Validation of a new menstrualpictogram (superabsorbentpolymer-c version) for use withultraslim towels that containsuperabsorbent polymers

Julia L. Magnay, M.Sc.,a Tracy M. Nevatte, Ph.D.,a Shaughn O'Brien, D.Sc.,a,b Christoph Gerlinger, Ph.D.,c,d

and Christian Seitz, M.D.c

a Institute for Science and Technology in Medicine, Guy Hilton Research Centre, Hartshill, and b Department of Obstetricsand Gynecology, University Hospital of North Staffordshire, Stoke-on-Trent, United Kingdom; c Bayer HealthCare, GlobalClinical Development, Berlin; and d Gynecology, Obstetrics and Reproductive Medicine, University of Saarland MedicalSchool, Homburg/Saar, Germany

Objective: To validate the menstrual pictogram (superabsorbent polymer-c version) for Always Ultra-slim feminine towels containingsuperabsorbent polymers.Design: Prospective, multicenter, evaluator-blinded study.Setting: Three gynecology research clinics in the United Kingdom.Patient(s): Women with self-perceived light, normal, or heavy menstrual periods who had not previously used a graphical method toassess their menstrual loss.Intervention(s): One hundred twenty-two women were asked to complete the menstrual pictogram throughout two menstrual periodsand collect their feminine towels for measurements of menstrual blood loss (MBL) by the alkaline hematin method and total menstrualfluid loss (MFL) by fluid weight.Main Outcome Measure(s): Agreement of menstrual pictogram MBL and MFL scores with alkaline hematin and towel weight, respec-tively. The percentage blood fraction was determined at various volumes of menstrual discharge.Result(s): Alkaline hematin and fluid weight were highly correlated (r ¼ .97). However, the percentage blood fraction progressivelyincreased with total MFL and MBL score. After correction for this incremental rise in blood fraction, the menstrual pictogram gavea sensitivity of 82% and a specificity of 92% for a diagnosis of heavy menstrual bleeding.

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Conclusion(s): The menstrual pictogram (superabsorbent polymer-c version) provides a simplemeans of measuring MBL in the clinical setting. (Fertil Steril� 2014;101:515–22. �2014 byAmerican Society for Reproductive Medicine.)Key Words: Heavy menstrual bleeding, menstrual pictogram, pictorial blood loss assessmentchart, menstrual blood loss, superabsorbent polymers

Discuss: You can discuss this article with its authors and with other ASRM members at http://fertstertforum.com/magnayjl-menstrual-pictogram-superabsorbent-polymers/

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eavy menstrual bleeding per cycle (1). The definitive method of confined to the research setting.

H (HMB) is defined as >80 mLof menstrual blood loss (MBL)

Received September 9, 2013; revised October 22, 20December 12, 2013.

J.L.M. reports a consultancy for Bayer HealthCare.S.O.B. reports a consultancy and payment forSymptometrics, a company involved in the devepain charts, and an alternative menstrual pictonothing to disclose. C.S. has nothing to disclose

Sponsored by Bayer HealthCare.Reprint requests: Julia L. Magnay, M.Sc., Guy Hilton

Stoke-on-Trent, Staffordshire, United Kingdom

Fertility and Sterility® Vol. 101, No. 2, February 2014Copyright ©2014 American Society for Reproductivehttp://dx.doi.org/10.1016/j.fertnstert.2013.10.051

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diagnosing HMB is the alkaline hema-tin technique (2), but it is mainly

13; accepted October 26, 2013; published online

T.M.N. reports a grant from Bayer Healthcare.lectures by Bayer HealthCare, and Funding forlopment of an electronic version of PMS charts,gram from Advantage West Midlands. C.G. has.

Research Centre, Thornburrow Drive, Hartshill,(E-mail: j.l.magnay@keele.ac.uk).

0015-0282/$36.00Medicine, Published by Elsevier Inc.

Furthermore, it measures only theblood component of menstrualdischarge, which typically comprisesabout 50% of the total volume,although variations have beenobserved at extremes of menstrualloss (3, 4). Because women assess theirmenstrual flow on the basis of thetotal amount of fluid lost, somestudies have suggested that menstrualfluid weight is a more relevantmeasurement than MBL (5–7). Both

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methods require patients to collect and store all their usedfeminine products and submit them for laboratory analysis,which may not be acceptable or feasible for many women.

Alternative semiquantitative techniques such as thePictorial Blood loss Assessment Chart (PBAC) (8) and a latermodification, the menstrual pictogram (9), relate the visualappearance of total menstrual fluid loss (MFL) on soiled femi-nine products to the estimation of MBL and provide a simplemeans for patients to subjectively assess their menstrual flow.The menstrual pictogram, which was introduced in 2001,comprises five diagrams (icons) depicting a graded series ofstained towels or tampons. Each icon was assigned an actualblood volume that was validated against the alkaline hematinmethod. The pictogram was developed using simulated men-strual fluid (SMF) that consisted of whole blood diluted withan equal volume of 0.9% saline (J.L. Magnay and K.M. Wyatt,personal communication). Consequently, the allocated bloodscore for each icon was exactly 50% of the total SMF volumeapplied. The towel component of the pictogram was specif-ically validated for use with thick KotexMaxi towels (Kimber-ley-Clark, Kent, UK) that were available over a decade ago,but their modern equivalents have different absorbency char-acteristics and staining patterns (10). Furthermore, manywomen now prefer ultraslim, more efficient feminine prod-ucts that contain superabsorbent polymer (SAP) granules.Therefore, the Kotex menstrual pictogram is obsolete.

With these facts in mind, we developed a new menstrualpictogram (SAP-c version) for use with modern femininetowels (11). We selected Always Ultra ‘‘With Wings’’ products(Proctor & Gamble) because this is the most widely used brandof ultraslim towels in both the United States and the UnitedKingdom (12–14). The new pictogram is shown in Figure 1.It was developed with 50% SMF (using 0.9% saline) andthree Always Ultra towel types: normal, long, and night,which have different dimensions and absorbency ratings. Toevaluate the device, 12 female volunteers were asked toscore a series of towels that contained between 0.5 and25 mL of SMF. Target volumes were assigned to all icons.Each volume represented the median score of all towelsmatched to the respective icon by the participants. The newmenstrual pictogram was then ready for testing in theclinical setting, with the potential to score either MBL ortotal MFL.

The aims of this study were [1] to establish the relation-ship between blood and total fluid at different levels of men-strual loss; [2] to determine whether the new menstrualpictogram can be used to reliably estimate MBL or totalMFL with the existing icon scores and to reassign blood scoresto accommodate changes in percentage blood fraction, ifindicated; and [3] to assess the user friendliness of the deviceand whether women would be prepared to use the menstrualpictogram as a diagnostic screening tool for HMB.

MATERIALS AND METHODSStudy Participants

Women were recruited from specific gynecology researchclinics at three study sites in England: University HospitalNorth Staffordshire, Royal Shrewsbury Hospital, and Stafford

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Hospital. Eligibility criteria were age 18–50 years, regularmenstrual cycles between 24 and 38 days with menses of %10 days, willingness to use and collect Always Ultra towelsfor two consecutive menstrual cycles, agreement to score per-sonal soiled towels with the new menstrual pictogram, and acommitment to complete the scorecard and then deliver thetowels and all documentation to the local study center within72 hours of the end of menstruation. Exclusion criteria werecontemplation of pregnancy within the participation period;likelihood of receiving treatment that could stop menstrua-tion (e.g., endometrial ablation, GnRH analogs, or a Mirenaintrauterine system); or any medical treatment or investiga-tions that could be delayed by study involvement, particularlyif endometrial hyperplasia or cancer was suspected on clinicalgrounds. The use of oral contraceptives was permitted. Onehundred twenty-two premenopausal women ages 18–49 yearswith self-perceived light, normal, or heavy menstrual losswere enrolled into the study. No woman had previouslyused a graphical method to assess her menstrual loss. Theproject was approved by the South Staffordshire ResearchEthics Committee, United Kingdom (reference no. 09/H1203/4), and written informed consent was obtained fromeach participant. All feminine towels used in this studywere purchased by the sponsor, Bayer HealthCare. Wereceived no financial support from Proctor & Gamble.

Study Protocol

At study entry (visit 1), a full menstrual, gynecological, andgeneral medical history was taken from each participant.Women were asked to rate their usual menstrual periods aslight, normal, or heavy. A venous blood sample was with-drawn for hemoglobin measurement, which was requiredfor the alkaline hematin analysis.

Participants were provided with the following items: Al-ways Ultra towels, sealable plastic bags that were prelabeledwith their unique participant identification (PID) number, poly-propylene towel containers, and a large polystyrene outer boxwith coolable gel packs to store the towels during menstrua-tion. They were also given a menstrual pictogram (SAP-cversion) and scorecard, which were combined in a foldoutbooklet. Women were instructed to compare each soiled femi-nine towel to the relevant set of icons on the menstrual picto-gram and decide which image it most closely represented. If astain appeared to fall midway between two icons, they shouldscore the higher icon. After assessment, participants should rolleach towel inside its colored wrapper, transfer it to a sealableplastic bag, and record the date, towel type, and icon scoreon the label and on the scorecard. They should place the sealedbag inside a polypropylene box and firmly secure the lid toform an airtight closure. All boxes had to be stored on pre-cooled gel packs in the designated polystyrene storagecontainer, and the cooling elements replaced every 24 hours.

Cycle 1 began on the first day of menstruation afterstudy entry. At this point, women contacted their local studycenter to arrange a second visit within 72 hours of the lastday of menstruation. At visit 2 (end of menses 1), the clinicalteam verified that the number of icons ticked on the score-card matched the number of soiled towels returned for

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FIGURE 1

The menstrual pictogram (SAP-c version).Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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processing. The section of icon sticker that displayed thetowel type and score was removed from each plastic bagand was filed in the participant's case report form by theclinical team. The PID, date, and towel number still remainedvisible. Women were given additional supplies for the nextmenstrual cycle, plus a Likert-style questionnaire to assessthe user friendliness of the device. Another blood samplewas taken for hemoglobin measurement. The towels werethen immediately transferred to the central reading site(Keele Menstrual Disorders Laboratory [KMDL] at UniversityHospital North Staffordshire) for expert icon assessment. At

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visit 3 (end of menses 2), all materials from cycle 2 werecollected for processing.

Towel Processing

The two expert evaluators at KMDLwere thefirst to develop themenstrual pictogram (SAP-c version). Both were blinded to thewomen's scores and performed the expert read before weighingthe towels to minimize any potential bias in their visual assess-ment. The experts used a menstrual pictogram that was scaledup to full towel size, and individual icons were printed on

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transparent 297� 210 mm acetate sheets. Each towel was laidflat on its colored wrapper with the underside facing upwards.Icons were placed in turn over the stain area, and the nearesticon match was recorded. The towel was then weighed to0.01 g using a P1200 N precision balance (Mettler Toledo). Tocalculate the fluid weight, 250 unused towels of each typewere accurately weighed, and the appropriate mean dry weightwas subtracted from the weight of the used product. Unity be-tween weight (g) and volume (mL) was assumed, and the twoparameters were used interchangeably for the purposes ofdata analysis (4, 6). Towels were repacked inside theiroriginal containers and shipped overnight to theLaboratorium f€ur Klinische Forschung (LKF) in Germany formeasurement of MBL by a modified alkaline hematin method(15). The analysts at LKF had no prior knowledge of theparticipant or expert readings or the towel weights. TotalMBL measured by the alkaline hematin method was used asthe reference standard and was dichotomized as %80 mL(normal blood loss) or >80 mL (HMB) per cycle.

Statistical Analysis

Following the intent-to-treat principle, all women who pro-vided data were included in the analyses. Menstrual volume,cycle length, duration of menses, and percentage blood frac-tion were expressed as median values. Comparisons betweenalkaline hematin and measured fluid weight were performedusing a quadratic regression model (intercept ¼ 0) withweight as the independent variable. Correlation of MBL scoresversus alkaline hematin and MFL scores versus total fluidweight was determined by linear regression analysis withparticipant score as the independent variable. Because thiswas an exploratory analysis, no correction was made for mul-tiple testing. Statistical analyses were two-sided with 95%confidence intervals and a significance level of 5%. Calcula-tions were performed using SigmaStat version 1.0 (JandelCorporation) and Microsoft Excel 2010.

RESULTSOne hundred twenty-two women were recruited to the study,and 116 (95.1%) completed two menstrual cycles. Data were

TABLE 1

Descriptive statistics for the total amount of fluid or blood loss estimatedalkaline hematin (AH) method, with respect to icon category.

Parameter Icon nAssigned icon score:normal/long/night Mean

Weight (g) 1 1,113 1/1/1 1.22 857 3/3/4 2.93 742 7/6/8 5.04 431 10/10/12 8.25 172 18/18/20 13.0

AH (mL) 1 1,112 0.5/0.5/0.5 0.42 857 1.5/1.5/2 1.43 741 3.5/3/4 3.04 431 5/5/6 5.55 172 9/9/10 9.1

Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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collected on all women who had saved towels from at leastone cycle (n ¼ 119, number of completed cycles ¼ 235).The median menstrual cycle length was 28 days (range, 24–38 days), with a menses of 4 days (range, 2–10 days). A totalof 3,325 towels were collected. Ten of these towels wereexcluded from analysis because of missing participant icondata, and a further two were omitted because of unsuccessfulalkaline hematin measurement. Therefore, 3,315 MFL scoreswere compared with towel weight, and 3,313 MBL scoreswere compared with alkaline hematin.

At study entry, 53 women (44.5%) described their usualmenstrual flow as heavy, but only 14 of these women (26%,20 cycles) had a measured blood loss of >80 mL by alkalinehematin. A further two women experienced a blood loss of>80 mL in one cycle, although they had considered their pe-riods to be normal. The median blood loss for the 22 HMB cy-cles was 111 mL (range, 80.1–245 mL), and the median fluidweight was 156 g (range, 104–286 g). The correspondingvalues for the 213 normal cycles were 17 mL (range, 1–80 mL) and 35 g (range, 6–160 g), respectively. In general,women with heavier blood loss used more feminine products,but there was no overall correlation between alkaline hematinand the number of towels used or the length of menstruation(see Supplemental Figs. 1 and 2). For example, one womanused 15 towels over 6 days to collect 4 mL of blood (13 g offluid), while another used the same number of towels over5 days to collect 122 mL (180 g of fluid). These findingsconcur with other studies (9, 16, 17).

Menstrual Fluid Weight Versus Blood Volume

Menstrual fluid weight and alkaline hematin were highlycorrelated (r ¼ .97, P< .0001, n ¼ 235 cycles; seeSupplemental Fig. 3), although the relationship was not linearbecause of a progressive increment in blood fraction withincreasing total menstrual volume (4, 18). Polynomialregression analysis showed that the 80-mL blood thresholdcorresponded to a cycle weight of 147 g. However, therewas considerable overlap between cycles with normal andexcessive blood loss, and 9/22 HMB cycles gave amenstrual fluid weight below 147 g.

by the menstrual pictogram (participant scores), towel weight, and

95% Confidence interval Median Minimum–Maximum

1.15–1.25 1.1 �0.3–6.02.8–3.0 2.6 0.2–14.94.8–5.2 4.6 0.3–17.77.8–8.6 7.9 0.5–24.8

12.0–14.0 13.0 0.1–36.80.37–0.43 0.3 0–4.31.3–1.5 1.1 0.1–10.82.9–3.2 2.5 0.1–11.75.2–5.8 5.2 0.3–20.18.2–10.0 8.8 0.1–29.7

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FIGURE 2

Bland-Altman analysis of participant menstrual pictogram (MP) estimate of MBL versus alkaline hematin estimate of MBL (A) before and (B) afterrevision of icon blood volumes; n¼ 235menstrual cycles. Alkaline hematin was used as the referencemethod to diagnose HMB (>80mL blood lossper cycle), and the MP categorization is shown. Symbol interpretation: light blue diamond ¼ true negative; red circle ¼ true positive; greentriangle ¼ false negative; black square ¼ false positive. The horizontal dotted lines denote the 95% limits of agreement.Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

Fertility and Sterility®

Menstrual Pictogram Scores

Fluid weight and menstrual pictogram MFL scores weresignificantly correlated (r ¼ .85, P< .0001). Table 1 showsmedian fluid weight and alkaline hematin values for eachicon category selected by the participants. Women tendedto slightly overestimate their fluid loss, although some un-der- and overrating occurred within each icon group. How-ever, 33 heavily stained towels had a measured weightgreater than the icon 5 score (range, 18–36.8 g).

Alkaline hematin and menstrual pictogram MBL scoreswere also significantly correlated (r ¼ .81, P< .0001), despiteindividual exceptions. A total of 70 heavily stained towelshad a measured blood loss in excess of the icon 5 score

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(range, 9–29.7 mL). Bland-Altman analysis (Fig. 2A) demon-strated a clear tendency for the menstrual pictogram to un-derscore MBL at high levels of menstrual loss andrepresented the cumulative effect of a high proportion ofheavily saturated towels.

Participant Versus Expert Assessments

Participant and expert ratings concurred for 59% (1,957/3,315)of towels. The associated kappa statistic was 0.46, and theweighted kappa was 0.65. A further 36% (1,200/3,315) oftowels showed a single icon difference. Participants' ratingsidentified 8/22 HMB cycles as >80 mL MBL and 209/213normal cycles as %80 mL MBL, which gave the menstrual

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TABLE 2

Descriptive statistics to show the percentage of whole blood in total menstrual fluid with respect to the expert icon score.

Icon n

Percentage blood in total fluid volume Revised icon score, mL

Mean 95% Confidence interval Median Interquartile range Normal Long Night

1 1,037 32.8 31.5–34.1 27.7 16.2–45.0 0.5 0.5 0.52 849 44.8 43.5–46.1 45.3 30.3–58.1 1.5 1.5 23 781 56.4 55.1–57.8 58.7 43.6–70.7 4 3.5 4.54 376 64.2 62.3–66.1 67.1 53.3–76.3 6.5 6.5 85 214 68.0 65.7–70.3 70.6 60.0–79.3 12.5 12.5 14Note: The revised icon blood scores are shown; n ¼ 3,257 towels.

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pictogram a sensitivity of 36% and a specificity of 98%. Thecorresponding expert ratings gave a sensitivity of 73% (16/22HMB cycles) and a specificity of 98% (208/213 normal cycles).

Recalculation of Icon Blood Scores

Table 2 shows the percentage proportion of whole blood in totalmenstrual fluid with respect to icon category. For this exercise,the calculations were based on the experts' icon allocationsbecause they were considered to be more reliable than thoseof the participants. For 58 (1.8%) towels, the blood fractionwas<�10% or >110%. This mainly occurred at very low vol-umes when alkaline hematin exceeded fluid weight or fluidweight was less than the generic dry towel weight. These datawere excluded from the analysis, although their inclusion hadvirtually no impact on the calculations (%0.2% difference inmedian blood fraction in any icon category, data not shown).There was a progressive nonlinear increase in median bloodfraction (see Supplemental Fig. 4). The original assigned MBLscore (shown in Table 1) was then recalculated to the nearest0.5 mL for each icon, using the following formula:

New MBL score ðmLÞ ¼ A50

� current MBL score ;

Where A ¼ median percentage blood loss, and 50 is the per-centage blood fraction on which the original target scoreswere based. Table 2 shows the revised MBL scores. Assignedvolumes for icons 1 and 2 were unchanged for all towel types;those for icons 3, 4 and 5 were increased accordingly.

MBL per cycle was recalculated using the new MBLscores. The participant assessments now identified 18/22HMB cycles as >80 mL and 197/213 normal cycles as %80 mL, which gave the menstrual pictogram a sensitivity of82% and a specificity of 92%. The corresponding expert rat-ings gave a sensitivity of 95% (21/22 HMB cycles) and a spec-ificity of 89% (190/213 normal cycles). Figure 2B depicts therevised Bland-Altman analysis of participant MBL scoresversus alkaline hematin. False-negative categorizations ofHMB by the menstrual pictogram decreased from 64% (14/22) to 18% (4/22), and false positives increased from 2% (4/213) to 8% (16/213).

Feedback Questionnaire

Supplemental Table 1 lists the questionnaire responses from116 participants. Women generally agreed that the menstrual

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pictogram was easy to use with respect to the towel color co-des, scorecard, and icon matching. The practicalities of stor-ing the towels and using the pictogram under everydayconditions were satisfactory. Always Ultra products wereacceptable, although some women expressed their preferencefor tampons (mainly related to sports activity), and there wasa perception that some blood loss occurred during urinationor taking a shower, which is not recorded by the menstrualpictogram. Some women reported difficulty in assigning anicon when the towel stain was a different shape from thosedepicted by the diagrams.

DISCUSSIONWe designed a new menstrual pictogram (SAP-c version) toestimate blood loss on the most widely used brand of ultraslimfeminine towel in the United States and United Kingdom. Likeits predecessors the PBAC and Kotexmenstrual pictogram, thenew device underestimated MBL on heavily stained itemsbecause of the score limit assigned to the higher icons (19,20). This particularly affected women who experiencedsevere menstrual loss; only 8/22 HMB cycles were rated as>80 mL by the menstrual pictogram. However, the initialicon scores assumed that whole blood comprisesapproximately half of the total fluid volume at all levels ofmenstrual discharge, but this widely reported figure of 50%has been measured with respect to total menstrual loss percycle, not at the level of single feminine products (4, 18).Individual measurement of menstrual fluid weight andalkaline hematin on soiled towels showed that this 50%assumption did not hold true. Blood fraction progressivelyincreased with volume, and thus with icon category, suchthat for towels rated as icon 5, the median blood fractionwas 71%, not 50%. For a system that relies on cumulativescoring of MBL on individual towels, this deviationbecomes a major consideration at high levels of menstrualloss because whole blood represents a greater proportion ofthe visible stain area. After applying correction factors tothe MBL scores to accommodate the change in bloodfraction with volume, the menstrual pictogram scored 18/22cycles as HMB, which dramatically increased the sensitivityfrom 36% to 82%, while marginally reducing the specificityfrom 98% to 92%. To our knowledge this is the first reportof pictorial MBL assessment using differential blood-to-fluid ratios.

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Since women judge their menstrual discharge on the totalvolume rather than the composition of menstrual fluid, we de-signed the menstrual pictogram (SAP-c version) to determinewhether total MFL (i.e., the visual appearance of a soiledtowel) could be used as an alternative assessment of HMB.We compared pictogram total fluid scores to accuratelymeasured fluid weight and related these to the primarycomparator, alkaline hematin. Our objective was to establisha cutoff score for MFL, above which HMB could be reliablydiagnosed. However, there was an overlap of cycle weightsbetween women with normal and excessive blood loss, whichprecluded the determination of a precise normal range for to-tal MFL. Although studies have suggested that fluid weight(either per se or converted to volume) is a simple and appro-priate measurement of menstrual loss (4–6), our data do notsupport this argument.

There are limitations to our study. Caution should beexercised when assessing a methodology that relies on sub-jective assessment by patients. Women assigned a range ofvolumes to each icon category, although extremes of varia-tion occurred in relatively few cases. Inconsistencies mayhave occurred because of individual perception and interpre-tation of stain areas or incorrectly recorded data; for example,erroneously selecting the wrong icon or ticking the wrongbox. We determined the best- and worst-case scenario foruse of the menstrual pictogram by comparing 3,315 expertand participant ratings. There was reasonable concurrence(59%) between the two sets of scores.

Apart from familiarity with the device, differences mayhave arisen because the experts used a full-sized scoring tem-plate rather than the reduced images of the pictogram. How-ever, most stain shapes did not match those of the icondiagrams (many were fragmented), and the experts had noexperience in interpreting nonstandard stain profiles in theclinical setting. There was also a time delay between partici-pant and expert assessment. This gave the potential forfurther stain spread and a higher icon rating, but there wasno clear scoring bias; the experts awarded a higher icon to771 towels and a lower icon to 587 towels. The productswere also assessed in batch mode in an undisturbed labora-tory setting. This was in contrast to the less than ideal condi-tions experienced by participants, such as a public restroomwhere there may be time constraints and restricted facilities,although the questionnaire responses indicated that womendid not consider the scoring environment to be a problem.Given these differences, there was actually little disagreementbetween experts and participants. In 95% of cases the scoringdiscrepancy was less than or equal to one icon category, thussupporting the concept that women are able to estimate theirown MBL, although not as well as a trained expert.

The validity of the menstrual pictogram (SAP-c version)was determined in a broad patient population. The diagnosticaccuracy of this method would benefit from further assess-ment in specific populations, such as women with heavyand/or abnormal menstrual bleeding. Also, we did not eval-uate extraneous MFL. Our primary goal was to validate themenstrual pictogram (SAP-c version) against alkaline hema-tin and menstrual fluid weight, which only measure MBL/MFL captured on sanitary products. Opinions are divided as

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to whether extraneous loss significantly contributes to theoverall volume of menstrual discharge (1, 9, 21, 22),although it may influence a woman's perception of hermenstrual loss.

Various new treatments for HMB have recently been re-ported, some of which have used the PBAC or Kotex men-strual pictogram to estimate MBL (23–25). Crucially, thevalidity of these pictorial devices requires consistent use ofspecific sanitary materials (26). The fluid absorbency ofdifferent feminine items varies considerably, and theassigned scores may be inappropriate for nonvalidatedproducts (16, 27). The menstrual pictogram (SAP-c version)is designed for use with Always Ultra ‘‘With Wings’’ultraslim towels and a choice of three absorbencies. Mostparticipants considered that the product range was suitablefor their personal requirements, although some womenwould have preferred to also use tampons. We did notassess tampons in this study. Although Tampax tampons(Proctor & Gamble) were validated for the originalmenstrual pictogram (9) and the absorbency ratings havenot changed during the last decade, new designs have beenintroduced to limit leakage of menstrual discharge, whichmay alter the visible stain profile. Revalidation wouldtherefore be required.

In summary, the menstrual pictogram (SAP-c version) is asimple, low-cost, user-friendly method for estimating MBL onmodern ultraslim feminine towels that avoids the inconve-nience of collecting used feminine products for laboratoryassessment of fluid weight and/or alkaline hematin. In clin-ical practice, this method could be used to investigate patientscomplaining of excessive menstrual bleeding and guide deci-sion making with respect to appropriate therapy. It is ideallysuited to clinical trials to screen women for HMB and to assessclinical improvement during the investigation of new treat-ment regimens.

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SUPPLEMENTAL FIGURE 1

Number of Always Ultra feminine towels used per menstrual periodversus total blood loss measured by the alkaline hematin method;n ¼ 235 menstrual cycles.Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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SUPPLEMENTAL FIGURE 2

Length of menstrual period versus total blood loss measured by thealkaline hematin method; n ¼ 235 menstrual cycles.Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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SUPPLEMENTAL FIGURE 3

Polynomial regression analysis of total MFL measured as fluid weightversus MBL measured by the alkaline hematin method; n ¼ 235menstrual cycles. Symbol interpretation: blue diamond ¼ blood loss%80 mL, red triangle ¼ blood loss >80 mL. Data points within thecircle denote the overlap in fluid weight between normal and HMBcycles.Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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SUPPLEMENTAL FIGURE 4

Second-order polynomial curve fit of median percentage bloodfraction of menstrual discharge, with respect to icon category;n ¼ 3,257 towels.Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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SUPPLEMENTAL TABLE 1

The participant feedback questionnaire.

Participant feedbackquestion Agreement Responses (%)

Q1. The instructions abouthow to use thepictogram were easy tounderstand.

1 02 03 04 56 (48.3)5 60 (51.7)

Q2. It was difficult to use thepictogram scorecardunder restroomconditions.

1 21 (18.1)2 69 (59.5)3 10 (8.6)4 14 (12.1)5 2 (1.7)

Q3. The size of thepictogram scorecard wasconvenient for everydayuse.

1 1 (0.9)2 5 (4.3)3 3 (2.6)4 71 (61.2)5 36 (31.0)

Q4. It was easy to distinguishthe towel types using thecolor codes.

1 3 (2.6)2 15 (12.9)3 1 (0.9)4 39 (33.6)5 58 (50.0)

Q5. It was hard to distinguishthe towel types using thename (e.g., ‘‘Normal’’).

1 38 (32.8)2 69 (59.5)3 2 (1.7)4 6 (5.2)5 1 (0.9)

Q6. It was easier to choosethe towel type using thename (e.g., ‘‘Normal’’).

1 3 (2.6)2 41 (35.3)3 31 (26.7)4 28 (24.1)5 12 (10.3)

Q7. It was difficult to matchtowel stains to thepictogram icons.

1 16 (13.8)2 81 (69.8)3 6 (5.2)4 10 (8.6)5 2 (1.7)

Q8. The pictogram iconsprovide a realistic imageof the real sanitaryproducts.

1 1 (0.9)2 10 (8.6)3 10 (8.6)4 80 (69.0)5 15 (12.9)

Q9. It was a bother to collectthe towels using thecontainers provided.

1 26 (22.4)2 65 (56.0)3 11 (9.5)4 11 (9.5)5 3 (2.6)

Q10. I was happy to use therefrigerated handbag asa collection vessel.

1 8 (6.9)2 11 (9.5)3 7 (6.0)4 68 (58.6)5 20 (17.2)

Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

SUPPLEMENTAL TABLE 1

Continued.

Participant feedbackquestion Agreement Responses (%)

Q11. It was inconvenient tokeep the containers coolby exchanging cool packsevery 24 hours

1 19 (16.4)2 55 (47.4)3 6 (5.2)4 25 (21.6)5 11 (9.5)

Magnay. Validation of a new menstrual pictogram. Fertil Steril 2014.

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