Best of the AANS Session-Statistical Discussant Prospective Randomized Trial Of Temporary Inferior Vena Cava Filter in Thrombophillic Patients That Had Cranial or Spinal Surgery

Statistical Discussant Prospective Randomized Trial Of Temporary Inferior Vena Cava Filter in Thrombophillic Patients That Had Cranial or Spinal Surgery

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Video Transcription

I'm Fred Barker, and I'll comment on Dr. Shapiro's presentation from a statistical standpoint.  I'd like to look at this trial through two useful lenses, the CONSORT statement on reporting of  randomized trials and the JAMA user's guides to medical literature. From the standpoint of the  CONSORT statement, not surprisingly, today's brief oral presentation is missing many of the  important aspects of a full published trial report. Importantly, though, the two treatment  groups appear well-balanced for risk factors, and follow-up appears complete. The JAMA user's  guide recommends we check two things, the size of the treatment benefit and whether the treatment  results can be applied to our own patients. First, focusing for brevity only on sudden death, the treatment benefit appears clear. Seven percent fewer patients died with filters.  This result is both statistically and clinically significant. One fewer patient died for every 14  patients treated with filters. These results justify Dr. Shapiro's recommendation to adopt  the treatment. Can we apply the results to our own patients? The death rate from PE of seven percent  seems very high. The inclusion criteria for the trial were very strict. A personal history of more  than one DVT or PE and a known molecular or clinical risk factor for thrombophilia. For  patients who match these limited criteria, the trial establishes better results with temporary  filters. For more common clinical scenarios, such as one prior PE or DVT with or without known  thrombotic risk factors, additional trials may be needed before we can make a confident recommendation for filters.

Video Summary

In this video, Fred Barker provides a statistical analysis of Dr. Shapiro's presentation on a trial. He applies the CONSORT statement, noting that the oral presentation lacks important aspects of a full trial report. However, the two treatment groups seem well-balanced and follow-up is complete. Using the JAMA user's guide, Barker examines the treatment benefit and applicability to patients. The treatment benefit for sudden death is evident, with 7% fewer deaths in the filter group. This result is statistically and clinically significant, justifying the adoption of the treatment. However, for patients who don't strictly fit the trial's criteria, more trials may be necessary before confidently recommending filters. (Video transcript by Fred Barker)

Keywords

Fred Barker

statistical analysis

CONSORT statement

trial report

treatment benefit