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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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

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). Domains were operationalized into items in a provisional questionnaire, and 'think-aloud' patient interviews explored face validity and acceptability (phase 2). The updated questionnaire was piloted in patients with a stoma who had undergone colorectal surgery and had a computed tomography scan available for review. Patient-reported symptoms were examined in relation to PSH (phase 3). Three sources determined PSH presence: (i) data about PSH presence recorded in hospital notes, (ii) independent expert review of the computed tomography scan and (iii) patient report of being informed of a PSH by a health professional., Results: For phase 1, 169 and 127 domains were identified from 70 PROMs and 29 interviews respectively. In phase 2, 14 domains specific to PSH were identified and operationalized into questionnaire items. Think-aloud interviews led to three minor modifications. In phase 3, 44 completed questionnaires were obtained. Missing data were few: 5/660 items. PSH symptom scores associated with PSH presence varied between different data sources. The scale with the most consistent differences between PSH presence and absence and all data sources was the stoma appearance scale., Conclusion: A PROM to examine the symptoms of PSH has been developed from the literature and views of key informants. Although preliminary testing shows it to be understandable and acceptable it is uncertain if it is sensitive to PSH-specific symptoms and further psychometric testing is needed., (© 2024 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

Age-related macular degeneration (AMD) has recently been linked to cognitive impairment. We hypothesized that AMD modifies the brain aging trajectory, and we conducted a longitudinal diffusion MRI study on 40 participants (20 with AMD and 20 controls) to reveal the location, extent, and dynamics of AMD-related brain changes. Voxel-based analyses at the first visit identified reduced volume in AMD participants in the cuneate gyrus, associated with vision, and the temporal and bilateral cingulate gyrus, linked to higher cognition and memory. The second visit occurred 2 years after the first and revealed that AMD participants had reduced cingulate and superior frontal gyrus volumes, as well as lower fractional anisotropy (FA) for the bilateral occipital lobe, including the visual and the superior frontal cortex. We detected faster rates of volume and FA reduction in AMD participants in the left temporal cortex. We identified inter-lingual and lingual-cerebellar connections as important differentiators in AMD participants. Bundle analyses revealed that the lingual gyrus had a lower streamline length in the AMD participants at the first visit, indicating a connection between retinal and brain health. FA differences in select inter-lingual and lingual cerebellar bundles at the second visit showed downstream effects of vision loss. Our analyses revealed widespread changes in AMD participants, beyond brain networks directly involved in vision processing.

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., Method: A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted., Results: From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9-49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews., Conclusion: Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs., Prospero Registration Number: CRD42021287371., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Asymptomatic, isolated cases of unilateral pulmonary artery atresia may present in adulthood with symptoms such as recurrent respiratory infections, dyspnea, hemoptysis, and pulmonary hypertension. Unlike previously reported patients that underwent surgical management for this pathology, the patient in this report had no chronic history of recurrent respiratory infections, dyspnea, or pulmonary hypertension, making a diagnosis prior to extensive imaging difficult., Case Presentation: A 55-year-old male presented to our emergency department (ED) with a 3-day history of recurrent cough with 2-3 tablespoons of hemoptysis per episode, chills, and occasional wheezing. A computed tomography angiography (CTA) was performed, which identified a congenital absence of the left pulmonary artery and a right-sided aortic arch. Hypertrophied left intercostal and bronchial arteries were noted to be perfusing the left lung. V/Q scan confirmed a heterogeneous distribution of gas throughout both lung fields with 97% perfusion to the right lung, but no visualization of the left lung on the perfusion images. Given extensive collateral blood supply to the left lung, interventional radiology performed a GELFOAM® embolization of the hypertrophied left bronchial artery and two parasitized arteries from the left subclavian artery to minimize intra-operative blood loss. This was immediately followed by a left thoracotomy, pneumonectomy, intercostal muscle flap placement, and bronchoscopy. The procedure was 360 min long with a total of 1500 cc blood loss that was salvaged and re-infused. No additional blood products were administered. The patient remained intubated post-operatively and was transferred to the surgical intensive care unit. His postoperative course was complicated by troponin leak, rhabdomyolysis, delirium, and ileus, all of which resolved over time. He was discharged home on postoperative day seven and continues to do well one-year later., Conclusions: The patient in this report presented with several episodes of isolated hemoptysis but unlike previously reported cases of unilateral pulmonary artery atresia, he had no history of recurrent respiratory infections, dyspnea, or pulmonary hypertension. Although unilateral pulmonary artery atresia is a rare diagnosis, in patients with unexplained, isolated hemoptysis, further examination of the vasculature may be warranted, and surgical management may be beneficial in appropriate, symptomatic patients., (© 2023. The Author(s).)

The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making., (© 2023. The Author(s).)

Climate change and habitat loss are recognized as important drivers of shifts in wildlife species' geographic distributions. While often considered independently, there is considerable overlap between these drivers, and understanding how they contribute to range shifts can predict future species assemblages and inform effective management. Our objective was to evaluate the impacts of habitat, climatic, and anthropogenic effects on the distributions of climate-sensitive vertebrates along a southern range boundary in Northern Michigan, USA. We combined multiple sources of occurrence data, including harvest and citizen-science data, then used hierarchical Bayesian spatial models to determine habitat and climatic associations for four climate-sensitive vertebrate species (American marten [ Martes americana ], snowshoe hare [ Lepus americanus ], ruffed grouse [ Bonasa umbellus ] and moose [ Alces alces ]). We used total basal area of at-risk forest types to represent habitat, and temperature and winter habitat indices to represent climate. Marten associated with upland spruce-fir and lowland riparian forest types, hares with lowland conifer and aspen-birch, grouse with lowland riparian hardwoods, and moose with upland spruce-fir. Species differed in climatic drivers with hares positively associated with cooler annual temperatures, moose with cooler summer temperatures and grouse with colder winter temperatures. Contrary to expectations, temperature variables outperformed winter habitat indices. Model performance varied greatly among species, as did predicted distributions along the southern edge of the Northwoods region. As multiple species were associated with lowland riparian and upland spruce-fir habitats, these results provide potential for efficient prioritization of habitat management. Both direct and indirect effects from climate change are likely to impact the distribution of climate-sensitive species in the future and the use of multiple data types and sources in the modelling of species distributions can result in more accurate predictions resulting in improved management at policy-relevant scales., Competing Interests: The authors declare no conflict of interest., (© 2023 The Authors. Ecology and Evolution published by John Wiley & Sons Ltd.)

To colonize a host, bacteria depend on an ensemble of signaling systems to convert information about the various environments encountered within the host into specific cellular activities. How these signaling systems coordinate transitions between cellular states in vivo remains poorly understood. To address this knowledge gap, we investigated how the bacterial symbiont Vibrio fischeri initially colonizes the light organ of the Hawaiian bobtail squid Euprymna scolopes . Previous work has shown that the small RNA Qrr1, which is a regulatory component of the quorum-sensing system in V. fischeri , promotes host colonization. Here, we report that transcriptional activation of Qrr1 is inhibited by the sensor kinase BinK, which suppresses cellular aggregation by V. fischeri prior to light organ entry. We show that Qrr1 expression depends on the alternative sigma factor σ 54 and the transcription factors LuxO and SypG, which function similar to an OR logic gate, thereby ensuring Qrr1 is expressed during colonization. Finally, we provide evidence that this regulatory mechanism is widespread throughout the Vibrionaceae family. Together, our work reveals how coordination between the signaling pathways underlying aggregation and quorum-sensing promotes host colonization, which provides insight into how integration among signaling systems facilitates complex processes in bacteria., Competing Interests: ES, KG, SC, TR, AC, DL, CO, MM, TM No competing interests declared, (© 2023, Surrett et al.)

The importance of physical activity (PA) for the health and wellbeing of older adults is well documented, yet many older adults are insufficiently active. This issue is more salient in regional and rural areas, where evidence of the most critical components of interventions that explain PA participation and maintenance in older populations is sparse. This realist review will (1) systematically identify and synthesise literature on PA interventions in community-dwelling older adults in regional and rural areas, and (2) explore how and why those interventions increase PA in that population. Using a realist synthesis framework and the behaviour change wheel (BCW), context-mechanism-outcome (C-M-O) patterns of PA interventions for older adults in regional and rural areas will be synthesised. Thematic analysis will be employed to compare, contrast, and refine emerging C-M-O patterns to understand how contextual factors trigger mechanisms that influence regional and rural community-dwelling older adults' participation in PA interventions. This realist review will be the first to adopt a BCW analysis and a realist synthesis framework to explore PA interventions in community-dwelling older adults in regional and rural areas. This review will provide recommendations for evidence-based interventions to improve PA participation and adherence by revealing the important mechanisms apparent in this context. Systematic review registration: (PROSPERO CRD42023402499).

Determining characteristics that define talent is critical for recruitment and player development. When developing predictive models, sensitivity is important, as it describes the ability of models to identify players with draft potential (true positives). In the current literature, modelling is limited to a small number of selected variables, and model sensitivity is often poor or unreported. The aim of this study was to determine how a technical factor combined with physical and in-game movement factors affects position-specific model sensitivity when evaluating draft outcome in an elite-junior National Australia Bank (NAB) League population. Physical, in-game movement, and technical involvement data were collated from draft-eligible (18th year) participants in the under 18 boys NAB League competition (n = 465). Factors identified through parallel analysis were used in binomial regression analyses. Models using factor combinations were developed to predict draft success for all-position, nomadic, fixed-position, and fixed&ruck players. Models that best characterised draft success were all-position (physical and technical: specificity = 97.2%, sensitivity = 36.6%, and accuracy = 86.3%), nomadic (physical and technical: specificity = 95.5%, sensitivity = 40.7%, and accuracy = 85.5%), fixed (physical: specificity = 96.4%, sensitivity = 41.7%, and accuracy = 86.6%), and fixed&ruck (physical and in-game movement: specificity = 96.3%, sensitivity = 41.2%, and accuracy = 86.7%). Including a technical factor improved sensitivity in the all-position and nomadic models. Physical factors and physical and in-game movement yielded the best models for fixed-position and fixed&ruck players, respectively. Models with improved sensitivity should be sought to assist practitioners to more confidently identify the players with draft potential.

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., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)

Aim: This study sought to identify adolescents' health information sources and determine the gap between what adolescents want to hear and what they actually hear from their healthcare providers (HCPs), a proxy for unmet health needs., Methods: A cross-sectional study was conducted in four high schools conveniently selected in Jamaica to ensure adequate representation in rural and urban locales. Adolescents 11-19 years old with relevant assent/consent completed a paper-based self-administered questionnaire. Questions were adapted from the Young Adult Health Care Survey to determine proportion of adolescents receiving confidential care, the level of counselling offered and difference between location and unmet needs., Results: Adolescents acknowledged multiple sources of information, with urban adolescents reporting television, radio and parents as sources more frequently than in rural setting (p < 0.05). They most commonly wanted to discuss weight management (n = 308, 64.2%), nutrition (n = 418, 87.1%), exercise (n = 361, 75.2%); and emotions they are experiencing (n = 246, 51.3%). Unmet needs differed by location; more rural than urban adolescents found that their desire to discuss school performance (p < 0.05) and sexual orientation (p < 0.05) was unmet, while more urban youth felt their need for discussions about STIs was unmet (p < 0.05), when compared to their rural counterparts., Conclusion: This study highlights that while there is some access to health information in Jamaica, especially via television, radio and internet, the needs of the adolescent population remain unmet. HCPs need to employ a patient-centred approach where confidentiality is established and screening is done for unmet needs in an effort to optimize health outcomes., (© The Author(s) [2023]. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Research over the last 20 years has investigated the processing costs for sentences such as John began the book. Much of this work has conflated sentences with aspectual verbs, like start or finish, with psychological verbs, like enjoy or tolerate. However, recent studies have reported greater costs for aspectual verbs compared to psychological verbs (e.g., Katsika et al. in Ment Lex 7:58-76, 2012; Lai et al. in Compositionality and concepts in linguistics and psychology, 2017). The present paper reports an eye-tracking study that examined the costs of processing both verb types in Mandarin Chinese. The results revealed greater costs both for aspectual verbs compared to controls (John read the book) and for aspectual verbs compared to psychological verbs, reinforcing the claims of the Structured Individual Hypothesis (Piñango and Deo in J Semant 33:359-408, 2016). Strikingly, there was an early effect at the verb for aspectual verbs but not for psychological verbs. We argue that this result, together with previous findings and other conceptual issues, necessitates a conservative modification of the SIH: aspectual verbs are semantically more complex than psychological verbs. This modification retains the core analysis underlying the SIH, but reconciles the SIH with experimental findings by bringing it in line with the view that lexical semantic complexity has immediate consequences in processing (e.g., Brennan and Pylkkänen in Lang Cogn Process 25:777-807, 2010)., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: To investigate how information about innovative surgical procedures is communicated to patients., Summary Background Data: Despite national and international guidance that patients should be informed if a procedure is innovative and has uncertain outcomes, little is known about current practice., Methods: This qualitative study followed seven 'case studies' of surgical innovation in hospitals across the UK. Pre-operative interviews were conducted with clinician innovators (n=9), pre-operative real-time consultations between clinicians and patients were audio-recorded (n=37). Patients were interviewed post-operatively (n=30). Data were synthesised using thematic analytical methods., Results: Interviews with clinicians demonstrated strong intentions to inform patients about the innovative nature of the procedure in a neutral manner, although tensions between fully informing patients and not distressing them were raised. In the consultations, only a minority of clinicians actually made explicit statements about, i) the procedure being innovative, ii) their limited clinical experience with it, iii) the paucity of evidence and iv) uncertainty/unknown outcomes. Discussions about risks were generalised and often did not relate to the innovative component. Instead, all clinicians optimistically presented potential benefits and many disclosed their own positive beliefs. Post-operative patient interviews revealed that many believed that the procedure was more established than it was and were unaware of the unknown risks., Conclusions: There were contradictions between clinicians' intentions to inform patients about the uncertain outcomes of innovative and their actual discussions with patients. There is a need for communication interventions and training to support clinicians to provide transparent data and shared decision-making for innovative procedures., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

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., Methods: One hundred and fifty acute NHS trusts in England and seven health boards in Wales were systematically approached for information about their policies. A modified framework approach was used to analyse when policies considered new procedures/devices to be within local organization remit and/or requiring research ethics committee (REC) approval., Results: Of 113 policies obtained, 109 and 34 described when local organization and REC approval was required, respectively. Procedures/devices being used for the first time in the organization (n = 69) or by a clinician (n = 67) were commonly within local remit, and only 36 stated that evidence was required. Others stated limited evidence as a rationale for needing REC approval (n = 13). External guidance categorizing procedures as 'research only' was the most common reason for gaining REC approval (n = 15). Procedures/devices with uncertain outcomes (n = 28), requiring additional training (n = 26), and not previously used (n = 6) were within the remit of policies, while others recommended REC application in these situations (n = 5, 2 and 7, respectively)., Conclusion: This study on NHS policies for surgical innovation shows variability in the introduction of procedures/devices in terms of local oversight and/or need for REC approval. Current NHS standards allow untested innovations to occur without the safety of research oversight and thus a standard approach is urgently needed., (© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.)

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., Participants: Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review., Results: From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure's novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon's experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included., Conclusions: Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients' and clinicians' views is required to address variability around information provision/consent for innovative procedures., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

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., Competing Interests: JB is a member of the Core Outcome Measures for Effectiveness Trials (COMET) Initiative Management Group. All other authors declare no conflict of interests., (Copyright: © 2021 The Author(s).)

The influence of environmental factors on the distribution and persistence of African elephants ( Loxodonta africana ) is pertinent to policy makers and managers to formulate balanced plans for different land-use types.The study focuses on movement of elephants and how they utilize foraging areas in Sioma Ngwezi landscape in Zambia by answering the following questions: (1) Which environmental variables and land-cover class predict the movement of elephants during the wet season in Sioma Ngwezi landscape? (2) What is the wet season suitable habitat for elephants in Sioma Ngwezi landscape? (3) What are the major wet season movement corridors for elephants in Sioma Ngwezi landscape?We used GPS telemetry data from the collared elephants to assess habitat connectivity. Maximum entropy (MaxEnt) and linkage mapper were the tools used to predict habitat suitability, movement corridors, and barriers in the landscape during the wet season.The study identified elevation, land cover, and NDVI as the most important environmental predictors that modify the dispersal of elephants in the landscape during the wet season. Additionally, a total of 36 potential wet season corridors were identified connecting 15 core areas mainly used for foraging and protection from poachers in the landscape. Of these, 24 corridors were highly utilized and are suggested as priority corridors for elephant movement in the landscape.The identified wet season habitats and functional corridors may help to combat elephant poaching by patrolling areas with high relative probability of elephant presence. The findings may also help abate human-elephant conflict such as crop-raiding by managing identified corridors that run into agriculture zones in the game management area., Competing Interests: None declared., (© 2021 The Authors. Ecology and Evolution published by John Wiley & Sons Ltd.)

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., Design: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout., Setting: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines., Results: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect., Conclusions: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial., Limitations: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS., Future Work: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space., Funding: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.

Objectives: COVID-19 presents a risk of infection and transmission for operating theatre teams. Guidelines to protect patients and staff emerged and changed rapidly based on expert opinion and limited evidence. This paper presents the experiences and innovations developed by international surgical teams during the early stages of the pandemic to attempt to mitigate risk., Design: In-depth, semistructured interviews were audio recorded, transcribed and analysed thematically using methods of constant comparison., Participants: 43 participants, including surgeons from a range of specialties (primarily general surgery, otolaryngology, neurosurgery, cardiothoracic and ophthalmology), anaesthetists and those in nursing roles., Setting: The UK, Italy, Spain, the USA, China and New Zealand between March and May 2020., Results: Surgical teams sought to mitigate COVID-19 risks by modifying their current practice with an abundance of strategies and innovations. Communication and teamwork played an integral role in how teams adapted, although participants reflected on the challenges of having to improvise in real time. Uncertainties remained about optimal surgical practice and there were significant tensions where teams were forced to balance what was best for patients while contemplating their own safety., Conclusions: The perceptions of risks during a pandemic such as COVID-19 can be complex and context dependent. Management of these risks in surgery must be driven by evidence-based practice resulting from a pragmatic and novel approach to collation of global evidence. The context of surgery has changed dramatically, and surgical teams have developed a plethora of innovations. There is an urgent need for high-quality evidence to inform surgical practice that optimises the safety of both patients and healthcare professionals as the COVID-19 pandemic unfolds., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Purpose: This study aims to meet a growing need for a fully automated, learning-based interpretation tool for retinal images obtained remotely (e.g. teleophthalmology) through different imaging modalities that may include imperfect (uninterpretable) images., Methods: A retrospective study of 1148 optical coherence tomography (OCT) and color fundus photography (CFP) retinal images obtained using Topcon's Maestro care unit on 647 patients with diabetes. To identify retinal pathology, a Convolutional Neural Network (CNN) with dual-modal inputs (i.e. CFP and OCT images) was developed. We developed a novel alternate gradient descent algorithm to train the CNN, which allows for the use of uninterpretable CFP/OCT images (i.e. ungradable images that do not contain sufficient image biomarkers for the reviewer to conclude absence or presence of retinal pathology). Specifically, a 9:1 ratio to split the training and testing dataset was used for training and validating the CNN. Paired CFP/OCT inputs (obtained from a single eye of a patient) were grouped as retinal pathology negative (RPN; 924 images) in the absence of retinal pathology in both imaging modalities, or if one of the imaging modalities was uninterpretable and the other without retinal pathology. If any imaging modality exhibited referable retinal pathology, the corresponding CFP/OCT inputs were deemed retinal pathology positive (RPP; 224 images) if any imaging modality exhibited referable retinal pathology., Results: Our approach achieved 88.60% (95% confidence interval [CI] = 82.76% to 94.43%) accuracy in identifying pathology, along with the false negative rate (FNR) of 12.28% (95% CI = 6.26% to 18.31%), recall (sensitivity) of 87.72% (95% CI = 81.69% to 93.74%), specificity of 89.47% (95% CI = 83.84% to 95.11%), and area under the curve of receiver operating characteristic (AUC-ROC) was 92.74% (95% CI = 87.71% to 97.76%)., Conclusions: Our model can be successfully deployed in clinical practice to facilitate automated remote retinal pathology identification., Translational Relevance: A fully automated tool for early diagnosis of retinal pathology might allow for earlier treatment and improved visual outcomes.

Background: Pemigatinib is an inhibitor of the fibroblast growth factor receptor (FGFR), recently approved for the treatment of cholangiocarcinoma. FGFR retinopathy is a newly recognized entity, with only two other FGFR inhibitors reported to cause serous retinopathy. Herein, we describe the first published report of a multifocal serous retinopathy secondary to pemigatinib., Case Presentation: A 67-year-old male with stage 4A metastatic colon adenocarcinoma undergoing systemic therapy with pemigatinib was found to have developed bilateral multifocal serous retinopathy. Fundus autofluorescence showed corresponding multifocal hypoautofluorescent foci, whereas fluorescein angiography and indocyanine green angiography were unremarkable. Subretinal fluid resolved rapidly after discontinuation of pemigatinib., Conclusions: Multifocal serous retinopathy appears to be a class effect of FGFR inhibitors. FGFR retinopathy clinically resembles MEK retinopathy-both feature multifocal subretinal fluid, low visual significance, and quick resolution. However, given that FGFR inhibitors have a broader molecular range than MEK inhibitors, further characterization of FGFR retinopathy is necessary to generate management guidelines.

Brighter Bites is a school-based health promotion program that delivers fresh produce and nutrition education to low-income children and their families across 6 locations in the US. This article provides a perspective on how, despite coronavirus disease 2019-related school closures, Brighter Bites pivoted rapidly to collaborate with medical and public health institutions to improve health and food literacy among their families. Through these partnerships, Brighter Bites was able to rapidly provide accurate, evidence-based information related to coronavirus disease 2019 and other social needs, including food, housing, transportation, and access to health care, to help fill a needed gap in vulnerable communities., (Copyright © 2020 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

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. Interviews were audio recorded, transcribed and analysed thematically., Participants: 42 interviews were conducted (26 surgeons and 16 governance representatives)., Setting: Surgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK., Results: Participants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that 'new' was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own., Conclusions: This study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and patients' views of these information exchanges., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Age-related macular degeneration (AMD) has been linked to memory deficits, with no established neural mechanisms. We collected resting-state brain functional magnetic resonance imaging and standardized verbal recall tests from 42 older adults with AMD and 41 age-matched controls. We used seed-based whole brain analysis to quantify the strength of functional connectivity between hubs of the default mode network and a network of medial temporal regions relevant for memory. Our results indicated neither memory performance nor network connectivity differed by AMD status. However, the AMD participants exhibited stronger relationships than the controls between memory performance and connectivity from the memory network hub (left parahippocampal) to 2 other regions: the left temporal pole and the right superior/middle frontal gyri. Also, the connectivity between the medial prefrontal cortex and posterior cingulate cortex of default mode network correlated more strongly with memory performance in AMD compared to control. We concluded that stronger brain-behavior correlation in AMD may suggest a role for region-specific connectivity in supporting memory in the context of AMD., (Published by Elsevier Inc.)

Background: Placebo-controlled trials play an important role in the evaluation of healthcare interventions. However, they can be challenging to design and deliver for invasive interventions, including surgery. In-depth understanding of the component parts of the treatment intervention is needed to ascertain what should, and should not, be delivered as part of the placebo. Assessment of risk to patients and strategies to ensure that the placebo effectively mimics the treatment are also required. To date, no guidance exists for the design of invasive placebo interventions. This study aimed to develop a framework to optimize the design and delivery of invasive placebo interventions in RCTs., Methods: A preliminary framework was developed using published literature to: expand the scope of an existing typology, which facilitates the deconstruction of invasive interventions; and identify placebo optimization strategies. The framework was refined after consultation with key stakeholders in surgical trials, consensus methodology and medical ethics., Results: The resulting DITTO framework consists of five stages: deconstruct treatment intervention into constituent components and co-interventions; identify critical surgical element(s); take out the critical element(s); think risk, feasibility and role of placebo in the trial when considering remaining components; and optimize placebo to ensure effective blinding of patients and trial personnel., Conclusion: DITTO considers invasive placebo composition systematically, accounting for risk, feasibility and placebo optimization. Use of the framework can support the design of high-quality RCTs, which are needed to underpin delivery of healthcare interventions., (© 2020 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.)

Purpose: To develop a neural network (NN)-based approach, with limited training resources, that identifies and counts the number of retinal pigment epithelium (RPE) cells in confocal microscopy images obtained from cell culture or mice RPE/choroid flat-mounts., Methods: Training and testing dataset contained two image types: wild-type mice RPE/choroid flat-mounts and ARPE 19 cells, stained for Rhodamine-phalloidin, and imaged with confocal microscopy. After image preprocessing for denoising and contrast adjustment, scale-invariant feature transform descriptors were used for feature extraction. Training labels were derived from cells in the original training images, annotated and converted to Gaussian density maps. NNs were trained using the set of training input features, such that the obtained NN models accurately predicted corresponding Gaussian density maps and thus accurately identifies/counts the cells in any such image., Results: Training and testing datasets contained 229 images from ARPE19 and 85 images from RPE/choroid flat-mounts. Within two data sets, 30% and 10% of the images, were selected for validation. We achieved 96.48% ± 6.56% and 96.88% ± 3.68% accuracy (95% CI), on ARPE19 and RPE/choroid flat-mounts., Conclusions: We developed an NN-based approach that can accurately estimate the number of RPE cells contained in confocal images. Our method achieved high accuracy with limited training images, proved that it can be effectively used on images with unclear and curvy boundaries, and outperformed existing relevant methods by decreasing prediction error and variance., Translational Relevance: This approach allows efficient and effective characterization of RPE pathology and furthermore allows the assessment of novel therapeutics., Competing Interests: Disclosure: Q. Gao, None; Y. Xu, None; J. Amason, None; A. Loksztejn, None; S. Cousins, None; M. Pajic, None; M. Hadziahmetovic, None, (Copyright 2020 The Authors.)