury (45%), nerve sacrifice for oncologic rea-ns (40%), lip resections for oncologic reasons (10%), androgenic nerve transection (5%). Mechanisms of lip rean-

    ure 1 Systematic review flow diagram showing includeddies and reasons for exclusions.ation included tendon suspension from mid-lip to com-ssure (45%), static sling from commissure to zygoma%), cable grafting (20%), and primary reanastamosis).

    liabilityr the patient-related subscale, internal consistencies for allmains (ICC range, 0.813-0.915) (Table 1) were excellent,d testretest reliability coefficients were substantial to ex-lent for all items (ICC range, 0.616-0.981) (Table 2).For the external rater subscale, interrater (ICC 0.852)

    d interlevel reliability (ICC 0.929) were excellent. Theernal consistency between the four poses was substantialC 0.736) but demonstrated even stronger internalsistency when assessing only the three smile poses (ICC 74) (Table 3).ntent ValidityI for all items was 1.0, except for item 4 (Did your lip

    ll to the non-paralyzed side before your operation; CVI 3) and item 12 (How do you feel about your ability told solids/liquids in your mouth; CVI 0.67). The CVIthe overall questionnaire was 0.87.

    nstruct Validitytest the first construct/hypothesis, mean postoperative

    pearance, oral competence, speech, and symmetry scoresFigure 2 Lip Reanimation Outcomes Questionnaire.

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    364 OtolaryngologyHead and Neck Surgery, Vol 143, No 3, September 2010re compared between patients who have had preservationthe nerve sheath versus those who have not (nerve sac-ced or iatrogenically transected) (Fig 3). Scores werenificantly poorer for patients who had violated nerve

    eaths in both appearance (2.9 1.5 vs 4.5 1.5; meanference 1.6, 95% confidence interval [95% CI] 0.14-1, P 0.04) and oral competence (2.4 1.5 vs 4.5 1.6;an difference 2.1; 95% CI 0.66-3.54, P 0.011). Scoresspeech (3.2 1.3 vs 4.5 1.6; mean difference 1.2;

    % CI0.14 to 2.6, P 0.074) and symmetry (2.7 2.3 vs 2.8; mean difference 1.6; 95% CI0.93 to 3.90, P7) also were poorer but did not reach statistical significance.To test the second hypothesis, mean scores of externalers were significantly better for control patients (n 3)n for patients with lip reanimation for paralysis (n 19;

    0.001) (Fig 4). To test the third hypothesis, mean scoreseach external rater item were compared. All items hadnificantly different mean scores; with a significant dif-

    able 1ternal consistencies for various domains of the patient-rated

    Domain Item

    reoperative appearance 1-4reoperative swallowing 5-6reoperative speech 7ostoperative appearance 8-11ostoperative swallowing 12-13ostoperative speech 14ymmetry 15

    I, confidence interval; NA, not applicable.

    able 2estretest reliability coefficients for patient ratedubscale of the Lip Reanimation Outcomesuestionnaire

    temTestretest 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 0.350-0.94...

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