Sample sizes and statistical methods in interventional studies on individuals with spinal cord injury: A systematic review

J Evid Based Med, 2019 · DOI: 10.1111/jebm.12356 · Published: September 1, 2019

Spinal Cord Injury Bioinformatics Research Methodology & Design

Simple Explanation

This study examines the sample sizes used in clinical trials involving individuals with spinal cord injuries (SCI). It also looks at the statistical methods used in studies with small sample sizes. The researchers reviewed studies published between 2014 and 2015 and analyzed the sample sizes and statistical methods employed. The study found that most SCI trials have small sample sizes, and the implications for statistical analysis and result validity are often not fully acknowledged.

Study Duration

2 years (2014-2015)

Participants

207 interventional studies on human SCI individuals

Evidence Level

Systematic Review

Key Findings

1
The median total sample size across the included studies was 18 individuals.
2
A large proportion (81%) of the studies were classified as small-sample size studies.
3
Among the small-sample size studies, a significant number (35%) did not mention any potential issues related to the small sample size.

Research Summary

This systematic review aimed to determine the median sample size in clinical trials involving individuals with spinal cord injury (SCI) and to examine the statistical methods used in small-sample size studies. The review included studies published between 2014 and 2015, revealing that most SCI trials are conducted with small sample sizes, and the consequences for statistical analysis and the validity of the results are often not acknowledged. The study highlights the need for increased awareness and collaboration among researchers to address the challenges posed by small sample sizes in SCI research.

Practical Implications

Collaboration

Encourage collaboration among researchers to conduct adequately powered multicenter trials.

Statistical Expertise

SCI journals should consider the advice of expert statistics reviewers and publish methodological papers regularly.

Interdisciplinary Exchange

Incorporate sessions focused on statistical methods at clinical research conferences to stimulate interdisciplinary exchange.

Study Limitations

1
The literature search was performed in only one database (PubMed).
2
No stratified analyses of the sample sizes were conducted.
3
The quality of the included studies was not taken into account in the analyses.

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