Patient acceptance of the anesthetic process.
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Using computer simulation, it was found that, at least in case of purple bacteria, the widely accepted model for the primary photosynthetic processes (energy migration to reaction centers and its further trapping) is unable to provide a fully consistent explanation for the available experimental data. Two physical mechanisms suggested in this work are thought to be able to resolve or at least decrease the severity of this problem.
PURPOSE: With this publication a subcommittee of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) makes recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules. METHODS: This subcommittee was comprised of 10 members representing Pharmaceutical, Biotechnology, and the contract research organization industries from the United States, Canada, and Europe. Each section of this consensus document addresses a specific analytical performance characteristic or aspect for validation of a LBA. Within each section the topics are organized by an assay's life cycle, the development phase, pre-study validation, and in-study validation. Because unique issues often accompany bioanalytical assays for macromolecules, this document should be viewed as a guide for designing and conducting the validation of ligand binding assays. RESULTS: Values of +/- 20% (25% at the lower limit of quantification [LLOQ]) are recommended as default acceptance criteria for accuracy (% relative error [RE], mean bias) and interbatch precision (%coefficient of variation [CV]). In addition, we propose as secondary criteria for method acceptance that the sum of the interbatch precision (%CV) and the absolute value of the mean bias (%RE) be less than or equal to 30%. This added criterion is recommended to help ensure that in-study runs of test samples will meet the proposed run acceptance criteria of 4-6-30. Exceptions to the proposed process and acceptance criteria are appropriate when accompanied by a sound scientific rationale. CONCLUSIONS: In this consensus document, we attempt to make recommendations that are based on bioanalytical best practices and statistical thinking for development and validation of LBAs.
This article analyzes the results of the hitherto privatization of health care in Slovenia based on statistical indices and public opinion data. The new legislation offered much more room for quasiprivatization than for real privatization. A greater room was left for privatization of financing than for the status of health care providers and infrastructure. The statistical data on private practitioners and the share of private resources in health care costs show that the privatization is relatively slow but irreversible process. Public opinion data revealed that the population of Slovenia accepted this process but some signs of distrust in private practice and new forms of health insurance were noticed. The new legislation leaves a high degree of regulation to the state in protecting citizens' rights but there are some risks of unrestrained development of the market due to insufficient implementation of legislation.
This study determined that high self-acceptance of adoptive parents influenced high parental acceptance of their adopted children. A case is made for emphasizing self-acceptance in adoption procedures.
The present article presents and reviews the model of psychopathology and treatment underlying Acceptance and Commitment Therapy (ACT). ACT is unusual in that it is linked to a comprehensive active basic research program on the nature of human language and cognition (Relational Frame Theory), echoing back to an earlier era of behavior therapy in which clinical treatments were consciously based on basic behavioral principles. The evidence from correlational, component, process of change, and outcome comparisons relevant to the model are broadly supportive, but the literature is not mature and many questions have not yet been examined. What evidence is available suggests that ACT works through different processes than active treatment comparisons, including traditional Cognitive-Behavior Therapy (CBT). There are not enough well-controlled studies to conclude that ACT is generally more effective than other active treatments across the range of problems examined, but so far the data are promising.
BACKGROUND: The role of informal spousal caregivers has increased as the population ages, levels of disability in society increase, and governments seek to restrain expenditure on the provision of institutional health care. Care giving has attracted a vast body of research, largely directed at caregiver burden. Incontinence, however, has been relatively unexplored, despite being a common problem faced by caregivers, and being recognised as a major caregiver burden and predictor of institutional placement. AIMS: This study began to explore the impact of care recipient incontinence on major care providers, that is, their spouses. APPROACH: A qualitative approach based on the grounded theory method was used. Eight home-based caregivers of spouses with incontinence were interviewed. FINDINGS: Data analysis revealed a number of categories, grouped under three major themes: underpinnings, processes and consequences. The underpinnings were lifelong love and friendship, and acceptance; the processes were problem-solving and constant watchfulness. The consequences were role change, financial cost, decreased intimacy, emotional responses, sleeping issues and social isolation. DISCUSSION: The research highlighted the interconnectedness of factors in the experiences of carers, reinforcing the need for holistic assessment beyond a focus on the "continence issue" alone. Nevertheless, simple interventions could make substantial differences. A framework is proposed which may guide nursing assessment.
Acceptance, attrition and outcome of the same outpatient treatment programme for alcoholics was studied first in a non-randomized and later in a randomized study. There was a lower (15%) rate of acceptance and a higher (19%) rate of attrition in the randomized study. Among treatment completers drinking outcome during the third year after commencement of treatment did not differ between the non-randomized and the randomized study. It is concluded that the characteristics of subjects accepting a randomly assigned study should always be clearly presented. The absence of a patient-therapist matching in a randomized design could negatively effect attrition and probably also acceptance of treatment, while it seems to be less influential on outcome in those completing therapy.
OBJECTIVE: To determine the minimal clinically important difference (MCID) of warfarin therapy for the treatment of nonvalvular atrial fibrillation from the perspective of patients using 2 different elicitation methods. DESIGN: All patients completed 2 face-to-face interviews, which were 2 weeks apart. For each interview, they were randomized to receive 1 of 2 elicitation methods: ping-ponging or starting at the known efficacy. SETTING: The practices of 2 university-affiliated family medicine centers (8 physicians each), 14 community-based family physicians, and 2 cardiologists. PATIENTS: Sixty-four patients with nonvalvular atrial fibrillation who were initiated with warfarin therapy at least 3 months before the study. INTERVENTION: During each interview, the patients' MCIDs were determined by using (1) a pictorial flip chart to describe atrial fibrillation; the consequences of a minor stroke, a major stroke, and a major bleeding episode; the chance of stroke if not taking warfarin; the chance of a major bleeding episode if taking warfarin; examples of the inconvenience, minor side effects, and costs of warfarin therapy; and then (2) 1 of the 2 elicitation methods to determine their MCIDs (the smallest reduction in stroke risk at which the patients were willing to take warfarin). Patients' knowledge of their stroke risk, acceptability of the interview process, and factors determining their preferences were also assessed. MAIN RESULTS: Given a baseline risk of having a stroke in the next 2 years, if not taking warfarin, of 10 of 100, the mean MCID was 2.01 of 100 (95% confidence interval, 1.60-2.42). Fifty-two percent of the patients would take warfarin for an absolute decrease in stroke risk of 1% over 2 years. Before eliciting their MCIDs, patients showed poor knowledge of their stroke risk, which improved afterward. The interview process was well accepted by the patients. The MCID using the ping-ponging elicitation method was 1.015 of 100 smaller compared with use of the starting at the known efficacy method (P = .01). CONCLUSIONS: We were able to determine the MCID of warfarin therapy for the prevention of stroke from the perspective of patients with nonvalvular atrial fibrillation. Their MCIDs were much smaller than those that have been implied by some experts and clinicians. The interview process, using the flip chart approach, appeared to improve the patients' knowledge of their disease and its consequences and treatment. The method used to elicit the patients' MCIDs can have a clinically important effect on patient responses. The method used in our study can be generalized to other conditions and, thus, could be helpful in 3 ways: (1) from a clinical decision-making perspective, it could facilitate patient-physician communication; (2) it could clarify the patient perspective when interpreting the results of previously completed trials; and (3) it could be used to derive more clinically relevant sample sizes for randomized treatment trials.
BACKGROUND AND OBJECTIVES: Nucleated cell content is one of the main components used when evaluating cord blood (CB) units for clinical use. However, other indicators of the haematopoietic potential of a CB unit, such as CD34+ cell and colony-forming cell (CFU-TOT) content, have also been investigated. The aim of this study was to determine whether the CD34+ cell content could be used in selecting CB collections for banking. MATERIALS AND METHODS: The collection data, as well as cellular contents of 588 CB collections obtained using a standardized CB banking process, were analysed. RESULTS: Altogether, 526 CB units from the 588 collections accepted for processing were included in international search registries. The volume collected was, as expected, 69 ml (range 28-116 ml). The correlation between total CD34+ cell and CFU-TOT (n = 88) content in the CB collection was higher (r = 0.87) than the correlation between the total nucleated cell and CFU-TOT content (r = 0.69, both P < 0.0001). The correlations of pre- and postvolume reduction values of the total nucleated cell and CD34+ cell numbers were highly significant (r = 0.96, P < 0.0001, both). The total CFU-TOT content of the CB collection correlated significantly with the total CD34+ cell content of the CB unit before cryopreservation (but after volume reduction) (r = 0.89, P < 0.0001). CONCLUSIONS: CD34+ cell content predicts the haematopoietic potential of a CB unit better than nucleated cell content. Accordingly, the CD34+ cell content of CB could be used to select CB for banking purposes and for transplantation.
THE PRESENT WORK IS DEVOTED TO THE FOLLOWING QUESTION: What is the relationship between the deterministic laws of dynamics and probabilistic description of physical processes? It is generally accepted that probabilistic processes can arise from deterministic dynamics only through a process of "coarse graining" or "contraction of description" that inevitably involves a loss of information. In this work we present an alternative point of view toward the relationship between deterministic dynamics and probabilistic descriptions. Speaking in general terms, we demonstrate the possibility of obtaining (stochastic) Markov processes from deterministic dynamics simply through a "change of representation" that involves no loss of information provided the dynamical system under consideration has a suitably high degree of instability of motion. The fundamental implications of this finding for statistical mechanics and other areas of physics are discussed. From a mathematical point of view, the theory we present is a theory of invertible, positivity-preserving, and necessarily nonunitary similarity transformations that convert the unitary groups associated with deterministic dynamics to contraction semigroups associated with stochastic Markov processes. We explicitly construct such similarity transformations for the so-called Bernoulli systems. This construction illustrates also the construction of the so-called Lyapounov variables and the operator of "internal time," which play an important role in our approach to the problem of irreversibility. The theory we present can also be viewed as a theory of entropy-increasing evolutions and their relationship to deterministic dynamics.
BACKGROUND: Patients with thick (Breslow>4 mm) primary melanoma and/or regional nodal metastasis have a high risk of tumor recurrence. High-dose adjuvant interferon (IFN) alfa-2b offers /=50% risk of recurrence/disease-related mortality and offered IFN. Telephone surveys delineated reasons behind patients' decisions to accept IFN. RESULTS: Acceptors, 60 of 135 (45%), decided to take IFN alfa-2b whereas 75 of 135 (55%) declined. Being female (OR, 2.4; 95% CI, 1.17-5.03; p=.017) and positive SLN status (OR, 2.2; 95% CI, 1.01-4.97; p=.048) were strongly associated with patients who chose IFN. Acceptors of IFN were younger, more influenced by physicians, and less affected by depression and side effect profile (p<.05 for all). Decliners were more concerned by strained relationships with family and social life (p<.05). CONCLUSIONS: Gender and positive SLN were predictive of high-risk melanoma patients' acceptance of IFN treatment. Physician insight into melanoma patients' therapeutic decision-making process can guide patients through this difficult disease.
The nursing process is accepted as a major framework for practice; but its integration in the quality assurance process, in a format where the phases of the nursing process are examined in a sequential manner has not been reported. The authors have developed a nursing process audit tool that provides an organized approach for evaluating independent nursing functions based on the nursing process. Each step in the nursing process can be evaluated individually and as a whole. The tool can be used concurrently and/or retrospectively. This tool provides nursing administrators with pertinent data that can be used to improve nursing practice.
A technique has been developed by which facial processes with adequately migrated neural crest tissue can be cultured and transplanted to embryos with induced craniofacial malformations. Culturing was carried out in the anterior eye chambers of adult rats or as whole embryo cultures in glass vials (n = 71). Facial processes transplanted to the anterior eye chamber differentiated to cartilage, bone, and mesenchymal tissues. It was possible to keep the embryos alive in whole tissue culture for up to 24 hours. The addition of epidermal growth factor to the culture medium resulted in accelerated growth of epithelium on the surface of the facial processes. Facial processes were accepted when transplanted to either normal or etretinate treated embryos. Epithelium covered the transplanted facial processes, neural crest tissue was seen in the centre, and capillaries were in close contact to the base of each one.
BACKGROUND: Involving patients in healthcare decisions makes a potentially significant and enduring difference to healthcare outcomes. One difficulty (among many) is that the 'involvement' of patients in decisions has been left undefined. It is usually conceptualised as 'patient centredness', which is a broad and variably interpreted concept that is difficult to assess using current tools. This paper attempts to gauge general practitioners' (GPs') attitudes to patient involvement in decision making and their views about the contextual factors, competences, and stages required to achieve shared decisions within consultations. AIM: To explore and understand what constitutes the appropriate involvement of patients in decision making within consultations, to consider previous theory in this field, and to propose a set of competences (skills) and steps that would enable clinical practitioners (generalists) to undertake 'shared decision making' in their clinical environment. METHOD: Qualitative study using focus group interviews of key informants. RESULTS: Experienced GPs with educational roles have positive attitudes to the involvement of patients in decisions, provided the process matches the role individuals wish to play. They perceive some clinical problems as being more suited to a cooperative approach to decision making and conceptualised the existence of professional equipoise towards the existence of legitimate treatment options as an important facilitative factor. A sequence of skills was proposed as follows: 1) implicit or explicit involvement of patients in the decision-making process; 2) explore ideas, fears, and expectations of the problem and possible treatments; 3) portrayal of equipoise and options; 4) identify preferred data format and provide tailor-made information; 5) checking process: understanding of information and reactions (e.g. ideas, fears, and expectations of possible options); 6) acceptance of process and decision making role preference; 7) make, discuss or defer decisions; 8) arrange follow-up. CONCLUSIONS: These clinicians viewed involvement as an implicit ethos that should permeate medical practice, provided that clinicians respect and remain alert to patients' individual preferred roles in decision making. The interpersonal skills and the information requirements needed to successfully share decisions are major challenges to the clinical consultation process in medical practice. The benefits of patient involvement and the skills required to achieve this approach need to be given much higher priority at all levels: at policy, education, and within further professional development strategies.
PURPOSE: Quality aspects of the anesthetic process are reflected in the rate of intraoperative adverse events. The purpose of this report is to illustrate how the quality of the anesthesia process can be analyzed using statistical process control methods, and exemplify how this analysis can be used for quality improvement. METHODS: We prospectively recorded anesthesia-related data from all anesthetics for five years. The data included intraoperative adverse events, which were graded into four levels, according to severity. We selected four adverse events, representing important quality and safety aspects, for statistical process control analysis. These were: inadequate regional anesthesia, difficult emergence from general anesthesia, intubation difficulties and drug errors. We analyzed the underlying process using 'p-charts' for statistical process control. RESULTS: In 65,170 anesthetics we recorded adverse events in 18.3%; mostly of lesser severity. Control charts were used to define statistically the predictable normal variation in problem rate, and then used as a basis for analysis of the selected problems with the following results: Inadequate plexus anesthesia: stable process, but unacceptably high failure rate; Difficult emergence: unstable process, because of quality improvement efforts; Intubation difficulties: stable process, rate acceptable; Medication errors: methodology not suited because of low rate of errors. CONCLUSION: By applying statistical process control methods to the analysis of adverse events, we have exemplified how this allows us to determine if a process is stable, whether an intervention is required, and if quality improvement efforts have the desired effect.
The publication of scientific research in medical journals is a lengthy process. Submitted manuscripts are often reviewed by two or more outside reviewers who evaluate each manuscript for publication acceptability. The process of manuscript evaluation by an editor-selected reviewer ("peers" or "referees") is termed "peer review." One issue involving the peer-review process is the use of blind versus nonblind referees. The purpose of this survey was to determine the percentage of a select group of medicine-related journals that blind their reviewers. We surveyed 114 English language journals. Journal editors were sent a survey that asked two questions: (1) are the referees who review your manuscripts blinded to the identity of the authors? and (2) is the editor blinded to the identity of the authors until after the review of the manuscripts is complete? Ninety-six of 114 (84.2 percent) surveys were returned. Ten journals published invited manuscripts only and were excluded from the survey. Only 18.6 percent (16 of 86) of the journals currently blind referees. None of the journals' editors were blind to the identity of the manuscripts' authors.