Suchergebnisse

Objective: To evaluate the effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke. Design: Multicentre, prospective, randomized controlled trial. Subjects: Adults (aged ≥ 18 years) who had their first or recurrent stroke within the last month, were medically stable, had sufficient cognitive functioning to participate and understood and spoke Norwegian. Methods: A total of 322 participants were randomly assigned to the intervention (n = 166) or control (n = 156) group. Participants in the intervention group received up to 8 individual sessions aimed at supporting the coping and life skills of stroke survivors in addition to usual care. The primary outcome was the proportion of participants with normal mood measured by the General Health Questionnaire-28 (GHQ-28). The secondary outcomes included health-related quality of life (Stroke and Aphasia Quality of Life Scale; SAQOL-39g), depression (Yale-Brown single-item questionnaire; Yale) and sense of coherence (SOC-13). Results: After controlling for the baseline values, no significant benefit was found in the intervention group over the control group (odds ratio (OR): 0.898: 95% confidence interval (95% CI): 0.54-1.50, p = 0.680) 6 months post-stroke. Conclusion: Psychosocial well-being improved during the first 6 months after stroke in both arms of the trial, but no statistically significant benefit of the dialogue-based intervention was found compared with usual care. Lay Abstract The aim of this study was to evaluate the effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke. A total of 322 participants were assigned to an intervention (= 166) or control (= 156) group. Participants in the intervention group received up to 8 individual sessions aimed at supporting the coping and life skills of stroke survivors in addition to usual care. Psychosocial well-being improved during the first 6 months after the stroke in both arms of the trial. However, no benefit of the dialogue-based intervention was found compared with usual care. ; The research leading to these results received funding from the European Union Seventh Framework Programme (FP7-PEOPLE-2013-COFUND) under grant agreement no. 609020 - Scientia Fellows (LKB), the South-Eastern Norway Regional Health Authority (Project number 2013086) (US, LKB) and the Extra Foundation (2015/FO13753) (EGH). ; publishedVersion

Background: A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is "usual care." The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants' reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. Methods: Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur's interpretation theory guided the analysis. Results: The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants' feelings of control and their ability to cope. Other participants' statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. Conclusions: RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. ; This study is part of a larger project that was supported by grants from the South-Eastern Norway Regional Health Authority and a grant from the Extra Foundation. The research leading to these results has received additional funding from the European Union Seventh Framework Program ((FP7-PEOPLE-2013-COFOUND) under grant agreement no. 609020_Scientia Fellows. The University of Oslo, Oslo University Hospital, the Inland Norway University of Applied Sciences, and the Arctic University of Norway. The funding is based on a protocol article (Kirkevold M, Bragstad KL, Bronken BA, Kvigne K, Martinsen R, Hjelle EG, et al. Promoting psychosocial well-being following stroke: Study protocol for a randomized, controlled trial. BMC Psy chol. 2018;6(1):12. and otherwise without any form of guidance regarding design and results. ; publishedVersion

Stroke patients' well-being is threatened after stroke. A psychosocial intervention was developed for Norwegian stroke patients living in the community. Eight individual sessions between people with stroke and a trained health care professional were conducted 1 to 6 months post-stroke with one group of participants and 6 to 12 months post-stroke with another group. Subsequently, 19 of these stroke patients were interviewed to gain an in-depth understanding of their lived experience of the influence of the intervention on their adjustment process. Interview texts were analyzed using Ricoeur's interpretation theory. Two participants did not personally find the intervention useful. The remaining participants greatly appreciated dialogues with the empathetic intervention personnel, feeling free to discuss their fears and worries. The intervention raised these participants' awareness of their needs and resources. They were guided to resume their everyday life and adopt a future-oriented attitude. The intervention facilitated their meaning-making endeavors and post-stroke adjustment. ; The study was part of a larger project that was supported by a grant from the South-Eastern Norway Regional Health Authority and a grant from the Extra Foundation. The research leading to these results has received additional funding from the European Union Seventh Framework Programme (FP7-PEOPLE-2013-COFUND) under grant agreement no. 609020 - Scientia Fellows. The University of Oslo, Oslo University Hospital, the Inland Norway University of Applied Sciences, and the Arctic University of Norway, Narvik have provided research time, administrative and organizational support and additional funding for the study. UiT The Arctic University of Norway funded the intervention for the participants from the Northern area. ; acceptedVersion

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group (n = 166) or control group (n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke. ; The following financial support was granted for the research, authorship, and/or publication of this article: the European Union Seventh Framework Program (FP7-PEOPLE-2013-COFUND; Grant Agreement No. 609020—Scientia Fellows); the South-Eastern Norway Regional Health Authority (Project no. 2013086); and the Extra Foundation (Grant No. 2015/FO13753). The University of Oslo, Oslo University Hospital, the Inland Norway University of Applied Sciences, and UiT, the Arctic University of Norway, Narvik have provided research time, administrative and organizational support, and additional funding for the study. ; publishedVersion

Altres ajuts: This work was partially supported by grant UM1 CA167551 from the National Cancer Institute (NCI), National Institutes of Health (NIH), and through cooperative agreements with members of the Colon Cancer Family Registry (CCFR) and Principal Investigators. Centers contributing to this analysis include the Seattle Colorectal Cancer Family Registry (U01/U24CA074794), Australasian Colorectal Cancer Family Registry (U01 CA074778 and U01/U24 CA097735), Mayo Clinic Cooperative Family Registry for Colon Cancer Studies (U01/U24 CA074800), and Ontario Familial Colorectal Cancer Registry (U01/U24 CA074783). This work was also supported by NCI/NIH grant K07CA172298 and K05CA152715 (to AIP). The content of this article does not necessarily reflect the views or policies of the NIH or any of the collaborating centers in the CCFR, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. This study was partly supported by the "Norwegian Cancer Society" and the "Research Council of Norway" (no grants apply). ; TNM staging alone does not accurately predict outcome in colon cancer (CC) patients who may be eligible for adjuvant chemotherapy. It is unknown to what extent the molecular markers microsatellite instability (MSI) and mutations in BRAF or KRAS improve prognostic estimation in multivariable models that include detailed clinicopathological annotation. After imputation of missing at random data, a subset of patients accrued in phase 3 trials with adjuvant chemotherapy (n = 3016)-N0147 (NCT00079274) and PETACC3 (NCT00026273)-was aggregated to construct multivariable Cox models for 5-year overall survival that were subsequently validated internally in the remaining clinical trial samples (n = 1499), and also externally in different population cohorts of chemotherapy-treated (n = 949) or -untreated (n = 1080) CC patients, and an additional series without treatment annotation (n = 782). TNM staging, MSI and BRAF V600E mutation status remained independent ...