Cross-cultural adaptation of the Italian version of the Voice Activity Participation Profile

The Vocal Activity Participation Profile (VAPP), originally developed in English, is a self-assessment tool used to measure individuals’ voice activity limitation and participation restriction. Based on the fact that the cultural/linguistic adaptation is an essential step of validating a protocol in another language, the purpose was to linguistically and culturally adapt the VAPP into Italian. The adaptation was performed in accordance to the Scientific Advisory Committee of the Medical Outcomes Trust. The translation was performed by one bilingual speech-language pathologist and by one bilingual interpreter, who knew about the purpose of this project. A bilingual English teacher, who had not participated in the previous step, performed the back translation.  A  committee composed by three speech-language pathologists specialized in voice and one laryngologist compared the forward and backward translations, to assess for any discrepancies. A final version was produced and called Profilo di Attività e Partecipazione Vocale (PAPV). A “not applicable” option was included to each item and was administered to 17 individuals with voice problems, six males and 11 females, aged between 21 to 55 years. All items were relevant, as no patients chose the “not applicable” option. However, four individuals, who had a lower educational level, did not fully understand the instructions of the opening statement. Therefore, the questionnaire was further reviewed and adjusted to clarify the information. Otherwise, no items were changed and/or deleted. The PAPV kept the same structure as the original version. The cultural equivalence of the Italian VAPP was demonstrated and entitled PAPV, whose validation is currently in process.

to the Scientific Advisory Committee of the Medical Outcomes Trust.The translation was performed by one bilingual speech-language pathologist and by one bilingual interpreter, who knew about the purpose of this project.A bilingual English teacher, who had not participated in the previous step, performed the back translation.A committee composed by three speech-language pathologists specialized in voice and one laryngologist compared the forward and backward translations, to assess for any discrepancies.A final version was produced and called Profilo di Attività e Partecipazione Vocale (PAPV).A "not applicable" option was included to each item and was administered to 17 individuals with voice problems, six males and 11 females, aged between 21 to 55 years.All items were relevant, as no patients chose the "not applicable" option.However, four individuals, who had a lower educational level, did not fully understand the instructions of the opening statement.
Therefore, the questionnaire was further reviewed and adjusted to clarify the information.Otherwise, no items were changed and/or deleted.The PAPV kept the same structure as the original version.The cultural equivalence of the Italian VAPP was demonstrated and entitled PAPV, whose validation is currently in process.

INTRODUCTION
Dysphonia is an oral communication disorder in which the voice does not perform its role of carrying the verbal and emotional message of an individual (1) .Usually, voice disorders indicate benign conditions and may be transitory (2) ; however, a voice deviation has psychological elements that can affect the individual's well-being and quality of life on a personal, social and professional level.Ideally, the voice examination includes a clinical history and a complete otolaryngological and voice evaluation.However, these evaluations alone are not able to quantify the patient's voice problem.More recently, researches showed the importance of including subjective parameters in voice evaluation to adequately measure the impact of such deviation (3)(4)(5)(6) .
Instruments that assess treatment outcomes and quality of life must be carefully developed taking into consideration psychometric measures of validity, reliability and sensitivity (7)(8)(9)(10)(11) .The majority of the quality of life instruments are produced in English, thus directed to a population that speaks this language.Therefore, in order to use these protocols in other languages, they must be culturally adapted, carefully translated following specific guidelines, and have measure properties demonstrated in the appropriate cultural context (10) .
The choice of the Vocal Activity Participation Profile (VAPP) (5) was based on the importance of having a voicerelated quality of life instrument translated into Italian that could address activity limitation and participation restriction in order to better conduct the intervention process.
The purpose of this study was to perform the linguistic and cultural equivalence of the Italian VAPP version.

METHODS
This research was approved by the medical direction of San Leopoldo Mandic Hospital in Merate-Lecco and all participants signed the Informed Consent.
Initially, the questionnaire was translated into Italian by one bilingual speech-language pathologist and by one bilingual interpreter, who knew about the purpose of this project.The translators were advised to perform the conceptual translation instead of using the literal meaning of words and sentences.After this first step, the two translations were compared by a pool of specialists composed by three speech-language pathologists specialized in voice and a laryngologist, who discussed discrepancies and agreed upon one single document.The back translation was performed by a bilingual English teacher, who had not participated in the previous stage of translation.The same committee of specialists compared the back translation to the original version of the VAPP, to evaluate again any discrepancies.A final version was produced and called Profilo di Attività e Partecipazione Vocale (PAPV) (Appendix 1).
For any cultural equivalence of a translated instrument, a "not applicable" option must be added to the response rating scale of each item to enable the identification of sentences that are not clear or inappropriate to the population the instrument is intended to address, and to have them modified or excluded afterwards.
The translated version of the VAPP was administered to 17 individuals with voice complaints, six males and 11 females, aged between 21 to 55 years.Inclusion criteria were the presence of dysphonia of any type or degree, diagnosed by a laryngologist.Exclusion criteria were the presence of any neurological, psychological and/or cognitive disorders that would unable the administration of the questionnaire, or interfere with the comprehension of instructions.

RESULTS
All items were relevant and appropriate as no patients chose the "not applicable" option.However, four individuals, who had a lower educational level, did not fully understand the instructions of the opening statement.Therefore, the questionnaire was further revised and the instruction sentence was adjusted to make the information about how the questionnaire should be answered clear.Otherwise, no items were changed and/or deleted.

DISCUSSION
Dysphonia can affect an individual on multiple levels, including personal, social, and professional one.A comprehensive voice evaluation conducted by a laryngologist and a voice specialized speech-language pathologist is crucial in appropriately assessing such disorders.Moreover, within the voice evaluation process, self-assessment protocols play an important role to adequately measure the impact of such deviations on the individual's quality of life (3)(4)(5)(6) .
In Italy, there is currently only one available validated self-assessment protocol: The Voice Handicap Index (VHI) (12) .The choice of adding the VAPP to the Italian repertoire of voice self-assessment tools was based on the importance of having a voice-related quality of life instrument translated into Italian that could address activity limitation and participation restriction in order to better conduct the intervention process.
Moreover, the VAPP is the only self-assessment protocol that uses the International Classification of Impairments, Disabilities and Handicaps-2 Beta 1 (ICIDH-2 Beta 1) concept (13) .As such, the VAPP takes into account the three levels of disablement presented in the ICIDH framework when describing the impact of voice disorders on an individual: Impairment, Disability, and Handicap, with the latter two being replaced by "limitation of activities", and "restriction in participation" respectfully in the newly revised 1997 version (13) .
The validation process of the Italian version of the VAPP will allow the use of this instrument in the clinical and research setting.The experience of performing all the steps of an instrument validation process will help understand aspects that patients with voice disorders have in common.