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Core Outcome Set and Reporting Checklist for Research on Critically Ill Obstetric Patients (COSCO)

COSCO is an international, multi-method study conducted between February 2023 and January 2024. It involved 68 participants, including 11 health service users (HSUs) with lived experience of critical illness during pregnancy and 57 healthcare professionals (HCPs) from 16 countries. Through systematic review, qualitative interviews, Delphi surveys, small group discussions, and a final consensus meeting, the study identified 10 core outcomes, and 7 reporting checklist items that should be measured and reported in all future studies on critically ill obstetric patients. Additionally, COSCO recommends 4 important non-core outcomes to be reported where feasible. This standardized framework aims to harmonize outcome reporting, enhance data comparability, and support the development of patient-centered, evidence-based clinical guidelines.

Core Outcome Set and Reporting Checklist for Research on Critically Ill Obstetric Patients (COSCO)

Study
Study
This represents the initial iteration of the COSCarP checklists. We invite and highly value your feedback,
which will inform future refinements and updates. Please direct any comments or suggestions to oros@mcmaster.ca.

Core Outcome Set

# Core Outcome Explanations and Reporting Recommendations Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Maternal all-cause mortality
Maternal all-cause mortality
  • For antepartum deaths, specify gestational age.
  • For post-pregnancy deaths, specify number of days following pregnancy loss.
  • In all cases, report the condition directly leading to death.
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2.
2.
Cardiac arrest and the need for cardiopulmonary resuscitation; not resulting in death
Cardiac arrest and the need for cardiopulmonary resuscitation; not resulting in death 		Specify gestational age (if antepartum) or days following pregnancy loss or childbirth.
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3.
3.
Severe (maternal) organ dysfunction
Severe (maternal) organ dysfunction 		Specify affected organ(s).
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4.
4.
Length of stay in the Intensive Care Unit (ICU) and total stay in hospital
Length of stay in the Intensive Care Unit (ICU) and total stay in hospital 		Report values separately e.g. ICU stay (days) + non-ICU stay (days) = Total hospital stay (days).
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5.
5.
Readmission to hospital or ICU or repeated hospital/emergency department visits following discharge from ICU
Readmission to hospital or ICU or repeated hospital/emergency department visits following discharge from ICU
  • Report any readmissions to hospital or ICU.
  • Specify admitting unit and list number of days admitted.
  • Report any other unplanned hospital visits, indicated number of visits during study period.
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6.
6.
Presence of a new medical condition at the time of discharge from hospital, which was not present at the time of admission to the hospital
Presence of a new medical condition at the time of discharge from hospital, which was not present at the time of admission to the hospital 		Specify condition(s) diagnosed.
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7.
7.
Permanent infertility as a consequence of critical illness or intervention
Permanent infertility as a consequence of critical illness or intervention 		Specify the illness or intervention resulting in permanent infertility (e.g. hysterectomy).
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8.
8.
Perinatal loss
Perinatal loss 		Yes/no. If yes, clearly state the threshold of viability used for this study, for e.g., 20 weeks, 24 weeks etc.

Define perinatal loss as follows
Intrauterine/fetal loss
  • Miscarriage: spontaneous fetal loss under the threshold of viability
  • Therapeutic abortion / pregnancy termination: medical or surgical termination of pregnancy under the threshold of viability
  • Stillbirth: intrauterine fetal death between threshold of viability and birth.
Report gestational ages for each of the above.

Neonatal death/ex utero loss
  • Early neonatal death: within first 7 days of life
  • Late neonatal death: days 8–28 of life
Report age in days following birth
[Any deaths occurring after 28 days of life should be reported as infant deaths specifying the age in days where possible]
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9.
9.
Severe neonatal morbidity requiring prolonged Neonatal Intensive Care Unit (NICU) admission
Severe neonatal morbidity requiring prolonged Neonatal Intensive Care Unit (NICU) admission 		Serious or life-threatening conditions experienced by neonates. State what conditions/indicators were used to define this term. Refer to severe morbidity indicator(s) published by professional organizations and indicate which source was used.

If NICU admission ≥ 24 hours, indicated length of stay in days.
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10.
10.
Gestational age at birth / Preterm birth
Gestational age at birth / Preterm birth 		State number of weeks.
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Important Non-Core Outcomes

These outcomes are important to report in studies on critical illness in pregnancy but may not always be applicable or feasible.
We suggest providing a justification when not reported.
# Important Non-Core Outcome Explanations and Reporting Recommendations Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Cost to families and healthcare systems
Cost to families and healthcare systems 		Given the diverse healthcare systems that include publicly-funded systems, third-party payer, and self-pay models, researchers are encouraged to estimate costs as appropriate, ideally in conjunction with health economists, as a separate study.
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2.
2.
Mother's quality of life
Mother's quality of life 		Various quality of life tools are available to assess physical functioning, role limitation including maternal role, social functioning including relationship status and isolation, mental health/psychological wellbeing, bodily pain. Include instrument used as well as timing and frequency of measurement.
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3.
3.
Emotional impact on partner and other children at home
Emotional impact on partner and other children at home 		Various tools are available to assess this impact. Include instrument used as well as timing and frequency of measurement.
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4.
4.
Baby's long-term neurodevelopmental, cognitive, and psychological outcomes
Baby's long-term neurodevelopmental, cognitive, and psychological outcomes 		Various tools are available depending on the age when assessed. Provide details on the instruments used and report long-term neurodevelopmental, cognitive, and psychological outcomes using standardized, age-appropriate assessment tools at specified time points (e.g., 12 months, 5 years, etc.).
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Reporting Checklist Items

These items, although not necessarily outcomes, are important to report in studies on critical illness in pregnancy.
# Reporting Checklist Item Explanation and reporting recommendations Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Hospital-acquired infections
Hospital-acquired infections 		Report any infections diagnosed after ICU admission. Specify the type (e.g., pneumonia, sepsis) and the timing of onset relative to admission (e.g., within 48 hours, after 72 hours).
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2.
2.
Location of birth within the hospital
Location of birth within the hospital 		Specify location of birth (ICU / labour and delivery ward / operating room / other).
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3.
3.
Mode of birth
Mode of birth
  • Mode of birth, categorizing as vaginal, assisted vaginal (forceps or vacuum), or caesarean birth.
  • For vaginal births, indicate if the birth was spontaneous or assisted/operative. If assisted, indicate which instrument was used e.g., vacuum (type) or forceps (type) and indication for use of instrument.
  • For Cesarean births, indicate whether it was planned or emergency. For emergency cesarean births, provide reasons such as non-reassuring fetal status, failure to progress in labour, failed induction, etc.
  • Include any complications related to the mode of birth.
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4.
4.
Type of analgesia/anesthesia used for labour and birth and complications
Type of analgesia/anesthesia used for labour and birth and complications 		Specify type(s) of analgesia/anesthesia used (e.g., epidural, general anesthesia, spinal block, or non-pharmacological methods).
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5.
5.
Breastfeeding concerns
Breastfeeding concerns 		Document any breastfeeding issues, specifying if the concern was related to milk production, latch, or inability to breastfeed. Include interventions or support provided (e.g., lactation consultant).
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6.
6.
Mother-newborn separation
Mother-newborn separation 		Length and reasons for mother-newborn separation if the critical illness involved the postpartum period (e.g., due to medical complications, NICU care). Include start and end date of separation in relation to birth.
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7.
7.
Birthweight
Birthweight 		State weight in grams.
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