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Clinical stage II non-small cell lung cancer treated with radiation therapy alone. The significance of clinically staged ipsilateral hilar adenopathy (N1 disease).

BACKGROUND: The prognosis of patients with clinically staged hilar nodal involvement (Stage N1) or clinical Stage II non-small cell lung cancer (NSCLC, Stage T1-2N1M0) treated with radiation therapy (RT) alone is not well established. METHODS: Records of 758 patients with clinical Stage I-III NSCLC treated with RT were reviewed. Sixty-two patients were identified with clinical Stage II NSCLC, and 126 patients had Stage N1 disease. RESULTS: The median survival time (MST) of the 62 patients with clinical Stage II disease was 17.9 months, with 1-year, 2-year, 3-year, and 5-year overall actuarial survival rates of 70%, 33%, 20%, and 12%, respectively. The survival of patients with clinical Stage II disease was significantly better than that of 389 patients with clinical Stage IIIA disease (MST, 11.3 months; P < 0.008) and 267 patients with clinical Stage IIIB disease (MST, 9.8 months; P = 0.0003), but it was similar to that of 40 patients with clinical Stage I lesions (MST, 15.0 months). Patients with performance statuses of 0-1 lived longer than those with a status of 2 or more (MST, 22.8 versus 6.1 months; P < 0.0001). The median survival for patients with N0, N1, N2, and N3 disease was 13.7, 12.6, 10.9, and 9.1 months, respectively. Patients with Stage N0-1 disease (MST, 13.2 months) had significantly improved MST compared with those with Stage N2-3 disease (MST, 10.3 months). CONCLUSIONS: The survival of patients with clinical Stage II NSCLC treated with RT alone was significantly better than that of those with clinical Stage IIIA or IIIB disease. It was comparable to that of patients with clinical Stage I lesions. The clinical staging of nodal involvement limited to the ipsilateral hilum does not necessarily portend a worse prognosis than that of patients with clinical Stage N0 disease. The absence of clinically evident Stage N2-3 disease is of significant predictive value for patients with NSCLC treated with RT.

Aged↗

Quantitative and qualitative assessment of women's experience of a one-stop menstrual clinic in comparison with traditional gynaecology clinics.

OBJECTIVE: A quantitative and qualitative evaluation of the views of patients attending two types of clinics for menstrual disorders. METHODS: Semi-structured qualitative interview and quantitative questionnaire. SETTING: Five traditional general gynaecology clinics and a one-stop menstrual clinic, where investigations are performed and results given to patients on the same day. PARTICIPANTS: Two hundred and thirty-nine women (126 from the gynaecology clinic and 113 from the menstrual clinic) were recruited into the quantitative study; 18 and 26 patients from the gynaecology and the menstrual clinic, respectively, were interviewed for the qualitative study. MAIN OUTCOME MEASURES: Women's views about their care and progress towards resolution of their problem. RESULTS: Following the initial consultation, 106 (84%) of the gynaecology clinic, and 98 (87%) of the menstrual clinic patients completed the first part of the questionnaire. Of those, 75 (71%) and 79 (81%) patients from the two types of clinic, respectively, completed a follow up questionnaire one year later. There were statistically significant differences in all the components of the first part of the questionnaire (information, continuity, waiting, organisation, and limbo) in favour of the one-stop menstrual clinic. After one year, there was a statistically significant difference in one of the components, patient centeredness, but not in overall process co-ordination. The interviews showed that patients attending the menstrual clinic appreciated getting the results of their investigations on the same day. They also found the organisation of the one-stop menstrual clinic more closely suited to their needs and as a result were more likely to feel they were making progress. CONCLUSION: Women were consistently more positive about their experience in the one-stop clinic. One-stop clinics organised to meet the needs of patients might be appropriate for other clinical conditions. The combination of quantitative and qualitative methods is an effective method of assessing patients' views of health services.

Adult↗

Faculty views of reimbursement changes and clinical training: a survey of award-winning clinical teachers.

BACKGROUND: Prominent authorities believe that managed care and governmental policies are compromising the clinical education of future physicians. PURPOSE: This study sought the views of clinical teachers to quantify the extent to which managed care and governmental policies have changed clinical education. METHODS: Questionnaires were mailed to faculty that U.S. medical schools had recognized for clinical teaching excellence. Measures included reports of change in quality of clinical teaching due to payment regulations, Liaison Committee on Medical Education (LCME) and Residency Review Committee (RRC) requirements, and institutional support for teaching; change in numbers of students-trainees in clinics; need to generate more clinical revenue; and change in enjoyment of teaching. Other measures about clinical teaching included faculty attitudes, institutional rewards, and teaching different levels of students. Characteristics of the respondents also were measured. RESULTS: Faculty reported that payment regulations have affected clinical teaching negatively and that faculty need to generate more clinical revenue. Institutions tend to provide a supportive teaching environment but do not reward teaching financially. Intrinsic incentives for teaching increase as the level of student increases. Faculty reports did not differ by medical specialty or other faculty characteristics. Differences among medical schools occurred on all measures. CONCLUSIONS: Clinical education is being negatively affected, but not yet critically. Continued clinical financial pressures on faculty will affect all levels of clinical education, particularly for medical students. Differences among institutions indicate that individual schools can moderate or exacerbate the impact of external forces on the teaching faculty. Medical schools should monitor increasing pressures on faculty and ensure that goals, processes, support, and rewards for clinical teaching are proportionate to those for clinical care.

Adult↗

Clinical pharmacology and clinical trials in Japan.

Clinical pharmacology is the pursuit of rational therapeutics by following the scientific principles of medicine and pharmacology. In Japan the roles for clinical pharmacology and clinical pharmacologists have been evolving since the discipline appeared in the 1950s. Clinical pharmacology and clinical trials for drug development depend on each other, and clinical pharmacologists play an important role in drug development in Japan. As the discipline becomes more important and complicated, many issues regarding drug therapeutics and clinical trials in Japan have been raised, and several points of view have been expressed. The following suggestions have been made to improve clinical pharmacology in Japan: (a) Medical education in the field of clinical pharmacology must be improved by creating or improving clinical pharmacology programs in medical schools. (b) The appropriate infrastructure for clinical trials must be established so that the physicians' workload is reduced, and patients' participation in clinical trials becomes much easier. (c) Scientific and ethical standards of the pharmaceutical industry must be improved, and the effort should be made to produce drugs with new mechanisms of action or with significant expected benefits. (d) The regulatory agency must provide stronger support, encompassing all the various points of view of academic institutes and the pharmaceutical industry. In light of the enthusiasm demonstrated by the government, physicians, and pharmaceutical industry in Japan for continued progress in clinical pharmacology, it seems likely that all its challenges will be overcome in the near future. Hence, despite the various problems discussed here the future seems promising for the continued development of clinical pharmacology.

Clinical Trials as Topic↗

Does an HIV clinical trial information booklet improve patient knowledge and understanding of HIV clinical trials?

OBJECTIVES: To evaluate the impact of an information booklet on HIV clinical trials, Clinical Trials in HIV and AIDS: Information For People Who Are Thinking About Joining a Trial, in addition to the standard trial information (SI) on patients' knowledge; understanding and attitudes about clinical trials; and to investigate patients' motivations and reasons for enrolling or not enrolling in a clinical trial. METHODS: Fifty HIV-1 positive patients who attended the HIV clinic at a west London hospital were randomized to receive either SI alone (n = 27) or SI and a 16 page information booklet explaining the principles and procedures of HIV clinical trials (n = 23). A self-administered questionnaire was used at baseline to assess past experience and attitudes to clinical trials (10 questions), knowledge and understanding of HIV treatments (8 questions) and clinical trials (11 questions). At 2-6 months after randomization, a second interviewer-administered questionnaire addressed the patient's assessment of the usefulness and comprehensiveness of the information provided by the SI and information booklet, whether or not the patient had enrolled in a clinical trial and reasons for enrolling/not enrolling, knowledge of specific aspects of the trial protocol the patient was eligible to join (13 questions) and general knowledge of clinical trial procedures (repeat of 11 baseline questions). Changes in the attitudes and scores on knowledge and understanding of clinical trials were compared for the two groups. RESULTS: In both groups, patient knowledge of clinical trial procedures improved significantly over the study period. The median score increased from 30 at baseline to 35/44 at follow-up (SI only) vs. 24-31/44 (SI plus booklet), but this did not differ significantly between the two groups. However, knowledge of the specific trial protocol was poor [median score 13/25, interquartile range (IQR) 8-14], and there was no difference in the scores for the two groups. The prime motivations for joining a clinical trial were to benefit personal health and to gain access to new treatments. Potential side-effects were the main concern of prospective trial participants. CONCLUSIONS: This small trial shows that, while the patients' general knowledge and understanding of clinical trials improved over time, this was not improved by the information booklet and recollection of the details of the relevant trial protocol remained poor.

Adult↗

A clinical trial of chronic care diabetic clinics in general practice in the United Arab Emirates: a preliminary analysis.

Control of diabetes mellitus is a high priority for primary health care systems. One innovative method of diabetes care delivery is the use of structured diabetes care in primary care. This includes the use of chronic care diabetes clinics or mini-clinics operated by general practitioners in primary care. There is limited experience with this model in non-Western settings. This study sought to evaluate a multi-component structured approach to diabetes care in primary care including chronic care diabetes clinics in a newly developed country in the Arabian Gulf. The study design used was a controlled before-after methodology. Three primary health centers were chosen for the intervention with six of the remaining clinics in a Health District being used as controls. A multifaceted intervention was initiated in the intervention clinics composed of chronic care diabetes clinics, a diabetic flow chart, and educational programs for clinic nurses and doctors and patients. The study intervention took place over a period of 18 months with three diabetic outcomes (fasting blood glucose, blood pressure and cholesterol) and adherence to seven diabetes guidelines being compared for the year prior to the intervention and during the last 12 months of the intervention period. Knowledge and satisfaction questionnaires were also administered to intervention and control subjects at the end of the study. In this study, 219 subjects were enrolled (130 males and 89 females). They had a mean age of 51.6 years and a mean of 3.1 years of formal education. Of these 109 were enrolled in one of three clinics that had a chronic care diabetes clinic and 110 were enrolled in one of the six control clinics. Subjects had diabetes for a mean of 7.8 +/- 4.8 years and the majority was treated with pharmacological therapy. Baseline characteristics in the intervention and the control clinics were similar with the exception of younger age (p = 0.01) and a trend for more males (p = 0.06) in the intervention clinics. There was a statistically insignificant change noted with the intervention in the three clinical outcomes studied (fasting blood glucose, blood pressure and cholesterol) both in comparison to the control group before and after and within the intervention group. However most changes noted were in the expected direction of improvement; six of the seven guidelines were statistically improved in the intervention group when compared with the control group. Within the intervention group, adherence with five of seven guidelines was also statistically significantly increased with the remaining guidelines showing a trend in favor of improvement (fasting blood glucose measurements (p = 0.07) and urine determinations for protein (p = 0.07)). Knowledge questionnaire scores were similar between the intervention and control groups on completion of the study but 2 of 4 items on a satisfaction scale were statistically significantly higher in the intervention group. The intervention described in this setting was successful in improving adherence to diabetes guidelines and increased some aspects of satisfaction with diabetes care. The intervention did not result in a statistically significant improvement in clinical outcomes but changes noted were in the expected direction of improvement. The significant improvement in adherence to diabetes guidelines suggests that this intervention is a promising model for diabetes care for newly developed countries.

Blood Glucose↗

A multilocation clinical trial in lactating dairy cows affected with clinical mastitis to compare the efficacy of treatment with intramammary infusions of a lincomycin/neomycin combination with an ampicillin/cloxacillin combination.

A study was conducted to compare the efficacy in lactating dairy cows of intramammary infusions in quarters affected with clinical mastitis between a formulation containing 330 mg lincomycin and 100 mg neomycin in a 10-mL aqueous solution (LINCOCIN FORTE S, Pharmacia & Upjohn) and a formulation containing 75 mg ampicillin and 200 mg cloxacillin in an oil suspension (AMPICLOX, Pfizer Animal Health). This study was designed as a multicentre clinical trial involving investigators in France, Germany and Belgium and carried out according to the European Commission guidelines on Good Clinical Practices. Cows in the herds were monitored for clinical mastitis. When evidence of clinical mastitis was detected in a single quarter, a pretherapy milk sample was collected from the affected quarter. After milk sampling, the cow was assigned to one of the two treatment groups at random and treated with an intramammary infusion of one syringe of either LINCOCIN FORTE S or AMPICLOX for three successive milkings in the mastitic quarter. At 4-5, 13-15 and 20-22 days after first infusion, the veterinarian returned to the farm to conduct a clinical examination and collect milk samples from the affected quarter. Milk samples were cultured for the presence of mastitis organisms and somatic cell count (SCC) was measured. Following a 10-month study period, 256 cases were enrolled in the study. A total of 232 and 189 cases were analysed for clinical cure and for clinical-plus-bacteriological cure, respectively. The proportions of cases cured clinically and cured clinically-plus-bacteriologically were compared between the two treatment groups. Somatic cell count differences between treatment groups were also tested. The clinical cure rate for LINCOCIN FORTE S (62.5%) was significantly better than for AMPICLOX (51.8%) (P = 0.035). The clinical-plus-bacteriological cure rate was also significantly better for LINCOCIN FORTE S (38.1%) than for AMPICLOX (21.7%) (P = 0.005). Among bacteriologically cured cases, the SCC declined in both treatment groups but the SCC was significantly higher for the AMPICLOX group than for the LINCOCIN FORTE S group (P = 0.036). In conclusion, clinical cure rate, clinical-plus-bacteriological cure rate, and SCC level were significantly better with LINCOCIN FORTE S than for AMPICLOX.

Ampicillin↗

Comparison of the quality of diabetes care in primary care diabetic clinics and general practice clinics.

OBJECTIVES: To compare the quality of care provided to diabetic hypertensive patients by diabetic clinics versus general practice clinics (GP-clinics) in a primary care setting. MATERIALS AND METHODS: A retrospective analysis of medical records of patients from six primary care centres in Bahrain. RESULTS: The recommended target blood pressure <130/85 mmHg was achieved in 6.8 and 10%, and glycated haemoglobin <7% was attained in 14.8 and 11% of patients attending diabetic clinics (n=177) and GP-clinics (n=180), respectively. Although complementary antihypertensive combinations were prescribed at a rate less than that recommended in guidelines, combinations were significantly more often prescribed for patients attending the GP-clinics (46.7% [95% CI 39.4-53.9] versus 33.4% [CI 26.8-40.6]; p=0.01). The prescribing pattern and rank-order of antihypertensive and oral hypoglycaemic agents prescribed, either as monotherapy or in combinations, were similar in both clinics. The majority of diabetic hypertensive patients attending diabetic clinics or GP-clinics were at high cardiovascular risk. Anthropometric characteristics were recorded consistently in patients attending diabetic clinics. Laboratory investigations were extensively utilized for monitoring patients attending diabetic clinics. CONCLUSIONS: In primary care, in both diabetic clinics and GP-clinics, hypertension and diabetes were inadequately controlled, with no difference between the two settings. An integrated approach involving diabetic clinics managed by primary care physicians and nurses trained in diabetes management, and supported by national guidelines, is needed.

Adult↗

Detection and assay of beta-lactamases in clinical and non-clinical strains of Yersinia enterocolitica biovar 1A.

OBJECTIVES: To detect beta-lactamases (A & B) and extended-spectrum beta-lactamases (ESBLs) in clinical and non-clinical isolates of Yersinia enterocolitica biovar 1A, and to determine their activity in the presence of specific lactamase inhibitors. METHODS: The presence of beta-lactamases and ESBLs was detected by disc diffusion in 219 (36 clinical, 183 non-clinical) isolates. beta-Lactamase activity was assayed spectrophotometrically in all 36 clinical and 10 representative non-clinical isolates using nitrocefin as the substrate. Inhibition of beta-lactamases was studied by clavulanic acid, aztreonam and cloxacillin. RESULTS: Of the 219 isolates, all except two non-clinical isolates indicated the presence of beta-lactamase A (Bla-A) based on the smaller (2-8 mm) radius of the inhibition zone around the ticarcillin disc. Synergy between ticarcillin and co-amoxiclav discs was, however, observed in only 34% of isolates of non-clinical origin. beta-Lactamase B (Bla-B) was found to be consistently positive among all the clinical and non-clinical isolates, as indicated by its characteristic appearance of flattening of the zone of inhibition around the cefotaxime disc adjacent to an imipenem disc. Bla-B was induced more strongly in clinical than in non-clinical isolates. Inhibition of enzyme A by clavulanic acid, aztreonam and cloxacillin was found to be similar, whereas enzyme B was inhibited more strongly by aztreonam and cloxacillin. None of the isolates showed the unequivocal presence of ESBL. CONCLUSION: This is the first report on beta-lactamases of Yersinia enterocolitica biovar 1A from Asia. Y. enterocolitica biovar 1A expressed both Bla-A and Bla-B. Heterogeneity was, however, discerned in the expression of Bla-A and by induction of Bla-B among clinical and non-clinical isolates of Y. enterocolitica biovar 1A.

Animals↗

Email teleconsultations: well formulated clinical referrals reduce the need for clinic consultation.

We examined how well primary-care physicians formulated their clinical referrals when asking for help with patient-related clinical problems using an email-based teleconsultation service. Over 100 family physicians made use of the service. The specialists were medical school faculty members. The service was initiated in May 1996 with 19 specialists and expanded to 34 specialties over the next five years. A total of 1618 patient-related clinical questions were analysed, the outcome for the analysis being whether specialists recommended a clinic consultation. Specialists recommended a clinic consultation in response to 10% of their clinical questions about patients. There was a strong association between how family physicians formulated their clinical questions and whether the specialist recommended a clinic consultation. When the family physicians specified a clinical task (P < 0.001), intervention (P = 0.004) and outcome (P < 0.001) in their questions, specialists were less likely to recommend a clinic consultation. This influence was independent of the amount of clinical information included with the question (P > 0.05). About 5% of the questions that included all three question components resulted in the recommendation for a clinic consultation, compared with nearly 30% of the questions containing none of these components. How family physicians formulate their clinical questions influences whether specialists request a clinic consultation.

Electronic Mail↗

Clinical Instructors' and Student Athletic Trainers' Perceptions of Helpful Clinical Instructor Characteristics.

OBJECTIVE: To compare the perceptions of students and clinical instructors regarding helpful clinical instructor characteristics. DESIGN AND SETTING: We developed a questionnaire containing helpful clinical instructor characteristics for facilitating student learning from a review of the medical and allied health clinical education literature. Respondents rated clinical instructor characteristics from 1 (among the least helpful) to 10 (among the most helpful). Respondents also identified the overall 10 most helpful and 10 least helpful characteristics. SUBJECTS: A total of 206 undergraduate students and 46 clinical instructors in the National Athletic Trainers' Association District 4 athletic training education programs accredited by the Commission on Accreditation of Allied Health Education Programs responded to the survey. MEASUREMENTS: We computed individual-item and subgroup mean scores for students, clinical instructors, and combined students and instructors. Pearson product moment correlations were computed to evaluate the level of agreement between students and instructors. Correlations were also computed to evaluate the level of agreement between the open-ended responses and the Likert-scale responses. RESULTS: Agreement was high between the students' and the clinical instructors' ratings of individual items. Agreement was also high between individual-item means and the directed, open-ended 10 most helpful and 10 least helpful clinical instructor characteristics. Modeling professional behavior was considered the most helpful subgroup of clinical instructor characteristics. Integration of knowledge and research into clinical education was considered the least helpful subgroup of clinical instructor characteristics. CONCLUSIONS: Clinical instructors should model professional behavior to best facilitate student learning. Integration of research into clinical education may need more emphasis.

Journal Article↗

Clinical education and clinical evaluation of respiratory therapy students.

Different blends of knowledge, decision making, problem solving,professional behaviors, values, and technical skills are necessary in the changing health care environments in which respiratory therapists practice. Frequently, novice students are expected to perform quickly and efficiently,and it may be forgotten that students are still learning and mastering the foundation pieces of practice. Clinical educators take on the responsibility of student development in addition to overseeing patient care. Normally,these volunteer instructors are role models for respiratory therapy students. The characteristic of initiative when demonstrated by a beginning student is attractive to the clinical instructor, promotes sharing of experiences, and may evolve into a mentor-protege relationship. Some clinical instructors may be underprepared to teach and are uncomfortable with student evaluation. Respiratory therapy facilities in conjunction with academic institutions may consider sponsoring ongoing programs for clinical teachers. Teaching and learning in the clinical environment is more than demonstration of skills and knowledge. Furthermore, it can be debated whether the memorization of facts or of the steps of a skill is more valuable than competency in problem solving, clinical reasoning, or information retrieval. New knowledge is built within a context and is further integrated when grounded by experience. Development of "prediction in practice" or the anticipation of the next necessary actions may be worth integrating into the instructional toolbox. Intuition has been defined as an "understanding without a rationale". This definition separates intuition from rational decision making and presents intuition as a type of innate ability. Reflection when guided by clinical instructors can help deepen critical thinking, as will Socratic questioning on a regular basis. Most clinical staff can agree on the performance of an incompetent student, but discrimination of the levels of competence is more challenging. Observations allow the assessor to obtain the data necessary to evaluate performance, followed by assessment, which denotes a judgment made on the basis of an observation of events. Performance assessment should have stability and consistency, measure what is intended to be measured, and truly determine competence. In contrast, reflective analysis has been shown to be successful for clinical evaluation, thus departing from strict competency and product-based assessment. Students yearn to become clinically knowledgeable, and their enthusiasm should be fostered. An interest in clinical practice is the primary reason individuals enroll in respiratory therapy education programs. Educators,managers, and staff should assure that students experience an appropriate, rich, and diverse clinical curriculum that with practice develops clinical judgment, reasoning, and reflection on practice.

Allied Health Personnel↗

Breast cancer patients' attitudes toward clinical trials in the radiation oncology clinic versus those searching for trial information on the Internet.

Web-based clinical trials matching systems including breast cancer patients are expanding rapidly. However, limited data exist regarding the demographics and attitudes of breast cancer patients using the Internet to search for clinical trials information. Biases in patient populations could be introduced by recruiting patients to trials through the Internet. This study was designed to compare breast cancer patients in the radiation oncology clinic to those using the Internet to search for clinical trials information. A piloted questionnaire assessing demographics and attitudes regarding clinical trials was offered through the radiation oncology clinic at the University of Pennsylvania and on the OncoLink website (http://www.oncolink.org). The questionnaire consisted of 18 questions and was answered by a total of 157 patients with breast cancer. Breast cancer patients using the Web were more likely to be interested in clinical trials testing new drugs or therapies (71 [53%] versus 4 [17%], p = 0.002). More clinic patients indicated they would need a greater than 50% chance of benefiting from a trial (12 [52%] versus 33 [25%], p = 0.01) and a less than 10% potential for serious toxicity from a trial (15 [65%] versus 51 [38%], p = 0.02) for consideration of enrollment. African Americans were more likely than other races to have never used the Internet to search for cancer-related information (4 [40%] versus 18 [12%], p = 0.01), more likely to indicate that they need a greater than 50% chance of benefit to enroll in clinical trials (8 [80%] versus 37 [25%], p = 0.001), and less likely to be interested in clinical trials testing new drugs or therapies (1 [10%] versus 73 [50%], p = 0.01). Breast cancer patients have different attitudes regarding clinical trials based on race, Internet usage, and previous trial enrollment. Biases may be introduced with recruitment for clinical trials through the Internet. Radiation oncologists must consider these issues when offering clinical trials information through the Internet.

Breast Neoplasms↗

Clinical evaluation--difficulties experienced by sessional clinical teachers of nursing: a qualitative study.

Evaluation of nursing students in the clinical field requires the clinical teacher to make judgements regarding student progress in a number of areas. In this study concepts of role theory, oppressed group behaviour and the ethics of caring emerged and were used as conceptual frameworks to interpret the data relating to the evaluation of undergraduate students. The number of experienced faculty available for clinical teaching and evaluation has become inadequate and a large number of casual or sessional clinical teachers are employed to teach students in the clinical field. Despite the well documented problems associated with clinical teaching and the use of inexperienced clinical teachers, sessional clinical teachers are nevertheless expected to evaluate student success in meeting the clinical requirements of the nursing course, often resulting in disparate decisions for students. A phenomenological study was carried out using unstructured interviews and written clinical scenarios, to explore the evaluation process from the perspective of the sessional clinical teachers. Research findings indicate that although the sessional clinical teachers were skilled at identifying student problems, they were reluctant to make difficult evaluation decisions, due to low self-esteem, role conflict and their ethic of caring. It seems that gender socialization, patriarchal dominance and apprenticeship training had effected their confidence in their own decision making. The implications of such findings are of concern for the ongoing credibility and integrity of nursing courses, as clinical teachers have an influence on the nursing profession through the preparation of its practitioners.

Clinical Competence↗

Clinical trials and clinical practice: do doctors use the same criteria to judge outcome?

AIMS: The results of clinical trials often seem to have little influence on the practice of individual doctors. This could be because trial information is presented in the style of a scientific experiment which cannot often be clearly related to the context of everyday patient care. We tested the hypothesis that such framing effects would cause doctors to assess the clinical significance of treatment outcomes differently when presented as clinical trial results rather than as individual patient data. METHODS: Fourteen rheumatologists independently reviewed the same 50 sets of data obtained from patients with rheumatoid arthritis. The data consisted of 10 commonly used clinical and laboratory variables measured before and after a period of treatment. The same data were presented in two formats on two separate occasions. The patient data format was a collection of typed sheets attributing each set of results to an individual patient. The clinical trial format was a professionally printed and bound booklet in which each set of results was laid out as summary results of a small uncontrolled clinical trial. Doctors judged the degree of improvement or deterioration and its clinical importance for each data set for both formats. These changes were converted into units of 'Clinical Importance'. RESULTS: Although some statistically significant differences emerged in the individual doctors' judgements between the formats none of these was of a clinically important size. The median of the mean trial--patient difference between the formats for all 14 doctors was 0.035 units of clinical importance [95% CI -0.244 to 0.074]. CONCLUSIONS: This evidence does not support the hypothesis that framing effects are a major cause of the failure of clinical trials to influence clinical practice.

Antirheumatic Agents↗

Guidelines for resident training in veterinary clinical pathology. I. Clinical chemistry.

BACKGROUND: The Education Committee of the American Society for Veterinary Clinical Pathology identified a need for improved structure and guidance of clinical pathology resident training in clinical chemistry. OBJECTIVES: The committee's goal was to develop learning objectives and competencies in knowledge, abilities, and skills in clinical chemistry; provide options and ideas for training activities; and identify clinical chemistry resources useful for clinical pathology faculty, training program coordinators, and residents. METHODS: Guidelines were developed and written with the input of Education Committee members and peer experts. RESULTS: The primary objectives of clinical chemistry training are: 1) to accrue a thorough, extensive, and relevant knowledge base of the types, principles, and properties of clinical chemistry tests and concepts of pathophysiology in animals; 2) to develop abilities to reason, think critically, and exercise judgment in clinical chemistry data interpretation, investigative problem-solving, and hypothesis-driven research; and 3) to acquire technical and statistical skills important in clinical chemistry and laboratory operations. CONCLUSIONS: These guidelines define expected competencies that will help ensure proficiency, leadership, and the advancement of knowledge in veterinary clinical chemistry and provide a useful framework for didactic and clinical activities in resident training programs. The learning objectives can readily be adapted to institutional and individual needs, interests, goals, and resources.

Animals↗

Is clinical diagnosis of heart failure reliable?-Clinical judgement of cardiologists versus internists.

BACKGROUND: Heart failure is a major cause of morbidity and mortality. Its diagnosis is mainly clinical. Most patients are seen by cardiologists and internists. However, it is not known whether clinical practices vary by specialty. We sought to evaluate the concordance in the clinical judgement of heart failure between cardiologists and internists. METHODS: Clinical judgement was investigated in 17 cardiologists and 25 internists from four district hospitals using the probability assessment of heart failure diagnosis in 30 case histories based on real patients. Use of clinical information in the diagnostic assessment was defined by the regression coefficients of multiple regression analysis, in which the diagnostic probability was the dependent variable and the clinical criteria the independent variables. The importance attributed to clinical variables, as reported by doctors in a questionnaire, and that of clinical practice, as expressed by the magnitude of the regression coefficients, were compared. RESULTS: We found no significant difference between cardiologists and internists. However, within each group of specialists, there was a wide inter-observer variation in the probability assessment of heart failure in the same case histories. The probability ranged from 25.6 to 83%. The relative importance of clinical variables actually used in diagnostic assessment was different from that reported by doctors. CONCLUSIONS: Cardiologists and internists do not differ in their clinical judgement of heart failure. However, within each group there can be wide discrepancies in the evaluation of the same case histories. This may be related to the different use of clinical information, as indicated by the wide confidence intervals of regression coefficients for clinical criteria. The way doctors use clinical information in practice differs from how they think they use it.

Journal Article↗

Meeting the challenges facing clinical research: solutions proposed by leaders of medical specialty and clinical research societies.

The development of a robust national clinical research enterprise is needed to improve health care, but faces formidable challenges. To define the impediments and formulate solutions, the Institute of Medicine's Clinical Research Roundtable convened leaders from medical specialty and clinical research societies in 2003. Participants considered how to influence clinical research funding priorities, promote mechanisms to train physicians and other health care professionals to conduct clinical research, and how to encourage health care providers to follow evidence-based medical practice. Consensus emerged on multiple issues, including intersociety collaboration, the need for a core clinical research curriculum for training the new cadre of clinical researchers, joint advocacy for increased funding of clinical research and for the education of policymakers and the public on the benefits of clinical research. Specific recommendations were made on mechanisms for recruitment, training, and retention of clinical research trainees and mentors. Steps were outlined (1) to overcome career disincentives and develop appropriate reward systems for mentors and trainees, (2) to encourage use of web-based and continuing-medical-education-based mechanisms to bring practitioners up to date on issues in and results of clinical research, and (3) to create incentives for individuals, clinics, and hospitals to practice evidence-based medicine (EBM). Collectively, the response and proposed strategies can serve as a roadmap to improve clinical research funding and training, evidence-based medical practice, and health care quality.

Biomedical Research↗