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
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.
Review
Dentistry, Oral Surgery & Medicine
Mariano Sanz, Ana Carrillo de Albornoz, Conchita Martin, Ian Needleman, Maurizio S. Tonetti
Summary: This study aimed to establish a core outcome set for implant dentistry through the Delphi methodology. Candidate outcomes were generated from scientific evidence and focus groups, and experts and people with lived experience participated in a three-round Delphi survey to assess and refine the outcomes. The study successfully identified 13 essential outcomes, which will contribute to the international consensus in implant dentistry.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Dentistry, Oral Surgery & Medicine
Mariano Sanz, Ana Carrillo de Albornoz, Conchita Martin, Ian Needleman, Maurizio S. Tonetti
Summary: This study used the Delphi methodology to obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry. Through systematic reviews and focus groups, candidate outcomes were identified and a three-round Delphi survey was conducted. The study resulted in the identification of 13 essential outcomes in four core areas.
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
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
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
Ophthalmology
Mohammad O. Tallouzi, Jonathan M. Mathers, David J. Moore, Nicholas Bucknall, Melanie J. Calvert, Philip I. Murray, Alastair K. Denniston
Summary: This study developed the world's first Core Outcome Set (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials, incorporating priorities from key stakeholders and providing a minimum set of outcomes for future NIU PS clinical trials. Adoption of this COS can enhance the value of uveitis clinical trials and reduce noninformative research. Some outcomes identified may require future international consensus development on measurement methods.
Article
Obstetrics & Gynecology
N. A. M. Cooper, C. Rivas, M. G. Munro, H. O. D. Critchley, T. J. Clark, K. A. Matteson, R. Papadantonaki, S. Yorke, A. Tan, M. Bofill Rodriguez, M. Bongers, A. Al-Hendy, L. Bahamondes, A. Connolly, C. Farquhar, T. Gray Valbrun, M. Hickey, H. S. Taylor, D. Toub, S. Vannuccini, S. Iliodromiti, K. Khan
Summary: The study aimed to develop a core outcome set (COS) for heavy menstrual bleeding (HMB). Through a systematic review and qualitative studies, 10 most important outcomes were identified, including subjective blood loss, menstrual cycle metrics, severity of dysmenorrhoea, quality of life, etc. These outcomes are applicable to clinical trials and guideline development, and are of great significance in informing policy-making.
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
(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)
Editorial Material
Dentistry, Oral Surgery & Medicine
Maurizio S. S. Tonetti, Lisa Heitz-Mayfield, Panos N. N. Papapanou, Mariano Sanz
Summary: Consensus on a valid and comprehensive set of outcomes for implant dentistry interventions is necessary for improving clinical guidelines and policy. The Implant Dentistry Core Outcome Set and Measurements (ID-COSM) initiative has identified four core outcome domain areas and several mandatory outcomes for trials. This innovative approach combines input from scientific evidence, patients, and industry representatives.
JOURNAL OF PERIODONTOLOGY
(2023)
Article
Dermatology
G. B. Langbroek, A. Wolkerstorfer, S. E. R. Horbach, P. I. Spuls, K. M. Kelly, S. J. Robertson, M. I. van Raath, F. Al-Niaimi, T. Kono, P. Boixeda, H. J. Laubach, A. M. Badawi, A. Troilius Rubin, M. Haedersdal, W. Manuskiatti, C. M. A. M. van der Horst, D. T. Ubbink
Summary: The COSCAM project aims to develop a core outcome set for capillary malformations, with the first stage identifying 67 potential outcome subdomains through systematic review, focus group sessions, and input from patient representatives. The final CDS will serve as a minimum standard in future CM trials, facilitating adequate comparison of treatment outcomes. Future steps include a Delphi study and online consensus meeting to finalize the core outcome (sub)domains.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2021)
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
Rheumatology
Melanie B. Morillon, Alexander Norup, Jasvinder A. Singh, Nicola Dalbeth, William J. Taylor, Martin A. Kennedy, Birthe Mette Pedersen, Rebecca Grainger, Peter Tugwell, Fernando Perez-Ruiz, Cesar Diaz-Torne, N. Lawrence Edwards, Beverley Shea, Torkell J. Ellingsen, Robin Christensen, Lisa K. Stamp
Summary: This study aimed to assess the adherence of gout clinical trials to the core outcome domains endorsed by OMERACT in 2009 and evaluate the reporting before and after the endorsement. The results showed that only a small percentage of acute trials (8%) and no chronic trials reported all the core domains. Therefore, there is a need for continuous encouragement and further guidance on outcome measurement reporting among gout researchers.
SEMINARS IN ARTHRITIS AND RHEUMATISM
(2023)
Article
Rheumatology
Karine Toupin-April, Simon Decary, Maarten de Wit, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverly Shea, Dawn Stacey, France Legare, Anne Lydiatt, Cathie Hofstetter, Laurie Proulx, Robin Christensen, Marieke Voshaar, Maria E. Suarez-Almazor, Annelies Boonen, Tanya Meade, Lyn March, Janet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Jessica Kaufman, Sophie Hill, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Jasvinder A. Singh, Melissa Mannion, Samah Ismail Nasef, Savia de Souza, Anne Boel, Adewale Adebajo, Laurent Arnaud, Tiffany K. Gill, Ellen Moholt, Jennifer Burt, Arundathi Jayatilleke, Ihsane Hmamouchi, David Carrott, Francisco J. Blanco, Kate Mather, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Anthony P. Fernandez, Sarah Mackie, Elena Nikiphorou, Allyson Jones, Regina Greer-Smith, Victor S. Sloan, Akpabio Akpabio, Vibeke Strand, Valerie Umaefulam, Sara Monti, Charmaine Melburn, Nouran Abaza, Kirsten Schultz, Simon Stones, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Lauren K. King, Peter Tugwell
Summary: This study utilized OMERACT methodology to establish a consensus on the core domain set for rheumatology trials of shared decision making interventions, involving patients from the beginning. The endorsed domains included knowledge of options, alignment with patient values and preferences, confidence in the chosen option, satisfaction with the decision-making process, adherence to the chosen option, and potential negative consequences of SDM interventions. Participants from 28 countries provided positive feedback, with 95% endorsing the proposed core domain set.
SEMINARS IN ARTHRITIS AND RHEUMATISM
(2021)
Review
Dentistry, Oral Surgery & Medicine
Jan Derks, Yuki Ichioka, Carlotta Dionigi, Anna Trullenque-Eriksson, Jessica Berglundh, Cristiano Tomasi, Filippo Graziani
Summary: This study evaluated outcome measures, assessment methods, and analysis in clinical studies on the prevention and management of peri-implant mucositis and peri-implantitis. The results showed that probing pocket depth (PPD) and bleeding/suppuration on probing (BOP) were commonly reported measures, while composite outcomes, adverse events, and patient-reported outcomes were less frequently described.
CLINICAL ORAL IMPLANTS RESEARCH
(2023)
Article
Dentistry, Oral Surgery & Medicine
Ingemar Abrahamsson, Ahmed Almohandes, Carlotta Dionigi, Tord Berglundh
Summary: This study aimed to investigate early bone healing around implants with non-modified and modified surfaces. Four different surface characteristics were tested in the mandibles of 6 dogs. The results showed that implants with surface modifications had higher bone-to-implant contact and more newly formed bone within the defect area compared to implants with non-modified surfaces. Acid-etching in oxalic and hydrofluoric acid was found to promote early formation of bone-to-implant contact.
CLINICAL ORAL IMPLANTS RESEARCH
(2023)
Article
Dentistry, Oral Surgery & Medicine
David Martin-Hernandez, Maria Martinez, Javier Robledo-Montana, Marina Munoz-Lopez, Leire Virto, Nagore Ambrosio, Maria Jose Marin, Eduardo Montero, David Herrera, Mariano Sanz, Juan C. Leza, Elena Figuero, Borja Garcia-Bueno
Summary: This study investigated the potential mechanisms underlying the association between periodontitis and depression. Using a rat model, the study found that neuroinflammation (microglia, blood-brain barrier permeability, and sphingosine-1-phosphate pathways) may play a role in this association. The findings showed that the combined effects of periodontitis and chronic mild stress increased neuroinflammation and disrupted the blood-brain barrier. The study also identified differential regulation of enzymes and receptors in the sphingosine-1-phosphate pathway. These findings contribute to our understanding of the relationship between periodontitis and depression.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Dentistry, Oral Surgery & Medicine
Anna Trullenque-Eriksson, Cristiano Tomasi, Max Petzold, Tord Berglundh, Jan Derks
Summary: This registry-based retrospective cohort study found that furcation status has a significant impact on the risk for molar loss. Molars with furcation involvement of degree 2 and 3 have higher risk compared to those without furcation involvement. Additionally, endodontic status and probing depth are also relevant risk factors for molar loss.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Dentistry, Oral Surgery & Medicine
Emilio Couso-Queiruga, Oscar Gonzalez-Martin, Sandra Stuhr, Inaki Gamborena, Leandro Chambrone, Gustavo Avila-Ortiz
Summary: This study evaluated the effectiveness of two different methods for de-epithelialization of autologous connective tissue graft samples. The results showed that both methods were effective in removing most of the oral epithelium, but none of them could completely predictably remove all oral epithelium.
JOURNAL OF PERIODONTOLOGY
(2023)
Article
Dentistry, Oral Surgery & Medicine
Olivier Carcuac, Anna Trullenque-Eriksson, Jan Derks
Summary: This study evaluated the clinical and patient-reported outcomes of using conventional free gingival graft (FGG) or modified FGG (ModFGG) for treating RT1 gingival recession defects at mandibular incisors. The results showed that ModFGG had a higher root coverage rate at 1 year compared to FGG (91.8% vs. 60.7%) and significantly improved the height of keratinized tissue (4.2mm vs. 2.2mm) with less shrinkage. ModFGG also had lower post-surgical morbidity at 2 weeks and higher patient satisfaction at 12 months.
JOURNAL OF PERIODONTOLOGY
(2023)
Review
Dentistry, Oral Surgery & Medicine
Leandro Chambrone, Francisco Salvador Garcia-Valenzuela, Gustavo Avila-Ortiz
Summary: Different types of errors and complications can occur during and after periodontal or implant-related procedures. Methodological biases and misinterpretation of evidence are often overlooked causes of these issues. Proper evaluation of the literature requires solid clinical knowledge and a systematic approach to recognize and avoid common biases and interpretive errors for the effective application of available information. This review focuses on methodological biases, interpretive errors, and the choice of relevant endpoints to accurately assess the real impact and potential consequences of therapeutic approaches.
PERIODONTOLOGY 2000
(2023)
Article
Dentistry, Oral Surgery & Medicine
Fernando Luengo, Javier Sanz-Esporrin, Ignacio Sanz-Sanchez, Myroslav Solonko, David Herrera, Mariano Sanz
Summary: The present study aimed to evaluate the effectiveness of a supportive peri-implant care (SPIC) protocol after surgical therapy of peri-implantitis, including ultrasonic mechanical debridement and glycine powder air polishing. After 12 months of SPIC, there was a significant reduction in probing depths (PD), with the test group showing a larger reduction compared to the control group. The SPIC protocol can maintain or even improve the results obtained after surgical treatment of peri-implantitis.
CLINICAL ORAL IMPLANTS RESEARCH
(2023)
Review
Dentistry, Oral Surgery & Medicine
Antonio Linares, Ignacio Sanz-Sanchez, Jose Dopico, Ana Molina, Juan Blanco, Eduardo Montero
Summary: The aim of this systematic review was to evaluate the efficacy of patient-performed or administered adjunctive measures to non-surgical peri-implantitis therapy. Different adjunctive measures have different impact in terms of probing depth (PD) and/or bleeding on probing (BoP) reductions.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Dentistry, Oral Surgery & Medicine
Erik Regidor, Alberto Ortiz-Vigon, Mario Romandini, Carlotta Dionigi, Jan Derks, Mariano Sanz
Summary: This study aimed to evaluate the potential adjunctive effect of a resorbable collagen membrane in the reconstructive surgical therapy of peri-implantitis. Clinical outcomes and radiographic bone levels were assessed at baseline and 12 months after surgery. The study failed to demonstrate any additional clinical or radiographic benefits of using a resorbable membrane in the treatment of peri-implantitis.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)
Article
Dentistry, Oral Surgery & Medicine
David Herrera, Tord Berglundh, Frank Schwarz, Iain Chapple, Soren Jepsen, Anton Sculean, Moritz Kebschull, Panos N. Papapanou, Maurizio S. Tonetti, Mariano Sanz
Summary: This study aims to develop clinical practice guidelines for the prevention and treatment of peri-implant diseases, emphasizing the need for interdisciplinary approaches and interventions at different stages. The guidelines provide recommendations for maintaining healthy peri-implant tissues and managing peri-implant diseases.
JOURNAL OF CLINICAL PERIODONTOLOGY
(2023)