Table 2 Eligibility criteria for the systematic review framed using the PICOTS system [36]

Population

Women with gestational diabetes (any diagnostic criteria).

Women with pre-gestational diabetes (type 1 and type 2 diabetes).

Index

Development or external validation of a prognostic prediction model for women (e.g. prediction model for women with gestational diabetes to predict pregnancy complications)

Diagnostic prediction models (e.g. prediction model for the diagnosis of GDM)

Comparator

Not applicable

Outcomes (primary)

Obstetric:

- Hypertensive disorders of pregnancy

- Caesarean delivery

Neonatal:

- Large-for-gestational age (LGA)

- Composite of perinatal (fetal and neonatal) mortality or serious morbidity* (e.g. birth trauma, shoulder dystocia, bone fracture or nerve palsy)

Outcomes (secondary)

Obstetric:

- Maternal mortality

- Placental abruption

- Induction of labour

- Perineal trauma

- Postpartum haemorrhage

- Postpartum infection

- Instrumental delivery

Neonatal:

- Perinatal (fetal and neonatal) mortality

- Serious morbidity (e.g. birth trauma, shoulder dystocia, bone fracture or nerve palsy)

- Fetal macrosomia

- Small-for-gestational age (SGA)

- Low birth weight

- Intrauterine growth restriction (IUGR)

- Preterm delivery or premature birth

- Neonatal hypoglycaemia

- Respiratory distress syndrome

- Neonatal jaundice

- Neonatal hypocalcaemia

- Neonatal adiposity

- Neonatal polycythaemia

- Apgar score < 7 at 5 min

- Admission to neonatal intensive care unit

Timing

Complications occurring during pregnancy or up to 6 weeks postpartum period (obstetric or maternal) or affecting the neonate (neonatal).

Complications affecting the mother pre-pregnancy or with an onset more than 6 weeks postpartum. Complications affecting the offspring after 28 days of age.

Setting

Prognostic prediction models that are intended to be used by healthcare professionals, in the antenatal clinic setting, at any time during pregnancy intended to inform clinicians’ therapeutic decision-making.

Prognostic prediction models, which are intended to be used before pregnancy (pre-conception) or after childbirth.

Study type

Any study design including primary research (e.g. randomised controlled trial, cohort study, case-control study) or secondary research (e.g. systematic review) that reports on

(ii) one or more statistical models, tools or scores with at least two predictors proposed to predict an individual’s risk of a future outcome (prediction modelling studies). Other names for prediction models include prognostic model, prognostic (or prediction) index or rule, risk (or clinical) prediction model and predictive model. Prediction models estimate the risk of experiencing the outcome and may be reported in absolute (absolute probability) or relative (risk score) terms [37]. Prediction modelling studies can be either model development, model validation or a combination.

Editorial comments or letters.