Guidance for delivering surgical procedures outside operating theatres: scoping review.

Background: This review aimed to examine in-depth the extent and content of guidance related to the delivery of surgical procedures outside of the operating theatre.

Methods: Documents concerning the delivery of surgical procedures in non-operating theatre settings were eligible for inclusion. Guidance documents were identified from three sources: electronic databases (MEDLINE and Embase), professional organization websites and expert knowledge.

Operative versus conservative management for inguinal hernia: a methodology scoping review of randomized controlled trials.

Introduction: There is a lack of consensus on the management of inguinal hernia with limited symptoms. To address this issue a systematic review of existing randomized clinical trials (RCTs) was performed to critically appraise all existing data on asymptomatic hernia management, focusing on generalizability.

Methods: A scoping review to identify all RCTs comparing surgical and conservative management of patients with inguinal hernias was undertaken.

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review.

Objectives: The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures.

Randomized controlled trials comparing gastric bypass, gastric band, and sleeve gastrectomy: A systematic review examining validity and applicability to wider clinical practice.

Consideration of how applicable the results of surgical trials are to clinical practice is important to inform decision-making. Randomized controlled trials comparing at least two surgical interventions (of gastric bypass, gastric band, and sleeve gastrectomy) for severe and complex obesity were examined using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, to consider how applicable the trial results are to clinical practice, and the Risk of Bias 2 tool, to examine validity. MEDLINE, Embase, and CENTRAL databases were searched for studies published between November 2013 and June 2021, and 15 were identified.

Development and pilot testing of a patient-reported outcome measure to assess symptoms of parastomal hernia.

Aim: The aim was to develop and pilot a patient-reported outcome measure (PROM) to assess symptoms of parastomal hernia (PSH).

Methods: Standard questionnaire development was undertaken (phases 1-3). An initial list of questionnaire domains was identified from validated colorectal cancer PROMs and from semi-structured interviews with patients with a PSH and health professionals (phase 1).

How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review.

Introduction: Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review.

Background: Innovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of 'modifications', and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking.

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.

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.

Safety and transparency in surgical innovation.

Advances in healthcare require safe and transparent innovation. Currently in surgery it can be difficult to identify when innovation is occurring because of inconsistent oversight and reporting. New ways of identifying, monitoring and reporting surgical innovation are called for in order to optimise the process.

Understanding stage of innovation of invasive procedures and devices: protocol for a systematic review and thematic analysis.

Introduction: Surgical innovation has generally occurred in an unstandardised manner. This has led to unnecessary exposure of patients to harm, research waste and inadequate evidence. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration provided a set of recommendations for evaluating surgical innovations based on their stage of innovation.

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.

Reporting Modifications in Surgical Innovation: A Systematic Scoping Review Protocol.

Introduction: Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation.

Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.

Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials.

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.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.

Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review.

Objectives: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery.

Study Design And Setting: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge.

Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).

Introduction: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK.

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.

Healthcare resource utilisation and costs of agitation in people with dementia living in care homes in England - The Managing Agitation and Raising QUality of LifE in Dementia (MARQUE) study.

Background: People with dementia living in care homes often experience clinically significant agitation; however, little is known about its economic impact.

Objective: To calculate the cost of agitation in people with dementia living in care homes.

Methods: We used the baseline data from 1,424 residents with dementia living in care homes (part of Managing Agitation and Raising QUality of lifE in dementia (MARQUE) study) that had Cohen-Mansfield Agitation Inventory (CMAI) scores recorded.