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

被引:19
作者
Bratton, Daniel J. [2 ]
Nunn, Andrew J. [2 ]
Wojnarowska, Fenella [3 ]
Kirtschig, Gudula [4 ]
Sandell, Anna [1 ]
Williams, Hywel C. [1 ]
机构
[1] Nottingham Univ Hosp NHS Trust, Ctr Evidence Based Dermatol, Nottingham, England
[2] MRC Clin Trials Unit, London, England
[3] Univ Oxford, Nuffield Dept Clin Med, Oxford, England
[4] Vrije Univ Med Ctr, Dept Dermatol, NL-1007 MB Amsterdam, Netherlands
基金
美国国家卫生研究院;
关键词
BLISTER; Bullous pemphigoid; Explanatory; Pragmatic; PRECIS; Clinical trial; TOPICAL CORTICOSTEROIDS; TRIALS; PRECIS; TOOL;
D O I
10.1186/1745-6215-13-50
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
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 ISRCTN13704604
引用
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页数:6
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