SEARCH · PubMed Health

Results for “Guidelines as Topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 451 records · Page 25Linked to original sources

PubMed1995

Interpreting and evaluating meta-analysis.

This article offers some guidelines for interpreting and evaluating meta-analytic reviews of research. The fundamental goals of meta-analysis are to combine results across studies to yield an overall estimate of effect and to compare effects between studies in order to understand moderating factors. Suggestions are made for what readers should look for in a meta-analysis, and a discussion is provided of several issues that are not often explicitly addressed: choice of unit of analysis, fixed versus random effects, the meaning of heterogeneity, determination of when contrasts are appropriate, and the choice of measure of central tendency. We recommend that readers adopt a skeptical attitude about the results of meta-analysis, particularly when only complex analyses are reported.

Evaluation Studies as Topic↗

PubMed2006

Stroke Active Guideline Evaluation (STAGE) project.

In 2005 the American Stroke Association's task force on the development of stroke systems established that providers and policymakers at the local, state and national levels can make significant contributions to reducing the devastating effects of stroke by working to promote coordinated systems that improve patient care. In the last few years in North America and Canada several quality stroke registers have been implemented with the aim of improving the processes of care by the diffusion and implementation of national guidelines and by the identification and correction of critical points of stroke care provided in the hospitals participating in the register. The Italian guidelines for stroke, SPREAD, have been developed with the aim of generating a tool applicable to the Italian clinical setting, able to promote the planning and linking of the assistant interventions between the different phases of the stroke care process, from the hyper-acute to the rehabilitation phase, and from primary to secondary prevention in order to harmonise and streamline the actions of the various health-care providers involved in the different phases of the diagnostic and therapeutic path of patients with stroke. The primary end-point of the Stroke Active Guideline Evaluation (STAGE) project, founded by the Italian Ministry of Health in 2003, is the diffusion, implementation and validation of the Italian Guideline for Stroke, SPREAD, in 15 acute care and 3 rehabilitative institutions across Italy. Secondary end-points are the evaluation of impact of the implementation of a workflow management in the processes of care and the identification of a national, streamlined diagnostic and therapeutic path for ischaemic stroke patients. An existing electronic patient record (EPR) has been shared with the referents of the Centres participating in the study and adapted to SPREAD's indicators. This EPR has been augmented with the decision support system. The STAGE project represents the first Italian effort in this direction. A lot of work has to be done before this goal will be achieved, but as Albert Einstein said "Imagination is more important than intelligence".

Database Management Systems↗

PubMed1996

Clinical trials: are they really useful for clinical decision making?

I have always maintained that clinical trials are important to provide prognostic information in patients with cardiac disease. However, clinical trials provide prognostic information for the population of patients under study. I still believe that clinical trials provide knowledge and information that improves patient care. As physicians, we should use the results of clinical trials as guidelines for decision making in individual patients. If we are to make clinical decisions based on results of clinical trials, then it is imperative that the patient would have been suitable for entry into that clinical trial. Thus, as always, additional factors remain important when one has to determine the appropriate therapy for any single patient. These factors include persistent symptoms despite aggressive therapy, objective evidence of end points such as recurrent myocardial ischemia, life-threatening arrhythmias, ventricular dsyfunction, and presence of absence of factors that would suggest one therapy or another-for example, coronary artery spasm. If the patient has coronary artery disease, the location and severity of the coronary artery stenosis certainly influences decisions about medical or revascularization therapy, as do the confidence and enthusiasm of the surgeon and the desires of the patient.

Cardiovascular Diseases↗

PubMed2005

Scientific authorship. Part 2. History, recurring issues, practices, and guidelines.

One challenge for most scientists is avoiding and resolving issues that center around authorship and the publishing of scientific manuscripts. While trying to place the research in proper context, impart new knowledge, follow proper guidelines, and publish in the most appropriate journal, the scientist often must deal with multi-collaborator issues like authorship allocation, trust and dependence, and resolution of publication conflicts. Most guidelines regarding publications, commentaries, and editorials have evolved from the ranks of editors in an effort to diminish the issues that faced them as editors. For example, the Ingelfinger rule attempts to prevent duplicate publications of the same study. This paper provides a historical overview of commonly encountered scientific authorship issues, a comparison of opinions on these issues, and the influence of various organizations and guidelines in regards to these issues. For example, a number of organizations provide guidelines for author allocation; however, a comparison shows that these guidelines differ on who should be an author, rules for ordering authors, and the level of responsibility for coauthors. Needs that emerge from this review are (a) a need for more controlled studies on authorship issues, (b) an increased awareness and a buy-in to consensus views by non-editor groups, e.g., managers, authors, reviewers, and scientific societies, and (c) a need for editors to express a greater understanding of authors' dilemmas and to exhibit greater flexibility. Also needed are occasions (e.g., an international congress) when editors and others (managers, authors, etc.) can directly exchange views, develop consensus approaches and solutions, and seek agreement on how to resolve authorship issues. Open dialogue is healthy, and it is essential for scientific integrity to be protected so that younger scientists can confidently follow the lead of their predecessors.

Authorship↗

PubMed2000

[A study of the guideline of case management for persons with mental disorders analyzed with fidelity index. The conditions of effective implementation].

OBJECTIVE: The present study examines the condition of effective case management based on the guideline of case management for persons with mental disorders. METHODS: A total of 295 clients were admitted to a case management trial for about 2 months. A fidelity index of program implementation and outcome measures of case management were developed. The relationship between implementation of critical program components measured by fidelity index, and outcome was analyzed. RESULTS: Fidelity Index was significantly correlated with outcome measures of clients, staffs and the care system. Effective but not-easily-feasible elements of program were having case-conference, application, of informal support and development of services. CONCLUSION: It is necessary to facilitate application of informal support with liaison with public health nurses, to standardize case-conference and to place development of care services in the core of programs for ensuring effective implementation of case management for persons with mental disorders in Japan.

Adult↗

PubMedDate not supplied

Prescribing indicators for evaluating drug use in nursing homes.

OBJECTIVE: To evaluate drug use in 2 Dutch nursing homes (254 residents) by developing and evaluating prescribing indicators based on pharmacy prescription data. METHODS: We evaluated the prescribing of benzodiazepines, nonsteroidal antiinflammatory drugs (NSAIDs), ulcer-healing drugs, and diuretics. Prescribing indicators were used to identify prescribing that was potentially not in line with recommendations in national and regional prescribing guidelines. We used both descriptive indicators, such as the number and percentage of users, and indicators reflecting potentially suboptimal prescribing, such as use of drugs outside the regional drug formulary, use of >1 drug from the same drug class, and prescription of drug dosages above recommended values. When potentially suboptimal prescribing was found, we verified the findings by means of an interview with 1 of the prescribers. RESULTS: The prescribing indicators we assessed were generally in agreement with national and regional guidelines. However, prescribing of NSAIDs without concomitant prescribing of gastroprotective drugs was found in a relatively high number of patients. After prescriber interview and patient chart review, it was found that some prescribing indicators, such as dosages above recommended values, were not always indicative for suboptimal prescribing. CONCLUSIONS: This pilot study showed that prescribing indicators based solely on pharmacy prescription data can be a useful tool to evaluate drug prescribing. With some of these prescribing indicators, we identified cases of potentially suboptimal prescribing. However, with other indicators such as those based on drug dosages, we could not identify suboptimal prescribing, and clinical information from the prescriber was necessary to get insight into the appropriateness of prescribing.

Aged↗

PubMed1996

[The guideline for clinical trials proposed by Japan Society for Cancer Therapy (JSCT)].

The purpose of the guideline is to improve the quality of clinical trials (especially in phase III) which are performed by the members of Japan Society for Cancer Therapy. It was summarized the following 5 points: 1) clinical studies using new anti cancer drugs after its permission by Ministry of Health of Welfare, 2) not only evaluation of the effect of new drugs, but also evaluation of multidisciply therapy of specific organ cancer, 3) the dose and administration method of the drug, which was admitted by ministry of Health & Welfare may be deviated by researcher, 4) true endpoint the therapy is patients' survival and 5) verification of hypothesis is requested to perform well planned randomized controlled trials. Much more, the problems of its clinical application, eg. qualification and authorization of coordinator, evaluation criteria (each organ specific evaluation criteria made by JSCT must be used in the clinical studies), evaluation of QOL, were referred.

Antineoplastic Agents↗

PubMed2005

Canadian Association for Immunization Research and Evaluation (CAIRE) guidelines for industry-sponsored clinical trial and epidemiology contract research.

In response to concerns about interactions of academic and public health investigators with industry, the Canadian Association for Immunization Research and Evaluation (CAIRE), in collaboration with six major vaccine manufacturers, developed guidelines for participation in industry-sponsored clinical trial and epidemiology contract research within Canada. Topics addressed include definition of investigators, data ownership, protocol development, data management, data analysis, producing a study report and publication of the results of the study.

Canada↗

PubMed2001

Developing a protocol for an educational software competition.

This project developed a protocol for the inaugural Instructional Software Competition of the American Dental Education Association (ADEA). The evaluation instrument was derived from the Guidelines for the Design of Educational Software developed by the ANSI-accredited Standards Committee for Dental Informatics. Eleven judges were calibrated in a conference call and rated a total of 30 submissions using a 66-question instrument. The maximum score was 204 points. The mean score of WWW-based programs was 106.7 points, and of CD-ROM-based programs 109.5 points. The summative review of the judging process identified several potential improvements, such as distinguishing between standalone programs and educational support material; increasing the number of answer choices on rating scales; differential weighting of criteria; and a more discriminative approach to judging formative and summative evaluations. We plan to improve the protocol by supporting the process through a Web-based application; calibrating judges with an online handbook; improving and adapting the rating instrument itself; using at least three judges for each program; and conducting a measurement study.

American Dental Association↗

PubMedDate not supplied

Does the architectural design of burn centers comply with the Americans with Disabilities Act?

Title III of the Americans with Disabilities Act (ADA) requires that hospitals and burn centers be designed and constructed so that all public and common-use areas are accessible. At least 10% of patient bedrooms and toilets must be accessible to persons with mobility disorders. The purpose of this study was to determine whether four hospitals with burn centers complied with Title III of the ADA. The burn centers agreed to participate in this study only if they were first assured anonymity, because of the Health Care Financing Administration of the U.S. Department of Health and Human Services requires that each hospital comply. With use of the ADA accessibility guidelines, we developed a survey instrument that was validated by a state government building inspector. This tool was used to inspect the burn center facility and common use areas in four hospitals with burn centers. In the four hospitals, numerous architectural barriers to persons with disabilities were noted. No burn center had a designated accessible room for persons with disabilities. The bedrooms, bathrooms, sinks, bathtubs, and toilets were not accessible to persons with disabilities. The common-use areas in the hospitals, in contrast, had few architectural barriers to persons with disabilities. Only one burn center had plans to eliminate architectural barriers in its hospital. Because the four hospitals with burn centers had numerous architectural barriers for persons with disabilities, it can be concluded they do not comply with Title III of the ADA and are subject to severe penalty from the Health Care Financing Administration and the U.S. Department of Justice.

Architectural Accessibility↗

PubMed2004

Ethical assessment of clinical asthma trials including children subjects.

BACKGROUND: The inclusion of children with asthma in clinical asthma trials is increasing, including their participation in placebo-controlled trials (PCTs). The objectives of this study are to assess whether children with asthma have been harmed by their participation in PCTs. METHODS: Seventy clinical asthma trials involving children published between January 1998 and December 2001 that involved distinct US research populations were identified. Studies were reviewed to determine whether all subjects with more than mild asthma received daily antiinflammatory medication as recommended by national guidelines. Sixty-two clinical asthma trials included data about subject withdrawal and were analyzed for the frequency of asthma exacerbations. RESULTS: Forty-five studies were designed as PCTs and did not require that all subjects with more than mild asthma receive antiinflammatory medications. Of 24,953 subjects, 4653 (19%) for whom data are available withdrew from research, and 1247 subjects (9.4%) withdrew from PCTs due to asthma exacerbations compared with 358 subjects (3.1%) in other trials. In PCTs, subjects withdrew more frequently from the placebo arms than the active-treatment arms and did so more frequently because of an asthma exacerbation (667 or 15% vs 580 or 6.5%). Fifty-two studies enrolled both children and adults, although only 1 performed subset analysis of the children. CONCLUSIONS: Subjects enrolled in PCTs of asthma have been exposed to unnecessary risks and harms. Clinical asthma trials involving children and adults do not benefit children as a class because they rarely provide subset analysis of children subjects.

Adult↗

PubMed2000

[New guidelines to evaluate the response to treatment "RECIST"].

Response evaluation criteria in solid tumors (RECIST) guidelines proposes the simplification of response evaluation through the use of unidimensional measurements and the sum of the longest diameters for all target lesions. Data from collaborative studies, including more than 4,600 patients assessed for tumor response, support the simplification of response evaluation through the use of unidimensional measurements in stead of the conventional method using two measurements and the sum of the products. In this criteria, PR is at least a 30% decrease and PD is at least a 20% increase in the sum of the longest diameter of target lesions. In Japan, we will use this RECIST criteria for clinical studies of the new drug, because of international harmonization on new GCP. But, in this criteria, there are some problems in Japanese studies. One of them is that we cannot use the endoscopic findings for the evaluation of gastric cancer except for validation purposes, and one is that long NC (long SD) on breast cancer does not exist in this response criteria. We had discussed these problems at the 38th meeting of Japan Society of Clinical Oncology.

Antineoplastic Agents↗

PubMed1999

Intervention research in rational use of drugs: a review.

Many studies have been done to document drug use patterns, and indicate that overprescribing, multi-drug prescribing, misuse of drugs, use of unnecessary expensive drugs and overuse of antibiotics and injections are the most common problems of irrational drug use by prescribers as well as consumers. Improving drug use would have important financial and public health benefits. Many efforts have been undertaken to improve drug use, but few evaluations have been done in this field. This article provides an overview of 50 intervention studies to improve drug use in developing countries. It highlights what type of interventions exist and what is known about their impact. It reveals that commonly used interventions, such as an essential drug list and standard treatment guidelines, have rarely been systematically evaluated so far. The majority of intervention studies are focused on prescribers in a public health setting, while irrational use of drugs is also widespread in the private sector. Furthermore, the magnitude of inappropriate drug use at community level is often overlooked and few interventions address drug use from a consumer's perspective. More research on different types of intervention strategies in various health care settings is needed to draw conclusions on the effectiveness of a specific intervention strategy. Also more research is needed on socio-cultural factors influencing the impact of drug use interventions, particularly from a user perspective. To enhance evaluative research, more technical support will be needed for researchers in developing countries. The design of available studies from developing countries is generally weak, only six of the 50 studies included in this overview were randomized controlled studies. In order to provide technical support and coordination of future intervention research the establishment of an international resource centre for drug use intervention research is recommended.

Developing Countries↗

PubMed1996

An interlaboratory evaluation of the Buehler test for the identification and classification of skin sensitizers.

The correct identification of potential skin sensitizers is an essential first step in enabling a proper risk assessment to be made and to permit the implementation of appropriate risk management practices designed to avoid the induction of sensitization. Consequently, regulatory guidelines around the world demand that new substances are evaluated to assess their skin sensitization potential. There are two guinea pig test methods which are generally recognised, the guinea pig maximisation test (GPMT) and the occluded patch test described by Buehler. In different countries, one procedure seems to be more prevalent and acceptable to regulatory authorities than the other. Notably, in the European Union, the latest revision of the Annex V (Directive 92/32/EC) Test Method for skin sensitization asks that justification should be given in the situation where the notifier does not use the GPMT, which is the preferred method. Thus in this paper, the validity of the Buehler protocol in the context of European legislation is critically examined. Results from two laboratories are collated, showing that the method can identify significant contact allergens, particularly those which would be registered formally as such according to European legislation. It is demonstrated that minor methodological variations can be tolerated without compromising test sensitivity, but it is recommended that suitable positive control testing is the best way to ensure proper test conduct.

1-Propanol↗

PubMed2000

Interlibrary loan in primary access libraries: challenging the traditional view.

INTRODUCTION: Primary access libraries serve as the foundation of the National Network of Libraries of Medicine (NN/LM) interlibrary loan (ILL) hierarchy, yet few published reports directly address the important role these libraries play in the ILL system. This may reflect the traditional view that small, primary access libraries are largely users of ILL, rather than important contributors to the effectiveness and efficiency of the national ILL system. OBJECTIVE: This study was undertaken to test several commonly held beliefs regarding ILL system use by primary access libraries. HYPOTHESES: Three hypotheses were developed. HI: Colorado and Wyoming primary access libraries comply with the recommended ILL guideline of adhering to a hierarchical structure, emphasizing local borrowing. H2: The closures of two Colorado Council of Medical Librarians (CCML) primary access libraries in 1996 resulted in twenty-three Colorado primary access libraries' borrowing more from their state resource library in 1997. H3: The number of subscriptions held by Colorado and Wyoming primary access libraries is positively correlated with the number of items they loan and negatively correlated with the number of items they borrow. METHODS: The hypotheses were tested using the 1992 and 1997 DOCLINE and OCLC data of fifty-four health sciences libraries, including fifty primary access libraries, two state resource libraries, and two general academic libraries in Colorado and Wyoming. The ILL data were obtained electronically and analyzed using Microsoft Word 98, Microsoft Excel 98, and JMP 3.2.2. RESULTS: CCML primary access libraries comply with the recommended guideline to emphasize local borrowing by supplying each other with the majority of their ILLs, instead of overburdening libraries located at higher levels in the ILL hierarchy (H1). The closures of two CCML primary access libraries appear to have affected the entire ILL system, resulting in a greater volume of ILL activity for the state resource library and other DOCLINE libraries higher up in the ILL hierarchy and highlighting the contribution made by CCML primary access libraries (H2). CCML primary access libraries borrow and lend in amounts that are proportional to their collection size, rather than overtaxing libraries at higher levels in the ILL hierarchy with large numbers of requests (H3). LIMITATIONS: The main limitations of this study were the small sample size and the use of data collected for another purpose, the CCML ILL survey. CONCLUSIONS: The findings suggest that there is little evidence to support several commonly held beliefs regarding ILL system use by primary access libraries. In addition to validating the important contributions made by primary access libraries to the national ILL system, baseline data that can be used to benchmark current practice performance are provided.

Benchmarking↗

PubMedDate not supplied

Developing an outcomes report card for hospitals: a case study and implementation guidelines.

Except for a few state mandates and dominant business coalitions in selected markets, the provider report card initiative is a voluntary response to a perceived public desire for performance data on healthcare providers. This study uses a detailed investigation of a single "typical" case to collect information about one hospital's decision processes and the operational activities required to develop a report card for communicating clinical outcomes and financial indicators to its external stakeholders. Three research questions are addressed: How did the organization identify who its key stakeholders for outcomes information were? How were the stakeholders' outcomes information needs determined? What were the stakeholders' information needs and preferred reporting formats? The research findings are reported as a case study. A general model for developing and implementing a report card for public dissemination is proposed. Crucial steps include: Hospital leaders should define the intent of the report card and identify key performance domains. Stakeholders' needs, desires, and intended use of the information should be explored when determining the format of the report card. External validation of the information presented should be obtained. The report should be made available through several mediums including direct mailing, print media, and the Internet. Usefulness of the information included in the report card should be continually evaluated. The outcomes report card can be useful to organizations and their stakeholders in many ways. They provide information about clinical outcomes, cost-effectiveness, and organizational performance in an era when healthcare organizations are competing for marketshare and consumers are demanding to be informed about their healthcare providers.

Alabama↗

PubMed2005

Intensity-modulated radiation therapy (IMRT) of cancers of the head and neck: comparison of split-field and whole-field techniques.

BACKGROUND: Oropharynx cancers treated with intensity-modulated radiation (IMRT) are often treated with a monoisocentric or half-beam technique (HB). IMRT is delivered to the primary tumor and upper neck alone, while the lower neck is treated with a matching anterior beam. Because IMRT can treat the entire volume or whole field (WF), the primary aim of the study was to test the ability to plan cases using WF-IMRT while obtaining an optimal plan and acceptable dose distribution and also respecting normal critical structures. METHODS AND MATERIALS: Thirteen patients with early-stage oropharynx cancers had treatment plans created with HB-IMRT and WF-IMRT techniques. Plans were deemed acceptable if they met the planning guidelines (as defined or with minor violations) of the Radiation Therapy Oncology Group protocol H0022. Comparisons included coverage to the planning target volume (PTV) of the primary (PTV66) and subclinical disease (PTV54). We also compared the ability of both techniques to respect the tolerance of critical structures. RESULTS: The volume of PTV66 treated to >110% was less in 9 of the 13 patients in the WF-IMRT plan as compared to the HB-IMRT plan. The calculated mean volume receiving >110% for all patients planned with WF-IMRT was 9.3% (0.8%-25%) compared to 13.7% (2.7%-23.7%) with HB-IMRT (p = 0.09). The PTV54 volume receiving >110% of dose was less in 10 of the 13 patients planned with WF-IMRT compared to HB-IMRT. The mean doses to all critical structures except the larynx were comparable with each plan. The mean dose to the larynx was significantly less (p = 0.001), 18.7 Gy, with HB-IMRT compared to 47 Gy with WF-IMRT. CONCLUSIONS: Regarding target volumes, acceptable plans can be generated with either WF-IMRT or HB-IMRT. WF-IMRT has an advantage if uncertainty at the match line is a concern, whereas HB-IMRT, particularly in cases not involving the base of tongue, can achieve much lower doses to the larynx.

Clinical Trials, Phase I as Topic↗

PubMed1999

Incorporating clinical outcomes and economic consequences into drug formulary decisions: a practical approach.

BACKGROUND: In 1994, Regence BlueShield (Regence), a large non-staff model health plan, adopted guidelines governing the review of new and existing drug products. However, certain limitations were apparent: adequate data were not available in a timely fashion; unpublished studies and information on unapproved indications were difficult to obtain; data addressing humanistic and economic outcomes were not routinely supplied by manufacturers; and the time required by Regence staff clinical pharmacists to assemble and summarize published clinical studies for the pharmacy and therapeutics (P&T) committee was excessive. OBJECTIVE: To describe the process used by Regence to collect and review clinical, economic, and other health outcomes data as part of the plan's drug formulary adoption process. PROCESS DESCRIPTION: To address these limitations, Regence revised its process to require pharmaceutical manufacturers to submit a detailed dossier with clinical and economic data from published and unpublished studies, along with a disease-based economic model projecting the potential impact that introducing the product would have on health outcomes and economic consequences occurring across the entire Regence system. After performing independent literature reviews to ensure the accuracy and comprehensiveness of the information obtained, clinical pharmacists at Regence complete a detailed summary of each drug for the P&T committee. CONCLUSION: The new process has addressed the limitations of the previous system and, by improving the timeliness and relevance of available information, it supports Regence's goal of maintaining an evidence-based formulary.

Blue Cross Blue Shield Insurance Plans↗