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. 2020 Jun 4;2020(6):CD012431. doi: 10.1002/14651858.CD012431.pub2

Maltezou 2008.

Study characteristics
Methods Clinical setting: offices of private‐practice paediatricians
Single‐ or multicentre study: multicentre
Country of study: Greece
Unit of allocation: clusters
Inclusion criteria: children aged 2 to 14 years with clinical evidence of pharyngitis including at least 1 of the following 4 criteria: fever (> 38.0 °C), tonsillar exudate, tender enlarged anterior cervical lymph nodes, and absence of cough.
Exclusion criteria: having received antibiotics within the previous week or being immunocompromised.
Follow‐up: 3 weeks after enrolment, paediatricians called their participants for follow‐up information (clinical course and complications, if any).
Participants Number of clusters (n): 17
Number of participants (n): 639
Participant characteristics:
  1. age (distribution): mean age in years (SD) 7.71 (3.17) in Group A and 6.86 (3.27) in Group B;

  2. female participants (%): 51.8%;

  3. clinical severity distribution of Centor/McIsaac score: not reported.

Interventions Management in intervention group(s): RADT alone (“Application of the RADT in children with at least one clinical criterion and prescription of antibiotics only if positive; throat culture was also taken and if positive, but RADT‐negative, prescription of antibiotics was done 48 h later” (Group B)).
Type of RADT system used: enzyme immunoassay
Commercial name and brand of the RADT: Link 2 Strep A Rapid Test (Becton‐Dickinson)
Management in control group(s): clinical grounds without a scoring system ("Decision to prescribe antibiotics by clinical criteria only" ("Group A")).
Outcomes
  1. Prevalence of laboratory‐diagnosed streptococcal pharyngitis

  2. Sensitivity, specificity, and positive and negative predictive values of the RADT using culture as the reference method

  3. Performance of the RADT in association with the number of clinical criteria

  4. Impact of the RADT on antibiotic prescription

Notes Type of report: journal article
Source(s) of funding: funded by The Hellenic Center for Disease Control and Prevention (Athens, Greece)
RCT registration number: not reported
“Group C” was excluded because paediatricians in this group managed children using the RADT/culture strategy without being randomised.
We contacted the trial authors to confirm that this was a cluster‐RCT and that paediatricians in Group A were not invited to prescribe antibiotics based on clinical criteria (although they had to collect Centor criteria for the study).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk From correspondence with the trial authors, the following information was provided: "it was a cluster randomized trial, with private‐practice pediatricians being randomized to strategy A or B (whereas hospital‐affiliated pediatricians were all assigned to strategy C)". Thus, not all were randomised.
Allocation concealment (selection bias) Unclear risk No description exists of any concealment of allocation.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding is impossible in this context, and this lack of blinding is likely to influence the outcome.
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding is impossible in this context, and this lack of blinding is likely to influence the outcome.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk There are unexplained inconsistencies, e.g. between the percentages mentioned in Table 3 and the actual percentage when dividing the number of prescriptions with the participants in each group. There is no mentioning of handling, or existence, of incomplete outcome data.
Selective reporting (reporting bias) Low risk All outcomes mentioned in the Methods section are presented in the Results section. There is no protocol to be used for comparison regarding outcomes mentioned.
Other bias Low risk None