This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe
This study is a combination of Prospective and Retrospective models.
Study Type
OBSERVATIONAL
Enrollment
227
Kepler Universittsklinikum Neuromed Campus
Linz, Wagner-Jauregg-Weg, Austria
Landeskrankenhaus Vocklabruck
Vöcklabruck, Austria
Helsinki University Central Hospital
Helsinki, Finland
Accuracy of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Accuracy was estimated as 100 percent (%) \*(number of true positives \[TP\] + number of true negatives \[TN\]) / (number of TP + number of TN + number of false positives \[FP\] + number of false negatives \[FN\]). The data presented are the point estimates representing percentage of accuracy, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Sensitivity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Sensitivity was defined as 100%\*number of TP / (number of TP + number of FN). The data presented are the point estimates representing percentage sensitivity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Specificity of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
Specificity was defined as 100%\*number of TN / (number of TN + number of FP). The data presented are the point estimates representing the percentage specificity, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Positive Predictive Value (PPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
The PPV was defined as 100%\*number of TP / (number of TP + number of FP). The data presented are the point estimates representing percentage PPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
Time frame: Up to 1093 days
Negative Predictive Value (NPV) of VIZAMYL™ PET Image Interpretations Made by Clinical Readers
The NPV was defined as 100%\*number of TN/ (number of TN + number of FN). The data presented are the point estimates representing percentage NPV, with Measure Type "Number" and 95% exact binomial confidence interval. These have been estimated using Clopper-Pearson method.
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Ospedal Mons Dimicolli - Barletta
Barletta, Italy
U.O. Medicina Nucleare- ASSST Spedali Civili P.O. di Brescia
Brescia, Italy
Azienda Ospedaliero Universitaria Careggi - S.O.D. Patologia Medica
Florence, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
Vall d'Hebron University Hospital
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Time frame: Up to 1093 days
Correlation Coefficient Between Clinical Reader Age and Accuracy
Correlation coefficient was used to assess the correlation between clinical reader age and accuracy. A scatterplot of clinical reader accuracy vs. reader age was plotted to check correlation (coefficient) between accuracy and age.
Time frame: Up to 1093 days
Number of Participants With Accuracy Less Than (<) 0.9333 or Greater Than Equal to (>=) 0.9333 in Terms of Sex of Clinical Readers
Number of participants with accuracy \< 0.9333 or \>= 0.9333 in terms of sex of clinical readers were reported.
Time frame: Up to 1093 days
Number of Participants With Association of Electronic Training (With or Without In-Person Training) With Clinical Reader Accuracy
Number of participants with association of electronic training (with or without In-person training) with clinical reader accuracy were reported.
Time frame: Up to 1093 days
Number of Participants With Association of In-Person Training (With or Without Electronic Training) With Clinical Reader Accuracy
Number of participants with association of In-person training (with or without electronic training) with clinical reader accuracy were reported.
Time frame: Up to 1093 days
Number of Participants With Association of Training Type With Clinical Reader Accuracy (Excluding Readers Who Took Both Types)
Number of participants with association of training type with clinical reader accuracy (excluding readers who took both types) were reported.
Time frame: Up to 1093 days
Time From Last Training
Time from last training was reported. Number of readers remaining at timepoint was number of readers with accuracy greater than or equal to 0.9333. All readers met this criterion at time 0 hence, data for all clinical reader is reported. All 18 readers were trained in interpretation of Vizamyl images \& as part of their training, had their interpretation accuracy tested using 15 test images. To pass test, a reader had to interpret atleast 14 of 15 images correctly. 14 represents 0.9333 of 15, so each reader had to have an accuracy of atleast 0.9333 in order to pass test. Date on which a reader took his/her test is considered to be Time 0. Each reader's accuracy at a later time was assessed in study.
Time frame: Retrospective data covering up to 8.1 years