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2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology.

OBJECTIVE: To update the 1997 clinical practice guidelines for the use of tumor marker tests in the prevention, screening, treatment, and surveillance of breast and colorectal cancers. These guidelines are intended for use in the care of patients outside of clinical trials. OPTIONS: Six tumor markers for colorectal cancer and eight for breast cancer were considered. They could be recommended or not for routine use or for special circumstances. In addition to carcinoembryonic antigen (CEA) and CA 15-3, CA 27.29 was also considered among the serum tumor markers for breast cancer. OUTCOMES: In general, the significant health outcomes identified for use in making clinical practice guidelines (overall survival, disease-free survival, quality of life, lesser toxicity, and cost-effectiveness) were used. EVIDENCE: A computerized literature search from 1994 to March 1999 was performed. VALUES: The same values for use, utility, and levels of evidence were used by the committee. BENEFITS, HARMS, AND COSTS: The same benefit, harms, and costs were used. RECOMMENDATION: Changes were recommended (see Appendix). VALIDATION: The updated recommendations were validated by external review by the American Society of Clinical Oncology's (ASCO's) Health Services Research Committee and by ASCO's Board of Directors. SPONSOR: American Society of Clinical Oncology.

Adult↗

Sabbatical leaves for nurse-midwives in clinical practice.

The demands of clinical practice seldom allow for time to pursue academic writing, teaching, or the development of individual advanced skills. The burnout rate in professions such as nurse-midwifery cannot be ignored. This article describes how one nurse-midwifery clinical practice implemented a short, rotating sabbatical; specific goals and guidelines are presented. It concludes that a sabbatical leave can be considered as one of many job-related benefits.

Burnout, Professional↗

IT support for administrative planning of clinical practice.

The administration of clinical practice placements for nursing students is a highly complex and information driven task. This demonstration is intended to give insight into the web based system KliPP (a Swedish acronym for Clinical Practice Planning) and to discuss the possibilities for further development and use.

Humans↗

Integrated care pathways: effective tools for continuous evaluation of clinical practice.

The critical examination of clinical practice should be an integral part of patient care. It includes the development and implementation of guidelines, together with continuous evaluation of clinical process and outcomes to improve the quality of care provided. Clinical audit has not been successful in achieving this. The use of Integrated Care Pathways facilitates the introduction of guidelines and the continuous evaluation of clinical practice. Improvements are achieved by frequently revising the pathways to reflect current, local best practice. Integrated Care Pathways define the expected course of events in the care of a patient with a particular condition, within a set time-scale. A pathway is divided into time intervals during which specific goals and expected progress are defined, together with appropriate investigations and treatment. A pathway reflects the activities of a multidisciplinary team and can incorporate established guidelines and evidence-based medicine. It is usually unique to the institution in which it was developed. The pathway forms part of the clinical record of every patient. All variations from the pathway are documented, and the reasons for the variations analysed. Solutions are developed to address the causes of potentially avoidable variation, and the pathway is revised to incorporate these improvements. Integrated Care Pathways provide a powerful audit tool, as all aspects of the process and outcome of clinical practice can be constantly monitored. Variations from set standards are minimized, and improvements are rapidly incorporated into routine practice and subsequently re-evaluated.

Clinical Medicine↗

The management of early breast carcinoma before and after the introduction of clinical practice guidelines.

BACKGROUND: Clinical practice guidelines for the management of breast carcinoma were introduced in Australia in October, 1995. This article describes the management of early-stage breast carcinoma both before and after the introduction of these guidelines. METHODS: All cases of early breast carcinoma that were diagnosed over the same 6-month period in 1995 and 1999 and registered with a state-based cancer registry were identified. Treating surgeons completed a survey assessing tumor characteristics and primary treatment. In 1995, 95% of 188 surgeons who were approached participated and 96% of the surveys were returned. In 1999, 92% of 159 surgeons who were approached participated and 91% of the surveys were returned. Analyses are based on 1066 cases from 1995 and 1001 cases from 1999. RESULTS: The pathologic disease stage of the patients was similar in both study years. The proportion of patients who underwent breast-conserving therapy (BCT) increased from 54% in 1995 to 69% in 1999. This increase was noted across most levels of disease characteristics but was not evident among those patients treated by the least active surgeons. The proportion of patients treated with BCT who received radiotherapy increased from 59% in 1995 to 80% in 1999. This trend was observed across most levels of tumor characteristics and surgeon caseload. The proportion of women with receptor-positive tumors who were treated with endocrine therapy increased, whereas the proportion of patients with receptor-negative tumors who received this therapy decreased from 39% in 1995 to 17% in 1999. CONCLUSIONS: The management of early breast carcinoma in the state of Victoria appeared to change between 1995 and 1999 in the direction expected if the national guidelines had been incorporated into the practice patterns of surgeons treating breast carcinoma patients.

Adult↗

Family physicians' opinions and attitudes to three clinical practice guidelines.

BACKGROUND: Clinical practice guidelines (CPGs) have been promoted as a strategy to measure and improve the quality of patient care. However, more effort has been expended on creating guidelines than implementing them. We surveyed family physicians about their knowledge of and attitudes toward 3 well-publicized CPGs. METHODS: A survey questionnaire was sent to a national sample of 600 family physicians selected at random from a file from the American Academy of Family Physicians (AAFP). RESULTS: After 2 mailings, the response rate was 71%. For each of the 3 guidelines, roughly 60% of respondents were familiar or somewhat familiar with the CPG. More than half of family physicians studied said they have changed their medical practices based on CPGs, and only 3% said they do not believe in guidelines and would not use them. Use of CPGs was lowest among physicians in solo practice and among those working in rural areas. However, no significant differences in CPG use or familiarity were noted based on number of years in practice. Many respondents indicated an interest in keeping CPGs current via the internet. CONCLUSIONS: Most American family physicians find CPGs to be helpful, and familiarity with them is fairly uniform across most subgroups studied.

Attitude of Health Personnel↗

Usefulness of therapeutic drug monitoring of antiretrovirals in routine clinical practice.

BACKGROUND: Clinical trials have shown that therapeutic drug monitoring (TDM) of antiretrovirals (ARV) improves patient care. However, little is known about the usefulness of TDM in routine practice. METHOD: We reviewed all the trough concentrations of protease inhibitors and nonnucleoside reverse transcriptase inhibitors that were performed for therapeutic failure, suspected drug toxicity, or routine purposes. RESULTS: Between 1998 and 2001, 146 TDMs were done in 109 HIV patients. Of the 48 patients with therapeutic failure, 62% had resistance to ARV with adequate ARV concentrations, 16% had insufficient drug exposure without any ARV resistance mutations, and 16% combined both resistance and suboptimal drug concentrations. Subsequent therapeutic interventions (increasing adherence and/or changing HAART) resulted in an undetectable viral load in 37.5% of the patients (14/48). Five (24%) of 21 patients with suspected drug toxicity had high drug concentrations associated with side effects. In all the cases, adverse events regressed after reduction of drug dosage. Of the 77 TDMs done for routine purposes, 26% were outside the therapeutic range. CONCLUSION: The data show that TDM of ARVs in the clinical setting provides important information that can be used to improve the management of HIV patients receiving antiretroviral therapy.

Diagnostic Tests, Routine↗

Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology.

Anemia resulting from cancer, or its treatment, is an important clinical problem increasingly treated with the recombinant hematopoietic growth factor erythropoietin. To address uncertainties regarding indications and efficacy, the American Society of Clinical Oncology and the American Society of Hematology developed an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. The guideline panel found good evidence to recommend use of epoetin as a treatment option for patients with chemotherapy-associated anemia with a hemoglobin level less than 10 g/dL. Use of epoetin for patients with less severe anemia (hemoglobin < 12 g/dL but never below 10 g/dL) should be determined by clinical circumstances. Good evidence from clinical trials supports the use of subcutaneous epoetin thrice weekly (150 U/kg tiw) for a minimum of 4 weeks. Less strong evidence supports an alternative weekly (40,000 U/wk) dosing regimen, based on common clinical practice. With either administration schedule, dose escalation should be considered for those not responding to the initial dose. In the absence of response, continuing epoetin beyond 6 to 8 weeks does not appear to be beneficial. Epoetin should be titrated once the hemoglobin concentration reaches 12 g/dL. Evidence from one randomized controlled trial supports use of epoetin for patients with anemia associated with low-risk myelodysplasia not receiving chemotherapy; however, there are no published high-quality studies to support its use for anemia in other hematologic malignancies in the absence of chemotherapy. Therefore, for anemic patients with hematologic malignancies, it is recommended that physicians initiate conventional therapy and observe hematologic response before considering use of epoetin.

Anemia↗

[New intensifying screens in clinical radiology. II. Examinations in clinical practice].

A clinically applicable procedure for testing new intensifying rare earth screens, as well as the special Siemens' screen is described. The results are related to universal screens. The film-screen combination alpha 4XD (gadolinium oxysulphide with normal, green sensitive film) results in a reduction of radiation dose to half with detail comparable with universal screens. The Siemens' special screen has similar advantages. Screens with a higher intensification factor and reduction of the mAs to one sixth results in loss of detail. This does not necessarily reduce their clinical use if they are used for appropriate purposes. The results of this clinically orientated technique agreed well with physically objective methods using lead grids. The advantages of the new screens are discussed in terms of their practical application.

Evaluation Studies as Topic↗

Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology.

Anemia resulting from cancer or its treatment is an important clinical problem increasingly treated with the recombinant hematopoietic growth factor erythropoietin. To address uncertainties regarding indications and efficacy, the American Society of Clinical Oncology and the American Society of Hematology developed an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. The guideline panel found good evidence to recommend use of epoetin as a treatment option for patients with chemotherapy-associated anemia with a hemoglobin (Hgb) concentration below 10 g/dL. Use of epoetin for patients with less severe anemia (Hgb level below 12 g/dL but never below 10 g/dL) should be determined by clinical circumstances. Good evidence from clinical trials supports the use of subcutaneous epoetin thrice weekly (150 U/kg) for a minimum of 4 weeks. Less strong evidence supports an alternative weekly (40 000 U/wk) dosing regimen, based on common clinical practice. With either administration schedule, dose escalation should be considered for those not responding to the initial dose. In the absence of response, continuing epoetin beyond 6-8 weeks does not appear to be beneficial. Epoetin should be titrated once the hemoglobin concentration reaches 12 g/dL. Evidence from one randomized controlled trial supports use of epoetin for patients with anemia associated with low-risk myelodysplasia not receiving chemotherapy; however, there are no published high-quality studies to support its use for anemia in other hematologic malignancies in the absence of chemotherapy. Therefore, for anemic patients with hematologic malignancies it is recommended that physicians initiate conventional therapy and observe hematologic response before considering use of epoetin.

Anemia↗

Automated application of clinical practice guidelines for asthma management.

Clinical practice guidelines will be more beneficial when they are integrated with the electronic medical record. We applied natural language processing (NLP) techniques to extract clinical findings from outpatient progress notes in an attempt to: 1) select outpatient chart notes appropriate for evaluation against the National Heart, Lung, and Blood/National Asthma Education Program clinical practice guidelines for the diagnosis and management of asthma, 2) determine patient need for inhaled anti-inflammatory agents, and 3) quantify the severity of asthma. Our results were compared to judgements by an expert panel of practitioners. We were able to correctly identify the need for inhaled anti-inflammatory agents 76% of the time. The success of this pilot project could have broad implications for the application of clinical practice guidelines.

Administration, Inhalation↗

Evidence-based treatment of stuttering: V. The art of clinical practice and the future of clinical research.

UNLABELLED: This epilogue summarizes and expands on some of the many points raised in Parts I through IV, emphasizing that evidence-based practice is not in conflict with the "art" of clinical practice but may actually be synonymous. An evidence-based practice framework is also used to suggest some future directions for clinical research in stuttering. EDUCATIONAL OBJECTIVES: The reader will learn about and be able to (1) describe the similarities between evidence-based practice and the art of clinical practice, (2) explain how evidence-based practice provides a structure for future stuttering research, and (3) evaluate the importance of an evidence-based approach to stuttering treatment.

Biomedical Research↗

Legal and policy considerations in using clinical practice guidelines.

The increased use of clinical practice guidelines has implications for both public policy and for litigation. Physicians are concerned that the introduction of practice guidelines will reduce their clinical decision-making authority and that the failure to follow clinical practice guidelines will lead to medical liability. Although practice guidelines are an increasing part of medical practice, there has been only limited litigation to determine the extent to which guidelines will be used to set the applicable standard of care. This article discusses the potential legal and public policy issues raised by the introduction and use of clinical practice guidelines. From a legal perspective, the primary issue is whether guidelines will be used to set the "standard of care" or will be one piece of evidence that a jury would use to determine the outcome of medical liability litigation. Based on an assessment of the applicable legal and policy considerations, the article concludes that courts should admit guidelines into evidence, but that they should not be used as the sole determinant of the standard of care. Instead, guidelines should be treated as one piece of evidence to be weighed by the jury. This approach will facilitate physician acceptance of guidelines by not imposing liability for the failure to follow guidelines without additional evidence to determine the standard of care.

Clinical Medicine↗

Clinical practice guidelines in nutrition support: can they be based on randomized clinical trials?

As rationing of health care services becomes an increasing reality, the pressure to justify interventions such as nutrition support will intensify. The establishment of clinical practice guidelines is one means of providing practitioners with such justification, but clinical practice guidelines for nutrition support cannot be based primarily on prospective randomized trials. This situation arises as the result of limitations specific to nutrition support whereby the most malnourished patients-those who appear most likely to show a benefit from the treatment-cannot be randomized to a no feeding group and are therefore excluded from participation in the study. As the result of this limitation, marginal candidates for nutrition support have been included in some trials, potentially masking the benefits of this treatment. An additional problem limiting present interpretation of published reports of randomized trials in nutrition support is the fact that ongoing research continues to yield improvements in the clinical practice of nutrition support. Thus the nutrition support group in such trials may not have received this treatment according to current practice. The A.S.P.E.N. Guidelines, based on both randomized prospective trials and other types of evidence, represent an important contribution to the practice of nutrition support. Testing of the performance of these and other guidelines in clinical practice and further outcomes research will be important steps toward revision and improvement of nutrition support, but may be difficult to achieve in the near future.

Humans↗

Usefulness of a prognostic inflammatory and nutritional index in pediatric clinical practice.

The clinical usefulness of a prognostic inflammatory and nutritional index (PINI) was evaluated in 47 hospitalized infants and 72 age-matched controls from 1 mth to 14 yr of age. The PINI formula is a combination of two markers each of infection (C-reactive protein and orosomucoid) and of malnutrition (albumin and transthyretin). Healthy children are identified by a PINI value less than 1 whereas sick patients are characterized by a progressive rise above 1 as the conditions worsens. The PINI scoring system provides the clinician with a sensitive and universal tool, allowing the correct follow-up of both inflammatory and nutritional poles of the disease spectrum. The formula is of particular help in pediatric practice in recognising early subclinical complications and efficacy of specific therapeutic strategies. The micromethod is simple, rapid and may be regularly repeated since it requires only 46 microliters of serum.

Adolescent↗

Perceived stress and physio-psycho-social status of nursing students during their initial period of clinical practice: the effect of coping behaviors.

Initial clinical practice is stressful. Nursing students entering clinical practice for the first time in a five-year associate degree program in Taiwan are young and have questionable coping skills, all of which can affect their own health. This study examined the following: (1) the degree of stress perceived and types of stressful events; (2) the physio-psycho-social status of nursing students during the practice; (3) the coping behaviors of these students; and (4) the effect of different coping behaviors on their physio-psycho-social health. The subjects were 561 nursing students who had completed their initial clinical practice at the largest nursing school in Taiwan. Three measurements, including Perceived Stress Scale (PSS), Physio-Psycho-Social Response Scale (PPSRS), and Coping Behavior Inventory (CBI), were adopted. Results showed that stress for these students came mainly from the lack of professional knowledge and skills as well as caring of patients. The most common response to stress was social behavioral symptoms. Staying optimistic had a positive main effect, which reduced the occurrence of physio-psycho-social symptoms and improved physio-psycho-social status. Finally, problem-solving behavior also had a positive main effect, while avoidance had a negative main effect, which deteriorated physio-psycho-social status. This study has important implications for nursing educators in helping their students to overcome stress during clinical practice.

Adaptation, Psychological↗

Using database information in your clinical practice.

BACKGROUND: Clinical database information is in wide demand, but it is not always used to its full potential. Clinicians must learn to be the experts and to assert leadership in the use of their own data. METHODS: Clinical databases provide unique perspectives on the full process of care for a heterogeneous population of patients. They focus beyond individual providers, to their interaction within a complex system of care. Exploring questions that arise from this data can identify system issues, which are invisible to individual practitioners or specialties using other traditional review methods. RESULTS: Clinical database information helped our hospital staff identify problems in their approach to a small subset of high risk coronary bypass patients. Multiple system changes resulted in a dramatic reduction in mortality. Collateral impact on all care reduced overall mortality from 4.5% to below 2%. CONCLUSIONS: The greatest opportunities for improvement in patient care often lie in the areas where specialties or teams interface, eg, in overlapping or transferring care. The whole system of care for each patient must be optimized, not just the individual specialty components. Clinical database information provides a way to evaluate and improve the overall process and results of the broader system of patient care.

Coronary Artery Bypass↗

Imiquimod in clinical practice.

Numerous clinical trials have shown topical imiquimod (Aldara) to be effective and safe for the treatment of anogenital warts. In addition, the recurrence rate appears to be lower than those reported for many standard therapies of genital warts. Clinical experience with this medication since its availability 2 years ago has shown that it is important in the therapy of this disease. However, it is not the ideal treatment in all cases, and the advantages and disadvantages in individual patients must be considered. In addition, the antiviral and antiproliferative effects of imiquimod, as well as early reports, indicate that this medication may prove useful in the treatment of other skin diseases, including some nongenital warts and molluscum contagiosum.

Aminoquinolines↗