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  • Quality, Equity and Utility of Observational Studies during 10 Years of Implementing the Structured Operational Research and Training Initiative in 72 Countries

    Zachariah, R; Rust, S; Thekkur, P; Khogali, M; Kumar, AM; Davtyan, K; Diro, E; Satyanarayana, S; Denisiuk, O; Griensven, JV; et al. (MDPI, 2020-11-06)
    Introduction: Observational studies are often inadequately reported, making it difficult to assess their validity and generalizability and judge whether they can be included in systematic reviews. We assessed the publication characteristics and quality of reporting of observational studies generated by the Structured Operational Research and Training Initiative (SORT IT). Methods: A cross-sectional analysis of original publications from SORT IT courses. SORT IT is a global partnership-based initiative aimed at building sustainable capacity for conducting operational research according to country priorities and using the generated evidence for informed decision-making to improve public health. Reporting quality was independently assessed using an adapted version of ‘Strengthening the Reporting of Observational Studies in Epidemiology’ (STROBE) checklist. Results: In 392 publications, involving 72 countries, 50 journals, 28 publishers and 24 disease domains, low- and middle-income countries (LMICs) first authorship was seen in 370 (94%) and LMIC last authorship in 214 (55%). Publications involved LMIC-LMIC collaboration in 90% and high-income-country-LMIC collaboration in 87%. The majority (89%) of publications were in immediate open access journals. A total of 346 (88.3%) publications achieved a STROBE reporting quality score of >85% (excellent), 41 (10.4%) achieved a score of 76–85% (good) and 5 (1.3%) a score of 65–75% (fair). Conclusion: The majority of publications from SORT IT adhere to STROBE guidelines, while also ensuring LMIC equity and collaborative partnerships. SORT IT is, thus, playing an important role in ensuring high-quality reporting of evidence for informed decision-making in public health.
  • Bridging research integrity and global health epidemiology (BRIDGE) guidelines: explanation and elaboration

    Alba, S; Lenglet, A; Verdonck, K; Roth, J; Patil, R; Mendoza, W; Juvekar, S; Rumisha, SF (BMJ Publishing Group, 2020-10-28)
    Over the past decade, two movements have profoundly changed the environment in which global health epidemiologists work: research integrity and research fairness. Both ought to be equally nurtured by global health epidemiologists who aim to produce high quality impactful research. Yet bridging between these two aspirations can lead to practical and ethical dilemmas. In the light of these reflections we have proposed the BRIDGE guidelines for the conduct of fair global health epidemiology, targeted at stakeholders involved in the commissioning, conduct, appraisal and publication of global health research. The guidelines follow the conduct of a study chronologically from the early stages of study preparation until the dissemination and communication of findings. They can be used as a checklist by research teams, funders and other stakeholders to ensure that a study is conducted in line with both research integrity and research fairness principles. In this paper we offer a detailed explanation for each item of the BRIDGE guidelines. We have focused on practical implementation issues, making this document most of interest to those who are actually conducting the epidemiological work.
  • Bridging research integrity and global health epidemiology (BRIDGE) statement: guidelines for good epidemiological practice

    Alba, S; Verdonck, K; Lenglet, A; Rumisha, SF; Wienia, M; Teunissen, I; Straetemans, M; Mendoza, W; Jeannetot, D; Weibel, D; et al. (BMJ Publishing Group, 2020-10-28)
    Background Research integrity and research fairness have gained considerable momentum in the past decade and have direct implications for global health epidemiology. Research integrity and research fairness principles should be equally nurtured to produce high-quality impactful research—but bridging the two can lead to practical and ethical dilemmas. In order to provide practical guidance to researchers and epidemiologist, we set out to develop good epidemiological practice guidelines specifically for global health epidemiology, targeted at stakeholders involved in the commissioning, conduct, appraisal and publication of global health research. Methods We developed preliminary guidelines based on targeted online searches on existing best practices for epidemiological studies and sought to align these with key elements of global health research and research fairness. We validated these guidelines through a Delphi consultation study, to reach a consensus among a wide representation of stakeholders. Results A total of 45 experts provided input on the first round of e-Delphi consultation and 40 in the second. Respondents covered a range of organisations (including for example academia, ministries, NGOs, research funders, technical agencies) involved in epidemiological studies from countries around the world (Europe: 19; Africa: 10; North America: 7; Asia: 5; South-America: 3 Australia: 1). A selection of eight experts were invited for a face-to-face meeting. The final guidelines consist of a set of 6 standards and 42 accompanying criteria including study preparation, protocol development, data collection, data management, data analysis, dissemination and communication. Conclusion While guidelines will not by themselves guard global health from questionable and unfair research practices, they are certainly part of a concerted effort to ensure not only mutual accountability between individual researchers, their institutions and their funders but most importantly their joint accountability towards the communities they study and society at large.
  • Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol Reporting Guidelines: Protocol for a Delphi Study

    Mahajan, R; Burza, S; Bouter, LM; Sijtsma, K; Knottnerus, A; Kleijnen, J; Dael, PV; Zeegers, MP (JMIR Publications, 2020-10-21)
    Background: Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain. Objective: The aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. Methods: A scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines. Results: A scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020. Conclusions: This project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies.
  • "They have been neglected for a long time": a qualitative study on the role and recognition of rural health motivators in the Shiselweni region, Eswatini.

    Walker, C; Burtscher, D; Myeni, J; Kerschberger, B; Schausberger, B; Rusch, B; Dlamini, N; Whitehouse, K (BMC, 2020-09-21)
    Background: Community health workers (CHWs) are increasingly engaged to address human resource shortages and fill primary healthcare gaps. In Eswatini, a cadre of CHWs called Rural Health Motivators (RHM) was introduced in 1976 to respond to key public health challenges. However, the emergence of health needs, particularly HIV/TB, has been met with inadequate programme amendments, and the role of RHMs has become marginalised following the addition of other CHWs supported by non-governmental organisations. This study was implemented to understand the role of RHMs in decentralised HIV/TB activities. In this paper, we explore the findings in relation to the recognition of RHMs and the programme. Methods: This exploratory qualitative study utilised individual in-depth interviews, group and focus group discussions, participatory methods (utilising a game format) and observations. Participants were purposively selected and comprised RHM programme implementers, community stakeholders and local and non-governmental personnel. Data collection took place between August and September 2019. Interviews were conducted in English or siSwati and transcribed. SiSwati interviews were translated directly into English. All interviews were audio-recorded, manually coded and thematically analysed. Data was validated through methodical triangulation. Results: Suboptimal organisational structure and support, primarily insufficient training and supervision for activities were factors identified through interviews and observation activities. Significant confusion of the RHM role was observed, with community expectations beyond formally endorsed tasks. Community participants expressed dissatisfaction with receiving health information only, preferring physical assistance in the form of goods. Additionally, gender emerged as a significant influencing factor on the acceptability of health messages and the engagement of RHMs with community members. Expectations and structurally limiting factors shape the extent to which RHMs are recognised as integral to the health system, at all social and organisational levels. Conclusions: Findings highlight the lack of recognition of RHMs and the programme at both community and national levels. This, along with historical neglect, has hindered the capacity of RHMs to successfully contribute to positive health outcomes for rural communities. Renewed attention and support mechanisms for this cadre are needed. Clarification of the RHM role in line with current health challenges and clearer role parameters is essential.
  • Knowledge production in humanitarian crises: beware of the innovation trap

    Smith, J; Whitehouse, K; Blanchet, K (Elsevier, 2020-04-01)
  • Knowledge production in humanitarian crises: beware of the innovation trap

    Smith, J; Whitehouse, K; Blanchet, K (Elsevier, 2020-04-01)
  • New ways to measure the effects of armed conflict in civilian population

    Kadir, A; Garcia, DM; Romero, F (Elsevier, 2019-10-24)
  • The STREAM trial: missed opportunities and lessons for future clinical trials.

    Loveday, M; Reuter, A; Furin, J; Seddon, JA; Cox, H (Elsevier, 2019-04-01)
    Final results of the STREAM trial were presented at the 2018, 49th Union World Conference on Lung Health, held in The Hague, The Netherlands. STREAM is a randomised controlled trial comparing the 18–24 month WHO-recommended multidrug-resistant tuberculosis (MDR-TB) treatment regimen with a 9–12 month regimen similar to that first described in Bangladesh. 1 Under programmatic conditions, the longer regimen results in treatment success for approximately 50% of patients, 2 whereas the shorter 9–12 month regimen improved treatment success to 80% or higher in selected countries. 3 , 4 Because these countries had relatively low HIV prevalence and relatively high percentages of treatment success with the longer regimens, questions around generalisability were raised. 4 STREAM was a multi-million dollar undertaking that took almost 10 years from the time of study design until the release of final results. Given the time and costs involved it is essential to reflect on lessons learned, and what the trial results tell us to inform how we accumulate future evidence to guide MDR-TB treatment.
  • SMS-based smartphone application for disease surveillance has doubled completeness and timeliness in a limited-resource setting – evaluation of a 15-week pilot program in Central African Republic (CAR)

    El-Khatib, Z; Shah, M; Zallappa, SN; Nabeth, P; Guerra, J; Manengu, CT; Yao, M; Philibert, A; Massina, L; Staiger, CP; et al. (BMC, 2018-10-24)
  • Blended SORT-IT for operational research capacity building: the model, its successes and challenges.

    Decroo, T; Van den Bergh, R; Kumar, AMV; Zachariah, R; Schillberg, E; Owiti, P; van den Boogaard, W; Benedetti, G; Shah, S; Ali, E; et al. (Taylor & Francis, 2018-05-10)
    The Structured Operational Research Training Initiative (SORT-IT) has been shown to be very effective in strengthening capacity for conducting operational research, publishing in scientific journals and fostering policy and practice change. The ‘classic’ model includes three face-to-face modules during which, respectively, a study protocol, a data analysis plan, and a manuscript are elaborated. Meanwhile, the lectures of the SORT-IT are available online as YouTube videos. Given the availability of this online material and the experiences with online mentorship of the faculty, we piloted a first blended distance/residential SORT-IT. To inform future implementers of our experience with blended operational research courses, we summarize the model, successes, and challenges of this approach in this perspective paper. The blended SORT-IT consisted of an online phase, covering modules 1 and 2, followed by a face-to-face writing module 3. Four out of six participants successfully completed the course, and submitted a manuscript to a peer-reviewed journal within four weeks of completing module 3. A blended approach may make the SORT-IT course more accessible to future participants and may favour the adoption of the course by other institutions, such as national Ministries of Health.
  • Inter-rater and intrarater reliability of the South African Triage Scale in low-resource settings of Haiti and Afghanistan

    Dalwai, M; Tayler-Smith, K; Twomey, M; Nasim, M; Popal, AQ; Haqdost, WH; Gayraud, O; Cheréstal, S; Wallis, L; Valles, P (BMJ Publishing Group, 2018-03-16)
    The South African Triage Scale (SATS) has demonstrated good validity in the EDs of Médecins Sans Frontières (MSF)-supported sites in Afghanistan and Haiti; however, corresponding reliability in these settings has not yet been reported on. This study set out to assess the inter-rater and intrarater reliability of the SATS in four MSF-supported EDs in Afghanistan and Haiti (two trauma-only EDs and two mixed (including both medical and trauma cases) EDs).
  • Beyond Open Data: Realising the Health Benefits of Sharing Data

    Pisani, E; Aaby, P; Breugelmans, JG; Carr, D; Groves, T; Helinski, M; Kamuya, D; Kern, S; Littler, K; Marsh, V; et al. (BMJ Publishing Group, 2016-10-10)
  • Overlooking the Importance of Immunoassays - Authors' Reply

    Cnops, L; van Griensven, J; Honko, AN; Bausch, DG; Sprecher, A; Hill, CE; Colebunders, R; Johnson, JC; Griffiths, A; Palacios, GF; et al. (Elsevier, 2016-10-01)
  • Open Source Software For Patient Data Management In Critical Care

    Massaut, J; Charretk, N; Gayraud, O; Van Den Bergh, R; Charles, A; Edema, N (IOS Press, 2015)
    We have previously developed a Patient Data Management System for Intensive Care based on Open Source Software. The aim of this work was to adapt this software to use in Emergency Departments in low resource environments. The new software includes facilities for utilization of the South African Triage Scale and prediction of mortality based on independent predictive factors derived from data from the Tabarre Emergency Trauma Center in Port au Prince, Haiti.
  • An alternative classification to mixture modeling for longitudinal counts or binary measures

    Subtil, F; Boussari, O; Bastard, M; Etard, J-F; Ecochard, R; Génolini, C (SAGE Publications, 2014-09-01)
    Classifying patients according to longitudinal measures, or trajectory classification, has become frequent in clinical research. The k-means algorithm is increasingly used for this task in case of continuous variables with standard deviations that do not depend on the mean. One feature of count and binary data modeled by Poisson or logistic regression is that the variance depends on the mean; hence, the within-group variability changes from one group to another depending on the mean trajectory level. Mixture modeling could be used here for classification though its main purpose is to model the data. The results obtained may change according to the main objective. This article presents an extension of the k-means algorithm that takes into account the features of count and binary data by using the deviance as distance metric. This approach is justified by its analogy with the classification likelihood. Two applications are presented with binary and count data to show the differences between the classifications obtained with the usual Euclidean distance versus the deviance distance.
  • Does research make a difference to public health? Time for scientific journals to cross the Rubicon

    Harries, A D; Zachariah, R; Ramsay, A; Kumar, A M V; Reid, A J; Terry, R F; Reeder, J C (International Union Against TB and Lung Disease, 2014-04-14)
  • Should mortality data for the elderly be collected routinely in emergencies? The practical challenges of age-disaggregated surveillance systems

    du Cros, P; Venis, S; Karunakara, U; Manson Unit, Médecins Sans Frontières, London, UK. (Oxford University Press, 2013-11)
    Data on the elderly are rarely collected in humanitarian emergencies. During a refugee crisis in South Sudan, Médecins Sans Frontières developed a prospective mortality surveillance system collecting data for those aged ≥50 years and found that the elderly were dying at five times the rate of those aged 5-49 years. Practical and ethical issues arose. Were reported ages accurate? Since no baseline exists, what does the mortality rate mean? Should programmatic changes be made without evidence that these would reduce the elderly mortality rate? We outline issues to be addressed to enable informed decisions on response to elderly populations in emergency settings.
  • The power of data: using routinely collected data to improve public health programmes and patient outcomes in low-and middle-income countries

    Harries, A D; Zachariah, R; Maher, D; International Union against Tuberculosis and Lung Disease, Paris, France; London School of Hygiene and Tropical Medicine, London, UK. (John Wiley & Sons Ltd., 2013-09-18)
  • Oops, what about ethics?

    Oladimeji, O; Isaakidis, P; Zachariah, R; Hinderaker, S G; Koghali, M; van Griensven, J; Harries, A D; Edginton, M E (2013-09)

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