Article
Public, Environmental & Occupational Health
Jacynthe L'Heureux, Helen McTaggart-Cowan, Gary Johns, Lin Chen, Theodore Steiner, Paige Tocher, Huiying Sun, Wei Zhang
Summary: This study aims to identify the most understandable and important results presentations regarding work productivity loss (WPL) outcomes from the perspectives of patients and caregivers. Using a mixed methods design, including interviews and surveys, the findings suggest that presenting WPL results in days or cost is the easiest to understand and most important to report in clinical trials.
SOCIAL SCIENCE & MEDICINE
(2023)
Article
Multidisciplinary Sciences
Sharib Ali, Debesh Jha, Noha Ghatwary, Stefano Realdon, Renato Cannizzaro, Osama E. Salem, Dominique Lamarque, Christian Daul, Michael A. Riegler, Kim V. Anonsen, Andreas Petlund, Pal Halvorsen, Jens Rittscher, Thomas de Lange, James E. East
Summary: Polyps in the colon are precursors to colon cancer and can be identified through colonoscopy. Automatic detection and segmentation methods have been developed, but they lack rigorous testing on a large dataset. To address this, a team has curated a dataset from six centers, including over 300 patients, with precise annotated polyp labels. This dataset, called PolypGen, is the most comprehensive in detection and segmentation and provides insight into data construction and validation.
Article
Computer Science, Artificial Intelligence
Saul Solorio-Fernandez, J. Ariel Carrasco-Ochoa, Jose Francisco Martinez-Trinidad
Summary: This paper provides a comprehensive review of existing supervised and unsupervised feature selection methods for mixed data, analyzing their characteristics, advantages, and disadvantages, and discussing important challenges and potential future research opportunities in this field.
ARTIFICIAL INTELLIGENCE REVIEW
(2022)
Article
Medical Informatics
Kai Fitzer, Renate Haeuslschmid, Romina Blasini, Fatma Betul Altun, Christopher Hampf, Sherry Freiesleben, Philipp Macho, Hans-Ulrich Prokosch, Christian Gulden
Summary: This study describes the current status of patient recruitment processes and identifies user requirements for the development of a patient recruitment system. Identifying eligible patients still requires significant manual efforts, and the roles and tasks of clinical staff and research staff vary in the recruitment process. Technical challenges for patient recruitment systems include requirements for features, data, infrastructure, and workflow integration.
JMIR MEDICAL INFORMATICS
(2022)
Article
Medicine, Research & Experimental
Mais Iflaifel, Kirsty Sprange, Jennifer Bell, Andrew Cook, Carrol Gamble, Steven A. Julious, Edmund Juszczak, Louise Linsell, Alan Montgomery, Christopher Partlett
Summary: This study aims to develop guidance for Clinical Trials Units (CTUs) on a risk-proportionate approach to blinding statisticians. The study employed a mixed methods approach involving quantitative and qualitative studies to assess the impact of blinding statisticians and to determine the perspectives of key stakeholders. The key finding is that the decision to blind statisticians should be based on the benefits and risks associated with a particular trial.
Article
Health Care Sciences & Services
Samuel Watson, Alan Girling, Karla Hemming
Summary: This article presents a review of statistical and computational methods for identifying optimal cluster randomised trial designs. Three broad classes of methods are identified: exact formulae for treatment effect estimator variance, generalised methods for estimating weights for experimental units, and combinatorial optimisation algorithms. The results show that these methods can be applied in various cluster trial scenarios, including optimal allocation and determination of the number of single observations to make in each cluster-period.
STATISTICAL METHODS IN MEDICAL RESEARCH
(2023)
Article
Rheumatology
Sabrina Mai Nielsen, Maarten Boers, Maarten de Wit, Beverly Shea, Danielle A. van der Windt, Barnaby C. Reeves, Dorcas Beaton, Rieke Alten, Karine Toupin April, Annelies Boonen, Reuben Escorpizo, Caroline Flurey, Daniel E. Furst, Francis Guillemin, Amye Leong, Christoph Pohl, Marianne Uggen Rasmussen, Jasvinder A. Singh, Josef S. Smolen, Vibeke Strand, Suzanne M. M. Verstappen, Marieke Voshaar, Thasia G. Woodworth, Torkell Ellingsen, Lyn March, George A. Wells, Peter Tugwell, Robin Christensen
Summary: This study developed an operational definition of contextual factors through consensus achieved in Delphi survey and Special Interest Group session, which was well received by OMERACT members.
SEMINARS IN ARTHRITIS AND RHEUMATISM
(2021)
Article
Health Care Sciences & Services
Mengting Ji, Georgi Z. Genchev, Hengye Huang, Ting Xu, Hui Lu, Guangjun Yu
Summary: This study aimed to develop and validate a measurement instrument and test the interrelationships of evaluation variables for an artificial intelligence-enabled clinical decision support system evaluation framework. The results showed that user acceptance is the central dimension of artificial intelligence-enabled clinical decision support system success, directly influenced by perceived ease of use, information quality, service quality, and perceived benefit, and indirectly influenced through system quality and information quality.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2021)
Article
Medicine, General & Internal
Shirley V. Wang, Sebastian Schneeweiss, RCT-DUPLICATE Initiative
Summary: Nonrandomized studies using insurance claims databases can provide real-world evidence on the effectiveness of medical products. By emulating the design parameters of randomized clinical trials and quantifying the agreement between database studies and RCTs, this study highlights the importance of closely replicating trial design and measurements for reliable conclusions.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2023)
Article
Health Care Sciences & Services
Johanna Graeber, Elke Warmerdam, Svenja Aufenberg, Christopher Bull, Kristen Davies, Jan Dixon, Kirsten Emmert, Claire Judd, Corina Maetzler, Ralf Reilmann, Wan-Fai Ng, Victoria Macrae, Walter Maetzler, Hanna Kaduszkiewicz, IDEA-FAST Consortium
Summary: This study investigated the technology acceptance of seven digital medical devices for home use. Through semi-structured interviews and qualitative content analysis, key factors that determine the acceptability of these devices were identified, including ease of use, minimal disruption to daily life, and support from the study team.
Article
Medicine, Research & Experimental
Lucy Ellen Selman, Clare Clement, Margaret Douglas, Keith Douglas, Jodi Taylor, Chris Metcalfe, J. Athene Lane, Jeremy Horwood
Summary: The study revealed various challenges in patient and public involvement (PPI) in clinical trials, including recruitment difficulties, maintaining professional boundaries, and lack of training. Successful PPI requires early planning, power sharing, clear roles, and collaboration and communication with public contributors.
Article
Multidisciplinary Sciences
Ala Taji Heravi, Anne Henn, Stefanie Deuster, Stuart McLennan, Viktoria Gloy, Vera Ruth Mitter, Matthias Briel, Ismaeel Yunusa
Summary: A study conducted in Switzerland found that there may be differences between planned and actual costs of investigational medicinal products (IMPs) in investigator-initiated trials (IITs). Multicenter trials and those with patient involvement were more likely to experience substantial cost differences. The main reasons for cost differences were patient recruitment and organizational issues. There was a lack of priority for IMP services in hospital pharmacies, but closer collaboration between the clinical trial unit and hospital pharmacy staff, as well as sufficient staffing, could improve IMP services.
Article
Genetics & Heredity
Chloe Mighton, Marc Clausen, Agnes Sebastian, Sarah M. Muir, Salma Shickh, Nancy N. Baxter, Adena Scheer, Emily Glogowski, Kasmintan A. Schrader, Kevin E. Thorpe, Theresa H. M. Kim, Jordan Lerner-Ellis, Raymond H. Kim, Dean A. Regier, Ahmed M. Bayoumi, Yvonne Bombard
Summary: The study found that preferences for how to be recontacted varied based on the certainty of the results. Participants were more willing to receive updates from a doctor for certain results, while they preferred using an online database for VUS results. Qualitative data revealed that preferences for provider-mediated recontact were influenced by trust and desire for control.
Review
Geriatrics & Gerontology
Muslim Abbas Syed, Olalekan Lee Aiyegbusi, Eliot Marston, Janet M. Lord, Harriet Teare, Melanie Calvert
Summary: Advancing age is associated with chronic diseases, and there is a need for trials aiming to extend healthy ageing and prevent ageing-related diseases. This study reviewed outcome measures used in healthy ageing trials and summarized the perspectives of key stakeholders. Heterogeneity in interventions and outcomes was found, and challenges in measuring outcomes included recruiting participants with diverse backgrounds and dealing with multi-morbidity in older adults.
Article
Health Care Sciences & Services
Siew Tiang Lau, Rosalind Chiew Jiat Siah, Khairul Dzakirin Bin Rusli, Wen Liang Loh, John Yin Gwee Yap, Emily Ang, Fui Ping Lim, Sok Ying Liaw
Summary: This study describes the design of a head-mounted virtual reality system for education on clinical procedures for nursing students and explores the experience of nursing students using the system. The results show that students had a largely positive perception and learning experience. However, there were challenges related to technology and physical discomfort that need to be addressed.
JMIR SERIOUS GAMES
(2023)
Article
Gastroenterology & Hepatology
Pamela Cairns, Jonathan Ives, Zuzana Deans
Summary: There is significant variation in views about outcomes and management choices for neonatal intestinal failure among different pediatric subspecialties, with gastroenterologists generally being more positive. This may lead to unjustified variation in counseling and parental choices.
FRONTLINE GASTROENTEROLOGY
(2023)
Editorial Material
Biochemistry & Molecular Biology
Isabelle Boisvert, Adam G. Dunn, Erik Lundmark, Jennifer Smith-Merry, Wendy Lipworth, Amber Willink, Sarah E. Hughes, Michele Nealon, Melanie Calvert
Review
Ophthalmology
Jesse Panthagani, Charles O'Donovan, Olalekan Lee Aiyegbusi, Xiaoxuan Liu, Susan Bayliss, Melanie Calvert, Konrad Pesudovs, Alastair K. Denniston, David J. Moore, Tasanee Braithwaite
Summary: This study aims to search for and critically evaluate the psychometric quality of patient-reported outcome measures (PROMs) developed or validated in optic neuritis. The results indicate that there is still a need for the development and improvement of PROMs applicable to optic neuritis.
Review
Medicine, General & Internal
Olalekan Lee Aiyegbusi, Sarah E. Hughes, John Devin Peipert, Liv Marit Valen Schougaard, Roger Wilson, Melanie J. Calvert
Summary: The global demand for hospital treatment exceeds capacity, and the COVID-19 pandemic has worsened this issue. Delayed referrals and decrease in outpatient attendances have led to longer wait times for patients. The use of digital health technologies, particularly remote symptom monitoring systems based on patient-reported outcomes, offers a solution to reduce outpatient waiting lists and provide tailored care to those in greatest need.
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE
(2023)
Editorial Material
Computer Science, Artificial Intelligence
Helen Smith, Kerstin Eder, Jonathan Ives
Article
Medicine, General & Internal
Olalekan Lee Aiyegbusi, Elin Haf Davies, Puja Myles, Tim Williams, Chris Frost, Shamil Haroon, Sarah E. Hughes, Roger Wilson, Christel McMullan, Anuradhaa Subramanian, Krishnarajah Nirantharakumar, Melanie J. Calvert
BMJ EVIDENCE-BASED MEDICINE
(2023)
Article
Medicine, Research & Experimental
Mary Alvarez, Emily J. Hotton, Sam Harding, Jonathan Ives, Joanna F. Crofts, Julia Wade
Summary: This study highlights the complexity of recruitment to intrapartum research and the challenges women face in understanding and making decisions during urgent interventions. The time pressures of intrapartum interventions make recruitment discussions difficult, yet little is known about these interactions. The study proposes a framework for good practice in information provision to address the concerns of women and midwives and ensure fair inclusion in intrapartum trials.
PILOT AND FEASIBILITY STUDIES
(2023)
Article
Ethics
Helen Smith, Giles Birchley, Jonathan Ives
Summary: Software developing companies are creating artificially intelligent systems (AISs) to influence clinical decision-making. AISs make SDCs new actors in the clinical decision-making space, although clinicians are still considered the final decision-makers. This paper argues that moral responsibility for the outcomes of using AISs in healthcare should be shared by the clinical users and SDCs, and proposes considering foreseeability as key in determining how personal moral responsibility can be justly attributed.
Article
Ethics
Helen Smith, John Downer, Jonathan Ives
Summary: With the introduction of AI in healthcare, there is a need for professional guidance to support its use. Reports from National Health Service AI Lab & Health Education England focus on understanding and confidence in AI clinical decision support systems (AI-CDDSs), but lack specific guidance for clinical users. This paper argues that without addressing this deficit, clinical, professional, and reputational safety will be at risk.
JOURNAL OF MEDICAL ETHICS
(2023)
Article
Health Care Sciences & Services
Lena Schnitzler, Aggie T. G. Paulus, Silvia M. A. A. Evers, Tracy E. Roberts, Louise J. Jackson
Summary: The study sought experts' views on the development of a checklist for cost-of-illness (COI) studies. Interviews with 21 experts from 11 countries confirmed the relevance of COI studies in estimating disease burden, identifying cost components, guiding decision making, and providing input for economic evaluations. A lack of standardized critical appraisal tools for COI studies was mentioned, with experts primarily relying on guidelines and checklists for full economic evaluations. Themes discussed during the interviews included the need for a critical appraisal tool, format and practicality, assessing questions, addressing subjectivity, and guidance requirements.
INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE
(2023)
Review
Medicine, General & Internal
Lauren L. O'Mahoney, Ash Routen, Clare Gillies, Winifred Ekezie, Anneka Welford, Alexa Zhang, Urvi Karamchandani, Nikita Simms-Williams, Shabana Cassambai, Ashkon Ardavani, Thomas J. Wilkinson, Grace Hawthorne, Ffoon Curtis, Andrew P. Kingsnorth, Abdullah Almaqhawi, Thomas Ward, Daniel Ayoubkhani, Amitava Banerjee, Melanie Calvert, Roz Shafran, Terence Stephenson, Jonathan Sterne, Helen Ward, Rachael A. Evans, Francesco Zaccardi, Shaney Wright, Kamlesh Khunti
Summary: This study systematically synthesised global evidence and found that at least 45% of COVID-19 survivors in a general population experience persistent symptoms for up to 4 months, with fatigue being the most common symptom. However, there is still limited understanding of the subtypes of Long Covid and effective treatment/management strategies.
Article
Ethics
Krishani Jayasinghe, W. A. S. Chamika, Kaushalya Jayaweera, Kalpani Abhayasinghe, Lasith Dissanayake, Athula Sumathipala, Jonathan Ives
Summary: Engagement with genomic medicine and research has increased globally, including in Sri Lanka. A qualitative study in Sri Lanka revealed potential issues with participants' understanding and attitudes towards genomic medicine. Trust can serve as a basis for consent, but researchers must address misconceptions and earn public trust.
ASIAN BIOETHICS REVIEW
(2023)
Review
Public, Environmental & Occupational Health
Ayesha Iqbal, Philip Kinghorn, Jon Glasby, Denise Tanner, Tracy Roberts
Summary: In the UK, the closure of care homes between 2015 and 2020 resulted in the displacement of a significant number of older and disabled individuals with high care and support needs. Despite the widely perceived impact of relocation on the health and well-being of older people, there is limited evidence due to data collection challenges. This study reviewed existing literature to identify evidence on the costs, consequences, and wider impacts of care home closures, as well as the causes and processes surrounding these closures.
HEALTH & SOCIAL CARE IN THE COMMUNITY
(2023)
Article
Health Care Sciences & Services
Lena Schnitzler, Tracy E. Roberts, Louise J. Jackson, Aggie T. G. Paulus, Silvia M. A. A. Evers
Summary: The objective of this study was to develop a consensus-based checklist for the critical appraisal of cost-of-illness studies. The checklist, comprising seventeen main questions, aims to improve comprehensiveness, transparency, and consistency in these studies. The study also developed guidance statements explaining each question and suggested answer categories to ensure better comparability across international studies.
INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE
(2023)
Article
Surgery
Jonathan Ives, Giles Birchley, Richard Huxtable, Jane Blazeby
BRITISH JOURNAL OF SURGERY
(2023)
