Cross-cultural adaptation and clinical validation of the Neonatal Skin Condition Score to Brazilian Portuguese 1

OBJECTIVE: to describe the process of cross-cultural adaptation and clinical validation of the Neonatal Skin Condition Score. METHODS: this methodological cross-cultural adaptation study included five steps: initial translation, synthesis of the initial translation, back translation, review by an Committee of Specialists and testing of the pre-final version, and an observational cross-sectional study with analysis of the psychometric properties using the Adjusted Kappa, Intraclass Correlation Coefficient, and Bland-Altman Method statistical tests. A total of 38 professionals were randomly recruited to review the clarity of the adapted instrument, and 47 newborns hospitalized in the Neonatology Unit of the Clinical Hospital of Porto Alegre were selected by convenience for the clinical validation of the instrument. RESULTS: the adapted scale showed approximately 85% clarity. The statistical tests showed moderate to strong intra and interobserver item to item reliability and from strong to very strong in the total score, with a variation of less than 2 points among the scores assigned by the nurses to the patients. CONCLUSIONS: the scale was adapted and validated to Brazilian Portuguese. The psychometric properties of the Brazilian version of the Neonatal Skin Condition Score instrument were similar to the validation results of the original scale.


Introduction
Birth is the principle and most rapid change of environment. The infant needs to adapt in the transition between the aquatic environment of the womb, with a constant temperature, into our environment, with characteristically lower humidity and other variations (1) .
The skin is of vital importance during this period. Its primary function is the barrier against pathogenic microorganisms and topical substances (toxic or not), and it is also involved in the maintenance of thermal and hydro-electrolytic balance (2)(3) .
Maintaining healthy skin is essential for newborns (NBs), especially for premature and full-term NBs hospitalized in the neonatal unit (2)(3) . The hospitalized babies are constantly exposed to invasive procedures, disinfectant substances, use of adhesives for fixing devices, as well as to nosocomial bacterial flora, therefore they usually present more obvious alterations in the skin surface than non-hospitalized babies (2) . Practice Guideline -Neonatal Skin Care. This is a short instrument of rapid application that can be included in the Brazilian healthcare practice to support the neonatology healthcare teams (2,(4)(5) . The NSCS evaluates three factors: dryness, erythema, and breakdown. Each item has three possible answers giving a score from 1 to 3. The final score of the patient is obtained by summing the responses of the three items, ranging from 3 to 9, 3 being the best condition and 9 the worst skin condition that the NB could have (4)(5) .
The use of scales in the care practice serves to standardize the evaluation of the health status of patients and nursing interventions through care protocols. The use of these scales in other countries with cultures and languages different from those in which the scales were created depends on the scientific rigor with which they are translated, evaluated and revised in the language for which they are to be used, therefore multicultural studies have gained ground in the same way as the use of instruments for standardization of the healthcare in different cultures (6) .
The development of the study is justified due to its

Methods
Two distinct steps were used to perform the study: and experimental (assessing whether the terms used in the instrument are appropriate for the clinical practice in the culture of the language into which the scale is being validated) equivalences were analyzed to avoid distortions from one language to the other (7) . This same process has been used in the validation of other instruments for use in Brazil (8)(9)(10)(11) .  Specialists, and testing of the pre-final version (7) .
The initial translation consisted of the translation of the original instrument from English to Brazilian Portuguese, carried out by two translators with different technical profiles (one with and one without knowledge in the healthcare area), both of who's native language was Brazilian Portuguese. Each translator produced one independent version relative to one another, in a blinded way (7) .
In the synthesis of the translations a technical review and evaluation of equivalence of the versions of the initial translation was carried out by a language professional and the translators. At the end of this step a consensus version of the initial translations was produced (7) .
In the back-translation the consensus version was re-translated from Portuguese back to English by two translators who's native language was English and who professional, 1 dermatology specialist nurse, and the translators (7) .
Testing of the pre-final version was carried out in the final phase of the cross-cultural adaptation process and aimed to evaluate the clarity of the items that compose the instrument (7) . A total of 38 professionals (physicians, nurses, auxiliary nurses and nursing technicians) of the Neonatal Hospitalization Unit of the Clinical Hospital of Porto Alegre (UIN/HCPA) were selected at random with the aid of a random number table (12) . Each professional recorded his impressions about the clarity of the pre-final Portuguese version of the instrument using a Likert type scale (12) . The Likert scale responses were numbered from 1 to 5 with 1 being "not at all clear" and 5 "totally clear". In addition to responding to the instrument, the participants recorded The internal consistency of the instrument could not be verified because the items of the NSCS are independent, i.e., one does not influence the value of the other. The concurrent criterion validity could not be verified due to the lack of other skin evaluation instruments for newborns that could be used as a gold standard (12)(13) .
The statistical analysis of the study was performed using the Statistical Package for the Social Sciences (SPSS) and from web based calculators for SCR analysis.  (12) .
A descriptive analysis of the demographic data of the study sample was performed. Categorical  profile of the study sample is shown below ( Table 1).

Analysis of the reproducibility and intraobserver
and interobserver reliabilities was tested through three simultaneous tests: the PABAK, the ICC and the Bland-Altman tests, as shown in Table 2 (12,(14)(15) .

The
Bland-Altman method was a test bias, presented in the charts, represents how much the differences between the scores moved away from zero (14) , i.e., the mean variation between the compared scores. The upper correlation limit (UCL) and the lower correlation limit (LCL) values are the upper and lower limits of the differences in the score of the patient among the evaluators (interobserver) and between the two evaluations performed by the same observer with each patient (intraobserver) (14) .

Discussion
The choice of the NSCS as the study object of this work was due to the importance of standardizing the daily evaluation of the skin integrity to detect early changes in the skin of NBs (4)(5) . This instrument is the only one published in the literature that can evaluate the skin conditions of NBs, although another instrument is able to evaluate the risk and occurrence of pressure ulcers in children (Braden Q Scale) (8) . The use of the NSCS can only be observed in studies published in the English language, which leads us to believe that this is the first translation of the instrument into another language (17)(18) .
The use of health scales is widespread. Differences Even with moderate magnitude in some items of the scale, calculated by the PABAK, in the final score of the scale the magnitudes were strong to very strong. This is probably due to the fact that the scale is composed of 3 independent items. The same trend was noticed in the validation study of the original version (4) , and these data show that even when an item is evaluated differently by nurses ultimately the skin condition score of the patient that future intervention studies with skin care for the newborn are performed using the ECPRN as an evaluation tool.