Association of Perioperative Antibiotics with the Prevention of Postoperative Fistula after Cleft Palate Repair.

Background: There is debate amongst surgeons regarding the use of antibiotics to prevent fistulae after palatoplasty. Prescribing should be evidence based, as antibiotic stewardship is integral to reducing antibiotic resistance. Our aim was to determine whether differing perioperative regimens affect the prevalence of postoperative fistulae.

Development of the 'ACT now & check-it-out' intervention to support patient-initiated follow up for Head and Neck cancer patients.

Objective: Current Head and Neck cancer (HNC) follow-up models are considered sub-optimal at detecting recurrences. We describe the development of a patient-initiated follow up (PIFU) trial intervention support package, to support HNC patients to engage in PIFU self-care behaviors.

Methods: An intervention mapping approach, informed by evidence synthesis, theory and stakeholder consultation, guided intervention development.

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations' policies in England and Wales.

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.

Managing surgical demand when needs outstrip resource: qualitative investigation of colorectal cancer surgery provision in the first wave of the COVID-19 pandemic.

Background: At the onset of the COVID-19 pandemic, elective surgical provision was severely affected by the need for hospital reorganization to care for critically ill patients. In response, National Health Service (NHS) England issued national guidance proposing acceptable time intervals for postponing different types of surgical procedure. This study reports healthcare professionals' private accounts of the strategies adopted to manage the imbalance of demand and resource, using colorectal cancer surgery as a case study.

Healthcare organization policy recommendations for the governance of surgical innovation: review of NHS policies.

Background: The governance for introducing innovative surgical procedures/devices differs from the research requirements needed for new drugs. New invasive procedures/devices may be offered to patients outside of research protocols with local organization oversight alone. Such institutional arrangements exist in many countries and written policies provide guidance for their use, but little is known about their scope or standards.

Metabolic disorders and the risk of head and neck cancer: a protocol for a systematic review and meta-analysis.

Introduction: Head and neck cancer squamous cell carcinoma (HNSCC) is the sixth most common cancer internationally. Established risk factors include smoking, alcohol and presence of human papillomavirus (HPV). The incidence rate of new disease continues to rise, despite falls in alcohol consumption and a reduction in smoking, the rising rates are unlikely to be solely attributed to HPV status alone.

Identification of outcomes to inform the development of a core outcome set for surgical innovation: a targeted review of case studies of novel surgical devices.

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.

A clinical observational analysis of aerosol emissions from dental procedures.

Aerosol 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.

Using qualitative research methods to understand how surgical procedures and devices are introduced into NHS hospitals: the Lotus study protocol.

Introduction: The development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of 'case studies' of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.

Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.

Background: 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.

Representation of published core outcome sets for research in regulatory guidance: protocol.

The COMET Initiative promotes the development and use of 'core outcome sets' (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders.

Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development.

Background: 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.

Slow to heal or slow to diagnose cancer?

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.

Discussing surgical innovation with patients: a qualitative study of surgeons' and governance representatives' views.

Objectives: 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.

A Systematic Review of Minimally Invasive Trans-thoracic Liver Resection to Examine Intervention Description, Governance, and Outcome Reporting of an Innovative Technique.

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).

Genome-Wide Association Study Identifies Genetic Associations with Perceived Age.

Failure of dermal protection or repair mechanisms might lead to visibly aged skin. The study aimed to identify genetic associations with perceived age. A genome-wide association study was undertaken in 423,992 adult participants of UK Biobank, using questionnaire data on perceived age and genetic data imputed to the Haplotype Reference Consortium imputation panel.

Development of a core information set for colorectal cancer surgery: a consensus study.

Objective: 'Core information sets' (CISs) represent baseline information, agreed by patients and professionals, to stimulate individualised patient-centred discussions. This study developed a CIS for use before colorectal cancer (CRC) surgery.

Design: Three phase consensus study: (1) Systematic literature reviews and patient interviews to identify potential information of importance to patients, (2) UK national Delphi survey of patients and professionals to rate the importance of the information, (3) international consensus meeting to agree on the final CIS.

Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study).

Introduction: Rigorous evaluation of innovative invasive procedures and medical devices is uncommon and lacks reporting standardisation. Devices may therefore enter routine practice without thorough evaluation, resulting in patient harm. Detailed guidance on how to select and report outcomes at each stage of evaluation is lacking.

Introduction and adoption of innovative invasive procedures and devices in the NHS: an in-depth analysis of written policies and qualitative interviews (the INTRODUCE study protocol).

Introduction: 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.

Protocol for the systematic review of the reporting of transoral robotic surgery.

Introduction: 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.

Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.

Background: 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.

A Core Outcome Set for the Benefits and Adverse Events of Bariatric and Metabolic Surgery: The BARIACT Project.

Background: Bariatric and metabolic surgery is used as a treatment for patients with severe and complex obesity. However, there is a need to improve outcome selection and reporting in bariatric surgery trials. A Core Outcome Set (COS), an agreed minimum set of outcomes reported in all studies of a specific condition, may achieve this.