Assessment of Interobserver and Intraobserver variability in Measuring Compliance of the Breasts wit

1
Assessment of Inter-observer and Intra-observer
variability in Measuring Compliance of the
Breasts with the Tissue Compliance Meter (TCM) in
Healthy Volunteers A. Gabriella Wernicke1, MD,
Preeti Parhar1, MD,, Margarita Rasca1, MD, Lea
Baer1, MD, Judith Goldberg2, ScD, Silvia C.
Formenti1, MD 1 Department of Radiation
Oncology, NYU School of Medicine, New York, NY2
Department of Biostatistics, NYU School of
Medicine, New York, NY

• A 2-way ANOVA was applied to assess the
  variability of obtained measurements. For both
  breasts, the average readings by the 3 observers
  are in Table 2

• INTRODUCTION
• Radiation-induced fibrosis (RIF) of the breast
  is a late effect of RT.
• Quantification of RIF remains a challenging
  task.
• TCM is a new non-invasive modality1 previously
  applied to studying tension of muscles in
  rehabilitation medicine.
• While rehabilitation literature indicates good
  inter-observer variability, TCM has never been
  validated in breast tissue.

PURPOSE Prior to embarking on measuring RIF with
TCM we explore TCM in measuring breast compliance
in healthy volunteers and compare inter-observer
and intra-observer variability amongst the
investigators.
Figure 1. TCM to measures compliance of the
breast

• For the 4 quadrants of the both breasts, there is
  no significant difference amongst the
  measurements by each investigator (pgt0.05).
• Further, while there is variability amongst
• subjects (plt0.0001), there is no significant
  variability amongst the observers (pgt0.05).

• METHODS
• Three independent radiation oncologists were
  trained in using TCM hand-held mechanical device
  (Figure.1)
• 1 kg force was applied to 4 locations of both
  breasts upper outer quadrant (UOQ), lower outer
  quadrant (LUQ), lower inner quadrant (LIQ), and
  upper outer quadrant (UOQ).
• Every investigator obtained 3 consecutive
  measurements in each quadrant of both breasts,
  respectively. All subjects were assessed in
  supine position with arms up.
• Twenty healthy volunteers, with no breast disease
  or prior surgical intervention, partook in this
  project. The median age was 33 years (range,
  24-55), median bra size was 34 B (range,
  32A-36B). All subjects were matched for oral
  contraceptive pill and hormonal replacement
  therapy use and menopausal status.

• RESULTS
• Using average of 3 ratings for each of 3 raters
  on 20 subjects, the paired data are in Table 1

CONCLUSION The inter-observer and intra-observer
variability is small using TCM in the population
of healthy women, and the measurements are
reproducible. Using this study, we can embark on
analyzing this technology in the setting of RIF.
REFERENCES 1. Marinus J, Niel CGJH, de Bie RA, et
al. Measuring radiation fibrosis the
interobserver reliability of two methods of
determining the degree of radiation fibrosis.
Int J Radiat Oncol Biol Phys 2000 471209-1217.