525 research outputs found

    Clinical Research Design and Biostatistical Methods

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    Purpose: To proceed effectively with clinical research requires an understanding of the fundamental principles of study design and biostatistical methods. In this article, we identified and summarized basic clinical research designs and some of the key biostatistical methods that have been commonly used in clinical research. Materials and Methods: In an observational study, cross-sectional, case- control and Cohort designs were illustrated and compared. In a clinical trial study, parallel group design and cross-over designs were described according to their characteristics. Also, the biostatistical methods for their usages classified and summarized. Results: Understanding and evaluating research design are part of the process researchers must use to determine both the quality and usefulness of their research. Adequate applications to biostatistical methods are need; i.e., descriptive statistics, Student´s t-test, ANOVA, nonparametrics, categorical data analysis, correlation and regression, and survival analysis. Conclusions: Research findings are used by clinical researcher to guide their practice and reduce their uncertainty in clinical decision making. However, to understand how to interpret research results, it is important to be able to understand basic statistical concepts and types of study design. Clinicians should also appropriately choose the biostatistical methods to suit their purposes.ope

    Intentional Observational Clinical Research Design : Innovative Design for Complex Clinical Research Using Advanced Technology

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    The growing use of robots in nursing and healthcare facilities has prompted increasing research on human–robot interactions. However, specific research designs that can guide researchers to conduct rigorous investigations on human–robot interactions are limited. This paper aims to discuss the development and application of a new research design—the Intentional Observational Clinical Research Design (IOCRD). Data sources to develop the IOCRD were derived from surveyed literature of the past decade, focusing on clinical nursing research and theories relating robotics to nursing and healthcare practice. The distinction between IOCRD and other research design is the simultaneous data generation collected using advanced technological devices, for example, the wireless Bonaly-light electrocardiogram (ECG) to track heart rate variability of research subjects, robot application programs on the iPad mini to control robot speech and gestures, and Natural Language Processing programs. Even though IOCRD was developed for human–robot research, there remain vast opportunities for its use in nursing practice and healthcare. With the unique feature of simultaneous data generation and analysis, an interdisciplinary collaborative research team is strongly suggested. The IOCRD is expected to contribute guidance for researchers in conducting clinical research related to robotics in nursing and healthcare

    EuroSpine Task Force on Research: support for spine researchers

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    In recognition of the value of research to the practice of spine care, Federico Balagué and Ferran Pellisé, at the time President and Secretary for EuroSpine, asked Margareta Nordin to set up a Task Force on Research (TFR) for EuroSpine during summer 2011. The concept was to stimulate and facilitate a research community within the society, through two main functions: (1) distribution of EuroSpine funds to researchers; (2) develop and deliver research training/education courses. What has the EuroSpine TFR accomplished since its inception

    Feasibility of Lifestyle Redesign® for community-dwelling older adults with and without disabilities : results from an exploratory descriptive qualitative clinical research design

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    Abstract : Introduction. Although Lifestyle Redesign® has been shown to be effective in improving older adults’ health and well-being, little is known about the feasibility of implementing this program to develop meaningful and health-promoting routines of community-dwelling older adults in Canada. This study thus aimed to explore the feasibility of implementing a culturally-adapted 6-month version of Lifestyle Redesign® with community-dwelling older French-Canadians with and without disabilities. Methods. An exploratory descriptive qualitative clinical research design was used with 17 older adults living at home or in a seniors’ residence, divided into two groups participating in Lifestyle Redesign®. Semi-structured interviews were conducted with participants and the occupational therapist who delivered the program and recorded clinical notes. Findings. Participants were aged between 65 and 90; they were mainly women (n=11; 64.7%) and 7 (41.2%) had disabilities. The intervention was tailored to the participants’ needs, interests and capacities in each group (e.g., modules selected, number of individual sessions, assistance of volunteer). Over the 6-month period, older adults participated in an average of about 25 group sessions with the occupational therapist and in four or five outings with their group (e.g., restaurant, market, museum) and attended between five and eleven individual sessions with the occupational therapist. The most common reasons for missing group sessions were being ill, working, or having another appointment. Personal facilitators and barriers to participation in the intervention were mainly related to abilities, needs, spiritual life, and health. Environmental facilitators were mostly the regularity of the sessions, group and external support, including human resources to deliver the intervention, while barriers were the residence’s time restrictions and staff’s attitudes, cost of some activities targeted in the program, and transportation problems. Conclusion. Lifestyle Redesign® is a feasible preventive occupational therapy intervention for community-dwelling older French-Canadians. These findings will guide future studies including large-scale clinical trials

    APPLICATION OF CONTINUOUS TIME STOCHASTIC PROCESSES IN SEQUENTIAL CLINICAL RESEARCH DESIGN AND ECONOMETRICS

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    The principal subject of this thesis is hypothesis testing and related problems of estimation for stochastic processes. The thesis is concerned in particular with two areas: sequential hypothesis testing in a Bayesian setting and estimation of the parameters governing a continuous-time stochastic differential equation that drives data sampled at high-frequency. The former area is concerned with hypothesis testing for a newly developed healthcare technology and makes use of optimal stopping theory. The latter area sees the application of limit theorems for stochastic processes that allow to recover the true volatility process that can be estimated using the methods of moments estimator

    A systematic review of criteria used to report complications in soft tissue and oncologic surgical clinical research studies in dogs and cats.

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    ObjectiveTo evaluate reporting of surgical complications and other adverse events in clinical research articles describing soft tissue and oncologic surgery in dogs and cats.Study designSystematic literature review.SampleEnglish-language articles describing soft tissue and oncologic surgeries in client-owned dogs and cats published in peer-reviewed journals from 2013 to 2016.MethodsCAB, AGRICOLA, and MEDLINE databases were searched for eligible articles. Article characteristics relevant to complications were abstracted and summarized, including reported events, definitions, criteria used to classify events according to severity and time frame, and relevant citations.ResultsOne hundred fifty-one articles involving 10 522 animals were included. Canine retrospective case series of dogs predominated. Ninety-two percent of articles mentioned complications in study results, but only 7.3% defined the term complication. Articles commonly described complications according to time frame and severity, but terminology and classification criteria were highly variable, conflicting between studies, or not provided. Most (58%) reported complications could have been graded with a published veterinary adverse event classification scheme, although common intraoperative complications were notable exceptions.ConclusionDefinitions and criteria used to classify and report soft tissue and oncologic surgical complications are often absent, incomplete, or contradictory among studies.Clinical significanceLack of consistent terminology contributes to inadequate communication of important information about surgical complications. Standardization of terminology and consistency in severity scoring will improve comparative evaluation of clinical research results

    Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03)

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    Purpose: Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC. Methods and Materials: This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment. Results: Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (β = −1.53 [−2.93 to −.13], P =.03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions. Conclusions: This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC

    Fall 09 Prescriptions for Excellence Download Full PDF

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