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Epidemiologia Clinica Fletcher Pdf 13


Epidemiologia Clinica Fletcher Pdf 13

Considering this scenario, since 2005, discussions in the literature regarding the needto develop instruments capable of indicating early the risk of clinical deterioration inhospitalized children have been expanded, considering that these tools already exist inthe hospital spaces for adult patients, known as Early Warning Scores (EWS)6-9.

The BPEWS has been translated and adapted to the Brazilian context (BPEWS-Br)13, however, its accuracy in identifying signs of clinical deterioration inhospitalized children has not been tested, which makes it difficult to adopt it in theclinical practice, since validity is an essential property for the use of healthmeasurement instruments.

In studies that validate pediatric early warning scores, certain authors havereported difficulty in establishing a reference standard for clinical deteriorationin children8,10,17. Some of these have used the call for the Rapid Response Team (RRT)11, while others have adopted the transfer to the Intensive Care Unit (ICU),however, they recommended that more standards should be tested10,18.

The sample consisted of 271 children from 0 to 10 years of age, hospitalized betweenMay and October 2015, in these units (108 children in clinical medical, 54 inclinical surgery, 30 in nephrology, 65 in observation and 14 in stabilization). Dueto the absence of national data on the prevalence of clinical deterioration inhospitalized children, the sample calculation was performed by applying a pilot testwith 30 children, for verification, using the reference standard adopted. Theestimated value of the expected proportion of children with clinical deteriorationused in the sample calculation was 20%.

A pediatrician was trained in the application of the reference standard and apediatric nurse was trained in the application of the BPEWS-Br. For the theoreticaltraining, an operational manual constructed to guide the measurement of clinicalindicators was read and discussed. For the practical training, sessions wereperformed with videos and clinical cases. After this phase, the pilot test wasapplied with 30 children.

For the qualitative variables, simple, absolute and relative frequencies werecalculated. In order to test the validity of the BPEWS-Br, compared to the referencestandard, the prevalence of clinical deterioration estimated by the referencestandard and by the test, the sensitivity, the specificity, the Receiver OperatingCharacteristic Curve (ROC curve) and the area under the ROC curve, the PositivePredictive Value (PPV), the Negative Predictive Value (NPV), the Positive LikelihoodRatio (LR+), the Negative Likelihood Ratio (LR-) and post-test probability werecalculated21.

Some important aspects of the studies that sought to validate the BPEWS in its original,adapted or modified versions need to be analyzed, discussed and compared with data fromthe present study, such as the various indicators/reference standards for clinicaldeterioration in children, the cut-off points that indicate the event of deterioration,the validity indicators calculated for the score, the scenarios, the samples and the agegroups of the children to whom the score was applied.

Among others, the following reference standards for identification of clinicaldeterioration have been used to verify the validity of the BPEWS, transfer to theICU10,12,18,22-23; call for the RRT; Code Blue - CB (called before cardiorespiratory arrest)11; and admission into the hospital22,24. In this study, none of these standards were used, choosing instead a set ofcriteria based on the Primary Clinical Evaluation of the Severely Ill Child guided bythe AHA and AAP19.

The above criteria were followed in order to verify the validity of the BPEWS-Brregarding its actual aim, which is to assist the health team in the early recognition ofpediatric clinical deterioration, to provide immediate assistance and to avoidcomplications arising from late perceived deterioration. This is because, in situationsof transfer to the ICU, call for the RRT or CB, the child is likely to be more severe.Admission to the hospital may be motivated by certain situations other than clinicaldeterioration - for example, for diagnostic investigation or use of medication for thetreatment of rare diseases.

Regarding the cut-off point of the BPEWS, in order to indicate clinical deterioration,some studies considered or found varied scores: 112,22, 212,18, 2,523, 310-11 e 411,24. The author of the BPEWS advised that a final score of 4 or a score of 3 in oneof the partial components should trigger the call for the RRT, characterizing theclinical deterioration event. However, this behavior could be adapted according to eachscenario6.

Thus, the PEWS were not constructed as indicators of emergency situations or ofadmission to the ICU or the hospital, which imposes certain limits on their use. It isimportant to note that, depending on the reference standard and cut-off points of theBPEWS, the prevalence of clinical deterioration, as well as performance indicators ofthe score, may vary and influence the study results.

Regarding the study scenarios, the BPEWS was conceived as an warning instrument forchildren hospitalized on wards6, where urgency and emergency situations are not part of the daily routine of thehealth team. Therefore, this is a score that can contribute as a support instrument forthese teams in the recognition of the clinical severity of the patient. Thus, themajority of the study scenarios for validation of the BPEWS were performed on wards10-11,18,23, however, some authors also applied the score in the emergency unit, uponarrival of the patients12,22,24.

For this study, the scenarios used were the clinical-surgical wards and emergencyobservation/stabilization units, where the patients would already be hospitalized. Theemergency units were included as they are places where clinical deterioration is morecommon when compared to the wards, since, in diagnostic test studies, the spectrum ofpatients evaluated should be considered, in order to be representative of those who willuse the test in the practice14.

Regarding the samples studied and the age groups of the children, this study clinicallyevaluated 271 children from 0 to 10 years of age, trying to standardize the entireevaluation, in order to avoid measurement bias and data loss. Large samples were used inthe studies that validated the BPEWS10,12,18,22, which may have generated inconsistency in the data collected due to thedifficulty of standardization in the evaluations of the patients.

Coagulation factors are expensive pharmaceutical products. In Brazil they are acquired directly by the Ministry of Health, and in 2019 alone, the federal government made available BRL 1.3 billion for the purchase of medicines for the treatment of hereditary hemorrhagic diseases for the Public Health System (SUS - Sistema Único de Saúde).(7)The costs of a medicine depend on several factors, such as the technology used in the development and production process, as well as its proven efficacy and magnitude of benefits found in phase III clinical trials. Thus, through the evaluation of all documentation made available by pharmaceutical companies to request a medicine registration, regulatory agencies assess whether this new product is effective and safe, and whether the cost-benefit ratio is positive, as it is necessary to rationalize the health system resources.(8,9)

The gold standard design for measuring intervention effects is the Randomized Clinical Trial, since this research design has strict methodological criteria, and parameters that allow controlling the influence of various factors on the investigated outcome.(13) However, it is important to highlight that non-randomized, uncontrolled clinical studies, with no blinding, and other systematic errors have increased and are being used as a technical scientific basis for the approval of new treatments.(14) These methodological flaws, which are called biases, may overestimate the benefits of the tested intervention, which can compromise the reliable analysis of the results and give the industries margins to increase the costs of these products.(15,16)

Individual analysis of the methodological quality of eligible clinical trials was performed using the Cochrane Collaboration 5.1.0 risk and bias tool. This tool consists of seven domains: - random sequence generation; - allocation concealment; - blinding of participants and professionals; - blinding of outcome evaluators; - incomplete outcomes; - selective outcome reporting; and - other sources of bias - for this domain, the conflict of interest in the analyzed studies was evaluated.(19,20)

Most studies analyzed did not control for performance bias and detection bias. It is important to emphasize that blinding is only possible in studies with Control Groups, as the results of outcomes assessed in single-arm studies are only those of the applied intervention.(36) Of the five studies that used Control Groups, only two were with blinded outcome evaluators, and three with blinded participants and professionals. According to Buehler et al.,(34) and Kamper(37) it is not always possible to apply blinding, possibly because it is difficult to perform blinding in studies that assess the efficacy and safety of coagulation factors for the treatment of hemophilia, as they are injectable preparations. On the other hand, some alternatives could have been used to overcome this barrier, like those used in the study by Sjamsoedin et al.,(25) such as coding interventions and using dark colored bottles and opaque syringes. The absence of blinding in clinical trials directly implies the estimation of the effect of the evaluated outcome. Schulz et al.(36) evaluated the impact of methodological quality on the effect estimate and showed that studies that were not double-blind produced effect estimates 17% higher than those that were double-blind. In this context, it is clear that once again, the results reported in the studies contained in the coagulation factors package inserts may not be as encouraging, as the reported effect estimates may also have been influenced by the performance and detection bias. 153554b96e

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