Clinical Trials: Endpoints and Outcome Assessment

2019 ◽  
pp. 407-421
Author(s):  
Nancy U. Lin
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment

The Chymopapain Clinical Trials

Neurosurgery ◽  
1985 ◽  
Vol 17 (1) ◽  
pp. 107-110 ◽  
Author(s):  
Stephen J. Haines
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment ◽  
Therapeutic Efficacy ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Successful Outcome ◽  
Relative Efficacy ◽  
Number Of Patients ◽  
Current Controversy ◽  
Probability Of Success

Abstract The three published randomized clinical trials of chymopapain injection vs. placebo injection for the treatment of herniated lumbar discs are reviewed. Despite some differences, the similarities in selection criteria, technique, and outcome assessment are great enough to justify pooling the results to obtain an overall assessment of chymopapain efficacy. These pooled results suggest that the odds of successful outcome (at least some improvement in symptoms after injection) are 2.6 times as great with chymopapain injection as those after placebo injection. This corresponds to a 50% greater probability of success with chymopapain than with placebo or a 23% increase in the number of patients successfully treated with chemonucleolysis over those successfully treated with placebo. The fact that data from 234 patients evaluated in randomized clinical trials could resolve a controversy over therapeutic efficacy that the uncontrolled evaluation of over 20,000 patients could not answer suggests that the current controversy over the relative efficacy of chymopapain and discectomy should be studied in the same way. The difficulties of such a study are discussed. (Neurosurgery 17:107-110, 1985)

Outcome Assessment in Traumatic Brain Injury Clinical Trials and Prognostic Studies

2010 ◽  
Vol 25 (2) ◽  
pp. 92-98 ◽  
Author(s):  
Mark Sherer ◽  
Tresa Roebuck-Spencer ◽  
Lynne Cole Davis
Keyword(s):  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Outcome Assessment

Outcome Assessment in Clinical Trials of Fracture-Healing

2008 ◽  
Vol 90 (Suppl 1) ◽  
pp. 62-67 ◽  
Author(s):  
Saam Morshed ◽  
Luis Corrales ◽  
Harry Genant ◽  
Theodore Miclau
Keyword(s):  
Clinical Trials ◽  
Fracture Healing ◽  
Outcome Assessment

scholarly journals Outcome assessment in cellulitis clinical trials: is telephone follow up sufficient?

2015 ◽  
Vol 21 (7) ◽  
pp. 676.e5-676.e7 ◽  
Author(s):  
V.E. Nambudiri ◽  
R.C. Dwyer ◽  
C.A. Camargo ◽  
T.S. Kupper ◽  
D.J. Pallin
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment

Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints

2015 ◽  
Vol 49 (6) ◽  
pp. 797-804 ◽  
Author(s):  
Sarah Fleming ◽  
◽  
Alexandra I. Barsdorf ◽  
Cindy Howry ◽  
Hannah O’Gorman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcome ◽  
Outcome Assessment ◽  
Assessment Data ◽  
Patient Reported

Outcome assessment for clinical trials: How many adjudicators do we need?

1997 ◽  
Vol 18 (1) ◽  
pp. 27-42 ◽  
Author(s):  
S.D. Walter ◽  
Deborah J. Cook ◽  
Gordon H. Guyatt ◽  
Derek King
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment
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