Publications by authors named "Piero Olliaro"

228 Publications

Scaling up COVID-19 rapid antigen tests: promises and challenges.

Lancet Infect Dis 2021 Feb 23. Epub 2021 Feb 23.

Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.

WHO recommends a minimum of 80% sensitivity and 97% specificity for antigen-detection rapid diagnostic tests (Ag-RDTs), which can be used for patients with symptoms consistent with COVID-19. However, after the acute phase when viral load decreases, use of Ag-RDTs might lead to high rates of false negatives, suggesting that the tests should be replaced by a combination of molecular and serological tests. When the likelihood of having COVID-19 is low, such as for asymptomatic individuals in low prevalence settings, for travel, return to schools, workplaces, and mass gatherings, Ag-RDTs with high negative predictive values can be used with confidence to rule out infection. For those who test positive in low prevalence settings, the high false positive rate means that mitigation strategies, such as molecular testing to confirm positive results, are needed. Ag-RDTs, when used appropriately, are promising tools for scaling up testing and ensuring that patient management and public health measures can be implemented without delay.
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http://dx.doi.org/10.1016/S1473-3099(21)00048-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906660PMC
February 2021

What does 95% COVID-19 vaccine efficacy really mean?

Authors:
Piero Olliaro

Lancet Infect Dis 2021 Feb 17. Epub 2021 Feb 17.

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7FZ, UK. Electronic address:

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http://dx.doi.org/10.1016/S1473-3099(21)00075-XDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906690PMC
February 2021

Remote-Controlled and Pulse Pressure-Guided Fluid Treatment for Adult Patients with Viral Hemorrhagic Fevers.

Am J Trop Med Hyg 2021 Feb 16. Epub 2021 Feb 16.

1Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

Circulatory shock, caused by severe intravascular volume depletion resulting from gastrointestinal losses and profound capillary leak, is a common clinical feature of viral hemorrhagic fevers, including Ebola virus disease, Marburg hemorrhagic fever, and Lassa fever. These conditions are associated with high case fatality rates, and they carry a significant risk of infection for treating personnel. Optimized fluid therapy is the cornerstone of management of these diseases, but there are few data on the extent of fluid losses and the severity of the capillary leak in patients with VHFs, and no specific guidelines for fluid resuscitation and hemodynamic monitoring exist. We propose an innovative approach for monitoring VHF patients, in particular suited for low-resource settings, facilitating optimizing fluid therapy through remote-controlled and pulse pressure-guided fluid resuscitation. This strategy would increase the capacity for adequate supportive care, while decreasing the risk for virus transmission to health personnel.
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http://dx.doi.org/10.4269/ajtmh.20-1515DOI Listing
February 2021

Development and validation of the ISARIC 4C Deterioration model for adults hospitalised with COVID-19: a prospective cohort study.

Lancet Respir Med 2021 Jan 11. Epub 2021 Jan 11.

Division of Infection and Immunity, University College London, London, UK. Electronic address:

Background: Prognostic models to predict the risk of clinical deterioration in acute COVID-19 cases are urgently required to inform clinical management decisions.

Methods: We developed and validated a multivariable logistic regression model for in-hospital clinical deterioration (defined as any requirement of ventilatory support or critical care, or death) among consecutively hospitalised adults with highly suspected or confirmed COVID-19 who were prospectively recruited to the International Severe Acute Respiratory and Emerging Infections Consortium Coronavirus Clinical Characterisation Consortium (ISARIC4C) study across 260 hospitals in England, Scotland, and Wales. Candidate predictors that were specified a priori were considered for inclusion in the model on the basis of previous prognostic scores and emerging literature describing routinely measured biomarkers associated with COVID-19 prognosis. We used internal-external cross-validation to evaluate discrimination, calibration, and clinical utility across eight National Health Service (NHS) regions in the development cohort. We further validated the final model in held-out data from an additional NHS region (London).

Findings: 74 944 participants (recruited between Feb 6 and Aug 26, 2020) were included, of whom 31 924 (43·2%) of 73 948 with available outcomes met the composite clinical deterioration outcome. In internal-external cross-validation in the development cohort of 66 705 participants, the selected model (comprising 11 predictors routinely measured at the point of hospital admission) showed consistent discrimination, calibration, and clinical utility across all eight NHS regions. In held-out data from London (n=8239), the model showed a similarly consistent performance (C-statistic 0·77 [95% CI 0·76 to 0·78]; calibration-in-the-large 0·00 [-0·05 to 0·05]); calibration slope 0·96 [0·91 to 1·01]), and greater net benefit than any other reproducible prognostic model.

Interpretation: The 4C Deterioration model has strong potential for clinical utility and generalisability to predict clinical deterioration and inform decision making among adults hospitalised with COVID-19.

Funding: National Institute for Health Research (NIHR), UK Medical Research Council, Wellcome Trust, Department for International Development, Bill & Melinda Gates Foundation, EU Platform for European Preparedness Against (Re-)emerging Epidemics, NIHR Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections at University of Liverpool, NIHR HPRU in Respiratory Infections at Imperial College London.
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http://dx.doi.org/10.1016/S2213-2600(20)30559-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832571PMC
January 2021

Psycho-social impacts, experiences and perspectives of patients with Cutaneous Leishmaniasis regarding treatment options and case management: An exploratory qualitative study in Tunisia.

PLoS One 2020 1;15(12):e0242494. Epub 2020 Dec 1.

Department of Medical Epidemiology, Pasteur Institute of Tunis, Tunis, Tunisia.

Although non-fatal and mostly self-healing in the case of Leishmania (L.) major, cutaneous leishmaniasis (CL) is mainly treated to reduce lesion healing time. Less attention is paid to the improvement of scars, especially in aesthetically relevant areas of the body, which can dramatically affect patients' wellbeing. We explored patients' perspectives about treatment options and the social and psychological burden of disease (lesion and scar). Individual in-depth interviews were conducted with ten confirmed CL patients at two L. major endemic sites in Southern Tunisia (Sidi Bouzid and Gafsa). Participants were selected using a sampling approach along a spectrum covering e.g. age, sex, and clinical presentation. Patients' experiences, opinions and preferences were explored, and their detailed accounts gave an insight on the impact of CL on their everyday lives. The impact of CL was found to be considerable. Most patients were not satisfied with treatment performance and case management. They expected a shorter healing time and better accessibility of the health system. Tolerance of the burden of disease was variable and ranged from acceptance of hidden scars to suicidal thoughts resulting from the fear to become handicapped, and the stress caused by close relatives. Some believed CL to be a form of skin cancer. Unexpectedly, this finding shows the big gap between the perspectives of patients and assumptions of health professionals regarding this disease. This study provided valuable information for better case management emphasizing the importance of improving communication with patients, and accessibility to treatment. It generated context-specific knowledge to policy makers in Tunisia to implement effective case management in a country where access to treatment remains a challenge due to socio-economic and geographic barriers despite a long tradition in CL control.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242494PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707605PMC
January 2021

Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial.

Trials 2020 Nov 25;21(1):974. Epub 2020 Nov 25.

Foundation for Innovative New Diagnostics (FIND) Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.

Background: The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the 'just-in-case' use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)?

Methods: We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion.

Discussion: This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs.

Trial Registration: Clinicaltrials.gov NCT04081051 . Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019.
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http://dx.doi.org/10.1186/s13063-020-04897-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687811PMC
November 2020

Symptoms at presentation for patients admitted to hospital with Covid-19: results from the ISARIC prospective multinational observational study.

medRxiv 2020 Oct 27. Epub 2020 Oct 27.

Background: Symptom recognition is necessary to identify people with possible Covid-19. Clinical case definitions vary in type and number of symptoms included. No large studies have investigated how these perform for hospitalized patients of different ages and sex.

Methods: We used international prospective observational data from patients admitted to hospital with laboratory-confirmed Covid-19. We investigated how symptoms varied by age and sex. We performed logistic regression to assess the relationship of age and sex with the most prevalent symptoms in our dataset and with published case definitions, allowing for clustering by country as a random intercept.

Results: 60 161 patients from 43 countries were included, with median age 70 years (interquartile range 55- 82). Fever (68%), cough (68%) and shortness of breath (63%) were the most prevalent symptoms. Their prevalence was greater among patients aged 30-60 years (respectively 79%, 78%, 66%), and lower in children (≤18 years: 68%, 47%, 22%) and older adults (≥70 years: 61%, 62%, 61%). The most sensitive case definition assessed was one or more of cough, shortness of breath, fever, muscle pains or sore throat, met by 92% of the whole cohort. Confusion was the most prevalent symptom for patients whose symptoms did not meet any of the assessed case definitions. Regression models showed significant differences in symptoms with age, and considerable heterogeneity between countries.

Conclusions: Older adults and children admitted to hospital with Covid-19 are less likely to present with typical symptoms of cough, fever and shortness of breath. Vigilance for atypical symptoms towards extremities of age increases sensitivity of identifying Covid-19.

Summary: Typical symptoms of fever, cough and shortness of breath are less common in people admitted to hospital with Covid-19 toward extremities of age. Published case definitions appear less sensitive toward extremes of age, and atypical symptoms need to be recognised.
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http://dx.doi.org/10.1101/2020.10.26.20219519DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605573PMC
October 2020

Neglected tropical diseases in non-endemic countries in the era of COVID-19 pandemic: the great forgotten.

J Travel Med 2021 01;28(1)

Department of Experimental and Clinical Medicine, University of Florence, Florence, Largo Brambilla 3, 50134, Italy.

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http://dx.doi.org/10.1093/jtm/taaa179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543559PMC
January 2021

Clinical characteristics of children and young people admitted to hospital with covid-19 in United Kingdom: prospective multicentre observational cohort study.

BMJ 2020 08 27;370:m3249. Epub 2020 Aug 27.

Respiratory Medicine, Alder Hey Children's NHS Foundation Trust, Liverpool L12 2AP, UK

Objective: To characterise the clinical features of children and young people admitted to hospital with laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the UK and explore factors associated with admission to critical care, mortality, and development of multisystem inflammatory syndrome in children and adolescents temporarily related to coronavirus disease 2019 (covid-19) (MIS-C).

Design: Prospective observational cohort study with rapid data gathering and near real time analysis.

Setting: 260 hospitals in England, Wales, and Scotland between 17 January and 3 July 2020, with a minimum follow-up time of two weeks (to 17 July 2020).

Participants: 651 children and young people aged less than 19 years admitted to 138 hospitals and enrolled into the International Severe Acute Respiratory and emergency Infections Consortium (ISARIC) WHO Clinical Characterisation Protocol UK study with laboratory confirmed SARS-CoV-2.

Main Outcome Measures: Admission to critical care (high dependency or intensive care), in-hospital mortality, or meeting the WHO preliminary case definition for MIS-C.

Results: Median age was 4.6 (interquartile range 0.3-13.7) years, 35% (225/651) were under 12 months old, and 56% (367/650) were male. 57% (330/576) were white, 12% (67/576) South Asian, and 10% (56/576) black. 42% (276/651) had at least one recorded comorbidity. A systemic mucocutaneous-enteric cluster of symptoms was identified, which encompassed the symptoms for the WHO MIS-C criteria. 18% (116/632) of children were admitted to critical care. On multivariable analysis, this was associated with age under 1 month (odds ratio 3.21, 95% confidence interval 1.36 to 7.66; P=0.008), age 10-14 years (3.23, 1.55 to 6.99; P=0.002), and black ethnicity (2.82, 1.41 to 5.57; P=0.003). Six (1%) of 627 patients died in hospital, all of whom had profound comorbidity. 11% (52/456) met the WHO MIS-C criteria, with the first patient developing symptoms in mid-March. Children meeting MIS-C criteria were older (median age 10.7 (8.3-14.1) 1.6 (0.2-12.9) years; P<0.001) and more likely to be of non-white ethnicity (64% (29/45) 42% (148/355); P=0.004). Children with MIS-C were five times more likely to be admitted to critical care (73% (38/52) 15% (62/404); P<0.001). In addition to the WHO criteria, children with MIS-C were more likely to present with fatigue (51% (24/47) 28% (86/302); P=0.004), headache (34% (16/47) 10% (26/263); P<0.001), myalgia (34% (15/44) 8% (21/270); P<0.001), sore throat (30% (14/47) (12% (34/284); P=0.003), and lymphadenopathy (20% (9/46) 3% (10/318); P<0.001) and to have a platelet count of less than 150 × 10/L (32% (16/50) 11% (38/348); P<0.001) than children who did not have MIS-C. No deaths occurred in the MIS-C group.

Conclusions: Children and young people have less severe acute covid-19 than adults. A systemic mucocutaneous-enteric symptom cluster was also identified in acute cases that shares features with MIS-C. This study provides additional evidence for refining the WHO MIS-C preliminary case definition. Children meeting the MIS-C criteria have different demographic and clinical features depending on whether they have acute SARS-CoV-2 infection (polymerase chain reaction positive) or are post-acute (antibody positive).

Study Registration: ISRCTN66726260.
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http://dx.doi.org/10.1136/bmj.m3249DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7488201PMC
August 2020

Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score.

BMJ 2020 09 9;370:m3339. Epub 2020 Sep 9.

Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.

Objective: To develop and validate a pragmatic risk score to predict mortality in patients admitted to hospital with coronavirus disease 2019 (covid-19).

Design: Prospective observational cohort study.

Setting: International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study (performed by the ISARIC Coronavirus Clinical Characterisation Consortium-ISARIC-4C) in 260 hospitals across England, Scotland, and Wales. Model training was performed on a cohort of patients recruited between 6 February and 20 May 2020, with validation conducted on a second cohort of patients recruited after model development between 21 May and 29 June 2020 PARTICIPANTS: Adults (age ≥18 years) admitted to hospital with covid-19 at least four weeks before final data extraction.

Main Outcome Measure: In-hospital mortality.

Results: 35 463 patients were included in the derivation dataset (mortality rate 32.2%) and 22 361 in the validation dataset (mortality rate 30.1%). The final 4C Mortality Score included eight variables readily available at initial hospital assessment: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness, urea level, and C reactive protein (score range 0-21 points). The 4C Score showed high discrimination for mortality (derivation cohort: area under the receiver operating characteristic curve 0.79, 95% confidence interval 0.78 to 0.79; validation cohort: 0.77, 0.76 to 0.77) with excellent calibration (validation: calibration-in-the-large=0, slope=1.0). Patients with a score of at least 15 (n=4158, 19%) had a 62% mortality (positive predictive value 62%) compared with 1% mortality for those with a score of 3 or less (n=1650, 7%; negative predictive value 99%). Discriminatory performance was higher than 15 pre-existing risk stratification scores (area under the receiver operating characteristic curve range 0.61-0.76), with scores developed in other covid-19 cohorts often performing poorly (range 0.63-0.73).

Conclusions: An easy-to-use risk stratification score has been developed and validated based on commonly available parameters at hospital presentation. The 4C Mortality Score outperformed existing scores, showed utility to directly inform clinical decision making, and can be used to stratify patients admitted to hospital with covid-19 into different management groups. The score should be further validated to determine its applicability in other populations.

Study Registration: ISRCTN66726260.
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http://dx.doi.org/10.1136/bmj.m3339DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7116472PMC
September 2020

Usefulness of C-Reactive Protein and Other Host BioMarker Point-of-Care Tests in the Assessment of Non-Malarial Acute Febrile Illnesses: A Systematic Review with Meta-Analysis.

Am J Trop Med Hyg 2020 11;103(5):1797-1802

Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Verona, Italy.

In low- and middle-income countries, in resource-limited settings, the implementation of diagnostic tools discriminating bacterial from nonbacterial fever is a matter of primary concern. The introduction of malaria rapid diagnostic tests highlighted the need for point-of-care tests (POCTs) supporting clinical decision-making for non-malarial febrile illnesses. The purpose of this work was to review the use of host biomarker POCTs for the assessment of acute non-malarial fever in resource-constraint settings. Specific objectives were as follows: 1) to estimate the accuracy of such tests in differentiating fever of bacterial from nonbacterial origin and 2) to assess the impact of host biomarkers on antibiotic prescription and clinical outcome. We conducted a systematic review searching PubMed, Embase, the Cochrane Library, and Bireme. The protocol was registered with PROSPERO (n CRD42019141735). Data on the accuracy of C-reactive protein (CRP) for the detection of bacterial infections were meta-analyzed using the hierarchical summary receiver operating characteristic model, obtaining a summary ROC (SROC). We identified 2,192 articles, eight of which were included in the review. Among the different biomarkers evaluated, CRP was the one most frequently studied. The SROC presented an area under the curve = 0.77 (CI: 0.73-0.81), which indicates good accuracy to distinguish bacterial from nonbacterial infections. However, the optimal cutoff of CRP could not be assessed, and we found insufficient evidence about its impact on antibiotic prescription and clinical outcome. The role of CRP and other host biomarker POCTs for the assessment of acute non-malarial febrile illnesses in resource-constraint settings deserves further studies.
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http://dx.doi.org/10.4269/ajtmh.19-0935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646768PMC
November 2020

Towards harmonization of microscopy methods for malaria clinical research studies.

Malar J 2020 Sep 4;19(1):324. Epub 2020 Sep 4.

UMR 257 IRD VITROME, Campus IRD-UCAD, Dakar, Senegal.

Microscopy performed on stained films of peripheral blood for detection, identification and quantification of malaria parasites is an essential reference standard for clinical trials of drugs, vaccines and diagnostic tests for malaria. The value of data from such research is greatly enhanced if this reference standard is consistent across time and geography. Adherence to common standards and practices is a prerequisite to achieve this. The rationale for proposed research standards and procedures for the preparation, staining and microscopic examination of blood films for malaria parasites is presented here with the aim of improving the consistency and reliability of malaria microscopy performed in such studies. These standards constitute the core of a quality management system for clinical research studies employing microscopy as a reference standard. They can be used as the basis for the design of training and proficiency testing programmes as well as for procedures and quality assurance of malaria microscopy in clinical research.
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http://dx.doi.org/10.1186/s12936-020-03352-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471592PMC
September 2020

An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial.

Trials 2020 Aug 17;21(1):722. Epub 2020 Aug 17.

University of Oxford, Oxford, UK.

Background: Bubonic plague is the primary manifestation of infection with Yersinia pestis, accounting for 90% of all plague cases and with 75% of global cases reported in Madagascar. All drugs in use for treating plague are registered based on experimental data and anecdotal evidence, and no regimen currently recommended is supported by a randomized clinical trial. The IMASOY trial intends to fill this knowledge gap by comparing two 10-day regimens included in the national guidelines in Madagascar. The primary objective of the trial is to test the hypothesis that ciprofloxacin monotherapy is non-inferior to streptomycin followed by ciprofloxacin for the treatment of bubonic plague, thus avoiding the need for injectable, potentially toxic, aminoglycosides.

Methods: A two-arm parallel-group randomized control trial will be conducted across peripheral health centres in Madagascar in five districts. Males and non-pregnant females of all ages with suspected bubonic or pneumonic plague will be recruited over the course of three plague 'seasons'. The primary endpoint of the trial is to assess the proportion of patients with bubonic plague who have a therapeutic response to treatment (defined as alive, resolution of fever, 25% reduction in the size of measurable buboes, has not received an alternative treatment and no clinical decision to continue antibiotics) as assessed on day 11.

Discussion: If successful, the trial has the potential to inform the standard of care guidelines not just in Madagascar but in other countries afflicted by plague. The trial is currently ongoing and expected to complete recruitment in 2022.

Trial Registration: ClinicalTrials.gov NCT04110340 . Registered on 1 October 2019.
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http://dx.doi.org/10.1186/s13063-020-04642-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429934PMC
August 2020

The time to do serosurveys for COVID-19 is now.

Lancet Respir Med 2020 09 24;8(9):836-838. Epub 2020 Jul 24.

ISARIC Global Support Centre, International Severe Acute Respiratory and emerging Infection Consortium, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.

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http://dx.doi.org/10.1016/S2213-2600(20)30313-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380934PMC
September 2020

Efficacy and safety of single-dose 40 mg/kg oral praziquantel in the treatment of schistosomiasis in preschool-age versus school-age children: An individual participant data meta-analysis.

PLoS Negl Trop Dis 2020 06 22;14(6):e0008277. Epub 2020 Jun 22.

Centre of Competences for Methodology and Statistics, Luxembourg Institute of Health, Strassen, Luxembourg.

Background: Better knowledge of the efficacy and safety of single-dose 40 mg/kg oral praziquantel in preschool-age children is required, should preventive chemotherapy programs for schistosomiasis be expanded to include this age group.

Methodology: We analyzed individual participant-level data from 16 studies (13 single-arm or cohort studies and three randomized trials), amounting to 683 preschool-age children (aged <6 years) and 2,010 school-age children (aged 6-14 years). Children had a documented Schistosoma mansoni or S. haematobium infection, were treated with single 40 mg/kg oral praziquantel, and assessed between 21 and 60 days post-treatment. Efficacy was expressed as arithmetic mean and individual egg reduction rate (ERR) and meta-analyzed using general linear models and mixed models. Safety was summarized using reported adverse events (AEs).

Principal Findings: Preschool-age children had significantly lower baseline Schistosoma egg counts and more losses to follow-up compared to school-age children. No difference in efficacy was found between preschool- and school-age children using a general linear model of individual-participant ERR with baseline log-transformed egg count as covariate and study, age, and sex as fixed variables, and a mixed model with a random effect on the study. Safety was reported in only four studies (n = 1,128 individuals); few AEs were reported in preschool-age children 4 and 24 hours post-treatment as well as at follow-up. Three severe but not serious AEs were recorded in school-age children during follow-up.

Conclusions/significance: There is no indication that single-dose 40 mg/kg oral praziquantel would be less efficacious and less safe in preschool-age children compared to school-age children, with the caveat that only few randomized comparisons exist between the two age groups. Preventive chemotherapy might therefore be extended to preschool-age children, with proper monitoring of its efficacy and safety.
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http://dx.doi.org/10.1371/journal.pntd.0008277DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360067PMC
June 2020

Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study.

PLoS Negl Trop Dis 2020 02 24;14(2):e0007996. Epub 2020 Feb 24.

Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.

Background: Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials.

Methodology/principal Findings: We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae.

Conclusions/significance: The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be addressed in clinical care.
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http://dx.doi.org/10.1371/journal.pntd.0007996DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7058360PMC
February 2020

C-reactive protein as a potential biomarker for disease progression in dengue: a multi-country observational study.

BMC Med 2020 02 17;18(1):35. Epub 2020 Feb 17.

Oxford University Clinical Research Unit, Wellcome Trust Asia Programme, Ho Chi Minh City, Vietnam.

Background: Dengue infection can cause a wide spectrum of clinical outcomes. The severe clinical manifestations occur sufficiently late in the disease course, during day 4-6 of illness, to allow a window of opportunity for risk stratification. Markers of inflammation may be useful biomarkers. We investigated the value of C-reactive protein (CRP) measured early on illness days 1-3 to predict dengue disease outcome and the difference in CRP levels between dengue and other febrile illnesses (OFI).

Method: We performed a nested case-control study using the clinical data and samples collected from the IDAMS-consortium multi-country study. This was a prospective multi-center observational study that enrolled almost 8000 participants presenting with a dengue-like illness to outpatient facilities in 8 countries across Asia and Latin America. Predefined severity definitions of severe and intermediate dengue were used as the primary outcomes. A total of 281 cases with severe/intermediate dengue were compared to 836 uncomplicated dengue patients as controls (ratio 1:3), and also 394 patients with OFI.

Results: In patients with confirmed dengue, median (interquartile range) of CRP level within the first 3 days was 30.2 mg/L (12.4-61.2 mg/L) (uncomplicated dengue, 28.6 (10.5-58.9); severe or intermediate dengue, 34.0 (17.4-71.8)). Higher CRP levels in the first 3 days of illness were associated with a higher risk of severe or intermediate outcome (OR 1.17, 95% CI 1.07-1.29), especially in children. Higher CRP levels, exceeding 30 mg/L, also associated with hospitalization (OR 1.37, 95% CI 1.14-1.64) and longer fever clearance time (HR 0.84, 95% CI 0.76-0.93), especially in adults. CRP levels in patients with dengue were higher than patients with potential viral infection but lower than patients with potential bacterial infection, resulting in a quadratic association between dengue diagnosis and CRP, with levels of approximately 30 mg/L associated with the highest risk of having dengue. CRP had a positive correlation with total white cell count and neutrophils and negative correlation with lymphocytes, but did not correlate with liver transaminases, albumin, or platelet nadir.

Conclusions: In summary, CRP measured in the first 3 days of illness could be a useful biomarker for early dengue risk prediction and may assist differentiating dengue from other febrile illnesses.
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http://dx.doi.org/10.1186/s12916-020-1496-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7025413PMC
February 2020

Decline in Total Serum IgE and Soluble CD30 in the Context of Soil-Transmitted Helminth Decline in Bolivia.

Am J Trop Med Hyg 2020 04;102(4):847-850

Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Firenze, Italy.

In the Bolivian Chaco, recent surveys documented a dramatic decrease in the prevalence of soil-transmitted helminth (STH) infections as compared with the 1980s after thirty years of preventive chemotherapy (PC). Concomitant immunological rearrangements are expected. Because nematode infections are associated with increased levels of circulating IgE and glycoprotein CD30 soluble form (sCD30), this study aims to evaluate changes in serological markers of T helper (Th)2-cells activity between 1987 (high STH prevalence) and 2013 (low STH prevalence) in rural communities in the Bolivian Chaco area. We collected 151 sera during two different surveys in 1987 ( = 65) and 2013 ( = 86) and measured the concentration of total IgE and sCD30 by immunoassays. We found a statistically significant age-independent decrease in the total IgE ( < 0.0001) and sCD30 ( < 0.0001) from 1987 to 2013. The significant decrease in serological Th2 markers (IgE and sCD30) between 1987 and 2013 is consistent with the drop in STH prevalence in this geographical area during the same period of time. Further studies might elucidate the clinical and epidemiological impact of these serological rearrangements.
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http://dx.doi.org/10.4269/ajtmh.19-0180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7124912PMC
April 2020

Schistosomiasis, strongyloidiasis and Chagas disease: the leading imported neglected tropical diseases in Italy.

J Travel Med 2020 Feb;27(1)

Department of Experimental & Clinical Medicine, University of Florence, Infectious and Tropical Diseases Unit, Careggi University and Hospital, Florence, 37024, Italy.

Background: In recent years, an increasing number of individuals affected by neglected tropical diseases (NTDs) have been observed in Italy, due to migration, international travels and climate changes. Reliable data on the current NTD epidemiology in Italy and the health system preparedness on this issue are not available.

Methods: We report the results of a survey on selected NTDs (schistosomiasis, strongyloidiasis, echinococcosis, Chagas disease, leishmaniasis, cysticercosis, filariasis and scabies) in nine Italian sentinel centres, in order to investigate their occurrence throughout the country and identify which ones are a priority for public health interventions, development of protocols for case management, and training activities. To explore the preparedness of the centres, we investigate the availability of specific diagnostic tools and drugs, needed for the management of the most common NTDs. We also reviewed and summarized the available national policies, recommendations and guidelines on NTDs in Italy.

Results: Overall, 4123 NTDs cases were diagnosed in nine Italian centres within a 7-year period (2011-2017). Schistosomiasis and strongyloidiasis were the most common NTDs, accounting for about one-third each of all the diagnosed cases, followed by Chagas disease. The number of cases showed a significant trend to increase over time, mainly due to foreign-born subjects. Serology for Schistosoma spp. and Strongyloides stercoralis was available in seven and five centres, respectively. Agar plate stool culture for S. stercoralis was available in three sites. Ivermectin and praziquantel were always available in six centres. Six national policies, recommendations and guidelines documents were available, but for the most part, they are not fully implemented yet.

Conclusions: This survey showed how some NTDs, such as schistosomiasis and strongyloidiasis, are becoming more common in Italy, due to multiple components. A list of seven key actions was proposed, in order to improve diagnosis, management and control of NTDs in Italy.
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http://dx.doi.org/10.1093/jtm/taz100DOI Listing
February 2020

Sensitivity of C-reactive protein for the identification of patients with laboratory-confirmed bacterial infections in northern Tanzania.

Trop Med Int Health 2020 03 6;25(3):291-300. Epub 2020 Jan 6.

Kilimanjaro Christian Medical Centre, Moshi, Tanzania.

Objective: Identifying febrile patients requiring antibacterial treatment is challenging, particularly in low-resource settings. In South-East Asia, C-reactive protein (CRP) has been demonstrated to be highly sensitive and moderately specific in detecting bacterial infections and to safely reduce unnecessary antibacterial prescriptions in primary care. As evidence is scant in sub-Saharan Africa, we assessed the sensitivity of CRP in identifying serious bacterial infections in Tanzania.

Methods: Samples were obtained from inpatients and outpatients in a prospective febrile illness study at two hospitals in Moshi, Tanzania, 2011-2014. Bacterial bloodstream infections (BSI) were established by blood culture, and bacterial zoonotic infections were defined by ≥4 fold rise in antibody titre between acute and convalescent sera. The sensitivity of CRP in identifying bacterial infections was estimated using thresholds of 10, 20 and 40 mg/l. Specificity was not assessed because determining false-positive CRP results was limited by the lack of diagnostic testing to confirm non-bacterial aetiologies and because ascertaining true-negative cases was limited by the imperfect sensitivity of the diagnostic tests used to identify bacterial infections.

Results: Among 235 febrile outpatients and 569 febrile inpatients evaluated, 31 (3.9%) had a bacterial BSI and 61 (7.6%) had a bacterial zoonosis. Median (interquartile range) CRP values were 173 (80-315) mg/l in bacterial BSI, and 108 (31-208) mg/l in bacterial zoonoses. The sensitivity (95% confidence intervals) of CRP was 97% (83%-99%), 94% (79%-98%) and 90% (74%-97%) for identifying bacterial BSI, and 87% (76%-93%), 82% (71%-90%) and 72% (60%-82%) for bacterial zoonoses, using thresholds of 10, 20 and 40 mg/l, respectively.

Conclusion: C-reactive protein was moderately sensitive for bacterial zoonoses and highly sensitive for identifying BSIs. Based on these results, operational studies are warranted to assess the safety and clinical utility of CRP for the management of non-malaria febrile illness at first-level health facilities in sub-Saharan Africa.
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http://dx.doi.org/10.1111/tmi.13358DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7265697PMC
March 2020

Legal Uncertainty-The Gray Area around Substandard Medicines: Where Public Health Meets Law.

Am J Trop Med Hyg 2020 02;102(2):262-267

Institute of Tropical Medicine, Antwerp, Belgium.

A vicious circle links lack of equitable access to health to the supply of poor-quality medicines, which amount to one-tenth of medicines available in low- and middle-income countries. The WHO introduced a new, public health-focused definition of substandard and falsified (SF) medicines, which offers opportunities for governments to broaden the scope of interventions to combat poor-quality medicines. At the same time, translating it into legal and regulatory measures may be challenging because this definition is not free of ambiguity (in that, there is a gray area between intentionally falsified and unintentional substandard medicines), and some countries may not have appropriate regulatory mechanisms/jurisdictions in place. The focus of the article is to consider what a public health-informed legal and regulatory environment could look like in light of WHO's SF definition and propose appropriate measures to put it into effect. We present a "legal levers matrix" that may assist legislators and policymakers evaluate the adequacy of measures (i.e., criminal, civil, and administrative mechanisms) to address the problem of poor-quality medicines, particularly in terms of their configuration. In addition, this matrix underscores the importance of fostering dialogue between medical/public health and the legal/regulatory communities and to develop alternative/complementary solutions, including regulatory strengthening and nonpunitive actions. Substandard and falsified medicines arise from the interplay between societies, economies, and behaviors: effective regulation is necessary to disincentivize the production and/or supply of SF medicines, whereas health systems should strive to provide affordable medicines to all levels of society.
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http://dx.doi.org/10.4269/ajtmh.19-0645DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008313PMC
February 2020

Relationship of Serum Antileishmanial Antibody With Development of Visceral Leishmaniasis, Post-kala-azar Dermal Leishmaniasis and Visceral Leishmaniasis Relapse.

Front Microbiol 2019 9;10:2268. Epub 2019 Oct 9.

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.

Introduction: To sustain the achievement of kala-azar elimination program (KEP), early detection and treatment of the visceral leishmaniasis (VL) cases and associated modalities such as treatment failure (TF), relapse VL (RVL), and Post-kala-azar dermal leishmaniasis (PKDL) is the cornerstone. A predictive biomarker for VL development and related complications could also play a crucial role in curtailing disease incidence and transmission. Investigations to find a biomarker with prospective capabilities are, however, scarce. Using samples and known clinical outcomes generated within two previous longitudinal cohort studies, we aimed to determine if fluctuations in serum anti-rK39 antibody levels could provide such predictive value.

Materials And Methods: Serum samples collected at four different time points (Baseline, 12, 18, and 24 months) from 16 patients who had developed VL within the monitoring period and 15 of their asymptomatic healthy controls counterparts were investigated. To investigate potential prediction of VL related complications, serum samples of 32 PKDL, 10 RVL, 07 TF, and 38 cured VL from a single dose AmBisome trial were analyzed. Of this second panel, all patients were monitored for 5 years and sera were collected at four time points (Baseline then 1, 6, and 12 months after treatment). The level of anti-rK39 antibodies in archived samples was measured by a semi-quantitative ELISA.

Results: The mean antibody level was significantly higher in VL patients compared to their asymptomatic healthy counterparts at each time point. Likewise, we observed a trend toward elevations in antibody levels for PKDL, RVL, TF relative to the reducing levels observed in cured VL. Receiver operating characteristic (ROC) analysis found a promising predictive power of rK39 antibody levels to reveal progression from asymptomatic infection stage to VL, defined as 87.5% sensitive and 95% specific. Following treatment, rk39 antibody notably showed 100% sensitivity and 95% specificity in predicting TF.

Conclusion: Our data indicate that the relative quantity of serum anti-rK39 antibody has promise within either a predictive or prognostic algorithm for VL and VL-related modalities. These could enable VL control programs to implement more effective measures to eliminate the disease. Further research is, however, imperative to standardize the rK39 antibody ELISA between sites prior to broader use.
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http://dx.doi.org/10.3389/fmicb.2019.02268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6795025PMC
October 2019

Clinical REsearch During Outbreaks (CREDO) Training for Low- and Middle-Income Countries.

Emerg Infect Dis 2019 11;25(11):2084-2087

We describe a pilot of the Clinical REsearch During Outbreaks (CREDO) initiative, a training curriculum for researchers in epidemic-prone low- and middle-income countries who may respond to disease outbreaks. Participants reported improved confidence in their ability to conduct such research and overall satisfaction with the course structure, content, and training.
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http://dx.doi.org/10.3201/eid2511.180628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810185PMC
November 2019

Designing noninferiority tuberculosis treatment trials: Identifying practical advantages for drug regimens with acceptable effectiveness.

PLoS Med 2019 07 12;16(7):e1002850. Epub 2019 Jul 12.

Competence Center in Methodology and Statistics, Department of Population Health, Luxembourg Institute of Health, Strassen, Luxembourg.

In this Collection Review for the Novel Treatments for Tuberculosis Collection, Piero Olliaro and Michael Vaillant discuss the considerations when choosing a non-inferiority margin that is meaningful from statistical, ethical, clinical, and health standpoint.
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http://dx.doi.org/10.1371/journal.pmed.1002850DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6625704PMC
July 2019

Breast Tuberculosis in Women: A Systematic Review.

Am J Trop Med Hyg 2019 07;101(1):12-21

Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.

Breast tuberculosis (TB) is rarely reported and poorly described. This review aims to update the existing literature on risk factors, clinical presentations, constitutional symptoms, diagnostic procedures, and medical and surgical treatments for breast TB. In all, 1,478 cases of breast TB were collected. Previous history of TB was reported in 19% of cases. The most common clinical appearance of the lesion was breast lump (75%). The most common associated finding was axillary lymphadenitis (33%) followed by sinus or fistula (24%). The most common symptoms were pain and fever, reported in 42% and 28% of cases, respectively. The most used diagnostic method was fine-needle aspiration cytology (32%), followed by biopsy (27%), acid-fast bacteria Ziehl-Neelsen stain (26%), culture (13%), and polymerase chain reaction (2%). These tested positive in 64%, 93%, 27%, 26%, and 58% of cases, respectively. The majority (69%) of patients received a 6-month anti-TB treatment (isoniazid, rifampicin, pyrazinamide, and ethambutol). Surgery consisted of excision in 39% of cases, drainage in 23%, and mastectomy in 5%. The great majority of patients had a positive outcome. It often mimics breast cancer, which makes it difficult to diagnose. Most patients, when diagnosed in time, respond to antitubercular therapy alone.
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http://dx.doi.org/10.4269/ajtmh.19-0061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609192PMC
July 2019

Correction to: The diagnosis and treatment of urogenital schistosomiasis in Italy in a retrospective cohort of immigrants from Sub-Saharan Africa.

Infection 2019 06;47(3):461-462

Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

The original version of this article unfortunately contained a mistake. The given name and family name of Filippo Parretti was transposed in the original publication. The correct name is as shown above.
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http://dx.doi.org/10.1007/s15010-019-01283-9DOI Listing
June 2019

The diagnosis and treatment of urogenital schistosomiasis in Italy in a retrospective cohort of immigrants from Sub-Saharan Africa.

Infection 2019 Jun 21;47(3):447-459. Epub 2019 Jan 21.

Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Objectives: To evaluate ultrasound and praziquantel to, respectively, assess and reduce urogenital schistosomiasis (UGS)-associated morbidity in migrants from Sub-Saharan Africa (SSA).

Methods: Migrants from SSA with UGS attending three Italian centres for tropical diseases during 2011-2016 were retrospectively enrolled. Data on clinical symptoms, routine laboratory, parasitological tests, and ultrasound reported as per the WHO-Niamey protocol were collected at baseline and at available follow-up visits after treatment with praziquantel 40 mg/kg/day for 3 days.

Results: One hundred and seventy patients with UGS were enrolled and treated with praziquantel. Baseline ultrasonography showed urinary tract abnormalities in 115/169 patients (68%); the mean global Schistosoma haematobium score was 2.29 (SD 2.84, IQR 0-2), the mean urinary bladder intermediate score 1.75 (SD 1.73, IQR 0-2), and the mean upper urinary tract intermediate score 0.54 (SD 2.37, IQR 1-10). Abnormalities were more common among the 111 (65%) who were symptomatic (p < 0.02; OR 2.53; 95% CI 1.19-5.35). Symptoms started in 94/111 (85%) before arriving (median 63 months, IQR 12-119). At follow-up, we observed a significant reduction in the prevalence of UGS-related symptoms, blood, urine, and ultrasound abnormalities.

Conclusions: Our study results support the use of ultrasound and praziquantel for assessing and reducing UGS-associated morbidity in migrants. Health-seeking behaviour, diagnostic, and treatment delays contribute to the advanced pathology and qualified treatment success. To ensure earlier treatment, based on our findings, clinical experience, and available literature, we propose an algorithm for the diagnosis and clinical management of UGS. Multicentre studies are needed to improve the management of subjects with UGS in non-endemic countries.
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http://dx.doi.org/10.1007/s15010-019-01270-0DOI Listing
June 2019

Sharing health research data - the role of funders in improving the impact.

F1000Res 2018 15;7:1641. Epub 2018 Oct 15.

Implementation and Intervention Research, TDR - The Special Programme for Research and Training in Tropical Diseases, Geneva, 1211, Switzerland.

Recent public health emergencies with outbreaks of influenza, Ebola and Zika revealed that the mechanisms for sharing research data are neither being used, or adequate for the purpose, particularly where data needs to be shared rapidly. A review of research papers, including completed clinical trials related to priority pathogens, found only 31% (98 out of 319 published papers, excluding case studies) provided access to all the data underlying the paper - 65% of these papers give no information on how to find or access the data. Only two clinical trials out of 58 on interventions for WHO priority pathogens provided any link in their registry entry to the background data. Interviews with researchers revealed a reluctance to share data included a lack of confidence in the utility of the data; an absence of academic-incentives for rapid dissemination that prevents subsequent publication and a disconnect between those who are collecting the data and those who wish to use it quickly.  The role of the funders of research needs to change to address this. Funders need to engage early with the researchers and related stakeholders to understand their concerns and work harder to define the more explicitly the benefits to all stakeholders.  Secondly, there needs to be a direct benefit to sharing data that is directly relevant to those people that collect and curate the data. Thirdly more work needs to be done to realise the intent of making data sharing resources more equitable, ethical and efficient.  Finally, a checklist of the issues that need to be addressed when designing new or revising existing data sharing resources should be created. This checklist would highlight the technical, cultural and ethical issues that need to be considered and point to examples of emerging good practice that can be used to address them.
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http://dx.doi.org/10.12688/f1000research.16523.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6317492PMC
October 2018