Mayes 2001a.
Study characteristics | |||
Patient sampling | Cross‐sectional study
Retrospective design
Sample: unclear
Direct comparison of different RADTs: no
Direct comparison of several throat culture techniques: no
Person performing the throat sample: not reported Exclusion if recent antibiotics use before inclusion: no Clinical selection of patients: implicit criteria (RADTs were not used for all patients presenting with pharyngitis; different physicians used varying individual criteria to determine whether or not to use the RADT or throat culture as the primary diagnostic test) Presenting signs and symptoms: unclear Age range for inclusion: not reported |
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Patient characteristics and setting | Sample size: total 4847
Age (distribution): not reported GAS prevalence according to culture (with 95% confidence interval): 28.8% (assuming all RADT positive results are true positives; 95CI not reported) Country of study: USA Sex (% of girls): 45% Clinical severity assessment: none Clinical setting: office‐based (laboratory records of the Elmwood Pediatric Group) Single‐centre study |
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Index tests | Throat swab: 2 different swabs (1 swab for performing the RADT, 1 swab for culture) Commercial name of the RADT: Qtest (Becton Dickinson) Type of RADT: EIA (liposomal test) |
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Target condition and reference standard(s) | Throat culture medium: not reported Atmosphere of incubation: not reported Duration of incubation: not reported GAS confirmation: not reported Number of plates inoculated: not reported Assessment of GAS antibody response: no Relevant details: throat culture technique not described | ||
Flow and timing | No follow‐up | ||
Comparative | |||
Type of study | Journal article | ||
Notes | We sub‐divided the study into 2 time periods (Mayes 2001a and Mayes 2001b) to take into account the fact that different criteria were used to determine whether or not a RADT should be performed, and because different RADTs were used during those 2 time periods. Funded in part by an academic grant (Strong Children's Research Center, Summer Student Scholar Program, University of Rochester). Throat culture performed only for children with negative RADT results (partial verification). | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | No | ||
Was it a cross‐sectional study or a RCT? | Yes | ||
Were selection criteria clearly described (at least presenting signs and symptoms and age limits for inclusion)? | No | ||
Was clinical selection of patients avoided? | No | ||
Were patients seen in an ambulatory care setting? | Yes | ||
High | High | ||
DOMAIN 2: Index Test All tests | |||
Were the RADT results interpreted with blinding of the results of culture? | Yes | ||
Was the type of the RADT mentioned (EIA or OIA)? | Yes | ||
Were RADTs conducted during consultation time? | Yes | ||
Low | Low | ||
DOMAIN 3: Reference Standard | |||
Were culture results interpreted with blinding of the results of the RADT? | Unclear | ||
Is the throat culture method likely to correctly identify GAS (laboratory culture on a blood agar plate during 48 hr)? | Unclear | ||
Were the culture medium, atmosphere, duration of incubation and GAS‐confirmation technique described? | No | ||
High | High | ||
DOMAIN 4: Flow and Timing | |||
Was the delay between the performance of the RADT and throat culture plating less than 48 hours? | Unclear | ||
Did all patients receive a throat culture? | No | ||
Did patients receive the same throat culture method? | Unclear | ||
Were undetermined/uninterpretable results reported? | No | ||
Were withdrawals from the study explained? | Yes | ||
High |