Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis
Introduction Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An indivi...
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BMJ Publishing Group
2023-12-01
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| author | James Wilson Koert Ritmeijer Fabiana Alves Prabin Dahal Kasia Stepniewska Shyam Sundar Philippe J Guérin Manju Rahi Ahmed Musa Krishna Pandey Rishikesh Kumar Sauman Singh-Phulgenda Niyamat Ali Siddiqui Abdalla Munir Caitlin Naylor Gemma Buck Paritosh Malaviya |
| author_facet | James Wilson Koert Ritmeijer Fabiana Alves Prabin Dahal Kasia Stepniewska Shyam Sundar Philippe J Guérin Manju Rahi Ahmed Musa Krishna Pandey Rishikesh Kumar Sauman Singh-Phulgenda Niyamat Ali Siddiqui Abdalla Munir Caitlin Naylor Gemma Buck Paritosh Malaviya |
| author_sort | James Wilson |
| collection | DOAJ |
| description | Introduction Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.Methods and analysis The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.Ethics and dissemination This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (exempt granted on 29 March 2023, OxTREC REF: IDDO). Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (letter no.: RMRI/EC/30/2022) on 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.PROSPERO registration number CRD42021284622. |
| format | Article |
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| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-da1da7b2a4ae4db39d942fe1e76b857a2025-08-20T01:48:37ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-074841Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysisJames Wilson0Koert Ritmeijer1Fabiana Alves2Prabin Dahal3Kasia Stepniewska4Shyam Sundar5Philippe J Guérin6Manju Rahi7Ahmed Musa8Krishna Pandey9Rishikesh Kumar10Sauman Singh-Phulgenda11Niyamat Ali Siddiqui12Abdalla Munir13Caitlin Naylor14Gemma Buck15Paritosh Malaviya16Infectious Diseases Data Observatory (IDDO), Oxford, UKMédecins Sans Frontières, Amsterdam, NetherlandsDrugs for Neglected Disease Initiative, Geneva, Switzerland4 Nuffield Department of Medicine, University of Oxford, Oxford, UK9 University of Oxford, Oxford, UKInfectious Disease Research Laboratory, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, IndiaCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKAcademy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, IndiaInstitute of Endemic Diseases, University of Khartoum, Khartoum, SudanRajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, IndiaRajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, IndiaInfectious Diseases Data Observatory (IDDO), Oxford, UKRajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, IndiaInfectious Diseases Data Observatory (IDDO), Oxford, UKInfectious Diseases Data Observatory (IDDO), Oxford, UKInfectious Diseases Data Observatory (IDDO), Oxford, UKInfectious Disease Research Laboratory, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, IndiaIntroduction Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.Methods and analysis The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.Ethics and dissemination This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (exempt granted on 29 March 2023, OxTREC REF: IDDO). Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (letter no.: RMRI/EC/30/2022) on 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.PROSPERO registration number CRD42021284622.https://bmjopen.bmj.com/content/13/12/e074841.full |
| spellingShingle | James Wilson Koert Ritmeijer Fabiana Alves Prabin Dahal Kasia Stepniewska Shyam Sundar Philippe J Guérin Manju Rahi Ahmed Musa Krishna Pandey Rishikesh Kumar Sauman Singh-Phulgenda Niyamat Ali Siddiqui Abdalla Munir Caitlin Naylor Gemma Buck Paritosh Malaviya Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis BMJ Open |
| title | Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis |
| title_full | Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis |
| title_fullStr | Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis |
| title_full_unstemmed | Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis |
| title_short | Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis |
| title_sort | haematological dynamics following treatment of visceral leishmaniasis a protocol for systematic review and individual participant data ipd meta analysis |
| url | https://bmjopen.bmj.com/content/13/12/e074841.full |
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