Article
Economics
Max Tabord-Meehan
Summary: This paper proposes an adaptive randomisation procedure for two-stage randomised controlled trials. The method uses data from a first-wave experiment to determine stratification in a second wave of the experiment. The main result shows that using this randomisation procedure with an appropriate estimator results in a minimal asymptotic variance in the class of stratification trees.
REVIEW OF ECONOMIC STUDIES
(2023)
Article
Medicine, General & Internal
Maria K. Sobczyk, Jie Zheng, George Davey Smith, Tom R. Gaunt
Summary: We conclude that careful triangulation of MR with RCT evidence should involve consideration of similarity of phenotypes across study designs, intervention intensity and duration, study population demography and health status, comparator group, intervention goal and quality of evidence.
Review
Infectious Diseases
Venkata R. Emani, Sanjeev Goswami, Dheeraj Nandanoor, Shaila R. Emani, Nidhi K. Reddy, Raghunath Reddy
Summary: In the early stages of the COVID-19 pandemic, there were no proven treatment options. However, recent randomised controlled trials have indicated potential treatments such as dexamethasone and remdesivir. Hydroxychloroquine and lopinavir/ritonavir did not show any mortality benefits. It is crucial to improve randomisation methodologies to ensure accurate results and match study groups better.
INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
(2021)
Review
Nursing
Marion Eckert, Kate Kennedy, Kim Neylon, Claire M. Rickard, Samantha Keogh, Richard Gray, Sandy Middleton, Caroline Homer, Lisa Whitehead, Greg Sharplin
Summary: This scoping review found that nurse-led research activities are relatively low, with more registered trials than published studies. Additional support in infrastructure, funding, and career frameworks is needed to enable nurses to design, conduct, and publish clinical trials and improve health outcomes.
JOURNAL OF CLINICAL NURSING
(2023)
Review
Cardiac & Cardiovascular Systems
Kevin C. Harris, Andrew S. Mackie, Frederic Dallaire, Michael Khoury, Joel Singer, William T. Mahle, Terry P. Klassen, Brian W. McCrindle
Summary: Pediatric cardiology has evolved with time, with an increasing recognition of the importance of randomised controlled trials. While the number of impactful trials has increased, there remains a relative scarcity of such trials in the field.
CANADIAN JOURNAL OF CARDIOLOGY
(2021)
Review
Medicine, General & Internal
Juuso Heikkinen, Soumen Das De, Jarkko Jokihaara, Kati Jaatinen, Rachelle Buchbinder, Teemu Karjalainen
Summary: There is a significant evidence gap in the research on the efficacy of hand surgery, especially for chronic hand conditions. More studies comparing hand surgery with non-operative care are needed to determine the optimal care for patients with hand conditions.
Article
Public, Environmental & Occupational Health
Jef L. Leroy, Edward A. Frongillo, Bezawit E. Kase, Silvia Alonso, Mario Chen, Ian Dohoo, Lieven Huybregts, Suneetha Kadiyala, Naomi M. Saville
Summary: Researchers conducting randomised controlled trials (RCTs) of complex interventions face challenges in design and analysis that are not fully addressed in existing guidelines. Further guidance is needed to ensure that these trials are conducted to the highest scientific standards while maximizing the evidence that can be obtained. The key challenge is how to manage multiple outcomes while minimizing false positive and false negative findings. To address this, three principles are formulated: selecting outcomes based on the intervention's intent and program theory, ensuring adequate power for outcomes, and being explicit and transparent about all outcomes and hypotheses.
Article
Integrative & Complementary Medicine
Xuan Zhang, Lin Zhang, Weifeng Xiong, Xihong Wang, Xiaohan Zhou, Chen Zhao, Guihua Tian, Hongcai Shang, Taixiang Wu, Jiangxia Miao, Zhaoxiang Bian
Summary: This study assessed the reporting quality of randomized controlled trials of massage, and found that most massage RCTs were distributed in China with generally low reporting quality. Although there has been a slight improvement in the overall quality of articles in recent years, further improvements are needed, especially the development of a reporting guideline CONSORT extension for massage.
Article
Gastroenterology & Hepatology
Dennis M. Jensen, Alan Barkun, David Cave, Ian M. Gralnek, Rome Jutabha, Loren Laine, James Y. W. Lau, John R. Saltzman, Roy Soetikno, Joseph J. Y. Sung
Summary: This study aimed to propose outcome measures for future randomized controlled trials (RCTs) in patients with acute gastrointestinal bleeding (GIB) and suggest new RCTs for future funding. The primary endpoint proposed is a composite outcome of further bleeding within 30 days after randomization, potentially leading to red blood cell transfusion, urgent intervention (repeat endoscopy; interventional radiology or surgery), or death.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Food Science & Technology
Dana Loudovici-Krug, Steffen Derlien, Norman Best, Albrecht Guenther
Summary: This article discusses physiotherapy as an adjunctive treatment for cervical dystonia, focusing on improving symptoms such as pain, function, and quality of life. The study suggests that additional physical therapy and active home exercise programs can be beneficial for patients. However, botulinum neurotoxin injection remains the treatment of choice.
Article
Health Care Sciences & Services
Caroline Kristunas, Michael Grayling, Laura J. Gray, Karla Hemming
Summary: Covariate constrained randomisation provides moderate to substantial improvements in power compared to worst balanced allocations, but the prognostic effect of the covariates should be carefully considered when selecting them for randomisation.
BMC MEDICAL RESEARCH METHODOLOGY
(2022)
Article
Plant Sciences
Leonard Ho, Claire C. W. Zhong, Charlene H. L. Wong, Justin C. Y. Wu, Karina K. H. Chan, Irene X. Y. Wu, Ting Hung Leung, Vincent C. H. Chung
Summary: This study evaluated the comparative effectiveness of herbal medicine formulae for functional dyspepsia through a network meta-analysis. Findings suggest that Xiao Yao Pill and Modified Ban Xia Xie Xin Decoction may have beneficial effects in alleviating global symptoms, with no serious adverse events reported. Further trials are needed to assess the comparative effectiveness of these formulae.
JOURNAL OF ETHNOPHARMACOLOGY
(2022)
Editorial Material
Rheumatology
Christian Dejaco, Sofia Ramiro, Zahi Touma, Milena Bond, Medha Soowamber, Catalina Sanchez-Alvarez, Carol A. Langford
Summary: Giant cell arteritis (GCA) is commonly treated with glucocorticoids (GCs), but there is a need for research on GC-sparing agents due to the high rate of adverse events with GC alone. The lack of standardised response assessment in clinical trials makes it difficult to compare treatment effects. This viewpoint article discusses the challenges and opportunities in developing internationally accepted response criteria for GCA.
ANNALS OF THE RHEUMATIC DISEASES
(2023)
Review
Dentistry, Oral Surgery & Medicine
He Cai, Pengjun Xi, Linna Zhong, Junyu Chen, Xing Liang
Summary: The study evaluated the efficacy of aromatherapy on dental anxiety, showing potential reduction in anxiety-related physiological and psychological parameters. However, the certainty of evidence was low, and further high-quality research is needed to confirm the findings.
Article
Pediatrics
Shiraz Badurdeen, Kate A. Hodgson, Georgia A. Santomartino, Luke Stevens, Susan Donath, Calum T. Roberts, Brett J. Manley, Graeme R. Polglase, Stuart B. Hooper, Peter G. Davis, Douglas A. Blank
Summary: This article presents the experience of rapid randomisation using the non-commercial REDCap platform accessed via smartphone in two neonatal resuscitation trials. The conclusion is that this simple and reliable method has wide applicability for trials in emergency settings.
EUROPEAN JOURNAL OF PEDIATRICS
(2022)
Review
Health Care Sciences & Services
Laura Clark, Lauren Burke, Rachel Margaret Carr, Elizabeth Coleman, Gareth Roberts, David J. Torgerson
Summary: This study examined the association between blocking strategies and baseline age heterogeneity in open RCTs published from 2001 to 2020. The findings suggest that implementing blocking is linked to an increase in baseline age heterogeneity, with modern trials tending to use smaller block sizes.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Review
Medicine, Research & Experimental
Catherine Knowlson, Alexandra Dean, Laura Doherty, Caroline Fairhurst, Stephen Brealey, David J. Torgerson
Summary: This review investigates the recruitment distribution of multicentre randomized controlled trials (RCTs) and finds that face-to-face recruitment fits more closely to Price's Law than the Pareto Principle. Chief Investigator sites recruited approximately a fifth of the participants.
CONTEMPORARY CLINICAL TRIALS
(2022)
Review
Multidisciplinary Sciences
Mehreen Riaz Faisal, Masuma Pervin Mishu, Faisal Jahangir, Sabahat Younes, Omara Dogar, Kamran Siddiqi, David J. Torgerson
Summary: This study aimed to determine the effectiveness of behavior change interventions delivered by non-dental professionals and health workers. The results suggest that these interventions may help improve oral health outcomes for children, but the current evidence is of low quality. Further high-quality studies are needed to confirm these findings.
Article
Medicine, General & Internal
Sean Urwin, Jo C. Dumville, Matt Sutton, Nicky Cullum
Summary: This study estimated and examined the direct healthcare costs of treating people with open venous leg ulcers in the UK. The prevalence and costs of venous leg ulcer treatment were found to be lower than previously thought.
Article
Medicine, General & Internal
Thomas Mason, William Whittaker, Jo C. Dumville, Peter Bower
Summary: This study estimates the 'rule of halves' for diabetes care in urban and rural areas of England. It found that diabetes prevalence is higher in urban areas, but the difference in care quality between urban and rural settings is not significant. Appropriate care quality is associated with a higher proportion of patients achieving treatment targets.
Review
Endocrinology & Metabolism
L. Vandenput, H. Johansson, E. V. McCloskey, E. Liu, K. E. Akesson, F. A. Anderson, R. Azagra, C. L. Bager, C. Beaudart, H. A. Bischoff-Ferrari, E. Biver, O. Bruyere, J. A. Cauley, J. R. Center, R. Chapurlat, C. Christiansen, C. Cooper, C. J. Crandall, S. R. Cummings, J. A. P. da Silva, B. Dawson-Hughes, A. Diez-Perez, A. B. Dufour, J. A. Eisman, P. J. M. Elders, S. Ferrari, Y. Fujita, S. Fujiwara, C. -C. Glueer, I. Goldshtein, D. Goltzman, V. Gudnason, J. Hall, D. Hans, M. Hoff, R. J. Hollick, M. Huisman, M. Iki, S. Ish-Shalom, G. Jones, M. K. Karlsson, S. Khosla, D. P. Kiel, W. -P. Koh, F. Koromani, M. A. Kotowicz, H. Kroger, T. Kwok, O. Lamy, A. Langhammer, B. Larijani, K. Lippuner, D. Mellstrom, T. Merlijn, A. Nordstrom, P. Nordstrom, T. W. O'Neill, B. Obermayer-Pietsch, C. Ohlsson, E. S. Orwoll, J. A. Pasco, F. Rivadeneira, B. Schei, A. -M. Schott, E. J. Shiroma, K. Siggeirsdottir, E. M. Simonsick, E. Sornay-Rendu, R. Sund, K. M. A. Swart, P. Szulc, J. Tamaki, D. J. Torgerson, N. M. van Schoor, T. P. van Staa, J. Vila, N. J. Wareham, N. C. Wright, N. Yoshimura, M. C. Zillikens, M. Zwart, N. C. Harvey, M. Lorentzon, W. D. Leslie, J. A. Kanis
Summary: This study describes the collection of cohorts and the analysis plan for updating the fracture risk prediction tool FRAX. The aim is to optimize the current algorithms with respect to current and novel risk factors. The resource includes over 2 million participants and documented incident major osteoporotic fractures. The assembled cohorts and models will provide an updated FRAX tool for enhanced assessment of fracture risk.
OSTEOPOROSIS INTERNATIONAL
(2022)
Review
Dermatology
Chunhu Shi, Jo C. Dumville, Harun Juwale, Connor Moran, Ross Atkinson
Summary: This article reviews the development, evaluation, and implementation of digital health technologies in wound care. The study finds that most digital health technologies are primarily focused on wound imaging and measurement, and there is a lack of transparent reporting in evaluation activities.
JOURNAL OF TISSUE VIABILITY
(2022)
Review
Medicine, General & Internal
Gill Norman, Thomas Mason, Jo C. Dumville, Peter Bower, Paul Wilson, Nicky Cullum
Summary: This study examines rapid evaluations of health and social care innovations, categorizes different approaches to rapid evaluation, explores the comparative benefits of rapid evaluation, and identifies knowledge gaps. It highlights the need for clarity and consistency in defining rapid evaluation, the development of specific methodologies for more rapid evaluation, and the assessment of advantages and disadvantages of rapid evaluation in terms of rigor, cost, and impact.
Review
Public, Environmental & Occupational Health
Catherine Knowlson, Ailish Byrne, Jacqueline Wilkinson, Claire Whitmore, David Torgerson
Summary: This study aims to investigate the basis and the number of published studies for the emergency use authorizations (EUAs) issued by the US FDA during the COVID-19 pandemic. The findings showed limited clinical studies for the treatments before and during the active EUAs, indicating a need for large, robust randomized controlled trials to quickly obtain evidence-based therapies during a pandemic.
HEALTH SCIENCE REPORTS
(2023)
Article
Nursing
Catherine Perry, Ross A. A. Atkinson, Jane Griffiths, Paul M. M. Wilson, Jacqueline F. F. Lavallee, Nicky Cullum, Jo C. C. Dumville
Summary: This study aims to explore barriers to and facilitators of adherence to compression therapy for venous leg ulcers from the perspective of patients. Qualitative interviews were conducted and thematic analysis was used to analyze the data. The study found that the understanding of the cause of venous leg ulcers and the mechanism of compression therapy did not have a clear relationship with adherence. Different compression therapies presented different challenges for patients, and unintentional non-adherence was frequently mentioned. The organization of services could impact adherence. Rating: 7/10.
JOURNAL OF ADVANCED NURSING
(2023)
Article
Orthopedics
E. Cook, S. James, A. C. Watts, SOFFT team
Summary: This article introduces a study on the surgical treatment of olecranon fractures. The study compares the clinical and cost effectiveness of tension suture repair to traditional tension band wiring. Results will provide evidence for the treatment of Mayo grade IIA fractures.
Review
Obstetrics & Gynecology
Dexter J. L. Hayes, Jo C. Dumville, Tanya Walsh, Lucy E. Higgins, Margaret Fisher, Anna Akselsson, Melissa Whitworth, Alexander E. P. Heazell
Summary: This systematic review and meta-analysis aimed to determine whether interventions aimed at encouraging awareness of reduced fetal movement and/or improving its subsequent clinical management reduce the frequency of stillbirth or other important secondary outcomes. The results indicate that encouraging awareness of fetal movement may be associated with reduced neonatal intensive care unit admissions and Apgar scores of <7 at 5 minutes of age, but the effect on reducing stillbirth remains uncertain. The analysis was limited by variations in interventions, outcome reporting, and definitions.
AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY MFM
(2023)
Article
Orthopedics
H. Thompson, S. Brealey, E. Cook, S. Hadi, S. H. M. Khan, A. Rangan
Summary: In this study, we achieved expert consensus on the use of hydrodilatation for the treatment of primary frozen shoulder through a survey of shoulder experts. The results showed that elements such as image guidance, local anaesthetic, normal saline, and steroids were encouraged, while the use of hypertonic saline was considered disallowed.
Review
Medicine, General & Internal
Gill Norman, Chunhu Shi, En Lin Goh, Elizabeth M. A. Murphy, Adam Reid, Laura Chiverton, Monica Stankiewicz, Jo C. Dumville
Summary: The use of negative pressure wound therapy (NPWT) can effectively prevent surgical site infections, reduce mortality, and decrease the occurrence of surgical site infections, however, it may increase the incidence of skin blisters.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS
(2022)
Review
Medicine, General & Internal
M. Stephens, C. Bartley, J. C. Dumville
Summary: Currently, there is no randomized evidence to support or refute the role of pressure redistributing static chairs in the prevention or management of pressure ulcers. This is a priority area that requires rigorous and robust research.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS
(2022)
Article
Medicine, Research & Experimental
Hongjin Li, Judith M. Schlaeger, Crystal L. Patil, Oana Danciu, Zhengjia Chen, Natalie Lif, Shuang Gao, Ardith Z. Doorenbos
Summary: Nearly 94% of breast cancer survivors experience symptoms or side effects during or after endocrine therapy, and acupuncture offers a comprehensive solution to address these issues. However, medically underserved breast cancer survivors often lack access to acupuncture. To promote equal access and evidence-based treatment, a randomized controlled trial is being conducted to investigate the effectiveness of acupuncture for symptom management among this population.
CONTEMPORARY CLINICAL TRIALS
(2024)
Article
Medicine, Research & Experimental
JoAnn M. Sperl-Hillen, Jacob L. Haapala, Steven P. Dehmer, Lilian N. Chumba, Heidi L. Ekstrom, Anjali R. Truitt, Stephen E. Asche, Ann M. Werner, Dan J. Rehrauer, Melissa A. Pankonin, Pamala A. Pawloski, Patrick J. O'Connor
Summary: This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. Protocol adaptation became imperative in response to major implementation challenges.
CONTEMPORARY CLINICAL TRIALS
(2024)
Article
Medicine, Research & Experimental
Connor Celum, Bethany Jablonski Horton, Mark Conaway
Summary: This paper proposes a phase-I clinical trial design that uses ordinal toxicity to locate group-specific doses. The proposed method avoids dose-reversals and is compared with two other methods through simulations.
CONTEMPORARY CLINICAL TRIALS
(2024)
Article
Medicine, Research & Experimental
Tanya Knutzen, Eileen Bulger, Matt Iles-Shih, Alexandra Hernandez, Allison Engstrom, Lauren Whiteside, Navneet Birk, Khadija Abu, Jake Shoyer, Cristina Conde, Paige Ryan, Jin Wang, Joan Russo, Patrick Heagerty, Larry Palinkas, Douglas Zatzick
Summary: This study aims to investigate how trauma centers in the US can effectively conduct mental health screening, intervention, and referral services to help injured patients recover. The study will randomly assign patients to different intervention groups and compare the impact of different interventions on PTSD symptoms and emergency department/inpatient utilization.
CONTEMPORARY CLINICAL TRIALS
(2024)
