A Core Outcome Set for Seamless, Standardized Evaluation of Innovative Surgical Procedures and Devices (COHESIVE): A Patient and Professional Stakeholder Consensus Study.

OBJECTIVE: To develop a COS, an agreed minimum set of outcomes to measure and report in all studies evaluating the introduction and evaluation of novel surgical techniques. SUMMARY OF BACKGROUND DATA: Agreement on the key outcomes to measure and report for safe and efficient surgical innovation is lacking, hindering transparency and risking patient harm. METHODS: (I) Generation of a list of outcome domains from published innovation-specific literature, policy/regulatory body documents, and surgeon interviews; (II) Prioritization of identified outcome domains using an international, multi-stakeholder Delphi survey; (III) Consensus meeting to agree the final COS. Participants were international stakeholders, including patients/public, surgeons, device manufacturers, regulators, trialists, methodologists, and journal editors. RESULTS: A total of 7972 verbatim outcomes were identified, categorized into 32 domains, and formatted into survey items/questions. Four hundred ten international participants (220 professionals, 190 patients/public) completed at least one round 1 survey item, of which 153 (69.5%) professionals and 116 (61.1%) patients completed at least one round 2 item. Twelve outcomes were scored "consensus in" ("very important" by ≥70% of patients and professionals) and 20 "no consensus." A consensus meeting, involvingcontext: modifications, unexpected disadvantages, device problems, technical procedure completion success, patients' experience relating to the procedure being innovative, surgeons'/operators' experience. Other domains relate to intended benefits, whether the overall desired effect was achieved and expected disadvantages. CONCLUSIONS: The COS is recommended for use in all studies before definitive randomized controlled trial evaluation to promote safe, transparent, and efficient surgical innovation.

Remote assessment of surgical site infection (SSI) using patient-taken wound images: Development and evaluation of a method for research and routine practice.

BACKGROUND/AIM: Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptability and usability of a method for patients to capture standardised wound images for remote wound assessment to detect SSI. MATERIALS AND METHODS: The work was conducted in two phases. Phase I involved: i) a review of literature to identify key components of photography relevant to taking wound images, ii) development of wound photography instructions for patients and a secure process for transmission of images using electronic survey software and iii) pre-testing of the photography instructions and processing method with a sample of 16 patients using cognitive interviews and observations. Phase II involved a prospective cohort study of 89 patients to evaluate the feasibility, acceptability and usability of the remote method following discharge from hospital after surgery. Quality of the images was assessed by three independent clinical reviewers. RESULTS: Some 21 key components for photographing wounds were identified from 11 documents. Of these, 16 were relevant to include in instructions for patients to photograph their wounds. Pre-testing and subsequent iterations improved understanding and ease of use of the instructions and the process for transmitting images. Fifty-two of 89 (58.4%) patients testing the method remotely took an image of their wound(s) and 46/52 (88.5%) successfully transmitted images. When it was possible to ascertain a reason for not taking/transmitting images, this was primarily health problems (n = 7) or lack of time/poor engagement with the study (n = 4) rather than problems relating to technology/competency (n = 2) or practical issues relating to the wound itself (n = 2). Eighty-seven (85.3%) of the 102 images received were evaluated to be of high quality and sufficient to remotely assess SSI by at least two independent reviewers. CONCLUSION: A simple, standardised and acceptable method for patients to take and transmit wound images suitable for remote assessment of SSI has been developed and tested and is now available for use in routine clinical care and research.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

BACKGROUND: Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. METHODS AND FINDINGS: The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). CONCLUSION: This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

A Systematic Review of Patient-reported Outcomes in Randomized Controlled Trials of Unplanned General Surgery.

Unplanned general surgery represents a major workload and requires comprehensive evaluation with appropriate outcomes. This study aimed to summarize current reporting of patient-reported outcomes (PROs) in randomized clinical trials (RCTs) in unplanned general surgery. A systematic review identified RCTs reporting PROs in the commonest six areas of unplanned general surgery. Details of the PRO measures were examined using the CONSORT extension for PRO reporting in RCTs. Extracted information about each PRO domain included the reporting of baseline PROs, rationale for PRO selection and whether PRO findings were used in conjunction with clinical outcomes to inform treatment recommendations. The internal validity of included studies was assessed using the Cochrane risk of bias tool. 12,519 abstracts were screened and 20 RCTs containing data from 2037 patients included. Included studies used 14 separate PRO measures covering 35 different health domains. A visual analogue assessment of pain was most frequently reported (n = 13). Reporting of baseline PRO data was uncommon (11/35 PRO domains). The rationale for PRO data collection and a PRO-specific hypothesis were provided for 9 (25.7 %) and 5 (14.3 %) domains, respectively. Seventeen RCTs (85.0 %) used the PRO data alongside clinical outcomes to inform treatment recommendations. Of the 116 risk of bias assessments, 77 (66.0 %) were judged as high or unclear. There is a lack of well designed, and conducted RCTs in unplanned general surgery that include PROs. Future work to define relevant PROs and methods for optimal assessment are needed to inform health care decision-making.

Dressings for the prevention of surgical site infection.

BACKGROUND: Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured, often with sutures, staples, or clips. Wound dressings applied after wound closure may provide physical support, protection and absorb exudate. There are many different types of wound dressings available and wounds can also be left uncovered (exposed). Surgical site infection (SSI) is a common complication of wounds and this may be associated with using (or not using) dressings, or different types of dressing. OBJECTIVES: To assess the effects of wound dressings compared with no wound dressings, and the effects of alternative wound dressings, in preventing SSIs in surgical wounds healing by primary intention. SEARCH METHODS: We searched the following databases: the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print; 1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); EBSCO CINAHL Plus (1937 to 19 September 2016).There were no restrictions based on language, date of publication or study setting. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing wound dressings with wound exposure (no dressing) or alternative wound dressings for the postoperative management of surgical wounds healing by primary intention. DATA COLLECTION AND ANALYSIS: Two review authors performed study selection, 'Risk of bias' assessment and data extraction independently. MAIN RESULTS: We included 29 trials (5718 participants). All studies except one were at an unclear or high risk of bias. Studies were small, reported low numbers of SSI events and were often not clearly reported. There were 16 trials that included people with wounds resulting from surgical procedures with a 'clean' classification, five trials that included people undergoing what was considered 'clean/contaminated' surgery, with the remaining studies including people undergoing a variety of surgical procedures with different contamination classifications. Four trials compared wound dressings with no wound dressing (wound exposure); the remaining 25 studies compared alternative dressing types, with the majority comparing a basic wound contact dressing with film dressings, silver dressings or hydrocolloid dressings. The review contains 11 comparisons in total. PRIMARY OUTCOME: SSIIt is uncertain whether wound exposure or any dressing reduces or increases the risk of SSI compared with alternative options investigated: we assessed the certainty of evidence as very low for most comparisons (and low for others), with downgrading (according to GRADE criteria) largely due to risk of bias and imprecision. We summarise the results of comparisons with meta-analysed data below:- film dressings compared with basic wound contact dressings following clean surgery (RR 1.34, 95% CI 0.70 to 2.55), very low certainty evidence downgraded once for risk of bias and twice for imprecision.- hydrocolloid dressings compared with basic wound contact dressings following clean surgery (RR 0.91, 95% CI 0.30 to 2.78), very low certainty evidence downgraded once for risk of bias and twice for imprecision.- hydrocolloid dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.57, 95% CI 0.22 to 1.51), very low certainty evidence downgraded twice for risk of bias and twice for imprecision.- silver-containing dressings compared with basic wound contact dressings following clean surgery (RR 1.11, 95% CI 0.47 to 2.62), very low certainty evidence downgraded once for risk of bias and twice for imprecision.- silver-containing dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.83, 95% CI 0.51 to 1.37), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. Secondary outcomesThere was limited and low or very low certainty evidence on secondary outcomes such as scarring, acceptability of dressing and ease of removal, and uncertainty whether wound dressings influenced these outcomes. AUTHORS' CONCLUSIONS: It is uncertain whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI, or whether any particular wound dressing is more effective than others in reducing the risk of SSI, improving scarring, reducing pain, improving acceptability to patients, or is easier to remove. Most studies in this review were small and at a high or unclear risk of bias. Based on the current evidence, decision makers may wish to base decisions about how to dress a wound following surgery on dressing costs as well as patient preference.

Selecting and measuring optimal outcomes for randomised controlled trials in surgery.

BACKGROUND: Randomised controlled trials (RCTs) in surgery are complex to design and conduct and face unique challenges compared to trials in other specialties. The appropriate selection, measurement and reporting of outcomes are one aspect that requires attention. Outcomes in surgical RCTs are often ill-defined, inconsistent and at high risk of bias in their assessment and historically, there has been an undue focus on short-term outcomes and adverse events meaning the value of trial results for clinical practice and decision-making is limited. PURPOSE: This review addresses three key problems with surgical trial outcomes­choosing the right outcomes for the trial design and purpose, selecting relevant outcomes to measure from the range of possible outcomes, and measuring outcomes with minimal risk of bias. Each obstacle is discussed in turn, highlighting some suggested solutions and current initiatives working towards improvements in these areas. Some examples of good practice in this field are also discussed. CONCLUSIONS: Many of the historical problems with surgical trial outcomes may be overcome with an increased understanding of the trial design and purpose and recognition that pragmatic trials require assessments of outcomes that are patient-centred in addition to measurement of short-term outcomes. The use of core outcome sets developed for specific surgical interventions and the application of novel methods to blind outcome assessors will also improve outcome measurement and reporting. It is recommended that surgeons work together with trial methodologists to integrate these approaches into RCTs in surgery. This will facilitate the appropriate evaluation of surgical interventions with informative outcomes so that results from trials can be useful for clinical practice.

Usability of an Automated System for Real-Time Monitoring of Shared Decision-Making for Surgery: Mixed Methods Evaluation.

BACKGROUND: Improving shared decision-making (SDM) for patients has become a health policy priority in many countries. Achieving high-quality SDM is particularly important for approximately 313 million surgical treatment decisions patients make globally every year. Large-scale monitoring of surgical patients' experience of SDM in real time is needed to identify the failings of SDM before surgery is performed. We developed a novel approach to automating real-time data collection using an electronic measurement system to address this. Examining usability will facilitate its optimization and wider implementation to inform interventions aimed at improving SDM. OBJECTIVE: This study examined the usability of an electronic real-time measurement system to monitor surgical patients' experience of SDM. We aimed to evaluate the metrics and indicators relevant to system effectiveness, system efficiency, and user satisfaction. METHODS: We performed a mixed methods usability evaluation using multiple participant cohorts. The measurement system was implemented in a large UK hospital to measure patients' experience of SDM electronically before surgery using 2 validated measures (CollaboRATE and SDM-Q-9). Quantitative data (collected between April 1 and December 31, 2021) provided measurement system metrics to assess system effectiveness and efficiency. We included adult patients booked for urgent and elective surgery across 7 specialties and excluded patients without the capacity to consent for medical procedures, those without access to an internet-enabled device, and those undergoing emergency or endoscopic procedures. Additional groups of service users (group 1: public members who had not engaged with the system; group 2: a subset of patients who completed the measurement system) completed user-testing sessions and semistructured interviews to assess system effectiveness and user satisfaction. We conducted quantitative data analysis using descriptive statistics and calculated the task completion rate and survey response rate (system effectiveness) as well as the task completion time, task efficiency, and relative efficiency (system efficiency). Qualitative thematic analysis identified indicators of and barriers to good usability (user satisfaction). RESULTS: A total of 2254 completed surveys were returned to the measurement system. A total of 25 service users (group 1: n=9; group 2: n=16) participated in user-testing sessions and interviews. The task completion rate was high (169/171, 98.8%) and the survey response rate was good (2254/5794, 38.9%). The median task completion time was 3 (IQR 2-13) minutes, suggesting good system efficiency and effectiveness. The qualitative findings emphasized good user satisfaction. The identified themes suggested that the measurement system is acceptable, easy to use, and easy to access. Service users identified potential barriers and solutions to acceptability and ease of access. CONCLUSIONS: A mixed methods evaluation of an electronic measurement system for automated, real-time monitoring of patients' experience of SDM showed that usability among patients was high. Future pilot work will optimize the system for wider implementation to ultimately inform intervention development to improve SDM. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2023-079155.

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.

Real-time monitoring and feedback to improve shared decision-making for surgery (the ALPACA Study): protocol for a mixed-methods study to inform co-development of an inclusive intervention.

INTRODUCTION: High-quality shared decision-making (SDM) is a priority of health services, but only achieved in a minority of surgical consultations. Improving SDM for surgical patients may lead to more effective care and moderate the impact of treatment consequences. There is a need to establish effective ways to achieve sustained and large-scale improvements in SDM for all patients whatever their background. The ALPACA Study aims to develop, pilot and evaluate a decision support intervention that uses real-time feedback of patients' experience of SDM to change patients' and healthcare professionals' decision-making processes before adult elective surgery and to improve patient and health service outcomes. METHODS AND ANALYSIS: This protocol outlines a mixed-methods study, involving diverse stakeholders (adult patients, healthcare professionals, members of the community) and three National Health Service (NHS) trusts in England. Detailed methods for the assessment of the feasibility, usability and stakeholder views of implementing a novel system to monitor the SDM process for surgery automatically and in real time are described. The study will measure the SDM process using validated instruments (CollaboRATE, SDM-Q-9, SHARED-Q10) and will conduct semi-structured interviews and focus groups to examine (1) the feasibility of automated data collection, (2) the usability of the novel system and (3) the views of diverse stakeholders to inform the use of the system to improve SDM. Future phases of this work will complete the development and evaluation of the intervention. ETHICS AND DISSEMINATION: Ethical approval was granted by the NHS Health Research Authority North West-Liverpool Central Research Ethics Committee (reference: 21/PR/0345). Approval was also granted by North Bristol NHS Trust to undertake quality improvement work (reference: Q80008) overseen by the Consent and SDM Programme Board and reporting to an Executive Assurance Committee. TRIAL REGISTRATION NUMBER: ISRCTN17951423; Pre-results.

Systematic review reveals limitations of studies evaluating health-related quality of life after potentially curative treatment for esophageal cancer.

PURPOSE: To (1) assess the quality of studies evaluating Health-Related Quality of Life (HRQL) after potentially curative treatment for esophageal cancer, and (2) to identify high-quality studies that provide robust HRQL results. METHODS: A systematic literature search is to identify studies evaluating HRQL with a validated multidimensional patient-reported outcome measure. Study quality focused on study design, risk of bias, HRQL outcome reporting, and additional issues of reporting and methodology. A study was deemed high-quality if criteria for robust study methodology and robust HRQL outcome reporting were met. RESULTS: Six RCTs, 12 cohort studies, 13 case-series, and 31 cross-sectional studies were identified. Overall risk of bias was high. Reporting of HRQL concept (e.g., a priori hypothesis), methodology (e.g., reasons for missing data), and interpretation (e.g., clinical significance) was often absent or unclear. Additional issues of reporting (e.g., unclear treatment descriptions) and methodology (e.g., no control for multiple testing) were identified. Four studies (6%) met the criteria for robust study methodology, and 26 studies (42%) met the criteria for robust HRQL outcome reporting. We identified three high-quality studies (5%)--two RCTs and one case-series--capable of providing robust results. CONCLUSIONS: Current evidence is restricted in its ability to inform practice on HRQL after potentially curative treatment for esophageal cancer.

A systematic review of on-site monitoring methods for health-care randomised controlled trials.

BACKGROUND: Monitoring the conduct of clinical trials is recommended by International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines and is integral to trial quality assurance. On-site monitoring, that is, visiting trial sites, is one part of this process but little is known about the procedures that are performed in practice. PURPOSE: To examine and summarise published on-site monitoring methods for health-care clinical trials, including evaluations of their benefits and costs to trials. METHODS: A systematic literature review identified all articles reporting the methods and practices of on-site monitoring of randomised controlled trials (RCTs). Articles were categorised into (1) reports from research groups and organisations, (2) reports from individual RCTs, (3) randomised trials of on-site monitoring interventions, (4) cost simulations, or (5) surveys of trial staff and monitors. Data were extracted on the characteristics of the trials and groups reporting on-site monitoring (e.g., geographical origin, sponsor, and trial focus). Information from articles in categories (1)-(3) was summarised on the frequency and scope of site monitoring visits, monitoring team size and composition, activities during site visits, and reporting structures. Evaluations of the benefits and disadvantages of on-site monitoring were examined for all included articles. RESULTS: In total, 57 articles were identified, comprising 21 articles about the on-site monitoring practices of 16 research groups, 30 articles from 26 RCTs, 1 on-site monitoring intervention RCT, 2 cost simulations, and 3 surveys. Publications in categories (1)-(3), mostly originated from the United States (33/52, 63%) or Europe (15/52, 29%), were predominantly describing non-commercial organisations or trials (45/52, 87%), with heart disease (9/26, 35%) or cancer (5/26, 19%) the commonest focus of individual RCTs. The frequency of visits ranged from every 6-8 weeks up to once every 3 years, with mostly all trial sites visited. The number of monitors visiting a site varied between 1 and 8. The most common on-site monitoring activity was verifying source data and consent forms, with a focus on data accuracy. Only six articles evaluated their on-site monitoring process, with improvements observed in recruitment rates and protocol adherence but with direct costs and staff time viewed as the major disadvantages. The on-site monitoring RCT ended prematurely so preventing full assessment. LIMITATIONS: Trialists and organisations may utilise additional unpublished on-site monitoring systems. The varied terminology used to describe monitoring may have limited identification of some relevant articles. CONCLUSIONS: This review demonstrated that on-site monitoring is utilised in trials worldwide but systems vary considerably with little evidence to support practice. These on-site monitoring practices need to be evaluated empirically, including costs, to provide robust evidence for the contribution of site visits to trial performance and quality.

Artificial intelligence as a diagnostic aid in cross-sectional radiological imaging of surgical pathology in the abdominopelvic cavity: a systematic review.

OBJECTIVES: There is emerging use of artificial intelligence (AI) models to aid diagnostic imaging. This review examined and critically appraised the application of AI models to identify surgical pathology from radiological images of the abdominopelvic cavity, to identify current limitations and inform future research. DESIGN: Systematic review. DATA SOURCES: Systematic database searches (Medline, EMBASE, Cochrane Central Register of Controlled Trials) were performed. Date limitations (January 2012 to July 2021) were applied. ELIGIBILITY CRITERIA: Primary research studies were considered for eligibility using the PIRT (participants, index test(s), reference standard and target condition) framework. Only publications in the English language were eligible for inclusion in the review. DATA EXTRACTION AND SYNTHESIS: Study characteristics, descriptions of AI models and outcomes assessing diagnostic performance were extracted by independent reviewers. A narrative synthesis was performed in accordance with the Synthesis Without Meta-analysis guidelines. Risk of bias was assessed (Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2)). RESULTS: Fifteen retrospective studies were included. Studies were diverse in surgical specialty, the intention of the AI applications and the models used. AI training and test sets comprised a median of 130 (range: 5-2440) and 37 (range: 10-1045) patients, respectively. Diagnostic performance of models varied (range: 70%-95% sensitivity, 53%-98% specificity). Only four studies compared the AI model with human performance. Reporting of studies was unstandardised and often lacking in detail. Most studies (n=14) were judged as having overall high risk of bias with concerns regarding applicability. CONCLUSIONS: AI application in this field is diverse. Adherence to reporting guidelines is warranted. With finite healthcare resources, future endeavours may benefit from targeting areas where radiological expertise is in high demand to provide greater efficiency in clinical care. Translation to clinical practice and adoption of a multidisciplinary approach should be of high priority. PROSPERO REGISTRATION NUMBER: CRD42021237249.

A standardized measurement instrument was recommended for evaluating operator experience in complex healthcare interventions.

OBJECTIVE: During development of complex surgical innovations, modifications occur to optimize safety and efficacy. Operators' experiences (how professionals feel undertaking the innovation) drive this process but comprehensive overviews of measures of this concept are lacking. This study identified and appraised measures to assess operators' experience of surgical innovation. STUDY DESIGN AND SETTING: There were three phases: (1) Literature reviews identified measures of operators' experience and concepts measured were extracted and grouped into domains. (2) Quality appraisal was conducted to assess content validity of identified instruments and was supported by COnsensus-based Standards for the selection of health Measurement Instruments methodology. Self-reported measurement instruments that had underdone formal development were eligible. Content validity was assessed using COnsensus-based Standards for the selection of health Measurement Instruments criteria for good content validity (rated sufficient/insufficient/indeterminate/inconsistent), informed by standards for measurement development and domains identified in phase 1. (3) Instruments determined suitable and of sufficient quality underwent supplemental appraisal in interviews with international multidisciplinary professionals and a focus group. RESULTS: Literature reviews identified 16 measurement instruments from 243 studies. Most assessed 'psychological' experiences and 'usability'. No instrument was specifically validated for innovative surgery. Three instruments were rated 'sufficient' (Surgery Task Load Index [SURG-TLX]) or 'indeterminate' (Spielberger State-Trait Anxiety Inventory, Imperial Stress Assessment Tool). Twenty professionals were interviewed (seven female; 15 specialties; six countries) and the focus group included 10 participants (four professionals, six researchers). The SURG-TLX was considered the most relevant, comprehensive, and comprehensible instrument. CONCLUSION: The SURG-TLX is preliminarily recommended to measure operators' experiences of innovation. Further work exploring its role and impact on surgical innovation is required.

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. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications. METHODS: A scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework. RESULTS: Forty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications. CONCLUSION: A conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.

A systematic scoping review protocol to summarise and appraise the use of artificial intelligence in the analysis of digital videos of invasive general surgical procedures.

Background: Intraoperative video recordings are a valuable addition to operative written documentation. However, the review of these videos often requires surgical expertise and takes considerable time. While a large amount of work has been undertaken to understand the role of artificial intelligence (AI) in healthcare more generally, the application of these techniques to automate the analysis of surgical videos is currently unclear. In this systematic scoping review, we sought to give a contemporary overview of the use of AI research in the analysis of digital videos of invasive general surgical procedures. We will describe and summarise the study characteristics, purpose of the applications and stage of development, to ascertain how these techniques might be applied in future research and to identify gaps in current knowledge (e.g. uncertainties about the study methods). Methods: Systematic searches will be conducted in OVID Medline and Embase, using terms related to 'artificial intelligence', 'surgery' and 'video' to identify all potentially relevant studies published since 1st January 2012. All primary studies where AI has been applied to the analysis of videos (recorded by conventional digital cameras or laparoscopic or robotic-assisted technology) of general surgical procedures will be included. Data extraction will include study characteristics, governance, details of video datasets and AI models, measures of accuracy, validation and any reported limitations. Ethics and dissemination: No ethical approval is required as primary data will not be collected. The results will be disseminated at relevant conferences, on social media and published in a peer-reviewed journal.

Patient Reported Outcome Measures for Rheumatoid Arthritis Disease Activity: a systematic review following COSMIN guidelines.

BACKGROUND: The current standard of care in rheumatoid arthritis (RA) requires regular assessment of disease activity (DA). All standard RA DA measurement instruments require joint counts to be undertaken by a healthcare professional with/without a blood test. Few healthcare providers have the capacity to assess patients as frequently as stipulated by guidelines. Patient Reported Outcome Measures (PROMs) could be an efficient and informative way to assess RA DA, which is highlighted by the SARS-COV-2 pandemic, as most consultations are remote rather than face-to-face. We aimed to assess all PROMs for RA DA against the internationally recognised COSMIN guidelines to provide evidence-based recommendations to select the most suitable PROMs. METHODS: Review registered on PROSPERO as CRD42020176176. The search strategy was based on a previous similar systematic review and expanded to include all articles up to January 2019. All identified articles were rated by two independent assessors following the COSMIN guidelines. RESULTS: 668 abstracts were identified, with 10 articles included. A further 21 were identified from a previous review. Ten PROMs were identified. There was insufficient evidence to place any of the identified PROMs into recommendation for use category A due to lack of evidence for content validity, as stipulated by the COSMIN guidelines. CONCLUSION: Lack of evidence of content validity limits suitable PROM selection, therefore none can be recommended for use. It is acknowledged that all included PROMs were developed before the COSMIN guidelines were published. Future research on PROMs for RA DA must provide evidence of content validity.

Shared Learning Utilizing Digital Methods in Surgery to Enhance Transparency in Surgical Innovation: Protocol for a Scoping Review.

BACKGROUND: Surgical innovation can lead to important improvements in patient outcomes. Currently, information and knowledge about novel procedures and devices are disseminated informally and in an unstandardized way (eg, through social media). This can lead to ineffective and inefficient knowledge sharing among surgeons, which can result in the harmful repetition of mistakes and delay in the uptake of promising innovation. Improvements are needed in the way that learning in surgical innovation is shared through the development of novel, real-time methods, informed by a contemporary and comprehensive investigation of existing methods. OBJECTIVE: The aim of this scoping review is to explore the application of existing digital methods for training/education and feedback to surgeons in the context of performing invasive surgical procedures. This work will (1) summarize existing methods for shared learning in surgery and how they are characterized and operationalized, (2) examine the impact of their application, and (3) explore their benefits and barriers to implementation. The findings of this scoping review will inform the development of novel, real-time methods to optimize shared learning in surgical innovation. METHODS: This study will adhere to the recommended guidelines for conducting scoping reviews. A total of 6 different searches will be conducted within multiple sources (2 electronic databases, journals, social media, gray literature, commercial websites, and snowball searches) to comprehensively identify relevant articles and data. Searches will be limited to articles published in the English language within the last 5 years. Wherever possible, a 2-stage study selection process will be followed whereby the eligibility of articles will be assessed through the title, abstract, and full-text screening independently by 2 reviewers. Inclusion criteria will be articles providing data on (1) fully qualified theater staff involved in performing invasive procedures, (2) one or more methods for shared learning (ie, digital means for training/education and feedback), and (3) qualitative or quantitative evaluations of this method. Data will be extracted (10% double data extraction by an independent reviewer) into a piloted proforma and analyzed using descriptive statistics, narrative summaries, and principles of thematic analysis. RESULTS: The study commenced in October 2021 and is planned to be completed in 2023. To date, systematic searches were applied to 2 electronic databases (MEDLINE and Web of Science) and returned a total of 10,093 records. The results of this scoping review will be published as open access in a peer-reviewed journal. CONCLUSIONS: This scoping review of methods for shared learning in surgery is, to our knowledge, the most comprehensive and up-to-date investigation that maps current information on this topic. Ultimately, efficient and effective sharing of information and knowledge of novel procedures and devices has the potential to optimize the evaluation of early-phase surgical research and reduce harmful innovation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37544.

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. DESIGN: A targeted review of 11 purposive selected case studies of innovative surgical devices. METHODS: Electronic database searches in PubMed (July 2018) identified publications reporting the introduction and evaluation of each device. Outcomes were extracted and categorised into domains until no new domains were conceptualised. Outcomes specifically relevant to evaluating innovation were further scrutinised. RESULTS: 112 relevant publications were identified, and 5926 outcomes extracted. Heterogeneity in study type, outcome selection and reporting was observed across surgical devices. Categorisation of outcomes was performed for 2689 (45.4%) outcomes into five broad outcome domains. Outcomes considered key to the evaluation of innovation (n=66; 2.5%) were further categorised as surgeon/operator experience (n=40; 1.5%), unanticipated events (n=15, 0.6%) and modifications (n=11; 0.4%). CONCLUSION: Outcome domains unique to evaluating innovative surgical devices have been identified. Findings have been combined with multiple other data sources relevant to the evaluation of surgical innovation to inform the development of a COS to measure and report in all studies evaluating novel surgical procedures/devices.

Artificial intelligence as a diagnostic aid in cross-sectional radiological imaging of the abdominopelvic cavity: a protocol for a systematic review.

INTRODUCTION: The application of artificial intelligence (AI) technologies as a diagnostic aid in healthcare is increasing. Benefits include applications to improve health systems, such as rapid and accurate interpretation of medical images. This may improve the performance of diagnostic, prognostic and management decisions. While a large amount of work has been undertaken discussing the role of AI little is understood regarding the performance of such applications in the clinical setting. This systematic review aims to critically appraise the diagnostic performance of AI algorithms to identify disease from cross-sectional radiological images of the abdominopelvic cavity, to identify current limitations and inform future research. METHODS AND ANALYSIS: A systematic search will be conducted on Medline, EMBASE and the Cochrane Central Register of Controlled Trials to identify relevant studies. Primary studies where AI-based technologies have been used as a diagnostic aid in cross-sectional radiological images of the abdominopelvic cavity will be included. Diagnostic accuracy of AI models, including reported sensitivity, specificity, predictive values, likelihood ratios and the area under the receiver operating characteristic curve will be examined and compared with standard practice. Risk of bias of included studies will be assessed using the QUADAS-2 tool. Findings will be reported according to the Synthesis Without Meta-analysis guidelines. ETHICS AND DISSEMINATION: No ethical approval is required as primary data will not be collected. The results will inform further research studies in this field. Findings will be disseminated at relevant conferences, on social media and published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021237249.

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. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation. MATERIALS AND METHODS: A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices. HIGHLIGHTS: This work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.