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Wellcome Leap: Unconventional Projects. Funded at Scale.

A $50M program

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SURGERY: ASSESS / VALIDATE / EXPAND

We are pleased to announce the selected performers.

Zev Williams, Columbia University

Antoniya Georgieva, University of Oxford

Michelle Oyen, Washington University in St. Louis

Every year 313 million operations are performed around the world – surgery is an indispensable part of healthcare.i, ii, iii Sixty percent of all surgery is conducted in high income countries where the infrastructure, financing, and highly skilled human resources are concentrated, but where only 15% of the population live.i, iv An additional 143 million operations are needed annually to meet basic health needs, most urgently in low resource settings, but also to achieve equity across communities in all countries.v This lack of access to essential and emergency surgery results in at least 1.5 million deaths each year,vi which is equivalent to the number of deaths from HIV, malaria, multi-drug resistant TB, and complications from pregnancy combined.

And this lack of access is set to get worse. Over 1/3 of the world’s population lives in regions without a sufficient surgical workforce. Trauma, pregnancy-related complications, and general surgical emergencies constitute up to 80% of preventable deaths due to lack of surgical access. In parts of Asia and Africa, the surgical workforce needs to be expanded 10-100x to meet basic needs.iv At the same time, healthcare staffing shortages are increasing worldwide. The World Health Organization has labeled the healthcare workforce shortage in Europe a “ticking time bomb”, with 40% of medical doctors (MDs) retiring within the next decade.vii, viii In the UK, the Royal College of Physicians noted that 52% of staff posts remained unfilled in the National Health Service.ix In the United States the current surgical workforce only meets 75% of demand in rural and suburban areas, with a projected shortage of over 16,000 surgical specialists in the next decade.x, xi

Of the 143 million “missing” operations required to save lives and prevent disability, we estimate that up to 30 million involve abdominal and pelvic conditions that could be treated using minimally invasive techniques. To date, laparoscopic surgery has improved the ability to deliver such operations while simultaneously reducing postoperative infections, length of stay, postoperative pain, and even long-term complications such as internal scarring. Moreover, it lends itself to advanced simulation, quantitative assessment, and validation that could dramatically expand the number of surgeons available.

To deliver 30 million abdominal and pelvic operations will require training an additional 100,000 surgeons. At current rates of training, this is unachievable. The number of MDs as a proportion of the population has remained essentially the same for the last 30 years; and in low- and middle-income countries, woefully inadequate.xii We need a fundamental change.

Program goals:

  1. Demonstrate the capability to train non-MD practitioners to deliver routine laparoscopic surgery with equivalent outcomes to MD surgeons using a next- generation simulation, validation, and certification program of 3 years or less.
  2. Shorten the timeline needed to train MD surgeons – by a full year – through the use of new tools that accelerate skills acquisition of minimally invasive techniques and enable objective quantification of competence.
  3. Reduce postoperative complications and mortality by >50% through advanced sensing, monitoring, and pattern recognition strategies, especially during periods of rapid expansion of services, thus increasing the confidence of surgeons, hospitals, patients, and families.

By combining these three advances, the program aims to double the number of surgical providers per year to an additional 100,000 within a decade, thus increasing the provisioning of minimally invasive abdominal operations by 30 million and simultaneously reducing global postoperative deaths by 1 million.

Two reasons this is possible now.

First, minimally invasive surgical techniques have dramatically changed the delivery of abdominal surgery.

Since the introduction of the first laparoscopic cholecystectomy (gall bladder removal) in Germany in 1985, laparoscopy has transformed surgery. By 1992 – less than 10 years – this approach surpassed the traditional open approach for cholecystectomy in the US. Similarly, minimally invasive approaches are now more common for appendectomy, colon resection, antireflux surgery, metabolic surgery, and peptic ulcer perforation repair. Laparoscopy improves visualization while reducing postoperative infections, pain, recovery time, and length of stay.

Minimally invasive approaches also enable immersive simulation training environments, objective assessment of skills, and virtual augmentation and overlays to assist visualization and anatomic identification during surgery. In fact, the only objective assessment of surgical skill in the US is the Fundamentals of Laparoscopic Surgery program, with its strict time and performance metrics for competence. Yet the skills being evaluated are only a partial proxy for actual laparoscopic performance during surgery.

Simulation enables accelerated skills acquisition in a controlled, predictable manner, and does so using techniques that directly translate to the successful start-to-finish execution of an operation. The evidence of what is possible can be found in many high-risk/high- reliability organizations that elevated human skill and performance. In pilot training, for example, simulation is an accepted component of skills development, and use of a simulator can reduce time to pilot certification by 40%.xiii, xiv Surgery lacks equivalent sophisticated, full spectrum simulators that are able to quantify, validate, and safely accelerate both general and rare event exposure so as to quantitatively validate acquisition of skill. Developing these tools will create new options for scaling the workforce.

Second, new sensing and algorithmic approaches have changed our ability to predict perioperative patient trajectories earlier and with greater accuracy.

The amount of patient data we capture in a hospitalized patient is extensive. Information derives from simple assessments of general patient appearance and mental state coupled with regular measurement of vital signs, to laboratory values, culture results from blood and fluid samples, and imaging studies. From this information clinicians attempt to make determinations for next steps in care and treatment based on experience, knowledge, and pattern recognition. Yet this information has become increasingly complicated, nuanced, and in many ways overwhelming, especially in the intensive care unit where continuous monitoring is obligatory and includes such measures as beat-to-beat heart rate variability, pulse pressure variation due to respiratory dynamics, bedside assessments of intravascular volume and heart function using ultrasound, and brain and pupillary activity. Integrating and interpreting all these signals requires years of training and frequently includes specialists in intensive care medicine. With recent advances in data analytics and machine learning, algorithms and automation – combined with ever increasing amounts of patient data captured— have allowed the early detection of patient deterioration and alerted teams to impending decline in some of the best-in-class hospitals in the world, resulting in up to a 15% decline in mortality.xv, xvi

We need advances in such tools and techniques to better evaluate patient biophysiology and we need to integrate data across modalities such as vital signs, laboratory results, tissue perfusion, and bedside assessments. Reliably understanding and accurately predicting patient recovery or deterioration is still lacking, and so we need new sensors, diagnostics, and analytics for anticipating the trajectory of a surgical patient. Hospitals that perform high numbers of surgeries often develop the capacity to recognize patient deterioration quickly. Our goal is to embody these lessons in scalable, predictive caregiver- sensor-algorithmic systems that can be broadly disseminated to reduce risk post- operatively, especially during periods of rapid expansion of services.

The arc of surgery.

Abdominal surgery is complex. For it to be successful, a patient must be properly diagnosed; undergo a timely and carefully performed operation while being continuously monitored for problems; safely emerge from anesthesia; recuperate from surgery; and, should a complication occur, quickly receive appropriate interventions and support. In the words of the late Paul Farmer, the arc of surgery requires “staff, stuff, space, and systems”. Human resources, consumable and durable materials, and organizational capacities are vital for managing and successfully treating patients. Failures at each step result in unnecessary delays, excess harm, additional costs, and avoidable mortality, each of which undermines confidence in the health system.

While the lack of durable and consumable goods is easy to blame for lack of service, the biggest factor is the lack of a surgical workforce. The Lancet Commission on Global Surgery recommends at least 20 surgeon/obstetrician/anesthesia providers per 100,000 population to meet basic health needs; many regions are an order of magnitude below this threshold, with little capacity to expand the workforce.iv Specialty surgical training typically requires completion of medical school followed by 5-7 years of graduated responsibility under the mentorship of fully qualified and credentialed surgeons. However, training is highly variable as the full breadth of operative experience is unpredictable; even common operations may be infrequently performed during the years of surgical apprenticeship.xvii, xviii Skills acquisition is assumed based on volume metrics, with numeric targets substituting for quantifiable, skills- based assessments. Countries with insufficient human resources are particularly challenged in expanding the workforce, since so few experienced surgeons exist to provide the necessary guidance, training, mentorship, and oversight for the next generation of clinicians.xix Yet even in highly resourced countries, the timeline of surgical training is failing to generate enough providers. The current paradigm of surgical skills training and development meets neither present day nor future health needs.

Beyond provider skill, the safety of surgery is paramount. Postoperative mortality is already the third leading cause of death globally, and expanding surgical capacity without simultaneously improving the monitoring and safety of surgery will save many lives but also result in 6 million postoperative deaths, most of which can be averted.xx Complications arise in 15-20% of patients undergoing open abdominal surgery regardless of locale, institution, or setting.xxi, xxii Many complications can be anticipated, and all must be identified and dealt with quickly. Early identification, rapid supportive care, early reintervention, and close monitoring and ongoing assessment – collectively called “rescue” care – can ensure patients suffering complications are safely steered back to recovery and hospital discharge. The ability to “rescue” is highly variable; in the US, the difference between hospitals with low mortality and high mortality following surgery is not a function of complication rates (which are roughly the same) but rather a function of the ability to “rescue” patients with complications and nurse them back to health.xxiii This disparity is seen more acutely across country income levels, with mortality rates following complications 2-3 fold higher in lower vs higher resource settings, even while complication rates are roughly equivalent.xxiv, xxv

The method of patient monitoring and evaluation is part of this variability in mortality. Assessment involves observing vital signs captured on a minute-by-minute basis, interpreting laboratory findings assessed over hours to days, and deciphering imaging studies, which may be rapidly available in some settings and entirely absent in others. None of these modalities are integrated, prognostic, or provide proactive decision support for clinicians caring for these complicated patients. Because the insults of surgery and the effects of perioperative medications mimic numerous conflicting physiological responses, differentiating between normal recovery and imminent complications is challenging, even for the most experienced clinician. Enhancing the discrimination of diagnostics would be invaluable for improving perioperative management and preventing perioperative mortality.

In the arc of surgery, recovery from an operation is as important as its provision.

Program objectives.

To achieve the program goals, we will:

  • Create and deploy new models for minimally invasive abdominal surgery skills acquisition and objective assessment, supported by instruments tailored for this task. These new models should support the ability to both:
    • Identify and screen innate capabilities in non-MD practitioners and provide surgical training with validation of skills and certifiably comparable outcomes.
    • Decrease training time for MD surgeons.
  • Produce new patient recovery or deterioration detection systems that utilize patterns from inputs as wide ranging as caregiver interactions, existing and new sensing methods, and novel biomarkers, to evaluate patient condition and predict recovery or deterioration following surgery.
  • Validate the impact of these programs through a demonstration at the health system, state/province, or national level.

We need advances in such tools and techniques to better evaluate patient biophysiology and we need to integrate data across modalities such as vital signs, laboratory results, tissue perfusion, and bedside assessments. Reliably understanding and accurately predicting patient recovery or deterioration is still lacking, and so we need new sensors, diagnostics, and analytics for anticipating the trajectory of a surgical patient. Hospitals that perform high numbers of surgeries often develop the capacity to recognize patient deterioration quickly. Our goal is to embody these lessons in scalable, predictive caregiver- sensor-algorithmic systems that can be broadly disseminated to reduce risk post- operatively, especially during periods of rapid expansion of services.

Program Director.

Thomas G Weiser, MD, MPH, is a practicing general and trauma surgeon at Stanford University. His research focuses on quality and safety of surgical care, compliance with standards, and implementation of best practices. He was part of the World Health Organization’s Safe Surgery Saves Lives program, where he quantified the global volume of surgery and helped to create and implement the WHO Surgical Safety Checklist. He earned his MD from the University of New Mexico and Master of Public Health (MPH) from Harvard T.H. Chan School of Public Health.

Who are eligible Wellcome Leap program performers?

Performers are from universities and research institutions: small, medium and large companies (including venture-backed); and government or non-profit research organizations. We encourage individuals, research labs, companies, or small teams to apply in program areas best aligned with their expertise and capabilities. It is not necessary to form a large consortium or a single team to address all thrusts or an entire program goal in an abstract or proposal. Indeed, one of the benefits of our programs is that we actively facilitate collaboration and synergies dynamically among performers as we make progress together toward the program’s goals.

Process and timeline

Program announcement.

30 DAYS FOR PREPARATION AND SUBMISSION OF ABSTRACT

15-Day Abstract review round.

/ Day 1
Submission deadline: 27 October 2022
/ Day 11
Abstract feedback sent: 7 November 2022

All submissions will receive technical and/or programmatic feedback as well as a recommendation to submit or not submit a full proposal.

30 DAYS FOR PREPARATION OF FULL PROPOSALS AFTER ABSTRACT FEEDBACK

30-Day Full proposal review round.

/ Day 41
Submission deadline: 7 December 2022
/ Day 71
Proposal decision sent: 6 January 2023

All submissions will receive a ‘selected for funding’ or ‘not selected for funding’ decision. Those selected will proceed to contract signature as the final gate with work expected to commence within approximately 30 days.

Mechanics of applying

Who is eligible?

Performers from universities and research institutions: small, medium and large companies (including venture-backed); and government or non-profit research organizations are invited to propose.

To submit an abstract, applicants will be asked to agree to the following:

I understand that the information being disclosed will be reviewed and evaluated independently on behalf of Wellcome Leap. I am submitting information with the intention that it imposes no confidentiality obligations on Wellcome Leap. Furthermore, my submission does not breach any confidentiality obligations that I owe to others; there is no legal reason why I cannot submit information; and I am not underage or otherwise legally incompetent. By submitting, I am not granting, other than for the purpose of evaluation, any rights in relation to any patent, copyright or design. I am not relying upon Wellcome Leap in any way for legal advice, including (but not limited to) whether the contents of my submission can be protected under IP law. I recognize that Wellcome Leap may already be aware of or funding the same or related efforts as described by my submission. I agree that no contractual obligation or working relationship is being created between myself and Wellcome Leap by submitting this information. If the submission is deemed of interest, I may be required to sign a further Agreement with Wellcome Leap so that any confidential information, that is subsequently shared, is protected.

Frequently asked questions.

If you have questions, please review our FAQ section. – updated 7 December 2022.

Send inquiries to save@wellcomeleap.org

i Weiser TG, Haynes AB, Molina G, et al. Size and distribution of the global volume of surgery in 2012. Bulletin World Health Organization 2016;94:201–209F. doi: http://dx.doi.org/10.2471/BLT.15.159293.

ii Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015;386(9993):569-624.

iii Bickler SW, Weiser TG, Kassebaum N, et al. Global Burden of Surgical Conditions. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, eds. Essential Surgery – Disease Control Priorities. Washington, DC: The World Bank. 2015.

iv Holmer H, Lantz A, Kunjumen T, et al. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Global Health. 2015;3 Suppl 2:S9-11.

v Rose J, Weiser TG, Hider P, Wilson L, Gruen RL, Bickler SW. Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate. Lancet Global Health. 2015;3 Suppl 2:S13-20.

vi Mock CN, Donkor P, Gawande A, Jamison DT, Kruk ME, Debas HT. Essential surgery: key messages from Disease Control Priorities, 3rd edition. Lancet. 2015;385(9983):2209-2219

vii World Health Organization. Health and care workforce in Europe: time to act. Copenhagen: WHO Regional Office for Europe; 2022. Licence: CC BY-NC-SA 3.0 IGO. https://www.who.int/europe/publications/i/item/9789289058339

viii Health Policy Watch. Shortage of Health Workers is a ‘Ticking Time Bomb’ – Even in Europe. 15 Sept 2022. https://healthpolicy-watch.news/shortage-of-health-workers-is-a-ticking-time-bomb-even-in-europe/

ix Royal College of Physicians. RCP census finds record number of physician jobs unfilled. 15 July 2022. https://www.rcplondon.ac.uk/news/rcp-census-finds-record-number-physician-jobs-unfilled

x IHS Markit Ltd. The Complexities of Physician Supply and Demand: Projections From 2019 to 2034. Washington, DC: American Association of Medical Colleges; 2021. https://www.aamc.org/news-insights/press-releases/aamc-report-reinforces-mounting-physician-shortage

xiAmerican College of Surgeons. Report to the Senate Committee on Appropriations. 2018. https://www.facs.org/media/aqaj2m1r/hrsa-general-surgeon-projection-report-to-appropriations.pdf

xiiOur World in Data. https://ourworldindata.org/grapher/physicians-per-1000-people

xiiiFederal Aviation Administration. https://www.faa.gov/newsroom/faa-issues-new-flight-simulator-regulations

xivLubner M, Dattel AR, Henneberry D, DeVivo S. Follow-Up Examination of Simulator-Based Training Effectiveness. 2015. 18th International Symposium on Aviation Psychology, 530-535. https://corescholar.libraries.wright.edu/isap_2015/17

xvEscobar GJ, Liu VX, Schuler A, Lawson B, Green JD, Kipnis P. Automated Identification of Adults at Risk for In-Hospital Clinical Deterioration. New England J Medicine. 2020 12;383(20):1951-1960.

xviAdams R, Henry KE, Sridharan A, et al. Prospective, multi-site study of patient outcomes after implementation of the TREWS machine learning-based early warning system for sepsis. Nature Medicine. 2022 Jul;28(7):1455-1460.

xviiBell RH, Beister TW, Tabuenca A, et al. Operative Experience of Residents in US General Surgery Programs: A Gap Between Expectation and Experience. Annals of Surgery 2009;249: 719–724.

xviiiStrosberg DS, Quinn KM, Abdel-Misih SR, Harzman AE. Redefining the Surgical Council of Resident Education (SCORE) Curriculum: A Comparison with the Operative Experiences of Graduated General Surgical Residents. American Surgeon. 2018 84:526-530.

xixHolmer H, Shrime MG, Riesel JN, Meara JG, Hagander L. Towards closing the gap of the global surgeon, anaesthesiologist, and obstetrician workforce: thresholds and projections towards 2030. Lancet. 2015;385 Suppl 2:S40.

xxNepogodiev D, Martin J, Biccard B, Makupe A, Bhangu A, National Institute for Health Research Global Health Research Unit on Global S. Global burden of postoperative death. Lancet. 2019;393(10170):401.

xxiGlobalSurg C. Mortality of emergency abdominal surgery in high-, middle- and low-income countries. British J Surgery. 2016;103(8):971-988.

xxiiGlobalSurg C, National Institute for Health Research Global Health Research Unit on Global S. Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries. Lancet. 2021;397(10272):387-397.

xxiiiGhaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. New England J Medicine. 2009;361(14):1368-1375.

xxivGlobalSurg C, Surgery NGHRUoG. Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study. Lancet Global Health. 2022;10(7):e1003-e1011.

xxvBiccard BM, Madiba TE, Kluyts HL, et al. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018;391(10130):1589-1598.

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