889 resultados para Respect to the Principle of the Fair Trial


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Mode of access: Internet.

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Background: Fetal pulse oximetry (FPO) may improve the assessment of the fetal well-being in labour. Reports of health-care provider's evaluations of new technology are important in the overall evaluation of that technology. Aims: To determine doctors' and midwives' perceptions of their experience placing FPO sensors. Methods: We surveyed clinicians (midwives and doctors) following placement of a FPO sensor during the FOREMOST trial (multicentre randomised trial of fetal pulse oximetry). Clinicians rated ease of sensor placement (poor, fair, good and excellent). Potential influences on ease of sensor placement (staff category, prior experience in Birth Suite, prior experience in placing sensors, epidural analgesia, cervical dilatation and fetal station) were examined by ordinal regression. Results: There were 281 surveys returned for the 294 sensor placement attempts (response rate 96%). Sensors were placed by midwives (29%), research midwives (48%), registrars (22%) and obstetricians (1%). The majority of clinicians had 1 or more years' Birth Suite experience, had placed six or more sensors previously, and rated ease of sensor placement as good. Advancing fetal station (P < 0.001) and the presence of epidural analgesia prior to sensor placement (P = 0.029) predicted improved ease of sensor placement. Having a clinician placing a sensor for the first time predicted a lower rating for ease of sensor placement (P = 0.001), compared to having placed one or more sensors previously. Conclusions: Clinicians with varying levels of Birth Suite experience successfully placed fetal oxygen saturation sensors, with the majority rating ease of sensor placement as good.

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Objective: Heavy menstrual bleeding (menorrhagia) is a common problem, yet evidence is limited to inform therapeutic decisions.We compared the levonorgestrel-releasing intrauterine system(LNG-IUS) to usual medical treatment in a pragmatic randomised trial in primary care. Methods: We randomly assigned 571 women consulting their primary care providers with menorrhagia to LNG-IUS or to usual medical treatment as clinically appropriate (tranexamic acid, mefenamic acid, combined estrogen/progestogen or progestogen only). The primary outcome was a patient-reported measure ofimpact of menorrhagia, the validated Menorrhagia Multi-Attribute Scale (MMAS), assessed over 2 years. Secondary measures included generic quality of life (SF-36), sexual activity and surgical intervention.Results MMAS scores improved from baseline in both the LNG-IUS and usual medical treatment groups by 6 months (mean increases 32.7 points versus 21.4 points, respectively; P < 0.001for both) and were maintained over 2 years, but improvements were significantly greater with LNG-IUS (mean between-group difference 13.4 points, 95%CI, 9.9–16.9; P < 0.001).All domains of MMAS (practical difficulties, social life, family life,work/daily routine, psychological well being and physical health)improved significantly more with LNG-IUS, as were seven of the eight domains of SF-36. More women were still using LNG-IUSthan usual medical treatment at 2 years (64% versus 38%,P < 0.001). There were no significant between-group differences in surgical intervention rates or sexual activity scores. There were no serious adverse events in either group.Conclusions Among women presenting to primary care providers with menorrhagia, LNG-IUS was more effective than usual medical treatment at reducing the impact of this problem on their quality of life. In practice therefore, conventional treatments, such as tranexamic and mefenamic acid, remain helpful choices in women for whom LNG-IUS is considered unsuitable, or due to individual preference. For other women, LNG-IUS can be confidently recommended as an effective initial medical therapy for menorrhagia. Funding: This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 02/06/02)

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OBJECTIVE: To evaluate the cost-effectiveness of adding zoledronic acid or strontium-89 to standard docetaxel chemotherapy for patients with castrate-refractory prostate cancer (CRPC).

PATIENTS AND METHODS: Data on resource use and quality of life for 707 patients collected prospectively in the TRAPEZE 2 × 2 factorial randomised trial (ISRCTN 12808747) were used to assess the cost-effectiveness of i) zoledronic acid versus no zoledronic acid (ZA vs. no ZA), and ii) strontium-89 versus no strontium-89 (Sr89 vs. no Sr89). Costs were estimated from the perspective of the National Health Service in the UK and included expenditures for trial treatments, concomitant medications, and use of related hospital and primary care services. Quality-adjusted life-years (QALYs) were calculated according to patients' responses to the generic EuroQol EQ-5D-3L instrument, which evaluates health status. Results are expressed as incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves.

RESULTS: The per-patient cost for ZA was £12 667, £251 higher than the equivalent cost in the no ZA group. Patients in the ZA group had on average 0.03 QALYs more than their counterparts in no ZA group. The ICER for this comparison was £8 005. Sr89 was associated with a cost of £13 230, £1365 higher than no Sr89, and a gain of 0.08 QALYs compared to no Sr89. The ICER for Sr89 was £16 884. The probabilities of ZA and Sr89 being cost-effective were 0.64 and 0.60, respectively.

CONCLUSIONS: The addition of bone-targeting treatments to standard chemotherapy led to a small improvement in QALYs for a modest increase in cost (or cost-savings). ZA and Sr89 resulted in ICERs below conventional willingness-to-pay per QALY thresholds, suggesting that their addition to chemotherapy may represent a cost-effective use of resources.

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From an ethical perspective, clinical research involving humans is only acceptable if it involves the potential for benefit. Various characteristics can be applied to differentiate research benefit. Often benefit is categorized in direct or indirect benefit, whereby indirect benefit might be further differentiated in collective or benefit for the society, excluding or including the trial patient in the long term. Ethical guidelines, such as the Declaration of Helsinki in its latest version, do not precisely favor a particular type of benefit.

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The thesis is an investigation of the principle of least effort (Zipf 1949 [1972]). The principle is simple (all effort should be least) and universal (it governs the totality of human behavior). Since the principle is also functional, the thesis adopts a functional theory of language as its theoretical framework, i.e. Natural Linguistics. The explanatory system of Natural Linguistics posits that higher principles govern preferences, which, in turn, manifest themselves as concrete, specific processes in a given language. Therefore, the thesis’ aim is to investigate the principle of least effort on the basis of external evidence from English. The investigation falls into the three following strands: the investigation of the principle itself, the investigation of its application in articulatory effort and the investigation of its application in phonological processes. The structure of the thesis reflects the division of its broad aims. The first part of the thesis presents its theoretical background (Chapter One and Chapter Two), the second part of the thesis deals with application of least effort in articulatory effort (Chapter Three and Chapter Four), whereas the third part discusses the principle of least effort in phonological processes (Chapter Five and Chapter Six). Chapter One serves as an introduction, examining various aspects of the principle of least effort such as its history, literature, operation and motivation. It overviews various names which denote least effort, explains the origins of the principle and reviews the literature devoted to the principle of least effort in a chronological order. The chapter also discusses the nature and operation of the principle, providing numerous examples of the principle at work. It emphasizes the universal character of the principle from the linguistic field (low-level phonetic processes and language universals) and the non-linguistic ones (physics, biology, psychology and cognitive sciences), proving that the principle governs human behavior and choices. Chapter Two provides the theoretical background of the thesis in terms of its theoretical framework and discusses the terms used in the thesis’ title, i.e. hierarchy and preference. It justifies the selection of Natural Linguistics as the thesis’ theoretical framework by outlining its major assumptions and demonstrating its explanatory power. As far as the concepts of hierarchy and preference are concerned, the chapter provides their definitions and reviews their various understandings via decision theories and linguistic preference-based theories. Since the thesis investigates the principle of least effort in language and speech, Chapter Three considers the articulatory aspect of effort. It reviews the notion of easy and difficult sounds and discusses the concept of articulatory effort, overviewing its literature as well as various understandings in a chronological fashion. The chapter also presents the concept of articulatory gestures within the framework of Articulatory Phonology. The thesis’ aim is to investigate the principle of least effort on the basis of external evidence, therefore Chapters Four and Six provide evidence in terms of three experiments, text message studies (Chapter Four) and phonological processes in English (Chapter Six). Chapter Four contains evidence for the principle of least effort in articulation on the basis of experiments. It describes the experiments in terms of their predictions and methodology. In particular, it discusses the adopted measure of effort established by means of the effort parameters as well as their status. The statistical methods of the experiments are also clarified. The chapter reports on the results of the experiments, presenting them in a graphical way and discusses their relation to the tested predictions. Chapter Four establishes a hierarchy of speakers’ preferences with reference to articulatory effort (Figures 30, 31). The thesis investigates the principle of least effort in phonological processes, thus Chapter Five is devoted to the discussion of phonological processes in Natural Phonology. The chapter explains the general nature and motivation of processes as well as the development of processes in child language. It also discusses the organization of processes in terms of their typology as well as the order in which processes apply. The chapter characterizes the semantic properties of processes and overviews Luschützky’s (1997) contribution to NP with respect to processes in terms of their typology and incorporation of articulatory gestures in the concept of a process. Chapter Six investigates phonological processes. In particular, it identifies the issues of lenition/fortition definition and process typology by presenting the current approaches to process definitions and their typology. Since the chapter concludes that no coherent definition of lenition/fortition exists, it develops alternative lenition/fortition definitions. The chapter also revises the typology of phonological processes under effort management, which is an extended version of the principle of least effort. Chapter Seven concludes the thesis with a list of the concepts discussed in the thesis, enumerates the proposals made by the thesis in discussing the concepts and presents some questions for future research which have emerged in the course of investigation. The chapter also specifies the extent to which the investigation of the principle of least effort is a meaningful contribution to phonology.