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Data is displayed into 3 tables for each immune assay, titled "Principal features of studies" (Tables 1, 2 and 3), "Demographic information" (Tables 4, 5 and 6) and "Experimental conduct and exclusion criteria" (Tables 7, 8 and 9). Figure 1 Flow diagram illustrating study identification and inclusion [11 66].
Table 2 summarizes the basic features of studies included.
Additionally, a data extraction tool was devised, based on an earlier literature review [ 9], to capture the main features of studies meeting the inclusion criteria (see Additional file 1).
A specific data extraction form was designed for assessment of quality features of studies, such as randomization, allocation concealment, intention-to-treat principle, similarity of treatment arms according to known prognostic factors, follow up and drop-outs [ 22, 23].
Based on well-established guidelines [ 13], we assessed the methodological features of studies including core items of quality criteria that could influence the risk of bias (sequence and allocation concealment, blinding of participants, personnel and outcome assessors and intention to treat (ITT)).
Issues relating to model design, 15, 100, 101, 107, 113 use of natural history data and, reliance on clinical data that are subject to a variety of interpretations have been common features of studies undertaken to date and have conspired to generate an evidence-base that is at best muddled and inconclusive.
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In addition, features of study design and sampling strategies are discussed.
Previous work has shown that abstracts frequently under report key features of study design [10] [11] and omit important results.
Clinical features of study patients.
Initial confidence set by key features of study design for each outcome.
Baseline clinical features of study participants are summarized in Table 1.
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