A method comparison study to assess the reliability of urine collection pads as a means of obtaining...

METHODOLOGICAL ISSUES IN NURSING RESEARCH

A method comparison study to assess the reliability of urine

collection pads as a means of obtaining urine specimens

from non-toilet-trained children for microbiological examination

Michael Farrell BSc RGN RSCN

Lecturer/Practitioner, Department of Nursing, University of Liverpool/Alder Hey ± Royal Liverpool Children's NHS Trust,

Liverpool, UK

Karen Devine RGN RSCN

School Nurse (formerly Staff Nurse Ward D2), Alder Hey ± Royal Liverpool Children's NHS Trust, Liverpool, UK

Gillian Lancaster BSc MSc PhD FRSS CSat

Medical Statistician, University Of Liverpool, Liverpool, UK

and B. Judd FRCPCH

Paediatric Consultant Nephrologist, Alder Hey ± Royal Liverpool Children's NHS Trust, Liverpool, UK

Submitted for publication 9 January 2001

Accepted for publication 19 November 2001

Ó 2002 Blackwell Science Ltd 387

Correspondence:

Michael Farrell,

Room 274 Mulberry House,

Royal Liverpool Children's NHS Trust,

Eaton Road,

Liverpool L12 2AP,

UK.

E-mail: [email protected]

F A R R E L LF A R R E L L MM., D E V I N ED E V IN E KK., L A N C A S T E RL A N C A S T E R GG. & J U DD& J U DD B . ( 2 00 2 )B . ( 2 00 2 ) Journal of

Advanced Nursing 37(4), 387±393

A method comparison study to assess the reliability of urine collection pads as a

means of obtaining urine specimens from non-toilet-trained children for

microbiological examination

Background. In young, non-toilet-trained children, the collection of a urine sample

for microbiology can be challenging, with the application of a urine bag being the

main method of collection. However, recent research has shown that absorbent pads

can be used yielding similar results to bag specimens. However, weaknesses in study

design erode con®dence in research ®ndings. Therefore, improvements in research

design are required to fully evaluate the reliability of pad collection.

Aims of the study. This pilot study sought to test the feasibility of a technique for

the collection of concurrent bag/pad urine samples from non-toilet-trained children,

and to assess the reliability of urine pads over bags as a collection method for urine

specimens for microbiological evaluation.

Design. A pilot, method comparison study.

Methods. Twenty concurrent bag and pad specimens were collected from non-

toilet-trained children, following parental consent. Urine specimens were analysed

for presence or absence of white cell count (WBC), and bacterial growth, using

standard laboratory methods.

Data analysis. The Kappa (j) statistics and con®dence interval (CI) estimation were

used to assess agreement between the two collection methods.

Results. Despite concurrent samples there was a lack of agreement between bag and

pad specimens on both main outcome measures. Agreement between bag and pad

specimens for the presence of WBC yielded a j� 0á10 (95% CI: 0á19, 0á39),

indicating poor agreement, while a j of 0á5 (95% CI: 0á12, 0á88) was calculated for

Introduction

Urinary tract infections (UTI) are common in children

(Woodward & Grif®ths 1993, Davies et al. 1996). The need

for early detection of urine infections in childhood to prevent

long-term urological sequelae, and promote the comfort of

the child, has been emphasized (Royal College of Physicians

1991, Kramer et al. 1993, Pead & Maskell 1994, Turner &

Coulthard 1995).

To facilitate prompt diagnosis of UTI, a specimen of urine

is collected and tested for microbiological culture. Usually a

mid-stream (or clean catch) urine specimen is preferred.

However, this method of collection is dif®cult in non-toilet-

trained children. For this group of children, a urine collection

bag device is usually ®tted. However, given that these bags

are prone to displacement, leakage and cause discomfort, and

are associated with a high contamination rate there has been

interest in developing other methods of obtaining urine

samples for microscopy, with signi®cant interest in the

development of urine collection pads (Roberts & Lucas

1985, Suri 1988, Ahmad et al. 1991, Pierro et al. 1993,

Vernon 1995, Liaw et al. 2000), and nurses taking a

particular lead in several studies (Suri 1988, Vernon et al.

1994, Lewis 1998, Feasey 1999).

Several studies have been undertaken to test the reliability

of retrieving urine from nappies for laboratory investigation

(Roberts & Lucas 1985, Suri 1988, Ahmad et al. 1991,

Vernon et al. 1994). These studies, although based on

relatively small samples (range 6±45), have demonstrated,

in part, that retrieval of urine for microbiological and

biochemical investigation is reliable. However, due to the

increased absorbency of current makes of nappies, it is now

more dif®cult to recover suf®cient amounts of urine. There-

fore, Vernon et al. (1994) tested the use of sanitary pads as a

way of collecting urine for microbiological investigation and

found that urine recovered from the pads yielded identical

culture results to urine collected from urine bags. As a result,

these pads are now commercially available in the United

Kingdom (UK).

The pad technique seems to have obvious bene®ts as a

method of collecting urine for laboratory investigation in that

pads are more comfortable and less expensive than bag-

collection methods. However, several methodological prob-

lems weaken the reliability of the available evidence. For

example, previous studies do not indicate whether the samples

compared were concurrent. For those samples taken in imme-

diate sequence there is often a lack of con®rmation that no

intervention occurred between sample collections. In addition,

operational de®nitions for con®rmation of either positive or

negative results have not always been speci®ed; sample sizes

have not been statistically determined and there have been no

indications as to whether children might have been receiving

antibiotics near or during the time that the sample was taken.

The impact of these de®cits means that it is not possible to fully

evaluate potential sources of bias and variation, and so

jeopardises the reliability of research ®ndings.

Reports in the literature have suggested that white blood

cell (WBC) count might be lower from urine collected from a

pad than collected from a urine bag (Ahmad et al. 1991,

Vernon et al. 1994, Feasey 1999). Again this is of critical

importance given that diagnosis of UTI is con®rmed when

there is a signi®cantly high urinary white blood count

(usually >100 WBC/mL). Given these limitations further

research is required to assess the reliability of the pad system.

Therefore, this pilot study sought to test the reliability of

pads compared with bags, which were used as the reference

method, as a means of collecting urine samples for micro-

biological examination. In this pilot study we particularly

wanted to establish the feasibility of using a concurrent

sample urine-collection technique as previously reported by

Suri (1988). In addition, we sought to gain preliminary data

to assess any degree in variation between pad and bag results,

the degree of agreement in bacterial growth re¯ecting moderate agreement.

Differences in proportions of the presence of WBC between bag and pad did not

quite reach signi®cance at the 5% level 0á2 (95% CI: 0á00, 0á42, P� 0á062). For

cultures the difference was calculated as 0á15 (95% CI: 0á05, 0á35, P� 0á125).

Conclusion. The pilot study demonstrates that concurrent urine samples can be

obtained without dif®culty. Despite poor to moderate agreement on outcome

measures the level of agreement is greater than reported in those other studies, that

use non-current methods of urine collection, suggesting an advantage of the

concurrent technique. It is recommended that larger scale studies be undertaken

using the concurrent collection technique to assess reliability of these ®ndings.

Keywords: method comparison, urine collection methods, pad, bag, children,

microbiology investigation

M. Farrell et al.

388 Ó 2002 Blackwell Science Ltd, Journal of Advanced Nursing, 37(4), 387±393

with the aim that such data could provide information for

planning a future large-scale study.

The study

Design

A pilot, method comparison study design was used.

Ethical considerations

The study received formal research approval from the Trust's

internal Research Review Committee. Ethical approval was

obtained from the Local Paediatric Ethics Committee.

Sample

A prospective, convenience, non-consecutive sampling tech-

nique was used. All samples were obtained from children

attending a large children's hospital, situated in the North-

west of England, UK. Parent(s) of 28, non-toilet-trained

children, who required urine microscopy as part of their

clinical care, were approached to participate in the study.

Most of the sample population were recruited from within the

outpatient setting (12/60%), where children were attending a

urology clinic for follow-up care, usually following a previous

incidence or suspected UTI. The remainder (8/40%) were

recruited from the inpatient setting. In 12 (60%) samples

urine microscopy was required as part of routine surveillance

care, whilst in eight (40%) microscopy was requested to

con®rm either the existence or absence of UTI in the presence

of signs of acute illness. The majority of samples were

collected from females (16/80%), whilst four (20%) were

collected from males. The children participating in this study

had an average age of 16 months (SDSD, 8á17, range 2±27).

Children were not recruited where it was known that they

had commenced antibiotic treatment within 7 days of the

proposed date of urine specimen collection as we were unsure

whether variability of differences in resolution of infection,

and type of antibiotics might affect results. However, chil-

dren who were receiving long-term prophylactic antibiotic

cover for UTI management, and had been receiving this

treatment in excess of 14 days, were recruited as we thought

this period of administration allowed for some stability of

antibiotic effects. In addition, we were aiming to recruit some

children with known urine infection to demonstrate validity

of the pad system.

Procedure

Specimens were collected by two members of the research

team (Farrell and Devine), having agreed and tested the

technique with the creative use of training manikins. This

meant that consistency in technique could be maintained,

thus satisfying criteria considered important for method

comparison studies (Craig et al. 2000).

In all cases, detailed explanation of the purpose of the study

was given and written consent for participation was obtained

from the child's parents. Following consent the child was

prepared for the procedure using appropriate comforting

measures. Collection of the specimen was undertaken in

accordance with universal precautions. In readiness for urine

collection the perineum was cleansed with tap water and

bacterial wipes, the skin was then dried using paper towelling.

A urine specimen bag (Biotrol Urinocol, B.B. Braun Medical

Ltd, Shef®eld, Great Britain), suitable for the size of the child,

was applied, having ®rst made a large bore perforation in the

bag, with a sterile 14 FG hypodermic needle, to allow some

drainage of urine into the pad. A pad (Euron Urine Collection

Pad, Ontex, Buggenhout) was then placed over the bag and

then the child's nappy secured. The Euron pad is non-sterile,

contains cotton wool-like material, measures 20 ´ 7 cm and

has an adhesive strip to assist in securing the pad in the nappy.

The child was then monitored every 30 min for evidence of

micturition following application of the bag and pad.

Following micturition, the nappy area was exposed and

then using a clean non-touch technique, urine was retrieved

from the pad by pressing the tip of a sterile syringe into the

pad. The plunger was then withdrawn, drawing urine into the

syringe barrel. Urine from this sample was then decanted into

a sterile specimen container, labelled with the child's details

and marked `Pad' specimen. The urine bag was then removed

and, using a similar clean non-touch technique, urine was

retrieved from the bag and decanted into a sterile specimen

container. The child's details were recorded and this container

labelled as the `Bag' specimen. Volumes of at least 0á5 mLs of

urine from both the pad and bag were retrieved to enable

analysis.

Within 30 min of collection all specimens were sent to the

laboratory, refrigerated and processed according to standard

hospital microbiological procedures. Laboratory staff was

not blinded to the urinary collection technique.

Given that we were using a concurrent collection method

we anticipated that the bag and pad would show exactly the

same microbiological results. To guide analysis and inter-

pretation of results, diagnostic de®nitions for con®rmation of

positive urinary tract infection, colonization and contamin-

ated specimen were agreed with a consultant microbiologist

(see Table 1).

Statistical methods

Statistical analysis was performed using the StatsDirect

statistical package (Ver 1.7.4, Buchan 2001). Because this

Methodological issues in nursing research The reliability of urine collection pads

Ó 2002 Blackwell Science Ltd, Journal of Advanced Nursing, 37(4), 387±393 389

was a pilot study the focus of the analysis was on levels of

agreement between bag and pad results and con®dence

interval (CI) estimation, rather than hypothesis testing.

Con®dence interval estimation provides an interval range

within which a true population value is likely to lie, within a

certain level of con®dence. It is usual for con®dence limits to

be set at 95% or higher (Gardner & Altman 1989). Thus a

95% CI indicates that under repeated sampling that there

would be a 95% con®dence level that the true value, of the

parameter being measured, would lie between the upper and

lower limits of the interval range.

The two key microbiological outcome measures analysed

were WBC count and bacteria growth pro®le. Given the small

sample size, we were not able to use the absolute data values

of WBC count or bacteria growth level to compute 95%

limits of agreement (Bland & Altman 1986). Instead, we

classi®ed urine results into whether WBCs were present or

absent, and likewise for bacteria growth. We used the Kappa

statistic to assess agreement between the two collection

methods. On computation of the Kappa statistic, a 95% CI

was generated to show the range of values for the true popu-

lation Kappa with 95% certainty. For WBC count 0á5 was

added to each cell in order to calculate the Kappa statistic. To

interpret the Kappa we used the levels of agreement as

suggested by Brennan and Silman (1992), as shown in

Table 2. In addition, we used Newcombe's (1998) method to

calculate the differences and 95% CIs for the population

paired differences in proportions between the two collection

methods in the proportion of samples with WBCs and with

bacterial growth.

Results

Concurrent bag and pad urine samples were eventually

collected from 20 non-toilet-trained children, aged less than

30 months. Lost samples were due to displacement of the urine

bag leading to inability to retrieve urine (two), and lengthy

micturition times for some children, resulting in the families

wishing to discontinue participation in the study (three), and

effects of faecal contamination (two). For the collected samples

median time from placement of bag and pad to micturition was

62á5 minutes (Interquartile range 49±119 minutes).

In the context of the operational de®nitions used to guide

this study no proven UTIs or colonizations were seen in this

series of results. However, microbiological analysis demon-

strated a lack of agreement between pad and urine specimens

in several specimens, as indicated in Tables 3 and 4.

There were four (20%) disagreements between the two

methods in terms of WBC count, and in the majority of cases

(80%) no WBCs were found (Table 3). Analysis yielded a

Kappa of 0á10 (95% CI: ÿ0á19, 0á39), suggesting poor

agreement between the two methods in terms of WBCs. The

difference in proportions of the presence of WBC between bag

and pad was found to be 0á2 (95% CI: 0á00, 0á42, P� 0á0625).

With respect to bacterial growth there were three (15%)

disagreements between the two methods (Table 4). A Kappa

Table 1 Operational de®nitions for the con®rmation of urinary tract

infection and other microbiological states

Infection: A microbiologically proven clinical diagnosis of

generalized and/or local in¯ammation. In case of

urinary tract infection, minimally 100 white

blood cells/mL combined with a pure culture

growth >105 bacteria/mL.

Colonization: The presence of one bacterium in a

concentration of 105/mL in general, with

WBC < 100/mL.

In¯ammation: The urine is sterile, i.e. no bacterium but there

are >100 WBC/mL.

Contamination: There is no clinical evidence of infection

(WBC < 100/mL) in the presence of two or

more microorganisms.

Table 2 Interpretation of Kappa Statistic as suggested by Brennan

and Silman (1992)

Kappa Statistic Strength of agreement

<0á21 Poor

0á21±0á40 Fair

0á41±0á60 Moderate

0á61±0á80 Good

0á81±1á00 Very good

Table 3 Agreement in white blood cells (WBC) count results between

pad and bag urine specimens

Bag

Pad WBC present WBC absent Total

WBC present 0 0 0

WBC absent 4 16 20

Total 4 16 20

Table 4 Agreement in culture result between pad and bag urine

specimens

Bag

Pad Bacteria present Bacteria absent Total

Bacteria present 2 0 2

Bacteria absent 3 15 18

Total 5 15 20

M. Farrell et al.


of 0á5 (95% CI: 0á12, 0á88) was calculated for the degree of

agreement in bacterial growth between bag and pad speci-

mens, suggesting moderate agreement. The difference in

proportions of bacterial growth between the two groups

was calculated as 0á15 (95% CI: 0á05, 0á35, P� 0á125).

Discussion

The use of urine pads for collection of urine samples for

microbiological analysis has gained popularity given that the

child's comfort is enhanced and that it is possible to extract

an appropriate amount of urine without dif®culty. An

additional bene®t is that the pad collection technique is less

expensive than collecting urine through the application of a

urine bag. Therefore, potential cost savings might be realized

should the pad method of collection be adopted. Previous

research has identi®ed the bene®ts of pad collection for home

collection of urine samples by parents (Liaw et al. 2000).

Our research supports these advantages, ®nding pads easy

to use and generally enabling easy retrieval of urine.

However, concerns regarding reduced WBC counts and

altered bacterial pro®les from pad samples remain signi®cant.

This study has shown that, despite concurrent paired samp-

ling there is a possibility of poor agreement between the pad

and bag systems. The danger is that a relatively large degree

of difference in WBC values between the two systems could

cause the recording of a false-negative result.

It is interesting to note that other studies have shown

differences in proportions of WBC between bag and pad

collection. Feasey (1999) compared WBC counts and bacterial

results in 48-paired samples (although not concurrent)

obtained from children. In that data set three positive urine

tract infections were microscopically con®rmed and the

researcher indicates that, despite variance, in the magnitude

of the differences obtained between bag and pad specimens,

that the pad specimen yielded suf®cient information to con®rm

a positive UTI. Accordingly, Feasey concluded that urine pads

were reliable. Yet, while the researcher rightly cautions that

WBC counts are lower she did not indicate the magnitude of

the change. Thus we reanalysed the raw data for agreement

and for differences in WBC proportions using CI estimation.

The results con®rm poor agreement between methods, giving a

Kappa 0á19 (95% CI: ÿ0á04, 0á43), and a difference between

proportions of children in whom WBCs were detected between

bag and pad as 0á31 (95% CI: 0á13, 0á46, P� 0á0009). This

difference between WBC count proportions is greater than in

our study, which used concurrent samples, thus suggesting

some advantage in the concurrent sampling method.

The difference in WBC and bacterial counts between bag

and pad specimens suggests that the pad system has some

deleterious impact on bacteria, although it is not possible to

indicate why this occurs. Perhaps cells become embedded in

the fabric, which prevents their reclaim, and thus distorts the

counts obtained from urine retrieved from pads.

There is some evidence from earlier studies, which have

shown that changes in other urine constituents can also be

affected when trying to retrieve urine from absorbent mater-

ials, con®rming the suspicion of some impairment in the

retrieval process. For example Roberts and Lucas (1985),

undertaking an laboratory based experimental study, found

that while urine reclaimed from commercially available brands

of nappies, yielded the same results against a known control

concentration for a range of urinary constituents, including

sodium, urea, creatinine levels, that the levels of some constit-

uents increased (phosphorous and calcium). While the

researchers note the stability of levels of the key urinary

constituents between nappy and usual collection methods is

equivalent, they postulate that the increase in some levels is due

to a leeching action, activated when urine contacts the nappy

material. In another study researchers retrieving urine from

absorbent cotton wool, placed in the nappy area to aid

collection of urine from 14 infants for the investigation of

proteinuria, found that urinary albumin and retinal binding

protein levels could be signi®cantly decreased, in comparison

to usual collection method (Smith & Taylor 1992). Interest-

ingly they noted that while albumin levels were decreased, the

level of decrease was not uniform, ranging from a small loss in

some samples up to 35±40% in others. These researchers also

found that in respect of retinal binding protein that most of the

loss occurred within 15 minutes of contact with the absorbent

material. They conclude that caution is needed when using

such materials for the retrieval of urine specimens required for

urinary analysis. The implications of such ®ndings for the

current study is that further research work is needed to con®rm

the mechanisms involved which precipitate reduction in

overall urinary pro®le when urine comes in contact with

absorbent material used for the collection of urine specimens.

Thus further research is required to explore further these

®ndings as there is a danger that any change in urine pro®le

may lead to errors in con®rming UTIs, by microscopic means.

Macfarlane et al. (1999) report their concerns that urine

pads have a high association with contamination and worry

that such contamination can hide infection. This must be a

considerable concern, given the signi®cant morbidity associ-

ated with UTIs in childhood. Therefore, Macfarlane and

colleagues consider that heavily contaminated urine pad

samples will often need to be repeated, thus eroding the

bene®ts of the pad collection system. However it should be

noted that urine bags also have a high contamination rate

(Ramage et al. 1999). Thus, given the limitations of current



collection methods in children the clean-catch technique

should remain the preferred way to collect urine from young

non-toilet-trained children (Macfarlane et al. 1999, Ramage

et al. 1999).

Limitations of the study

Several limitations impact upon the ®ndings of the present

study. This was a pilot study and thus sample size has not

been statistically determined. The small sample size requires

that a larger study be undertaken, with the sample size

determined by power calculation, to study the reliability and

validity of ®ndings. Furthermore, in a larger study, it may be

possible to use the methods of Bland and Altman (1986) to

analyse data in their original form, rather than having to

dichotomise the results into presence or absence of WBCs and

bacterial growth. Using these methods it would be possible to

determine the magnitude of differences between the two

methods using 95% limits of agreement.

In this study no children were con®rmed as having a UTI.

Therefore, it is not possible to indicate the degree of variance in

results between pads and bags in the presence of signs of urinary

tract infection. There is a particular need to study the magni-

tude of difference in WBC counts and culture growths between

bag and pad specimens in children known to have a UTI.

Conclusion

Notwithstanding its limitations, the study has shown that it is

possible to obtain concurrent paired samples without dif®-

culty. It has also shown that, despite concurrent sampling,

there is a likelihood of poor agreement between microbio-

logical results, suggesting that pads have a deleterious impact

on WBC and bacterial counts. Although the concurrent

method shows differences in key microbiological results it

appears that these differences are less than would be found in

studies that use non-concurrent urine samples. Therefore, it is

suggested that the concurrent technique of bag/pad urine

collection should be used in larger studies to enhance study

design in ascertaining the reliability of urine pads for the

collection of urine.

Acknowledgements

We appreciate the comments made by peer reviewers and

thank Dr C Watkins, University of Manchester, for helpful

additional comments.

This study was supported with a research grant made by

the Endowment Committee of the Royal Liverpool Childrens

NHS Trust.

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