MUAC z-score tape and methods of use thereof

#The World Health Organization has determined that anthropometry, the comparative measurement and study of the human body, reflects both nutritional and health status and that it is predictive of performance, health, survival, and the risk of disease. Anthropometric measurements can also be used to assess the need of an individual for special services such as nutritional rehabilitation and support, or to assess the response of a patient to an intervention. The middle-upper arm circumference (MUAC) of an individual is an anthropometric measurement known to be a reliable indicator of skeletal protein and subcutaneous fat, both important determinants of malnutrition. In some studies, MUAC has been found to be better at predicting death in children than any other anthropometric indicator. The MUAC measurement, which is taken on the left arm, at the mid-point between the tip of the shoulder (i.e., the upper edge of the posterior border of the acromion process) and the tip of the elbow (i.e., the olecranon process), has been widely adopted as a favored anthropometric technique. MUAC measurement has been vigorously promoted as the preferred anthropometric technique by the World Health Organization (WHO), United Nations Children's Fund (UNICEF), and many governmental and private health organizations throughout the world. In addition to its value as a nutritional status assessment tool, MUAC measurement is favored because it requires no expensive equipment or extensive training, is portable, easy to use and widely applicable. MUAC measurement can be taken regardless of the age or health status of the individual or the ability to stand, sit or walk. MUAC measurements can be taken on even the most debilitated individuals.

#Currently MUAC is widely used by international agencies to evaluate the nutritional status of children in medically underserved areas such as developing nations. More recently, The Academy of Nutrition and Dietetics and the American Society for Parenteral and Enteral Nutrition drafted a consensus statement with recommendations for diagnosing and documenting pediatric malnutrition in the United States, (Becker et al. J Acad. Nutr. Diet. 2014; 114: 1988-2000). MUAC was among the indicators of malnutrition the consensus panel recommended for evaluation. The panel proposed that “MUAC measurements should be part of the full anthropometric assessment in all patients, and are particularly important in those whose weight may be affected by lower-extremity edema, ascites, or steroids, as weight trends alone are unreliable related to fluid status. When serial z scores are unavailable, serial MUAC measurements can be used to monitor changes in body composition using the child as his or her own control. MUAC has been indicated as a more sensitive prognostic indicator for mortality than weight-for-height parameters in malnourished pediatric patients.” These entities advise that, “trained individuals consistently perform these measurements for best long-term comparison of data.” They further explicitly recommend that “z score, decline in z score, and negative z score” be used to classify and document pediatric malnutrition.

#The World Health Organization has developed Child Growth Standards, comprising a set of population norms for malnutrition based on MUAC measurements for boys and girls from age 3 months to 5 years. While MUAC measurements can be taken with any measuring tape marked in millimeters, nutritional status is determined by referencing a set of norms that establish the measurements associated with various stages of malnutrition. Typically, these norms reflect a standard reference value that represents the central tendency (i.e., the mean or median) arm measurement for a nutritionally healthy child of a given age in the reference population. Variance from the reference mean value is measured in standard deviations. How far (i.e. how many standard deviations) away a child's measurement is from this population mean is represented by a number or standard score commonly known as the z-score. Thus, the reference mean value is assigned a z-score of 0. The various stages of malnutrition (specifically under nutrition) are defined by negative standard deviations from the mean, or negative z-scores. However, the World Health Organization (WHO) has developed a single child growth threshold for the identification of severe acute malnutrition in infants and children that is not based on z-score. It has issued the MUAC measuring tape that incorporates color bands which discriminate between severe acute malnutrition, moderate acute malnutrition, at risk for acute malnutrition, and normal in children up to 5 years of age. Importantly, the WHO MUAC tape reflects singular categorical color-banding thresholds for all children irrespective of age, such that reliability suffers considerably at the extremes of age.

#The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

#FIG. 1 is an illustration of a strip of one embodiment of the device of the present disclosure (MUAC z-score tape) for use on children aged 2 months to 47 months including standard score indicia that represent standard score ranges calculated from lambda, mu, and sigma (LMS) values that derive from population data that has been transformed and smoothed. The strip illustrated in FIG. 1 has been cut into two sections so that it fits onto a single page;

#FIG. 2 is an illustration of another strip of one embodiment of the device for use on ages 4 years to 18 years including standard score indicia that represent standard score ranges calculated from lambda, mu, and sigma (LMS) values that derive from population data that has been transformed and smoothed. The strip illustrated in FIG. 2 has been cut into two sections so that it fits onto a single page;

#In one preferred embodiment of the present disclosure, illustrated in FIGS. 1 and 2, the device 1 comprises a plurality of elongate flexible strips 10, 11. The strips are of similar construction and unless otherwise indicated, each reference numeral applies to both strips. The strips 10 and 11 each have a respective first side 20 and an opposing second side 30, each of which includes imprinted indicia. The strips also each have a respective first end 40 and a second end 50. The first end 40 includes a fastener member 60, which may or may not be of unitary construction with the strip. The fastener 60 is sized and shaped to extend laterally beyond the sides of the strip sufficient to include an opening 61 such as a slit or slot 61. The slot 61 is positioned orthogonal to the strip and is sized for sliding reception of the second end 50 of the strip, thereby forming the strip 10 into a band for encircling a body part of an individual. The second end of each strip may be shaped at the sides to form a slightly narrower tip 51 for ease of insertion into the slot 61. The fastener members 60 and the respective strips 10 and 11 may be of unitary construction, or the fasteners may be formed separately and attached to form the first end 40 of the respective strip. Preferred body parts include the middle-upper arm, middle thigh, abdomen, and chest.

#The first and second sides 20, 30 of the strips are each imprinted with two types of scales of indicia. A first scale of linear measurement indicia 70 includes a linear measurement scale marked with 1 mm, 0.5 mm and 1 cm gradations for measuring the circumference of a body part of an individual. The gradations may extend from 0 cm to 100 cm depending on the anticipated girth of body part of the individuals to be measured. Strip 10 is designed for use in individuals aged 2 months to 36 months, and includes gradations from 8 cm to 36 cm. Strip 11 is designed for individuals aged 4 years to 18 years and includes gradations from 9 cm to 57 cm. Preferred body parts include the middle-upper arm, middle thigh, abdomen, and chest. With specific reference to FIGS. 1-4, the strips and scales thereon are particularly adapted for instances when the body part is the middle upper arm.

#Scales of standard score indicia 80 corresponding to preselected ages or age ranges are arranged in stacked relation above and/or below the first scale of indicia 70. The standard score indicia 80 can represent standard score ranges calculated from lambda, mu, and sigma (LMS) values that derive from population data that has been transformed and smoothed as previously described. Alternatively, the demarcated ranges can reflect the centiles for the raw untransformed data that correspond to selected standard scores as defined in standard normal probability tables. The standard score indicia scales 80 include a plurality of age or age range-specific scales of indicia, each of which indicates the range of linear measurements corresponding to a respective number of standard deviations from the mean measurement associated with nutritional status. For example, on strip 11 a first standard score indicia scale 81 represents standard scores for children aged 2 months. A second standard score indicia scale 82 represents standard scores for children aged 3 months. A third standard score indicia scale 83 represents standard scores for children aged 4 months. A fourth standard score indicia scale 84 represents standard scores for children aged 5 months. A fifth standard score indicia scale 85 represents standard scores for children aged 6 to 11 months. A sixth standard score indicia scale 86 represents standard scores for children aged 12 to 23 months. A seventh standard score indicia scale 87 represents standard scores for children aged 24 to 35 months. A second standard score indicia scale 88 represents standard scores for children aged 36 to 47 months.