Модель общественного реформирования Беларуси : между Польшей и Россией

Touch has been a part of the healing process in many civilisations and cultures throughout the centuries. Nurses frequently use touch to provide comfort and reach their patients. The aim of this study was to illuminate the meaning of receiving tactile touch when being cared for in an intensive care unit. Tactile touch is a complementary method including the use of effleurage, which means soft stroking movements along the body. The context used to illuminate the meaning of receiving tactile touch was two general intensive care units (ICUs). Six patients, who have been cared for in the two ICUs, participated in the study. A phenomenological–hermeneutical method based on the philosophy of Ricoeur and developed for nursing research by Lindseth and Norberg [Lindseth A, Norberg A. A phenomenological hermeneutical method for researching lived experience. Scandinavian Journal of Caring Sciences, 2004;18:145–53] was chosen for the analysis. Data consisted of narratives, which were analysed in three recurring phases: naïve understanding, structural analyses and comprehensive understanding. Two main themes were found: being connected to oneself and being unable to gain and maintain pleasure. The comprehensive understanding of receiving tactile touch during intensive care seems to be an expression of enjoying tactile touch and gaining hope for the future. This study reveals that it is possible to experience moments of pleasure in the midst of being a severely ill patient at an ICU and, through this experience also gain hope

Safety and effectiveness of ataluren in patients with nonsense mutation DMD in the STRIDE Registry compared with the CINRG Duchenne Natural History Study (2015-2022): 2022 interim analysis

OBJECTIVE: Strategic Targeting of Registries and International Database of Excellence (STRIDE) is an ongoing, international, multicenter registry of real-world ataluren use in individuals with nonsense mutation Duchenne muscular dystrophy (nmDMD) in clinical practice. This updated interim report (data cut-off: January 31, 2022), describes STRIDE patient characteristics and ataluren safety data, as well as the effectiveness of ataluren plus standard of care (SoC) in STRIDE versus SoC alone in the Cooperative International Neuromuscular Research Group (CINRG) Duchenne Natural History Study (DNHS). METHODS: Patients are followed up from enrollment for at least 5 years or until study withdrawal. Propensity score matching was performed to identify STRIDE and CINRG DNHS patients who were comparable in established predictors of disease progression. RESULTS: As of January 31, 2022, 307 patients were enrolled from 14 countries. Mean (standard deviation [SD]) ages at first symptoms and at genetic diagnosis were 2.9 (1.7) years and 4.5 (3.7) years, respectively. Mean (SD) duration of ataluren exposure was 1671 (56.8) days. Ataluren had a favorable safety profile; most treatment-emergent adverse events were mild or moderate and unrelated to ataluren. Kaplan-Meier analyses demonstrated that ataluren plus SoC significantly delayed age at loss of ambulation by 4 years (p < 0.0001) and age at decline to %-predicted forced vital capacity of < 60% and < 50% by 1.8 years (p = 0.0021) and 2.3 years (p = 0.0207), respectively, compared with SoC alone. CONCLUSION: Long-term, real-world treatment with ataluren plus SoC delays several disease progression milestones in individuals with nmDMD. NCT02369731; registration date: February 24, 2015

Suitability of external controls for drug evaluation in Duchenne muscular dystrophy

OBJECTIVE: To evaluate the suitability of real-world data (RWD) and natural history data (NHD) for use as external controls in drug evaluations for ambulatory Duchenne muscular dystrophy (DMD). METHODS: The consistency of changes in the 6-minute walk distance (Δ6MWD) was assessed across multiple clinical trial placebo arms and sources of NHD/RWD. Six placebo arms reporting 48-week Δ6MWD were identified via literature review and represented 4 sets of inclusion/exclusion criteria (n = 383 patients in total). Five sources of RWD/NHD were contributed by Universitaire Ziekenhuizen Leuven, DMD Italian Group, The Cooperative International Neuromuscular Research Group, ImagingDMD, and the PRO-DMD-01 study (n = 430 patients, in total). Mean Δ6MWD was compared between each placebo arm and RWD/NHD source after subjecting the latter to the inclusion/exclusion criteria of the trial for baseline age, ambulatory function, and steroid use. Baseline covariate adjustment was investigated in a subset of patients with available data. RESULTS: Analyses included ∼1,200 patient-years of follow-up. Differences in mean Δ6MWD between trial placebo arms and RWD/NHD cohorts ranged from -19.4 m (i.e., better outcomes in RWD/NHD) to 19.5 m (i.e., worse outcomes in RWD/NHD) and were not statistically significant before or after covariate adjustment. CONCLUSIONS: We found that Δ6MWD was consistent between placebo arms and RWD/NHD subjected to equivalent inclusion/exclusion criteria. No evidence for systematic bias was detected. These findings are encouraging for the use of RWD/NHD to augment, or possibly replace, placebo controls in DMD trials. Multi-institution collaboration through the Collaborative Trajectory Analysis Project rendered this study feasible

Tactile touch in intensive care : Nurses' preparation, patients' experiences and the effect on stress parameters

Aim: The overall aim of this thesis was to acquire knowledge about whether tactile touch as a complementary method can (i) promote comfort and (ii) reduce stress reactions during care in an intensive care unit (ICU) Method: In Paper I, five nurses with a touch therapist training were interviewed about their experiences of preparation before giving tactile touch in an ICU. To analyse the meaning of preparation as a phenomenon, Giorgi’s descriptive phenomenological approach was used. In Paper II and III a randomised controlled trial was set up to investigate the effects of a five-day tactile touch intervention on patients’ oxytocin levels in arterial blood (II), on patients’ blood pressure, heart rate and blood glucose level, and on patients’ levels of anxiety, sedation and alertness (III). Forty-four patients were randomised to either an intervention group (n = 21) or a control group (n = 23). Data were analysed with non-parametric statistics. In Paper IV, six patients who had received the tactile touch intervention were interviewed to illuminate the experience of receiving tactile touch during intensive care. To gain a deeper understanding of the phenomenon and to illuminate the meaning, Ricoeur’s phenomenological hermeneutical method, developed by Lindseth and Norberg, was used. Findings: The nurses need four constituents (inner balance, unconditional respect for the patients’ integrity, a relationship with the patient characterized by reciprocal trust and a supportive environment) to be prepared and go through the transition from nurse to touch therapist (I). In the intervention study, no significant differences were shown for oxytocin levels between intervention and control group over time or within each day (II). There were significantly lower levels of anxiety for patients in the intervention group. There were no significant differences between the intervention and control groups for blood pressure, heart rate, the use of drugs, levels of sedation or blood glucose levels (III). The significance of receiving tactile touch during intensive care was described as the creation of an imagined room along with the touch therapist. In this imagined room, the patients enjoyed tactile touch and gained hope for the future (IV). Conclusion: Nurses needed internal and external balance to be prepared for providing tactile touch. Patients did not notice the surroundings as much as the nurses did. Patients enjoyed the tactile touch and experienced comfort. The impact on stress parameters were limited, except for levels of anxiety which declined significantly. The results gave some evidence for the benefit of tactile touch given to patients in intensive care

Tactile touch in intensive care : Nurses' preparation, patients' experiences and the effect on stress parameters

Aim: The overall aim of this thesis was to acquire knowledge about whether tactile touch as a complementary method can (i) promote comfort and (ii) reduce stress reactions during care in an intensive care unit (ICU) Method: In Paper I, five nurses with a touch therapist training were interviewed about their experiences of preparation before giving tactile touch in an ICU. To analyse the meaning of preparation as a phenomenon, Giorgi’s descriptive phenomenological approach was used. In Paper II and III a randomised controlled trial was set up to investigate the effects of a five-day tactile touch intervention on patients’ oxytocin levels in arterial blood (II), on patients’ blood pressure, heart rate and blood glucose level, and on patients’ levels of anxiety, sedation and alertness (III). Forty-four patients were randomised to either an intervention group (n = 21) or a control group (n = 23). Data were analysed with non-parametric statistics. In Paper IV, six patients who had received the tactile touch intervention were interviewed to illuminate the experience of receiving tactile touch during intensive care. To gain a deeper understanding of the phenomenon and to illuminate the meaning, Ricoeur’s phenomenological hermeneutical method, developed by Lindseth and Norberg, was used. Findings: The nurses need four constituents (inner balance, unconditional respect for the patients’ integrity, a relationship with the patient characterized by reciprocal trust and a supportive environment) to be prepared and go through the transition from nurse to touch therapist (I). In the intervention study, no significant differences were shown for oxytocin levels between intervention and control group over time or within each day (II). There were significantly lower levels of anxiety for patients in the intervention group. There were no significant differences between the intervention and control groups for blood pressure, heart rate, the use of drugs, levels of sedation or blood glucose levels (III). The significance of receiving tactile touch during intensive care was described as the creation of an imagined room along with the touch therapist. In this imagined room, the patients enjoyed tactile touch and gained hope for the future (IV). Conclusion: Nurses needed internal and external balance to be prepared for providing tactile touch. Patients did not notice the surroundings as much as the nurses did. Patients enjoyed the tactile touch and experienced comfort. The impact on stress parameters were limited, except for levels of anxiety which declined significantly. The results gave some evidence for the benefit of tactile touch given to patients in intensive care

Tactile touch in intensive care : Nurses’ preparation, patients’ experiences and the effect on stress parameters

Aim: The overall aim of this thesis was to acquire knowledge about whether tactile touch as a complementary method can (i) promote comfort and (ii) reduce stress reactions during care in an intensive care unit (ICU) Method: In Paper I, five nurses with a touch therapist training were interviewed about their experiences of preparation before giving tactile touch in an ICU. To analyse the meaning of preparation as a phenomenon, Giorgi’s descriptive phenomenological approach was used. In Paper II and III a randomised controlled trial was set up to investigate the effects of a five-day tactile touch intervention on patients’ oxytocin levels in arterial blood (II), on patients’ blood pressure, heart rate and blood glucose level, and on patients’ levels of anxiety, sedation and alertness (III). Forty-four patients were randomised to either an intervention group (n = 21) or a control group (n = 23). Data were analysed with non-parametric statistics. In Paper IV, six patients who had received the tactile touch intervention were interviewed to illuminate the experience of receiving tactile touch during intensive care. To gain a deeper understanding of the phenomenon and to illuminate the meaning, Ricoeur’s phenomenological hermeneutical method, developed by Lindseth and Norberg, was used. Findings: The nurses need four constituents (inner balance, unconditional respect for the patients’ integrity, a relationship with the patient characterized by reciprocal trust and a supportive environment) to be prepared and go through the transition from nurse to touch therapist (I). In the intervention study, no significant differences were shown for oxytocin levels between intervention and control group over time or within each day (II). There were significantly lower levels of anxiety for patients in the intervention group. There were no significant differences between the intervention and control groups for blood pressure, heart rate, the use of drugs, levels of sedation or blood glucose levels (III). The significance of receiving tactile touch during intensive care was described as the creation of an imagined room along with the touch therapist. In this imagined room, the patients enjoyed tactile touch and gained hope for the future (IV). Conclusion: Nurses needed internal and external balance to be prepared for providing tactile touch. Patients did not notice the surroundings as much as the nurses did. Patients enjoyed the tactile touch and experienced comfort. The impact on stress parameters were limited, except for levels of anxiety which declined significantly. The results gave some evidence for the benefit of tactile touch given to patients in intensive care.För avläggande av filosofie doktorsexamen i omvårdnad, som medtillstånd av Fakultetsnämnden vid Fakulteten för samhälls- och livsvetenskaper vidKarlstads universtitet framläggs till offentlig granskning fredagen den 18 april 2008 kl.10:00M204, Högskolan i Borås.</p