Table 5

Grading the quality of evidence
Quality assessment No of patients Effect Quality
No of studies Design Risk of bias Inconsistency Indirectness Imprecision Other considerations Early vs. deferred androgen suppression therapy Control Relative(95% CI) Absolute
Overall survival (follow-up median 6.5-11.9 years)
3 randomized trials serious1,2,3 no serious inconsistency no serious indirectness serious5,6,7,8 none 78/165 (47.3%) 92/145 (63.4%) HR 0.62 (0.46 to 0.84) 170 fewer per 1000 (from 64 fewer to 264 fewer) ⊕⊕ΟΟ low
Cancer-specific survival (follow-up median 11.9 years)
1 randomized trials serious1 no serious inconsistency no serious indirectness Serious5,6 none 7/47 (14.9%) 25/51 (49%) HR 0.34 (0.18 to 0.64) 285 fewer per 1000 (from 140 fewer to 376 fewer) ⊕⊕ΟΟ low
Clinical progression at 3 years (follow-up median 3-11.9 years)
4 randomized trials serious1,2,3,4 no serious inconsistency no serious indirectness serious5,6,7,8,9 none 13/187 (7%) 44/171 (25.7%) RR 0.29 (0.16 to 0.52) 183 fewer per 1000 (from 124 fewer to 216 fewer) ⊕⊕ΟΟ low
Clinical progression at 9 years (follow-up median 6.5-11.9 years)
3 randomized trials serious1,2,3 no serious inconsistency no serious indirectness serious5,6,7,8 none 43/165 (26.1%) 78/144 (54.2%) RR 0.49 (0.36 to 0.67) 276 fewer per 1000 (from 179 fewer to 347 fewer) ⊕⊕ΟΟ low

1 EST-3886: Random sequence generation: Random number generator; Allocation concealment: Central allocation; Blinding of participants/personnel: No (only pathologists were blinded); Blinding of outcome assessment: Unclear; Incomplete outcome data: We found no evidence for missing outcome data for patients with node-positive prostate cancer and survival/progression outcome data were presented by intention-to-treat; Selective reporting: The study protocol is not available but we suggest that the published reports include all expected outcomes; Note: Staging was retrospectively regraded to ensure comparable groups.

2 Granfors et al.: Random sequence generation: Not described; Allocation concealment: Not described; Blinding of participants/personnel: No; Blinding of outcome assessment: Unclear; Incomplete outcome data: We found no evidence for missing outcome data for patients with node-positive prostate cancer and survival/progression outcome data were presented by intention-to-treat; Selective reporting: One or more outcomes of interest are reported incompletely so that they cannot be entered in a meta-analysis; Note: Staging was retrospectively regraded to ensure comparable groups.

3 RTOG-85-31: Random sequence generation: Random number generator; Allocation concealment: Central allocation; Blinding of participants/personnel: No; Blinding of outcome assessment: Unclear; Incomplete outcome data: We found no evidence for missing outcome data for patients with node-positive prostate cancer and survival/progression outcome data were presented by intention-to-treat; Selective reporting: The study protocol is not available but we suggest that the published reports include all expected outcomes.

4 EPC program: Random sequence generation: Random number generator, Allocation concealment: Central allocation; Blinding of participants/personnel: Double-blinded (placebo-controlled); Blinding of outcome assessment: Unclear; Incomplete outcome data: We found no evidence for missing outcome data for patients with node-positive prostate cancer and survival/progression outcome data were presented by intention-to-treat; Selective reporting: The study protocol is not available but we suggest that the published reports include all expected outcomes.

5 Heterogeneity may arise from differences in interventions (radical prostatectomy or radiotherapy) or populations (medical or surgical castration) or different lymph node assessments (lymphangiogram, computed tomography, lymphadenectomy).

6 EST-3886: Initially planned for 220 lymph node-positive patients but stopped after inclusion of 100 of which only 98 were randomized.

7 Granfors et al.: Initially planned for 400 patients but stopped after inclusion of 91 of which only 39 patients (43%) presented with lymph node-positive disease.

8 RTOG-85-31: Randomization of 977 patients but only 173 (18%) presented with lymph node-positive disease.

9 EPC program: Randomization of 8113 patients but only 150 (2%) presented lymph node-positive disease (radical prostatectomy: 74 patients, radiotherapy: 14 patients, watchful waiting: 62 patients).

Kunath et al.

Kunath et al. BMC Cancer 2013 13:131   doi:10.1186/1471-2407-13-131

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