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+. Blinded patient population. -. Controlled, Randomized, Double-Blind, Multicenter, Prospective, Phase III Clinical Trial with Single Crossover. Experimental variable (CPE). Experimental variable (CPE). Recruit patients: 67 at MDACC, 33 at TSRCC.

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Presentation Transcript
slide1

+

Blinded

patient

population

-

Controlled, Randomized, Double-Blind, Multicenter, Prospective, Phase III Clinical Trial with Single Crossover

Experimental variable (CPE)

Experimental variable (CPE)

Recruit patients:

67 at MDACC,

33 at TSRCC.

Entry Health Q,

Informed Consent

4 months

+

4 months

Indefinite time

=======►

-

-

C

R

O

S

S

O

V

E

R

RANDOMIZE

OutcomeMeasures:

Incoming Clinical Q, Patient Evaluation Q, TOMCP, LASA, SF-8™

(Exit Q), Temp/humidity

______________________________________________________________________-

Global question:Which prosthesis

do you want to

continue wearing?

Patient

wears the

preferred

prosthesis;

follow-up

by 4-month

PEQ-Telephone Survey

Outcome Measure:

Outgoing Clinical Q,

TOMCP, LASA,SF-8™

Temp/humidity

Outcome Measure:

Outgoing Clinical Q, TOMCP, Temp/humidity

Outcome Measures:

Incoming Clinical Q, Patient Evaluation Q, TOMCP, LASA, SF-8™ (Exit Q), Temp/humidity

Visit 4

Visit 5

Visit 3

+

Visit 6

4 months

+

4 months

Visits 1 & 2

=======►

-

Control variable (silicone)

Indefinite time

Control variable

(silicone)

Fabrication

of 1st prosthesis

by anaplastologist;

ADLTQ

Fabrication

of 2nd prosthesis

by anaplastologist;

ADLTQ

Q ≡ questionnaire

“Multicenter Trial of CPE for Maxillofacial Prosthetics”

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