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Article ; Online: Febrile illness mapping—much of the world without data and without evidence-based treatments

Paul N. Newton / Philippe J. Guerin

BMC Medicine, Vol 18, Iss 1, Pp 1-

2020 Volume 3

Keywords	Medicine ; R
Language	English
Publishing date	2020-09-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A living systematic review protocol for COVID-19 clinical trial registrations [version 1; peer review

Brittany J. Maguire / Philippe J. Guérin

Wellcome Open Research, Vol

2 approved]

2020 Volume 5

Abstract: Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, ... ...

Abstract	Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.
Keywords	Medicine ; R ; Science ; Q ; covid19
Subject code	610
Language	English
Publishing date	2020-04-01T00:00:00Z
Publisher	Wellcome
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prognostic prediction models for clinical outcomes in patients diagnosed with visceral leishmaniasis

James Wilson / Fabiana Alves / Prabin Dahal / Kasia Stepniewska / Philippe J Guérin / Elinor K Harriss / Forhad Chowdhury / Shermarke Hassan

BMJ Open, Vol 13, Iss

protocol for a systematic review

2023 Volume 10

Abstract: Introduction Visceral leishmaniasis (VL) is a neglected tropical disease responsible for many thousands of preventable deaths each year. Symptomatic patients often struggle to access effective treatment, without which death is the norm. Risk prediction ... ...

Abstract	Introduction Visceral leishmaniasis (VL) is a neglected tropical disease responsible for many thousands of preventable deaths each year. Symptomatic patients often struggle to access effective treatment, without which death is the norm. Risk prediction tools support clinical teams and policymakers in identifying high-risk patients who could benefit from more intensive management pathways. Investigators interested in using their clinical data for prognostic research should first identify currently available models that are candidates for validation and possible updating. Addressing these needs, we aim to identify, summarise and appraise the available models predicting clinical outcomes in VL patients.Methods and analysis We will include studies that have developed, validated or updated prognostic models predicting future clinical outcomes in patients diagnosed with VL. Systematic reviews and meta-analyses that include eligible studies are also considered for review. Conference abstracts and educational theses are excluded. Data extraction, appraisal and reporting will follow current methodological guidelines. Ovid Embase; Ovid MEDLINE; the Web of Science Core Collection, SciELO and LILACS are searched from database inception to 1 March 2023 using terms developed for the identification of prediction models, and with no language restriction. Screening, data extraction and risk of bias assessment will be performed in duplicate with discordance resolved by a third independent reviewer. Risk of bias will be assessed using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). Tables and figures will compare and contrast key model information, including source data, participants, model development and performance measures, and risk of bias. We will consider the strengths, limitations and clinical applicability of the identified models.Ethics and dissemination Ethics approval is not required for this review. The systematic review and all accompanying data will be submitted to an open-access journal. Findings will ...
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2023-10-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The consequence of COVID-19 on the global supply of medical products

Philippe J Guerin / Sauman Singh-Phulgenda / Nathalie Strub-Wourgaft

F1000Research, Vol

Why Indian generics matter for the world? [version 1; peer review: 3 approved, 1 approved with reservations]

2020 Volume 9

Abstract: While the world is facing the urgency of the COVID-19 pandemic, policymakers must plan for the direct response to the outbreak while minimising its collateral impact. Maintaining the supply chain of pharmaceutical products is not only paramount to cover ... ...

Abstract	While the world is facing the urgency of the COVID-19 pandemic, policymakers must plan for the direct response to the outbreak while minimising its collateral impact. Maintaining the supply chain of pharmaceutical products is not only paramount to cover the immediate medical response but will be fundamental to reducing disruption of the healthcare delivery system, which requires constant medicines, diagnostic tools and vaccines for smooth functioning. In this equation, the role of the Indian pharmaceutical industry will not only be critical to meet the domestic need of over 1.3 billion inhabitants but will equally be important for the rest of the world, including wealthy economies. Preventing a significant disruption of the Indian pharmaceutical supply chain during the outbreak and preparing it for large scale production for COVID-19 therapeutic or preventive medical products will not only help India but will assist the global response to this outbreak.
Keywords	Medicine ; R ; Science ; Q ; covid19
Language	English
Publishing date	2020-04-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Gender disparity in cases enrolled in clinical trials of visceral leishmaniasis

Prabin Dahal / Sauman Singh-Phulgenda / Piero L Olliaro / Philippe J Guerin

PLoS Neglected Tropical Diseases, Vol 15, Iss 3, p e

A systematic review and meta-analysis.

2021 Volume 0009204

Abstract: Background A higher caseload of visceral leishmaniasis (VL) has been observed among males in community-based surveys. We carried out this review to investigate how the observed disparity in gender distribution is reflected in clinical trials of ... ...

Abstract	Background A higher caseload of visceral leishmaniasis (VL) has been observed among males in community-based surveys. We carried out this review to investigate how the observed disparity in gender distribution is reflected in clinical trials of antileishmanial therapies. Methods We identified relevant studies by searching a database of all published clinical trials in VL from 1980 through 2019 indexed in the Infectious Diseases Data Observatory (IDDO) VL clinical trials library. The proportion of male participants enrolled in studies eligible for inclusion in this review were extracted and combined using random effects meta-analysis of proportion. Results were expressed as percentages and presented with respective 95% confidence intervals (95% CIs). Heterogeneity was quantified using I2 statistics and sub-group meta-analyses were carried out to explore the sources of heterogeneity. Results We identified 135 published studies (1980-2019; 32,177 patients) with 68.0% [95% CI: 65.9%-70.0%; I2 = 92.6%] of the enrolled participants being males. The corresponding estimates were 67.6% [95% CI: 65.5%-69.7%; n = 91 trials; I2 = 90.5%; 24,218 patients] in studies conducted in the Indian sub-continent and 74.1% [95% CI: 68.4%-79.1%; n = 24 trials; I2 = 94.4%; 6,716 patients] in studies from Eastern Africa. The proportion of male participants was 57.9% [95% CI: 54.2%-61.5%] in studies enrolling children aged <15 years, 78.2% [95% CI: 66.0%-86.9%] in studies that enrolled adults (≥15 years), and 68.1% [95% CI: 65.9%-70.0%] in studies that enrolled patients of all ages. There was a trend for decreased proportions of males enrolled over time: 77.1% [95% CI: 70.2%-82.8%; 1356 patients] in studies published prior to the 1990s whereas 64.3% [95% CI: 60.3%-68.2%; 15,611 patients] in studies published on or after 2010. In studies that allowed the inclusion of patients with HIV co-infections, 76.5% [95% CI: 63.8%-85.9%; 5,123 patients] were males and the corresponding estimate was 64.0% [95% CI: 61.4%-66.5% 17,500 patients] in ...
Keywords	Arctic medicine. Tropical medicine ; RC955-962 ; Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Malaria patient spectrum representation in therapeutic clinical trials of uncomplicated malaria

Lorenzo Arena / Mazvita Zanamwe / Christine M. Halleux / Verena Carrara / Brian J. Angus / Proochista Ariana / Georgina S. Humphreys / Caitlin Richmond / Kasia Stepniewska / Philippe J. Guérin / Piero L. Olliaro

Malaria Journal, Vol 22, Iss 1, Pp 1-

a scoping review of the literature

2023 Volume 11

Abstract: Abstract Background For the results of clinical trials to have external validity, the patients included in the study must be representative of the population presenting in the general clinical settings. A scoping literature review was performed to ... ...

Abstract	Abstract Background For the results of clinical trials to have external validity, the patients included in the study must be representative of the population presenting in the general clinical settings. A scoping literature review was performed to evaluate how the eligibility criteria used in anti-malarial efficacy and safety trials translate into patient selection. Methods A search of the WorldWide Antimalarial Resistance Network (WWARN) Clinical Trials Publication Library, MEDLINE, The Cochrane Library, and clinicaltrials.gov was conducted to identify trials investigating anti-malarial efficacy and safety, published between 14th April 2001 and 31st December 2017. An updated search using the WWARN Clinical Trial Publication Library was undertaken to identify eligible publications from 1st January 2018 to 31st July 2021. The review included studies in patients of any age with uncomplicated malaria and any pharmaceutical therapeutic intervention administered. The proportion of trials with malaria-positive patients excluded was calculated and linked to the reported reason for exclusion. A subgroup analysis on eligibility criteria and trial baseline demographics was conducted to assess whether criteria are complied with when recruiting patients. Results Out of 847 studies, 176 (21%) trials were included in the final synthesis, screening a total of 157,516 malaria-positive patients, of whom 56,293 (36%) were enrolled and treated. Across the 176 studies included, 84 different inclusion and exclusion criteria were identified. The reason for exclusion of patients who tested positive for malaria was reported in 144 (82%) studies. Three criteria account for about 70% of malaria-positive patients excluded: mixed-species malaria infections or other specific Plasmodium species, parasite counts outside the set study ranges, and refusal of consent. Conclusions Nearly two-thirds of the malaria-positive subjects who present to health facilities are systematically excluded from anti-malarial treatment trials. Reasons for ...
Keywords	Malaria ; Antimalarials ; Clinical trial ; Patient selection ; Review ; Uncomplicated malaria ; Arctic medicine. Tropical medicine ; RC955-962 ; Infectious and parasitic diseases ; RC109-216
Subject code	610
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Characterisation of populations at risk of sub-optimal dosing of artemisinin-based combination therapy in Africa

Abena Takyi / Verena I. Carrara / Prabin Dahal / Marianna Przybylska / Eli Harriss / Genevieve Insaidoo / Karen I. Barnes / Philippe J. Guerin / Kasia Stepniewska

PLOS Global Public Health, Vol 3, Iss

2023 Volume 12

Keywords	Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Characterisation of populations at risk of sub-optimal dosing of artemisinin-based combination therapy in Africa.

Abena Takyi / Verena I Carrara / Prabin Dahal / Marianna Przybylska / Eli Harriss / Genevieve Insaidoo / Karen I Barnes / Philippe J Guerin / Kasia Stepniewska

PLOS Global Public Health, Vol 3, Iss 12, p e

2023 Volume 0002059

Abstract: Selection of resistant malaria strains occurs when parasites are exposed to inadequate antimalarial drug concentrations. The proportion of uncomplicated falciparum malaria patients at risk of being sub-optimally dosed with the current World Health ... ...

Abstract	Selection of resistant malaria strains occurs when parasites are exposed to inadequate antimalarial drug concentrations. The proportion of uncomplicated falciparum malaria patients at risk of being sub-optimally dosed with the current World Health Organization (WHO) recommended artemisinin-based combination therapies (ACTs) is unknown. This study aims to estimate this proportion and the excess number of treatment failures (recrudescences) associated with sub-optimal dosing in Sub-Saharan Africa. Sub-populations at risk of sub-optimal dosing include wasted children <5 years of age, patients with hyperparasitaemia, pregnant women, people living with HIV, and overweight adults. Country-level data on population structure were extracted from openly accessible data sources. Pooled adjusted Hazard Ratios for PCR-confirmed recrudescence were estimated for each risk group from published meta-analyses using fixed-effect meta-analysis. In 2020, of the estimated 153.1 million uncomplicated P. falciparum malaria patients in Africa, the largest risk groups were the hyperparasitaemic patients (13.2 million, 8.6% of uncomplicated malaria cases) and overweight adults (10.3 million, 6.7% of uncomplicated cases). The estimated excess total number of treatment failures ranged from 0.338 million for a 98% baseline ACT efficacy to 1.352 million for a 92% baseline ACT efficacy. Our study shows that an estimated nearly 1 in 4 people with uncomplicated confirmed P. falciparum malaria in Africa are at risk of receiving a sub-optimal antimalarial drug dosing. This increases the risk of antimalarial drug resistance and poses a serious threat to malaria control and elimination efforts. Changes in antimalarial dosing or treatment duration of current antimalarials may be needed and new antimalarials development should ensure sufficient drug concentration levels in these sub-populations that carry a high malaria burden.
Keywords	Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Visceral Leishmaniasis in pregnancy and vertical transmission

Prabin Dahal / Sauman Singh-Phulgenda / Brittany J Maguire / Eli Harriss / Koert Ritmeijer / Fabiana Alves / Philippe J Guerin / Piero L Olliaro

PLoS Neglected Tropical Diseases, Vol 15, Iss 8, p e

A systematic literature review on the therapeutic orphans.

2021 Volume 0009650

Abstract: Background Reports on the occurrence and outcome of Visceral Leishmaniasis (VL) in pregnant women is rare in published literature. The occurrence of VL in pregnancy is not systematically captured and cases are rarely followed-up to detect consequences of ...

Abstract	Background Reports on the occurrence and outcome of Visceral Leishmaniasis (VL) in pregnant women is rare in published literature. The occurrence of VL in pregnancy is not systematically captured and cases are rarely followed-up to detect consequences of infection and treatment on the pregnant women and foetus. Methods A review of all published literature was undertaken to identify cases of VL infections among pregnant women by searching the following database: Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials; World Health Organization Global Index Medicus: LILACS (Americas); IMSEAR (South-East Asia); IMEMR (Eastern Mediterranean); WPRIM (Western Pacific); ClinicalTrials.gov; and the WHO International Clinical Trials Registry Platform. Selection criteria included any clinical reports describing the disease in pregnancy or vertical transmission of the disease in humans. Articles meeting pre-specified inclusion criteria and non-primary research articles such as textbook, chapters, letters, retrospective case description, or reports of accidental inclusion in trials were also considered. Results The systematic literature search identified 272 unique articles of which 54 records were included in this review; a further 18 records were identified from additional search of the references of the included studies or from personal communication leading to a total of 72 records (71 case reports/case series; 1 retrospective cohort study; 1926-2020) describing 451 cases of VL in pregnant women. The disease was detected during pregnancy in 398 (88.2%), retrospectively confirmed after giving birth in 52 (11.5%), and the time of identification was not clear in 1 (0.2%). Of the 398 pregnant women whose infection was identified during pregnancy, 346 (86.9%) received a treatment, 3 (0.8%) were untreated, and the treatment status was not clear in the remaining 49 (12.3%). Of 346 pregnant women, Liposomal amphotericin B (L-AmB) was administered in 202 (58.4%) and ...
Keywords	Arctic medicine. Tropical medicine ; RC955-962 ; Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2021-08-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evaluating antimalarial efficacy in single-armed and comparative drug trials using competing risk survival analysis

Prabin Dahal / Philippe J. Guerin / Ric N. Price / Julie A. Simpson / Kasia Stepniewska

BMC Medical Research Methodology, Vol 19, Iss 1, Pp 1-

a simulation study

2019 Volume 14

Abstract: Abstract Background Antimalarial efficacy studies in patients with uncomplicated Plasmodium falciparum are confounded by a new infection (a competing risk event) since this event can potentially preclude a recrudescent event (primary endpoint of interest) ...

Abstract	Abstract Background Antimalarial efficacy studies in patients with uncomplicated Plasmodium falciparum are confounded by a new infection (a competing risk event) since this event can potentially preclude a recrudescent event (primary endpoint of interest). The current WHO guidelines recommend censoring competing risk events when deriving antimalarial efficacy. We investigated the impact of considering a new infection as a competing risk event on the estimation of antimalarial efficacy in single-armed and comparative drug trials using two simulation studies. Methods The first simulation study explored differences in the estimates of treatment failure for areas of varying transmission intensities using the complement of the Kaplan-Meier (K-M) estimate and the Cumulative Incidence Function (CIF). The second simulation study extended this to a comparative drug efficacy trial for comparing the K-M curves using the log-rank test, and Gray’s k-sample test for comparing the equality of CIFs. Results The complement of the K-M approach produced larger estimates of cumulative treatment failure compared to the CIF method; the magnitude of which was correlated with the observed proportion of new infection and recrudescence. When the drug efficacy was 90%, the absolute overestimation in failure was 0.3% in areas of low transmission rising to 3.1% in the high transmission settings. In a scenario which is most likely to be observed in a comparative trial of antimalarials, where a new drug regimen is associated with an increased (or decreased) rate of recrudescences and new infections compared to an existing drug, the log-rank test was found to be more powerful to detect treatment differences compared to the Gray’s k-sample test. Conclusions The CIF approach should be considered for deriving estimates of antimalarial efficacy, in high transmission areas or for failing drugs. For comparative studies of antimalarial treatments, researchers need to select the statistical test that is best suited to whether the rate or cumulative ...
Keywords	Malaria ; Plasmodium falciparum ; Efficacy ; Competing risk events ; Cumulative incidence function ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2019-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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