Figures and data in The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials | eLife

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Version of Record published: October 21, 2022 (This version)
Accepted Manuscript published: September 20, 2022 (Go to version)
Accepted: September 13, 2022
Received: April 19, 2022
Preprint posted: March 28, 2022 (Go to version)

Figures
Tables
Additional files

4 figures, 4 tables and 2 additional files

Figures

Figure 1

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Ellipse of insignificance example.

(a) An example ellipse of insignificance for the $a = 50$ , $b = 50$ , $c = 10$ , $d = 90$ at a significance level of $α = 0.05$ . All points bounded by the ellipse depict $(x, y)$ combinations which would not lead to the null being rejected. (b) Relevant vectors for ascertaining misconding thresholds. In this example, the Fewest Experimental/Control Knowingly Uncoded Participants (FECKUP) point is $(x_{e}, y_{e}) = (12.8, 14.4)$ , $f_{m i n} = 19.3$ , and $(x_{i}, y_{i}) = (30.1, 26.3)$ . See text for details.

Figure 2

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Application of ellipse of insignificance analysis to existent data.

(a) Ellipses of insignificance analysis for a published study (n = 913) for illustrative example 1 of published data. The shaded region denotes the ellipse of insignificance, the red line shows the Fewest Experimental/Control Knowingly Uncoded Participants (FECKUP) vector (the minimum vector from the origin to the ellipse).

Figure 3

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Illustrative example 2.

(a) Ellipses of insignificance analysis for two studies with same $χ^{2}$ statistic. (b) Fewest Experimental/Control Knowingly Uncoded Participants (FECKUP) vectors for both studies. Experiment 1 is given by orange ellipse and red dotted line, Experiment 2 by the blue ellipse and dotted line.

Figure 4

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Illustrative example 3.

An ellipse of insignificance (EOI) analysis on the data supplied in the City A/City B screening comparison yields a Fewest Experimental/Control Knowingly Uncoded Participants (FECKUP) vector (in red) of 46.2 subjects, corresponding to a minimum tolerance of 66.5 total subjects after resolving the vector.

As $x_{i} = 73.7$ (shown in green) with $y_{i} = 62.7$ (shown in blue), but as the sensitivity and specificity of the tests used in City A are known, it can be shown that $x_{m} \approx 93$ , exceeding the limits of x_i, placing the point within the ellipse and rendering any seeming significance void. Note that only a part of the EOI (denoted by the blue solid shape) is shown for clarity.

Tables

Table 1

Reported groups and related variables.

	Endpoint positive	Endpoint negative
Experimental group	$a - x$	$b + x$
Control group	$c + y$	$d - y$

Table 2

Ellipse of insignificance (EOI) derived metrics for published data.

EOI statistic ( $α = 0.05$ )	Derived value
Experimental group tolerance x_i	6.9 subjects
Control group tolerance y_i	1.9 subjects
FECKUP vector length	1.9 subjects
Tolerance threshold for error (experimental group) $ϵ_{E}$	0.99%
Tolerance threshold for error (control group) $ϵ_{C}$	0.89%
Absolute tolerance threshold for error (all subjects) $ϵ_{A}$	0.22%

Table 3

Experimental metrics for similar test statistics.

Significance level	Data	$ϵ_{E}$	$ϵ_{C}$	$ϵ_{A}$
$α = 0.05$	Experiment 1	17.7%	18.2%	8.9%
	Experiment 2	11%	9.5%	5.0%
$α = 0.01$	Experiment 1	16.3%	17.0%	8.3%
	Experiment 2	10.4%	8.6%	4.6%
$α = 0.001$	Experiment 1	14.8%	15.5%	7.5%
	Experiment 2	9.8%	7.6%	4.1%
$α = 0.0001$	Experiment 1	13.5%	14.3%	6.9%
	Experiment 2	9.2%	6.8%	3.8%

Table 4

Results of different analysis.

	CIN2 + positive	No CIN2 + detected	Methodology
City A (measured)	113	887	LBC only
City B (measured)	24	976	HPV screening/LBC reflex
True values (both cities)	20	980	N/A

Additional files

MDAR checklist: https://cdn.elifesciences.org/articles/79573/elife-79573-mdarchecklist1-v2.pdf
Download elife-79573-mdarchecklist1-v2.pdf
Source code 1 Sample MATLAB/OCTAVE code for rapid implementation of EOI analysis method outlined.: https://cdn.elifesciences.org/articles/79573/elife-79573-code1-v2.zip
Download elife-79573-code1-v2.zip

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David Robert Grimes

(2022)

The ellipse of insignificance, a refined fragility index for ascertaining robustness of results in dichotomous outcome trials

eLife 11:e79573.

https://doi.org/10.7554/eLife.79573

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