Research and implementation interactions in a social accountability study: utilizing guidance for conducting process evaluations of complex interventions.

BACKGROUND: In recent years, researchers and evaluators have made efforts to identify and use appropriate and innovative research designs that account for the complexity in studying social accountability. The relationship between the researchers and those implementing the activities and how this impacts the study have received little attention. In this paper, we reflect on how we managed the relationship between researchers and implementers using the United Kingdom Medical Research Council (MRC) guidance on process evaluation of a complex intervention. MAIN BODY: The MRC guidance focuses on three areas of interaction between researchers and stakeholders involved in developing and delivering the intervention: (i) working with program developers and implementers; (ii) communication of emerging findings between researchers/evaluators and implementers; and (iii) overlapping roles of the intervention and research/evaluation. We summarize how the recommendations for each of the three areas were operationalized in the Community and Provider driven Social Accountability Intervention (CaPSAI) Project and provide reflections based on experience. We co-developed various tools, including standard operating procedures, contact lists, and manuals. Activities such as training sessions, regular calls, and meetings were also conducted to enable a good working relationship between the different partners. CONCLUSIONS: Studying social accountability requires the collaboration of multiple partners that need to be planned to ensure a good working relationship while safeguarding both the research and intervention implementation. The MRC guidance is a useful tool for making interaction issues explicit and establishing procedures. Planning procedures for dealing with research and implementers' interactions could be more comprehensive and better adapted to social accountability interventions if both researchers and implementers are involved. There is a need for social accountability research to include clear statements explaining the nature and types of relationships between researchers and implementers involved in the intervention.

Studying social accountability in the context of health system strengthening: innovations and considerations for future work.

There is a growing body of research on the role of social accountability in bringing about more accessible and better-quality healthcare. Here, we refer to social accountability as "citizens' efforts at ongoing meaningful collective engagement with public institutions for accountability in the provision of public goods" (Joshi, World Dev 99:160-172, 2017). These processes have multiple interrelated components and sub-processes and engage a range of actors in community-driven, often unpredictable and context-dependent actions, which pose many methodological challenges for researchers. In June 2017, scientists and implementers working in this area came together to share experiences, discuss approaches, identify research gaps and consider directions for future studies. This paper shares learnings from this discussion.In particular, participants considered (1) how best to define and measure the complex processual nature of social accountability; (2) the study of social accountability as an inherently political process; and (3) the challenges of generalising unpredictable, community-driven and context-dependent processes. Key among a range of consensus areas was the need for researchers to capture a broader range of outcomes and better understand the nuances of implementation processes in order to effectively test theories and assumptions. Furthermore, power relationships are inherent in social accountability and the research process itself. In presenting details on these deliberations, we hope to prompt a wider discussion on the study of social accountability in health programming.

What is the current evidence for the relationship between the climate and environmental crises and child marriage? A scoping review.

Environmental crises such as climate change threaten the realisation of sexual and reproductive health and rights. In this scoping review, we examine the evidence for the relationship between environmental crises and child marriage. We conducted a search of Google Scholar, Scopus and MedLine from their origin to 4th June 2021 for both peer-reviewed academic literature and 'grey' literature. A total of 24 relevant articles were identified, including both quantitative and qualitative work. while there are limitations of the current evidence base such as its narrow geographical scope, we find that environmental crises worsen known drivers of child marriage, pushing families to marry their daughters early through loss of assets and opportunities for income generation, displacement of people from their homes, educational disruption, and the creation of settings in which sexual violence and the fear of sexual violence increase. Local socio-cultural contexts such as bride price or dowry practices further shape how these factors affect child marriage. Given many of the areas with the highest current rates of child marriage face the gravest environmental threats, action to tackle child marriage must take account of the link identified in this review.

Ringing the Existential Alarm: Exploring BirthStrike for Climate.

Climate change is altering the horizon of a liveable future and as a result giving rise to a host of anxieties: ecological, demographic, reproductive, and existential. The BirthStrike for Climate collective was a group of people who were reconsidering reproduction as a result of the climate crisis. In exploring the case of BirthStrike we consider how these decisions were used as a tool for "existential" activism and how the campaign was encountered and discredited in the public realm. We argue the campaign ignited numerous anxieties, resulting in an inability to "hear" the existential threat BirthStrikers aimed to call into focus.

Accounting for complexity - Intervention design in the context of studying social accountability for reproductive health.

Background: Social accountability interventions aim to propel change by raising community voices and holding duty bearers accountable for delivering on rights and entitlements. Evidence on the role of such interventions for improving community health outcomes is steadily emerging, including for sexual and reproductive health and rights (SRHR). However, these interventions are complex social processes with numerous actors, multiple components, and a highly influential local context. Unsurprisingly, determining the mechanisms of change and what outcomes may be transferable to other similar settings can be a challenge. We report our methodological considerations to account for complexity in a social accountability intervention exploring contraceptive uptake and use in Ghana and Tanzania. Main Body: The Community and Provider driven Social Accountability Intervention (CaPSAI) study explores the relationship between a health facility-focused social accountability intervention and contraceptive service provision in two countries. This 24-month mixed-method quasi-experimental study, using an interrupted time series with a parallel control group, is being undertaken in 16 sites across Ghana and Tanzania in collaboration with local research and implementation partners. The primary outcomes include changes in contraceptive uptake and use. We also measure outcomes related to current social accountability theories of change and undertake a process evaluation. We present three design features: co-design, 'conceptual' fidelity, and how we aim to track the intervention as 'intended vs. implemented' to explore how the intervention could be responsive to the embedded routines, local contextual realities, and the processual nature of the social accountability intervention. Conclusions: Through a discussion of these design features and their rationale, we conclude by suggesting approaches to intervention design that may go some way in responding to recent challenges in accounting for social accountability interventions, bearing relevance for evaluating health system interventions.

Rationale and design of a complex intervention measuring the impact and processes of social accountability applied to contraceptive programming: CaPSAI Project.

Background: There are numerous barriers leading to a high unmet need for family planning and contraceptives (FP/C).  These include limited knowledge and information, poor access to quality services, structural inefficiencies in service provision and inadequately trained and supervised health professionals. Recently, social accountability programs have shown promising results in addressing barriers to accessing sexual and reproductive health services. As a highly complex participatory process with multiple and interrelated components, steps and actors, studying social accountability poses methodological challenges. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project study protocol was developed to measure the impact of a social accountability intervention on contraceptive uptake and use and to understand the mechanisms and contextual factors that influence and generate these effects (with emphasis on health services actors and community members). Methods: CaPSAI Project is implementing a social accountability intervention where service users and providers assess the quality of local FP/C services and jointly identify ways to improve the delivery and quality of such services. In the project, a quasi-experimental study utilizing an interrupted time series design with a control group is conducted in eight intervention and eight control facilities in each study country, which are Ghana and Tanzania. A cross-sectional survey of service users and health care providers is used to measure social accountability outcomes, and a cohort of women who are new users of FP/C is followed up after the completion of the intervention to measure contraceptive use and continuation. The process evaluation utilizes a range of methods and data sources to enable a fuller description of how the findings were produced. Conclusion: This complex study design could provide researchers and implementers with the means to better measure and understand the mechanisms and contextual factors that influence social accountability processes in reproductive health, adding important findings to the evidence base.

A report on the FIGO Saving Mothers and Newborns Project.

In collaboration with member national professional associations, the International Federation of Gynecology and Obstetrics (FIGO) has been conducting a Saving Mothers and Newborns Project in 10 low- and middle-resource countries. The project aims to achieve the objectives set out in Millennium Development Goals 4 and 5 related to child survival and maternal mortality and to develop organizational capacity among member associations. Projects are developed in response to the needs of the local country, through a twinning of professional associations between high- and low-resource countries.

Need for parenteral iron therapy after bariatric surgery.

BACKGROUND: Malabsorptive bariatric procedures such as Roux-en-Y gastric bypass and biliopancreatic diversion/duodenal switch expose the patient to malnutrition and commonly cause iron deficiency. The optimal replacement and monitoring method remain undetermined. To identify high-risk patients who might need intravenous iron supplementation after bariatric surgery, we evaluated bariatric surgery patients who received parenteral iron at a university hospital-affiliated hematology center. METHODS: We performed a retrospective analysis and reviewed the records of 165 patients who had received parenteral iron from May 2004 to June 2007. Of the 165 patients, 42 bariatric surgery patients were identified. The type of bariatric procedure and menstrual status of the patients were compared. RESULTS: The average patient age was 40 years. Of the 42 patients, 2 were men and 40 were women. Of the 40 women, 32 were premenopausal and 8 were postmenopausal. The patients in the biliopancreatic diversion/duodenal switch group had a significantly lower hemoglobin at presentation (P = .02), relatively lower ferritin levels, and required more additional parenteral iron treatment after the initial resolution of anemia (P = .001). The premenopausal women required earlier parenteral replacement (P = .008) and were at a greater risk of anemia-related hospitalization (P = .00033). CONCLUSION: The available published studies lack any data regarding parenteral iron replacement needs after bariatric surgery. Our results have identified the need for long-term parenteral iron replacement therapy after malabsorptive bariatric procedures, especially in premenopausal women. Patients who do not respond to oral iron therapy should be referred early for parenteral iron replacement therapy to prevent anemia-related complications and to maintain patients' quality of life. Iron monitoring should continue indefinitely even after the initial repletion of iron stores and the resolution of anemia.

Cost-effectiveness of screening for HIV in primary care: a health economics modelling analysis.

BACKGROUND: Early HIV diagnosis reduces morbidity, mortality, the probability of onward transmission, and their associated costs, but might increase cost because of earlier initiation of antiretroviral treatment (ART). We investigated this trade-off by estimating the cost-effectiveness of HIV screening in primary care. METHODS: We modelled the effect of the four-times higher diagnosis rate observed in the intervention arm of the RHIVA2 randomised controlled trial done in Hackney, London (UK), a borough with high HIV prevalence (≥0·2% adult prevalence). We constructed a dynamic, compartmental model representing incidence of infection and the effect of screening for HIV in general practices in Hackney. We assessed cost-effectiveness of the RHIVA2 trial by fitting model diagnosis rates to the trial data, parameterising with epidemiological and behavioural data from the literature when required, using trial testing costs and projecting future costs of treatment. FINDINGS: Over a 40 year time horizon, incremental cost-effectiveness ratios were £22 201 (95% credible interval 12 662-132 452) per quality-adjusted life-year (QALY) gained, £372 207 (268 162-1 903 385) per death averted, and £628 874 (434 902-4 740 724) per HIV transmission averted. Under this model scenario, with UK cost data, RHIVA2 would reach the upper National Institute for Health and Care Excellence cost-effectiveness threshold (about £30 000 per QALY gained) after 33 years. Scenarios using cost data from Canada (which indicate prolonged and even higher health-care costs for patients diagnosed late) suggest this threshold could be reached in as little as 13 years. INTERPRETATION: Screening for HIV in primary care has important public health benefits as well as clinical benefits. We predict it to be cost-effective in the UK in the medium term. However, this intervention might be cost-effective far sooner, and even cost-saving, in settings where long-term health-care costs of late-diagnosed patients in high-prevalence regions are much higher (≥60%) than those of patients diagnosed earlier. Screening for HIV in primary care is cost-effective and should be promoted. FUNDING: NHS City and Hackney, UK Department of Health, National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care.

Effectiveness and cost-effectiveness of implementing HIV testing in primary care in East London: protocol for an interrupted time series analysis.

INTRODUCTION: HIV remains underdiagnosed. Guidelines recommend routine HIV testing in primary care, but evidence on implementing testing is lacking. In a previous study, the Rapid HIV Assessment 2 (RHIVA2) cluster randomised controlled trial, we showed that providing training and rapid point-of-care HIV testing at general practice registration (RHIVA2 intervention) in Hackney led to cost-effective, increased and earlier diagnosis of HIV. However, interventions effective in a trial context may be less so when implemented in routine practice. We describe the protocol for an MRC phase IV implementation programme, evaluating the impact of rolling out the RHIVA2 intervention in a post-trial setting. We will use a longitudinal study to examine if the post-trial implementation in Hackney practices is effective and cost-effective, and a cross-sectional study to compare Hackney with two adjacent boroughs providing usual primary care (Newham) and an enhanced service promoting HIV testing in primary care (Tower Hamlets). METHODS AND ANALYSIS: Service evaluation using interrupted time series and cost-effectiveness analyses. We will include all general practices in three contiguous high HIV prevalence East London boroughs. All adults aged 16 and above registered with the practices will be included. The interventions to be examined are: a post-trial RHIVA2 implementation programme (including practice-based education and training, external quality assurance, incentive payments for rapid HIV testing and incorporation of rapid HIV testing in the sexual health Local Enhanced Service) in Hackney; the general practice sexual health Network Improved Service in Tower Hamlets and usual care in Newham. Coprimary outcomes are rates of HIV testing and new HIV diagnoses. ETHICS AND DISSEMINATION: The chair of the Camden and Islington NHS Research Ethics Committee, London, has endorsed this programme as an evaluation of routine care. Study results will be published in peer-reviewed journals and reported to commissioners.

Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory.

BACKGROUND: Complex intervention trials may require health care organisations to implement new service models. In a recent cluster randomised controlled trial, some participating organisations achieved high recruitment, whereas others found it difficult to assimilate the intervention and were low recruiters. We sought to explain this variation and develop a model to inform organisational participation in future complex intervention trials. METHODS: The trial included 40 general practices in a London borough with high HIV prevalence. The intervention was offering a rapid HIV test as part of the New Patient Health Check. The primary outcome was mean CD4 cell count at diagnosis. The process evaluation consisted of several hundred hours of ethnographic observation, 21 semi-structured interviews and analysis of routine documents (e.g., patient leaflets, clinical protocols) and trial documents (e.g., inclusion criteria, recruitment statistics). Qualitative data were analysed thematically using--and, where necessary, extending--Greenhalgh et al.'s model of diffusion of innovations. Narrative synthesis was used to prepare case studies of four practices representing maximum variety in clinicians' interest in HIV (assessed by level of serological testing prior to the trial) and performance in the trial (high vs. low recruiters). RESULTS: High-recruiting practices were, in general though not invariably, also innovative practices. They were characterised by strong leadership, good managerial relations, readiness for change, a culture of staff training and available staff time ('slack resources'). Their front-line staff believed that patients might benefit from the rapid HIV test ('relative advantage'), were emotionally comfortable administering it ('compatibility'), skilled in performing it ('task issues') and made creative adaptations to embed the test in local working practices ('reinvention'). Early experience of a positive HIV test ('observability') appeared to reinforce staff commitment to recruiting more participants. Low-performing practices typically had less good managerial relations, significant resource constraints, staff discomfort with the test and no positive results early in the trial. CONCLUSIONS: An adaptation of the diffusion of innovations model was an effective analytical tool for retrospectively explaining high and low-performing practices in a complex intervention research trial. Whether the model will work prospectively to predict performance (and hence shape the design of future trials) is unknown. TRIAL REGISTRATION: ISRCTN Registry number: ISRCTN63473710. Date assigned: 22 April 2010.

Promotion of rapid testing for HIV in primary care (RHIVA2): a cluster-randomised controlled trial.

BACKGROUND: Many people with HIV are undiagnosed. Early diagnosis saves lives and reduces onward transmission. We assessed whether an education programme promoting rapid HIV testing in general practice would lead to increased and earlier HIV diagnosis. METHODS: In this cluster randomised controlled trial in Hackney (London, UK), general practices were randomly assigned (1:1) to offer either opt-out rapid HIV testing to newly registering adults or continue usual care. All practices were invited to take part. Practices were randomised by an independent clinical trials unit statistician with a minimisation program, maintaining allocation concealment. Neither patients nor investigators were masked to treatment allocation. The primary outcome was CD4 count at diagnosis. Secondary outcomes were rate of diagnosis, proportion with CD4 count less than 350 cells per µL, and proportion with CD4 count less than 200 cells per µL. This study is registered with ClinicalTrials.gov, number ISRCTN63473710. FINDINGS: 40 of 45 (89%) general practices agreed to participate: 20 were assigned to the intervention group (44 971 newly registered adult patients) and 20 to the control group (38 464 newly registered adult patients), between April 19, 2010, and Aug 31, 2012. Intervention practices diagnosed 32 people with HIV versus 14 in control practices. Mean CD4 count at diagnosis was 356 cells per µL (SD 254) intervention practices versus 270 (SD 257) in control practices (adjusted difference of square root CD4 count 3·1, 95% CI -1·2 to 7·4; p=0·16);); in a pre-planned sensitivity analysis excluding patients diagnosed via antenatal care, the difference was 6·4 (95% CI, 1·2 to 11·6; p=0·017). Rate of HIV diagnosis was 0·30 (95% CI 0·11 to 0·85) per 10 000 patients per year in intervention practices versus 0·07 (0·02 to 0·20) in control practices (adjusted ratio of geometric means 4·51, 95% CI 1·27 to 16·05; p=0·021). 55% of patients in intervention practices versus 73% in control practices had CD4 count less than 350 cells per µL (risk ratio 0·75, 95% CI 0·53 to 1·07). 28% versus 46% had CD4 count less than 200 cells per µL (0·60, 0·32 to 1·13). All patients diagnosed by rapid testing were successfully transferred into specialist care. No adverse events occurred. INTERPRETATION: Promotion of opt-out rapid testing in general practice led to increased rate of diagnosis, and might increase early detection, of HIV. We therefore recommend implementation of HIV screening in general practices in areas with high HIV prevalence. FUNDING: UK Department of Health, NHS City and Hackney.

Anthropogenic noise affects vocal interactions.

Animal communication plays a crucial role in many species, and it involves a sender producing a signal and a receiver responding to that signal. The shape of a signal is determined by selection pressures acting upon it. One factor that exerts selection on acoustic signals is the acoustic environment through which the signal is transmitted. Recent experimental studies clearly show that senders adjust their signals in response to increased levels of anthropogenic noise. However, to understand how noise affects the whole process of communication, it is vital to know how noise affects the receiver's response during vocal interactions. Therefore, we experimentally manipulated ambient noise levels to expose male European robins (Erithacus rubecula) to two playback treatments consisting of the same song: one with noise and another one without noise. We found that males responding to a conspecific in a noise polluted environment increased minimum frequency and decreased song complexity and song duration. Thus, we show that the whole process of communication is affected by noise, not just the behaviour of the sender.

Safe motherhood and newborn health: FIGO initiatives 2006-2010.

Through international partnerships, FIGO has been delivering safe motherhood and newborn health (SMNH) projects in a number of low-income countries. The projects aim to achieve the objectives set out in the ICPD Programme of Action and the Millennium Development Goals 4 and 5, which are related to child survival and maternal mortality. Each project is developed in response to the needs of the intervention region and can be organized around the following themes: provision of maternal and newborn health care services to underserved and hard-to-reach areas; improvement and provision of quality basic emergency obstetric care; establishment of functional clinical and perinatal audits; development of new maternal and newborn health care protocols; community education and sensitization to women's rights in sexual and reproductive health; and reducing the risk of unsafe abortion.

A retrospective analysis of the incidence of hemolysis in type and screen specimens from trauma patients.

BACKGROUND: Hemolysis of blood samples has been a concern in hospitals. Currently, residents and nurses have replaced traditional teams of skilled phlebotomists for both routine and 'stat' blood draws. Although this leads to a decreased operating cost for institutions, the lack of skill and experience leads to a higher percentage of hemolyzed specimens. OBJECTIVE: To determine the incidence of hemolyzed 'type and screen' blood samples at Staten Island University Hospital (SIUH) (New York, USA). METHODS: The study group comprised 615 consecutive trauma patients at SIUH between July 2006 and June 2007. Patients were treated according to the Advanced Trauma Life Support protocol. The primary survey for a trauma patient consists of 'airway', 'breathing' and 'circulation'. The primary objective of 'circulation' is to establish vascular access and collect blood samples for analysis. The SIUH in-house laboratory provided all of the reports. RESULTS: Of the 615 samples collected, 155 samples (25.2%) were hemolyzed. CONCLUSIONS: The hemolysis rate of 25.2% for type and screen samples is higher than previously reported in the literature. The data suggest that the high rate of hemolysis in these trauma patients is due to the residents' lack of experience and skills required to obtain an adequate blood draw.