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 |