As part of a larger study designed to improve doctor-patient communication in randomised clinical trials (RCT), we audiotaped the discussions between doctor and patient in which consent was being obtained for a RCT. This paper reports on 82 discussions conducted by 5 clinical oncologists in both District General and University Hospital outpatient departments. When introducing the subject of trials, uncertainty about treatment decisions was expressed by the doctors in the majority of cases (79, 96.3%). This was most often stated in a general sense (78, 95.1%), but some mentioned personal uncertainty (12, 14.6%), an approach which helps to maintain a trusting doctor-patient relationship. The word randomization was mentioned in 51 (62.2%) consultations, although the process itself was usually described implicitly (78, 95.1%), e.g. by telling the patient that they would be allocated either one or other treatment. Analogies were used in 28 (34.1%) cases to describe the randomisation process. In addition, although treatments and side-effects were described frequently, (68, 82.9%) and (72, 87.8%) respectively, information leaflets about the trials were not given to 23 (28%) patients. The study shows that U.K. clinicians adopt individual methods when providing information and eliciting consent to trials.
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http://dx.doi.org/10.1016/s0959-8049(99)00116-1 | DOI Listing |
J Reprod Immunol
January 2025
Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address:
To further evaluate the effects of lymphocyte immunotherapy (LIT) for the treatment of RPL patients this study aimed to utilize this type of treatment in RPL patients with positive antinuclear antibodies (ANA) in comparison to ANA-negative RPL women. To this aim, 84 ANA-positive, 114 ANA negative, and 50 healthy pregnant women were recruited. To examine the frequency of cells before and after LIT, flowcytometry technique was employed.
View Article and Find Full Text PDFBurns
January 2025
Department of Nursing, School of Nursing and Midwifery, Islamic Azad University, Kazerun, Iran.
The psychological impact of pediatric burn injuries is profound, often resulting in elevated levels of anxiety for both children and their mothers. This quasi-experimental study was conducted to explore the effectiveness of a resilience training program aimed at reducing anxiety among mothers and their hospitalized children with burn injuries at a burn hospital in Shiraz, Iran. Fifty-six eligible mothers were initially selected through purposive sampling and assigned to either the experimental or control group in a 1:1 ratio through random assignment.
View Article and Find Full Text PDFClin Orthop Relat Res
January 2025
Department of Rehabilitation Medicine, Brooke Army Medical Center, JBSA Fort Sam Houston, TX, USA.
Background: A number of efforts have been made to tailor behavioral healthcare treatments to the variable needs of patients with low back pain (LBP). The most common approach involves the STarT Back Screening Tool (SBST) to triage the need for psychologically informed care, which explores concerns about pain and addresses unhelpful beliefs, attitudes, and behaviors. Such beliefs that pain always signifies injury or tissue damage and that exercise should be avoided have been implied as psychosocial mediators of chronic pain and can impede recovery.
View Article and Find Full Text PDFClin 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 PDFN 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.
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