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Minimal requirements for test evaluation.

Evaluations of diagnostic (clinical) tests should be conducted so that the material can be critically assessed. The results should be reported in a manner that will allow synthesis with data from other similar investigations. Collective professional efforts to fulfil these minimal requirements comprise the continued development of recommendations on research methods and good reporting practice. This paper presents some examples of suggested requirements for good reporting practice for further consideration and discussion.

Clinical Laboratory Techniques↗

Facilitating the shift to population-based public health programs: innovation through the use of framework and logic model tools.

Program planning and evaluation are critical steps in using a population health approach. This paper outlines how logic models have been adapted within a health promotion framework to guide public health programs and facilitate program description. It is important that we take the time to describe clearly what we are doing, reflect on practice and elaborate the conceptual base for the new public health programs so that we can evaluate the impact of our work. Ongoing research is required to identify appropriate and measurable indicators that capture the process, as well as the outcome, of population-based health promotion.

Canada↗

Clinical evaluation and analysis of heart valve substitutes.

We discuss the clinical assessment of heart valve substitutes, primarily with regard to pre-market evaluation. We concentrate on the current FDA heart valve guidance document. This guidance is self-acknowledged to be an evolving document, scheduled to be revised between three and five years after its initial release on December 1993. We outline the history and some of the strengths of the present system, and discuss areas for possible improvement. We selected one important statistical issue to address thoroughly how to compute the confidence limit of a linearized rate.

Bioprosthesis↗

Venous thromboembolism in multiple trauma patients.

Thromboembolic complications are frequent in patients with multiple trauma. The efficacy of unfractionated heparin for venous thrombosis prophylaxis has not been established. Based on limited prospective data, low-molecular-weight heparin appears to be more effective than unfractionated heparin and at least as effective as compression devices for preventing thromboembolic complications in these patients. Vena cava filters should be considered in high-risk patients who cannot receive anticoagulant therapy, but long-term filter use without concomitant anticoagulant therapy is associated with a substantial risk of recurrent thromboembolism.

Bandages↗

[Guidelines for clinical evaluation of topical antifungal agents].

The Japanese Society for Medical Mycology (JSMM) decided in 2002 to establish guidelines for the clinical evaluation of antifungal agents. The JSMM committee presents here guidelines for the clinical evaluation of topical antifungal agents in the dermatology field. Guidelines for the Clinical Evaluation of Antibiotic Agents established by the Japanese Society of Chemotherapy were referred to, and the diseases subjected to clinical evaluation include tinea (tinea pedis and tinea glabrosa), cutaneous candidiasis, and pityriasis versicolor. Among superficial mycoses, tinea pedis is viewed as the pivotal disease because it is intractable and is the most common. Therefore, the clinical efficacy of antifungal agents for external use in this condition should be established, and tinea pedis is subjected to phase III clinical studies. If efficacy of the antifungal agents is confirmed in the treatment of tinea pedis, a comparative study need not necessarily be performed for tinea glabrosa. If the number of patients is adequate for statistical analysis, a comparative study should be considered for both cutaneous candidiasis and pityriasis versicolor. However, if the number of patients is low, the efficacy of the agents should be evaluated based on their antifungal activity on pathogens and the results of open trials, and a comparative study is not necessarily performed for such diseases. The safety should be strictly evaluated.

Anti-Infective Agents, Local↗

Development of clinical practice guidelines for dentists: methods for topic selection.

OBJECTIVES: The aim of this study was to compare four methods for assessing the preferences of the dental profession for topics to be considered for the development of clinical practice guidelines. METHODS: The methods were: (1) a survey among dentists, (2) an analysis of topics discussed in dental peer groups, and (3) screening of dental journals. A fourth method was obtained from method number 3. The frequencies of the reported topics were calculated for each of the methods. For the fourth method, the number of publications per topic were plotted against the year of publication, and the slope of the linear regression line was used as an indicator. Within each of the four methods, the topics were ranked according to the frequency in which they were reported, and to the slope value. The reliability of the methods was tested by the "item-rest sum correlation", which is the correlation of the rank positions of one method with the sum of the rank positions obtained by the remaining three methods. RESULTS: In using all methods, a total of 1027 topics were obtained. Reclassification resulted in 34 topics. Moderate item-rest sum correlations ranging from 0.34 to 0.48 were found for all methods, indicating that the rank order of every method moderately predicts the sum of the rank orders obtained by all other methods. The topic 'prevention of cross-infection' had the highest overall rank position. CONCLUSION: It is concluded that the four applied methods appeared to provide a consistent ranking of potential topics. In view of the fact that the questionnaire method is generally applicable, this method should be preferred for assessing dentists' preferences for topics to be considered for the development of clinical practice guidelines.

Data Collection↗

Quality of evidence-based pediatric guidelines.

OBJECTIVE: To identify evidence-based pediatric guidelines and to assess their quality. METHODS: We searched Medline, Embase, and relevant Web sites of guideline development programs and national pediatric societies to identify evidence-based pediatric guidelines. A list with titles of identified guidelines was sent to 51 leading pediatricians in the Netherlands, who were asked to select the 5 most urgent topics for guideline development. Three pediatrician reviewers appraised the available guidelines on the 10 most frequently mentioned topics with the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. RESULTS: A total of 215 evidence-based pediatric guidelines were identified; of these, 17 guidelines on the 10 most frequently mentioned topics were appraised. The AGREE instrument rates guidelines among 6 domains. For the scope and purpose domain, the mean score was 84% of the maximal mark. For stakeholder involvement, the mean score was 42%, with 12 guidelines (71%) scoring <50%. For rigor of development, the mean score was 54%, with 5 guidelines (29%) scoring <50%. For clarity and presentation, the mean score was 78%, with 4 guidelines (24%) scoring <50%. For applicability and editorial independence, performance was poor, with mean scores of 19% and 40%, respectively. Low scores were partly attributable to poor reporting. After considering all domain scores, the reviewers recommended 14 of 17 guidelines (82%) to be used in local practice. CONCLUSIONS: The current volume of pediatric guidelines categorized as evidence based in popular databases is large. Overall, these guidelines scored well, compared with other studies on guideline quality in fields outside pediatrics, when assessed for quality with the AGREE instrument. This holds especially for guidelines published or endorsed by the American Academy of Pediatrics or registered in the National Guideline Clearinghouse.

Child↗

[Guidelines: state of the art and peculiar aspects in pediatric emergency].

In recent years pediatric guidelines have increasingly become part of clinical practice, in Italy too. Aim of the present work is, on the basis of a review of national and international literature, to focus on the Italian situation about the use of guidelines in pediatric emergency, with particular respect to methodology, correct use, and related risks and benefits. The developing of efficient guidelines is achieved in different steps: 1) identifying and refining the topic for guidelines, in order to obtain an improvement of healthcare; 2) correct developing strategies, based on scientific evidence, leading to production of recommendations validated by external review; 3) adequate implementation and diffusion in local settings; 4) application with sensible and appropriate clinical discretion. Benefits obtained with the correct use of efficient pediatric guidelines, can be identified at different levels: patients' care (outcome improvement, increased patients' consciousness, influence on public healthcare policy); healthcare professionals (improving quality of clinical decisions, agreement on clinical and therapeutic strategies; medicolegal protection, representing a reference for prospective and retrospective audits); healthcare systems (standardising care, improving efficacy of care; optimising costs). Personal experience in systematic development of emergency pediatric guidelines, applied in a second level Emergency Department is also presented.

Child↗

Managed care plans' requirements for screening for alcohol, drug, and mental health problems in primary care.

OBJECTIVE: To determine managed care organizations' (MCOs) requirements for screening for alcohol, drug, or mental health problems in primary care settings. STUDY DESIGN: A telephone survey was used to gather information on the 3 largest commercial products offered by MCOs. Products included health maintenance organizations, preferred provider organizations, and point-of-service plans. METHODS: Managed care organizations were asked whether their products required screening for alcohol, drug, or mental health problems in primary care settings. Chi-square tests were performed to ascertain whether screening requirements, the distribution of practice guidelines, and the topics addressed in those guidelines varied by product type and contracting with specialty behavioral health vendors. The data were weighted to produce national estimates. RESULTS: Only 14.9% of the products surveyed required any alcohol, drug, or mental health screening by primary care practitioners. Slightly more than half of all the products surveyed distributed practice guidelines that addressed mental illness, and about one third distributed substance abuse practice guidelines. CONCLUSIONS: Although the feasibility, utility, and effectiveness of screening are increasingly recognized, few MCOs currently require alcohol, drug, or mental health screening by primary care physicians in any of their product types.

Health Care Surveys↗