Review
Health Care Sciences & Services
Susanna Dodd, Sarah L. Gorst, Amber Young, Samuel W. Lucas, Paula R. Williamson
Summary: The importance of including patients, carers, and the public in health research is recognized, and core outcome sets (COS) define the minimum set of outcomes to be measured and reported. This study assesses the impact of patient participation on COS.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Article
Medicine, Research & Experimental
Fiona A. Quirke, Patricia Healy, Elaine Ni Bhraonain, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy, Declan Devane
Summary: The Delphi method is commonly used for building consensus on important issues, especially in developing core outcome sets. Participants prioritize outcomes through multiple survey rounds.
Article
Dentistry, Oral Surgery & Medicine
Ian Needleman, Mariano Sanz, Ana Carrillo de Albornoz, Syarida Safii, Norul Husna Mohamad Hassan, Shujiao Qian, Maurizio Tonetti
Summary: The aim of this project was to establish a core outcome set (COS) for dental implant research that aligns with the needs of people with lived experience (PWLE) and dental professionals (DPs). Through focus groups and a Delphi process, a set of core outcomes for dental implant research was determined.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Obstetrics & Gynecology
J. M. N. Duffy, H. AlAhwany, S. Bhattacharya, B. Collura, C. Curtis, J. L. H. Evers, R. G. Farquharson, S. Franik, L. C. Giudice, Y. Khalaf, J. M. L. Knijnenburg, B. Leeners, R. S. Legro, S. Lensen, J. C. Vazquez-Niebla, D. Mavrelos, B. W. J. Mol, C. Niederberger, E. H. Y. Ng, A. S. Otter, L. Puscasiu, S. Rautakallio-Hokkanen, S. Repping, I. Sarris, J. L. Simpson, A. Strandell, C. Strawbridge, H. L. Torrance, A. Vail, M. van Wely, M. A. Vercoe, N. L. Vuong, A. Y. Wang, R. Wang, J. Wilkinson, M. A. Youssef, C. M. Farquharg
Summary: A core outcome set has been developed for infertility research, including key indicators related to pregnancy, delivery information, and newborn health. Implementing this core outcome set is expected to improve the interpretability and comparability of infertility research results.
FERTILITY AND STERILITY
(2021)
Article
Medicine, Research & Experimental
Fiona A. Quirke, Malcolm R. Battin, Caitlin Bernard, Linda Biesty, Frank H. Bloomfield, Mandy Daly, Elaine Finucane, David M. Haas, Patricia Healy, Tim Hurley, Sarah Koskei, Shireen Meher, Eleanor J. Molloy, Maira Niaz, Elaine Ni Bhraonain, Christabell Omukagah Okaronon, Farhana Tabassum, Karen Walker, James R. H. Webbe, Matthew J. Parkes, Jamie J. Kirkham, Declan Devane
Summary: This study compared the effects of a Multi-Round Delphi (MRD) and a Real-Time Delphi (RTD) in the prioritisation of outcomes for a core outcome set (COS) in neonatal encephalopathy treatments. The results showed differences in the outcomes prioritised between the two methods, with participants in the RTD method making fewer changes to their scores compared to participants in the MRD method, indicating greater convergence in the RTD method. The RTD method also had lower drop-out rates and shorter completion time, suggesting advantages over the MRD method.
Article
Dentistry, Oral Surgery & Medicine
Ian Needleman, Mariano Sanz, Ana Carrillo de Albornoz, Syarida Safii, Norul Husna Mohamad Hassan, Shujiao Qian, Maurizio Tonetti
Summary: This study aimed to establish outcomes important to people with dental implant experience and achieve consensus with dental professionals for a core outcome set. The research process involved focus groups with participants from different countries, followed by a three-stage Delphi process to reach consensus. The study concluded that involving people with lived experience in the development of a core outcome set is feasible and enriches the overall consensus.
CLINICAL ORAL IMPLANTS RESEARCH
(2023)
Article
Health Care Sciences & Services
Jamie C. Brehaut, Kelly Carroll, Justin Presseau, Dawn P. Richards, Jenn Gordon, Angele Benard, Natasha Hudek, Ian D. Graham, Dean A. Fergusson, Susan Marlin
Summary: This study introduces a theory-driven approach for designing pretrial surveys related to barriers and drivers of clinical trial participation, aiming to optimize trial recruitment strategies by considering research participation as a behavior subject to similar forces as other human behaviors.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Article
Medicine, Research & Experimental
Xiaoli Liu, Qiuyue Ma, Jie Chen, Huiqi Yang
Summary: This study aims to develop a core outcome set for laparoscopic hiatal hernia repair, providing unique assessment criteria for clinical research and improving comparative analyses among studies.
Article
Public, Environmental & Occupational Health
Tongtong Wu, Yan Yu, Qian Huang, Xueyin Chen, Lihong Yang, Shaonan Liu, Xinfeng Guo
Summary: This study investigated the current status of patient participation and education in Core Outcome Set (COS) studies. The findings showed that although COS developers are increasingly focusing on patient participation, only a few studies reported explicit measures related to patient education. Further patient education is necessary in the development of a new Core Outcome Set.
PATIENT EDUCATION AND COUNSELING
(2024)
Article
Surgery
Nusrat Iqbal, Astrid J. H. M. Machielsen, Merel L. Kimman, Gillian Kane, Rebecca Woodcock, Ugo Grossi, Phil J. Tozer, Stephanie O. Breukink
Summary: The objective of this study was to develop a core outcome set for cryptoglandular anal fistula treatment. In order to achieve consistency in fistula research and identify the best treatment, candidate outcomes were generated through systematic review and patient interviews, and then prioritized by key stakeholders in an online Delphi consensus process. The final core outcome set includes clinical and radiological healing, recurrence, development of additional fistulas, fistula symptoms, incontinence, psychological impact of treatment, complications and reinterventions, patient satisfaction, and quality of life.
Article
Health Care Sciences & Services
Anne Boel, Victoria Navarro-Compan, Robert Landewe, Desiree van der Heijde
Summary: The study found that inviting panel members who missed a round to a subsequent round leads to a better representation of opinions and reduces the chance of false consensus. However, this approach does not influence the final outcome of the Delphi survey.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Article
Medicine, Research & Experimental
Chiara Bellucci, Karen Hughes, Elaine Toomey, Paula R. Williamson, Karen Matvienko-Sikar
Summary: This study examined clinical trialists' knowledge, perceptions, and experiences of Core Outcome Sets (COS). Results showed that while 65% of participants were familiar with COS, only about half of them had used COS in trials. Main barriers to using COS included poor knowledge and difficulties in identifying relevant COS, while main enablers included clear understanding and perceived importance of COS.
Article
Anesthesiology
Carolina Venda Nova, Richeal Ni Riordain, Sarah R. Baker, Joanna M. Zakrzewska
Summary: This study aimed to reach consensus on the importance of treatment outcomes for different stakeholders involved in trigeminal neuralgia (TN) and to establish a core outcome set. The results of this study will improve the consistency of future clinical trials, reduce redundancy in outcome assessment, and facilitate effective comparison of different treatments.
EUROPEAN JOURNAL OF PAIN
(2023)
Article
Endocrinology & Metabolism
Vicki Brown, Marj Moodie, Marufa Sultana, Kylie E. Hunter, Rebecca Byrne, Anna Lene Seidler, Rebecca Golley, Rachael W. Taylor, Kylie D. Hesketh, Karen Matvienko-Sikar
Summary: This study aimed to develop a core outcome set for early childhood obesity prevention intervention studies in children aged 0-5 years. Through systematic stakeholder engagement, 22 core outcomes were identified, providing standardized guidance for outcome measurement and reporting in this field.
INTERNATIONAL JOURNAL OF OBESITY
(2022)
Article
Pharmacology & Pharmacy
Geng Li, Ruxue Han, Mingjun Lin, Zehuai Wen, Xiankun Chen
Summary: In this study, a core outcome set (COS) for Chinese medicine clinical trials for hyperlipidemia was developed to address the issue of outcome heterogeneity. Through a systematic review and a three-round Delphi survey, the most important outcomes for COS-CM-Hyperlipidemia were determined, including cardiovascular events, lipid levels, and cardiovascular disease risk.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Health Care Sciences & Services
Astrid Chevance, Axel Fortel, Adeline Jouannin, Faustine Denis, Marie-France Mamzer, Philippe Ravaud, Stephanie Sidorkiewicz
Summary: Digital pills face limitations in prospective acceptability and willingness to use, primarily due to clinical and ethical concerns. Results indicate that willingness to take digital pills is associated with gender and the current use of connected devices to record health settings.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2022)
Article
Health Care Sciences & Services
Van Thu Nguyen, Philippe Ravaud, Viet Thi Tran, Bridget Young, Isabelle Boutron
Summary: The study investigates patients' preferences for the organization of randomized controlled trials (RCTs) and finds that most patients prefer a hybrid model involving both on-site and remote visits. Patients are more likely to participate in a trial organized according to their preferences.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2022)
Review
Medicine, Research & Experimental
Heather Starmer, Mary Gemma Cherry, Joanne Patterson, Bridget Young, Jason Fleming
Summary: There is a lack of validation and reliability data for assessment tools of head and neck lymphedema, and further efforts are needed to establish a core set of metrics for this condition.
LYMPHATIC RESEARCH AND BIOLOGY
(2023)
Article
Health Care Sciences & Services
Helen Brooks, Angela Devereux-Fitzgerald, Laura Richmond, Neil Caton, Alice Newton, James Downs, Karina Lovell, Penny Bee, Mary Gemma Cherry, Bridget Young, Ivaylo Vassilev, Clare Rotheram, Anne Rogers
Summary: Background social integration, shared decision-making and personalised care are important aspects of mental health and social care policy. To address social isolation among service users, the research team co-adapted a web-based social network intervention called GENIE. Feedback and discussions with stakeholders suggest that the intervention can be most effective within the care planning process, on discharge from hospital, and within early intervention services.
BMC HEALTH SERVICES RESEARCH
(2022)
Article
Medicine, Research & Experimental
Nicola Farrar, Daisy Elliott, Catherine Houghton, Marcus Jepson, Nicola Mills, Sangeetha Paramasivan, Lucy Plumb, Julia Wade, Bridget Young, Jenny L. Donovan, Leila Rooshenas
Summary: This study provides a comprehensive analysis of recruiters' potential challenges and their experiences and perspectives in the clinical environment. The study identifies complex situations that recruiters face when recruiting patients for RCTs, including recruitment in a clinical environment, enthusiasm for RCTs, making judgement about approaching patients, communication challenges, and the interplay between recruiters and professional roles.
Article
Environmental Sciences
Kathy McKay, Eilis Kennedy, Talen Wright, Bridget Young
Summary: LOGiC-Q is a study that explores the experiences of children and young people, and their families, who have been referred to the Gender Identity Development Service (GIDS) in the UK. The study found variations in how waiting is experienced depending on the age of the child and their level of distress about their body. Young people and their parents offered suggestions for how the service could support families on the waiting list.
INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH
(2022)
Article
Medicine, General & Internal
Katie Paddock, Kerry Woolfall, Anna Kearney, Natalie Pattison, Lucy Frith, Carrol Gamble, Ingeborg Welters, John Trinder, Bridget Young
Summary: Obtaining informed consent from patients in ICUs before enrolling them in a study is complex. Stakeholders have different perspectives on consent procedures, with most supporting relatives as SDMs. Participants also prioritize patient care over research recruitment and highlight the importance of clear explanations and safeguards in research procedures.
Article
Pediatrics
Nigel J. Hall, Frances C. Sherratt, Simon Eaton, Erin Walker, Maria Chorozoglou, Lucy Beasant, Michael Stanton, Harriet Corbett, Dean Rex, Natalie Hutchings, Elizabeth Dixon, Esther Crawley, Jane Blazeby, Bridget Young, Isabel Reading
Summary: This study investigated the comparative patient-centered outcomes between non-operative and surgical treatment for uncomplicated acute appendicitis in children. The preliminary data showed that children treated with non-operative treatment reported higher short-term quality of life scores, shorter duration of requiring analgesia, more rapid return to normal activities, and shorter parental absence from work compared to those who underwent appendectomy. These findings suggest the importance of further measuring recovery profile and quality of life in a larger randomized controlled trial.
BMJ PAEDIATRICS OPEN
(2023)
Editorial Material
Medicine, Research & Experimental
Amy M. M. Russell, Victoria Shepherd, Kerry Woolfall, Bridget Young, Katie Gillies, Anna Volkmer, Mark Jayes, Richard Huxtable, Alexander Perkins, Nurulamin M. M. Noor, Beverley Nickolls, Julia Wade
Summary: Informed consent is a fundamental requirement for participation in trials, but obtaining consent can be challenging in certain populations and situations. The complex challenges of alternative consent pathways contribute to underserved populations being excluded from research. A UK-wide collaboration has been formed to address these challenges and identify research gaps in key populations such as individuals with disabilities, fluctuating capacity to consent, and those in emergency care settings. Collaboration across disciplines is essential to address the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways.
Article
Education & Educational Research
Christopher D. Huntley, Bridget Young, Catrin Tudur Smith, Peter L. Fisher
Summary: Test anxiety is common among university students and negatively affects their examination performance. Existing interventions for test anxiety are not very effective, so identifying the key psychological beliefs that predict test anxiety is necessary. This study found that metacognitive beliefs, specifically negative beliefs about the uncontrollability and danger of worry, were significantly correlated with test anxiety. The relationship between these beliefs and examination performance was mediated by the worry dimension of test anxiety. Modifying these metacognitive beliefs within a well-being or study skills program could reduce test anxiety and improve academic performance.
FRONTIERS IN EDUCATION
(2023)
Article
Medicine, General & Internal
Peter Knapp, Thirimon Moe-Byrne, Jacqueline Martin-Kerry, Rebecca Sheridan, Jenny Roche, Elizabeth Coleman, Peter Bower, Steven Higgins, Catherine Stones, Jonathan Graffy, Jenny Preston, Carrol Gamble, Bridget Young, Daniel Perry, Annegret Dahlmann-Noor, Mohamed Abbas, Payal Khandelwal, Siobhan Ludden, Augusto Azuara-Blanco, Emma McConnell, Nicky Mandall, Anna Lawson, Chris A. Rogers, Helena J. M. Smartt, Rachael Heys, Simon R. Stones, Danielle Horton Taylor, Sophie Ainsworth, Jenny Ainsworth
Summary: By comparing multimedia information (MMI) and printed participant information sheets (PIS), the study found that MMI can increase the recruitment rate of trials, but has no effect on the quality of decision-making. MMI is a useful tool for recruiting children and young people in trials.
Article
Dermatology
Laura Fertitta, Kavita Y. Sarin, Christina Bergqvist, Ekshika Patel, Bastien Peiffer, Sabine Moryousef, Marie-Laure Armand, Arnaud Jannic, Salah Ferkal, Philippe Ravaud, Viet-Thi Tran, Jaishri O. Blakeley, Carlos G. Romo, Khaled Ezzedine, Pierre Wolkenstein
Summary: This study first defined severity strata for cutaneous neurofibromas using an anchoring approach. After validation in French and United States populations, the cNF-Skindex and the strata showed a strong correlation in interpreting cutaneous neurofibromas in daily practice and clinical trials.
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2023)
Article
Orthopedics
L. Swaby, D. C. Perry, K. Walker, D. Hind, A. Mills, R. Jayasuriya, N. Totton, L. Desoysa, R. Chatters, B. Young, F. Sherratt, N. Latimer, A. Keetharuth, L. Kenison, S. Walters, A. Gardner, S. Ahuja, L. Campbell, S. Greenwood, A. Cole
Summary: Scoliosis is a lateral curvature of the spine that can cause distress due to appearance. A randomized controlled trial is being conducted to compare the effectiveness of full-time bracing and night-time bracing in adolescent idiopathic scoliosis patients. The study aims to assess treatment outcomes and quality of life measures.
Article
Psychology, Multidisciplinary
Christopher Huntley, Bridget Young, Catrin Tudur Smith, Vikram Jha, Peter Fisher
Summary: The study found that both intolerance of uncertainty and metacognitive beliefs are significantly associated with test anxiety, with metacognitive beliefs having a greater explanatory utility, supporting the S-REF model. Modifying intolerance of uncertainty and metacognitive beliefs may help alleviate test anxiety and help students reach their academic potential.
Article
Psychology, Multidisciplinary
Christopher D. Huntley, Bridget Young, Catrin Tudur Smith, Vikram Jha, Peter L. Fisher
Summary: This study validated the psychometric properties of the MCQ-30 in test anxiety among university students and found good internal consistency. Structural equation modeling revealed that negative beliefs about uncontrollability and danger of worry had the strongest association with anxiety. The findings provide a basis for further testing the validity of the metacognitive model in test anxiety.
CURRENT PSYCHOLOGY
(2022)
