Comment
Paediatric surgery for congenital anomalies: the next
frontier for global health
Paediatric surgery has historically been neglected in global
health efforts.1,2 Estimates suggest that 6% of children
worldwide are born with a congenital anomaly and 94% of
these children are born in low-income and middle-income
countries (LMICs).3 Surgical intervention for these children
is potentially life-saving. However, many are among
the two-thirds of the world’s children, or an estimated
BSIP/Getty Images
1·7 billion children, who lack access to surgical care.4 In
The Lancet, the Global PaedSurg Research Collaboration
Published Online report that the mortality of patients with congenital
July 13, 2021
https://doi.org/10.1016/
gastrointestinal anomalies in low-income countries is
S0140-6736(21)01547-6 seven times that of children in high-income countries.5
See Articles page 325 The authors did a prospective, multicentre, international
study evaluating children younger than 16 years with
congenital gastrointestinal anomalies, with the primary
outcome of in-hospital 30-day mortality. Outcomes were
compared between children in low-income, middle-
income, and high-income countries. Data were collected
from 264 hospitals across 74 countries. The majority of
patients (2860 [74·3%] of 3849) were treated in middle-
income countries, with 93 (2·4%) treated in low-income
countries and 896 (23·3%) treated in high-income
countries. Overall, 2231 (58·0%) of patients were male
and 3464 (90·0%) were neonates. The all-cause in-
hospital mortality was 37 (39·8%) of 93 children in low-
income countries, compared with 583 (20·4%) of 2860 in
middle-income countries and 50 (5·6%) of 896 in high-
income countries (p<0·0001 between all country income
groups). On multivariable analysis, treatment in LMICs
conferred the greatest risk of mortality (low-income vs
high-income country, risk ratio 2·78, 95% CI 1·88–4·11;
middle-income vs high-income country, 2·11, 1·59–2·79).
Factors associated with mortality in LMICs included sepsis
at presentation, absence of a physician anaesthetist,
absence of a surgical safety checklist, absence of available
ventilation, and absence of available parenteral nutrition.
This study provides detailed information on outcomes
of children with congenital anomalies across multiple
countries, allowing for identification of areas where
clinical care in LMICs does not meet the standards of care
in high-income countries, and identification of factors
associated with mortality in LMICs. These results are
essential to guide intervention. However, the study has
280 www.thelancet.com Vol 398 July 24, 2021
several limitations. First, due to the disproportionate
burden of congenital anomalies in LMICs,3 the
representation of children with congenital anomalies in
LMICs compared with those in high-income countries in
this study could be more heavily skewed than estimated
by the authors. Second, the major limitation of the study,
as acknowledged by the authors, is related to the very
limited access to paediatric surgical centres in LMICs.2 In
countries in Africa, more than 90% of paediatric surgeons
work in large cities, and many countries have fewer
than one paediatric surgeon per million children.6 As a
result, the actual outcomes for children with congenital
anomalies in LMICs are likely to be even worse than
those presented in this study. Finally, the clinical care
disparities between LMICs and high-income countries
identified by the authors require further research. For
example, in low-income countries, 81% of patients
were reported to not require ventilation, and 11% were
reported to require ventilation but it was not available.
In high-income countries, only 29% of patients did not
require ventilation. The results are similar for use of
parenteral nutrition. Previous studies have shown a severe
shortage of neonatal critical care resources in low-income
countries. Only approximately 50% of hospitals providing
paediatric surgery in west African countries have neonatal
intensive care units,7 and parenteral nutrition is often
not available.8 If a resource is so frequently not available,
providers might not consider it as part of a standard
treatment algorithm, or the relative scarcity of paediatric
surgeons in low-income countries could mean that the
expertise to know when these interventions are beneficial
is not available.
The results of this study highlight the urgency for
increased attention to paediatric surgery in global
health, and can be used to advocate for the dedication of
resources to paediatric surgical care and neonatal critical
care in LMICs. Collaboration between providers in high-
income countries and LMICs, and prioritisation of LMIC
leadership, will be essential to these efforts. Over the past
few years, the Global Initiative for Children’s Surgery has
worked to advance global paediatric surgery through
the development of standards for paediatric surgical
care at each level of a health-care facility,9 and with the

Global Assessment of Pediatric Surgery tool.10 Further
research into specific infrastructure and resource needs of
paediatric surgical care centres in LMICs is urgently needed,
as is training of paediatric surgeons and anaesthetists.
We declare no competing interests.
Sarah C Stokes, *Diana L Farmer
dlfarmer@ucdavis.edu
Division of Pediatric General, Thoracic and Fetal Surgery, Department of Surgery,
University of California Davis Medical Center, Sacramento, CA 95817, USA
(SCS, DLF); Shriners Hospital for Children—Northern California, Sacramento, CA,
USA (DLF)
1 Farmer PE, Kim JY. Surgery and global health: a view from beyond the OR.
World J Surg 2008; 32: 533–36.
2 Sitkin NA, Ozgediz D, Donkor P, Farmer DL. Congenital anomalies in
low- and middle-income countries: the unborn child of global surgery.
World J Surg 2015; 39: 36–40.
3 WHO. Congenital anomalies. Dec 1, 2020. https://www.who.int/en/news-
room/fact-sheets/detail/congenital-anomalies (accessed March 31, 2021).
A strategy to reduce the carbon footprint of clinical trials
Clinical trials need to be decarbonised and we propose a
strategy for doing so. Almost 14 years ago the Sustainable
Clinical Trials Group concluded that “clinical trials con­
tribute substantially to greenhouse gas emissions”,
notably through energy use in research premises and
air travel.1 The group developed guidelines for reducing
the carbon footprint of trials and showed that they
improved carbon efficiency.2 Improvements resulted from
faster patient recruitment, lighter trial materials, and
web-based data entry.2 A study in 2009 of 12 pragmatic
randomised trials showed that the average carbon
emission of the trials was about the same as that of nine
people in the UK in 1 year.3 Since then little seems to have
happened to reduce the carbon consumption of clinical
trials, with the exception of developments such as the
UK National Institute for Health Research (NIHR) Carbon
Reduction Guidelines.4 Yet the urgency of the threat from
the climate crisis has greatly increased.5 Governments,
companies, and many organisations, including National
Health Service (NHS) England,6 have committed to
reaching net-zero carbon before the middle of the century.
ClinicalTrials.gov has about 350  000 national and
international trials registered,7 which, using the average
calculated by the Sustainable Clinical Trials Group, would
give a carbon consumption of an estimated 27·5 million
tonnes, which is just under a third of the total annual
carbon emissions of Bangladesh, a country of 163 million
people. Almost half of the trials are of drugs,7 and drugs
www.thelancet.com Vol 398 July 24, 2021 281
Comment
4 Mullapudi B, Grabski D, Ameh E, et al. Estimates of number of children and
adolescents without access to surgical care. Bull World Health Organ 2019;
97: 254–58.
5 Global PaedSurg Research Collaboration. Mortality from gastrointestinal
congenital anomalies at 264 hospitals in 74 low-income, middle-income,
and high-income countries: a multicentre, international, prospective
cohort study. Lancet 2021; published online July 13. https://doi.org/
10.1016/S0140-6736(21)00767-4.
6 Chirdan LB, Ameh EA, Abantanga FA, Sidler D, Elhalaby EA. Challenges of
training and delivery of pediatric surgical services in Africa. J Pediatr Surg
2010; 45: 610–18.
7 Okoye MT, Ameh EA, Kushner AL, Nwomeh BC. A pilot survey of pediatric
surgical capacity in West Africa. World J Surg 2015; 39: 669–76.
8 Ameh EA, Chirdan LB. Ruptured exomphalos and gastroschisis:
a retrospective analysis of morbidity and mortality in Nigerian children.
Pediatr Surg Int 2000; 16: 23–25.
9 Goodman LF, St-Louis E, Yousef Y, et al. The Global Initiative for Children’s
Surgery: optimal resources for improving care. Eur J Pediatr Surg 2018;
28: 51–59.
10 Global Initiative for Children’s Surgery. Global Initiative for Children’s
Surgery: a model of global collaboration to advance the surgical care of
children. World J Surg 2019; 43: 1416–25.
account for a fifth of the carbon footprint of NHS
England.6 Most trials of drugs are done by pharmaceutical
companies, and clinical trials are an important part of the
carbon footprint of the companies, which, for example,
is 17·7 million tonnes for GlaxoSmithKline,8 a company
Luis Alvarez/Getty Images
like many others that has committed to decarbonising.
The first step to reducing the carbon footprint of
clinical trials is to develop a tool to measure reliably the
carbon footprint of trials and identify which elements
of trials are carbon-heavy. The Sustainable Healthcare Published Online
June 22, 2021
Coalition, which was set up by NHS England to bring https://doi.org/10.1016/
together the public health sector with commercial S0140-6736(21)01384-2
suppliers, has developed a tool it is now testing on trials. For the Sustainable Healthcare
Coalition see https://
The coalition has brought together a working party of shcoalition.org/
triallists, clinicians, commercial companies, and others
to work to reduce the carbon footprint of clinical trials
to net zero. Tools to measure the carbon footprint are
never perfect, but the tool that is being tested by the
Sustainable Healthcare Coalition is expected to be reliable
enough for measuring progress and benchmarking.
Everybody planning a trial should perform a systematic
review and search trial registries to confirm the trial is
needed to justify the value of the information and the
value of the carbon used during a trial. Ideally, triallists
would estimate the carbon footprint of the trial when
they apply for a grant, find ways to reduce the carbon
footprint as low as possible—eg, using the NIHR
guidelines4—and plan to measure the carbon footprint of