Critical appraisal:Mariappan P, Chong WL, Sundram M, Mohamed SR 2004 4

Risk of bias assessment: diagnostic accuracy study

Patient Selection

Prior tests and any referral filters

PSA, DRE

Condition that defined entry into study

<80 yrs, PSA 4-20ng/mL, No malignant features on DRE

Setting

Urology clinic, prostate-awareness campaign

Was a diagnostic case-control design avoided?

Yes

Consecutive or random sample?

Yes

Did the study avoid inappropriate exclusions?

Yes

Reasons

Inclusion/exclusion criteria outlined, PSA and DRE, 1st biopsy

If comparing more than one index test was the design fully paired or paired randomly?

Not applicable

If a paired randomised design was used, was allocation to groups concealed and was the generation of allocation sequence adequate?

No

What is the risk that the selection of participants introduced bias?

High

Comments

Index test 1

Describe index test and how it was conducted and interpreted

Were the index test results interpreted without knowledge of the results of the reference standard?

Not applicable

If a threshold was used, was it pre-specified?

Not applicable

If two tests are being compared, have they been assessed independently / blind to each other?

Unclear

What is the risk that the conduct or interpretation of the index test introduced bias?

Unclear

Comments

Index test 2

Describe index test and how it was conducted and interpreted, if applicable

Were the index test results interpreted without knowledge of the results of the reference standard?

Not applicable

If a threshold was used, was it pre-specified?

Not applicable

What is the risk that the conduct or interpretation of the index test introduced bias?

Not applicable

Comments

Reference Standard

Describe the reference standard and how it was conducted and interpreted

Is the reference standard likely to correctly classify the target condition?

Not applicable

Were the reference standard results interpreted without knowedge of the results of the index test/s?

Not applicable

Was the reference test standard independent of the index test?
(i.e. the index test did not form part of the reference standard)

Not applicable

What is the risk that the reference standard, its conduct or interpretation introduced bias?

Not applicable

Comments

Flow and timing

Describe any patients who did not receive the index test(s) and/or reference standard or who were excluded from the 2x2 table

Describe the time interval and any interventions between index test(s) and reference standard

If a predictive test (the reference standard is a later event that the test aims to predict) were any subsequent interventions between test and later event blind to test result?

Not applicable

Was there an appropriate interval between index test(s) and reference standard?

Not applicable

Did either all participants or a random sample of participants receive a reference standard test?

Not applicable

Did all patients receive the same reference standard irrespective of index test result?

Not applicable

Were all test results including unclear results reported?

Unclear

Were all patients included in the analysis?

Yes

What is the risk that the patient flow introduced bias?

Low

Comments

Overall risk of bias

At risk of bias

Additional comments:

This appraisal has been completed.

Article

Mariappan P, Chong WL, Sundram M, Mohamed SR. Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity. BJU Int 2004 Aug;94(3):307-10 Available from: http://www.ncbi.nlm.nih.gov/pubmed/15291857.

Assigned to

User:Katherine.sheridan

Topic area

Guidelines:PSA Testing

Clinical question

• For men undergoing an initial prostate biopsy how many biopsy cores, which pattern of biopsy sampling sites and which approach constitute an adequate prostate biopsy?

Form

Form:Quality appraisal quadas

Section below only relevant for Cancer Council Project Officer

Edit appraisal assignment