DOI: 10.5061/dryad.6wwpzgn59
title: Data from: A cross-sectional study investigating the relationship between pit recovery time and serum albumin levels in bilateral lower extremity pitting oedema

description: Objectives: In this study, we re-evaluated the relationship between pit
 recovery time (PRT) and serum albumin levels and elucidated the factors
 influencing PRT. Design: Cross-sectional study. Setting: Patients who
 visited the outpatient department or were admitted to a small urban
 hospital in Japan. Participants: 135 adult Japanese patients with
 bilateral lower extremity pitting oedema. Interventions: Primary and
 secondary outcome measures: This study assessed the correlation between
 PRT and serum albumin levels, calculated the predictive accuracy for
 identifying a group with low albumin levels when the PRT of the lower leg
 was &lt; 40 s, and identified variables that influence PRT. Results:
 We found no significant correlation between lower leg PRT and serum
 albumin levels. Furthermore, a PRT of &lt; 40 s was largely
 ineffective in predicting low albumin levels. Factors influencing PRT
 included the diagnosis of malnutrition oedema, examinations conducted
 during hospitalisation, diagnosis of cardiac oedema, use of diuretics,
 thickness of the lower limb soft tissue, serum creatinine level, estimated
 right ventricular systolic pressure (RVSP), age, serum albumin level,
 potassium level, and blood urea nitrogen to serum creatinine ratio.
 Notable correlations with PRT were observed in relation to lower limb soft
 tissue thickness, age, and estimated RVSP. Conclusions: Given that the PRT
 is influenced by multiple factors, its correlation with serum albumin
 levels is weak. Thus, predicting hypoalbuminaemia based solely on PRT is
 inaccurate.
description: <strong>Study design</strong>: This was a cross-sectional study in a single
 hospital. <strong>Study
 population</strong>:
 This study included patients aged 15 years or older (to exclude children)
 who visited the outpatient department or were admitted to the Department
 of Internal Medicine at the Kameyama Municipal Medical Centre in Japan
 from 1 May 2021 to 31 March 2023. We recruited patients who exhibited
 pitting oedema distal to the knee joint. We excluded patients with oedema
 in unilateral lower limb, significant asymmetry in oedema between the left
 and right sides, non-pitting oedema, oedema due to localised skin
 inflammation or injury (such as cellulitis, burns, and anaphylaxis),
 undergoing dialysis, and individuals with critical life-threatening
 conditions who did not have the time for PRT measurement or examination.
 Based on a prior study by Henry et al., we estimated that our sample size
 should be more than 126 cases. The calculation method was as follows:
 first, we inferred data from the plot diagram of their study and
 categorised it into two groups, a low albumin group with serum albumin
 levels less than 3.5 g/dl and a normal albumin group with serum albumin
 levels of 3.5 g/dl or more. We calculated the average PRT scores for each
 group. The results were 53 and 117 s, respectively, with an average
 difference in PRT of approximately 64 s between the two groups. The
 standard deviation for both groups was about 55 seconds, yielding an
 effect size of 1.0 or more. As the prior study had a small number of
 cases, we estimated the effect size to be small at 0.5 and calculated the
 sample size using an alpha value (two-sided) of 0.05 and a beta value of
 0.20, resulting in a requirement of more than 63 cases per
 group. <strong>Data
 collection</strong>:
 Data collected from the medical interview included age, sex,
 admission status
 (inpatient/outpatient),
 body height, body weight, Birthel Index, Charlson Comorbidity Index,
 medication, medical history, paralysis, snoring, onset of oedema, and
 exacerbation of oedema depending on body position or time of day. The
 variables related to the physical examination included being examined in a
 sitting or lying posture, skin changes related to lower limb varicose
 veins [1], soft tissue thickness in the oedema and PRT. Laboratory
 variables included haematocrit (Hct), albumin, total protein (TP), sodium
 (Na), potassium (K), blood urea nitrogen (BUN), serum creatinine (sCr),
 BUN/sCr, glucose, estimated plasma osmolarity (Posm), C-reactive protein
 (CRP), and brain natriuretic peptide (BNP). The variables being assessed
 in the transthoracic echocardiography were inferior vena cava (IVC)
 diameter, respiratory variation of the IVC, estimated transtricuspid
 pressure gradient (TRPG) and estimated right ventricular systolic pressure
 (RVSP) [2]. <strong>Methods for measuring PRT and soft tissue
 thickness in the oedema</strong>: Lower leg oedema is measured at the midpoint
 on the rough surface of the tibia at the distal 1/3 height of the line
 connecting the medial malleolus and medial condyle of the tibia [3], and
 foot oedema is measured at the dorsum of the 3rd metatarsal head, which is
 the midpoint of the line connecting the heads of the 1st and 5th
 metatarsals [4]. For each measurement of soft tissue thickness, the
 distance from the skin surface to the anterior surface of the tibia was
 measured for lower leg oedema, and the distance from the skin surface to
 the head of the third metatarsal was measured for foot oedema, using an
 ultrasound device. The examiner then firmly pressed the oedema with the
 thumb for 2 s until a clear indentation remained and subjectively measured
 the number of seconds (up to a maximum of 600 s) it took for the
 indentation to completely disappear. This was performed by the same
 examiner for all patients. If indentations from socks or compression
 stockings are observed, they were removed and measurements were taken
 after the indentations have disappeared. The average of the soft tissue
 thickness at all locations is defined as the 'lower limb soft tissue
 thickness'. The average of the PRT at the two lower leg locations is
 defined as the 'lower leg PRT', the average PRT at the two feet
 locations is defined as the 'foot PRT', and the average PRT at
 all locations is defined as the 'lower limb
 PRT'. <strong>Diagnosis of the cause of
 oedema</strong>:
 Two general practitioners
 skilled in diagnosing oedema will make judgments based on medical chart data,
 algorithms for the differential diagnosis of bilateral lower-limb
 oedema and
 reviews of each oedema
 pathology. Please note
 that the PRT was not used as a reference. Additionally, if necessary for
 the diagnosis of lower limb oedema, appropriate additional tests (such as
 urinary protein
 concentration, lower limb
 venous ultrasound and abdominal imaging) will be
 conducted. <strong>References</strong> Lurie F, Passman M, Meisner M et al. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord 2020 May;8:342–52. Rudski LG, Lai WW, Afilalo J et al. Guidelines for the echocardiographic assessment of the right heart in adults: A report from the American Society of Echocardiography. J Am Soc Echocardiogr 2010;23:685–713; quiz 786. Henry JA, Altmann P. Assessment of hypoproteinaemic edema: A simple physical sign. Br Med J 1978 Apr 8;1:890–1. Kogo H, Higashi T, Murata J. Reliability of a new practical evaluation method for pitting edema based on the depth of the surface imprint. J Phys Ther Sci 2015;27:1735–8.
description: # Data from: A cross-sectional study investigating the relationship
 between pit recovery time and serum albumin levels in bilateral lower
 extremity pitting oedema 
 This is a dataset from a cross-sectional study that examined the
 correlation between Pit recovery time(PRT) and serum Albumin levels in
 patients presenting with bilateral lower extremity pitting oedema. This
 study included patients aged 15 years or older who visited the outpatient
 department or were admitted to the Department of Internal Medicine at the
 Kameyama Municipal Medical Centre in Japan from 1 May 2021 to 31 March
 2023. Data collected from the medical interview, physical examinations,
 laboratory tests and a transthoracic echocardiography. ## Description of
 the data and file structure List of Columns 1\. Columns on red background
 * Age [year] * Sex: 0 means male, 1 means female. * Admission statues: 0
 means an outpatient, 1 means an inpatient. * Body height [cm] * Body
 weight [kg] * Birthel index [point]: It is a measure used to assess
 activities of daily living (ADL) such as transfers, dressing, and eating.
 * Charlson comorbidity index [points]: It is a measure used to assess a
 patient's health status. It evaluates whether a patient has specific
 diseases or conditions and considers the severity of these illnesses to
 calculate an overall health risk. 2\. Columns on orange background: This
 includes medical history. 0 means none, 1 means present. 3\. Columns on
 yellow background: This includes medication. 0 means none, 1 means
 present. 4\. Columns on light green background: This includes symptoms. 0
 means none, 1 means present. 5\. Columns on green background: This
 includes history of oedema. * Onset [day]: This indicates the number of
 days since the onset of edema before the medical consultation. *
 Exacerbation depending on body position or time of day: 0 means none, 1
 means present. 6\. Columns on light blue background: This includes items
 related to physical examination. * Position during examiation: 0 means
 supine, 1 means sitting. * Skin changes related to lower limb varicose
 veins: 0 means none, 1 means present. Columns on blue background: This
 includes thickness of soft tissue in the oedema [mm]. The measurement
 method is described later. Columns on purple background: This includes pit
 recovery time in the oedema [second]. The measurement method is described
 later. Columns on 2nd red background: This includes laboratory variavles.
 * TP (total protein) [g/dL] * Albumin (serum albumin) [g/dL] * BUN (blood
 urea nitrogen) [mg/dL] * sCr (serum creatinine) [mg/dL] * Na (sodium)
 [mEq/L] * K (potassium) [mEq/L] * Glucose [mg/dL] * Hct (haematocrit) [%]
 * CRP (C-reactive protein) [mg/dL] * BNP (brain natriuretic peptide)
 [pg/mL] * Estimated Posm (plasma osmolarity) [mOsm/L] 10\. Columns on 2nd
 orange background: This includes results of echocardiogram test. *
 Estimated TRPG (transtricuspid pressure gradient) [mmHg] * IVC (inferior
 vena cava) diameter [mm] * Respiratory variations in IVC(inferior vena
 cava) : 0 means none, 1 means present. * Estimated RVSP (right ventricular
 systolic pressure) [mmHg] Columns on 2nd yellow background: This includes
 primary cause of oedema. 0 means none, 1 means present. Methods for
 measuring PRT and soft tissue thickness in the oedema: Lower leg oedema is
 measured at the midpoint on the rough surface of the tibia at the distal
 1/3 height of the line connecting the medial malleolus and medial condyle
 of the tibia, and foot oedema is measured at the dorsum of the 3rd
 metatarsal head, which is the midpoint of the line connecting the heads of
 the 1st and 5th metatarsals. For each measurement of soft tissue
 thickness, the distance from the skin surface to the anterior surface of
 the tibia was measured for lower leg oedema, and the distance from the
 skin surface to the head of the third metatarsal was measured for foot
 oedema, using an ultrasound device. The examiner then firmly pressed the
 oedema with the thumb for 2 s until a clear indentation remained and
 subjectively measured the number of seconds (up to a maximum of 600 s) it
 took for the indentation to completely disappear. Abbreviation:
 haematocrit (Hct), albumin, total protein (TP), sodium (Na), potassium
 (K), blood urea nitrogen (BUN), serum creatinine (sCr), estimated plasma
 osmolarity (Posm), C-reactive protein (CRP), brain natriuretic peptide
 (BNP), inferior vena cava (IVC), estimated transtricuspid pressure
 gradient (TRPG) and estimated right ventricular systolic pressure (RVSP).
 missing values: NA ## Code/Software Data compilation was performed using
 Microsoft Excel®. ## SHARING/ACCESS INFORMATION 1\. Licenses/restrictions
 placed on the data: No copyright - non-commercial use only 2\. Links to
 other publicly accessible locations of the data: None 3\.
 Links/relationships to ancillary data sets: None 4\. Was data derived from
 another source? No\ A. If yes, list source(s): NA 5\. Recommended citation
 for this dataset: R Ono, K Horibata. Data from: A cross-sectional study
 investigating the relationship between pit recovery time and serum albumin
 levels in bilateral lower extremity pitting oedema. Dryad Digital
 Repository.
 ##
 Author Information A. Principal Investigator Contact Information\ Name:
 Ryosuke Ono Institution: Department of Community Medicine, Kameyama, Mie
 University School of Medicine Address: 2-174 Edobashi, Tsu City, Mie
 Prefecture, Japan Email: B.
 Co-investigator Contact Information\ Name: Ken Horibata Institution:
 Department of Community Medicine, Kameyama, Mie University School of
 Medicine Address: 2-174 Edobashi, Tsu City, Mie Prefecture, Japan