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. 2010 Apr 20;7(4):e1000267. doi: 10.1371/journal.pmed.1000267

Table 8. Quality assessment.

Category Outcome
Resection Rate Exploration Rate Response Evaluation Toxicity Morbidity Mortality Median Survival 1 y/2 y Survival
Number of studies (range) 35–111 32–88 2–82 22–63 22–50 30–85 19–70 11–54
Study design Phase I–II trials Phase I–II trials Phase I–II trials Phase I–II trials Phase I–II trials Phase I–II trials Phase I–II trials Phase I–II trials
Cohort studies Cohort studies Cohort studies Cohort studies Cohort studies Cohort studies Cohort studies Cohort studies
Case series Case series Case series Case series Case series Case series Case series Case series
Limitations No serious limitation No serious limitation No serious limitationa No serious limitation No serious limitationb No serious limitationb No serious limitationc No serious limitationd
Inconsistency Serious inconsistencye Serious inconsistencye Serious inconsistencye No serious inconsistencyf No serious inconsistencyg No serious inconsistencyh Serious inconsistencye Serious inconsistencye
Indirectness i
Imprecisionj No serious imprecisionk No serious imprecisionk No serious imprecisionk No serious imprecisionl Serious imprecisionm Serious imprecisionn Serious imprecisiono Serious imprecisiono
Other considerations Studies weighted by number of initial patients Studies weighted by number of initial patients
Quality ++ ++ ++ +++ ++ ++ + +
Importance Critically important Important Important Important Important Critically important Critically important Critically important

The quality assessment for the indicated outcome parameters was carried out according to the grade profiler as described in the Methods section. +, very low; ++, low; +++, moderate.

a

Separated evaluation of response categories, several evaluation criteria, proportions experiencing each type of response are not independent.

b

Based only on resected patients.

c

Assumption of uniform (exponential) distributed survival times.

d

Different trials for estimating 1 y/2 y survival.

e

High heterogeneity which could not be sufficiently explained by potential sources of variation within the meta-regression analysis.

f

Obvious heterogeneity partly explained by different chemotherapy treatment regimes within the trials.

g

Obvious heterogeneity partly explained by differences in mean patient age and study design between the trials.

h

No considerable heterogeneity obvious from the data.

i

Since no direct comparison was feasible for any considered outcome measurement, indirectness has to be fixed as “very serious” for the entire topic of the investigation.

j

For the same reason no particular measure of precision (e.g. confidence intervals) was available for any single trial considered; therefore, imprecision is rather crude assessed in reference to the number of study participants within any meta-analysis.

k

Substantial sample sizes per study: median (IQR): 30 (18 to 47).

l

Substantial sample sizes per study: median (IQR): 29 (19 to 39).

m

Insufficient sample sizes per study: median (IQR): 16 (7 to 25).

n

Insufficient sample sizes per study: median (IQR): 13 (6 to 25).

o

No sufficient information about patients at risk.