Purpose: To develop an agreed upon set of outcomes known as a "core outcome set" (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials.
Design: Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting.
Participants: Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners.
Methods: A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of "include," "exclude," or "for discussion" that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS.
Main Outcome Measure: Items recommended for inclusion in the COS for NIU-PS.
Results: A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control.
Conclusions: This study builds on international work across the clinical trials community and our qualitative research to construct the world's first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ophtha.2021.01.022 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Kinematic Alignment Does Not Result in Clinically Important Improvements After TKA Compared With Mechanical Alignment: A Meta-analysis of Randomized Trials.
Clin Orthop Relat Res
January 2025
Division of Orthopaedic Surgery, University of Toronto, Toronto, ON, Canada.
Background: There is debate as to whether kinematic TKA or mechanical alignment TKA is superior. Recent systematic reviews have suggested that kinematically aligned TKAs may be the preferred option. However, the observed differences in alignment favoring kinematic alignment may not improve outcomes (performance or durability) in ways that patients can perceive, and likewise, statistical differences in outcome scores sometimes observed in clinical trials may be too small for patients to notice.
View Article and Find Full Text PDFAbelacimab versus Rivaroxaban in Patients with Atrial Fibrillation.
N Engl J Med
January 2025
From the TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston (C.T.R., S.M.P., R.P.G., D.A.M., J.F.K., E.L.G., S.A.M., S.D.W., M.S.S.); Anthos Therapeutics, Cambridge, MA (B.H., S.P., D.B.); the Heart Rhythm Center, Taipei Veterans General Hospital and Cardiovascular Center, Taipei, Taiwan (S.-A.C.); Taichung Veterans Hospital, Taichung, Taiwan (S.-A.C.); National Yang Ming Chiao Tung University, Hsinchu, Taiwan (S.-A.C.); National Chung Hsing University, Taichung, Taiwan (S.-A.C.); St. Michael's Hospital, Unity Health Toronto, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto (S.G.G.); Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.); the Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea (B.J.); the Department of Cardiology, Central Hospital of Northern Pest-Military Hospital, Budapest, Hungary (R.G.K.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (R.G.K.); the Internal Cardiology Department, St. Ann University Hospital and Masaryk University, Brno, Czech Republic (J.S.); the Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland (W.W.); the Departments of Medicine and of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, ON, Canada (J.W.); and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.).
Background: Abelacimab is a fully human monoclonal antibody that binds to the inactive form of factor XI and blocks its activation. The safety of abelacimab as compared with a direct oral anticoagulant in patients with atrial fibrillation is unknown.
Methods: Patients with atrial fibrillation and a moderate-to-high risk of stroke were randomly assigned, in a 1:1:1 ratio, to receive subcutaneous injection of abelacimab (150 mg or 90 mg once monthly) administered in a blinded fashion or oral rivaroxaban (20 mg once daily) administered in an open-label fashion.
Perioperative Chemotherapy or Preoperative Chemoradiotherapy in Esophageal Cancer.
N Engl J Med
January 2025
From Bielefeld University, Medical School and University Medical Center Ostwestfalen-Lippe, Campus Hospital Lippe, Detmold, Germany (J.H.); the Department of Radiation Oncology, Medical University of Graz, Graz, Austria (T.B.); the Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany (C.S.); the Institute of Surgical Pathology, University Medical Center Freiburg, Germany (P.B.); the Department of Surgery, University Medical Center Schleswig-Holstein-Campus Lübeck, Lübeck, Germany (B.K., T.K.); Comprehensive Cancer Center Augsburg, Faculty of Medicine, University of Augsburg, Augsburg, Germany (R.C.); the Department of General and Visceral Surgery, University Medical Center Freiburg, Freiburg, Germany (S.U.); the Department of General, Visceral, and Thoracic Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (J.R.I.); the Department of Gastrointestinal Surgery, IRCCS San Raffaele Scientific Institute and San Raffaele Vita-Salute University, Milan (I.G.); the Department of General, Visceral, Thoracic, and Endocrine Surgery, Johannes Wesling University Hospital Minden, Ruhr University Bochum, Minden, Germany (B.G.); the Department of General, Visceral, and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany (M.G.); the Department of General, Visceral, Thoracic, Transplantation, and Pediatric Surgery, University Medical Center Schleswig-Holstein-Campus Kiel, Kiel, Germany (B.R.); the Department of General, Visceral, Transplantation, Vascular, and Pediatric Surgery, University Hospital, University of Würzburg, Würzburg, Germany (J.F.L.); the Department of General, Visceral, Cancer, and Transplantation Surgery, University Hospital of Cologne, Cologne, Germany (C.B.); the Department of Hematology and Oncology, Sana Klinikum Offenbach, Offenbach am Main, Germany (E.R.); the Department of Surgery, Klinikum Dortmund, Klinikum der Universität Witten-Herdecke, Dortmund, Germany (M.S.); the Department of Surgery, University Hospital Magdeburg, Magdeburg, Germany (F.B.); the Department of Medicine I, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany (G.F.); the Department of Hematology, Oncology, and Cancer Immunology, Charité-University Medicine Berlin, Campus Virchow-Klinikum, Berlin (P.T.-P.); the Department of General, Visceral, Cancer, and Transplantation Surgery, University Hospital Essen, Essen, Germany (U.P.N.); the Department of General, Visceral, and Transplantation Surgery, University Hospital Muenster, Muenster, Germany (A.P.); the Department of Radiotherapy and Oncology, Goethe University Frankfurt, University Hospital, Frankfurt, Germany (D.I.); the Division of Gastroenterology, Rheumatology, and Infectology, Department of Medicine, Charité-Universitätsmedizin Berlin, Berlin (S.D.); the Department of Surgery, Robert Bosch Hospital, Stuttgart, Germany (T.S.); the Department of Surgery, University Medical Center Erlangen, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany (C.K.); the Department of Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany (S.Z.); the Department of General, Visceral, and Transplant Surgery, Ludwig Maximilian University Hospital, Munich, Germany (J.W.); the Department of Internal Medicine I, Klinikum Mutterhaus der Borromaerinnen, Trier, Germany (R.M.); the Departments of Hematology, Oncology, and Palliative Care, Klinikum Stuttgart, Stuttgart, Germany (G.I.); the Department of General, Visceral, and Transplant Surgery, University Medical Center Mainz, Mainz, Germany (P.G.); and the Department of Medicine II, University Cancer Center Leipzig, Cancer Center Central Germany, University Medical Center Leipzig, Leipzig, Germany (F.L.).
Background: The best multimodal approach for resectable locally advanced esophageal adenocarcinoma is unclear. An important question is whether perioperative chemotherapy is preferable to preoperative chemoradiotherapy.
Methods: In this phase 3, multicenter, randomized trial, we assigned in a 1:1 ratio patients with resectable esophageal adenocarcinoma to receive perioperative chemotherapy with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) plus surgery or preoperative chemoradiotherapy (radiotherapy at a dose of 41.
Efficacy of a Mobile Health-Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial.
J Med Internet Res
January 2025
Department of Internal Medicine, Hospital Clinic, Institut d'Investigacio Biomèdica August Pi i Sunyer, Barcelona, Spain.
Background: Enhancing self-management in health care through digital tools is a promising strategy to empower patients with type 2 diabetes (T2D) to improve self-care.
Objective: This study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care.
Methods: A 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50%, female; mean age 58.
Integrating Videoconferencing Therapist Guidance Into Stepped Care Internet-Delivered Cognitive Behavioral Therapy for Child and Adolescent Anxiety: Noninferiority Randomized Controlled Trial.
JMIR Ment Health
January 2025
School of Applied Psychology & Centre for Mental Health, Griffith University, Mt Gravatt, Australia.
Background: Self-guided internet-delivered cognitive behavioral therapy (ICBT) achieves greater reach than ICBT delivered with therapist guidance, but demonstrates poorer engagement and fewer clinical benefits. Alternative models of care are required that promote engagement and are effective, accessible, and scalable.
Objective: This randomized trial evaluated whether a stepped care approach to ICBT using therapist guidance via videoconferencing for the step-up component (ICBT-SC[VC]) is noninferior to ICBT with full therapist delivery by videoconferencing (ICBT-TG[VC]) for child and adolescent anxiety.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!