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What Evidence Underlies Clinical Practice in Paediatric Surgery? A Systematic Review Assessing Choice of Study Design
Benjamin Allin1,2, Nicholas Aveyard3, Timothy Campion-Smith3
1National Perinatal Epidemiology Unit, Oxford, United Kingdom.
Insights
Most pediatric surgical studies use weak designs like retrospective case series, with few randomized controlled trials (RCTs). This highlights a need for better research methods in pediatric surgery to improve patient outcomes.
Area of Science:
- Pediatric Surgery
- Clinical Research Methodology
- Evidence-Based Medicine
Background:
- Paediatric surgical literature is crucial for advancing care for children and adolescents.
- Assessing the quality of study designs in paediatric surgery is essential for reliable evidence generation.
- The IDEAL collaboration provides recommendations for robust study designs in surgical interventions.
Purpose of the Study:
- To identify and analyze study designs used in paediatric surgical articles published in 1998 and 2013.
- To determine the appropriateness of these designs for robustly assessing surgical interventions.
- To evaluate changes in the proportion of recommended study designs over time.
Main Methods:
- A systematic review of paediatric surgical articles from 1998 and 2013 was conducted.
- Studies were screened and included based on predefined population, condition, and intervention criteria.
- Articles were classified according to IDEAL collaboration recommendations for study designs, with changes calculated between the two publication years.
Main Results:
- The number of paediatric surgical articles increased from 1581 in 1998 to 3453 in 2013.
- Retrospective case series remained the most common study design (45% in 1998, 46.8% in 2013).
- Randomized controlled trials (RCTs) constituted a small fraction of studies (1.8% in 1998, 1.9% in 2013); only 9.8% (1998) and 11.9% (2013) used recommended designs.
Conclusions:
- A low proportion of published paediatric surgical manuscripts employ designs recommended for robust intervention assessment.
- Randomized controlled trials are infrequently used, representing less than 2% of studies.
- The majority of paediatric surgical research in 2013 utilized less robust designs, indicating a need for improved research methodologies.
Objective:
Identify every paediatric surgical article published in 1998 and every paediatric surgical article published in 2013, and determine which study designs were used and whether they were appropriate for robustly assessing interventions in surgical conditions.
Methods:
A systematic review was conducted according to a pre-specified protocol (CRD42014007629), using EMBASE and Medline. Non-English language studies were excluded. Studies were included if meeting population criteria and either condition or intervention criteria.
Population:
Children under the age of 18, or adults who underwent intervention for a condition managed by paediatric surgeons when they were under 18 years of age.
Condition:
One managed by general paediatric surgeons.
Intervention:
Used for treatment of a condition managed by general paediatric surgeons.
Main Outcome Measure:
Studies were classified according to whether the IDEAL collaboration recommended their design for assessing surgical interventions or not. Change in proportions between 1998 and 2013 was calculated.
Results:
1581 paediatric surgical articles were published in 1998, and 3453 in 2013. The most commonly used design, accounting for 45% of studies in 1998 and 46.8% in 2013, was the retrospective case series. Only 1.8% of studies were RCTs in 1998, and 1.9% in 2013. Overall, in 1998, 9.8% of studies used a recommended design. In 2013, 11.9% used a recommended design (proportion increase 2.3%, 95% confidence interval 0.5% increase to 4% increase, p = 0.017).
Conclusions And Relevance:
A low proportion of published paediatric surgical manuscripts utilise a design that is recommended for assessing surgical interventions. RCTs represent fewer than 1 in 50 studies. In 2013, 88.1% of studies used a less robust design, suggesting the need for a new way of approaching paediatric surgical research.
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