Alho 2007.
Methods | Allocation: randomised ‐ replacement randomisation Design: parallel groups, average follow‐up about 6 months | |
Participants |
Number: 70 adults out of 298 screened
Age: 15 years and above
Setting: ENT Department of the University of Oulu Hospital (Finland)
Eligibility criteria:
Exclusion criteria:
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Interventions |
Intervention group: tonsillectomy (total extracapsular tonsillectomy using blunt or diathermy dissection); n = 36 Comparator group: watchful waiting (remaining on waiting list); n = 34 Use of additional interventions: participants in the control group did not receive prophylactic treatment for their tonsillitis. No information was provided on any standardised treatment strategy in case of tonsillitis recurrence during follow‐up |
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Outcomes |
Primary outcome: Proportion of patients with an acute episode of group A streptococcal pharyngitis during the 90 days' follow‐up, as determined by signs and symptoms of acute pharyngitis with a positive result of throat culture Secondary outcomes:
The mean length of follow‐up was 164 (SD 63) in the control group and 170 (SD 12) in the tonsillectomy group Patients recorded episodes and days with symptoms in diaries All participants were advised to visit their own general practitioner if they had acute symptoms suggestive of pharyngitis. The general practitioner would then take a culture sample from the pharynx and send it to Oulu University Hospital for analysis. Patients were given written instructions for their general practitioner about the study and how to obtain the culture sample (from surface of both tonsils or tonsillar fossae in patients who had undergone tonsillectomy and the posterior pharyngeal wall). The patients were told that it was important to seek medical advice for their symptoms during the trial in exactly the same way they had done before the trial and that it was possible to have streptococcal pharyngitis after tonsillectomy |
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Funding sources | None declared | |
Declarations of interest | None declared | |
Notes | Baseline characteristics were balanced | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quotes: "generated the randomisation sequence with a computer random number generator". "To avoid disparity between group sizes, we used replacement randomisation" |
Allocation concealment (selection bias) | Low risk | Quotes: "... concealed from the investigators who enrolled the participants ... sequentially numbered sealed opaque envelopes. These were opened sequentially only after an eligible participant had been found and informed consent obtained..." "This task was performed by research assistant not involved in the assignment of care to the trial participants" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. No information about standardised treatment for sore throats during follow‐up |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. Outcomes were patient‐reported (subjective) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up at 90 days. Patients analysed according to group randomised |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit a judgement of low or high risk |
Other bias | Low risk | No other important sources of bias were found Proportion of patients who did not receive assigned treatment:
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