Background
Methods
Aim
Design
Participants
Interventions
Real-Time Delphi method
Consensus Classification | Description | Definition |
---|---|---|
Consensus in (parent-weighted vote) | Consensus that the outcome should be included in the core outcome set | 70% or more participants overall scoring as 7 to 9 AND < 15% participants scoring a 1 to 3 OR > 70% or more of parent group scoring as 7 to 9 |
Consensus out | Consensus that the outcome should not be included in the COS | 50% or fewer participants scoring as 7 to 9 in each stakeholder group |
Neither consensus in nor consensus out (consensus undetermined) | Uncertainty about the importance of the outcome, so retain for next round | Anything else |
Multi-Round Delphi method
Recruitment
Randomisation
Statistical analysis
Outcomes
Results
Deviations from the protocol
Sample
Findings
Primary outcome
Outcome | Multi-Round | Real-Time |
---|---|---|
Brain injury on imaging | In | In |
EEG abnormalities | In | In |
Intracranial haemorrhage | In | In |
Severity of encephalopathy | In | In |
Absence of neonatal reflexes | In | In |
Gag reflex (absence) | In | In |
Swallow (absent) | In | In |
Neonatal seizures | In | In |
Normal tone | In | In |
Need for neonatal resuscitation | In | In |
Oxygen requirement | In | In |
Need for mechanical ventilation | In | In |
Respiratory distress | In | In |
Ability to breathe normally and unaided | In | In |
Need for tube feeding | In | In |
Oral feeding ability | In | In |
General gross motor ability | In | In |
General fine motor ability | In | In |
Need for physiotherapy | In | In |
General cognitive ability | In | In |
Normal memory | In | In |
Child mental health | In | In |
Visual impairment | In | In |
Speech delay | In | In |
Ability to make noises/verbalise | In | In |
General communication ability | In | In |
Psychological development | In | In |
Self-esteem | In | In |
Behavioural issues | In | In |
Cerebral palsy | In | In |
Epilepsy | In | In |
Survival | In | In |
Suffering | In | In |
Full recovery from acute illness | In | In |
Quality of life of the patient | In | In |
Readmission in childhood | In | In |
Adverse events | In | In |
Hypoxia | In | In |
Multi-organ dysfunction | In | In |
Emotional impact on parents | In | In |
Parental involvement in care | In | In |
Parental attachment with their baby | In | In |
Parental sense of loss of normal | In | In |
Uncertainty for child’s future wellbeing | In | In |
Parental psychological impact of NICU experience | In | In |
Impact of child’s condition on parent’s relationship | In | In |
Financial burden of healthcare costs of care for an infant on parents | In | In |
Effective communication | In | In |
Parental ability to work | In | Undetermined |
Feeding intolerance | In | Undetermined |
Biomarker evidence of brain injury | Undetermined | In |
Myocardial dysfunction | Undetermined | In |
Cardiac ischaemia | Undetermined | In |
Need for extracorporeal membrane oxygenation | Undetermined | In |
Persistent pulmonary hypertension | Undetermined | In |
Pulmonary haemorrhage | Undetermined | In |
ADD | Undetermined | In |
Heightened sensory sensitivity | Undetermined | In |
Hearing impairment | Undetermined | In |
Requirement for antiepileptic drugs at discharge | Undetermined | In |
Need for occupational therapy | Undetermined | In |
Growth | Undetermined | In |
Requirement for analgesics | Undetermined | In |
Sepsis | Undetermined | In |
Duration of neonatal stay | Undetermined | In |
Need for multiple operations | Undetermined | In |
Impact on family decision to have other children | Undetermined | In |
Abnormal changes in heart rate or rhythm | Undetermined | Undetermined |
Coagulopathy | Undetermined | Undetermined |
Thrombosis | Undetermined | Undetermined |
Hypotension | Undetermined | Undetermined |
Need for inhaled nitric oxide | Undetermined | Undetermined |
Necrotising enterocolitis | Undetermined | Undetermined |
ADHD | Undetermined | Undetermined |
Pyrexia | Undetermined | Undetermined |
Poor renal function | Undetermined | Undetermined |
Hepatic dysfunction | Undetermined | Undetermined |
Metabolic acidosis | Undetermined | Undetermined |
Pneumonia | Undetermined | Undetermined |
Hypoglycaemia | Undetermined | Undetermined |
Sleep disorders | Out | Undetermined |
Hypertension | Out | Undetermined |
Haematological variables | Out | Undetermined |
Healthcare costs | Out | Undetermined |
Electrolyte disturbance | Out | Undetermined |
Impact of child’s condition on Neonatal Intensive Care Unit experience on wider family (stress, disappointment, sadness, grief, etc.) | Out | Undetermined |
Lung air leaks | Out | Out |
Need for surgical treatment of gastroesophageal reflux disease | Out | Out |
Meconium passage | Out | Out |
Ability to undertake sport | Out | Out |
Jaundice | Out | Out |
Hyperglycaemia | Out | Out |
Secondary outcomes
Recruitment order | b coefficient | Lower 95% CI | Upper 95% CI | |
---|---|---|---|---|
Min | 1st participant | 0.78 | 0.69 | 0.86 |
25th centile | 28th participant | 0.83 | 0.78 | 0.89 |
median | 56th participant | 0.89 | 0.85 | 0.94 |
75th centile | 84th participant | 0.95 | 0.88 | 1.02 |
Max | 111th participant | 1.01 | 0.91 | 1.11 |