{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T23:15:28Z","timestamp":1785885328364,"version":"3.56.0"},"reference-count":34,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2023,12,14]],"date-time":"2023-12-14T00:00:00Z","timestamp":1702512000000},"content-version":"unspecified","delay-in-days":13,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill & Melinda Gates Foundation","doi-asserted-by":"crossref","award":["INV-004713"],"award-info":[{"award-number":["INV-004713"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,10,31]]},"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>PROSPERO registration number<\/jats:title>\n                  <jats:p>CRD42021284622.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-074841","type":"journal-article","created":{"date-parts":[[2023,12,15]],"date-time":"2023-12-15T02:06:09Z","timestamp":1702605969000},"page":"e074841","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2994-0154","authenticated-orcid":false,"given":"Abdalla","family":"Munir","sequence":"first","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2158-846X","authenticated-orcid":false,"given":"Prabin","family":"Dahal","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rishikesh","family":"Kumar","sequence":"additional","affiliation":[{"name":"Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2892-3053","authenticated-orcid":false,"given":"Sauman","family":"Singh-Phulgenda","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niyamat Ali","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin","family":"Naylor","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3615-4928","authenticated-orcid":false,"given":"James","family":"Wilson","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gemma","family":"Buck","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0932-0935","authenticated-orcid":false,"given":"Manju","family":"Rahi","sequence":"additional","affiliation":[{"name":"Indian Council of Medical Research (ICMR), New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabiana","family":"Alves","sequence":"additional","affiliation":[{"name":"Drugs for Neglected Disease Initiative, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paritosh","family":"Malaviya","sequence":"additional","affiliation":[{"name":"Infectious Disease Research Laboratory, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shyam","family":"Sundar","sequence":"additional","affiliation":[{"name":"Infectious Disease Research Laboratory, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koert","family":"Ritmeijer","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res, Amsterdam, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kasia","family":"Stepniewska","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5930-2458","authenticated-orcid":false,"given":"Krishna","family":"Pandey","sequence":"additional","affiliation":[{"name":"Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe J","family":"Gu\u00e9rin","sequence":"additional","affiliation":[{"name":"Infectious Diseases Data Observatory (IDDO), Oxford, UK"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Musa","sequence":"additional","affiliation":[{"name":"Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,12,14]]},"reference":[{"key":"2025101810195822000_13.12.e074841.1","doi-asserted-by":"crossref","unstructured":"Boelaert M , Sundar S . Leishmaniasis. In: Farrar J , Hotez PJ , Junghanss T , eds. Manson\u2019s Tropical Diseases. 23rd edition. Elsevier Health Sciences, 2013: 631\u201351.","DOI":"10.1016\/B978-0-7020-5101-2.00048-0"},{"key":"2025101810195822000_13.12.e074841.2","doi-asserted-by":"publisher","DOI":"10.1007\/s00436-016-5313-x"},{"key":"2025101810195822000_13.12.e074841.3","doi-asserted-by":"publisher","DOI":"10.1007\/s12288-010-0027-1"},{"key":"2025101810195822000_13.12.e074841.4","first-page":"371","article-title":"Haematological investigations in visceral Leishmaniasis","volume":"38","author":"Kager","year":"1986","journal-title":"Trop Geogr Med"},{"key":"2025101810195822000_13.12.e074841.5","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1111\/j.1365-2141.1972.tb05678.x","article-title":"The anaemia of Kala Azar","volume":"22","author":"Woodruff","year":"1972","journal-title":"Br J Haematol"},{"key":"2025101810195822000_13.12.e074841.6","doi-asserted-by":"publisher","DOI":"10.1016\/0035-9203(84)90131-7"},{"key":"2025101810195822000_13.12.e074841.7","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/148.1.148"},{"key":"2025101810195822000_13.12.e074841.8","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1186\/s12879-021-06691-7","article-title":"Hematological profiles of visceral Leishmaniasis patients before and after treatment of anti-Leishmanial drugs at University of Gondar hospital; Leishmania research and treatment center Northwest, Ethiopia","volume":"21","author":"Shiferaw","year":"2021","journal-title":"BMC Infect Dis"},{"key":"2025101810195822000_13.12.e074841.9","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0009302","article-title":"Serious adverse events following treatment of visceral Leishmaniasis: A systematic review and meta-analysis","volume":"15","author":"Singh-Phulgenda","year":"2021","journal-title":"PLoS Negl Trop Dis"},{"key":"2025101810195822000_13.12.e074841.10","unstructured":"Infectious Diseases Data Observatory . Visceral Leishmaniasis data inventory. www.iddo.org. 2023. Available: https:\/\/www.iddo.org\/document\/visceral-leishmaniasis-data-inventory [Accessed 27 Feb 2023]."},{"key":"2025101810195822000_13.12.e074841.11","unstructured":"WHO . Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. vitamin and mineral nutrition information system. Geneva, world health organization 2011. Geneva World Health Organization; WHO\/NMH\/NHD\/MNM\/11.1. Available: http:\/\/www.who.int\/vmnis\/indicators\/haemoglobin.pdf [Accessed 5 Dec 2023]."},{"key":"2025101810195822000_13.12.e074841.12","unstructured":"Infectious Diseases Data Observatory . VL surveyor. www.Iddo.org. 2020. Available: https:\/\/www.iddo.org\/vlSurveyor\/#0 [Accessed 17 Sep 2020]."},{"key":"2025101810195822000_13.12.e074841.13","doi-asserted-by":"crossref","first-page":"155","DOI":"10.12688\/wellcomeopenres.17739.1","article-title":"Infectious diseases data Observatory (IDDO) visceral Leishmaniasis library of clinical therapeutic studies: A protocol for a living systematic review of clinical studies","volume":"7","author":"Singh-Phulgenda","year":"2022","journal-title":"Wellcome Open Res"},{"key":"2025101810195822000_13.12.e074841.14","unstructured":"Infectious Diseases Data Observatory . New global collaboration developing standards for standardised data collection across the VL research community. 2020. Available: https:\/\/www.iddo.org\/news\/new-global-collaboration-developing-standards-standardised-data-collection-across-vl-research [Accessed 28 Feb 2023]."},{"key":"2025101810195822000_13.12.e074841.15","unstructured":"WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards . Length\/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. Geneva World Heal Organ 2006:312."},{"key":"2025101810195822000_13.12.e074841.16","doi-asserted-by":"crossref","unstructured":"Riley RD , Moons KGM , Debray TPA . IPD Meta\u2010Analysis for Prognostic factor research. In: Riley RD , LAS JFT , eds. Individual Participant Data Meta-Analysis: John Wiley & Sons Ltd, 2021: 421\u201345. doi:10.1002\/9781119333784","DOI":"10.1002\/9781119333784.ch16"},{"key":"2025101810195822000_13.12.e074841.17","doi-asserted-by":"crossref","first-page":"431","DOI":"10.1002\/bimj.201700067","article-title":"Variable selection \u2013 A review and recommendations for the practicing statistician","volume":"60","author":"Heinze","year":"2018","journal-title":"Biom J"},{"key":"2025101810195822000_13.12.e074841.18","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3148"},{"key":"2025101810195822000_13.12.e074841.19","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4067"},{"key":"2025101810195822000_13.12.e074841.20","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1599"},{"key":"2025101810195822000_13.12.e074841.21","doi-asserted-by":"crossref","unstructured":"Royston P , Sauerbrei W . Multivariable Model\u2010Building. In: Multivariable Model-Building: A Pragmatic Approach to Regression Analysis based on Fractional Polynomials for Modelling Continuous Variables. In: Multivariable Model-Building: A Pragmatic Approach to Regression Analysis based on Fractional Polynomials for Modelling Continuous Variables. John Wiley & Sons, Ltd, 2008: 71\u201398. doi:10.1002\/9780470770771","DOI":"10.1002\/9780470770771.ch4"},{"key":"2025101810195822000_13.12.e074841.22","unstructured":"World Health Organization . WHO guidelines for the treatment of visceral Leishmaniasis in HIV Co-infected patients in East Africa and South-East Asia. Geneva, Switzerland, 2022."},{"key":"2025101810195822000_13.12.e074841.23","doi-asserted-by":"crossref","unstructured":"Alves F , Bilbe G , Blesson S , et al . Recent development of visceral Leishmaniasis treatments: successes, pitfalls, and perspectives. Clin Microbiol Rev 2018;31. doi:10.1128\/CMR.00048-18","DOI":"10.1128\/CMR.00048-18"},{"key":"2025101810195822000_13.12.e074841.24","unstructured":"Levis B , Snell K , Takwoingi Y , et al . Evaluating risk of bias and applicability in individual participant data meta-analyses. In: Advances in Evidence Synthesis: special issue Cochrane Database of Systematic Reviews. 2020: 9."},{"key":"2025101810195822000_13.12.e074841.25","unstructured":"R Core . R: A language and environment for statistical computing. 2021."},{"key":"2025101810195822000_13.12.e074841.26","unstructured":"StataCorp . Stata statistical software: release 17; 2021."},{"key":"2025101810195822000_13.12.e074841.27","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.3656"},{"key":"2025101810195822000_13.12.e074841.28","unstructured":"Infectious Diseases Data Observatory . Visceral Leishmaniasis research agenda. 2019. Available: https:\/\/www.iddo.org\/vl\/research\/research-agenda [Accessed 28 Feb 2023]."},{"key":"2025101810195822000_13.12.e074841.29","unstructured":"Infectious Diseases Data Observatory . Anaemia among patients with visceral Leishmaniasis and haematological Dynamics post treatment. 2022. Available: https:\/\/www.iddo.org\/anaemia-among-patients-visceral-leishmaniasis-and-haematological-dynamics-post-treatment [Accessed 27 Apr 2022]."},{"key":"2025101810195822000_13.12.e074841.30","doi-asserted-by":"crossref","unstructured":"Riley RD , Lambert PC , Abo-Zaid G . Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ 2010;340. doi:10.1136\/bmj.c221","DOI":"10.1136\/bmj.c221"},{"key":"2025101810195822000_13.12.e074841.31","doi-asserted-by":"publisher","DOI":"10.1016\/j.cub.2013.11.014"},{"key":"2025101810195822000_13.12.e074841.32","doi-asserted-by":"crossref","unstructured":"Nevitt SJ , Marson AG , Davie B , et al . Exploring changes over time and characteristics associated with data retrieval across individual participant data meta-analyses: systematic review. BMJ 2017;357. doi:10.1136\/bmj.j1390","DOI":"10.1136\/bmj.j1390"},{"key":"2025101810195822000_13.12.e074841.33","doi-asserted-by":"crossref","unstructured":"Dahal P , Singh-Phulgenda S , Naylor C , et al . Design, conduct, analysis, and reporting of therapeutic efficacy studies in visceral Leishmaniasis: a systematic review of published reports, 2000-2021. [Preprint] 2023. doi:10.1101\/2023.09.06.23295148","DOI":"10.1101\/2023.09.06.23295148"},{"key":"2025101810195822000_13.12.e074841.34","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0007992","article-title":"Outcomes of visceral Leishmaniasis in pregnancy: a retrospective cohort study from South Sudan","volume":"14","author":"Pekelharing","year":"2020","journal-title":"PLoS Negl Trop Dis"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-074841","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T17:20:10Z","timestamp":1760808010000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-074841"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12]]},"references-count":34,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2023,12,14]]},"published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1136\/bmjopen-2023-074841"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-074841","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12]]}}}