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1. Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial

Author

Paul R Kalra, John G F Cleland, Mark C Petrie, Elizabeth A Thomson, Philip A Kalra, Iain B Squire, Fozia Z Ahmed, Abdallah Al-Mohammad, Peter J Cowburn, Paul W X Foley, Fraser J Graham, Alan G Japp, Rebecca E Lane, Ninian N Lang, Andrew J Ludman, Iain C Macdougall, Pierpaolo Pellicori, Robin Ray, Michele Robertson, Alison Seed, Ian Ford, John GF Cleland, Paul WX Foley, Nicholas Boon, Shannon Amoils, Callum Chapman, Thomas G Diness, John McMurray, Richard Mindham, Pamela Sandu, Claes C Strom, Maureen Travers, Robert Wilcox, Allan Struthers, Patrick Mark, Christopher Weir, Elena Cowan, Charlotte Turner, Rosalynn Austin, Paula Rogers, Badri Chandrasekaran, Eva Fraile, Lynsey Kyeremeh, Lorraine McGregor, Joanna Osmanska, Barbara Meyer, Faheem Ahmad, Jude Fisher, Christina Summersgill, Katarzyna Adeniji, Rajkumar Chinnadurai, Lisa Massimo, Clare Hardman, Daisy Sykes, Sarah Frank, Simon Smith, Mohamed Anwar, Beth Whittington, Vennessa Sookhoo, Sinead Lyons, Janet Middle, Kay Housley, Andrew Clark, Jeanne Bulemfu, Christopher Critoph, Victor Chong, Stephen Wood, Benjamin Szwejkowski, Chim Lang, Jackie Duff, Susan MacDonald, Rebekah Schiff, Patrick Donnelly, Thuraia Nageh, Swapna Kunhunny, Roy Gardner, Marion McAdam, Elizabeth McPherson, Prithwish Banerjee, Eleanor Sear, Nigel Edwards, Jason Glover, Clare Murphy, Justin Cooke, Charles Spencer, Mark Francis, Iain Matthews, Hayley McKie, Andrew Marshall, Janet Large, Jenny Stratford, Piers Clifford, Christopher Boos, Philip Keeling, Debbie Hughes, Aaron Wong, Deborah Jones, Alex James, Rhys Williams, Stephen Leslie, Jim Finlayson, Andrew Hannah, Philip Campbell, John Walsh, Jane Quinn, Susan Piper, Sheetal Patale, Preeti Gupta, Victor Sim, Lucy Knibbs, Kristopher Lyons, Lana Dixon, Colin Petrie, Yuk-ki Wong, Catherine Labinjoh, Simon Duckett, Ian Massey, Henry Savage, Sofia Matias, Jonaifah Ramirez, Charlotte Manisty, Ifza Hussain, Rajiv Sankaranarayanan, Gershan Davis, Samuel McClure, John Baxter, Eleanor Wicks, Jolanta Sobolewska, Jerry Murphy, Ahmed Elzayat, Alastair Cooke, Jay Wright, Simon Williams, Amal Muthumala, Parminder Chaggar, Sue Webber, Gethin Ellis, Mandie Welch, Sudantha Bulugahapitiya, Thomas Jackson, Tapesh Pakrashi, Ameet Bakhai, Vinodh Krishnamurthy, Reto Gamma, Susan Ellery, Geraint Jenkins, Gladdys Thomas, Angus Nightingale, Nicola Greenlaw, Kirsty Wetherall, Ross Clarke, Christopher Graham, Sharon Kean, Alan Stevenson, Robbie Wilson, Sarah Boyle, John McHugh, Lisa Hall, Joanne Woollard, Claire Brunton, Eleanor Dinnett, Amanda Reid, Serena Howe, Jill Nicholls, Anna Cunnington, Elizabeth Douglas, Margaret Fegen, Marc Jones, Sheila McGowan, Barbara Ross, Pamela Surtees, and Debra Stuart

Subjects
General Medicine
Published
2022

2. Effect of Corneal Cross-linking versus Standard Care on Keratoconus Progression in Young Patients

Author

Daniel F.P. Larkin, Kashfia Chowdhury, Jennifer M. Burr, Mathew Raynor, Matthew Edwards, Stephen J. Tuft, Catey Bunce, Emilia Caverly, Caroline Doré, Susmito Biswas, Jennifer Burr, Lisa French, Stephen Kaye, Anne Klepacz, Dimitra Kopsini, Frank Larkin, Stephen Tuft, Sue Webber, and Colin Willoughbys

Subjects
medicine.medical_specialty, Keratoconus, Randomization, Visual acuity, genetic structures, medicine.medical_treatment, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Ophthalmology, Cornea, medicine, Corneal transplantation, 030304 developmental biology, 0303 health sciences, business.industry, Odds ratio, medicine.disease, eye diseases, Contact lens, medicine.anatomical_structure, 030221 ophthalmology & optometry, sense organs, medicine.symptom, business
Abstract

Purpose To examine the efficacy and safety of corneal cross-linking (CXL) for stabilization of progressive keratoconus. Design Observer-masked, randomized, controlled, parallel-group superiority trial. Participants Sixty participants 10 to 16 years of age with progressive keratoconus, one eye of each deemed the study eye. Methods The study eye was randomized to either CXL plus standard care or standard care alone, with spectacle or contact lens correction as necessary for vision. Main Outcome Measures The primary outcome was steep keratometry (K2) in the study eye as a measure of the steepness of the cornea at 18 months. Secondary outcomes included keratoconus progression defined as a 1.5-diopter (D) increase in K2, visual acuity, keratoconus apex corneal thickness, and quality of life. Results Of 60 participants, 30 were randomized to CXL and standard care groups. Of these, 30 patients in the CXL group and 28 patients in the standard care group were analyzed. Mean K2 in the study eye 18 months after randomization was 49.7 D (standard deviation [SD], 3.8 D) in the CXL group and 53.4 D (SD, 5.8 D) in the standard care group. The adjusted mean difference in K2 in the study eye was –3.0 D (95% confidence interval [CI], –4.9 to –1.1 D; P = 0.002), favoring CXL. Adjusted differences between groups in uncorrected and corrected vision favored eyes receiving CXL: –0.31 logarithm of the minimum angle of resolution (logMAR; 95% CI, –0.50 to –0.11 logMAR; P = 0.002) and –0.51 logMAR (95% CI, –1.37 to 0.35 logMAR; P = 0.002). Keratoconus progression in the study eye occurred in 2 patients (7%) randomized to CXL compared with 12 patients (43%) randomized to standard care. The unadjusted odds ratio suggests that on average, patients in the CXL arm had 90% (odds ratio, 0.1; 95% CI, 0.02–0.48; P = 0.004) lower odds of experiencing progression compared with those receiving standard care. Conclusions CXL arrests progression of keratoconus in the majority of young patients. CXL should be considered as a first-line treatment in progressive disease. If the arrest of keratoconus progression induced by CXL is sustained in longer follow-up, particular benefit may be derived from avoiding a later requirement for contact lens wear or corneal transplantation.

Published
2021

3. Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage: a randomised, open-label, assessor-blinded, pilot phase, non-inferiority trial

Author

Rustam Al-Shahi Salman, Catriona Keerie, Jacqueline Stephen, Steff Lewis, John Norrie, Martin S. Dennis, David E. Newby, Joanna M. Wardlaw, Gregory Y.H. Lip, Adrian Parry-Jones, Philip M. White, Colin Baigent, Dan Lasserson, Colin Oliver, Fiach O'Mahony, Shannon Amoils, John Bamford, Jane Armitage, Jonathan Emberson, Gabriël J.R. Rinkel, Gordon Lowe, Karen Innes, Kasia Adamczuk, Lynn Dinsmore, Jonathan Drever, Garry Milne, Allan Walker, Aidan Hutchison, Carol Williams, Ruth Fraser, Rosemary Anderson, Kate Covil, Kelly Stewart, Jessica Rees, Peter Hall, Alistair Bullen, Andrew Stoddart, Tom J. Moullaali, Jeb Palmer, Eleni Sakka, Joanne Perthen, Nicola Lyttle, Neshika Samarasekera, Allan MacRaild, Seona Burgess, Jessica Teasdale, Michelle Coakley, Pat Taylor, Gordon Blair, William Whiteley, Susan Shenkin, Una Clancy, Malcolm Macleod, Rachel Sutherland, Tom Moullaali, Amanda Barugh, Christine Lerpiniere, Fiona Moreton, Nicholas Fethers, Tal Anjum, Manju Krishnan, Peter Slade, Sharon Storton, Marie Williams, Caroline Davies, Lynda Connor, Glyn Gainard, Carl Murphy, Mark Barber, Derek Esson, James Choulerton, Louise Shaw, Suzanne Lucas, Sarah Hierons, Joanne Avis, Andrew Stone, Lukuman Gbadamoshi, Telma Costa, Lauren Pearce, Kirsty Harkness, Emma Richards, Jo Howe, Christine Kamara, Ralf Lindert, Ali Ali, Jahanzeb Rehan, Sarah Chapman, Maria Edwards, Raj Bathula, David Cohen, Joseph Devine, Mushiya Mpelembue, Priya Yesupatham, Swati Chhabra, Gbadebo Adewetan, Robert Ballantine, Daniel Brooks, Gemma Smith, Gill Rogers, Stuart Marsden, Sarah Clark, Ami Wilkinson, Ellen Brown, Lynsey Stephenson, Khin Nyo, Annie Abraham, Yogish Pai, Gek Shim, Vidya Baliga, Anand Nair, Matthew Robinson, Catherine Hawksworth, Jill Greig, Irfan Alam, Tonicha Nortcliffe, Ridha Ramiz, Ryan Shaw, Stephanie Lee, Tracy Marsden, Jane Perez, Emily Birleson, Rajendra Yadava, Mirriam Sangombe, Sam Stafford, Tom Hughes, Lucy Knibbs, Bethan Morse, Stefan Schwarz, Benjamin Jelley, Susan White, Bella Richard, Heidi Lawson, Sally Moseley, Michelle Tayler, Mandy Edwards, Claire Triscott, Rebecca Wallace, Angela Hall, Amanda Dell, Khalid Rashed, Sarah Board, Clare Buckley, Alfonso Tanate, Tressy Pitt-Kerby, Kate Beesley, Jess Perry, Christine Hellyer, Paul Guyler, Nisha Menon, Sharon Tysoe, Raji Prabakaran, Martin Cooper, Anoja Rajapakse, Inez Wynter, Susan Smith, Nic Weir, Cherish Boxall, Hannah Yates, Simon Smith, Pamela Crawford, James Marigold, Fiona Smith, Jake Harvey, Sue Evans, Laura Baldwin, Sarah Hammond, Paul Mudd, Angela Bowring, Samantha Keenan, Kevin Thorpe, Mohammad Haque, Joanne Taaffe, Natalie Temple, Tracey Peachey, Kim Wells, Fiona Haines, Nicola Butterworth-Cowin, Zoey Horne, Radim Licenik, Hayley Boughton, Timothy England, Amanda Hedstrom, Brian Menezes, Ruth Davies, Venetia Johnson, Simon Whittingham-Jones, David Werring, Sabaa Obarey, Caroline Watchurst, Amy Ashton, Shez Feerick, Nina Francia, Azra Banaras, Daniel Epstein, Marilena Marinescu, Annick Williams, Anna Robinson, Fiona Humphries, Ijaz Anwar, Arunkumar Annamalai, Susan Crawford, Vicky Collins, Lorna Shepherd, Elaine Siddle, Justin Penge, Sam Qureshi, Vinodh Krishnamurthy, Vasileios Papavasileiou, Dean Waugh, Emelda Veraque, Nathan Douglas, Numan Khan, Sankaranarayanan Ramachandran, Peter Sommerville, Anthony Rudd, Sagal Kullane, Ajay Bhalla, Jonathan Birns, Rowshanara Ahmed, Meegan Gibbons, Eva Klamerus, Benjie Cendreda, Keith Muir, Nicola Day, Angela Welch, Wilma Smith, Jennifer Elliot, Salwa Eltawil, Ammad Mahmood, Kim Hatherley, Shirley Mitchell, Harjit Bains, Lauren Quinn, Rachel Teal, Ivie Gbinigie, George Harston, Phil Mathieson, Gary Ford, Ursula Schulz, James Kennedy, Kirubananthan Nagaratnam, Kiran Bangalore, Neelima Bhupathiraju, Chris Wharton, Ken Fotherby, Ahmad Nasar, Angie Stevens, Angela Willberry, Rachel Evans, Baljinder Rai, Chloe Blake, Kamy Thavanesan, Gail Hann, Tanith Changuion, Sara Nix, Amanda Whiting, Michelle Dharmasiri, Louise Mallon, Marketa Keltos, Nigel Smyth, Charlotte Eglinton, John Duffy, Ela Tone, Lucy Sykes, Emily Porter, Carolyn Fitton, Nikolaos Kirkineziadis, Gillian Cluckie, Kate Kennedy, Sarah Trippier, Rebecca Williams, Elizabeth Hayter, James Rackie, Bhavini Patel, Ghatala Rita, Adrian Blight, Val Jones, Liqun Zhang, Lillian Choy, Anthony Pereira, Brian Clarke, Samer Al-Hussayni, Lynn Dixon, Andrew Young, Adrian Bergin, David Broughton, Senthil Raghunathan, Benjamin Jackson, Jason Appleton, Gwendoline Wilkes, Amanda Buck, Carla Richardson, Judith Clarke, Lucy Fleming, Gemma Squires, Zhe Law, Camille Hutchinson, Vera Cvoro, Mandy Couser, Amanda McGregor, Sean McAuley, Susan Pound, Patricia Cochrane, Clare Holmes, Peter Murphy, Nicola Devitt, Mairead Osborn, Amy Steele, Lucy Belle Guthrie, Elizabeth Smith, Jonathan Hewitt, Natalie Chaston, Min Myint, Andrew Smith, Louise Fairlie, Michelle Davis, Beth Atkinson, Stephen Woodward, Valerie Hogg, Michelle Fawcett, Louise Finlay, Anand Dixit, Eleanor Cameron, Breffni Keegan, Jim Kelly, Dónal Concannon, Dipankar Dutta, Deborah Ward, Jon Glass, Susan O'Connell, Joseph Ngeh, Alison O'Kelly, Emma Williams, Suzanne Ragab, Damian Jenkinson, Judith Dube, Laura Gleave, Jacqui Leggett, Nisha Kissoon, Louise Southern, Utpal Naghotra, Maria Bokhari, Beverley McClelland, Katja Adie, Abhijit Mate, Frances Harrington, Ali James, Elizabeth Swanson, Terri Chant, Miriam Naccache, Abbie Coutts, Gillian Courtauld, Sarah Whurr, Sue Webber, Emily Shead, Robert Luder, Maneesh Bhargava, Elodie Murali, Larissa Cuenoud, Kath Pasco, O Speirs, Lianne Chapman, Linda Inskip, Lisa Kavanagh, Meena Srinivasan, Nichola Motherwell, Indranil Mukherjee, Louise Tonks, Denise Donaldson, Heather Button, Rebecca Wilcox, Fran Hurford, Rachel Logan, Andy Taylor, Tracie Arden, Michael Carpenter, Prabal Datta, Tajammal Zahoor, Linda Jackson, Ann Needle, Andrew Stanners, Imran Ghouri, Donna Exley, Salman Akhtar, Hollie Brooke, Shannen Beadle, Eoin O'Brien, Jobbin Francis, Joanne McGee, Elaine Amis, Jennifer Mitchell, Sarah Finlay, Devesh Sinha, Csilla Manoczki, Sam King, James Tarka, Sumita Choudhary, Jegamalini Premaruban, Dorothy Sutton, Pradeep Kumar, Charlotte Culmsee, Caroline Winckley, Holly Davies, Hilary Thatcher, Evangelos Vasileiadis, Basaam Aweid, Melinda Holden, Cathy Mason, Thant Hlaing, Gladys Madzamba, Tanya Ingram, Michelle Linforth, Claire Cullen, Nibu Thomas, John France, Afaq Saulat, Biju Bhaskaran, Pauline Fitzell, Kathleen Horan, Catherine Manyoni, Josie Garfield-Smith, Hannah Griffin, Stacey Atkins, Joan Redome, Girish Muddegowda, Holly Maguire, Adrian Barry, Nenette Abano, Resti Varquez, Joanne Hiden, Susan Lyjko, Alda Remegoso, Kay Finney, Adrian Butler, Martin Strecker, Mary Joan MaCleod, Janice Irvine, Sandra Nelson, German Guzmangutierrez, Jacqueline Furnace, Vicky Taylor, Hawraman Ramadan, Kim Storton, Sohail Hassan, Eman Abdus Sami, Ruth Bellfield, Kelvin Stewart, Outi Quinn, Chris Patterson, Hedley Emsley, Bindu Gregary, Shakeel Ahmed, Shakeelah Patel, Sonia Raj, Sulaiman Sultan, Fiona Wright, Peter Langhorne, Ruth Graham, Terry Quinn, and Kate McArthur

Subjects
Adult, medicine.medical_specialty, Adolescent, medicine.drug_class, Population, Minimisation (clinical trials), Intracranial haemorrhage, subarachnoid haemorrhage, antiplatelet therapy, law.invention, Randomized controlled trial, law, Internal medicine, Atrial Fibrillation, Medicine, Humans, atrial fibrillation, Prospective Studies, education, Adverse effect, Stroke, oral anticoagulation, education.field_of_study, business.industry, Hazard ratio, intraventricular haemorrhage, Anticoagulants, Atrial fibrillation, intracerebral haemorrhage, Vitamin K antagonist, medicine.disease, United Kingdom, subdural haemorrhage, Neurology (clinical), business, Intracranial Hemorrhages, randomised controlled trial
Abstract

Summary Background Oral anticoagulation reduces the rate of systemic embolism for patients with atrial fibrillation by two-thirds, but its benefits for patients with previous intracranial haemorrhage are uncertain. In the Start or STop Anticoagulants Randomised Trial (SoSTART), we aimed to establish whether starting is non-inferior to avoiding oral anticoagulation for survivors of intracranial haemorrhage who have atrial fibrillation. Methods SoSTART was a prospective, randomised, open-label, assessor-masked, parallel-group, pilot phase trial done at 67 hospitals in the UK. We recruited adults (aged ≥18 years) who had survived at least 24 h after symptomatic spontaneous intracranial haemorrhage, had atrial fibrillation, and had a CHA2DS2-VASc score of at least 2. Web-based computerised randomisation incorporating a minimisation algorithm allocated participants (1:1) to start or avoid long-term (≥1 year) full treatment dose open-label oral anticoagulation. The participants assigned to start oral anticoagulation received either a direct oral anticoagulant or vitamin K antagonist, and the group assigned to avoid oral anticoagulation received standard clinical practice (antiplatelet agent or no antithrombotic agent). The primary outcome was recurrent symptomatic spontaneous intracranial haemorrhage, and was adjudicated by an individual masked to treatment allocation. All outcomes were ascertained for at least 1 year after randomisation and assessed in the intention-to-treat population of all randomly assigned participants, using Cox proportional hazards regression adjusted for minimisation covariates. We planned a sample size of 190 participants (one-sided p=0·025, power 90%, allowing for non-adherence) based on a non-inferiority margin of 12% (or adjusted hazard ratio [HR] of 3·2). This trial is registered with ClinicalTrials.gov (NCT03153150) and is complete. Findings Between March 29, 2018, and Feb 27, 2020, consent was obtained at 61 sites for 218 participants, of whom 203 were randomly assigned at a median of 115 days (IQR 49–265) after intracranial haemorrhage onset. 101 were assigned to start and 102 to avoid oral anticoagulation. Participants were followed up for median of 1·2 years (IQR 0·97–1·95; completeness 97·2%). Starting oral anticoagulation was not non-inferior to avoiding oral anticoagulation: eight (8%) of 101 in the start group versus four (4%) of 102 in the avoid group had intracranial haemorrhage recurrences (adjusted HR 2·42 [95% CI 0·72–8·09]; p=0·152). Serious adverse events occurred in 17 (17%) participants in the start group and 15 (15%) in the avoid group. 22 (22%) patients in the start group and 11 (11%) patients in the avoid group died during the study. Interpretation Whether starting oral anticoagulation was non-inferior to avoiding it for people with atrial fibrillation after intracranial haemorrhage was inconclusive, although rates of recurrent intracranial haemorrhage were lower than expected. In view of weak evidence from analyses of three composite secondary outcomes, the possibility that oral anticoagulation might be superior for preventing symptomatic major vascular events should be investigated in adequately powered randomised trials. Funding British Heart Foundation, Medical Research Council, Chest Heart & Stroke Scotland.

Published
2021

4. Bilateral corneal injury after face-paint application to upper eyelids

Author

Sue Webber, Derek Kwun-hong Ho, and Ravi Ramessur

Subjects
Adult, medicine.medical_specialty, genetic structures, Ascorbic Acid, Cosmetics, Diagnosis, Differential, Blurred vision, Corneal Injury, Ophthalmology, medicine, Humans, Burning Sensation, Wound Healing, Unexpected Outcome (Positive or Negative) Including Adverse Drug Reactions, business.industry, Eyelids, General Medicine, Ascorbic acid, Cyclopentolate, eye diseases, Chloramphenicol, Ophthalmic solutions, Female, sense organs, Ophthalmic Solutions, medicine.symptom, business, Corneal Injuries, medicine.drug
Abstract

A 40-year-old woman with no known medical conditions or allergies presented with severely painful, watery eyes and blurred vision. She reported topical application of face-paint onto both upper eyelids prior to attending a Halloween party. She subsequently noticed a burning sensation, epiphora and misty vision within a few hours. On examination, bilateral large corneal epithelial defects were highlighted with fluorescein dye under cobalt-blue light. Antibiotic ointment, mydriatic and sodium ascorbate 10% eye-drops were given, and patient was advised to keep the eyelids shut to promote healing. No corneal defects were visible by day 4 and the patient was discharged with vision recovering to normal levels.

Published
2017

5. Beyond the boulevards—the reality of Hounslow an analysis of the role of local authorities in seeking to improve environmental quality

Author

Lynda Addison and Sue Webber

Subjects
Ecology, business.industry, media_common.quotation_subject, Context (language use), Management, Monitoring, Policy and Law, Public relations, Urban Studies, Quality of life (healthcare), Borough, Work (electrical), Realm, Quality (business), Sociology, business, Integrated management, Environmental quality, Nature and Landscape Conservation, media_common
Abstract

This paper explores to what extent a local authority can influence environmental quality within the streets of its area, so as to meet its corporate objectives of improving the environment and quality of life for all who live, work, visit and trade in the borough. The approach for the study undertaken by Hounslow was based on an internal policy review, which aimed to identify and draw together all the elements, players, and relationships within the street scene that could influence the visual quality of the public realm. The ‘street scene’ has been defined as being the spaces between buildings which are on public view, but it was also considered essential to assess the buildings and other vertical elements which ‘frames’ the streets and set the context for the main performers. From this a Street Scene Strategy was produced to promote the integrated management of all streets and to develop the concept of partnership working with the many other players involved in the street scene. This paper sets out the background to this work, the results to date, the aims of the pilot study and the wider issues and conclusions the study raises for local authorities.

Published
1996

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