Table 2 Some key resources on pragmatic trials

The what, how, and why

1 Sackett DL. Clinician-trialist rounds: 16. Mind your explanatory and pragmatic attitudes! - part 1: what? Clin Trials. 2013; 10(3):495–8.

2 Macpherson H. Pragmatic clinical trials. Complement Ther Med. 2004 Jun-Sep; 12(2–3):136–40.

3 Sackett DL. Clinician-trialist rounds: 17. Mind your explanatory and pragmatic attitudes! Part 2: How? Clin Trials. 2013 Aug; 10(4):633–6.

4 Staa TP, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, et al. Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ. 2012; 344:e55.

5 McMahon AD. Study control, violators, inclusion criteria and defining explanatory and pragmatic trials. Stat Med. 2002 May 30; 21(10):1365–76.

6 Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24; 290(12):1624–32.

7 Yoong SL, Wolfenden L, Clinton-McHarg T, Waters E, Pettman TL, Steele E, Wiggers J: Exploring the pragmatic and explanatory study design on outcomes of systematic reviews of public health interventions: a case study on obesity prevention trials. J Public Health (Oxf) 2014, 36(1):170–176.

Ethical issues pragmatic trials using cluster randomization

8 Hutton JL. Are distinctive ethical principles required for cluster randomized controlled trials? Stat Med. 2001 Feb 15; 20(3):473–88.

9 McRae AD, Weijer C, Binik A, Grimshaw JM, Boruch R, Brehaut JC, et al. When is informed consent required in cluster randomized trials in health research? Trials. 2011; 12:202.

10 Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, et al. Challenges in the research ethics review of cluster randomized trials: international survey of investigators. Clin Trials. 2013 Apr; 10(2):257–68.

PRECIS (pragmatic-explanatory continuum indicator summary) design tool and applications

11 Riddle DL, Johnson RE, Jensen MP, Keefe FJ, Kroenke K, Bair MJ, et al. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) instrument was useful for refining a randomized trial design: experiences from an investigative team. J Clin Epidemiol. 2010 Nov; 63(11):1271–5.

12 Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May; 62(5):464–75.

13 Zwarenstein M, Treweek S. What kind of randomized trials do we need? J Clin Epidemiol. 2009 May; 62(5):461–3.

14 Maclure M. Explaining pragmatic trials to pragmatic policymakers. J Clin Epidemiol. 2009 May; 62(5):476–8.

15 Tosh G, Soares-Weiser K, Adams CE. Pragmatic vs explanatory trials: the pragmascope tool to help measure differences in protocols of mental health

16 Randomized controlled trials. Dialogues in clinical neuroscience. 2011; 13(2):209–15.

17 Koppenaal T, Linmans J, Knottnerus JA, Spigt M. Pragmatic vs. explanatory: an adaptation of the PRECIS tool helps to judge the applicability of systematic reviews for daily practice. J Clin Epidemiol. 2011 Oct; 64(10):1095–101.

18 Selby P, Brosky G, Oh PI, Raymond V, Ranger S. How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial. BMC Med Res Methodol. 2012; 12:101.

Reporting of pragmatic trials

19 Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008; 337:a2390.

20 Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012; 345:e5661.

21 Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008 Jan 26; 371(9609):281–3.