1.
TEMPLATE EVIDENCE TABLES
1.1. Evidence table of systematic reviews
Table X Evidence table of systematic reviews regarding the diagnosis of pathology or effect of Intervention
Title + study ID (+ref endnote)
Methods
Design
Source of funding and Specify the source of funding: public research funds, government, not governmental organization, healthcare industry
competing interest or other (give name of organization or corporation) and the presence of declaration of interest (stated/not stated and
specify if any)
Search date
Searched databases
Included study designs Specify the type of study: RCT, CCT, case control, case series
Number of included
studies
Statistical analysis Specify the statistical methods used
Patient characteristics
Eligibility criteria State the most relevant inclusion criteria for population (patients and pathology)
Exclusion criteria State the most relevant exclusion criteria for population (patients and pathology)
Patient & disease State the most relevant baseline characteristics
characteristics
Interventions
Intervention group Precise details of the interventions for each group (including dose, length, regimen and timing if relevant)
Control group Precise details of the interventions for each group (including dose, length, regimen and timing if relevant)
Results
Outcome 1 Summary of the critical and important outcomes within and between groups: effect size (absolute risk reduction,
relative risk (reduction), odds ratio) and its precision (p value, CI)
Outcome 2
Outcome 3
Outcome 4
Outcome 5
Limitations and other comments
Limitations Comments on limitations of the study (external and internal validity)
1.2. Evidence tables of intervention studies
Table X Evidence table of intervention studies regarding the effect of Intervention vs Comparator in population
Title + study ID (+ref endnote)
Methods
Design Specify the study design: randomized study, cross sectional study, cohort study, case control study, time series, before and after
studies, other; prospective or retrospective study. Precise if it’s the design cited by author(s)
Source of funding and Specify the source of funding: public research funds, government, not governmental organization, healthcare industry
competing interest or other (give name of organization or corporation) and the presence of declaration of interest (stated/not stated and
specify if any)
Setting Number of centres, countries involved, healthcare setting, urban/rural/mixed
Sample size Give the number of patients needed (= the calculated before protocol) as cited (described) by the author(s) (should clearly report
if it is numbers by group or not) and the number of patients actually included
Duration and follow-up Start and end dates of the study (precise if includes follow up or not), precise inclusion and follow up periods (length rather than
dates)
Statistical analysis Specify the statistical methods used
Patient characteristics
Eligibility criteria State the inclusion criteria cited in the paper
Exclusion criteria State the exclusion criteria cited in the paper
Patient & disease Describe baseline characteristics cited in the paper (precise if it is on involved and/or analysed numbers). Highlight discrepancies
characteristics between groups (i.e. involved and analysed)
Interventions
Intervention group Precise details of the interventions for each group (including dose, length, regimen and timing when relevant)
Control group Precise details of the interventions for each group (including dose, length, regimen and timing when relevant)
Results
Outcome 1 Summary of the critical and important outcomes within and between groups: effect size (absolute risk reduction,
relative risk (reduction), odds ratio) and its precision (p value, CI)
Outcome 2
Outcome 3
Outcome 4
Outcome 5
Limitations and other comments
Limitations Comments on limitations of the study (external and internal validity)
1.3. Evidence tables of diagnostic studies
Table Evidence table of diagnostic studies regarding the diagnosis of pathology with test 1
Title + study ID (+ref endnote)
Methods
Design Specify the study design: randomized study, cross sectional study, cohort study, case control study, time series, before and after
studies, other; prospective or retrospective study. Precise if it’s the design cited by author(s)
Source of funding and Specify the source of funding: public research funds, government, not governmental organization, healthcare industry or
competing interest other (give name of organization or corporation) and the presence of declaration of interest (stated/not stated and specify
if any)
Setting Number of centres, countries involved, healthcare setting, urban/rural/mixed
Sample size Give the number of patients needed (= the calculated before protocol) as cited (described) by the author(s) (should clearly report if it
is numbers by group or not) and the number of patients actually included
Time interval between Specify if any
tests
Statistical analysis Specify the statistical methods used
Patient characteristics
Eligibility criteria State the inclusion criteria cited in the paper
Patient characteristics Describe baseline characteristics cited in the paper (precise if it is on involved and/or analysed numbers). Highlight discrepancies
between groups (i.e. involved and analysed)
Prevalence of disease State the prevalence estimation of the disease in the general population
Interventions
Index test(s) Describe the evaluated test(s):
- What (including the provider’s name if applicable), by whom and how, when
- Cut-offs, categories of results
- Blinding (investigator) to clinical information and/or to index test results, if applicable
Reference standard Describe the reference standard test:
- What (including the provider’s name if applicable), by whom and how, when
- Cut-offs, categories of results
- Blinding (investigator) to clinical information and/or to index test results, if applicable
Results
Outcome 1 Summary of the critical and important outcomes within and between groups: effect size (absolute risk reduction, relative
risk (reduction), odds ratio) and its precision (p value, CI); diagnostic accuracy (Se, Sp, PPV, NPV, DOR, AUC, LR+,
LR-) and its precision (p value, CI)
Outcome 2
Outcome 3
Outcome 4
Outcome 5
Limitations and other
comments
Limitations Comments on limitations of the study (external and internal validity)
1.4. Evidence tables of prognostic studies
Table X Evidence table of prognostic studies regarding the effect of Intervention vs Comparator in population
Title + study ID (+ref endnote)
Methods
Design Specify the study design: randomized study, cross sectional study, cohort study, case control study, time series, before and after
studies, other; prospective or retrospective study. Precise if it’s the design cited by author(s)
Source of funding and Specify the source of funding: public research funds, government, not governmental organization, healthcare industry or
competing interest other (give name of organization or corporation) and the presence of declaration of interest (stated/not stated and specify
if any)
Setting Number of centres, countries involved, healthcare setting, urban/rural/mixed
Sample size Give the number of patients needed (= the calculated before protocol) as cited (described) by the author(s) (should clearly report if it
is numbers by group or not) and the number of patients actually included
Duration and follow-up Start and end dates of the study (precise if includes follow up or not), precise inclusion and follow up periods (length rather than
dates)
Statistical analysis Specify the statistical methods used
Patient characteristics
Eligibility criteria State the inclusion criteria cited in the paper
Exclusion criteria State the exclusion criteria cited in the paper
Patient & disease Describe baseline characteristics cited in the paper (precise if it is on involved and/or analysed numbers). Highlight discrepancies
characteristics between groups (i.e. involved and analysed)
Interventions
Exposure Precise details on the exposure for each group
Confounders Precise details on the confounders for each group
Results
Outcome 1 Summary of the critical and important outcomes within and between groups: effect size (absolute risk reduction, relative
risk (reduction), odds ratio) and its precision (p value, CI)
Outcome 2
Outcome 3
Outcome 4
Outcome 5
Limitations and other
comments
Limitations Comments on limitations of the study (external and internal validity)
1.4.1. Example of evidence table of intervention study
The American College of Surgeons Oncology Group Z0011 trial, addressed by: Lucci 2007, Giuliano 2010, Giuliano 2011 3
Methods
Design RCT
Source of funding and National Cancer Institute
competing interest
Setting Multicenter
Sample size N=891
Duration Patient enrollment from May 1999 to December 2004. Targeted enrolment was 1900 women with final analysis after 500
deaths, but the trial closed early because mortality rate was lower than expected.
Follow-up Patients were assessed for disease recurrence by history and physical examination (every 6 months for the first 36
months and yearly thereafter) and annual mammography. Other testing was based on symptoms and investigator
preference. Median follow-up of 6.3 years (last follow-up, March 4, 2010)
Statistical analysis
Patient characteristics
Eligibility criteria women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases
identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section.
Exclusion criteria women were excluded if they were pregnant or lactating, were treated with neoadjuvant chemo or hormonal therapy, had
bilateral breast cancer, multicentric disease, a history of ipsilateral axillary surgery, prepectoral implants, or medical
contraindications to ALND. Patients with matted nodes or gross extranodal disease at the time of SLND were excluded as
were patients with 3 or more involved SLNs.
Patient & disease Group 1: n= 436; Group 2: n= 420
characteristics - Median age (range): 56 (24-92) vs. 54 (25-90);
- Clinical T stage: T1: 284 (67.9%) vs. 303 (70.6%), T2: 134 (32.1%) vs.126 (29.4%)
- Micrometastases in SLNs: 164/366 (44.8%) vs. 137/365 (37.5%)
The characteristics were well balanced between the 2 groups (T stage, tumour size, receptor status for estrogen and
progesterone, LVI, loom- Richardson score, tumour type).
Interventions
Intervention group (1) Group 1: Sentinel lymph node dissection (SLND) only (no further axillary surgery)
SLND was performed with isosulfan blue, a radiopharmaceutical or both. All patients underwent breast conservation
therapy and whole breast irradiation.
Control group (2) Group 2 : SLND and axillary lymph node dissection (ALND)
SLND was performed with isosulfan blue, a radiopharmaceutical or both. All patients underwent breast conservation
therapy and whole breast irradiation.
Results
Overall survival Median follow-up of 6.3years with a noninferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND
alone is non-inferior to ALND)
Group 1: 42 deaths vs Group 2: 52 deaths
HR = 0.79 (90% CI 0.56 to 1.10), which did not cross the pre-specified boundary of 1.3
NOTE: a 2-sided 90% CI corresponds to a 1-sided significance level of 0.05. If the 90% CI for the HR was below 1.3, this
would indicate that patients undergoing SLND alone do not have an unacceptably worse overall survival than patients
undergoing SLND plus ALND.
5-year overall survival Group 1 92.5% vs Group 2 91.8%
HR (adjusted for adjuvant therapy (chemotherapy, endocrine therapy, and/or radiation therapy) and age) = 0.87 (90% CI
0.62 to 1.23)
5-year disease-free Group 1: 83.9% vs Group 2: 82.2%
survival HR (unadjusted) = 0.82 (95% CI 0.58 to 1.17)
HR (adjusted for adjuvant therapy (chemotherapy, endocrine therapy, and/or radiation therapy) and age) = 0.88 (95% CI
0.62 to 1.25)
Local/regional Local recurrence after median follow-up of 6.3 years:
recurrence Group 1: 8/436 (1.8%) vs Group 2: 15/420 (3.6%)RR= 0.51 (95% CI 0.22 to 1.20)
At 5 years:
Group 1: 7/436 (1.6%) vs Group 2: 13/420 (3.1%) RR= 0.52 (95% CI 0.21 to 1.29)
Regional recurrences in ipsilateral axilla:
Group 1: 4/436 (0.9%) vs Group 2: 2/420 (0.5%)RR= 1.93 (95% CI 0.35 to 10.46)
Median time of local recurrence-free survival and regional recurrence-free survival was not reached in either group and did
not differ between the arms.
5-year locoregional recurrence–free survival
Group 1: 96.7% vs Group 2: 95.7% (P=0.28).
Recurrence in ‘Treatment received’ sample*:
Locoregional recurrence:
Group 1: 12/425 (2.8%) vs Group 2: 16/388 (4.1%) RR= 0.68 (95% CI 0.33 to 1.43)
Local recurrence:
Group 1: 8/425 (1.9%) vs Group 2: 14/388 (3.6%) RR= 0.52 (95% CI 0.22 to 1.23)
Regional recurrence:
Group 1: 4/425 (0.9%) vs Group 2: 2/388 (0.5%) RR= 1.83 (95% CI 0.34 to 9.91)
Arm morbidity Wound infections at 30 days
Group 1: 11/371 vs Group 2: 31/373 RR= 0.36 (95% CI 0.18 to 0.70)
Axillary seromas at 30 days
Group 1: 21/371 vs Group 2: 53/373 RR= 0.40 (95% CI 0.25 to 0.65)
Axillary paresthesias
At 30 days:
Group 1: 43/371 vs Group 2: 174/373 RR= 0.25 (95% CI 0.18 to 0.34)
At 6 months:
Group 1: 35/288 vs Group 2: 146/335 RR=0.28 (95% CI 0.20 to 0.39)
At 12 months:
Group 1: 24/268 vs Group 2: 113/287 RR= 0.23 (95% CI 0.15 to 0.34)
Lymphedema (reported subjectively)
At 6 months:
Group 1: 19/339 vs Group 2: 27/327 RR= 0.68 (95% CI 0.39 to 1.20)
At 12 months:
Group 1: 16/268 vs Group 2: 37/288 RR= 0.46 (95% CI 0.26 to 0.82)
After 12 months:
Group 1: 14/253 vs Group 2: 52/272 RR= 0.29 (95% CI 0.16 to 0.51)
Lymphedema (by arm measurements)
At 30 days:
Group 1: 17/272 vs Group 2: 23/255 RR= 0.69 (95% CI 0.38 to 1.27)
At 6 months:
Group 1: 21/271 vs Group 2: 29/270 RR= 0.72 (95% CI 0.42 to 1.23)
At 12 months:
Group 1: 14/226 vs Group 2: 26/242 RR = 0.58 (95% CI 0.31 to 1.08)
Brachial plexus injury (BPI)
“Eighteen BPIs were reported originally, but after each injury was re-evaluated, it was discovered that 10 would have been
more accurately classified as axillary paresthesias. Three BPIs occurred after SLND alone, but all of these had resolved at
last follow-up, as had 88% of all BPIs.”
Quality of life Not addressed
Limitations and other comments
Limitations Thirty-two women in the ALND group did not have ALND and 11 women in the SLND-alone group had ALND. Therefore,
the treatment-received sample consisted of 388 women who indeed did receive ALND and 425 women who indeed did
receive SLND alone. The primary analyses were performed on the intent-to-treat sample, and all were repeated for the
treatment received sample. Both analyses yielded similar results with no significant change in results.
