A Systematic Review to Summarise and Appraise the Reporting of Surgical Innovation: a Case Study in Robotic Roux-en-Y Gastric Bypass.

Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to traditional laparoscopic approaches. Literature has been published investigating its safety/efficacy; however, the quality of reporting is uncertain. This systematic review used the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework to assess the reporting quality of available literature. A narrative summary was formulated, assessing how comprehensively governance/ethics, patient selection, demographics, surgeon expertise/training, technique description and outcomes were reported. Forty-seven studies published between 2005 and 2024 were included. There was incomplete/inconsistent reporting of governance/ethics, patient selection, surgeon expertise/training and technique description, with heterogenous outcome reporting. RRYGB reporting was poor and did not align with IDEAL guidance. Robust prospective studies reporting findings using IDEAL/other guidance are required to facilitate safe widespread adoption of RRYGB and other surgical innovations.

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. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design. DESIGN: Secondary qualitative analysis of a systematic review. DATA SOURCES: Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers. ELIGIBILITY CRITERIA: Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers. DATA EXTRACTION AND SYNTHESIS: All relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage. RESULTS: 48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes. CONCLUSION: Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors' rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.

A systematic review of robot-assisted anti-reflux surgery to examine reporting standards.

Robot-assisted anti-reflux surgery (RA-ARS) is increasingly being used to treat refractory gastro-oesophageal reflux disease. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow up) Collaboration's framework aims to improve the evaluation of surgical innovation, but the extent to which the evolution of RA-ARS has followed this model is unclear. This study aims to evaluate the standard to which RA-ARS has been reported during its evolution, in relation to the IDEAL framework. A systematic review from inception to June 2020 was undertaken to identify all primary English language studies pertaining to RA-ARS. Studies of paraoesophageal or giant hernias were excluded. Data extraction was informed by IDEAL guidelines and summarised by narrative synthesis. Twenty-three studies were included: two case reports, five case series, ten cohort studies and six randomised controlled trials. The majority were single-centre studies comparing RA-ARS and laparoscopic Nissen fundoplication. Eleven (48%) studies reported patient selection criteria, with high variability between studies. Few studies reported conflicts of interest (30%), funding arrangements (26%), or surgeons' prior robotic experience (13%). Outcome reporting was heterogeneous; 157 distinct outcomes were identified. No single outcome was reported in all studies.The under-reporting of important aspects of study design and high degree of outcome heterogeneity impedes the ability to draw meaningful conclusions from the body of evidence. There is a need for further well-designed prospective studies and randomised trials, alongside agreement about outcome selection, measurement and reporting for future RA-ARS studies.

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. Despite further refinements and guidance, adoption of the IDEAL recommendations has been slow; an important reason may be that determining the stage of innovation is often difficult. To facilitate evaluation of surgical innovations, there is a need for a detailed insight into what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature. METHODS AND ANALYSIS: A systematic review is being conducted. Ovid MEDLINE and Embase databases were searched from their inception until July 2021 using an iteratively developed strategy based on the concepts of stage of innovation, invasive procedures or devices and guidance. Articles were included if they described an approach to evaluating surgical innovations in stages, described a method for determining stage of innovation, described indicators of stage of innovation, defined stages or described potential sources of stage-related information. Conference abstracts and non-English language articles were excluded. Other articles were detected from citations within included articles and suggestions from experts in surgical innovation. Data will be extracted regarding approaches to evaluating surgical innovations, methods for determining stage of innovation, indicators of stage of innovation, definitions of stages and potential sources of stage-related information. A thematic analysis will be conducted, and findings summarised in a narrative report. ETHICS AND DISSEMINATION: Ethical approval will not be required. This systematic review will be published in a peer-reviewed journal and presented at appropriate conferences. PROSPERO REGISTRATION NUMBER: CRD42021270812.

A systematic review of robot-assisted cholecystectomy to examine the quality of reporting in relation to the IDEAL recommendations: systematic review.

INTRODUCTION: Robotic cholecystectomy (RC) is a recent innovation in minimally invasive gallbladder surgery. The IDEAL (idea, development, exploration, assessment, long-term study) framework aims to provide a safe method for evaluating innovative procedures. This study aimed to understand how RC was introduced, in accordance with IDEAL guidelines. METHODS: Systematic searches were used to identify studies reporting RC. Eligible studies were classified according to IDEAL stage and data were collected on general study characteristics, patient selection, governance procedures, surgeon/centre expertise, and outcome reporting. RESULTS: Of 1425 abstracts screened, 90 studies were included (5 case reports, 38 case series, 44 non-randomized comparative studies, and 3 randomized clinical trials). Sixty-four were single-centre and 15 were prospective. No authors described their work in the context of IDEAL. One study was classified as IDEAL stage 1, 43 as IDEAL 2a, 43 as IDEAL 2b, and three as IDEAL 3. Sixty-four and 51 provided inclusion and exclusion criteria respectively. Ethical approval was reported in 51 and conflicts of interest in 34. Only 21 reported provision of training for surgeons in RC. A total of 864 outcomes were reported; 198 were used in only one study. Only 30 reported a follow-up interval which, in 13, was 1 month or less. CONCLUSION: The IDEAL framework was not followed during the adoption of RC. Few studies were conducted within a research setting, many were retrospective, and outcomes were heterogeneous. There is a need to implement appropriate tools to facilitate the incremental evaluation and reporting of surgical innovation.

Surgical ampullectomy: A comprehensive review.

Tumours of the ampulla of Vater are relatively uncommon lesions of the digestive system. They are typically diagnosed at an earlier stage than other types of tumours in this region, due to their tendency to invoke symptoms by obstructing the bile duct or pancreatic duct. Consequently, many are potentially curable by excision. Surgical ampullectomy (SA) (or transduodenal ampullectomy) for an ampullary tumour was first described in 1899, but was soon surpassed by pancreatoduodenectomy (PD), which offered a more extensive resection resulting in a lower risk of recurrence. Ongoing innovation in endoscopic techniques over recent decades has led to the popularization of endoscopic papillectomy (EP), particularly for adenomas and even early cancers. The vast majority of resectable ampullary tumours are now treated using either PD or EP. However, SA continues to play a role in specific circumstances. Many authors have suggested specific indications for SA based on their own data, practices, or interpretations of the literature. However, certain issues have attracted controversy, such as its use for early ampullary cancers. Consequently, there has been a lack of clarity regarding indications for SA, and no evidence-based consensus guidelines have been produced. All studies reporting SA have employed observational designs, and have been heterogeneous in their methodologies. Accordingly, characteristics of patients and their tumours have differed substantially across treatment groups. Therefore, meaningful comparisons of clinical outcomes between SA, PD and EP have been elusive. Nevertheless, it appears that suitably selected cases of ampullary tumours subjected to SA may benefit from favourable peri-operative and long-term outcomes with very low mortality and significantly long survival, hence its role in this setting warrants further clarification, while it can also be useful in the management of specific benign entities. Whilst the commissioning of a randomised controlled trial seems unlikely, well-designed observational studies incorporating adjustments for confounding variables may become the best available comparative evidence for SA, potentially informing the eventual development of consensus guidelines. In this comprehensive review, we explore the role of SA in the modern management of ampullary lesions.

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. METHODS AND ANALYSIS: This qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordings will be audio-recorded, transcribed verbatim and analysed thematically using constant comparison techniques. Video-recordings will be reviewed to deconstruct procedures into key components and document how the procedure evolves. Comparisons will be made between the different data sources. ETHICS AND DISSEMINATION: The study protocol has Health Research Authority (HRA) and Health and Care Research Wales approval (Ref 18/SW/0277). Results will be disseminated at appropriate conferences and will be published in peer-reviewed journals. The findings of this study will provide a better understanding of how innovative invasive procedures and/or devices are introduced into practice.