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Cultural adaptation to Brazilian Portuguese of the Face, Legs, Activity, Cry, Consolability revised (FLACCr) scale of pain assessment

Abstract Objective: to perform the translation into Brazilian Portuguese and cultural adaptation of the Face, Legs, Activity, Cry, Consolability revised (FLACCr) scale, with children under 18 years old, affected by cerebral palsy, presenting or not cognitive impairment and unable to report their pain. Method: methodological development study of translation into Portuguese and cultural adaptation of the FLACCr. After approval by the ethics committee, the process aimed at translation and back-translation, evaluation of translation and back-translation using the Delphi technique and assessment of cultural equivalence. The process included the five categories of the scale and the four application instructions, considering levels of agreement equal to or greater than 80%. Results: it was necessary three rounds of the Delphi technique to achieve consensus among experts. The agreement achieved for the five categories was: Face 95.5%, Legs 90%, Activity 94.4%, Cry 94.4% and Consolability 99.4%. The four instructions achieved the following consensus levels: 1st 99.1%, 2nd 99.2%, 3rd 99.1% and 4th 98.3%. Conclusion: the method enabled the translation and cultural adaptation of the FLACCr. This is a study able to expand the knowledge of Brazilian professionals on pain assessment in children with CP


Introduction
Pain assessment in the pediatric population demands technical-scientific knowledge and practical skill. It is a complex process, both for the professionals who provide care, and for researchers (1) . The challenge becomes more evident when related to the pain assessment in children with neurological impairment, especially of the cognitive system and speech.
Among the most prevalent pathologies that compromise the neurological system of the child stands out Cerebral Palsy (CP), which affects around 2 to 3:1000 live births in developed countries (2) and anchors the focus of this study.
CP is defined as a group of disorders of the development of posture and movement, causing restriction of activity, attributed to non-progressive disturbances in the brain during fetal development or infancy. The motor disorders of CP are often accompanied by sensory, cognitive, communication and perception disturbances, occurring or not behavioral disorders and convulsive process (3) . In view of this complexity, the use of validated and reliable pain assessment tools is a recommended practice (4)(5) .
Among the structured tools for pain assessment in children with neurological impairment, stands out the Face, Legs, Activity, Cry, Consolability revised (FLACCr).
The FLACC scale of pain assessment was developed in 1997, based on behavioral parameters, intended for use by health professionals and aiming at contributing to clinical practice in pain assessment in nonverbal children or with speech impairment, which are unable to report their pain (4) . Since 2002, the authors of the FLACC scale made modifications in the evaluation descriptors, in order to adapt it to the care of children with cognitive impairment, aged between 4 and 19 years. The authors named it FLACC revised (FLACCr) or revised FLACC (rFLACC) (5)(6)(7) , and changed and expanded to four the number of application instructions of the scale.
The FLACCr presents five evaluation categories, with combined scores ranging from zero to ten. The author classified the scores as follows: zero to three (mild pain); four to six (moderate pain) and seven to ten (severe pain).
Given the paucity of research on systematic pain assessment in children with CP, this study aimed to perform the translation into Brazilian Portuguese and cultural adaptation of the FLACCr scale of pain assessment with children affected by CP, presenting cognitive impairment or not and unable to report their pain.  (8) .

Translation into Portuguese and back-translation into English
Translation and back-translation were performed by two independent certified translators, not belonging to the healthcare area, with fluency in both languages, inclusive in their colloquial forms. The method used to achieve consensus was the Delphi technique, which ensures anonymity of the experts, with absolute confidentiality of the responses.

Evaluation of translation and back-translation by an expert committee
The evaluation was performed based on the set of these experts' responses. The method allowed to achieve consensus among a group of experts on a phenomenon of a certain area of knowledge (9) . It was asked to the experts to assess the semantic equivalence, idiomatic equivalence and experimental or cultural equivalence (8) . This evaluation also aimed to verify the validation of the content of the scale.

Cultural equivalence
This phase aimed to analyze the equivalence between the original and final versions of the scale. Some researchers consider that the minimum consensus levels are between 50% and 80% (12)(13) . Therefore, it was selected the minimum level    Bussotti EA, Guinsburg R, Pedreira MLG.  Rev. Latino-Am. Enfermagem 2015 July-Aug.;23(4):651-9.

Discussion
The selection of the scale to be translated and  Bussotti EA, Guinsburg R, Pedreira MLG.
This study provides a specific method. Researchers in this area recommend two translators for validation and two translators for back-translation (8) . In 2003, it was proposed to simplify the methodology, specifically in the stages of translation and back-translation (17) . In this sense, some authors have simplified the stages of translation and back-translation without compromising the quality of the final version (18)(19) .
This study followed the method described in the literature (8) , with variation in the number of translators in the stages of translation and back-translation, which did not influence in the results presented in Tables 1, 2 and 3. As consensus, it was considered agreement indexes greater than or equal to 80%.
The 30 professionals (experts) who participated in the assessment of cultural equivalence of the FLACCr were from different categories (multidisciplinary), according to the theoretical reference used (8,10) . In the absence of family/caregiver, the professional is committed to observe the child more frequently, recognizing behaviors and normal postures and warning signs (20) . It was also investigated the definition of the word "Normal" in a Portuguese dictionary (21) (20,22) .
The other categories of the scale achieved consensus greater than 80%, with some considerations on the approximation of the professional at the bedside, in the approach of family/caregiver.
Is worth mentioning that, it is still incipient the discussions on pain assessment in vulnerable populations, such as children with CP. The difficulties are broad and the lack of professionals qualified and interested in the theme generates inefficiency in clinical practice. Some studies reveal that individuals with cognitive impairment are particularly vulnerable to undertreatment of pain when compared to those without cognitive impairment and able to report their pain. Moreover, some researchers have described the lack of standards of pain assessment for this population as vulnerable (5)(6) . Consequently, it is urgent in this environment, the instrumentalization of health professionals with tools able to standardize the practices and generate clinical and administrative indicators.
Validated instruments of pain assessment are useful tools when used in a planned and systematic manner, particularly in the development of the discussion within the care team on forms of assessment and management of pain, enabling continuous process improvement (14) .

Conclusion
By following the methodological instructions, it was possible to develop, with satisfactory results, the translation and adaptation of the FLACCr scale of pain assessment.
The selection of the participating professionals of this first stage was essential to achieve the stated results.
The use of scales of pain assessment is a reality in some institutions. It is recommended the provision of properly validated scales. If the healthcare team chooses an existing instrument in another language, it is necessary to develop the process of translation and cultural adaptation. Therefore, it will be possible to assess pain more reliably.
The next stage of this study is to evaluate the reliability and consistency of the psychometric properties of the FLACCr in children with CP.
This is one of the pioneering works in Brazil focused on the pediatric population with CP, presenting or not cognitive impairment. In addition, the study requires continuity, so that this population is favored with adequate pain management.