Review: Surgery versus radiosurgery for participants with single or solitary brain metastasis
Study ID (surname of first author and year first full report of study was published e.g. Smith 2001)
Report ID
General Information
Date form completed	(dd/mm/yyyy)
Name/ID of person extracting data
Reference citation
Study author contact details
Publication type	(e.g. full report, abstract, letter)
Study eligibility
1. Type of study (Randomised controlled trials)	(Yes or no)
2. Participants (Adults aged 18 years or more, with single or solitary brain metastasis of any size, a biopsy‐proven malignancy of any tumour histology, no previous cranial radiation, and any chemotherapy or target therapy administered before the study intervention)	(Yes or no)
3. Types of intervention (Any neurosurgical technique where complete resection was intended)	(Yes or no)
4. Types of comparison (Any type of radiosurgery: robotic delivering of radiation, multiple convergent sources of cobalt or other technical devices adapted to linear accelerators e.g. any form of LINAC stereotactic radiotherapy with or without relocatable frame using single or multiple fractions or Gamma Knife radiosurgery	(Yes or no)
Inclusion (Do not proceed if the study does not meet the four eligibility criteria)	(Included or excluded)
Reason for exclusion
Notes(any other information you consider important)
Methods (descriptions as stated in report/paper)
Country	(where the study was conducted)
Design	(e.g. parallel, cluster)
Was the study multicentred?	(if yes, state No. of centres)
Funders of the trial
Duration of trial	(state start date and end date of trial)
Duration of participation	(from start of recruitment to last follow‐up)
Ethical approval needed/obtained for study	(Yes, no, unclear)
Notes (any other information you consider important)
Participants (Include comparative information for each intervention or comparison group if available)
Population description	(Describe any risk factors, and criteria for diagnosing the metastasis)
Setting	(From where were participants enrolled?)
Inclusion criteria
Exclusion criteria
Method of recruitment of participants	(e.g. phone, mail, clinic patients)
Total no. randomised
No. of participants assigned to each group
No. of participants receiving the intended treatment
No. of participants analysed
Withdrawals and exclusions	(If not provided below by outcome)
Age
Sex
Race/ethnicity
Characteristics of the primary tumour and metastasis	(Time to diagnosis, time to metastasis, characteristics of brain metastasis, solitary versus single?)
Notes (any other information you consider important)
Intervention group
Intervention name
No. randomised to group	(Specify whether no. people or clusters)
Details of the intervention	(Type of surgery, details of the technique)
	(Was a postoperative confirmation of metastasis resection with MRI done?)
Cointerventions	(Any additional interventions given e.g. WBRT, chemotherapy or other target therapy. Has the cointervention been used equally in both study groups)
Notes (any other information you consider important)
Comparator group
Intervention name	E.g. robotic delivering of radiation, LINAC stereotactic radiotherapy, gamma knife radiosurgery or other multiple convergent sources of cobalt or other technical devices adapted to linear accelerators
No. randomised to group
Details of the intervention	(Brand, doses, frequency, duration)
Cointerventions	(Any additional interventions given e.g. WBRT, chemotherapy or other target therapy. Has the cointervention been used equally in both study groups)
Notes (any other information you consider important)
Outcome characteristics
Outcome 1 name	Overall survival: survival from the intervention (surgery or radiosurgery) until death from any cause
Time points measured	(specify whether from start or end of intervention) (How long was the follow‐up for this outcome?)
Time points reported
Person measuring/reporting
Imputation of missing data	(e.g. assumptions made for ITT analysis)
Notes (any other information you consider important)
Outcome 2 name	Any adverse event
Time points measured	(Specify whether from start or end of intervention) (How long was the follow‐up for this outcome?)
Person measuring/reporting
Notes (any other information you consider important)
Outcome 3 name	Survival free of brain relapses: survival from the intervention until the diagnosis of a new brain metastasis by imaging, either by computed tomography (CT) or by magnetic resonance (MRI)
Time points measured	(Specify whether from start or end of intervention) (How long was the follow‐up for this outcome?)
Person measuring/reporting
Imputation of missing data	(e.g. assumptions made for ITT analysis)
Notes (any other information you consider important)
Outcome 4 name	Quality of life: assessed through validated questionnaires
Time points measured
Time points reported
Person measuring/reporting
How was quality of life assessed? (measurement scale)
Scales: upper and lower limits (indicate whether high or low score is good)
Is outcome/tool validated?
Imputation of missing data	(e.g. assumptions made for ITT analysis)
Notes (any other information you consider important)
Data and analysis (Descriptions as stated in report/paper)
Outcome 1. Overall survival: survival from the intervention until death from any cause
Comparison
Outcome
Subgroups
Time point	(Specify from start or end of intervention)
Results	Intervention # Event Total in group Control # Event Total in group
Any other results reported	(e.g. odds ratio, risk difference, CI or P value)
No. participants moved from other group	# Reason
Unit of analysis	(By individuals, cluster/groups or body parts)
Statistical methods used and appropriateness of these	Was any adjustment done?
Notes (any other information you consider important)
Outcome 2. Any adverse event
Comparison
Outcome
Subgroups
Time point	(Specify from start or end of intervention)
Results	Intervention # Event Total in group Control # Event Total in group
Any other results reported	(e.g. odds ratio, risk difference, CI or P value)
No. missing participants	# Reason
No. participants moved from other group	# Reason
Unit of analysis	(By individuals, cluster/groups or body parts)
Statistical methods used and appropriateness of these	Was any adjustment done?
Notes (any other information you consider important)
Outcome 3. Survival free of brain relapses
Comparison
Outcome
Subgroups
Time point	(Specify from start or end of intervention)
Results	Intervention # Event Total in group Control # Event Total in group
Any other results reported	(e.g. odds ratio, risk difference, CI or P value)
No. participants moved from other group	# Reason
Unit of analysis	(By individuals, cluster/groups or body parts)
Statistical methods used and appropriateness of these	Was any adjustment done?
Notes (any other information you consider important)
Outcome 4. Quality of life: assessed through validated questionnaires
Comparison
Outcome
Subgroups
Time point	(Specify from start or end of intervention)
Results	Intervention Mean, median Standard deviation Total in group Control Mean, median Standard deviation Total in group
Any other results reported	(e.g. odds ratio, risk difference, CI or P value)
No. missing participants	# Reason
No. participants moved from other group	# Reason
Unit of analysis	(By individuals, cluster/groups or body parts)
Statistical methods used and appropriateness of these	Was any adjustment done?
Notes (any other information you consider important)
Risk of bias assessment
Random sequence generation (selection bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Allocation concealment (selection bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of participants and personnel for outcome 1 (overall survival) (performance bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of participants and personnel for outcome 2 (any adverse event) (performance bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of participants and personnel for outcome 3 (survival free of brain relapses) (performance bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of participants and personnel for outcome 4 (quality of life) (performance bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of outcome 1 assessment (overall survival) (detection bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of outcome 2 assessment (any adverse event) (detection bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of outcome 3 assessment (survival free of brain relapses) (detection bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Blinding of outcome 4 assessment (quality of life) (detection bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Incomplete outcome 1 data (overall survival) (attrition bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Incomplete outcome 2 data (any adverse event) (attrition bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Incomplete outcome 3 data (survival free of brain relapses) (attrition bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Incomplete outcome 4 data (quality of life) (attrition bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Selective outcome reporting? (reporting bias)	Low risk High risk Unclear (Include direct quotes where available with explanatory comments)
Notes (any other information you consider important)