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Using NIPPV for ALS patients with higher forced vital capacity

Using NIPPV for ALS patients with higher forced vital capacity. Shane Fitzgerald Sung Eun Lim Xingyu Pan. Outline. Background Objectives Analysis Conclusion. Background. ALS

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Using NIPPV for ALS patients with higher forced vital capacity

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  1. Using NIPPV for ALS patients with higher forced vital capacity Shane Fitzgerald Sung Eun Lim Xingyu Pan

  2. Outline • Background • Objectives • Analysis • Conclusion

  3. Background • ALS • Amyotrophic lateral sclerosis, or ALS, is a disease of the nerve cells in the brain and spinal cord that control voluntary muscle movement. • Difficult in breathing • NIPPV • Helps with breathing in night • Treatment for patient with lower breathing function (FVC<50%)

  4. Objectives--what if starting nippv early? • Can ALS patients with a forced vital capacity (FVC) ≥ 50% who are randomized to receive NIPPV tolerate this treatment for 4 hours or more of nightly use? • Active • Sham • Difference in tolerance to standard NIPPV after FVC falls below 50% will be compared between patients who have received active or sham treatments. • Is sham NIPPV to be a believable treatment? • Will patients allocated to the active or sham treatment groups have equal likelihood of suspecting they had received the real treatment? • Whether NIPPV in ALS patients with an FVC ≥ 50% will have better clinical outcomes than those given sham NIPPV.   • a higher quality of life • a slower decline in pulmonary function

  5. Summary of data • Summary of data • 60 patient, randomly assigned to 2 treatment groups • In each group, there are 16 female and 14 males • Patients visit the clinic once every three months

  6. Question 1:can patients tolerate the machine for 4+ hours per day?

  7. Average hours used by patients (FVC >50%) • 50.34% of observations used 4 or more hours. (73 out of 145 observations)

  8. Logistic Regression Analysis • To predict the probability of using BIPAP more than 4 hours <Result of Logistic Regression>

  9. Linear Regression • Response: average hours used <Result of Linear Regression>

  10. Number of Clinic Visit and 4 or more Hours Used

  11. Patients with the most visits

  12. Q2: What’s the difference in tolerance of the machine for patients under active VS sham treatments when their FVC drops to below 50%

  13. Difference in tolerance: fvc< 50% • We would like to compare machine usage times among participants with fvc< 50% • We can not reliably perform any statistical test as only 10 observations have an fvc< 50%. • It is worth noting that 8 of the 10 observations were using the active machine, leaving only 2 using the sham machine.

  14. Boxplot of machine use when fvc< 50%

  15. Quantile Regression • We turn to quantile regression as an investigation technique. • Here we are not so interested in significance levels, but rather the trends of the regression coefficients across various quantiles. • Our response variable will be time spent using the machine.

  16. Quantile regression coefficients treatment: [active = 1, sham = 0] functioning level: [continuous, increases w/ greater functioning] life quality measure: [continuous, increases w/ better quality] patient perception: [discrete; shame = 0, neutral = 1, active = 2]

  17. Q3: Difference in Clinical outcome for patients under active vs sham treatments

  18. Is sham NIPPV a believable treatment? • Actual treatment VS perceived treatment

  19. Progress of disease over time • Who stays in the study? Perceived active VS sham machine user Actual active VS sham machine user

  20. Left: Distribution of speed of decreasing body function and quality of life Right: Distribution of initial body function and quality of life Progress of clinical outcome over time

  21. Progress of decease over time • Which factors can predict the progress of disease? • Regression models: • Dependent variable: change of ALSFRS, FVC, and quality of life over time • Predictor: health status at initial visit, time in the study, gender, age, treatment (active or sham) • Speed of decrease in terms of FVC:

  22. Progress of disease over time • Speed of decrease in terms of ALSFRS (ALS functional rating scale)

  23. Progress of disease over time • Speed of decrease in quality of life

  24. Conclusions

  25. Conclusions • Can patients tolerate NIPPV for 4 hours or more of nightly use when FVC is above 50%? • About half of the patients seem to tolerate this treatment for 4 hours or more. • The number of clinic visit is associated with whether or not to use BIPAP for 4 hours or more and average number of hours used. • Does the tolerance for NIPPV differ between patients under active VS sham treatments when the FVC drops to below 50%? • It appears that machine usage is occurring in a way that is potentially in line with the studies expectations. However, some further, potentially more sophisticated analysis should be done to verify this. • Does treatment impact patients’ disease progress? • Older patients and those who stay in study longer have a slower decreasing rate in body function and quality of life • Treatment (active or sham) doesn’t have a big impact

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