scholarly journals 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

2020 ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  

Abstract 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, identifier NCT04081051, registered 06 SEP 2019.Protocol version 1.4 Dated 20 December 2019

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E. Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  

Abstract 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


2020 ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  

Abstract 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, identifier NCT04081051, registered 06 SEP 2019.Protocol version 1.4 Dated 20 December 2019


2020 ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  

Abstract 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.DiscussionThis 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, identifier NCT04081051, registered 06 SEP 2019.Protocol version 1.4 Date 20 December 2019


2021 ◽  
pp. 004947552199818
Author(s):  
Ellen Wilkinson ◽  
Noel Aruparayil ◽  
J Gnanaraj ◽  
Julia Brown ◽  
David Jayne

Laparoscopic surgery has the potential to improve care in resource-deprived low- and-middle-income countries (LMICs). This study aims to analyse the barriers to training in laparoscopic surgery in LMICs. Medline, Embase, Global Health and Web of Science were searched using ‘LMIC’, ‘Laparoscopy’ and ‘Training’. Two researchers screened results with mutual agreement. Included papers were in English, focused on abdominal laparoscopy and training in LMICs. PRISMA guidelines were followed; 2992 records were screened, and 86 full-text articles reviewed to give 26 key papers. Thematic grouping identified seven key barriers: funding; availability and maintenance of equipment; local access to experienced laparoscopic trainers; stakeholder dynamics; lack of knowledge on effective training curricula; surgical departmental structure and practical opportunities for trainees. In low-resource settings, technological advances may offer low-cost solutions in the successful implementation of laparoscopic training and improve access to surgical care.


Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1163
Author(s):  
Fien Vanroye ◽  
Dorien Van den Bossche ◽  
Isabel Brosius ◽  
Bieke Tack ◽  
Marjan Van Esbroeck ◽  
...  

COVID-19 Antibody Detecting Rapid Diagnostic Tests (COVID-19 Ab RDTs) are the preferred tool for SARS-CoV-2 seroprevalence studies, particularly in low- and middle-income countries. The present study challenged COVID-19 Ab RDTs with pre-pandemic samples of patients exposed to tropical pathogens. A retrospective study was performed on archived serum (n = 94) and EDTA whole blood (n = 126) samples obtained during 2010–2018 from 196 travelers with malaria (n = 170), schistosomiasis (n = 25) and dengue (n = 25). COVID-19 Ab RDTs were selected based on regulatory approval status, independent evaluation results and detecting antigens. Among 13 COVID-19 Ab RDT products, overall cross-reactivity was 18.5%; cross-reactivity for malaria, schistosomiasis and dengue was 20.3%, 18.1% and 7.5%, respectively. Cross-reactivity for current and recent malaria, malaria antibodies, Plasmodium species and parasite densities was similar. Cross-reactivity among the different RDT products ranged from 2.7% to 48.9% (median value 14.5%). IgM represented 67.9% of cross-reactive test lines. Cross-reactivity was not associated with detecting antigens, patient categories or disease (sub)groups, except for schistosomiasis (two products with ≥60% cross-reactivity). The high cross-reactivity for malaria, schistosomiasis and—to a lesser extent—dengue calls for risk mitigation when using COVID-19 Ab RDTs in co-endemic regions.


2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Katherine Tumlinson ◽  
Dilshad Jaff ◽  
Barbara Stilwell ◽  
Dickens Otieno Onyango ◽  
Kenneth L. Leonard

AbstractRecent studies reveal public-sector healthcare providers in low- and middle-income countries (LMICs) are frequently absent from work, solicit informal payments for service delivery, and engage in disrespectful or abusive treatment of patients. While extrinsic factors may foster and facilitate these negative practices, it is not often feasible to alter the external environment in low-resource settings. In contrast, healthcare professionals with strong intrinsic motivation and a desire to serve the needs of their community are less likely to engage in these negative behaviors and may draw upon internal incentives to deliver a high quality of care. Reforming medical education admission and training practices in LMICs is one promising strategy for increasing the prevalence of medical professionals with strong intrinsic motivation.


PLoS Medicine ◽  
2020 ◽  
Vol 17 (6) ◽  
pp. e1003139 ◽  
Author(s):  
Giorgia Sulis ◽  
Pierrick Adam ◽  
Vaidehi Nafade ◽  
Genevieve Gore ◽  
Benjamin Daniels ◽  
...  

2016 ◽  
Vol 8 (9) ◽  
pp. 183 ◽  
Author(s):  
Kathryn Hurt ◽  
Rebekah J. Walker ◽  
Jennifer A. Campbell ◽  
Leonard E. Egede

<p>The purpose of this review was to determine whether mHealth interventions were effective in low- and middle-income countries in order to create a baseline for the evidence to support mHealth in developing countries. Studies were identified by searching Medline on 02 October 2014 for articles published in the English language between January 2000 and September 2014. Inclusion criteria were: 1) written in English, 2) completion of an mHealth intervention in a low or middle-income country, 3) measurement of patient outcomes, and 4) participants 18 years of age or older. 7,920 titles were reviewed and 7 were determined eligible based on inclusion criteria. Interventions included a cluster randomized trial, mixed methods study, retrospective comparison of an opt-in text message program, a two-arm proof of concept, single arm trial, a randomized trial, and a single subject design. Five out of seven of the studies showed significant difference between the control and intervention. Currently there is little evidence on mHealth interventions in developing countries, and existing studies are very diverse; however initial studies show changes in clinical outcomes, adherence, and health communication, including improved communication with providers, decrease in travel time, ability to receive expert advice, changes in clinical outcomes, and new forms of cost-effective education.<em> </em>While this initial review is promising, more evidence is needed to support and direct system-level resource investment.</p>


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