Książki na temat „Randomised clinical trial (RCT)”
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1
G, Zermansky A., National Co-ordinating Centre for HTA (Great Britain) i Health Technology Assessment Programme, red. Clinical medication review by a pharmacist of patients on repeat prescriptions in general practice: A randomised controlled trial. Alton: Core Research on behalf of the NCCHTA, 2002.
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2
Downe, Susan Mary. Reducing the risk of adverse outcome for nulliparous women using epidural analgesia in labour: A randomised clinical trial and longitudinal follow-up survey.... [Derby: University of Derby], 1999.
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3
Strand, Vibeke, Jeremy Sokolove i Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0030.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
4
Strand, Vibeke, Jeremy Sokolove i Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_001.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
5
Strand, Vibeke, Jeremy Sokolove i Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_002.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
6
Farrar, John T. Understanding clinical trials in palliative care research. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199656097.003.0193.
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Advances in basic science, translational, and clinical research have led to rapid improvements in our understanding of many disease processes. The randomized clinical trial (RCT) has played an important role in validating the benefits and harms of therapies thought to be potentially useful based on scientific theory or clinical observation, and has become the ‘gold standard’ for the demonstration of efficacy. As in all clinical study designs, the RCT has strengths and weaknesses that must be understood to appropriately interpret the study results. While randomization of the intended study population is the primary strength of such trials, choice of the study population, control condition, outcome measures, analysis procedure, and procedures for blinding the study participants can all affect the results. Understanding the requirements of a valid RCT and what can potentially go wrong will improve the conduct of palliative care research and the usefulness of published information in the care of patients.
7
Fishman, Daniel B., Stanley B. Messer, David J. A. Edwards i Frank M. Dattilio, red. Case Studies Within Psychotherapy Trials. Oxford University Press, 2017. http://dx.doi.org/10.1093/med:psych/9780199344635.001.0001.
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The Cases Within Trials (CWT) model combines the randomized clinical trial (RCT) research design, based on quantitative group research, with richly and qualitatively detailed systematic case studies involving contrasting outcomes drawn from the experimental condition of the RCT. Chapter 1 of the book provides the broad historical and methodological context out of which the CWT method developed, including the recent dramatic growth of mixed-methods approaches in psychotherapy research generally, with an associated increase in their credibility and rigor. Chapter 2 presents the details of the CWT method and its application to Chapters 3–6, which present four specific projects that concretely illustrate the CWT method. The four projects vary across such dimensions as theoretical orientation and type of mental disorder. To facilitate comparison across projects, each is organized in three main sections, including results gained from the RCT, results gained from the case studies, and a synthesis of the two types of knowledge. Each project concludes with a commentary by an outside expert (or expert team) in the theoretical and disorder focus of the project. Chapter 7 presents an outside perspective on the four projects from a research team highly experienced in conducting and thinking about traditional RCTs. In view of the four projects as a whole, Chapter 8 presents the editors’ summary and analysis of themes and guidelines for the future embodied in the knowledge gained from the four projects.
8
Elwood, Mark. Critical appraisal of a randomized clinical trial. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0012.
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This chapter presents a randomised trial carried out in primary care in the UK, assessing the use of an antibiotic, chloramphenicol, for acute eye infections (conjunctivitis) in children. This study shows the challenges of conducting a high quality randomised trial in primary care, including issues of the appropriate assessment of outcome. The critical assessment follows the scheme set out in chapter 10: describing the study, assessing the non-causal explanations of observation bias, confounding, and chance variation; assessing time relationships, strength, dose-response, consistency and specificity, and applying the results to the eligible, source, and target populations; and then comparing the results with evidence from other studies, considering consistency and specificity, biological mechanisms, and coherence with the distribution of exposures and outcomes. The chapter gives a summary and table of the critical assessment and its conclusions; and comments on the impact of the study and research carried out since.
9
Levy, David. History, epidemiology, and aetiology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198766452.003.0001.
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Outline of the key landmarks in the history of Type 1 diabetes. Epidemiology, focusing on its rising incidence and the increasing prevalence of later-onset autoimmune diabetes. Genetics are briefly covered; the evidence for and against the impact of a variety of environmental factors thought to be important in aetiology are emphasized, especially in relation to prospective randomized clinical trials (RCT) in early Type 1 diabetes, aiming to delay the onset of autoimmunity in high-risk individuals or slow the decline in C-peptide levels shortly after clinical diagnosis. The balance-risk hypothesis, which allows for inclusion of protective and promoting factors, is introduced.
10
West, Amy E., Sally M. Weinstein i Mani N. Pavuluri. RAINBOW. Oxford University Press, 2017. http://dx.doi.org/10.1093/med-psych/9780190609139.001.0001.
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RAINBOW: A Child- and Family-Focused Cognitive-Behavioral Treatment for Pediatric Bipolar Disorder is a comprehensive, evidence-based treatment manual designed specifically for children ages 7–13 with bipolar spectrum disorders and their families. Developed by experts in pediatric mood disorders and tested in a randomized clinical trial (RCT), RAINBOW integrates psychoeducation and cognitive-behavioral therapy (CBT) with complementary techniques from mindfulness-based intervention, positive psychology, and interpersonal therapy to address the range of therapeutic needs of families affected by this disorder. Guided by the evidence on the neurobiological and psychosocial difficulties accompanying pediatric bipolar disorder, this treatment targets the child and family across seven core components: Routine, Affect Regulation, I Can Do It, No Negative Thoughts and Live in the Now, Be a Good Friend/Balanced Lifestyle for Parents, Oh How Do We Solve This Problem, and Ways to Get Support. Throughout the treatment, the child and family will learn how to identify mood states and triggers of mood dysregulation, and develop cognitive and behavioral strategies for improving mood stability. Children will build social skills, and caregivers will develop greater balance and self-care in their own lives. The family will learn ways to use routines, problem-solving, and social support to improve overall family functioning. Intended for qualified child-focused mental health professionals, this manual includes the conceptual background of the treatment and user-friendly step-by-step instruction in delivering RAINBOW with families, including handy session outlines and engaging worksheets for the child and caregiver(s).
11
Qu, Lirong, i Darrell J. Triulzi. Blood product therapy in the ICU. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0267.
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Transfusions are among the most common medical procedures in the intensive care unit. Several randomized controlled trials (RCT) indicate that restrictive red cell transfusion practice using a haemoglobin of <7g/dL is safe in critically-ill patients. Although similar RCT are not available for plasma or platelet transfusion guidelines, a large body of observational studies suggest that plasma transfusion for an invasive procedure has not been shown to be of benefit in patients with INR <2.0. Similarly, in thrombocytopenic patients, the target platelet count for bleeding or for an invasive procedure is 50,000/µl. Viral transmission risk has become exceedingly low. Other risks such as transfusion-associated circulatory overload and, to a lesser extent, transfusion-related acute lung injury, are much more common. Storage of red cells does not seem to be associated with adverse clinical outcomes. Alternatives using haemostatic agents, salvaged blood, and adherence to evidence-based transfusion guidelines probably reduce the need for transfusion in critically-ill patients.
12
Alhazzani, Waleed, i Deborah J. Cook. Stress ulcer prophylaxis and treatment drugs in critical illness. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0041.
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Many changes have occurred over the last three decades in the field of stress ulcer gastrointestinal bleeding and its prevention. The topic is controversial, fuelled by disparate data, studies at risk of bias, and the impression that the problem is not as serious as it once was. Indeed, compared with over four decades ago when mucosal ulceration of the stomach causing serious bleeding was first described, a relatively small proportion of critically-ill patients now develop clinically important bleeding. Acid suppression is commonly prescribed for stress ulcer prophylaxis (SUP), targeting subgroups of patients at high risk in the intensive care unit (ICU), rather than universal prevention. The randomized clinical trials to date suggest a significant reduction in CIB with use of histamine-2-receptor antagonists (H2RAs) compared with no SUP, with no impact on pneumonia, ICU mortality, or length of stay. However, these trials are of moderate quality. More recent RCTs suggest proton pump inhibitors compared with H2RAs may significantly reduce the risk of CIB without influencing the risk of pneumonia, ICU mortality, or length of stay. These trials are also of moderate quality. Today, the decision whether to use SUP, and which agent to use, is complex. Clinical considerations include local epidemiological data (for centres documenting these outcomes), and patient-specific risks of gastrointestinal bleeding and infection, indexed to case mix.
13
Burns, Tom, i Mike Firn. Research and development. Redaktorzy Tom Burns i Mike Firn. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198754237.003.0029.
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This chapter covers the spectrum of routine monitoring, audit, service evaluation, and formal research. Routine monitoring is an essential task for all mental health professionals, and techniques to make it more palatable are explored, including using routine data for clinical supervision and monitoring team targets. Regular audit is described as an essential tool for logical service development and quality improvement. In the discussion of research, the importance of choosing the correct methodology and of paying attention to detail are stressed. In community psychiatry, sampling bias, regression to the mean, and the Hawthorne effect pose important risks. The hierarchy of research methods is outlined with randomized controlled trials (RCTs) at the top, preferably with either single- or double-blinding. Careful statistics and systematic reviews support evidence-based practice. In addition to experimental quantitative trials, there is a place for cohort and case control trials, as well as for qualitative trials to generate hypotheses.
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A Randomised controlled trial to evaluate the clinical and cost-effectiveness of Hickman line insertions in adult cancer patients by nurses. Tunbridge Wells: Gray Publishing, on behalf of the NCCHTA, 2003.
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15
Holden, Melanie A., Martin J. Thomas i Krysia S. Dziedzic. Miscellaneous physical therapies. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199668847.003.0026.
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Miscellaneous physical therapies, such as assistive devices, thermotherapy, manual therapy, and electrotherapy are commonly used to treat patients with osteoarthritis (OA) in addition to written information and exercise. However, the evidence underpinning specific miscellaneous physical therapies is often limited, with small study sizes, heterogeneous populations, and differing study designs making it difficult to draw firm conclusions about their effectiveness. One or more miscellaneous physical therapies feature within 15 current clinical guidelines for OA. The specific types of physical therapies addressed are variable, as are their recommendations. There is most agreement for miscellaneous physical therapies in hand OA, with multiple guidelines addressing and consistently recommending joint protection, splinting, and thermotherapy in addition to core treatment. However these recommendations are predominantly based on a small number of randomized controlled trials (RCTs). Use of walking aids and footwear is commonly addressed and recommended for patients with hip and knee OA, although recommendations are predominantly based on expert opinion. Other physical therapies recommended for hip and knee OA range from orthoses to less conventional leech therapy. When a recommendation for a miscellaneous physical therapy is not made, it is commonly due to limited clinical evidence, rather than evidence of harm. Due to limited evidence and lack of consensus between clinical guidelines, for some therapies, use of specific miscellaneous physical therapies in clinical practice should be based upon the best available evidence, a holistic, individualized clinical assessment and shared decision-making with the patient. Further large-scale, high-quality RCTs would be useful to inform future guideline recommendations and clinical practice.
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Validation of the PROSQOLI as an outcome measure for clinical trials in advanced hormone-resistant prostate cancer: Assessment of convergent, discriminative and predictive validity with baseline data from a randomised trial. Ottawa: National Library of Canada, 1996.
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