Objectives: To assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities.
Design: Survey of outcome measures used in primary studies identified by a systematic review.
Data sources: ASSIA; CENTRAL; Cochrane Database of Systematic Reviews; Conference Proceedings Citation Index; CINAHL; DARE; Embase; HMIC; MEDLINE; MEDLINE In-Process; PsycINFO; Science Citation Index; Social Care Online; Social Policy & Practice; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform (ICTRP); and the UK Clinical Trials Gateway were searched up to February 2017.
Eligibility criteria: Studies evaluating pharmacological or non-pharmacological interventions for children (≤ 18 years old) with a neurodisability and experiencing non-respiratory sleep disturbance.
Data extraction and synthesis: Outcomes related to child and parent sleep-related outcomes; measures of perceived parenting confidence, efficacy or understanding of sleep management; child-related quality of life, daytime behaviour and cognition; parent/carer outcomes; and adverse events were listed from each study and categorised into domains.
Results: Thirty-nine studies (13 melatonin and 26 non-pharmacological) assessed five core outcome areas: child sleep, other child outcomes, parent outcomes, adverse events and process measures. There were 54 different measures of child related sleep across five domains: global measures; sleep initiation; maintenance; scheduling; and other outcomes. The most commonly reported measure in melatonin studies was total sleep time (n=12; 92%); and for non-pharmacological studies was the parent-reported Child Sleep Habits Questionnaire (CSHQ; 58%), both classified as global measures. Fifteen non-pharmacological (58%) and four pharmacological studies (31%) reported child outcomes other than sleep. The domains assessed (using 29 different measures) were child behaviour, quality of life, ADHD symptoms, cognition, school-related, and other.
One pharmacological and 14 non-pharmacological (54%) studies reported parent outcomes (17 different measures). Eleven melatonin studies (85%) recorded adverse events, with variation in how data were collected and reported. One non-pharmacological study reported an explicit method of collecting on adverse events. Several process measures were reported, related to adherence, feasibility of delivery, acceptability and experiences of receiving the intervention.
Conclusions: There is a lack of consistency between studies in the outcome measures used to assess the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. A minimum core outcome set, with international consensus, should be developed in consultation with parents, children and young people, and those involved in supporting families.
Registration number systematic review PROSPERO (CRD42016034067)