DEVELOPMENT OF A PRECIS-2 SCORING GRID- HOW PRAGMATIC ARE PRAGMATIC TRIALS OF SURGICAL AND PHARMACEUTICAL INTERVENTIONS?

Author(s)

Chen G, Ma Q
Costello Medical Singapore, Singapore, Singapore

OBJECTIVES: Pragmatic trials should be designed with the aim to maximise applicability of trial outcomes to clinical practice. The PRECIS-2 tool, published in May 2015, aims to assist investigators in assessing the pragmatism of trial protocols using a scoring scale (1-5) on 9 domains. However, the lack of scoring criteria makes scoring subjective and hinders comparison of trial scores assigned by different users of PRECIS-2. We propose a PRECIS-2 scoring grid to assist objective scoring of trial protocols or completed studies. METHODS: A scoring grid with criteria for scores 1 to 5, in each of the 9 domains of PRECIS-2 (‘Eligibility’, ‘Recruitment’, ‘Setting’, ‘Organisation’, ‘Flexibility: Delivery’, ‘Flexibility: Adherence’, ‘Follow-up’, ‘Primary Outcome’ and ‘Primary Analysis’) was constructed by reviewing the scores assigned to example trials in the PRECIS-2 publication and by reviewing the subjective guidelines provided by the authors. A structured literature review was conducted in PubMed (search terms “pragmatic[title] AND trial[title]”) to find pragmatic trials from the last 5 years. Studies with a single experimental arm compared to usual care, in surgical or pharmaceutical settings were included. Non-patient, behavioural, health service delivery, prognostics, diagnostics and exercise studies were excluded. Included studies were assessed according to the PRECIS-2 scoring grid. RESULTS: Of 341 search results, 8 surgical trials and 11 pharmaceutical trials were included. No trials were considered ‘very pragmatic’ (score 5) in all 9 domains. ‘Recruitment’ and ‘Flexibility: Adherence’ were not reported in several studies (3 and 9, respectively). On average, surgical trials and pharmaceutical trials were comparable in the degree of pragmatism (mean score [SD]: 4.2 [1.0] vs 4.1 [1.0]). CONCLUSIONS: Our PRECIS-2 scoring grid provides a tool for objective evaluation of pragmatic trials. The next step should be to validate the scoring grid across more reviewers and to apply the grid to a broader range of pragmatic trials.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PRM267

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

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