Jarhult 2005.
| 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 |
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| Participants |
Condition: Graves' disease Enrolment: 44 in total Inclusion criteria: 1. Diagnosis of Graves disease 2. Preop treatment with antithyroid drugs for at least 3 months 3. Euthyroidism at time of operation 4. Active Graves opthalmopathy of at least moderate degree Exclusion criteria: 1. Previous thyroid or parathyroid surgery 2. Previous treatment with radioiodine 3. Elevation of TSH value more than 200% above normal during antithyroid treatment and within three months prior to surgery Diagnostic criteria: Graves' disease with ophthalmopathy, TFT, TSH antibodies and histological diagnosis based on tissue obtained form surgery. |
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| Interventions |
Number of study centres: 10 Treatment before study: preoperative treatment with antithyroid medications for at least 3 months. Titration period: none Intervention(s): total thyroidectomy (complete macroscopic removal of thyroid tissue) Comparator(s): subtotal thyroidectomy (either subtotal bilateral resection or hemithyroidectomy plus unilateral subtotal resection leaving no more than a total of 4 g of remnant tissue) |
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| Outcomes |
Primary outcome(s): 1. Change in Graves' ophthalmopathy Secondary outcome(s): 2. Permanent hypoparathyroidism 3. Recurrent laryngeal nerve palsy Other outcome(s): TRAb measurements |
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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: not stated Study completion date: not stated |
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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 | This study enrolled patients with moderate‐severe endocrine ophthalmopathy and discussed long term results of a prospective, randomised trial of treatment with total or subtotal thyroidectomy | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Forty‐four patients with Graves' disease (GD) and a moderate‐severe Grave's ophthalmopathy were randomly allocated to undergo total or subtotal thyroidectomy" Comment: method of randomisation not specified; took place after consent for surgery |
| Allocation concealment (selection bias) | Unclear risk | Comment: not stated whether allocation concealment took place |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Quote from publication: "The design of the study left decisions about the surgical and postoperative care to the attending surgeon" Comment: surgeon could not be blinded to group allocation; note that multiple centres were involved in recruitment for the study |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: not stated that patients were blinded to the intervention |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote from publication: "the follow up consisted of ... biochemical analyses of TSH, free T3 and free T4, TRAB titre and calcium" Comment: evaluation of TRAb, thyroid function and calcium: laboratory standard tests |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote from publication: "Evaluation of eye disease activity was carried out by an ophthalmologist... the ophthalmologist was not informed of the type of thyroid surgery performed" Comment: ophthalmopathy ‐ assessed by blinded ophthalmologist |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote from publication: "one patient in the subtotal resection group... refused to come for evaluation after the first two post operative check ups" Comment: one patient lost to follow‐up out of 44; all other outcomes reported |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote from publication: "one patient in the subtotal resection group... refused to come for evaluation after the first two post operative check ups" Comment: one patient lost to follow‐up out of 44; all other outcomes reported |
| Selective reporting (reporting bias) | High risk | Comment: postoperative thyroid function (recurrent hyperthyroidism) was measured but not reported; mortality not reported |
| Other bias | Low risk | Comment: none identified |