‘A novel approach to expedite evidence to impact in Pre-eclampsia: co-developed Policy Labs in Zambia and Sierra Leone.’

doi:10.21203/rs.3.rs-4437908/v1

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Research Article

‘A novel approach to expedite evidence to impact in Pre-eclampsia: co-developed Policy Labs in Zambia and Sierra Leone.’

https://doi.org/10.21203/rs.3.rs-4437908/v1

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Background

Pre-eclampsia (PE) is a leading causes of maternal and neonatal mortality; 30,000 PE-related maternal deaths occur annually, with 70% in Sub-Saharan Africa (SSA) and 16% in South Asia. We have shown that early, accurate detection of hypertension combined with planned early delivery in women with suspected pre-eclampsia between 34 and 37 weeks of gestation significantly reduces stillbirth and severe maternal hypertension. There is an urgent need for this novel evidence to be included clinical management of women and babies suffering the worst outcomes. This article describes co-development and delivery of Policy Labs in Sierra Leone and Zambia as part of a strategy to expedite integration of new knowledge into Pre-eclampsia care pathways.

Methods

Working with King’s Policy Institute, we co-developed and delivered two Policy Labs based on their 8-step process and the ‘trust-translation-timing’ model. Policy Labs were undertaken in Freetown, Sierra Leone and Lusaka, Zambia. Participants were purposively selected in each setting to represent a diverse range of relevant stakeholders. Main outcome measures included Policy Lab attendance; Policy Lab delivery; Policy Lab report and agreed outputs.

Results

Two Policy Labs were held: in Zambia (14th February 2023) and Sierra Leone (7th March 2023), attended by 35 and 39 diverse stakeholders respectively, included women via pre-recorded video clips. Both labs were successfully facilitated by local, well-respected female team members, and addressed co-developed questions (‘What are enablers and barriers to offering planned early delivery between 34 and 37 weeks?’ – Zambia; ‘How can we improve timely detection and appropriate action in women with Pre-eclampsia?’ – Sierra Leone) in answer to context-specific emerging evidence. Participants at both labs identified lack of Pre-eclampsia awareness as a key barrier, and recommended development of locally designed, community based strategies to increase access to timely, evidence-based Pre-eclampsia management.

Conclusions

Policy Labs are a novel approach to facilitate transfer of new knowledge into policy and action. Future Policy Labs should feature the women, participating in real time, at the forefront of the discussion.

Policy Lab

Pre-eclampsia

hypertensive disorders of pregnancy

low-and middle-income settings.

Pre-eclampsia (PE) is a leading causes of maternal and neonatal mortality; 30,000 PE-related maternal deaths occur annually, with 70% in Sub-Saharan Africa (SSA) and 16% in South Asia(1, 2). There are 500,000 fetal and neonatal deaths every year, with 99% in SSA and South Asia(3). Sierra Leone (SL) and Zambia have differing maternal mortality ratios (443(4) vs 213 per 100 000 live births). In SL 16% of deaths are due to hypertensive disorders and whilst Zambia experiences lower PE-related maternal mortality (10%)(5), disease burden remains high, with 12% of pregnancies affected(6). In both settings many deliveries occur rurally, and early, accurate identification of women with PE and appropriately timed delivery would facilitate safer care and better maternal and neonatal outcomes.

To improve prompt PE detection, our team developed the CRADLE vital signs alert (VSA), an accurate, validated tool for blood pressure (BP) and heart rate (HR) measurement in pregnant women, with an early-warning traffic-light system. The CRADLE-VSA intervention was associated with a 60% reduction in maternal mortality in SL (RR 0.37 [95% CI 0.25 to 0.55], p < 0.0001)(7) (CRADLE-3). In Zambia and India, we demonstrated that CRADLE-VSA based identification of hypertensive women followed by planned early delivery for late preterm PE was associated with a significant improvement in severe maternal hypertension and a 75% reduction in stillbirth (CRADLE-4)(8). In SL and Zambia, there are common challenges in the detection and management of PE, and expediting this new knowledge into policy and clinical practise is critical to improve maternal and neonatal outcomes in both settings.

The failure to translate evidence into patient care – ‘the know-do gap’ – has been described as, ‘the biggest hurdle to achieving health equity around the world (9).’ Policy Labs are a novel engagement approach designed to influence the policy cycle, primarily through the use of design principles and co-creation to bring evidence and policy closer together(10). The Policy Institute at King’s College London developed the “Trust-Translation-Timing” framework, which advocates for; coalition-building through participation of diverse communities (‘trust’); work on the presentation of evidence to engage key stakeholders (‘translation’); and creating or leveraging “policy windows” (‘timing’) (10). We co-developed and delivered Policy Labs in Sierra Leone and Zambia, tailored to reflect the specific needs and challenges of each setting, to expedite translation of CRADLE-3 and CRADLE-4 research findings into policy. To our knowledge these are the first to be held in low-and middle-income settings.

Working with the Policy Institute at King’s, guided by their 8-step process for delivering Policy Labs [Figure 1] and the ‘trust-translation-timing’ model (10), we co-developed two Policy Labs with local partners. In SL, based on positive CRADLE-3 study results, the Policy Lab focused on CRADLE VSA integration to aid early detection of PE. In Zambia, the Policy Lab aimed to determine strategies for translation of CRADLE-4 evidence (8) into a national policy of planned early delivery for women with PE. Ethical approval granted for CRADLE-5 trial included Policy Lab workshops, from the Office of the Sierra Leone Ethics and Scientific Review Committee on 24th January 2022 and from the King’s College London, UK Research Ethic Committee on 27 January 2022 [reference: HR/DP-21/22-27014]. Individual participant level written consent was given for ethnographic observation and sharing of photographs.

Steps 1–2

Establishing the need and purpose of the Policy Lab. The primary purpose of these Policy Labs was to facilitate accelerated achievement of national and global targets for prevention of maternal and neonatal deaths through integration of novel research into clinical practise. The Policy Lab questions in SL and Zambia were intended to address different but related aspects of women’s care to reflect the evidence emerging in each setting. The CRADLE-3 trial showed introduction of CRADLE VSA was most impactful in SL, with reductions in maternal mortality and morbidity of 60 and 40% respectively(7), so the Policy Lab question was designed to facilitate development of strategies to improve detection of PE, based on this novel evidence - ‘How can we improve timely detection and appropriate action in women with pre-eclampsia in Sierra Leone?’ The Zambia Policy Lab, based on the CRADLE-4 trial(8), focused on the more upstream and specific aspect of timely delivery; What are enablers and barriers to offering planned early delivery between 34 and 37 weeks’ gestation, to women with pre-eclampsia?.

Step 3

Selection and Invitation of participants. In SL we co-designed the Policy Lab with our colleagues at the Department of Policy Planning and Information, and the Department of Reproductive Health and Family Planning, both within the Ministry of Health and Sanitation (MoHS). MoHS recommended a participant list which was shared and updated with the Policy Lab facilitator and a local community engagement specialist involved in our ongoing NIHR Global Health Research Group, CRIBS. Both hard and electronic invitations were distributed by MoHS. We deliberately included a range of different stakeholders with diverse perspectives, for example Christian and Muslim religious leaders, traditional healers and healthcare workers. In Zambia, the primary delegate list, comprising Ministry of Health Officials, clinical maternal health researchers, programme officers, obstetricians, midwives and paediatricians, all working across urban and rural settings, was curated by a team from the University of Zambia, with input from invited delegates for inclusion of additional stakeholders.

In both SL and Zambia, building trust was a key priority, enabling honest, rigorous discussions, amongst a small group of diverse delegates, ranging from high level government ministers, implementers who could identify barriers and facilitators to change in practice, and community representatives. We were advised against inviting patients to attend the labs due to concerns about their vulnerability in an imbalanced power dynamic. To our knowledge, neither Zambia nor SL have “professional patients”, nor community-based advocacy groups specifically targeted at PE, and as such patient voices and experiences were represented through pre-recorded videos.

Step 4

(Synthesise and communicate the evidence). Policy briefing packs for SL and Zambia were developed collaboratively by King’s College London team members, Policy Lab facilitators and stakeholders in each country in an iterative process over a number of weeks [Additional File 1]. We aimed to summarise emerging research evidence in the context of the existing literature, and to translate information into an accessible format for a mixed audience, to provide a basis on which to discuss barriers, facilitators and novel strategies for integration of the research during the lab itself. Briefing packs were disseminated via WhatsApp (SL) and email, and participants received a printed copy on arrival.

Step 5: (Plan agenda and facilitation). In both settings we gave careful consideration to the length of the Policy Labs (10am − 4pm), with lunch and refreshments provided, and accommodation for those travelling from rural districts. The agendas were based on a structure provided by King’s Policy Institute and adapted to include a series of brief break-out sessions during which groups deliberated on topic-based questions, interspersed with short talks and video presentations [Additional File 2]. In SL, a social networking event followed the lab, to enable continued discussion and evolution of ideas and follow-up plans. In Zambia, the Policy Lab was planned as part of a three-day meeting to disseminate the CRADLE-4 trial results and plan future research collaborations. Local facilitators, familiar with the context and infrastructure of their respective settings, were identified to support development and delivery of both labs: in SL, a midwife with over 30 years clinical experience, who has worked with the Ministry of Health and Sanitation and was technical advisor to the recently completed national CRADLE VSA scale up, and in Zambia, a female doctor who acted as a district health director and community maternal health liaison officer. In both cases, facilitators were involved from the outset and throughout the process, including early discussions around tailoring Policy Lab questions, planning a focused agenda, moderating group debate at the group itself, and collating final outputs.

Step 6: (Conduct the Policy Lab). Following an introductory presentation where the definition and aim of a Policy Lab approach was described, and key elements of the briefing pack summarised, pre-allocated breakout groups discussed barriers and facilitators to integration of new evidence and developed strategies to address challenges. The programme accommodated extending a session to allow greater focus on a point of interest or contention, or moving on if consensus was reached quickly. Groups fed back between breakout sessions, and follow-up steps were agreed in a summary session at the end of the day. In SL, a qualitative researcher carried out an ethnographic observation of the lab to capture the intangible outputs, e.g.: the interpersonal dynamics as well as the systemic challenges identified and solutions developed and documented by each group. In Zambia the final session consisted of a group discussion about next steps and participants committed to championing specific initiatives. Zambian delegates also completed a brief survey to garner immediate impressions of the meeting and inform subsequent engagements.

Steps 7–8. (Report the results and create and support the new coalition). Each group had a scribe who documented outputs on flipcharts. Flipchart notes and ethnographic field notes were separately transcribed and analysed thematically to identify key themes. A joint policy brief was prepared which compiled outputs for SL and Zambia and presented an overview of next steps in an accessible format to promote fast follow-up. In addition, comprehensive Policy Lab reports were created for each lab for distribution to decision makers and other key stakeholders. Whatsapp groups were set up to enable ongoing communication between Policy Lab attendees keen to remain involved in delivering agreed outputs.

We held two Policy Labs, in Lusaka, Zambia (14th February 2023) and Freetown, SL (7th March 2023. Both were held in conference venues that had been carefully selected based on accessibility for participants and suitability for small group break-out sessions as well as wider group discussions. .

Trust – collaborative interactions between producers and consumers of evidence.

In SL, the Policy Lab was co-hosted by MoHS, who assisted with event coordination, including design and distribution of invitations, phone and WhatsApp reminders to the 39 participants. This ensured good attendance with different stakeholder groups well represented, including civil society and grass roots organisation representatives, traditional healers, healthcare workers (tertiary, secondary and community level), national and local government representatives, NGO workers, Christian and Muslim religious leaders and researchers (both from KCL, and Zambia to enable cross country learning). In Zambia 35 national and international delegates attended, including clinicians (obstetricians, midwives and neonatal care providers), researchers, programme officers from local and international maternal and child health-focused organisations based in Zambia, and Ministry of Health officials. A series of mixed break-out groups enabled focused discussions from different stakeholder perspectives around current attitudes and beliefs towards PE (session 1), feasibility and acceptability of integration of novel research evidence (session 2), brainstorming interventions for change (session 3), and feedback and discussion of selected interventions (session 4). Key discussion points arising from sessions 1 and 2 highlighted factors contributing to delayed antenatal care access, which participants cited as potential barriers to integration and uptake of novel research evidence in both settings [see Table 1 – SL, and Table 2 – Zambia].

Table 1

Factors identified by Sierra Leone Lab participants contributing to delayed diagnosis and timely Pre-eclampsia management.
Delay	Examples
Misconceptions	Common misconceptions reported by lab participants held by some communities included beliefs such as: • ‘Fits are a sign that a woman is possessed by demons or devils’ • ‘Pre-eclampsia is associated with taking a bath at night’ • ‘Swollen feet show that the woman is expecting a male infant’
Transport costs and logistics	Distance to healthcare facility and cost of transport
Lack of trust in the quality of care received at the health facility or hospital	• Residual fear from Ebola of contracting disease at health facilities • Lack of trained staff • Many staff are volunteers with no regular salary • Poor adherence to guidance and management pathways • No accountability resulting in a lack of urgency to refer patients or deliver key interventions
Stockouts of basic equipment and medications	i.e.: blood pressure machines, urine dipsticks, blood pressure medication, scanners
Cost of care	‘Free’ healthcare is not free; women are often asked to pay for consumables

Table 2

Potential barriers identified by Policy Lab Participants in Zambia to planned early delivery.
Barrier	Examples
Community concerns	Common beliefs and concerns held by some communities included: • Early delivery is a sign of infidelity • Fear amongst women of a ‘forced’, painful labour which may be bad for the baby. • Natural birth ‘prized’ by society: caesarean delivery = lazy, a failure. • Family’s ‘negative perceptions’ heavily influence decision making. Women’s voices often go unheard.
Widespread uncertainty of true gestational age amongst women and clinicians	Women often present to antenatal care late in pregnancy. Ultrasound scans are not widely available.
Fear of Neonatal Intensive Care Unit	Families: • Cost of care • Competing commitments – childcare, work, household Clinicians: • Planned early delivery would overwhelm NICU with sick babies. • Cost and logistical burden

In both SL and Zambia, the Policy Lab approach of including mixed stakeholders was welcomed as novel and productive, as described by the SL facilitator;

The group was dynamic and you had these multi-disciplinary and diverse groups. There were interesting conversations generated. People were focused. They didn't want to leave their group discussions because there was a lot of interest.

Translation – making the research relevant and readable.

Participants attending both labs received briefing packs prior to the event which summarised background information, key research findings, and the Policy Lab questions to be addressed. The Policy Lab questions were designed to be relevant to the research evidence emerging from each setting, and as a result differed in their focus. In SL, the Policy Lab asked its participants, ‘How do we improve timely detection and appropriate action in women with pre-eclampsia?’ based on CRADLE-3 results, and integration of CRADLE VSA to improve identification of women with PE. In Zambia, participants were asked to explore ‘Enablers and barriers to offering planned early delivery (CRADLE-4 results) to women with pre-eclampsia’. In answer to these questions the majority of key recommendations from the Policy Labs in SL and Zambia were broadly similar and focused on the need to develop strategies to increase awareness of PE, in order to facilitate acceptance and uptake of novel management strategies amongst healthcare workers, women and key decision makers (partners, family members, communities). In SL, participants prioritised development of community based strategies to raise awareness of PE, and to dissolve misconceptions which delay detection of PE. The importance of developing relatable approaches to delivering information was emphasised, including by a Christian Religious leader in attendance who said:

Our role as religious leaders is to compliment health services. After today I will take this information away and preach it at to church services

The healthcare worker representatives amongst the participants identified the need for development of Pre-eclampsia Care Pathways, with staff training, mentoring and accountability to improve adherence to guidelines and protocols in order to increase trust amongst women seeking care, and improve appropriateness of care delivered. In addition, in Zambia, participants recommended targeted education to hospital-based clinicians about planned early delivery, given anticipated resistance at hospital as well as community level [see Fig. 2 for overview schematic]. In SL, an ethnographic observation piece captured the context and interpersonal dynamics both during the sessions, and in the breaks. For example,

‘There was a district health officer from Kailahun who knows the health system way too much and knows the lapses, and when she was talking…there was momentous laughter and clapping for hitting the nail on the head.’ (Participant at Policy Lab Sierra Leone).

Timing - Policy, politics & problems colliding at the right time for policymaking to take action.’

Both Policy Labs were timely. New research derived from CRADLE-3(7) study followed by the recently completed MoHS backed national scale up of the CRADLE VSA, in the spotlight of unprecedented improvements in SL’s maternal mortality ratio (1,682 in 2000 to 443 in 2020(4), provided an opportune policy window, and an appetite to develop and support strategies and interventions that could further accelerate progress towards SDG 3.1(11). This enthusiasm manifested in the immediate and self-directed formation of a technical working group amongst SL Policy Lab participants to further develop key recommendations. The Zambia lab was held shortly after the launch of Zambia’s 8th National Development Plan (2022 to 2026)(12), and the announcement of the CRADLE-4 results(8), which stakeholders were keen to see rapidly translated into positive clinical impact. Outputs developed in the aftermath of both labs were timed to coincide with World Pre-eclampsia Day (22nd May) which provided a global platform for dissemination beyond the local participants and settings. In SL initial outputs included co-creation of a docu-film about PE (Nema’s Choice) with local film makers and actors, which was disseminated, along with specially designed infographics, to antenatal clinics, rural community hubs, universities, and on social media. In both SL and Zambia, radio and TV appearances promoted key messages about Pre-eclampsia and described emerging research, and in Zambia, education sessions were held with midwives working at delivery facilities in and around Lusaka to further consolidate new evidence into clinical care pathways.

Main findings

Novel evidence from CRADLE-3 and CRADLE-4 studies is relevant to both SL and Zambia, with a critical need for integration into clinical practise to reduce maternal and neonatal morbidity and mortality. We applied the same method – a Policy Lab, novel in both SL and Zambia, albeit with a slightly different focus to reflect context specific clinical priorities and challenges. The Policy Labs, based on King’s Policy Institutes’ ‘Trust-Translation-Timing’ model, were designed to bridge the ‘know-do gap’, and aimed to engage change-makers ‘on the shop floor’ rather than restricting dissemination to academic outputs and international conference presentations. Both Policy Labs stimulated lively discussions amongst mixed stakeholders in small breakout groups (‘trust’), who discussed the research evidence, presented via a briefing pack, in the context of relevant barriers and facilitators, and developed interventions for change (‘translation’), which were disseminated on a receptive backdrop of positive progress and priority setting in maternal health at government and policy level in both settings (‘timing’). During both labs participants’ challenges identified to uptake of novel evidence were focused on a lack of awareness about PE and misconceptions amongst women and their communities, with associated reluctance to prioritise accessing care. As such, participants unanimously agreed on the need for collaboratively designed community engagement strategies, with education programmes for hospital and facility-based clinicians to ensure that women receive appropriate, evidence-based interventions.

Strengths

Tangible outputs were agreed at both Policy Labs and have materialised in the form of a Pre-eclampsia Awareness Campaign in Sierra Leone, substantial media engagement in both SL and Zambia, and district level meetings at health facilities conducting deliveries along with clinical guideline updates to reflect CRADLE-4 evidence in Zambia.

We have demonstrated that Policy Labs are an effective tool to initiate discussions amongst diverse stakeholders about rapid integration of novel research evidence into clinical care. This is an important blueprint for other low-and middle-income countries (LMICs), where multiple challenges, including limited infrastructure, lack of technical, financial and skilled resources, and a ‘top-down’ policy making approach, means that the most vulnerable women, who would benefit most from novel interventions, are often the last to receive them(13, 14). Our Policy Labs in SL and Zambia were well-received, collaborative, and highlighted a novel opportunity for expedited policy development, feasible in LMICs. In addition, in both cases local facilitators were involved from the outset, both female, well-respected, experienced health professionals, who were able to inform contextually appropriate tailoring of each Policy Lab to suit the setting, as well as to effectively moderate lively discussions amongst participants.

Limitations

A specific limitation of these Policy Labs was that the voice of the women themselves was represented via video link, and as a result, seemed quieter than the rest. Future labs should aim to include all participants in person to ensure that all have the opportunity to add equal weight to the discussion. More generally, transition of a “successful knowledge translation workshop” to a credible and scalable tool for meaningful engagement with the formal policymaking machinery has been identified as an ongoing dilemma faced by Policy Labs worldwide(10, 15–18). Lewis highlights the fragility of Policy Labs citing funding constraints, divergent reasoning styles and skill-sets in knowledge translation and policymaking, and the heavy reliance on political patronage(17). In our case, whilst Ministry of Health officials attended both Policy Labs, there is currently no formal infrastructure through which recommendations can be actioned and integrated into policy. However, the Policy Lab can be seen as one part of a process or one brick towards bridging the ‘know-do’ gap. In both settings, the Policy Labs set wheels in motion, with manifestations of short term change already apparent in the form of tangible, well-received community and hospital based strategies. In addition, Policy Lab outputs informed a successful funding application to co-develop shared decision making tools for healthcare workers and women to support delivery of evidence based care.

Implications of the findings in the context of existing research

Policy Labs have not yet been widely adopted in SSA. Olejniczak et al. deliberately excluded the small number of Policy Labs identified in SSA, as their research analysis aimed to include nationally grown Policy Labs, rather than international (for example, UNESCO) labs hosted by a SSA country(15). Kim et al reviewed 133 Policy Innovation Labs, three of which were reported to have been held in SSA, but provided no further detail about their content or conduct(19). To our knowledge these two Policy Labs are the first to be held in maternal health in SSA, where the burden of disease is the greatest in the world, and locally derived strategies are desperately needed to inform integration of novel evidence into clinical practise to reduce the number of mothers and babies dying of causes related to Pre-eclampsia. Against this backdrop Policy Labs could represent a valuable approach, especially given the reported lack of alignment between current evidence and health policy, which in cases may be outdated or restrictive(20)

Policy Labs are a novel tool to facilitate transfer of new knowledge into policy and action. Both Policy Labs, to our knowledge the first to be held in these settings, highlighted the need to raise awareness of PE to increase the likelihood of women accessing and accepting evidence based care underpinned by novel evidence. Policy Lab outputs from both SL and Zambia reflect key priorities identified during the labs and have been designed in collaboration with participants. Whilst the Policy Labs in SL and Zambia are only part of the process in translating new evidence into practise, based on the ‘Trust, translation, timing’ model described by KPI, they successfully enabled development of collaborations between academics, policy members and community members (trust), synthesized new evidence into an accessible format (translation) and provided timely access to new knowledge (timing), urgently needed to improve maternal and neonatal outcomes. Future Policy Labs should include the voice of the woman at the forefront of the discussion.

PE: Pre-eclampsia

SSA: Sub-Saharan Africa

SL: Sierra Leone

VSA: Vital Signs Alert

BP: Blood pressure

HR: Heart rate

MoHS: Ministry of Health and Sanitation

LMICs: Low-and middle-income countries

Ethics approval and consent to participate

Ethical approval was granted for CRADLE-5 trial, which included Policy Lab workshops, from the Office of the Sierra Leone Ethics and Scientific Review Committee on 24th January 2022 and from the King’s College London, UK Research Ethic Committee on 27 January 2022 (reference: HR/DP-21/22-27014). Individual participant level written consent was given for ethnographic observation and sharing of photographs.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was funded by UKRI/Newton Fund/ ODA Consolidation Funding [EP/X527920/1]. This included external peer review. The funders had no role in the study design, data collection and analysis, decision to publish or preparation of the article

Authors’ contributions

All authors contributed to the conception and planning of the work. KK, CMB, ABG, AR, OK, BS, PTW, IM, MM, MC, RM, AH, CM, BV, AS, KB contributed to carrying out the work. KK and CMB led the writing. All authors contributed to analysis and interpretation of the work, writing the manuscript, final approval of this version, and agree to be accountable for all aspects of the work.

Acknowledgements

We thank everyone who participated in the Policy Labs in Zambia and Sierra Leone, including Mrs Fatmata Bah who carried out the ethnographic observation. This paper is written on behalf of the CRIBS collaborative group (for more on CRIBS, see https://cribs-i.org/).

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No competing interests reported.

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