The Lotus Study: Understanding and improving how surgical procedures and devices are introduced in research and clinical practice

Research summary

Background: Modifications to existing surgical procedures can have the potential to improve clinical practice and patient outcomes. Modifications commonly occur as part of everyday routine practice. Despite this, little is known about how modifications are initially introduced into practice or what information is communicated to patients about evolving surgical procedures. While it is common for surgeons to make modifications to procedures, it is much less common for them to publish results. When results are published, they tend to be reported in the format of ‘case series’ and thus only include simple descriptions of the procedure and patient outcomes. This makes it difficult to know what factors may have hindered or facilitated surgeons in successfully and safely modifying a procedure or to understand the transition of a procedure from evolving to stabilised. Objectives: The study will explore how modified procedures are undertaken and evolve to the point of stabilisation, the role of non-technical skills in the operating theatre, what outcomes are recorded and viewed as important, and how modified procedures are being communicated to patients. Study sample: The sample will include i) surgeons and other healthcare professionals involved in a surgical procedure or device that is being modified, ii) patients who are offered a modified surgical procedure (those that accept or decline it) and those who have recently undergone a modified surgical procedure. Study measures: With consent (healthcare professional and patient), the study team will audio record patient-clinician consultations in which modified procedures/device are discussed, video record and observe modified procedures being performed, carry out multiple interviews with both patients and clinicians, and review patient outcome data as reported in their medical records.

Principal Investigator

Ms Isabel Quiroga

Contact us

Email: renalandtransplanttrials@ouh.nhs.uk

IRAS number

255502