-
Byrne Bonner posted an update 1 year, 4 months ago
s high (7/48; 15%). CONCLUSION Our hypothesis was confirmed since the outcomes were satisfactory, but mortality and morbidity were high. Performing hTKA remains an option in the post-fracture context, although surgeons must carefully consider the indications. LEVEL OF EVIDENCE IV, retrospective study. BACKGROUND One-stage bilateral hip replacement has the advantage of involving a single anesthesia, single hospital admission and single rehabilitation program. The theoretic drawback is increased surgical risk. Few French series have been reported, and none with comparison versus unilateral arthroplasty. selleck We therefore conducted a comparative case-control study between 1-stage bilateral (1B-THA) and unilateral total hip arthroplasty (U-THA), assessing (1) morbidity/mortality, (2) survival, and (3) functional scores and forgotten hip rates. HYPOTHESIS In a selected ASA 1 or 2 population, 1B-THA shows complications rates and implant survival comparable to U-THA. MATERIAL AND METHOD Between 2004 and 2018, 327 patients were included 109 with 1B-THA, 218 with U-THA. One 1B-THA patient was matched to 2 U-THA patients on age, gender, diagnosis, ASA score 1 or 2, and anterior or posterior approach. Minimum follow-up was 12 months. Complications were collected for all patients in both groups. Early (≤90 days) or late (>cations and implant survival were unaffected, but the 1-stage bilateral procedure allowed better control of limb-length and provided a higher rate of forgotten hip. LEVEL OF EVIDENCE III, matched case-control study. OBJECTIVES To describe the increasing complexity and scope of clinical trials research, convergent research, and the clinical nurse roles and responsibilities to ensure safe patient care and study data integrity. DATA SOURCES Textbooks, journal publications, federal regulations, US Food and Drug Administration documents, clinical practice guidelines. CONCLUSION The immune system, genetics, and molecular pathology are not new in the context of oncology treatments. The reliability and clinical validation of in vitro diagnostic medical devices is, however, becoming increasingly more important in the development of marker driven targeted therapies, immunotherapy, and adoptive T-cell transfer. Protecting patients and preserving the integrity of clinical trials is of utmost importance. IMPLICATIONS FOR NURSING PRACTICE The role and scope of oncology and research nurses will intersect and shift as clinical care continues to involve high-acuity patients who participate in complex in vitro diagnostic and therapeutics clinical trials. The expertise of oncology nurses may vary in skills and knowledge domain; however, all scopes of practice are underpinned by the nursing code of ethics to ensure accountability for all aspects of patient care. OBJECTIVE To explore the various types and phases of clinical trials, the regulatory oversight, drug approval process, and implications of clinical trials for the oncology nurse. DATA SOURCES Peer-reviewed journal articles, internet, book chapters, white papers. CONCLUSION Oncology nurses’ interactions with patients entered on clinical trial and communication with the clinical research team is crucial to the successful conduct of clinical trials. The oncology nurse must work in concert with the clinical research team to protect patient safety and to produce accurate information for protocol requirements that will be used to evaluate whether a drug becomes approved or not by the US Food and Drug Administration. IMPLICATIONS FOR NURSING PRACTICE Oncology nurses play a central role to the successful outcome of clinical research studies. Nurses must work in close collaboration with the clinical research teams for the successful completion and adherence of the clinical trial and to maintain the safety of the patient enrolled into clinical trial. OBJECTIVES This article will provide an overview of the purpose, structure, and function of an investigational pharmacy in oncology clinical research. It will also discuss the role of the oncology nurse in managing investigational drugs (ID) when caring for a patient receiving treatment on a clinical trial and the importance of their role in the trial process. DATA SOURCES Government regulations, professional guidelines, and best practices. CONCLUSION ID management for clinical trials is a multidisciplinary process requiring input from various professionals to ensure safe, accurate, and study-specific administration. The nurse’s role in the process of clinical trial ID management is dependent on each institution’s expectations of clinical research nurses and the scope of their role. IMPLICATIONS FOR NURSING PRACTICE Multiple nursing roles may be involved in caring for patients who are being treated as part of a clinical trial, including clinical research nurses, infusion nurses, or as nurses providing direct patient care (inpatient or outpatient). Providing education on ID management, specific to the nurse’s involvement, is a responsibility of the study team. Ensuring proper safeguards, accurate and protocol-specific delivery and documentation of ID, and completion of patient education are key in the conduct of oncology clinical research. OBJECTIVES To explore the federal regulations governing clinical trials and human subject protection, the importance of research participant’s informed consent, and the role the oncology clinical research nurse has within the clinical trial setting. DATA SOURCES Peer-reviewed journal articles, internet, book chapters, white papers. CONCLUSION Federal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process. IMPLICATIONS FOR NURSING PRACTICE The oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process. OBJECTIVES To describe the evolution and structure of the National Cancer Institute clinical trials programs, their notable accomplishments, nurses’ roles in these accomplishments, and the essential role of nursing today and in the future. DATA SOURCES Manuscripts, government publications, websites, and professional communications. CONCLUSION Change is inevitable and a constant factor in the world of advancing science and clinical research. Nurses’ contribution to research and evidence-based practice will continue to grow and is vital as the scientific landscape evolves. IMPLICATIONS FOR NURSING PRACTICE As the understanding of cancer biology increases and clinical trials evolve, nurses will need to remain key team members and leaders in National Cancer Institute Community Oncology Research Program and National Cancer Trials Network trials and their associated infrastructure. Published by Elsevier Inc.

