The Real-world evidence (RWE) Navigator discusses study design choices and analyses related to demonstrating the relative effectiveness of new medicines.

The CONSORT extension for pragmatic trials has been developed specifically for pragmatic trials, building on the existing CONSORT checklist for proper reporting of randomized controlled trials.

For further information, please also see:

• Moher 2010
• Zwarenstein 2008
• Campbell 2009

PRACTIHC is a European Union-funded converted action which provides open-access tools, training and mentoring to researchers in developing countries who are interested in designing and conducting pragmatic randomized controlled trials of healthcare interventions.

For further information, please also see Treweek 2006.

The European Patients’ Academy (EUPATI) aims to increase patients’ understanding and contribution to medical research and development, as well as to improve the accessibility of reliable and patient-friendly information.

The PICOT structure helps trialist to formulate research questions. By following the PICOT structure, trial designers can clearly define the participants, intervention to be tested, comparison intervention, outcomes and timing of those outcomes.

For further information, please also see: 

• Richardson 1995

The PRagmatic-Explanatory Continuum Indicator Summary (PRECIS) tool supports trial designers to make sure that the trial they design (more pragmatic or more explanatory) matches the intended research question.

The PRECIS-2 tool has been developed to guide the decision making process during trial design, to obtain trials that are fit for purpose. The PRECIS-2 tool is based on nine domains.

For further information, please also read: 

• Loudon 2015