Table 7Strengths and Limitations of Clinical Studies using the Downs and Black Checklist11

StrengthsLimitations
Kasivisvanathan, 201820
Reporting
  • The objective of the study, main outcomes, inclusion and exclusion criteria, interventions being compared, potential confounders, and main findings are clearly described
  • A list of complications to be recorded was cited but not provided
  • 95% confidence intervals and exact P values are reported for the main outcomes

External validity
  • Patients asked to participate were representative of the population from which they were recruited
  • Staff, places, and facilities were representative of the treatment received by the source population

Internal validity
  • Post hoc analyses were clearly indicated
  • Follow-up was similar between groups (biopsy pathology)
  • Statistical tests for the main outcomes were appropriate, including adjustment for centre
  • The main outcome measures were valid and reliable (cancers and significant cancers on pathology)
  • Patients in both groups were recruited from the same population over the same time period
  • Patients were randomized to intervention groups
  • Patients lost to follow-up were accounted for
  • The study had sufficient power to demonstrate non-inferiority
Reporting
  • Characteristics of patients lost to follow-up were not described

External validity
  • Characteristics were not provided for patients who declined participation

Internal validity
  • Patients and investigators were not blinded to intervention allocation
  • It is unclear whether outcomes assessors (pathologists) were blinded to intervention allocation
  • Some patients did not undergo assigned intervention (< 10% in each group) and reasons differed between the groups
Tontilla, 201622
Reporting
  • The objective of the study, main outcomes, inclusion and exclusion criteria, interventions being compared, potential confounders, and main findings are clearly described
  • Interquartile ranges and exact P values are reported for the main outcomes
  • Reasons for exclusion and available biopsy results were reported for patients excluded due to protocol violations

External validity
  • Patients asked to participate were representative of the population from which they were recruited
  • Staff, places, and facilities were representative of the treatment received by the source population

Internal validity
  • Random biopsies were conducted with urologists blinded to MRI results
  • Post hoc analyses were not conducted
  • Follow-up was similar between groups (biopsy pathology)
  • Statistical tests for the main outcomes were appropriate
  • Compliance with the interventions was reliable
  • The main outcome measures were valid and reliable (cancers and significant cancers on pathology)
  • Patients in both groups were recruited from the same population over the same time period
  • Patients were randomized to intervention groups
  • Patients lost to follow-up were accounted for
Reporting
  • A list of complications to be recorded was not provided

External validity
  • Characteristics were not provided for patients excluded from analysis

Internal validity
  • Patients were not blinded to the intervention they received
  • It is unclear whether outcomes assessors (pathologists) were blinded to intervention allocation
  • It was unclear whether the study met the calculated minimum sample size (one group did and the other group did not)
Panebianco, 201521
Reporting
  • The objective of the study is clearly described, inclusion and exclusion criteria, and interventions being compared are clearly described

External validity
  • Patients asked to participate were representative of the population from which they were recruited
  • Staff, places, and facilities were representative of the treatment received by the source population

Internal validity
  • Post hoc analyses were not conducted
  • Follow-up was similar between groups (biopsy pathology)
  • Compliance with the interventions was reliable
  • The main outcome measure was valid and reliable (significant cancers on pathology)
  • Patients in both groups were recruited from the same population over the same time period
  • Patients were randomized to intervention groups
Reporting
  • The main outcome is not clearly describe in the Methods section
  • Potential confounders and main findings are not clearly described
  • Patient characteristics are not described
  • Statistical tests comparing groups were not performed
  • Adverse events or complications are not reported

External validity
  • The number of patients who were screened but not enrolled was not reported

Internal validity
  • Patients and investigators were not blinded to intervention allocation
  • It is unclear whether outcomes assessors (pathologists) were blinded to intervention allocation
  • Patients lost to follow-up are not described

From: Magnetic Resonance Imaging for Prostate Assessment: A Review of Clinical and Cost-Effectiveness

Cover of Magnetic Resonance Imaging for Prostate Assessment: A Review of Clinical and Cost-Effectiveness
Magnetic Resonance Imaging for Prostate Assessment: A Review of Clinical and Cost-Effectiveness [Internet].
Chiu S, Adcock L.
Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.