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An analysis of sickness absence in chronically ill patients receiving complementary and alternative medicine: a longterm prospective intermittent study.

BACKGROUND: The popularity of complementary and alternative medicine (CAM) has led to a growing amount of research in this area. All the same little is known about the effects of these special treatments in every-day practice of primary care, delivered by general practitioners within the health insurance system. From 1994 to 2000 more than 20 German Company health insurances initiated the first model project on CAM according to the German social law. Aim of this contribution is to investigate the effectiveness of multi-modal CAM on chronic diseases within primary health care. METHODS: A long-term prospective intermittent study was conducted including 44 CAM practitioners and 1221 self-selected chronically ill patients (64% women) of whom 441 were employed. Main outcome measure is sick-leave, controlled for secular trends and regression-to-the mean and self-perceived health status. RESULTS: Sick-leave per year of 441 patients at work increased from 22 (SD +/- 45.2) to 31 (+/- 61.0) days within three years prior to intervention, and decreased to 24 (+/- 55.6) in the second year of treatment, sustaining at this level in the following two years. Detailed statistical analysis show that this development exceeds secular trends and the regression-toward-the-mean effect. Sick-leave reduction was corroborated by data on self-reported improvement of patients' health status. CONCLUSION: Results of this longterm observational study show a reduction of sick leave in chronically ill patients after a complex multimodal CAM intervention. However, as this is an uncontrolled observational study efficacy of any specific CAM treatment can not be proven. The results might indicate an general effectiveness of CAM in primary care, worthwhile further investigations. Future studies should identify the most suitable patients for CAM practices, the most appropriate and safe treatments, provide information on the magnitude of the effects to facilitate subsequent definitive randomised controlled studies that will help to position complementary and alternative medicine in health care.

Adult↗

Selfobjects in psychosis--the twinship compensation.

Psychoanalysts and psychotherapists who work with psychotic patients often encounter unusual clinical phenomena. In this article, a certain kind of phenomena is described, wherein the patient refers to a body part of the therapist as being owned by the patient. This "body part borrowing" or "merger" can be explained by the classical and object relations schools in terms of part and transitional object concepts. These diagnostic formulations will then guide therapeutic intervention. Newer concepts, from the psychoanalytic school of self psychology, particularly that of the twinship selfobject experience, provide for a more effective intervention in these complex clinical situations. Certain psychotic responses, in these cases, delusional misperceptions, can be viewed as the patient's attempt to stave off empathic rupture and fragmentation. "Body-part borrowing" in the treatment setting thus serves as a twinship selfobject compensation; it attenuates the unbearable affects generated by empathic failure. In this article, we offered clinical vignettes to illustrate these processes in two patients with psychosis and one with neurosis. We then offered various suggestions for clinical intervention based on a selfobject understanding of these phenomena.

Adult↗

Evaluation of endoscopic retrograde cholangiopancreatography under conscious sedation and general anesthesia.

BACKGROUND AND STUDY AIMS: In adults, general anesthesia is usually only provided during endoscopic retrograde cholangiopancreatography (ERCP) when prior attempts using conscious sedation have failed. It was hypothesized that in our hospital, other factors might be associated with general anesthesia for ERCP. The aim of this study was therefore to assess the indications for ERCP under general anesthesia, and to evaluate the underlying diseases, type, and efficacy of ERCP under general anesthesia in comparison with conscious sedation. PATIENTS AND METHODS: We retrospectively analyzed 1,056 ERCPs that had been carried out with the patients under general anesthesia or conscious sedation. The indications for general anesthesia were recorded, and the underlying diseases, the type and success of the interventions, and the causes of premature ERCP termination in both groups were assessed. RESULTS: Eighteen percent of the ERCPs were performed under general anesthesia and 82% under conscious sedation. The indications for general anesthesia were related to the type of procedure planned (46%), premature termination of ERCP under conscious sedation (28%), and other reasons. Patients with primary sclerosing cholangitis and liver transplant recipients received general anesthesia more frequently (general anesthesia vs. conscious sedation, 36% vs. 16%, P < 0.0001 and 22% vs. 13%, P = 0.003). Conscious sedation was provided more frequently in patients with neoplasms and cholelithiasis (21% vs. 12%, P = 0.004 and 13% vs. 3%, P < 0.001). Painful dilations were performed more frequently with the patients under general anesthesia (60% vs. 19%, P < 0.001), whereas major papillotomies were preferably performed with conscious sedation (34% vs. 21%, P = 0.006). More interventions per ERCP were performed with the patient under general anesthesia compared to conscious sedation (P < 0.001), during the same time (51 +/- 28 min vs. 52 +/- 26 min, P = 0.39). With conscious sedation, the ERCP failure rate was double that with general anesthesia (7% vs. 14%, P = 0.012), mainly due to inadequate conscious sedation (61%). CONCLUSIONS: The frequent use of general anesthesia for ERCP at our institution is related to the underlying diseases, which are frequently treated with complex and painful ERCP procedures. The efficacy of ERCP with general anesthesia supports a continued preference for general anesthesia rather than conscious sedation when complex and painful interventional ERCP procedures are planned.

Anesthesia, General↗

Utility of an intervention scoring system in documenting effects of changes in burn treatment.

The consequences of the introduction of a program of consistent use of topical antimicrobials and early aggressive excision of deep burn wounds by utilizing a comprehensive, computerized patient registry/therapeutic intervention scoring system, were investigated. Prospectively, the clinical course, mortality, outcome and hospital costs were compared for the year preceding (89 patients) and the 4 years following (226 patients) the introduction of the new treatment program. It was found that mortality decreased from 10.1 to 4.6% after change in therapy (P<0.001), despite an increase in mean burn extent. The length of hospital stay per % burn surface area declined from 1.2 to 1.0 days (P<0.001). The number and complexity of therapeutic interventions and the associated costs, also declined. Patients in the new treatment program had a better level of physical and psychosocial function at follow up. In conclusion, the introduction of a program of consistent use of topical antimicrobials and early, aggressive surgical excision was associated with an improved outcome at lesser cost. The combined registry-intervention scoring system permits ready analysis of results using data entered on a daily, near-real time basis.

Adult↗

Abciximab-facilitated percutaneous coronary intervention and long-term survival--a prospective single-center registry.

AIMS: To identify predictors of use of abciximab and evaluate the long-term survival after percutaneous coronary intervention with or without abciximab in a broad spectrum of patients. METHODS: We prospectively evaluated, in a dedicated registry, the 4-year survival of patients undergoing percutaneous revascularization and the treatment with or without abciximab, using the Social Security Death Index. RESULTS: Among 10,471 patients treated between 2/1/1995 and 12/31/2001, 5655 received abciximab and 4816 did not. Propensity score analysis (c-statistic 0.83) identified the following variables to be independently associated with abciximab use: later date of procedure, stent use, acute or recent infarction, increasing lesion complexity, vein graft intervention, hyperlipidemia, normal renal function, male gender and decreasing age. Procedural success was higher in the abciximab group, 93 vs. 89%, P<0.001. Unadjusted Kaplan-Meyer survival analysis demonstrated a strong trend for improved survival in the abciximab group at 4 years, 86.3 vs. 84.7%, P=0.09. In the 7533 patients with acute coronary syndromes (ACS), the respective values were 86.0 vs. 83.6%, P=0.03. Multivariate Cox proportional hazard analysis identified increasing age, significant left ventricular dysfunction or congestive heart failure, chronic renal insufficiency and diabetes mellitus as main predictors of mortality. Abciximab was independently associated with improved survival only in patients with ACS (adjusted HR 0.87, 95% confidence interval, 0.81-1.00, P=0.05). Abciximab use was associated with a higher rate of access site hematoma (2.8 vs. 1.5%) and blood product transfusion (6.8% vs. 4.8%), P<0.001 for both. CONCLUSION: Abciximab use improves procedural success and is associated with lower 4-year mortality in patients with ACS, for whom it should be strongly considered. A lesser effect is seen in patients without high-risk characteristics.

Abciximab↗

[Effectiveness of comprehensive geriatric assessment in primary care].

OBJECTIVE: To review and update evidence on the effectiveness of the comprehensive geriatric assessment (CGA) of the elderly in the community environment. DESIGN: Systematic review. DATA SOURCES: MEDLINE (January 1997 to November 2001) and The Cochrane Library, completed with a manual search. SELECTION OF STUDIES: Randomised clinical trials (RCT) to study the effects of a CGA in people over 64 and not in an institution. Trials that assessed mortality, institutionalisation and functional status were included. Those conducted after hospital discharge or not in a community environment were excluded. 133 summaries were reviewed and 16 articles analysed. DATA EXTRACTION: Methodological quality assessed with adapted Jadad scale. A data archive was worked out to collect information on characteristics of the population and the intervention and on the main findings. RESULTS: The quality of the trials was adequate, though they had important methodological differences. Eleven trials found no favourable effects in the result variables studied. Five of the twelve trials which assessed functional status and one of the twelve that evaluated admissions to institutions found some favourable effect. None of the nine studies with mortality data found favourable results. CONCLUSIONS: Evidence for the effectiveness of the CGA for the elderly not in institutions continues to be inconsistent and insufficient. Nevertheless, given the complexity of this intervention, it seems prudent to continue to conduct CGAs of the elderly in the PC environment until such time as further studies clarify the role of these programmes.

Aged↗

Community psychiatric nurse caseloads and the 'worried well': misspent time vital work?

Community psychiatric nurses (CPNs) in the United Kingdom are being repeatedly urged to focus their attention upon those with serious and enduring psychotic illnesses, and to withdraw from working with the 'worried well' in the primary health care setting. In view of this pressure, it is important to discover the nature of community psychiatric nurses' non-psychotic caseloads. The aim of this study was to describe these cases, what precipitated their referral, what problems they suffered from, what effects these problems had upon their lives and what kinds of therapeutic interventions they were receiving. A random sample was drawn of non-psychotic CPN patients. The community psychiatric nurses then received a structured interview about the history, care and treatment of these patients. These patients did not, in general, suffer from minor, self-limiting conditions. They typically had had 5 years of contact with psychiatric services, and their psychiatric symptoms blighted their occupational, social and personal lives. Their condition caused significant carer burden, and there was frequently a risk of suicide. The CPNs case-managed a complex combination of interventions for these patients, of which psychotherapeutic methods were only one part. The findings show that community psychiatric nurses have a valid role to play in the care of those with non-psychotic mental disorders, and should continue to receive the opportunity, and appropriate training, to do so.

Case Management↗

The content, integrity, and efficacy of a nurse coaching intervention in type 2 diabetes.

PURPOSE: The purpose of this study was to systematically evaluate the content, integrity, and efficacy of a nurse coaching intervention provided after diabetes education that focused on dietary and exercise lifestyle change in persons with type 2 diabetes. METHODS: A multimethod design incorporated an interpretive approach to examine the content and integrity of the intervention and a multiple-baseline, single-subject method to determine the preliminary efficacy of the intervention. RESULTS: The primary strategies of the nurse coaching intervention consisted of facilitating lifestyle change through educational reinforcement, psychosocial support, and motivational guidance. Aggregate quantitative outcomes revealed a modest increase in health-promoting behaviors and a decrease in fasting blood glucose, indicating a trend toward physiologic adaptation. Participants demonstrated a significant increase in integration reflective of psychosocial adaptation. CONCLUSIONS: Providing individualized nursing care after diabetes education may improve health outcomes and the quality of life of persons newly diagnosed with type 2 diabetes. This multimethod design is a cost-effective approach for preliminary evaluation of complex and/or novel interventions.

Diabetes Mellitus, Type 2↗

Metabolic inertia in contracting skeletal muscle: a novel approach for pharmacological intervention in peripheral vascular disease.

Peripheral vascular disease (PVD) is generally accepted to result in the failure of skeletal muscle blood flow to increase adequately at the onset of muscular work. There are currently no routine pharmacological interventions towards the treatment of PVD, however, recent Phase III trials in the USA have demonstrated the clinical potential of the phosphodiesterase III inhibitor Cilostazol for pain-free and maximal walking distances in patients with intermittent claudication. PVD is characterized by a marked reliance on oxygen-independent routes of ATP regeneration (phosphocreatine hydrolysis and glycolysis) in skeletal muscle during contraction and the rapid onset of muscular pain and fatigue. The accumulation of metabolic by-products of oxygen-independent ATP production (hydrogen and lactate ions and inorganic phosphate) has long been associated with an inhibition in contractile function in both healthy volunteers and PVD patients. Therefore, any strategy that could reduce the reliance upon ATP re-synthesis from oxygen-independent routes, and increase the contribution of oxygen-dependent (mitochondrial) ATP re-synthesis, particularly at the onset of exercise, might be expected to improve functional capacity and be of considerable therapeutic value. Historically, the increased contribution of oxygen-independent ATP re-synthesis to total ATP generation at the onset of exercise has been attributed to a lag in muscle blood flow limiting oxygen delivery during this period. However, recent evidence suggests that limited inertia is present at the level of oxygen delivery, whilst considerable inertia exists at the level of mitochondrial enzyme activation and substrate supply. In support of this latter hypothesis, we have reported on a number of occasions that activation of the pyruvate dehydrogenase complex, using pharmacological interventions, can markedly reduce the dependence on ATP re-synthesis from oxygen-independent routes at the onset of muscle contraction. This review will focus on these findings and will highlight the pyruvate dehydrogenase complex as a novel therapeutic target towards the treatment of peripheral vascular disease, or any other disease state where premature muscular fatigue is prevalent due to metabolite accumulation.

Acetyl Coenzyme A↗

Combined percutaneous biosense-guided laser myocardial revascularization and coronary intervention.

Laser myocardial revascularization is a promising new treatment strategy for patients with severe ischemic heart disease who are not candidates for conventional percutaneous or surgical revascularization. The open chest surgical approach to transmyocardial revascularization has been approved by the FDA for the treatment of angina in inoperable patients, but has had limited use as a stand-alone procedure. More recently, use of fiber-optic catheters has made it possible to use a holmium:yttrium aluminum garnet laser to perform percutaneous catheter-based transmyocardial revascularization. To the extent that many patients have a combination of ischemic sources, some amenable to conventional revascularization and some not, combination or hybrid approaches have been considered. We report herein two patients with class IV angina who underwent laser myocardial revascularization using the Biosense system and complex percutaneous coronary intervention during the same procedure. Areas amenable to conventional percutaneous coronary intervention (PCI) were so treated, and viable but ischemic areas were supplied by totally occluded native vessels and bypass grafts underwent Biosense-guided laser myocardial revascularization (LMR). As the results of more controlled and blinded studies of laser myocardial revascularization become available (if results continue to be promising) and a better understanding of the mechanism of action of this treatment modality is achieved, LMR-PTCA hybrid will be performed in increasing frequency. However, even after establishing LMR efficacy, studies of LMR-PTCA hybrid should be conducted to determine the efficacy of this approach.

Adolescent↗

Clinical impact of abciximab on long-term outcome after complex coronary angioplasty.

Glycoprotein IIb/IIIa receptor antagonists, such as abciximab, are used to reduce major adverse cardiac events (MACEs) in patients undergoing percutaneous transluminal coronary angioplasty. The goal of this study was to evaluate the administration of abciximab in relation to lesion complexity and periprocedural complications. A total of 357 patients with 435 de novo lesions were included in this study. Lesions were divided into simple (type A and type B1) and complex (type B2 and type C) lesions according to the American College of Cardiology/American Heart Association Task Force lesion complexity system. Abciximab was given to unstable complex lesions and simple lesions with a periprocedural unstable complicated course. The overall incidence of MACE during the 9-month follow-up period was 17.0%. Patients treated with abciximab had a higher lesion complexity (P < 0.001), dissections (P = 0.014), stents (P < 0.001), and vessels involved (P < 0.001). in addition, the abciximab group was characterized by a higher angina NYHA class (P = 0.005), lower TIMI flow prior to stenting (P = 0.01), and a longer total inflation time (P = 0.006). Despite these clinical differences, the occurrence of MACE within the abciximab group was slightly less than in the group without abciximab (16.2% and 17.3%, respectively). Lesion complexity was directly related to MACE in the group that did not receive abciximab (simple and stable complex lesions; P = 0.04). On the other hand, in subjects treated with abciximab, lesion complexity was not related to a higher incidence of MACE (P = 0.76). The use of abciximab equalizes the difference in outcome between simple and complex lesions. Therefore, abciximab should be advocated especially in unstable and complex percutaneous coronary interventions.

Abciximab↗

Use of abciximab during infrainguinal peripheral vascular interventions: initial experience.

PURPOSE: To investigate the use of abciximab as an adjunct during infrainguinal angioplasty. MATERIALS AND METHODS: Abciximab was used in conjunction with recanalization techniques and angioplasty to treat stenoses or occlusions in 16 patients: 10 patients had high-grade stenoses or occlusions longer than 5 cm in the superficial femoral artery and popliteal artery, and six patients had stenoses or occlusions below the popliteal artery. All patients received a bolus of heparin after arterial access was achieved. Abciximab was administered by means of a weight-base nomogram that consisted of an initial bolus followed by an overnight infusion. Technical success was defined as a less than 30% residual stenosis after angioplasty. Patients were carefully followed up for possible postprocedural complications. Platelet counts were monitored for 24 hours. RESULTS: Technical success was achieved in 15 (94%) of 16 patients. One occlusion of the superficial femoral artery could not be crossed. There was a mean postprocedural increase of 0.23 in the ankle-brachial index. There was no significant effect on platelet count. Two minor complications occurred. One major complication occurred; this was a groin hematoma, which required a blood transfusion. CONCLUSION: The use of abciximab as an adjunct during complex infrainguinal arterial interventions appears promising, on the basis of initial experience.

Abciximab↗

Repair of recurrent coarctation using an ascending aortic autograft.

Results of aortic arch repair for interrupted aortic arch or aortic coarctation have considerably improved. However, re-stenosis or aneurysm formation is a common complication requiring complex re-interventions or even extra-anatomic bypass grafting. In two patients with recurrent coarctation, the use of cardiopulmonary bypass was mandatory, in one due to the concomitant repair of the intra-cardiac defect, in the other due to the small aortic arch, the long segment aortic coarctation and the small diameter of the supra-aortic vessels. In both patients a segment of the ascending aorta was interposed between the distal aortic arch and the proximal descending aorta with uneventful postoperative courses and freedom from pathological findings at 1 year and 6 months follow-up. In patients undergoing complex congenital heart surgery involving the ascending aorta, a segment of the autologous ascending aorta may be used to repair recurrent isthmic stenosis, avoiding the use of any foreign material.

Anastomosis, Surgical↗

Impact and temporal trends of percutaneous coronary intervention in the drug-eluting stent versus bare metal stent eras.

Limited published data exist about how the introduction of drug-eluting stents (DESs) has affected the technical aspects of percutaneous coronary intervention and in-hospital patient outcomes in clinical practice. A total of 2,215 consecutive patients who underwent percutaneous coronary intervention for de novo coronary artery disease were divided into 2 cohorts: the pre-DES era (May 1, 2002 to April 30, 2003) and the DES era (May 1, 2003 to April 30, 2004). The procedural success rates (94.9% vs 96.4%, respectively; p = 0.075) and the in-hospital major adverse events (6.4% vs 5.7%, respectively; p = 0.53) were similar between the pre-DES and DES eras. The DES percentage of use increased from 49.5% in the first quarter to 84.1% in the final quarter of the first year after the introduction of this technology (p <0.0001). The results of our study have shown that despite more complex percutaneous coronary intervention procedures with tendencies for more complete lesion coverage and anatomic revascularization, the procedural success and in-hospital outcomes have been comparable since the introduction of DESs.

Angioplasty, Balloon, Coronary↗

Importance of access to fixed-imaging fluoroscopy: practice implications for the vascular surgeon.

PURPOSE: To examine the impact of unfettered access to high quality fixed-imaging fluoroscopy in a vascular surgery practice. METHODS: The case mix of 2 vascular surgeons was retrospectively examined for a 12-month period before (period A) and after (period B) routine access to fixed-imaging equipment was established. Operative and endovascular cases were identified by their CPT codes. Trends in procedure frequency and gross charges were assessed. RESULTS: Endovascular code usage increased 174% (p<0.001) following routine access to fixed imaging equipment. There was an overall 2.3-fold increase in angioplasty across all vascular beds (p<0.001), as well as a 2.1-fold increase in stent utilization (p<0.001). More complex diagnostic and interventional procedures were performed, as evidenced by a large increase in third-order catheterizations (p<0.001). Open surgical therapy decreased overall by 11.4% (p=0.051) in period B. Reductions in open surgery for peripheral arterial occlusive disease were most pronounced, decreasing 35.6% (p<0.001). Overall gross charges increased 6% in group B. Endovascular procedures accounted for 36.6% of gross charges in period B, doubling its contributions from period A (17.1%, p=0.01). Open major vascular case contributions to gross charges fell from 54.4% to 36.2%. CONCLUSIONS: A significant shift in case mix was observed after routine access to fixed imaging equipment was established, with a dramatic increase seen in percutaneous endovascular case volume and complexity. Corresponding contributions to gross charges for endovascular procedures became equivalent to that of all open major vascular cases combined. Routine access to fixed imaging fluoroscopy appeared to be the chronological fulcrum on which the balance of endovascular and open vascular cases has shifted, allowing the development of a fully integrated vascular and endovascular practice.

Angioplasty↗

[Economic aspects of telemedicine].

The aim of health technology assessments is to study the incremental impact of health interventions within a complex care system characterised by a multitude of individual behaviours and institutions. Most frameworks available for telemedicine evaluation simply examine financial costs relative to face-to-face consultations. Current data collection systems are poorly suited to rigorous analyses of new networks in everyday situations. Randomised trials are designed to remove sources of interference that could mask a causal relationship between a new organization and a set of results. Their methodology, which introduces the term ceteris paribus into the principles of good practice, is poorly suited to analyzing individual behaviours. Observational studies attempt to describe actual treatment situations as accurately as possible. By definition, however, they assume that the natural course of events is not deviated by interventions. The absence of an experimental plan increases the likelihood of bias and makes it more difficult to test for causal relationships. These approaches are poorly suited to testing for incremental effectiveness. Quasi-experimental studies and a staged approach would be more suited to a comprehensive assessment of telemedicine initiatives. In this way its impact on effectiveness, integration of care, quality of life and social costs may be identified in normal conditions of use.

Cost-Benefit Analysis↗

[Economic assessment, a field between clinical research and observational studies].

Health technology assessments propose to study the differential impact of health interventions in a complex care system which is characterised by the multitude of individual behaviours and the diverse nature of the institutions involved. Current systems for data collection lend themselves poorly to this rigorous analysis of efficacy of treatments in the actual situations where they are used. Randomised trials endeavour to neutralise any parasitic interference which could compromise testing for a causal relationship between the treatment administered and the result obtained. Their methodology which establishes the term ceteris paribus in the principle of good practice lends itself poorly to an analysis of individual behaviour. Observational studies are start from actual treatment situations to describe them as reliably as possible. By definition, however, these assume that the natural course of events is not deviated by any intervention. The absence of an experimental plan increases the likelihood of bias and makes it more difficult to test for causal relationships. They lend themselves poorly to testing for incremental efficacy. The two instruments to be preferred are decisional analysis and quasi-experimental studies. Decisional analysis help to avoid the problems of external validity associated with randomised clinical trials by associating parameters which are extracted from data obtained from everyday practice. Quasi-experimental studies or pragmatic trials are based on the reality of behaviour of the prescriber and his/her patients; their impact on efficacy, quality of life social costs of the disease and of treatments may be identified under normal conditions of use.

Biomedical Research↗

Management of ventricular arrhythmias.

Left ventricular dysfunction and complex VPCs are independent risk factors for subsequent cardiac death in patients with ischemic or nonischemic heart disease. The use of antiarrhythmic drugs during acute myocardial infarction is discussed. Patients with complex VPCs associated with heart disease should be treated with antiarrhythmic drugs. Drug efficacy should be evaluated by a 24-hour ambulatory ECG recording and by a treadmill exercise stress test. Blood drug levels should be measured at appropriate times. Maintenance doses of the various antiarrhythmic drugs are listed. Electrophysiologic testing with induction of ventricular tachycardia by extrastimulation may predict the clinical efficacy of the antiarrhythmic drug or combination of drugs needed for the long-term treatment of ventricular tachyarrhythmias. Electrophysiologic testing must be used for selecting antiarrhythmic drugs in patients who have experienced sustained ventricular tachycardia or ventricular fibrillation but who are free of VPCs during ambulatory ECG monitoring and exercise stress testing. If patients have life-threatening ventricular tachycardia or fibrillation resistant to antiarrhythmic drugs, surgical intervention is indicated. Complex VPCs in asymptomatic patients without heart disease should not be treated with antiarrhythmic drugs.

Anti-Arrhythmia Agents↗