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Table 5 Grading the quality of evidence

From: Early versus deferred androgen suppression therapy for patients with lymph node-positive prostate cancer after local therapy with curative intent: a systematic review

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. 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. 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. 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. 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. 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. 6 EST-3886: Initially planned for 220 lymph node-positive patients but stopped after inclusion of 100 of which only 98 were randomized.
  7. 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. 8 RTOG-85-31: Randomization of 977 patients but only 173 (18%) presented with lymph node-positive disease.
  9. 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).
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BMC Cancer

ISSN: 1471-2407

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