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A Spreadsheet for Analysis of Straightforward
Controlled Trials
Will G Hopkins
Auckland University of Technology
Auckland NZ
Preamble: controlled trials, crossovers, spreadsheets
Controlled trials: unpaired t statistic, transformations, plots for nonuniformity, back-transformations, reliability, individual responses,
exptalof groups in pre-test, uncertainties.
comparison
Y
Y
Crossovers: paired t statistic
control
pre post1 post2
Trial
C
A
B
Treatment
Controlled Trials
 Best design to determine
effects of treatments.
 Measurements at least once
exptal
Y
pre treatment and at least once
during and/or post treatment.
control
 Control and experimental groups.
pre post1 post2
 Outcome statistic is difference
Trial
between groups in their mean
change due to the experimental and control treatments.
Crossovers
 All subjects receive all control and
experimental treatments.
 Aim for balance (equal number of
subjects on each treatment order).
 Aim for enough time following each
treatment to allow washout.
 Outcome statistic is the mean
change between treatments.
Spreadsheets
 Instructive and save time.
 OK for straightforward designs.
Y
C
A
B
Treatment
Features of Spreadsheet for Controlled Trials
 Usual analysis of the raw values of the dependent variable.
 Based on the unequal-variances unpaired t statistic.
 Use for yes/no variables (score as 0 or 100) and Likert scales.
 Analysis of transformed values of the dependent variable.
 To reduce any systematic effect of an individual's pre-test value
on the change due to the treatment.
 Log transformation for most physiological and performance
measures, where effects are percents or factors.
 Square-root transformation for counts of injuries or events.
 Arcsine-root transformation for proportions.
 Percentile-rank transformation (= non-parametric analysis)
when a transformation function is unclear or unspecifiable.
Another feature of Spreadsheet for Controlled Trials
 Plots of change scores of raw and transformed data against
pre-test values.
 To check for outliers.
 To confirm that the chosen transformation results in a similar
magnitude of change across the range of pre-test values.
 Achieve the same purpose as plots of residual vs predicted
values in more powerful statistical packages.
 Addresses need to avoid heteroscedasticity = non-uniformity of
error = non-uniformity in the effect of the treatment.
• If all pre-test values are similar, transformation is irrelevant, but…
• Choose a transformation to minimize the effect of potentially
wide variation in pre-test values on the effect of the treatment.
 Beware of regression to the mean: lower pre-test values tend to
produce more-positive changes.
More features of Spreadsheet for Controlled Trials
 Various solutions to the problem of back-transformation of
treatment effects into meaningful magnitudes.
 Back transformation of logs into percents and factors.
 Novel approach: estimate the value of the effect at a chosen
value of the raw variable. (No need with log transformation.)
 Cohen effects for raw analysis and all transformations.
 Estimates of reliability in the control group.




Control group is a reliability study.
For comparison with reliability studies.
Typical error = (SD of change score)/2.
Change in mean.
• A large change due to familiarization can account for large
typical error via individual differences in familiarization.
Even more features of Spreadsheet for Controlled Trials
 Estimates of individual responses to the treatment.
 Expressed as a standard deviation for the mean effect.
 Example: effect of the treatment is typically 3.0 ± 2.0 units
(mean ± SD)…
 where the SD = (diff in SD2 for change scores).
 For all transformations and back transformations.
 Comparison of pre-test values of means and standard
deviations in the two groups.
 If means differ and plots show that the pre-test value affects
change scores, do an ANOVA with pre-test as a covariate.
• Estimate the treatment effect at the mean value of the covariate.
 Use for comparison of independent groups in a non-repeated
measures study. (Ignore all the change-score stats.)
Yet another feature of Spreadsheet for Controlled Trials
 Estimates of uncertainty expressed as confidence limits at
any percent level (95%, 90%…) for all effects.
 Including confidence limits for standard deviations
representing individual responses!
• A negative standard deviation implies no individual responses.
 There is no adjustment of p values for multiple comparisons.
• Such adjustment is a relic of hypothesis testing, but even so…
• It never applied to the most important pre-planned effect.
 Ignore the uncertainties for comparison of groups in the
pre-test, because…
• What matters is how different the groups were, not how
different their corresponding populations might be.
• But use the uncertainties for comparison of independent groups
in non-repeated measures study .
One more feature of Spreadsheet for Controlled Trials
 Chances that the true value of an effect is important
 You provide a value for the effect that you consider is the
smallest that would be important for your subjects.
 The spreadsheet estimates the chances that the true value is
greater than this smallest important value.
 It also shows the chances in a qualitative form (unlikely,
possible, almost certain…).
 The default smallest value for the Cohen effect size is 0.2.
 Try 0.6, 1.2, or 2.0 to estimate the chances that the true value
is moderate, large, or very large; then state something like…
 "The mean effect could be trivial or small, but it is unlikely to
be moderate and is almost certainly not large."
 Might help get your otherwise inconclusive study into a journal.
Features of Spreadsheet for Crossovers
 Can have more than one control and experiment treatment.
 Can use for a time series (= only one treatment).
 Based on paired t statistic.
 Uses column of zeros to pair with change scores, which…
 Allows analysis of other effects from within-subject modeling.
 No analysis of individual responses.
 But possible with two control treatments (preferably balanced)
in a crossover or two baseline treatments in a time series.
 Typical error is provided for comparison with reliability study.
 But may be inflated by individual responses to treatment.
 Familiarization effect between trials can also inflate error, but…
 Need analysis via mixed modeling to reduce this error.
Conclusion
 Can't (yet) use the spreadsheet to estimate effects of
covariates such as gender and age on the treatment effects.
 But the spreadsheets will work for most data and help you get
more complex analyses right with a stats package.
Article and spreadsheets available at:
See Sportscience 7, 2003