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1. Continuous Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT): study protocol for an adaptive randomised crossover trial comparing the benefits and costs of combining two established treatments for obstructive sleep apnoea

Author

Martin Law, Sofia Villar, Nicholas Oscroft, Victoria Stoneman, Julia Fox-Rushby, Yi-Da Chiu, Jo Steele, Thomas Devine, Claire Francis, Thomas Claydon, Graham Hill, Ka Keat Lim, Joanna Rayner, Mandy Williams, Emma Spires, and Timothy Quinnell

Subjects
Sleep apnoea, CPAP, MAD, Combination, Crossover, Sample size re-estimation, Medicine (General), R5-920
Abstract

Abstract Background Obstructive sleep apnoea (OSA) involves repeated breathing pauses during sleep due to upper airway obstruction. It causes excessive daytime sleepiness and has other health impacts. Continuous positive airway pressure (CPAP) therapy is effective first line treatment for moderate to severe OSA. Unfortunately, many patients have difficulty tolerating CPAP and pressure intolerance is probably an important contributing factor. Mandibular advancement devices (MAD) are an alternative to CPAP. They are worn in the mouth during sleep to reduce airway obstruction. There is some evidence that, when used in combination with CPAP, MADs improve airway anatomy enough to reduce the CPAP pressure required to treat OSA and that this combination therapy could improve CPAP adherence. Methods Consecutive patients starting on CPAP for moderate to severe OSA will be recruited at a regional NHS sleep service. Patients with high CPAP pressure requirements after initial titration, who satisfy all entry criteria and consent to participate, will undertake a 2-arm randomised crossover trial. The arms will be (i) standalone CPAP and (ii) CPAP + MAD therapy. Each arm will last 12 weeks, including 2 weeks acclimatisation. CPAP machines will be auto-titrating and with facility for data download, so the impact of MAD on CPAP pressure requirements and CPAP adherence can be easily measured. The primary outcome will be CPAP adherence. Secondary outcomes will include measures of OSA severity, patient-reported outcome measures including subjective daytime sleepiness, quality of life, and treatment preference at the trial exit and health service use. Cost-effectiveness analyses will be undertaken. Discussion If the intervention is shown to be effective and cost-effective in improving adherence in this standard CPAP-eligible OSA patient population it would be relatively straightforward to introduce into existing OSA treatment pathways, within the wider NHS and more widely. Both MAD and CPAP are already used by sleep services so their combination would require only minor adjustments to existing clinical pathways. It would be straightforward to disseminate the results of the study through regional, national, and international respiratory meetings. The health economics analysis would provide cost-effectiveness data to inform service planning and clinical guidelines through policy briefing papers, including those by NICE and SIGN. Trial registration PAPMAT was registered with ISRCTN prior to recruitment beginning (ISRCTN Registry 2021): https://www.isrctn.com/ISRCTN33966032 . Registered on 17th November 2021.

Published
2023
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2. Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial

Author

Melissa Earwaker, Sofia Villar, Julia Fox-Rushby, Melissa Duckworth, Sarah Dawson, Jo Steele, Yi-da Chiu, Edward Litton, Gudrun Kunst, Gavin Murphy, Guillermo Martinez, Vasileios Zochios, Val Brown, Geoff Brown, and Andrew Klein

Subjects
Cardiothoracic surgery, High-flow nasal therapy, Post-operative pulmonary complications, Adaptive design, Medicine (General), R5-920
Abstract

Abstract Background High-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy. The co-primary objective is to estimate the incremental cost-effectiveness and cost-utility of high-flow nasal therapy vs standard oxygen therapy at 90 days, from the view-point of the public sector, the health service and patients. Methods This is an adaptive, multicentre, international parallel-group, randomised controlled trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy with control in patients at high risk of respiratory complications following cardiac surgery. Participants will be randomised before tracheal extubation and allocated either high-flow nasal therapy or standard oxygen therapy for a minimum of 16 h immediately post extubation. Participants will be followed up until 90 days after surgery. The total sample size needed to detect a 2-day increase in DAH90 with 90% power with an intention to treat analysis is 850 patients. The adaptive design includes an interim sample size re-estimation which will provide protection against deviations from the original sample size assumptions made from the single-centre pilot study and will allow for a maximum sample size increase to 1152 patients. Discussion Evidence to support routine use of high-flow nasal therapy will inform the development of effective enhanced recovery care bundles. Reducing complications should reduce length of stay and re-admission to hospital and provide an important focus for cost reduction. However; high-quality studies evaluating the clinical and cost effectiveness of high-flow nasal therapy after cardiothoracic surgery are lacking. Trial registration The study has been registered with ISRCTN ( ISRCTN14092678 , 13/05/2020) Clinicaltrials.gov Registration Pending

Published
2022
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3. How achievable are COVID-19 clinical trial recruitment targets? A UK observational cohort study and trials registry analysis

Author

Darrel P Francis, Michael Brown, Nicholas J Matheson, Grant D Stewart, Jane Greenaway, Nick G Cunniffe, Simon J Gunter, Sarah W Burge, Tom Dymond, Hanif Esmail, Jacqui Galloway, Effrossyni Gkrania-Klotsas, George Katritsis, Martin D Knolle, Kelly Leonard, Zoe C McIntyre, Ben Prudon, Tommy Rampling, Mili Estee Torok, Ben Warne, Mark Yates, and Sofia Villar

Subjects
Medicine
Abstract

Objectives To analyse enrolment to interventional trials during the first wave of the COVID-19 pandemic in England and describe the barriers to successful recruitment in the circumstance of a further wave or future pandemics.Design We analysed registered interventional COVID-19 trial data and concurrently did a prospective observational study of hospitalised patients with COVID-19 who were being assessed for eligibility to one of the RECOVERY, C19-ACS or SIMPLE trials.Setting Interventional COVID-19 trial data were analysed from the clinicaltrials.gov and International Standard Randomized Controlled Trial Number databases on 12 July 2020. The patient cohort was taken from five centres in a respiratory National Institute for Health Research network. Population and modelling data were taken from published reports from the UK government and Medical Research Council Biostatistics Unit.Participants 2082 consecutive admitted patients with laboratory-confirmed SARS-CoV-2 infection from 27 March 2020 were included.Main outcome measures Proportions enrolled, and reasons for exclusion from the aforementioned trials. Comparisons of trial recruitment targets with estimated feasible recruitment numbers.Results Analysis of trial registration data for COVID-19 treatment studies enrolling in England showed that by 12 July 2020, 29 142 participants were needed. In the observational study, 430 (20.7%) proceeded to randomisation. 82 (3.9%) declined participation, 699 (33.6%) were excluded on clinical grounds, 363 (17.4%) were medically fit for discharge and 153 (7.3%) were receiving palliative care. With 111 037 people hospitalised with COVID-19 in England by 12 July 2020, we determine that 22 985 people were potentially suitable for trial enrolment. We estimate a UK hospitalisation rate of 2.38%, and that another 1.25 million infections would be required to meet recruitment targets of ongoing trials.Conclusions Feasible recruitment rates, study design and proliferation of trials can limit the number, and size, that will successfully complete recruitment. We consider that fewer, more appropriately designed trials, prioritising cooperation between centres would maximise productivity in a further wave.

Published
2020
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4. Casemix, management, and mortality of patients receiving emergency neurosurgery for traumatic brain injury in the Global Neurotrauma Outcomes Study: a prospective observational cohort study

Author

David Clark, Alexis Joannides, Amos Olufemi Adeleye, Abdul Hafid Bajamal, Tom Bashford, Hagos Biluts, Karol Budohoski, Ari Ercole, Rocío Fernández-Méndez, Anthony Figaji, Deepak Kumar Gupta, Roger Härtl, Corrado Iaccarino, Tariq Khan, Tsegazeab Laeke, Andrés Rubiano, Hamisi K Shabani, Kachinga Sichizya, Manoj Tewari, Abenezer Tirsit, Myat Thu, Manjul Tripathi, Rikin Trivedi, Bhagavatula Indira Devi, Franco Servadei, David Menon, Angelos Kolias, Peter Hutchinson, Ghayur Abbas, Omar Ibrahim Abdallah, Ahmed Abdel-Lateef, Khalif Abdifatah, Awfa Abdullateef, Ruvini Abeygunaratne, Mostafa Aboellil, Abass Adam, Robert Adams, Amos Adeleye, Augustine Adeolu, Novan Krisno Adji, Nur Afianti, Sudarsan Agarwal, Ifeanyi Kene Aghadi, Paúl Martín Méndez Aguilar, Syeda Rida Ahmad, Daniyal Ahmed, Nafees Ahmed, Haider Aizaz, Yunus Kuntawi Aji, Alex Alamri, Augusto Jacinto Mussindo Alberto, Luis Alcocer Alcocer, Lesly Gonzales Alfaro, Amro Al-Habib, Ahmad Alhourani, Syed Muhammad Rafay Ali, Fahad Alkherayf, Ahmed AlMenabbawy, Aliyah Alshareef, Muhammad Adil s/o Aminullah, Madeha Amjad, Robson Luis Oliveira de Amorim, Sathiaprabhu Anbazhagan, Almir Andrade, Waleed Antar, Theophilus T.K. Anyomih, Salah Aoun, Tedy Apriawan, Daniele Armocida, Paul Arnold, Miguel Arraez, Temesgen Assefa, Andres Asser, S.P. Athiththan, Deepal Attanayake, Maung Maung Aung, Allan Avi, Victor Enrique Antolinez Ayala, Mohammed Azab, Gaousul Azam, Mohd Azharuddin, Olukemi Badejo, Mohamed Badran, Azam Ali Baig, Rehman Ali Baig, Ankur Bajaj, Paul Baker, Renu Bala, Artur Balasa, Ross Balchin, James Balogun, Vin Shen Ban, Bharath Kumar Reddy Bandi, Soham Bandyopadhyay, Matthew Bank, Ernest Barthelemy, Mohammed Talha Bashir, Luciano Silveira Basso, Surajit Basu, Auricelio Batista, Marlies Bauer, Devi Bavishi, Abi Beane, Shmuel Bejell, Anteneh Belachew, Antonio Belli, Amani Belouaer, Najia El Abbadi Bendahane, Okanga Benjamin, Youssef Benslimane, Chaymae Benyaiche, Claudio Bernucci, Luigi Valentino Berra, Arnold Bhebe, Alexios Bimpis, Diana Blanaru, Jean Claude Bonfim, Luis A B Borba, Alp Ozgun Borcek, Erika Borotto, Ahmad Elmabri Mohammad Bouhuwaish, Facundo Bourilhon, Gioia Brachini, Joshua Breedon, Maximilian Broger, Giacoma Maria Floriana Brunetto, Placido Bruzzaniti, Natalia Budohoska, Hira Burhan, Maximiliano Luis Calatroni, Catherine Camargo, Pier Francesco Cappai, Salvatore Massimiliano Cardali, Ana M Castaño-Leon, David Cederberg, Mikel Celaya, Marco Cenzato, Lakshmi Madhavi Challa, Dhanny Charest, Bipin Chaurasia, Rabah Chenna, Iype Cherian, Juliana Henry Ching'o, Tejas Chotai, Ajay Choudhary, Nabeel Choudhary, Florence Choumin, Tomislav Cigic, Juan Ciro, Carlo Conti, Antônio Carlos de Souza Corrêa, Giulia Cossu, Maíra Piani Couto, Aurora Cruz, Divya D'Silva, Giuseppe Antonio D'Aliberti, Lamin Dampha, Roy Thomas Daniel, Andrew Dapaah, Aneela Darbar, Gabriel Dascalu, Happy Amos Dauda, Owain Davies, Andrea Delgado-Babiano, Markus Dengl, Marko Despotovic, Indira Devi, Celeste Dias, Mohamed Dirar, Melina Dissanayake, Hananiah Djimbaye, Simon Dockrell, Ali Dolachee, Julija Dolgopolova, Muge Dolgun, Abdalrouf Dow, Davide Drusiani, Artjom Dugan, Dinh Tuan Duong, Trung Kien Duong, Tomasz Dziedzic, Ali Ebrahim, Nizar El Fatemi, Antonios El El Helou, Rachid El El Maaqili, Brahim El El Mostarchid, Abdessamad El El Ouahabi, Mohammad Elbaroody, Ahmed El-Fiki, Ahmed El-Garci, Nasser M.F. El-Ghandour, Muhammed Elhadi, Vanessa Elleder, Safa Elrais, Mohamed El-shazly, Mohamed Elshenawy, Hesham Elshitany, Omar El-Sobky, Marwa Emhamed, Basil Enicker, Onur Erdogan, Sebastian Ertl, Ignatius Esene, Omar Ocampo Espinosa, Tarig Fadalla, Mohammed Fadelalla, Rodrigo Moreira Faleiro, Nida Fatima, Charbel Fawaz, Assefa Fentaw, Carla Eiriz Fernandez, Ana Ferreira, Francesco Ferri, Tony Figaji, Emerson L B Filho, Loic Fin, Benjamin Fisher, Fitra Fitra, Alexis Palpan Flores, Ioan Stefan Florian, Vincenzo Fontana, Lauren Ford, Daniel Fountain, Jose Maria Roda Frade, Antonio Fratto, Christian Freyschlag, Aranzazu Sánchez Gabin, Clare Gallagher, Mario Ganau, Maria Luisa Gandia-Gonzalez, Andoni Garcia, Borja Hernandez Garcia, Sanjeewa Garusinghe, Biniam Gebreegziabher, Adrian Gelb, Jerome St George, Antonino Francesco Germanò, Ilaria Ghetti, Prajwal Ghimire, Alessandro Giammarusti, Jose Luis Gil, Panagiota Gkolia, Yoseph Godebo, Prakash Rao Gollapudi, Jagos Golubovic, Jeremias Fernando Gomes, Javier Gonzales, William Gormley, Alexander Gots, Giulia Letizia Gribaudi, Dylan Griswold, Paolo Gritti, Ruan Grobler, Rudy Gunawan, Birhanu Hailemichael, Elmehdi Hakkou, Mark Haley, Alhafidz Hamdan, Ali Hammed, Waeel Hamouda, Nurul Ashikin Hamzah, Nyein Latt Han, Sahin Hanalioglu, Rashan Haniffa, Martin Hanko, John Hanrahan, Timothy Hardcastle, Fahd Derkaoui Hassani, Volkmar Heidecke, Eirik Helseth, Miguel Ángel Hernández-Hernández, Zachary Hickman, Le Minh Chau Hoang, Alexa Hollinger, Lenka Horakova, Kismet Hossain-Ibrahim, Boru Hou, Samer Hoz, Janine Hsu, Martin Hunn, Madiha Hussain, Giorgia Iacopino, Mylena Miki Lopes Ideta, Irene Iglesias, Ali Ilunga, Nafiz Imtiaz, Rafiza Islam, Serge Ivashchenko, Karim Izirouel, Mohamed Sobhi Jabal, Soubhi Jabal, John Nute Jabang, Aimun Jamjoom, Irfan Jan, Landing BM Jarju, Saad Javed, Bojan Jelaca, Sukhdeep Singh Jhawar, Ting Ting Jiang, Fernando Jimenez, Jorge Jiris, Ron Jithoo, Walt Johnson, Mathew Joseph, Rameshman Joshi, Eija Junttila, Mubashir Jusabani, Stephen Akau Kache, Satyavara Prasad Kadali, Gabriela F Kalkmann, Usman Kamboh, Hitham Kandel, Ahmet Kamil Karakus, Mengistu Kassa, Ari Katila, Yoko Kato, Martin Keba, Kristy Kehoe, Huseyin Hayri Kertmen, Soha Khafaji, Monty Khajanchi, Mohammed Khan, Muhammad Mukhtar Khan, Sohail Daud Khan, Ahtesham Khizar, Amir Khriesh, Sara Kierońska, Paul Kisanga, Boniface Kivevele, Kacper Koczyk, Anna-Lucia Koerling, Danielle Koffenberger, Kennet Kõiv, Leho Kõiv, Branislav Kolarovszki, Marton König, Dilek Könü-Leblebicioglu, Santhoshi Devi Koppala, Tommi Korhonen, Boguslaw Kostkiewicz, Kacper Kostyra, Srinivas Kotakadira, Arjun Reddy Kotha, Madhu Narayana Rao Kottakki, Nenad Krajcinovic, Michal Krakowiak, Andreas Kramer, Selvamuthukumaran Krishnamoorthy, Ashok Kumar, Pankaj Kumar, Pradhumna Kumar, Nilaksha Kumarasinghe, Gowtham Kuncha, Raja K. Kutty, Ghazwan Lafta, Simon Lammy, Pierfrancesco Lapolla, Jacopo Lardani, Nebojsa Lasica, Giancarlo Lastrucci, Yoann Launey, Laura Lavalle, Tim Lawrence, Albert Lazaro, Vitalii Lebed, Ville Leinonen, Lawrence Lemeri, Leon Levi, Jia Yi Lim, Xiao Yi Lim, Jorge Linares-Torres, Laura Lippa, Lurdes Lisboa, Jinfang Liu, Ziyuan Liu, William B Lo, Jan Lodin, Federico Loi, Daniella Londono, Pedro Antonio Gomez Lopez, Cristina Barceló López, Madeleine De Lotbiniere-Bassett, Rihards Lulens, Facundo Hector Luna, Teemu Luoto, Vijaya Sekhar M.V., Ndyebo Mabovula, Matthew MacAllister, Alcina Americo Macie, Rodolfo Maduri, Moufid Mahfoud, Ashraf Mahmood, Fathia Mahmoud, Dominic Mahoney, Wissam Makhlouf, George Malcolm, Adefolarin Malomo, Toluyemi Malomo, Manoranjitha Kumari Mani, Tomás Gazzinelli Marçal, Jacopo Marchello, Nicolò Marchesini, Franz Marhold, Niklas Marklund, Rubén Martín-Láez, Vickneswaran Mathaneswaran, David José Mato-Mañas, Helen Maye, Aaron Lawson McLean, Catherine McMahon, Saniya Mediratta, Mehreen Mehboob, Alisson Meneses, Nesrine Mentri, Hagos Mersha, Ana Milena Mesa, Cristy Meyer, Christopher Millward, Salomao Amone Mimbir, Andrea Mingoli, Parashruram Mishra, Tejesh Mishra, Basant Misra, Siddharth Mittal, Imran Mohammed, Ioana Moldovan, Masechaba Molefe, Alexis Moles, Preston Moodley, Mario Augusto Narváez Morales, Lucy Morgan, German Del Castillo Morillo, Wahab Moustafa, Nikolaos Moustakis, Salma Mrichi, Satya Shiva Munjal, Abdul-Jalilu Mohammed Muntaka, Denver Naicker, Paulo E H Nakashima, Pratap Kumar Nandigama, Samantha Nash, Ionut Negoi, Valetina Negoita, Samundra Neupane, Manh Hung Nguyen, Fajar Herbowo Niantiarno, Abbi Noble, Mohd Arman Muhamad Nor, Blazej Nowak, Andrei Oancea, Frazer O'Brien, Oghenekevwe Okere, Sandra Olaya, Leandro Oliveira, Louise Makarem Oliveira, Fatma Omar, Okezi Ononeme, René Opšenák, Simone Orlandini, Alrobah Osama, Dorcas Osei-Poku, Haytham Osman, Alvaro Otero, Malte Ottenhausen, Shuli Otzri, Oumaima Outani, Emmanuel Abem Owusu, Kevin Owusu-Agyemang, Ahmad Ozair, Baris Ozoner, Elli Paal, Mauro Sérgio Paiva, Wellingson Paiva, Sharad Pandey, Gastone Pansini, Luigi Pansini, Tobias Pantel, Nikolaos Pantelas, Konstantinos Papadopoulos, Vladimir Papic, Kee Park, Nick Park, Eric Homero Albuquerque Paschoal, Mylla Christie de Oliveira Paschoalino, Rajesh Pathi, Anilkumar Peethambaran, Thiago Andrade Pereira, Irene Panero Perez, Claudio José Piqueras Pérez, Tamilanandh Periyasamy, Stefano Peron, Michael Phillips, Sofía Sotos Picazo, Ertugrul Pinar, Daniel Pinggera, Rory Piper, Pathmanesan Pirakash, Branko Popadic, Jussi P. Posti, Rajmohan Bhanu Prabhakar, Sivanesalingam Pradeepan, Manjunath Prasad, Paola Calvachi Prieto, Ron Prince, Andrea Prontera, Eva Provaznikova, Danilo Quadros, Nezly Jadid Romero Quintero, Mahmood Qureshi, Happiness Rabiel, Gabriel Rada, Sivagnanam Ragavan, Jueria Rahman, Omar Ramadhan, Padma Ramaswamy, Sakina Rashid, Jagath Rathugamage, Tõnu Rätsep, Minna Rauhala, Asif Raza, Naga Raju Reddycherla, Linus Reen, Mohamed Refaat, Luca Regli, Haijun Ren, Antonio Ria, Thales Francisco Ribeiro, Alessandro Ricci, Romana Richterová, Florian Ringel, Faith Robertson, Catarina Mayrink Siqueira Cabral Rocha, Juvenal de Souza Rogério, Adan Anibal Romano, Sally Rothemeyer, Gail Rousseau Gail Rousseau, Ranette Roza, Kevin David Farelo Rueda, Raiza Ruiz, Malin Rundgren, Radoslaw Rzeplinski, Raj S.Chandran, Ramesh Andi Sadayandi, William Sage, André Norbert Josef Sagerer, Mustafa Sakar, Mohcine Salami, Danjuma Sale, Youssuf Saleh, Cristina Sánchez-Viguera, Saning'o Sandila, Ahmet Metin Sanli, Laura Santi, Antonio Santoro, Aieska Kellen Dantas Dos Santos, Samir Cezimbra dos Santos, Borja Sanz, Shabal Sapkota, Gopalakrishnan Sasidharan, Ibrahim Sasillo, Rajeev Satoskar, Ali Caner Sayar, Vignesh Sayee, Florian Scheichel, Felipe Lourenzon Schiavo, Alexander Schupper, Andreas Schwarz, Teresa Scott, Esther Seeberger, Claudionor Nogueira Costa Segundo, Anwar Sadat Seidu, Antonio Selfa, Nazan Has Selmi, Claudiya Selvarajah, Necmiye Şengel, Martin Seule, Luiz Severo, Purva Shah, Muhammad Shahzad, Thobekile Shangase, Mayur Sharma, Ehab Shiban, Emnet Shimber, Temitayo Shokunbi, Kaynat Siddiqui, Emily Sieg, Martin Siegemund, Shahidur Rahman Sikder, Ana Cristina Veiga Silva, Ana Silva, Pedro Alberto Silva, Deepinder Singh, Carly Skadden, Josef Skola, Eirini Skouteli, Pawel Słoniewski, Brandon Smith, Guirish Solanki, Davi Fontoura Solla, Davi Solla, Ozcan Sonmez, Müge Sönmez, Wai Cheong Soon, Roberto Stefini, Martin Nikolaus Stienen, Bogdan Stoica, Matthew Stovell, Maria Natalia Suarez, Alaa Sulaiman, Mazin Suliman, Adi Sulistyanto, Şeniz Sulubulut, Sandra Sungailaite, Madlen Surbeck, Tomasz Szmuda, Graziano Taddei, Abraham Tadele, Ahmed Saleh Ahmed Taher, Riikka Takala, Krishna Murthy Talari, Bih Huei Tan, Leonardo Tariciotti, Murad Tarmohamed, Oumayma Taroua, Emiliano Tatti, Olli Tenovuo, Sami Tetri, Poojan Thakkar, Nqobile Thango, Satish Kumar Thatikonda, Tuomo Thesleff, Claudius Thomé, Owen Thornton, Shelly Timmons, Eva Ercilio Timoteo, Campbell Tingate, Souhil Tliba, Christos Tolias, Emma Toman, Ivan Torres, Luis Torres, Youness Touissi, Musa Touray, Maria Pia Tropeano, Georgios Tsermoulas, Christos Tsitsipanis, Mehmet Erhan Turkoglu, Özhan Merzuk Uçkun, Jamie Ullman, Gheorghe Ungureanu, Sarah Urasa, Obaid Ur-Rehman, Muhammed Uysal, Antonios Vakis, Egils Valeinis, Vaishali Valluru, Debby Vannoy, Pablo Vargas, Phillipos Varotsis, Rahul Varshney, Atul Vats, Damjan Veljanoski, Sara Venturini, Abhijit Verma, Clara Villa, Genaro Villa, Sofia Villar, Erin Villard, Antonio Viruez, Stefanos Voglis, Petar Vulekovic, Saman Wadanamby, Katherine Wagner, Rebecca Walshe, Jan Walter, Marriam Waseem, Tony Whitworth, Ruwani Wijeyekoon, Adam Williams, Mark Wilson, Sein Win, Achmad Wahib Wahju Winarso, Abraão Wagner Pessoa Ximenes, Anurag Yadav, Dipak Yadav, Kamal Makram Yakoub, Ali Yalcinkaya, Guizhong Yan, Eesha Yaqoob, Carlos Yepes, Ayfer Nazmiye Yılmaz, Betelehem Yishak, Farhat Basheer Yousuf, Muhammad Zamzuri Zahari, Hussein Zakaria, Diego Zambonin, Luca Zavatto, Bassel Zebian, Anna Maria Zeitlberger, Furong Zhang, Fengwei Zheng, and Michal Ziga

Subjects
casemix, management, mortality, emergency neurosurgery, traumatic brain injury, prospective observational cohort study, Neurology (clinical)
Abstract

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Traumatic brain injury (TBI) is increasingly recognised as being responsible for a substantial proportion of the global burden of disease. Neurosurgical interventions are an important aspect of care for patients with TBI, but there is little epidemiological data available on this patient population. We aimed to characterise differences in casemix, management, and mortality of patients receiving emergency neurosurgery for TBI across different levels of human development. Methods: We did a prospective observational cohort study of consecutive patients with TBI undergoing emergency neurosurgery, in a convenience sample of hospitals identified by open invitation, through international and regional scientific societies and meetings, individual contacts, and social media. Patients receiving emergency neurosurgery for TBI in each hospital's 30-day study period were all eligible for inclusion, with the exception of patients undergoing insertion of an intracranial pressure monitor only, ventriculostomy placement only, or a procedure for drainage of a chronic subdural haematoma. The primary outcome was mortality at 14 days postoperatively (or last point of observation if the patient was discharged before this time point). Countries were stratified according to their Human Development Index (HDI)—a composite of life expectancy, education, and income measures—into very high HDI, high HDI, medium HDI, and low HDI tiers. Mixed effects logistic regression was used to examine the effect of HDI on mortality while accounting for and quantifying between-hospital and between-country variation. Findings: Our study included 1635 records from 159 hospitals in 57 countries, collected between Nov 1, 2018, and Jan 31, 2020. 328 (20%) records were from countries in the very high HDI tier, 539 (33%) from countries in the high HDI tier, 614 (38%) from countries in the medium HDI tier, and 154 (9%) from countries in the low HDI tier. The median age was 35 years (IQR 24–51), with the oldest patients in the very high HDI tier (median 54 years, IQR 34–69) and the youngest in the low HDI tier (median 28 years, IQR 20–38). The most common procedures were elevation of a depressed skull fracture in the low HDI tier (69 [45%]), evacuation of a supratentorial extradural haematoma in the medium HDI tier (189 [31%]) and high HDI tier (173 [32%]), and evacuation of a supratentorial acute subdural haematoma in the very high HDI tier (155 [47%]). Median time from injury to surgery was 13 h (IQR 6–32). Overall mortality was 18% (299 of 1635). After adjustment for casemix, the odds of mortality were greater in the medium HDI tier (odds ratio [OR] 2·84, 95% CI 1·55–5·2) and high HDI tier (2·26, 1·23–4·15), but not the low HDI tier (1·66, 0·61–4·46), relative to the very high HDI tier. There was significant between-hospital variation in mortality (median OR 2·04, 95% CI 1·17–2·49). Interpretation: Patients receiving emergency neurosurgery for TBI differed considerably in their admission characteristics and management across human development settings. Level of human development was associated with mortality. Substantial opportunities to improve care globally were identified, including reducing delays to surgery. Between-hospital variation in mortality suggests changes at an institutional level could influence outcome and comparative effectiveness research could identify best practices. Funding: National Institute for Health Research Global Health Research Group.

Published
2022

5. Multi-disciplinary fairness considerations in machine learning for clinical trials

Author

Isabel Chien, Nina Deliu, Richard Turner, Adrian Weller, Sofia Villar, and Niki Kilbertus

Subjects
FOS: Computer and information sciences, clinical trials, adaptive clinical trials, Computer Science - Machine Learning, Computer Science - Computers and Society, Computers and Society (cs.CY), health informatics, machine learning for healthcare, fairness in machine learning, education, Machine Learning (cs.LG)
Abstract

While interest in the application of machine learning to improve healthcare has grown tremendously in recent years, a number of barriers prevent deployment in medical practice. A notable concern is the potential to exacerbate entrenched biases and existing health disparities in society. The area of fairness in machine learning seeks to address these issues of equity; however, appropriate approaches are context-dependent, necessitating domain-specific consideration. We focus on clinical trials, i.e., research studies conducted on humans to evaluate medical treatments. Clinical trials are a relatively under-explored application in machine learning for healthcare, in part due to complex ethical, legal, and regulatory requirements and high costs. Our aim is to provide a multi-disciplinary assessment of how fairness for machine learning fits into the context of clinical trials research and practice. We start by reviewing the current ethical considerations and guidelines for clinical trials and examine their relationship with common definitions of fairness in machine learning. We examine potential sources of unfairness in clinical trials, providing concrete examples, and discuss the role machine learning might play in either mitigating potential biases or exacerbating them when applied without care. Particular focus is given to adaptive clinical trials, which may employ machine learning. Finally, we highlight concepts that require further investigation and development, and emphasize new approaches to fairness that may be relevant to the design of clinical trials., Appeared at ACM FAccT 2022

Published
2022

6. Overlap Syndrome (Systemic Sclerosis and Rheumatoid Arthritis) with Achalasia: An Unusual Association

Author

Alicia Sofia Villar-Chavez, Daniel Ruiz-Romero, Enrique Coss-Adame, and Miguel Angel Valdovinos-Diaz

Subjects
030203 arthritis & rheumatology, Pathology, medicine.medical_specialty, business.industry, Achalasia, Overlap syndrome, medicine.disease, Omics, Gastroenterology, Pathogenesis, 03 medical and health sciences, 0302 clinical medicine, Rheumatoid arthritis, Internal medicine, Esophageal dysphagia, otorhinolaryngologic diseases, medicine, Esophageal manometer, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

Both patients with achalasia and systemic sclerosis can complain of esophageal dysphagia. Esophageal manometer remains the most accurate method to evaluate esophageal dismotility. The association of achalasia and systemic sclerosis as an overlap syndrome has not been described yet. This entity could be possibly based on common autoimmune mechanisms and an analogous pathogenesis explained mainly by viral association.

Published
2016

7. A comparative study of well-being, resilience, mindfulness, negative emotions, stress, and burnout among nurses after an online mind–body based intervention during the first COVID-19 pandemic crisis

Author

Ana Carla Cepeda-Lopez, Leticia Solís Domínguez, Sofía Villarreal Zambrano, Iris Y. Garza-Rodriguez, Alejandra Cortes del Valle, and Angélica Quiroga-Garza

Subjects
well-being, COVID-19, nurses, mindfulness, negative emotion, mind–body, Psychology, BF1-990
Abstract

BackgroundTo mitigate against the possible adverse effects of stress among nurses due to the COVID-19 outbreak, we designed a 12-week mind–body based online intervention program to promote well-being and prevent stress-related disorders such as burnout. Our study aimed to compare the impact of the intervention on perception of stress, negative emotions, burnout, mindfulness, resilience, and well-being at pretest and 6 months post-intervention and to compare the effect among nurses working at two different hospitals.MethodsWe conducted an uncontrolled trial using a convenience sample of nurses working at two hospitals in Mexico: one designated to treat confirmed COVID-19 patients (COVID-hospital) and the other whose patients had a negative COVID-19 test on admission (Non COVID-hospital). The 12 week online intervention consisted of 36 mind–body based micropractices, with subjective well-being as the primary outcome. Secondary outcomes were health perception, resilience, mindfulness, negative emotions, stress, and burnout.ResultsA pretest survey was completed by 643 nurses. Of the remaining valid responses, 82% were women, with a mean age of 34.8 (SD = 8.95) years old. For the analysis two groups of nurses were sampled by cluster: a COVID-hospital group of 429 (67%) nurses, and a non-COVID Hospital group of 214 (33%) nurses. The proportion lost to follow-up was 71% at postest (n = 188) and 42% at 6 months follow-up (n = 371). At pretest, non-COVID hospital nurses had lower subjective well-being and higher burnout than their COVID hospital counterparts. At postest, non-COVID hospital nurses displayed more negative emotions than their COVID hospital peers. At 6 months post-intervention, nurses experienced improved mindfulness, reduced negative emotions and stress, but a decrease in subjective well-being and resilience. Nurses working at the non-COVID hospital had significantly higher mean scores for burnout than those working at the COVID hospital.ConclusionThe results of our study suggest that our online mind–body interventions can help to reduce stress and negative emotions, yet the effects on subjective well-being and resilience are uncertain. Further research is needed to gain a better understanding of their potential mechanisms and the associated efforts of such online interventions.Clinical Trial RegistrationClinicalTrials.gov, NCT05515172.

Published
2023
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9. How Having a Clear Why Can Help Us Cope With Almost Anything: Meaningful Well-Being and the COVID-19 Pandemic in México

Author

Angelica Quiroga-Garza, Ana C. Cepeda-Lopez, Sofía Villarreal Zambrano, Victor E. Villalobos-Daniel, David F. Carreno, and Nikolett Eisenbeck

Subjects
wellbeing, psychological distress, coping strategies, COVID-19 pandemic, perceived physical health, meaning-centered coping, Psychology, BF1-990
Abstract

Background: Coronavirus disease 2019 (COVID-19) has resulted in an increase in known risk factors for mental health problems. Mexico adopted lockdown and physical distancing as a containment strategy with potential consequences on day to day life, such as social isolation, loss of income and loneliness that can have important consequences in terms of mental health.Objective: We aimed to examine the effect of the initial phases of the COVID-19 pandemic on psychological distress, well-being and perceived physical health among Mexican-base respondents and to examine whether coping strategies would play a potential intermediating role in relation to these variables. Under the Existential Positive Psychology perspective, an emphasis was made on meaning-centered coping.Methods: A cross-sectional study was conducted between April 30 and June 16th 2020 among 604 Mexicans-base respondents of which 471 were women and 132 men. Data was collected by using online questionnaires. Psychological distress was measured using the Depression, Anxiety, and Stress Scale (DASS-21). The Brief COPE Inventory was used to assess problem-focused and emotion-focused coping strategies. We also used the Meaning-Centered Coping Scale (MCCS). PERMA-Profiler was used to assess well-being, perceived physical health, and loneliness. Profiler and Descriptive analyses and bivariate linear regression were performed to examine the association of variables.Results: 45.9% of the participants reported moderate to extremely severe psychological distress. Our results demonstrate that problem-focused and emotion-focused coping were positively related to psychological distress, whereas meaning-centered coping was negatively associated with distress. Furthermore, psychological distress played a potential negative role in the perceived physical health, while meaning-centered coping and well-being buffered the negative influence of psychological distress on perceived physical health (completely standardized indirect effect = –0.01, SE: 0.012, 95% CI [−0.065; −0.017].Conclusion: Meaning-centered coping was found to suppress the negative influence of psychological distress on sensation of decreased physical health corroborating the critical role of meaning in life in promoting well-being. Future studies can further examine the value of the critical role of meaning in life in promoting well-being as a protective factor against severe distress during traumatic events. Findings of this study can be used to orient policies and interventions aimed to alleviate suffering in the midst of the COVID-19 pandemic.

Published
2021
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10. Inter-pregnancy interval and pregnancy outcomes among women with delayed childbearing: protocol for a systematic review

Author

Mani Asgharpour, Sofia Villarreal, Laura Schummers, Jennifer Hutcheon, Dorothy Shaw, and Wendy V. Norman

Subjects
Advanced maternal age, Birth interval, Birth spacing, Inter-pregnancy interval, Maternal outcome, Pregnancy complication, Medicine
Abstract

Abstract Background Women in high resource nations are increasingly delaying childbearing until their thirties. Delayed childbearing poses challenges for the spacing of a woman’s pregnancies. Inter-pregnancy intervals

Published
2017
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