CLINICAL DETERIORATION OF THE ONCOLOGY CHILD: RELIABILITY OF A NEW TOOL ADAPTED FROM THE BRIGHTON PEDIATRIC EARLY WARNING SCOREABSTRACT
Objective: To measure the degree of reliability of the construction of new items and the adaptation of the Brighton Pediatric Early Warning Score for children with cancer.
Method: Methodological study to analyze the equivalence of inter-judge content regarding the inclusion of items in the scale to detect early clinical deterioration in children with cancer: signs of bleeding, changes in temperature, and presence of grade III/IV mucositis. The Intraclass Correlation Coefficient and Cronbach’s Alpha were used for analysis, considering a value ≥0.750.
Results: Based on the judges’ feedback, the items proposed for inclusion were retained, with minor adjustments to the scores. Thirty nurses (86.1%) and six doctors (13.9%) from Brazil evaluated the scale, resulting in an intraclass correlation coefficient of 0.823.
Conclusion: The instrument proved suitable, with theoretical relevance and practical application, for early detection of clinical deterioration in children with cancer. To this end, it contributes to timely identification by the team, minimizing unfavorable outcomes.
DESCRIPTORS:
Medical Oncology; Clinical Deterioration; Pediatrics; Hospitalization; Methodological Studies.
HIGHLIGHTS
Early detection of clinical deterioration in pediatric oncology.
Evaluation of predictors of clinical deterioration in children with cancer.
Inter-judge reliability of the modified alertness scale for pediatric oncology.
RESUMO:
Objetivo: Mensurar o grau de confiabilidade da construção de novos itens e a adaptação da escala Brighton Pediatric Early Warning Score para crianças oncológicas.
Método: Estudo metodológico para análise da equivalência de conteúdo interjuízes quanto à inclusão de itens na escala, para detectar precocemente a deterioração clínica em crianças oncológicas, sendo: sinais de sangramento, alterações na temperatura e presença de mucosite grau III/IV. Para análise, foi utilizado o Coeficiente de Correlação Intraclasse e Alfa de Cronbach considerando valor ≥0,750.
Resultados: Os itens sugeridos para inclusão foram mantidos, com pequenas modificações nas pontuações, conforme sugestões dos juízes. Trinta enfermeiros (86,1%) e seis médicos (13,9%) do Brasil avaliaram a escala, obtendo coeficiente de correlação intraclasse de 0,823.
Conclusão: O instrumento se mostrou apto, com relevância teórica e aplicação prática para detectar precocemente a deterioração clínica de crianças oncológicas. Para tanto, contribui para a identificação a tempo oportuno pela equipe, minimizando desfechos desfavoráveis.
DESCRITORES:
Oncologia; Deterioração Clínica; Pediatria; Hospitalização; Estudos Metodológicos.
HIGHLIGHTS
Detecção precoce de deterioração clínica em oncologia pediátrica.
Avaliação de sinais preditores de deterioração clínica em crianças oncológicas.
Confiabilidade interjuízes frente escala de alerta modificada para oncologia pediátrica.
RESUMEN
Objetivo: Medir el grado de fiabilidad de la construcción de nuevos ítems y la adaptación de la escala Brighton Paediatric Early Warning Score para niños oncológicos.
Método: Estudio metodológico para analizar la equivalencia de contenido interjueces en cuanto a la inclusión de ítems en la escala para detectar el deterioro clínico precoz en niños oncológicos, a saber: signos de hemorragia, cambios de temperatura y presencia de mucositis grado III/IV. Para el análisis se utilizaron el Coeficiente de Correlación Intraclase y el Alfa de Cronbach, considerando un valor ≥0,750.
Resultados: Los ítems sugeridos para inclusión fueron mantenidos, con pequeñas modificaciones en las puntuaciones, de acuerdo con las sugerencias de los jueces. Treinta enfermeros (86,1%) y seis médicos (13,9%) de Brasil evaluaron la escala, obteniendo un coeficiente de correlación intraclase de 0,823.
Conclusión: El instrumento demostró ser adecuado, con relevancia teórica y aplicación práctica para la detección precoz del deterioro clínico en niños oncológicos. Para ello, contribuye a la identificación oportuna por parte del equipo, minimizando los desenlaces desfavorables.
DESCRIPTORES:
Oncología Médica; Deterioro Clínico; Pediatría; Hospitalización; Métodos.
HIGHLIGHTS
Detección precoz del deterioro clínico en oncología pediátrica.
Evaluación de signos predictivos de deterioro clínico en niños oncológicos.
Fiabilidad interjueces de la escala de alerta modificada para oncología pediátrica
INTRODUCTION
Advances in the treatment of childhood cancer offer greater chances of remission and cure but also a more significant occurrence of adverse events1. Febrile neutropenia and sepsis are the most frequent events, with sepsis being responsible for most ICU referrals and deaths in pediatric oncology and the fever being one of the central warning signs1-2. There is evidence that children who died in the first 24 hours of poor perfusion, in addition to neutropenia, also had respiratory, hematological, and neurological alterations3.
The mortality rate for these patients is up to 35%, which is very high compared to children in general (5%)1. As a result, around 38% will need an ICU at some point during their cancer treatment1, with the risk of severe sepsis increasing fourfold when there is associated mucositis and febrile neutropenia2.
One way of detecting these alterations early is through assessment scales such as the Pediatric Early Warning Score (PEWS), which use quick and simple resources and do not depend on more complex equipment or tests4. In pediatrics, more than 30 scales are being used and adapted worldwide; however, the Brighton Pediatric Early Warning Score (BPEWS) was the first PEWS published and is the scale translated and validated for the Brazilian context (BPEWS-Br)4. The authors of the BPEWS-Br also developed the Pediatric Early Warning Score (EPA, in Portuguese), adding temperature, diuresis, and other modifications4. However, although essential for oncology, we understand that diuresis can generate subjectivity during assessment and interfere with the patient’s score.
A study adapted the Bedside Pews scale for pediatric oncology in the Netherlands with the addition of temperature1. However, it is longer and requires a blood pressure cuff for each age group, which could make it unfeasible to use routinely in many centers. We couldn’t find any scales aimed at the child oncology population that covered the main adverse events, and considering the above, the BPEWS-Br scale turned out to be the most appropriate for this adaptation.
This study aimed to measure the degree of reliability of the construction of new items and the adaptation of the Brighton Paediatric Early Warning Score (BPEWS-Br) for Pediatric oncology.
METHOD
This is a two-stage methodological study. The present study reports on the first phase, in which the items applied to oncology children admitted to pediatric units were developed and validated by expert judges regarding adapting the BPEWS-Br scale, which aims to detect early clinical deterioration during hospitalization for cancer treatment.
Data was collected from May 1 to September 13, 2022, by sending a form via email or the multiplatform messaging application WhatsApp® using the Google Forms® link. When accessing the form, the first page contained the Free and Informed Consent Form, which the participant could only continue with if they accepted.
At this stage, the judges individually analyzed the BPEWS-Br scale and the new proposal, including items constructed specifically for the clinical deterioration of hospitalized cancer children. They assigned a degree of importance from 0 (not important) to 10 (totally important) to one decimal place after the comma. The reliability of the inter-judge agreement was measured by the Intraclass Correlation Coefficient (ICC).
The inclusion criteria were meticulously designed to ensure the participation of professionals with a degree in nursing or medicine and at least one year’s experience with children with cancer, either in hospital clinical practice or in teaching and research. To reach the desired number of professionals, the number suggested by Gwet5 was adopted, which would be at least 35 subjects selected randomly from a larger population of subjects with similar characteristics when the bilateral randomization method is recommended.
The aim was to choose a profile of judges representative of the field of care work so that the data from the study could be generalized and applied to the care of children with cancer. 83 professionals (doctors and nurses) from Brazil were randomly invited5 after consulting their Lattes curriculum vitae. Of these, 37 participated in the study and thoroughly answered the adapted BPEWS-Br scale for Pediatric oncology.
This scale was developed based on the original scale translated and adapted for use in Brazil, the BPEWS-Br, as well as the scientific evidence from the literature on pediatric oncology and the main emergencies that affect this population2,6-7, especially while they are undergoing treatment or monitoring the disease during hospitalization.
Items for hematological evaluation and “complementary states” were included. The presence of mucositis was added to the scale based on the mucositis scale proposed by the World Health Organization (WHO) at the time of the nurse’s evaluation8 (Chart 1).
Brighton Pediatric Early Warning Score (BPEWS-Br) for Pediatric oncology adapted9. Londrina, PR, Brazil, 2022
The survey form for the experts consisted of three parts: sociodemographic characterization (age, length of training, length of time working at the institution, length of time working at the institution and profession); the adapted BPEWS-Br scale for Pediatric oncology (Figure 1); and the question in which the judge scored (from zero to 10) the importance of the scale for assisting children with cancer during hospitalization, as well as an open question for them to add comments to improve the scale. It is worth noting that the original scale has a total score of 13 points. The new scale adapted for Pediatric oncology now scores 18 points.
The data were entered into Microsoft Excel® and analyzed using the Statistical Package for the Social Science, v.26 (SPSS)®. Reliability analysis was carried out using the ICC, with bilateral randomization, and the homogeneity of the judges’ judgments using Cronbach’s alpha to demonstrate equivalence between the judges/evaluators10. A minimum ICC value of ≥0.750 was considered adequate to attest to the reliability between the experts11.
The research project for this study was authorized by the research department of the study institution and approved by the Research Ethics Committee, opinion no. 4.562.827. It is worth noting that the authors’ authorization was previously obtained from BPEWS-Br in October 2020.
RESULTS
According to Table 1, of the five Brazilian regions, three had some professional taking part in the survey: the south with thirty (83.3%), followed by the southeast with five (13.9%), and the northeast with one (2.8%).
Of the experts, 30 were nurses (83.3%) and six were doctors (16.7%). The age ranged from 20 and 40 to 31 (86.1%) and fifteen (58.3%) had worked in pediatrics or Pediatric oncology for up to three years. All the doctors had a specialization/residency in oncology, while only half the nurses (15) reported having a specialization in the area (Table 1).
Sociodemographic characterization of the Brazilian experts participating in the study. Londrina, PR, Brazil, 2022
Clinical observations
Contributions scored by 19 experts refer mainly to cardiovascular and neurological assessment, temperature, and mucositis. About cardiovascular alterations, the caveat was skin pallor since children with cancer tend to be paler because of the pathology and the treatment, and this is not necessarily a clinical risk.
However, others pointed out that, although it is a common characteristic in children with cancer, it is an essential clinical sign to consider, even though it is a subjective alteration since it is related to the gaze of the person assessing it. As the original scale has already validated this item, keeping it in the scale adapted for pediatric oncology was essential.
As for the neurological state, the observation was in the item drowsiness/hypoactivity and irritability, with the suggestion to invert the score of both, considering that the former may represent greater severity than the latter and, therefore, could have a higher score. However, it is not an item exclusive to children with cancer and, as validated in the translation and cross-cultural adaptation of the original scale, the decision was to keep it.
The items “temperature” and “mucositis” scores were suggested to increase from 1 to 2 points, as these are essential alterations in children with cancer and can impact the early detection of clinical deterioration. As temperature is part of the hospitalized patient’s daily assessment and has well-defined parameters for alteration and normality, it was moved from a complementary state to a component in the leading score.
Another expert suggestion was to indicate on the scale whether the child is undergoing chemotherapy or in a period corresponding to NADIR12, which ranges from 7 to 14 days after the start of chemotherapy. Therefore, the experts’ suggestions were accepted for inclusion in the final version of the scale.
With regard to the clinical sign “persistent vomiting after surgery”, the expression “after surgery” was removed and replaced with “after chemotherapy”. The clinical sign “diarrhea” was added, as it is an alteration frequently present in children undergoing chemotherapy, as is “vomiting”. As a result, the final scale was configured as shown in Chart 2 below.
Adapted Brighton Pediatric Early Warning Score (BPEWS-Br) for pediatric oncology. Londrina, PR, Brazil, 2022
It should be noted that the version sent to the experts scored 18 points, and after suggestions, the final version of the BPEWS-Br scale adapted for pediatric oncology was changed to a score of 20 points.
As for the experts’ assessment (0 to 10) of the importance of the BPEWS-Br scale for pediatric oncology, with an emphasis on clinical practice in pediatric oncology units, an average of 9.36 was obtained.
Inter-judge reliability
The reliability test of the BPEWS-Br scale for pediatric oncology, which 37 experts answered, resulted in a reliability of 0.78. However, based on the analysis of the homogeneity of the judges10, it was possible to detect that expert E17 had a heterogeneous score compared to the others. When he was excluded from the analysis, the result changed to 0.82, with a lower limit of 0.71 and an upper limit of 0.91. Therefore, this study excluded E17, keeping the other 36 (Table 2).
DISCUSSION
Regarding the evaluation of the experts in this study and considering the interpretation standards for the use of the ICC, that an ICC >0.75 indicates good inter-judge reliability11, the results obtained after excluding one of the experts for a Cronbach’s Alpha score of 0.82 showed greater homogeneity in the inter-judge judgment regarding the inclusion of items in the scale for detecting clinical deterioration in hospitalized oncology children. Using Cronbach’s alpha score to assess the homogeneity of inter-judge judgment is characterized as a skillful and innovative strategy to complement this stage in validation studies10.
According to the results of this study, most of the experts belonged to the category of nurses, and some had no specific training in pediatric oncology. One study13 corroborates the findings of this study, in which most of the experts had no specialization in their field. On the contrary, doctors must hold a specialist qualification, as determined by the Federal Council of Medicine, for pediatric oncology training after specializing in pediatrics, clinical oncology, or hematology/chemotherapy14.
It is worth noting that nurses are trained to work more generally, focusing on humanistic, critical, and reflective guidelines based on scientific rigor, with the capacity for an intellectual and ethical outlook. Thus, on this basis, professionals often establish their work and care in oncology, even though it is challenginge15.
Although the medical team and other healthcare team members are essential in-patient care, nurses play a leading role in applying scales to the early detection of clinical deterioration in adults and children. They are professionals in full-time contact with patients, with adequate clinical judgment to reliably and assertively recognize the presence of signs and symptoms suggestive of clinical worsening16, which justifies the fact that most of the experts are nurses.
Regarding the theoretical relevance and practical application of the items included to assess children with cancer, bleeding stands out as one of the main oncological emergencies in pediatrics. It is mainly related to the effects of chemotherapy on the bone medulla, with a decrease in platelet production. Its severity is characterized by mucosal bleeding/epistaxis and is due to thrombocytopenia, evidenced in laboratory tests by a drop in the platelet count17-18.
When considering the inclusion of temperature as a warning sign in hospitalized oncology children, we considered three critical issues that permeate the phases of chemotherapy treatment: NADIR, febrile neutropenia, and sepsis. NADIR is the period that comprises the phase with the lowest hematological count and, therefore, with the most excellent chance of infections by various types of microorganisms and opportunistic diseases, which makes this the phase with the most amazing chance of severe clinical deterioration in children with cancer undergoing treatment. This period usually occurs between the 7th and 14th day after chemotherapy infusion and requires constant care and monitoring12.
Febrile neutropenia is one of the main concerns in children with cancer, especially during the period between chemotherapy infusions, which is often linked to the NADIR period. Children diagnosed with lymphomas and leukemias are more likely to develop febrile neutropenia than children with solid tumors due to the more aggressive chemotherapy treatment19.
This alteration refers to a low neutrophil count, which are the defense cells, added to the presence of hyperthermia, which leads to an imminent risk of infections and requires the immediate administration of antibiotics because, if not detected and treated early, it can become a severe clinical condition and potentially fatal, thus characterizing it as one of the main oncological emergencies in pediatrics19-20.
To characterize the diagnosis of febrile neutropenia, neutrophil values of less than 500µL or less than 1000µL with a predicted drop in 48 hours are considered, in addition to the presence of fever. Although some studies consider neutropenia fever when the axillary temperature is equal to or greater than 38°C, for the present study, fever was considered when values were equal to or greater than 37.8°C, as recommended by the Brazilian Society of Pediatrics19,21. However, some patients may present in hypothermia and, therefore, any sign of clinical deterioration in the presence of neutropenia should be considered for treatment, even if empirical, to avoid a poor prognosis19.
Fever is also frequently related to Systemic Inflammatory Response Syndrome (SIRS), which can occur precisely because of the low immune response in neutropenia. If it is not possible to quantify leukocytes, in addition to temperature changes, heart or respiratory rate variations outside the normal range for each age group should be considered22. In addition, the new Phoenix sepsis criteria include four organ dysfunctions (respiratory, cardiovascular, coagulation, and neurological). The SIRS criteria were not included but continue to have value in clinical practice for assessing the presence of infection23.
Many patients (around 80%) experience some episode of fever while they are suffering from neutropenia, and even after starting antibiotic treatment, around 10% can still die. Furthermore, the longer a child remains in febrile neutropenia, the greater the risk of clinical worsening and worsening of the condition. For this reason, early detection and intervention can help ensure a faster and more effective recovery24.
Another critical alteration, mucositis, is one of the most common oral manifestations in patients undergoing chemotherapy or radiotherapy, and the younger the child, the greater the chances of developing it in the severe form induced by chemotherapy22. Its presence can be a determining factor for interrupting treatment, which implies a risk of disease progression with the advance of cancer cell proliferation and a worsening prognosis. In addition, severe mucositis results in limited food and fluid intake, which leads to malnutrition and dehydration, as well as the risk of bacteremia and sepsis, mainly when associated with neutropenia, since it can affect the oral mucosa and the entire gastrointestinal tract, with the risk of death25.
To evaluate and monitor mucositis, the World Health Organization (WHO) has developed an instrument that evaluates severity based on the signs of the lesion and the ability to swallow water and food. It is divided into grades I, II, III, and IV, with grades III and IV considered severe mucositis8.
Vomiting and diarrhea are common adverse reactions in chemotherapy treatment; however, even if they are expected, they can have a direct impact on the child’s clinical condition and treatment, resulting in dehydration, malnutrition, and treatment interruption if there is no monitoring and early intervention7,26. For evaluation purposes, persistent vomiting or diarrhea, that is, more than three episodes a day, is considered to be critical for the child’s clinical deterioration9,27.
The study’s limitations were the low number of pediatric medical professionals with experience in caring for children with cancer and experts working exclusively in the field of pediatric oncology, making it necessary to expand to pediatric areas that had experience or work in oncology.
CONCLUSION
The study indicated good inter-judge reliability when new elements were added to the scale, allowing us to infer that the new tool will be a good resource for the care team, especially nurses, to identify early warning signs of clinical deterioration in children with cancer, thus minimizing late actions and unfavorable outcomes.
In addition, the method of selecting the judges applied to the study, how it was analyzed, and the profile of the participating judges conferred the degree of generalization of the tool to the national territory. From then on, the BPEWS-Br scale, adapted to detect clinical deterioration in children affected by cancer, proved valid for use in hospital units and was renamed BPEWS-Br for pediatric oncology.
After reliability testing, the scale developed and validated by experts is recommended to be applied to a sample of the target audience to guarantee its applicability and effectiveness in clinical practice so that it can be instituted as a scale for detecting early clinical deterioration in children with cancer in hospital units.
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HOW TO REFERENCE THIS ARTICLE:Soares NTI, Soares MH, Pimenta RA. Clinical deterioration of the oncology child: reliability of a new tool adapted from the Brighton Pediatric Early Warning Score. Cogitare Enferm. [Internet]. 2024 [cited “insert year, month and day”]; 29. Available from: https://doi.org/10.1590/ce.v29i0.97256.
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Article extracted from the doctoral thesis “EVIDÊNCIA DE CONFIABILIDADE INTERJUIZES DE NOVA FERRAMENTA ADAPTADA DA BRIGHTON PEDIATRIC EARLY WARNING SCORE PARA ONCOLOGIA PEDIÁTRICA NO BRASIL”, Universidade Estadual de Londrina, Centro de Ciências da Saúde, Programa de Pós-Graduação em Enfermagem, Londrina, Paraná, Brasil, 2024.
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21 Sociedade Brasileira de Pediatria (SBP). Manejo da febre aguda. Documento científico. Departamento Científico de Pediatria Ambulatorial e Infectologia [Internet]. 2021 [cited 2022 Feb. 10]. 14p. Available from: https://www.sbp.com.br/fileadmin/user_upload/23229c-DC_Manejo_da_febre_aguda.pdf
» https://www.sbp.com.br/fileadmin/user_upload/23229c-DC_Manejo_da_febre_aguda.pdf -
22 Instituto Latino Americano de Sepse (ILAS). Survival from sepsis pediatric clinical protocol. Care for pediatric patients with sepsis, severe sepsis and septic shock [Internet]. 2019. [cited 2021 June 10]. Available from: https://ilas.org.br/wp-content/uploads/2022/02/protocolo-de-tratamento-pediatria.pdf
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23 Schlapbach LJ, Watson RS, Source LR, Argent AC, Menon K, Hall MW, et al International consensus criteria for pediatric sepsis and septic shock. JAMA. [Internet]. 2024 [cited 2024 Jan. 30]; 331(8):665-74. Available from: http://dx.doi.org/10.1001/jama.2024.0179
» http://dx.doi.org/10.1001/jama.2024.0179 -
24 Sociedade Brasileira de Pediatria (SBP). Diretrizes para o manejo inicial da neutropenia febril, após quimioterapia, em crianças e adolescentes com câncer. Diretrizes. Departamento Cientifico de Oncologia [Internet]. 2018 [cited 2023 Feb. 12]; 2. Available from: https://www.sbp.com.br/fileadmin/user_upload/Oncologia_-_20942d-Diretrizes_manejo_inicial_neutropenia_febril_pos_quimio__003_.pdf
» https://www.sbp.com.br/fileadmin/user_upload/Oncologia_-_20942d-Diretrizes_manejo_inicial_neutropenia_febril_pos_quimio__003_.pdf -
25 Damascena LCL, Lucena NNN de, Ribeiro ILA, Pereira TL, Lima-Filho LMA, Valença AMG. Severe oral mucositis in pediatric cancer patients: survival analysis and predictive factors. Int J Environ Res Public Health. [Internet]. 2020 [cited 2023 June 10]; 14;17(4):1235. Available from: http://dx.doi.org/10.3390/ijerph17041235
» http://dx.doi.org/10.3390/ijerph17041235 -
26 Lima EC, Fernandes TB, Land MGP, Gonzalez C, Thorbinson C, Bains C, et al The utility of the Liverpool Adverse Drug Reaction Assessment Tools in the evaluation of chemotherapy-induced náusea and vomiting in children. Rev Bras Cancerol. [Internet]. 2023 [cited 2023 Jan. 15]; 69(3):e-133986. Available from: https://doi.org/10.32635/2176-9745.RBC.2023v69n3.3986
» https://doi.org/10.32635/2176-9745.RBC.2023v69n3.3986 -
27 Sociedade Brasileira de Pediatria (SBP). Diarreia aguda infecciosa. Guia prático de atualização. Departamento Cientifico de Gastroenterologia [Internet]. 2023. [cited 2024 Aug. 21]. 72. Available from: https://www.sbp.com.br/fileadmin/user_upload/sbp/2023/junho/14/24048aPRESS-GPA-Diarreia_Aguda_Infecciosa-pSITE.pdf
» https://www.sbp.com.br/fileadmin/user_upload/sbp/2023/junho/14/24048aPRESS-GPA-Diarreia_Aguda_Infecciosa-pSITE.pdf
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Associate editor:
Dra. Claudia Palombo
