Critical appraisal:Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, et al 2015 3
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Risk of bias assessment: Randomised Controlled Trial (Cochrane risk of bias tool)
Random sequence generation
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
- Patients after lymphadenectomy were assigned to either adjuvant therapy or observation only. This was done with a balance between the groups in respect to institution, lymph-node field (parotid and cervical, axilla, or groin). number of involved nodes (≤ 3 vs >3); maximum node diameter (≤4 cm vs 4cms); and extend of extracapsular extension of tumour (none, limited or extensive) by use of minimisation with a random component.
Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of or during, enrolment.
- Patients were randomly assigned via a telephone call to the trial Centre.
Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
- Participants, those giving treatment, and those assessing outcomes were not masked to treatment allocation; however at the time of randomisation the identity of the assigned treatment groups was unknown to anyone until assignment.
Incomplete outcome data
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
- Two study populations were analysed in this study, intention-to-treat and eligible population. The reason being that 41 major eligibility infringements were found within 31 patients, and it was suggested that these patients should be excluded from analysis. The only other incomplete data was that of 2 patients, who withdrew their consent after the randomisation process, so they were excluded from analysis but this was reported.
Selective outcome reporting
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
- Follow-up occurred up until November 15th 2008 and to minimise bias, follow-up that happened after this date was not included in analysis.
What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).
Other sources of bias
Overall risk of bias
|Low risk of bias||Additional comments: Please replace this text and include any additional comments in regards to your risk of bias rating|
- Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, et al. Adjuvant lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial. Lancet Oncol 2015 Jul 20 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26206146.
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- Topic area
- Clinical question
Section below only relevant for Cancer Council Project Officer