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Primary trials are listed chronologically by candidate therapy and clustered with associated open-label extension studies or secondary analyses.
The study characteristics extracted from the 16 primary trials are outlined in tables 1 and 2. Three primary trials 7 8 37 38 were multicentre and designed to investigate the endpoint of all-cause mortality in 3820 randomised patients with severe sepsis and septic shock.
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Authors of included primary trials were asked to contribute additional data relevant for the purpose of this analysis.
Prespecified end points of the primary trial were used: dyspnea, 60-day heart failure/renal failure rehospitalization or cardiovascular (CV) death, and 180-day CV death.
The aim of the primary trial was to measure the effect of an intervention targeting patients at high risk of hospital re-admission on health service utilisation, health-related quality of life, general health, psycho-social outcomes and functional ability.
Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS.
Intra-cluster correlation coefficients (ICC) in cluster primary care trials are generally lower than 0.05 [ 22].
The target population for primary prevention trials are young children who carry high-risk HLA-DR,DQ genotypes.
Sepsis patient characteristics extracted from the 16 primary clinical trials are outlined in table 1 and the online data supplement.
Factors thought to contribute to retention and loss to follow-up in primary care trials are also presented.
A common methodological issue in general practice and primary care trials is the Hawthorne effect [ 19].
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