The value of the pragmatic-explanatory continuum indicator summary wheel in an ongoing study: the bullous pemphigoid steroids and tetracyclines study

Trials

Hywel C Williams²  Anna Sandell²  Gudula Kirtschig¹  Fenella Wojnarowska³  Andrew J Nunn⁴  Daniel J Bratton⁴ 

[1] Department of Dermatology, Vrije Universiteit Medisch Centrum, Amsterdam, MB, 1007, Netherlands;Centre of Evidence-Based Dermatology, Nottingham University Hospitals NHS Trust, Nottingham, UK;Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK;MRC Clinical Trials Unit, London, UK

关键词: Clinical trial;    PRECIS;    Pragmatic;    Explanatory;    Bullous pemphigoid;    BLISTER;   

Others  :  1095605
DOI  :  10.1186/1745-6215-13-50

 received in 2011-11-15, accepted in 2012-04-27,  发布年份 2012

【 摘 要 】

Background

The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool is intended to be used in the design phase of trials to help investigative teams design trials in-line with their purpose. Our team applied this tool to an ongoing trial (BLISTER) to determine whether the initial suggestion among some team members that the trial could be described as largely pragmatic was the consensus.

Methods

Each of the six members of the BLISTER trial team was sent a blank PRECIS wheel to independently complete. The results obtained were averaged and plotted on a single PRECIS wheel to illustrate the degree of pragmatism of the trial.

Results

The trial team found that the design of the trial was closest to the pragmatic end of the pragmatic-explanatory continuum. The strongest consensus was found on the ‘flexibility of the comparison intervention’ and ‘practitioner adherence’ domains (SD = 13). The trial team appeared to disagree most on the ‘eligibility criteria’ (SD = 35) and ‘participant compliance’ (SD = 31) domains, although the large standard deviations were a result of a single outlier in the two domains.

Conclusion

The PRECIS tool can be used to retrospectively determine the pragmatism of a trial provided enough expertise and information on the trial is available. Illustrating the design of a trial on the PRECIS wheel can help research users more easily identify studies of interest. We hope our recommendations for applying this useful tool will encourage others to consider using it when designing, conducting and reporting studies.

Trial registration

Current Controlled Trials http://www.controlled-trials.com/ISRCTN13704604 webcite

【 授权许可】

   
2012 Bratton et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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