Objective: To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).
Design: A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.
Setting: NHS trusts in England and health boards in Wales, UK.
Br Dent J
November 2022
Objective: Outcome selection and reporting in studies of novel surgical procedures and devices lacks standardisation, hindering safe and effective evaluation. A core outcome set (COS) to measure and report in all studies of surgical innovation is needed. We explored outcomes in a specific sample of innovative surgical device case studies to identify outcome domains specifically relevant to innovation to inform the development of a COS.
View Article and Find Full Text PDFAerosol generating procedures (AGPs) are defined as any procedure releasing airborne particles <5 μm in size from the respiratory tract. There remains uncertainty about which dental procedures constitute AGPs. We quantified the aerosol number concentration generated during a range of periodontal, oral surgery and orthodontic procedures using an aerodynamic particle sizer, which measures aerosol number concentrations and size distribution across the 0.
View Article and Find Full Text PDFBackground: In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty.
View Article and Find Full Text PDFBackground: More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients' perspectives on conflicts of interest?
Methods: We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research.
Results: Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included.
There are around 8,500 new cases of oral squamous cell carcinoma (SCC) diagnosed in the UK each year and the incidence appears to be increasing. Although surgical and non-surgical treatment options have improved significantly in the last few decades, five-year survival has not, with an average five-year survival of 56% in the UK. Providing patients have access, there are frequent opportunities for oral cancer screening by their general dental practitioner.
View Article and Find Full Text PDFObjectives: Little is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.
Design: Qualitative study involving semi-structured interviews.
Introduction: The number of laparoscopic liver resections undertaken has increased. However, lesions located postero-superiorly are difficult to access. This may be overcome by the novel use of trans-thoracic port(s).
View Article and Find Full Text PDFIntroduction: Innovation is key to improving outcomes in healthcare. Innovative pharmaceutical products undergo rigorous phased research evaluation before they are introduced into practice. The introduction of innovative invasive procedures and devices is much less rigorous and phased research, including randomised controlled trials, is not always undertaken.
View Article and Find Full Text PDFIntroduction: Transoral robotic surgery (TORS) has been adopted in some parts of the world as an innovative approach to the resection of oropharyngeal tumours. The development, details and outcomes of early-to-later phase evaluation of this technique and the quality of evidence to support its adoption into practice have hitherto not been summarised. The aim of this review is to identify and summarise the early and later phase studies of, and evidence for, TORS and to understand how early phase studies report intervention development, governance procedures and selection and reporting of outcomes to optimise methods for using the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for surgical innovation that informs evidence-based practice.
View Article and Find Full Text PDFBackground: Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England.
View Article and Find Full Text PDFA patient presented with impending airway obstruction due to a dislodged interim maxillary obturator. The removal was complicated by the presence of severe trismus due to previous maxillectomy and recent radiotherapy. An emergency tracheotomy with the patient under local anesthetic was required to provide a definitive airway and to permit subsequent removal of the obturator with the patient under general anesthesia.
View Article and Find Full Text PDFWe report a case of Langerhans cell histiocytosis with a restricted presentation (eosinophilic granuloma of the mandible) complicated by multiple reactivations.
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