Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries
Abstract Background The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) focus is on randomized trials of different approaches to mass drug administration (MDA) in endemic countries in Africa. Because their studies provided an opportunity to evaluate the effects of mass tre...
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BMC
2017-09-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | http://link.springer.com/article/10.1186/s12879-017-2738-5 |
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| author | Ye Shen Charles H. King Sue Binder Feng Zhang Christopher C. Whalen W. Evan Secor Susan P. Montgomery Pauline N. M. Mwinzi Annette Olsen Pascal Magnussen Safari Kinung’hi Anna E. Phillips Rassul Nalá Josefo Ferro H. Osvaldo Aurelio Fiona Fleming Amadou Garba Amina Hamidou Alan Fenwick Carl H. Campbell Daniel G. Colley |
| author_facet | Ye Shen Charles H. King Sue Binder Feng Zhang Christopher C. Whalen W. Evan Secor Susan P. Montgomery Pauline N. M. Mwinzi Annette Olsen Pascal Magnussen Safari Kinung’hi Anna E. Phillips Rassul Nalá Josefo Ferro H. Osvaldo Aurelio Fiona Fleming Amadou Garba Amina Hamidou Alan Fenwick Carl H. Campbell Daniel G. Colley |
| author_sort | Ye Shen |
| collection | DOAJ |
| description | Abstract Background The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) focus is on randomized trials of different approaches to mass drug administration (MDA) in endemic countries in Africa. Because their studies provided an opportunity to evaluate the effects of mass treatment on Schistosoma-associated morbidity, nested cohort studies were developed within SCORE’s intervention trials to monitor changes in a suite of schistosomiasis disease outcomes. This paper describes the process SCORE used to select markers for prospective monitoring and the baseline prevalence of these morbidities in four parallel cohort studies. Methods In July 2009, SCORE hosted a discussion of the potential impact of MDA on morbidities due to Schistosoma infection that might be measured in the context of multi-year control. Candidate markers were reviewed and selected for study implementation. Baseline data were then collected from cohorts of children in four country studies: two in high endemic S. mansoni sites (Kenya and Tanzania), and two in high endemic S. haematobium sites (Niger and Mozambique), these cohorts to be followed prospectively over 5 years. Results At baseline, 62% of children in the S. mansoni sites had detectable eggs in their stool, and 10% had heavy infections (≥ 400 eggs/g feces). Heavy S. mansoni infections were found to be associated with increased baseline risk of anemia, although children with moderate or heavy intensity infections had lower risk of physical wasting. Prevalence of egg-positive infection in the combined S. haematobium cohorts was 27%, with 5% of individuals having heavy infection (≥50 eggs/10 mL urine). At baseline, light intensity S. haematobium infection was associated with anemia and with lower scores in the social domain of health-related quality-of-life (HRQoL) assessed by Pediatric Quality of Life Inventory. Conclusions Our consensus on practical markers of Schistosoma-associated morbidity indicated that height, weight, hemoglobin, exercise tolerance, HRQoL, and ultrasound abnormalities could be used as reference points for gauging treatment impact. Data collected over five years of program implementation will provide guidance for future evaluation of morbidity control in areas endemic for schistosomiasis. Trial registration These cohort studies are registered and performed in conjunction with the International Standard Randomised Controlled Trial Registry trials ISRCTN16755535 , ISRCTN14117624 , ISRCTN95819193 , and ISRCTN32045736 . |
| first_indexed | 2024-12-19T15:08:23Z |
| format | Article |
| id | doaj.art-65edcd9ebdb9449780153fa584733881 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-19T15:08:23Z |
| publishDate | 2017-09-01 |
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| spelling | doaj.art-65edcd9ebdb9449780153fa5847338812022-12-21T20:16:22ZengBMCBMC Infectious Diseases1471-23342017-09-0117111110.1186/s12879-017-2738-5Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countriesYe Shen0Charles H. King1Sue Binder2Feng Zhang3Christopher C. Whalen4W. Evan Secor5Susan P. Montgomery6Pauline N. M. Mwinzi7Annette Olsen8Pascal Magnussen9Safari Kinung’hi10Anna E. Phillips11Rassul Nalá12Josefo Ferro13H. Osvaldo Aurelio14Fiona Fleming15Amadou Garba16Amina Hamidou17Alan Fenwick18Carl H. Campbell19Daniel G. Colley20Department of Epidemiology and Biostatistics, University of GeorgiaCenter for Global Health and Diseases, Case Western Reserve UniversitySchistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases and Department of Microbiology, University of GeorgiaDepartment of Epidemiology and Biostatistics, University of GeorgiaDepartment of Epidemiology and Biostatistics, University of GeorgiaParasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and PreventionParasitic Diseases Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and PreventionCentre for Global Health Research, Kenya Medical Research InstituteParasitology and Aquatic Diseases, Faculty of Health and Medical Sciences, University of CopenhagenParasitology and Aquatic Diseases, Faculty of Health and Medical Sciences, University of CopenhagenNational Institute for Medical Research, Mwanza Research CentreSchistosomiasis Control Initiative, Department of Infectious Disease Epidemiology, Imperial CollegeInstituto Nacional de SaúdeUniversidade Católica de MoçambiqueSchistosomiasis Control Initiative, Department of Infectious Disease Epidemiology, Imperial CollegeSchistosomiasis Control Initiative, Department of Infectious Disease Epidemiology, Imperial CollegeRéseau International Schistosomoses, Environnement, Aménagement et Lutte (RISEAL-Niger)Réseau International Schistosomoses, Environnement, Aménagement et Lutte (RISEAL-Niger)Schistosomiasis Control Initiative, Department of Infectious Disease Epidemiology, Imperial CollegeSchistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases and Department of Microbiology, University of GeorgiaSchistosomiasis Consortium for Operational Research and Evaluation, Center for Tropical and Emerging Global Diseases and Department of Microbiology, University of GeorgiaAbstract Background The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) focus is on randomized trials of different approaches to mass drug administration (MDA) in endemic countries in Africa. Because their studies provided an opportunity to evaluate the effects of mass treatment on Schistosoma-associated morbidity, nested cohort studies were developed within SCORE’s intervention trials to monitor changes in a suite of schistosomiasis disease outcomes. This paper describes the process SCORE used to select markers for prospective monitoring and the baseline prevalence of these morbidities in four parallel cohort studies. Methods In July 2009, SCORE hosted a discussion of the potential impact of MDA on morbidities due to Schistosoma infection that might be measured in the context of multi-year control. Candidate markers were reviewed and selected for study implementation. Baseline data were then collected from cohorts of children in four country studies: two in high endemic S. mansoni sites (Kenya and Tanzania), and two in high endemic S. haematobium sites (Niger and Mozambique), these cohorts to be followed prospectively over 5 years. Results At baseline, 62% of children in the S. mansoni sites had detectable eggs in their stool, and 10% had heavy infections (≥ 400 eggs/g feces). Heavy S. mansoni infections were found to be associated with increased baseline risk of anemia, although children with moderate or heavy intensity infections had lower risk of physical wasting. Prevalence of egg-positive infection in the combined S. haematobium cohorts was 27%, with 5% of individuals having heavy infection (≥50 eggs/10 mL urine). At baseline, light intensity S. haematobium infection was associated with anemia and with lower scores in the social domain of health-related quality-of-life (HRQoL) assessed by Pediatric Quality of Life Inventory. Conclusions Our consensus on practical markers of Schistosoma-associated morbidity indicated that height, weight, hemoglobin, exercise tolerance, HRQoL, and ultrasound abnormalities could be used as reference points for gauging treatment impact. Data collected over five years of program implementation will provide guidance for future evaluation of morbidity control in areas endemic for schistosomiasis. Trial registration These cohort studies are registered and performed in conjunction with the International Standard Randomised Controlled Trial Registry trials ISRCTN16755535 , ISRCTN14117624 , ISRCTN95819193 , and ISRCTN32045736 .http://link.springer.com/article/10.1186/s12879-017-2738-5SchistosomiasisSchistosoma haematobiumSchistosoma mansoniMorbidityDrug therapyPraziquantel |
| spellingShingle | Ye Shen Charles H. King Sue Binder Feng Zhang Christopher C. Whalen W. Evan Secor Susan P. Montgomery Pauline N. M. Mwinzi Annette Olsen Pascal Magnussen Safari Kinung’hi Anna E. Phillips Rassul Nalá Josefo Ferro H. Osvaldo Aurelio Fiona Fleming Amadou Garba Amina Hamidou Alan Fenwick Carl H. Campbell Daniel G. Colley Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries BMC Infectious Diseases Schistosomiasis Schistosoma haematobium Schistosoma mansoni Morbidity Drug therapy Praziquantel |
| title | Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries |
| title_full | Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries |
| title_fullStr | Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries |
| title_full_unstemmed | Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries |
| title_short | Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries |
| title_sort | protocol and baseline data for a multi year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four african countries |
| topic | Schistosomiasis Schistosoma haematobium Schistosoma mansoni Morbidity Drug therapy Praziquantel |
| url | http://link.springer.com/article/10.1186/s12879-017-2738-5 |
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