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.
Separated evaluation of response categories, several evaluation criteria, proportions experiencing each type of response are not independent.
Based only on resected patients.
Assumption of uniform (exponential) distributed survival times.
Different trials for estimating 1 y/2 y survival.
High heterogeneity which could not be sufficiently explained by potential sources of variation within the meta-regression analysis.
Obvious heterogeneity partly explained by different chemotherapy treatment regimes within the trials.
Obvious heterogeneity partly explained by differences in mean patient age and study design between the trials.
No considerable heterogeneity obvious from the data.
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.
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.
Substantial sample sizes per study: median (IQR): 30 (18 to 47).
Substantial sample sizes per study: median (IQR): 29 (19 to 39).
Insufficient sample sizes per study: median (IQR): 16 (7 to 25).
Insufficient sample sizes per study: median (IQR): 13 (6 to 25).
No sufficient information about patients at risk.