Critical appraisal:Videtic GM, Hu C, Singh AK, Chang JY, Parker W, Olivier KR, et al 2015

To compare two different stereotactic radiotherapy dose fraction schedules for the treatment of stage I non-small cell lung cancer, primary endpoint was protocol specified adverse events.

Number of Patients:

84

single fraction arm n=39, multiple fraction arm n=45.

Reported outcome(s):

adverse events (primary), overall survival, disease free survival, primary control.

Results of outcome(s):

Adverse events: 10% single fraction, 13% multifraction, no difference
Overall survival and progression free survival favoured multi fraction arm, but overlapping 95% C.I.s. Local control at 1 year: single fraction 97%; multi fraction 92.7%.

Comments on results:

Phase 2 study

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias

Unclear

Comments: Randomised phase 2 trial, primary endpoint is protocol specified adverse events. Secondary endpoint: primary tumourcontrol and survival atone year.

Show/Hide Risk of bias assessment

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.

Method of randomisation not described, but cooperative group trial, so likely to be rigorous.

What was the risk of bias from the random sequence generation?

Unclear

Allocation concealment

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.

Not stated

What was the risk of bias from the allocation concealment?

Unclear

Blinding

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.

No blinding

What was the risk of bias from the blinding of participants and personnel and outcome assessors?

High

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.

10 patients excluded, no protocol treatment (2); withdrawal of consent (1); baseline investigations unavavailable (4); tumour location not per protocol (2).

What was the risk of bias from incomplete outcome data?

Low

Selective outcome reporting

State how the possibility of selective outcome reporting was examined by the review authors and what was found.

No response

What was the risk of bias from selective outcome reporting? Assessments should be made for each main outcome (or class of outcomes).

Low

Other sources of bias

Describe any other sources of bias

No response

What was the risk of bias from other sources?

Low

Size of effect

3	Reason for decision: No benefit with either schedule, main purpose is to determine if the more convenient single dose is as safe as 4 doses.

Relevance of evidence

1	Additional comments: No difference in AEs between schedules

Result of appraisal

Included

Completed by

Professor David Ball MB BS, MD, FRANCZR