Evidence map›Paper›PMID 42885368›Full record

ArticleF1000Research2022

Sample size variation in single-time post-dose assessment

Sarfaraz Sayyed, Ashwini Mathur, Asha Kamath

Abstract read
In one paragraph

Article in F1000Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Sarfaraz SayyedAnalytics, Novartis Healthcare Pvt. Ltd., Hyderabad, Telangana, 500080, India.ORCID https://orcid.org/0000-0003-4322-9377
Ashwini MathurClinical Technology & Innovation, Novartis Ireland Ltd., Dublin, Ireland.
Asha KamathDepartment of Data Science, Manipal Academy of Higher Studies, Manipal, Karnataka, 576104, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Many randomized trials measure a continuous outcome simultaneously at baseline and after taking the drug. For a single continuous post-treatment outcome, the sample size calculation is simple, but if there are assessments at multiple time point post-treatment then this longitudinal data may give more insights by analyzing the data using the repeated measures method. Also, if the sample size is calculated using the single time-point method for longitudinal data, it may lead to a larger than required sample size, increasing the cost and time. Methods: In this research, an effort is made to determine the size of the sample for repeated measures case and then compare with the single post-baseline case. The sample sizes were examined under different scenarios for the continuous type of response variable. Under 'Mean contrast' and 'Diff contrast' the sample sizes were calculated with different correlations. These two scenarios were again examined under compound symmetry as well as discrete Auto regressive of order 1 type of correlation structure in longitudinal data. The graphical presentation is given for better visualization of the scenarios. Results: The sample size required for highly correlated longitudinal data using the multi-timepoint sample size derivation method led to a smaller sample size requirement compared to the single timepoint sample size calculation method. Conclusions: This study will help researchers to make better decisions in choosing the right method for sample size determination which may reduce the time and cost of conducting the experiment. Additionally, it is crucial to carefully evaluate and choose the appropriate method when the correlation is weak, as this can significantly impact the accuracy of the results. More complex correlation structures are not studied in this article but can be studied in the same fashion.

Indexed as

Randomized Controlled Trials as TopicHumansLongitudinal StudiesSample SizeTime Factorssample size estimation; longitudinal study; repeated measure analysis; univariate analysis

Identifiers

PMID42885368
PMCPMC13662387

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.