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All residents of McGill University's Department of Family Medicine were surveyed by mail about their family practice clinic experience. Residents were generally satisfied with their training site and their supervision, but noted problems with volume and diversity of patients, learning certain procedures, and knowledge of community resources. They did not want more family medicine clinic time.
The requirements for Good Laboratory (GLP) and Good Clinical Practices (CGP) were established as a matter of urgency by the United States in the early 1970s. These were in response to gross misconduct and, in many instances, fraud. Over the next 15 years, a plethora of regulatory principles, guidelines, and regulations was produced by many countries of the world, culminating in single standards for European, Japanese, and United States authorities. Although with regard to GLP this has basically become a worldwide recognized standard within the preclinical (toxicology) studies, in the veterinary, chemical, agrochemical, and pharmaceutical industries, the GCPs are now seeing a rebirth. Within a clinical trials environment, there is most certainly a requirement for compliance with GCP, especially with regard to the harmonization of data within the European Community. The goal of this article is to cover the following aspects: Why should we have good practices? Why should laboratory data be audited? Why is there a need for a QA unit or function? What is the QA operational approach? How does a laboratory audit take place within laboratories? In discussing the laboratories and their subsequent data audits, the pitfalls and benefits are addressed and an examination of the data from the sponsor's viewpoint is compared with that produced by the laboratory. The types of laboratories present in a clinical environment are examined. They obviously comprise clinical pathology, microbiology, and analytical as well as ancillary hospital areas such as X-ray and cardiology. These laboratories may also be in the private sector, the National Health Service, contract laboratories, universities, or the general practitioner population.(ABSTRACT TRUNCATED AT 250 WORDS)
Outlines the complimentary and, at times, the seemingly contradictory relation between developmental epidemiology and the practice of clinical child psychology from the perspective of a clinical child psychologist. I argue that, although there has been a perception of tension between clinical practice and epidemiological research, the two are, in fact, closely related. Epidemiology can contribute to clinical practice by advancing psychology as a primary care profession, informing case conceptualization, and facilitating psychologists' communication with the public. Clinicians, in turn, can help advance the field of epidemiology by using clinical observations to inform the design of epidemiological studies and providing solid theoretical modeling for epidemiological research.
Sleep problems are highly prevalent in children and adolescents, but often go unrecognized and untreated in clinical settings. The purposes of this paper are to provide pediatric nurse practitioners with an understanding of the impact of sleep problems on children, their families, and on clinical pediatric practice; examine clinical practice issues that pediatric nurse practitioners identify as important regarding pediatric sleep; and provide practical information on current resources available for pediatric nurse practitioners and their patients on the prevention and treatment of pediatric sleep problems. The discussion of these issues incorporates results from a needs assessment survey on pediatric sleep completed by 317 pediatric nurse practitioners who attended the April 2003 Annual Conference of the National Association of Pediatric Nurse Practitioners.
OBJECTIVE: The aim of this study was to report the clinical outcome and adverse events in the first 100 patients with refractory inflammatory and/or fistulizing Crohn's disease treated with infliximab at the Mayo Clinic. METHODS: Patient data was abstracted from medical records. Clinical response was classified as complete response, partial response, and nonresponse. RESULTS: Indications for infliximab therapy were: inflammatory disease (61 patients), fistulizing disease (26 patients), or both (13 patients). Patients received one to seven infusions of infliximab (5 mg/kg) for a total of 242 infusions. In all, 50 patients had complete response, 22 had partial response, and 28 had nonresponse. Median time to response was 7 days (range 1-21 days). Median duration of response was 10.3 weeks (range 3-25 wk). A total of 95 patients received concomitant treatment with immune modifiers. Steroid withdrawal was possible in 29/40 patients (73%). Median time of follow-up was 34 wk (range 14-48 wk). Clinically significant adverse events after infliximab included: abscess formation in two patients (perianal, peristomal), pneumonia in two patients, varicella zoster in three patients, candida esophagitis in one patient, and infusion-related reactions in 19 patients. A total of 23 patients were continued on infliximab as maintenance treatment. CONCLUSIONS: This study provides additional evidence that infliximab is safe and beneficial in clinical practice for refractory Crohn's disease.
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One of the goals listed in the American Association of Spinal Cord Injury Nurses (AASCIN) strategic plan 1993-1998, is to provide strategic vision to advance professional practice in spinal cord injury (SCI) nursing. In this quest, along with the development of Standards of Spinal Cord Injury Nursing Practice, the AASCIN Clinical Practice Committee is developing Clinical Practice Guidelines to describe a suggested course of action to address specific clinical conditions or needs of individuals with spinal cord injury. The first Clinical Practice Guideline to be completed is Autonomic Dysreflexia (AD) (Kuric & Hixon, 1996). The purpose of this article is to review the pathophysiology of AD and then describe the symptoms, assessment parameters and nursing interventions suggested in the Clinical Practice Guidelines.
Given that clinicians presented with identical clinical information will act in different ways, there is a need to introduce into routine clinical practice methods and tools to support the scientific homogeneity and accountability of healthcare decisions and actions. The benefits expected from such action include an overall reduction in cost, improved quality of care, patient and public opinion satisfaction. Computer-based medical data processing has yielded methods and tools for managing the task away from the hospital management level and closer to the desired disease and patient management level. To this end, advanced applications of information and disease process modelling technologies have already demonstrated an ability to significantly augment clinical decision making as a by-product. The wide-spread acceptance of evidence-based medicine as the basis of cost-conscious and concurrently quality-wise accountable clinical practice suffices as evidence supporting this claim. Electronic libraries are one-step towards an online status of this key health-care delivery quality control environment. Nonetheless, to date, the underlying information and knowledge management technologies have failed to be integrated into any form of pragmatic or marketable online and real-time clinical decision making tool. One of the main obstacles that needs to be overcome is the development of systems that treat both information and knowledge as clinical objects with same modelling requirements. This paper describes the development of such a system in the form of an intelligent clinical information management system: a system which at the most fundamental level of clinical decision support facilitates both the organised acquisition of clinical information and knowledge and provides a test-bed for the development and evaluation of knowledge-based decision support functions.
Rheumatoid arthritis is a heterogeneous and progressive autoimmune disease, and patients with this condition show varied responses to treatment. Practical, reliable, individually tailored measures of disease activity and treatment responses are needed. Outcome measures used in randomized, controlled trials, including American College of Rheumatology response criteria and Disease Activity Scores, identify when treatment should be initiated or changed, but can be time consuming and impractical in daily practice. Simplified disease activity indices, abbreviated joint counts and patient-report questionnaires are more-convenient ways to assess therapeutic responses in the clinic. Patient-reported measures of physical function, pain and global disease activity best differentiate the results of active treatment from those of placebo treatment in randomized, controlled trials. Improvements in physical function closely reflect changes in health-related quality of life. Recent trials have demonstrated limited correlations between clinical responses and radiographically demonstrated responses; both should be assessed on a regular basis. It is recommended that three domains be assessed in the clinic for therapeutic responses: patient-reported measures of physical function and/or global disease activity; physician assessment of disease activity; and imaging of the hands and/or feet on a biannual basis. Problematic joints and cervical spine involvement should be followed as clinically indicated. Measures of improvement for individually relevant physical activities need to be defined for each patient.
RATIONALE: There is a pressing need for practical clinical trials (PCTs) that are more relevant to clinicians and decision-makers, but many are unaware of these trials. Furthermore, such trials can be challenging to conduct and to report. OBJECTIVE: The objective of this study was to build on the seminal paper by Tunis et al (Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624-1632.) and to provide recommendations and examples of how practical clinical trials can be conducted and the results reported to enhance external validity without sacrificing internal validity. KEY ISSUES: We discuss evaluating practical intervention options, alternative research designs, representativeness of samples participating at both the patient and the setting/clinician level, and the need for multiple outcomes to address clinical and policy implications. CONCLUSIONS: We provide a set of specific recommendations for issues to be reported in PCTs to increase their relevance to clinicians and policymakers, and to help reduce the gap between research and practice.
BACKGROUND: Clinical trials involving frequent, standardized monitoring of the international normalized ratio (INR) demonstrated that a short course of low-molecular-weight-heparin (LMWH) can successfully bridge patients to oral anticoagulation. However, rigidly performed INR testing is often not feasible in the outpatient setting in actual clinical practice. The purpose of this study was to determine if the anticoagulation results of clinical trials of LMWH bridging therapy are also achieved in a single-center clinical practice setting. METHODS: We conducted a retrospective analysis of 100 patients initiating warfarin while receiving LMWH under the care of a university-based anticoagulation management service. RESULTS: Mean patient age was 56.1 +/- 16.3 years. The commonest indications for anticoagulation were venous thrombosis (57%) and atrial fibrillation (25%). Mean initial warfarin dose was 5.1 +/- 1.8 mg/day; 30% of patients received antiplatelet therapy. The mean total duration of LMWH therapy was 12.0 +/- 8.2 days, of which 9.8 +/- 8.0 days (median 7.5 days; interquartile range 4.3-13.0 days) occurred in the outpatient setting. Forty-one percent of patients received outpatient LMWH for < 7 days, 40% for 7-14 days, and 19% for > 14 days. A mean of 3.9 +/- 2.0 INRs were performed during LMWH therapy. Complications included 11 minor and 1 major bleeding episodes and 1 thrombotic event. CONCLUSIONS: The duration of LMWH bridging therapy in practice may be significantly greater than previously reported in clinical trials, and the incidence of patients requiring prolonged (>14 days) LMWH therapy is relatively high. Outpatient LMWH as employed in clinical practice safely bridges patients to oral anticoagulation. Strategies to shorten the duration of LMWH therapy are needed and are likely to improve clinical outcomes and reduce health care expenses. In prospective clinical trials low-molecular-weight-heparin (LMWH) has proven effective in transitioning patients with venous thromboembolic disease to therapeutic warfarin anticoagulation. However, it is unknown if the anticoagulation results obtained in these trials, which involved rigidly performed anticoagulation monitoring, are achieved in standard clinical practice involving patients with a variety of indications for anticoagulation. We conducted a retrospective analysis of 100 patients initiating warfarin while receiving LMWH under the management of a university-based anticoagulation management service. The mean total duration of LMWH therapy was 12.0 +/- 8.2 days, of which 9.8 +/- 8.0 days (median 7.5 days; interquartile range 4.3-13.0 days) occurred in the outpatient setting. Forty-one percent of patients received outpatient LMWH for <7 days, 40% for 7-14 days, and 19% for >14 days. We conclude that the duration of LMWH bridging therapy in practice may be significantly greater than previously reported in clinical trials, and the incidence of patients requiring prolonged (>14 days) LMWH therapy is relatively high.
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Current clinical laboratory methods utilize the Henderson-Hasselbalch equation to calculate plasma bicarbonate from measured pH and pCO2. This practice assumes that the apparent first dissociation constant for carbon dioxide in serum, pK'1, is invariable in clinical situations. This assumption has been questioned recently. Our study examined arterial blood samples from 50 acutely ill patients who were routinely sent for blood gas analysis. The pH and pCO2 were measured on a blood gas analyzer and the total CO2 was determined on the same blood sample using a microgasometer. The calculated pK'1 from these parameters was 6.10 +/- 0.018 (m +/- SD) with a range of 6.06 to 6.15. This amount of variability could be explained by the error in the methods. The correlation for calculated to measured total CO2 was y = 094x + 1.81, r = 0.98, p less than 0.001. These findings indicate that pK'1 is functionally fixed in clinical practice and that the methods used to calculate serum bicarbonate are acceptable.
Practice learning is an important part of the curriculum and accounts for approximately 50% of the pre-qualifying nursing programme in the United Kingdom. However, the nature of practice learning is very often ill defined, and mentors and nurse teachers apply a range of models to enhance learning in practice settings. Supporting students to learn is an important function for both educators and practitioners, yet there is little consensus in the literature as to what constitutes appropriate support and more importantly which methods promote deep learning. Mentorship is widely relied upon not just as a support mechanism for students but also as the main vehicle for the activities associated with learning, teaching and assessment of practice. Although in recent years nurse education in the UK has embraced mentorship alongside the development of the lecturer practitioner and more recently practice educator roles, other models may be worth further examination, especially those that more overtly enable students to learn through clinical practice encounters. The Clinical Guide is a concept developed by the University of Salford as part of a response to the Fitness for Practice report (UKCC 1999), which encourages Higher Education Institutions together with health care providers to develop partnerships to support students and deliver and monitor learning in practice. The following account outlines the role of the Clinical Guide in relation to pre-registration nursing students and highlights some general inadequacies of the mentor's role in developing deep learning in students in practice settings. It does acknowledge the part mentors have to play in the supporting students and relates to the research literature in this area.
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Clinical practice guidelines have been defined as "systematically developed statements to assist practitioners and patients in their decisions about appropriate health care for specific clinical circumstances". Their objectives are to improve the quality of health care and to optimise the use of limited health care resources. However reduction of unnecessary costs of delivered health care is proceed most often in an implicit way by identifying inappropriate health care strategies. The increase of health care costs needs to look at this issue in a more explicit way and to consider costs in the guideline development process. The key objective of our study is to analyse the methodological aspects of dealing with cost issues in the guideline development process. The integration of cost issues is in fact limited by two major problems: first, the lack of economic evaluation for many strategies in the scientific literature and second, the lack of generalizability of the published results to temporally and/or geographically different settings. These difficulties are likely to result in the need for local cost evaluation (for a given setting), and though to make the guideline development process much more complex. Further methodological research is important to define the role of economic evaluation in clinical practice guidelines and to enable the integration of cost issues into the guideline development process. They should go closely together with international standardisation of the methodology for designing, conducting and reporting economic evaluation.