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What are WEE Waiting for? The Quick-Wee Method for Faster Clean Catch Urine Collection

Where can I find this paper?

https://www.ncbi.nlm.nih.gov/pubmed/28389435

Please note this paper is OPEN ACCESS. You are strongly advised to read the original paper before reading any further.

What is this paper about (what is the research question)?

Does suprapubic cutaneous stimulation with cold fluid-soaked gauze (the “Quick-Wee” method) reduce the amount of time spent waiting for clean catch urine?

Summary of the Paper

Design: single centre, randomised, prospective non-blinded trial

Objective: to evaluate the efficacy of the Quick-Wee method

Outcome of interest: voiding of urine within five minutes (binary outcome)

Intervention: genital cleaning for 10 seconds with sterile water at room temperature, followed by continued rubbing of the suprapubic area in a circular pattern with gauze (soaked in cold saline) held by forceps

Reference standard: genital cleaning for 10 seconds with sterile water at room temperature (standard practice)

Participants: patients presenting to an Australian paediatric emergency department between September 2015-April 2016

Inclusions: pre-continent infants aged 1-12 months in whom clean catch urine sample was required

Exclusions: neonates (defined as <1 month of age); infants with anatomical or neurological abnormalities affecting voiding of urine or sensation; those patients with need for an immediate sample by invasive method

Results: 354 subjects were recruited of whom 344 participated in the analysis; 175 in the control group and 179 in the intervention group (5 patients were excluded from each group after randomisation, giving 170 in the control group and 174 in the intervention group).

54/174 (31%) of patients voided within five minutes in the Quick-Wee group

20/170 (12%) of patients voided within five minutes in the control group

The difference in proportions was 19% (95% confidence interval for difference 11-28%).

This gave an NNT of 4.7 to successfully catch one additional sample within five minutes (95% confidence interval 3.4-7.7).

Authors’ Conclusions:

The Quick-Wee method requires minimal resources and is a simple way to trigger faster voiding for clean catch urine from infants in the acute care setting.

On the study design

Firstly it is important to note that this was a single-centre study in which trained clinicians were identifying and recruiting potential test subjects in addition to performing the intervention. This introduces a potential for innovation or novelty bias, whereby new treatments or procedures are preferred (or possibly considered less favourably) than traditional treatments or methods. This could be exacerbated by a lack of blinding, such as in this study, although it would be practically impossible to blind subjects to the treatment they are receiving in this particular case. In an ideal world, the clinicians recruiting and randomising patients would be different from those performing the procedure, and the results would be interpreted by people blinded to the groups to which patients were randomised – but research rarely occurs under ideal circumstances (if ever).

That said, a considerable effort has been made to overcome this through blinding which was carried out in a 1:1 ratio of consecutive patients using random permuted blocks of different sizes and allocation concealment (opaque envelopes) selected sequentially.

The Quick-Wee procedure itself was well standardised; teaching was delivered through face-to-face intervention and written instruction and standardised packs were used for the initial cleaning phase. A separate pack was prepared for the Quick-Wee intervention itself.

Several secondary outcomes were considered, including successful catch of the specimen, contamination of sample, parental and clinician satisfaction with method.

A sample size calculation was performed, requiring 322 patients (161 in each group) to achieve 80% power to detect a difference in the primary outcome; based on pilot study data, the expected change in proportions was 15% with a baseline expected proportion of 21% in the control group and therefore 35% in the intervention arm (a small inconsistency in these percentages is likely due to rounding). The authors performed an intention-to-treat analysis and planned to recruit an additional 10% of subjects beyond the sample size calculation to account for anticipated attrition.

What were the results and what does this mean?

The study achieved the required sample size due in part to the forethought of including 10% more patients to account for attrition.

The 344 subjects analysed were divided into control (170 patients) and intervention (174 patients) groups and in each case successful voiding was determined if it occurred within five minutes of the initial cleaning step. The data collection section mentions paper case record forms but it is not clear whether these were standardised for the research study or the usual clinical documentation. In addition, interobserver reliability is inferred through the use of a timer but in practice there is an opportunity for bias here if the observer is not independent of the clinician carrying out the procedure (forgetting to press “start” and adding a few extra seconds, for example).

The results are certainly impressive; 54/174 patients voided within five minutes with the Quick-Wee method (31% – 95% confidence interval 24%-39%) compared with 20/170 in the control group (12% – 95% confidence interval 7%-18%). The difference in proportions was 19% with a 95% confidence interval of 11%-28% and a P value of <0.001 using the $χ$ ² test.

The use of binary data here certainly makes for simpler analysis rather than looking at specific timings for each subject; five minutes is not an unreasonable amount of time to wait for a sample but it should be recalled that there is a member of staff tied up in undertaking the Quick-Wee method for potentially the entire five minute duration – this might prove challenging in busy Emergency Departments.

The authors also looked at voiding with successful catch and found similar proportions (Quick-Wee 52/174 [30%: 95% confidence interval 23%-37%]; control 15/170 [9%: 95% confidence interval 5%-4%]). Does the Quick-Wee method make missed voids less likely? Perhaps, due to increased attention focus on the relevant anatomical area..!

The difference in rates of contamination was not statistically significant (27% in the Quick-Wee group [95% confidence interval 15%-43%], 46% in the control group [95% confidence interval 17%-77%] – this could be an area for further work in a larger sample, given high contamination rates in both groups.

Finally, the satisfaction scores of both parents and clinicians were better in the Quick-Wee group. The data is given in a slightly counter-intuitive way (the Likert scale runs from 1=very satisfied to 5=very unsatisfied) which they have called “higher rate” of satisfaction – it is worth noting that this does not correspond to a higher number! In the Quick-Wee group, median parental and clinician satisfaction was 2, while in the control group the median for both was 3.

What can we take from this paper into clinical practice?

This method appears to be reliable from this pragmatic and robust study. It is certainly appealing as a first-line technique over invasive methods such as suprapubic aspiration or catheterisation. It certainly seems worthy of adoption into clinical practice provided you can spare the staff.

More questions to ask

Would this technique work in older children, given its theoretical basis in the neonatal cutaneous voiding reflex?
Would warmer water work as reliably?
Would time be further reduced with a pre-emptive feed (or oral hydration) as in the study by Herreros et al?
Could this method also reduce contamination rates?

Probing Questions: Lung Ultrasound in Diagnosis and Management of Bronchiolitis

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Thanks to Casey Parker of Broomedocs for this guest contribution – his review is cross-posted here.

Where can I find this paper?

http://www.biomedcentral.com/1471-2431/15/63

What is this paper about (what is the research question)?

This paper aimed to correlate sonographic lung findings with clinically diagnosed bronchiolitis in infants. The authors also attempted to provide some prognostic information [the need for oxygen support] based on sonographic lung features.

Summary of the Paper

The subjects were infants admitted for clinically suspected bronchiolitis. There was also a cohort of “normal controls” used as a comparison. The children underwent a clinical scoring by the treating Paediatrician and lung ultrasound by both a radiologist and Paediatrician sonographer. The scans were all completed by two of the authors.

Design: Single-centre, observational cohort study conducted in an Italian Paediatric unit.

Objective: to evaluate the accuracy of lung ultrasonography in the diagnosis and management of bronchiolitis in infants.

Outcome of interest: correlation between clinical and sonographic lung findings in bronchiolitic infants. Can LUS findings be used to predict the need for supplemental oxygen requirements?

Participants: One hundred six infants, aged from 9 to 239 days old were enrolled.

Inclusions: clinically “suspected bronchiolitis” in infants. Unclear as to whether these were consecutive cases – only 106 over a 3 year study period.
Exclusions: radiological pneumonia, other “concomitant pathology” or the unavailability of the study sonographer.

Results: There was a high level [ ~90%] of agreement between the clinician’s severity rating and the predetermined sonographic severity scores. There was also a high level of agreement between the two sonographers scoring of the LUS findings (K = 89.6%). The lung US scoring predicted the need for oxygen supplementation with good accuracy [sensitivity: 96.6 %, specificity 98.7 % ] although there were wide confidence intervals as a result of the small numbers in this trial.

Authors’ Conclusions:

In summary, this pilot study demonstrates that the use of LUS in bronchiolitis can be considered as an extension of the clinical evaluation and could be incorporated into clinical algorithms to aid decision-making. Our promising data needs to be confirmed in larger cohort studies also involving critical patients.

On the study design

This study design is typical of many pilot ultrasound papers. Small numbers of patients in which sonography is compared to a gold-standard that may not be entirely accurate of itself. Bronchiolitis is a clinical diagnosis, with no really objective diagnostic standard. The use of just 2 experienced Paediatric sonographers in a single centre does raise questions about the external validity of the results and there is a high likelihood of bias here. The clinicians were blinded to the sonographic findings – and therefore the risk of bias here was removed. The use of “normal cohort” and the “RSV swabs” in the study design was a little confusing and doesn’t really add to the results.

What were the results and what does this mean?

The results suggest that clinically diagnosed bronchiolitis looks like…. sonographic bronchiolitis as per the defined criteria used in this paper. The protocol used did identify infants with more severe lung disease. The need for supplemental oxygen was consistent with more severe LUS changes. However, given the “standard” was clinical examination it is unclear exactly what LUS would add to the prognostication by paediatricians. The high degree of agreement between the two study sonographers is difficult to extrapolate given they are both highly skilled, ultrasound enthusiasts – a larger mix of observers would be needed to draw any conclusions about our ability to utilise LUS in small kids.

What can we take from this paper into clinical practice?

Lung ultrasound for the diagnosis and severity scoring of bronchiolitis is reasonably accurate. Does it add anything? Probably not, unless you are currently using CXR to ‘diagnose’ bronchiolitis. This paper does provide some useful descriptions of the spectrum of disease and their sonographic appearance.

I think this paper is interesting in that it describes the sonographic spectrum of a common disease of infants. The study is not really large enough, nor does it have the external validity to make it a “practice changer”. This pilot can help inform us about the appearance of bronchiolitis – and in the future this may become a more commonplace part of our clinical assessment of children – but for now I am not sure it adds to our quiver.

More questions to ask

Can ultrasound reliably differentiate bronchiolitis from important differential diagnoses in infants ? (e.g.. pneumonia, heart failure, upper airway obstruction… )
Are the sonographic findings in bronchiolitis consistent when obtained by sonographers of various experience?
Previous papers have compared LUS to conventional CXR for the diagnosis of bronchiolitis – and LUS was favourable. It would be nice to see a paper looking at children with severe disease in which clinicians often turn to CXR to “reconfirm the working diagnosis” in order to ascertain its utility at that end of the spectrum.

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15th May: Should We Cool Children Following Out-Of-Hospital Cardiac Arrest?

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Where can I find this paper?

http://www.ncbi.nlm.nih.gov/pubmed/25913022

What is this paper about (what is the research question)?

Does therapeutic hypothermia increase the proportion of patients surviving at one year with good functional status following paediatric out-of-hospital cardiac arrest?

Summary of the Paper

Design: single-blinded, multicentre randomised controlled trial

Objective: to determine whether therapeutic hypothermia after out-of-hospital cardiac arrest confers a benefit in children

Primary outcome measure: survival at 12 months with good neurological function (defined as age-corrected standard score of 70 or more on the Vineland Adaptive Behaviour Scales (VABS-II)

Intervention: subjects were randomly assigned in 1:1 (permuted blocks stratified by age) to therapeutic hypothermia (target temperature 33°C) for 48h then normothermia (target temperature 36.8°C) for 72h, or normothermia for 120h. Active cooling was undertaken in either case to achieve the target temperature.

Participants: 295 patients randomised between September 2009 – December 2012. 155 were randomised to hypothermia, 140 to normothermia.

Inclusions: patients aged 48hrs-18 years presenting following out-of-hospital cardiac arrest to one of 38 sites in the US and Canada, having required chest compressions for at least two minutes and with an ongoing requirement for mechanical ventilation after return of spontaneous circulation (ROSC)
Exclusions: inability to undergo randomisation within 6h, score of 5-6 on the motor component of the Glasgow Coma Scale, decision to withhold aggressive treatment, major trauma as cause of arrest, patients with pre-existing VABS-II score <70

Results:

Survivors at 12 months with VABS-II score >70

Hypothermia 27/138 (20%)

Normothermia 15/122 (12%)

Risk difference 7.3 (95% confidence interval -1.5 to 16.1)

Relative likelihood 1.54 (95% confidence interval 0.86 to 2.76, P=0.14)

Authors’ conclusions

In comatose children who survive out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit with respect to survival with good functional outcome at one year.

On the study design

The study was utilised multicentre collaboration to recruit a sample with 85% power to detect a 15-20% difference in the primary outcome between treatment groups. This was a pragmatic design; although the subjects and those providing care to the patients could not be blinded to the intervention, reasonable steps were taken to ensure that the investigators recording the primary outcome were a) independent from those delivering care and b) blinded to the arm of the study to which subjects had been randomised.

Unlike other studies, the normothermia in this case was also an active decision; the patients’ temperature was actively controlled according to the group to which they were randomised.

The authors tells us that other than the temperature targeted, care between the groups was identical although they later state that “all other aspects of care were determined by the clinical teams.” This does leave us to wonder what if and how knowledge of the treatment arm and expectation of its efficacy (or otherwise) might have influenced those treating clinicians.

What were the results and what does this mean?

There was no statistical difference in survival with a good neurological outcome at 12 months between the two groups. In the secondary outcomes, there was no difference in absolute survival between the groups, nor in the reduction in neurological performance score, however there was increased incidence of hypokalaemia and thrombocytopenia in the hypothermia group and increased requirement for renal replacement therapy in the normothermia group.

Results were analysed using intention to treat analysis, which includes subjects in the final analysis of the arm to which they were randomised irrespective of whether they dropped out of the study or received an alternative treatment in the end. This is a conservative approach which can help to ameliorate the effects of unpleasant side effects of treatments; there’s a nice explanation of intention to treat here. It helps give us a realistic expectation of the results we might see in clinical practice.

What can we take from this paper into clinical practice?

In this study the null hypothesis was no difference between the groups, this study doesn’t prove that hypothermia is harmful or not beneficial; there is simply insufficient evidence to reject the null hypothesis of no difference, based on this study. We should continue to follow local protocols in terms of cooling but this paper does give clinicians a little additional confidence in deviating from protocols if indicated.

More questions to ask

Is there evidence for cooling patients following in-hospital cardiac arrest?
Would a larger sample size demonstrate a benefit and is this feasible?