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

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 experience

Scaling up context-tailored clinical guidelines and training to improve childbirth care in urban, low-resource maternity units in Tanzania: A protocol for a stepped-wedged cluster randomized trial with embedded qualitative and economic analyses (The PartoMa Scale-Up Study)

While facility births are increasing in many low-resource settings, quality of care often does not follow suit; maternal and perinatal mortality and morbidity remain unacceptably high. Therefore, realistic, context-tailored clinical support is crucially needed to assist birth attendants in resource-constrained realities to provide best possible evidence-based and respectful care. Our pilot study in Zanzibar suggested that co-created clinical practice guidelines (CPGs) and low-dose, high-frequency training (PartoMa intervention) were associated with improved childbirth care and survival. We now aim to modify, implement, and evaluate this multi-faceted intervention in five high-volume, urban maternity units in Dar es Salaam, Tanzania (approximately 60,000 births annually). This PartoMa Scale-up Study will include four main steps: I. Mixed-methods situational analysis exploring factors affecting care; II. Co-created contextual modifications to the pilot CPGs and training, based on step I; III. Implementation and evaluation of the modified intervention; IV. Development of a framework for co-creation of context-specific CPGs and training, of relevance in comparable fields. The implementation and evaluation design is a theory-based, stepped-wedged cluster-randomised trial with embedded qualitative and economic assessments. Women in active labour and their offspring will be followed until discharge to assess provided and experienced care, intra-hospital perinatal deaths, Apgar scores, and caesarean sections that could potentially be avoided. Birth attendants\u27 perceptions, intervention use and possible associated learning will be analysed. Moreover, as further detailed in the accompanying article, a qualitative in-depth investigation will explore behavioural, biomedical, and structural elements that might interact with non-linear and multiplying effects to shape health providers\u27 clinical practices. Finally, the incremental cost-effectiveness of co-creating and implementing the PartoMa intervention is calculated. Such real-world scale-up of context-tailored CPGs and training within an existing health system may enable a comprehensive understanding of how impact is achieved or not, and how it may be translated between contexts and sustained.Trial registration number: NCT04685668

Health Perceptions in Relation to Child Health and Mortality in a Rural Context, Sierra Leone: A Mixed Method Study

Child survival and wellbeing remain a global health challenge despite vast development within the area and a significant decline in mortality rates of children under five years of age. This study investigates the perceived causes of ill health and childhood mortality in the context of five villages located in the Tonkolili district of Sierra Leone. Mixed method methodology was applied in this study consisting of both quantitative and qualitative data contribution. The quantitative part consisted of a household survey on child health, where 341 households, equivalent to 50.6% of the total number of households in the five villages, participated with a response rate of 100%. The qualitative part consisted of six semi structured interviews—one with a health care worker and five with mothers from each village. The main perceived reason for child morbidity was inadequate care of children related to personal hygiene of the child, hygiene and safety in the environment, in-sufficient nutrition, inadequate supervision and poor healthcare seeking behavior. Additionally, reasons given for disease included supernatural forces such as witchcraft. In relation to the survey, the perceived causes of child mortality for ill children in the villages were mainly malaria (33.6%), diarrhea (11.6%), pneumonia (8.6%), and unknown (26%). The observed symptoms of illness among children were fever (43.7%), cough and difficulty breathing (10.7%), frequent watery stool (10.3%) and no symptoms (20.3%). The perception of ill health in children was mainly associated with the parent’s ability to cater for the child’s physical needs, but also associated with external factors such as witchcraft and “God’s will”. In addition, biomedical causes for disease and supernatural causes for disease were seen to coexist

Inconsistent definitions of labour progress and over-medicalisation cause unnecessary harm during birth

Nanna Maaløe and colleagues argue that resource challenges, unclear and outdated clinical practice guidelines, and lack of women’s perspectives lead to overdiagnosis and overtreatment of prolonged labou

WHO next-generation partograph: revolutionary steps towards individualised labour care?

In their recent commentary, Hofmeyr et al. anticipate that departure from the familiar partograph “may provoke anxiety and even antipathy among healthcare professionals”.1 We agree that change is urgently needed to reach beyond the co-existence of “too little, too late” and “too much, too soon” care during childbirth.2 In particular, we applaud the World Health Organization (WHO) for their underlying Better Outcomes in Labour Difficulty (BOLD) project, which has disclosed the urgency of delaying the onset of the active phase of the first stage of labour from 3-4 centimeters of cervical dilatation to at least 5 centimetre.

Labor augmentation with oxytocin in low- and lower-middle-income countries: a systematic review and meta-analysis

OBJECTIVE Despite its worldwide use, reviews of oxytocin for labor augmentation include mainly studies from high-income countries. Meanwhile, oxytocin is a potentially harmful medication and risks may be higher in low-resource settings. We conducted a systematic review and meta-analysis of practices, benefits, and risks of oxytocin for labor augmentation in low- and lower-middle-income countries. DATA SOURCES PubMed, Embase, PsycINFO, Index Medicus, Cochrane, and Google Scholar were searched for publications until January 1, 2022. STUDY ELIGIBILITY CRITERIA All studies evaluating oxytocin augmentation rates were included. To investigate benefits and risks, randomized and quasi-randomized trials comparing oxytocin augmentation with placebo or no oxytocin were included. To explore risks more broadly, cohort and case–control studies were also included. METHODS Data were extracted and quality-assessed by 2 researchers using a modified Newcastle–Ottawa scale. Generic inverse variance outcome and a random-effects model were used. Adjusted or crude effect measures with 95% confidence intervals were used. RESULTS In total, 42 studies were included, presenting data from 885 health facilities in 25 low- and lower-middle-income countries (124,643 women). Rates of oxytocin for labor augmentation varied from 0.7% to 97.0%, exceeding 30% in 14 countries. Four studies investigated timing of oxytocin for augmentation and found that 89.5% (2745) of labors augmented with oxytocin did not cross the partograph\u27s action line. Four cohort and 7 case–control studies assessed perinatal outcomes. Meta-analysis revealed that oxytocin was associated with: stillbirth and day-1 neonatal mortality (relative risk, 1.45; 95% confidence interval, 1.02–2.06; N=84,077; 6 studies); low Apgar score (relative risk, 1.54; 95% confidence interval, 1.21–1.96; N=80,157; 4 studies); neonatal resuscitation (relative risk, 2.69; 95% confidence interval, 1.87–3.88; N=86,750; 3 studies); and neonatal encephalopathy (relative risk, 2.90; 95% confidence interval, 1.87–4.49; N=1383; 2 studies). No studies assessed effects on cesarean birth rate and uterine rupture. CONCLUSION This review discloses a concerning level of oxytocin use, including in labors that often did not fulfill criteria for dystocia. Although this finding is limited by confounding by indication, oxytocin seems associated with increased perinatal risks, which are likely mediated by inadequate fetal monitoring. We call for cautious use on clear indications and robust implementation research to support evidence-based guidelines for labor augmentation, particularly in low-resource settings

Labor augmentation with oxytocin in low- and lower-middle-income countries: a systematic review and meta-analysis

OBJECTIVE: Despite its worldwide use, reviews of oxytocin for labor augmentation include mainly studies from high-income countries. Meanwhile, oxytocin is a potentially harmful medication and risks may be higher in low-resource settings. We conducted a systematic review and meta-analysis of practices, benefits, and risks of oxytocin for labor augmentation in low- and lower-middle-income countries. DATA SOURCES: PubMed, Embase, PsycINFO, Index Medicus, Cochrane, and Google Scholar were searched for publications until January 1, 2022. STUDY ELIGIBILITY CRITERIA: All studies evaluating oxytocin augmentation rates were included. To investigate benefits and risks, randomized and quasi-randomized trials comparing oxytocin augmentation with placebo or no oxytocin were included. To explore risks more broadly, cohort and case–control studies were also included. METHODS: Data were extracted and quality-assessed by 2 researchers using a modified Newcastle–Ottawa scale. Generic inverse variance outcome and a random-effects model were used. Adjusted or crude effect measures with 95% confidence intervals were used. RESULTS: In total, 42 studies were included, presenting data from 885 health facilities in 25 low- and lower-middle-income countries (124,643 women). Rates of oxytocin for labor augmentation varied from 0.7% to 97.0%, exceeding 30% in 14 countries. Four studies investigated timing of oxytocin for augmentation and found that 89.5% (2745) of labors augmented with oxytocin did not cross the partograph's action line. Four cohort and 7 case–control studies assessed perinatal outcomes. Meta-analysis revealed that oxytocin was associated with: stillbirth and day-1 neonatal mortality (relative risk, 1.45; 95% confidence interval, 1.02–2.06; N=84,077; 6 studies); low Apgar score (relative risk, 1.54; 95% confidence interval, 1.21–1.96; N=80,157; 4 studies); neonatal resuscitation (relative risk, 2.69; 95% confidence interval, 1.87–3.88; N=86,750; 3 studies); and neonatal encephalopathy (relative risk, 2.90; 95% confidence interval, 1.87–4.49; N=1383; 2 studies). No studies assessed effects on cesarean birth rate and uterine rupture. CONCLUSION: This review discloses a concerning level of oxytocin use, including in labors that often did not fulfill criteria for dystocia. Although this finding is limited by confounding by indication, oxytocin seems associated with increased perinatal risks, which are likely mediated by inadequate fetal monitoring. We call for cautious use on clear indications and robust implementation research to support evidence-based guidelines for labor augmentation, particularly in low-resource settings

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

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

Incidence and determinants of perinatal mortality in five urban hospitals in Dar es Salaam, Tanzania: a cohort study with an embedded case–control analysis

Introduction Tanzania has one of the highest burdens of perinatal mortality, with a higher risk among urban ver- sus rural women. To understand the characteristics of perinatal mortality in urban health facilities, study objectives were: I. To assess the incidence of perinatal deaths in public health facilities in Dar es Salaam and classify these into a) pre-facility stillbirths (absence of fetal heart tones on admission to the study health facilities) and b) intra-facility perinatal deaths before discharge; and II. To identify determinants of perinatal deaths by comparing each of the two groups of perinatal deaths with healthy newborns. Methods This was a retrospective cohort study among women who gave birth in five urban, public health facilities in Dar es Salaam. I. Incidence of perinatal death in the year 2020 was calculated based on routinely collected health facility records and the Perinatal Problem Identification Database. II. An embedded case–control study was conducted within a sub-population of singletons with birthweight ≥ 2000 g (excluding newborns with congenital malforma- tions); pre-facility stillbirths and intra-facility perinatal deaths were compared with ‘healthy newborns’ (Apgar score ≥ 8 at one and ≥ 9 at five minutes and discharged home alive). Descriptive and logistic regression analyses were per- formed to explore the determinants of deaths. Results A total of 37,787 births were recorded in 2020. The pre-discharge perinatal death rate was 38.3 per 1,000 total births: a stillbirth rate of 27.7 per 1,000 total births and an intra-facility neonatal death rate of 10.9 per 1,000 live births. Pre-facility stillbirths accounted for 88.4% of the stillbirths. The case-control study included 2,224 women (452 pre- facility stillbirths; 287 intra-facility perinatal deaths and 1,485 controls), 99% of whom attended antenatal clinic (75% with more than three visits). Pre-facility stillbirths were associated with low birth weight (cOR 4.40; (95% CI: 3.13-6.18) and with maternal hypertension (cOR 4.72; 95% CI: 3.30-6.76). Intra-facility perinatal deaths were associated with breech presentation (aOR 40.3; 95% CI: 8.75-185.61), complications in the second stage (aOR 20.04; 95% CI: 12.02-33.41), low birth weight (aOR 5.57; 95% CI: 2.62-11.84), cervical dilation crossing the partograph’s action line (aOR 4.16; 95% CI:2.29- 7.56), and hypertension during intrapartum care (aOR 2.9; 95% CI 1.03-8.14), among other factors. Conclusion The perinatal death rate in the five urban hospitals was linked to gaps in the quality of antena- tal and intrapartum care, in the study health facilities and in lower-level referral clinics. Urgent action is required to implement context-specific interventions and conduct implementation research to strengthen the urban referral system across the entire continuum of care from pregnancy onset to postpartum. The role of hypertensive disor- ders in pregnancy as a crucial determinant of perinatal deaths emphasizes the complexities of maternal-perinatal health within urban settings

Scaling up Locally Adapted Clinical Practice Guidelines for Improving Childbirth Care in Tanzania: A Protocol for Programme Theory and Qualitative Methods of the PartoMa Scale-up Study

Effective, low-cost clinical interventions to improve facility-based care during childbirth are critical to reduce maternal and perinatal mortality and morbidity in low-resource settings. While health interventions for low- and lower-middle-income countries are often developed and implemented top-down, needs and circumstances vary greatly across locations. Our pilot study in Zanzibar improved care through locally co-created intrapartum clinical practice guidelines (CPGs) and associated training (the PartoMa intervention). This intervention was context-tailored with health-care providers in Zanzibar and now scaled up within five maternity units in Dar es Salaam, Tanzania. This PartoMa Scale-up Study thereby provides an opportunity to explore the co-creation process and modification of the intervention in another context and how scale-up might be successfully achieved. The overall protocol is presented in a separate paper. The aim of the present paper is to account for the Scale-up Study\u27s programme theory and qualitative methodology. We introduce social practice theory and argue for its value within the programme theory and towards qualitative explorations of shifts in clinical practice. The theory recognizes that the practice we aim to strengthen - safe and respectful clinical childbirth care - is not practiced in a vacuum but embedded within a socio-material context and intertwined with other practices. Methodologically, the project draws on ethnographic and participatory methodologies to explore current childbirth care practices. In line with our programme theory, explorations will focus on meanings of childbirth care, material tools and competencies that are being drawn upon, birth attendants\u27 motivations and relational contexts, as well as other everyday practices of childbirth care. Insights generated from this study will not only elucidate active ingredients that make the PartoMa intervention feasible (or not) but develop the knowledge foundation for scaling-up and replicability of future interventions based on the principles of co-creation and contextualisation