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Appendix

Appendix

Contents

Data tables

Table 1: Overview of the Bevan et al. (2011) study

Table 2: Overview of the Buntsma et al. (2012) study

Table 3: Overview of the Marciano et al. (2013) study

Table 4: Overview of the Rowe et al. (2014) study

Table 1 Overview of the Bevan et al. (2011) study

Study component

Description

Objectives/hypotheses

To assess the reproducibility and accuracy of the BladderScan BVI 9400 (ABUS), in measuring bladder volume in children aged 0 to 24 months when compared with real‑time ultrasound.

Study design

Prospective cohort, single centre.

Setting

The radiology department of a hospital in Australia, between August and October 2009.

No follow‑up period was reported.

Inclusion/exclusion criteria

Inclusion:

  • healthy children aged 0 to 24 months.

Exclusion:

  • children with a history of renal tract abnormality, abdominal surgery or abdominal scar tissue

  • open skin wounds or wounds to the suprapubic area.

Primary outcomes

Accuracy and reproducibility of bladder volume measurements.

Statistical methods

Bland–Altman limits of agreement for accuracy, Bland–Altman repeatability coefficient for reproducibility.

Patients included

61 children (31 males; mean age±SD=11±6.2 months, range=0–24 months).

Results

The 95% limits of agreement between the BladderScan and real‑time ultrasound were –31 to +19 ml. ABUS also detected no values between 0 and 10 ml.

The repeatability coefficient within ABUS readings was 20 ml.

Conclusions

Study showed poor repeatability and accuracy in bladder volume measurements using BladderScan when compared with real‑time ultrasound. The BladderScan method does not appear to be a reliable method for assessing bladder volumes in children aged 0 to 24 months before bladder instrumentation.

Abbreviations: ABUS, automated bladder ultrasound scanner.

Table 2 Overview of the Buntsma et al. (2012) study

Study component

Description

Objectives/hypotheses

To determine the success rate of SPA when assisted by the BladderScan BVI 9400 (PBUS; as was standard practice in the A&E of the study hospital).

Study design

Prospective cohort, single centre.

Setting

The A&E of a hospital in Australia. Results were recorded over an 8‑month period between August 2009 and March 2010.

No follow‑up period was reported.

Inclusion/exclusion criteria

Inclusion:

  • children aged 0 to 24 months presenting to the ED needing acute urine collection by SPA.

Exclusion: none stated.

Primary outcomes

The success rate of SPA.

Magnitude of PBUS reading (in ml).

Statistical methods

Descriptive statistics. Chi‑square analyses were used to assess proportions (success rates for different BladderScan reading ranges).

Patients included

Children (n=60) aged 0 to 24 months (mean age=5.0 months (range 0 to 18.6 months) presenting to A&E needing acute urine collection by SPA.

Results

The audit showed an overall success rate of 53% (32/60; 95% confidence interval 41%–66%). Success rates were 63%, 32%, 82% and 63% for the BladderScan readings of 0–9 ml (n=8), 10–19 ml (n=25), 20–29 ml (n=11) and ≥30 ml (n=16), respectively, or 39% at <20 ml and 70% at ≥20 ml (p=0.02).

Conclusions

The PBUS‑assisted SPA success rate was higher in children with readings ≤20 ml.

These rates were lower than previous success rates using RTUS reported in the literature.

Abbreviations: PBUS, portable bladder ultrasound; SPA, suprapubic aspiration; RTUS, real‑time ultrasound.

Table 3 Overview of the Marciano et al. (2013) study

Study component

Description

Objectives/hypotheses

To evaluate diagnostic accuracy of the child mode on the BladderScan BVI 9400 in paediatric patients.

Study design

Prospective cohort; additional information not specified.

BladderScan BVI 9400 was used in children scheduled for diagnostic evaluation or treatment under general anaesthesia or deep sedation. The underlying conditions of the children were not reported. The ethical implications of catheterising children to determine bladder volume were not reported.

Bladder volume was evaluated immediately after bladder emptying and after the infusion of 20, 50, and 100 ml of saline solution via transurethral catheter in all patients.

Published as an abstract only.

Setting

Acute care setting in Italy.

Recruitment period not listed.

No follow‑up period was reported.

Inclusion/exclusion criteria

Inclusion and exclusion criteria were not specified.

Primary outcomes

Comparison of BladderScan measures and volume infused via catheter; measure was performed 3 times by the same operator.

Statistical methods

Analysis of variance among the BladderScan evaluation for each volume; measures were compared using Student's t‑test with bladder volume obtained via catheter.

Patients were stratified into 3 age groups: 0–6, 7–12, and >12 years.

Patients included

n=59; average age 7.1±5 years (range 1–19 years).

Results

No significant differences were found among repeated BladderScan volume measurements.

BladderScan measurements according to the volume of saline infused (ml; mean±SD; p‑value)

All children (average age: 7.1±5 years)

  • 0 ml: 1.4±8.1; p=0.166

  • 20 ml: 15.1±10.1; p=0.0005

  • 50 ml: 42.9±13.1; p=0.0003

  • 100 ml: 92.9±19.5; p=0.021.

1–6 years (average age: 3±1.6 years)

  • 0 ml: 0.7±3; p=0.184

  • 20 ml: 12.3±8.9; p=0.0001

  • 50 ml: 36.9±15; p=0.0005

  • 100 ml: 83.5±15.1; p=0.0013.

7–12 years (average age: 8.7±1.2 years)

  • 0 ml: 0±0; p=0.331

  • 20 ml: 15.7±6; p=0.0084

  • 50 ml: 46.3±9.9; p=0.134

  • 100 ml: 92±17.5; p=0.072.

Over 12 years (average age:15±1.9 years)

  • 0 ml: 5.8±17.1; p=0.260

  • 20 ml: 20.8±15.1; p=0.852

  • 50 ml: 48.9±9.2; p=0.707

  • 100 ml: 106.2±21.3; p=0.355.

Conclusions

The authors concluded that BladderScan BVI 9400 is a reliable and accurate alternative to catheterisation for children older than 6 years.

Abbreviations: SD, standard deviation.

Table 4 Overview of the Rowe et al. (2014) study

Study component

Description

Objectives/hypotheses

To evaluate the accuracy of the BladderScan BVI 9400 using its child mode compared with the volume obtained at catheterisation.

Study design

Prospective cohort study, single centre.

Setting

New Zealand paediatric hospital.

Data collection from April to September 2011.

No follow‑up period was reported.

Inclusion/exclusion criteria

Inclusion criteria:

  • written and informed consent from the participant or their guardian

  • being cared for by 2 paediatric urologists

  • scheduled for urodynamics or surgery, where urethral catheterisation would be done.

No exclusion criteria were listed.

Primary outcomes

Bladder volume measurement obtained at catheterisation compared with the volume obtained by BladderScan BVI 9400.

Statistical methods

Non‑parametric correlation between bladder volumes obtained using catheterisation compared with the BladderScan BVI 9400. Sample size of 50 would provide a 95% confidence interval of ±0.12 for correlation coefficients.

The sample size would give levels of agreement with 95% CI of approximately ±10 ml for Bland–Altman agreement analysis.

Patients included

n=50; 12 girls and 38 boys, average age of 6.2 years (range 6 weeks to 14 years).

The BladderScan was done following anaesthetic induction and before catheter insertion for those having surgery (n=45). For those having urodynamic studies, the BladderScan measurement was done before the urodynamic catheter was inserted (n=14).

Results

Overall, the correlation between the BladderScan and catheterisation volume (n=50) was 0.96 (95% confidence interval 0.92–0.97); the mean difference between the volumes was −2.0±21 ml. Correlation between the BladderScan and catheterisation volume in patients less than 36 months (n=12) was not as strong (rho=0.82) with a mean volume difference of −2.6 ml.

Conclusions

The authors concluded that the BladderScan BVI 9400 showed a high correlation with catheter volume with good clinical agreement between measures overall.

Abbreviations: None.