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Can surveying practitioners about their practices help identify priority clinical practice guideline topics?

BACKGROUND: Clinical practice guidelines are systematically developed statements designed to assist in patient and physician clinical decision making for specific clinical circumstances. In order to establish which guideline topics are priorities, practitioners were surveyed regarding their current practice. METHODS: One hundred ninety-seven practitioners in Ontario, Canada were mailed a survey exploring their current practice or opinion regarding the prophylactic use of anticonvulsant drugs in patients with malignant glioma who had never had a seizure. The survey consisted of seven questions regarding the relevance of a guideline on the subject to the practitioner's practice, the proportion of clinical cases involving anticonvulsant use, knowledge of existing guidelines on this topic, interest in reviewing a completed practice guideline and three clinical scenarios. RESULTS: There were 122 respondents who returned the survey (62% rate of return). Eighty percent of the practitioners who responded indicated that less than 25% of their clinical cases involved the use of anticonvulsants; however, only 16% of respondents indicated that a practice guideline would be irrelevant to their practice. Eighty percent of respondents volunteered to review a draft version of a practice guideline on the use of anticonvulsants. The survey presented the practitioners with three scenarios where anticonvulsants in patients with brain tumours may be appropriate: peri-operatively in patients without seizures, postoperatively in patients currently using anticonvulsants, and thirdly in patients not currently using anticonvulsants or undergoing surgery. In contrast to the third situation, the first two situations yielded considerable variation in practitioner response. CONCLUSION: The survey established that there is some variation present in the current practice of anticonvulsant use in the patients with brain tumours. Whether there is an optimal treatment practice has yet to be determined. Practitioners do seem to feel that a guideline on anticonvulsant use in warranted, and most practitioners would be interested in being part of the guideline development process.

Anticonvulsants↗

Clinical management protocols: the bedside answer to clinical practice guidelines.

TOPIC: Clinical Management Protocols for trauma patients. PURPOSE: The goals and process for developing and implementing Clinical Management Protocols are presented. Protocol development and the differences between clinical practice guidelines, critical pathways, and clinical management protocols are discussed. SOURCES: Published literature, experience, and clinical expertise. CONCLUSIONS: Utilizing annotated algorithms, the protocols are designed for and driven by patient care based on patient need and require the collaboration of experts and trauma team members.

Algorithms↗

Guidelines for topical photodynamic therapy: report of a workshop of the British Photodermatology Group.

Topical photodynamic therapy (PDT) is effective in the treatment of certain non-melanoma skin cancers and is under evaluation in other dermatoses. Its development has been enhanced by a low rate of adverse events and good cosmesis. 5-Aminolaevulinic acid (ALA) is the main agent used, converted within cells into the photosensitizer protoporphyrin IX, with surface illumination then triggering the photodynamic reaction. Despite the relative simplicity of the technique, accurate dosimetry in PDT is complicated by multiple variables in drug formulation, delivery and duration of application, in addition to light-specific parameters. Several non-coherent and coherent light sources are effective in PDT. Optimal disease-specific irradiance, wavelength and total dose characteristics have yet to be established, and are compounded by difficulties comparing light sources. The carcinogenic risk of ALA-PDT appears to be low. Current evidence indicates topical PDT to be effective in actinic keratoses on the face and scalp, Bowen's disease and superficial basal cell carcinomas (BCCs). PDT may prove advantageous where size, site or number of lesions limits the efficacy and/or acceptability of conventional therapies. Topical ALA-PDT alone is a relatively poor option for both nodular BCCs and squamous cell carcinomas. Experience of the modality in other skin diseases remains limited; areas where there is potential benefit include viral warts, acne, psoriasis and cutaneous T-cell lymphoma. A recent British Photodermatology Group workshop considered published evidence on topical PDT in order to establish guidelines to promote the efficacy and safety of this increasingly practised treatment modality.

Aminolevulinic Acid↗

Current treatment guidelines for topical corticosteroids.

The effectiveness of a topical corticosteroid is related to various factors which should be considered when planning treatment. The most relevant factor is the potency of the drug. Another important factor is the absorption through the skin, which is influenced by marked regional variations in percutaneous penetration, hydration and the degree of inflammation present, types of dressings, the solubility of the drug and the age of the patient. Multiple daily applications do not lead to better or faster resolution of the disease. Intermittent therapy with treatment-free intervals, when the vehicle alone is applied, can be as effective as continuous treatment. The choice of a topical corticosteroid depends not only on the severity or activity of the disease, but also on the age of the subject, the body site affected and the extent of the surface area to be treated. In addition, the choice of vehicle depends on the type of lesion and on the body region afflicted. Combinations of a corticosteroid with other agents can be useful, but they are recommended in only a few specific indications. Treatment guidelines for topical corticosteroids must therefore take into account a number of factors which will influence the clinician's ultimate decision in providing care for the patient with steroid-responsive dermatoses.

Administration, Topical↗

Family physicians' perspectives on practice guidelines related to cancer control.

BACKGROUND: Family physicians (FPs) play an important role in cancer control. While FPs' attitudes towards, and use of guidelines in general have been explored, no study has looked at the needs of FPs with respect to guidelines for the continuum of cancer control. The objective of this study was to understand which guideline topics FPs consider important. METHODS: Five group interviews were conducted by telephone with FPs from across Ontario, Canada. Transcripts were analyzed inductively. Content analysis identified emergent themes. Themes are illustrated by representative quotes taken from the transcripts. RESULTS: The main areas where FPs felt guidelines were needed most included screening - a traditional area of responsibility for FPs - and treatment and follow-up - areas where they felt they lacked the knowledge to best support patients. Confusion over best practice when faced with conflicting guidelines varied according to disease site. FPs defined good guideline formats; the most often cited forms of presentation were tear-off sheets to use interactively with patients, or a binder. Computer-based dissemination was acknowledged as the best way of widely distributing material that needs frequent updates. However, until computer use is a common aspect of practice, mail was considered the most viable method of dissemination. Guidelines designed for use by patients were supported by FPs. CONCLUSIONS: Preferred guideline topics, format, dissemination methods and role of patient guidelines identified by FPs in this study reflect the nature of their practice situations. Guideline developers and those supporting use of evidence-based guidelines (e.g., Canadian Strategy for Cancer Control) have a responsibility to ensure that FPs are provided with the resources they identify as important, and to provide them in a format that will best support their use.

Adult↗

Guidelines for topical PUVA: a report of a workshop of the British photodermatology group.

Psoralen photochemotherapy [psoralen ultraviolet A (PUVA)] plays an important part in dermatological therapeutics, being an effective and generally safe treatment for psoriasis and other dermatoses. In order to maintain optimal efficacy and safety, guidelines concerning best practice should be available to operators and supervisors. The British Photodermatology Group (BPG) have previously published recommendations on PUVA, including UVA dosimetry and calibration, patient pretreatment assessment, indications and contraindications, and the management of adverse reactions.1 While most current knowledge relates to oral PUVA, the use of topical PUVA regimens is also popular and presents a number of questions peculiar to this modality, including the choice of psoralen, formulation, method of application, optimal timing of treatment, UVA regimens and relative benefits or risks as compared with oral PUVA. Bath PUVA, i.e. generalized immersion, is the most frequently used modality of topical treatment, practised by about 100 centres in the U.K., while other topical preparations tend to be used for localized diseases such as those affecting the hands and feet. This paper is the product of a recent workshop of the BPG and includes guidelines for bath, local immersion and other topical PUVA. These recommendations are based, where possible, on the results of controlled studies, or otherwise on the consensus view on current practice.

Administration, Oral↗

Dressings and more: guidelines for topical wound management.

Principle-based topical therapy is a key element of effective wound care. Most products on the market provide passive support for wound healing by creating an environment favorable to repair (ie, clean, moist, insulated, and protected). There are also emerging therapies designed to actively manipulate the repair process. The clinician must make product decisions based on wound characteristics and response to treatment.

Anti-Infective Agents, Local↗

Clinical practice guidelines. The Agency for Health Care Policy and Research fosters the development of evidence-based guidelines.

As medical technology increases rapidly and becomes more complex, clinical practice guidelines can help healthcare providers assess current practices and integrate technological advances. Through the Agency for Health Care Policy and Research (AHCPR), the federal government has begun to facilitate the development of clinical practice guidelines. Expert or contract panels, authorized by the AHCPR, develop guidelines on specific clinical conditions. The AHCPR guideline methodology is designed to produce evidence-based guidelines that are valid, clinically applicable, and clinically flexible. Each panel spends a year or more developing the guideline, beginning with an extensive literature search and review. The panel prepares evidence tables, statistically analyzes aggregate data (where appropriate), conducts harm and benefit analyses, and prepares health policy analyses (or cost-impact studies). During this process, the panel holds an open forum to solicit comments on the guideline topic. After this public discussion, the panel prepares a final draft of the guideline. Several hundred individuals review the guideline. Some policymakers believe clinical practice guidelines can lead to better healthcare outcomes. Guidelines can provide information in a useful format for clinicians to use at the bedside or the point of decision making in patient care. Guidelines also provide information that can be used in continuing education and professional education programs.

Decision Making↗

[Diagnosis and therapy of sepsis].

A recent survey conducted by the publicly funded Competence Network Sepsis (Sep- Net) reveals that severe sepsis and/or septic shock occurs in 75,000 inhabitants (110 out of 100,000) and sepsis in 79,000 inhabitants (116 out of 100,000) in Germany annually. This illness is responsible for approx. 60,000 deaths and ranges as the third most frequent cause of death after acute myocardial infarction. Direct costs for the intensive care of patients with severe sepsis alone amount to approx. 1.77 billion euros, which means that about 30% of the budget in intensive care is used to treat severe sepsis. However, until now German guidelines for the diagnosis and therapy of severe sepsis did not exist. Therefore, the German Sepsis Society initiated the development of guidelines which are based on international recommendations by the International Sepsis Forum (ISF) and the Surviving Sepsis Campaign (SSC) and take into account the structure and organisation of the German health care system. Priority was given to the following guideline topics: a) diagnosis, b) prevention, c) causative therapy, d) supportive therapy, e) adjunctive therapy. The guidelines development process was carefully planned and strictly adhered to according to the requirements of the Working Group of Scientific Medical Societies (AWMF).

Critical Care↗

Use of clinical practice guidelines by executive directors of optometric associations.

BACKGROUND: The process of developing the American Optometric Association's (AOA) Optometric Clinical Practice Guidelines began in 1989 under the direction of John F. Amos, O.D., M.S., then chair of the AOA's Clinical Care Center. The guideline development process used by the AOA was modeled after the recommendations established by the Agency for Health Care Policy and Research in response to the federal government encouraging health care groups to develop clinical guidelines to enhance the quality, appropriateness, and effectiveness of health care. The guideline topics were chosen for their importance in the education of members, health care payers, and state legislators. A principal author and a consensus panel of experts then were chosen for each subject area. This group was responsible for transforming the latest scientific research and expert judgment into a document that would apply to everyday optometric practice. Thirteen guidelines were developed and mailed to AOA members in 1994 and 1995. Additional guidelines were mailed as they were approved. Currently, there are 20 guidelines available. METHODS: A survey was mailed to the executive director of the optometric association of each state and the District of Columbia and to the chief of optometry of each of the federal services. Telephone follow-up was made to nonrespondents, and an additional copy of the survey was mailed to them with telephone follow-up again taking place for those who did not respond. RESULT: Forty-three of the surveys were returned for a response rate of 78%. Seventy-six percent of the respondents stated that they had received the guidelines. The sections that were found most useful to the respondents were those related to Description and Classification, Basis of Treatment, and Treatment Options. The guidelines were most often used by these groups to improve the quality of eye care, expand optometric involvement in health programs, affect public policy, and overcome problems with insurance groups. DISCUSSION: Optometric organizations have found the clinical practice guidelines useful beyond their primary goal of enhancing the quality of patient care. They have been used effectively to help educate other parties about optometry and its role as a primary health care profession.

Humans↗

Single cell gel/comet assay: guidelines for in vitro and in vivo genetic toxicology testing.

Atthe International Workshop on Genotoxicity Test Procedures (IWGTP) held in Washington, DC, March 25-26, 1999, an expert panel met to develop guidelines for the use of the single-cell gel (SCG)/Comet assay in genetic toxicology. The expert panel reached a consensus that the optimal version of the Comet assay for identifying agents with genotoxic activity was the alkaline (pH > 13) version of the assay developed by Singh et al. [1988]. The pH > 13 version is capable of detecting DNA single-strand breaks (SSB), alkali-labile sites (ALS), DNA-DNA/DNA-protein cross-linking, and SSB associated with incomplete excision repair sites. Relative to other genotoxicity tests, the advantages of the SCG assay include its demonstrated sensitivity for detecting low levels of DNA damage, the requirement for small numbers of cells per sample, its flexibility, its low costs, its ease of application, and the short time needed to complete a study. The expert panel decided that no single version of the alkaline (pH > 13) Comet assay was clearly superior. However, critical technical steps within the assay were discussed and guidelines developed for preparing slides with agarose gels, lysing cells to liberate DNA, exposing the liberated DNA to alkali to produce single-stranded DNA and to express ALS as SSB, electrophoresing the DNA using pH > 13 alkaline conditions, alkali neutralization, DNA staining, comet visualization, and data collection. Based on the current state of knowledge, the expert panel developed guidelines for conducting in vitro or in vivo Comet assays. The goal of the expert panel was to identify minimal standards for obtaining reproducible and reliable Comet data deemed suitable for regulatory submission. The expert panel used the current Organization for Economic Co-operation and Development (OECD) guidelines for in vitro and in vivo genetic toxicological studies as guides during the development of the corresponding in vitro and in vivo SCG assay guidelines. Guideline topics considered included initial considerations, principles of the test method, description of the test method, procedure, results, data analysis and reporting. Special consideration was given by the expert panel to the potential adverse effect of DNA degradation associated with cytotoxicity on the interpretation of Comet assay results. The expert panel also discussed related SCG methodologies that might be useful in the interpretation of positive Comet data. The related methodologies discussed included: (1) the use of different pH conditions during electrophoreses to discriminate between DNA strand breaks and ALS; (2) the use of repair enzymes or antibodies to detect specific classes of DNA damage; (3) the use of a neutral diffusion assay to identify apoptotic/necrotic cells; and (4) the use of the acellular SCG assay to evaluate the ability of a test substance to interact directly with DNA. The alkaline (pH > 13) Comet assay guidelines developed by the expert panel represent a work in progress. Additional information is needed before the assay can be critically evaluated for its utility in genetic toxicology. The information needed includes comprehensive data on the different sources of variability (e.g., cell to cell, gel to gel, run to run, culture to culture, animal to animal, experiment to experiment) intrinsic to the alkaline (pH > 3) SCG assay, the generation of a large database based on in vitro and in vivo testing using these guidelines, and the results of appropriately designed multilaboratory international validation studies.

Animals↗

[Diagnosis and therapy of sepsis. Guidelines of the German Sepsis Society Inc. and the German Interdisciplinary Society for Intensive and Emergency Medicine].

A recent survey conducted by the publicly funded Competence Network Sepsis (SepNet) reveals that severe sepsis and/or septic shock occurs in 75,000 inhabitants (110 out of 100,000) and sepsis in 79,000 inhabitants (116 out of 100,000) in Germany annually. This illness is responsible for approximately 60,000 deaths and ranges as the third most frequent cause of death after acute myocardial infarction. Direct costs for the intensive care of patients with severe sepsis alone amount to approximately 1.77 billion euros, which means that about 30% of the budget in intensive care is used to treat severe sepsis. However, until now German guidelines for the diagnosis and therapy of severe sepsis did not exist. Therefore, the German Sepsis Society initiated the development of guidelines which are based on international recommendations by the International Sepsis Forum (ISF) and the Surviving Sepsis Campaign (SSC) and take into account the structure and organization of the German health care system. Priority was given to the following guideline topics: a) diagnosis, b) prevention, c) causative therapy, d) supportive therapy, e) adjunctive therapy. The guidelines development process was carefully planned and strictly adhered to the requirements of the Working Group of Scientific Medical Societies (AWMF).

Delivery of Health Care, Integrated↗

[Diagnosis and therapy of sepsis: guidelines of the German Sepsis Society Inc. and the German Interdisciplinary Society for Intensive and Emergency Medicine].

A recent survey conducted by the publicly funded Competence Network Sepsis (SepNet) reveals that severe sepsis and/or septic shock occurs in 75,000 inhabitants (110 out of 100,000) and sepsis in 79,000 inhabitants (116 out of 100,000) in Germany annually. This illness is responsible for approximately 60,000 deaths and ranges as the third most frequent cause of death after acute myocardial infarction. Direct costs for the intensive care of patients with severe sepsis alone amount to approximately 1.77 billion euros, which means that about 30% of the budget in intensive care is used to treat severe sepsis. However, until now German guidelines for the diagnosis and therapy of severe sepsis did not exist. Therefore, the German Sepsis Society initiated the development of guidelines which are based on international recommendations by the International Sepsis Forum (ISF) and the Surviving Sepsis Campaign (SSC) and take into account the structure and organization of the German health care system. Priority was given to the following guideline topics: a) diagnosis, b) prevention, c) causative therapy, d) supportive therapy, e) adjunctive therapy. The guidelines development process was carefully planned and strictly adhered to the requirements of the Working Group of Scientific Medical Societies (AWMF).

Anti-Bacterial Agents↗

Validation in pharmaceutical analysis. Part I: an integrated approach.

The ICH guidelines achieved a great deal in harmonising the definitions of the required validation characteristics and their basic requirements. However, they provide only a basis for a general discussion of the validation parameters, their calculation and interpretation. It is the responsibility of the analyst to identify parameters which are relevant to the performance of the given analytical procedure as well as to design proper validation protocols including acceptance criteria and to perform an appropriate evaluation. In order to fulfil this responsibility properly, the background of the validation parameters and their consequences must be understood. In this part, the general concept of an integrated validation is discussed. The interdependencies to other ICH guidelines and topics during drug development (e.g. impurities and degradants, stability and specification design) must be taken into account to define the required acceptance criteria. Evaluation of the results in order to prove the suitability of the analytical procedure must be based on the specification limits. Important parameters and aspects are discussed for the individual validation characteristics. In the following parts, these parameters will be discussed in detail. Examples will be given for their interpretation in order to facilitate the selection of parameters which are relevant to the performance and suitability of the given analytical procedure.

Chemistry, Pharmaceutical↗

Pharmaceutical policies in Canadian family medicine training. Survey of residency programs.

OBJECTIVE: To determine whether family medicine residency training programs have formal policies regarding interactions between residents and the pharmaceutical industry, to identify existing practices, and to find out what issues in industry-physician interaction are addressed during the 2-year core curriculum training in Canada. DESIGN: Mailed survey using a questionnaire. SETTING: The 16 Canadian residency training programs in family medicine. PARTICIPANTS: Program directors of all 16 Canadian family medicine residency training programs replied. MAIN OUTCOME MEASURES: Number of programs with formal pharmaceutical policies; number of programs offering formal curriculum coverage of related topics in the field; program practices regarding industry sampling, detailing, sponsorship, and access. RESULTS: Only four of the 16 programs have formal policies or guidelines. Topics generally covered in core curriculum included critical appraisal (13/16) and cost trends (11/16). Few programs address determinants of prescribing (5/16), marketing techniques (4/16), provincial drug access programs (6/16), or the Canadian Medical Association guidelines on physician-industry interaction (5/16). Industry presence and sponsorship in family medicine training is notable, and screening is limited. Great variation exists, and programs are interested in future initiatives. CONCLUSIONS: Family medicine training in Canada is attempting to address pharmaceutical issues. Interest is strong, but these issues need to be given more emphasis.

Canada↗

Setting priorities and selecting topics for clinical practice guidelines.

Setting priorities and selecting topics are important steps in guidelines development, but they have received relatively little attention to date. Responses from a survey of guidelines stakeholders in Canada suggest that the health burden of a clinical condition on the population is an important factor in priority setting. Economic considerations, cast as either costs of treatment to the health care system or the economic burden of illness to society, are given varying importance by different stakeholder groups. Drawing on the literature and the survey results, the authors propose a framework for priority setting. Important issues requiring consideration include the role of public and community participation, the need for and appropriate emphasis on quantitative data regarding current practice and its variation, and mechanisms to link guidelines to health-policy development and management of the health care system.

Canada↗