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Dura, Marta Perez-Grau, Laura Samara, John Phillips, Francisco Larrosa" "autores" => array:6 [ 0 => array:3 [ "nombre" => "Nesly" "apellidos" => "Gonzalez-Sanchez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 1 => array:3 [ "nombre" => "Maria J." "apellidos" => "Dura" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Marta" "apellidos" => "Perez-Grau" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "Laura" "apellidos" => "Samara" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] 4 => array:3 [ "nombre" => "John" "apellidos" => "Phillips" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "aff0025" ] ] ] 5 => array:4 [ "nombre" => "Francisco" "apellidos" => "Larrosa" "email" => array:1 [ 0 => "flarrosa@clinic.cat" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:5 [ 0 => array:3 [ "entidad" => "Department of Otorhinolaryngology-Head and Neck Surgery, Institut Clinic Especialitats Mediques i Quirurgiques, Universitat de Barcelona School of Medicine, Hospital Clinic de Barcelona, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Department of Physical Medicine and Rehabilitation, Universitat Autonoma de Barcelona School of Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Department of Otorhinolaryngology-Head and Neck Surgery, Universitat Autonoma de Barcelona School of Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Department of Otorhinolaryngology-Head and Neck Surgery, Consorci Sanitari Alt Penedes-Garraf, Badalona, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Department of Otorhinolaryngology-Head and Neck Surgery, Norfolk AND Norwich University Hospital, Norwich, Norfolk, UK" "etiqueta" => "e" "identificador" => "aff0025" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Adaptación y validación inicial de la versión en lengua española del Cuestionario de otitis media crónica-12 (COMQ-12) y del Inventario de beneficios en otitis media crónica (COMBI)" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3411 "Ancho" => 2508 "Tamanyo" => 753351 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Spanish version of the COMQ-12 (COMQ-12-Spa).</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Chronic middle ear disease is associated with material morbidity and affects approximately 2% of the population. The Chronic otitis media questionnaire-12 (COMQ-12) and the Chronic otitis media benefit inventory (COMBI) were developed to assess the patient-reported health-related quality of life (HRQoL) due to chronic otitis media and evaluate outcomes following surgery.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">1,2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The use of patient-reported outcome measures (PROMs) is rapidly growing in studies of clinical effectiveness and quality of care.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> To our knowledge, no Spanish versions of both the COMQ-12 and COMBI are available at present.<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">4–6</span></a> The aim of this study is to validate the Spanish cross-cultural adaptation of the COMQ-12 and COMBI tools.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Patients and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design</span><p id="par0015" class="elsevierStylePara elsevierViewall">Multicenter prospective instrument validation study.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Subjects and setting</span><p id="par0020" class="elsevierStylePara elsevierViewall">Patients with chronic otitis media (COM) undergoing tympanoplasty were enrolled consecutively from a university tertiary referral centre, a public level three hospital, and a public level one regional hospital in the area of Barcelona, Spain, between March 20, 2019 and March 11, 2020. Data collection ended September 15, 2020. Inclusion criteria were age over 18 years, and indication of the need for a tympanoplasty or mastoidectomy. Exclusion criteria were: possible malignant neoplasm; emergency surgery; marked immunodeficiency; complete cleft palate; and illiterate or non-Spanish-speaking.</p><p id="par0025" class="elsevierStylePara elsevierViewall">A separate cohort of healthy adults in a comparable age range was also studied. This second population included a convenience sample of asymptomatic adults.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Methods: cross-cultural adaptation and validation processes</span><p id="par0030" class="elsevierStylePara elsevierViewall">Guidelines for the cross-cultural adaptation process of the COMQ-12 and COMBI surveys were followed.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a> A final version of the Spanish questionnaires (COMQ-12-Spa and COMBI-Spa) for testing was then produced by an expert committee (<a class="elsevierStyleCrossRefs" href="#fig0005">Figs. 1 and 2</a>).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">For the validation process, consenting adults completed the COMQ-12-Spa questionnaire before surgery and 2–4 weeks after the initial completion. The COMBI-Spa and the Spanish version of the Glasgow Benefit Inventory (GBI)<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> were completed at least 6 months after surgery. All tympanoplasty patients were eligible. Tympanoplasty included the following procedures: tympanoplasty for non-cholesteatoma (i.e., tympanic membrane perforation), mastoidectomy for cholesteatoma, and revision mastoidectomy and obliteration.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Supplementary information on the patients’ medical history and current status included the age and sex of the patient, the indication for surgery, the type of surgery performed, pure-tone audiometry, and otoendoscopy finding at review documented in the patient's medical record.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Unaffected adults completed the COMQ-12-Spa survey during the enrolment visit and two to four weeks after the initial completion.</p><p id="par0050" class="elsevierStylePara elsevierViewall">It was estimated that 25–50 patients constituted an adequate sample size for initial psychometric validation.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical methods</span><p id="par0055" class="elsevierStylePara elsevierViewall">The demographic data were compared between the two groups (i.e., tympanoplasty patients and unaffected adults). The psychometric properties (i.e., reproducibility, reliability, and validity) of the COMQ-12-Spa and COMBI-Spa were assessed by a test-retest procedure, internal consistency, correlation intra and inter-item, and factor analysis.</p><p id="par0060" class="elsevierStylePara elsevierViewall">To determine the reproducibility of the COMQ-12-Spa questionnaire, the mean total scores obtained during the test-retest procedure were compared using the Spearman correlation test; a value of at least 0.70 was considered acceptable. Cronbach's <span class="elsevierStyleItalic">α</span> coefficient was calculated to assess the internal consistency. An <span class="elsevierStyleItalic">α</span> value of ≥ 0.70 was considered adequate.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Dual translation was an important part of the process for linguistic validation. Content validity for both tests was assessed with the Spearman correlation test. Responses obtained for each item were correlated with the subscales (item-subscale) and with the overall questionnaire score (item-total). A significant level of association was set as a correlation coefficient of ≥0.40.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> Discriminant ability was estimated by comparing the COMQ-12-Spa total scores between the clinical and unaffected population groups (unmatched case–control contrast), with the Mann–Whitney <span class="elsevierStyleItalic">U</span> test. Normally distributed variables were compared using the Student's <span class="elsevierStyleItalic">t</span>-test.</p><p id="par0070" class="elsevierStylePara elsevierViewall">To confirm that that the domains remained stable, factor analysis of the COMQ-12-Spa was performed by means of Variamax orthogonal rotation.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Correlations between the COMBI-Spa and the generic GBI were established through Pearson correlation coefficient.</p><p id="par0080" class="elsevierStylePara elsevierViewall">The statistical significance threshold used for all tests was <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>≤<span class="elsevierStyleHsp" style=""></span>0.05. Analysis was performed using SPSS version 22.0 for Windows (SPSS Inc., Chicago, IL, USA).</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><p id="par0085" class="elsevierStylePara elsevierViewall">Twenty-five patients completed the study. A separate cohort of 25 asymptomatic adults in a similar age range was recruited.</p><p id="par0090" class="elsevierStylePara elsevierViewall">The mean age of subjects in the patient and control groups were 50.2<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>15.1 (range: 22–75) and 47.3<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>15.5 years (range: 26–87), respectively. There were 14 and 15 females in the COM and unaffected groups, respectively. No significant differences in age and gender between the two groups were found (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05). Twenty-eight percent of participants had a wet ear when they completed the questionnaire; 20% of patients had visible cholesteatoma; and 80% of patients had a perforated tympanic membrane.</p><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">COMQ-12-Spa</span><p id="par0095" class="elsevierStylePara elsevierViewall">Ninety-six completed COMQ-12-Spa questionnaires were received. One response was missing from one questionnaire (1.04% of all questionnaires).</p><p id="par0100" class="elsevierStylePara elsevierViewall">Cronbach's correlation coefficient assessing the internal consistency was <span class="elsevierStyleItalic">α</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.92.</p><p id="par0105" class="elsevierStylePara elsevierViewall">Twenty-one patients and 25 controls completed the test-retest portion of the validation process. The reliability coefficient was adequate at <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.98.</p><p id="par0110" class="elsevierStylePara elsevierViewall">Content validity was approved by the expert committee. The item-subscale, the item-total and the subscale-total correlation coefficients were all ≥0.40, thus showing a high-intensity relationship.</p><p id="par0115" class="elsevierStylePara elsevierViewall">The mean COMQ-12-Spa score in the COM group was 23.10<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>12.32 (range: 4–44). The mean score in the unaffected adults was 0.7<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.2 (range: 0–4). The Spanish COMQ-12 discriminated well between adults listed for surgical intervention and a group of healthy controls (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001). The calculated binomial effect size was large (<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.86).</p><p id="par0120" class="elsevierStylePara elsevierViewall">The data were suitable for factor analysis (Bartlett test of sphericity<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>183.68; fd 66; sig. 0.000 and Kaiser–Meyer–Olkin test<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.73). Three factors were extracted a priori based on the original English language validation.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">1,2</span></a></p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">COMBI-Spa</span><p id="par0125" class="elsevierStylePara elsevierViewall">All 25 COMBI-Spa questionnaires given to patients six months after surgery were returned. There were no missing responses. The mean score at six months post-operation was 45.12<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>8.78 (range: 29–60). Preoperative and 6-month postoperative audiometric values are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>. A statistically significant improvement in AC and ABG means was found (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0130" class="elsevierStylePara elsevierViewall">Cronbach's correlation coefficient assessing the internal consistency was <span class="elsevierStyleItalic">α</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.96.</p><p id="par0135" class="elsevierStylePara elsevierViewall">Content validity was approved by the expert committee. The item-subscale, the item-total and the subscale-total correlation coefficients were all ≥0.40.</p><p id="par0140" class="elsevierStylePara elsevierViewall">The mean GBI score at six months post-operation was 61.20<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>9.60 (range: 47–80). A strong correlation between the COMBI-Spa and the Spanish GBI scores was established (<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.89; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01).</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Discussion</span><p id="par0145" class="elsevierStylePara elsevierViewall">Cross-cultural adaptation and validation of the Spanish version of the COMQ-12 and COMBI surveys were accomplished.</p><p id="par0150" class="elsevierStylePara elsevierViewall">To our knowledge, the pre/postoperative validation of both questionnaires together in the same group of patients (pre and postintervention) has not been previously reported in literature. Only the COMQ-12 was assessed pre and postintervention in its Arabic version.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">The COMQ-12-Spa internal consistency results do not appear to differ from the original version whose <span class="elsevierStyleItalic">α</span> coefficient was 0.88. Correlations between individual items and both the total COMQ-12-Spa score and the subscale scores demonstrated strong relationships that compare favourably with the original COMQ-12.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> Discriminatory validity was also adequate.</p><p id="par0160" class="elsevierStylePara elsevierViewall">The internal consistency found in the present study compared well with the original COMBI<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> whose <span class="elsevierStyleItalic">α</span> coefficient was 0.91. In terms of validity, the scores previously published appear to be in line with those observed in our study. In addition, the correlations between the COMBI total and the GBI total were very high, showing some criterion validity. The COMBI instrument can be completed by the patients within 5<span class="elsevierStyleHsp" style=""></span>min, which is ideal for multiple administrations in prospective or longitudinal trials.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">1,2</span></a> Combined with otoendoscopy and audiometry the use of the COMBI could improve professional standards of care.</p><p id="par0165" class="elsevierStylePara elsevierViewall">The small sample size can offer limited precision and generalizability. Another potential limitation of this study could be the consecutive convenience sampling used. Furthermore, it might be argued that the post-operative improvement was not confirmed with objective measures (e.g. tympanogram). Nevertheless, we believe that sufficient consistency and initial validity information has been obtained to justify clinical use. This will provide additional information on the clinical relevance of the different scores and on the minimal clinically important difference.</p><p id="par0170" class="elsevierStylePara elsevierViewall">Increased uptake of the COMQ-12-Spa and COMBI-Spa will allow further evaluation, facilitate international multicentre projects and finally, enable its use to guide management decisions.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Conclusions</span><p id="par0175" class="elsevierStylePara elsevierViewall">The Spanish versions of the COMQ-12 and COMBI appear to be as reliable and valid as the English versions, thus allowing assessment of the impact of chronic otitis media or its treatment in Spain.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Funding</span><p id="par0180" class="elsevierStylePara elsevierViewall">This research received no specific grant from any funding agency, commercial or not-for-profit sectors.</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Conflict of interest</span><p id="par0185" class="elsevierStylePara elsevierViewall">None to declare.</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Ethical standards</span><p id="par0190" class="elsevierStylePara elsevierViewall">The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional guidelines on human experimentation (Barcelona Clinic Hospital Ethics Committee, case report guidelines) and with the Helsinki Declaration of 1975, as revised in 2008.</p><p id="par0195" class="elsevierStylePara elsevierViewall">The authors have obtained the individual's free prior informed consent.</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Author contribution</span><p id="par0200" class="elsevierStylePara elsevierViewall">All authors have contributed substantially in (1) conception and design of the study, or data acquisition, or data analysis and interpretation, (2) drafting of the manuscript or revising it critically for important intellectual content, (3) approval of the final version.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:15 [ 0 => array:3 [ "identificador" => "xres1805950" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Patients and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1578257" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1805949" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Antecedentes y objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1578258" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Patients and methods" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study design" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Subjects and setting" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Methods: cross-cultural adaptation and validation processes" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Statistical methods" ] ] ] 6 => array:3 [ "identificador" => "sec0035" "titulo" => "Results" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0040" "titulo" => "COMQ-12-Spa" ] 1 => array:2 [ "identificador" => "sec0045" "titulo" => "COMBI-Spa" ] ] ] 7 => array:2 [ "identificador" => "sec0050" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0055" "titulo" => "Conclusions" ] 9 => array:2 [ "identificador" => "sec0060" "titulo" => "Funding" ] 10 => array:2 [ "identificador" => "sec0065" "titulo" => "Conflict of interest" ] 11 => array:2 [ "identificador" => "sec0070" "titulo" => "Ethical standards" ] 12 => array:2 [ "identificador" => "sec0075" "titulo" => "Author contribution" ] 13 => array:2 [ "identificador" => "xack637240" "titulo" => "Acknowledgements" ] 14 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2022-01-15" "fechaAceptado" => "2022-03-29" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1578257" "palabras" => array:5 [ 0 => "Questionnaire validation" 1 => "Chronic otitis media questionnaire-12 (COMQ-12)" 2 => "Chronic otitis media benefit inventory (COMBI)" 3 => "Tympanoplasty" 4 => "Outcome assessment" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1578258" "palabras" => array:5 [ 0 => "Validación de cuestionario" 1 => "Cuestionario de otitis media crónica-12 (COMQ-12)" 2 => "Inventario de beneficio en otitis media crónica (COMBI)" 3 => "Timpanoplastia" 4 => "Evaluación de resultado" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The chronic otitis media questionnaire-12 (COMQ-12) and chronic otitis media benefit inventory (COMBI) aim to assess the quality of life related to chronic otitis media or its surgical treatment. The objective of this study was to validate the Spanish adaptation of the COMQ-12 and COMBI.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Patients and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Multicentre prospective instrument validation study. guidelines for the cross-cultural adaptation process were followed. The psychometric properties of the Spanish versions (“COMQ-12-Spa” for “COMQ-12-Spanish” and “COMBI-Spa” for “COMBI-Spanish”) were assessed in 25 consecutive adults undergoing tympanoplasty and in a separate cohort of 25 unaffected adults.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">COMQ-12-Spa: test–retest reliability, <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.98; internal consistency reliability, <span class="elsevierStyleItalic">α</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.92. Item-subscale and item-total coefficients, ≥0.40. Between-group discrimination, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.0001. COMBI-Spa: internal consistency, <span class="elsevierStyleItalic">α</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.96. A high-intensity relationship between the variables was shown, ≥0.40. Correlation between the COMBI-Spa and the Spanish Glasgow Benefit Inventory (GBI), <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.89; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Psychometric testing of the Spanish versions of the COMQ-12-Spa and COMBI-Spa yielded satisfactory results, thus allowing pre- and postintervention assessment of the subjective severity of chronic otitis media in adult patients.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Patients and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Antecedentes y objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El Cuestionario de otitis media crónica-12 (COMQ-12) y el Inventario de beneficios en otitis media crónica (COMBI) valoran la calidad de vida relacionada con la otitis media crónica o su tratamiento quirúrgico. El objetivo del estudio fue validar la adaptación española de los originales británicos.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Pacientes y métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Estudio multicéntrico prospectivo de validación de instrumento. Se siguieron las pautas para el proceso de adaptación transcultural. Las propiedades psicométricas de las versiones españolas, COMQ-12-Spa y COMBI-Spa, fueron evaluadas en 25 adultos consecutivos intervenidos de timpanoplastia y en una cohorte separada de 25 adultos sanos.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">COMQ-12-Spa: fiabilidad test-retest, r<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,98; consistencia interna, α<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,92; coeficientes ítem-subescala e ítem-total, ≥0,40; discriminación entre grupos, p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0,0001. COMBI-Spa: consistencia interna, α<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.96. Se encontró una relación de intensidad elevada entre las variables, ≥0,40. Correlación entre COMBI-Spa y Glasgow Benefit Inventory español (GBI), r<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,89; p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0,01.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Las pruebas psicométricas de las versiones españolas COMQ-12-Spa y COMBI-Spa ofrecieron resultados satisfactorios, lo que permite la valoración pre y postintervención de la severidad subjetiva de la otitis media crónica en pacientes adultos.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Antecedentes y objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "multimedia" => array:3 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3411 "Ancho" => 2508 "Tamanyo" => 753351 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Spanish version of the COMQ-12 (COMQ-12-Spa).</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 3578 "Ancho" => 2508 "Tamanyo" => 1107395 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Spanish version of the COMBI (COMBI-Spa).</p>" ] ] 2 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:3 [ "leyenda" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">AC = pure-tone air-conduction thresholds; BC<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>pure-tone bone-conduction thresholds; ABG<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>air bone gap; dB<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>decibels; NS<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>no statistical significance.</p>" "tablatextoimagen" => array:1 [ 0 => array:1 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Preoperative <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>25 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">6 mos postoperative <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>25 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span> value \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Contralateral ear <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>25 \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">AC, dB (mean ± SD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">43.6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>14.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">35.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>15.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.004<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25.6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>13.4 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">BC, dB (mean ± SD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25.8<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>13.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23.5<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>13.5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">NS<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">19.0<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>8.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">ABG, dB (mean ± SD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">17.8<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>6.9 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11.6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>9.0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.007<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5.0<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>8.0 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "*" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Student's <span class="elsevierStyleItalic">t</span>.</p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Comparison of mean preoperative and 6-month postoperative values in the COM group. Contralateral ear hearing values are included in the last column.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0055" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A new Health-related quality of life measure for active chronic otitis media (COMQ-12): development and initial validation" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "J.S. Phillips" 1 => "M. Haggard" 2 => "M. 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