Strengthening respectful communication with patients and colleagues in neonatal units - developing and evaluating a communication and emotional competence training for nurse managers in Kenya.

Introduction: Effective communication is essential to delivering compassionate, high-quality nursing care. The intensive, stressful and technical environment of a new-born unit (NBU) in a low-resource setting presents communication-related challenges for nurses, with negative implications for nurse well-being, team relationships and patient care. We adapted a pre-existing communication and emotional competence course with NBU nurse managers working in Kenya, explored its' value to participants and developed a theory of change to evaluate its' potential impact. Methods: 18 neonatal nurse managers from 14 county referral hospitals helped adapt and participated in a nine-month participatory training process. Training involved guided 'on the job' self-observation and reflection to build self-awareness, and two face-to-face skills-building workshops. The course and potential for future scale up was assessed using written responses from participant nurses (baseline questionnaires, reflective assignments, pre and post workshop questionnaires), workshop observation notes, two group discussions and nine individual in-depth interviews. Results: Participants were extremely positive about the course, with many emphasizing its direct relevance and applicability to their daily work. Increased self-awareness and ability to recognize their own, colleagues' and patients' emotional triggers, together with new knowledge and practical skills, reportedly inspired nurses to change; in turn influencing their ability to provide respectful care, improving their confidence and relationships and giving them a stronger sense of professional identity. Conclusion: Providing respectful care is a major challenge in low-resource, high-pressure clinical settings but there are few strategies to address this problem. The participatory training process examined addresses this challenge and has potential for positive impacts for families, individual workers and teams, including worker well-being. We present an initial theory of change to support future evaluations aimed at exploring if and how positive gains can be sustained and spread within the wider system.

"My heart burns" - A qualitative study of perceptions and experiences of type 1 diabetes among children and youths in Tajikistan.

Aims To explore and describe perceptions and experiences of living with type 1 Diabetes Mellitus among children/youths in Tajikistan. Methods Qualitative methods were employed. Participants were recruited through purposive and snowball samplings. Data were collected using a semi-structured interview guide with children/youths having diabetes, their parents as well as health professionals. Data were analyzed according to Malterud's systematic text condensation. Results Children/youths with diabetes (n = 18), their parents (n = 19) and endocrinologists (n = 4) were interviewed. Families described unique stories in which "emotional stress" and a spiritual "evil eye" were perceived as possible causes of diabetes. Life-threatening complications and maltreatment preceding diagnosis of diabetes were frequent. From manifestation of diabetes onwards, families struggled with systemic and cultural obstacles, causing stigma, discrimination, high school-drop-out rates, diabetic coma, chronic complications or death of the child/youth with diabetes. Conclusions Results of this qualitative study highlight the severity and complexity of challenges families living with a child/youth having diabetes in this low-income country face. Efforts to improve life expectancy and life quality are strongly needed and require addressing both systemic and cultural factors in order to accomplish sustainable impact.

Examining Intervention Design: Lessons from the Development of Eight Related Malaria Health Care Intervention Studies.

Abstract-Rigorous evidence of "what works" to improve health care is in demand, but methods for the development of interventions have not been scrutinized in the same ways as methods for evaluation. This article presents and examines intervention development processes of eight malaria health care interventions in East and West Africa. A case study approach was used to draw out experiences and insights from multidisciplinary teams who undertook to design and evaluate these studies. Four steps appeared necessary for intervention design: (1) definition of scope, with reference to evaluation possibilities; (2) research to inform design, including evidence and theory reviews and empirical formative research; (3) intervention design, including consideration and selection of approaches and development of activities and materials; and (4) refining and finalizing the intervention, incorporating piloting and pretesting. Alongside these steps, projects produced theories, explicitly or implicitly, about (1) intended pathways of change and (2) how their intervention would be implemented.The work required to design interventions that meet and contribute to current standards of evidence should not be underestimated. Furthermore, the process should be recognized not only as technical but as the result of micro and macro social, political, and economic contexts, which should be acknowledged and documented in order to infer generalizability. Reporting of interventions should go beyond descriptions of final intervention components or techniques to encompass the development process. The role that evaluation possibilities play in intervention design should be brought to the fore in debates over health care improvement.

Behind the scenes of the PRIME intervention: designing a complex intervention to improve malaria care at public health centres in Uganda.

BACKGROUND: In Uganda, health system challenges limit access to good quality healthcare and contribute to slow progress on malaria control. We developed a complex intervention (PRIME), which was designed to improve quality of care for malaria at public health centres. OBJECTIVE: Responding to calls for increased transparency, we describe the PRIME intervention's design process, rationale, and final content and reflect on the choices and challenges encountered during the design of this complex intervention. DESIGN: To develop the intervention, we followed a multistep approach, including the following: 1) formative research to identify intervention target areas and objectives; 2) prioritization of intervention components; 3) review of relevant evidence; 4) development of intervention components; 5) piloting and refinement of workshop modules; and 6) consolidation of the PRIME intervention theories of change to articulate why and how the intervention was hypothesized to produce desired outcomes. We aimed to develop an intervention that was evidence-based, grounded in theory, and appropriate for the study context; could be evaluated within a randomized controlled trial; and had the potential to be scaled up sustainably. RESULTS: The process of developing the PRIME intervention package was lengthy and dynamic. The final intervention package consisted of four components: 1) training in fever case management and use of rapid diagnostic tests for malaria (mRDTs); 2) workshops in health centre management; 3) workshops in patient-centred services; and 4) provision of mRDTs and antimalarials when stocks ran low. CONCLUSIONS: The slow and iterative process of intervention design contrasted with the continually shifting study context. We highlight the considerations and choices made at each design stage, discussing elements we included and why, as well as those that were ultimately excluded. Reflection on and reporting of 'behind the scenes' accounts of intervention design may improve the design, assessment, and generalizability of complex interventions and their evaluations.

The development of effective behaviour change interventions to support the use of malaria rapid diagnostic tests by Tanzanian clinicians.

BACKGROUND: Parasitological confirmation is now recommended for all cases of suspected malaria. The roll-out of rapid diagnostic tests (RDTs) is hoped to enable this goal in low resource settings through point of care testing. However, simply making RDTs available has not led to high uptake of the tests or adherence to results by clinicians, with malaria continuing to be overdiagnosed in many settings. We undertook to design an evidence-based intervention package that would be sufficient to support the introduction of RDTs at dispensaries in Tanzania, to be evaluated through the Targeting Artemisinin Combination Therapy (TACT) cluster randomised controlled trial. METHODS: We describe five steps in our intervention design: formative research, review of existing evidence and theory, a workshop to define the intervention approach and content and results of formative research, engagement with behaviour change theory and literature, detailed design of intervention materials and piloting and pretesting of intervention materials. This involved fieldwork with a total of 19 health workers and 212 community members in northeast Tanzania. RESULTS: The formative research suggested that RDTs were a potential source of conflict in the health worker-patient interaction, but that health workers used various techniques to resolve this, including provision of antimalarial drugs for RDT-negative patients. Our reviews showed that evidence was mixed regarding the effectiveness of different methods and theories to support change in prescribing practice. Our design process is presented, drawing from this collective evidence. We describe the final TACT intervention package (including interactive small group workshops, feedback text messages, motivational text messages and patient information leaflets and posters) in terms of its programme theory and implementation theory. CONCLUSIONS: Our study suggests that evidence-based design of complex interventions is possible. The use of formative research to understand malaria overdiagnosis in context was central to the design of the intervention as well as empirical research to test materials and methods prior to implementation. The TACT interventions may be appropriate for other settings where clinicians face similar challenges with malaria diagnostics. TRIAL REGISTRATION: NCT01292707.

Strengthening patient-centred communication in rural Ugandan health centres: A theory-driven evaluation within a cluster randomized trial.

This article describes a theory-driven evaluation of one component of an intervention to improve the quality of health care at Ugandan public health centres. Patient-centred services have been advocated widely, but such approaches have received little attention in Africa. A cluster randomized trial is evaluating population-level outcomes of an intervention with multiple components, including 'patient-centred services.' A process evaluation was designed within this trial to articulate and evaluate the implementation and programme theories of the intervention. This article evaluates one hypothesized mechanism of change within the programme theory: the impact of the Patient Centred Services component on health-worker communication. The theory-driven approach extended to evaluation of the outcome measures. The study found that the proximal outcome of patient-centred communication was rated 10 percent higher (p < 0.008) by care seekers consulting with the health workers who were at the intervention health centres compared with those at control health centres. This finding will strengthen interpretation of more distal trial outcomes.

Designing adverse event forms for real-world reporting: participatory research in Uganda.

The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve quality and quantity of drug safety reports as new medicines are scaled-up.

Beyond registration--measuring the public-health potential of new treatments for malaria in Africa.

Malaria claims over one million lives a year in some of the poorest countries of the world. Affected populations and governments cannot afford to pay for expensive new therapies. Most antimalarial treatments are purchased from local shops and administered in the home. These factors make for a complex set of requirements for any new treatment for malaria if a substantial reduction in mortality is ever to be achieved. Thankfully there are several treatments being developed, mostly within public-private partnerships. Typically, the goal of public-private partnerships is the granting of a product license, so work plans end after phase III trials. As these drugs will ultimately be used unsupervised, malaria control programme managers will require further data on safety and whether the drug is as efficacious when used outside of controlled clinical trials before allowing widespread use of these new products. These data need to be collected in highly specific phase IV programmes. We explain why public-private partnerships should extend their development plans well beyond drug registration, and set out the requirements of such a programme. We aim to generate debate and discussion so that guidelines that are internationally accepted and adhered to can be developed not only for antimalarials but for all drugs that are being developed specifically for use in resource-poor settings.