Design Approaches to Developing Technologies for Global Surgery

Surgical care is a fundamental component of an effective healthcare system, yet most people living in low and middle-income countries have no access to it. Critical to addressing this is the ability to equip low-resource healthcare contexts with appropriate surgical technologies. An estimated 40% of healthcare equipment is unused in these contexts, and there is increasing recognition that new technologies must be designed specifically for them, to provide Affordable, Available, Accessible, Appropriate and Quality solutions. For this, researchers suggest conventional approaches to medical device design are not appropriate, but recommended alternative approaches are in early development stages, and since their use is rarely reported in the literature, little evidence exists with which to improve them. This thesis addresses this paucity of evidence, and describes the integration, implementation, and evaluation of recommended approaches to designing technologies for low-resource healthcare contexts. A design roadmap, and the principles of frugal innovation and participatory design are applied to design a device for gasless laparoscopy in rural hospitals in Northeast India. The evaluation of these approaches considers their influence on the development of the design through a review of the design history of the device and uses an exploratory qualitative study to understand whether the participatory approach was beneficial to the clinical stakeholders, who were participants. The design roadmap provided appropriate structure and advice for the design process but requires further development. A thorough understanding of the use context, local stakeholder participation and ability to maintain quality are important for innovating frugally, but specific methods to guide frugal innovation are required. Clinical stakeholders benefited from participating throughout the design process and supported the process by revealing potential barriers to collaboration as well as potential solutions to them. The results highlight the value and potential for using these approaches to increase global access to surgical care.

We Asked the Experts: The Promises and Challenges of Surgical Telehealth in Low Resourced Settings

Access to safe and timely surgical care saves lives, but its multiple barriers in low- and middle-income countries (LMICs) contribute to high postoperative mortality [1]. In these settings, surgical health systems are fragile due to a shortage of supplies such as drugs, anesthesia equipment and oxygen, the maldistribution of surgical specialists, poor referral systems, and an inability to routinely track processes and outcomes indicators for quality improvement. The ongoing Covid-19 pandemic has heightened barriers to surgical care in LMICs with resultant increases in unmet surgical needs. On the other hand, the pandemic has revealed the great potentials of telehealth.

Telehealth, which is the provision of healthcare-related services over a distance using electronic and telecommunication technologies, has created solutions to leapfrog certain barriers to surgical care in LMICs. Long distance travel to reach facilities and extended waiting times to see specialists can be circumvented by phone and online consultations. These virtual visits are not only cost saving but can prevent critical delays in patient care. Remote consultations can take on various forms. Firstly, initial visits and preoperative instructions can be done through telehealth platforms from the comfort of patient homes. In certain low acuity and elective cases, video visits may make it possible to determine the need for an operation or the need for in-person visitation to assist surgical planning. Additionally, mobile apps, direct phone calls, and instant messaging are suitable for preoperative education and assisting patients in navigating barriers to surgical access in addition to using video chat platforms. Likewise, mHealth apps and real-time video features allow for postoperative follow-up including routine wound inspection and utilize community health workers, nurses, or general medical doctors located closer to the patient than the hospital that provided the surgical care. The addition of artificial intelligence technology to mHealth could aid these cadres to identify wound infections. In Rwanda, machine learning is being harnessed to detect postoperative wound infections in rural women after Cesarean sections [2]. Finally, outreach by surgeons to rural areas can be strengthened by remote preoperative consultations to identify appropriate operative candidates, provide virtual spaces for planning with local teams, and conduct postoperative follow-up. Therefore, telehealth maximizes the impact of visiting specialists and improves the quality of patient care.

Poor communication and referral networks between health facilities are major barriers to timely and quality access to surgical care in LMICs. Telehealth allows doctors and nurses in rural and primary care facilities to communicate quickly with surgeons at regional and tertiary hospitals. The mHealth app, Vula Mobile, is used ubiquitously by South African rural doctors and nurses to refer persons with surgical conditions to specialists at higher level hospitals. A 2019 study showed that one-third of acute orthopedic conditions were managed on this platform through expert advice without the need for transfer [3]. The median response time on the app was less than 30 minutes. In addition, metadata from mHealth referral apps can be used to track volumes, referral times, and patient flow, which might be used for quality improvement efforts. This type of telehealth platform shows promise and might be scaled-up in other LMICs to better link networks of non-specialist health care providers and surgeons.

If higher bandwidth is available, real-time video platforms, which allow for in-depth consultations and case discussions, can be used to overcome specialist shortages in LMICs. Virtual multi-disciplinary conferences are being used in South–South and North–South collaborations. For example, the Global Cancer Institute has a network of over 500 doctors from Africa, Asia, and Latin America who present cancer cases for discussion with US oncology experts [4].

The limited case mix at some LMIC training hospitals and the shortage of surgical subspecialists can impede the acquisition of certain operative skills. Telesurgery, or intra-operative tele-mentoring, is where a senior surgeon located remotely can give immediate and continuous feedback to the operating surgeon. Early attempts at South–South telesurgery collaborations have shown good patient outcomes [5].

Another telehealth innovation for skills acquisition is simulation, or the use of models to imitate the steps of an operation. Simulators can be high-fidelity units with computer animation or low-fidelity models made from inexpensive materials like cardboard boxes and graspers to learn three-dimensional techniques such as laparoscopic suturing and knot tying. Simulation has been shown to be particularly useful during the Covid-19 pandemic to augment training since elective operative volume has decreased in almost every country worldwide…

Unmet Surgical Need in Malawi

Introduction
Globally, and especially in sub-Saharan Africa, including Malawi, surgical conditions receive a low level of priority in national health systems. The burden of surgical diseases is not well documented and the reasons for which people still live with treatable conditions and disabilities or sometimes present late for care have also not been studied. There is also little information on surgical deaths from untreated conditions in both adults and children, including trauma, as well as potential barriers to obtaining surgical care.
Objectives
The aim of this thesis was therefore to describe the untreated surgical conditions, in both adults and children, the barriers to surgical health care, as well as to document information about deaths from surgical conditions in Malawi.
Methods
This thesis is based on four papers. All four involved data collected using the SOSAS tool, which is a questionnaire-based data collection tool for documenting household information in the communities. The tool had three sections, the first section capturing demographic data for the households; including number of occupants, ages, gender, location and type of household, and tribe. The next two sections were similar but involved interviewing two different people and asking about information relating to surgical conditions present for both adults and paediatric age groups, including injuries, associated disability from acquired or congenital disorders, transportation to health facility and location of death from different surgical conditions. The two household members interviewed, included the head of household and another random member within the household. Data collection was centrally organized by a project group, and performed by third year medical students from the University of Malawi, College of Medicine.
Data was collected as a national survey from the 28 districts in Malawi. The National Statistics Board helped us to identify the villages used in the study.
Results
We found that a third of the Malawian population were living with a surgical condition and were in need of a surgical consultation or treatment. These conditions were either congenital or the result of a traumatic or other non-traumatic condition. We also found that almost one fifth of the children with a surgical condition that could have been treated by surgery, instead remained with a disability that affected their daily lives.
In addition, we found that transportation poses a barrier to timely access to surgical health care. Transportation barriers included the lack of efficient public transportation, cost implications, and long travel distances to get to a health facility capable of offering care by either consultation or surgical procedures.
Other findings were that acute abdominal distention, body masses and trauma, contribute to surgical conditions that are highly associated with mortality in Malawian communities. We also noted that there are various reasons that lead to delays in obtaining formal health care, including initial consultations with traditional herbalists before going to the hospital.
Conclusion
Almost 6 million Malawian people, including an estimated 2 million children, are living with a condition that could be treated by either a surgical procedure or consultation. There are an estimated 1 million disabled children currently living with such surgically treatable conditions. The treatment of these conditions is hampered by transportation barriers. The transportation barriers have led to delays in obtaining timely surgical health care service, something that often leads to mortality. The common causes of these deaths are from injuries, but also other surgical emergencies. Most of these deaths occur outside a health facility environment.

Addressing quality in surgical services in sub-Saharan Africa: hospital context and data standardisation matter

In low-and-middle-income countries (LMICs), there remain critical gaps in the quality of surgical care. Comparatively high rates of surgical adverse events occur and are likely highly preventable. There has been substantial focus on improving access to health services, including surgical care in LMICs, yet quality oversight and improvement practices remain limited in these settings.4 Over the past decade, surgical volume has doubled in the most resource-poor settings; between 2004 and 2012, the annual number of operations jumped from 234 million to 313 million, with the biggest growth occurring in countries with the lowest amount of healthcare spending.5 6 This signals a profound shift: whereas prior efforts were focused on infections and maternal health, non-communicable diseases such as cancers and trauma are an increasing priority for LMIC health systems. With the rapid growth in surgical delivery, the quality and safety of care are critically important. Poor outcomes and high morbidity breed mistrust, scepticism and fear among local populations, and thus hinder the mission of health systems to provide timely and essential services, especially risky ones like surgery.

Global community perception of ‘surgical care’ as a public health issue: a cross sectional survey

Background
In the last decade surgical care has been propelled into the public health domain with the establishment of a World Health Organisation (WHO) designated programme and key publications. The passing of the historic World Health Assembly Resolution (WHA) acknowledged surgical care as a vital component towards achieving Universal Health Coverage (UHC). We conducted the first worldwide survey to explore the perception of surgical care as a public health issue.

Method
The anonymous, cross sectional survey targeted worldwide participants across a range of professional backgrounds, including non-medical using virtual snowball sampling method (in English) using Google Forms (Google Inc., Mountain View, CA, USA) from 20th February 2019 to 25th June 2019. The survey questions were designed to gauge awareness on Sustainable Development Goals (SDGs), UHC, WHO programmes and key publications on surgical care as well as perception of surgical care as a priority topic in public health.

Results
The survey was completed by 1954 respondents from 118 countries. Respondents were least aware of surgical care as a teaching topic in public health courses (27%; n = 526) and as a WHO programme (20%; n = 384). 82% of respondents were aware of UHC (n = 1599) and of this 72% (n = 1152) agreed that surgical care fits within UHC. While 77% (n = 1495) of respondents were aware of SDGs, only 19% (n = 370) agreed that surgery was a priority to meet SDGs. 48% (n = 941) rated surgical care as a cost-effective component of Primary Health Care. 88% (n = 1712) respondents had not read the WHA Resolution on ‘Strengthening emergency and essential surgical care and anaesthesia as a component of UHC’.

Conclusion
There is still a widespread gap in awareness on the importance of surgical care as a public health issue amongst our respondents. Surgical care was not seen as a priority to reach the SDGs, less visible as a WHO programme and not perceived as an important topic for public health courses.

Development of an Interactive Global Surgery Course for Interdisciplinary Learners

Introduction: Global surgical care is increasingly recognized in the global health agenda and requires multidisciplinary engagement. Despite high interest among medical students, residents and other learners, many surgical faculty and health experts remain uniformed about global surgical care.

Methods: We have operated an interdisciplinary graduate-level course in Global Surgical Care based on didactics and interactive group learning. Students completed a pre- and post-course survey regarding their learning experiences and results were analyzed using the Wilcoxon signed-rank test.

Results: Fourteen students completed the pre-course survey, and 11 completed the post-course survey. Eleven students (79%) were enrolled in a Master’s degree program in global health, with eight students (57%) planning to attend medical school. The median ranking of surgery on the global health agenda was fifth at the beginning of the course and third at the conclusion (p = 0.11). Non-infectious disease priorities tended to stay the same or increase in rank from pre- to post-course. Infectious disease priorities tended to decrease in rank (HIV/AIDS, p = 0.07; malaria, p = 0.02; neglected infectious disease, p = 0.3). Students reported that their understanding of global health (p = 0.03), global surgery (p = 0.001) and challenges faced by the underserved (p = 0.03) improved during the course. When asked if surgery was an indispensable part of healthcare, before the course 64% of students strongly agreed, while after the course 91% of students strongly agreed (p = 0.3). Students reported that the interactive nature of the course strengthened their skills in collaborative problem-solving.

Conclusions: We describe an interdisciplinary global surgery course that integrates didactics with team-based projects. Students appeared to learn core topics and held a different view of global surgery after the course. Similar courses in global surgery can educate clinicians and other stakeholders about strategies for building healthy surgical systems worldwide.

Methods for estimating economic benefits of surgical interventions in low-income and middle-income countries: a scoping review

Objectives Studies indicate that many types of surgical care are cost-effective compared with other health interventions in low-income and middle-income countries (LMICs). However, global health investments to support these interventions remain limited. This study undertakes a scoping review of research on the economic impact of surgical interventions in LMICs to determine the methodologies used in measuring economic benefits.

Design The Arksey and O’Malley methodological framework for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist were used to review the data systematically. Online databases were used to identify papers published between 2005 and 2020, from which we selected 19 publications that quantitatively examined the economic benefits of surgical interventions in LMICs.

Results Majority of publications (79%) reported the use of disability-adjusted life-years (DALYs) to assess economic impact. In comparison, 21% used other measures, such as the value of statistical life or cost-effectiveness ratios, or no measure at all. 31% were systematic or retrospective reviews of the literature on surgical procedures in LMICs, while 69% either directly assessed economic impact in a specific area or evaluated the need for surgical procedures in LMICs. All studies reviewed related to the economic impact of surgical procedures in LMICs, with most about paediatric surgical procedures or a specific surgical specialty.

Conclusion To make informed policy decisions regarding global health investments, the economic impact must be accurately measured. Researchers employ a range of techniques to quantify the economic benefit of surgeries in LMICs, which limits understanding of overall economic value. We conclude that the literature would benefit from a careful selection of methods, incorporating age and disability weights based on the Global Burden of Disease weights, and converting DALYs to dollars using the value of statistical life approach and the human capital approach, reporting both estimates.

Delays in hospital admissions in patients with fractures across 18 LMIC (INORMUS): a prospective observational study

Background: The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission. Methods: In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and fracture location. We further calculated adjusted relative risk (RR) from adjusted odds ratios, adjusted for the same variables. This study was registered with ClinicalTrials.gov, NCT02150980, and is ongoing. Findings: Between April 3, 2014, and May 10, 2019, we enrolled 31 255 patients with fractures, with a median age of 45 years (IQR 31-62), of whom 19 937 (63·8%) were men, and 14 524 (46·5%) had lower limb fractures, making them the most common fractures. Of 5256 patients with open fractures, 3778 (71·9%) were not admitted to hospital within 2 h. Of 25 999 patients with closed fractures, 7141 (27·5%) were delayed by more than 24 h. Of all regions, Latin America had the greatest proportions of patients with delays (173 [88·7%] of 195 patients with open fractures; 426 [44·7%] of 952 with closed fractures). Among patients delayed by more than 24 h, the most common reason for delays were interfacility referrals (3755 [47·7%] of 7875) and Third Delays (cumulatively interfacility referral and delay in emergency department: 3974 [50·5%]), while Second Delays (delays in reaching care) were the least common (423 [5·4%]). Compared with other methods of transportation (eg, walking, rickshaw), ambulances led to delay in transporting patients with open fractures to a treating hospital (adjusted RR 0·66, 99% CI 0·46-0·93)…(abstract continued on full journal site)

Does insurance protect individuals from catastrophic payments for surgical care? An analysis of Ghana’s National Health Insurance Scheme at Korle-Bu teaching Hospital

Background
According to the World Health Organization, essential surgery should be recognized as an essential component of universal health coverage. In Ghana, insurance is associated with a reduction in maternal mortality and improved access to essential medications, but whether it eliminates financial barriers to surgery is unknown. This study tested the hypothesis that insurance protects surgical patients against financial catastrophe.

Methods
We interviewed patients admitted to the general surgery wards of Korle-Bu Teaching Hospital (KBTH) between February 1, 2017 – October 1, 2017 to obtain demographic data, income, occupation, household expenditures, and insurance status. Surgical diagnoses and procedures, procedural fees, and anesthesia fees incurred were collected through chart review. The data were collected on a Qualtrics platform and analyzed in STATA version 14.1. Fisher exact and Student T-tests were used to compare the insured and uninsured groups. Threshold for financial catastrophe was defined as health costs that exceeded 10% of household expenditures, 40% of non-food expenditures, or 20% of the individual’s income.

Results
Among 196 enrolled patients, insured patients were slightly older [mean 49 years vs 40 years P < 0.05] and more of them were female [65% vs 41% p < 0.05]. Laparotomy (22.2%) was the most common surgical procedure for both groups. Depending on the definition, 58–87% of insured patients would face financial catastrophe, versus 83–98% of uninsured patients (all comparisons by definition were significant, p < .05).

Conclusion
This study—the first to evaluate the impact of insurance on financial risk protection for surgical patients in Ghana—found that although insured patients were less likely than uninsured to face financial catastrophe as a result of their surgery, more than half of insured surgical patients treated at KBTH were not protected from financial catastrophe under the Ghana’s national health insurance scheme due to out-of-pocket payments. Government-specific strategies to increase the proportion of cost covered and to enroll the uninsured is crucial to achieving universal health coverage inclusive of surgical care.