The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might particularly enrich the necessary future discussion on surgical innovation: integration of research and practice and a moral emphasis on "learning activities." Future research should evaluate whether the learning health care system and its adjacent moral framework provides ethical guidance for evidence-based surgery.
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BACKGROUND: Existing surgical innovation frameworks suffer from a unifying limitation, their qualitative nature. A rigorous approach to measuring surgical innovation is needed that extends beyond detecting simply publication, citation, and patent counts and instead uncovers an implementation-based value from the structure of the entire adoption cascades produced over time by diffusion processes. Based on the principles of evidence-based medicine and existing surgical regulatory frameworks, the surgical innovation funnel is described. This illustrates the different stages through which innovation in surgery typically progresses. The aim is to propose a novel and quantitative network-based framework that will permit modeling and visualizing innovation diffusion cascades in surgery and measuring virality and value of innovations. MATERIALS AND METHODS: Network analysis of constructed citation networks of all articles concerned with robotic surgery (n = 13,240, Scopus®) was performed (1974-2014). The virality of each cascade was measured as was innovation value (measured by the innovation index) derived from the evidence-based stage occupied by the corresponding seed article in the surgical innovation funnel. The network-based surgical innovation metrics were also validated against real world big data (National Inpatient Sample-NIS®). RESULTS: Rankings of surgical innovation across specialties by cascade size and structural virality (structural depth and width) were found to correlate closely with the ranking by innovation value (Spearman's rank correlation coefficient = 0.758 (p = 0.01), 0.782 (p = 0.008), 0.624 (p = 0.05), respectively) which in turn matches the ranking based on real world big data from the NIS® (Spearman's coefficient = 0.673;p = 0.033). CONCLUSION: Network analysis offers unique new opportunities for understanding, modeling and measuring surgical innovation, and ultimately for assessing and comparing generative value between different specialties. The novel surgical innovation metrics developed may prove valuable especially in guiding policy makers, funding bodies, surgeons, and healthcare providers in the current climate of competing national priorities for investment.
OBJECTIVE: This study explores how surgeons define innovation, critically examines and evaluates these views, and uses the findings to develop practical criteria for identifying surgical innovation for ethical and regulatory purposes. BACKGROUND: Surgical innovation is crucial for progress in surgery, but can be harmful to patients and difficult to identify and therefore support appropriately. Current attempts to define surgical innovation lack precision, and do not give enough guidance to identify innovations in practice. This study is the first to give an account of surgeons' own views about defining innovation. METHODS: This qualitative study involved interviews with 18 Australian surgeons. Participants provided examples of innovation and distinguished innovation from variations in practice and from research. Data were collected using audio-recorded semistructured interviews. The data were coded using a template and analyzed to develop a thematic account of innovative surgery in practice. RESULTS: There was no uniform view about innovation, but participants identified 5 features of surgical innovation that distinguish it from variations: newness or novelty; degree of change; level of risk; impact; and requiring formal processes. There was no agreement on the distinction between innovation and research. CONCLUSIONS: Drawing on surgeons' own views is important for the development of a practical definition of surgical innovation. We have used a critical analysis of surgeons' own views as the basis for defining the core features of innovation. A precise definition of innovation will assist surgeons to identify and manage innovation and thereby enhance patient safety.
OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new." CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations.
Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (surgical) innovation, that we categorised alliteratively under the themes of "purpose" (about drivers of innovation), "place" (about contexts of innovation), "process" (about differentiating innovation), "product" (about tangible and intangible results of innovation) and "person" (about personal factors and viewpoint). These conceptual areas are used in varying-sometimes contradictory-ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term "innovation" carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term "innovation" from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery.
BACKGROUND: As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. MAIN BODY: In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture. CONCLUSION: We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.
Innovation is responsible for most advances in the field of surgery. Innovative approaches to solving clinical problems have significantly decreased morbidity and mortality for many surgical procedures, and have led to improved patient outcomes. While innovation is motivated by the surgeon's expectation that the new approach will be beneficial to patients, not all innovations are successful or result in improved patient care. The ethical dilemma of surgical innovation lies in the uncertainty of whether a particular innovation will prove to be a "good thing." This uncertainty creates challenges for surgeons, patients, and the healthcare system. By its very nature, innovation introduces a potential risk to patient safety, a risk that may not be fully known, and it simultaneously fosters an optimism bias. These factors increase the complexity of informed consent and shared decision making for the surgeon and the patient. Innovative procedures and their associated technology raise issues of cost and resource distribution in the contemporary, financially conscious, healthcare environment. Surgeons and institutions must identify and address conflicts of interest created by the development and application of an innovation, always preserving the best interest of the patient above the academic or financial rewards of success. Potential strategies to address the challenges inherent in surgical innovation include collecting and reporting objective outcomes data, enhancing the informed consent process, and adhering to the principles of disclosure and professionalism. As surgeons, we must encourage creativity and innovation while maintaining our ethical awareness and responsibility to patients.
Prologue Glaucoma surgery has been, for many decades now, dominated by the universal gold standard which is trabeculectomy augmented with antimetabolites. Tubes also came into the scene to complement what we use to call conventional or traditional glaucoma surgery. More recently we experienced a changing glaucoma surgery environment with the “advent” of what we have become used to calling Minimally Invasive Glaucoma Surgery (MIGS). What is the unmet need, what is the gap that these newcomers aim to fill? Hippocrates taught us “bring benefit, not harm” and new glaucoma techniques and devices aim to provide safer surgery compared to conventional surgery. For the patient, but also for the clinician, safety is important. Is more safety achieved with new glaucoma surgery and, if so, is it associated with better, equivalent, or worse efficacy? Is new glaucoma surgery intended to replace conventional surgery or to complement it as an ‘add-on’ to what clinicians already have in their hands to manage glaucoma? Which surgery should be chosen for which patient? What are the options? Are they equivalent? These are too many questions for the clinician! What are the answers to the questions? What is the evidence to support answers? Do we need more evidence and how can we produce high-quality evidence? This EGS Guide explores the changing and challenging glaucoma surgery environment aiming to provide answers to these questions. The EGS uses four words to highlight a continuum: Innovation, Education, Communication, and Implementation. Translating innovation to successful implementation is crucially important and requires high-quality evidence to ensure steps forward to a positive impact on health care when it comes to implementation. The vision of EGS is to provide the best possible well-being and minimal glaucomainduced visual disability in individuals with glaucoma within an affordable healthcare system. In this regard, assessing the changes in glaucoma surgery is a pivotal contribution to better care. As mentioned, this Guide aims to provide answers to the crucial questions above. However, every clinician is aware that answers may differ for every person: an individualised approach is needed. Therefore, there will be no uniform answer for all situations and all patients. Clinicians would need, through the clinical method and possibly some algorithm, to reach answers and decisions at the individual level. In this regard, evidence is needed to support clinicians to make decisions. Of key importance in this Guide is to provide an overview of existing evidence on glaucoma surgery and specifically on recent innovations and novel devices, but also to set standards in surgical design and reporting for future studies on glaucoma surgical innovation. Designing studies in surgery is particularly challenging because of many subtle variations inherent to surgery and hence multiple factors involved in the outcome, but even more because one needs to define carefully outcomes relevant to the research question but also to the future translation into clinical practice. In addition this Guide aims to provide clinical recommendations on novel procedures already in use when insufficient evidence exists. EGS has a long tradition to provide guidance to the ophthalmic community in Europe and worldwide through the EGS Guidelines (now in their 5th Edition). The EGS leadership recognized that the changing environment in glaucoma surgery currently represents a major challenge for the clinician, needing specific guidance. Therefore, the decision was made to issue this Guide on Glaucoma Surgery in order to help clinicians to make appropriate decisions for their patients and also to provide the framework and guidance for researchers to improve the quality of evidence in future studies. Ultimately this Guide will support better Glaucoma Care in accordance with EGS’s Vision and Mission. Fotis Topouzis EGS President Contributors All contributors have provided the appropriate COI visible in detail at www.eugs.org/pages/guidesurgical/ This manuscript reflects the work and thoughts of the list of individuals recognized above, but importantly, it reflects EGS views on the subject matter. Its strength originates from a team effort, where a cohesive group of authors and reviewers have worked towards a common goal and now stand behind the text in its entirety. The EGS nevertheless wishes to thank the following external contributors for their additional expertise, which was particularly valuable to the development of this Surgical Guide: Amanda Bicket, Jonathan Bonnar, Catey Bunce, Kuan Hu, Sheffinea Koshy, Jimmy Le, Tianjing Li, Francisco Otarola, Riaz Qureshi, Anupa Shah, Richard Stead and Marta Toth. A particular appreciation goes to Ian Saldanha for drafting the introductory overview on Core Outcomes on chapter 8. Finally, EGS would like to acknowledge Augusto Azuara Blanco, Chair of the Scientific and Guidelines Committee, for his expertise and advisory role throughout the entire process. Luis Abegao Pinto , Centro Hospitalar Universitário Lisboa Norte Editor Gordana Sunaric Mégevand , Eye Research Centre, Adolphe de Rothschild Hospital, Geneva, Switzerland and Centre Ophtalmologique de Florissant, Geneva, Switzerland Editor Ingeborg Stalmans , Ingeborg Stalmans, University Hospitals UZ Leuven, Catholic University KU Leuven Editor Luis Abegao Pinto , Centro Hospitalar Universitário Lisboa Norte Hana Abouzeid , Clinical Eye Research Centre Adolph de Rothschild, AZ Ophthalmologie Eleftherios Anastasopoulos , Aristotle University of Thessaloniki, Papageorgiou Hospital, Thessaloniki, Greece Augusto Azuara Blanco , Centre for Public Health, Queen’s University Belfast Luca Bagnasco , Clinica Oculistica, DiNOGMI University of Genoa Alessandro Bagnis , Clinica Oculistica, IRCCS Ospedale Policlinico San Martino Joao Barbosa Breda , Faculty of Medicine of the University of Porto, Porto, Portugal. Centro Hospitalar e Universitário São João, Porto, Portugal. KULeuven, Belgium Keith Barton , University College London, Moorfields Eye Hospital Amanda Bicket , University of Michigan (Ann Arbor, MI, USA) Jonathan Bonnar , Belfast Health and Social Care Trust Chiara Bonzano , Clinica Oculistica, IRCCS Ospedale Policlinico San Martino Rupert Bourne , Cambridge University Hospital Alain Bron , University Hospital Dijon Catey Bunce , King’s College London Carlo Cutolo , Clinica Oculistica, DiNOGMI University of Genoa, and IRCCS Ospedale Policlinico San Martino Barbara Cvenkel , University Medical Centre Ljubljana Faculty of Medicine, University of Ljubljana Antonio Fea , University of Turin Theodoros Filippopoulos , Athens Vision Eye Institute Panayiota Founti , Moorfields Eye Hospital NHS Foundation Trust Stefano Gandolfi , U.O.C. Oculistica, University of Parma Julian Garcia Feijoo , Hospital Clinico San Carlos, Universidad Complutense, Madrid Gerhard Garhoefer , Medical University of Vienna, Austria David Garway Heath , Moorfields Eye Hospital NHS Foundation Trust, London. Institute of Ophthalmology, University College London. Gus Gazzard , Moorfields Eye Hospital NHS Foundation Trust, London. Institute of Ophthalmology, University College London. Stylianos Georgoulas , Addenbrooke’s, Cambridge University Hospitals Dimitrios Giannoulis , Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece Franz Grehn , University Hospitals Wuerzburg Kuang Hu , NIHR Moorfields Biomedical Research Centre, London – Institute of Ophthalmology – University College London Michele Iester , Clinica Oculistica, DiNOGMI University of Genoa, and IRCCS Ospedale Policlinico San Martino Hari Jayaram , Moorfields Eye Hospital Gauti Johannesson , Umea University Stylianos Kandarakis , National and Kapodistrian University of Athens, G. Gennimatas Hospital, Athens, Greece.</jat
The landscape of cancer treatment has witnessed a remarkable transformation in recent years, marked by the convergence of medical and surgical innovations. Historically, cancer therapy faced challenges, including limited efficacy and severe side effects. This narrative review explores the historical progression of cancer treatments, shedding light on significant breakthroughs in both medical and surgical oncology. It comprehensively addresses the medical domain, covering chemotherapy, targeted therapies, immunotherapy, hormonal treatments, and radiological procedures. Simultaneously, it delves into the surgical realm, discussing the evolution of surgical techniques, minimally invasive procedures, and the role of surgery across various stages of cancer. The article emphasizes the fusion of medical and surgical approaches, highlighting neoadjuvant and adjuvant therapies and the significance of multidisciplinary tumor boards. It also addresses innovations, challenges, and the pivotal role of patient-centered care. Furthermore, it offers insights into the future directions and forecasts in the constantly evolving field of integrated oncological care. This review provides a comprehensive understanding of the dynamic and transformative nature of cancer treatment, reflecting the unwavering commitment of the medical and surgical communities in the ongoing fight against cancer.
OBJECTIVE: To present a novel network-based framework for the study of collaboration in surgery and demonstrate how this can be used in practice to help build and nurture collaborations that foster innovation. BACKGROUND: Surgical innovation is a social process that originates from complex interactions among diverse participants. This has led to the emergence of numerous surgical collaboration networks. What is still needed is a rigorous investigation of these networks and of the relative benefits of various collaboration structures for research and innovation. METHODS: Network analysis of the real-world innovation network in robotic surgery. Hierarchical mixed-effect models were estimated to assess associations between network measures, research impact and innovation, controlling for the geographical diversity of collaborators, institutional categories, and whether collaborators belonged to industry or academia. RESULTS: The network comprised of 1700 organizations and 6000 links. The ability to reach many others along few steps in the network (closeness centrality), forging a geographically diverse international profile (network entropy), and collaboration with industry were all shown to be positively associated with research impact and innovation. Closed structures (clustering coefficient), in which collaborators also collaborate with each other, were found to have a negative association with innovation (P < 0.05 for all associations). CONCLUSIONS: In the era of global surgery and increasing complexity of surgical innovation, this study highlights the importance of establishing open networks spanning geographical boundaries. Network analysis offers a valuable framework for assisting surgeons in their efforts to forge and sustain collaborations with the highest potential of maximizing innovation and patient care.
OBJECTIVE: To review efficiency metrics and patient safety data before and after implementation of a structured review process for surgical innovations. SUMMARY BACKGROUND DATA: Surgical innovation ranges from minor incremental improvement to radical experimentation. Although innovation paradigms have been described, these are not widely adopted or enforced in the surgical community. METHODS: A Continuous Quality Improvement Team (CQIT) of surgical quality officers and perioperative nurses was organized to perform structured reviews of proposed new surgical devices and procedures at a large quaternary cancer care center. The CQIT process was placed to precede an established Value Analysis Team business evaluation. Pre- and post-CQIT implementation metrics of approval process efficiency and patient safety data were compared. Seven novel procedures were also vetted by the CQIT. RESULTS: Forty-six product requests were evaluated after CQIT implementation. Compared with 34 products evaluated prior to CQIT establishment, the total mean evaluation time decreased from 124 to 51 days (P= 0.007). For new devices requiring intraoperative trial, the time between product proposal and trial decreased from a mean of 260 to 99 days (P= 0.014). The rate of device-related complications in the pre-CQIT group was 10% compared with 0% post-CQIT. Two devices, which administratively bypassed CQIT review, had both minor and major complications, including a mortality. Five novel procedures approved by CQIT with simulation were performed without complications. CONCLUSIONS: Using novel algorithms, the addition of a dedicated team of surgical quality officers to the surgical innovation evaluation process improved both the efficiency and the safety associated with introducing new devices and procedures into practice.
The future of surgical progress depends on surgeons finding innovative solutions to their patients' problems. Surgical innovation is critical to advances in surgery. However, surgical innovation also raises a series of ethical issues that challenge the professionalism of surgeons. The very criteria for defining surgical progress have changed as patients may value more than simply reductions in morbidity and mortality. The requirement for informed consent prior to surgery is difficult when an innovative surgical procedure is planned since the risks of the novel operation may not be known. In addition, even if the risks are known in the hands of the innovator, the actual risks to patients when surgeons are learning the new technique are unknown. New techniques often depend on new technology which may be significantly more expensive than traditional techniques. There are no clear criteria to decide which new innovative techniques are going to turn out to be truly beneficial to patients. Many surgical innovations depend on new products which may have been developed as collaborative efforts between surgical device companies and surgeons. Although many currently accepted therapies were developed in this fashion, the collaboration of surgeons and device companies raises the potential for significant harmful conflicts of interest. In the decades to come, careful attention to these and other ethical issues will help to define the future professional standing of surgeons.
OBJECT: Surgical innovation is an important driver of improvements in technique and technology, which ultimately translates into improvements in patients' outcomes. Nevertheless, patients may face new risks of morbidity and mortality when surgical innovation is used, and well-intentioned surgical "experimentation" on patients must be regulated and monitored. In this paper the authors examine the challenges of defining surgical innovation and briefly review the literature on this challenging subject. METHODS: Using examples from the field of neurosurgery and in part from the personal experience of the senior author, the authors develop a model of levels of experimental acuity of surgical procedures and offer recommendations on how these procedures would best be regulated. CONCLUSIONS: The authors propose guidelines for determining the need for regulation of innovation. The potential role of institutional review boards in this process is highlighted.
BACKGROUND: Surgical innovation has advanced outcomes in the field, but carries inherent risk for surgeons and patients alike. Oversight mechanisms exist to support surgeon-innovators through difficulties associated with the innovation process. METHODS: A literature review of ethical risks and oversight mechanisms was conducted. RESULTS: Oversight mechanisms range from the historical concept of surgical exceptionalism to departmental, hospital, and centralized committees. These fragmentary and non-standardized oversight mechanisms leave surgeon-innovators and patients open to significant risk of breaching the ethical principles at the core of surgical practice. A systematized approach that mitigates these risks while maintaining the independence and dignity of the surgical profession is necessary. We propose an oversight framework that incorporates multiple structures tailored toward the ethical risk introduced by different forms of innovation. DISCUSSION: We summarize ethical risks and current regulatory structures, and we then use these findings to outline an oversight framework that may be applied to surgical practice.
Surgical innovation promises improvements in healthcare, but it also raises ethical issues including risks of harm to patients, conflicts of interest and increased injustice in access to health care. In this article, we focus on risks of injustice, and use a case study of robotic prostatectomy to identify features of surgical innovation that risk introducing or exacerbating injustices. Interpreting justice as encompassing matters of both efficiency and equity, we first examine questions relating to government decisions about whether to publicly fund access to innovative treatments. Here the case of robotic prostatectomy exemplifies the difficulty of accommodating healthcare priorities such as improving the health of marginalized groups. It also illustrates challenges with estimating the likely long-term costs and benefits of a new intervention, the difficulty of comparing outcomes of an innovative treatment to those of established treatments, and the further complexity associated with patient and surgeon preferences. Once the decision has been made to fund a new procedure, separate issues of justice arise at the level of providing care to individual patients. Here, the case of robotic prostatectomy exemplifies how features of surgical innovation, such as surgeon learning curves and the need for an adequate volume of cases at a treatment centre, can exacerbate injustices associated with treatment cost and the logistics of travelling for treatment. Drawing on our analysis, we conclude by making a number of recommendations for the just introduction of surgical innovations.
OBJECTIVE: To update, clarify, and extend IDEAL concepts and recommendations. BACKGROUND: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. METHODS: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions-Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a "Pre-IDEAL" stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. CONCLUSIONS: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.
This review covers the most recent clinical and surgical advances made in the development and application of cochlear implants (CIs). In recent years, dramatic progress has been made in both clinical and basic science aspect of cochlear implantation. Today's modern CI uses multi-channel electrodes with highly miniaturized powerful digital processing chips. This review article describes the function of various components of the modern multi-channel CIs. A selection of the most recent clinical and surgical innovations is presented. This includes the preliminary results with electro-acoustic stimulation or hybrid devices and ongoing basic science research that is focused on the preservation of residual hearing post-implantation. The result of an original device that uses a binaural stimulation mode with a single implanted receiver/stimulator is also presented. The benefit and surgical design of a temporalis pocket technique for the implant's receiver stimulator is discussed. Advances in biomedical engineering and surgical innovations that lead to an increasingly favorable clinical outcome and to an expansion of the indication of CI surgery are presented and discussed.
The complexity of surgical procedures often poses challenges for conducting a rigorous and comprehensive evaluation. This paper considers the final two IDEAL stages of surgical innovation. Surgical randomised controlled trials are often challenging to undertake and require careful consideration of the intervention definition, who should deliver it, and the impact of surgeon and patient preferences. In the long term study stage, better monitoring of surgical procedures is needed, along with improved surveillance of devices.
INTRODUCTION: Limited resources in low- and middle-income countries (LMICs) drive tremendous innovation in medicine, as well as in other fields. It is not often recognized that several important surgical tools and methods, widely used in high-income countries, have their origins in LMICs. Surgical care around the world stands much to gain from these innovations. In this paper, we provide a short review of some of these successful innovations and their origins that have had an important impact in healthcare delivery worldwide. REVIEW: Examples of LMIC innovations that have been adapted in high-income countries include the Bogotá bag for temporary abdominal wound closure, the orthopaedic external fixator for complex fractures, a hydrocephalus fluid valve for normal pressure hydrocephalus, and intra-ocular lens and manual small incision cataract surgery. LMIC innovations that have had tremendous potential global impact include mosquito net mesh for inguinal hernia repair, and a flutter valve for intercostal drainage of pneumothorax. CONCLUSION: Surgical innovations from LMICs have been shown to have comparable outcomes at a fraction of the cost of tools used in high-income countries. These innovations have the potential to revolutionize global surgical care. Advocates should actively seek out these innovations, campaign for the financial gains from these innovations to benefit their originators and their countries, and find ways to develop and distribute them locally as well as globally.