Implementing effective community-based surveillance in research studies of maternal, newborn and infant outcomes in low resource settings

Background Globally adopted health and development milestones have not only encouraged improvements in the health and wellbeing of women and infants worldwide, but also a better understanding of the epidemiology of key outcomes and the development of effective interventions in these vulnerable groups. Monitoring of maternal and child health outcomes for milestone tracking requires the collection of good quality data over the long term, which can be particularly challenging in poorly-resourced settings. Despite the wealth of general advice on conducting field trials, there is a lack of specific guidance on designing and implementing studies on mothers and infants. Additional considerations are required when establishing surveillance systems to capture real-time information at scale on pregnancies, pregnancy outcomes, and maternal and infant health outcomes. Main body Based on two decades of collaborative research experience between the Kintampo Health Research Centre in Ghana and the London School of Hygiene and Tropical Medicine, we propose a checklist of key items to consider when designing and implementing systems for pregnancy surveillance and the identification and classification of maternal and infant outcomes in research studies. These are summarised under four key headings: understanding your population; planning data collection cycles; enhancing routine surveillance with additional data collection methods; and designing data collection and management systems that are adaptable in real-time. Conclusion High-quality population-based research studies in low resource communities are essential to ensure continued improvement in health metrics and a reduction in inequalities in maternal and infant outcomes. We hope that the lessons learnt described in this paper will help researchers when planning and implementing their studies.

Protocol for data extraction: how real-world data have been used in the National Institute for Health and Care Excellence appraisals of cancer therapy

IntroductionDue to the limitations of relying on randomised controlled trials, the potential benefits of real-world data (RWD) in enriching evidence for health technology assessment (HTA) are highlighted. Despite increased interest in RWD, there is limited systematic research investigating how RWD have been used in HTA. The main purpose of this protocol is to extract relevant data from National Institute for Health and Care Excellence (NICE) appraisals in a transparent and reproducible manner in order to determine how NICE has incorporated a broader range of evidence in the appraisal of oncology medicines.Methods and analysisThe appraisals issued between January 2011 and May 2021 are included following inclusion criteria. The data extraction tool newly developed for this research includes the critical components of economic evaluation. The information is extracted from identified appraisals in accordance with extraction rules. The data extraction tool will be validated by a second researcher independently. The extracted data will be analysed quantitatively to investigate to what extent RWD have been used in appraisals. This is the first protocol to enable data to be extracted comprehensively and systematically in order to review the use of RWD.Ethics and disseminationThis study is approved by the Ethics Committee of the London School of Hygiene and Tropical Medicine on 14 November 2019 (17315). Results will be published in peer-reviewed journals.

The Scientisation of Economics

Lionel Robbins was appointed head of the Department of Economics at the London School of Economics (LSE) in 1929 following the sudden death of Allyn Young, the incumbent professor. Young had not made any significant alteration to the teaching at LSE, but from the very first Robbins set about reorganising the profile of economics teaching. The framework within which he did this was one of a ‘science’ based upon ‘economic principles’, and in 1932 his Essay on the Nature and Significance of Economic Science provided the methodological template for his project. This work appears to owe a great deal to Austrian economics, but it can be demonstrated that this was indirect, chiefly through the work of Wicksteed and Wicksell, hence reflecting economics where it had stood in the 1880s. Nonetheless, Robbins was successful in repackaging this work, and his Essay stimulated the development of discussions of economic method. In addition, Robbins’s lectures provided the template for the textbook literature of the 1950s, cementing the influence of the LSE on the training of young economists. However, this training remained at the undergraduate level for the most part due to the lack of labour market demand for economists in Britain; in the United States, by contrast, graduate teaching became the motor through which American economics came to dominate the international teaching of economics.

Commerce and Economics at the London School of Economics

The London School of Economics was founded in 1895 to teach vocational and commercial subjects to part-time students. By 1920 the majority of students were full-time, studying the London BSc (Econ.) degree that was, however, a general social sciences degree for which very few students pursued the economics major option. The appointment of Lionel Robbins as Professor of Economics in 1929 opened the way for undergraduate teaching at the LSE to be moved towards economics, with staff appointments being made that would further this end. The bulk of the student body, however, continued to pursue a broad social sciences pathway, and it was only by shutting down the BCom degree in the later 1940s that Robbins was eventually able to bring about the shift from a broadly vocational school to one in which ‘modern’ social sciences dominated.

Reconstructing the University

The ‘modern university’—research-based, in which teaching and research are pursued by academic specialists organised departmentally—was created in the United States in the later nineteenth century in a productive misunderstanding of the organisation of knowledge and teaching in contemporary German universities. While the latter enjoyed international recognition, academic careers remained in thrall to an apprenticeship structure in which senior staff represented their entire discipline, supported by their juniors. The American structure, fostered by endowments and grants, presumed that departments would be composed of specialists who advanced their careers by developing their specialism. This was decisive for the disciplinary development of universities around the world. In London, the university was a federal, administrative body whose degree courses could be followed both within Britain and in the wider Empire. As a component part of this structure, the London School of Economics shared in this reach, and so came to dominate the teaching of the social sciences in Britain and the Empire.

What Is ‘Marshallianism’?

Marshall’s intellectual heritage is often described as ‘Marshallianism’, a general designation of his intellectual style as teacher and writer. But what exactly might this mean? While it is not necessarily wrong to describe his work in this way, it is necessary to have a clear idea of what the term denotes. To begin with, the work of Marshall is distinguished from that of his near (senior) contemporary, Stanley Jevons; but his death in 1882 came at a point when his version of economics had been gaining ground in Britain. While soon eclipsed by Marshall, this more formal approach later became the trademark of the London School of Economics in the 1920s, mediated by its Professor of Political Economy, Edwin Cannan. Then the work of Marshall as a teacher is examined, identifying an approach that sought to encourage students to apply their economic knowledge to the contemporary world. What he sought to inculcate in his students is shown by a discussion of the work of two of his students, A. C. Pigou and Sydney Chapman. This is then followed by a consideration of the composition and editorial changes to Marshall’s Principles of Economics, first published in 1890 and reaching a very much changed final edition in 1920, in which form it continued to be reprinted for much of the twentieth century. Notwithstanding the long life of this work, it can then be shown that, by the 1920s, criticism of Marshall’s approach to economic analysis was increasing, signalling the demise of the Marshallian heritage.

Constructing Economic Science

Constructing Economic Science demonstrates how an existing public discourse, political economy, was transformed in the early twentieth century into a new university discipline: economics. This change in location brought about a restructuring of economic knowledge. Finance, student numbers, curricula, teaching, new media, and the demands of employment all played their part in shaping economics as it is known today. It was broadly accepted in the later nineteenth century that industrialising economies required the skilled and specialised workforce that universities could provide. Advocacy for the teaching of commercial subjects was widespread and international. In Cambridge, Alfred Marshall was alone in arguing that economics, not commerce, provided the most suitable training for the administration and business of the future; and in 1903 he founded the first three-year undergraduate economics programme. This was by no means the end of the story, however. What economics was, how Marshall thought it should be taught, had by the 1920s become contested, and in Britain the London School of Economics gained dominance in defining the new science. By the 1930s, American universities had already moved on from undergraduate to graduate teaching, whereas in Britain university education remained focussed upon undergraduate education. At the same time, public policy was reformulated in terms of economic means and ends—relating to postwar reconstruction, employment, and social welfare—and international economics became American economics. This study charts the conditions that initially shaped the “science” of economics, providing in turn a foundation for an understanding of the way in which this new language itself subsequently transformed public policy.

Tb-practecal: Study Protocol for a Randomised, Controlled, Open-label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis

BackgroundGlobally rifampicin-resistant tuberculosis disease affects around 460 000 people each year. Current recommended regimens are 9-24 months duration, have poor efficacy and carry significant toxicity. A shorter, less toxic and more efficacious regimen would improve outcomes for people with rifampicin-resistant tuberculosis. MethodsTB-PRACTECAL is an open-label, randomised, controlled, phase II/III non-inferiority trial evaluating the safety and efficacy of 24 week regimens containing bedaquiline and pretomanid to treat rifampicin resistant tuberculosis. Conducted in Uzbekistan, South Africa and Belarus, patients aged 15 and above with rifampicin resistant pulmonary tuberculosis and requiring a new course of therapy are eligible for inclusion irrespective of HIV status. In the first stage, equivalent to a phase IIB trial, patients are randomly assigned one of four regimens, stratified by site. Investigational regimens include oral bedaquiline, pretomanid and linezolid. Additionally, two of the regimens also include moxifloxacin (arm 1) and clofazimine (arm 2) respectively. Treatment is administered under direct observation for 24 weeks in investigational arms and 36 to 96 weeks in the standard of care arm. The second stage of the study is equivalent to a phase III trial, investigating the safety and efficacy of the most promising regimen/s. The primary outcome is the percentage of unfavourable outcomes at 72 weeks post randomisation. This is a composite of early treatment discontinuation, treatment failure, recurrence, lost to follow up and death. The study is conducted in accordance with ICH-GCP and full ethical approval was obtained from Médecins sans Frontières ethical review board, London School of Hygiene and Tropical Medicine ethical review board as well as ERBs and regulatory authorities at each site. DiscussionTB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel regimens that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to end of recruitment and additionally, the planned final analysis at 72 weeks after end of recruitment. Trial registrationClinicaltrials.gov registration number NCT02589782

Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T)

IntroductionType 2 diabetes mellitus is a major global challenge, including for Thai policy-makers, as an estimated 4 million people in Thailand (population 68 million) have this condition. Premature death and disability due to diabetes are primarily due to complications which can be prevented by good risk factor control. Diabetes Self-Management Education (DSME) programmes provide patients with diabetes with the necessary knowledge and skills to effectively manage their disease. Currently, a trial is being conducted in Thailand to evaluate the effectiveness, defined as HbA1c<7 at 12 months after enrolment, of a culturally tailored DSME in Thailand. A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context.Methods and analysisThe aim of the process evaluation is to understand how and why the intervention was effective or ineffective and to identify contextually relevant strategies for future successful implementation. For the process evaluation, the design will be a mixed-method study collecting data from nurse providers, and village health volunteers (community health workers) as well as patients. This will be conducted using observations, interviews and focus groups from the three purposively selected groups at the beginning and end of trial. Quantitative data will be collected through surveys conducted at the beginning, during 6-month follow-up, and at the end of trial. The mixed-methods analysis will be triangulated to assess differences and similarities across the various data sources. The overall effectiveness of the intervention will be examined using multilevel analysis of repeated measures.Ethics and disseminationStudy approved by the Chiang Mai University Research Ethics Committee (326/2018) and the London School of Hygiene & Tropical Medicine (16113/RR/12850). Results will be published in open access, peer-reviewed scientific journals.Trial registration numberNCT03938233.