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Article: A living systematic review protocol for COVID-19 clinical trial registrations.

Maguire, Brittany J / Guérin, Philippe J

Wellcome open research

2020 Volume 5, Page(s) 60

Abstract: Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, ... ...

Abstract	Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website ( COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.
Keywords	covid19
Language	English
Publishing date	2020-04-02
Publishing country	England
Document type	Journal Article
ISSN	2398-502X
ISSN	2398-502X
DOI	10.12688/wellcomeopenres.15821.1
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: A living systematic review protocol for COVID-19 clinical trial registrations

Guérin, Philippe J. / Maguire, Brittany J.

Wellcome Open Res.

Abstract	Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website ( COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #66591
Database	COVID19

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Article ; Online: A living systematic review protocol for COVID-19 clinical trial registrations [version 1; peer review

Brittany J. Maguire / Philippe J. Guérin

Wellcome Open Research, Vol

2 approved]

2020 Volume 5

Abstract	Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.
Keywords	Medicine ; R ; Science ; Q ; covid19
Subject code	610
Language	English
Publishing date	2020-04-01T00:00:00Z
Publisher	Wellcome
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A living systematic review protocol for COVID-19 clinical trial registrations

Maguire, Brittany Jane / Guérin, Philippe J.

Wellcome open research, 5:60

2020

Abstract	Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.
Keywords	COVID-19 ; emerging infections ; coronavirus ; clinical trials ; Living systematic review ; covid19
Language	English
Publishing country	de
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Systemic phaeohyphomycosis in splitnose rockfish (Sebastes diploproa) caused by Devriesia sp.

Peel, Melanie J / Adams, Lance / Stevens, Brittany / Garner, Michael M / Maguire, Cheryl

Journal of fish diseases

2021 Volume 44, Issue 5, Page(s) 639–644

Abstract: A novel pathogen was documented after two wild-caught, juvenile, splitnose rockfish presented with buphthalmia, grey corneal endothelial plaques and evidence of uveitis. Cytologic evaluation of ocular contents revealed fungal hyphae. Histologic ... ...

Abstract	A novel pathogen was documented after two wild-caught, juvenile, splitnose rockfish presented with buphthalmia, grey corneal endothelial plaques and evidence of uveitis. Cytologic evaluation of ocular contents revealed fungal hyphae. Histologic evaluation identified multiple fungal granulomas and granulomatous inflammation in the globes, periocular tissue and heart. Fungi were slender, hyphenated and branched at angles, had parallel cell walls and had brown pigmentation in haematoxylin- and eosin-stained sections. Both fish were diagnosed with phaeohyphomycosis. Culture with nuclear ribosomal RNA internal transcribed spacer (ITS) segment identification further classified the fungus as Devriesia sp., which has not been previously documented as a cause of disease in animals.
MeSH term(s)	Animals ; Animals, Zoo ; Ascomycota/isolation & purification ; California ; Fish Diseases/diagnosis ; Fish Diseases/microbiology ; Fishes ; Perciformes ; Phaeohyphomycosis/diagnosis ; Phaeohyphomycosis/microbiology ; Phaeohyphomycosis/veterinary
Language	English
Publishing date	2021-01-27
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	432109-1
ISSN	1365-2761 ; 0140-7775
ISSN (online)	1365-2761
ISSN	0140-7775
DOI	10.1111/jfd.13342
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Post-kala-azar dermal leishmaniasis (PKDL) drug efficacy study landscape: A systematic scoping review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform.

Singh-Phulgenda, Sauman / Kumar, Rishikesh / Dahal, Prabin / Munir, Abdalla / Rashan, Sumayyah / Chhajed, Rutuja / Naylor, Caitlin / Maguire, Brittany J / Siddiqui, Niyamat Ali / Harriss, Eli / Rahi, Manju / Alves, Fabiana / Sundar, Shyam / Stepniewska, Kasia / Musa, Ahmed / Guerin, Philippe J / Pandey, Krishna

PLoS neglected tropical diseases

2024 Volume 18, Issue 4, Page(s) e0011635

Abstract: Background: Post-kala-azar dermal leishmaniasis (PKDL) is a dermatosis which can occur after successful treatment of visceral leishmaniasis (VL) and is a public health problem in VL endemic areas. We conducted a systematic scoping review to assess the ... ...

Abstract	Background: Post-kala-azar dermal leishmaniasis (PKDL) is a dermatosis which can occur after successful treatment of visceral leishmaniasis (VL) and is a public health problem in VL endemic areas. We conducted a systematic scoping review to assess the characteristics of published PKDL clinical studies, understand the scope of research and explore the feasibility and value of developing a PKDL individual patient data (IPD) platform. Methods: A systematic review of published literature was conducted to identify PKDL clinical studies by searching the following databases: PubMed, Scopus, Ovid Embase, Web of Science Core Collection, WHO Global Index Medicus, PASCAL, Clinicaltrials.gov, Ovid Global Health, Cochrane Database and CENTRAL, and the WHO International Clinical Trials Registry Platform. Only prospective studies in humans with PKDL diagnosis, treatment, and follow-up measurements between January 1973 and March 2023 were included. Extracted data includes variables on patient characteristics, treatment regimens, diagnostic methods, geographical locations, efficacy endpoints, adverse events and statistical methodology. Results: A total of 3,418 records were screened, of which 56 unique studies (n = 2,486 patients) were included in this review. Out of the 56 studies, 36 (64.3%) were from India (1983-2022), 12 (21.4%) from Sudan (1992-2021), 6 (10.7%) were from Bangladesh (1991-2019), and 2 (3.6%) from Nepal (2001-2007). Five (8.9%) studies were published between 1981-1990 (n = 193 patients), 10 (17.9%) between 1991-2000 (n = 230 patients), 10 (17.9%) between 2001-2010 (n = 198 patients), and 31 (55.4%) from 2011 onwards (n = 1,865 patients). Eight (14.3%) were randomised clinical trials, and 48 (85.7%) were non-randomised studies. The median post-treatment follow-up duration was 365 days (range: 90-540 days) in 8 RCTs and 360 days (range: 28-2,373 days) in 48 non-randomised studies. Disease diagnosis was based on clinical criterion in 3 (5.4%) studies, a mixture of clinical and parasitological methods in 47 (83.9%) and was unclear in 6 (10.7%) studies. Major drugs used for treatment were miltefosine (n = 636 patients), liposomal amphotericin B (L-AmB) (n = 508 patients), and antinomy regimens (n = 454 patients). Ten other drug regimens were tested in 270 patients with less than 60 patients per regimen. Conclusions: Our review identified studies with very limited sample size for the three major drugs (miltefosine, L-AmB, and pentavalent antimony), while the number of patients combined across studies suggest that the IPD platform would be valuable. With the support of relevant stakeholders, the global PKDL community and sufficient financing, a PKDL IPD platform can be realised. This will allow for exploration of different aspects of treatment safety and efficacy, which can potentially guide future healthcare decisions and clinical practices.
MeSH term(s)	Humans ; Leishmaniasis, Visceral/drug therapy ; Leishmaniasis, Cutaneous/drug therapy ; Antiprotozoal Agents/therapeutic use ; Observational Studies as Topic ; Clinical Trials as Topic ; Feasibility Studies ; Treatment Outcome ; India/epidemiology ; Bangladesh/epidemiology
Chemical Substances	Antiprotozoal Agents
Language	English
Publishing date	2024-04-16
Publishing country	United States
Document type	Journal Article ; Systematic Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2429704-5
ISSN	1935-2735 ; 1935-2735
ISSN (online)	1935-2735
ISSN	1935-2735
DOI	10.1371/journal.pntd.0011635
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Systemic phaeohyphomycosis in splitnose rockfish (Sebastes diploproa) caused by Devriesia sp

Peel, Melanie J / Adams, Lance / Stevens, Brittany / Garner, Michael M / Maguire, Cheryl

Journal of fish diseases. 2021 May, v. 44, no. 5

2021

Abstract: A novel pathogen was documented after two wild‐caught, juvenile, splitnose rockfish presented with buphthalmia, grey corneal endothelial plaques and evidence of uveitis. Cytologic evaluation of ocular contents revealed fungal hyphae. Histologic ... ...

Abstract	A novel pathogen was documented after two wild‐caught, juvenile, splitnose rockfish presented with buphthalmia, grey corneal endothelial plaques and evidence of uveitis. Cytologic evaluation of ocular contents revealed fungal hyphae. Histologic evaluation identified multiple fungal granulomas and granulomatous inflammation in the globes, periocular tissue and heart. Fungi were slender, hyphenated and branched at angles, had parallel cell walls and had brown pigmentation in haematoxylin‐ and eosin‐stained sections. Both fish were diagnosed with phaeohyphomycosis. Culture with nuclear ribosomal RNA internal transcribed spacer (ITS) segment identification further classified the fungus as Devriesia sp., which has not been previously documented as a cause of disease in animals.
Keywords	Sebastes ; cornea ; fungi ; granuloma ; heart ; histology ; hyphae ; inflammation ; internal transcribed spacers ; juveniles ; pathogens ; pigmentation ; ribosomal RNA ; rockfish
Language	English
Dates of publication	2021-05
Size	p. 639-644.
Publishing place	John Wiley & Sons, Ltd
Document type	Article
Note	NAL-AP-2-clean ; JOURNAL ARTICLE
ZDB-ID	432109-1
ISSN	1365-2761 ; 0140-7775
ISSN (online)	1365-2761
ISSN	0140-7775
DOI	10.1111/jfd.13342
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Visceral Leishmaniasis in pregnancy and vertical transmission: A systematic literature review on the therapeutic orphans.

Dahal, Prabin / Singh-Phulgenda, Sauman / Maguire, Brittany J / Harriss, Eli / Ritmeijer, Koert / Alves, Fabiana / Guerin, Philippe J / Olliaro, Piero L

PLoS neglected tropical diseases

2021 Volume 15, Issue 8, Page(s) e0009650

Abstract: Background: Reports on the occurrence and outcome of Visceral Leishmaniasis (VL) in pregnant women is rare in published literature. The occurrence of VL in pregnancy is not systematically captured and cases are rarely followed-up to detect consequences ... ...

Abstract	Background: Reports on the occurrence and outcome of Visceral Leishmaniasis (VL) in pregnant women is rare in published literature. The occurrence of VL in pregnancy is not systematically captured and cases are rarely followed-up to detect consequences of infection and treatment on the pregnant women and foetus. Methods: A review of all published literature was undertaken to identify cases of VL infections among pregnant women by searching the following database: Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials; World Health Organization Global Index Medicus: LILACS (Americas); IMSEAR (South-East Asia); IMEMR (Eastern Mediterranean); WPRIM (Western Pacific); ClinicalTrials.gov; and the WHO International Clinical Trials Registry Platform. Selection criteria included any clinical reports describing the disease in pregnancy or vertical transmission of the disease in humans. Articles meeting pre-specified inclusion criteria and non-primary research articles such as textbook, chapters, letters, retrospective case description, or reports of accidental inclusion in trials were also considered. Results: The systematic literature search identified 272 unique articles of which 54 records were included in this review; a further 18 records were identified from additional search of the references of the included studies or from personal communication leading to a total of 72 records (71 case reports/case series; 1 retrospective cohort study; 1926-2020) describing 451 cases of VL in pregnant women. The disease was detected during pregnancy in 398 (88.2%), retrospectively confirmed after giving birth in 52 (11.5%), and the time of identification was not clear in 1 (0.2%). Of the 398 pregnant women whose infection was identified during pregnancy, 346 (86.9%) received a treatment, 3 (0.8%) were untreated, and the treatment status was not clear in the remaining 49 (12.3%). Of 346 pregnant women, Liposomal amphotericin B (L-AmB) was administered in 202 (58.4%) and pentavalent antimony (PA) in 93 (26.9%). Outcomes were reported in 176 pregnant women treated with L-AmB with 4 (2.3%) reports of maternal deaths, 5 (2.8%) miscarriages, and 2 (1.1%) foetal death/stillbirth. For PA, outcomes were reported in 88 of whom 4 (4.5%) died, 24 (27.3%) had spontaneous abortion, 2 (2.3%) had miscarriages. A total of 26 cases of confirmed, probable or suspected cases of vertical transmission were identified with a median detection time of 6 months (range: 0-18 months). Conclusions: Outcomes of VL treatment during pregnancy is rarely reported and under-researched. The reported articles were mainly case reports and case series and the reported information was often incomplete. From the studies identified, it is difficult to derive a generalisable information on outcomes for pregnant women and babies, although reported data favours the usage of liposomal amphotericin B for the treatment of VL in pregnant women.
MeSH term(s)	Abortion, Spontaneous/epidemiology ; Amphotericin B/therapeutic use ; Antiprotozoal Agents/therapeutic use ; Female ; Humans ; Infectious Disease Transmission, Vertical/prevention & control ; Leishmaniasis, Visceral/complications ; Leishmaniasis, Visceral/drug therapy ; Leishmaniasis, Visceral/mortality ; Maternal Death ; Pregnancy ; Pregnancy Complications, Parasitic/drug therapy ; Pregnancy Complications, Parasitic/mortality ; Pregnancy Outcome/epidemiology ; Treatment Outcome
Chemical Substances	Antiprotozoal Agents ; liposomal amphotericin B ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2021-08-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	2429704-5
ISSN	1935-2735 ; 1935-2727
ISSN (online)	1935-2735
ISSN	1935-2727
DOI	10.1371/journal.pntd.0009650
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Visceral Leishmaniasis in pregnancy and vertical transmission

Prabin Dahal / Sauman Singh-Phulgenda / Brittany J Maguire / Eli Harriss / Koert Ritmeijer / Fabiana Alves / Philippe J Guerin / Piero L Olliaro

PLoS Neglected Tropical Diseases, Vol 15, Iss 8, p e

A systematic literature review on the therapeutic orphans.

2021 Volume 0009650

Abstract: Background Reports on the occurrence and outcome of Visceral Leishmaniasis (VL) in pregnant women is rare in published literature. The occurrence of VL in pregnancy is not systematically captured and cases are rarely followed-up to detect consequences of ...

Abstract	Background Reports on the occurrence and outcome of Visceral Leishmaniasis (VL) in pregnant women is rare in published literature. The occurrence of VL in pregnancy is not systematically captured and cases are rarely followed-up to detect consequences of infection and treatment on the pregnant women and foetus. Methods A review of all published literature was undertaken to identify cases of VL infections among pregnant women by searching the following database: Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials; World Health Organization Global Index Medicus: LILACS (Americas); IMSEAR (South-East Asia); IMEMR (Eastern Mediterranean); WPRIM (Western Pacific); ClinicalTrials.gov; and the WHO International Clinical Trials Registry Platform. Selection criteria included any clinical reports describing the disease in pregnancy or vertical transmission of the disease in humans. Articles meeting pre-specified inclusion criteria and non-primary research articles such as textbook, chapters, letters, retrospective case description, or reports of accidental inclusion in trials were also considered. Results The systematic literature search identified 272 unique articles of which 54 records were included in this review; a further 18 records were identified from additional search of the references of the included studies or from personal communication leading to a total of 72 records (71 case reports/case series; 1 retrospective cohort study; 1926-2020) describing 451 cases of VL in pregnant women. The disease was detected during pregnancy in 398 (88.2%), retrospectively confirmed after giving birth in 52 (11.5%), and the time of identification was not clear in 1 (0.2%). Of the 398 pregnant women whose infection was identified during pregnancy, 346 (86.9%) received a treatment, 3 (0.8%) were untreated, and the treatment status was not clear in the remaining 49 (12.3%). Of 346 pregnant women, Liposomal amphotericin B (L-AmB) was administered in 202 (58.4%) and ...
Keywords	Arctic medicine. Tropical medicine ; RC955-962 ; Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2021-08-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Eating Disorders In weight-related Therapy (EDIT) Collaboration: rationale and study design.

Nutrition research reviews

2023 , Page(s) 1–11

Abstract: The cornerstone of obesity treatment is behavioural weight management, resulting in significant improvements in cardio-metabolic and psychosocial health. However, there is ongoing concern that dietary interventions used for weight management may ... ...

Abstract	The cornerstone of obesity treatment is behavioural weight management, resulting in significant improvements in cardio-metabolic and psychosocial health. However, there is ongoing concern that dietary interventions used for weight management may precipitate the development of eating disorders. Systematic reviews demonstrate that, while for most participants medically supervised obesity treatment improves risk scores related to eating disorders, a subset of people who undergo obesity treatment may have poor outcomes for eating disorders. This review summarises the background and rationale for the formation of the Eating Disorders In weight-related Therapy (EDIT) Collaboration. The EDIT Collaboration will explore the complex risk factor interactions that precede changes to eating disorder risk following weight management. In this review, we also outline the programme of work and design of studies for the EDIT Collaboration, including expected knowledge gains. The EDIT studies explore risk factors and the interactions between them using individual-level data from international weight management trials. Combining all available data on eating disorder risk from weight management trials will allow sufficient sample size to interrogate our hypothesis: that individuals undertaking weight management interventions will vary in their eating disorder risk profile, on the basis of personal characteristics and intervention strategies available to them. The collaboration includes the integration of health consumers in project development and translation. An important knowledge gain from this project is a comprehensive understanding of the impact of weight management interventions on eating disorder risk.
Language	English
Publishing date	2023-02-15
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1003534-5
ISSN	1475-2700 ; 0954-4224
ISSN (online)	1475-2700
ISSN	0954-4224
DOI	10.1017/S0954422423000045
Database	MEDical Literature Analysis and Retrieval System OnLINE

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