STOP Signs: A Population-based Interrupted Time Series Analysis of Antibiotic Duration for Complicated Intraabdominal Infection Before and After the Publication of a Landmark RCT.

OBJECTIVE: To determine if the STOP-IT randomized controlled trial changed antibiotic prescribing in patients with Complicated Intraabdominal Infection (CIAI). SUMMARY OF BACKGROUND DATA: CIAI is common and causes significant morbidity. In May 2015, the STOP-IT randomized controlled trial showed equivalent outcomes between four-day and clinically determined antibiotic duration. METHODS: This was a population-based retrospective cohort study using interrupted time series methods. The STOP-IT publication date was the exposure. Median duration of inpatient antibiotic prescription was the outcome. All adult patients admitted to four hospitals in Calgary, Canada between July 2012 and December 2018 with CIAI who survived at least four days following source control were included. Analysis was stratified by infectious source as appendix or biliary tract (group A) versus other (group B). RESULTS: Among 4384 included patients, clinical and demographic attributes were similar before vs after publication. In Group A, median inpatient antibiotic duration was 3 days and unchanged from the beginning to the end of the study period [adjusted median difference -0.00 days, 95% confidence interval (CI) -0.37 - 0.37 days]. In Group B, antibiotic duration was shorter at the end of the study period (7.87 vs 6.73 days; -1.14 days, CI-2.37 - 0.09 days), however there was no change in trend following publication (-0.03 days, CI -0.16 - 0.09). CONCLUSIONS: For appendiceal or biliary sources of CIAI, antibiotic duration was commensurate with the experimental arm of STOP-IT. For other sources, antibiotic duration was long and did not change in response to trial publication. Additional implementation science is needed to improve antibiotic stewardship.

Compact for care: how the Affordable Care Act marketplaces fell short for a vulnerable population in Hawaii.

The Patient Protection and Affordable Care Act (ACA) was passed in 2010 to expand access to health insurance in the USA and promote innovation in health care delivery. While the law significantly reduced the proportion of uninsured, the market-based protection it provides for poor and vulnerable US residents is an imperfect substitute for government programs such as Medicaid. In 2015, residents of Hawaii from three Compact of Free Association nations (the Federated States of Micronesia, Palau and Marshall Islands) lost their eligibility for the state's Medicaid program and were instructed to enrol in coverage via the ACA marketplace. This transition resulted in worsened access to health care and ultimately increased mortality in this group. We explain these changes via four mechanisms: difficulty communicating the policy change to affected individuals, administrative barriers to coverage under the ACA, increased out of pocket health care costs and short enrolment windows. To achieve universal health coverage in the USA, these challenges must be addressed by policy-makers.

Canadian Doctors for Protection from Guns: how physicians contributed to policy change.

Physicians played a key role in advancing Canada's recent assault weapons ban. Indeed, after announcing the ban in May 2020, the Trudeau government thanked Dr. Najma Ahmed and the group Canadian Doctors for Protection from Guns (CDPG) for their support of responsible gun control measures. In this piece, we explore the context in which CDPG was formed, the strategies used by the group in building nationwide support for gun control measures, and the public health framing of their messaging that proved critical in engendering political change. The work of CDPG holds valuable lessons for physicians seeking to engage in political advocacy by bearing witness to the harms experienced by their patients.

Perioperative mortality as a meaningful indicator: Challenges and solutions for measurement, interpretation, and health system improvement.

Expanding global access to safe surgical and anaesthesia care is crucial to meet the health targets of the Sustainable Development Goals (SDGs). As global surgical volume increases, improving safety throughout the patient care pathway is a public health priority. At present, an estimated 4.2 million individuals die within 30 days of surgery each year, and many of these deaths are preventable. Important considerations for the collection and reporting of perioperative mortality data have been identified in the literature, but consensus has not been established on the best methodology for the quantification of excess surgical mortality at a hospital or health system level. In this narrative review, we address challenges in the use of perioperative mortality rates (POMR) for improving patient safety. First, we discuss controversies in the use of POMR as a health system indicator and suggest advantages for using a "basket" of procedure-specific mortality rates as an adjunct to gross POMR. We offer then solutions to challenges in the collection and reporting of POMR data, and propose interventions for improving care in the preoperative, operative, and postoperative periods. Finally, we discuss how health systems leaders and frontline clinicians can integrate surgical safety into both national health plans and patient care pathways to drive a sustainable safety revolution in perioperative care.

Protocol for a parallel economic evaluation of a trial comparing two surgical strategies in severe complicated intra-abdominal sepsis: the COOL-cost study.

BACKGROUND: The risk of death in severe complicated intra-abdominal sepsis (SCIAS) remains high despite decades of surgical and antimicrobial research. New management strategies are required to improve outcomes. The Closed Or Open after Laparotomy (COOL) trial investigates an open-abdomen (OA) approach with active negative pressure peritoneal therapy. This therapy is hypothesized to better manage peritoneal bacterial contamination, drain inflammatory ascites, and reduce the risk of intra-abdominal hypertension leading to improved survival and decreased complications. The total costs and cost-effectiveness of this therapy (as compared with standard fascial closure) are unknown. METHODS: We propose a parallel cost-utility analysis of this intervention to be conducted alongside the 1-year trial, extrapolating beyond that using decision analysis. Using resource use metrics (e.g., length of stay, re-admissions) from patients at all study sites and microcosting data from patients enrolled in Calgary, Alberta, the mean cost difference between treatment arms will be established from a publicly-funded health care payer perspective. Quality of life will be measured at 6 months and 1 year postoperatively with the Euroqol EQ-5D-5 L and SF-36 surveys. A within-trial analysis will establish cost and utility at 1 year, using a bootstrapping approach to provide confidence intervals around an estimated incremental cost-effectiveness ratio. If neither operative strategy is economically dominant, Markov modeling will be used to extrapolate the cost per quality-adjusted life years gained to 2-, 5-, 10-year, and lifetime horizons. Future costs and benefits will be discounted at 1.5% per annum. A cost-effectiveness acceptability curve will be generated using Monte Carlo simulation. If all trial outcomes are similar, the primary analysis will default to a cost-minimization approach. Subgroup analysis will be carried out for patients with and without septic shock at presentation, and for patients whose initial APACHE II scores are > 20 versus ≤ 20. DISCUSSION: In addition to an estimate of the clinical effectiveness of an OA approach for SCIAS, an understanding of its cost effectiveness will be required prior to its adoption in any resource-constrained environment. We will estimate this key parameter for use by clinicians and policymakers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03163095, registered May 22, 2017.

Perioperative mortality rates in low-income and middle-income countries: a systematic review and meta-analysis.

INTRODUCTION: The Lancet Commission on Global Surgery proposed the perioperative mortality rate (POMR) as one of the six key indicators of the strength of a country's surgical system. Despite its widespread use in high-income settings, few studies have described procedure-specific POMR across low-income and middle-income countries (LMICs). We aimed to estimate POMR across a wide range of surgical procedures in LMICs. We also describe how POMR is defined and reported in the LMIC literature to provide recommendations for future monitoring in resource-constrained settings. METHODS: We did a systematic review of studies from LMICs published from 2009 to 2014 reporting POMR for any surgical procedure. We extracted select variables in duplicate from each included study and pooled estimates of POMR by type of procedure using random-effects meta-analysis of proportions and the Freeman-Tukey double arcsine transformation to stabilise variances. RESULTS: We included 985 studies conducted across 83 LMICs, covering 191 types of surgical procedures performed on 1 020 869 patients. Pooled POMR ranged from less than 0.1% for appendectomy, cholecystectomy and caesarean delivery to 20%-27% for typhoid intestinal perforation, intracranial haemorrhage and operative head injury. We found no consistent associations between procedure-specific POMR and Human Development Index (HDI) or income-group apart from emergency peripartum hysterectomy POMR, which appeared higher in low-income countries. Inpatient mortality was the most commonly used definition, though only 46.2% of studies explicitly defined the time frame during which deaths accrued. CONCLUSIONS: Efforts to improve access to surgical care in LMICs should be accompanied by investment in improving the quality and safety of care. To improve the usefulness of POMR as a safety benchmark, standard reporting items should be included with any POMR estimate. Choosing a basket of procedures for which POMR is tracked may offer institutions and countries the standardisation required to meaningfully compare surgical outcomes across contexts and improve population health outcomes.

The Role of Plastic Surgeons in Advancing Development Global.

In September 2015, the international community came together to agree on the 2030 Agenda for Sustainable Development, a plan of action for people, the planet, and prosperity. Ambitious and far-reaching as they are, they are built on three keystones: the elimination of extreme poverty, fighting climate change, and a commitment to fighting injustice and inequality. Critical to the achievement of the Agenda is the global realization of access to safe, affordable surgical and anesthesia care when needed. The landmark report by the Lancet Commission on Global Surgery estimated that between 28 and 32 percent of the global burden of disease is amenable to surgical treatment. However, as many as five billion people lack access to safe, timely, and affordable surgical care, a burden felt most severely in low- and middle-income countries (LMICs). Surgery, and specifically plastic surgery, should be incorporated into the international development and humanitarian agenda. As a community of care providers dedicated to the restoration of the form and function of the human body, plastics surgeons have a collective opportunity to contribute to global development, making the world more equitable and helping to reduce extreme poverty. As surgical disease comprises a significant burden of disease and surgery can be delivered in a cost-effective manner, surgery must be considered a public health priority.

Surgical Non-governmental Organizations: Global Surgery's Unknown Nonprofit Sector.

BACKGROUND: Charitable organizations may play a significant role in the delivery of surgical care in low- and middle-income countries (LMICs). However, in order to quantify their collective contribution, to account for the care they provide in national surgical plans, and to maximize coordination between organizations, a comprehensive database of these groups is required. We aimed to create such a database using web-available data. METHODS: We searched for organizations that meet the United Nations Rule of Law definition of non-governmental organizations and provide surgery in LMICs. We termed these surgical non-governmental organizations (s-NGOs). We screened multiple sources including a listing of disaster relief organizations, medical volunteerism databases, charity commissions, and the results of a literature search. We performed a secondary review of each eligible organization's website to verify inclusion criteria and extracted data. RESULTS: We found 403 s-NGOs providing surgery in all 139 LMICs, with most (61 %) incorporating surgery into a broader spectrum of health services. Over 80 % of s-NGOs had an office in the USA, the UK, Canada, India, or Australia, and they most commonly provided surgery in India (87 s-NGOs), Haiti (71), Kenya (60), and Ethiopia (55). The most common specialties provided were general surgery (184), obstetrics and gynecology (140), and plastic surgery (116). CONCLUSIONS: This new catalog includes the largest number of s-NGOs to date, but this is likely to be incomplete. This list will be made publicly available to promote collaboration between s-NGOs, national health systems, and global health policymakers.

An investment in knowledge: Research in global pediatric surgery for the 21st century.

The body of literature addressing surgical and anesthesia care for children in low- and middle-income countries (LMICs) is small. This lack of research hinders full understanding of the nature of many surgical conditions in LMICs and compromises potential efforts to alleviate the significant health, welfare and economic burdens surgical conditions impose on children, families and countries. This article will evaluate the need for improved global pediatric surgery research by (1) presenting the current state of surgical research for children in LMICs and (2) discussing methods and opportunities for improvement within the political context of current global health priorities.

Global Surgery 2030: a roadmap for high income country actors.

The Millennium Development Goals have ended and the Sustainable Development Goals have begun, marking a shift in the global health landscape. The frame of reference has changed from a focus on 8 development priorities to an expansive set of 17 interrelated goals intended to improve the well-being of all people. In this time of change, several groups, including the Lancet Commission on Global Surgery, have brought a critical problem to the fore: 5 billion people lack access to safe, affordable surgical and anaesthesia care when needed. The magnitude of this problem and the world's new focus on strengthening health systems mandate reimagined roles for and renewed commitments from high income country actors in global surgery. To discuss the way forward, on 6 May 2015, the Commission held its North American launch event in Boston, Massachusetts. Panels of experts outlined the current state of knowledge and agreed on the roles of surgical colleges and academic medical centres; trainees and training programmes; academia; global health funders; the biomedical devices industry, and news media and advocacy organisations in building sustainable, resilient surgical systems. This paper summarises these discussions and serves as a consensus statement providing practical advice to these groups. It traces a common policy agenda between major actors and provides a roadmap for maximising benefit to surgical patients worldwide. To close the access gap by 2030, individuals and organisations must work collectively, interprofessionally and globally. High income country actors must abandon colonial narratives and work alongside low and middle income country partners to build the surgical systems of the future.

Deaths from acute abdominal conditions and geographical access to surgical care in India: a nationally representative spatial analysis.

BACKGROUND: Few population-based studies quantify mortality from surgical conditions and relate mortality to access to surgical care in low-income and middle-income countries. METHODS: We linked deaths from acute abdominal conditions within a nationally representative, population-based mortality survey of 1·1 million households in India to nationally representative facility data. We calculated total and age-standardised death rates for acute abdominal conditions. Using 4064 postal codes, we undertook a spatial clustering analysis to compare geographical access to well-resourced government district hospitals (24 h surgical and anaesthesia services, blood bank, critical care beds, basic laboratory, and radiology) in high-mortality or low-mortality clusters from acute abdominal conditions. FINDINGS: 923 (1·1%) of 86,806 study deaths at ages 0-69 years were identified as deaths from acute abdominal conditions, corresponding to 72,000 deaths nationally in 2010 in India. Most deaths occurred at home (71%) and in rural areas (87%). Compared with 567 low-mortality geographical clusters, the 393 high-mortality clusters had a nine times higher age-standardised acute abdominal mortality rate and significantly greater distance to a well-resourced hospital. The odds ratio (OR) of being a high-mortality cluster was 4·4 (99% CI 3·2-6·0) for living 50 km or more from well-resourced district hospitals (rising to an OR of 16·1 [95% CI 7·9-32·8] for >100 km). No such relation was seen for deaths from non-acute surgical conditions (ie, oral, breast, and uterine cancer). INTERPRETATION: Improvements in human and physical resources at existing government hospitals are needed to reduce deaths from acute abdominal conditions in India. Full access to well-resourced hospitals within 50 km by all of India's population could have avoided about 50,000 deaths from acute abdominal conditions, and probably more from other emergency surgical conditions. FUNDING: Bill & Melinda Gates Foundation, Dalla Lana School of Public Health, Canadian Institute of Health Research.

Monitoring and evaluating surgical care: defining perioperative mortality rate and standardising data collection.

BACKGROUND: Case volume per 100 000 population and perioperative mortality rate (POMR) are key indicators to monitor and strengthen surgical services. However, comparisons of POMR have been restricted by absence of standardised approaches to when it is measured, the ideal denominator, need for risk adjustment, and whether data are available. We aimed to address these issues and recommend a minimum dataset by analysing four large mixed surgical datasets, two from well-resourced settings with sophisticated electronic patient information systems and two from resource-limited settings where clinicians maintain locally developed databases. METHODS: We obtained data from the New Zealand (NZ) National Minimum Dataset, the Geelong Hospital patient management system in Australia, and purpose-built surgical databases in Pietermaritzburg, South Africa (PMZ) and Port Moresby, Papua New Guinea (PNG). Information was sought on inclusion and exclusion criteria, coding criteria, and completeness of patient identifiers, admission, procedure, discharge and death dates, operation details, urgency of admission, and American Society of Anesthesiologists (ASA) score. Date-related errors were defined as missing dates and impossible discrepancies. For every site, we then calculated the POMR, the effect of admission episodes or procedures as denominator, and the difference between in-hospital POMR and 30-day POMR. To determine the need for risk adjustment, we used univariate and multivariate logistic regression to assess the effect on relative POMR for each site of age, admission urgency, ASA score, and procedure type. FINDINGS: 1 365 773 patient admissions involving 1 514 242 procedures were included, among which 8655 deaths were recorded within 30 days. Database inclusion and exclusion criteria differed substantially. NZ and Geelong records had less than 0·1% date-related errors and greater than 99·9% completeness. PMZ databases had 99·9% or greater completeness of all data except date-related items (94·0%). PNG had 99·9% or greater completeness for date of birth or age and admission date and operative procedure, but 80-83% completeness of patient identifiers and date related items. Coding of procedures was not standardised, and only NZ recorded ASA status and complete post-discharge mortality. In-hospital POMR range was 0·38% in NZ to 3·44% in PMZ, and in NZ it underestimated 30-day POMR by roughly a third. The difference in POMR by procedures instead of admission episodes as denominator ranged from 10% to 70%. Age older than 65 years and emergency admission had large independent effects on POMR, but relatively little effect in multivariate analysis on the relative odds of in-hospital death at each site. INTERPRETATION: Hospitals can collect and provide data for case volume and POMR without sophisticated electronic information systems. POMR should initially be defined by in-hospital mortality because post-discharge deaths are not usually recorded, and with procedures as denominator because details allowing linkage of several operations within one patient's admission are not always present. Although age and admission urgency are independently associated with POMR, and ASA and case mix were not included, risk adjustment might not be essential because the relative odds between sites persisted. Standardisation of inclusion criteria and definitions is needed, as is attention to accuracy and completeness of dates of procedures, discharge and death. A one-page, paper-based form, or alternatively a simple electronic data collection form, containing a minimum dataset commenced in the operating theatre could facilitate this process. FUNDING: None.

Use and definitions of perioperative mortality rates in low-income and middle-income countries: a systematic review.

BACKGROUND: Aggregate and risk-stratified perioperative mortality rates (POMR) are well-documented in high-income countries where surgical databases are common. In many low-income and middle-income country (LMIC) settings, such data are unavailable, compromising efforts to understand and improve surgical outcomes. We undertook a systematic review to determine how POMR is used and defined in LMICs and to inform baseline rates. METHODS: We searched PubMed for all articles published between Jan 1, 2009, and Sept 1, 2014, reporting surgical mortality in LMICs. Search criteria, inclusion and exclusion criteria, and study assessment methodology are reported in the appendix. Titles and abstracts were screened independently by two reviewers. Full-text review and data extraction were completed by four trained clinician coders with regular validation for consistency. We extracted the definition of POMR used, clinical risk scores reported, and strategies for risk adjustment in addition to reported mortality rates. FINDINGS: We screened 2657 abstracts and included 373 full-text articles. 493 409 patients in 68 countries and 12 surgical specialties were represented. The most common definition for the numerator of POMR was in-hospital deaths following surgery (55·3%) and for the denominator it was the number of operative patients (96·2%). Few studies reported preoperative comorbidities (41·8%), ASA status (11·3%), and HIV status (7·8%), with a smaller proportion stratifying on or adjusting mortality for these factors. Studies reporting on planned procedures recorded a median mortality of 1·2% (n=121 [IQR 0·0-4·7]). Median mortality was 10·1% (n=182 [IQR 2·5-16·2) for emergent procedures. INTERPRETATION: POMR is frequently reported in LMICs, but a standardised approach for reporting and risk stratification is absent from the literature. There was wide variation in POMR across procedures and specialties. A quality assessment checklist for surgical mortality studies could improve mortality reporting and facilitate benchmarking across sites and countries. FUNDING: None.

Deaths from acute abdominal conditions and geographic access to surgical care in India: a nationally representative population-based spatial analysis.

BACKGROUND: Acute abdominal conditions have high case-fatality rates in the absence of timely surgical care. In India, and many other low-income and middle-income countries, few population-based studies have quantified mortality from surgical conditions and related mortality to access to surgical care. We aimed to describe the spatial and socioeconomic distributions of deaths from acute abdomen (DAA) in India and to quantify potential access to surgical facilities in relation to such deaths. METHODS: We examined deaths from acute abdominal conditions within a nationally representative, population-based mortality survey of 1·1 million Indian households and linked these to nationally representative facility data. Spatial clustering of deaths from acute abdominal conditions was calculated with the Getis-Ord Gi* statistic from about 4000 postal codes. We compared high or low acute abdominal mortality clusters for their geographic access to well-resourced surgical care (24 h surgical and anaesthesia services, blood bank, critical care beds, basic laboratory, and radiology). FINDINGS: 923 (1·1%) of 86 806 study deaths in those aged 0-69 years were identified as deaths from acute abdominal conditions, corresponding to an estimated 72 000 deaths nationally in India in 2010. Most deaths occurred at home (71%), in rural areas (87%), and were caused by peptic ulcer disease (79%). There was wide variation in rates of deaths from acute abdominal conditions. We identified 393 high-mortality geographic clusters and 567 low-mortality clusters. High-mortality clusters of acute abdominal conditions were located significantly further from well-resourced hospitals than were low-mortality clusters. The odds ratio of a postal code area being a high-mortality cluster was 4·4 (99% CI 3·2-6·0) for living 50 km or more from well-resourced district hospitals (rising to an OR of 16·1 for >100 km), after adjustment for socioeconomic status and caste. INTERPRETATION: Improvements in human and physical resources at existing public hospitals are required to reduce deaths from acute abdominal conditions in India. Had all of the Indian population had access to well-resourced hospitals within 50 km, more than 50 000 deaths from acute abdominal conditions could have been averted in 2010, and likely more from other emergency surgical conditions. Our geocoded facility data were limited to public district hospitals. However, noting the high rate of catastrophic health expenditures in India, we chose to focus on publicly provided services which are the only option usually available to the poor. FUNDING: The Bill & Melinda Gates Foundation, Dalla Lana School of Public Health, and Canadian Institute of Health Research.

Mapping the playing field-a novel web-based strategy to identify non-governmental actors in global surgery.

BACKGROUND: In the face of staggering global unmet need for surgical care, non-governmental organisations (NGOs) play a substantial part in the surgical workforce, providing surgical care for those who are without it. The number of NGOs providing surgical care in low-income and middle-income countries (LMICs) is unknown. This information is needed to determine the scope of such care, its contributions to global surgical case volume, to improve collaboration in an effort to maximise efficiency, and to inform national surgical workforce planning. We aimed to create a comprehensive, publicly available catalogue of NGOs providing surgery in LMICs. METHODS: We used the United Nations Rule Of Law definition to define NGOs. We included low-income, lower-middle- income, and upper-middle-income countries as defined by World Bank lending groups. Delivery of surgical care by an NGO was defined as the therapeutic manipulation of tissues taking place within an operating room, and was distinguished from the financial or logistical support of such care. We screened an online humanitarian clearing house (ReliefWeb), a large public NGO database (Idealist.org), two surgical volunteerism databases (Operation Giving Back and the Society for Pediatric Anesthesia), and the US State Department Private Volunteer Organizations database, did a review of the literature, and used a social media outlet (Twitter) to identify organisations meeting criteria for inclusion. A complementary analysis additionally provided a list of organisations delivering exclusively surgical care from a search of the OmniMed database, the Foundation Center Online Directory, UK Charity Commission, Australia Charity Commission, New Zealand Charity Commission, and the Canada Revenue Agency Charity Search. FINDINGS: We identified 313 unique organisations, working in all 139 LMICs. Organisations often used more than one model of care and engaged in several surgical specialties. Both short-term surgical missions (206 organisations, 66%) and long-term partnerships (213, 68%) were common models, with 40 organisations (13%) engaging in humanitarian interventions in crisis settings. The most commonly represented specialty was general surgery (120, 38%), but subspecialty surgery such as ophthalmology (88, 28%) and cleft lip and palate surgery (70, 22%) were also frequently performed. INTERPRETATION: To our knowledge, this is the most complete directory of NGOs undertaking surgery in resource-limited settings in existence. However, it is difficult to determine whether this review is exhaustive. Further work is needed to determine the total and relative contributions of these organisations to global surgical volume. This database will be made available for public use and should be maintained and updated to further coordinate global efforts and maximise impact. FUNDING: None.