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1. Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma – protocol for the Cavernomas: A Randomised Effectiveness (CARE) pilot trial

Author

Khalid Hamandi, Julie Woodfield, Smriti Agarwal, Richard Edwards, John Williamson, Ravindran Visagan, Rustam Al-Shahi Salman, Howard Brydon, Diederik Bulters, Dawn Hennigan, Paul Leach, Conor Mallucci, Nitin Mukerji, Marios Papadopoulos, Nicholas Ross, Martin Tisdall, Carole Turner, Shungu Ushewokunze, Raghu Vindlacheruvu, Paul Brennan, Phil White, Sophie Hunter, Karen Coy, Julia Wade, James Stewart, Tom Hughes, Laura Forsyth, Kirsty Harkness, David White, Rupal Shah, Sanjay Bhate, Neil Kitchen, Peter J Hutchinson, Emanuel Cirstea, Ramesh Nair, Rebecca Hall, Varduhi Cahill, Tom Hayton, Silvia Tarantino, Christin Eltze, Jack Lee, Arlo Whitehouse, Daniel Walsh, Jacqueline Stephen, Nicola Phillips, Steff Lewis, Susan Davies, Mathew Guilfoyle, Peter S Hall, Andrew Stoddart, Francesca Colombo, Emma Richards, Greg James, Sarah Illingworth, William B Lo, Andrew Bacon, Vijeya Ganesan, Sabina Patel, Aileen R Neilson, Felicia Jennings, Saba Raza-Knight, Andrew Brodbelt, Aswin Chari, Hasan Asif, Ian Kamaly-Asl, Milan Makwana, Zubair Tahir, Allan MacRaild, Grace Vassallo, Ian Anderson, Daniel Holsgrove, Carole Chambers, Sandra Williams, Francesca Spickett-Jones, Marios C Papadopoulos, John Preston, Edward White, Adel Helmy, Sarah Ali, John Reid, Daniel Brown, Louis Taylor, Christopher Uff, Patrick Grover, Azra Banaras, Linetty Makawa, Anil Israni, Richard J Edwards, William Muirhead, Daniel Brooks, Debbie Brown, Ciaran Scott Hill, Kerry Smith, Beth Atkinson, Michelle Fawcett, Sifelani Tshuma, Oliver Kennion, Jo Howe, James J M Loan, Philip Clatworthy, Claire Hudson, Rebecca Hodnett, Madalina Roman, Mary Sikaonga, Elaine Kinsella, Mario Teo, Venetia Giannakaki, James Loan, Lauren Harris, Jack Wildman, Emmanuel Chavredakis, Nihal Gurusinghe, Alex Rossdeutsch, Anthony Wiggins, Giannis Sokratous, Lucie Ferguson, Shakeelah Patel, Sonia Raj, Oishik Raha, Janneke van Beijnum, Pragnesh Bhatt, Anna Bjornson, Nicole Broomes, Alistair Bullen, Julian Cahill, Mihai Danciut, Ronneil Digpal, Ioannis Fouyas, Lauren S Harris, Sohail Majeed, Matthias Radatz, Oliver Wroe Wright, Jessica Teasdale, Michelle Coakley, Drahoslav Sokol, Chandru Kaliaperumal, Mairi MacDonald, Sarah Risbridger, Siobhan Kearney, Ellaine Bosetta, Thomas Doke, Sonny Coskuner, Christine Kamara, Jonathan Gardner, Imron Hamina, Kishor Chaudhari, Liliana Chapas, Karen Caldwell, Sarah Holland, Tamara Tajsic, Rachael Dore, Taya Anderson, Shelley Mayor, Laura O'Malley, Samantha Glover, Janice Irvine, Annika Walch, Farah Muir, Eng Tah Goh, Andrew McDarby, Michelle Bates, Rebecca Hancox, Claudia Kate Auyeung, Elizabeth Goff, Deanna Stephens, Borislava Borislavova, Ruth Worner, Sandeep Buddha, Lisa Tucker, Sandra Dymond, Andrew Mallick, Dymona McAleer, Belinda Gunning, Emma Clarkson, Cathy Stoneley, Jibril Osman Farah, Niamh Bohnacker, Rosette Marimon, Lydia Parker, Puneet Sharma, Dan Holsgrove, Danielle McLaughlan, Tracey Marsden, Kathryn Cawley, Hellen Raffalli, Imedla Mayor, Dipek Ram, Rebecca Keeping, Katie Hennessy, Ammar Kadhim, Md Moidul Islam, Manjunath Prasad, Cheryl Webster, Vicky Slater, Saffnan Mohamed, Saba Raza Knight, Terri-Louise Cromie, Allan Brown, Ruth Pennington, Charlene Campbell, Anthony Ghosh, Teresa Fitzpatrick, Mohammed Patel, Winnington Ruiz, Mirriam Taylor, Divina Anyog, Katarzyna Tluchowska, Jackson Nolasco, Kleopatra Angelopoulou, Bethany Welch, Ida Ponce, Lucy Bailey, Mia Marsden, Angelene Cope, Deepthy Blesson, Rachel Sutton, Mary Kambafwile, and Jade McAndrew

Subjects
Medicine
Abstract

Introduction The top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was ‘Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people diagnosed with a cavernoma?’ This pilot randomised controlled trial (RCT) aims to determine the feasibility of answering this question in a main phase RCT.Methods and analysis We will perform a pilot phase, parallel group, pragmatic RCT involving approximately 60 children or adults with mental capacity, resident in the UK or Ireland, with an unresected symptomatic brain cavernoma. Participants will be randomised by web-based randomisation 1:1 to treatment with medical management and with surgery (neurosurgery or stereotactic radiosurgery) versus medical management alone, stratified by prerandomisation preference for type of surgery. In addition to 13 feasibility outcomes, the primary clinical outcome is symptomatic intracranial haemorrhage or new persistent/progressive focal neurological deficit measured at 6 monthly intervals. An integrated QuinteT Recruitment Intervention (QRI) evaluates screening logs, audio recordings of recruitment discussions, and interviews with recruiters and patients/parents/carers to identify and address barriers to participation. A Patient Advisory Group has codesigned the study and will oversee its progress.Ethics and dissemination This study was approved by the Yorkshire and The Humber—Leeds East Research Ethics Committee (21/YH/0046). We will submit manuscripts to peer-reviewed journals, describing the findings of the QRI and the Cavernomas: A Randomised Evaluation (CARE) pilot trial. We will present at national specialty meetings. We will disseminate a plain English summary of the findings of the CARE pilot trial to participants and public audiences with input from, and acknowledgement of, the Patient Advisory Group.Trial registration number ISRCTN41647111.

Published
2023
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5. 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

6. Embryo Glue: The Use of Hyaluronan in Embryo Transfer Media

Author

Emma Woodland and Beth Atkinson

Subjects
0301 basic medicine, Adult, medicine.medical_specialty, Pregnancy Rate, Embryo glue, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Single Embryo Transfer, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Pregnancy, Physiology (medical), Medicine, Humans, Embryo Implantation, Hyaluronic Acid, 030219 obstetrics & reproductive medicine, In vitro fertilisation, business.industry, Obstetrics, Obstetrics and Gynecology, Embryo Transfer, Embryo transfer, Review article, Pregnancy rate, 030104 developmental biology, Reproductive Medicine, Female, business, Live birth
Abstract

EmbryoGlue is available to patients at many in vitro fertilization clinics, usually at an additional cost. The efficacy of hyaluronan-enriched transfer medium (HETM) is supported by moderate quality evidence that indicates a significant improvement in clinical outcomes such as live birth rates for patients, including poorer prognosis women (i.e., maternal age factor [>35 years] and recurrent implantation failure). An increased multiple pregnancy rate has been reported with the use of HETM; therefore, a single embryo transfer policy should be considered in conjunction with the use of EmbryoGlue. There is no evidence to suggest that HETM has any detrimental impact, and therefore the use of HETM in clinics may be justified for a specific demographic of patients. Further robust evidence, in the form of meta-analyses or large-scale randomized controlled trials, is needed to build a sufficient consensus regarding the benefit of hyaluronan supplementation in embryo transfer media.

Published
2021

7. A multicentre clinical evaluation of paediatric cochlear implant users upgrading to the Nucleus® 6 system

Author

Dimity Dornan, Janine Del Dot, Leen Theuwis, Anke Plasmans, Robert Cowan, Andrzej Zarowski, Jane McGovern, Arielle Kaicer, Stefan J. Mauger, Rod Hollow, Esti Nel, Valerie Looi, Michelle Moran, Erwin Offeciers, Jaime Leigh, Leigh Martelli, Claire Spence, Emma Rushbrooke, and Beth Atkinson

Subjects
Male, medicine.medical_specialty, Automatic scene classification, Speech perception, Microphone, Noise reduction, medicine.medical_treatment, Audiology, Session (web analytics), 03 medical and health sciences, 0302 clinical medicine, Cochlear implant, Medicine, Humans, Active listening, Pediatrics, Perinatology, and Child Health, 030223 otorhinolaryngology, Child, Children, Language, business.industry, General Medicine, Cochlear Implantation, Noise, Cochlear Implants, Otorhinolaryngology, QUIET, Pediatrics, Perinatology and Child Health, Female, business, 030217 neurology & neurosurgery, Directional microphones
Abstract

Objectives The aim of this study was to investigate whether experienced paediatric cochlear implant users could show benefits to speech perception outcomes from the introduction of noise reduction and automated scene classification technologies as implemented in the Nucleus® 6 sound processor. Previous research with adult cochlear implant users had shown significant improvements in speech intelligibility for listening in noisy conditions and good user acceptance for upgrading to the Nucleus 6 processor. In adults, these improvements for listening in noise were primarily attributed to the use of a range of new input processing technologies including noise reduction, as well as introduction of automatic scene classification technology. Methods Experienced paediatric cochlear implant users (n = 25) were recruited from four clinics located in three countries. Research participants were evaluated on three occasions, an initial session using their Nucleus 5 sound processor; a second session in which participants used the Nucleus 6 processor programmed with the same technologies as were used in their Nucleus 5 sound processor; and a final session in which participants used the Nucleus 6 processor programmed with the default technologies including automatic scene classification (SCAN) which automatically selects the microphone directionality, noise reduction (SNR-NR), and wind noise reduction (WNR) technologies. Prior to both the second and third evaluations, research participants had approximately two weeks take-home experience with the new system. Speech perception performances on monosyllabic word tests presented in quiet and in noise, and a sentence test presented in noise, were compared across the three processor conditions. Acceptance of the Nucleus 6 default settings was assessed in a final session. Results No group mean difference in performance was found for monosyllabic words in quiet. A significant improvement in speech perception was found for both monosyllabic words and sentences in noise with the default Nucleus 6 program condition as compared with the Nucleus 5 condition. No acceptance issues were noted for any of the children. Conclusions Experienced paediatric cochlear implant users showed a significant improvement in speech perception in listening in noise when upgraded to the Nucleus 6 sound processor primarily due to the introduction of a noise reduction technology, and all children accepted the default program. These findings suggest that school-aged children may benefit from upgrading to the Nucleus 6 sound processor using the default program.

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