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      The injustice of unfit clinical practice guidelines in low-resource realities

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          Abstract

          To end the international crisis of preventable deaths in low-income and middle-income countries, evidence-informed and cost-efficient health care is urgently needed, and contextualised clinical practice guidelines are pivotal. However, as exposed by indirect consequences of poorly adapted COVID-19 guidelines, fundamental gaps continue to be reported between international recommendations and realistic best practice. To address this long-standing injustice of leaving health providers without useful guidance, we draw on examples from maternal health and the COVID-19 pandemic. We propose a framework for how global guideline developers can more effectively stratify recommendations for low-resource settings and account for predictable contextual barriers of implementation (eg, human resources) as well as gains and losses (eg, cost-efficiency). Such development of more realistic clinical practice guidelines at the global level will pave the way for simpler and achievable adaptation at local levels. We also urge the development and adaptation of high-quality clinical practice guidelines at national and subnational levels in low-income and middle-income countries through co-creation with end-users, and we encourage global sharing of these experiences.

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          Most cited references27

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          Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study

          Summary Background While the COVID-19 pandemic will increase mortality due to the virus, it is also likely to increase mortality indirectly. In this study, we estimate the additional maternal and under-5 child deaths resulting from the potential disruption of health systems and decreased access to food. Methods We modelled three scenarios in which the coverage of essential maternal and child health interventions is reduced by 9·8–51·9% and the prevalence of wasting is increased by 10–50%. Although our scenarios are hypothetical, we sought to reflect real-world possibilities, given emerging reports of the supply-side and demand-side effects of the pandemic. We used the Lives Saved Tool to estimate the additional maternal and under-5 child deaths under each scenario, in 118 low-income and middle-income countries. We estimated additional deaths for a single month and extrapolated for 3 months, 6 months, and 12 months. Findings Our least severe scenario (coverage reductions of 9·8–18·5% and wasting increase of 10%) over 6 months would result in 253 500 additional child deaths and 12 200 additional maternal deaths. Our most severe scenario (coverage reductions of 39·3–51·9% and wasting increase of 50%) over 6 months would result in 1 157 000 additional child deaths and 56 700 additional maternal deaths. These additional deaths would represent an increase of 9·8–44·7% in under-5 child deaths per month, and an 8·3–38·6% increase in maternal deaths per month, across the 118 countries. Across our three scenarios, the reduced coverage of four childbirth interventions (parenteral administration of uterotonics, antibiotics, and anticonvulsants, and clean birth environments) would account for approximately 60% of additional maternal deaths. The increase in wasting prevalence would account for 18–23% of additional child deaths and reduced coverage of antibiotics for pneumonia and neonatal sepsis and of oral rehydration solution for diarrhoea would together account for around 41% of additional child deaths. Interpretation Our estimates are based on tentative assumptions and represent a wide range of outcomes. Nonetheless, they show that, if routine health care is disrupted and access to food is decreased (as a result of unavoidable shocks, health system collapse, or intentional choices made in responding to the pandemic), the increase in child and maternal deaths will be devastating. We hope these numbers add context as policy makers establish guidelines and allocate resources in the days and months to come. Funding Bill & Melinda Gates Foundation, Global Affairs Canada.
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            Beyond too little, too late and too much, too soon: a pathway towards evidence-based, respectful maternity care worldwide.

            On the continuum of maternal health care, two extreme situations exist: too little, too late (TLTL) and too much, too soon (TMTS). TLTL describes care with inadequate resources, below evidence-based standards, or care withheld or unavailable until too late to help. TLTL is an underlying problem associated with high maternal mortality and morbidity. TMTS describes the routine over-medicalisation of normal pregnancy and birth. TMTS includes unnecessary use of non-evidence-based interventions, as well as use of interventions that can be life saving when used appropriately, but harmful when applied routinely or overused. As facility births increase, so does the recognition that TMTS causes harm and increases health costs, and often concentrates disrespect and abuse. Although TMTS is typically ascribed to high-income countries and TLTL to low-income and middle-income ones, social and health inequities mean these extremes coexist in many countries. A global approach to quality and equitable maternal health, supporting the implementation of respectful, evidence-based care for all, is urgently needed. We present a systematic review of evidence-based clinical practice guidelines for routine antenatal, intrapartum, and postnatal care, categorising them as recommended, recommended only for clinical indications, and not recommended. We also present prevalence data from middle-income countries for specific clinical practices, which demonstrate TLTL and increasing TMTS. Health-care providers and health systems need to ensure that all women receive high-quality, evidence-based, equitable and respectful care. The right amount of care needs to be offered at the right time, and delivered in a manner that respects, protects, and promotes human rights.
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              Stillbirths: rates, risk factors, and acceleration towards 2030

              An estimated 2.6 million third trimester stillbirths occurred in 2015 (uncertainty range 2.4-3.0 million). The number of stillbirths has reduced more slowly than has maternal mortality or mortality in children younger than 5 years, which were explicitly targeted in the Millennium Development Goals. The Every Newborn Action Plan has the target of 12 or fewer stillbirths per 1000 births in every country by 2030. 94 mainly high-income countries and upper middle-income countries have already met this target, although with noticeable disparities. At least 56 countries, particularly in Africa and in areas affected by conflict, will have to more than double present progress to reach this target. Most (98%) stillbirths are in low-income and middle-income countries. Improved care at birth is essential to prevent 1.3 million (uncertainty range 1.2-1.6 million) intrapartum stillbirths, end preventable maternal and neonatal deaths, and improve child development. Estimates for stillbirth causation are impeded by various classification systems, but for 18 countries with reliable data, congenital abnormalities account for a median of only 7.4% of stillbirths. Many disorders associated with stillbirths are potentially modifiable and often coexist, such as maternal infections (population attributable fraction: malaria 8.0% and syphilis 7.7%), non-communicable diseases, nutrition and lifestyle factors (each about 10%), and maternal age older than 35 years (6.7%). Prolonged pregnancies contribute to 14.0% of stillbirths. Causal pathways for stillbirth frequently involve impaired placental function, either with fetal growth restriction or preterm labour, or both. Two-thirds of newborns have their births registered. However, less than 5% of neonatal deaths and even fewer stillbirths have death registration. Records and registrations of all births, stillbirths, neonatal, and maternal deaths in a health facility would substantially increase data availability. Improved data alone will not save lives but provide a way to target interventions to reach more than 7000 women every day worldwide who experience the reality of stillbirth.
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                Author and article information

                Journal
                Lancet Glob Health
                Lancet Glob Health
                The Lancet. Global Health
                The Author(s). Published by Elsevier Ltd.
                2214-109X
                23 March 2021
                23 March 2021
                Affiliations
                [a ]Global Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
                [b ]Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark
                [c ]Comprehensive Community-Based Rehabilitation in Tanzania, Dar es salaam, Tanzania
                [d ]Medical College of East Africa, Aga Khan University, Dar es Salaam, Tanzania
                [e ]Athena Institute, Faculty of Science, VU University, Amsterdam, Netherlands
                [f ]Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, Netherlands
                [g ]Department of Obstetrics and Gynaecology, Edna Adan Hospital, Hargeisa, Somalia
                [h ]Village Health Works, Kigutu, Burundi
                Author notes
                [* ]Correspondence to: Dr Nanna Maaløe, Global Health Section, Department of Public Health, University of Copenhagen, 1353 Copenhagen, Denmark
                Article
                S2214-109X(21)00059-0
                10.1016/S2214-109X(21)00059-0
                7984859
                33765437
                04f42ebe-a1db-40b6-b241-c42105938711
                © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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