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. 2018 Sep 5;362:k3519. doi: 10.1136/bmj.k3519

Table 3.

Summary of findings from lower risk of bias data (sensitivity analysis based on ERSPC trial)

Outcome and timeframe Study results and measurements Absolute effect estimates Certainty in effect estimates (quality of evidence) Plain text summary
No screening PSA screening Difference (95% CI)
Mortality and cancer incidence at 10 years*
All-cause mortality IR 1.0 (95% CI 0.98 to 1.02) based on data from 162 243 patients in 1 study.
Follow-up 13 years
129/1000 men 129/1000 men 0 (3 fewer to 3 more) Moderate (serious risk of bias†) PSA screening probably has little or no effect on all-cause mortality
Prostate cancer mortality IR 0.79 (0.69 to 0.91) based on data from 162 243 patients in 1 study.
Follow-up 13 years
3/1000 men 2/1000 men 1 fewer (1 fewer to 0) Moderate (serious risk of bias†) PSA screening probably has little or no effect on prostate cancer mortality
Incidence of prostate cancer (any stage) IR 1.57 (1.51 to 1.62) based on data from 162 243 patients in 1 study.
Follow-up 13 years
32/1000 men 50/1000 men 18 more (16 to 20 more) Moderate (serious risk of bias†) PSA screening probably increases the detection of prostate cancer (any stage)
Incidence of localised prostate cancer (stages I and II) RR 1.79 (1.68 to 1.82) based on data from 162 243 patients in 1 study.
Follow-up 13 years
19/1000 men 33/1000 men 14 more (13 to 16 more) Moderate (serious risk of bias†) PSA screening probably increases the detection of localised cancer
Incidence of advanced prostate cancer (stages III and IV) RR 0.75 (0.69 to 0.82) based on data from 162 243 patients in 1 study.
Follow-up 13 years
13/1000 men 10/1000 men 3 fewer (4 to 2 fewer) Moderate (serious risk of bias‡) PSA screening probably has little effect on detection of advanced cancer
Quality of life
Quality of life Measured by SF-6D (scale 0-1, high better) based on data from 1088 patients in 1 study 0.76 mean 0.75 mean 0.01 lower (0.01 lower to 0.02 higher) Low (risk of bias and indirectness)§.
Data from surveys on a subsample of patients invited from sample of the Finnish ERSPC trial
PSA screening may have little or no difference on quality of life
Complications and adverse effects (identical to results in table 2)

IR=incidence ratio. RR=relative risk. PSA=prostate-specific antigen.

*

We used relative estimates of effect at the longest available follow-up time. However, we estimated the absolute effect on a 10-year time-horizon. We used as baseline risk in the non-screening arm of the CAP trial, because it provided the most contemporary estimates of risks from large sample of men representative of a general practice setting.

Risk of bias, serious: inadequate concealment of allocation during randomisation resulting in potential for selection bias; inadequate or lack of blinding of participants and personnel, resulting in potential for performance bias; some contamination.

Risk of bias, serious: inadequate concealment of allocation during randomisation resulting in potential for selection bias; inadequate or lack of blinding of participants and personnel, resulting in potential for performance bias; inadequate or lack of blinding of outcome assessors, resulting in potential for detection bias; some contamination.

§

Risk of bias, serious: based on cross-sectional analysis of random sample, self-reported measure of health related quality of life. Indirectness, serious: patients without prostate cancer were excluded from the screening arm (health related quality of life of patients screened with no diagnosis of prostate cancer may differ).