Cunarro‐Lopez 2020.
Study characteristics | |||
Patient Sampling |
Purpose: diagnosis of SARS‐CoV‐2 infection (mild COVID‐19 disease); to examine maternal‐perinatal outcomes in pregnant women with suspected COVID‐19 according to the result of a RT‐PCR test and to investigate possible variables that could be useful for predicting a negative RT‐PCR result Design: cross‐sectional cohort study, retrospective data collection Recruitment: obstetrics patient (pregnant, in labour or puerperium) with suspected COVID‐19 who attended the hospital Sample size: n = 111 (68 cases) Inclusion criteria: all obstetrics patients (pregnant, in labour or puerperium) with suspected COVID‐19 who attended the hospital Exclusion criteria: non‐conclusive RT‐PCR result, those patients who did not undergo obstetric follow‐up in the hospital and asymptomatic patients with SARS‐CoV‐2 infections |
||
Patient characteristics and setting |
Facility cases: RT‐PCR positive for SARS‐CoV‐2 Facility controls: RT‐PCR negative for SARS‐CoV‐2 Country: Spain Dates: 10 March 2020‐12 May 2020 Symptoms and severity
Demographics: mean age cases 34 years, controls 32 years M%/F%: cases 0.0/100.0, controls 40.0/100.0 Exposure history: not specified |
||
Index tests |
|
||
Target condition and reference standard(s) |
|
||
Flow and timing | Timing of RS not specified | ||
Comparative | |||
Notes | Funding: by University of Alcalá (COVID‐19 UAH 2019/00003/016/001/023) and by (FIS‐PI18/00912) the Instituto de Salud Carlos III (Plan Estatal de I + D+I 2013‐2016) and co financed by the European Development Regional Fund | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | No | ||
Did the study avoid inappropriate inclusions? | Yes | ||
Could the selection of patients have introduced bias? | High risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
DOMAIN 2: Index Test (All tests) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | No | ||
Could the conduct or interpretation of the index test have introduced bias? | High risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Unclear risk |