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). |
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Participants |
Number of clusters (n): 17 Number of participants (n): 639 Participant characteristics:
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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")). |
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Outcomes |
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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). |
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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 |