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To investigate the relationship of

The aim serum prostate-specific antigen

(PSA) levels with out comes of
prostate needle biopsy

Measured serum PSA levels in 1472 healthy men

Materials and 50 or more years old, if there were elevated PSA

methods level (4ng/mL) transrectal ultrasound guided

prostate biopsy was performed.

The serum free PSA showed no significant

Results corelation with histologic results of prostate

needle biopsy,

This study revealed that no level of PSA was assosiated with a

Conclusion 100% positive predictive value and negative biopsy can occur
virtually at any PSA level
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 Advantages

The study was conducted with no nancial support from

any Organization and independent from any funders.

Applicable for this country

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Disadvantages

Single centre Study.

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Will the result help me locally
Can the result applied to the local
population ? YES
 Clinical Description Prefered Study
category Design

Therapy Tests the effectiveness of a Randomized,

treatment, such as a drug, double-blinded,
surgical procedure, or other placebo- controlled
intervention trial
Diagnosis Measures the validity (is it Cross-sectional
dependable?) and reliability survey (comparing
(will the same results be the new test with a
obtained every time?) of a reference standard)
diagnostic test, or evaluates the
effectiveness of a test in
detecting disease at a
presymptomatic stage when
applied to a large population
Causation Assesses whether a substance is Cohort or case-
related to the development of
control
an illness or condition
Prognosis Determines the outcome of a Longitudinal cohort
disease study 7
 Level 1 of Evidence
Level Therapy/Prevention, Prognosis Diagnosis
Aetiology/Harm

1a SR (with homogeneity*) of SR (with homogeneity*) of SR (with homogeneity*) of Level

RCTs inception cohort studies; 1 diagnostic studies; CDR
CDR validated in with 1b studies from
different populations different clinical centres

1b Individual RCT (with narrow
Confidence Interval)
Individual inception cohort Validating** cohort study with
study with > 80% good reference standards;
follow-up; CDR or CDR tested within one
validated in a single clinical centre
population

1c All or none All or none case-series Absolute SpPins and SnNouts

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 Level 2 of Evidence
Level Therapy/Prevention, Prognosis Diagnosis
Aetiology/Harm
2a SR (with homogeneity* ) of SR (with homogeneity*) SR (with homogeneity*) of
cohort studies of either retrospective Level >2 diagnostic studies
cohort studies or
untreated control groups
in RCTs
2b Individual cohort study Retrospective cohort Exploratory** cohort study
(including low quality RCT; study or follow-up of with good reference
e.g., <80% follow-up) untreated control standards; CDR after
patients in an RCT; derivation, or validated only
Derivation of CDR or on split-sample or databases
validated on split-
sample only
2c "Outcomes" Research; "Outcomes" Research
Ecological studies
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 Level 3, 4, 5, of Evidence
Level Therapy/Prevention, Prognosis Diagnosis
Aetiology/Harm
3a SR (with homogeneity*) of SR (with homogeneity*) of 3b
case-control studies and better studies
3b Individual Case-Control Non-consecutive study; or
Study without consistently applied
reference standards

4 Case-series (and poor Case-series (and poor Case-control study, poor or

quality cohort and case- quality prognostic cohort
control studies ) studies***)
5 Expert opinion without Expert opinion without
explicit critical appraisal, or explicit critical
based on physiology, bench appraisal, or based on
research or "first principles" physiology, bench
research or "first
principles"
non-independent reference
standard
Expert opinion without
explicit critical appraisal, or
based on physiology, bench
research or "first principles"
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Grades of Recommendation
A consistent level 1 studies

consistent level 2 or 3 studies or extrapolations from

B
level 1 studies
level 4 studies or extrapolations from level 2 or 3
C
studies
level 5 evidence or troublingly inconsistent or
D
inconclusive studies of any level
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