‘Do anti-embolism stockings fit our legs? Leg survey and data analysis’ Abstract Background Anti-embolism stockings are commonly used worldwide to prevent the development of thrombosis in hospitalised patients. Patients are typically measured for, and fitted with, anti-embolism stockings during extended periods of non-ambulation. Anti-embolism stockings must critically fit the leg to achieve optimum blood flow and thus success of prophylaxis. Therefore, hospitals endeavour to maintain stock of anti-embolism stockings that fit the majority of their patients. Objectives The objective of this study was to establish whether popular styles/brands of anti-embolism stockings “fitted” the legs of randomly selected volunteers. Design/Methods Volunteer’s legs were measured at ankle, calf and thigh following guidance from British nurses and in accordance with brand instructions. Leg measurements were subsequently compared to the size charts of 10 anti-embolism stocking styles made by 4 different manufacturers. Where a volunteer’s leg measurements matched all measurement points for any size, in style’s range, “fit” was achieved. Settings Volunteers were measured in different settings around Scotland, including private homes, work places and shopping centres. Participants A convenience sample of 471 volunteers (283 female, 188 male) were recruited on the basis of willingness to participate and being over 16 years old. Volunteers ranged from 17 to 82 years old with an average age of 35. Results The 10 different styles of anti-embolism stockings, made by 4 different brands, examined for this paper had a “fit” coefficient ranging from 0% to 100% for our volunteer’s legs. The fit coefficient is strongly influenced by the Brand’s sizing policy. Conclusions The proportion of legs that “fit” a particular brand of anti-embolism stockings can be increased through: 1. the reduction of the number of leg measurement points that need to be matched to the size chart of the stockings; 2. the use of open-ended size ranges; 3. the use of increased size range width and 4. the use of increased overlap between sizes. However, all but the last of these measures can have a potentially deleterious impact on the ability of the stocking to deliver the optimum graduated pressure profile to all legs that “fit” the stocking, resulting in important implications to the efficacy of prophylaxis. Key words: Anti-embolism stockings; fit; leg shape; leg size; mechanical thromboprophylaxis; Sigel profile. What is already known about this topic? Anti-embolism stockings are commonly used worldwide to prevent thrombosis development in hospitalised patients. Fitting the correct size of anti-embolism stockings to patients is critical to patient compliance and the success of thromboprophylaxis. Incorrect use or fitting of anti-embolism stockings may cause skin problems, ischaema, and increased risk of thrombosis development. What this paper adds? The proportion of our sample that “fitted” different AES brands and styles ranged from 0% to 100%. Good “fit” was significantly easier to achieve with knee length anti-embolism stockings compared to thigh length anti-embolism stockings. Open-ended sizing and reduction of the number of measurement points on the size charts increase the proportion of patients that appear to “fit” anti-embolism stockings. However, these measures may have implications on the ability of the stockings to deliver optimum pressure profile (Sigel profile) to those patients. Introduction Pulmonary embolism is believed to be the most common cause of preventable death in hospitalised patients [Geerts et al, 2008] and approximately 25,000 people die annually as a result of venous thromboembolism in England alone [Dumbleton and Clift, 2008]. Venous thromboembolism is the collective term for pulmonary embolism and deep vein thrombosis, a pulmonary embolism often results from deep vein thrombosis [SIGN, 2010] when part of the blood clot breaks off and occludes a vein [Dumbleton and Clift, 2008]. Deep vein thrombosis has been found in between 10 and 80% of hospitalised patients not receiving prophylaxis [Dumbleton and Clift, 2008, Geerts et al, 2008] and approximately 0.1% of the general population present per year with clinical symptoms of deep vein thrombosis in the UK [SIGN, 2010]. Therefore, the majority of surgical patients and many medical patients are routinely given thromboprophylaxis in order to prevent or reduce the occurrence of venous thromboembolism [Guyatt et al, 2012, NICE, 2010, SIGN, 2010]. A range of thromboprophylaxis are available including pharmacologic and mechanical methods. The recommended thromboprophylaxis for each patient depends on their condition and risk factors [Guyatt et al, 2012, NICE, 2010, SIGN, 2010]. There are 3 different types of mechanical thromboprophylaxis: anti-embolism stockings (AES); intermittent pneumatic compression devices and venous/pneumatic foot pumps. The use of mechanical thromboprophylaxis has been shown to reduce the incidence of deep vein thrombosis by 40% and combined mechanical and pharmaceutical thromboprophylaxis reduce the incidence of deep vein thrombosis by up to 80% [Dumbleton and Clift, 2008]. This paper examines the “fit” of anti-embolism stockings (AES), the commonly used form of thromboprophylaxis for hospitalised non-ambulatory, recumbent patients. AES apply graduated compression to the leg, which increases blood flow [Dumbleton and Clift, 2008], reduces stasis [Geerts et al, 2008] and venous distension [NICE, 2010] in the legs, thereby lowering the risk of thrombosis formation and embolism [Dumbleton and Clift, 2008]. The ideal compression profile is generally agreed to be the ‘Sigel profile’ [Dumbleton and Clift, 2008, NICE, 2007, Sigel et al, 1975] and most manufacturers design their AES to deliver this pressure profile to legs properly “fitted” with their stockings [Arjo Huntleigh, 2012, Carolon, 2009, Preventex, 2012]. A stocking that exerts the Sigel profile would exert 18mmHg to the ankle, 14mmHg to calf, 8mmHg at the knee (popliteal break), 10mmHg at the lower thigh and 8mmHg at the upper thigh. This level of compression has been shown to increase blood flow in the deep veins by 75% [Sigel et al, 1975]. The pressure exerted by AES is rarely measured in a clinical environment due to lack of time and availability of an appropriate pressure sensor. Instead stockings are tested using laboratory methods through the measurement of tension and subsequent calculation of pressures that would be exerted on a range of limb circumferences. A number of test methods and devices exist for measuring anti-embolism stockings [BSI, 1993, RAL, 2008] but all measure the tension of the stocking at the ankle, calf and thigh area (if present) for particular extensions or circumferences. The pressures that would be exerted by that stocking at particular circumference of ankle, calf and or thigh are then calculated using an equation based on the Laplace Law [BSI, 1993]. The simple form of the Laplace Law states that pressure is equal to tension divided by the radius of curvature (which is easily calculated from the circumference). Therefore, if a particular stocking is put on a leg that is thicker or thinner than that for which it was designed, both the tension and circumference change and it is likely that a different pressure profile will be exerted. Thomas, Toyick and Fisher (2000) measured changes in pressure (referred to as % stiffness) of up to 36% when stockings were tested in accordance with the standard BS 7672, “Specification for Compression, stiffness and labelling of anti-embolism hosiery”, at one size larger and smaller than that recommended by the manufacturer. Moreover, MacLellan (2002) showed that the pressure exerted on the maximum recommended leg measurement was frequently 4 to 5mmHg higher than on the minimum recommended leg measurement for commercially available AES. He further demonstrated that the pressure profiles exerted on the minimum and maximum recommended leg dimensions were frequently different [MacLellan, 2002]. Therefore, the match between stocking size and leg size is critical to achieving the ideal pressures at ankle, calf and thigh and the ideal positive pressure gradient from ankle to the proximal part of the leg. Guidelines on thromboprophylaxis stress the importance of measuring legs carefully and correctly, and fitting the correct size of AES in order to ensure good fit, optimum benefit and compliance with anti-embolism stockings [Geerts et al, 2008, NICE, 2010, SIGN, 2010] as well as minimising the risks associated with their use [Dumbleton and Clift, 2008, NICE, 2010]. It is also recommended that staff be trained in the use and fitting of AES and that stocking use be “closely monitored” and patients’ legs be re-measured and re-fitted if oedema develops [NICE, 2010] or leg size changes. Further, the NICE guideline 92 cautions against fitting AES to “unusual leg size or shape” due to the risks associated with poorly fitted stockings. They cite the risks of potential tourniquet effects at the proximal part of the leg leading to ischaemia and increased risk of thrombosis development if stockings are the wrong size or shape for the leg [NICE, 2010]. However, the judgement of what constitutes an “unusual leg size or shape” is normally left to the nurse fitting the stockings and may be influenced by the size charts of AES stocked by that hospital. Each brand has its own size ranges at a variety of measuring points and its own methods of communicating the sizes. Some brands offer fewer measurement points than others and some have open-ended sizing (where the upper or lower limit of a size range is not specified), both of which give the impression that they are appropriate for use on a wider range of patients than brands with narrower or more specific size ranges and or more measurement points. This can result in confusion as to which products are most suitable for an individual patient. Given the critical nature of the fit of AES on the leg in achieving optimum venous return and maximum protective benefit we turn to the question of whether the AES currently available in our hospitals is available in the correct sizes for our patient’s legs. To the best of the author’s knowledge no survey of patient’s leg sizes could be found and the British Standards committee members for compression hosiery were unaware of a survey having been conducted. Therefore, since any member of the public could be admitted to hospital for many of the surgical and medical conditions for which AES is recommended a survey of randomly selected volunteer’s legs around Scotland was undertaken. These measurements were compared to the size charts of 10 styles of AES produced by 4 major brands in order to determine how many of our volunteer’s legs would fit a standard AES and how many had "unusual leg size or shape” according to the current AES provision. Method Measures: The circumferential leg measurements, also called girths, at the ankle, calf and thigh of 471 volunteers were measured in a variety of locations around Scotland. Both legs of each volunteer were measured to the nearest cm at the ankle, largest calf girth and largest thigh girth as indicated by the measurement instructions for anti-embolism stockings (AES) and following training provided by 2 Scottish National Health Service nurses. Determination of “fit”: The girths of each volunteer’s left and right legs were separately compared to the size charts of 4 major brands of AES: Covidien’s (Kendall) T.E.D.; Arjo Hunteigh’s Flowtron; Urgo’s Preventex; H&R Healthcare’s Carolon. For below knee AES, each volunteer’s ankle girth was matched to the size chart and size matches were noted; this was repeated for the calf girth. Where both ankle and calf matched the same size of below knee stocking the volunteer’s leg was said to match, or “fit”, a particular size. If no ankle girth range was specified then the match to the brand was determined based on calf girth only. If the ankle and calf did not match the same product size, e.g. the ankle was ‘small’ but the calf was ‘medium’, then no stocking in that range would be deemed to “fit” the volunteer. This process was repeated for thigh length stockings using ankle, calf and thigh girths. The percentage of our volunteers’ legs to “fit” each size of stocking in the range is presented, as is the percentage of volunteers’ legs that “fitted” no size in the range. The “fit” coefficient for a brand is defined as the percentage of our volunteers’ legs that fitted any one or more sizes in a range at all relevant measurement points. Legs may not “fit” any size in a brands’ range because the leg is too thin or too thick for the sizes available or because the leg has a different profile to the size charts, being either too conical (e.g. larger calves) or too cylindrical (e.g. larger ankles), for example. Participants and recruitment: Volunteers were recruited to the survey using convenience sampling methods in a variety of locations and settings around Scotland including: private homes, work places, shopping centres and a nursing home. Attempts were made to cover different social/economic demographics in the choice of measurement locations and measurements were made on all days of the week and at different times of day in an attempt to avoid bias. However, measurement setting was largely determined by the researchers’ ability to obtain permission to measure thus the sample may not be representative of the wider population. In shopping centres, researchers set up a screen to enable private measurements. During quiet periods all passers-by were approached until someone agreed to participate, at busy periods the researchers approached as many passers-by as possible. Once a volunteer showed interest in participation the terms and purpose of the research and the measurement process were explained using a standardised script. All willing volunteers were taken behind the screen in order to have both legs measured for this study, the only exclusion criteria were absence of legs or being younger than 17 years old. All volunteers signed an ethical consent form prior to being measured. Their sex was noted by the researcher on the measurement form and each participant was asked their age, no other demographic information was requested or noted. In work places and the nursing home, all available employees or residents were asked whether they wished to participate in the study, if they were willing to participate they were measured in a private room. In the nursing home a member of staff was also present. The same exclusion criteria, script, ethical consent form and measurement form were used for all measurements in all locations and settings. Data analysis: All leg measurements were recorded in a Microsoft Excel spreadsheet. Separate copies of this spreadsheet were made for each AES brand and style evaluated in this study. Each leg measurement was manually matched to sizes according to the size chart of each brand and style at ankle, calf and thigh. Microsoft excel functions were then used to determine whether all measurement points for each leg “fitted” all measurement points for each size of stocking. Where a leg matched the same size of stocking at ankle and calf for below knee AES or at ankle, calf and thigh for above knee AES it was deemed to “fit”. The unit of measurement for analysis was legs and 942 legs were measured and analysed in total. Note: Each brand of AES evaluated in this study provided a range of sizes in 2 or 3 leg lengths for each of their products. Three of the 4 brands examined provided open-ended leg length ranges, such as a short thigh length AES being suitable for patients with a leg length “less than 74cm”; therefore all of our volunteers would be said to “fit” these AES in terms of length. Carolon was the only brand to set upper and lower limits for its AES lengths; this may have further reduced the proportion of our volunteers to “fit” their products. However, leg length was not included in this evaluation as it is less critical in determining the pressure gradient delivered to legs than circumferential measurements and most brands utilise an open-ended sizing policy. All brands require that leg length and a number of circumferential measurements be taken before selecting the correct size of AES for a patient. For the rest of this paper however, only the circumferential measurements required will be discussed. Results Survey volunteers ranged from 17 to 82 years of age, with an average age of 35 and standard deviation of 14. 283 of the volunteers were female and 188 were male. Table 1 shows that different brands of anti-embolism stockings (AES) vary significantly in terms of the number of sizes available and the proportion of our volunteers whose measurements “fit” a particular size. The size ranges and reasons for these differences of percentage “fit” are explored in later in this paper. Note that the percentage of volunteers “fitting” each size for some styles adds up to more than 100% because some of the volunteers “fitted” 2 sizes. The “fit” coefficient is defined as the percentage of our volunteers who “fitted” any one, or more, sizes in a range of AES at all relevant measurement points and is found by subtracting the percentage of volunteers who did not fit any size of AES in Table 1 from 100%. Table 1 shows that, according to the manufacturer’s size charts, Covidien’s below knee T.E.D. stockings had a “fit” coefficient of 100%, meaning that they “fitted” all of our volunteer’s legs, with 10% (n=95) “fitting” 2 sizes of below knee stocking. Urgo’s Preventex brand below knee stockings had a “fit” coefficient of 82% (n=776), Flowtron AES “fitted” 74% (n=701) and Carolon “fitted” 62% (n=583) of our sample. Table 1 – Number and percentage of legs that match each AES size chart at all relevant measurement points brand T.E.D. Preventex Flowtron AES Carolon n= % n= % n= % n= % Brand and style T.E.D. T.E.D. with belt Preventex Flowtron AES Carolon standard Carolon ATS Below knee anti-embolism stockings legs "fitting" size at ankle and calf legs that fit 1 size xs s m l xl xxl xxxl 7 556 305 143 23 3 847 n/a 1% 59% 32% 15% 2% 0% 90% 1 178 406 150 113 704 n/a n/a 0% 19% 43% 16% 12% 75% 7 138 425 89 96 18 2 627 1% 15% 45% 9% 10% 2% 0% 67% 7 81 355 106 51 566 n/a n/a 1% 9% 38% 11% 5% 60% Thigh length anti-embolism stockings legs "fitting" size at ankle, calf and thigh legs xs n= % n= % n= % n= % n= % n= % n/a 0 0% n/a 7 1% n/a n/a s m l xl xxl xlp/ xxxl 7 1% 7 1% 1 0% 59 6% 4 0% 0 0% 556 59% 556 59% 178 19% 120 13% 13 1% 0 0% 290 31% 290 31% 399 42% 42 4% 29 3% 0 0% 15 2% 15 2% 34 4% 32 3% 14 1% 0 0% 0 0% 50 5% n/a n/a n/a n/a 1 0% 0 0% n/a n/a 0 0% n/a that fit 1 size 728 77% 678 72% 544 58% 257 27% 60 6% 0 0% legs that fit 2 sizes 95 10% 72 8% 74 8% 17 2% legs that don't fit any size 0 0% 166 18% 241 26% 359 38% legs that fit 2 sizes 95 10% 95 10% 34 4% 2 0% 0 0% 0 0% legs that don't fit any size 119 13% 169 18% 364 39% 683 73% 882 94% 942 100% Table 1 also shows that all thigh length AES brands studied had lower “fit” coefficients than the below knee AES. Further, 3 of the 6 styles examined “fitted” significantly fewer than half of our volunteers’ legs and Carolon’s Adjustable Thigh Stockings (ATS) had a “fit” coefficient of 0%, i.e. they “fitted” none of our volunteers’ 942 legs. Covidien (Kendall) T.E.D. anti-embolism stockings Figure 1 shows the T.E.D. stocking size ranges above plots of the distribution of our volunteers’ leg girths. In this and subsequent Figures: The plots show the total number of volunteers’ ankles, calves and thighs at each circumference. The rectangles above the plots indicate closed AES size ranges with defined lower and upper limits Single headed arrows indicate open-ended sizing: an arrow facing left indicates a ‘less than’ size range while an arrow facing right indicates a ‘more than’ size range. The double headed arrow indicates a size range that is ‘unspecified’, i.e. the absence of a measurement point. This could be interpreted to mean that the AES will “fit” any girth at that measurement point. The vertical ends of each rectangle, left or right facing arrow are in-line with the circumferential limits of that size as shown on the horizontal axis. Figure 1 clearly shows that all of our volunteers could be assumed to “fit” a below knee T.E.D. stocking, because the AES calf girths extend beyond the plot of volunteer’s calf girths. (The small below knee T.E.D. stocking ‘“fits” any leg with a calf smaller than 30.5cm and the generous extra extra extra large (xxxl) size extended well beyond the largest calf girth in our sample.) The ankle girth is unspecified, therefore no T.E.D. stocking size will be rejected for any leg on the basis of ankle girth, the potential implications of this will be discussed at the end of this paper. Figure 1 and Table 1 show that medium sized below knee T.E.D. stockings “fitted” most of our volunteers and that almost all our volunteers could be “fitted” with a medium, large or extra large size. 400 l m s 350 300 xs 250 number of legs with specified girth xlp xl 2s 1s s 200 xl l m m l xxl xlp xl xxl xxxl xxl thigh girths for TED AES calf girths for thigh length TED AES calf girths for knee length TED AES ankle girths for TED AES are unspecified 150 volunteer's ankle girths 100 volunteer's calf girths 50 0 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 volunteer's thigh girths leg and AES girth in cm at ankle, calf and thigh Figure 1 – Plot showing volunteers’ leg girths and Covidien T.E.D. AES size ranges at ankle, calf and thigh Covidien manufacture 2 styles of thigh length AES; with belt and without belt, the later being the ‘standard’ thigh length stocking. Figure 1 shows the size ranges of both styles of thigh length T.E.D. stocking above the plots of our volunteers’ ankle, calf and thigh girths. The calf size range for small ‘without belt’ style is labelled as 1s while the small size range for the ‘with belt’ style is labelled as 2s in Figure 1. The thigh length T.E.D. with belt is available in extra small (xs) to extra large (xl) sizes, while the thigh length T.E.D. without belt is available in small to extra extra large (xxl) sizes. The only deviation in shared size ranges between these styles is in the calf measurement. As indicated earlier, Figure 1 shows that the ankle girth of all thigh length sizes is unspecified, so all T.E.D. stockings are deemed to “fit” all legs at the ankle. The small standard thigh length stockings have open-ended size ranges for calf (labelled 1s) and thigh measurement points and therefore “fit” any leg smaller than the upper calf and thigh limits for that size. The medium and large T.E.D. stockings have open-ended size ranges for thigh dimensions, while the xl, extra large plus (xlp) and xxl sizes have closed size ranges for both calf and thigh. In this case the open-ended sizing on small, medium and large thigh length T.E.D. stockings meant that all our volunteers who “fitted” these sizes in below knee stockings also “fitted” these (or xl) thigh length T.E.D. stockings as shown in Table 1, leading to a “fit” coefficient of 87% (n=823) for standard thigh length T.E.D. stockings. The potential implications of open-ended sizing are discussed at the end of this paper. Figure 1 shows that most of our volunteers thigh girths are covered by the small, medium, large size and that the medium AES calf size range matched more of our volunteers’ calves than any other, with the large and xl size matching a significant minority. The reason that the xl thigh length T.E.D. stocking matched less than 2% (n=15) of our volunteers’ legs was because it had the same sized calf as the large T.E.D. stocking but a larger thigh circumference (63.5 – 81.3cm). In our study the volunteers who had larger (xl or xlp) thigh girth tended also to have a larger (xlp) calf girth; 5% (n=50) of our volunteers “fitted” an xlp T.E.D. stocking. None of our volunteers with xxl calves had thighs big enough to “fit” the xxl thigh size range. Figure 1 also shows that the medium, large and extra large sizes of thigh length T.E.D. stocking with belt are identical to the standard thigh length T.E.D. stockings. The extra small (xs) thigh length with belt and small T.E.D. stockings in both ranges share the same thigh size (less than 63cm) and unspecified ankle girth. However, the calf girth range is subdivided in the thigh length with belt T.E.D. stocking: the xs calf size is less than 25cm and the small (2s) calf size ranges from 25 to 30.5cm. None of our volunteers “fitted” the xs thigh length with belt T.E.D. stocking as the smallest calf we measured had a girth of 29cm. Urgo Preventex Urgo manufacture Preventex brand AES in 3 styles: below knee, thigh length and thigh length with belt. Figure 2 shows the 5 sizes of below knee and 4 sizes of thigh length Preventex AES (both styles are produced in identical sizes) above the plots of our volunteers’ leg sizes. The calf size ranges are identical in all styles for small to xl stockings but the xxl size is only available in below-knee style, the ankle size is identical for ‘small’ to ‘large’ stockings in all styles. However, the ankle size for both xl thigh length styles is greater than 26cm, while in below knee stockings the xl ankle range is 25-28cm and the xxl size (below knee only ) “fits” ankles with a circumference greater than 28cm. Table 1 showed that 82% (n=776) of our volunteers’ legs “fitted” at least one size of Preventex below knee AES; this was the second highest “fit” coefficient for our sample. 17% (n=159) of our volunteers had ankles and calves that matched different AES sizes at the ankle and calf measurement points, while 1% (n=7) had calves that were bigger than the upper limit for the below-knee xxl size. Preventex AES medium to xl ankle and calf sizes were specified in narrow bands that did not overlap each other significantly, as shown in Figure 2. This limited the variety of volunteers’ leg profiles that would “fit” these sizes. However, the open-ended ankle sizing and wider calf girth range on the xxl Preventex AES size meant the level of “fit” for this size was better than it would have been if entirely closed and narrow size ranges had been used. 400 l m s 350 300 s number of legs with specified girth 250 200 s m l xl l m xxl xl xl xxl xl thigh girths for Preventex AES calf girths for Preventex AES ankle girths for knee length Preventex AES, small to xxl ankle girths for thigh length Preventex AES, small to xl volunteer's ankle girths 150 100 volunteer's calf girths 50 0 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 volunteer's thigh girths leg and AES girth in cm at ankle, calf and thigh Figure 2 – Plot showing volunteers’ leg girths and Preventex AES size ranges at ankle, calf and thigh Figure 2 shows that the thigh size range of Preventex AES was wide enough to accommodate all our volunteers’ thighs, with the majority (89%, n=839) having a girth less than 63cm and therefore “fitting” small, medium and large AES at the thigh. As with T.E.D. stockings nearly all our volunteers who “fitted” a small, medium or large below knee Preventex stocking also “fitted” a thigh length Preventex stocking as shown in Table 1. The potential implications of open-ended sizing are discussed at the end of this paper. Figure 2 shows that large Preventex AES matched more of our volunteer’s ankles (62%, n=585) and calves (53%, n=500) than any other size and that the small size matched very few of our volunteers’ ankles (0.1%, n=1) and calves (3%, n=30). However, Figure 2 also shows that Preventex AES size ranges do not provide adequate provision for our volunteers’ calf girths. In fact 1% (n=7) of our volunteers’ calves were larger than the below knee xxl size and 6% (n=56) of our volunteers’ calves were larger than the thigh length xl size. Therefore, patients with large calf girths could only be “fitted” with below knee, if any, Preventex AES. Furthermore, and of significance to the thigh length products, 29% (n=277) of our volunteers’ calf girths were between 40 and 46cm matching the xl size range, whereas only 11% (n=103) had thigh girths of 63cm or more, matching the xl thigh size range. Therefore, there may be scope to further increase the “fit” coefficients of Preventex AES by adjusting the size range boundaries on the basis of a larger scale study. Arjo Huntleigh Flowtron anti-embolism stockings Arjo Huntleigh produce Flowtron AES in 3 styles: below knee; thigh length and belted/full length stockings. Each style of stockings is available in 7 sizes and 3 lengths. The girth range for each stocking size at ankle, calf and thigh do not vary between the different styles or lengths of stockings and are shown in Figure 3. Table 1 showed that, despite having more sizes than any other manufacturer in this study, Flowtron below-knee stockings had a fit coefficient of only 74% (n=701), with 26% (n=241) of our volunteer’s legs not “fitting” any of the same Flowtron sizes at both measurement points. This relatively low level of “fit” for below- knee stockings is principally due to their use of exclusively closed (i.e. defined upper and lower limits) and relatively narrow size ranges with little overlap between sizes at the ankle, as shown in Figure 3. Further, when the number of measurement points increased from 2 for below knee products to 3 for thigh length products, the number of legs with the required profile to match the stockings decreased significantly. Only 27% (n=257) of the legs we measured matched the Flowtron AES size chart at all 3 measurement points, with 73% (n=683) not “fitting” a Flowtron thigh length size. This low “fit” coefficient was largely due to their exclusive use of closed size ranges at 3 measurement points. The flowtron sizing structure means that a limited leg shape is catered for in 7 different sizes. Legs that were more conical or more cylindrical than the Flowtron size provision are not catered for by these stockings. 400 350 s xs 300 xs number of legs with specified girth 250 200 xs s m l xl s xxl m xxxl l xl xxl m xxxl l xl xxl xxxl thigh girths for Flowtron AES calf girths for Flowtron AES ankle girths for Flowtron AES volunteer's ankle girths 150 volunteer's calf girths 100 50 volunteer's thigh girths 0 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 leg and AES girth in cm at ankle, calf and thigh Figure 3 – Plot showing volunteers’ leg girths overlaid with Flowtron AES size ranges at ankle, calf and thigh Despite the relatively low “fit” coefficients, less than 1% of our sample had leg girths that didn’t match any ‘Flowtron AES’ size at a single measurement point: 2 ankles and 7 calves required a stocking larger than Flowtron’s xxxl and 7 thighs were smaller than the xs size range. H&R Healthcare Carolon anti-embolism stockings Carolon produce below knee AES in 5 sizes and standard thigh length AES in 4 sizes, both styles have the same ankle and calf girth ranges for sizes small to xl, however no xxl standard thigh length size is available. The girth ranges of these sizes for below knee and standard thigh length AES are shown in black above plots of our volunteers’ legs in Figure 4. Figure 4 shows that the ankle girths of Carolon below knee and standard thigh length AES are designed to accommodate a narrow range of ankle girths with very little overlap (0.5cm) between the sizes. In our sample, 62 ankles (7%) were bigger than the 30.5cm upper limit of Carolon’s below knee xxl AES stocking and 182 (19%) of our sample ankles were bigger than the 28cm upper limit of the standard thigh length xl size. Similarly, 2% (n=20) and 13% (n=119) of our volunteers’ calves were too large for the xxl below knee and xl thigh length AES, respectively. However, 5% (n=46) of our volunteers’ thighs were smaller than Carolon’s small thigh length stocking; none of our sample had thighs that were too large for the xl size. Therefore, Carolon’s sizing was both too limited to accommodate the measured range of ankle, calf and thigh girths but they had also anticipated different shapes of leg at ankle, calf and thigh to the majority of those we measured. In addition they used (inconsistent) narrow size ranges with limited overlap that provide limited flexibility in accommodating a range of leg shapes. These issues with Carolon sizing for our sample are reflected in Table 1, which shows that Carolon below knee AES had a “fit” coefficient of 60% (n=566) and their standard thigh length AES had a “fit” coefficient of only 6% (n=60). 450 s 400 s 350 300 s s number of legs with specified girth 250 l 200 xl m s l m s xxl xxl xl m m xxl xl l l xl m m l l xl xl xxl thigh girths for Carolon ATS AES thigh girths for standard Carolon AES calf girths for Carolon ATS AES xxl calf girths for standard Carolon AES ankle girths for Carolon ATS AES ankle girths for standard Carolon AES volunteer's ankle girths 150 volunteer's calf girths 100 volunteer's thigh girths 50 0 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 leg and AES girth in cm at ankle, calf and thigh Figure 4 – Plot showing volunteers’ leg girths and Carolon AES size ranges at ankle, calf and thigh Carolon also produce a range of Adjustable Thigh length Stockings (ATS) available in 5 sizes; these are shown in grey above our volunteers’ leg girths in Figure 4. The ATS stockings are intended for bariatric patients, those with oedema and over bandages following surgery. Therefore, Carolon ATS cater for very large thighs, as a result of which 17% (n=163) of our volunteers had thighs that were too small for Carolon ATS stockings and 75% (n=702) of our volunteers matched the ‘small’ thigh size, as might be expected. However, as Figure 4 shows, the sizing of Carolon ATS stockings at ankle and calf was not significantly larger than their standard stockings, with 7% (n=62) of our volunteers’ ankles and 2% (n=26) of their calves being too large for Carolon ATS stockings. This massive offset between the belowknee and above-knee measurements meant that none of our volunteers would “fit” a Carolon ATS stocking at all measurement points (“fit” coefficient of 0%). It may be that Carolon ATS cater for an important minority of patients that we did not encounter but it seems odd that the ankle and calf girths should be so restricted when oedema and bandages are commonly found in the lower leg and bariatric patients often have large lower legs as well as thighs. Discussion Number of measurement points As might be expected, when the number of circumferential measurement points that need to be compared to size charts increases from 1 (calf only) to 2 (ankle and calf or calf and thigh) or 3 (ankle, calf and thigh) the match or “fit” rate decreased. The only style in this study with 1 measurement point , the below-knee T.E.D. stocking, had a “fit” coefficient of 100%. Products with 2 measurement points, Carolon, Preventex and Flowtron below-knee and T.E.D. thigh length AES, had “fit” coefficients ranging from 62% to 87%; while products with 3 measurement points, Carolon, Preventex and Flowtron thigh length AES, had “fit” coefficients ranging from 0 to 61%. By not specifying a measurement at all, e.g. T.E.D. stockings unspecified ankle girth, the process of deciding which stocking to “fit” is much simpler, since fewer leg measurements are required and a match between below knee AES and patient dimensions is almost guaranteed. However, the erroneous implication to nurses fitting these stockings is that the ankle girth does not matter and/or that the stockings will “fit” any ankle. All AES manufacturers strive to design and manufacture stockings with stiffness profiles that minimise the difference in pressure delivered to different sized legs. However, it is unlikely that stockings would be able to deliver the same level of compression to all legs within an un-specified size range. Therefore, legs may receive more or less compression than is desirable and in some instances negative pressure gradients are likely to occur (MacLellan, 2002), that decrease blood flow rather than enhance it. Both MacLellan (2002) and Thomas, Toyick and Fisher (2000) showed that the majority of T.E.D. stockings tested provided significantly lower pressures at the ankle than the accepted ideal 18mmHg when tested at ‘in-proportion’ ankle circumferences. Thomas, Toyick and Fisher showed that these ankle pressures varied by 7 to 24% when the ankle circumference was changed by between only 1.5 and 2.3cm. Figure 1 shows that the ankles we measured ranged from 19 to 44cm, a difference of 25cm. Open-ended sizing Figures 1 and 2 show that Preventex and T.E.D. brand AES both use open-ended sizing (as indicated by a single headed arrow) in their products, this meant that no ankle, calf or thigh was considered too small for these brands and no ankle was too large. This led to considerably higher “fit” coefficients for Preventex and T.E.D. stockings, 82% and 100% for below-knee stockings and 61 to 87% for thigh length stockings respectively, than for Carolon and Flowtron in both below-knee and thigh length styles. For example, both T.E.D. and Preventex specify that their small, medium and large thigh length stockings “fit” thighs smaller than 63.5 or 63cm respectively. If these stockings were able to deliver the same pressure to all these thighs, this open-ended sizing would be very convenient as it maintains high levels of “fit” to a wide range of leg shapes and sizes. However, this is very difficult to achieve in practice as demonstrated by MacLellan (2002) and Thomas, Toyick and Fisher (2000). In our study the thighs that would “fit” these stockings ranged from 36 to 63 cm in circumference and it is likely that if the stockings were designed not to produce a tourniquet effect on larger thighs they would tend to slip down the smaller thighs. As a matter of interest, if Flowtron were to adopt the open-ended thigh sizing used by T.E.D. and Preventex in their 3 smallest sizes, they would increase the proportion of our volunteers who “fitted” their thigh length stockings from 27% (n=257) to 64% (n=603). However, Flowtron’s existing narrow size ranges, with defined upper and lower limits, means there is a greater likelihood that their stockings will achieve the ideal pressure profile on legs that “fit” their sizes. Adjustment of size bands based on leg measurement data When our volunteers’ legs did not match an AES size at all measurement points it was because their legs had a different shape profile to the brand’s size range. In some instances this was due to the normal variation in human shape, which would be difficult to address in a standardised product, but in some instances the brand’s size ranges appeared to be out of alignment with the majority of our volunteers. For example, 62% (n=585) of our volunteers’ ankles and 56% (n=528) of their calves matched Flowtron’s medium size range, as indicated in Figure 3. However, 61% (n=572) of our volunteer’s thighs matched Flowtron’s small size range at the thigh. If Arjo Huntleigh were to re-assign the thigh size ranges of Flowtron AES, and re-design the thigh portion of their stockings accordingly, so that what is currently their xs size became their small, what is currently their small became their medium, etc., then the “fit” coefficient of this sample for their thigh size AES would increase from 27% (n=257) to 60% (n=565). Clearly no such changes should be made on the basis of this relatively small sample, but these results indicate that significant improvements could be made to product sizing with access to the results of a large scale survey. Conclusions Different brands and styles of anti-embolism stockings “fitted” different proportions of our volunteers’ legs, ranging from 100% at best to 0% at worst. Each brand studied here manufactured below-knee stockings that “fitted” more than half of our volunteers’ legs but only 2 brands produced thigh length stockings that “fitted” more than half of our volunteers’ legs. The difference in the proportion of our volunteers that “fitted” each brand of stockings was largely due to different sizing policies by different brands: 1. Reducing the number of measurement points on the leg increases the likelihood that the leg measurements provided will match the stocking’s size chart and a “fit” can be achieved. However, by not providing a size range for an important leg dimension, such as the ankle, the quality of “fit” is unknown and the pressure profile exerted by the stocking may not be the same as that measured in the laboratory during product development or quality control. 2. Open-ended size ranges will increase the number of patients that a brand of AES “fits” however they may not exert the same pressure or pressure profile on all legs that appear to “fit” the stocking. 3. Wide size ranges that overlap between sizes are more likely to “fit” more people than narrow size ranges with little overlap, but again this may give a wider range of pressures on the leg. 4. Improvements could be made to brand’s “fit” coefficients with access to a large sample of patient’s leg measurements. These results are based on an analysis of a relatively small random sample of UK resident’s legs. However, we hope that the significant variation in the “fit” of different AES brands to these legs demonstrates the need for a large scale, international survey of leg sizes and similar analysis to be conducted before hospitals select the brands they wish to stock in order to “fit” the widest possible number of patients. Ideally such a survey of leg sizes would be conducted on patients as “unusual leg shapes” may be more prevalent in hospitalised patients than in the general population. The results of such a study should be used to inform brand’s sizing and product developments in addition to hospital’s choice of brands and sizes. References Arjo Huntleigh, 2012. http://www.arjohuntleigh.com/Page.asp?PageNumber=3980 BSI, 1993. British Standards Institute. BS 7672: 1993 Specification for Compression, stiffness and labelling of anti-embolism hosiery. 1993. 1-9. Carolon, 2009. http://www.hrhealthcare.co.uk/downloads/carolon/Test-Results-vs-SiegelProfile.pdf Dumbleton, T., Clift, M., 2008. Buyers Guide: Compression Hosiery. CEP08036. NHS Purchasing and Supply Agency. Accessed at http://www.derbyatec.co.uk/buyers-guidecompression-hosiery-now-published/ on 7-6-11. p1-73 Geerts, W.H., Bergqvist, D., Pineo, G. F., Heit, J.A., Samama, C.M., Lassen, M.R., Colwell, C.W., 2008. Prevention of Venous Thromboembolism*: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). CHEST 2008; 133; 381453S. 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