Table 5Strengths and Limitations of Clinical Studies Using the Downs and Black Checklist10

StrengthsLimitations
Gallois et al. (2022) 13
  • Objective, main outcomes, patient inclusion criteria, patient characteristics, and interventions were clearly described
  • Main findings were clearly described including the 95% confidence interval and actual p-values where reported
  • As this is a retrospective review, it is possible that patients were representative of the population of interest and the treatment received was representative of typical treatment
  • All patients were recruited from the same locations
  • Statistical tests appear to have been appropriate, including use of survival analysis for survival outcomes
  • Compliance with the intervention was likely reliable
  • Main outcome measures were likely accurate and reliable
  • Reported conflicts of interest and funding
  • List of confounders not provided
  • Unclear if all important adverse events were reported
  • Unclear if patients who participated in this study were representative of the entire population
  • Comparisons were within-group (before-after) or no comparator; without between-group comparisons (i.e., without a separate control group that received a different treatment, placebo, or no treatment), the results are susceptible to several types of bias, which may impact internal and external validity; overall, all findings should be interpreted with caution, as uncontrolled factors may have influenced the findings
  • Unlikely that participants or research staff were blinded to treatment; however, the outcome was objective, so it is unlikely this caused bias
  • Unclear if subgroup analyses were pre-planned
  • Patients varied in the number of cycles they received; it is unclear if this could have impacted outcomes, or if this was considered in the analysis
  • Patients were not randomized to intervention
  • Unclear if a sample size was calculated
Batra et al. (2021) 14
  • Objective, main outcomes, patient inclusion criteria, patient characteristics, and interventions were clearly described
  • Main findings were clearly described including the 95% confidence interval and actual p-values where reported
  • As this is a retrospective review, it is possible that patients were representative of the population of interest and the treatment received was representative of typical treatment
  • All patients were recruited from the same locations
  • Discussed potential causes of heterogeneity in their results
  • Statistical tests appear to have been appropriate
  • Compliance with the intervention was likely reliable
  • Main outcome measures were likely accurate and reliable
  • Reported no conflicts of interest
  • List of confounders not provided
  • Unclear if all important adverse events were reported
  • Unclear if patients who participated in this study were representative of the entire population
  • Unlikely that participants or research staff were blinded to treatment; however, the outcome was objective, so it is unlikely this caused bias
  • Comparisons were within-group (before-after) or no comparator; without between-group comparisons (i.e., without a separate control group that received a different treatment, placebo, or no treatment), the results are susceptible to several types of bias, which may impact internal and external validity; overall, all findings should be interpreted with caution, as uncontrolled factors may have influenced the findings
  • Unclear if subgroup analyses were pre-planned
  • Patients varied in the number of cycles they received; it is unclear if this could have impacted outcomes, or if this was considered in the analysis
  • Patients were not randomized to intervention
  • Unclear if a sample size was calculated, though this was a population-based study
  • Did not report funding
Khan et al. (2019) 15
  • Objective, main outcomes, patient inclusion criteria, patient characteristics, and interventions were clearly described
  • Main results were clearly described including the 95% confidence interval and actual p-values where reported
  • As this is a retrospective review, it is possible that patients were representative of the population of interest and the treatment received was representative of typical treatment
  • All patients were recruited from the same locations
  • Statistical tests appear to have been appropriate, including use of survival analysis for survival outcomes
  • Compliance with the intervention was likely reliable
  • Main outcome measures were likely accurate and reliable
  • Reported conflicts of interest
  • Subgroup comparisons did not report the 95% confidence interval
  • List of confounders not provided
  • Unclear if all important adverse events were reported
  • Unclear if patients who participated in this study were representative of the entire population
  • Unlikely that participants or research staff were blinded to treatment; however, the outcome was objective, so it is unlikely this caused bias
  • Comparisons were within-group (before-after); without between-group comparisons (i.e., without a separate control group that received a different treatment, placebo, or no treatment), the results are susceptible to several types of bias, which may impact internal and external validity; overall, all findings should be interpreted with caution, as uncontrolled factors may have influenced the findings
  • Unclear if subgroup analyses were pre-planned
  • Patients varied in the number of cycles they received; it is unclear if this could have impacted outcomes, or if this was considered in the analysis
  • Patients were not randomized to intervention
  • Unclear if a sample size was calculated
  • Unclear reporting of funding
Ransom et al. (2014) 16
  • Objective, main outcome, patient inclusion criteria, and interventions were clearly described
  • Main findings were clearly described including the 95% confidence interval and actual P value
  • As this is a retrospective review, it is possible that patients included in this study were representative of the population of interest and that the treatment received was representative of typical treatment
  • All patients appear to have been recruited from the same locations (participating centres)
  • No retrospective unplanned subgroup analyses were reported
  • Compliance with the intervention was likely reliable
  • Main outcome measure was likely accurate and reliable
  • Reported source of funding and no conflicts of interest
  • Patient characteristics not well-described other than type of cancer and risk of cardiac event; missing age, sex, and so forth
  • List of confounders not provided
  • Unclear if all important adverse events were reported
  • Unclear if patients who participated in this study were representative of the entire population
  • Unlikely that participants or research staff were blinded to treatment; however, the outcome was objective, so it is unlikely this caused bias
  • Comparisons were within-group (before-after); without between-group comparisons (i.e., without a separate control group that received a different treatment, placebo, or no treatment), the results are susceptible to several types of bias, which may impact internal and external validity; overall, all findings should be interpreted with caution, as uncontrolled factors may have influenced the findings
  • Follow-up was up to 30 days after the last dose of raltitrexed, but patients varied in the number of cycles they received; it is unclear if this could have impacted outcomes, or if this was considered in the analysis
  • Statistical test used was not described
  • Analysis did not appear to adjust for confounding
  • Patients were not randomized to intervention
  • Unclear if a sample size was calculated
Kelly et al. (2013) 12
  • Objective, main outcomes, patient inclusion criteria, patient characteristics, and interventions were clearly described
  • As this is a retrospective review, it is possible that patients were representative of the population of interest and the treatment received was representative of typical treatment
  • All patients were recruited from the same locations
  • Compliance with the intervention was likely reliable
  • Main outcome measures were likely accurate and reliable
  • Reported conflicts of interest
  • Main findings were not reported in detail, and did not present 95% confidence intervals or p-values as no statistical analyses were conducted
  • List of confounders not provided; unclear if these results may be biased due to confounding
  • Unclear if all important adverse events were reported
  • Unclear if patients who participated in this study were representative of the entire population
  • Unlikely that participants or research staff were blinded to treatment; however, the outcome was objective, so it is unlikely this caused bias
  • Comparisons were within-group (before-after); without between-group comparisons (i.e., without a separate control group that received a different treatment, placebo, or no treatment), the results are susceptible to several types of bias, which may impact internal and external validity; overall, all findings should be interpreted with caution, as uncontrolled factors may have influenced the findings
  • Number of cycles and follow-up length were not reported
  • Patients were not randomized to intervention
  • Unclear if a sample size was calculated
  • Unclear reporting of funding

From: Raltitrexed in Patients With Dihydropyrimidine Dehydrogenase Deficiency

Cover of Raltitrexed in Patients With Dihydropyrimidine Dehydrogenase Deficiency
Raltitrexed in Patients With Dihydropyrimidine Dehydrogenase Deficiency: Rapid Review [Internet].
Vu T, Spry C; Authors.
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