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At least 577 records · Page 32Linked to original sources
PubMed2005

Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes.

High shear granulation is a complex unit operation with several interacting process parameters. No generally accepted real-time in-line tools are available to gain insight into this process, and in practice, a highly experienced process formulator and operator are needed to develop a wet granulated solid dosage form. In this study, the use of in-line near-infrared (NIR) spectroscopy as a process analytical tool for high shear granulation was investigated. In combination with principal component-based methods, process analysis of three separate phases of high shear wet granulation (mixing, spraying, and wet massing) was facilitated. Critical information, both chemical and physical, was collected during processing. Chemical information included the homogeneity of the formulation and the amount of water in wet mass. In addition, physical information related to the particle size of granules was extracted. Principal component loadings were fully interpreted to validate the conclusions drawn from scores and predictions. Thus NIR spectroscopy could be used to determine the end points of the three subphases of high shear wet granulation and, as such, provide a fast in-line quality control tool.

Cellulose↗
PubMed2004

Trust and confidence: towards mutual acceptance of ethics committee approval of multicentre studies.

AIMS: To compare issues raised by Human Research Ethics Committees (HREC) during the ethics review process and to determine the length of time taken to gain HREC approval for multicentre research studies. METHODS: Review and analysis of HREC documentation and correspondence for all multicentre research studies were conducted through three HREC under the auspices of Cancer Trials Australia, Melbourne, Victoria, Australia, between November 1997 and March 2001 to determine the variance of documentation, correspondence and recommendations across the three HREC and the time taken for study approval. RESULTS: Thirty-one projects were submitted to any two of the HREC (16 studies) or all three HREC (15 studies). The median time for study approval at an individual HREC was 75 days, but it was 111 days for approval at all participating sites. There were 554 clarifications or comments made by the reviewing HREC, the majority of which had no significant bearing on the ethical or scientific calibre of the study. There was only one study in which a significant protocol change was requested by a HREC. CONCLUSIONS: Multicentre study approvals are delayed when submitted to multiple HREC. The three HREC raised similar issues without substantive differences in their recommendations. A process for the mutual acceptance of HREC recommendations could facilitate multicentre research.

Australia↗
PubMed1999

Application of grounded theory to content definition: a case study.

Successful implementation of a clinical information system requires clinician involvement throughout the process of content definition and system development to ensure acceptance of the automated care process. In these times of downsizing, however, clinicians are not always able to participate fully in the dontent definition phase of system development and often become frustrated with their inability to obtain the patient information they need from the system. The qualitative research principles of grounded theory afford clinicians the opportunity to participate in content definition for information systems. This article presents a case study of the application of grounded theory to develop systematically the content definition for a clinical information system in preparation for implementation on four medical-surgical units.

Abstracting and Indexing↗
PubMed2006

Other conceivable renditions of some of the oxidative processes used in the biosynthesis of steroid hormones.

The generally accepted version (GAV) of the chemical processes by which the steroid hormones are biosynthesized cannot be considered to be an inerrant description of in vivo processes. Customarily this version is derived by piecing together the results obtained from several independent artificial in vitro incubation experiments. Extrapolation of such results from in vitro to in vivo requires untested assumptions which introduce varying degrees of uncertainty. In vitro incubation experiments reveal only what is possible; not what actually prevails in situ. Presented here are hypothetical alternative renditions of some of the oxidative processes involved in steroidogenesis. These versions suggest that some cytochrome P-450's catalyze the introduction of both oxygen atoms of dioxygen into an appropriate sterol precursor. The products are conceived as oxygen free radicals (peroxy or 1,2-cyclic peroxy) which serve as the "reactive intermediates" (the precursors) for the hormones. The true intermediates are not stable, isolable, hydroxylated compounds as they are customarily portrayed in the GAV. Central to these new renditions is the hypothesis that the appropriate P-450 introduces dioxygen into the precursor yielding either: A, a 20 peroxy sterol species or B, a species oxygenated at both C-17 and C-20 or C, a species oxygenated at both C-20 and C-21. In this hypothesis, A would serve as the precursor for progesterone, B, for the C19-androgens and C18-estrogens and C, for the mineralocorticoids (corticosterone and aldosterone) and the glucocorticoid (cortisol). How this version of steroidogenesis can be used to understand the etiologies of various genetically derived enzyme deficiency diseases of the adrenal and ovaries will be discussed. If as proposed here, the various polyfunctional cytochromes (P-450(scc), P-450(c17,) P-45011B1 (P-450(cortisol)), P-45011B2 (P-450(aldo)), etc.) catalyze conversions that are different from simple hydroxylations, the labels usually given these deficiency diseases may not be appropriate. More importantly, these new conceptions may clarify the etiology of some of the characteristic symptoms of these diseases that are not now adequately explained by the GAV.

Cytochrome P-450 Enzyme System↗
PubMed2004

A questionnaire study of women's views regarding the effectiveness of serum Down screening in north west Wales.

Questionnaires were circulated to 300 women awaiting mid-trimester anomaly scanning in north west Wales to determine women's views of the adequacy of counselling, availability of pretest scanning, method of receiving test results and whether the Down screening process in general was acceptable. Seventy-five per cent of respondents had serum Down screening; 80.3% of women agreed or strongly agreed that counselling prior to antenatal testing for Down syndrome was adequate; 80.7% of women agreed or strongly agreed that the consequences of a high risk result were explained before testing; 88.7% of women agreed or strongly agreed that they had a choice as to whether screening was accepted or not; 81.7% of women agreed or strongly agreed that they were involved in the decision process; and 40.0% of women having Down testing did not have previous ultrasound biometry. Routine pretest ultrasound scanning remains a resource priority.

Adult↗
PubMed1997

Use of predictive microbiology in meat hygiene regulatory activity.

New Zealand is a supplier of refrigerated raw meat to world markets. To maintain this supply, from regulatory and commercial perspectives, production standards need to deliver products that are both hygienically adequate and commercially viable. A dynamic Temperature Function Integration (TFI) model, as a form of predictive microbiology, was used jointly by regulators and processors to develop justifiable criteria for the management of refrigeration during the production of hot and warm-boned meat, the post-slaughter handling of ovine carcasses and the handling of offals. Current processes operating according to accepted standards for Good Manufacturing Practice (GMP) were quantified in terms of TFI. The hygienic adequacy of new processes were similarly determined using the TFI model and compared to relevant GMP standards. From a regulatory perspective, the dynamic TFI model has provided a rapid and cost effective method of quantifying a temperature dependent process in terms of the potential for microbial proliferation. It has also produced a method for determining parameters for new or intended processes by comparing the potential for microbial proliferation with previously validated outputs, and has complemented traditional quantitative microbiology to provide a rapid, cost effective method of verifying that a process is performing according to design parameters. However, it could not be used to validate standards for processing in the absence of existing standards for GMP, or in the absence of microbial standards previously established using the principles of risk assessment.

Animals↗
PubMed1996

National health expenditure limits: the case for a global budget process.

The health reform cost-containment debate has set up a dichotomy between market and regulatory approaches. Expenditures are excessive in the American health system because there is no effective constraint on aggregate demand, and the rigid limits imposed by sectoral global budgets in other nations do not effectively use supply side forces to achieve efficiency. The case for an intermediate option is presented, a process that can flexibly encompass both what buyers are willing to pay and what suppliers are willing to accept. A negotiated contracting process for multiple payors and multiple providers could constrain aggregate demand and harness provider incentives.

Arizona↗
PubMed2005

Testing and expanding a model of cognitive processing of risk information.

Scholars have begun to explore the role of modes of information processing and related audience characteristics in reactions to risky situations and risk information.((11, 12, 14, 17, 18, 20))"Information processing" concerns how people attend to and consider available information: systematic processors analyze messages and situations carefully, while heuristic processors skim and use cues (e.g., opinions of trusted reference groups) for quick judgments. This article uses scenarios about a semi-hypothetical industrial facility, in particular risk comparisons being considered by its manager for inclusion in a talk to the community, to explore the impact of information processing. Information insufficiency, self-assessed capacity to understand information, and information-seeking propensities are tested for potential effects on information processing about industrial risks by people living near industry. As well as testing established models, this article explores the additional explanatory value of involvement, relevance, and ability (Earle et al., 1990) and objective knowledge. Both existing model variables and new ones have significant effects on information seeking and information processing in this case, and partly confirm earlier results. Trumbo((17,18)) found that heuristic processors saw lower risk and systematic processors higher risk from suspected cancer clusters. In this study, reporting knowledge about local industrial risks as insufficient for one's purposes and self-reported avoidance of such information both raised ratings of the facility's risk and lowered ratings of its acceptability. Neither type of information processing significantly affected risk or acceptability judgments, but both increased risk ratings and heuristic processing had more effect than systematic processing. Positive ratings of risk comparisons' clarity and meaningfulness decreased risk and increased acceptability ratings, dominated other information variables in predictive power, and exceeded risk, benefit, and trust in contribution to acceptability judgments. Despite differences across studies in designs and variables, and the embryonic development of appropriate (self-reported) measures for use in field surveys, these results confirm the potential value of further research in how information seeking and processing affect risk beliefs and reactions to risk communications.

Journal Article↗
PubMedDate not supplied

Time-frequency distribution technique in biological signal processing.

Time-frequency distribution (TFD) has gained wide acceptance for deterministic non-stationary signal processing, particularly for biological signals, in both basic research and commercial production. This paper presents the results of a comparison of the TFD technique with other methods for determining physiologic parameters, particularly the ventricular ejection time (VET) and (dZ/dtmax), the differentiation of the thoracic-fluid signal Z0 from non-stationary impedence cardiography dZ/dt. The TFD technique was found to be more accurate--in terms of both time and signal magnitude--than traditional methods such as the baseline and ensemble-averaging techniques when compared with phonocardiograms and hand calculations by experts in the field. It is shown that TFD can also reduce ventilatory/respiratory noise, electrical and muscle noise, and patient-motion artifacts. Correlation analysis and regression analysis as well as Bland-Altman studies showed stronger correlational methods tested.

Algorithms↗
PubMedDate not supplied

Lack of relationship between acceptance and knowledge of asthma in school-age children and early adolescents.

ISSUES AND PURPOSE: Early adolescents diagnosed with asthma have difficulty accepting their condition. This study is part of an ongoing program of research designed to increase understanding of the adolescent process of coming to acceptance. The purpose was to explore relationships among variables in the Acceptance of Asthma Model. DESIGN AND METHODS: A cross-sectional, theory-testing design with a sample of 94 students ages 9 to 14 years. RESULTS: Acceptance was dependent on psychosocial influences and disease characteristics rather than knowledge of asthma. PRACTICE IMPLICATIONS: Psychosocial interventions are needed to facilitate acceptance.

Adaptation, Psychological↗
PubMed1997

Development of a discharge lounge: the use of E-mail to facilitate the quality improvement process.

Quality improvement is often seen as a time-consuming and cumbersome process with high "people" overhead as employees are pulled from their regular duties to attend meetings. As a result, there has been a trend toward tackling smaller, well defined problems with quickly achievable results. The E-mail approach used in this instance offers an approach that may bridge this gap. It allows a large group of people to participate in a complex project without the need for structured meetings spread out over a long period of time. The result, a blend of the strong points of quality improvement (inclusive, using the wisdom of a group of people) with a speedy, low overhead process, seems to address the concerns that have slowed the acceptance of the quality improvement process in many organizations thus far.

Computer Communication Networks↗
PubMed1993

Acceptance of mementos of fetal and perinatal loss in a south Australian population.

A package of mementos of a fetal or perinatal loss has been shown to help with the grieving process. The level of acceptance and the factors influencing acceptance of these mementos in a South Australian population was examined over a 27-month period. Data were available on 447 women and the acceptance rate was 79.6%. Major influences on the acceptance of mementos were maternal age and gestational age. Mothers in the 20-30 year age group were more likely to accept mementos than younger and older mothers. This age-related effect was more noticeable among genetic terminations and neonatal deaths than among spontaneous abortions or stillbirths. Memento acceptance of miscarriages and stillbirths over 20 weeks' gestation was significantly greater than for younger gestation. These findings may have an impact on the psychosocial management of perinatal loss. The high level of acceptance of these mementos is encouraging and vindicates our current practice which we recommend to others involved in the management of perinatal loss.

Australia↗
PubMed2005

Microbicide acceptability research: current approaches and future directions.

With growing recognition of the potential value of microbicides for HIV/STI prevention, the importance of the acceptability of this brand-new technology has been widely acknowledged. We review the current body of microbicide acceptability research, characterize the limitations in assessment approaches, and suggest strategies for improvement. Electronic databases and abstracts of recent meetings were searched for acceptability data regarding vaginal and rectal products that may be used for HIV prevention. Of the 61 studies reviewed, more than half assessed acceptability based primarily on the description of a hypothetical microbicide, or with the demonstration of a spermicide or lubricant. Physical characteristics of microbicidal products, their effects after insertion, and their effects on sensation during intercourse (for both partners) were the dimensions most frequently assessed (measured in 77%, 49% and 49% of studies, respectively). Attention to the social context of use was inadequate. As acceptability is likely to be a key determinant in the use-effectiveness of microbicides, in-depth understanding of the social processes that shape microbicide acceptability across diverse populations will become increasingly valuable. This includes exploring the effects that sexual partners, health care providers, and key opinion leaders have on the acceptability of microbicides among women and men, including youth and people living with HIV. Future research will benefit from studies of the acceptability of other contraceptive-barrier methods (especially the female condom), use of an agreed-upon operationalization of acceptability, use of acceptability assessments within clinical trials, expansion of measurement domains, and assessment of changes in perceptions of acceptability and use over time. Failure to understand the key factors associated with microbicide acceptability is likely to hinder the adoption and continued use of products that are effective in preventing HIV infection.

Anti-Infective Agents, Local↗
PubMed2002

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): a review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM).

Over the last decade, national authorities in the USA and Europe have launched initiatives to validate new and improved toxicological test methods. In the USA, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its supporting National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) were established by the Federal Government to work with test developers and Federal agencies to facilitate the validation, review, and adoption of new scientifically sound test methods, including alternatives that can refine, reduce, and replace animal use. In Europe, the European Centre for the Validation of Alternative Methods (ECVAM) was established to conduct validation studies on alternative test methods. Despite differences in organisational structure and processes, both organisations seek to achieve the adoption and use of alternative test methods. Accordingly, both have adopted similar validation and regulatory acceptance criteria. Collaborations and processes have also evolved to facilitate the international adoption of new test methods recommended by ECVAM and ICCVAM. These collaborations involve the sharing of expertise and data for test-method workshops and independent scientific peer reviews, and the adoption of processes to expedite the consideration of test methods already reviewed by the other organisation. More recently, NICEATM and ECVAM initiated a joint international validation study on in vitro methods for assessing acute systemic toxicity. These collaborations are expected to contribute to accelerated international adoption of harmonised new test methods that will support improved public health and provide for reduced and more-humane use of laboratory animals.

Animal Testing Alternatives↗
PubMed2000

Measuring health care quality. How do you know your care has improved?

Statistical process control (SPC) was developed in the 1920s as a way of detecting defects in manufacturing processes. During the past decade, SPC has been adopted by service industries and is increasingly being employed by health care organizations. The methodology involves the construction of a control chart to detect variation within processes. Variation is neither good nor bad in itself; therefore, the impact of variation must be interpreted within the context of expected outcomes, acceptable limits, and the process itself. In this article, the concept of statistical process control is explained, and examples are provided to illustrate how SPC can be applied in a clinical setting.

Audiovisual Aids↗
PubMed2001

Trust and the acceptance of and adherence to antiretroviral therapy.

BACKGROUND: Antiretroviral therapy (ART) has resulted in reduced AIDS incidence and mortality. Socially marginalized individuals with HIV infection, particularly injection drug users (IDUs), have received less ART and derived less benefit than others. Little is known about the therapeutic process necessary to promote acceptance of and adherence to ART among marginalized HIV-infected populations. We report on the correlates of both acceptance of and adherence to ART among HIV infected prisoners, most of whom are IDUs. DESIGN: Using a cross-sectional survey design within four ambulatory prison HIV clinics, 205 HIV-infected prisoners eligible for ART were recruited between March and October 1996. MEASUREMENTS: Detailed interviews were conducted that included personal characteristics, health status and beliefs, and validated standardized scales measuring depression, health locus of control, social desirability and trust in physician, medical institutions and society. Acceptance and adherence were documented by self-report and validated for a subset by pharmacy review. Clinical information was obtained from standardized chart review. Adherence was defined as having taken > or = 80% of ART. RESULTS: The acceptance of (80%) and adherence to (84%) ART among this group of prisoners was high. Multiple regression models demonstrated that correlates of acceptance of and adherence to ART differed. Acceptance was associated with trust in physician (8% increase for each unit increase with trust in physician scale) and trust in HIV medications (threefold reduction for those mistrustful of medication). Side effects (OR = 0.09), social isolation (OR = 0.08), and complexity of the antiretroviral regimen (OR = 0.33) were associated with decreased adherence. The prevalence of health beliefs suggesting an adverse relationship between ART and drugs of abuse was high (range 59 to 77%). Adherence did not differ among those receiving directly observed therapy (82%) or self-administration (85%). CONCLUSIONS: ART can be successfully administered within a correctional setting. Trust and the therapeutic relationship between patient and physician remain central in the ART initiation process. Characteristics of the therapeutic agents and the degree of social isolation predict adherence. These results may inform the design of interventions to improve both acceptance of and adherence to ART particularly among marginalized populations who have not derived full benefit from these potent new therapies.

Adult↗
PubMed1994

Consultation competence in general practice: testing the reliability of the Leicester assessment package.

BACKGROUND: An acceptable assessment must be both valid and reliable; the face validity of the Leicester assessment package has already been established. AIM: This study set out to test the reliability of the Leicester assessment package, and the factors influencing it, when used by multiple assessors to assess performance in general practice consultations. METHOD: Six randomly selected course organizer assessors simultaneously used the package to conduct independent assessments of the performance of five doctors of widely varying abilities in consultation with six simulated patients. The scores allocated were subjected to generalizability analysis. RESULTS: The mean scores allocated for consultation performance of individual doctors ranged from 51% to 70%, with the lower scores being allocated to the less experienced doctors. Scores of each assessor across the cases were examined for internal consistency and five of the six assessors consistently scored the doctors with an alpha coefficient of the minimum accepted level of 0.80 or greater. The other assessor had a consistency of only 0.22. Measurements of consistency within cases between markers indicated that the first case produced unreliable results (alpha coefficient 0.25) but all other cases were scored consistently. Two independent assessors scoring eight consultations are the requisite numbers to achieve acceptable levels of reliability in a formal assessment process; seven consultations produce the minimum acceptable generalizability coefficient of 0.80 plus the first 'non-counting' consultation. CONCLUSION: Required levels of reliability can be achieved when the package is used by multiple markers assessing the same consultations over a wide range of consultation performance. To achieve reliability only two hours of assessment time are required using the Leicester package compared with the previously regarded minimum of 32 hours. Although assessors can produce reliable scores with minimal training, intra-assessor reliability cannot be taken for granted and all assessors should be trained and calibrated before being sanctioned to conduct assessments, particularly for regulatory purposes. The Leicester assessment package has now been shown to be valid, reliable, feasible and easy to use in practice. It can, therefore, be recommended for use in both formative and summative assessment of consultation competence in general practice.

Communication↗
PubMedDate not supplied

Laparoscopic colonic procedures.

With the advent and general acceptance of laparoscopy as a means of surgically treating intraabdominal disease processes, procedures on organs other than the gallbladder and female genital tract have slowly evolved. After developing basic techniques in an animal model, a clinical series (n = 19) of laparoscopic procedures for a variety of colonic lesions was undertaken and is herein presented. It included both malignant and nonmalignant disease processes and has carried an acceptable complication rate and survival. The average age of our patients was 68, and except for two extended postoperative hospitalizations and one death for non-procedure-related complications, the patients were generally ready for discharge in less than 96 hours. Our current techniques and indications for laparoscopic colonic surgery are detailed.

Aged↗