Stafford 1986.
Methods | Allocation: randomised Design: prospective, parallel | |
Participants |
Number: 40
Age: range 16 to 42 years
Setting: ENT outpatient department of tertiary centre in London. Patients were referred by general practitioners Male/female: 3/17 in surgery group, 6/14 in antibiotic group Average number of tonsillitis episodes per year: 6 in tonsillectomy, 5 in antibiotics group Eligibility criteria:
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Interventions |
Intervention group: tonsillectomy; n = 20 Comparator group: antibiotics, n = 20 Penicillin V 250 mg, 4 times per day for 8 days for each episode of tonsillitis for the following year Patients with penicillin allergy are given either co‐trimoxazole "2 tablets" 2 times daily or erythromycin 250 mg 4 times per day Use of additional interventions: none described |
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Outcomes | Time point of measure unclear, most likely between 18 months to 2 years
Patients in the surgery group were reviewed at 6, 12 and 18 months postoperatively Patients in the antibiotics group were reviewed every 3 months in outpatients. GPs were sent questionnaires to complete and return each time a patient was seen and prescribed an antibiotic for tonsillitis |
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Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly allocated" No description of allocation concealment method |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment method |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. Patients, investigators and general practitioners in charge of follow‐up of both groups were aware of treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no blinding. Outcomes were patient‐reported (whether patients "felt cured" of symptoms) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients analysed |
Selective reporting (reporting bias) | Unclear risk | No access to protocol. Insufficient information to judge |
Other bias | High risk | Follow‐up frequency and setting were different between groups. Method of eliciting results most likely different. 6/20 patients in the control arm had received tonsillectomy within 2 years |