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. 2015 Nov 25;2015(11):CD010576. doi: 10.1002/14651858.CD010576.pub2

Muller 2001.

Methods Type of study: randomised controlled clinical trial
Allocation: 1:1
Intervention model: parallel group superiority design
Masking: no blinding of patients or personnel
Primary purpose: treatment of Graves' disease
Participants Condition: Graves' disease
Enrolment: 152 in total
Inclusion criteria:
1. Diagnosis of Graves disease
2. Completed six years follow‐up
3. Euthyroidism at time of operation
Exclusion criteria: not specified
Diagnostic criteria: hyperthyroidism with endocrine ophthalmopathy or TSH‐R antibodies and characteristics of Graves' disease on ultrasound scan
Interventions Number of study centres: 1
Treatment before study: preoperative treatment with antithyroid medications if hyperthyroid
Titration period: none
Intervention(s):
1. Bilateral subtotal thyroidectomy with 3 mL of remaining tissue
Comparator(s):
2. Ipsilateral lobectomy and contralateral subtotal resection with 3 mL thyroid remnant per side (6 mL total)
Outcomes Primary outcome(s):
1. Recurrent hyperthyroidism
Secondary outcome(s):
2. Permanent hypoparathyroidism
3. Recurrent laryngeal nerve palsy
4. Wound complications (seroma, infection, haematoma)
5. Progression of Graves' Ophthalmopathy
Other outcome(s): ‐
Study details Run‐in period: none
Study terminated before regular end (for benefit/because of adverse events): no
Study start date: 1988
Study completion date: 1992
Publication details Language of publication: English
Funding: not stated
Publication status: peer‐reviewed journal, full article
Stated aim for study In this prospective randomised study, the two methods (bilateral subtotal resection and the Dunhill operation) are evaluated with respect to their operative and postoperative complications and their long term results [in treatment of Grave's disease]
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: "We examined 152 patients... in a prospective randomised study"
Comment: the study is prospectively randomised although randomisation techniques not described
Allocation concealment (selection bias) Unclear risk Comment: not clearly stated whether allocation concealment took place
Blinding of participants and personnel (performance bias) 
 Objective outcomes High risk Quote from publication: "The surgeons were specialised surgeons or were directly supervised by specialised surgeons"
Comment: not stated whether surgeons were blinded to group allocation
Blinding of participants and personnel (performance bias) 
 Subjective outcomes High risk Comment: not stated whether patients were blinded to group allocation
Blinding of outcome assessment (detection bias) 
 Objective outcomes Unclear risk Quote from publication: "Following surgery, patients were started on a thyroxine replacement regimen with iodine and levothyroxine, and the regimen was later adjusted according to their free T3, T4 and TSH levels. All patients had a repeat ... measurement of their plasma calcium"
Comment: evaluation of TRAb, thyroid function and calcium: laboratory standard tests
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk Quote form publication: "the 6 year follow up period ended with a questionnaire sent to the physician currently treating the patient"
Comment: unclear whether physician completing follow‐up questionnaire was blinded to intervention; not clear who assessed eye involvement
Incomplete outcome data (attrition bias) 
 Objective outcomes High risk Quote from publication: "after 6 years, 99 patients returned the questionnaire"
Comment: outcomes only reported in 99/152 (63%) participants
Incomplete outcome data (attrition bias) 
 Subjective outcomes High risk Quote from publication: "after 6 years, 99 patients returned the questionnaire"
Comment: outcomes only reported in 99/152 (63%) participants
Selective reporting (reporting bias) Low risk Comment: outcomes reported appear to be standard for studies addressing this type of question
Other bias Low risk Comment: no other risk of bias detected