Trials and tribulations: cross-learning from the practices of epidemiologists and economists in the evaluation of public health interventions.

The randomized controlled trial is commonly used by both epidemiologists and economists to test the effectiveness of public health interventions. Yet we have noticed differences in practice between the two disciplines. In this article, we propose that there are some underlying differences between the disciplines in the way trials are used, how they are conducted and how results from trials are reported and disseminated. We hypothesize that evidence-based public health could be strengthened by understanding these differences, harvesting best-practice across the disciplines and breaking down communication barriers between economists and epidemiologists who conduct trials of public health interventions

Integrated delivery of family planning and childhood immunisation services in routine outreach clinics: findings from a realist evaluation in Malawi.

BACKGROUND: Family planning (FP) needs among postpartum women in low- and middle-income countries remain largely unmet. Integrating FP with childhood immunisation services could partially reduce this unmet need by creating multiple opportunities for timely contact with FP services during the 12 months following childbirth. METHODS: A realist evaluation of an intervention integrating FP and childhood immunisation services in routine outreach clinics in two rural districts of Malawi was conducted. A Context-Mechanism-Outcome (CMO) framework was used to describe the drivers of the intervention. A detailed programme theory was developed based on the analysis of semi-structured interviews and focus group discussions with 50 stakeholders. RESULTS: A total of 9 core mechanisms were identified, which centred on constructs of access. Findings revealed that on the demand side, women were motivated to attend outreach clinics due to shorter travel distances; they felt confident they could access FP services and use contraceptive methods covertly if needed; and when supported by their husband, they were empowered to take up the use of contraceptive methods. On the supply side, providers were empowered through the training they received to provide integrated services; they were confident in their ability to provide essential services; and they were motivated by teamwork and by the recognition they received for their work. Additionally, some providers were found to be unwilling to walk long distances to reach remote clinics, which was seen to negatively affect the availability of services. CONCLUSIONS: The delivery of integrated FP and childhood immunisation services in the context of routine outreach clinics in rural Malawi was seen to trigger mechanisms of accessibility and to improve the acceptability and availability of FP services. However, further research is needed to understand how the integration of these services in a routine outreach clinic setting may affect other dimensions of accessibility, including the approachability, appropriateness and affordability of services

Acceptability of family planning in a changing context in Uganda: a realist evaluation at two time points.

OBJECTIVES: This study sought to understand, during an intervention which integrated family planning (FP) and immunisation, (1) if and how prevailing contextual factors influenced acceptability and use of modern contraceptive methods (MCMs) in a pastoral community in Uganda, (2) what mechanisms were triggered by these contextual factors (3) if these contextual factors changed between two time points 2 years apart and (4) the impact of contextual changes on mechanisms triggered and acceptability and use outcomes. DESIGN: Qualitative realist evaluation over two time points. SETTING: Government health facilities in Moroto District, Karamoja, Uganda. PARTICIPANTS: 69 participants involved in the delivery and uptake of integrated FP and childhood immunisation services. INTERVENTION: Integrated delivery of FP and childhood immunisation services offered to women accessing immunisation services in health facilities between January 2016 and December 2019. RESULTS: Four key themes were identified that encompassed context and mechanisms influencing acceptability of MCMs across both time points of the evaluation. These were: (1) fear of side effects of MCMs; (2) preference for natural FP methods; (3) pastoral lifestyles in the community and (4) food insecurity. The context of these themes changed over time leading to the triggering of mechanisms with an overall increase in acceptability of MCMs over time. Key mechanisms of acceptability triggered included: affective attitude, intervention coherence, self-efficacy, perceived effectiveness and opportunity cost, leading to the development of three context-acceptability theories. CONCLUSIONS: In this study, social and cultural norms played a strong role in influencing acceptability of the intervention. The context combined with intervention components were found to trigger several mechanisms that mapped to constructs of diffusion of innovations and acted as catalysts for mechanisms of acceptability. The context in which the intervention was implemented changed leading to the triggering of mechanisms and an increase in the perceived value and acceptability of MCM use

Lessons learnt: Undertaking rapid reviews on public health and social measures during a global pandemic.

Public health and social measures (PHSM) have been central to the COVID-19 response. Consequently, there has been much pressure on decision-makers to make evidence-informed decisions and on researchers to synthesize the evidence regarding these measures. This article describes our experiences, responses and lessons learnt regarding key challenges when planning and conducting rapid reviews of PHSM during the COVID-19 pandemic. Stakeholder consultations and scoping reviews to obtain an overview of the evidence inform the scope of reviews that are policy-relevant and feasible. Multiple complementary reviews serve to examine the benefits and harms of PHSM across different populations and contexts. Conceiving reviews of effectiveness as adaptable living reviews helps to respond to evolving evidence needs and an expanding evidence base. An appropriately skilled review team and good planning, coordination and communication ensures smooth and rigorous processes and efficient use of resources. Scientific rigor, the practical implications of PHSM-related complexity and likely time savings should be carefully weighed in deciding on methodological shortcuts. Making the best possible use of modeling studies represents a particular challenge, and methods should be carefully chosen, piloted and implemented. Our experience raises questions regarding the nature of rapid reviews and regarding how different types of evidence should be considered in making decisions about PHSM during a global pandemic. We highlight the need for readily available protocols for conducting studies on the effectiveness, unintended consequences and implementation of PHSM in a timely manner, as well as the need for rapid review standards tailored to "rapid" versus "emergency" mode reviewing

Mass deworming to improve developmental health and wellbeing of children in low-income and middle-income countries: a systematic review and network meta-analysis.

BACKGROUND: Soil-transmitted helminthiasis and schistosomiasis, considered among the neglected tropical diseases by WHO, affect more than a third of the world's population, with varying intensity of infection. We aimed to evaluate the effects of mass deworming for soil-transmitted helminths (with or without deworming for schistosomiasis or co-interventions) on growth, educational achievement, cognition, school attendance, quality of life, and adverse effects in children in endemic helminth areas. METHODS: We searched 11 databases up to Jan 14, 2016, websites and trial registers, contacted authors, and reviewed reference lists. We included studies published in any language of children aged 6 months to 16 years, with mass deworming for soil-transmitted helminths or schistosomiasis (alone or in combination with other interventions) for 4 months or longer, that reported the primary outcomes of interest. We included randomised and quasi-randomised trials, controlled before-after studies, interrupted time series, and quasi-experimental studies. We screened in duplicate, then extracted data and appraised risk of bias in duplicate with a pre-tested form. We conducted random-effects meta-analysis and Bayesian network meta-analysis. FINDINGS: We included 52 studies of duration 5 years or less with 1 108 541 children, and four long-term studies 8-10 years after mass deworming programmes with more than 160 000 children. Overall risk of bias was moderate. Mass deworming for soil-transmitted helminths compared with controls led to little to no improvement in weight over a period of about 12 months (0·99 kg, 95% credible interval [CrI] -0·09 to 0·28; moderate certainty evidence) or height (0·07 cm, 95% CrI -0·10 to 0·24; moderate certainty evidence), little to no difference in proportion stunted (eight fewer per 1000 children, 95% CrI -48 to 32; high certainty evidence), cognition measured by short-term attention (-0·23 points on a 100 point scale, 95% CI -0·56 to 0·14; high certainty evidence), school attendance (1% higher, 95% CI -1 to 3; high certainty evidence), or mortality (one fewer per 1000 children, 95% CI -3 to 1; high certainty evidence). We found no data on quality of life and little evidence of adverse effects. Mass deworming for schistosomiasis might slightly increase weight (0·41 kg, 95% CrI -0·20 to 0·91) and has little to no effect on height (low certainty evidence) and cognition (moderate certainty evidence). Our analyses do not suggest indirect benefits for untreated children from being exposed to treated children in the community. We are uncertain about effects on long-term economic productivity (hours worked), cognition, literacy, and school enrolment owing to very low certainty evidence. Results were consistent across sensitivity and subgroup analyses by age, worm prevalence, baseline nutritional status, infection status, impact on worms, infection intensity, types of worms (ascaris, hookworm, or trichuris), risk of bias, cluster versus individual trials, compliance, and attrition. INTERPRETATION: Mass deworming for soil-transmitted helminths with or without deworming for schistosomiasis had little effect. For schistosomiasis, mass deworming might be effective for weight but is probably ineffective for height, cognition, and attendance. Future research should assess which subset of children do benefit from mass deworming, if any, using individual participant data meta-analysis. FUNDING: Canadian Institutes of Health Research and WHO

Mass deworming to improve developmental health and wellbeing of children in low-income and middle-income countries: a systematic review and network meta-analysis

Background Soil-transmitted helminthiasis and schistosomiasis, considered among the neglected tropical diseases by WHO, aff ect more than a third of the world’s population, with varying intensity of infection. We aimed to evaluate the eff ects of mass deworming for soil-transmitted helminths (with or without deworming for schistosomiasis or cointerventions) on growth, educational achievement, cognition, school attendance, quality of life, and adverse eff ects in children in endemic helminth areas. Methods We searched 11 databases up to Jan 14, 2016, websites and trial registers, contacted authors, and reviewed reference lists. We included studies published in any language of children aged 6 months to 16 years, with mass deworming for soil-transmitted helminths or schistosomiasis (alone or in combination with other interventions) for 4 months or longer, that reported the primary outcomes of interest. We included randomised and quasi-randomised trials, controlled before–after studies, interrupted time series, and quasi-experimental studies. We screened in duplicate, then extracted data and appraised risk of bias in duplicate with a pre-tested form. We conducted randomeff ects meta-analysis and Bayesian network meta-analysis. Findings We included 52 studies of duration 5 years or less with 1 108 541 children, and four long-term studies 8–10 years after mass deworming programmes with more than 160 000 children. Overall risk of bias was moderate. Mass deworming for soil-transmitted helminths compared with controls led to little to no improvement in weight over a period of about 12 months (0·99 kg, 95% credible interval [CrI] −0·09 to 0·28; moderate certainty evidence) or height (0·07 cm, 95% CrI −0·10 to 0·24; moderate certainty evidence), little to no diff erence in proportion stunted (eight fewer per 1000 children, 95% CrI −48 to 32; high certainty evidence), cognition measured by short-term attention (−0·23 points on a 100 point scale, 95% CI −0·56 to 0·14; high certainty evidence), school attendance (1% higher, 95% CI −1 to 3; high certainty evidence), or mortality (one fewer per 1000 children, 95% CI −3 to 1; high certainty evidence). We found no data on quality of life and little evidence of adverse eff ects. Mass deworming for schistosomiasis might slightly increase weight (0·41 kg, 95% CrI −0·20 to 0·91) and has little to no eff ect on height (low certainty evidence) and cognition (moderate certainty evidence). Our analyses do not suggest indirect benefi ts for untreated children from being exposed to treated children in the community. We are uncertain about eff ects on long-term economic productivity (hours worked), cognition, literacy, and school enrolment owing to very low certainty evidence. Results were consistent across sensitivity and subgroup analyses by age, worm prevalence, baseline nutritional status, infection status, impact on worms, infection intensity, types of worms (ascaris, hookworm, or trichuris), risk of bias, cluster versus individual trials, compliance, and attrition. Interpretation Mass deworming for soil-transmitted helminths with or without deworming for schistosomiasis had little eff ect. For schistosomiasis, mass deworming might be eff ective for weight but is probably ineff ective for height, cognition, and attendance. Future research should assess which subset of children do benefi t from mass deworming, if any, using individual participant data meta-analysis

Context-acceptability theories: example of family planning interventions in five African countries.

BACKGROUND: Family planning (FP) can lengthen birth intervals and potentially reduce the risk of foetal death, low birthweight, prematurity, and being small for gestational age. Effective FP is most easily achieved through access to and acceptability of modern contraceptive methods (MCMs). This study aimed to identify mechanisms of acceptability and the contexts in which they are triggered and to generate theories to improve the selection and implementation of effective interventions by studying an intervention integrating FP with childhood immunisation services. METHODS: Qualitative interpretative synthesis of findings from realist evaluations of FP interventions in five African countries was guided by an analytical framework. Empirical mechanisms of acceptability were identified from semi-structured interviews and focus group discussions with key stakeholders (N = 253). The context in which these mechanisms were triggered was also defined. Empirical mechanisms of acceptability were matched to constructs of a theoretical framework of acceptability. Context-acceptability theories (CATs) were developed, which summarised constructs of acceptability triggered for specific actors in specified contexts. Examples of interventions that may be used to trigger acceptability for these actors were described. RESULTS: Seven CATs were developed for contexts with strong beliefs in religious values and with powerful religious leaders, a traditional desire for large families, stigmatisation of MCM use, male partners who are non-accepting of FP, and rumours or experiences of MCM side effects. Acceptability mechanisms included alignment with values and beliefs without requiring compromise, actors' certainty about their ability to avoid harm and make the intervention work, and understanding the intervention and how it works. Additionally, acceptability by one group of actors was found to alter the context, triggering acceptability mechanisms amongst others. CONCLUSIONS: This study demonstrated the value of embedding realist approaches within implementation research. CATs are transferable theories that answer the question: given the context, what construct of acceptability does an intervention need to trigger, or more simply, what intervention do we need to apply here to achieve our outcomes? CATs facilitate transfer of interventions across geographies within defined contexts