Protocol allocation and exclusion in two Danish randomised trials in ovarian cancer
1991

Danish Trials on Ovarian Cancer Treatment

Sample size: 716 publication Evidence: moderate

Author Information

Author(s): K. Bertelsen

Primary Institution: Odense University Hospital

Hypothesis

What are the reasons for patient exclusion in randomised trials for ovarian cancer treatment?

Conclusion

The study found that a significant number of eligible patients were not randomised due to both avoidable and unavoidable reasons.

Supporting Evidence

  • Only 60% of eligible patients in early stages were randomised.
  • 73% of eligible patients in advanced stages were randomised.
  • 11% of early stage patients were excluded for unavoidable reasons.
  • 29% of early stage patients were excluded for avoidable reasons.
  • Survival for randomised patients was better than for non-randomised patients.

Takeaway

The study looked at why some patients with ovarian cancer didn't get to participate in important treatment trials, and it found that many could have been included if the reasons for exclusion were better managed.

Methodology

The study registered patients diagnosed with epithelial ovarian cancer and analyzed the reasons for exclusion from randomised trials.

Potential Biases

The randomised population may not represent the overall patient population due to selective inclusion.

Limitations

The study's findings may not be generalizable due to the specific criteria and patient selection processes used.

Participant Demographics

Patients were primarily women diagnosed with epithelial ovarian cancer, aged below 70 years.

Statistical Information

P-Value

0.0055

Statistical Significance

p=0.0005

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication