Randomised Controlled Trials (RCTs) are regarded as a ‘gold standard’ technique to evaluate and compare clinical interventions. Strict ethical criteria dictate the participation of humans in clinical research, based on informed consent, voluntary decision making and putting patients’ interests first. Demand for RCTs in Trauma and Orthopaedics is high, but patient recruitment continues to pose a significant challenge, especially when the treatments being compared are obviously different. Lack of blinding, treatment preference and negative perception of random allocation to interventions are among the obstacles which need to be considered. Based on review and analysis of current knowledge, an attempt is made to develop a new recruitment process that incorporates high ethical standards and provision of the best possible clinical care for an individual patient. By integrating the principle of clinical equipoise, modern technology and statistical concepts, such as subjective probability, the Patient Eligibility Assessment through Clinical Equipoise (PEACE) framework has been introduced. This provides an alternative that could be used in trials where the fixed eligibility criteria approach is likely to fail. It was tested involving 77 real clinical cases from a national multi-centre trauma RCT, which compared contrasting treatments. A new trial recruitment approach aiming to avoid direct contact between a patient and a treating clinician was rolled out in the same trial. The feedback was collected from both the clinicians and the patients involved. Thematic analysis of 23 semi-structured interviews improved understanding of the various factors influencing patients’ decision about trial participation. Further typological analysis provided a valuable insight into the different attitudes that patients adopted when faced with the dilemma. In particular, that many are positive towards research involvement, but not comfortable with randomisation based on fixed eligibility criteria. According to these results, a new model for patient recruitment is suggested, which could be researched and tested in future trials.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:640968 |
| Date | January 2014 |
| Creators | Kulikov, Yuri |
| Publisher | University of Warwick |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | http://wrap.warwick.ac.uk/66691/ |
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