05/30/2023
For those of you who attended the Kripalu event and had REMS testing done or anyone else who is curious:
Better Bones - REMS Report Explanation
We commend your interest in Bone Health and your interest in Echolight – REMS. The accuracy of REMS in determining BMD and the ability of REMS to measure Bone Quality called the Fragility Score are important parts of your Bone Health assessment. And remember that since we all have a skeleton made up of bones, we need to pay attention to and take care of our bones because………...
If you ignore your bones, they will go away!
What is REMS?
REMS is a method of bone assessment the utilizes pulsed echographic ultrasonography – REMS is a technology developed by Echolight. REMS is utilized by the EchoS, an ultrasound unit that generates a sound wave that bounces off your bones creating echoes. REMS will then listen to the echoes to determine properties of your bones. REMS can do that because an echo from a strong bone will be different than an echo from a weak bone. The measurements obtained by REMS comply with the standards established by the World Health Organization for bone assessment. REMS assess your spine and left and right hips to generate two values that are critical to your bone health: These numbers are:
(1) Fragility Score - FS
(2) Bone Mineral Density - BMD
Historically, Bone Mineral Density (BMD) has been the number that was used to determine if you were at risk of sustaining a fragility fracture. However, it is now recognized that BMD is not the only important number because there are individuals with low BMD that never fracture and there are other individuals who sustain fragility fractures and have good BMD. Research is showing that there are other properties of bone that need to be measured. The important bone equation is:
Strength = Bone Quality & BMD
Fragility Score (FS) is a measure of bone quality that can help you have a better understanding of your risk of a fragility fracture. Also, there is a third bit of information that the REMS assessment will provide. This is:
(3) Body Composition and Estimated Activity Metabolism
The information provided by the Body Composition Analysis may provide useful information for a comprehensive weight loss program. The results obtained by REMS examinations are clinically valid and can be used in your bone health care.
How will I know what my REMS results mean?
A written generalized explanation of REMS reports will be made available. For a more detailed explanation of the information presented in a REMS report or for additional information concerning your bone health, please contact Central Carolina Orthopedic Associates:
• Office – 919-774-1355 – ask for Cindy
• Cindy – cmcauley@centralcarolinaortho.com
• Web address – www.centralcarolinaortho.com
What is included on a REMS report?
SPINE PAGE 1 of the report will have a graph with your T-score and an anatomical diagram of the spine Region of Interest (ROI) that are color-coded based on the BMD and T-score results.
• To the left of the anatomical diagram is a color-coded graph (green, yellow, red) plots age vs. T-score.
• T-score results will appear on the graph as a target providing a quick and easy way to visualize T-score values.
• The blue-gray table located immediately below the graph has the BMD, T-score, Z-score, and Diagnosis.
• The presence of two colors on the spine diagram is acceptable if the color combinations are either green-yellow or yellow-red. A green-red combination will need further assessment by your examiner.
• If any of the vertebral bodies are resulted as gray color, then that is an indication that REMS did not have enough information at that particular bone for analysis and it was excluded from the final report. If that were to happen, ND (Not Diagnostic) will be listed in the accessory blue-gray table underneath the diagram next to the level (L1-L4) that was excluded.
• Up to two levels can be excluded by REMS and the results will still be clinically valid.
• The blue-gray table below the diagram of the spine provides the BMD values and T-scores for each individual vertebral body evaluated and should be qualitatively assessed but has no quantitative clinical application.
• It is important to look at all the BMD values on the table – the BMD values should be getting larger as the numbers go from L1 to L4. Unfortunately, that does not happen all the time - L3 is sometimes larger than L4. Also, in general, if the numbers are close in value, they are acceptable.
• If any single BMD value and T-score is way out of line with the other vales (i.e., green, and red on the same diagram) the out-of-range number needs to be assessed by your provider but disregarded in the final test scores. This situation is rare in REMS assessments.
• The REMS spine exam will report the statistically-weighted averaged total of the areal BMD values (g/cm2) of the individual vertebral bodies that were successfully examined.
• The TOTAL (statistically-weighted average of L1-L4) BMD then is converted to a T-score and Z-score. A Diagnosis is determined from the T-score.
• The TOTAL BMD is also used for quantitative comparisons year-to-year.
• In addition, on the bottom of SPINE PAGE 1 you will find very important clinical information in the Fracture Risk Assessment Box. The Fragility Score will be presented as a number from1 to 100. This will be explained in greater detail on SPINE PAGE 2.
• The next line of information, the 5 Year Risk of a Major Osteoporotic Fracture, will be presented as a number out of 1000!!! Presenting the data as a per thousand is a scientific method of data presentation and reflects the ability of the REMS to measure to the BMD to the thousandth.
• To convert that number to a percent, just divide by ten – that will yield the fracture risk as a percent.
SPINE PAGE 2 depicts the position of the obtained FS value on a colored graph. The graph represents a database of individuals who were determined to be either fragile (had a history of one or more fragility fractures) or non-fragile (no history of a fragility fracture).
• The FS has been determined to be currently most reliable number in determining fracture risk.
• The FS value is presented as a unitless number that is plotted on the Age vs. FS graph.
• FS values that are present in the green area of the graph indicate low fracture risk.
• FS values in the red area of the graph indicate very high fracture risk.
• The yellow zone is a zone of some uncertainty – if the FS is close to the green zone, then that would indicate that the fracture risk is still relatively low. If the FS value is plotted in the yellow zone near the red zone, then the fracture risk would be high.
• Therefore, fracture risk increases as the FS rises and the position on the graph gets closer to or into the red zone.
• It is important to remember that the FS is independent from the BMD – FS was determined by a unique soundwave.
• Academic studies have determined the validity of FS as a predictive value for fracture risk and in those studies, FS was found to be both the most sensitive (true-positive for fracture) and the most specific (true-negative for no fracture) test when compared to either DXA-derived or REMS-derived BMD.
• The SPINE FS database includes individuals who sustained major fragility-type fractures.
• The FS value was derived from the mathematical analysis of the backscatter radiofrequency wave (echo) that was produced by the interaction of the sound wave with the micro structural elements of your bone. The FS is compared to a database of individuals who were identified as either fragile (had sustained a fragility fracture) or non-fragile (had not sustained a fragility fracture). Fracture risk is determined by that comparison.
SPINE PAGE 3 is currently under development and has no practical clinical application.
SPINE PAGE 4 is also still under development but it does provide some clinical value in the form of basic body composition information.
• Since the ultrasound waves pass through body tissue to reach the bones, some of the echoes received and analyzed contain information on % adipose (fat) composition.
• Estimates for kilocalorie requirements is listed.
• This information is available on the spine examination only.
SPINE PAGE 5 is the page with the B-mode doppler images used during the REMS examination for determining correct depth and focal settings.
HIP PAGE 1 of the report will have a graph of your T-score and an anatomical diagram of the hip (Right or Left Femur) Region of Interest (ROI) that are color-coded based on the BMD and T-score results.
• The REMS hip exam is similar in format to the spine report but has slightly different information that is relevant to the hip.
• To the left of the anatomical diagram of the hip is a color-coded graph (green, yellow, red) plots age vs. T-score.
• T-score results will appear on the graph as a target providing a quick and easy way to visualize T-score values.
• The blue-gray table located immediately below the graph reports the BMD, T-score, Z-score, and Diagnosis for the hip (NECK).
• There are two important values on the REMS hip report: NECK and TOTAL HIP. The TROCHANTER is reported but it is not important.
• NECK is the femoral neck (or hip) and is the ROI being evaluated for fracture risk.
• The NECK is the colored region on the diagram of the femur (hip bone).
• The blue-gray table below the diagram of the hip provides the BMD values and T-scores for two other structures – the TOTAL HIP and the TROCHANTER.
• The TROCHANTER is the darker shaded pointed knuckle of bone neck to the colored NECK on the diagram.
• The TROCHANTER has no quantitative clinical application but it is included in the bone that is assessed to generate the TOTAL HIP values.
• The TOTAL HIP is the part of the hip that includes the NECK, TROCHANTER, and the bone in-between the NECK and TROCHANTER.
• The TOTAL HIP is important for 2 reasons – (1) it should be larger than the NECK BMD value to indicate appropriate positioning (especially on the DXA report) and (2) the TOTAL HIP BMD is also used for quantitative comparisons year-to-year.
• The NECK BMD is converted to a T-score and Z-score. A Diagnosis is determined from the T-score.
• In addition, on the bottom of HIP PAGE 1 you will find very important clinical information in the Fracture Risk Assessment Box. The Fragility Score will be presented as a number from 1 to 100. This will be explained in greater detail on HIP PAGE 2.
• The next line of information, the 5 Year Risk of a Major Osteoporotic Fracture, will be presented as a number out of 1000!!! Presenting the data as a per thousand is a scientific method of data presentation and reflects the ability of the REMS to measure to the BMD to the thousandth.
• To convert that number to a percent, just divide by ten – that will yield the fracture risk as a percent.
HIP PAGE 2 depicts the position of the obtained FS value on a colored graph. The graph represents a database of individuals who were determined to be either fragile (had a history of one or more fragility fractures) or non-fragile (no history of a fragility fracture).
• The FS has been determined to be currently most reliable number in determining fracture risk.
• The FS value is presented as a unitless number that is plotted on the Age vs. FS graph.
• FS values that are present in the green area of the graph indicate low fracture risk.
• FS values in the red area of the graph indicate very high fracture risk.
• The yellow zone is a zone of some uncertainty – if the FS is close to the green zone, then that would indicate that the fracture risk is still relatively low. If the FS value is plotted in the yellow zone near the red zone, then the fracture risk would be high.
• Therefore, fracture risk increases as the FS rises and the position on the graph gets closer to or into the red zone.
• It is important to remember that the FS is independent from the BMD – FS was determined by a unique soundwave.
• Academic studies have determined the validity of FS as a predictive value for fracture risk and in those studies, FS was found to be both the most sensitive (true-positive for fracture) and the most specific (true-negative for no fracture) test when compared to either DXA-derived or REMS-derived BMD.
• The HIP FS database includes individuals who sustained fragility-type hip fractures.
• The FS value was derived from the mathematical analysis of the backscatter radiofrequency wave (echo) that was produced by the interaction of the sound wave with the micro structural elements of your bone. The FS is compared to a database of individuals who were identified as either fragile (had sustained a fragility fracture) or non-fragile (had not sustained a fragility fracture). Fracture risk is determined by that comparison.
HIP PAGE 3 is currently under development and has no practical clinical application.
HIP PAGE 4 is not relevant to Body Composition determination.
HIP PAGE 5 is the page with the B-mode doppler images used during the REMS examination for determining correct depth and focal settings.
References:
(1) Section 510(k) premarket notification of intent to market - FDA REMS approval
(2) Delia Ciardo, Paola Pisani, Francesco Conversano, Sergio Casciaro, Pulse-Echo Measurements of Bone tissue; Techniches and Clinical results at the Spine and Femur, Bone Quantitative Ultrasound, Advances in Experimental Medicine and Biology, 2022, 1364, https://doi.org/10.1007/978-3-030-91979-5_7
(3) M. Di Paola, D. Gatti, L. Cianferotti, L. Cavalli, C. Caffarelli, F. Conversano, E. Quarta, P. Pisani, G. Girasole, A. Giusti, M. Manfredini, G. Arioli, M. Matucci-Cerinic, G. Bianchi, R. Nuti, S. Gonnelli, M. L. Brandi, M. Muratore, M. Rossini, Radiofrequency echographic multispectrometry compared with dual X-ray absorptiometry for osteoporosis diagnosis on lumbar spine and femoral neck Osteoporosis International (2019) 30:391–402 https://doi.org/10.1007/s00198-018-4686-3
(4) Paola Pisani, Francesco Conversano, Maurizio Muratore, Giovanni Adami, Maria Luisa Brandi, Carla Cafarelli, Ernesto Casciaro, Marco Di Paola, Roberto Franchini, Davide Gatti, Stefano Gonnelli, Giuseppe Guglielmi, Fiorella Anna Lombardi, Alessandra Natale, Valentina Testini, Sergio Casciaro, Fragility Score: a REMS based indicator for the prediction of incident fragility fractures at 5 years Aging Clinical and Experimental Research https://doi.org/10.1007/s40520-023-02358-2.
(5) Paola Pisani, Antonio Greco, Francesco Conversano, Maria Daniela Renna, Ernesto Casciaro, Laura Quarta, Daniela Costanza, Maurizio Muratore, Sergio Casciaro, A quantitative ultrasound approach to estimate bone fragility: A first comparison with dual X-ray absorptiometry Measurement 101 (2017) 243–249 http://dx.doi.org/10.1016/j.measurement.2016.07.033 0263-2241/ 2016 Elsevier Ltd. All rights reserved.
All rights reserved and property of Andrew Bush MD, FAAOS and Kimberly Zambito MD, FAOA, FAAOS
May 2023
