Validation of the global resource of eczema trials (GREAT database)

Nankervis, Helen; Devine, Alison; Williams, Hywel C; Ingram, John R.; Doney, Liz; Delamere, Finola M; Smith, Sherie; Kim, Thomas

doi:10.1186/s12895-015-0024-z

Cited by 9 publications

(8 citation statements)

References 30 publications

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“…We followed a predefined protocol and the PRISMA statement. Our search was performed using a validated search filter . Two reviewers independently extracted data for each study, and disagreements or uncertainties were resolved through discussions.…”

Section: Discussionmentioning

confidence: 99%

“…The Global Resource for Eczema Trials (GREAT) database was used to identify all RCTs on AE treatments published since 2000, as a previous review already evaluated many RCTs before 2000 . The GREAT database (http://www.greatdatabase.org.uk) contains records of all RCTs of treatments for established AE published since the inception of Medline (1966) and Embase (1980), the Cochrane Library and the Skin Group Specialised Register databases, plus the CINAHL, Allied and Complementary Medicine Database and LILACS databases from 2000 onwards . RCTs published between January 2000 and April 2014 were included.…”

Section: Methodsmentioning

confidence: 99%

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Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review

et al. 2016

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Summary'Symptoms' is a core outcome domain for atopic eczema (AE) trials, agreed by consensus as part of the Harmonising Outcome Measures for Eczema (HOME) initiative. To standardize and validate the core domain symptoms and symptom instruments for AE trials the HOME roadmap is followed. Its first step is to establish if and how symptoms have been measured in published AE treatment trials. Therefore the Global Resource for Eczema Trials database was used to collect all randomized controlled trials (RCTs) of treatments for AE between January 2000 and April 2014. Study selection and data extraction were performed by three reviewers independently. We identified the use of symptoms in 295 of 378 trials (78%). Symptoms as a primary end point were applied by 147 RCTs (50%). Seventeen different symptoms were measured, but mostly itch and sleep loss. Symptoms were assessed by only 37% of trials by a stand-alone symptom measurement. Overall 63% of RCTs used a composite instrument, and 30 different instruments were identified. The Scoring Atopic Dermatitis (SCORAD) index was the most commonly applied, but only 23% of RCTs reported the SCORAD symptom score separately. This systematic review demonstrates that symptoms, most frequently itch and sleep loss, are commonly reported in AE treatment trials, but are measured using many different instruments. Often symptoms are evaluated as part of a composite instrument, and currently it is not possible to extract symptoms-only data from most published studies. Future trials should report symptom scores to permit meta-analysis of the core outcomes.What's already known about this topic?• There is a high level of variation in outcome domains and instruments used for atopic eczema (AE).• Harmonization of AE instruments is necessary to allow better evidence-based clinical decision making.• The Harmonising Outcome Measures for Eczema (HOME) initiative aims to validate a core outcome set (COS) for AE clinical trials; 'symptoms' is selected as one of the four core outcome domains beside clinical signs, quality of life and long-term control.What does this study add?• Symptoms, most frequently itch and sleep loss, are commonly reported in AE trials, but are often poorly measured using many different instruments and as part of a composite instrument, most commonly the SCORing Atopic Dermatitis (SCORAD) index.• Describing patient-reported symptoms and clinician-reported signs separately will improve trial reporting and facilitate meta-analysis.• Deployment of the COS for AE in future trials is a key requirement in moving forward.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review

et al. 2016

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“…A strength of this study was the use of the GREAT database, which searches 6 databases, including 3 specialist databases. A recent study showed a high sensitivity of the GREAT database, with 94% of trials cited in systematic reviews on eczema treatments listed in the GREAT database (104). The GREAT database therefore is considered a primary and comprehensive source to identify eczema RCTs.…”

Section: Discussionmentioning

confidence: 99%

Eczema Trials: Quality of Life Instruments Used and Their Relation to Patient-reported Outcomes. A Systematic Review

Heinl¹,

Chalmers²,

Nankervis³

et al. 2016

Acta Derm Venerol

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It is unclear which quality of life instruments have thus far been used in eczema trials. Therefore, we aimed to identify these instruments. We searched the Global Resource of Eczema Trials (GREAT) database for reports of randomized controlled trials. Information on patient-reported outcomes, particularly quality of life, was extracted from eligible studies. 287 full texts reporting on 303 trials and 72 abstracts were included. 63/303 studies (20.8%) assessed quality of life and used 18 named and 4 unnamed instruments. The Dermatology Life Quality Index (DLQI), the Children's Dermatology Life Quality Index (CDLQI), the Infant's Dermatitis Quality of Life Index (IDQOL), and the Dermatitis Family Impact (DFI) were the most common measures in adults, children, infants, and caregivers, respectively. In conclusion, only about one fifth of eczema trials include a quality of life measure as outcome. Many different instruments are used, limiting the possibilities of comparing and synthesising individual trials' findings.

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“…One group included articles that conduct systematic reviews using a variety of online databases. These covered a wide variety of therapies, including medications, brachytherapy, exercise, nutrition, and ophthalmological treatments [101][102][103][104][105][106][107][108]. Another group analyzed various trends in publications, such as how researchers access the literature, extent to which studies comply with registration and reporting requirements, reasons for study termination, transparency regarding sponsorship and conflicts of interest, and inclusion of patient-reported outcomes [109,110,[111][112][113][114][115].…”

Section: Analyzing Study Publicationsmentioning

confidence: 99%

Clinical Research Informatics: Supporting the Research Study Lifecycle

Johnson¹

2017

Yearb Med Inform

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SummaryObjectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years [2015][2016]. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions.

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Validation of the global resource of eczema trials (GREAT database)

Cited by 9 publications

References 30 publications

Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review

Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review

Eczema Trials: Quality of Life Instruments Used and Their Relation to Patient-reported Outcomes. A Systematic Review

Clinical Research Informatics: Supporting the Research Study Lifecycle

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