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Subjective validation study

Tarek Loubani edited this page Apr 1, 2015 · 3 revisions

Introduction

Study design

Population:

  • 20 physicians split into two groups

  • 10 physicians in placebo group

  • 10 physicians in intervention group

  • Intervention: 3d printed stethoscope

  • Control: Littmann stethoscope

  • Outcomes:

  • Physician satisfaction

  • Subjective quality of sound

Methods

Blinding and Randomization

Ten 3D Printed stethoscopes and ten Littmann Cardiology 3 stethoscopes will be covered and weight-matched so that visual and tactile distinction is impossible between the two stethoscopes. As well, opaque diaphragms will be used and sealed onto the stethoscope to prevent tampering.

A randomized 4-digit number will be assigned to to each package.

A second person will then take the list of packages and randomize the order of distribution to study participants.

First stage study

During the first stage, twenty physicians will be given stethoscopes and asked to use them as per normal for a period of 14 days in a blinded fashion.

Second stage study

During the second stage, stethoscopes will again be randomized and assigned to physicians. Stethoscopes will be unblinded, and physicians will use them as per normal for a period of 14 days.

Data collection

Data will be collected from participants as they receive the stethoscope, at the 7-day mark, and at the 14-day mark. Data will be anonymous.

Data will consist of a short questionnaire delivered either on paper or digitally.

Data analysis

Analysis is TBD.

Results

Discussion

Conclusion