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Article ; Online: Acute Olfactory Dysfunction-A Primary Presentation of COVID-19 Infection.

Brookes, Natalie R G / Fairley, James W / Brookes, Gerald B

2020 Volume 99, Issue 9, Page(s) 94–98

Abstract: ... the onset of nasal symptoms showed positive immunoglobulin G antibodies in 3 of the 4 patients. Acute severe ...

Abstract	COVID-19 is a zoonotic illness caused by a new strain of coronavirus and has recently been declared a pandemic by the World Health Organization, with an estimated fatality rate of 1% to 2%. Early identification and isolation of patients in the preliminary infective stage has been a mainstay of most governmental strategies in order to limit transmission. Four otherwise healthy patients presented to a specialist open access Ear, Nose & Throat Clinic in central London with acute total or subtotal loss of their sense of smell in a single one-week period, coinciding with rapid escalation of COVID-19 infection in the indigenous population. The diagnosis was confirmed by the validated University of Pennsylvania Smell Identification Test (UPSIT) in 3. Endoscopic examination and magnetic resonance imaging (2 cases) excluded a range of alternative potential pathological conditions. Covid-19 antibody testing carried out 6 to 8 weeks after the onset of nasal symptoms showed positive immunoglobulin G antibodies in 3 of the 4 patients. Acute severe anosmia is therefore almost certainly an unusual presenting local nasal feature of a COVID-19 viral infection. All 4 patients achieved significant partial olfactory recovery by one week after treatment with subjective ratings of 40% to 85% of normal (mean 60%) and complete olfaction recovery after 2 to 3 weeks in all 4 patients. The significance, possible pathogenesis, and public health implications are highlighted and discussed.
MeSH term(s)	Acute Disease ; Adult ; Antibodies, Viral ; Betacoronavirus ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques ; Coronavirus Infections/complications ; Coronavirus Infections/diagnosis ; Female ; Glucocorticoids/therapeutic use ; Humans ; Immunoglobulin G ; Male ; Olfaction Disorders/diagnosis ; Olfaction Disorders/drug therapy ; Olfaction Disorders/etiology ; Pandemics ; Pneumonia, Viral/complications ; Pneumonia, Viral/diagnosis ; Recovery of Function ; SARS-CoV-2
Chemical Substances	Antibodies, Viral ; Glucocorticoids ; Immunoglobulin G
Keywords	covid19
Language	English
Publishing date	2020-08-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	750153-5
ISSN	1942-7522 ; 0145-5613
ISSN (online)	1942-7522
ISSN	0145-5613
DOI	10.1177/0145561320940119
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Article: Acute Olfactory Dysfunction-A Primary Presentation of COVID-19 Infection

Brookes, Natalie R G / Fairley, James W / Brookes, Gerald B

Ear Nose Throat J

Abstract: ... the onset of nasal symptoms showed positive immunoglobulin G antibodies in 3 of the 4 patients. Acute severe ...

Abstract	COVID-19 is a zoonotic illness caused by a new strain of coronavirus and has recently been declared a pandemic by the World Health Organization, with an estimated fatality rate of 1% to 2%. Early identification and isolation of patients in the preliminary infective stage has been a mainstay of most governmental strategies in order to limit transmission. Four otherwise healthy patients presented to a specialist open access Ear, Nose & Throat Clinic in central London with acute total or subtotal loss of their sense of smell in a single one-week period, coinciding with rapid escalation of COVID-19 infection in the indigenous population. The diagnosis was confirmed by the validated University of Pennsylvania Smell Identification Test (UPSIT) in 3. Endoscopic examination and magnetic resonance imaging (2 cases) excluded a range of alternative potential pathological conditions. Covid-19 antibody testing carried out 6 to 8 weeks after the onset of nasal symptoms showed positive immunoglobulin G antibodies in 3 of the 4 patients. Acute severe anosmia is therefore almost certainly an unusual presenting local nasal feature of a COVID-19 viral infection. All 4 patients achieved significant partial olfactory recovery by one week after treatment with subjective ratings of 40% to 85% of normal (mean 60%) and complete olfaction recovery after 2 to 3 weeks in all 4 patients. The significance, possible pathogenesis, and public health implications are highlighted and discussed.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #695367
Database	COVID19

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Article ; Online: Acute Olfactory Dysfunction—A Primary Presentation of COVID-19 Infection

Brookes, Natalie R. G. / Fairley, James W. / Brookes, Gerald B.

Ear, Nose & Throat Journal

2020 Volume 99, Issue 9, Page(s) 94–98

Abstract: ... the onset of nasal symptoms showed positive immunoglobulin G antibodies in 3 of the 4 patients. Acute severe ...

Abstract	COVID-19 is a zoonotic illness caused by a new strain of coronavirus and has recently been declared a pandemic by the World Health Organization, with an estimated fatality rate of 1% to 2%. Early identification and isolation of patients in the preliminary infective stage has been a mainstay of most governmental strategies in order to limit transmission. Four otherwise healthy patients presented to a specialist open access Ear, Nose & Throat Clinic in central London with acute total or subtotal loss of their sense of smell in a single one-week period, coinciding with rapid escalation of COVID-19 infection in the indigenous population. The diagnosis was confirmed by the validated University of Pennsylvania Smell Identification Test (UPSIT) in 3. Endoscopic examination and magnetic resonance imaging (2 cases) excluded a range of alternative potential pathological conditions. Covid-19 antibody testing carried out 6 to 8 weeks after the onset of nasal symptoms showed positive immunoglobulin G antibodies in 3 of the 4 patients. Acute severe anosmia is therefore almost certainly an unusual presenting local nasal feature of a COVID-19 viral infection. All 4 patients achieved significant partial olfactory recovery by one week after treatment with subjective ratings of 40% to 85% of normal (mean 60%) and complete olfaction recovery after 2 to 3 weeks in all 4 patients. The significance, possible pathogenesis, and public health implications are highlighted and discussed.
Keywords	Otorhinolaryngology ; covid19
Language	English
Publisher	SAGE Publications
Publishing country	us
Document type	Article ; Online
ZDB-ID	750153-5
ISSN	1942-7522 ; 0145-5613
ISSN (online)	1942-7522
ISSN	0145-5613
DOI	10.1177/0145561320940119
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development.

Brookes, Sara T / Macefield, Rhiannon C / Williamson, Paula R / McNair, Angus G / Potter, Shelley / Blencowe, Natalie S / Strong, Sean / Blazeby, Jane M

Trials

2016 Volume 17, Issue 1, Page(s) 409

Abstract: Background: Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in ...

Abstract	Background: Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Methods: Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Results: Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3-22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65-82 % agreement for peer-only feedback versus 74-94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. Conclusions: In the development of a core outcome or information set, providing feedback within Delphi questionnaires from all stakeholder groups separately may influence the final core set and improve consensus between the groups. Further work is needed to better understand how participants rate and re-rate items within a Delphi process. Trial registration: The three randomized controlled trials reported here were each nested within the development of a core information or outcome set to investigate processes in core outcome and information set development. Outcomes were not health-related and therefore trial registration was not applicable.
MeSH term(s)	Aged ; Attitude of Health Personnel ; Colorectal Neoplasms/surgery ; Consensus ; Cooperative Behavior ; Delphi Technique ; Esophageal Neoplasms/surgery ; Feedback, Psychological ; Female ; Health Personnel/psychology ; Humans ; Interdisciplinary Communication ; Length of Stay ; Male ; Mammaplasty ; Middle Aged ; Patients/psychology ; Peer Group ; Postoperative Complications/etiology ; Research Design ; Stakeholder Participation/psychology ; Surveys and Questionnaires ; Treatment Outcome ; Wound Healing
Language	English
Publishing date	2016-08-17
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-016-1479-x
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Article ; Online: Standards of outcome reporting in surgical oncology: a case study in esophageal cancer.

Blencowe, Natalie S / McNair, Angus G K / Davis, Christopher R / Brookes, Sara T / Blazeby, Jane M

Annals of surgical oncology

2012 Volume 19, Issue 13, Page(s) 4012–4018

Abstract: Background: Multimodal strategies before surgery are often used to improve outcomes, but disease progression (precluding surgical resection) and inoperability at planned surgery still occur following neoadjuvant treatment. The standards of reporting of ... ...

Abstract	Background: Multimodal strategies before surgery are often used to improve outcomes, but disease progression (precluding surgical resection) and inoperability at planned surgery still occur following neoadjuvant treatment. The standards of reporting of these outcomes have not previously been considered. This study examined reporting of rates of progression to surgical resection and inoperability at planned surgery following neoadjuvant treatment in surgical oncology, using esophageal cancer as a case study. Methods: A systematic review identified randomized trials and prospective nonrandomized studies reporting short-term outcomes of neoadjuvant treatment and surgery for esophageal cancer. Results: Of 4,763 abstracts, 224 papers were retrieved and 76 studies included (8 randomized trials and 68 cohort studies of 19,441 esophagectomies). Articles reported outcomes of preoperative chemotherapy (n = 33, 43.4 %), chemoradiotherapy (n = 13, 17.1 %), or both within one paper (n = 18, 23.7 %) and 12 (15.8 %) did not specify the type of neoadjuvant treatment. Also, 20 papers (26.3 %) reported numbers of patients not progressing to surgery after neoadjuvant treatment (with rates of nonprogression ranging between 2.0 and 35.3 %). In addition, 24 papers (31.6 %) reported rates of inoperability at planned surgery (with inoperability rates ranging between 0 and 26.2 %). More randomized controlled trials (RCTs) than observational studies reported nonprogression (4 randomized and 16 nonrandomized studies, 95 % CI -9.6 to 62.6 %, p = 0.108) and inoperability (6 randomized trials and 18 observational studies, 95 % CI 16.8-80.3 %, p = 0.005). Some 17 and 10 articles provided reasons for the observed rates of nonprogression and inoperability, respectively. Conclusions: Reporting rates of progression to surgery after neoadjuvant treatment and inoperability at planned surgery for esophageal cancer were poor, limiting data synthesis and comparisons. It is suggested that core outcome sets for trials in surgical oncology are developed with inclusion of these important endpoints. Collaboration between medical and surgical oncologists is necessary to achieve this.
MeSH term(s)	Clinical Trials as Topic ; Combined Modality Therapy ; Esophageal Neoplasms/surgery ; Esophageal Neoplasms/therapy ; Esophagectomy/standards ; Humans ; Neoadjuvant Therapy ; Outcome Assessment, Health Care ; Practice Guidelines as Topic/standards ; Review Literature as Topic
Language	English
Publishing date	2012-07-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1200469-8
ISSN	1534-4681 ; 1068-9265
ISSN (online)	1534-4681
ISSN	1068-9265
DOI	10.1245/s10434-012-2497-x
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Article ; Online: Intravenous iron is non-inferior to oral iron regarding cell growth and iron metabolism in colorectal cancer associated with iron-deficiency anaemia.

Al-Hassi, Hafid O / Ng, Oliver / Evstatiev, Rayko / Mangalika, Manel / Worton, Natalie / Jambrich, Manuela / Khare, Vineeta / Phipps, Oliver / Keeler, Barrie / Gasche, Christoph / Acheson, Austin G / Brookes, Matthew J

Scientific reports

2021 Volume 11, Issue 1, Page(s) 13699

Abstract: Oral iron promotes intestinal tumourigenesis in animal models. In humans, expression of iron transport proteins are altered in colorectal cancer. This study examined whether the route of iron therapy alters iron transport and tumour growth. Colorectal ... ...

Abstract	Oral iron promotes intestinal tumourigenesis in animal models. In humans, expression of iron transport proteins are altered in colorectal cancer. This study examined whether the route of iron therapy alters iron transport and tumour growth. Colorectal adenocarcinoma patients with pre-operative iron deficiency anaemia received oral ferrous sulphate (n = 15), or intravenous ferric carboxymaltose (n = 15). Paired (normal and tumour tissues) samples were compared for expression of iron loading, iron transporters, proliferation, apoptosis and Wnt signalling using immunohistochemistry and RT-PCR. Iron loading was increased in tumour and distributed to the stroma in intravenous treatment and to the epithelium in oral treatment. Protein and mRNA expression of proliferation and iron transporters were increased in tumours compared to normal tissues but there were no significant differences between the treatment groups. However, intravenous iron treatment reduced ferritin mRNA levels in tumours and replenished body iron stores. Iron distribution to non-epithelial cells in intravenous iron suggests that iron is less bioavailable to tumour cells. Therefore, intravenous iron may be a better option in the treatment of colorectal cancer patients with iron deficiency anaemia due to its efficiency in replenishing iron levels while its effect on proliferation and iron metabolism is similar to that of oral iron treatment.
MeSH term(s)	Administration, Intravenous ; Administration, Oral ; Aged ; Aged, 80 and over ; Anemia, Iron-Deficiency/complications ; Anemia, Iron-Deficiency/metabolism ; Anemia, Iron-Deficiency/therapy ; Cell Proliferation/drug effects ; Colorectal Neoplasms/complications ; Colorectal Neoplasms/metabolism ; Colorectal Neoplasms/therapy ; Female ; Ferric Compounds/administration & dosage ; Ferric Compounds/therapeutic use ; Ferrous Compounds/administration & dosage ; Ferrous Compounds/therapeutic use ; Humans ; Iron/metabolism ; Male ; Maltose/administration & dosage ; Maltose/analogs & derivatives ; Maltose/therapeutic use ; Middle Aged
Chemical Substances	Ferric Compounds ; Ferrous Compounds ; ferrous sulfate (39R4TAN1VT) ; ferric carboxymaltose (6897GXD6OE) ; Maltose (69-79-4) ; Iron (E1UOL152H7)
Language	English
Publishing date	2021-07-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-93155-2
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Article ; Online: Efficacy of Nivolumab in Pediatric Cancers with High Mutation Burden and Mismatch Repair Deficiency.

Das, Anirban / Tabori, Uri / Sambira Nahum, Lauren C / Collins, Natalie B / Deyell, Rebecca / Dvir, Rina / Faure-Conter, Cecile / Hassall, Timothy E / Minturn, Jane E / Edwards, Melissa / Brookes, Elissa / Bianchi, Vanessa / Levine, Adrian / Stone, Simone C / Sudhaman, Sumedha / Sanchez Ramirez, Santiago / Ercan, Ayse B / Stengs, Lucie / Chung, Jill /

Negm, Logine / Getz, Gad / Maruvka, Yosef E / Ertl-Wagner, Birgit / Ohashi, Pamela S / Pugh, Trevor / Hawkins, Cynthia / Bouffet, Eric / Morgenstern, Daniel A

Clinical cancer research : an official journal of the American Association for Cancer Research

2023 Volume 29, Issue 23, Page(s) 4770–4783

Abstract: Purpose: Checkpoint inhibitors have limited efficacy for children with unselected solid and brain tumors. We report the first prospective pediatric trial (NCT02992964) using nivolumab exclusively for refractory nonhematologic cancers harboring tumor ... ...

Abstract	Purpose: Checkpoint inhibitors have limited efficacy for children with unselected solid and brain tumors. We report the first prospective pediatric trial (NCT02992964) using nivolumab exclusively for refractory nonhematologic cancers harboring tumor mutation burden (TMB) ≥5 mutations/megabase (mut/Mb) and/or mismatch repair deficiency (MMRD). Patients and methods: Twenty patients were screened, and 10 were ultimately included in the response cohort of whom nine had TMB >10 mut/Mb (three initially eligible based on MMRD) and one patient had TMB between 5 and 10 mut/Mb. Results: Delayed immune responses contributed to best overall response of 50%, improving on initial objective responses (20%) and leading to 2-year overall survival (OS) of 50% [95% confidence interval (CI), 27-93]. Four children, including three with refractory malignant gliomas are in complete remission at a median follow-up of 37 months (range, 32.4-60), culminating in 2-year OS of 43% (95% CI, 18.2-100). Biomarker analyses confirmed benefit in children with germline MMRD, microsatellite instability, higher activated and lower regulatory circulating T cells. Stochastic mutation accumulation driven by underlying germline MMRD impacted the tumor microenvironment, contributing to delayed responses. No benefit was observed in the single patient with an MMR-proficient tumor and TMB 7.4 mut/Mb. Conclusions: Nivolumab resulted in durable responses and prolonged survival for the first time in a pediatric trial of refractory hypermutated cancers including malignant gliomas. Novel biomarkers identified here need to be translated rapidly to clinical care to identify children who can benefit from checkpoint inhibitors, including upfront management of cancer. See related commentary by Mardis, p. 4701.
MeSH term(s)	Humans ; Child ; Nivolumab/therapeutic use ; Prospective Studies ; Mutation ; Brain Neoplasms/drug therapy ; Brain Neoplasms/genetics ; Brain Neoplasms/pathology ; Glioma/drug therapy ; Glioma/genetics ; Glioma/pathology ; Biomarkers, Tumor/genetics ; DNA Mismatch Repair/genetics ; Tumor Microenvironment
Chemical Substances	Nivolumab (31YO63LBSN) ; Biomarkers, Tumor
Language	English
Publishing date	2023-05-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-23-0411
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Article ; Online: Intravenous iron is non-inferior to oral iron regarding cell growth and iron metabolism in colorectal cancer associated with iron-deficiency anaemia

Hafid O. Al-Hassi / Oliver Ng / Rayko Evstatiev / Manel Mangalika / Natalie Worton / Manuela Jambrich / Vineeta Khare / Oliver Phipps / Barrie Keeler / Christoph Gasche / Austin G. Acheson / Matthew J. Brookes

Scientific Reports, Vol 11, Iss 1, Pp 1-

2021 Volume 12

Abstract: Abstract Oral iron promotes intestinal tumourigenesis in animal models. In humans, expression of iron transport proteins are altered in colorectal cancer. This study examined whether the route of iron therapy alters iron transport and tumour growth. ... ...

Abstract	Abstract Oral iron promotes intestinal tumourigenesis in animal models. In humans, expression of iron transport proteins are altered in colorectal cancer. This study examined whether the route of iron therapy alters iron transport and tumour growth. Colorectal adenocarcinoma patients with pre-operative iron deficiency anaemia received oral ferrous sulphate (n = 15), or intravenous ferric carboxymaltose (n = 15). Paired (normal and tumour tissues) samples were compared for expression of iron loading, iron transporters, proliferation, apoptosis and Wnt signalling using immunohistochemistry and RT-PCR. Iron loading was increased in tumour and distributed to the stroma in intravenous treatment and to the epithelium in oral treatment. Protein and mRNA expression of proliferation and iron transporters were increased in tumours compared to normal tissues but there were no significant differences between the treatment groups. However, intravenous iron treatment reduced ferritin mRNA levels in tumours and replenished body iron stores. Iron distribution to non-epithelial cells in intravenous iron suggests that iron is less bioavailable to tumour cells. Therefore, intravenous iron may be a better option in the treatment of colorectal cancer patients with iron deficiency anaemia due to its efficiency in replenishing iron levels while its effect on proliferation and iron metabolism is similar to that of oral iron treatment.
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2021-07-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Book ; Online: Author response

Rivett, Lucy / Sridhar, Sushmita / Sparkes, Dominic / Routledge, Matthew / Jones, Nick K / Forrest, Sally / Young, Jamie / Pereira-Dias, Joana / Hamilton, William L / Ferris, Mark / Torok, M Estee / Meredith, Luke / Gupta, Ravi / Lyons, Paul A / Toshner, Mark / Warne, Ben / Bartholdson Scott, Josefin / Cormie, Claire / Gill, Harmeet /

Kean, Iain / Maes, Mailis / Reynolds, Nicola / Wantoch, Michelle / Caddy, Sarah / Caller, Laura / Feltwell, Theresa / Hall, Grant / Hosmillo, Myra / Houldcroft, Charlotte / Jahun, Aminu / Khokhar, Fahad / Yakovleva, Anna / Butcher, Helen / Caputo, Daniela / Clapham-Riley, Debra / Dolling, Helen / Furlong, Anita / Graves, Barbara / Gresley, Emma Le / Kingston, Nathalie / Papadia, Sofia / Stark, Hannah / Stirrups, Kathleen E / Webster, Jennifer / Calder, Joanna / Harris, Julie / Hewitt, Sarah / Kennet, Jane / Meadows, Anne / Rastall, Rebecca / Brien, Criona O / Price, Jo / Publico, Cherry / Rowlands, Jane / Ruffolo, Valentina / Tordesillas, Hugo / Brookes, Karen / Canna, Laura / Cruz, Isabel / Dempsey, Katie / Elmer, Anne / Escoffery, Naidine / Jones, Heather / Ribeiro, Carla / Saunders, Caroline / Wright, Angela / Nyagumbo, Rutendo / Roberts, Anne / Bucke, Ashlea / Hargreaves, Simone / Johnson, Danielle / Narcorda, Aileen / Read, Debbie / Sparke, Christian / Warboys, Lucy / Lagadu, Kirsty / Mactavous, Lenette / Gould, Tim / Raine, Tim / Mather, Claire / Ramenatte, Nicola / Vallier, Anne-Laure / Kasanicki, Mary / Eames, Penelope-Jane / McNicholas, Chris / Thake, Lisa / Bartholomew, Neil / Brown, Nick / Parmar, Surendra / Zhang, Hongyi / Bowring, Ailsa / Martell, Geraldine / Quinnell, Natalie / Wright, Jo / Murphy, Helen / Dunmore, Benjamin J / Legchenko, Ekaterina / Gräf, Stefan / Huang, Christopher / Hodgson, Josh / Hunter, Kelvin / Martin, Jennifer / Mescia, Federica / O'Donnell, Ciara / Pointon, Linda / Shih, Joy / Sutcliffe, Rachel / Tilly, Tobias / Tong, Zhen / Treacy, Carmen / Wood, Jennifer / Bergamaschi, Laura / Betancourt, Ariana / Bowyer, Georgie / De Sa, Aloka / Epping, Maddie / Hinch, Andrew / Huhn, Oisin / Jarvis, Isobel / Lewis, Daniel / Marsden, Joe / McCallum, Simon / Nice, Francescsa / Curran, Martin D / Fuller, Stewart / Chaudhry, Afzal / Shaw, Ashley / Samworth, Richard J / Bradley, John R / Dougan, Gordon / Smith, Kenneth GC / Lehner, Paul J / Matheson, Nicholas J / Wright, Giles / Goodfellow, Ian G / Baker, Stephen / Weekes, Michael P

Screening of healthcare workers for SARS-CoV-2 highlights the role of asymptomatic carriage in COVID-19 transmission

2020

Keywords	covid19
Publisher	eLife Sciences Publications, Ltd
Publishing country	uk
Document type	Book ; Online
DOI	10.7554/elife.58728.sa2
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: 'Trial Exegesis'

Angus G K McNair / Rhiannon C Macefield / Natalie S Blencowe / Sara T Brookes / Jane M Blazeby

PLoS ONE, Vol 11, Iss 8, p e

Methods for Synthesizing Clinical and Patient Reported Outcome (PRO) Data in Trials to Inform Clinical Practice. A Systematic Review.

2016 Volume 0160998

Abstract: PURPOSE:The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized ... ...

Abstract	PURPOSE:The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice. MATERIALS AND METHODS:The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. RESULTS:From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). CONCLUSION:It is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2016-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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