Barczynski 2012.
| Methods |
Type of study: randomised controlled clinical trial Allocation: 1:1 Intervention model: parallel group superiority design Masking: single‐blinded for participants Primary purpose: treatment of Graves' disease |
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| Participants |
Condition: Graves' disease Enrolment: 200 in total Inclusion criteria: patients diagnosed with Graves’ disease and mild active ophthalmopathy undergoing surgical treatment Exclusion criteria: previous thyroid or parathyroid surgery, recurrent hyperthyroidism after radioiodine ablation, a history of Graves’ disease of more than 24 months, thyroid nodules within the posterior aspect(s) of the thyroid lobe(s), suspicion of thyroid cancer, preoperative recurrent laryngeal nerve palsy, pregnancy or lactation, age below 18 years, American Society of Anesthesiologists fitness grade IV, and inability to comply with the follow‐up protocol Diagnostic criteria: clinical features of Graves' disease and TFT supportive of the diagnosis |
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| Interventions |
Number of study centres: 1 Treatment before study: patients were rendered euthyroid with thiamazole Titration period: none Intervention(s): bilateral subtotal thyroidectomy Comparator(s): total thyroidectomy |
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| Outcomes |
Primary outcome(s): resolution of Graves ophthalmopathy; recurrence of hyperthyroidism Secondary outcome(s): temporary/permanent hypoparathyroidism; temporary/permanent RLN paresis Other outcome(s): ‐ |
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| Study details |
Run‐in period: none Study terminated before regular end (for benefit/because of adverse events): no Study start date: 2000 Study completion date: 2004 |
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| Publication details |
Language of publication: English Funding: non‐commercial funding Publication status: peer‐reviewed journal, full article |
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| Stated aim for study | "To evaluate long term results of bilateral subtotal thyroidectomy compared with total thyroidectomy in patients with Graves' disease and mild active ophthalmopathy" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "The randomisation sequence was generated by the computer. Sequencing was based on permutated blocks of two and three to balance the number of patients in the treatment groups" Comment: computer generated random numbers. Does not state if randomisation after consent obtained for surgery; sequence may be guessed easily with use of permutated blocks of two and three |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "Information on the type of intervention remained in consecutively numbered and sealed envelopes that were stored in the operating theatre. An envelope containing the allocation was added to the patient's file in the operating room. The envelope was opened and the surgeon performed the assigned intervention" Comment: sealed envelope opened by surgeon in theatre |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Quote from publication: "the patients and ophthalmologist involved in this study were blinded to the group assignment" Comment: patients blinded, surgical team not blinded |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote from publication: "the patients and ophthalmologist involved in this study were blinded to the group assignment" Comment: ophthalmology assessment blinded |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote from publication: "biochemical evaluation consisted of measurement of serum concentrations of TSH, fT3 and fT4 at each visit and serum TBII levels yearly" Comment: objective outcomes assessed by independent third party; thyroid status and calcium status monitored by regular blood tests (externally referenced laboratory) |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote from publication: "ophthalmologists involved in this study were blinded to the group assignment" and "indirect laryngoscopy was performed before surgery and on the first day after operation by external ENT specialist" Comment: subjective outcomes assessed by independent third party; (1) ophthalmology assessment of thyroid eye status at regular intervals, (2) RLN palsy checked by external ENT specialist |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote from publication: "CONSORT diagram: five lost to follow up in bilateral subtotal thyroidectomy group, four lost to follow up in total thyroidectomy group" Comment: nine out of 200 lost to follow‐up |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote from publication: "CONSORT diagram: 5 lost to follow up in bilateral subtotal thyroidectomy group, 4 lost to follow up in total thyroidectomy group" Comment: nine out of 200 lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes in the methods section reported in the results section (except for mean difference in TSH concentration postoperatively) |
| Other bias | Low risk | Comment: no other sources of bias detected |