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A clinical audit is a low-cost process used for quality improvement in healthcare. Such audits are however infrequently used in resource poor countries, where the need for and potential impact of quality improvement is higher. Sets of standards for use in maternal and newborn care have been established based on internal guidelines and evidence. The before-after design of a clinical audit is prone to bias in the estimation of the impact of conducting a clinical audit. A trial design that would provide an unbiased estimate of the impact of implementing a clinical audit process on the attainment of standards selected (a standards-based audit) was needed. The aim of this paper is to introduce and describe the design of trials we developed to meet this need. A novel randomised stepped-wedge trial design to estimate the impact of conducting standards-based audits is presented. A multi-dimensional incomplete stepped-wedge cluster randomised trial design suitable for estimation of the impact of Standards-based audits on compliance with standard is proposed; two variants are described in detail. A method for sample size estimation is described. Analyses can be performed for the binary outcome using a generalised linear mixed model framework to estimate the impact of the approach on compliance with standards subjected to a standards-based audit; additional terms to consider including in sensitivity analyses are considered. The design presented has the potential to estimate the impact of introducing the standards-based audit process on compliance with standard, while providing participating healthcare providers opportunity to gain experience of implementing the standards-based audit process. The design may be applicable in other areas in which multiple processes are to be studied.

Background The three delays model proposes that maternal mortality is associated with delays in: 1) deciding to seek care; 2) reaching the healthcare facility; and 3) receiving care. Previously, the majority of women who died were reported to have experienced type 1 and 2 delays. With increased coverage of healthcare services, we sought to explore the relative contribution of each type of delay. Method 151 maternal deaths were identified during a 12-month reproductive age mortality survey (RAMOS) conducted in Malawi; verbal autopsy and facility-based medical record reviews were conducted to obtain details about the circumstances surrounding each death. Using the three delays framework, data were analysed for women who had; 1) died at a healthcare facility, 2) died at home but had previously accessed care and 3) died at home and had not accessed care. Results 62.2% (94/151) of maternal deaths occurred in a healthcare facility and a further 21.2% (32/151) of mothers died at home after they had accessed care at a healthcare facility. More than half of all women who died at a healthcare facility (52.1%) had experienced more than one type of delay. Type 3 delays were the most significant delay for women who died at a healthcare facility or women who died at home after they had accessed care, and was identified in 96.8% of cases. Type 2 delays were experienced by 59.6% and type 1 delays by 39.7% of all women. Long waiting hours before receiving treatment at a healthcare facility, multiple delays at the time of admission, shortage of drugs, non-availability and incompetence of skilled staff were some of the major causes of type 3 delays. Distance to a healthcare facility was the main problem resulting in type 2 delays. Conclusion The majority of women do try to reach health services when an emergency occurs, but type 3 delays present a major problem. Improving quality of care at healthcare facility level will help reduce maternal mortality.

Audit is a quality improvement approach used in maternal and newborn health. Our objective was to introduce the practice of standards-based audit at healthcare facility level, and to examine if this would improve quality of care assessed by compliance with standards developed and agreed with healthcare providers. Our focus was on emergency obstetric and newborn care (EmONC). A multidimensional incomplete stepped-wedge cluster randomised trial with 8 steps was conducted in 44 healthcare facilities in Malawi. A total of 25 standards of care were developed. At each healthcare facility one (health centres) or two (hospitals) standards were audited per cycle with two consecutive audit cycles conducted. Each cycle consisted of five steps: (i) select standard to be audited, (ii) measure compliance with standard (measurement 1), (iii) review findings and identify what changes are required to increase compliance (iv) implement changes, (v) re-measure compliance (measurement 2). Each compliance measurement assessed 25 women. Multilevel mixed effects logistic regression models were used to analyse data for all standards. The crude overall compliance rate rose from 45% in the control phase (measurement 1) to 63% in the intervention phase (measurement 2) (from 51.6% to70.6% at Basic and from 34.5% to 50.8% at Comprehensive EmONC healthcare facilities. When adjusted for standard, facility type, month, and healthcare facility by month, the adjusted OR (95% CI) was 2.80 (1.65, 4.76). Actions taken to improve compliance with standards included improving staff performance of clinical duties and general conduct through re-orientation and staff meetings as well as improved supervision, and, ensuring basic equipment and consumables were available on site (thermometers, rapid diagnostic tests, partograph). The introduction of standards-based audit helped healthcare providers identify problems with service provision, which when addressed, resulted in a measurable and significant improvement in quality of care. ISRCTN registration number: 59931298.

Background Adolescents in Sub-Saharan Africa (SSA) face significant health and social challenges related to sexual and reproductive health (SRH), including unwanted pregnancies, unsafe abortions, and sexually transmitted infections (STI). Barriers to information and services are compounded by lack of access to appropriate information, fear of being judged, health provider attitudes and contextual factors such as culture, religion, poverty, and illiteracy. Facility-based service delivery models for adolescents offer a structured environment and provide an opportunity to deliver such information and services. The review critically examined how well these models meet the SRH needs of adolescents in SSA. Methods A systematic search was conducted using five databases: Web of Science, MEDLINE, Scopus, PubMed, and Google Scholar. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to maintain transparency and completeness. Covidence software was used for screening and data extraction, and NVIVO 12 PRO was used to manage the analysis. A narrative synthesis using Thomas and Harden’s thematic analysis was used to identify themes. Results The search yielded 14,415 articles, and 20 papers met the inclusion criteria and were included in this review. From the findings, adolescents expressed the need for comprehensive SRH information, adolescent-friendly facilities, parental and male involvement, and respectful healthcare providers. Three facility-based adolescent-friendly SRH delivery models are used in SSA: Stand-alone clinics, Youth-friendly corners, and Integrated/mainstreamed models. Adolescent-friendly interventions, friendly staff, and accessibility were reported as facilitators to services meeting the needs of adolescents and promoting positive experiences. However, several barriers were identified: negative attitudes of health workers, financial constraints, transportation challenges, waiting time, intimidating environments, and lack of confidentiality pose a challenge to the effectiveness of the model. Conclusion Facility-based SRH service delivery models can improve access to information and services when complemented with community-based interventions, adolescent-friendly providers, and assurance of service accessibility. However, significant gaps, such as healthcare providers' negative attitudes and behaviours, concerns about privacy and confidentiality, financial constraints, and transportation challenges, limit their effectiveness. These findings call for expanding out-of-facility services, adopting mHealth solutions, enhancing provider training, strengthening confidentiality, and reducing financial barriers to ensure equitable and effective access to services.

Background Experiences and perceptions of poor quality of care is a powerful determinant of utilisation of maternity services. With many reports of disrespect and abuse in healthcare facilities in low-resource settings, women’s and healthcare providers’ understanding and perception of disrespect and abuse are important in eliminating disrespect and abuse, but these are rarely explored together. Methods This was a qualitative study assessing the continuum of maternity care (antenatal, intrapartum and postnatal care) at the Maternity Unit of Bwaila Hospital in Lilongwe, Malawi. Focus group discussions (FGDs) were conducted separately for mothers attending antenatal clinic and those attending postnatal clinic. For women who accessed intrapartum care services, in-depth interviews were used. Participants were recruited purposively. Key informant interviews were conducted with healthcare providers involved in the delivery of maternal and newborn health services. Topic guides were developed based on the seven domains of the Respectful Maternity Care (RMC) Charter. Data was transcribed verbatim, coded and analysed using the thematic framework approach. Results A total of 8 focus group discussions and 9 in-depth interviews involving 64 women and 9 key informant interviews with health care providers were conducted. Important themes that emerged included: the importance of a valued patient-provider relationship as determined by a good attitude and method of communication, the need for more education of women regarding the stages of pregnancy and labour, what happens at each stage and which complications could occur, the importance of a woman’s involvement in decision-making, the need to maintain confidentiality when required and the problem of insufficient human resources. Prompt and timely service was considered a priority. Neither women accessing maternity care nor trained healthcare providers providing this care were aware of the RMC Charter. Conclusions This study has highlighted the most essential aspects of respectful maternity care from the viewpoint of both women accessing maternity care and healthcare providers. Although RMC components are in place, healthcare providers were not aware of them. There is the need to promote the RMC Charter among both women who seek care and healthcare providers.

Background The blended learning (BL) approach to training health care professionals is increasingly adopted in many countries because of high costs and disruption to service delivery in the light of severe human resource shortage in low resource settings. The Covid-19 pandemic increased the urgency to identify alternatives to traditional face-to-face (f2f) education approach. A four-day f2f antenatal care (ANC) and postnatal care (PNC) continuous professional development course (CPD) was repackaged into a 3-part BL course; (1) self-directed learning (16 h) (2) facilitated virtual sessions (2.5 h over 3 days) and (3) 2-day f2f sessions. This study assessed the feasibility, change in healthcare providers’ knowledge and costs of the BL package in Nigeria, Tanzania, and Kenya. Methods A mixed methods design was used. A total of 89 healthcare professionals, were purposively selected. Quantitative data was collected through an online questionnaire and skills assessments, analyzed using STATA 12 software. Qualitative data was collected through key informant interviews and focus group discussions, analysed using thematic analysis. Results Majority of participants (86%) accessed the online sessions using a mobile phone from home and health facilities. The median (IQR) time of completing the self-directed component was 16 h, IQR (8, 30). A multi-disciplinary team comprising of 42% nurse-midwives, 28% doctors, 20% clinical officers and 10% other healthcare professionals completed the BL course. Participants liked the BL approach due to its flexibility in learning, highly educative/relevant content, mixing of health worker cadres and CPD points. Aspects that were noted as challenging were related to personal log-in details and network connectivity issues during the self-directed learning and facilitated virtual sessions respectively. Conclusion The blended learning approach to ANC-PNC in-service training was found to be acceptable, feasible and cost less to implement compared to face-to-face training approach in the study settings. The BL training approach was effective in improving the knowledge and skills of healthcare providers who participated in the training.

Background In 2014 the World Health Organization (WHO) developed a new tool to be used to assess the quality of care for mothers, newborns and children provided at healthcare facility level. This paper reports on the feasibility of using the tool, its limitations and strengths. Methods Across 5 districts in Malawi, 35 healthcare facilities were assessed. The WHO tool includes checklists, interviews and observation of case management by which care is assessed against agreed standards using a Likert scale (1 lowest: not meeting standard, 5 highest: compliant with standard). Descriptive statistics were used to provide summary scores for each standard. A ‘dashboard’ system was developed to display the results. Results For maternal care three areas met standards; 1) supportive care for admitted patients (71% of healthcare facilities scored 4 or 5); 2) prevention and management of infections during pregnancy (71% scored 4 or 5); and 3) management of unsatisfactory progress of labour (84% scored 4 or 5). Availability of essential equipment and supplies was noted to be a critical barrier to achieving satisfactory standards of paediatric care (mean score; standard deviation: 2.9; SD 0.95) and child care (2.7; SD 1.1). Infection control is inadequate across all districts for maternal, newborn and paediatric care. Quality of care varies across districts with a mean (SD) score for all standards combined of 3 (SD 0.19) for the worst performing district and 4 (SD 0.27) for the best. The best performing district has an average score of 4 (SD 0.27). Hospitals had good scores for overall infrastructure, essential drugs, organisation of care and management of preterm labour. However, health centres were better at case management of HIV/AIDS patients and follow-up of sick children. Conclusions There is a need to develop an expanded framework of standards which is inclusive of all areas of care. In addition, it is important to ensure structure, process and outcomes of health care are reflected.

This is the protocol for a Campbell systematic review. The objectives are as follows. The primary objective of this systematic review is to evaluate and synthesise both published and unpublished literature on the effectiveness of sexual and reproductive health blended learning approaches for capacity strengthening of healthcare practitioners in LMICs. Within this context, sexual and reproductive health interventions refer to any of the following four key interventions or services aimed at improving maternal and newborn health (Starrs et al. 2018): (a) antenatal, childbirth and postnatal care, including emergency obstetric and newborn care, (b) safe abortion services and treatment of the complications of unsafe abortion, (c) prevention and treatment of malaria, tuberculosis, HIV and other sexually transmitted infections in pregnant women and d) family planning. In this systematic review, blended learning is defined as any teaching and learning method that combines face‐to‐face learning with e‐learning or online learning. The component of face‐to‐face and online learning may include any of the components identified by Alammary (2019): (1) face‐to‐face instructor‐led, where students attend a class and an instructor presents teaching and learning materials, with little engagement from students; (2) face‐to‐face collaboration, where students work together in class, for example, in discussion groups; (3) online instructor‐led, where instruction is delivered online and facilitated by an instructor who sets the pace (e.g., virtual classrooms); (4) online collaboration, where students work together online with their peers, for example, online learning communities; and (5) online self‐paced, where students study at their own pace and time, and from their chosen location, for example, watching videos, online reading. Specifically, this systematic review will answer the following research questions: (1) What sexual and reproductive health blended learning approaches have been used in LMICs? (2) Does participating in sexual and reproductive health blended learning interventions alone (i.e., compared with no intervention) improve the effective provision of care among healthcare workers in LMICs? (3) Does participating in sexual and reproductive health blended learning interventions compared with non‐blended learning approaches (such as conventional face‐to‐face learning or pure e‐learning) facilitate the effective provision of care among healthcare workers in LMICs (measured by, e.g., self‐reports of effective maternal and neonatal care)? (4) What is the cost‐effectiveness of sexual and reproductive health blended learning compared with non‐blended learning approaches (i.e., face‐to‐face learning or e‐learning)? (5) What factors affect the effectiveness of sexual and reproductive health blended learning interventions (e.g., characteristics of participants, type of intervention, course content, setting and mode of delivery)? (6) Do sexual and reproductive health blended learning interventions targeted at healthcare practitioners working in LMICs lead to improvement in patient outcomes (e.g., reduced maternal and neonatal mortality, patient satisfaction reports)?

Background Assessing the feasibility of conducting a prospective Reproductive Age Mortality Survey (RAMOS) study in the low-income setting of Mangochi District, Malawi to obtain cotemporaneous estimates of the number, cause of and conditions associated with maternal deaths (MD) in all women of reproductive age (WRA) ( n = 207 688). Methods MD among all deaths of WRA were identified using the ICD-10 definition. Cause of death and contributing conditions identified by a panel of experts using the classification system for deaths during pregnancy, childbirth and puerperium (ICD-MM). Results Out of 424 deaths of WRA, 151 were MD giving a Maternal Mortality Ratio (MMR) of 363 per 100,000 live births (95 % CI: 307–425). Only 86 MD had been reported via existing reporting mechanisms representing an underreporting of 43 %. The majority of MD (62.3 %) occurred in a health facility and were the result of direct obstetric causes (74.8 %) with obstetric haemorrhage as the leading cause (35.8 %), followed by pregnancy-related infections (19.4 %), hypertensive disorders (16.8 %) and pregnancy with abortive outcome (13.2 %). Malaria was the most frequently identified indirect cause (9.9 %). Contributing conditions were more frequently identified when both verbal autopsy and facility-based death review had taken place and included obstructed labour (28.5 %), anaemia (12.6 %) and positive HIV status (4.0 %). Conclusion The high number of MD that occur at health facility level, cause of death and contributing conditions reflect deficiencies in the quality of care at health facility level. A RAMOS is feasible in low- and middle-income settings and provides contemporaneous estimates of MMR.

Introduction: The recent World Health Organization (WHO) report on trends in Maternal mortality (MM), from 1990 to 2013, ranks Malawi as one of the fifteen sub-Saharan countries with the highest Maternal Mortality Ratio (MM) of above 500 per 100,000live births (WHO 2014b). Malawi has no registration system for recording births and deaths. MM estimates are based on direct sisterhood methods, (used in Demographic and Health Surveys) and WHO modelled estimates, which are both highly susceptible to inaccuracies because they are both indirect methods which do not identify individual deaths within a defined population. The difficulties in obtaining accurate MMR estimates highlight the need to explore other methodologies that give more reliable data on levels as well as the cause of maternal deaths (MDs). A Reproductive Age Mortality Survey (RAMOS) is one such approach and can provide more direct and complete estimation of MMR in countries without reliable vital registration or other data sources. This is the first RAMOS used in Malawi. The aim of this study was to identify the magnitude, causes of, and factors associated with MDs in the Mangochi district in Malawi. Methods: Deaths of women of reproductive age (WRA), (15 to 49 years) that occurred from December, 2011 to November, 2012 in the district were identified. Multiple data sources were used to identify deaths, including; health facilities, communities, mortuary records and police records. Classification the death as a MD or not was done according to the ICD-10 definition. Facility based audit were conducted for all facility based MDs and verbal autopsies for all MDs. Cause of death attribution was done in three ways, 1) by a panel of experts in maternal health using the WHO application of ICD-10 to deaths during pregnancy, childbirth and puerperium (ICD-MM) (WHO 2012c), 2) by health professionals working in health facilities and 3) by using an InterVA-4 computer model. Cause of death attributed by the three methods was then compared. The three delays model was used to identify delays associated with MDs. The number of MDs identified in this study was compared to the official register in the district. MMR was calculated based on three proxy denominators; 1) number of babies who received BCG vaccine, 2) live births from the census report and 3) live births calculated from general fertility estimates. Results: A total of 424 deaths of WRA were identified and 151 of these (35.6%) were identified to be MDs. Based on the three denominators, the MMR for the Mangochi district was within the range of 341-363 per 100,000 live births (95% CI: 289-425 per 100,000 live births). Only 86 MDs had been reported via existing registers, giving an underreporting rate of 43%. The highest MMR was in age group 25-29 years (494/100,000 live births (95% CI: 349-683 per 100,000). Most MDs (62.3% (94/151)) occurred in health facilities. Based on ICD-MM cause classification, 74.8% were direct MDs, 17.3% were indirect and 7.9% were due to unknown causes. The leading cause of direct MDs (n=113) was obstetric haemorrhage (35.8%) followed by pregnancy related infections (14.4%) and hypertensive disorders (12.6%). The most frequent indirect cause of MD (n=26) was malaria (56.7%). There was low level of agreement over the cause of death between the panel of experts and health the professionals (κ= 0.37), while a substantial level of agreement was observed between the panel of experts and the InterVA-4 model (κ= 0.66). Based on ICD-MM, health professionals identified contributory factors (morbidity group) to 15.1% of MDs (n=86) as the underlying cause of death. Substandard care for obstetric emergencies, lack of blood, lack of transport, failures to recognize the severity of a problem at community level and delays in starting the decision-making process to seek health care were frequently factors associated with MDs. Conclusion: The current MD reporting system in Malawi needs strengthening. The high numbers of health facility deaths, cause of MDs and their contributing factors in Mangochi reflect serious deficiencies in the quality of maternal care that need to be urgently rectified. Urgent orientation of health workers on ICD-MM is required to obtain accurate information on cause of MDs that can be used to design effective interventions. There is need to strengthen the referral system and educate women on obstetric danger signs.