results, CES-I is a reliable tool for evaluation of QoL in patients with CSOM among ... KEY WORDS: Quality of life ⢠Chronic suppurative otitis media ⢠Chronic ear ...
ACTA OTORHINOLARYNGOLOGICA ITALICA 2017;37:51-57; doi: 10.14639/0392-100X-1041
Otology
Quality of life measurements for patients with chronic suppurative otitis media: Italian adaptation of “Chronic Ear Survey” La misura della qualità della vita in pazienti con otite media suppurativa cronica: adattamento in italiano del “Chronic Ear Survey” G. RALLI1, C. MILELLA1, M. RALLI2, M. FUSCONI1, G. LA TORRE3 Dipartimento Organi di Senso, Sapienza Università di Roma “La Sapienza”; 2 Dipartimento di Scienze Odontostomatologiche e Maxillo Facciali, Università di Roma “La Sapienza”; 3 Dipartimento di Sanità Pubblica e Malattie Infettive, Università di Roma “La Sapienza” 1
SUMMARY The chronic ear survey (CES) is a sensitive and disease specific quality of life (QoL) measurement tool in patients with chronic suppurative otitis media (CSOM). It is a 13-item survey that evaluates the frequency, duration and severity of problems associated with this disease. It is composed of three subscales that describe activity restrictions, symptoms and medical resource utilisation. Based on patient’s answers, it is possible to obtain a score resulting in a scale ranging from 0 to 100; the highest indicates the best health, while the lowest denotes poor health. The questionnaire was originally created in English. The aim of this study is to validate the CES questionnaire in Italian (CES-I). Translation was made following international guidelines. The application follows the stages of translation from English to Italian and linguistic adaptation, and grammatical and idiomatic equivalence review. The CES-I and the Short Form Health Survey 36 (SF-36) questionnaires were administered to 54 patients with CSOM. A cross-sectional design was used to examine the internal consistency (Cronbach’s alpha) and concurrent validity (Pearson’s product moment correlation). To confirm the external validity of CES-I, Pearson correlation coefficient, considering the total score and single subscales of CES and the 8 scales of the SF-36, was calculated. Cronbach’s alpha coefficient for internal consistency was 0.737. The intraclass correlation coefficient, measured through mixed effects, was 0.737 (95% CI: 0.600–0.835, p 6 times q >5 times, but not constantly q 3-4 times q 1-2 times q not at all In the past 6 months, how many separate times have ear drops been necessary to treat your ear condition? q >6 times q >5 times, but not constantly q 3-4 times q 1-2 times q not at all
Table II. Chronic Ear Survey (CES) score calculation. Activity Restriction: (A1 + A2 + A3) / 3 = A A1 A2 A3
0-25-50-75-100 0-20-40-60-80-100 0-20-40-60-80-100
Symptoms: (S1 + S2 + S3 + S4 + S5 + S6 + S7) / 7 = S S1 S2 S3 S4 S5 S6 S7
0-20-40-60-80-100 0-20-40-60-80-100 0-20-40-60-80-100 0-25-50-75-100 0-20-40-60-80-100 0-25-50-75-100 0-20-40-60-80-100
Medical Resource: (M1 + M2 + M3) / 3 = M M1 M2 M3
0-25-50-75-100 0-25-50-75-100 0-25-50-75-100
psychologists performed, separately, an initial translation from the English language. The translated versions were then discussed and adjusted to obtain consensus and close equivalence to the original version. The text was then back translated from Italian into English by a bilingual person with a professional academic level of Italian and English and by a native English speaker. The original and back-translated English versions were compared by the two translators and, if discrepancies were found, the new version was adjusted to optimise the conceptual overlap. Study validation In the second phase of this study, we enrolled 54 patients affected by CSOM presenting to our clinic between November 2014 and November 2015 to evaluate the validity of the CES-I questionnaire and compare the results to those obtained with the Italian validated SF-36 survey. Diagnosis of CSOM was performed with medical history, 53
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Table III. Italian version of Chronic Ear survey (CES-I). Limitazione delle attività A1
A causa della malattia dell’orecchio, non può nuotare o fare la doccia senza proteggerlo.
A2
q sicuramente vero q vero q non so q falso q sicuramente falso In questo momento quanto è grave dover tenere l’acqua lontano dall’orecchio?
A3
q molto grave q grave q moderato q medio q lieve q nullo Nelle ultime 4 settimane la malattia dell’orecchio ha condizionato le sue attività in famiglia o con gli amici? q sempre q molto spesso q una buona parte del tempo q talvolta q per un breve periodo q mai
Sintomi S1
Ora, la perdita di udito è:
S2
q molto grave q grave q moderata q media q lieve q nulla Ora, la secrezione dell’orecchio è:
S3
q molto abbondante q abbondante q moderata q media q lieve q nulla Ora, il dolore dell’orecchio è:
S4
q molto grave q grave q moderato q medio q lieve q nullo L’odore dell’orecchio la preoccupa molto e/o preoccupa gli altri:
S5
q sicuramente vero q vero q non so q falso q sicuramente falso La perdita di udito la preoccupa:
S6
q sempre q molto spesso q una buona parte del tempo q talvolta q per un breve periodo q mai Negli ultimi 6 mesi quante volte l’orecchio ha prodotto pus:
S7
q costantemente q 5 o più volte ma non costantemente q 3-4 volte q 1-2 volte q mai L’odore dell’orecchio la preoccupa e/o preoccupa gli altri: q sempre q molto spesso q una buona parte del tempo q talvolta q per un breve periodo q mai
Interventi medici M1
Negli ultimi 6 mesi, quante volte è stato visitato dal suo medico per l’orecchio:
M2
q più di 6 volte q 5-6 volte q 3-4 volte q 1-2 volte q nessuna Negli ultimi 6 mesi, quante volte ha usato antibiotici orali per curare l’infezione dell’orecchio:
M3
q più di 6 volte q 5-6 volte q 3-4 volte q 1-2 volte q nessuna Negli ultimi 6 mesi quante volte sono stati necessari periodi di cura con gocce auricolari? q più di 6 volte q 5-6 volte q 3-4 volte q 1-2 volte q nessuna
general ENT examination (including micro-otoscopy), pure tone audiometry (PTA) and high resolution computerised tomography (CT) of temporal bone. Further data (age, gender, unilateral or bilateral disease) were collected. After obtaining written consent, the CES-I and SF-36 forms were administered to all patients.
Results
Statistical analysis Collected data were analysed statistically. Measures of central tendency (mean and median) as well as dispersion measures (standard deviation, SD; range: minimum – maximum) were calculated. Test-retest reliability of the CES-I was determined by the intraclass correlation coefficient (ICC). A cross-sectional design was used to examine the internal consistency (Cronbach’s alpha) and concurrent validity (Pearson’s product moment correlation). Pearson correlation coefficient between the total score and single subscales of CES and the 8 scales of the SF-36 was used to examine the correlation between the CES-I and SF36. Physical composite score (PCS) and
54 patients were enrolled in the study, 26 (48.1%) were females and 28 (51.9%) males, with a median age of 42 (range 24-61) years. Bilateral CSOM was diagnosed in 18% of subjects. In our sample, the CES-I presented a median value for activity restriction, symptoms and medical resources of 8, 22.5 and 9, respectively. The total score had a median value of 38.5 (range 14-53). The median PCS and MCS scores of SF-36 were 50.3 and 47.5, respectively, which are close to the median values for the Italian population (PCS = 53.3 and MCS = 49.3) The validity analysis of the CES-I questionnaire was strongly supported by our statistical analysis: Cronbach’s
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mental composite score (MCS) were calculated as summary criteria for the HRQoL. Statistical significance was set at p
