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 χ2 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?

 


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

 

-nativeNEJM2

 

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?

See Also:

This post at St Emlyns: JC: Getting Chilly Quickly 4. Doing It For The Kids

This post at Academic Life in Emergency Medicine:

This post at Resus.Me: Post Arrest Hypothermia in Children Did Not Improve Outcome

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Reducing PED Reattendance Rates

Title 060914

http://www.ncbi.nlm.nih.gov/pubmed/25162691

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

Can we reduce the number of reattendances to the paediatric emergency department by telephoning within 24h of discharge?

Summary of the Paper

Design: Single-centre, prospective randomised controlled trial

Objective:  to examine whether a follow-up telephone call by a non-health care provider from the ED within 24h of discharge can reduce the rate of returning to the ED within 72h

Outcomes:  rate of return visits within 72h of discharge. It is unclear how this was determined but subjects were contacted by telephone at 96h after discharge in both intervention and control groups.

Intervention: follow-up phone call within 12-24h of discharge undertaken by a “research assistant” (medical student)

Comparison:  standard care (i.e. no follow up phone call)

Participants: convenience sample of parents of patients presenting to a single centre between 1st July 2009 and 30th August 2009.

  • Inclusions: parents of patients for whom the responsible clinician thought ED discharge was likely
  • Exclusions: families without a telephone, those who left without being seen, those leaving against medical advice

Results: 371 subjects were recruited of whom 171 were in the study group and received a follow-up phone call and 200 were in the control group. Demographics were broadly similar between the two groups.

24/171 in the study group reattended within 72h (14%)

14/200 in the control group reattended within 72h (7%)

There was a statistically significant difference between reattendance rates with a greater proportion of reattendances in the intervention group (p<0.03).

Authors’  conclusions

 Emergency Departments practicing follow-up calls without response to medical questions should consider a forecasted increase in return rates

On the study design

This is a single centre pseudo-randomised controlled trial – the authors tell us that it was pseudo-randomised because there were research staff available to recruit at different hours of the day. It’s not clear exactly how this statement refers to randomisation but if the time of day patients presented to the ED predicted whether they entered the intervention or control group then there’s potentially a major confounder in the first premise of the paper.

Inclusion and exclusion criteria seem reasonable but the demographics of the subjects throws up some interesting issues; the mean age of the presenting child was 5.7years with a mean parental age of 38.3 years. I can’t help but wonder whether a similar study in my own department would reveal a rather different (substantially younger) parental population and there are sociological implications to this.

There is no sample size calculation so although there were reasonable numbers in each group we don’t know whether the study was fundamentally underpowered and unable to detect a statistical difference between groups. Whether this statistical difference represents a clinically relevant outcome measure is also in question (and addressed below).

What were the results and what does this mean?

On the surface it seems that telephone follow-up within 12-24 hours of ED discharge increases rather than decreases reattendance rates, but the picture is rather more complicated.

Firstly, there is an intrinsic uncertainty surrounding the value of follow-up calls by non-healthcare professionals. Of particular note, the telephone interviews were undertaken by medical students. It seems that conversations were one-way; parents were asked whether they had any questions but there was no opportunity for them to be answered. It seems possible that introducing the concept that there might be unanswered questions could actualise occult parental anxiety, prompting them to seek clarification from a healthcare professional.

Secondly, it’s not even clear how reattendance data was obtained. Was this self-reported by parents at the 96h phone call? It seems so – in which case it could almost certainly have been collected more reliably using ED computerised records.

Thirdly, all manner of data about these reattending subjects is omitted. Were they actually unwell and then admitted to the hospital? Were all reattenders in both groups discharged from  ED again? Without this information it is difficult to ascertain whether reattendance was inappropriate.

What can we take from this paper into clinical practice?

Follow-up phone calls by non-healthcare professionals do not seem to reduce reattendances. However it’s unlikely that this model would ever be rolled out and there are plenty of other questions we still need answers to.

More questions to ask

  • Are these effects the same in an adequately powered study where outcomes are divided into admission or discharge at reattendance (arguably more clinical relevant)?
  • Would attendances be reduced if phone calls were made by healthcare professionals and provided an opportunity to obtain advice and have questions answered?

 

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