This study investigates the effectiveness and adequacy of the informed consent process for patients undergoing hip fracture surgery. While informed consent is a legal and ethical responsibility, factors in the trauma setting can impair patients’ understanding and retention of information. This study seeks to evaluate patients’ recall of perioperative complications and explore their perceptions of the consent process. A mixed-methods, multicentre cohort study will be conducted in the Southeast of Scotland. Adult patients with hip fractures will be recruited via consecutive sampling. An information recall questionnaire will be administered within 36 hours of admission to assess unprompted and prompted recall of complications. A subset of participants will then undergo a semi-structured qualitative interview postoperatively to explore their experiences and perceptions of the consent process. Data will be analyzed using a social constructivist grounded theory to assess their perceptions of consent. Ethical approval has been granted by the East of England Research Ethics Committee (reference 23/EE/0233).Aims
Methods
During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.Aims
Methods
