Article
Critical Care Medicine
T. W. Davies, R. J. J. van Gassel, M. van de Poll, J. Gunst, M. P. Casaer, K. B. Christopher, J. C. Preiser, A. Hill, K. Gundogan, A. Reintam-Blaser, A. F. Rousseau, C. Hodgson, D. M. Needham, M. Castro, S. Schaller, T. McClelland, J. J. Pilkington, C. M. Sevin, P. E. Wischmeyer, Z. Y. Lee, D. Govil, A. Li, L. Chapple, L. Denehy, J. C. Montejo-Gonzalez, B. Taylor, D. E. Bear, R. Pearse, A. McNelly, J. Prowle, Z. A. Puthucheary
Summary: This study identified a core outcome set for nutritional and metabolic clinical research in critically ill adults, reaching consensus on essential domains and measurement instruments for use at 30 and 90 days post-randomisation. The CONCISE core outcome set provides internationally agreed minimum outcomes to guide future research.
Article
Obstetrics & Gynecology
T. Tellum, J. Naftalin, C. Chapron, M. Dueholm, S-W Guo, M. Hirsch, E. R. Larby, M. G. Munro, E. Saridogan, Z. M. van der Spuy, D. Jurkovic
Summary: This study identified a set of core outcomes for all studies investigating uterus-sparing interventions for treating uterine adenomyosis. These core outcomes cover a wide range of domains, including pain, uterine bleeding, reproductive outcomes, haematology, urinary system, life impact, delivery of care, adverse events, and reporting items.
HUMAN REPRODUCTION
(2022)
Article
Geriatrics & Gerontology
Jeanette C. Prorok, Paula R. Williamson, Beverley Shea, Darryl Rolfson, Leocadio Rodriguez Manas, Matteo Cesari, Perry Kim, John Muscedere
Summary: This study aimed to establish a global consensus on frailty by developing a core set of minimum data elements and outcomes to guide frailty research. Through the Delphi consensus process, experts from different countries reached a consensus and identified data elements and outcomes forming primary and secondary core sets. The implementation of this consensus is expected to improve care and outcomes for frailty patients.
Article
Clinical Neurology
Jennifer H. H. Carroll, J. Helen Cross, Mary Hickson, Emma Williams, Val Aldridge, Avril Collinson
Summary: This study aims to establish a core outcome set to reflect the benefits of ketogenic diet therapy (KDT) for children with drug-resistant epilepsy. Through literature review, interviews, and surveys, 14 core outcomes were identified, which will standardize research and clinical practice, and enhance the relevance of outcomes.
Article
Obstetrics & Gynecology
R. K. Dhillon-Smith, P. Melo, A. J. Devall, P. P. Smith, M. Al-Memar, K. Barnhart, G. Condous, O. B. Christiansen, M. Goddijn, D. Jurkovic, D. Lissauer, A. Maheshwari, O. T. Oladapo, J. Preisler, L. Regan, R. Small, M. Stephenson, C. Wijeyaratne, S. Quenby, T. Bourne, A. Coomarasamy
Summary: The objective of this study was to develop core outcome sets (COS) for miscarriage management and prevention. Through a modified Delphi survey and consensus development meeting, stakeholders from 15 countries were included. The final COS for miscarriage management and prevention were established, providing important guidance for future randomized trials and systematic reviews.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
(2023)
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
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
Surgery
Kerry N. L. Avery, Nicholas Wilson, Rhiannon Macefield, Angus McNair, Christin Hoffmann, Jane M. Blazeby, Shelley Potter
Summary: This study aims to develop a COS, an agreed minimum set of outcomes to measure and report in studies evaluating novel surgical techniques. Currently, there is a lack of agreement on key outcomes for safe and efficient surgical innovation. The study generated a list of outcome domains, prioritized them through a Delphi survey, and reached consensus through a meeting involving international stakeholders.
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
Orthopedics
I. R. Murray, N. S. Makaram, R. F. LaPrade, F. S. Haddad
Summary: The Bone & Joint Journal has published consensus statements that have influenced clinical practice and policy. However, even valuable consensus statements have limitations as they represent Level V evidence. Consensus studies are most valuable when higher-order evidence is lacking. Critical appraisal of methodological standards, including potential biases, is essential.
BONE & JOINT JOURNAL
(2023)
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
Dermatology
Rosalind C. Simpson, Gudula Kirtschig, Amanda Selk, Suzanne von Seitzberg, Gitte Vittrup, Ione Bissonnette, Jan Kottner, Jaclyn Lanthier, Chris Stanton, David Foster, Martin Promm, Angelo Augenti, Stefano Lauretti, Kim S. Thomas
Summary: This article summarizes the international consensus process on which outcome domains should be measured in interventional trials of genital lichen sclerosus. Three key outcome domains have been agreed upon and it is recommended that researchers incorporate them into study protocols with immediate effect.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Medicine, General & Internal
Italo Calamai, Massimiliano Greco, Marzia Savi, Gaia Vitiello, Elena Garbero, Rosario Spina, Luigi Pisani, Silvia Mongodi, Stefano Finazzi, TUONO Study Investigators
Summary: The lack of a standardized reporting tool for lung ultrasound (LUS) in the ICU has hindered consistency and reproducibility in clinical examinations. This study aimed to develop a structured model form for LUS reporting to enhance diagnostic potential and guide intensivists in daily clinical practice. A committee of critical care physicians from 19 ICUs in Italy, including experienced ultrasound intensivists and LUS experts, reached consensus on 31 out of 33 statements through a modified Delphi process. The approved statements were used to create a structured model form. Further research is needed to evaluate the impact of standardized reports on critically ill patients.
Review
Biochemistry & Molecular Biology
Kelly D. Cobey, Stefanie Haustein, Jamie Brehaut, Ulrich Dirnagl, Delwen L. Franzen, Lars G. Hemkens, Justin Presseau, Nico Riedel, Daniel Strech, Juan Pablo Alperin, Rodrigo Costas, Emily S. Sena, Thed van Leeuwen, Clare L. Ardern, Isabel O. L. Bacellar, Nancy Camack, Marcos Britto Correa, Roberto Buccione, Maximiliano Sergio Cenci, Dean A. Fergusson, Cassandra Gould van Praag, Michael M. Hoffman, Renata Moraes Bielemann, Ugo Moschini, Mauro Paschetta, Valentina Pasquale, Valeria E. Rac, Dylan Roskams-Edris, Hermann M. Schatzl, Jo Anne Stratton, David Moher
Summary: To monitor the state of open science, a modified 3-round Delphi study was conducted to reach consensus on 19 open science practices. Participants included research administrators, researchers, specialists in dedicated open science roles, and librarians. These core practices will serve as the foundation for institutional dashboards and can contribute to policy development, education, and interventions.
Article
Clinical Neurology
Sharon Chiang, Robert Moss, John M. Stern, Inna Hughes, S. Andrew Josephson, Jennifer R. Pearce, Brandon E. Kopald, Anup D. Patel, Vikram R. R. Rao
Summary: Using patient-centered Delphi methodology, this study defines the first core outcome set for measuring quality of life in clinical practice for adults with drug-resistant epilepsy. This set includes 32 outcomes that are not related to seizure frequency and severity.
Article
Pediatrics
Eleanor Mitchell, Sam J. Oddie, Jon Dorling, Chris Gale, Mark John Johnson, William McGuire, Shalini Ojha
Summary: This article describes the implementation of a two-stage consent pathway in the FEED1 trial and the steps taken by the trial team to support sites. Recommendations for future trials considering a similar pathway are also provided.
ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION
(2023)
Article
Acoustics
Bronacha Mylrea-Foley, Hans Wolf, Tamara Stampalija, Christoph Lees
ULTRASCHALL IN DER MEDIZIN
(2023)
Article
Pediatrics
Susanna Sakonidou, Sophia Kotzamanis, Amy Tallett, Alan J. Poots, Neena Modi, Derek Bell, Chris Gale
Summary: This study aimed to refine an existing retrospective survey for 'real-time' feedback in assessing parent experiences of neonatal services. The revised Parents' Experiences of Communication in Neonatal Care (PEC) survey contains 28 questions (10 new) focusing on communication and parent involvement. Developed with parents, it is the first UK instrument formally evaluated to assess parent experience while infants are still receiving neonatal care.
ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION
(2023)
Article
Medicine, Research & Experimental
Katharine Cheng, Fenna Mahler, Irja Lutsar, Begonya Nafria Escalera, Stefanie Breitenstein, Gilles Vassal, Joana Claverol, Nuria Noel Palacio, Ron Portman, Gavin Pope, Martijn Bakker, Tessa van Der Geest, Mark A. A. Turner, Saskia N. N. de Wildt
Summary: Many medicines are used off-label in children outside the terms of the license. The Conect4children project aims to establish a pan-European pediatric clinical trial network to facilitate the development of new medicines for children. The project has successfully set up a multidisciplinary advice service, including the input of young patients and families, to optimize pediatric trial development and provide valuable advice to trial sponsors.
CTS-CLINICAL AND TRANSLATIONAL SCIENCE
(2023)
Correction
Obstetrics & Gynecology
Anna Aprile, Giuseppe Cali, Nicola Chianchiano, Valentina Chiappa, Paola Corbella, Vincenzo D'Addario, Andrea Dall'Asta, Valentina De Robertis, Caterina Exacustos, Alessandra Familiari, Anna Fichera, Chiara Formigoni, Tiziana Frusca, Tullio Ghi, Stefano Guerriero, Ambra Iuculano, Francesco Labate, Pasquale Martinelli, Giovanni Monni, Maddalena Morlano, Francesco Nonino, Claudiana Olivieri, Dario Paladini, Cristina Peddes, Federico Prefumo, Giuseppe Rizzo, Mariangela Rustico, Laura Sarno, Irene Sciacovelli, Andrea Sciarrone, Tamara Stampalija, Fabrizio Taddei, Tullia Todros, Herbert Valensise, Patrizia Vergani, Nicola Volpe, Paolo Volpe, Carmela Votino, Germano Bettoncelli, Gabriella Bracalente, Monica Collini Ceccatelli, Mariapaola Costantini, Antonino D'Aloia, Enrico Ferrazzi, Claudio Giorlandino, Mariavittoria Locci, Carla Verrotti di Pianella, Elsa Viora, Riccardo Zoia, Katia Bilardo, Maria Vicar
EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY
(2023)
Review
Peripheral Vascular Disease
James E. Sharman, Pedro Ordunez, Tammy Brady, Gianfranco Parati, George Stergiou, Paul K. Whelton, Raj Padwal, Michael Hecht Olsen, Christian Delles, Aletta E. Schutte, Maciej Tomaszewski, Daniel T. Lackland, Nadia Khan, Richard J. McManus, Ross T. Tsuyuki, Xin-Hua Zhang, Lisa D. Murphy, Andrew E. Moran, Markus P. Schlaich, Norm R. C. Campbell
JOURNAL OF HUMAN HYPERTENSION
(2023)
Article
Pharmacology & Pharmacy
Evelina Cardoso, Anaelle Monfort, Ema Ferreira, Hedvig Nordeng, Ursula Winterfeld, Karel Allegaert, Peggy Gandia, Monia Guidi, Alice Panchaud
Summary: Human milk is the best nutrition for infants, and taking medication postpartum is common. Discontinuing breastfeeding is often wrongly advised due to concerns of adverse effects on the infant, even though only a few drugs are strictly prohibited while breastfeeding. Most drugs are transferred from the mother's blood to the milk, but the amount ingested by the infant is usually small. As there is limited population-based evidence on drug safety during breastfeeding, risk assessment relies on available clinical evidence, pharmacokinetic principles, and specialized sources of information for clinical decision-making. Risk assessment should consider both the potential risk to the infant and the benefits and risks associated with breastfeeding and maternal disease. Identifying situations with potential for drug accumulation in the infant is crucial for risk assessment. Healthcare providers should assume maternal concerns and utilize risk communication to ensure medication adherence without interrupting breastfeeding unnecessarily. Decision support algorithms and strategies can be used to minimize drug exposure in the breastfed infant, even when clinically not justified.
Letter
Obstetrics & Gynecology
Renee J. Burger, Anita C. J. Ravelli, Sanne J. Gordijn, Wessel Ganzevoort
ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA
(2023)
Article
Obstetrics & Gynecology
Jiaxin Qiu, Tong Du, Haiyan Guo, Ben W. W. Mol, Jiaying Lin, Dong Zhao, Yun Wang, Yanping Kuang, Wentao Li
Summary: This study aimed to investigate the impact of Day 3 embryo status on reproductive outcomes of blastocyst transfer cycles. The findings showed that high-quality blastocysts derived from poor-grade Day 3 embryos had comparable pregnancy outcomes to those derived from high-grade Day 3 embryos. However, cycles with low Day 3 cell number (five cells or fewer) had a significantly higher miscarriage rate compared to cycles with eight cells on Day 3.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
(2023)
Editorial Material
Obstetrics & Gynecology
L. A. Magee, P. von Dadelszen
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
(2023)
Article
Obstetrics & Gynecology
Chunyan Sun, Mingming Ye, Yuanyuan Wu, Qiaoyu Chen, Zhenzhen Meng, Lulu Geng, Orhan Bukulmez, Ben W. Mol, Xiaoming Teng, Miaoxin Chen
Summary: This retrospective cohort study aimed to compare clinical outcomes following fresh or frozen embryo transfer (FET) in women with advanced reproductive age (ARA). The results showed that FET did not improve live birth and other clinical outcomes as compared with fresh embryo transfer in women with ARA who underwent their first IVF cycle.
Editorial Material
Primary Health Care
Caroline Mitchell, Kate Fryer, Nicola Guess, Habiba Aminu, Ben Jackson, Anna Gordon, Josephine Reynolds, Qizhi Huang, Shamanthi Jayasooriya, Rebecca Mawson, Tom Lawy, Emma Linton, Janet Brown
BRITISH JOURNAL OF GENERAL PRACTICE
(2023)
Article
Peripheral Vascular Disease
Sukainah Al Khalaf, Lucy C. C. Chappell, Ali S. S. Khashan, Fergus P. P. McCarthy, Eilis J. O'Reilly
Summary: There is a strong association between chronic hypertension and the risk of cardiovascular disease (CVD) in mothers, especially those with adverse pregnancy outcomes (APOs). This risk can lead to premature CVD, thus intervention programs targeting these high-risk groups might reduce their risk of subsequent CVD.
Review
Obstetrics & Gynecology
Themistoklis Dagklis, Ranjit Akolekar, Cecilia Villalain, Ioannis Tsakiridis, Assaad Kesrouani, Aydin Tekay, Walter Plasencia, Sven Wellmann, Satoshi Kusuda, Nelly Jekova, Federico Prefumo, Nicola Volpe, Petya Chaveeva, Karel Allegaert, Asma Khalil, Cihat Sen
Summary: This practice guideline aims to improve the management of preterm labor and provides further guidance for healthcare practitioners on diagnosing preterm labor and the appropriate use of medications.
EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY
(2023)
Article
Obstetrics & Gynecology
Margaret Mascherpa, Anna Fichera, Rossana Orabona, Daniela Recupero, Barbara Borroni, Franco Edoardo Odicino, Federico Prefumo
Summary: An optimal materno-neonatal outcome was achieved in a pregnancy involving inherited episodic ataxia through a multidisciplinary team managing the timing and mode of delivery.
INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS
(2023)
