How can we strengthen partnership and coordination for health system emergency preparedness and response? Findings from a synthesis of experience across countries facing shocks.

BACKGROUND: Discussions of health system resilience and emergency management often highlight the importance of coordination and partnership across government and with other stakeholders. However, both coordination and partnership have been identified as areas requiring further research. This paper identifies characteristics and enablers of effective coordination for emergency preparedness and response, drawing on experience from different countries with a range of shocks, including floods, drought, and COVID-19. METHODS: The paper synthesises evidence from a set of reports related to research, evaluation and technical assistance projects, bringing together evidence from 11 countries in sub-Saharan Africa and South Asia. Methods for the original reports included primary data collection through interviews, focus groups and workshop discussions, analysis of secondary data, and document review. Reports were synthesised using a coding framework, and quality of evidence was considered for reliability of the findings. RESULTS: The reports highlighted the role played by coordination and partnership in preparedness and response, and identified four key areas that characterise and enable effective coordination. First, coordination needs to be inclusive, bringing together different government sectors and levels, and stakeholders such as development agencies, universities, the private sector, local leaders and civil society, with equitable gender representation. Second, structural aspects of coordination bodies are important, including availability of coordination structures and regular meeting fora; clear roles, mandates and sufficient authority; the value of building on existing coordination mechanisms; and ongoing functioning of coordination bodies, before and after crises. Third, organisations responsible for coordination require sufficient capacity, including staff, funding, communication infrastructure and other resources, and learning from previous emergencies. Fourth, effective coordination is supported by high-level political leadership and incentives for collaboration. Country experience also highlighted interactions between these components, and with the wider health system and governance architecture, pointing to the need to consider coordination as part of a complex adaptive system. CONCLUSION: COVID-19 and other shocks have highlighted the importance of effective coordination and partnership across government and with other stakeholders. Using country experience, the paper identifies a set of recommendations to strengthen coordination for health system resilience and emergency management.

A qualitative study exploring stakeholder perspectives on the use of biological samples for future unspecified research in Malawi.

BACKGROUND: There is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research. METHODS: This study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed. RESULTS: On the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted. Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns. CONCLUSIONS: Study findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants.

Stakeholder views on the acceptability of human infection studies in Malawi.

BACKGROUND: Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs. METHODS: We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials. RESULTS: Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria. CONCLUSIONS: Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.

Community Engagement Before Initiation of Typhoid Conjugate Vaccine Trial in Schools in Two Urban Townships in Blantyre, Malawi: Experience and Lessons.

BACKGROUND: To determine the efficacy of a new typhoid conjugate vaccine in an endemic setting in sub-Saharan Africa, the Typhoid Vaccine Acceleration Consortium is conducting a phase-3 randomized controlled trial in Blantyre, Malawi. This article describes community and stakeholder engagement activities before and during the trial, challenges, and lessons learned. METHODS: In October 2017, Malawi-Liverpool Wellcome Trust (MLW) organized a wide range of community engagement activities, including meetings with Ministry of Health and Education officials at the district and facility level, local community leadership, and parent teacher association groups. We engaged media outlets to include local and international television, radio, and print media. Community members were informed directly through a study jingle played via loudspeaker from a van and by community-based activities.To review engagement activity effectiveness: The MLW team met to discuss progress and challenges; and a focus group discussion (FGD), consisting of trial staff, sought feedback from the community on each engagement modality. RESULTS: The school-based vaccine campaign increased community participation exceeding recruitment targets to date (on average, >200 children/day). CONCLUSIONS: The FGD concluded that the van and local activities improved awareness and turnout for the trial, but prior engagement with local government and community leadership is an essential mechanism to provide details of the study, answer questions, communicate the value of the study, and address safety concerns. Effective community engagement is essential in a large intervention trial. Multiple channels of communication are required to reach the community and deliver information needed for participation and provide opportunity for dialogue with the trial team.

How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi.

BACKGROUND: Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. METHODS: Qualitative research was conducted with children and parents in three settings in Southern Malawi (low- and high-income urban and rural), to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. RESULTS: We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children's capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. CONCLUSIONS: Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children's decision-making capacity while respecting parents' interests in children's welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children's capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines.

'We are the eyes and ears of researchers and community': Understanding the role of community advisory groups in representing researchers and communities in Malawi.

Community engagement to protect and empower participating individuals and communities is an ethical requirement in research. There is however limited evidence on effectiveness or relevance of some of the approaches used to improve ethical practice. We conducted a study to understand the rationale, relevance and benefits of community engagement in health research. This paper draws from this wider study and focuses on factors that shaped Community Advisory Group (CAG) members' selection processes and functions in Malawi. A qualitative research design was used; two participatory workshops were conducted with CAG members to understand their roles in research. Workshop findings were triangulated with insights from ethnographic field notes, key informant interviews with stakeholders, focus group discussions with community members and document reviews. Data were coded manually and thematic content analysis was used to identify main issues. Results have shown that democratic selection of CAG members presented challenges in both urban and rural settings. We also noted that CAG members perceived their role as a form of employment which potentially led to ineffective representation of community interests. We conclude that democratic voting is not enough to ensure effective representation of community's interests of ethical relevance. CAG members' abilities to understand research ethics, identify potential harms to community and communicate feedback to researchers is critical to optimise engagement of lay community and avoid tokenistic engagement.

The role of NGOs' service delivery experience in developing relevant research agendas: experience and challenges among NGOs in Malawi.

BACKGROUND: There has been growing interest in the contribution of non-governmental organisations (NGOs) to international health research. One strength that NGOs may bring to research involves the potential value of service delivery experience for indicating relevant research questions, namely through their involvement in service delivery, NGO staff may be aware of frontline knowledge gaps, allowing these staff to identify questions that lead to research with immediate relevance. However, there is little empirical evidence on research agendas within NGOs to assess whether their service delivery experience does lead to relevant research or conditions that affect this. This article examines the identification and selection of research questions within NGOs to explore the role of their service delivery experience in generating relevant research agendas. METHODS: The article reports comparative case study research on four NGOs in Malawi, including two international and two Malawian organisations. Each NGO conducts research and undertakes service delivery and advocacy. Data collection included interviews, focus groups, observation and document review. Analysis involved thematic coding and use of diagrams. RESULTS: The case NGOs' experiences suggest that using service delivery to identify research questions does not always match NGOs' aims or capacities, and does not guarantee relevance. First, NGOs do not want to rely only on service delivery when developing research agendas; they consider other criteria and additional sources of ideas when selecting questions they see as relevant. Second, service delivery staff are not always well-placed to identify research topics; indeed, involvement in hectic, target-driven service delivery can hinder input to research agendas. Third, NGOs' ability to pursue questions inspired by service delivery depends on control over their research agendas; relationships with external actors and financial autonomy affect NGOs' capacity to undertake the research they see as relevant. Finally, the perceived relevance of research findings varies between audiences and depends on more than the research question. CONCLUSIONS: The findings suggest limits to the value and feasibility of a research agenda based on service delivery experience. Based on the analysis, the conclusion outlines strategies to support an effective role for NGOs' service delivery experience in development of research agendas.

Community health workers and Covid-19: Cross-country evidence on their roles, experiences, challenges and adaptive strategies.

Community health workers (CHWs) are a key part of the health workforce, with particular importance for reaching the most marginalised. CHWs' contributions during pandemics have received growing attention, including for COVID-19. This paper contributes to learning about CHWs' experiences during COVID-19, based on evidence from India, Bangladesh, Pakistan, Sierra Leone, Kenya and Ethiopia. The paper synthesises evidence from a set of research projects undertaken over 2020-2021. A thematic framework based on the research focus and related literature was used to code material from the reports. Following further analysis, interpretations were verified with the original research teams. CHWs made important contributions to the COVID-19 response, including in surveillance, community education, and support for people with COVID-19. There was some support for CHWs' work, including training, personal protective equipment and financial incentives. However, support varied between countries, cadres and individual CHWs, and there were significant gaps, leaving CHWs vulnerable to infection and stress. CHWs also faced a range of other challenges, including health system issues such as disrupted medical supply chains, insufficient staff and high workloads, a particular difficulty for female CHWs who were balancing domestic responsibilities. Their work was also affected by COVID-19 public health measures, such as restrictions on gatherings and travel; and by supply-side constraints related to community access and attitudes, including distrust and stigmatization of CHWs as infectious or informers. CHWs demonstrated commitment in adapting their work, for example ensuring patients had adequate drugs in advance of lockdowns, and using their own money and time to address increased transport costs and higher workloads. Effectiveness of these adaptations varied, and some involved coping in a context of inadequate support. CHW are critical for effective response to disease outbreaks, including pandemics like COVID-19. To support CHWs' contribution and protect their wellbeing, CHWs need adequate resources, managerial support, and motivation.

Facilitating high quality acute care in resource-constrained environments: Perspectives of patients recovering from sepsis, their caregivers and healthcare workers in Uganda and Malawi.

Sepsis is a major global health problem, especially in sub-Saharan Africa. Improving patient care requires that healthcare providers understand patients' priorities and provide quality care within the confines of the context they work. We report the perspectives of patients, caregivers and healthcare workers regarding care quality for patients admitted for sepsis to public hospitals in Uganda and Malawi. This qualitative descriptive study in two hospitals included face-to face semi-structured interviews with purposively selected patients recovering from sepsis, their caregivers and healthcare workers. In both Malawi and Uganda, sepsis care often occurred in resource-constrained environments which undermined healthcare workers' capacity to deliver safe, consistent and accessible care. Constraints included limited space, strained; water, sanitation and hygiene (WASH) amenities and practices, inadequate human and material resources and inadequate provision for basic needs including nutrition. Heavy workloads for healthcare workers strained relationships, led to poor communication and reduced engagement with patients and caregivers. These consequences were exacerbated by understaffing which affected handover and continuity of care. All groups (healthcare workers, patients and caregivers) reported delays in care due to long queues and lack of compliance with procedures for triage, treatment, stabilization and monitoring due to a lack of expertise, supervision and context-specific sepsis management guidelines. Quality sepsis care relies on effective severity-based triaging, rapid treatment of emergencies and individualised testing to confirm diagnosis and monitoring. Hospitals in resource-constrained systems contend with limitations in key resources, including for space, staff, expertise, equipment and medicines, in turn contributing to gaps in areas such as WASH and effective care delivery, as well as communication and other relational aspects of care. These limitations are the predominant challenges to achieving high quality care.

"At first, I was very afraid"-a qualitative description of participants' views and experiences in the first Human Infection Study in Malawi.

Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model's feasibility, we sought to understand the participant's opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants' experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.

"Are we getting the biometric bioethics right?" - the use of biometrics within the healthcare system in Malawi.

Biometrics is the science of establishing the identity of an individual based on their physical attributes. Ethical concerns surrounding the appropriate use of biometrics have been raised, especially in resource-poor settings. A qualitative investigation was conducted to explore biometrics clients (n = 14), implementers (n = 12) and policy makers as well as bioethicists (n = 4) perceptions of the ethical aspects of implementing biometrics within the healthcare system in Malawi. Informed use, privacy and confidentiality as well as perceptions of benefits and harms were identified as major issues in the application of biometrics. Implementation of biometrics within the healthcare system in Malawi poses a range of potential ethical issues and practical challenges that impact on equitable uptake. There is a need for more research to explore the benefits and harms of biometrics in practice. Improved community engagement and sensitization should be a required component of biometrics introduction in Malawi.

A Formative Qualitative Study on the Acceptability of Deferred Consent in Adult Emergency Care Research in Malawi.

Research in emergency medical care is challenging due to a limited therapeutic window for intervention, which may compromise informed consent. "Deferred consent" allows initiation of study procedures before full consent is recorded. We conducted a formative qualitative study exploring perspectives on deferred consent in Malawi among research ethics committee members, health care professionals, and lay representatives. Participants identified several advantages of deferred consent including scientific value and potential health benefits to the study subjects and wider population. Participants also had concerns, including regulatory barriers and the risk of abuse and malpractice. Conditions affecting acceptability are related to the role of proxies, the nature of the research, the availability of robust regulatory oversight, and the need for community engagement. Our findings show deferred consent would be acceptable in Malawi, provided that a clear case can be made to advance medical knowledge and that adequate regulatory and ethical protections are in place.

Dust or disease? Perceptions of influenza in rural Southern Malawi.

Influenza virus infections cause between 291 243 and 645 832 deaths annually, with the highest burden in low-income settings. Research in high-income countries has examined public understanding of influenza, but there is little information on views and behaviours about influenza in low-income countries. We explored communities' ideas about the severity, causes, prevention and treatment of influenza in Chikwawa district, Malawi. We conducted 64 in-depth interviews with parents of children aged <5 years, and 7 focus groups with community health workers, parents, and traditional healers. Data were analysed thematically and using a framework matrix to compare views between groups. Respondents held varied ideas about influenza, and many were uncertain about its causes and treatment. Some parents, traditional healers and health workers thought influenza was not severe because they felt it did not cause death or limit activities, but others disagreed. Many saw influenza as a symptom of other conditions, especially malaria and pneumonia, rather than as a disease of its own. Most mentioned dust as the main cause of influenza and believed influenza could be prevented by cleaning the home thoroughly. Treatment seeking for influenza followed different stages, usually starting with home remedies followed by purchasing drugs from groceries and then visiting a health centre. Seeking a clinician tended to be triggered by severe symptoms like high fever or difficulty breathing, and suspicions of malaria or pneumonia. Community health workers provide health education for communities, but some lacked understanding of influenza. Our findings suggest uncertainty about the causes and control of influenza among parents and varied levels of understanding among health providers. Strengthening the capacity of community health workers to provide relevant information about influenza prevention and treatment could address parents' interest in further information and support informed health seeking and engagement with future influenza interventions.

Capacity to conduct health research among NGOs in Malawi: Diverse strengths, needs and opportunities for development.

BACKGROUND: The role of non-governmental organisations (NGOs) in health research has attracted growing attention. NGOs are important service providers and advocates in international health, and conducting research can help NGOs to strengthen these service delivery and advocacy activities. However, capacity to conduct research varies among NGOs. There is currently limited evidence on NGOs' research capacity that can explain why capacity varies or indicate potential areas for support. We examined NGOs' capacity to conduct research, identifying factors that affect their access to the funds, time and skills needed to undertake research. METHODS: We examined research capacity through qualitative case studies of three NGOs in Malawi, including one national and two international NGOs. Data were generated through interviews and focus groups with NGO staff, observation of NGO activities, and document reviews. RESULTS: Availability of funding, skills and time to conduct research varies considerably between the case NGOs. Access to these resources is affected by internal processes such as sources of funding and prioritisation of research, and by the wider environment and external relationships, including the nature of donor support. Constraints include limited ability to apply for research funding, a perception that donors will not support research costs, lack of funding to hire or train research staff, and prioritisation of service delivery over research in funding proposals and staff schedules. CONCLUSION: The findings suggest strategies for NGOs and for donors interested in supporting NGOs' research capacity. Above all, the findings reinforce the importance of initial capacity assessments to identify organisational needs and opportunities. In addition, the need for time and funding as well as skills suggests that strengthening NGOs' research capacity will often require more than research training.

Using theories of change to design monitoring and evaluation of community engagement in research: experiences from a research institute in Malawi.

Background: Evaluation of community and public engagement in research is important to deepen understanding of how engagement works and to enhance its effectiveness. Theories of change have been recommended for evaluating community engagement, for their ability to make explicit intended outcomes and understandings of how engagement activities contribute to these outcomes. However, there are few documented examples of using theories of change for evaluation of engagement. This article reports experience of using theories of change to develop a framework for evaluating community engagement in research at a clinical research organisation in Malawi. We describe the steps used to develop theories of change, and the way theories of change were used to design data collection plans. Based on our experience, we reflect on the advantages and challenges of the theory of change approach. Methods: The theories of change and evaluation framework were developed through a series of workshops and meetings between engagement practitioners, monitoring and evaluation staff, and researchers. We first identified goals for engagement, then used 'so that' chains to clarify pathways and intermediate outcomes between engagement activities and goals. Further meetings were held to refine initial theories of change, identify priority information needs, and define feasible evaluation methods. Results: The theory of change approach had several benefits. In particular, it helped to construct an evaluation framework focused on relevant outcomes and not just activities. The process of reflecting on intended goals and pathways also helped staff to review the design of engagement activities. Challenges included practical considerations around time to consider evaluation plans among practitioners (a challenge for evaluation more generally regardless of method), and more fundamental difficulties related to identifying feasible and agreed outcomes. Conclusions: These experiences from Malawi provide lessons for other research organisations considering use of theories of change to support evaluation of community engagement.

Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

Ethics guidelines emphasise that research should be acceptable to the people invited to take part. However, acceptability is subjective and dependent on context, complicating its assessment and use as an ethical standard. This paper examines the concept of acceptability in relation to parents' perspectives on a paediatric vaccine trial in Malawi. We examined decisions on participation and experiences of the trial through interviews with parents in 41 households invited to enrol their children and participant observation of trial processes. Fieldwork took place in Chikwawa, Southern Malawi from February-October 2016. Parents were not neatly split between those who saw the trial as acceptable and those who did not; instead there were mixed and changing feelings among parents who enrolled their children, and among those who withdrew or did not take part. Some parents agreed to participate but had concerns about the trial, while others expressed satisfaction with the trial but still did not take part. These experiences indicate substantial variation in the nature of acceptance. We describe these variations in relation to six dimensions of acceptability: how acceptable the trial is, what aspects are acceptable, changes over time, circumstances affecting acceptability, variations between people, and reasons for participation or non-participation. The findings illustrate the difficulty of determining whether a trial is sufficiently acceptable to potential participants. We suggest that clarifying definitions of acceptability and examining how acceptability varies in degree, between trial components, over time, and between people and contexts may help researchers generate more nuanced descriptions of acceptability that support responsive and ethical trial design.

"Not just dogs, but rabid dogs": tensions and conflicts amongst research volunteers in Malawi.

Building trust between researchers and communities involved in research is one goal of community engagement. This paper examines the implications of community engagement for trust within communities, including trust among community volunteers who assist with research and between these volunteers and other community members. We describe the experiences of two groups of community volunteers recruited as part of an HIV and TB intervention trial in Malawi: cluster representatives, recruited both to act as key informants for TB suspects and mortality reporting and to identify and report community concerns, and community counsellors, recruited to provide semi-supervised HIV self-testing. We examine tensions experienced due to playing multiple roles, and the implications of volunteer responsibilities for short- and long-term community relationships. Data was collected through a workshop, in-depth interviews and focus group discussions with volunteers and community members. While the volunteer system initially enhanced trust among volunteers and with the community, relationships deteriorated when cluster representatives assumed an additional supervisory role part-way through the trial. Combined with challenging recruitment targets and unequal power relations between volunteers, this new role damaged trust, with implications for volunteer well-being and social relationships. These experiences suggest researchers should consider potential social implications when designing community engagement systems.

Strengthening ethical community engagement in contemporary Malawi.

Although community engagement is increasingly promoted in global health research to improve ethical research practice, there is sometimes a disconnect between the broader moral ambitions for community engagement in the literature and guidelines on the one hand and its rather narrower practical application in health research on the other. In practice, less attention is paid to engaging communities for the 'intrinsic' value of showing respect and ensuring inclusive participation of community partners in research design. Rather, more attention is paid to the use of community engagement for 'instrumental' purposes to improve community understanding of research and ensure successful study implementation. Against this backdrop, we reviewed the literature and engaged various research stakeholders at a workshop to discuss ways of strengthening ethical engagement of communities and to develop context-relevant guidelines for community engagement in health research in Malawi.

How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis.

BACKGROUND: In this paper, we report the findings of a realist synthesis that aimed to understand how and in what circumstances patient reported outcome measures (PROMs) support patient-clinician communication and subsequent care processes and outcomes in clinical care. We tested two overarching programme theories: (1) PROMs completion prompts a process of self-reflection and supports patients to raise issues with clinicians and (2) PROMs scores raise clinicians' awareness of patients' problems and prompts discussion and action. We examined how the structure of the PROM and care context shaped the ways in which PROMs support clinician-patient communication and subsequent care processes. RESULTS: PROMs completion prompts patients to reflect on their health and gives them permission to raise issues with clinicians. However, clinicians found standardised PROMs completion during patient assessments sometimes constrained rather than supported communication. In response, clinicians adapted their use of PROMs to render them compatible with the ongoing management of patient relationships. Individualised PROMs supported dialogue by enabling the patient to tell their story. In oncology, PROMs completion outside of the consultation enabled clinicians to identify problematic symptoms when the PROM acted as a substitute rather than addition to the clinical encounter and when the PROM focused on symptoms and side effects, rather than health related quality of life (HRQoL). Patients did not always feel it was appropriate to discuss emotional, functional or HRQoL issues with doctors and doctors did not perceive this was within their remit. CONCLUSIONS: This paper makes two important contributions to the literature. First, our findings show that PROMs completion is not a neutral act of information retrieval but can change how patients think about their condition. Second, our findings reveal that the ways in which clinicians use PROMs is shaped by their relationships with patients and professional roles and boundaries. Future research should examine how PROMs completion and feedback shapes and is influenced by the process of building relationships with patients, rather than just their impact on information exchange and decision making.

Complexities and dilemmas in community consultation on the design of a research project logo in Malawi.

BACKGROUND: Community engagement on research design is widely highlighted as an important approach for ethical research. This article reports the experience of consulting with communities on the logo used for an influenza study in Malawi. The logo was designed for use on badges worn by study researchers, participant information sheets and other project documents, and could affect perceptions of the study and consequent engagement in the research. METHODS: Four focus group discussions were conducted with populations targeted by the influenza study: pregnant women, people with HIV, mothers and community members. The focus groups incorporated a participatory matrix exercise focusing on key themes emerging from the discussions such as: attractiveness, comprehension, acceptability and suggestions for improvement. Findings from the focus groups were analyzed according to these key themes. RESULTS: The consultation highlighted important benefits of discussion with communities on research design, including providing new perspectives and helping to avoid harm. For example, people living with HIV felt that one of the possible logos could increase stigma within communities. The experience also indicated potential challenges of consultation. In particular, there were contrasting perspectives among the groups, such that the consultation did not provide a clear answer about which logo should be selected. CONCLUSIONS: Our experience adds to current evidence on community engagement by reporting on an area where there is less discussion of community consultation for design of a study logo. The consultation exercise reaffirmed the value of community engagement, but also the difficulty of relying on a brief consultation for decision-making in research design. Further ethical guidance is required on how to negotiate contradictory views during consultations.