878 resultados para Randomized-trials
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Background Injury is the leading cause of adolescent death and injury around the road is a common source of adolescent injuries. Skills for Preventing Injury in Youth (SPIY) is a comprehensive program developed in Australia for early adolescents (term-long curriculum, including looking out for friends, first-aid training coupled with teacher school-connectedness professional development). Jessors’ Protection-Risk Framework guided the program approach focusing on building protective relationships. Method A randomized controlled trial with 35 schools was undertaken. Students completed surveys at baseline, six-months post-intervention and twelve-months post intervention. There were 1686 students (56% female) who completed the twelve-month survey, including the Extended-Adolescent Injury Checklist whereby students self-report on medically-treated injuries over the previous three-months (only road-related items are reported in this study; cycling, motorcycle riding, pedestrian, and riding as a passenger). Randomly selected SPIY classes also participated in focus groups and reported on perceptions of SPIY and injury risk behavior. Results As a check of randomization baseline differences of the variables were examined, with no significant differences between intervention and control groups. At the 12-month follow-up, there were fewer medically-treated injuries among the intervention students compared with the control group, particularly associated with being a passenger. The process evaluation revealed students perceived change in injury risk and risk behaviors. Conclusions While data analyses are continuing, the results indicate that the program seeking to encourage adolescents to look out for their friends, build connections to school and provide first aid skills training goes some way to reducing self-reported medically-treated injuries around the road.
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In response to the Travelsafe Committee Report No. 51 – report on the inquiry into Automatic Plate Recognition Technology – it was recommended that the Queensland Police Service continue to trial the deployment of ANPR technology for traffic enforcement work and to evaluate the road safety impacts and operational effectiveness of the technology. As such, the purpose of this report is to provide an independent evaluation of a trial of ANPR that was conducted by a project team within the State Traffic Support Branch of the Queensland Police Service (QPS) and provide recommendations as to the applicability and usability of the technology for use throughout Queensland...
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Background Women with young children (<5 years) are an important group for physical activity intervention. Purpose To evaluate the feasibility, acceptability and efficacy of MobileMums- a physical activity intervention for women with young children. Methods Women were randomized to MobileMums (n=133) or a control group (n=130). MobileMums was delivered primarily via individually-tailored text messages. Moderate to vigorous physical activity (MVPA) was measured by self-report and accelerometer at baseline, end of the intervention (13-weeks) and 6-months later (9-months). Changes were analyzed using repeated measures models. Results MobileMums was feasible to deliver and acceptable to women. Self-reported MVPA duration (minutes/week) and frequency (days/week) increased significantly post intervention (13-week intervention effect 48.5 min/week, 95%CI [13.4, 82.9] and 1.6 days/week, 95%CI [0.6, 2.6]). Intervention effects were not maintained 6-months later. No effects observed in accelerometer-derived MVPA. Conclusions MobileMums increased women’s self-reported MVPA immediately post intervention. Future investigations need to target sustained physical activity improvements.
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Decision-making is such an integral aspect in health care routine that the ability to make the right decisions at crucial moments can lead to patient health improvements. Evidence-based practice, the paradigm used to make those informed decisions, relies on the use of current best evidence from systematic research such as randomized controlled trials. Limitations of the outcomes from randomized controlled trials (RCT), such as “quantity” and “quality” of evidence generated, has lowered healthcare professionals’ confidence in using EBP. An alternate paradigm of Practice-Based Evidence has evolved with the key being evidence drawn from practice settings. Through the use of health information technology, electronic health records (EHR) capture relevant clinical practice “evidence”. A data-driven approach is proposed to capitalize on the benefits of EHR. The issues of data privacy, security and integrity are diminished by an information accountability concept. Data warehouse architecture completes the data-driven approach by integrating health data from multi-source systems, unique within the healthcare environment.
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Purpose This study tested the effectiveness of a pressure ulcer (PU) prevention bundle in reducing the incidence of PUs in critically ill patients in two Saudi intensive care units (ICUs). Design A two-arm cluster randomized experimental control trial. Methods Participants in the intervention group received the PU prevention bundle, while the control group received standard skin care as per the local ICU policies. Data collected included demographic variables (age, diagnosis, comorbidities, admission trajectory, length of stay) and clinical variables (Braden Scale score, severity of organ function score, mechanical ventilation, PU presence, and staging). All patients were followed every two days from admission through to discharge, death, or up to a maximum of 28 days. Data were analyzed with descriptive correlation statistics, Kaplan-Meier survival analysis, and Poisson regression. Findings The total number of participants recruited was 140: 70 control participants (with a total of 728 days of observation) and 70 intervention participants (784 days of observation). PU cumulative incidence was significantly lower in the intervention group (7.14%) compared to the control group (32.86%). Poisson regression revealed the likelihood of PU development was 70% lower in the intervention group. The intervention group had significantly less Stage I (p = 002) and Stage II PU development (p = 026). Conclusions Significant improvements were observed in PU-related outcomes with the implementation of the PU prevention bundle in the ICU; PU incidence, severity, and total number of PUs per patient were reduced. Clinical Relevance Utilizing a bundle approach and standardized nursing language through skin assessment and translation of the knowledge to practice has the potential to impact positively on the quality of care and patient outcome.
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Background Procedural sedation and analgesia (PSA) is used to attenuate the pain and distress that may otherwise be experienced during diagnostic and interventional medical or dental procedures. As the risk of adverse events increases with the depth of sedation induced, frequent monitoring of level of consciousness is recommended. Level of consciousness is usually monitored during PSA with clinical observation. Processed electroencephalogram-based depth of anaesthesia (DoA) monitoring devices provide an alternative method to monitor level of consciousness that can be used in addition to clinical observation. However, there is uncertainty as to whether their routine use in PSA would be justified. Rigorous evaluation of the clinical benefits of DoA monitors during PSA, including comprehensive syntheses of the available evidence, is therefore required. One potential clinical benefit of using DoA monitoring during PSA is that the technology could improve patient safety by reducing sedation-related adverse events, such as death or permanent neurological disability. We hypothesise that earlier identification of lapses into deeper than intended levels of sedation using DoA monitoring leads to more effective titration of sedative and analgesic medications, and results in a reduction in the risk of adverse events caused by the consequences of over-sedation, such as hypoxaemia. The primary objective of this review is to determine whether using DoA monitoring during PSA in the hospital setting improves patient safety by reducing the risk of hypoxaemia (defined as an arterial partial pressure of oxygen below 60 mmHg or percentage of haemoglobin that is saturated with oxygen [SpO2] less than 90 %). Other potential clinical benefits of using DoA monitoring devices during sedation will be assessed as secondary outcomes. Methods/design Electronic databases will be systematically searched for randomized controlled trials comparing the use of depth of anaesthesia monitoring devices with clinical observation of level of consciousness during PSA. Language restrictions will not be imposed. Screening, study selection and data extraction will be performed by two independent reviewers. Disagreements will be resolved by discussion. Meta-analyses will be performed if suitable. Discussion This review will synthesise the evidence on an important potential clinical benefit of DoA monitoring during PSA within hospital settings.
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Objective: The aim of the present pilot study was to examine the effectiveness of a relaxation massage therapy programme in reducing stress, anxiety and aggression on a young adult psychiatric inpatient unit. Method: This was a prospective, non-randomized intervention study comparing treatment as usual (TAU) with TAU plus massage therapy intervention (MT) over consecutive 7 week blocks (May–August 2006). MT consisted of a 20 min massage therapy session offered daily to patients during their period of hospitalization. The Kennedy Nurses’ Observational Scale for Inpatient Evaluation (NOSIE), the Symptom Checklist-90–Revised (SCL-90-R), the State–Trait Anxiety Inventory (STAI) and stress hormone (saliva cortisol) levels were used to measure patient outcomes at admission and discharge from the unit. The Staff Observation Aggression Scale–Revised (SOAS-R) was used to monitor the frequency and severity of aggressive incidents on the unit. Results: There was a significant reduction in self-reported anxiety (p < 0.001), resting heart rate (p < 0.05) and cortisol levels (p < 0.05) immediately following the initial and final massage therapy sessions. Significant improvements in hostility (p = 0.007) and depression scores (p < 0.001) on the SCL-90-R were observed in both treatment groups. There was no group×time interaction on any of the measures. Poor reliability of staff-reported incidents on the SOAS-R limited the validity of results in this domain. Conclusions: Massage therapy had immediate beneficial effects on anxiety-related measures and may be a useful de-escalating tool for reducing stress and anxiety in acutely hospitalized psychiatric patients. Study limitations preclude any definite conclusions on the effect of massage therapy on aggressive incidents in an acute psychiatric setting. Randomized controlled trials are warranted.
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Objectives The rapid uptake of nurse practitioner (NP) services in Australia has outpaced evaluation of this service model. A randomized controlled trial was conducted to compare the effectiveness of NP service versus standard medical care in the emergency department (ED) of a major referral hospital in Australia. Methods Patients presenting with pain were randomly assigned to receive either standard ED medical care or NP care. Primary investigators were blinded to treatment allocation for data analyses. The primary outcome measure was the proportion of patients receiving analgesia within 30 minutes from being seen by care group. Secondary outcome measures were time to analgesia from presentation and documentation of and changes in pain scores. Results There were 260 patients randomized; 128 received standard care (medical practitioner led), and 130 received NP care. Two patients needed to be excluded due to incomplete consent forms. The proportion of patients who received analgesia within 30 minutes from being seen was 49.2% (n = 64) in the NP group and 29.7% (n = 38) in the standard group, a difference of 19.5% (95% confidence interval [CI] = 7.9% to 31.2%; p = 0.001). Of 165 patients who received analgesia, 64 (84.2%) received analgesia within 30 minutes in the NP group compared to 38 (42.7%) in the standard care group, a difference in proportions of 41.5% (95% CI = 28.3% to 54.7%; p < 0.001). The mean (±SD) time from being seen to analgesia was 25.4 (±39.2) minutes for NP care and 43.0 (±35.5) minutes for standard care, a difference of 17.6 minutes (95% CI = 6.1 to 29.1 minutes; p = 0.003). There was a difference in the median change in pain score of 0.5 between care groups, but this was not statistically significant (p = 0.13). Conclusions Nurse practitioner service effectiveness was demonstrated through superior performance in achieving timely analgesia for ED patients.
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Background Family caregivers provide invaluable support to stroke survivors during their recovery, rehabilitation, and community re-integration. Unfortunately, it is not standard clinical practice to prepare and support caregivers in this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of keeping the stroke survivor at home. We developed the Timing it Right Stroke Family Support Program (TIRSFSP) to guide the timing of delivering specific types of education and support to meet caregivers' evolving needs. The objective of this multi-site randomized controlled trial is to determine if delivering the TIRSFSP across the stroke care continuum improves caregivers' sense of being supported and emotional well-being. Methods/design Our multi-site single-blinded randomized controlled trial will recruit 300 family caregivers of stroke survivors from urban and rural acute care hospitals. After completing a baseline assessment, participants will be randomly allocated to one of three groups: 1) TIRSFSP guided by a stroke support person (health care professional with stroke care experience), delivered in-person during acute care and by telephone for approximately the first six to 12 months post-stroke; 2) caregiver self-directed TIRSFSP with an initial introduction to the program by a stroke support person, or; 3) standard care receiving the educational resource "Let's Talk about Stroke" prepared by the Heart and Stroke Foundation. Participants will complete three follow-up quantitative assessments 3, 6, and 12-months post-stroke. These include assessments of depression, social support, psychological well-being, stroke knowledge, mastery (sense of control over life), caregiving assistance provided, caregiving impact on everyday life, and indicators of stroke severity and disability. Qualitative methods will also be used to obtain information about caregivers' experiences with the education and support received and the impact on caregivers' perception of being supported and emotional well-being. Discussion This research will determine if the TIRSFSP benefits family caregivers by improving their perception of being supported and emotional well-being. If proven effective, it could be recommended as a model of stroke family education and support that meets the Canadian Stroke Best Practice Guideline recommendation for providing timely education and support to families through transitions.
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Research publication is one of the final steps in the research process, which begins with development of a research idea. Moving through the process of bringing together collaborators, design of the study protocol, securing of grant or study funding, and obtaining ethic(s) approval to conduct the research, and implementation of the research, analysis and drawing of conclusions based on the data leads to publication of the study results. Although a final step in the research process entails dissemination of the results, many studies go unreported or are improperly reported. Indeed, reviewers have suggested that many randomized controlled trials, observational studies, and qualitative studies lack crucial methodological features or details that lend credibility to study results (Simera et al., 2010).
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- Objective Examine feasibility of conducting a randomized controlled trial of the Timing it Right Stroke Family Support Program (TIRSFSP) and collect pilot data. - Design Multi-site mixed method randomized controlled trial. - Setting Acute and community care in three Canadian cities. - Subjects Caregivers were family members or friends providing care to individuals who experienced their first stroke. - Intervention The TIRSFSP offered in two formats, self-directed by the caregiver or stroke support person-directed over time, were compared to standard care. - Main Measures Caregivers completed baseline and follow-up measures 1, 3 and 6 months post-stroke including Centre for Epidemiological Studies Depression, Positive Affect, Social Support, and Mastery Scales. We completed in-depth qualitative interviews with caregivers and maintained intervention records describing support provided to each caregiver. - Results Thirty-one caregivers received standard care (n=10), self-directed (n=10), or stroke support person-directed (n=11) interventions. We retained 77% of the sample through 6-months. Key areas of support derived from intervention records (n=11) related to caregiver wellbeing, caregiving strategies, patient wellbeing, community re-integration, and service delivery. Compared to standard care, caregivers receiving the stroke support person-directed intervention reported improvements in perceived support (estimate 3.1, P=.04) and mastery (estimate .35, P=.06). Qualitative caregiver interviews (n=19) reflected the complex interaction between caregiver needs, preferences and available options when reporting on level of satisfaction. - Conclusions Preliminary findings suggest the research design is feasible, caregivers’ needs are complex, and the support intervention may enhance caregivers’ perceived support and mastery. The intervention will be tested further in a large scale trial.
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Background Comparison of a multimodal intervention WE CALL (study initiated phone support/information provision) versus a passive intervention YOU CALL (participant can contact a resource person) in individuals with first mild stroke. Methods and Results This study is a single-blinded randomized clinical trial. Primary outcome includes unplanned use of health services (participant diaries) for adverse events and quality of life (Euroquol-5D, Quality of Life Index). Secondary outcomes include planned use of health services (diaries), mood (Beck Depression Inventory II), and participation (Assessment of Life Habits [LIFE-H]). Blind assessments were done at baseline, 6, and 12 months. A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time, with a significance level of 0.01. We enrolled 186 patients (WE=92; YOU=94) with a mean age of 62.5±12.5 years, and 42.5% were women. No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures (effect sizes ranged from 0.25 to 0.7). The only significant change for both groups from 6 months to 1 year (n=139) was in the social domains of the LIFE-H (increment in score, 0.4/9±1.3 [95% confidence interval, 0.1–0.7]; effect size, 0.3). Qualitatively, the WE CALL intervention was perceived as reassuring, increased insight, and problem solving while decreasing anxiety. Only 6 of 94 (6.4%) YOU CALL participants availed themselves of the intervention. Conclusions Although the 2 groups improved equally over time, WE CALL intervention was perceived as helpful, whereas YOU CALL intervention was not used.
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Purpose To test the effectiveness of static and dynamic orthoses using them as an exclusive treatment for proximal interphalangeal (PIP) joint flexion contracture compared with other hand therapy conservative treatments described in the literature. Methods 60 patients who used orthoses were compared with a control group that received other hand therapy treatments. Clinical assessments were measured before the experiment and 3 months after and included active PIP joint extension and function. Results A significant improvement in the extension active range of motion at the PIP joint in the second measurement was found in both groups, but it was significantly greater in the experimental group. Improvement in function (Disabilities of the Arm, Shoulder, and Hand score) between the first and second assessment was similar in the control and experimental groups. Conclusions Using night progressive static and daily dynamic orthoses as an exclusive treatment during the proliferative phase led to significant improvements in the PIP joint active extension, but the improvement did not correlate with increased function as perceived by the patient.
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The aim of this study was to develop a new method for quantifying intersegmental motion of the spine in an instrumented motion segment L4–L5 model using ultrasound image post-processing combined with an electromagnetic device. A prospective test–retest design was employed, combined with an evaluation of stability and within- and between-day intra-tester reliability during forward bending by 15 healthy male patients. The accuracy of the measurement system using the model was calculated to be ± 0.9° (standard deviation = 0.43) over a 40° range and ± 0.4 cm (standard deviation = 0.28) over 1.5 cm. The mean composite range of forward bending was 15.5 ± 2.04° during a single trial (standard error of the mean = 0.54, coefficient of variation = 4.18). Reliability (intra-class correlation coefficient = 2.1) was found to be excellent for both within-day measures (0.995–0.999) and between-day measures (0.996–0.999). Further work is necessary to explore the use of this approach in the evaluation of biomechanics, clinical assessments and interventions.
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Latinos report less leisure time physical activity (PA) than non–Latino Whites and suffer disproportionately from diseases related to sedentary lifestyle, yet remain underserved and understudied. Gaining a better understanding of PA behavior in Latinos is critical to intervene on this significant public health issue. This article discusses the growing literature on the facilitators and barriers of PA in Latino men and women and reviews recent interventions to promote activity. Apart from acculturation influences, facilitators of PA in Latinos are similar to those of non–Latino Whites, with most research focusing on self-efficacy and social support. Barriers for Latinas, however, are more culturally distinct, such as a focus on caregiving and cultural standards for body shape. Barriers unique to Latino men largely have not been studied. Researchers have adopted a variety of approaches to increase PA, including using promotores and incorporating culturally appropriate activities, and have had mixed success. However, the community and randomized controlled trials almost exclusively included only women. Studies reviewed here suggest that interventions should target culturally specific barriers beyond language to successfully increase PA in Latinos and highlight a need for formative research and design of interventions for Latino men.