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Construction and validation of the Self-care Assessment Instrument for patients with type 2 diabetes mellitus 1

ABSTRACT Objective: to construct and validate the contents of the Self-care Assessment instrument for patients with type 2 diabetes mellitus. Method: methodological study, based on Orem's General Theory of Nursing. The empirical categories and the items of the instrument were elucidated through a focus group. The content validation process was performed by seven specialists and the semantic analysis by 14 patients. The Content Validity Indices of the items, ≥0.78, and of the scale, ≥0.90, were considered excellent. Results: the instrument contains 131 items in six dimensions corresponding to the health deviation self-care requisites. Regarding the maintenance, a Content Validity Index of 0.98 was obtained for the full set of items, and, regarding the relevance, Content Validity Indices ≥0.80 were obtained for the majority of the assessed psychometric criteria. Conclusion: the instrument showed evidence of content validity.


Introduction
Diabetes mellitus (DM) stands out among the chronic diseases due to its high prevalence and its impact on morbidity and mortality indicators in the national (1)(2) and global contexts (3) . The concept of selfcare in DM is related to a variety of factors, ranging from maintaining a healthy diet, self-monitoring of blood glucose, use of medications, regular physical activity, foot care, healthy coping and risk reduction (4)(5) . From this perspective, the implementation of strategies aimed at the self-management of the disease and the encouragement of self-care is critical.
Structured education for the self-management of type 2 diabetes mellitus (DM2) is a strategic resource to equip patients for making decisions in relation to the treatment. A review study of the educational process showed positive results for the self-management of DM2. These results relate to the support provided for the self-management of the disease and the continuous monitoring in the control of blood glucose, as well as for the prevention of acute and chronic complications (6) .
It is recognized that the multidisciplinary health team should promote the development of self-care skills in order to make people with DM co-responsible for the requirements of their daily life, with regard to the treatment, modifying or maintaining healthy habits and strengthening self-confidence (7)(8) . Thus, self-care should be understood as learned behavior that is performed by individuals for their own benefit (9) . In this sense, the evaluation of self-care actions taken by patients with DM2 should be integrated into the care provided by the health professionals. The use of instruments that measure self-care actions constitutes a methodological tool that assists in the evaluation of the responses of the patients to treatment, allowing the comparison of data over time and the understanding and study of the problems observed (10) , in addition to guiding behavior in the clinical practice.
There are instruments for self-care assessment described in the literature (10)(11)(12)(13) , however, these do not cover the multidimensionality of the disease, and are mostly directed toward the evaluation of adherence to the medication therapy, not including seeking multidisciplinary care, knowledge about the disease and discomforts of the treatment or the process of acceptance of the disease. Systematic review studies (14)(15) have highlighted the lack of instruments for the assessment of self-care behavior in people with DM2.
Given this gap and considering the lack of instruments based on the theoretical model of self-care suggested by Dorothea Orem (9) , the development of an instrument based on the health deviation selfcare requisites was proposed. This theoretical model has been used as the theoretical and philosophical basis to support the practice of Nursing in a variety of situations, with an emphasis on the care of patients with chronic diseases (16) . The Orem assumptions fit the purpose of this study, as they cover promotion and education actions, with individuals encouraged to take responsibility for the care of their own health.
The construction of a measurement tool based on the theoretical model of Orem (9)

Method
Methodological study, which adopted the psychometric procedures (17) for the preparation of measurement instruments as a reference, which After the design of the items, the first version of the instrument and the instruction manual were sent, via email, to seven diabetes specialists, requesting the content validation (17) . The specialists were selected from the database of the Coordination for the Improvement of Higher Education Personnel -CAPES, with the inclusion of those who obtained a minimum score of five points, according to the adapted criteria for the selection of specialists (21) .
There was no restriction regarding the participation of different professional categories, with the selection of those whose academic profile revealed expertise in the construct that the instrument was intended to measure.
The questionnaire for the analysis of the instrument was made available in two formats: Valorization of the lifestyle Self-esteem Grammatical modifications were carried out, as well as the substitution of negative terms and words that were difficult for the lower strata of the population to understand.
Regarding the relevance of the items to the psychometric criteria (17) , the evaluation of the specialists was satisfactory, since the domains presented CVIs ≥0.80 for the majority of the criteria evaluated (Table 1).

Discussion
The construction of a measuring instrument requires the design of the items that behaviorally represent the construct of interest (17) . The choice of Orem's Self-care conceptual model for the theoretical basis of the instrument and the use of the focus group technique allowed the relevant topics to be identified to cover the domains that make up the construct and to promote ideas of how the items should be displayed.
Thus, the realization of these groups with health professionals and patients enabled the factors, barriers and difficulties involved in the therapeutic requirement to be contemplated and the construct and the theoretical framework adopted to be better represented.
These aspects were analyzed from the perspective of the six health deviation self-care requisites postulated by Orem (9) . The items of domain A cover the importance of the mutual accountability of the professionals and patients in order to ensure accessibility to health services, as well as including conditioning factors for seeking appropriate care, such as financial status, family

Conclusion
This study allowed a better comprehension of the meanings of the self-care requisites, from the perspective of health professionals and DM2 patients, and allowed an instrument to measure this construct to be developed, with evidence of content validity. Future studies are recommended to test its psychometric properties and make it a valid and reliable tool in the assessment of the self-care of DM2 patients, by identifying the requirements for their compliance. This will contribute to decision making in the clinical practice, as well as to obtaining better results in the self-management of the care by the patients.