Graphic Protocol for Assessing Safe Nursing Care in Hemodialysis: a Validation Study

doi:10.21203/rs.3.rs-1964314/v1

Background

The use of protocols allows systematizing, organizing and assessing services based on scientific evidence, thus helping the health work process. To validate the content and appearance of a graphic protocol for assessing safe nursing care for patients under hemodialysis.

Method

This is a methodological study with a quantitative approach developed between 2019 and 2020, organized into three procedures: theoretical, from a scoping review, regarding safe hemodialysis care; empirical studies in which the graphic protocol and checklist construction process took place. Finally, for validation using the Delphi technique, nine judges participated in two rounds to reach agreement among them. Data were tabulated and analyzed using simple descriptive statistics, Content Validity Coefficient (CVC) and level of agreement.

Results

Based on this scoping review content, a checklist and a graphic protocol were created, grouped into structure, process and result items. Regarding the content validity verification in Delphi I, the clarity, accuracy and modality criteria obtained CVC = 0.77 in the checklist. After adjustments and Delphi II, all indices were above 0.80. In the appearance validation process, in Delphi I, it was possible to achieve a total CVC greater than 0.80, in Delphi II, they were greater than 0.88, and the checklist presented a CVC of 0.91.

Conclusion

A graphic protocol and a checklist for assessing safe care for patients under hemodialysis, valid in their content and appearance, are presented.

hemodialysis

care

patient safety

validation studies

chronic kidney disease

Chronic Kidney Disease (CKD) is characterized by the progressive loss of kidney functions with a consequent reduction in glomerular filtration for a period longer than three months and is commonly associated with chronic diseases such as diabetes and hypertension¹. According to the International Society of Nephrology (ISN), kidney disease is considered an important public health concern worldwide and is linked to high health costs and low quality of life².

About 850 million people suffer from CKD worldwide, and 2.4 million of them die annually. In Brazil, it is estimated that more than 10 million people have the disease, with an evolving morbidity and mortality rate^3,4.

CKD has the capacity to affect different systems of the organism, thus generating other damages to health. As a result, treatment consists mainly of Renal Replacement Therapy (RRT), through invasive techniques such as dialysis, which aims to take over the main function of the kidneys. Among its types, there are peritoneal dialysis (PD) and hemodialysis (HD)^2,5.

Accordingly, HD stands out, since it is the predominant renal clearance technique, currently adopted for 92% of patients with end-stage renal disease (ESRD)⁶. This procedure is performed by means of equipment with the purpose of removing toxic substances and liquid concentrated in the blood due to kidney failure⁷.

Due to its complexity, HD can confer risks inherent to the care of patients undergoing this condition, provided by factors of the environment itself and the work process, such as: constant infusion of high-alert medications; handling of patients by different professionals; problems related to vascular access; and poor communication in urgent decisions related to treatment, aspects that can favor the occurrence of adverse events (AE)⁸.

Studies^9,10 reveal high rates of occurrence of AE inpatients under HD, and indicate infections, hemorrhages in vascular access, extracorporeal system coagulation, hypo/hypertension, dizziness and nausea as main damages.

That said, it is understood the need to implement patient safety (PS) in HD services, which involves a multidisciplinary team performing correct and essential care actions such as the use of aseptic techniques, infection prevention and assessment of individual parameters^11,12.

Such practices encourage safe and qualified care exercised with protagonism by nursing, which has a key role in also acting in the resolution of intercurrences and monitoring of HD, in addition to being responsible for performing the technique, preparing patients, implementing dialysis equipment, in addition to providing guidance on the procedure and health education, practices that demand qualification, training and tools that enhance suitable and safe HD^7,12,13.

In this regard, it is considered important to build instruments that aim to promote PS in the scope of identifying the level of safety in the processes related to the care provided in the scenario of dialysis units, as well as pointing out weaknesses/gaps, in order to take measures be taken for safer HD care⁸.

The use of protocols stands out among them, which allow systematizing and organizing services, in addition to assessing safe HD care by standardizing techniques based on scientific evidence, thus assisting professionals’ work by guiding procedures and conducts inherent to the care provided and offering better assistance¹⁴.

Therefore, it is essential to assess nursing care in dialysis units through specific instruments, such as graphic protocols, duly prepared and validated, which enable implementing interventions in order to minimize occurrence of AE, promoting PS and providing better care to patients with CKD.

Thus, the following guiding question was outlined: what contents and appearance need to have a protocol to assess safe care for patients under HD? The aim of this study is to validate a graphic protocol content and appearance for assessing safe nursing care for patients under hemodialysis.

2.1 Study design

This is a methodological study with a quantitative approach, conducted according to Pasquali’s psychometric framework¹⁵. This study design is characterized by promoting data investigation, organization, and analysis, as well as instrument and technique production and validation within the scope of research, in order to generate suitable and reliable materials that can be used by other researchers¹⁶.

2.2. Sample

The study population consisted of expert judges in the area. They had the role of assessing whether the material content and appearance was suitable and consistent with what is proposed¹⁹.

Experts were after an analysis of their resumes submitted to the Plataforma Lattes through the following search strategy: Search mode [subject (title or production keyword)] – Hemodialysis; in the databases – doctors and other researchers; Professional practice: Major Area – Health Sciences/Area – Nursing, in order to identify health professionals in Brazil able to act as instrument evaluators.

To select the judges, the criteria adapted from Fehring²⁰ were used, consisting of a minimum score of five points, namely: Master’s degree in nursing, with dissertation on HD and/or PS (1 point); Research published in the HD area (3 points); Article published in the nursing field in a reference journal (3 points); Experience as a professor in the PS area in nursing for at least 6 months (2 points); Specialization certificate in the PS area (1 point) with a maximum score of 14 points.

An initial number of 40 judges was selected. It is known that, for the validation process, a minimum number of six experts is needed according to the framework¹⁵; however, considering possible losses that are recurrent in this approach, this number was chosen²¹. After selection, an invitation letter was sent by email, which contained clarifications about the research content and objectives and the importance of their participation.

2.3. Data collection instruments

For validation, the Delphi technique was used, which is characterized by the organized and progressive use of a questionnaire, used to structure the communication process and enable experts to provide a collective and qualified opinion on existing problems. It is noteworthy that the Delphi technique can have as many rounds of analysis as necessary until reaching the recommended level of agreement¹⁷.

2.4 Procedures

The research validation process took place between 2019 and 2020, according to theoretical, empirical and analytical procedures. For theorists, a scoping review was built in order to identify and map the contents related to safe care in HD. The scientific evidence identified in the scoping review supported the process of building a graphic protocol and a checklist to assess safe care for patients with CKD under HD. Still in the empirical procedures, it is worth highlighting the validation carried out through analysis and judgment by expert judges in the area.

Considering the positive responses, the Informed Consent Form (ICF) was sent via e-mail for participants to sign. After receiving the document, the form was provided to experts, in order to start the graphic protocol content and appearance validation, which were granted in full for assessment via Google Forms.

According to changes suggested by judges, the protocol was adjusted and sent back for analysis with indicated modifications. It should be noted that two Delphi rounds were needed to reach a significant level of agreement among judges^15,17.

Regarding the criteria used to validate the protocol content, judges assessed the protocol according to suitability requirements as follows: behavior, objectivity, simplicity, clarity, relevance, accuracy, variety, modality, typicality, credibility, range, and balance¹⁵.

For the appearance validation procedures, the adapted categories proposed by the Suitability Assessment of Materials (SAM) were defined as criteria, namely: content, language, illustrations, layout, motivation and culture, which are scored using a scale, where two means adequate and zero, not adequate²².

2.5. Data assessment

In the analytical procedures, judge validation data were tabulated in Microsoft Excel 2010 and, later, analyzed using simple descriptive statistics with regard to judge characteristics. The Content Validity Coefficient (CVC) was also calculated according to the formula inferred by the methodological framework¹⁵, in addition to the level of agreement¹⁸. CVC > 0.8 and agreement parameters equal to or greater than 80% as to its suitability were considered relevant for the study^15,17.

2.6. Study ethical aspects

The research followed the ethical precepts contained in Resolution 466, of December 12, 2012, of the Brazilian National Health Council, approved by a Research Ethics Committee, with CAAE (Certificado de Apresentação para Apreciação Ética - Certificate of Presentation for Ethical Consideration) 29259020.7.0000.5537.

Initially, a scoping review (SR) was developed to identify contents related to safe health care for patients with CKD under HD, the search for studies resulted, after eligibility criteria, in eight studies that comprised the final sample. The main findings regarding safe HD care are in Fig. 1, grouped into structure, process and result items.

Based on the content provided by the SR, a checklist and a graphic protocol were elaborated, which were formulated in line with the Donabedian framework²³. Its organization took place through the presentation of three aspects of protocols regarding safe HD care in dialysis sectors, which have the purpose of assessing specific elements.

Such protocols are divided into: structure (infrastructure, materials, equipment and human resources); process (patient identification, effective communication, healthcare-associated infection prevention, safety in the use of medications, care with the session); and result (PS indicators). Along with these protocols, a checklist was created, consisting of the same elements and dimensions already mentioned, as the protocol is assessed based on checklist responses to consider safe, partially safe or unsafe care.

The graphic protocol content and appearance validation was carried out in two Delphi rounds; in Delphi I, nine judges participated, and in Delphi II, six. Its sociodemographic characteristics are described in Table 1.

Table 1

Sociodemographic characteristics of the judges participating in the study in Delphi I and II rounds. Natal/RN, 2022
Sociodemographic characteristics	Delphi I (n = 9) n (%)	Delphi II (n = 6) n (%)
Sex
Female	8 (88.9)	5 (83.3)
Male	1 (11.1)	1 (16.7)
Field of action
Teaching	3 (33.3)	3 (50.0)
Care	1 (11.1)	1(16.7)
Teaching and care	5 (55.6)	2(33.3)
Professional patient safety practice
5 to 9 years	2 (22.2)	2 (33.3)
Over 10 years	7 (77.8)	4 (67.7)

Regarding content validity verification, it was found that, in the first Delphi round, checklist clarity, accuracy and modality (CVC = 0.77) did not reach levels of suitability. As for the protocol items, all of them presented CVC greater than or equal to 0.80.

Regarding appearance validity through SAM, in the first round, it was possible to achieve a total CVC greater than 0.80 in all materials, although the culture component referring to the process protocol did not reach a minimum CVC of 0.80 (CVC = 0.06).

After Delphi I, judges’ considerations about the protocol and the checklist were received and assessed whether they would be included or not. Suggestions considered relevant were accepted and inserted into the material for later reassessment by re-sending with the modifications, and those discarded were forwarded to judges with a justification for their non-use. The synthesis of these suggestions is described in Fig. 2.

Corresponding to the Delphi technique’s second round, the level of agreement reached at this stage was greater than 80% in all items assessed by experts, thus confirming the suitability of these aspects when integrating the instrument. As for CVC, all contents reached validation indexes above 0.80, with a total CVC of 0.88.

Regarding the appearance validation process using the SAM criteria, in the second round, the protocol reached agreement greater than 80% and CVC greater than 0.88. The checklist presented a higher CVC with 0.91, according to Tables 2 and 3, with Pasquali’s adapted criteria and SAM.

Table 2

CVC values after Delphi I and II in Pasquali’s criteria. Natal/RN, 2022
CVC content validity agreement
Pasquali’s adapted criteria	Checklist Delphi I	Delphi II	Protocol structure Delphi I	Delphi II	Protocol process Delphi I	Delphi II	Protocol result Delphi I	Delphi II
Behavior	0.85	0.88	0.88	0.88	0.88	0.88	0.85	0.88
Objectivity	0.92	0.88	0.92	0.88	0.88	0.88	0.88	0.88
Simplicity	0.88	0.88	0.92	0.88	0.92	0.88	0.92	0.88
Clarity	0.77	0.88	0.88	0.88	0.85	0.88	0.88	0.88
Relevance	0.96	0.94	0.92	0.88	0.92	0.88	0.92	0.88
Accuracy	0.77	0.83	0.92	0.88	0.88	0.88	0.88	0.88
Variety	0.81	0.83	0.88	0.88	0.88	0.88	0.88	0.88
Modality	0.77	0.83	0.92	0.88	0.92	0.88	0.88	0.88
Typicality	0.92	0.99	0.92	0.88	0.92	0.88	0.92	0.88
Credibility	0.85	0.94	0.92	0.88	0.92	0.88	0.92	0.88
Range	0.88	0.94	0.92	0.88	0.92	0.88	0.92	0.88
Balance	0.88	0.94	0.92	0.88	0.88	0.88	0.88	0.88
Total CVC	0.87	0.88	0.92	0.88	0.90	0.88	0.88	0.88

Table 3

CVC values after Delphi I and II in the SAM criteria. Natal/RN, 2022
CVC content validity agreement
SAM criteria	Checklist Delphi I	Delphi II	Protocol structure Delphi I	Delphi II	Protocol process Delphi I	Delphi II	Protocol result Delphi I	Delphi II
Content	0.96	0.94	0.96	0.94	0.92	0.88	0.92	0.88
Language	0.88	0.88	0.96	0.94	0.92	0.88	0.92	0.88
Illustration	0.96	0.88	0.92	0.94	0.88	0.88	0.88	0.88
Layout	0.96	0.94	0.96	0.88	0.92	0.88	0.92	0.88
Motivation	0.96	0.88	0.96	0.88	0.92	0.88	0.92	0.88
Culture	0.99	0.94	0.99	0.88	0.06	0.88	0.92	0.88
Total CVC	0.96	0.91	0.96	0.91	0.92	0.88	0.92	0.88

Regarding the main findings of this SR, they were organized according to structure, process and result (Donabedian’s triad)²⁴. Items classified into structure are highlighted as infrastructure, inputs and human resources.

The indicators found in the studies highlighted the dialyzer processing, dialysis machine type, exclusively for nursing professionals for patients with unknown serology^8,25.

From this perspective, studies emphasize that water quality control was essential in preventing risks to patients, indicating that this should be organized before the HD procedure^8,25.

As for the items classified as process, hand hygiene, use of checklists to avoid infection, relationship between professional and patient and patient data collection in printed form for each session were pointed out^,27,28.

It is emphasized that patient protection and safety activities must be performed by a multidisciplinary team, with aseptic techniques for infection prevention and assessment of individual patient results^11,29.

Furthermore, the items highlighted as a result are related to care products, changes in health status related to this care. Studies have highlighted catheter insertion reduction by using the Fistula First program to maintain arteriovenous fistula (AVF).

The use of AVF can present complications, such as stenosis and infection, although, when compared to the central venous catheter, which has a lower mortality rate, it is therefore recommended as the first choice access in patients under HD in the Fistula First Catheter Last guideline^27,30.

The graphic protocol construction aimed to contribute to the development of new interventions to promote safe HD care through identification of strengths and weaknesses in services, which occurred through the checklist production as the main part. The aforementioned made it possible to organize and structure the instrument by making it possible to visually verify the proposed tasks and consult to assist in assessing and analyzing the various graphic protocol items¹⁸.

For a safe use of the instrument in health services, the item validation process becomes necessary to reach reliability. This procedure was carried out by judges’ assessment.

It is noted that most experts in the study have more than 10 years of professional experience in the PS area.

With regard to sex, women prevailed among judges who were part of the study. The fact is consistent with the historical context of nursing and its first schools in which there was a predominance of women in the profession, although over the years men have been increasingly inserted^32,33.

Regarding the field of action, it was identified that the majority works with care and teaching linked to PS and HD. A study says that the combination of these areas of activity makes professionals develop approximation and better associations between patient care and scientific research^34,35.

In the content and appearance validation process, in the first Delphi round, three criteria did not have suitability values greater than or equal to 0.80. We sought to reassess the items, in order to make them understandable, as clarity was not validated in the checklist, which could cause inconsistency in understanding and consequent inappropriate use of the instrument. This criterion has higher levels of difficulty to be valid, as it varies according to the interpretation capacity of both the builder and the user³⁶.

The second criterion not validated was accuracy, which indicates that an item may not be suitable and cause confusion, since accuracy means that each item must have a distinct and defined position¹⁵. Modality, third criterion, refers to the formulation of sentences with expression of modal reaction¹⁵.

For appearance validation, using the SAM criteria, in the Delphi I round, only the process protocol culture item was below 0.80. This criterion is characterized by the observation of the instrument content regarding its logic, language and experience, in order to verify if it is culturally suitable for the target audience.

Thus, it is observed that the graphic protocol obtained CVC values above 0.80, which highlights the significant agreement among judges and that the use of the instrument helps assessing safe care in HD.

Regarding the level of agreement of the instruments after completion of two Delphi rounds, it is clear that the material has valid content to assess safe care for patients under HD through agreement among judges.

As limitations of this validation study, the number of judges who made up this stage stands out, as in the first Delphi round it consisted of nine, and in the second round, six. Loss of judges can represent losses. Despite the limitations, this study contributes to PS and quality management of HD services.

The graphic protocol for assessing safe nursing care in HD was validated through assessment by expert judges and reached agreement on all instrument items after the Delphi rounds.

Thus, the instrument use and adoption in health institutions that have HD service can contribute to PS and quality management, as it aims to assist in safe care for patients with CKD under HD and, with that, the possibility of minimizing AE through improvement cycles.

It is considered that further research on this topic is essential to optimize knowledge on PS and HD, in order to ensure quality care for patients with CKD.

Ethics approval and consente to participate

The research followed the ethical precepts contained in Resolution 466, of December 12, 2012, of the Brazilian National Health Council, approved by a Research Ethics Committee, with CAAE (Certificado de Apresentação para Apreciação Ética - Certificate of Presentation for Ethical Consideration) 29259020.7.0000.5537. The study followed the Helsinki Declaration, and all participants gave individual informed written consent to take part in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Authors’ Contributions

Renilly de Melo Paiva: Conceptualization, Methodology, Writing - Original Draft

Flávia Barreto Tavares Chiavone: Writing - Original Draf, Formal analysis, Investigation

Manaces dos Santos Bezerril: Writing - Original Draft, Formal analysis, Investigation

Marianny Nayara Paiva: Writing - Original Draft, Formal analysis, Investigation

Isabelle Campos de Azevedo: Writing - Review & Editing, Methodology

Adriana Catarina de Souza Oliveira: Writing - Review & Editing, Methodology

Marcos Antonio Ferreira Júnior: Writing - Review & Editing, Methodology

Viviane Euzébia Pereira Santos: Conceptualization, Writing - Review & Editing, Supervision

Acknowledgements

The authors thank the judges for participating in the study.

Availability of data and materials

The data material is available on request from the corresponding author.

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No competing interests reported.

Graphic Protocol for Assessing Safe Nursing Care in Hemodialysis: a Validation Study

Status:

Version 1

Abstract

Background

Method

Results

Conclusion

Figures

1. Introduction

2. Methods

2.1 Study design

2.2. Sample

2.3. Data collection instruments

2.4 Procedures

2.5. Data assessment

2.6. Study ethical aspects

3. Results

4. Discussion

5. Conclusion

Declarations

References

Additional Declarations

Status:

Version 1