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Chiu S, Adcock L. Magnetic Resonance Imaging for Prostate Assessment: A Review of Clinical and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Sep 5.

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Magnetic Resonance Imaging for Prostate Assessment: A Review of Clinical and Cost-Effectiveness [Internet].

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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

Copyright © 2018 Canadian Agency for Drugs and Technologies in Health.

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