ABSTRACT
Objective: this study aims to develop and validate the content and appearance of a bedside checklist for preventive care against Ventilator-Associated Pneumonia in adult Intensive Care Units.
Method: a methodological research study was conducted from July 2022 to June 2023 in two phases: the development of the checklist and the validation of its content and appearance. The instrument was evaluated by 23 experts (nurses, physicians, physiotherapists, and dentists). The evaluation criteria focused on clarity and relevance, as well as the application of the Suitability Assessment of Materials, with scoring conducted using a Likert scale. Consensus among the experts was measured using the Content Validity Index, with items achieving over 80% agreement considered valid.
Results: the first version of the instrument comprised four domains and 34 items. Following validation, modifications were made to three items, one domain was detached, and another was excluded due to an agreement score below 0.80. The final version of the checklist consists of four domains distributed across 22 items: three items in the Patient Identification domain, seven items in the Clinical Information domain, nine items in the Essential Practices domain, and three items in the Additional Approaches domain. The checklist demonstrated excellent internal consistency, with a Cronbach’s alpha value of 0.972.
Conclusion: the checklist was considered valid and could serve as an essential tool for preventing Ventilator-Associated Pneumonia in adult patients.
DESCRIPTORS:
Ventilator-associated pneumonia; Critical care; Disease prevention; Checklist; Validation study
RESUMO
Objetivo: construir e validar o conteúdo e a aparência de um checklist para a verificação, à beira leito, de cuidados preventivos à Pneumonia Associada à Ventilação Mecânica em Unidade de Terapia Intensiva adulto.
Método: pesquisa metodológica, desenvolvida no período de julho de 2022 a junho de 2023, em duas etapas: construção do checklist e validação do conteúdo e aparência. O instrumento foi submetido à avaliação de 23 especialistas (enfermeiros, médicos, fisioterapeutas e odontólogos). Avaliou-se os critérios de clareza e relevância, bem como a aplicação do Suitability Assessment of Materials, com pontuação por meio de escala do tipo Likert. O consenso entre os especialistas foi mensurado pelo Índice de Validade de Conteúdo. Considerou-se válido o item com mais de 80% de concordância.
Resultados: a primeira versão do instrumento foi construída com quatro domínios e 34 itens. Após a validação, realizou-se modificações em três itens, desvinculação de um domínio e exclusão de outro domínio devido à concordância inferior a 0,80. Assim, a versão final do checklist está composta por quatro domínios distribuídos em 22 itens, sendo três itens no domínio Identificação do Paciente, sete itens do domínio Informações Clínicas, nove itens no domínio Práticas Essenciais e três itens no domínio Abordagens Adicionais. O checklist apresentou ótima consistência interna, com valor de 0,972 através do Alfa de Cronbach.
Conclusão: o checklist foi considerado válido e a sua utilização pode contribuir como importante ferramenta para a prevenção da Pneumonia Associada à Ventilação Mecânica no paciente adulto.
DESCRITORES:
Pneumonia associada à ventilação mecânica; Cuidados críticos; Prevenção de doenças; Lista de checagem; Estudo de validação
RESUMEN
Objetivo: construir y validar el contenido y la apariencia de un checklist para la verificación a pie de cama de la atención preventiva de la Neumonía Asociada a la Ventilación en una Unidad de Cuidados Intensivos de adultos.
Método: investigación metodológica, desarrollada de julio de 2022 a junio de 2023, en dos etapas: construcción del checklist y validación de contenido y apariencia. El instrumento fue sometido a evaluación por 23 especialistas (enfermeros, médicos, fisioterapeutas y odontólogos). Se evaluaron los criterios de claridad y pertinencia, así como la aplicación de la Suitability Assessment of Materials, con puntajes mediante una escala tipo Likert. El consenso entre los jueces se midió por medio del Índice de Validez de Contenido. Se consideró válido el ítem con más del 80% de acuerdo.
Resultados: la primera versión del instrumento se construyó con cuatro dominios y 34 ítems. Luego de la validación se realizaron modificaciones en tres ítems, desvinculando un dominio y excluyendo otro por concordancia inferior a 0,80. Así, la versión final del checklist se compone de cuatro dominios distribuidos en 22 ítems, con tres ítems en el dominio de Identificación del Paciente, siete ítems en el dominio de Información Clínica, nueve ítems en el dominio de Prácticas Esenciales y tres ítems en el dominio de Enfoques Adicionales. El checklist presentó excelente consistencia interna, con un valor de 0,972 utilizando el Alfa de Cronbach.
DESCRIPTORES:
Pneumonia associada a ventilación mecánica; Cuidados críticos; Prevención de enfermedades; Checklist; Estudio de validación
INTRODUCTION
The adult Intensive Care Unit (ICU) is a complex environment that cares for patients with severe and unstable conditions, often involving invasive procedures to sustain life. These procedures can increase the risk of Healthcare-Associated Infections (HAIs), defined as infections acquired during healthcare processes, which represent a significant public health issue. HAIs are common adverse events in healthcare delivery, directly affecting patient safety. These infections significantly contribute to morbidity, mortality, and financial burden for both patients and their families, as well as for healthcare systems1-2.
HAIs include ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (CAUTI), and central line-associated bloodstream infection (CLABSI), among others. VAP is an infection of the lung parenchyma acquired by patients who have been on mechanical ventilation, such as those who have undergone endotracheal intubation, for at least 48 hours. The mortality rate for these patients is substantial, reaching 10%, and can rise to 40% in cases involving multidrug-resistant microorganisms3. This high prevalence is related to the microorganism's potential for mortality, the use of antibiotic therapy, the underlying pathology, prolonged use of mechanical ventilation, and extended hospital stays. Therefore, preventive measures must be implemented3.
To meet the comprehensive needs of critically ill patients and provide adequate care, interdisciplinary interventions are necessary. These should include preventive actions and best care practices, such as the development of protocols that facilitate the adoption of daily actions and minimize the risks to which patients are exposed4.
Among the healthcare professionals involved in caring for patients affected by VAP, nurses play a key role in team leadership and care management. They implement preventive and therapeutic measures with an emphasis on HAIs, resulting in improved care quality and patient safety5.
Preventive interventions include protocols and checklists, which, when based on scientific evidence, make the evaluation process reliable and accurate. The use of these tools has become increasingly common as they promote safety and reduce patient harm when used regularly and when items are aligned with the prevention of a specific infection4,6.
In this context, the new guidelines for clinical care in the prevention of VAP, updated in 2022 by The Society for Healthcare Epidemiology of America (SHEA), were developed based on recommendations from over 100 experts worldwide7. Each institution is responsible for analyzing and determining the best way to implement these SHEA updates, which need to be effectively translated into practice.
This study brought together a team of experts in adult intensive care who reviewed the SHEA guidelines and developed an instrument that consolidates and synthesizes the information, so that nurses, physiotherapists, dentists, and physicians may have a checklist that can help them in the daily practice of VAP prevention. It serves as a daily reminder of evidence-based practices, helping to reduce information gaps and standardize reproducible protocols for healthcare professionals, thereby enhancing patient safety6. Given the above, this research aimed to develop and validate the content and appearance of a checklist for bedside verification of preventive care against Ventilator-Associated Pneumonia in adult intensive care units.
METHOD
This study is a methodological, quantitative, and descriptive research. This type of study is used to verify the methods of data collection, organization, and analysis, with the aim of developing, validating, and evaluating instruments and techniques relevant to the research context. t was conducted from July 2022 to June 2023 in two phases: 1) the development of the checklist, and 2) the validation of its content and appearance.
The construction of the checklist was based on the guidelines established by SHEA7 in 2022, which provided new recommendations for the clinical care practices of the multidisciplinary team in the prevention of VAP. Other sources were also consulted, such as the regulations from the professional councils of Nursing, Physiotherapy, and Medicine, which support the practice of these professionals in caring for patients on mechanical ventilation, as well as national recommendations from the Ministry of Health and the National Health Surveillance Agency (ANVISA), international guidelines from the World Health Organization (WHO), and other relevant guidelines.
The validation process was conducted online in one round. The sample was selected through a search on the Lattes Platform of the National Council for Scientific and Technological Development (CNPq) (http://lattes.cnpq.br/) and through expert referrals using the snowball technique.
The selection of referees was guided by the expert scoring system from Fehring's content validation model8, adapted to direct the selection of professionals specializing in adult intensive care. A minimum score of five points was sought, considering the following criteria: a master’s or doctoral degree in the field or a related area, with a thesis or dissertation on mechanical ventilation care (four points), research on ventilator-associated pneumonia or adult intensive care (three points), a published article in the field in a Qualis B1 to A1 indexed journal (three points), and at least one year of experience in adult intensive care.
A total of 162 expert referees (nurses, physicians, physiotherapists, and dentists) were invited to participate in the research via email or the WhatsApp application, containing a link to a Google Forms survey for the anonymous signing of the Informed Consent Form (ICF). The decision to invite referees from the aforementioned fields of practice was due to their direct involvement in the care of critically ill patients in ICUs, following the guidelines for VAP prevention. It is noteworthy that these guidelines are based on robust scientific evidence to be effectively utilized in care and are periodically reviewed to incorporate the best available evidence.
Two attempts were made to send the invitation to the judges, spaced 15 days apart, using both email and WhatsApp. For those who had already responded, the second invitation and evaluation form were canceled. Those who did not respond after the two invitation attempts were automatically excluded from the study, as the researchers understood that they were not interested in participating. As a result, the sample of judges for content and appearance validation comprised 23 specialists who met the established criteria, in accordance with the psychometric concepts recommending a range of six to 20 experts9.
The data collection instrument was created using the electronic tool Google Forms, structured in three sections: 1) characterization of the referees; 2) analysis of the relevance of the checklist content, considering the psychometric criteria of clarity and relevance/pertinence9; and 3) evaluation of the checklist's appearance using criteria adapted from the "Suitability Assessment of Materials" (SAM) for assessing content, language, illustrations, layout, motivation, and usability10.
In the second and third stages, the data collection instrument was organized using a Likert scale with four levels of agreement (1 to 4). In stage 2, the clarity criterion was assessed as follows: 1. Incomprehensible; 2. Slightly comprehensible; 3. Comprehensible; 4. Fully comprehensible, while relevance/pertinence was assessed as: 1. Irrelevant; 2. Slightly relevant; 3. Relevant; 4. Highly relevant, and spaces for comments or writing suggestions.
In stage 3, the evaluation options for the items were also considered as: 1. Inadequate; 2. Partially adequate; 3. Adequate; 4. Fully adequate. At the end of each evaluated requirement, an open space was provided for comments or suggestions regarding any potential inadequacies. The data were analyzed using descriptive statistics (absolute and relative frequencies, minimum, maximum, mean, median, and standard deviation).
To validate the checklist, the Content Validity Index (CVI) was used, which assesses the proportion of judges in agreement on specific aspects of the instrument and its items. The item-Level Content Validity Index (I-CVI) was applied to evaluate the agreement among referees for each assessment item, calculated based on the number of referees rating the item as relevant/clear and very relevant/very clear. The Scale-Level Content Validity Index, Average Calculation Method (S-CVI/AVE), was used to measure the proportion of scale items rated as relevant and very relevant by each referee. Items with a CVI ≥ 0.80 were considered validated11. To determine whether the proportion of agreement regarding the adequacy and relevance of the checklist was statistically equal to or greater than 0.8, a binomial test with a significance level of 5% was conducted12. The internal consistency of the instrument was verified by calculating the Cronbach's Alpha coefficient13.
The study followed the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) checklist, which aids in the reliability of presenting the results of agreement studies14.
RESULTS
The study of the guidelines established by The Society for Healthcare Epidemiology of America7 enabled the identification of content for developing the checklist for VAP prevention.
The sociodemographic characterization of the sample of 23 participants showed that their ages ranged from 26 to 63 years, with a mean age of 43.10 (SD ± 9.3), and the majority were female (n=14; 60.9%). Regarding the location of the experts, ten (43.5%) were from the South region, nine (39.1%) from the Southeast, two (8.7%) from the Northeast, and two (8.7%) from the Midwest. In terms of professional background, 11 (47.8%) were nurses, six (26.1%) were physicians, four (17.4%) were physiotherapists, and two (8.7%) were dentists. The academic qualifications varied, with nine (39.1%) holding doctorates, nine (39.1%) holding master's degrees, and five (21.7%) holding specialist titles.
Initially, the first version of the instrument was structured with 34 items distributed across 4 domains: Domain 1: Patient Identification (9 items); Domain 2: Essential Practices (9 items) Domain 3: Additional Approaches (3 items); Domain 4: Non-recommended (13 items). Each item was analyzed separately, except for the items in Domain 4, which were evaluated as a whole. In the analysis of the checklist's clarity and relevance, the "non-recommended" domain presented a CVI <0.80 in relation to its relevance (Table 1).
Items 12 and 13 scored below 0.80 in clarity (Table 2). The experts indicated that there were difficulties in understanding the proposed question. Based on these recommendations, the items were modified in the final version for greater clarity. Domain 4 was excluded, following the specialists' suggestions, to avoid confusion (Figure 1).
Consensus among the referees regarding the checklist content. Caxias do Sul, RS, Brazil, 2023. (n=23).
Validated version of the checklist for the prevention of ventilator-associated pneumonia. Caxias do Sul, RS, Brazil, 2023.
Regarding internal reliability measured by Cronbach's Alpha coefficient, although items 16 and 17 showed low reliability, the overall instrument achieved a final value of 0.972, demonstrating an almost perfect internal consistency.
Regarding the overall validation of the checklist (content and appearance) (Table 3), 11 (47.8%) of the specialists considered it unclear (CVI 0.73), although the average score for the motivation criterion was above 0.80. For the usability criterion, nine (39.1%) specialists opined that the proposal did not reflect the key aspects that should be emphasized (CVI 0.73). Given the above, usability was the only criterion that did not reach an average CVI above 0.80 (Table 3).
After validating the content and appearance, the final version of the checklist for VAP prevention was produced with 4 domains distributed across 22 items: three items in the Patient Identification Domain, seven items in the Clinical Information Domain, nine items in the Essential Practices Domain, and three items in the Additional Approaches Domain (Figure 1).
DISCUSSION
The development and validation of a checklist for VAP prevention in the context of adult patients is effective and promising as it assists in care and overall assistance while evaluating the necessary conditions for safe care for these patients, based on scientific evidence that promotes continuous improvement. Moreover, for successful outcomes regarding this HAI, it is crucial that this instrument is accompanied by a cultural change with active engagement from interdisciplinary teams4.
This finding was also observed by the researchers in this study, who identified that preventing VAP requires prioritization that was reflected in the checklist's development, based on the evaluation of ICU needs and the realities of hospitalized patients. Demonstrating that actions taken by the multidisciplinary team can contribute to or hinder the hospitalization of critically ill patients highlights the need for developing new technologies to offer more efficient care, providing better prognoses, safety in care, infection prevention, and comfort for patients.
The use of VAP prevention measures is presented as a necessary action that, when applied, contributes to reducing its occurrence. However, despite this, there is still a lack of standardization and instruments with VAP prevention measures15. The SHEA updates related to VAP, published with the collaboration of over 100 specialists worldwide, introduced improvements in essential practices for prevention, as well as special approaches, actions that are no longer recommended, and actions that do not impact the reduction of VAP rates in adult patients. The compiled recommendations aim to assist in implementing the most effective practices for preventing events associated with mechanical ventilation in intubated patients7.
From this perspective, the development of a checklist based on scientific evidence to guide professionals in processes for preventing VAP proves to be a useful tool to enhance patient safety.
Therefore, it is essential to validate the content and appearance of the instrument, assess its reliability, and ensure it is safe and reliable for use in healthcare services16. The Fehring criteria model, adapted for this research, allowed for the selection of referees with experience in clinical practice, education, and research, contributing to the validation process and the instrument's reliability8. This approach made it possible to link the practical experience of professionals in the ICU field with the expertise of educators and researchers who have knowledge of the processes involved in developing technologies and their application, and who can foresee the feasibility of implementing these technologies in educational and healthcare settings.
The instrument was validated by professionals from the multidisciplinary team with prior professional experience in the ICU: nurses, physicians, physiotherapists, and dentists, as it is understood that the responsibility for VAP prevention lies with everyone involved. However, nurses play a prominent role in the team, as part of their function is to implement preventive and therapeutic measures for HAIs and to improve the quality of care and patient safety5.
Regarding the checklist, it begins with patient identification (Domain 1). Correct patient identification is the first of the six International Patient Safety Goals, which aim to minimize the occurrence of risks during care delivery, reducing or eliminating adverse events that could harm the patient17-18. This study's instrument chose the patient's name and date of birth as identification indicators, considering that the National Patient Safety Program's patient identification protocol recommends using at least two identifiers for the patient19. After suggestions from specialists regarding the possibility of patients with the same name, the medical record number was also added as an identifier. The results of the evaluation of this domain, in terms of clarity and relevance, demonstrated excellence. It was decided to revise the wording of item 8 for better understanding, based on a suggestion from a specialist referee, despite the item showing good results in the evaluations. Based on feedback from referees who expressed that the domain contained data collection beyond patient identification, the domain was split, creating a new one titled Clinical Information, which includes data related to intubation, extubation, and reintubation.
Although SHEA made a significant contribution to knowledge construction in the healthcare field, some referees questioned the removal of chlorhexidine from the oral hygiene practice for patients on mechanical ventilation. While item 16, related to this practice, showed clarity and relevance above the recommended threshold, some study participants noted that the new recommendations did not consider reviews demonstrating the effectiveness of chlorhexidine in prevention, nor did they specify what the new recommendation for use would be.
A study on mouthwashes highlighted that their use might increase the risk of mortality, and there are conflicting data regarding whether mouthwashes are necessary as part of daily oral hygiene. Despite this, the study concluded that they could be used daily to control the incidence of VAP, although they did not demonstrate efficacy in reducing mortality, the duration of mechanical ventilation, or bacterial colonization in adult patients18.
In items 12 and 13 of the Essential Practices domain, changes were suggested in the wording of the questions due to difficulties in clarity, despite the agreement on the relevance of these items. Because the evaluation results indicated potential weaknesses in understanding these items, adjustments were made to better clarify the purpose of the questions. The Additional Approaches domain did not require adjustments, as it showed clarity and relevance with scores above the recommended level.
The Evaluation Criteria were modified based on feedback from the referees. Initially, the criteria were: compliant, non-compliant, not applicable, and contraindicated. Some specialists noted that classifying the items as compliant and non-compliant seemed to carry a punitive connotation. To improve the description, it was decided to change the Evaluation Criteria from compliant to yes and non-compliant to no.
Another adjustment made to the instrument was in the “Non-recommended” domain. According to the opinions of the specialists, who justified their scores, this domain made the checklist lengthy and cluttered with information, causing confusion about the necessity of including these items in the instrument. To align with the recommendations, the domain was removed, as it was deemed unnecessary for the instrument.
It is worth noting that during the referees' evaluation, adaptations and removals of items from the checklist were made, similar to the validation process of a multidisciplinary checklist for ICU rounds20. This occurred because, although the items in the instrument were considered relevant, the specialists recommended reformulations or exclusions of certain items to improve the clarity of the checklist.
Checklists are fundamental tools for patient safety. They help minimize errors in healthcare delivery and promote the provision of excellent care21. The use of these instruments facilitates the assessment of healthcare professionals' practices. In this context, researchers argue that by adopting evidence-based approaches to inform their decisions, professionals aim to enhance care practices, grounding them in technical-scientific knowledge22.
A clinical study conducted in Iran with patients admitted to ICU units under mechanical ventilation observed that the implementation of infection control guidelines could significantly reduce the incidence of VAP and its diagnostic indicators in ICU patients. Similarly, the study suggests that nurses are advised to use these guidelines to prevent VAP in ICU patients15,17.
A similar study identified that, before the application of a checklist, there was an average of 3.22 VAP cases, which significantly decreased to 0.33 (p=0.001) after the checklist was instituted, with a corresponding reduction in the days of mechanical ventilation4
To ensure the reliability of this instrument, making it safe for use in adult intensive care services, the validation process was indispensable. The results from the evaluation conducted by specialist referees played a crucial role in enhancing the quality of the instrument, significantly contributing to the improvement of the checklist model. Another positive impact of using the checklist in the context of VAP concerns the duration of mechanical ventilation, which decreased from 157 days to 133 days (p=0.037), with the VAP density outcome dropping from 21.62 to 2.82 (p=0.003). As a result, the VAP cases were reduced by 4.9% per month in an adult intensive care unit4.
The percentage of specialist referees who assessed the checklist as a beneficial tool for preventing VAP was considered satisfactory. Given the level of agreement, which remained above the recommended threshold in terms of content and appearance, the checklist is considered a viable tool for implementation in adult intensive care services.
One limitation of the study is the lack of a second round of validation, which could have improved the CVI scores for aspects like usability. This limitation will be addressed through the continuation of the validation process over time, as after the tool is in use, the need for adjustments may be identified by the professionals who use it, or as new evidence for VAP prevention emerges. Additionally, the instrument's specificity to adult patients is another limitation. It is recommended that further research be conducted to develop and validate instruments related to other intensive care settings, such as neonatal and pediatric.
This research contributes to the field of Nursing by introducing an innovative instrument that translates recently updated international recommendations for healthcare professionals in Brazil. The entire instrument was designed with the potential to transform the work process in intensive care, featuring accessible language for professionals and aiming to update practices in this context. It is believed that, as a result of this research, multidisciplinary teams can use the checklist developed in this study as a basis for their practice.
The panel of professionals from various fields assisted in the validation process, comprising specialists from different parts of Brazil, covering four regions of the country. The fact that this validity has national proportions helps in disseminating knowledge. Future research with this instrument will focus on improving its usability, with another round of validation to improve the scores of items with CVI < 0.80. Implementation studies in the practical field of adult intensive care, aimed at evaluating the effectiveness of using the checklist in daily practice, will also be conducted.
CONCLUSION
The checklist for the prevention of Ventilator-Associated Pneumonia in adults was developed based on the 2022 updates from The Society for Healthcare Epidemiology of America. The content and appearance validation process was carried out by a group of specialist referees who deemed the instrument valid and recommended its use in adult intensive care services. Therefore, the use of the checklist serves as an important means in the prevention of VAP, always aiming for patient safety and the continuous improvement of the prevention process.
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NOTES
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ORIGIN OF THE ARTICLE
Extracted from the final course work - Development and validation of a checklist for the prevention of Ventilator-Associated Pneumonia, presented to the Nursing Undergraduate Program at Centro Universitário da Serra Gaúcha, in 2023.
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APPROVAL OF ETHICS COMMITTEE IN RESEARCH
Approved by the Research Ethics Committee of Centro Universitário da Serra Gaúcha - FSG, opinion n.º 5.988.955/2023, Certificate of Ethical Presentation 67399323.7.0000.5668.
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TRANSLATED BY
Leonardo Parachú.


