Heads’n'Tails matching

So the new Heads’n'Tails matching is ready. Hooray! I will be sending out your individual site sheets over the next few days. Please also have a look at the guidance notes.

Apologies

I know you are waiting for the next Heads’n'Tails report which I had hoped to be able to produce within a month of the first which would have been mid-September. We are now at the beginning of October, and I am still working on this. It has not been as simple as re-running the matching process because we have been trying to incorporate a number of improvements.

Most importantly, you should be able in the next report to see the issues month by month. We think this will help identify months which are close to being complete.  Missing matches from these months can then be prioritised so that as much of your data is ready for analysis as soon as possible.

Thanks for being patient.

The next report is coming soon …

 

(SPOT)light Prizes

We’re giving away a prize for every thousandth patient entered on the (SPOT)light web portal, so congratulations to the following people who entered these milestone patients:

1st patient - Nuno Pinto, Medway Maritime Hospital 

1,000 – Thomas Hughes, Colchester General Hospital 

2,000 – Ben Booth, Bradford Royal Infirmary

3,000 – Angela Peskett, Maidstone Hospital

4,000 – Andy Hall, Torbay Hospital

5,000 – Harnita Chohan, Freeman Hospital

6,000 – Ken Inweregbu, Barnsley Hospital

7,000 – Jennifer Ricketts, Wycombe Hospital

8,000 – Parizade Raymode, Kettering General Hospital

9,000 – Ed Ekanem, Queen Elizabeth II Hospital

10,000 – Isobel Bird, Whipps Cross University Hospital

11,000 – Yvette Brigdale, The Royal Blackburn Hospital

12,000 – Michele Bianchi, Whittington Hospital

13,000 – Christine Carroll, Yeovil District Hospital

14,000 – Lesley Hawkins, Southampton General Hospital

15,000 – Alison Dinning, Queen’s Medical Centre

16,000 – Chris Smalley, Arrowe Park

17,000 – Samuel Magombe, North Middlesex Hospital

18,000 – Jennifer Plume, Diana Princess of Wales

19,000 – Tracey Robson, Sunderland Royal Hospital

20,000 – Ronald Jones, New Cross Hospital

21,000 – Clare Jackson, Stafford Hospital

22,000 – Neil Smith, Hull Royal Infirmary

23,000 – Carly Claxton, Pilgrim Hospital

24,000 – Sally Humphreys, West Suffolk Hospital

25,000 – Helen Robertson, Countess of Chester Hospital

Please keep entering patients on the portal and maybe you could win a prize!

The (SPOT)light Top Ten – July

Every month we upload all records to the NIHR accruals system that contain the minimum essential data, and you will all have now received emails letting you know how many of your records meet these criteria. So to say a big thank you to those sites with the highest percentage of records meeting this standard then here is the (SPOT)light top ten for July!

  1. Kettering General Hospital
  2. Medway Maritime Hospital
  3. Ulster Hospital
  4. Tameside General Hospital
  5. Royal Preston Hospital
  6. Colchester General Hospital
  7. The Royal Blackburn Hospital
  8. Bradford Royal Infirmary
  9. Southend University Hospital
  10. Craigavnon Hospital

Watch this space for the August Top 10!

Website upgrade

Next Tuesday we will be upgrading the (SPOT)light website. The main change is that your records will be sorted by month. The default view when you click through will show you ALL patients from the last 30 days. If you want to look further back then hover over the ‘Last 30 days’ and you will be able to choose the month your wish to view.

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Just as before you can similarly select whether you are looking at ‘Open’ visits (those where the patient was neither discharged from follow-up nor admitted to ICU) via the same approach.

Please also note that long lists of patients are now broken up by pages using the icons in the top right.

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What if the baseline CXR is clear?

Question: With the current screening regime, and the screening out if the CXR result is reported clear, you are quite likely to miss a large part of the viral pneumonias I would think. It may be conceivable that a patient indeed is quite unwell, but nonetheless is deemed to have a viral pathology, so antibiotics are stopped. So while he may need respiratory support, and be a candidate for the study in the spirit of the trial, we would have to filter him/her out. Was this intentional and pre-planned or just unavoidable?

Answer: So a clear CXR is not an exclusion (just something we might stratify differently). The CXR can be used to rule out a case if a different diagnosis is confirmed but to use a cliché (sorry) “absence of evidence isn’t …”. However, this leaves us with the sticky problem of exacerbation of COPD. To distinguish an exacerbation of COPD from pneumonia then it will be necessary for the CXR to have pneumonic changes. Sorry this is not 100% consistent but I think it gets at the spirit of the study.

 

Is a tracheostomy a clinical event in (SPOT)id?

Question: One of our SpotID patients had a percutaneous tracheostomy performed – I assume this is an “event” (on the daily CRF sheet) but cannot find a code for it within the coding system.

Answer: One the one hand I probably wouldn’t code this as an event on the ground that assuming it went well it shouldn’t be a cause of major physiological disturbance but if the patient was sedated and this affected the physiological observations then please use the code 1.1.1.x.x. which is Surgery/Respiratory/Upper Airway/x/x … (the ‘x’s meaning that there is no more specific code beyond this level).  If you have written a diagnosis in the free text then we’ll be fine with that.

(SPOT)light Heads’n'Tails Matching: Update 1 August 2011

Later this week we will send you the first validation of your data from the (SPOT)light study. We are calling this the “Heads’n’Tails” matching. The (SPOT)light visit is the head, and the tail is the admission to the Critical Care Unit participating in the Case Mix Programme (CMP). For every (SPOT)light patient who has gone to a critical care bed, we need to extract their critical care episode from the CMP, and for every critical care admission from the ward we need to identify their (SPOT)light visit.

It is only through this matching that we can time admission to critical care.

You will understand how crucial it is that we do not miss any patients both for the study as a whole, and for your own individual site report of 90 day survival. You will also agree, we hope, that we cannot assume that the missing cases do not matter. For example, if research documentation was missed because of time pressures when admitting the sickest patients then your report would then include only the less sick but more delayed cases. This would be an inaccurate and unfair description of your case load.

We are aiming to link 100% of cases, and if we fall significantly short of this then to avoid the risk of bias we cannot use your data.

However this is a pragmatic observational study which depends on the energy of busy clinical teams. Some missing data is inevitable which is why we are writing to explain the options that will be available. If there is a problem, then we can then work to use as much data as possible.

The options include …

  • backfilling missing cases by pulling the notes of these patients. If required we would ask you to complete this process within one (1) month of the Heads’n’Tails validation report. If there is more work than can be reasonably done within this time frame, then you might consider
  • switching to retrospective data collection (if you are currently collecting prospectively) to free up time for backfilling the existing data, or you might consider
  • stopping data collection now (if you are already following the retrospective strategy) and focussing on backfilling your existing data. We would much prefer for all sites to complete one year’s data collection, but because we do want to discard any submitted data then an abbreviated but complete dataset is preferable to a longer incomplete one.

We are sending this notice now because this Wednesday (August 3) is changeover day for the junior medical staff. Please therefore consider reminding them of the inclusion criteria for the study, and highlighting that even when time pressure does not permit a Case Report Form to be completed simply documenting the fact of the visit (with the date and time) in the notes is enormously helpful as many of the vitals and laboratory measurements can be abstracted at a later date.

Yours sincerely

Steve (on behalf of the (SPOT)light team)

S:F ratio update

Those of you with sharp mental arithmetic will have noticed it is impossible to have a SOFA score with zero points when calculating the Day 4 SOFA for the (SPOT)id study.  The SpO2:FiO2 cut-off for a SOFA score of 1 is currently 502 which means that all patients with perfect oxygen saturations on room air (100% over 0.21) have an S:F ratio of 476 and earn 1 SOFA point.  The numbers come from a Critical Care Medicine paper (Pandharipande 2009).

I think that we should continue to use the rest of the thresholds that they suggest, but if the S:F ratio is ≥ 450 patients should be assigned zero (0) SOFA points. This means that using the S:F ratio you will skip directly from zero to two SOFA points.

  • S:F ≥ 450 – SOFA 0
  • S:F < 450
    • Do not estimate SOFA score from this value
    • Use the last recorded P:F if available and measured within 48 hours
    • If not available assign SOFA 0
  • S:F < 370 – SOFA 2
  • S:F < 240 – SOFA 3
  • S:F < 115 – SOFA 4

The old threshold of S:F < 502 to give a SOFA score of 1 comes from the limits of the data set and possibly shows the problems with following a regression line beyond your data set.

 

Hourly urines

On the SpotID CRF the hourly urine output is requested.  For some patients the urine output is not measured hourly – so there may be a recording of, say, 300ml on the observation chart – but this will be for a few hours not one.  Do you want this figure added to the hourly urine box(es) on the CRF?

No.

The number should always be an hourly total. If hourly measurements were not available at the first hour after the start of the time period then please use the 2nd (or 3rd of 4th if necessary). If you are confident that the 300ml accurately summarises the 4 hour observation period then it would be acceptable to divide this by 4 and enter the answer (75). If you are not confident then better just to stick with 24 hour totals.