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Statistical vs. Clinical Significance: They Are Not the Same

Discussion in 'General Discussion' started by Dr.Scorpiowoman, Sep 11, 2016.

  1. Dr.Scorpiowoman

    Dr.Scorpiowoman Golden Member

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    MedPage Today featured an article about the beneficial effects of daytime wearing of compression stockings on obstructive sleep apnea. The premise was that increased edema in the neck could be caused by fluid coming from the legs when patients were in the supine position at night. Twelve patients who served as their own controls wore compression stockings for a week and then no stockings for a week alternating. The stockings lowered the amount of fluid in the neck by 60%, a statistically significant difference. So far, so good.

    This resulted in another highly statistically significant finding, which was a 36% reduction in episodes of apnea [cessation of breathing] and hypopnea [inadequate breathing]. Sounds good, right? The problem is that the average number of episodes of apnea/hypopnea decreased from 48 per hour to 31 per hour. Patients experiencing more than 30 episodes of apnea/hypopnea per hour are classified as having severe obstructive sleep apnea. This means that the treatment only put the patients in the low range of severe obstructive sleep apnea. They still would require maximum therapy. Is a reduction in apnea/hypopnea episodes that does not move the patient out of the severe category really clinically significant? It does not seem so to me.

    Although the MedPage piece did not address that issue, it did mention other limitations of the study including that study was small and brief, it included only otherwise healthy, non-obese patients and it did not look at whether the stockings had any impact of daytime sleepiness.

    Another possible problem which I am familiar with concerning patients with varicose veins is that wearing compression stockings is uncomfortable, especially in the summer. They often do not fit well and are not particularly stylish. All of those factors lead to non-compliance.

    Bottom line: Although there was a statistically significant improvement in the number of apnea/hypopnea episodes when compression stockings were worn, it does not appear that there was a clinically significant improvement in the course of obstructive sleep apnea.

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