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Sökning: L773:2055 5784

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1.
  • Bergling, Karin, et al. (författare)
  • Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR) : Study protocol for a randomized controlled crossover trial
  • 2020
  • Ingår i: Pilot and Feasibility Studies. - BioMed Central (BMC). - 2055-5784. ; 6:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having "UF cycles"using a higher glucose concentration, and "Clearance cycles"using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes. Methods: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 × 2 L 1.36% over 9 h) or optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. Discussion: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies. Trial registration: ClinicalTrials.gov identifier: NCT04017572. Registration date: July 12, 2019, retrospectively registered.
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  • Gifford, Wendy, et al. (författare)
  • Feasibility and usefulness of a leadership intervention to implement evidence-based falls prevention practices in residential care in Canada
  • 2019
  • Ingår i: Pilot and Feasibility Studies. - 2055-5784. ; 5:1
  • Tidskriftsartikel (refereegranskat)abstract
    • <p>Background: Leadership is critical to supporting and facilitating the implementation of evidence-based practices in health care. Yet, little is known about how to develop leadership capacity for this purpose. The aims of this study were to explore the (1) feasibility of delivering a leadership intervention to promote implementation, (2) usefulnessof the leadership intervention, and (3) participants’ engagement in leadership to implement evidence-based fall prevention practices in Canadian residential care.</p><p>Methods: We conducted a mixed-method before-and-after feasibility study on two units in a Canadian residential care facility. The leadership intervention was based on the Ottawa model of implementation leadership (O-MILe) and consisted of two workshops and two individualized coaching sessions over 3 months to develop leadership capacity for implementing evidence-based fall prevention practices. Participants (n = 10) included both formal (e.g., managers) and informal (e.g., nurses and care aids leaders). Outcome measures were parameters of feasibility (e.g., number of eligible candidates who attended the workshops and coaching sessions) and usefulness of the leadership intervention (e.g., ratings, suggested modifications). We conducted semi-structured interviews guided by the Implementation Leadership Scale (ILS), a validated measure of 12-item in four subcategories (proactive, supportive, knowledgeable, and perseverant), to explore the leadership behaviors that participants used to implement fall prevention practices. We repeated the ILS in a focus group meeting to understand the collective leadership behaviors used by the intervention team. Barriers and facilitators to leading implementation were also explored.</p><p>Results: Delivery of the leadership intervention was feasible. All participants (n = 10) attended the workshops and eight participated in at least one coaching session. Workshops and coaching were rated useful (≥ 3 on a 0–4 Likert scale where 4 = highly useful) by 71% and 86% of participants, respectively. Participants rated the O-MILe subcategories of supportive and perseverant leadership highest for individual leadership, whereas supportive and knowledgeable leadership were rated highest for team leadership.</p><p>Conclusions: The leadership intervention was feasible to deliver, deemed useful by participants, and fostered engagement in implementation leadership activities. Study findings highlight the complexity of developing implementation leadership and modifications required to optimize impact. Future trials are now required to test the effectiveness of the leadership intervention on developing leadership for implementing evidence-based practices.</p>
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4.
  • Gifford, Wendy, et al. (författare)
  • Feasibility and usefulness of a leadership intervention to implement evidence-based falls prevention practices in residential care in Canada
  • 2019
  • Ingår i: Pilot and Feasibility Studies. - BioMed Central. - 2055-5784. ; 5:103
  • Tidskriftsartikel (refereegranskat)abstract
    • <p>Background</p><p>Leadership is critical to supporting and facilitating the implementation of evidence-based practices in health care. Yet, little is known about how to develop leadership capacity for this purpose. The aims of this study were to explore the (1) feasibility of delivering a leadership intervention to promote implementation, (2) usefulness of the leadership intervention, and (3) participants’ engagement in leadership to implement evidence-based fall prevention practices in Canadian residential care.</p><p>Methods</p><p>We conducted a mixed-method before-and-after feasibility study on two units in a Canadian residential care facility. The leadership intervention was based on the Ottawa model of implementation leadership (O-MILe) and consisted of two workshops and two individualized coaching sessions over 3 months to develop leadership capacity for implementing evidence-based fall prevention practices. Participants (<em>n</em> = 10) included both formal (e.g., managers) and informal (e.g., nurses and care aids leaders). Outcome measures were parameters of feasibility (e.g., number of eligible candidates who attended the workshops and coaching sessions) and usefulness of the leadership intervention (e.g., ratings, suggested modifications). We conducted semi-structured interviews guided by the Implementation Leadership Scale (ILS), a validated measure of 12-item in four subcategories (proactive, supportive, knowledgeable, and perseverant), to explore the leadership behaviors that participants used to implement fall prevention practices. We repeated the ILS in a focus group meeting to understand the collective leadership behaviors used by the intervention team. Barriers and facilitators to leading implementation were also explored.</p><p>Results</p><p>Delivery of the leadership intervention was feasible. All participants (<em>n</em> = 10) attended the workshops and eight participated in at least one coaching session. Workshops and coaching were rated useful (≥ 3 on a 0–4 Likert scale where 4 = highly useful) by 71% and 86% of participants, respectively. Participants rated the O-MILe subcategories of supportive and perseverant leadership highest for individual leadership, whereas supportive and knowledgeable leadership were rated highest for team leadership.</p><p>Conclusions</p><p>The leadership intervention was feasible to deliver, deemed useful by participants, and fostered engagement in implementation leadership activities. Study findings highlight the complexity of developing implementation leadership and modifications required to optimize impact. Future trials are now required to test the effectiveness of the leadership intervention on developing leadership for implementing evidence-based practices.</p>
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5.
  • Lindgren, Britt-Marie, et al. (författare)
  • Does a new spatial design in psychiatric inpatient care influence patients’ and staff’s perception of their care/working environment? A study protocol of a pilot study using a single-system experimental design
  • 2018
  • Ingår i: Pilot and Feasibility Studies. - 2055-5784. ; 4
  • Tidskriftsartikel (refereegranskat)abstract
    • <p><strong>Background:</strong> Research shows that worn-out physical environments are obstacles to psychiatric inpatient care. Patients want better relationships with staff and things to do; staff want an environment that offers hope, a calm atmosphere, and joint activities. A county council in northern Sweden and Philips Healthcare partnered to create solutions to the environmental challenges of psychiatric inpatient care. One ward at a county psychiatric clinic was selected for a pilot project to test solutions that could improve the care environment for patients, staff, and relatives. The aim of the overall project is to evaluate the effects of a newly designed psychiatric inpatient ward on patients and staff in terms of quality of care and stress. In this study, we focus on the feasibility through testing questionnaires and exploring barriers to recruiting staff and patients.</p><p><strong>Methods:</strong> This study had a single-system experimental design, comparing a psychiatric unit pre- and post-implementation of the novel spatial design, using repeated measures with the same questionnaires twice a week during baseline and intervention phases. Primary outcomes were quality interactions (patients) and perceived stress (staff). Secondary outcomes were levels of anxiety and depression (patients), and stress of conscience (staff). A process evaluation was aimed to describe contextual factors and participant experiences of the new design. Data was collected using questionnaires and semi-structured individual interviews with patients and focus group discussions with staff. Both visual and statistical methods were used to analyse the quantitative data and content analysis for the qualitative data.</p><p><strong>Discussion:</strong> The findings will contribute insights into whether and how a new spatial design might contribute to quality interactions and reduced stress. This is relevant both nationally and internationally, as similar interventions are needed but sparse. The findings will be disseminated through peer-reviewed publications and conference presentations.</p><p><strong>Trial registration:</strong> ClinicalTrials.gov, NCT03140618, registered 4 May 2017.</p>
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6.
  • Molander, Olof, et al. (författare)
  • Internet-based cognitive behavior therapy for problem gambling in routine care : protocol for a non-randomized pilot and feasibility trial
  • 2020
  • Ingår i: Pilot and Feasibility Studies. - 2055-5784. ; 6
  • Tidskriftsartikel (refereegranskat)abstract
    • <p>Background: Problem gambling and gambling disorder are major public health concerns worldwide, and awareness of associated negative consequences is rising. In parallel, treatment demand has increased, and Internet interventions offer a promising alternative for providing evidence-based treatment at scale to a low cost.</p><p>Method: We developed a novel Internet-delivered cognitive behavioral treatment for gambling, based on qualitative interviews with treatment-seeking gamblers, behavioral research on gambling behavior, and the pathway model for problem gambling. This research protocol describes a non-randomized pilot and feasibility trial conducted in routine addiction care with adult treatment-seeking patients (max <em>N</em> = 25) with problem gambling. The primary aim is to ensure acceptability and safety, measured by satisfaction, credibility, working alliance, and possible negative effects. Secondary aims are feasibility of study procedures in terms of recruitment and measurement procedures as well as potential effectiveness measured weekly by gambling symptoms as primary outcome and gambling behavior, quality of life, symptoms of depression and anxiety, alcohol, and drug use as secondary outcomes. Potential mediators measured weekly are loss of control, verbal rules, and well-being.</p><p>Discussion: This study is innovative in several respects, regarding both treatment development and implementation. The results of the study will guide a future randomized controlled trial, as well as the development of the intervention and intervention implementation within ordinary addiction care.</p><p>Trial registration: Clinical trials.gov, NCT ID: NCT03946098. Registered 10 May 2019</p>
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7.
  • Mukka, Sebastian, et al. (författare)
  • A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly a pilot study for a clinical trial
  • 2020
  • Ingår i: Pilot and Feasibility Studies. - Springer Nature. - 2055-5784. ; 6
  • Tidskriftsartikel (refereegranskat)abstract
    • <p><strong>Introduction:</strong> The literature regarding undisplaced femoral neck fractures (FNF) is sparse. The aim of this prospective feasibility study is to compare the clinical outcome after undisplaced FNF treated with internal fixation (IF) and displaced FNF treated with hip arthroplasty. We hypothesized that hip arthroplasty would give a lower incidence of reoperations.</p><p><strong>Methods:</strong> A total of 235 patients were included with a median age of 84 years (range 65-99). A consecutive series of 65 patients with undisplaced FNF were treated with IF, and 170 patients with displaced FNF were treated with either a total hip arthroplasty or a hemiarthroplasty. Follow-up interviews were conducted at 1 year using the Harris Hip Score (HHS), WOMAC, and pain numeric rating scale (PNRS). The minimum follow-up time was 22 months. There was no difference in baseline data between the groups.</p><p><strong>Results:</strong> Nineteen (8%) hips required reoperation at least once at a mean of 6 months (range 0-35). The rate of reoperation was higher in the IF group compared to the hip arthroplasty group (13.8% vs. 5.9%, 95% CI 0.9-6.4). The overall 1-year and 2-year mortality was 28% and 40%, respectively, with no difference between the groups. The most common reasons for reoperations in the IF group were non-union and avascular necrosis, and 6 patients were treated with hip or excision arthroplasty. In the arthroplasty group, the most common indications were deep infection and dislocation. We did not find any differences between the groups in terms of HHS, WOMAC, and PNRS.</p><p><strong>Conclusions:</strong> In this feasibility study, we found no differences in patient-reported outcomes between the groups although IF required a higher rate of reoperations. Further randomized trials are needed to establish the optimal treatment of undisplaced FNF in the elderly.</p><p><strong>Trial registration:</strong> ClinicalTrial.org, NCT03392285. Retrospectively registered on 5 February 2018.</p>
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9.
  • Murphy, Patrick J., et al. (författare)
  • The CHARMS pilot study: a multi-method assessment of the feasibility of a sexual counselling implementation intervention in cardiac rehabilitation in Ireland
  • 2018
  • Ingår i: Pilot and feasibility studies. - BioMed Central. - 2055-5784. ; 4
  • Tidskriftsartikel (refereegranskat)abstract
    • <p>Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland.</p>
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