Skip to main content
. 2024 Jul 18;14(7):e083600. doi: 10.1136/bmjopen-2023-083600

Table 1. Overview of outcomes.

Outcome Method of measurement Definition Outcome measurement
Neurodevelopment Ages and Stages Questionnaire third edition (ASQ-3) Scores on five domains:

  • Communication

  • Gross motor skills

  • Fine motor skills

  • Problem-solving skills

  • Personal-social skills

 Mean (SD)Abnormal:≥2 SD below mean in any domain≥1 SD below mean in multiple domains*Mildly abnormal:≥1 and <2 SD below mean in one domain*
Vineland screener Total adaptive functioning score based on four domains:

  • Communication

  • Social skills

  • Daily living skills

  • Motor skills

 Mean (SD)Abnormal:≤10th percentile of the population*Mildly abnormal:11th–25th percentile of the population*
Behaviour Strength and Difficulties Questionnaire (SDQ) Total difficulties score including four subscales:

  • Conduct problems

  • Emotional symptoms

  • Hyperactivity

  • Peer relationships

 Mean (SD)Abnormal:>90th percentile of the population*Mildly abnormal:80th–90th percentile of the population*
Mortality Cross-check medical files and Dutch Personal Record database Perinatal mortality and death up to around 4 years of corrected age Number (%)†
General health General Health Questionnaire‡ Height Mean (SD)Abnormal: 1.6 SD above or below target height range*
BMI Mean (SD)Abnormal34 35:

  • underweight*

  • overweight*

  • obesity*
Morbidity, medication use, hospital admissions, surgeries Number (%)
Primary outcome ASQ-3, Vineland screener, SDQ and mortality Composite outcome is divided into abnormal and mildly abnormal Abnormal:Score in ASQ-3, vineland screener or SDQ questionnaire is abnormal as defined aboveMildly abnormal:Score in ASQ-3, vineland screener or SDQ questionnaire is mildly abnormal as defined above
*

Cut-off according to age and gender.The denominator changes into all children born to participants of the original APOSTEL 8 trial.

†

This questionnaire was developed by our research team that is specialised in follow-up research of obstetric intervention studies. The questionnaire has been used in multiple follow-up studies.The denominator changes into all children born to participants of the original APOSTEL 8 trial.

‡

This questionnaire was developed by our research team that is specialised in follow-up research of obstetric intervention studies. The questionnaire has been used in multiple follow-up studies.22 30 38

APOSTEL 8Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour 8BMI, body mass indexSDS, SD Score