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
Dentistry, Oral Surgery & Medicine
Maurizio S. Tonetti, Mariano Sanz, Gustavo Avila-Ortiz, Tord Berglundh, Francesco Cairo, Jan Derks, Elena Figuero, Filippo Graziani, Fernando Guerra, Lisa Heitz-Mayfield, Ronald E. E. Jung, Hongchang Lai, Ian Needleman, Panos N. Papapanou, Irena Sailer, Ignacio Sanz-Sanchez, Frank Schwarz, Junyu Shi, Daniel Thoma
Summary: This study aimed to develop a core outcome set and measurements for implant dentistry clinical trials in order to improve evidence-based implant dentistry and quality of care. The study involved steps such as systematic reviews, patient focus groups, a Delphi project, and expert group discussions. The results identified 22 core outcomes in four domains, including pathophysiology, implant/prosthesis lifespan, life impact, and access to care. This study is of significant importance in improving implant dentistry and quality of care.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Surgery
B. Alkhaffaf, A. Metryka, J. M. Blazeby, A. M. Glenny, A. Adeyeye, P. M. Costa, I. Diez del Val, S. S. Gisbertz, A. Guner, S. Law, H. J. Lee, Z. Li, K. Nakada, D. Reim, P. Vorwald, G. L. Baiocchi, W. Allum, M. A. Chaudry, E. A. Griffiths, P. R. Williamson, I. A. Bruce
Summary: This study developed a core outcome set (COS) for surgical trials in gastric cancer through patient interviews, international Delphi survey, and a consensus meeting. The COS includes 8 key outcomes, recommended for use in all future trials for improved trial design and evidence synthesis.
BRITISH JOURNAL OF SURGERY
(2021)
Article
Dentistry, Oral Surgery & Medicine
Maurizio S. Tonetti, Mariano Sanz, Gustavo Avila-Ortiz, Tord Berglundh, Francesco Cairo, Jan Derks, Elena Figuero, Filippo Graziani, Fernando Guerra, Lisa Heitz-Mayfield, Ronald E. Jung, Hongchang Lai, Ian Needleman, Panos N. Papapanou, Irena Sailer, Ignacio Sanz-Sanchez, Frank Schwarz, Junyu Shi, Daniel Thoma
Summary: To improve evidence-based implant dentistry and quality of care, this study aimed to develop a core outcome set and measurements for implant dentistry clinical trials. Through systematic reviews, patient focus groups, and expert discussions, 13 mandatory outcome domains were identified, including pathophysiology, implant/prosthesis lifespan, life impact, and access to care. These domains captured both the benefits and harms of therapy and will contribute to improving evidence-informed implant dentistry and quality of care.
CLINICAL ORAL IMPLANTS RESEARCH
(2023)
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
Krystle Y. Chong, Sarah Solangon, Kurt Barnhart, Pamela Causa-Andrieu, Perrine Capmas, George Condous, Liesl de Waard, James M. N. Duffy, Andrew W. Horne, Maria Memtsa, Femke Mol, Munira Oza, Romina Pesce, Annika Strandell, Madelon van Wely, Janneke van't Hooft, Lan N. Vuong, Jian Zhang, Davor Jurkovic, Ben W. Mol
Summary: This study developed a core outcome set for ectopic pregnancy (EP) to address methodological deficiencies in published randomized controlled trials and systematic reviews. The core outcome set consists of 6 outcomes, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction.
FERTILITY AND STERILITY
(2023)
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
Gastroenterology & Hepatology
Christopher Ma, Jurij Hanzel, Remo Panaccione, William J. Sandborn, Geert R. D'Haens, Vineet Ahuja, Raja Atreya, Charles N. Bernstein, Peter Bossuyt, Brian Bressler, Robert Bryant, Benjamin Cohen, Jean-Frederic Colombel, Silvio Danese, Axel Dignass, Marla C. Dubinsky, Phillip R. Fleshner, Richard B. Gearry, Stephen B. Hanauer, Ailsa Hart, Paulo Gustavo Kotze, Torsten Kucharzik, Peter L. Lakatos, Rupert W. Leong, Fernando Magro, Julian Panes, Laurent Peyrin-Biroulet, Zhihua Ran, Miguel Regueiro, Siddharth Singh, Antonino Spinelli, A. Hillary Steinhart, Simon P. Travis, C. Janneke van der Woude, Bruce Yacyshyn, Takayuki Yamamoto, Matthieu Allez, Willem A. Bemelman, Amy L. Lightner, Edouard Louis, David T. Rubin, Ellen J. Scherl, Corey A. Siegel, Mark S. Silverberg, Severine Vermeire, Claire E. Parker, Stefanie C. McFarlane, Leonardo Guizzetti, Michelle Smith, Niels Vande Casteele, Brian G. Feagan, Vipul Jairath
Summary: This study establishes a core outcome set for randomized controlled trials of CD and UC through a multidisciplinary collaboration involving patients and clinical experts. Candidate outcome domains and measures were generated from literature reviews and patient engagement. The study highlights the importance of harmonizing endpoints for drug development in inflammatory bowel disease.
Article
Anesthesiology
Tonya M. Palermo, Gary A. Walco, Unmesha Roy Paladhi, Kathryn A. Birnie, Geert Crombez, Rocio de la Vega, Christopher Eccleston, Susmita Kashikar-Zuck, Amanda L. Stone
Summary: By conducting a modified Delphi study involving different stakeholder groups, a core outcome set for pediatric chronic pain interventions was updated. Mandatory and optional outcome domains were identified, with pain severity, daily functioning interference, overall well-being, and adverse events being considered mandatory. Future work includes selecting appropriate measures to assess each outcome domain.
Article
Obstetrics & Gynecology
O. Kgosidialwa, D. Bogdanet, A. M. Egan, P. M. O'Shea, C. Newman, T. P. Griffin, C. McDonagh, C. O'Shea, L. Carmody, S. D. Cooray, E. Anastasiou, E. Wender-Ozegowska, C. Clarson, A. Spadola, F. Alvarado, E. Noctor, E. Dempsey, A. Napoli, C. Crowther, S. Galjaard, M. R. Loeken, M. J. A. Maresh, P. Gillespie, H. de Valk, A. Agostini, L. Biesty, D. Devane, F. Dunne
Summary: A core outcome set (COS) for determining the effectiveness of interventions for pregnant women with pregestational diabetes mellitus (PGDM) was developed through a systematic review, online surveys, and a consensus meeting, identifying key outcomes for future research and clinical trials.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
(2021)
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
Medicine, Research & Experimental
Wendy Thompson, Leanne Teoh, Celine Pulcini, David Williams, Carole Pitkeathley, Vanessa Carter, Susie Sanderson, Glauco Torres, Tanya Walsh
Summary: Antimicrobial resistance is a global issue, with antibiotic stewardship being crucial for preserving effectiveness. This study aims to establish an international consensus on core outcome set for dental antibiotic stewardship. Utilizing Delphi survey and online consensus meeting, input will be sought from stakeholder groups to determine critical outcomes.
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
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, Research & Experimental
Roulla Katiri, Deborah A. Hall, Derek J. Hoare, Kathryn Fackrell, Adele Horobin, Nicholas Hogan, Nora Buggy, Paul H. Van de Heyning, Jill B. Firszt, Iain A. Bruce, Padraig T. Kitterick
Summary: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. However, there is inconsistency in reporting the benefits and harms of these interventions in clinical trials, preventing meaningful comparisons or syntheses of trial results. The CROSSSD initiative aimed to achieve consensus among healthcare users and professionals on a set of core outcome domains that are critically important to assess in all clinical trials of SSD interventions.
Article
Rheumatology
Catherine Beauvais, Bruno Pereira, Thao Pham, Christelle Sordet, Pascal Claudepierre, Francoise Fayet, Daniel Wendling, Felicie Costantino, Laurence Carton, Laurent Grange, Martin Soubrier, Nathalie Legoupil, Aleth Perdriger, Isabel Tavares, Emmanuelle Dernis, Laure Gossec, Malory Rodere
Summary: This study aimed to develop and validate a questionnaire that assesses the knowledge of patients with axial spondyloarthritis (axSpA). The questionnaire, named Spondyloarthritis Knowledge Questionnaire (SPAKE), consists of 42 items and a 32-item short form, which assesses knowledge of disease, comorbidities, treatments, self-care, and adaptive skills. The questionnaire showed good internal validity, reproducibility, and sensitivity to change.
JOURNAL OF RHEUMATOLOGY
(2023)
Article
Rheumatology
Ana-Maria Orbai, William Tillett, Suzanne Grieb, Steve Peterson, Elizabeth A. Holdsworth, Nicola Booth, Soumya D. Chakravarty, Laure Gossec
Summary: This study described the flares of psoriatic arthritis (PsA) and their impact on patient-reported outcomes (PROs). Results showed that flare status was associated with worse quality of life, work impairment, and disability. The study suggests that PsA flares should be regularly assessed and managed in clinical care.
JOURNAL OF RHEUMATOLOGY
(2023)
Article
Rheumatology
Philip J. Mease, Akihiko Asahina, Dafna D. Gladman, Yoshiya Tanaka, William Tillett, Barbara Ink, Deepak Assudani, Christine de la Loge, Jason Coarse, Jason Eells, Laure Gossec
Summary: This study evaluated the effects of long-term bimekizumab treatment on symptoms and impact of PsA on patients. The results showed sustained improvements in pain and fatigue, reducing the overall impact of PsA on patients. Physical function and quality of life also improved up to 3 years.
Review
Rheumatology
Ying-Ying Leung, Tatiana V. Korotaeva, Liliana Candia, Susanne Juhl Pedersen, Wilson Bautista Molano, Eric M. Ruderman, Radjesh Bisoendial, Rodolfo Perez-Alamino, Wendy Olsder, Burkhard Moeller, Simeon Grazio, Tania Gudu, Girish M. Mody, Carlos Pineda, Helena Raffayova, Sherry Rohekar, Claudia Goldenstein-Schainberg, Sergio R. Gutierrez Urena, Julio Cesar Casasola Vargas, Bhowmik Meghnathi, Roopa Prasad, Pascal Richette, Jose Roberto S. Miranda, Nikolas Malliotis, Ulla Lindqvist, David Simon, Amara Ezeonyeli, Enrique R. Soriano, Oliver FitzGerald
Summary: The objective of this study was to provide evidence for the efficacy and safety of therapeutic options for the peripheral arthritis domain of PsA for the revised 2021 GRAPPA treatment recommendations. Evidence was derived from new RCTs and recommendations were made for different patient groups based on their treatment history and response. Different classes of therapeutic options were strongly recommended for different patient groups.
JOURNAL OF RHEUMATOLOGY
(2023)
Article
Medicine, General & Internal
Iain B. McInnes, Akihiko Asahina, Laura C. Coates, Robert Landewe, Joseph F. Merola, Christopher Ritchlin, Yoshiya Tanaka, Laure Gossec, Alice B. Gottlieb, Richard B. Warren, Barbara Ink, Deepak Assudani, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Philip J. Mease
Summary: This study evaluated the efficacy and safety of Bimekizumab in patients with active psoriatic arthritis who were naive to biologic DMARDs. The results showed that Bimekizumab treatment had superior improvements in joint, skin, and radiographic efficacy outcomes compared with placebo, and the safety profile was consistent with previous studies.
Article
Rheumatology
Marlene Sousa, Ennio Lubrano, Josef S. Smolen, Clemence Gorlier, Maarten de Wit, Laura C. Coates, Umut Kalyoncu, Adeline Ruyssen-Witrand, Ying-Ying Leung, Rossana Scrivo, Juan D. Canete, Penelope Palominos, Sandra Meisalu, Andra Balanescu, Uta Kiltz, Sibel Zehra Aydin, Inna Gaydukova, Emmanuelle Dernis, Bruno Fautrel, Ana-Maria Orbai, Laure Gossec
Summary: This study aimed to explore patient-defined flares in psoriatic arthritis (PsA) and compare them to an increase in disease activity in psoriatic arthritis (DAPSA). The validity of a patient-reported flare question was also analyzed. The results showed that patient-reported flares were associated with disease activity and symptoms, and there was moderate agreement between patient and physician definitions of worsening.
Article
Rheumatology
Z. R. Stisen, S. M. Nielsen, S. B. Ditlev, M. Skougaard, A. Egeberg, M. Mogensen, T. S. Jorgensen, L. Dreyer, R. Christensen, L. E. Kristensen
Summary: The study aimed to assess the changes and trajectories in serum NGAL during 12 months of anti-inflammatory treatment in PsA patients. The results showed that serum NGAL did not show significant changes or correlations with PsA outcomes, indicating that it is not a suitable biomarker for disease activity and monitoring.
SCANDINAVIAN JOURNAL OF RHEUMATOLOGY
(2023)
Review
Rheumatology
P. H. Duhn, E. E. Waehrens, M. B. Pedersen, S. M. Nielsen, H. Locht, H. Bliddal, R. Christensen, K. Amris
Summary: This systematic review evaluates the benefits and potential harms of patient education as a stand-alone intervention for individuals with chronic widespread pain and fibromyalgia. The results show that patient education as a stand-alone intervention can improve patients' global assessment. However, no significant differences were found in terms of functioning, pain level, emotional distress, and pain cognition when comparing patient education with usual care, no intervention, or waiting list.
SCANDINAVIAN JOURNAL OF RHEUMATOLOGY
(2023)
Article
Rheumatology
Krystel Aouad, Anne Tournadre, Florian Lucasson, Daniel Wendling, Anna Molto, Bruno Fautrel, Laure Gossec
Summary: The study aimed to determine sex differences in disease outcomes in recent axial spondyloarthritis (SpA). The first 6 years of follow-up data from the French DESIR cohort were analyzed. Both men and women showed improvements in disease activity, patient global assessment, and C-reactive protein level over 6 years. However, women had worse clinical outcomes compared to men, with higher disease activity and patient global assessment, while men had more frequent structural damage.
ARTHRITIS CARE & RESEARCH
(2023)
Article
Rheumatology
Ling Xiang, Sungwon Yoon, Andrea H. L. Low, Ying Ying Leung, Warren Fong, Tang Ching Lau, Dow Rhoon Koh, Julian Thumboo
Summary: This study explores the applicability of social cognitive theory (SCT) in improving symptom appraisal and help-seeking among patients with autoimmune rheumatic diseases (ARDs). Semi-structured interviews were conducted with 33 ARD patients and the transcripts were coded using SCT as the framework. The study found that behavioral capacity and self-efficacy were lacking in symptom interpretation, leading to delayed help-seeking. Possible approaches to address this include education to improve behavioral capacity and self-efficacy and enhance expectations, observational learning, reinforcements, and reciprocal determinism.
INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES
(2023)
Article
Rheumatology
Ying Ying Leung, Lihi Eder, Ana-Maria Orbai, Laura C. Coates, Maarten de Wit, Josef S. Smolen, Uta Kiltz, Penelope Palominos, Juan D. Canete, Rossana Scrivo, Andra Balanescu, Emanuelle Dernis, Sandra Meisalu, Martin Soubrier, Umut Kalyoncu, Laure Gossec
Article
Medicine, General & Internal
Oriana Ciani, Anthony M. Manyara, Philippa Davies, Derek Stewart, Christopher J. Weir, Amber E. Young, Jane Blazeby, Nancy J. Butcher, Sylwia Bujkiewicz, An-Wen Chan, Dalia Dawoud, Martin Offringa, Mario Ouwens, Asbjorn Hrobjartssson, Alain Amstutz, Luca Bertolaccini, Vito Domenico Bruno, Declan Devane, Christina D. C. M. Faria, Peter B. Gilbert, Ray Harris, Marissa Lassere, Lucio Marinelli, Sarah Markham, John H. Powers, Yousef Rezaei, Laura Richert, Falk Schwendicke, Larisa G. Tereshchenko, Achilles Thoma, Alparslan Turan, Andrew Worrall, Robin Christensen, Gary S. Collins, Joseph S. Ross, Rod S. Taylor
Summary: Interventional trials that use surrogate endpoints to evaluate treatment effects are increasingly common. However, there is currently inconsistency and lack of clarity in the definition and interpretation of surrogate endpoints. Surrogate endpoints are used as substitutes for the treatment effects on ultimate outcomes of interest. While traditionally biomarkers have been the focus of surrogate endpoint consideration, intermediate outcomes that include measures of function or symptoms can also act as surrogate endpoints. However, there is a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes as surrogate endpoints. Better understanding and reporting on the use of surrogate endpoints in interventional trials is urgently needed.
Article
Rheumatology
Andriko Palmowski, Zhivana Boyadzhieva, Sabrina M. Nielsen, Burkhard Muche, Sandra Hermann, Maarten Boers, Henning Bliddal, Robin Christensen, Edgar Wiebe, Frank Buttgereit
Summary: This study investigated whether the association between glucocorticoid (GC) use and reduced bone mineral density (BMD) in rheumatoid arthritis (RA) patients is modified by sex or age. The results showed no significant differences in the association between GC use and BMD reduction, regardless of sex or age.
ARTHRITIS RESEARCH & THERAPY
(2023)
Article
Rheumatology
Dorthe B. Berthelsen, Lee S. Simon, John P. A. Ioannidis, Marieke Voshaar, Pam Richards, Niti Goel, Vibeke Strand, Sabrina M. Nielsen, Beverly J. Shea, Peter Tugwell, Susan J. Bartlett, Glen S. Hazlewood, Lyn March, Jasvinder A. Singh, Maria E. Suarez-Almazor, Maarten Boers, Randall M. Stevens, Daniel E. Furst, Thasia Woodworth, Amye Leong, Peter M. Brooks, Caroline Flurey, Robin Christensen
Summary: This study aims to develop an understanding of the safety/harm concept in clinical trials for patients with rheumatic and musculoskeletal diseases (RMDs). The study presents a detailed definition of safety/harms and concludes that enough qualitative data are available to begin a Delphi survey.
SEMINARS IN ARTHRITIS AND RHEUMATISM
(2023)