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«J. Pers. Med. 2015, 5, 341-353; doi:10.3390/jpm5040341 OPEN ACCESS Journal of Personalized Medicine ISSN 2075-4426 Article ...»

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J. Pers. Med. 2015, 5, 341-353; doi:10.3390/jpm5040341

OPEN ACCESS

Journal of

Personalized

Medicine

ISSN 2075-4426

www.mdpi.com/journal/jpm/

Article

Measurement Issues in Anthropometric Measures of Limb

Volume Change in Persons at Risk for and Living with

Lymphedema: A Reliability Study

Dorit Tidhar 1,*, Jane M. Armer 2, Daniel Deutscher 1, Chi-Ren Shyu 3, Josef Azuri 4,5 and Richard Madsen 6 1 Physical Therapy Service, Maccabi Healthcare Services, Tel-Aviv 6812511, Israel;

E-Mail: Tidhar_d@mac.org.il 2 Sinclair School of Nursing, University of Missouri, Columbia, MO 65211, USA;

E-Mail: armer@missouri.edu 3 Department of Computer Science, Informatics Institute, University of Missouri, Columbia, MO 65211, USA; E-Mail: shyuc@missouri.edu 4 Health Division, Maccabi Healthcare Services, Tel-Aviv 6812511, Israel;

E-Mail: azuri_yo@mac.org.il 5 Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel 6 Office of Medical Research, University of Missouri, Columbia, MO 65212, USA;

E-Mail: MadsenR@missouri.edu * Author to whom correspondence should be addressed; E-Mail: tidhar_d@mac.org.il;

Tel.: +97-25-3522-9155; Fax: +97-27-7700-3128.

Academic Editor: Stephen B. Liggett Received: 30 July 2015 / Accepted: 17 September 2015 / Published: 30 September 2015 Abstract: Understanding whether a true change has occurred during the process of care is of utmost importance in lymphedema management secondary to cancer treatments.

Decisions about when to order a garment, start an exercise program, and begin or end therapy are based primarily on measurements of limb volume, based on circumferences taken by physiotherapists using a flexible tape. This study aimed to assess intra-rater and inter-rater reliability of measurements taken by physiotherapists of legs and arms with and without lymphedema and to evaluate whether there is a difference in reliability when measuring a healthy versus a lymphedematous limb. The intra-rater reliability of arm and leg measurements J. Pers. Med. 2015, 5 342 by trained physiotherapist were very high (scaled standard error of measurements (SEMs) for an arm and a leg volume were 0.82% and 0.64%, respectively) and a cut-point of 1% scaled SEM may be recommended as a threshold for acceptable reliability. Physiotherapists can rely on thesame error when assessing lymphedematous or healthy limbs. For those who work in teams and share patients, practice is needed in synchronizing the measurements and regularly monitoring their inter-rater reliability.

Keywords: decision-making; lymphedema; lymphedema management; minimal clinical;

detectable change; reliability; standard error of measurement; tape measurement

1. Introduction Post-cancer treatments lymphedema (LE) is a chronic disease, which has no cure [1]; however, it can be managed successfully by reducing symptoms and volume and maintaining that reduction [2]. LE early detection is performed by measuring volume and assessing symptoms and comparing them to baseline measurements [3]. Management strategies vary and may include, for example, daily bandaging, performing exercises twice weekly, using a pneumatic compression device, or receiving manual lymph drainage. As long as patients improve by reaching their treatment goals, the treatment will be considered a success [4]. Examples of treatment goals may be: improving a specific function, reducing symptoms such as pain or heaviness, preventing infection, improving body image, improving limb shape, etc.

Assessing LE outcomes only from the patient’s perspective is not sufficient for therapists in their decision-making process; objective assessment, such as volume measurement, is needed as well.

Therefore, when resources are limited, and the question of adherence to treatment is considered physiotherapists (PTs) are interested in offering patients the most efficient tool or technique, one that will achieve successful outcomes.

One of the main outcomes for LE treatment is volume reduction that can be measured using different approaches. The Perometer™ is a device that uses infrared light beams to estimate the volume of a limb [5].

Water displacement is used to assess the volume of a limb by submerging the arm or leg in a water tank and measuring the water that is displaced. This method has been considered to be the “gold standard” [6].

A flexible measurement tape is a practical low-cost tool available in any clinic. Volume is derived from calculations of several circumferential measurements taken at predetermined points along the limb using a truncated cone formula [7].

Knowing the minimum clinically important difference (MCID) of limb volume change is essential for the clinician in determining the existence of LE, its improvement, progression, or stability [4]. There are numerous possible consequences to that decision. A garment ordered too soon may not fit and, therefore, result in a financial loss. Requiring a patient to wait longer than necessary and continue treatments may lead to reduced adherence to attend the therapy sessions as she/he may feel stable and resent wasting time and money going to therapy. Prolonging treatment beyond what is needed could increase patient waiting lists to the detriment of lymphedema management services. When assessing patients’ progress using the flexible tape method, the standard error of measurement (SEM) may be used by clinicians as a Distribution based MCID [8]. In a case series by Tidhar et al. [9], the clinical decision-making to order J. Pers. Med. 2015, 5 343 a garment was based on volume stability. The authors reported a SEM of 30 mL for the therapist treating patients in a self-bandaging clinic, a threshold below which was considered stable and beyond which was considered unstable [9]. Schmidt et al. [10] defined the term “stable lymphedema” to help determine whether a woman with breast cancer-related LE (BCRL) could begin a weight-lifting program; one criterion was that the woman experience no more than 10% increase in arm swelling in the three preceding months. PTs who want to implement this weight-lifting program and who must decide whether to approve an individual’s participation need to know their own scaled SEM in order to determine whether their patients are stable or not.





Few studies have examined the Distribution based MCID of limb volume change: Katz Leurer et al. [11] reported SEM of 78.8 mL of the healthy arm vs. 47.1 mL of the affected arm in BCRL, Taylor et al. [7] found the SEM of BCRL to be in a range of 64.5–65.4 mL [7], and Devoogt et al. [12] reported a minimal detectable change (MDC) of 55 mL to detect a true change. One study by Sawan et al. [13] reported a repeatability limit of 270 mL for leg volume; no other reports were found for SEM of leg volume.

Devoogt et al. [12] reported on scaled SEM that ranged from 0.8%–2% for measuring arms; no report was found on scaled SEM for leg LE measurement.

Sometimes PTs work together in the same clinic and share patient management. Knowing the inter-rater reliability of volume measurements is most important if they want to base their decisions on their colleague's assessment. Several studies have examined the inter-rater reliability in measuring arm volume and reported an intra-class correlation (ICC) of more than 0.97 between raters [7,14].

Unfortunately, ICC cannot be translated to clinical practice as the dimensions are different from those used in practice. Sawan et al. (2009) reported on inter-rater reliability and measured reproducibility of 1000 mL when measuring one leg volume by 17 assessors. These findings have not been supported by any other study.

The aims of this study were: (a) to determine the SEM for measuring volume of an arm and a leg with and without LE for the purpose of assessing and following up on patients with LE and surveying those who have not yet developed LE; (b) to assess if there is a difference between SEM of healthy vs. LE limbs; and (c) to examine the reliability between therapists when measuring an arm and a leg with and without LE.

2. Design and Methods

Sixty PTs who work in lymphedema management in Maccabi Healthcare Services and in private practice, received an invitation to attend the day of research, which contained the purpose and schedule of the day. Forty-one PTs volunteered and participated in the study that took place as part of a conference organized by the physiotherapy department of Maccabi Healthcare Services in Israel. All PTs were lymphedema specialists who had received 140 h of training and had more than one year’s experience in measuring patients’ limb volume (range from 1 to 20 years). This study was conducted as part of a practice-based evidence research process in which we test the reliability of PT’s documentation before we start collecting data. In all, 41 PTs attend and volunteered to participate. The study was approved by the Ethics committee of Maccabi Healthcare Services.

Five patients were invited to participate in the study. Patients were asked to be present half an hour prior to the taking of measurements so they could lie supine to reduce any excess fluid that might have J. Pers. Med. 2015, 5 344 accumulated from commuting to the study venue. Prior to participation, consent was obtained from all patients. At the beginning of the conference, the primary author (DT) gave a short demonstration of the measuring procedure. Each physiotherapist (PT) left the conference for approximately 20 min throughout the day and measured one patient. Each patient volunteered his/her LE limb and a healthy limb (e.g., a woman with arm LE had her lymphedematous arm and a healthy leg measured). Both limbs were measured 3 times.

Circumferential measurements were taken at 6 points on an arm according to anatomical landmarks [7] (mid palm, wrist, 10 cm above the wrist point, elbow, 10 cm above elbow and axilla), and 8 measurements for a leg using a measurement board (10 cm from heel towards toes, 10 cm from heel towards ankle, 20 cm, 30 cm, 40 cm, knee, 55 cm and Groin).

The circumferences were then entered into a spreadsheet and a truncated cone formula applied with

each segment volume calculated:

ℎ( × + × + × ) = (1) 12 where Vs. was volume of a segment, h was the distance between two points of measurement, Ct represented the circumference at the top measurements of the segment, Cb represented the circumference at the base of the segment. Once each segment was calculated, a sum of five segments of an arm and seven segments of the leg were computed into a volume estimate [15]. This method was found to be valid (criterion validity) in several studies when compared to the gold standard of water displacement with intra class correlation coefficient (ICC) of 0.95 [7,16].

3. Data Analysis

–  –  –

For analysis of the quality of the limb volume measurements made by different PTs, we used the difference between their first measurement from the true mean (which was defined as the average of all measurements by all therapists of the same limb) scaled by the true mean (Formula (4)). We then estimated the proportion of therapists whose measurements were within 5% of the true mean. As 10% difference between limbs is considered one of the definitions for LE [18,19], and was determined as defining stable LE as well [20], and while recognizing that the choice is arbitrary, a 5% limit within the true mean was chosen to be an appropriate cutoff point for a team of PTs measuring the same patient.

The percentage difference (% diff) from the true mean for a single PT was calculated using the formula:

1 − ̅ %diff = × 100 (4) ̅ where 1 is the first volume measurement (out of three), ̅ is the average of the volumes from all PTs who measured the same limb (only the first volume measurement was used since in clinical practice usually only one measurement is taken).

Differences between measurements from healthy and lymphedemadematous limbs were analyzed by Wilcoxon Rank Sum test. IBM SPSS software version 21 was used to analyze all data.

4. Results

Five patients with secondary lymphedema participated in the study. Two were women with upper extremity LE following breast cancer, one was a woman with lower limb LE following treatment for sarcoma and two were men with phlebolymphedema of the lower extremity. The limbs to be measured included three healthy arms and two with LE (one severe and one mild), and two healthy legs and three with LE (one moderate and two severe). Forty-one PTs were divided into five groups of 6–11 each.

Aim 1: Intera-rater reliability.

Average SEM for arm measurements was 27.5 mL (CI 20.5–34.4 mL). Figure 1 demonstrates the distributions of all SEM’s of the arm. Mean scaled SEM was 0.82% (CI 0.59%–1.05%). The proportion of PTs with scaled SEM less than 1% was 83% (Figure 2). From both Figures 1 and 2, an outlier is obvious with a SEM of 110 mL and scaled SEM of 4.6%. Since all other PTs who had measured the same patient’s arm had scaled SEM below 1%, it is obvious that this PT’s technique requires improvement. The group who measured patient 4 seemed to have fewer PTs who measured within the 1% cutoff point; however, when analyzing the differences between groups, no statistical differences were found in the scaled SEM (p = 0.847).

Average SEM for leg measurements was 83.6 mL (CI 65–102 mL). Figure 3 demonstrates the distributions of all SEM’s of the leg.

Scaled SEM was 0.64% SEM (CI 0.5%–0.78%). The proportion of PTs whose scaled SEM was less than 1% was 83% (34/41) (Figure 4). There was no statistically significant difference of scaled SEM of legs (p = 0.598) between the groups measuring different patients.

Aim 2: SEM of healthy vs. lymphedema.

There was no statistically significant difference between scaled SEM for healthy vs. LE arms (p = 0.945) or for legs (p = 0.533).

J. Pers. Med. 2015, 5 346 Aim 3: Inter-rater reliability.

Fifty-six percent (23/41) of PTs’ first measurement was within 5% of the true mean value for measuring an arm with CI of 42%–72% (Figure 5) and 80.5% (33/41) of PTs’ first measurement was within 5% of the true mean value for measuring a leg with CI of 68%–93% (Figure 6).

Figure 1. SEM in mL for 41 PTs measuring an arm; each symbol represents a patient.



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