Critical appraisal:Faries MB, Thompson JF, Cochran AJ, Andtbacka RH, Mozzillo N, Zager JS, et al 2017

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Critical Appraisal

Article being appraised

Faries MB, Thompson JF, Cochran AJ, Andtbacka RH, Mozzillo N, Zager JS, et al. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. N Engl J Med 2017 Jun 8;376(23):2211-2222 Available from: http://www.ncbi.nlm.nih.gov/pubmed/28591523.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Study aims:

To evaluate the usefulness of completion lymph-node dissection in patients with melanoma and sentinel lymph-node metastases as compared with observation with frequent nodal ultrasonography and dissection only in patients in whom clinically detected nodal recurrence had developed.

Number of Patients:

1939

randomised: 199

- assigned to completion lymph-node dissection: 971

- assigned to nodal observation: 968
Reported outcome(s):

Melanoma-specific survival
Overall survival
Survival without recurrence of regional nodal metastases

Other outcomes (not relevant to PICO):
Disease-free survival
distant metastasis-free survival
extent of nodal involvement

Results of outcome(s):

>Melanoma-specific survival:
3y of follow-up, there was no significant difference in the mean rate of melanoma-specific survival between the dissection group and the observation group in the per-protocol analysis (86+/-1.3% and 8.6+/-1.2%, p=0.42)

>Overall survival:
not reported

>Survival without recurrence of regional nodal metastases (disease control in regional nodes at 3 years):
dissection vs observation group - 92+/-1.0% vs 77+/-1.5%, p<0.001

Comments on results:

distant mets-free survival, prognostic factors and adverse events reported in this paper but not extracted

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
High risk of bias Comments: outcomes not blinded, allocation schedule not concealed, per-protocol population

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?
Outcomes not blinded, substantial side-effects, or not reported.
Was the treatment allocation schedule concealed?
No concealment or unclear (e.g. no approach described, open randomisation lists, person doing recruitment tossing a coin).
Were all randomised participants included in the analysis?
Exclusions not likely to cause bias (>80% follow-up for all groups, <5% difference in follow-up between groups)
The field below is not considered when calculating the risk of bias rating
How was the allocation schedule generated?
Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)
Size of effect
3 Reason for decision: Please replace this text and briefly describe the reasons for your rating
Relevance of evidence
1 Additional comments: Please replace this text and briefly describe the reasons for your rating
Result of appraisal

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Completed by

Cecilia Taing


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Article
Faries MB, Thompson JF, Cochran AJ, Andtbacka RH, Mozzillo N, Zager JS, et al. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. N Engl J Med 2017 Jun 8;376(23):2211-2222 Available from: http://www.ncbi.nlm.nih.gov/pubmed/28591523.
Assigned to
User:Cecilia.taing
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Critical appraisal


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