3. Monitoring and updating multiple of medians (MoM) values within the laboratory

Monitoring and updating MoM values

Updating MoM values • When to make changes

• Factor updates

• Discussion

CUSUM charts • Practical session

Confidence intervals • Practical session

CUSUM Charts

Practical session: Constructing CUSUM charts

• Quick demonstration in XL

• Some illustrative examples with no random variation to illustrate the methodology

• Discussion of features of the CUSUM charts

Practical session: Constructing CUSUM charts

For each series of MoM values

1. Compute the log10MoM values

2. Produce the CUSUM

3. Plot the CUSUM and interpret

Observation Series 1 Series 2 Series 3 Series 4 Series 5

1 1.1 0.9 1.0 0.9 1.00

2 1.1 0.9 1.0 0.92 1.00

3 1.1 0.9 1.0 0.94 1.00

4 1.1 0.9 1.0 0.96 1.00

5 1.1 0.9 1.0 0.98 1.00

6 1.1 0.9 1.2 1.00 0.99

7 1.1 0.9 1.2 1.02 0.98

8 1.1 0.9 1.2 1.04 0.97

9 1.1 0.9 1.2 1.06 0.96

10 1.1 0.9 1.2 1.08 0.95

11 1.1 0.9 1.2 1.10 0.94

12 1.1 0.9 1.2 1.12 0.93

13 1.1 0.9 1.2 1.14 0.92

14 1.1 0.9 1.2 1.16 0.91

15 1.1 0.9 1.2 1.18 0.9

16 1.1 0.9 1.0 1.2 0.89

17 1.1 0.9 1.0 1.22 0.88

18 1.1 0.9 1.0 1.24 0.87

19 1.1 0.9 1.0 1.26 0.86

20 1.1 0.9 1.0 1.28 0.85

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log

10 M

oM

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Feb Mar

Apr

May

Jun

Jul

Aug

1 MoM

0.9 MoM

1.1 MoM

0.95 MoM

1.05 MoM

Log MoM CUSUM: Perfect

The horizontal trajectory reflects the situation where there is no bias in MoM values.

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Sample

log

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arApr

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1 MoM

0.9 MoM

1.1 MoM

0.95 MoM

1.05 MoM

Log MoM CUSUM with bias

Positive bias apparent from May.

Interpretation of CUSUM charts

• CUSUM charts are a powerful way of monitoring MoM values over time

• Interpretation of CUSUM charts can be far from straightforward

• There is always a danger of over interpretation

• Confidence intervals can be used to account for the uncertainty in estimation of median MoM values

Confidence Intervals for Median MoM values

Confidence Intervals

Given a series of n MoM values, the process of obtaining a confidence interval is as follows

1. First ensure that no updates to medians have taken place in the series

2. Second check that the CUSUM scatters about a straight line

3. Compute the log10 MoM values

4. Compute the mean (i.e. average) and standard deviation

5. Compute the standard error (SE = standard deviation/sqrt(n))

6. The lower and upper limits are given by mean ± 1.96×SE

Practical session: Constructing Confidence Intervals

• Quick demonstration in XL

• Hands on

Confidence intervals for MoM values - practical.xls

Updating MoM values

Dealing with changes

• Detecting changes

• When to make changes

• What changes to make

12

• The aim is to keep median MoM levels close to the target by making changes to remove biases that are going to continue

• We need to avoid ‘chasing noise’ which will make things worse

13

Deciding when to make changes

Given an apparent shift in

a temporal plot, try to

identify the cause. Decide

whether that cause is likely

to persist. If so, consider

making a change.

Information on a ‘special

cause’ such as a lot

change would provide

further evidence that the

change is likely to persist.

Deciding when to make changes

log(M

oM

)

14

Lot change

Factor Updates

• If the median MoM is running at a value different from 1 and this situation is going to persist into the future, then make a factor update.

• The methodology is dependent on the software.

ViewPoint

Changes to ViewPoint involve completing a form specifying the median MoM.

ViewPoint

Changes to ViewPoint involve completing a form specifying the median MoM.

LifeCycle

• If a log10 polynomial regression is used for gestational age, the intercept parameter A in the regression is updated by adding log10(Median MoM).

• New A = Current A + log10(Median MoM)

• For example if the median MoM is running consistently at 0.95 log10(0.95) = -0.022276 is added to A.

• New A = Current A - 0.022276

Testing

• It is important to test all updates.

• If the current median MoM is 0.95 and a factor update is applied, then the effect should be to divide by 0.95 so that, for example, a MoM that was 0.95 before the change should become 0.95/0.95 = 1.

• A simple way of testing is to look take samples before the change and verify that after the change the factor has been applied correctly.

Updating the full equations

• Anything other than a factor updates requires specialist input

• This requires • new coefficients

• test data

• Diagnostics based on the data provided

20

21

Discussion

• What processes do you have in your laboratory for applying factor updates?

• How do you document these updates?

• Does the software supplier provide any advice on updating and testing the software configuration?

• Are there any suggestions for improvement?

Laboratory throughput

Rationale

• Need for sufficient precision to estimate performance (standardised SPR)

• To enable monitoring of laboratory medians and early detection of change points

• For proficiency/expertise

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5 labs 1,000 samples

1 lab5,000 samples