Scolaris Content Display Scolaris Content Display

Primary surgery versus primary radiation therapy with or without chemotherapy for early adenocarcinoma of the uterine cervix

Esta versión no es la más reciente

Table 1. Data collection form

intervention A

intervention B

Study identification: Form filled in by:

Reference checked by:

Date completing form:

Name study:

1st author, journal, year:

Study properties

RCT, non‐randomised controlled study, CCT, observational study prospective/retrospective

Time of inclusion:

Purpose of the study, as stated by authors:

Selection bias
Performance bias
Attribution bias
Detection bias
Analysis (statistics)

Study eligible for review: yes / no
If not, why not:

Types of participants: Intervention A Intervention B
Number of patients:
Age:
Mean:
Median:
SD:
Ranges:

Primary tumours:
FIGOstage IA
IB‐IIA
IIB‐

Histological type
Adenocarcinoma
Adenosquamous
Other (specify)

Grade: I
II
III
unknown

Performance Status: WHO

Types of intervention:
Surgery planned
Conservative surgery
Radical surgery
Protocol violations

Radiationtherapy planned
‐External & brachytherapy:
total Gy: fractions: frequency: field:
‐Chemoradiation
total Gy: fractions: frequency: field:
CT agent(s) doses: frequency
Protocol violations

Surgery & Radiationtherapy
‐reason:

Outcome A B
Total patients entering the study
Declared ineligible
Removed from study for other reasons
Included in analysis
Completed prescribed treatment plan
(and available for response)

Follow up: A B
Known of .. patients.
Time of f.u. median:
SD:
Range:

Alive (5‐yr survival)
Without evidence of disease
With disease
Death:
DOD
Treatment complications
Not related death
Unknown
Recurrence: yes / no
If yes time‐interval (month)
If yes: local, distant, both

Complications:
‐radiation‐related
‐surgery‐related
‐death

Figuras y tablas -
Table 1. Data collection form
Table 2. Critical review form; observational studies

yes ‐ no

Did study population meet our criteria?
or: is it possible to analyse patients that meet our criteria separately?

Were all observed patients accounted for at the end of follow up?

How long was follow up?

Were interventions defined adequately?

Is the study cohort defined temporally?
Is the study cohort defined geographically?
Percentage of defined patient population who are included in the study?

Were all clinically important outcomes considered?
‐disease free survival
‐complications

Figuras y tablas -
Table 2. Critical review form; observational studies
Table 3. Critical review form; studies with non‐randomised controls

yes ‐ no

Did study population meet our criteria?
or: is it possible to analyse patients that meet our criteria separately?

Is the study adjusted for confounders?

Were patients analysed in the groups to which they were assigned?

Were the groups similar before treatment?

Aside from the experimental intervention, were the groups treated equally?

Are controls concurrent or retrspective?

Were all patients accounted for at the end of follow up?

How long was follow up?

Were interventions defined adequately?

How precise was the estimate of the treatment effect?
‐disease free survival
‐complications

Were all clinically important outcomes considered?
‐disease free survival
‐complications

Figuras y tablas -
Table 3. Critical review form; studies with non‐randomised controls
Table 4. Critical review form; randomised studies

yes ‐ no

Did study population meet our criteria?
or: is it possible to analyse patients that meet our criteria separately?

Was assignment of patients to treatment randomised?

Were patients analysed in the groups to which they were randomised?

Were the groups similar at the start of the trial?

Aside from the experimental intervention, were the groups treated equally?

Were all patients who entered the trial accounted for at its conclusion?

How long was follow up? (Median and range)

Were interventions defined adequately?

Were all clinically important outcomes considered?
‐disease free survival
‐complications

Figuras y tablas -
Table 4. Critical review form; randomised studies
Table 5. QUOROM statement flow diagram

RCT's included

RCTs excluded

potentially relevant RCTs identified and screened for retrievel (n=...)

RCTs excluded with reason (n=...)

RCTs retreaved for more detailed evaluation (n=...)

RCTs excluded, with reasons (n=...)

Potentially appropriate RCTs to be included in the meta analysis (n=...)

RCTs excluded from meta‐analysis, with reason (n=...)

RCTs included in meta‐analysis (n=...)

RCTs withdrawn, by outcome, with reasons (n=...)

RCTs with usable information, by outcome (n=...)

Figuras y tablas -
Table 5. QUOROM statement flow diagram