Malawi newborn and child health national clinical practice guidelines: a landscape analysis

Abstract

Background

Clinical practice guidelines (CPGs) are essential for standardizing healthcare, but their adoption, updating and adaptation remain inconsistent in Malawi. This review evaluated publicly available newborn and child health CPGs from 2017 to 2022, identifying relevant guidelines and assessing their quality using the Appraisal of Guidelines, Research and Evaluation (AGREE) II tool. Key gaps were found in stakeholder involvement and accessibility, highlighting the need to strengthen CPG development and dissemination to improve health outcomes.

Methods

A total of 322 records were identified through Google Scholar, Google, the Ministry of Health (MOH) website and MOH offices using predetermined search terms. Hand searches were also conducted. The quality of reporting was appraised using the AGREE II tool.

Results

Six CPGs met the eligibility criteria, five covering child health from the perinatal period onwards. CPGs targeted healthcare providers (n=6), program managers (n=2) and researchers (n=2). Topics included prevention, management and treatment. Reporting quality was generally poor, particularly regarding methodological rigour and editorial independence.

Conclusions

A collaborative effort including the MOH, non-governmental organizations, professional associations and researchers in developing and adapting newborn and child health CPGs could yield large benefits in improving the quality of care of children in Malawi.

Introduction

There has been substantial global progress in reducing child mortality in children <5 y of age since 1990,¹ with neonatal deaths decreasing from 5 million in 1990 to 2.4 million in 2020.² However, sub-Saharan Africa (SSA) still has the highest neonatal mortality rate in the world, accounting for 43% of global newborn deaths.³ Mortality within the first 28 days of life is often preventable and associated with factors such as a lack of appropriate postnatal care. In Malawi there has been a slight decline in the infant mortality rate over the years. For instance, the infant mortality rate is currently at 34.327 deaths per 1000 live births, representing a 4.85% decline from 2021.⁴

Malawi is one of the few countries in SSA to meet the millennium development goal (MDG) of reducing under-five mortality by two-thirds between 1990 and 2015.⁵ This reduction has been attributed to the increased coverage of health interventions such as antenatal and delivery care, immunization, distribution of insecticide-treated nets and prevention and treatment of common infectious diseases.⁶ Despite global advances in the prevention and management of infectious diseases, evidence suggests that malaria, human immunodeficiency virus (HIV), tuberculosis (TB), acute respiratory infections and diarrhoeal diseases remain among the leading causes of death in children <5 y of age in Malawi.⁶ In resource-constrained countries such as Malawi, where children succumb to preventable disease due to inequitable access to health services, the World Health Organization (WHO) recommends the use of evidence-based clinical practice guidelines (CPGs) in primary healthcare to improve the quality of healthcare for newborns and young children.⁵ Recommendations for interventions that have been proven to work and are cost-effective should be a priority to be adapted in the Malawian context.⁷

CPGs are evidence-informed recommendations intended to optimize patient care and a high-quality guideline has the potential to influence care outcomes.⁸ CPGs are essential tools for standardizing care across all levels of healthcare, from primary to tertiary facilities, in both high- and low-income settings.⁹ Well-developed CPGs, such as the WHO’s Pocketbook of Hospital Care for Children and National Institute for Health and Care Excellence guidelines, provide evidence-based recommendations to improve patient outcomes, enhance clinical decision-making and optimize resource use.⁹ Expanding the definition of CPGs to reflect their broad applicability and highlighting key examples can strengthen our understanding of their role in improving neonatal and child health globally. If developed and implemented according to international standards, CPGs have the potential to improve quality of care by assessing the benefits and harms of alternative care options and reducing unwarranted practice variations; however, their successful implementation remains a persistent challenge. In many instances, efforts are disproportionately focused on creating CPG documents rather than ensuring their integration into clinical practice.¹⁰ Malawi faces a similar issue, with many high-quality CPGs addressing neonatal and child health concerns readily available but underutilized. These guidelines can be effectively adapted to the local context, with a focus on implementation strategies such as training, monitoring and resource allocation.¹⁰ Prioritizing action-oriented efforts over duplicative guideline development can significantly improve health outcomes.

The development of CPGs in Malawi includes defining the clinical problem, assembling a multidisciplinary CPG development group comprised of experts who translate the evidence from a systematic review of the literature to recommendations, critically appraising the CPG and updating the literature.¹¹ This process is supported by the Malawi Ministry of Health (MOH) and mostly funded by non-governmental organizations. Although collaborative efforts ensure the effective development of child health CPGs, there is still more to be done to ensure the adaptation and effective use of CPGs.¹² Studies have highlighted challenges in the development of these CPGs, including a lack of resources to update them, failure to digitize CPGs to facilitate updates and a lack of stakeholder involvement and local context adaptation.¹³

Development of new CPGs is resource intensive and requires adequate funding, technical expertise and ample time to complete.⁵ As a result, countries opt for CPG adaptation and contextualization to local settings or country needs to save costs and resources associated with developing CPGs from scratch. Adoption and local contextualization of CPGs minimizes wasting of resources and duplication of effort. The WHO has developed high-quality, global-level CPGs for use in low-resource settings that cover all key infectious conditions that cause most deaths. However, these CPGs have not consistently been adopted, updated or adapted in SSA countries.¹⁴ Furthermore, lack of transparency in adaptation methods poses questions as to the credibility of the guidelines and recommendations. Therefore, in this review we identify, describe and appraise the quality of the existing newborn and child health guidelines in Malawi.

This is a substudy of a larger project, Global Evidence, Local Adaptation (GELA), which aims to increase decision-makers’ capacity to use global research evidence to develop locally relevant CPGs for newborn and child health. This review evaluated publicly available newborn and child health CPGs from 2017 to 2022, identifying relevant guidelines and assessing their quality using the Appraisal of Guidelines, Research and Evaluation (AGREE) II tool.

Methods

Inclusion criteria

Clinical practice guidelines were eligible for inclusion if they were addressing newborn and child health and were published in Malawi in the years 2017–2022 (Figure 1).

Figure 1.

Eligibility criteria.

Exclusion criteria

The exclusion criteria included clinical practice guidelines that were published prior to 2017, reports focusing on an older population (adult women and men), reports conducted at the district level, primary studies, briefing documents, systematic reviews and theses.

Information sources

We searched Google and Google Scholar for CPGs addressing newborn and child health published in Malawi in the years 2017–2022. In addition, we consulted the MOH departments (i.e. Paediatrics and Child Health Association, National Malaria Control Program, Department of HIV/AIDS [acquired immunodeficiency syndrome], TB control program, schistosomiasis program and more) as well as other relevant stakeholders to assist with identifying published, updated CPGs as well as non-published hardcopy files.

Search strategy

A comprehensive literature search was done by two independent authors using the following keyword combinations of ‘guideline’ OR ‘protocol’ OR ‘recommendations’ OR ‘standards’ OR ‘strategies’ OR ‘consensus’ AND ‘newborn health’ OR ‘Infant health’ OR ‘childhood illnesses’ OR ‘perinatal health’ OR ‘newborn illnesses’ OR ‘poverty related diseases’ AND ‘Malawi’.

Data extraction

Two authors independently extracted data using a predeveloped and piloted extraction form (Excel spreadsheet Microsoft, Redmond, WA, USA) from included CPGs. Any discrepancies were resolved by the third author. These data included title of the CPG, year of publication, CPG scope, topic or condition covered by the CPG, target population, target users of the CPG, responsible developers, stakeholder consultations, CPG development groups, consultation with external reviewers, assessment of overall certainty of evidence (using GRADE, etc.) and a detailed description of the methods used for adapting the CPG.

Quality assessment of CPGs

We used the AGREE II tool to appraise the methodological quality of the CPGs. The AGREE II tool evaluates guidelines based on key domains such as scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability and editorial independence. High scores in domains such as rigor of development and applicability are especially critical in ensuring guidelines are both evidence-based and feasible for implementation, which can indirectly influence health outcomes. In the context of Malawi, the domains of applicability and stakeholder involvement are particularly crucial. Given the resource constraints and the need for local ownership, guidelines must be practical and address barriers to implementation while also engaging diverse stakeholders, including policymakers, healthcare providers and community representatives. Each guideline was appraised independently by two trained reviewers and any discrepancies in scoring were resolved by consensus. A third reviewer resolved any persisting disputes. We evaluated the quality of parent guidelines, developed from 2017 to 2022, that explicitly stated that they were adapted. Each guideline was appraised using 23 key items divided into six domains and scored on a scale of 1 (strongly disagree) to 7 (strongly agree) for each item. The domain and overall scores can serve as a benchmark for assessing the methodological quality of CPGs. Stakeholders, such as guideline developers and policymakers, can use this information to identify strengths and address weaknesses in future guideline development processes. For instance, a low score in the editorial independence domain might signal a need for greater transparency in funding and conflict-of-interest disclosures, while a low applicability score might highlight the need to focus on implementation planning. We calculated standardized domain scores by summing up all the scores of individual items in a domain and by standardizing the total as a percentage of the maximum possible score for that domain.

Data analysis

We analysed the data descriptively using Excel and reported median AGREE II domain scores and associated ranges for all included CPGs.

Results

Study selection

In total, 322 records were identified, 272 CPGs in Google Scholar and 50 additional records from the Google search and MOH documents (Figure 2). After removing 5 duplicates, we screened 317 titles and abstracts and then 34 full texts of potentially eligible CPGs. Of the latter, 28 records were excluded for the following reasons: one was a technical report, nine were published before 2017, one included an older population (i.e. adult men and women only), four were done at the district level, seven were published primary studies, one was a briefing document, one was a systematic review, one was a thesis and three had the same title but were published in different years, of which we included only the latest version. Therefore, six CPGs were included for review.

Figure 2.

PRISMA flow diagram.

Characteristics of included CPGs

Of the six included CPGs, there was a mix of disease-specific, broad-concept and collection-based guidelines. One CPG focused specifically on a communicable disease, HIV/AIDS, while the remaining five addressed broader maternal and child health issues. These included general frameworks such as the Baby-Friendly Hospital Initiative (BFHI), integrated approaches like the Integrated Management of Childhood Illnesses (IMCI) and other guidelines encompassing diverse health concerns (Table 1). Five of the CPGs indicated that the main CPG developer was the MOH. In the IMCI guideline, the WHO and UNICEF logos were included in the document, however, whether the CPG was adopted from the original or adapted or whether these organizations had a role in the national development was not reported. Most of the target audiences were health practitioners (private/public) (n=6)^15–18 followed by program managers (n=2)^17,19 and researchers (n=2).^17–19 Target populations included perinatal (n=3),¹⁹ prenatal (n=2),^15,17 neonates, newborn, infants and young children (n=6).¹⁹ The scope covered by CPGs included prevention (n=1),¹⁹ prevention and treatment (n=1),¹⁹ and treatment (n=4).^15,19,20 The CPGs were relevant for primary (n=5), secondary (n=3) and tertiary levels of care (n=1)^15,17,19 (Table 1).

Table 1.

Characteristics of included guidelines

Guideline title	Level of care	Topic	Scope	Population	Target	Guideline developer
PM_Newborns (unpublished/2022)	Primary Secondary	Management of emergency signs (difficulties in breathing, bleeding and shock)	Treatment	Perinatal child neonate, infant, newborn	Health practitioners	Ministry of Health
COIN	Primary	Newborn quality care	Treatment	Neonate, newborn, infant, child	Health practitioners	Ministry of Health
CM_HIV	Primary Secondary	HIV/AIDS	Treatment	Prenatal, perinatal, neonate, newborn, infant, child	Health practitioners	Ministry of Health
IYCN_Policy	Primary	Infant and young child nutrition	Prevention and treatment	Perinatal, neonates, newborn, infant, child	Health practitioners, program managers, researchers	Ministry of Health
BFHI	Secondary Tertiary	Exclusive breastfeeding	Prevention	Prenatal, perinatal, neonate, newborn, infant, child	Health practitioners, program managers, researchers	USAID, Health policy plus
IMCI	Primary	Management of newborn and childhood illnesses	Treatment	Perinatal, neonate, newborn, infant child	Health practitioners, parents/guardians	Ministry of Health, WHO, UNICEF

COIN: Care for Infant and Newborn in Malawi; IMCI: Integrated Management of Childhood Illnesses in Malawi; IYCN Policy: Infant and Young Child Nutrition Policy; CM_HIV: Clinical Management of HIV in Children; PM_Newborns: Protocols for Management of Newborns in Malawi; BFHI: Baby Friendly Hospital Initiative.

Quality assessment of included studies

Table 2 and Figure 3 presents a summary of AGREE II scores for included CPGs, which are presented as percentages across all domains. The quality of the included CPGs varied. Domains with the lowest median scores were editorial independence (0% [range 0–42%]) and rigour of development (11% [range 3–51%]). The scope and purpose domain scored the highest (73.5% [range 28–78%]). All identified CPGs did not report on the use of systematic methods to identify or assess the certainty of evidence, as well as consultation with external reviewers. Stakeholders were consulted in three of the six CPGs. Assessment of contextual data or CPG acceptability was not described in any of the included CPGs.

Table 2.

Summary of guideline AGREE II scores in percentages.

Figure 3.

Summary of guideline AGREE II scores in percentages.

Discussion

This review describes and evaluates the quality of six national CPGs for newborn and child health in Malawi. The evaluated CPGs align with Malawi's disease burden, providing clear treatment protocols for common childhood illnesses and ensuring national credibility through MOH endorsement. Some incorporate global recommendations, reflecting best practices. However, gaps in rigor of development, stakeholder involvement and editorial independence need improvement. Given that many of these guidelines were adapted from global recommendations rather than independently developed, some AGREE II domains such as stakeholder engagement in guideline formulation may not fully apply, particularly in cases where CPGs are compilations of multiple protocols. However, ensuring transparency in adaptation processes remains critical to ensuring guideline credibility and local relevance. Given the resource-limited settings in which these guidelines are applied, it is essential to strike a balance between adaptability and methodological rigor. Applying stringent AGREE II criteria to adapted guidelines may overlook their pragmatic value. Instead, future efforts should focus on improving transparency in the adaptation process, ensuring that guidelines reflect local epidemiology, feasibility and end-user needs while maintaining sufficient methodological robustness.

Unlike other SSA countries, Malawi has a higher burden of infectious disease in the under-five age category.²¹ Thus most of the conditions addressed by the identified CPGs clearly align with the current disease burden in this population. According to Mill et al.,²¹ the leading causes of death in children <5 y of age in Malawi are sepsis (85%, of which 28 were neonatal sepsis), lower respiratory tract infection (50%), gastroenteritis (32%), meningitis (30%) and malaria (28%).²¹ Furthermore, malnutrition (26%) and HIV/AIDS (38%) account for most of the childhood-related deaths.

Despite the poor reporting standards, these CPGs contain useful information and recommendations. A key observation from our review is that many of the included guidelines appear to be adapted from WHO recommendations, even in cases where the WHO logo is absent. This raises an important question about the role of branding in guideline implementation. In practice, healthcare providers may not be primarily concerned with the source of a guideline, but rather with what is endorsed by the MOH and aligns with national policies. Understanding how branding influences adherence and implementation could be more critical than simply assessing the methodological rigor of adaptation.

While the AGREE II appraisal provides valuable insights into guideline quality, it does not capture these practical aspects of guideline use. Poor-quality CPGs can lead to inconsistencies in clinical decision-making, reduced adherence to evidence-based practices and suboptimal healthcare outcomes for children and newborns in Malawi. Inadequate stakeholder engagement and lack of transparency in guideline development may result in recommendations that are not contextually relevant or feasible for implementation. Strengthening CPG quality is crucial to improving healthcare delivery, ensuring better patient outcomes and reducing morbidity and mortality in this vulnerable population.²² Future research may explore whether including WHO logos or other international endorsements enhances credibility and uptake or whether local MOH endorsement is the primary driver of implementation. This distinction is crucial for ensuring that guidelines are not only well-developed, but also effectively integrated into routine clinical practice.

While our assessment highlights methodological gaps in the development of CPGs, the more pressing concern is whether these guidelines are effectively implemented in clinical practice. There is limited evidence on the extent to which these guidelines are used by healthcare providers in Malawi, underscoring the need for strategies that enhance their accessibility, usability and integration into routine care. Rather than focusing solely on improving AGREE II scores, future efforts should prioritize ensuring that high-quality, contextually relevant recommendations are available, widely disseminated and actively used to improve patient outcomes.

In summary, the following are the gaps that need to be addressed:

1. CPGs did not clearly report on the methods of CPG development and thus future versions should provide more clarity on this element, such as descriptions of the systematic approaches to identifying, selecting and assessing evidence or methods used in adaptation from other CPGs such as those from the WHO.

2. The majority of the CPGs did not clearly report on the funding and how interests of contributors were collected and managed.

3. There is potential to increase the participation of a range of contributors, such as healthcare providers working in the health facilities or the public, along with greater consideration of contextual factors during the development of CPGs.

4. Although it is possible that we did not identify all CPGs, as they were not easily available in a CPG repository, we found that there may be several gaps in available CPGs for informing healthcare for newborn and child health, specifically in the fields of malnutrition, HIV/AIDS and respiratory tract infections.

5. It would be advantageous to increase cooperation between the Malawi MOH and professional organizations in order to reduce duplication of effort, improve CPG development techniques, and streamline attention to the conditions that contribute to the burden of disease in infant and child health.

6. A dedicated CPG repository could ease dissemination and identification of CPGs for healthcare providers, program managers and the public. By strengthening cooperation between the MOH and professional organizations and establishing a dedicated CPG repository, Malawi can significantly enhance the quality and consistency of care provided to infants and children. This approach would lead to better health outcomes, more efficient use of resources and greater alignment with national and global health priorities.

Limitations

This review identified six national CPGs for child and newborn health in Malawi, but some limitations should be acknowledged. First, our search was restricted to updated or adopted CPGs published within the last 5 y (2017–2022), meaning older but potentially relevant guidelines may have been missed. Additionally, the absence of a centralized CPG repository may have limited our ability to identify all available guidelines. The AGREE II framework, while useful for assessing methodological rigor, does not fully capture the practical aspects of guideline implementation. Moreover, many CPGs were adapted from WHO recommendations, raising questions about the extent of stakeholder engagement in their development. Another limitation of this study is the heavy reliance on the AGREE II tool for the quantitative assessment of clinical practice guidelines. While AGREE II offers a standardized evaluation of guideline quality, it may not fully capture the complexities of guideline implementation or their real-world impact. Future research should consider integrating qualitative methods to complement this assessment and provide a more comprehensive understanding of the guidelines’ effectiveness in practice. Finally, the limited reporting on funding sources and conflict-of-interest management underscores the need for greater transparency in future CPG development.

Conclusions

This review evaluated national CPGs for newborn and child health in Malawi, revealing significant gaps in content coverage, methodological rigor and reporting transparency. While the Malawi MOH was the primary CPG developer, limited stakeholder involvement, unclear adaptation processes and outdated guidelines weaken their effectiveness. Addressing these shortcomings requires enhanced collaboration between the MOH, professional organizations, researchers and frontline healthcare providers to improve CPG development methods and reduce duplication. Future efforts should prioritize systematic approaches for evidence assessment, transparent funding disclosures and stakeholder engagement to ensure credibility and usability. Strengthening CPGs can improve healthcare delivery by promoting standardized, evidence-based practices, potentially reducing newborn and child mortality from preventable diseases. Establishing a national CPG repository and implementing continuous updates based on local epidemiology and resource availability could further enhance accessibility and impact.

Author's contributions

RC was responsible for data curation, data analysis, quality assessment of the articles, draft preparation and writing the original manuscript. RA and GK were responsible for methodology, editing and supervision. SL was responsible for data curation, methodology and review. MM was responsible for data curation, supervision and quality assessment of the articles. NMM was responsible for methodology, review and editing and supervision. RN was responsible for conceptualization and project administration.

Funding

This project was funded as part of the EDCTP2 program supported by the European Union (grant RIA2020S-3303-GELA).

Competing interests

None declared.

Ethical approval

Not required.

Data availability

The data underlying this article will be shared upon reasonable request to the corresponding author.