Skip to main content

# Questions tagged [non-inferiority]

A non-inferiority study is designed to test whether one treatment is not worse than another.

47 questions
Filter by
Sorted by
Tagged with
3 votes
1 answer
97 views

### How to analyse a non-inferiority trial using GEE in R?

I'm trying to analyse a non-inferiority trial in R. Since there are correlated observations and a population averaged interpretation seems fine, I want to use GEE. To illustrate my problem, I will use ...
0 votes
0 answers
21 views

### Account for prevalence in sample size calculations?

I want to calculate the sample size for a retrospective non-inferiority study. I want to test if methodB has a sensitivity that is non-inferior to methodA in regards to detecting head traumas on ...
• 139
1 vote
0 answers
60 views

### Sample size calculation for paired binary proportion - non-inferiority study?

I want to conduct a retrospective study, validating an algorithm. My data will be something like the following: id doctor prediction 1 0 0 2 1 1 ... ... ... n 0 1 My study design is non-...
• 139
0 votes
1 answer
36 views

### ANOVA is significant but also demonstrates non-inferiority

I have data that is looking at comparing a cheap (T) to expensive (V) ultrasound device with the hopes that the cheap is the same as expensive. There was 4 different examiners that used 4 different ...
4 votes
1 answer
99 views

### Statistical test for nominal data, multiple variables and within-subject design in R

I have run a study comparing if a cheap ultrasound device (T) is as efficient at determining osteophytes as an expensive device (V). There was four examiners who reviewed each participant (ID) and ...
1 vote
0 answers
101 views

### How to calculate p-value from non-inferiority study after OR?

I am conducting a study in which I test two different treatments A and B. The outcome is binary (success, fail). We want to demonstrate if treatment B is non-inferior to A with a margin of the ...
3 votes
2 answers
106 views

### Is this explanation of a Non-Inferiority Margin Correct?

I'm relatively new to the field of biostats and was reading up on Non-Inferiority Trials and Margins and came across this explanation which is tripping me off a bit. "For example, the oral ...
4 votes
2 answers
739 views

### How to properly analyze a non-inferiority study

In my study I try to show that treatment A is not inferior to treatment B. With a delta margin of tolerance =-2. I had discussed the subject in a previous post, of which here is the link. For two-...
• 919
3 votes
1 answer
3k views

### How to calculate p.value for non inferiority study with R?

I'll give a little background on my study. It is a non-inferiority study. We have to show that treatment A is non-inferior to treatment B with a delta acceptability margin of -2 for the outcome. The ...
• 919
1 vote
0 answers
83 views

### Sample size calculation for non-inferiority prospective observational study with paired nominal data?

I'm doing a diagnostic observational study, where doctors in two different fields (emergency physicians vs radiologists) try to diagnose same patient (paired sample). The question we are trying to ...
1 vote
1 answer
58 views

### Stability of results in non-inferiority test in small sample size with rare events

I am working with a dataset including 65 participants, 35 in the control group and 30 in the experimental group. The objective is to assess wether the experimental group is non-inferior to the control ...
• 11
3 votes
1 answer
520 views

### Confidence level and alpha with two one-sided t-tests (TOST)

I'm making a non-inferiority study: two groups complete a test (where it is possible to score 0-30 points). I already have the test results for groupB. I want to investigate if groupA performs non-...
• 139
1 vote
0 answers
65 views

### Do multiple measurements on each patient require mixed effect methods if the number of measurements per patient is the same?

For the purposes of this question, let's acknowledge that accuracy is not the best way to measure a model's performance, and that a proper scoring rule is best. However, the decision to use accuracy ...
0 votes
1 answer
266 views

### Noninferiority test for nonparametric distributions -- which statistical test to use?

I'm trying to conduct a noninferiority test to determine whether one treatment is no worse than another. The distributions of the two populations are likely not normal, so I want to use a non-...
1 vote
0 answers
46 views

### When switching from non-inferiority to superiority - is the adjustment for significance needed (confusion)?

On this blog: http://onbiostatistics.blogspot.com/2012/06/switching-from-non-inferiority-to.html which also cites the opinion of FDA and EMA we can read, that no adjustment is necessary. Could anyone ...
2 votes
0 answers
123 views

### Sample size calculation for a non-inferiority RCT

I am planning to test the non-inferiority of a new resistance training program compared to the standard training program. The primary outcome will be maximal muscle strength that will be measured pre ...
2 votes
1 answer
76 views

### In clinical trials, why do we not always use Equivalence trials instead of superiority and non-inferiorty?

So I understand what these three types are aimed for, I know they answer different questions. However, why wouldn't we always use equivalence trials? I mean if for example were are comparing two drugs ...
1 vote
1 answer
130 views

### Non-inferiority test for Spearman correlation

Let's say I have the following data and want to test whether the Spearman's correlation is > 0.5 ...
• 408
1 vote
0 answers
277 views

### Sample size for non-Inferiority Tests for Two Survival Curves Using Cox’s Proportional Hazards, parameter specification of actual hazard ratio

I am looking into at trying to understand the parameter, "Actual Hazard Ratio", used in the following sample size calculation. Example 1 in the following pdf. https://ncss-wpengine.netdna-...
• 303
0 votes
1 answer
74 views

### Best method for paired survival/time-to-event non-inferiority sample size calculation (using median survival time)?

I am trying to design a theoretical study in which one group of patients uses two wearable devices (i.e., every participant uses both devices) that gather information about their vitals, which is then ...
2 votes
0 answers
34 views

• 1,202
0 votes
0 answers
116 views

### Why does a non-inferiority design require a smaller sample size than a superiority design?

I understand that theoretically, because a non-inferiority design has a wider range of successful outcomes (equivalence or superiority) vs. a superiority design which only has one successful outcome, ...
1 vote
1 answer
656 views

### Non-inferiority margin and minimum detectable effect vs sample size

I am trying to understand why testing for non-inferiority requires pretty much the same sample size as testing for superiority (I assume the latter is the same as a one-sided test for a given MDE). I ...
• 171
3 votes
0 answers
88 views

### Is there a less arbitrary way define the margin in non-inferiority and/or equivalence trials?

In a typical equivalence trial, the researcher defines some threshold below which the difference between two means is not considered practically meaningful. In a non-inferiority trial, the same kind ...
• 283
0 votes
0 answers
101 views

### Noninferiority in a multilevel model

I am working on a randomized trial in which patients were randomized to one of two groups and followed over time, they were assessed at 5 time points including baseline. The outcomes include ...
• 125k
1 vote
0 answers
304 views

### Sample size estimation for superiority/non-inferiority study

I am trying to estimate sample size for a superiority/non-inferiority study between two diagnostic tests. I have the AUCs of Model0 (standard test) and Model1 (new test), and other required parameters....
1 vote
0 answers
318 views

### Sample size calculation for 3 arm study "non-inferiority design" and continuous endpoints

I need to do a sample size calculation for a 3 arm study. Something like mentioned HIER! The endpoint is a severity score. The score can take integer values from 0 to 100 points. (i would consider ...
• 141
2 votes
1 answer
266 views

### Inconclusive results in non-inferiority design

I am interested in how an inconclusive result occurs given the formal null and alternative hypotheses required for non-inferiority testing. I have pre-specified a noninferiority design comparing ...
• 2,231
1 vote
0 answers
760 views

### How to perform multiple noninferiority tests with linear mixed models?

I want to test a theory that predicts that certain measures are greater than or equal than others. Consequently, I want to perform noninferiority tests. Furthermore, I want to get rid of some ...
• 105
1 vote
1 answer
2k views

### Determining Non-Inferiority with a 95% Confidence Interval

I have a sample of 1000 observations, divided into 2 groups: treatment and control (500 in each group). Each observation is dichotomous: 1 if an event occurred (bad event), and 0 if no event occurred. ...
• 785
4 votes
1 answer
201 views

### Non-inferiority test and bootstrapping

Background: I am trying to show that my method is as good as or better than a previously published work in the field of Automatic Speech Recognition. Usually, in the literature people usually report ...
• 91
11 votes
2 answers
565 views

### Can we accept the null in noninferiority tests?

In a usual t-test of means, using the usual hypothesis testing methods, we either reject the null or fail to reject the null but we never accept the null. One reason for this is that if we got more ...
• 125k
1 vote
1 answer
72 views

### Testing equivalence (mean stayed the same)

We have an app, where you post projects and we'll be running A/B test on new version of posting page. How do we ensure that the new version is not worse? We have 14 days of time to decide that. And ...
9 votes
1 answer
2k views

### Noninferiority Using Logistic Regression

From the paper Equivalence and Noninferiority Testing in Regression Models and Repeated-Measures Designs the following graphic is taken. I am interested in a non-inferiority test between two ...
• 8,810
7 votes
1 answer
423 views

### Determine if two distributions are the same

I develop GNU Parallel. For each release I would like to test whether the version I am about to release has a memory leak. I can measure the memory usage. Unfortunately the usage varies slightly ...
• 171
2 votes
1 answer
119 views

### Estimating non-inferiority sample size

I'm projecting the number of patients needed for a clinical trial. Specifically, I'm using this model (https://www.sealedenvelope.com/power/binary-noninferior), and setting the variables as: (1) alpha ...
5 votes
1 answer
4k views

### Does statistically insignificant difference of means imply equality of means?

Suppose I have sets A and B of normally distributed data so that: A: mean=250, SD=200, N=25 B: mean=248, SD=200, N=20 Clearly, there is no statistically ...
• 215
2 votes
0 answers
97 views

### How to use a meta-analysis to assess the equivalence of two different procedures?

I'm making a comparison of two surgical procedures, and I want to know how I can analyze the data I have for a meta-analysis. The overall surgical procedure is the same, but some authors choose to ...
1 vote
0 answers
135 views

### Non-inferiority testing without normal approximation

I am performing a non-inferiority test on two binomial trials. I want to determine if my test proportion, pT, is not worse than my control, pC, by more than an amount d. Assuming nT trials of my test ...
• 11
5 votes
2 answers
16k views

### One-sided Fisher's exact test and its complement

If a one-sided Fisher's exact test testing the null hypothesis that A is not superior to B has a p-value of 0.98, is it true that the Fisher's exact test p-value for the null hypothesis that B is not ...
• 5,831