Evidence map›Paper›PMID 31221881›Full record

SynthesisBMJ open2019

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.

Catriona McDaid, Adwoa Parker, Arabella Scantlebury, Caroline Fairhurst, Vicky Dawson, Heather Elphick, Catherine Hewitt, Gemma Spiers, Megan Thomas, Bryony Beresford

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Catriona McDaidYork Trials Unit, Department of Health Sciences, University of York, York, UK.ORCID 0000-0002-3751-7260
Adwoa ParkerYork Trials Unit, Department of Health Sciences, University of York, York, UK.ORCID 0000-0002-2880-3935
Arabella ScantleburyYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Caroline FairhurstYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Vicky DawsonThe Children's Sleep Charity, Doncaster, UK.
Heather ElphickDepartment of Respiratory Medicine, Sheffield Children's NHS Foundation Trust, Sheffield, UK.
Catherine HewittYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Gemma SpiersNewcastle University, Newcastle upon Tyne, UK.
Megan ThomasInstitute of Health and Society, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.ORCID 0000-0002-4358-6166
Bryony BeresfordChildren's and Adolescent Services, Social Policy Research Unit, University of York, York, UK.

Funding

Department of Health HTA/14/212/02
6 · The paper itself

Abstract

objectivesTo assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities.

designSurvey 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.

resultsThirty-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.

conclusionsThere 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.

Indexed as

Outcome Assessment, Health CareAttention Deficit Disorder with HyperactivityAutism Spectrum DisorderCentral Nervous System DepressantsChildChild, PreschoolDevelopmental DisabilitiesHumansMelatoninRandomized Controlled Trials as TopicSleep Initiation and Maintenance DisordersCentral Nervous System DepressantsMelatoninclinical trialssleep medicine

Identifiers

PMID31221881
PMCPMC6589007

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.