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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.

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.

SUBMITTER: McDaid C

PROVIDER: S-EPMC6589007 | biostudies-other | 2019 Jun

REPOSITORIES: biostudies-other

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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.

McDaid Catriona C Parker Adwoa A Scantlebury Arabella A Fairhurst Caroline C Dawson Vicky V Elphick Heather H Hewitt Catherine C Spiers Gemma G Thomas Megan M Beresford Bryony B

BMJ open 20190619 6

<h4>Objectives</h4>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.<h4>Design</h4>Survey of outcome measures used in primary studies identified by a systematic review.<h4>Data sources</h4>ASSIA, CENTRAL, Cochrane Database of Systematic Reviews, Conference Proceedings Citation Index, CINAHL, DARE, Embase, HMIC, MEDLINE, MEDLINE In-Process, PsycINFO, Science Citation ...[more]

PMID: 31221881

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Project description:OBJECTIVES:The aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients. SETTING:University-initiated international survey. PARTICIPANTS:The expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers. PROCEDURES:The initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache. Suggested outcome measures were rated by each expert, blinded towards the other members of the panel, for its usefulness on a 5-point Likert scale ranging from definitely not useful to extremely useful. Results were combined using median values and IQRs. Tools rated overall as definitely or probably not useful were excluded from subsequent rounds. Experts further suggested additional outcome measures that were presented to the panel in subsequent rounds. Additionally, experts were asked to rank the most useful tools and provide information on feasible cut-off levels for effectiveness for the three highest ranked tools. RESULTS:Results suggest the use of the Migraine Disability Assessment (MIDAS), Headache Impact Test (HIT-6) and headache frequency as primary outcome measures. Patient experts suggested the inclusion of a measure of quality of life and evaluation of associated symptoms and fear of attacks. CONCLUSIONS:Recommendations are for the use of the MIDAS, the HIT-6 and headache frequency, in combination with an outcome measure for quality of life. Associated symptoms and fear of attacks should also be considered as secondary outcomes, if relevant for the individual target population. The cut-off level for effectiveness should be lower for non-pharmacological interventions, especially when used as an adjunct to medication. TRIAL REGISTRATION NUMBER:German Register of Clinical Trials (DRKS00011777).

Project description:AimsThe aims of this review were (i) to evaluate whether patient-reported outcome measures used in clinical studies for assessing sensation after mastectomy and breast reconstruction are suitable for this purpose, and (ii) to explore whether any measures used for assessing sensation after non-oncologic breast surgery are worth modifying for use in post-mastectomy patients.MethodsPRISMA guidelines were followed (PROSPERO number CRD42020178066). We searched six databases for studies of oncologic (i.e., therapeutic, prophylactic, and reconstructive) and non-oncologic breast surgery (e.g., breast reduction) in which sensation was assessed with a patient-reported outcome measure. From the selected studies, we extracted eligible measures, evaluated their fitness for purpose, and summarized the content of sensation-specific items.ResultsOf 6728 articles identified, we selected 135 studies that used 124 eligible patient-reported outcome measures. For 97% of these measures, details regarding development and measurement properties were unavailable. Four (3%) validated measures-the Sensory Disturbances subscale of the Breast Cancer Sequelae Cause Scales, the Discomfort subscale of the Breast Sensation Assessment Scale (BSAS), Didier et al.'s questionnaire for "Assessment of the patients' satisfaction with cosmetic results, physical and emotional impact of mastectomy", and the Breast Specific Pain subscale of the Breast Cancer Treatment Outcomes Scale (BCTOS)-each contain at least one item pertaining to breast sensation, but target different concepts of interest. In total, the measures feature 215 sensation-specific items, most of which concern symptom severity (97%) as opposed to impact on daily functioning (3%).ConclusionPatient-reported outcome measures used in clinical studies for assessing sensation after mastectomy and breast reconstruction are unsuitable for this purpose: they are either non-validated or non-specific. We failed to identify any measures for use in non-oncologic breast surgery populations worth modifying. To collect meaningful, patient-relevant data regarding sensation after mastectomy, it is pertinent that future clinical trials adopt psychometrically robust, specific patient-reported outcome measures.

Project description:Sleep is a crucial factor for human health and is closely related to quality of life. Sleep disturbances constitute a health problem that should be solved, especially when it affects the elderly. This study aims to examine the effectiveness of information and communication technologies (ICT) interventions in managing sleep disturbances in the elderly. The study used a systematic review of three databases: Ovid-Medline, Ovid-EMBASE, and the Cochrane library database for papers published till 15 April 2021. Two authors independently selected and screened relevant studies based on predefined inclusion criteria. The meta-analysis of randomized controlled trials (RCTs) was carried out using Review Manager 5.4. Two authors independently screened the titles and abstracts of 4297 studies considering both inclusion and exclusion criteria. The complete texts of 47 articles were then evaluated, 31 articles were excluded, and finally, 16 articles were selected. Our meta-analysis showed that the cognitive-behavioral therapy for insomnia (CBT-I) group had a significantly reduced Insomnia Severity Index (ISI) compared to the control group (-4.81 [-5.56, -4.06], p < 0.00001, I2 = 83%) in RCTs, with a significant reduction in ISI (3.47 [1.58, 5.35], p = 0.0003) found in quasi-experimental studies. A significant improvement was found in total sleep time in the CBT-I group compared to the control group (29.24 [15.41, 43.07], p <0.0001) in RCTs, while the CBT-I group showed significantly reduced wake time after sleep onset compared to the control group (-20.50 [-26.60, -14.41], p < 0.00001). In addition, a significant reduction in depression was found in the CBT-I group compared to the control group (-2.11 [-2.85, -1.37], p < 0.00001, I2 = 0%) in RCTs. The quality of life-mental component score (5.75 [1.64, 9.87], p = 0.006, I2 = 0%) and the quality of life-physical component score (5.19 [0.76, 9.62], p = 0.02, I2 = 0%) showed significant improvement in the CBT-I group compared to the control group. ICT interventions showed positive effects on sleep disturbances of the elderly, specifically confirming the positive effect on depression and quality of life as well as the indicators directly related to sleep such as ISI and quality of sleep. Thus, the application of ICT in the healthcare sector will be greater in the future, with changes in the nursing education and practice guidelines so that nurses can play a pivotal role in promoting health behaviors such as sleep-related quality of life and daily activities of the elderly.

Project description:ObjectiveEquinus foot deformity (EFD) is the most common deviation after stroke. Several physiotherapy interventions have been suggested to treat it. However, studies evaluating the efficacy of these treatments vary widely in terms of assessment modalities, type of data analysis, and nomenclature. This scoping review aimed to map current available evidence on outcome measures and the modalities employed to assess the effectiveness of physiotherapy programs for the reduction of triceps surae (TS) spasticity and EFD in patients with stroke.MethodsScoping review methodological frameworks have been used. Three databases were investigated. Primary literature addressing TS spasticity in adult patients with stroke using physiotherapy interventions was included. Findings were systematically summarized in tables according to the intervention used, intervention dosage, control group, clinical, and instrumental outcome measures.ResultsOf the 642 retrieved studies, 53 papers were included. TS spasticity was assessed by manual maneuvers performed by clinicians (mainly using the Ashworth Scale), functional tests, mechanical evaluation through robotic devices, or instrumental analysis and imaging (such as the torque-angle ratio, the H-reflex, and ultrasound images). A thorough critical appraisal of the construct validity of the scales and of the statistics employed was provided, particularly focusing on the choice of parametric and non-parametric approaches when using ordinal scales. Finally, the complexity surrounding the concept of "spasticity" and the possibility of assessing the several underlying active and passive causes of EFD, with a consequent bespoke treatment for each of them, was discussed.ConclusionThis scoping review provides a comprehensive description of all outcome measures and assessment modalities used in literature to assess the effectiveness of physiotherapy treatments, when used for the reduction of TS spasticity and EFD in patients with stroke. Clinicians and researchers can find an easy-to-consult summary that can support both their clinical and research activities.

Project description:ObjectiveThe aim of this systematic scoping review is to identify and categorize the outcome measures that have been reported in clinical studies, where therapeutic plasma exchange (TPE) has been used as an intervention in any clinical settings, excluding thrombotic thrombocytopenic purpura (TTP).MethodsWe searched electronic databases using a predefined search strategy from inception to October 9, 2020. Two reviewers independently screened and extracted data.ResultsWe included 42 studies (37 RCTs and 5 prospective cohort studies) grouped into six main categories (neurology, immunology, renal, rheumatology, hematology, and dermatology). Primary outcomes were defined in eight studies (19%, 8/42) and were categorized as efficacy (five studies) or patient reported outcomes (three studies). A power calculation was reported in six studies (75%, 6/8): five neurology studies (mainly patient reported outcomes) and a single immunological study (efficacy outcome). Disease-specific efficacy outcomes were dependent on the clinical setting of the population receiving TPE. Most of the trials (43%, 18/42) were undertaken in patients with neurology conditions where clear, disease-specific, clinical outcome measures were used, including neurological disability scales (11/18, 61%), change in neurological examination (9/18, 50%), and functional improvement scores (7/18, 39%). For other conditions, the reporting of disease-specific outcomes was poorly reported. Safety outcomes were mainly related to replacement fluid type rather than being disease-specific. The most common outcome reported was hypotension (19%, 8/42), and this was primarily in patients exchanged with albumin.ConclusionFuture clinical studies to determine which fluid replacement option is most efficacious and safe should use disease-specific outcomes, as a trial in one therapeutic area may not necessarily translate to another therapeutic area. Patient reported outcomes are not universally reported for all disease areas. Safety measures focused primarily on fluid safety.

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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.

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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.

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