Related Experiment Video
Updated: Jan 2, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Adequate reporting of the sample size calculation in surgical randomized controlled trials
1Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University Basel, Basel, Switzerland.
Reporting of sample size calculations in surgical trials is crucial for critical appraisal. Adherence to reporting guidelines is moderate, with significant gaps in comprehensive sub-item reporting.
Area of Science:
- Medical Statistics
- Clinical Trial Design
- Surgical Research
Background:
- Sample size calculation in randomized controlled trials (RCTs) is vital for detecting statistically significant and clinically relevant differences.
- Transparent reporting of sample size assumptions allows critical evaluation of RCTs.
Purpose of the Study:
- To assess the frequency of adequate reporting for specific sample size calculation sub-items in surgical RCTs.
- To evaluate adherence to reporting guidelines like Consolidated Standards for Reporting Trials (CONSORT) and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT).
Main Methods:
- A minireview of surgical RCTs published in 5 leading general surgical journals in 2017.
- Identification of 85 relevant RCTs via PubMed.
- Assessment of reporting completeness based on CONSORT and SPIRIT sub-items.
Main Results:
- Overall adequate reporting of sample size according to CONSORT was 53% (45/85).
- Adherence decreased to 12% (10/85) when including additional SPIRIT sub-items not explicitly in CONSORT.
- Moderate adherence to reporting potentially important sample size sub-items was observed.
Conclusions:
- Adherence to comprehensive sample size reporting in surgical RCTs is moderate.
- Surgeons planning and conducting RCTs must be aware of essential sample size reporting sub-items.
- Improved reporting is necessary for critical appraisal of surgical trial validity.
More Related Videos
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
03:07Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Related Concept Videos
Sample Size Calculation
The sample size for the given experiment or sampling effort is fundamental to any study design. Sample size decides the number of...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Randomized Experiments
Simple randomization
Simple...
Hazard Ratio
For example, in a clinical trial...
One-Way ANOVA: Unequal Sample Sizes
Comparing the Survival Analysis of Two or More Groups