VALIDITY AND RELIABILITY OF THE EXPECTED RESULTS OF THE EVALUATION OF CHRONIC WOUND HEALING (RESVECH 2.0)

Introduction: Wounds that are difficult to heal are a health problem due to their high prevalence and multifactorial etiologies. Treatment begins with the prescription of the appropriate therapeutic agent, followed by the use of instruments that allow the professional to document wound assessments. Objective: The study aims to evaluate the reliability and validity of the Brazilian version of the RESVECH 2.0 instrument in the context of difficult-to-heal wounds. Methods: A methodological study was carried out. Initially, participants were interviewed in order to establish a profile; then evaluations of difficult-to-heal wounds of any etiology (n = 179) were performed with RESVECH 2.0 and Pressure Ulcer Scale for Healing 3.0 (PUSH 3.0) instruments. Results: The psychometric properties evaluated were convergent construct validity, interobserver reliability and internal consistency. Internal consistency reliability showed the values of 0.561 and 0.535. Interobserver reliability showed a Kappa value ranging from 0.14 to 0.76 and an intraclass correlation coefficient (ICC) of 0.87. For convergent construct validity, Spearman’s correlation coefficient was applied to RESVECH 2.0 and PUSH 3.0 scores (n = 150); the coefficient obtained was 0.717. Conclusion: It is concluded that the instrument showed evidence of reliability and validity. DESCRIPTORS: Wounds and iInjuries. Healing. Evaluation of research programs and tools. Enterostomal therapy.


INTRODUCTION
Wounds that are difficult to heal are a health problem due to their high prevalence and multifactorial etiologies. This scenario concerns managers due to the high cost required for treating individuals within institutions, characterizing it as a public health problem 1 .
While wound care is a multibillion-dollar worldwide misfortune, in the US alone, 5.7 million people are affected (about 2% of the population) at an annual cost of US$20 billion. A report from the UK suggested that the treatment and care of difficult-to-heal wounds account for 3% of healthcare spending in developed countries 2 .
The term "chronic wounds" was changed to "wounds that are diff icult to heal", as they are wounds that do not respond to standardized care 3 . The treatment of wounds that are difficult to heal begins with the prescription of the appropriate therapeutic agent, followed by the use of instruments that allow the professional to document the assessments of the wound and consequently facilitate the identification of its characteristics that indicate positive or negative evolution 4 .
There are three instruments available in the Brazilian literature for this assessment: Bates-Jensen Wound Assessment Tool (BWAT), Pressure Ulcer Scale for Healing (PUSH 3.0) and RESVECH 2.0 5 .
In 2001, the Pressure Sore Status Tool (PSST) was revised and renamed BWAT to treat wounds of different etiologies and not just pressure injuries (PI) 6 .
The PUSH 3.0 scale, created in 1996, was translated into Brazilian Portuguese in 2005 and referred to as an instrument that safely and quickly measures PIs. The PUSH 3.0 scale is practical, easy to apply, and allows a brief assessment of different apresentou um valor Kappa que varia entre 0,14 e 0,76 e um coeficiente de correlação intraclasse (ICC) de 0,87. Para a validade de construto convergente, foi aplicado o coeficiente de correlação de Spearman para os dados dos escores dos instrumentos RESVECH 2.0 e PUSH 3.0 (n = 150), coeficiente obtido foi igual a 0,717.

Estomaterapia.
Validity and reliability of the expected results of the evaluation of chronic wound healing (RESVECH 2.0) types of injuries 7 . In 2009, the PUSH 3.0 scale was followed by an interobserver reliability test in individuals with chronic leg ulcers, exposing adequate measurement properties 8 .
In 2011 was developed the scale named "Resultados Esperados de la Valoración y Evolución de la Cicatrización de las Heridas Crónicas 2.0" (RESVECH 2.0) 5 , which was culturally adapted to the Portuguese language in 2018 4 .
The RESVECH instrument was created and validated by Juan Carlos Restrepo-Medrano, in his doctoral thesis in 2011. This instrument was developed sequentially from three stages: a systematic review of the literature, development of the measurement index of the healing process of PIs and lower limb ulcers and, later, the validation of the constructed tool 9 .
Intending to produce a consensus among professionals when dealing with wounds that are difficult to heal, the instrument adapted with validity and reliability becomes an ideal tool to be used in any scope and type of injury that is difficult to heal 10 .
Thus, the purpose of the research was to evaluate the convergent construct validity, interobserver reliability and internal consistency of the Brazilian version of the RESVECH 2.0 instrument in the context of assessing wounds that are difficult to heal in outpatient follow-up.

Type of Study
It was methodological research with a quantitative approach. The methodological study covers established investigations in the quality and development of methods, providing control of rigorous and high-quality research 11 .
The study was carried out in an outpatient wound unit in a city in the inner part of São Paulo. This unit is a reference for the 32 health units in the town. It has a multidisciplinary team (stoma therapist nurse, nursing technicians and assistants, vascular surgeon, plastic surgeon, nutritionist, social worker, podiatrist, physiotherapist and psychologist) to care for people with wounds of the health network. This location was chosen due to the convenience of the unit providing comprehensive care to people in the community with wounds of different etiologies and guidelines for prevention. Data collection took place between July and August 2021.
The study included 129 individuals over 18 years with difficult-to-heal wounds that had developed for at least six weeks. People with acute injuries were excluded. Of these 129 people with lesions that are difficult to heal, a total of 179 wounds were evaluated.
Study participants were recruited according to the day their consultations at the service were scheduled. Sampling was done for convenience. The sample size was estimated according to the previous study of the development of the RESVECH 2.0 instrument, which used a minimum number of 34 people to carry out reliability 8 .
Concerning validity, according to the study "Guide of the European Group of Measuring Instruments Researchers", a sample of 100 individuals was used for the sample calculation and for the appointment of minimum necessary values to achieve more satisfactory results and due to the availability of time for data collection. This guide indicates the ideal number of people to conduct this type of study 12 .
The adapted RESVECH 2.0 instrument and PUSH 3.0 were used for data collection. The first version of RESVECH consisted of nine components: lesion dimensions; depth/tissues affected; edges; perilesional maceration; tunnel; type of tissue in the wound bed; exudate; infection/inflammation (signs of biofilm), and frequency of pain in the last ten days. A score is obtained that can vary from 0 to 40, with the lowest score being a healed wound and the highest score being the worst state of the wound 13 .
After evaluations of the psychometric measures, the RESVECH 1.0 instrument required changes, resulting in the RESVECH 2.0 version. The new version comprises six criteria: lesion dimensions; depth and tissues affected; edges; type of tissue in the wound bed; exudate, and infection/inflammation (a sign of biofilm). Its total score ranges from 0 to 35 points, and zero is considered a determination of complete healing. The criteria are evaluated using a Likert scale 14 .
The RESVECH 2.0 presented, in its first analysis, a Cronbach's alpha of 0.74 and demonstrated reliability to the instrument. It was also seen that this value increases as the lesion evolves positively. This instrument proved to be sensitive to internal variations of the study sample and exposed correlation between its variables 9 .
The RESVECH 2.0 instrument was developed to analyze the tissue repair process of difficult-to-heal wounds of any etiology 10 . It was adapted to the Portuguese language of Brazil satisfactorily following the conditions of the recommended international bibliography, based on a methodological study following the process of cultural adaptation through the stages: translation, synthesis of translations, back-translations and a committee of experts 4 .
For the application of this instrument, the wound was evaluated according to the six domains 10 . The application steps are: • Domain 1: this is the analysis of the lesion size: it should be measured using a metric ruler, checking the area (length and width) and multiplying them together to obtain the result in cm². Finally, the measurement corresponding to the result obtained is selected on the instrument 15 .
• Domain 2: after its measurement, the depth and affected tissues are evaluated. Initially, the wound is cleaned, and then the clinical evaluation of the tissue compromise is performed, aiming at the most injured tissue 15 .
• Domain 3: consists of assessing the condition of the edges of the lesion, seeking to identify the compromised edge.
The edges comprise the tissue area of the margin with the wound bed, which can be classified as unidentified, diffuse, delimited, damaged, or thickened 15 .
• Domain 4: the worst tissue in the wound bed is identified. Being classified in a score from 0 to 4 according to the type of tissue present: Necrotic (dry necrosis), necrotic tissue (wet necrosis), granulation tissue, epithelial tissue, and closed/healed tissue 15 .
• Domain 5: only one option is selected to assess the exudate and its quantity after removing the dressing and before any topical application. The scores range from 0 to 3, emphasizing dry exudate and a large amount of exudate, which have identical scores as they characterize the worst scenario. At this evaluation stage, the classifications are divided into exudate: dry, wet, small, medium or large amount 15 .
The PUSH 3.0 instrument was adapted to the Portuguese language in 2005, renamed Instrument for the Evaluation of UP 3.08. Initially, it was adjusted only for the assessment of PI and then for chronic leg ulcers. The high levels of agreement between nurses and stoma therapists confirmed the instrument's interobserver reliability for use in chronic wounds as well 16 .
Three items for wound assessment are presented: total wound area, amount of exudate and appearance of the wound bed 17 . The PUSH 3.0 scale was chosen for this study because it stands out among the analyzed studies (about 40% use the PUSH 3.0 scale as a reference).In addition to being the most recurrent instrument in the surveyed studies, it was also used to evaluate the widest variety of wounds 18 .
An assistant nurse and a specialist TiSOBEST stoma therapist nurse carried out the collected data. In the nursing course curriculum, it is emphasized that the nurse experienced theoretical-practical concepts and clinical experiences in people with wounds. Interobserver reliability comprises having two or more observers independently apply the measurements to the same people to check whether the scores are consistent with each other 10 .
After orientation regarding the study, a previous interview was carried out with the participants. The wound was cleaned, and later the professionals applied the RESVECH 2.0 scale; the PUSH 3.0 scale was used only by the clinical nurse.
Evaluation of the measurement properties of RESVECH 2.0

Reliability
Reliability was calculated using two procedures: homogeneity (internal consistency) and interobserver agreement.
Validity and reliability of the expected results of the evaluation of chronic wound healing (RESVECH 2.0) Internal consistency was measured using Cronbach' s alpha, whose values vary from 0.00 to 1.00. Higher Cronbach' s alpha values point to more excellent instrument reliability and, therefore, greater measurement accuracy. It is established for all reliability indices that the closer they are to 1.00, the more substantial the evidence of good reliability 9 . This statistical test was applied to both evaluators.
Despite being widely used to assess internal consistency, The interpretation of Cronbach's alpha has yet to have a consensus. Although studies determine that values greater than 0.7 are ideal, Souza et al. consider values below 0.70 but close to 0.60 as satisfactory 19 .
The interobserver reliability was calculated by measuring the Kappa concordance index and the intraclass correlation coefficient (ICC), which concern a measure of concordance between the evaluators and can present a maximum value equal to 1.00 10  In the analysis of interobserver reliability, both evaluators showed a substantial agreement regarding the dimensions of the lesion and Depth/Tissues affected, a moderate agreement regarding the Type of Tissue in the Wound Bed and Exudate, and an insignificant concordance regarding inflammation. According to Table 1, it is possible to verify the Kappa values for each item.

Convergent validity
Spearman's correlation coefficient was estimated between the RESVECH 2.0 and PUSH 3.0 scores to assess the convergent construct validity, considering the responses of 150 participants. The coefficient obtained was equal to 0.717 with a p-value < 0.0001 (substantial degree), exposing a significant relationship between the instruments.

DISCUSSION
Evaluating and documenting wounds is based on the knowledge that is the basis for all these measurements, with measuring instruments being an option for assessing the entire healing process and qualifying care for people with wounds 8 .
Regarding An instrument is reliable when its measures accurately reflect the standards of the evaluated attribute. The smaller the variation it produces in repeated measurements, the greater its reliability 8 .
For interobserver reliability, the ICC obtained was equal to 0.87 with a confidence interval of 95%, with lower and upper limits equivalent to 0.83 and 0.91, respectively. According to the manual of systematic reviews for psychometric assessment studies developed by the initiative 22,23 , an ICC greater than or equal to 0.70 indicates good agreement between measurements. A good correlation between the observed measures was considered for the ICC, exposing a positive correlation.
Given the data acquired within our analysis, the RESVECH 2.0 scale adapted for Brazil presents internal consistency and interobserver reliability data suitable for its use.
The Kappa coefficient was also used to evaluate interobserver reliability, ranging from 0.76 to 0.14. In the previous study carried out for the classification items of the scale, the coefficient varied between 0.78 and 0.96 14  A study aiming to evaluate the clinical profile of a sample of individuals with wounds that are difficult to heal using the RESVECH 2.0 scale performed Pearson's correlation between the dimensions of the RESVECH 2.0 and the homonymous dimensions of the BWAT, which presented data greater than 0.90, except for the item "Edges" which was 0.79 (still a strong correlation). The total score of both scales is strong (r = 0.84; p < 0.001) 24 .
As for the total score, it promotes a classification from 1 to 7, giving dimensions from 0 to ≥ 100 cm2 representing an adequate range referring to the areas of wounds in Brazil14, while on the PUSH 3.0 scale18, in the item referring to the parameter length × width, there is a classification from 1 to 10, ranging from 0 to > 24 cm².
For the assessment of the item "Depth/tissues affected", the involvement of the dermis/epidermis, subcutaneous tissue, muscle tissue, bones and/or annexes are considered. Measurements of the size and depth of the wound are fundamental tools for the evolution of the healing process, as they provide objective information on the reduction of the injured area and the increase in scar tissue. However, when performed in isolation, they do not allow a greater understanding of the elements and the evaluation of the healing process 18 25 .
In RESVECH 2.0, the item "Type of tissue in the wound bed" presents a score from 0 to 4, taking into account: necrotic, necrotic tissue, granulation tissue, epithelial tissue and closed/healed tissue. The PUSH 3.0 scale also assesses tissue types in the following order: closed wound, epithelial tissue, granulation tissue, slough, and necrotic tissue. Tissue type is a crucial indicator in the healing process26. It allows nurses to identify which stage of healing the wound is in to make objective decisions regarding the treatment of the injury 27 .
Regarding the item "Exudate", a score between 0 and 3 was evaluated, taking into account dry, wet wounds with small, medium and large amounts of exudate. For this assessment, the nurses, after removing the dressing, inspected the condition of the covering versus the amount of exudate. The PUSH 3.0 scale evaluation considers quantity as absent, small, moderate and large 16 . The exudate is another tool used to monitor the evolution of wound healing, as it is one of the main parameters for the evaluation of difficult-to-heal wounds, given that its characteristics point to the presence of pathogenic organisms and/or inflammation in the wound 13 .In 2007, the World Union of Wound Healing Societies published a guiding consensus regarding the management of exudate, intending to assess the quantity and its respective characteristics. This document was used to determine this subitem in the RESVECH 2.0 scale in its Spanish version 28.
The item "Infection/inflammation" may have been compromised because it has 14 subtopics: increased pain, perilesional erythema, perilesional edema, increased temperature, increased exudate, purulent exudate, friable or easily bleeding tissue, stagnant or non-progressing wound, tissue compatible with biofilm, odor, hypergranulation, increased wound size, satellite lesions and tissue pallor. The PUSH 3.0 instrument does not assess signs of infection and inflammation in lesions.
The study has some limitations. The participating nurse received prior practical training in the care of people with wounds in the wound clinic with the specialist nurse. Although this aspect is not established as a requirement for the use of RESVECH 2.0, this preparation may have influenced the performance of the scale. On the other hand, the need for more literature referring to RESVECH 2.0 in evaluating different types of injuries makes it difficult to discuss the findings.
This study is one of the first to verify the validity of RESVECH 2.0 in the translated and adapted version for the Brazilian reality, applied in the different etiologies of wounds that are difficult to heal. Thus, there is a need for new studies that confirm its validity and recommend it for managerial use more than in evaluation and documentation protocols.

CONCLUSION
The findings allow us to conclude that the RESVECH 2.0 scale showed good measurement properties evaluated through homogeneity and substantial interobserver agreement concerning the items, as well as significantly correlated with the domains of the PUSH 3.0 instrument, confirming its convergent construct validity. Thus, the Brazilian version of the RESVECH 2.0 scale is reliable and valid for the Portuguese language.
It is hoped that the research will help in actions that contribute to the evaluation of tissue repair of difficult-to-heal wounds for better assistance to people with injuries. Future research in other populations using other types of instrument validation is suggested.

CONFLICT OF INTEREST
The authors declare no conflicts.