Koskenkorva 2013.
Methods | Allocation: randomised ‐ simple randomisation Design: parallel groups, average follow‐up about 6 months | |
Participants |
Number: 86 adults out of 260 screened
Age: 13 years and above
Setting: tertiary care ENT centre in Oulu (Finland)
Eligibility criteria:
Exclusion criteria:
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Interventions |
Intervention group: tonsillectomy (total extracapsular tonsillectomy using blunt or diathermy dissection); n = 46 (45 patients underwent tonsillectomy and 1 patient underwent adenotonsillectomy) Comparator group: watchful waiting (placement on waiting list for tonsillectomy to undergo surgery after 5 to 6 months); n = 40 Use of additional interventions: no information was provided on a standardised treatment strategy in cases where there was an acute sore throat/pharyngitis recurrence during follow‐up |
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Outcomes |
Primary outcome:
Secondary outcomes:
The patients used a symptom diary to record the presence and severity (mild, moderate or severe) of throat pain, cough, rhinitis, fever and absence from school or work. Data concerning acute visits and tonsillectomy were recorded from patients' charts Patients were advised to visit the study physician or their general practitioner whenever they had acute symptoms suggestive of pharyngitis. In addition, they were told that it was important to seek medical advice for their symptoms during the trial exactly as they had done before. At the acute visit, patients underwent a clinical examination including a throat swab and a blood test to measure serum levels of C‐reactive protein. The blood test was repeated 3 days later. All laboratory and microbiological analyses were performed by staff blinded to the clinical data |
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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 | Quote: "We assigned patients ... using simple randomisation" |
Allocation concealment (selection bias) | Low risk | Quote: "The allocation sequence was concealed from the investigators using sequentially numbered sealed opaque envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. No additional information about management of sore throats |
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 losses to follow‐up 2 patients, 1 in each group, lost their symptom diaries but reported not having consulted a physician for throat pain. These patients were assumed to have no symptoms during the study period |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit a judgement of low or high risk |
Other bias | Low risk | No other sources of bias were found Proportion of patients who did not receive assigned treatment:
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