Hospital at Home for Intrathecal Pump Refills: A Prospective Effectiveness, Safety and Feasibility Study.
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ABSTRACT:
SUBMITTER: Goudman L
PROVIDER: S-EPMC8617747 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Virtual reality has proven to be an effective approach to decrease pain in acute settings, both in adults and children. The aim of this study is to evaluate whether virtual reality (VR) could reduce pain during an intrathecal pump refill procedure in children receiving intrathecal drug delivery, compared to a standard refill procedure. This is a three-arm crossover randomized controlled trial, evaluating the effect of VR on pain in children with cerebral palsy undergoing an intrathecal pump refill compared to a standard refill and a refill with distraction (watching a video). Pain was evaluated using the Wong-Baker Faces Scale. Secondary outcomes were procedural pain, fear, state anxiety, the incidence of adverse events and satisfaction. Six children participated in this study, whereby all children underwent the three conditions. Five children indicated an equal of lower pain score during VR, compared to a standard refill. This finding of an equal or lower pain intensity score for the VR condition compared to the control condition was also revealed by the ratings of the parents, physician and the researcher. The influence of VR on anxiety and fear seem to be in line with the influence of watching a video. In terms of satisfaction, all children and parents agreed with the statement that they would like to use VR again for a next refill. Due to the lack of adverse events, the high degree of satisfaction of children with VR and the decreased pain levels after a refill with VR, physicians may aim to explore the implementation of VR during intrathecal pump refill procedures in children in a daily clinical routine care setting.
| S-EPMC9571798 | biostudies-literature
Project description:BACKGROUND AND OBJECTIVES:We evaluated the infusion accuracy and device-related safety of implantable drug infusion pumps in subjects with chronic pain or severe spasticity. METHODS:Nine centers in the United States enrolled patients receiving intrathecal drug delivery systems to manage chronic pain and/or severe spasticity. Infusion accuracy was assessed at 6 and 12 months by comparing syringe-measured delivered volumes to programmer-predicted volumes. Safety was evaluated through analysis of adverse events. Separate laboratory testing conducted by the manufacturer also evaluated infusion accuracy. RESULTS:Eighty of 82 enrolled subjects were implanted. Sixty-five and 54 subjects, respectively, were analyzable for accuracy at 6 and 12 months. On average at 6 months, the pumps were measured to have delivered 1% more than the programmed delivery volume. Analyzed on a per-refill basis, the pumps delivered, on average, 2.5% more than the programmed delivery volume. Differences between per-refill means versus per-subject cumulative means were due to limitations in clinicians' ability to precisely visualize single small syringe-volume differences, or possibly incomplete withdrawal of fluid from the pump. Laboratory testing demonstrated a per-refill mean accuracy error of minus 2.4%. Because average observed flow-rate error at 6 and 12 months (1% overinfusion) was derived from pump residual volume measurements by syringe and carried out in a clinical setting, clinical volume ratios were larger than direct volume measurements by weight observed in the laboratory. No deaths, permanent injuries, or unanticipated adverse device effects occurred. CONCLUSIONS:The pump accurately delivered intrathecal medication in the clinical setting of this study. Adverse events were similar in nature and severity to those described in the product labeling and literature.
| S-EPMC4218763 | biostudies-literature
Project description:Despite the effectiveness of occupational therapy home modification interventions, persons with disabilities may not receive them due to service delivery costs, limited number of therapists, and expansive geographic service areas. The need for occupational therapy home modification interventions will increase with the rising U.S. aging population, incidence of chronic illness, and shift toward community-based care. This study examined the feasibility of telehealth occupational therapy home modification interventions using participant owned smart phones, tablets, or computers. A pretest posttest design (n=4) demonstrated improvement in home safety and perception of performance of daily activities. Participants reported satisfaction with the mode of intervention citing ease of use and reduction in client and caregiver burden. Two key implementation challenges were (1) inconsistent quality of synchronous audio and video and (2) limited funding for home modification interventions. A large-scale telehealth occupational therapy home modification interventions pilot study is warranted.
| S-EPMC6095682 | biostudies-other
Project description:Mesenchymal stromal cells (MSCs) are multipotent cells with anti-inflammatory properties. Here we tested the safety of MSCs in patients with progressive supranuclear palsy (PSP; ClinicalTrials.gov: NCT01824121; Eudract No. 2011-004051-39). Seven patients were treated. To improve the safety, protocol adjustments were made during the performance of the study. The objectives of our work were: (1) to assess the safety of MSCs and (2) to identify critical issues in cell therapies for neurodegenerative diseases. Autologous MSCs from the bone marrow of PSP patients were administered through the internal carotid arteries. 1-year survival and number of severe adverse events were considered as safety endpoints. Clinical rating scales, neuropsychological assessments, gait and posture analysis, single-photon emission computed tomography, positron emission tomography, and brain magnetic resonance (BMR) were performed at different follow-up times. Peripheral blood levels of inflammatory cytokines were measured before and after cell infusion. Six of the seven treated patients were living 1 year after cell infusion. Asymptomatic spotty lesions were observed at BMR after 24 h in six of the seven treated patients. The last patient in the preliminary cohort (Case 5) exhibited transiently symptomatic BMR ischemic alterations. No severe adverse events were recorded in the last two treated patients. Interleukin-8 serum concentrations decreased in three patients (Case 2, 3, and 4). An adaptive study design, appropriate and up-to-date efficacy measures, adequate sample size estimation, and, possibly, the use of a cellular and/or allogeneic cell sources may help in performing phase II trials in the field.
| S-EPMC8546103 | biostudies-literature
Project description:IntroductionAntibiotic resistant bacterial infections (ARBIs) are extremely common in nursing home residents. These infections typically occur after a course of antibiotics, which eradicate both pathological and beneficial organisms. The eradication of beneficial organisms likely facilitates subsequent ARBIs. Autologous fecal microbiota transplant (aFMT) has been proposed as a potential treatment to reduce ARBIs in nursing home residents. Our objective was to determine the feasibility and safety of aFMT in a nursing home population.MethodsPilot clinical trial. We evaluated feasibility as total number of stool samples collected for aFMT production and safety as the number and relatedness of serious (SAE) and non-serious adverse events (AE).ResultsWe screened 468 nursing home residents aged ≥18 years for eligibility; 67 enrolled, distributed among three nursing homes. Participants were 62.7% female and 35.8% Black. Mean age was 82.2 ± 8.5 years. Thirty-three participants underwent successful stool collection. Seven participants received antibiotics; four participants underwent aFMT. There were 40 SAEs (17 deaths) and 11 AEs. In the aFMT group, there were 3 SAEs (2 deaths) and 10 AEs. All SAEs and AEs were judged unrelated to the study intervention.ConclusionsIn this pilot study of aFMT in nursing home residents, less than half were able to provide adequate stool samples for aFMT. There were no related SAEs or AEs during the study. In sum, we conclude aFMT has limited feasibility in a nursing home population due to logistic and technical challenges but is likely safe.Trial registrationClinicalTrials.gov Identifier: NCT03061097.
| S-EPMC8921299 | biostudies-literature
Project description:Purpose The aim of this study was to assess the feasibility of delivering a prospective surveillance model in the home over 6 months for women at high risk of developing lymphoedema. Methods A single-group, intervention study recruited 20 women who had surgical and medical treatment for confirmed node-positive invasive breast cancer and therefore at high risk of developing arm lymphoedema. Participants received a package including Bioimpedance Spectroscopy (BIS) monitoring, lymphoedema education and support to promote self-management and physical activity. Results Participants adhered to BIS monitoring 74% of the time, and felt extremely confident in using the device. By 6 months, mean BIS L-Dex scores had increased from 3.5 (SD 5.6) to 8.4 (SD 11.1); five women (25%) who experienced?>??+?6.5 increase in L-Dex score were fitted with a compression garment. Self-reported symptoms and distress decreased by 0.4 out of 10 (95% CI 0.1 to 0.7); number of self-management strategies used increased by 0.6 (95% CI 0.1 to 1.2); and planned exercise increased by 2.8 h/week (95% CI 0.4 to 5.2). Conclusions These findings indicate a prospective surveillance model of care in the home with BIS is feasible and associated with increased self-management. A Phase II randomised trial is warranted as well as research exploring the costs associated with implementing this model of care for high-risk individuals.
| S-EPMC7529356 | biostudies-literature
Project description:Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programmes are effective in all older population studied. However, the application of these programmes may not be the same in all National health care setting and, consequently, needs to be evaluated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention programme at home has never been explored.This will be a two-group randomised controlled trial aiming to evaluate the effects of a home-based intervention programme delivered by a multidisciplinary health team. The home tele-management programme, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at hospital discharge. The programme will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed for 6 months after hospital discharge. A nurse-tutor telephone support and tele-exercise will characterize the intervention programme. People in the control group will receive usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios.To date, no adequately powered studies have investigated the effect of the Information and Communication Technologies (ICT) in a home fall prevention program. We aim the program will be feasible in terms of intensity and characteristics, but particularly in terms of patient and provider compliance. The results of the economic evaluation could provide information about the cost-effectiveness of the intervention and the effects on quality of life. In case of shown effectiveness and cost effectiveness, the program could be implemented into health services settings.ClinicalTrials.gov ( NCT02487589 ).
| S-EPMC5142145 | biostudies-literature
Project description:BACKGROUND:Newer designs and techniques of total ankle arthroplasty (TAA) have challenged the assumption of ankle arthrodesis (AA) as the primary treatment for end-stage ankle arthritis. The objective of this study was to compare physical and mental function, ankle-specific function, pain intensity, and rates of revision surgery and minor complications between these 2 procedures and to explore heterogeneous treatment effects due to age, body mass index (BMI), patient sex, comorbidities, and employment on patients treated by 1 of these 2 methods. METHODS:This was a multisite prospective cohort study comparing outcomes of surgical treatment of ankle arthritis. Subjects who presented after nonoperative management had failed received either TAA or AA using standard-of-treatment care and rehabilitation. Outcomes included the Foot and Ankle Ability Measure (FAAM), Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) scores, pain, ankle-related adverse events, and treatment success. RESULTS:Five hundred and seventeen participants underwent surgery and completed a baseline assessment. At 24 months, the mean improvement in FAAM activities of daily living (ADL) and SF-36 PCS scores was significantly greater in the TAA group than in the AA group, with a difference between groups of 9 points (95% confidence interval [CI] = 3, 15) and 4 points (95% CI = 1, 7), respectively. The crude incidence risks of revision surgery and complications were greater in the AA group; however, these differences were no longer significant after adjusting for age, sex, BMI, and Functional Comorbidity Index (FCI). The treatment success rate was greater after TAA than after AA for those with an FCI of 4 (80% versus 62%) and not fully employed (81% versus 58%) but similar for those with an FCI score of 2 (81% versus 77%) and full-time employment (79% versus 78%). CONCLUSIONS:At 2-year follow-up, both AA and TAA were effective. Improvement in several patient-reported outcomes was greater after TAA than after AA, without a significant difference in the rates of revision surgery and complications. LEVEL OF EVIDENCE:Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
| S-EPMC7001770 | biostudies-literature
Project description:PURPOSE:Most real-world studies on anticoagulants have been based on health insurance databases or performed in secondary care. The aim of this study was to compare safety and effectiveness between patients treated with vitamin K antagonists (VKAs) and patients treated with direct oral anticoagulants (DOACs) in a general practice setting. METHODS:The CACAO study (Comparison of Accidents and their Circumstances with Oral Anticoagulants) is a multicenter prospective cohort study conducted among ambulatory patients taking an oral anticoagulant. Participants were patients from the study's cross-sectional phase receiving oral anticoagulants because of nonvalvular atrial fibrillation, for secondary prevention of venous thromboembolism, or both. They were followed as usual for 1 year by their general practitioners, who collected data on changes in therapy, thromboembolic events, bleeding, and deaths. All events were adjudicated by an independent committee. We used a propensity score and a Cox regression model to derive hazard ratios. RESULTS:Between April and December 2014, a total of 3,082 patients were included. At 1 year, 42 patients (1.7%) had experienced an arterial or venous event; 151 (6.1%) had experienced bleeding, including 47 (1.9%) who experienced major bleeding; and 105 (4.1%) had died. There was no significant difference between the VKA and DOAC groups regarding arterial or venous events, or major bleeding. The VKA group had a lower risk of overall bleeding (hazard ratio = 0.65; 95% CI, 0.43-0.98) but twice the risk of death (hazard ratio = 1.98; 95% CI, 1.15-3.42). CONCLUSIONS:VKAs and DOACs had fairly similar safety and effectiveness in general practice. The substantially higher incidence of deaths with VKAs is consistent with known data from health insurance databases and calls for further research to understand its cause.
| S-EPMC7062492 | biostudies-literature
Project description:IntroductionThe aim of the cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS).Methods and analysisWe will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks' gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41 000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost-utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained.Research ethics approval and disseminationCHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals.Trial registration numberISRCTN32652461.
| S-EPMC8098973 | biostudies-literature