Core Outcome Measures in Effectiveness Trials

Outcome domains and outcome measures used in studies assessing the effectiveness of interventions to manage non-respiratory sleep disturbances in children with neurodisabilities: A systematic review

General Information

Abstract:
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 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 Outcome measures were listed from each study and categorised into domains.

Results Thirty-nine studies assessed five core outcome areas: child sleep, other child outcomes, parent outcomes, adverse events and process measures. There were 54 different measures of child sleep across five domains: global measures; sleep initiation; maintenance; scheduling; and other outcomes. Fifteen non-pharmacological (58%) and four pharmacological studies (31%) reported child outcomes other than sleep using 29 different measures.

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.

PROSPERO registration number CRD42016034067

Authors:
McDaid, C. Parker, A. Scantlebury, A. Fairhurst, C. Dawson, V. Elphick, H. Hewitt, C. Spiers, G. Thomas, M. Beresford, B.

Publication

Journal:
BMJ Open
Volume:
9
Issue:
6
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):
National Institute for Health Research (NIHR) HTA Programme (project number 14/212/02).

Health Area

Disease Category
Neurology

Disease Name
Neurodevelopmental disorders
Neurodisability

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Any

Method(s)

Systematic review

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 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 Outcome measures were listed from each study and categorised into domains.


Stakeholders Involved

None

Study Type

Systematic review of outcome measures/measurement instruments
Systematic review of outcomes measured in trials

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