Introduction

The use of hypodermoclysis (HDC) as a method for administering medications and fluids has shown greater levels of acceptance in infusion therapy. Its use is indicated as an alternative technique when oral medications are unfeasible, there is weakness of the venous network, in volume replacement in mild to moderate dehydration, and when there is the possibility of keeping the patient at home ^1,2.

The technique consists of inserting a catheter (needled or not) in the subcutaneous space. Fluids and drugs are absorbed into the tissue using simple diffusion forces, as the tissue is composed of dense connections and adipose tissue, harboring blood vessels, lymphatics, glands, and nerves, which allow the solution to reach the intra-vascular space ³.

Subcutaneous infusion is an effective technique for administering fluids and has a favorable safety profile without serious complications. In addition, the use of this route is less costly and invasive than other access routes for infusion therapies. Moreover, the use of HDC must be carefully evaluated, considering the characteristics of patients, prescribed medications, and technical capabilities ⁴.

Thus, HDC is mainly used in the fields of geriatrics and palliative care, due to the impaired venous access and the clinical conditions these patients present. This technique appears as an option for controlling symptoms, combating dehydration, and hydroelectrolyte replacement, that is, in the maintenance therapy, to contemplate the clinical efficacy expected from a route of parenteral administration ^5,6.

Despite HDC being recognized as an effective technique, with minimal complications, research conducted in Spain exposed some reasons for not using this route by professionals and lists the lack of experience due to lack of knowledge of it as one of the main justifications. Added to this is the lack of protocols and guidelines both for selecting patients and applying the technique ⁷.

From this perspective, it is understood that, from a clinical point of view, decision-making tools are useful to standardize and aggregate criteria about the care that will be provided. Thus, resulting in possible benefits such as high rates of accuracy and diagnostic efficiency, increased patient safety, support for decision-making, decreased incidence of errors and improved outcomes ⁸.

In this way, the tools stand out in helping with more effective cornmunication, establishing the relationship between the professional and the patient to understand preferences, values and needs, in addition to transferring knowledge about the treatment, risks, benefits, and alternatives to make clinical decisions. Therefore, management focuses on the results of cost-benefit analyses and financial planning for the implementation of a system that assists in sustainable decision-making to meet health demands ^9,10.

Thus, the development of protocols/algorithms and guidelines for better use of hypodermoclysis can benefit not only elderly or oncology patients, as most studies suggest, but also can help in the treatment of various clinical situations, such as patients with Acquired Immunodeficiency Syndrome (AIDS) and end-stage congestive heart failure, among others ¹¹.

Furthermore, the construction of this algorithm follows the logic of evaluating health technologies since its objective is to support decision-making regarding the use of technology in a more cautious % way and, consequently, makes the system and the health programs more effective in promoting, protecting, and restoring health ¹².

Given the importance of designing and implementing instruments for standardizing care, the following research question emerged: What elements are needed to develop and validate the content and appearance of an algorithm that guides the eligibility of adult patients for the use of HDC?

From the above, the objective of this study was to develop and validate the content and appearance of an algorithm to guide the eligibility of HDC in adult patients.

Materials and Methods

This is a methodological study, consisting of two distinct stages, which were guided by the methodological framework of psycho-metrics by Pasquali ¹³. This type of study enables the development, validation, and evaluation of instruments and techniques for the research context ¹³.

The study took place from April to December 2020, in two stages: i) Construction of an algorithm to choose adult patients to use Hypodermoclysis; and ii) Validation of content and appearance by judges, using the Delphi technique.

For the first stage of the research, a scoping review was constructed, whose objective was to identify and map the evidence on the eligibility criteria/indication of adult patients for the use of hypodermoclysis available in different databases, portals of national and international theses and dissertations, with the aim of synthesizing and scientifically subsidizing the content of the algorithm, which was later developed by using the Bizagi Modeler software.

The validation process of the content and appearance of the algorithm was conducted through the judgment and analysis of judges selected for research. For the search and selection of judges, the Lattes Platform on the National Council for Scientific and Technological Development of Brazil portal was used, based on the advanced search by subject to identify nurses who could act as specialists.

The adapted Fehring model was used to screen the judges. The model gives a score of 14 points; however, a minimum score of 5 points was assigned to this selection. Thus, 38 judges were intentionally identified. That said, an invitation letter was sent to the judges via email to explain the content of the research and the importance of their participation. Based on the positive feedback from these judges, the Free and Informed Consent Form (TCLE) was sent electronically. Then the algorithm was sent via the Google Forms software.

The material sent to the judges was presented in a Likert scale format, with variation for judgment of "adequate", "partially adequate," and "inadequate". For each of the items, a value of 1 to 3 was established, in which 1 was attributed to the item considered "inadequate," 2 to "partially adequate," and 3 to "adequate." It was decided to use the Delphi technique to enable the validation process and subsequent refinement.

Hence, two rounds of validation were necessary; at each stage, the verification calculation of the content validity coefficient (CVC) and the level of accordance was performed, according to Pasquali ¹³. Namely, both the content and appearance of the algorithm were validated based on the 12 criteria indicated: Behavior, objectivity, simplicity, clarity, relevance, precision, variety, modality, typicality, credibility, extent, and balance.

The data obtained from the judges' assessment were entered into an Excel spreadsheet, and the scores assigned to each judged item were verified. Based on the judges' evaluation, the CVC was verified. Therefore, the item that reached a CVC equal to or greater than 80 % was considered valid. Based on the suggestions made by the judges, a careful evaluation was performed, and the appropriate recommendations and justifications were presented.

The research included the ethical precepts in research with human beings approved by the Research Ethics Committee of the College of Health Sciences of Trairi of the Universidade Federal do Rio Grande do Norte under Opinion number 39785520.6.0000.5568 on November 16, 2020. Furthermore, it followed the International Ethical Guidelines for Research Involving Human Subjects of the Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization ¹⁴.

Results

From the theoretical foundation offered by the scoping review, the elaboration and disposition of the items for the construction of the algorithm presented in Figure 1 took place. In it, the elements were systematized to reach a feasible proposal for the patient who needs a route of drug administration, and it presented HDC as a possible alternative for treatment continuity.

Source: Bizagi Process Modeler freeware.

Figure 1 Eligibility Algorithm for Hypodermoclysis in an Adult Patient. Natal/RN 2021 

Figure 2 presents the legend for understanding the eligibility algorithm for HDC.

Source: Bizagi Process Modeler freeware.

Figure 2 Key to the eligibility algorithm for hypodermoclysis in an adult patient. Natal/RN 2021 

After systematizing the contents in the review of the scope and construction of the algorithm, the process of validating the content and appearance began. The Delphi I round had the participation of 11 judges. Of these, 8 (72.7 %) were female, and 3 (27.3 %) aged between 30 and 49 (mean = 38.2). Of the participants, 4 (36.4 %) work mainly in teaching, 4 (36.4 %) perform their activities in care, and 3 (27.2 %) combine teaching and care.

In the Delphi II stage, the number of evaluators who participated was 8, as 3 of the 11 judges who participated in stage I did not return within the established period, and according to the eligibility criteria, they were excluded from this stage.

Therefore, the sample consisted of 6 (75 %) women and 2 (25 %) men, aged between 30 and 49 according to Delphi I (mean = 37.7). At this stage, 3 (37.5 %) worked mainly in teaching, 3 (37.5 %) combined teaching and assistance, and 2 (25 %) performed their activities only in care. Thus, the time in which the judges have been working with ° the theme ranged from 6 to 20 years.

Even with the concordance value (CVC ≥ 0.8) being valid in the Delphi stage, the judges' suggestions were evaluated for permanence and proposition for improvement, through relevance analysis. Table 1 presents the recommendations and justifications.

After the adjustments suggested by the judges, the algorithm was sent again with the necessary changes and the table with the answers and suggestions.

Thus, for validation of the content and appearance of the topics that comprise the algorithm, all items obtained agreement within the established level (CVC≥0.8). In the first round, it was possible to obtain a concordance index for the analyzed questions, in which the total CVC for content was 0.92 and appearance was 0.89. Regarding the overall estimate, the instrument had a CVC of 0.95 for content and 0.93 for appearance.

It was possible to verify the increase in CVC values compared to the Delphi I round. Furthermore, it was shown that the constructed algorithm is valid, that is, it is relevant to be used in healthcare environments that use HDC.

Discussion

The construction and validation of an algorithm to guide the eligibility of HDC in adult patients was developed with methodological rigor to allow scientific knowledge to be accessible to nursing professionals who work in care spaces where it can be used. Its construction allowed to summarize the main available evidence, and from that, base the dissemination of knowledge about the technique, in addition to contributing to decision making and, consequently, more qualified nursing care ^3,15.

It is understood that the development and implementation of care standardization instruments, such as algorithms, guide nursing actions, which has a positive impact on care practices, with systematized recommendations based on quality and patient safety. This ensures that patients receive adequate, timely, and qualified care, as it is a theoretical-practical support tool ^16,17.

Therefore, for validation of content and appearance, it was decided to apply the Delphi technique, as it is a tool that allows evaluation of information systematically, in the effort of expert consensus (evaluating judges or specialists) on a defined theme ^13,18.

Regarding the judges participating in the content and appearance validation of the algorithm, a predominance of teaching activities was identified and those who reconcile teaching with assistance. Thus, the construction of a standardization instrument aims to increase the capacity of health services to use evidence in favor of more effective policies, linking new scientific knowledge and its application in care to produce beneficial results ¹⁹.

It is also clarified that the experts' contributions were the result of their clinical experience on the subjects. The methodological framework states that these modifications are relevant in validation studies because even when dealing with subjective assessments, such changes allow for a better understanding of the content and appearance, clarity, as well as simplifying the reading, facilitating the z interpretation and objectivity of the instrument ^13,18.

In addition, group discussions on complex issues are conducted by experts, called "judges," in an interactive and structured process. In this way, they become capable of understanding and evaluating the situations presented in the algorithm that contributed with relevant and pertinent suggestions to evaluate the instrument. Evidence-based knowledge and practical experience from everyday life are gathered in a structured way, which makes it possible to judge the viability of the instrument ²⁰.

It is noteworthy that the psychometric model used has beenwidely employed in nursing research since Pasquali's methodological framework encourages the construction of an instrument capable of assessing what is expected. Thus, methodological studies aim to obtain and organize reliable, accurate and applicable data in different realities that deal with people eligible for HDC ^13,21.

In the process of validating the content and appearance of the algorithm, two Delphi validation stages were necessary to reach the final version of the instrument. This process of adapting the material made it more grounded and will facilitate its use by the nursing team. It is important to highlight that the technological tools that standardize assistance have the capacity to transform the provision of care, regardless of the sector in which it is used. Thus, it contributes to improving the quality of care and enhancing the experience individually and collectively ²².

Thus, the final Delphi stage of validation reached suitability values both in content and appearance in all criteria, as they contemplated the indices recommended by the reference adopted in this study, which was 0.8 according to Pasquali ¹³.

Furthermore, as a limitation of the study, the impasse of HDC being a more widespread technique in palliative care stands out, and thus the studies limit the profile of the patient who uses it, which may imply limitations of the findings presented.

As for the validation process, the difficulty of initial contact with the judges is highlighted, since most of the participants found in the advanced search of the lattes platform did not provide the e-mail in this tool. In addition, the loss of judges on the research panel can be mentioned as a limitation, due to the delay in returning the material sent to them.

Conclusions

The algorithm for electing adult patients to use HDC was built and validated through the judges' assessment and reached levels of agreement and adequacy according to the requirements established and foreseen in the reference used. It is noteworthy that the experts' contributions were essential, since they provided the construction of an instrument suitable for the reality of care, with the use of more coherent flows and terms.

It is understood that the use of this algorithm will contribute to safer nursing care, as it reinforces the use of evidence-based praxis because it is an instrument capable of bringing the theoretical and practical fields closer together. Moreover, it contributes to the appreciation of the work performed by nurses, by allowing a continuous process of care. In addition, the material produced has the potential to favor the use of a simple, inexpensive and effective technique-HDC.