Screening intervention
Conditions
Interventions
In the CEP substantiated opinion number 5,282,299, the study begins with the objective of making an understandable exploration of 50 participants hospitalized with the diagnosis of COVID-19. This is a
Sponsors
GlucoScan Whatch
Universidade Estadual de Maringá
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged 18 or over; both genders; non pregnant
Exclusion criteria
Exclusion criteria: Worsening of the disease; ICU admission, intubation or any other factor that may occur; pregnant women; death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Thus, considering a margin of error of approximately 5%, a significance level of 95%, which implies a z-score of 1.96. The sample size sufficient to determine an accuracy (proportion p) of 90%, which was obtained in the pre-clinical stage of the study, the calculated N was 103, the result also being in agreement with the study by A`Hern (2001). ), which presents tables for the minimum size for trials in this phase, based on the exact binomial distribution, instead of approximations by the normal, considering a confidence level of 95% and power of 90%;Outcome found 1: All recommended criteria were maintained, from sample size calculation to data analysis, it can be verified that the results reached the desired effectiveness for a screening test. The consistency of the results can be verified throughout the development of the study, due to its precision and accuracy, as well as confidence intervals and hypothesis tests to verify the statistical significance of the accuracy obtained, which remained above 92% in all study days. It can be observed that the sensitivity, precision and PPV were always above 94%, with specificity above 90% on most days, while the NPV was between 80 and 90% during all days, which is quite adequate for a screening test | — |
Secondary
| Measure | Time frame |
|---|---|
| Were not observed | — |
Countries
Brazil
Contacts
Public ContactJoão Sedovski
GlucoScan Whatch
Outcome results
None listed