An investigation of the repeatability and reproducibility of ISO 11948-1 (the Rothwell method) for measuring the absorption capacity of incontinence pads.
The repeatability and reproducibility (precision within and between laboratories, respectively) of an international standard method (ISO 11948-1, the Rothwell method) for measuring the absorption capacity of incontinence pads was investigated. The 74 shaped disposable bodyworn insert pads for heavy incontinence on the UK market in spring 1997 were tested in three laboratories experienced in using the method, one in each of England, Spain and Sweden. Coefficients of variation (standard deviation as a proportion of the mean) for five repeats rarely exceeded 5% within any laboratory. However, there were systematic differences between laboratories: results from the Swedish and Spanish laboratories typically exceeded those from the English laboratory by 13% and 8%, respectively. The good repeatability suggests that the method is capable of adequate precision but the poor reproducibility implies that the instructions in the standard for building and/or using the test apparatus are inadequate, leaving too much room for interpretation. Having studied the data presented here and viewed videos of the apparatus in use in five laboratories (including the three contributing to this note) the ISO working group which wrote the original standard has identified several likely sources of imprecision and is now working to revise the standard to improve its reproducibility.
Cottenden
A M
AM
Department of Medical Physics and Bioengineering, University College London, Shropshire House, 11-20 Capper Street, London WC1E 6JA, UK. a.cottenden@medphys.ucl.ac.uk
Rothwell
J G
JG
Leander
H
H
Grau
C
C
Brooks
R J
RJ
D004739:England; D004867:Equipment Design; D006801:Humans; D016496:Incontinence Pads / Q000592:standards* / Q000706:statistics & numerical data*; D007753:Laboratories; D008422:Materials Testing; D015203:Reproducibility of Results; D013030:Spain; D013548:Sweden