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PubMed2003

Therapeutic procedures of sublingual immunotherapy in clinical practice.

Clinical practice shows that a number of important measures are required to reach a high efficacy of sublingual immunotherapy. These measures include a specific and exact diagnosis of allergy, a high and reliable compliance of the patient, detailed guidance and explanation by the physician, and a strict monitoring of clinical symptoms and possible side effects. The complex inflammatory situation of the allergic patient, especially concerning the conjunctival, nasal and bronchial mucosa as well as eczema, should be explored in detail and treated with anti-inflammatory medication. After having reviewed the international literature combined with personal practical experience, we interpret and suggest that noninflammatory circumstances increase the chances of success of immunotherapies in allergy; nonetheless, several of these interpretations have not yet been confirmed by clinical studies.

Administration, Sublingual↗
PubMed2006

Peak flow monitoring in clinical practice and clinical asthma trials.

PURPOSE OF REVIEW: This review summarizes recent reports on peak expiratory flow (PEF) monitoring in clinical asthma trials and clinical practice. RECENT FINDINGS: In clinical trials, summary measures such as average morning PEF provide only a fraction of the available information about asthma control and treatment response. New statistical models should improve the yield from PEF datasets. Improved criteria are needed for the diagnosis of exacerbations, and these may be developed from quality-control analysis of existing datasets. In clinical practice we must reduce the burden of monitoring and increase the ease of interpretation of PEF data. Electronic monitoring, with short message service or Internet communication, may assist with both. There is a need for standardized user-friendly PEF charts and simple statistically appropriate interpretative tools, which will facilitate the development of clinical algorithms and individualized written action plans. Normal values for diurnal variability should be updated to reflect twice daily monitoring. SUMMARY: Current use of PEF data is limited by the burden of monitoring and the continuing use of interpretative tools that were originally developed for their practical feasibility rather than their clinical validity. Both of these problems may be improved by giving attention to methods for recording, displaying and analysing PEF data.

Asthma↗
PubMed2005

Teaching and learning in dental student clinical practice.

Clinical learning in restorative dentistry is principally centred around the provision of patient care, yet we know very little about the learning processes occurring within the clinical environment. A study of undergraduate dental student clinical practice used a combination of group interview and questionnaire techniques to explore some of the characteristics of student/teacher interaction that students finds significant, and which they consider to affect their learning of clinical skills. Study data, when analysed, revealed three major categories of teacher or student behaviour which appear to be of importance to students. This paper focuses on one of these, describing a number of behaviours, grouped together under the category of 'teaching/learning behaviours'. The aim of the paper is to report these results and to discuss their application to clinical teaching of restorative dentistry.

Education, Dental↗
PubMed2006

Colorectal cancer screening using stool DNA analysis in clinical practice: early clinical experience with respect to patient acceptance and colonoscopic follow-up of abnormal tests.

BACKGROUND: Stool-based DNA screening for colorectal cancer (CRC) was recently made available for use in daily clinical practice (PreGen-Plus). The main objectives of this study were to examine patients' screening experiences with stool DNA testing in routine clinical practice and the results of diagnostic colonoscopy in patients with an antecedent abnormal stool DNA test. PATIENTS AND METHODS: Patients undergoing stool-based DNA testing were asked to complete and return via mail an anonymous 10-item questionnaire inquiring about their test-related experiences. Colonoscopy findings for all abnormal stool-based DNA tests were ascertained via a telephone survey of the ordering primary care clinicians' offices. RESULTS: Patient survey responses were collected between August 2003 and July 2005 and reflect an 18% (1211 of 6730) response rate. The majority reported that the specimen collection process was very easy/easy to perform (87%), that they were very likely/likely to use the test again (91%), and that they had never been screened for CRC previously by any method (52%). Tests were ordered predominantly by the patient's primary care clinician (90%), including obstetrician/gynecologist providers. Colonoscopy findings from 69 of 159 patients with an antecedent abnormal stool DNA test screened with PreGen-Plus between August 2003 and July 2004 were available for review. An abnormal stool DNA test correlated with a colonoscopically demonstrable abnormality in 49% of cases (34 of 69). Abnormal findings, including CRC in 3 patients (4%; 1 with Dukes A and 2 with Dukes B disease), single or multiple adenomatous polyps in 23 patients (33%), hyperplastic polyps in 3 patients (4%), and colitis in 5 patients (7%). Colonoscopy was reported as negative in 51% of patients (35 of 69), including 2 cases (3%) with an altered BAT-26 microsatellite caused by a normal polymorphism. CONCLUSION: Stool DNA testing provides an acceptable noninvasive alternative for CRC screening that can identify early-stage CRCs and adenomatous polyps in routine clinical practice. Ongoing and broader surveys are indicated to support these early findings.

Aged↗
PubMed2000

Pediatricians' attitudes, beliefs, and practices regarding clinical practice guidelines: a national survey.

BACKGROUND: Clinical practice guidelines are increasingly being used for a wide variety of medical conditions, but not enough is known about physicians' attitudes and beliefs about guidelines, how often and under what circumstances they are used, and factors associated with their acceptance. OBJECTIVE: To determine practice guideline attitudes, beliefs, practices, and factors associated with use among a representative national sample of general pediatricians. STUDY DESIGN: Cross-sectional mail survey. SUBJECTS: Random sample of general pediatrician members of the American Academy of Pediatrics residing in all 50 states and Puerto Rico. SURVEY INSTRUMENT: Twenty-four multiple-choice, Likert scale, yes-no, and open-ended questions about pediatric clinical practice guidelines. RESULTS: From 1088 respondents, 461 specialists were excluded; the remaining 627 general pediatricians were mostly male (61%), white (81%), and in group practice (62%) in a suburban location (48%). Practice guidelines are used by 35% of pediatricians, in part by 44%, and not at all by 21%. Over 100 different practice guidelines are used, most commonly for asthma (77%), hyperbilirubinemia (27%), and otitis media (19%). Common reasons for use of practice guidelines include standardization of care (17%) and helpfulness (10%). Commonly cited problems with practice guidelines include failure to allow for clinical judgment (54%), use in litigation (16%), and limitation of autonomy (5%). In multivariate analysis, the odds of practice guideline use were greater among pediatricians in health maintenance organization practices (odds ratio [OR]: 9.1; 95% confidence interval [CI]: 1.2-68.0) and those who were nonwhite (OR: 2.3; 95% CI: 1.1-4.8), but lower in those with more weekly patient visits (OR:.7; 95% CI:.5-.9). Features most likely to lead to practice guideline use include simplicity (16%), feasibility (12%), and evidence of improved outcomes (10%). Most pediatricians agree that practice guidelines improve outcomes (89%), are motivated by a desire to improve quality (94%), and should not be used in litigation (82%) or disciplinary actions (77%), nor be motivated by a desire to reduce costs (73%). CONCLUSIONS: Most general pediatricians use practice guidelines, but no specific guidelines, except those for asthma, are used by >27% of pediatricians. The results of this study suggest that practice guidelines are most likely to be followed if they are simple, flexible, rigorously tested, not used punitively, and are motivated by desires to improve quality, not reduce costs.

Attitude of Health Personnel↗
PubMed1999

Pinopodes as markers of endometrial receptivity in clinical practice.

Clinical evidence indicates the existence in the human of a narrow window of uterine receptivity which opens during the mid-luteal phase. At the same time, formation of pinopodes on the apical membranes of the endometrial epithelial cells occurs. To develop a specific marker for receptivity in clinical practice, the kinetics of pinopode formation has been investigated through sequential endometrial biopsying in natural, hormone replacement and stimulated cycles. The results show that pinopodes last <48 h in all cycles, and the timing of their formation depends both on the hormonal treatment applied and on the patient's individual response. On average, pinopodes form earlier in stimulated cycles and later in hormone replacement cycles, compared with natural cycles. Pinopode expression is strongly correlated with implantation following embryo transfer and furthermore, detection of pinopodes in assessment cycles may be extremely useful for the assessment of receptivity on an individual basis to optimize embryo transfer, resulting in increased implantation rates. Finally, pinopodes seem to be correlated well with other cellular and molecular events occurring in the mid-luteal endometrium.

Biomarkers↗
PubMed2004

Integrating the principles of evidence-based practice into clinical practice.

This series of articles illustrates many considerations relevant to the application of clinical practice guidelines (CPGs). This particular column describes the actions of a nurse practitioner (NP) striving to understand the foundations of recommendations that are based largely on expert opinion. Although application of CPGs does not generally require this degree of investigation, it is essential that providers understand the processes used to interpret the basis of recommendations, including the application of the basic statistical concepts, when making decisions about how recommendations apply to individual patient scenarios. Utilizing evidence-based practice when providing patient care requires a range of skills that allows the NP to locate appropriate research evidence, to develop an understanding of the statistics used in interpreting and reporting research, and to evaluate the effects of interventions on patient outcomes. The application of the key concepts of evidenced-based practice within the primary care setting is explored through a hypothetical patient scenario, which was created as the focal point for three articles that illustrate principles of evidence-based practice. The goal of this series of articles is to provide a basic understanding of evidence-based practice and its application in clinical practice. This article explores the use of interventions selected from CPGs and investigates the potential effects of recommended interventions on patient outcomes. Commonly encountered statistical concepts are reviewed, and examples of their application in interpreting and reporting research are demonstrated. The principles of relative risk, relative risk reduction, absolute risk reduction, and numbers needed to treat are described. This review provides the NP with some basic skills to determine both the quality and usefulness of research.

Clinical Competence↗
PubMed1993

[Good clinical practice in clinical trials: the responsibilities of the investigator. A survey of 827 hospital physicians (and II). Patient consent].

BACKGROUND: Among the responsibilities of the investigator, good clinical practice (GCP) includes that of obtaining informed consent (IC) from the patients prior to his/her inclusion into a clinical trial (CT). The attitude of the hospital physicians towards this question before the implementation of the GCP became mandatory in Spain was considered to be of interest. METHODS: An anonymous survey with closed response questions was used. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members of any specialty who had or had not participated in CT. The results of the questions regarding different aspects intimately linked to the obtaining of the IC from the patient are presented in this article. RESULTS: A total of 827 hospital doctors responded to the survey. Most (96%) of those surveyed considered that the investigator must obtain the IC prior to inclusion in the CT with almost two thirds obtaining the same in writing in all CT. Nine out ten of those surveyed considered that the information provided to the patient to obtain the IC should be laid out in a document. At least 90% of the above consider that the document should always invite the patient to participate in a CT, declaring that participation is voluntary, that the patient may leave the study when he/she wishes and that refusing to participate does not imply loss of normal health care. To the contrary, at least 10% would not provide information as to who the promoter was, the design of the CT, specific experimental procedures of the CT as the number of patients to participate in the CT. CONCLUSIONS: According to the good clinical practice guidelines, the responsibilities of the researcher with respect to informed consent of patients to participate in a clinical trial have, in general, been accepted by most of the hospital physicians surveyed in the present study. Theoretically, only the reduced acceptance of informing the patient as to the design of the clinical trial may cause some problems in the future.

Clinical Trials as Topic↗
PubMed2001

Measurement of somatic neuropathy for clinical practice and clinical trials.

Distal sensory polyneuropathy is a common and unpleasant complication of diabetes mellitus. It is the main initiating factor for foot ulceration. The increasing prevalence of diabetes has important associated health implications, both in terms of morbidity and mortality, and results in the consumption of scarce medical resources. Identification of somatic neuropathy in clinical practice is therefore important for targeted educational and other interventions. In this article, we describe methods for detecting somatic neuropathy in clinical practice and highlight those tests that are proven to be predictors of foot ulceration. The approach for detecting and characterizing somatic neuropathy for clinical trials, however, differs significantly. These methods must ideally have high levels of reproducibility, sensitivity, and specificity. Currently, several neurophysiologic tests are employed in clinical trials in order to accurately characterize diabetic neuropathy. The recent introduction of the computer-assisted programs for the measurement of sensory modalities for clinical trials has been a major advance. Due to their invasive nature and associated morbidity, nerve biopsy studies are no longer used in clinical trials. Recently, using magnetic resonance imaging (MRI), significant spinal cord atrophy has been demonstrated in established neuropathy. If this observation proves to be an early feature, then a relatively rapid, noninvasive MRI technique may be used in the future to characterize diabetic neuropathy.

Clinical Trials as Topic↗
PubMedDate not supplied

Use of off-pump and on-pump CABG strategies in current clinical practice: the Clinical Outcomes Assessment Program of the state of Washington.

BACKGROUND: The purpose of this study is to assess clinical outcomes and regional differences in the use of on-pump and off-pump CABG in current clinical practice. METHODS: Between January 1, 1999, and December 31, 2000, there were 10,429 CABG procedures performed in 16 Washington state hospitals, all of which participate in Clinical Outcomes Assessment Program database. This analysis excluded patients with a history of prior CABG as well as those who underwent emergent surgery. After applying these exclusion criteria, 8402 patients (7169 on-pump and 1233 off-pump CABG procedures) were evaluated and presented as both unadjusted and risk-adjusted outcomes. OUTCOMES: Off-pump CABG constituted 14.7% of all surgical revascularization procedures. These varied enormously among individual centers from an incidence of 0% to 68.9%. The use of off-pump CABG was not associated with a decreased risk of risk-adjusted hospital mortality or stroke, but was associated with a reduction in hospital stay > 7 days (OR 0.62, CI 0.51-0.76), ventilator > 24 hours (OR 0.52, CI 0.34-0.81), dialysis (OR 0.34, CI 0.14-0.86), and RBC transfusion (OR 0.5, CI 0.40-0.61). CONCLUSIONS: Despite its highly variable use, off-pump CABG seems to be judiciously used in current clinical practice in the State of Washington and is associated with a decrease in morbidity in appropriately selected patients.

Adolescent↗
PubMed1993

[Good clinical practices in clinical trials: the responsibility of the researcher. A survey of 827 hospital physicians (I). Availability. Monitoring. Safety. Contract].

BACKGROUND: The Law of Medicaments establishes that clinical trials (CT) with drugs must be carried out following the of Good Clinical Practice guidelines (GCP). The attitude of hospital physicians to the GCP prior to its implementation as mandatory in accordance with Spanish legislation was considered to be of interest. METHODS: An anonymous survey was used with closed response questions. Questions referring to the responsibilities of the investigator included in the GCP were included. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members, of any specialty, who had or had not participated in CT. In this article the results of the questions regarding the availability of the investigative team, CT monitorization, management of adverse reactions, the safety of the participants in the CT and the contract between the sponsor and the researcher are presented. RESULTS: A total of 827 hospital doctors replied to the survey. Fifty-nine percent had intervened in CT with drugs. At least 94% of those surveyed considered that the researcher must have the time and number of eligible patients which the CT requires. There was high acceptance (> or = 78%) of the clinical audits to be performed by the health authorities and the sponsor company of the CT. The need of urgent communication of the severe adverse reactions is admitted by a great majority (> or = 95%) of those surveyed. Eighty-five percent believe that patients should be insured against damage derived from CT with 76% considering that the investigator should sign a contract with the sponsor; 68% and 59% would hand in a copy of the same to the CT committee and the remainder of the research team, respectively. CONCLUSIONS: According to the Good Clinical Practice dealt with in this article, the responsibilities of the investigator have been widely accepted by the hospital physicians surveyed, therefore no problems should be expected upon the implementation of the same in this country. However, the economic transparency in the clinical trial does not appear to be absolutely necessary by the doctors surveyed.

Adult↗
PubMed2006

The new KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and CKD.

BACKGROUND/AIMS: The National Kidney Foundation (NKF) recently published new guidelines and clinical practice recommendations for the diagnosis and management of patients with diabetes and chronic kidney disease (CKD). METHODS: Guidelines were developed using an evidence-based approach. When sufficient evidence was lacking, recommendations were developed that reflect expert opinion. RESULTS: Guidelines describe the process for screening and diagnosis of kidney disease in the setting of diabetes and the management of hyperglycemia, hypertension, dyslipidemia, and nutrition. Recommendations describe the management of albuminuria in the normotensive diabetic patient and the potential value of albuminuria as a marker of treatment efficacy; the impact of diabetes and CKD in special populations; the importance of behavioral self-management; and the value of intensive multifaceted intervention in these high risk patients. CONCLUSIONS: The new guidelines and recommendations update and extend the scope of the NKF's Kidney Disease Outcomes Quality Initiative (KDOQI(TM)).

Diabetes Complications↗
PubMedDate not supplied

The KDOQI clinical practice guidelines and clinical practice recommendations for treating anemia in patients with chronic kidney disease: implications for nurses.

The National Kidney Foundation Kidney Disease Outcomes Quality Initiative recently published revised clinical practice guidelines and recommendations for the treatment of anemia. This article provides an overview of the new guidelines and recommendations, with a focus on the hemoglobin treatment range, iron status, use of erythropoiesis-stimulating agents, and adjuvant therapies.

Anemia↗
PubMed2005

Effects on immunological and virological outcome of patients using one protease inhibitor or one non-nucleoside reverse transcriptase inhibitor in a triple antiretroviral therapy: normal clinical practice versus clinical trial findings.

We compared the response of two standard 3-drug regimens containing two-nucleoside reverse transcriptase inhibitor (Zidovudine +Lamivudine) plus either a protease inhibitor (PIs) (Indinavir) or a non-nucleoside reverse transcriptase inhibitor (NNRTIs) (Efavirenz) among treatment-naïve or treatment-experienced HIV-infected persons. The obtained results will be compared to clinical trial findings. Through a retrospective study, we compared the virological and immunological response of 119 Tunisian HIV-1 infected patients (North Africa) who started for the first time/ in salvage use a triple antiretroviral treatment containing one NNRTI (group A1/group A2) or one PI (group B1/group B2). Viral load (VL) was analysed with Amplicor HIV-1 Monitor test and drug resistance mutations were examined by using two distinct line probe assays (LiPA). The analysis according to the received treatment showed an average of 0.45 log(10) drop in the mean VL among groups A2 and B2. For naïve patients, 62.5% of group A1 reached an undetectable VL versus 53.5% for group B1 (p < 0.001). With regard to the CD4 cell count change, we observed a mean increase of more than 65% versus baseline within group A1 in comparison with 42% for group B1 (p < 0.001). Genotypic resistance assays showed that patients of group A2 had significantly more resistance mutations than those of group B2 (2.66 vs. 0.75 (p = 0.0039)). Finally, 15 patients who were failing were switched to indinavir or efavirenz. When indinavir was replaced by efavirenz, we observed an increase in the plasma VL. With regard to the effects on immunological and virological outcome of patients using PIs or NNRTIs in a triple antiretroviral therapy, our observations in normal clinical practice supported the reported clinical trial findings but are not in favour of replacing indinavir by efavirenz in failing regimen.

Adult↗
PubMed2005

ALLHAT in perspective: implications to clinical practice and clinical trials.

ALLHAT study is the biggest randomized clinical trial in hypertension ever conducted. Its objective was to ompare the efficacy of newer (calcium channel blocker amlodipine and angiotensin-converting enzyme inhibitor inopril) to the older (diuretic chlorthalidone) antihypertensive agents in the treatment of patients with hypertension. After enrolling 42,000 patients who were followed for an average of 4.9 years, ALLHAT did not find significant differences in the primary end-points between these antihypertenive agents. ALLHAT however found significant differences in the secondary end-points such as heart failure and strokes between chlorthalidone and amlodipine or lisinopril. Based on these and on economic reasons, the investigators unequivocally recommended diuretics as the first line therapy for hypertension. Since its publication, ALLHAT has been much discussed, debated A and opined. The choice of drugs for study, the study design, the conduct of the study and the conclusions drawn by the investigators had all been criticised or controversial. Yet ALLHAT has been widely quoted, commented upon or referred to and it has been instrumental in initiating the JNC VII Guidelines. Thus a thorough understanding of ALLHAT is necessary for clinical practice and in designing and evaluating clinical trials in the future. Moving Points: in Medicine will capture the essence of ALLHAT, discusses its implications to clinical trials and explores its possible impact on the practice of medicine in this country.

Antihypertensive Agents↗
PubMed2006

Research in clinical practice.

Clinical research in the practice setting can be a rewarding experience. The atmosphere of research is changing, however, with tighter budgets, more oversight, increasing litigation risks, financial pressures, and increased competition. Sites must be increasingly careful to negotiate appropriate study budgets and contract language that is not overly burdensome or risky for the site. The focus on investigator training and use of qualifies personnel is paramount to preserve and improve the quality of clinical research in the United STates. The future may find certification examinations necessary for all research staff, including investigators. Eventually, the number of clinical research sites in the community will decrease, and academic sites, along with international sites, will once again fill the void.

Biomedical Research↗
PubMed1990

Beyond relationship: the current challenge in clinical practice.

Clinical social workers in health settings have used time and relationship and the understanding of individual and family dynamics, biophysiology, and larger systems issues to assist patients and families in resolving health related problems. The current economic crisis is limiting time and focus and necessitating revisions in intervention techniques. Clinicians experience this as a threat to their identity as a caring profession and to their ability to support patient autonomy within the health care environment. Effective adaptation requires a different use of self, expanded diagnostic skills, greater use of networking and systems interventions, and more sophisticated clinical techniques. Often, engagement, assessment and intervention have to occur within the same session. To accomplish this shift in practice, there has to be strong clinical leadership and a conscious focus on adapting clinical models to meet the current economic restrictions.

Continuity of Patient Care↗
PubMed1995

[Psychiatric clinical practice and medical clinical practice].

The field of Psychiatry encompasses the study of both nomothetic (i.e. submitted to a lawfulness) and idiographic (i.e. unpredictable, submitted to the free will or decisions of the individuals) phenomena. Clinical-diagnostic investigations function at three different speeds: -Adagio: slow gathering of diversified data, pertaining to: .history of malady (or psychological maladjustment); .personal history of the patient; .opinion of members of the family; .opinion of the referring practitioner; .last but not least: opinion of the nursing staff. -Allegro: selective grouping of the most significant symptoms; the putative syndrome is then compared with classical well-recognized diagnostic entities (inferential diagnosis). -Presto: the immediate primal impression; this type of perception deals mainly with a tentative and almost reflex appraisal of the personality; it is based on disputable data. This type of unconscious guess is actually more emotional than rational. Psychiatry cannot rely upon "hard symptoms" (such as a cardiac murmur), nor on images (if the latter are convincing they actually contribute to a diagnosis of organic brain impairment), or on chemical evidence of an underlying metabolic disorder. Dexamethazone suppression test did not hold its promises. Only the shortening of the latency time of the paradoxical (R.E.M.) sleep might be useful. All this contributes to the use of psychotropic drugs as a diagnostic tool. It is legitimate because what is known of the action of these drugs on various neuro-transmitters has given us some insight. Nevertheless simplistic ideas which flourished some twenty of thirty years ago, have not been entirely validated.

Antidepressive Agents↗