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The heterogeneity of current computer systems may complicate the extraction of outcomes and of variables.
Given the nature of the intervention, the time scale of the study, and the extraction of outcomes from existing administrative systems, no data monitoring committee is required.
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Two researchers independently conducted the data extraction of outcome data and the assessment of risk of bias.
The extraction of outcome data and linkage to scan data using NHS numbers was co-ordinated by the NHS Wales Informatics Service (NWIS) (work completed during 2012 and 2013).
Assessment of eligibility criteria for inclusion or exclusion and extraction of outcome variables was performed independently by two investigators (CN and ELM) with an intraobserver agreement kappa statistic of 1.
There are four basic steps: (1) identification and extraction of indicators, (2) identification and extraction of outcome measurements from RCTs, (3) mapping both sets of metrics to underlying concepts as defined in the UMLS using MetaMap and (4) matching and comparing clinical quality indicators and RCT measurements, with an evaluation of the basis for any differences.
11 The systematic literature review, whose objective was to capture the perspective of researchers, was performed in three steps: (1) searches in databases (MEDLINE, EMBASE, PSYCINFO, CENTRAL and CINAHL); (2) extraction of outcome parameters included in the studies; (3) linkage of the concepts within the outcome parameters with the ICF categories.
Following extraction of health outcomes, data on all socio-economic impacts were extracted by two independent reviewers from both qualitative and quantitative studies.
Statisticians should be involved for the data extraction of more complex outcomes, for example, time to event.
Extraction of the clinical outcome measures will be performed primarily by administrative staff not involved in the study (as part of their ordinary duties), who will be blinded to intervention groups.
Extraction of items from existing outcome measures used in studies of people with proximal humeral fracture resulted in 138 items.
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