REDUCING VARIABILITY / PLACEBO RESPONSE

PATIENT EDUCATION – How can variability be reduced?

Placebo Response Education

  • Understanding the Terms Placebo Control and Double Blind
  • What is the Placebo Effect?
  • The Difference Between a Treatment Relationship and a Research Relationship
  • How to Rate Your Pain Consistently Using Pain Scales
  • Measuring Pain on a Visual Analog Scale (VAS)
  • NPRS-Numerical Pain Scale
  • Collecting Pain Relief Assessments
  • Measuring Pain Relief Using the Two Stopwatch Technique
  • What is Rescue Medication?
  • Conclusion

The properly educated patient can be your greatest ally in producing a positive analgesic clinical trial. A significant portion of an analgesic investigation's variability is produced secondary to cognitive gaps that the patient may have when interpreting the various protocol mandated scales and questions. All pharmaceutical companies spend a large amount of time perfecting their protocol and selecting/educating quality sites so that the efficacy of their drug can be statistically demonstrated. However, an equal amount of effort is rarely placed on patient education. At Lotus, we believe this piece of the puzzle is the responsibility of the site and as such, we have developed proprietary educational materials including a patient education video and a detailed patient post-test.

Click here to view a sample of our
Analgesic Post‐Test


STAFF TRAINING

Properly educated staff can stabilize patient expectations and reduce placebo response. At Lotus we believe that following the protocol is only the beginning of our responsibility. Subjective endpoint clinical trials require finesse and critical thinking that move beyond a robotic examination of protocol mandated duties. All members of our staff are required to understand the primary endpoint and its method of calculation so that they can focus their efforts on obtaining nonbiased and accurate data.

Click here to view a sample of our Clinical Vignettes


Maximizing Effect Size /
Reducing Placebo Response Video

Experimental error can reduce effect size and lead to a false negative result. In this video our CSO Dr. Neil Singla describes the three most common sources of experimental error in analgesic investigations and provides insights on how to minimize them.