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The case of cardiovascular disease: evaluating complex health programs targeted at prevention, remediation, and rehabilitation.

This report analyzes the complexities of evaluating prevention, remediation, and rehabilitation treatments for cardiovascular disease. A comparison of treatments revealed that distinct differences exist in terms of motivation of subjects to participate and steps required for a maximum treatment effect. Large-scale prevention programs are generally the most complex of all interventions to complete. If complex health programs are initially subdivided into their detailed planning and implementation steps, proper assessments of each step will lead to a much less difficult comprehensive evaluation.

Cardiovascular Diseases↗

AIDS and social work treatment: a single-system analysis.

This article reports on an exploratory study that examined the efficacy of a social work intervention for people with acquired immune deficiency syndrome (AIDS) and AIDS-related complex. The intervention was based on Heimler's Human Social Functioning theory and method. A single-system design was used to analyze change due to intervention, and two instruments were used to collect data across the phases. The study was replicated with seven subjects; four completed the study, two died, and one withdrew because of physical deterioration. Results indicated that a statistically significant change occurred as a result of intervention for the subjects who completed the study. The intervention facilitated subjects' self-awareness, which led to self-help and a sense of control over their own lives.

AIDS-Related Complex↗

Home caregivers of the person with advanced cancer: an Australian perspective.

Australian palliative care services are predominantly community based, with an emphasis on enabling the person to live at home for as long as possible. Home care of the person with advanced cancer receiving palliative care in the community depends largely on the availability of a family caregiver. Family caregivers are required to assess, monitor, and deliver complex therapeutic interventions such as pain and symptom control, including the administration and adjustment of complex medication regimens. This article reports a study of 42 family caregivers providing home care to persons with advanced cancer. This study sought to describe a number of caregiver variables that may influence reactions to caring roles and caregiver well-being. The study found that family caregivers are significantly involved in symptom management, and that they take on almost total responsibility for routine household tasks. In addition, the caregiver role has a negative impact on caregiver health, schedule, anxiety, and energy. However, caregivers find significant meaning in their role and feel relatively well prepared for caregiving. The results of this study support the applicability of the vast international literature on caregiver issues for the Australian setting and suggest the need to move toward development of caregiver-focused nursing interventions.

Aged↗

Improving the performance of the health service delivery system? Lessons from the Towards Unity for Health projects.

CONTEXT: The World Health Organization developed the Towards Unity for Health (TUFH) strategy in 2000 for the improvement of health system performance. Twelve projects worldwide were supported to put this strategy into practice. A standard evaluation and monitoring framework was developed on the basis of which project coordinators prepared technical progress reports. OBJECTIVES: To review the utility and effectiveness of the evaluation criteria recommended by TUFH and their application in four of the original twelve projects. METHODS: We reviewed status reports provided by European project coordinators and developed a standardized reporting template to extract information using original TUFH evaluation criteria. RESULTS: The original TUFH evaluation framework is very comprehensive and has only partly been followed by the field projects. The evaluation strategies employed by the projects were insufficient to demonstrate the connections between the intervention and the desired process improvements, and few of the evaluation measures address outcomes. DISCUSSION: The evaluation strategies employed by the projects are limited in allowing us to associate the intervention with the desired process improvements. Few measures address outcomes. The evaluation of complex community interventions poses many challenges, however, tools are available to assess impact on structures and process, and selected outcome indicators may be identified to monitor progress in future projects. CONCLUSION: Based on the review of evaluation status of the TUFH projects and resources available we recommend moving away from uniform evaluation and towards monitoring minimal, context-specific performance indicators criteria.

Delivery of Health Care↗

Pediatric interventional radiology.

In the last several years, we have witnessed a steady growth in both the number and the complexity of interventional procedures in the pediatric population. This article presents our approach to interventional techniques in children of different ages, specifying our methods of sedation, patient monitoring, and selection or modification of equipment. We present our experience with nonvascular and vascular intervention. In the nonvascular group, we have focused on genitourinary and gastrointestinal procedures, outlining the techniques we have found to be safe and effective. Percutaneous aspiration, drainage, and biopsy can be successfully accomplished in the majority of cases, even in the smallest child. Over this same period, the indications for vascular intervention have dramatically increased. Embolization has become an important asset for treatment of vascular malformations, management of hemorrhage, and medical renal ablation. In our institution, embolization is now the preferred method in many cases previously considered only amenable to surgery. Percutaneous transluminal angioplasty and the use of fibrinolytic therapy are considered effective in all age groups, but continue to have limited indications in the pediatric population. It is our hope that this experience will stimulate others to continue development of pediatric interventional techniques, thereby making them more widely available to children of all ages.

Diagnostic Imaging↗

Biologic interventions in rheumatoid arthritis.

An increasing understanding of the immunopathogenesis of rheumatoid arthritis and advances in biotechnology have lead to the therapeutic application of immune-specific interventions. The complexity of this disorder has generated numerous investigations using a wide range of biologic interventions. This article presents the current and potential targets for such biopharmaceutical agents and discusses their utility in rheumatoid arthritis.

Adjuvants, Immunologic↗

Sex bodies and synaptonemal complexes of Balb/C mice: antioxidant intervention of oxyradical insult.

Spermatogenesis is inhibited in Balb/C mice as a result of oxyradical insult. However, mammalian spermatocytes and synaptonemal complexes retain their structure and function after oxyradical insult due to protection afforded by the antioxidant vitamin E. Control groups were compared with experimental groups which were fed various vitamin E-deficient diets and subjected to varying times in an humidified 100% oxygen (hyperoxia) chamber. Measurements were made of sex body volume (SBV), nuclear envelope aberrations (NEA), and synaptonemal complex structure in spermatocytes during pachytene of meiosis prophase I. Changes in the volume of the sex body were positively correlated with increased oxyradical insult. The structure of the synaptonemal complex was not altered in any of the experimental groups which is a significant observation. It is suggested that vitamin E affords antioxidant protection and inhibits the alteration of membranes and sex chromosomes in mice during meiosis.

Animals↗

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

CONTEXT: Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. MAIN ARGUMENT: This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. LITERARY METHOD: Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. CONCLUSION: Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Benchmarking↗

[Viability of a proposal of change for the continuous improvement of a complex organization: the nursing department].

The nursing department is a complex organization, or a social system, made up of two or more groups interconnected through a complex net of social relations, common values and goals, used as the context for nursing interventions. The complex organization embodies type, subsystems, limitations, philosophy, life styles and process of adaptation to the environment, integration of subsystems, decision making, information processing, communications, coalition-formation and commitment. Theoretical interchange proposal to achieve full quality parameters is based on the seven stages of Lippit's exchange theory.

Decision Making, Organizational↗

[Operation of multidisciplinary, interventional 0.5 Tesla magnetic resonance tomograph. Technical and logistic problems and initial clinical results].

Multidisciplinary usage of a MRI system with a superconducting 0.5-T magnet (Signa SP, General Electric) with a vertical gap suited for diagnostic and therapeutic interventions raises complex problems. The MR equipment, including a special localizing system and the instruments for diagnostic and therapeutic interventions, is described. Before putting the system into operation tests were necessary to check MR compatibility of various materials and instruments and to build some auxiliary equipment. We report on the coordinating activities of the radiologist in the context of MR use by different medical specialities. Within the course of 12 months, 428 examinations/interventions of different kinds were carried out, among them 75 functional examinations of the spine or of joints, 31 diagnostic biopsies, 23 cerebral biopsies, and 23 operations. The special design of the Signa SP allows the whole scale of functional examinations, up to complete neurosurgical interventions, in the sitting position and under nearly real-time imaging control.

Equipment Design↗

Adherence to pharmacological interventions. Current trends and future directions. The Pharmacological Intervention Working Group.

The complexity of adherence to pharmacological interventions is frequently underestimated. Consequently, little research has been done to understand, improve, or evaluate the effects of adherence to drug protocols. While efforts to better measure and increase adherence require dedicated resources, improved adherence in existing clinical research can potentially cut costs in trial size and length. This paper outlines strategies to facilitate research on adherence to pharmacological interventions including: reporting of adherence data, changing how we conceptualize adherence to pharmaceuticals, understanding issues unique to older adults' pill-taking behavior, and creating standardized methodologies to measure adherence. Further, we describe some promising research areas that may lead to effective interventions: adherence "typologies" and modality matching. Control Clin Trials 2000;21:218S-225S

Aged↗

[Prevention and patient's compliance. Two key factors to deal with non communicable chronic diseases].

Over 50% of adults in Chile have a high cardiovascular risk. Thus, non communicable chronic diseases may surpass the capacity of the health systems. Therefore the prevention and treatment of their risk factors is urgent. Unfortunately, the low patient's compliance with prescribed treatment, reduces their efficacy. The best interventions to improve compliance with chronic treatment programs are: to simplify daily doses of medications and to do complex behavioral interventions. Risk factor prevention is a highly recommended action that has obtained promising results in Chile with the program "Mírame". To modify health behavior is also necessary to give people more power in their own care and to increase behavioral and social science contents into medical curricula.

Adult↗

[Ambulatory therapy in varicose veins].

The treatment of varicose veins comprises conservative and active options. Every patient with varices has to be informed on the conservative modalities and should apply them in daily life. Compression therapy, as the most important part of the conservative treatment, should be considered individually for any patient according to the varicose-type, the grade of chronic venous insufficiency and the compliance of the patient. Active treatment modalities are clearly indicated in varices with complications such as trophic skin changes, varicophlebitis or when varices cause pain. But the cosmetic problem should not be underestimated. Morphologic and hemodynamic information obtained by noninvasive duplex technique allows the individualization of the surgical strategy for each patient. Besides surgical techniques used being less and less traumatic (invagination stripping, stab evulsion phlebectomy), more and more interventions are realized under ambulatory conditions in local anesthesia, even crossectomy with partial stripping of truncal varices. More important and complex operations, interventions involving more than one saphenous vein or reinterventions in recurrent varices are still performed under hospital conditions. They require only a short hospitalization time (2 to 4 days). Considering this very favourable evolution in surgery with a net trend to ambulatory, thus more economic treatment, the indications for sclerotherapy--a traditionally ambulatory modality with high recurrence-rate--are limited to reticular varices and telangiectasies.

Ambulatory Care↗

Alloantigen gene therapy for squamous cell carcinoma of the head and neck: results of a phase-1 trial.

OBJECTIVE: To determine the safety and efficacy of an immunogenic gene therapy using a drug designed to produce expression of a foreign class I major histocompatibility complex protein in patients with head and neck cancer. DESIGN: Phase 1 prospective clinical trial. SETTING: Academic medical setting. PATIENTS: Nine patients with advanced head and neck squamous cell carcinoma who had failed conventional therapy and did not express HLA-B7, a class I major histocompatibility complex protein. INTERVENTION: Patients were treated with Allovectin-7 (Vical Inc, San Diego, Calif) by direct intratumoral injection. Allovectin-7 contains a plasmid complementary DNA complexed with a cationic lipid, which results in expression of HLA-B7. MAIN OUTCOME MEASURES: Patients were assessed for any toxic effects and for any change in tumor volume. Biopsy specimens obtained before and after therapy were evaluated by immunohistochemistry to detect HLA-B7 expression and with the terminal deoxynucleotide transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL) assay to detect any induction of apoptosis. RESULTS: There were no toxic effects of the gene therapy. In 4 of these 9 patients there was a partial response to treatment, evidenced by a gradual reduction in tumor size. One patient has remained alive for more than 17 months since commencing treatment, with no clinical evidence of disease but with persistent histological evidence of cancer. Analysis of the biopsy specimens from 2 of the patients who responded to therapy demonstrated HLA-B7 expression. The TUNEL assay demonstrated extensive apoptosis in both of these patients, suggesting that this may be the mechanism of tumor reduction. CONCLUSIONS: These data demonstrate the potential efficacy and lack of toxicity of this form of alloantigen gene therapy. A multi-institutional study has been initiated to expand on these findings.

Adult↗

Cardiac surgery in patients aged at least 80 years.

Cardiac surgery in patients aged 80 years and over has become more acceptable with improvements in health care services and the steady increase in the number of octogenarians in the population. These demographic changes are reflected in an increasing number of octogenarians with advanced symptomatic disease undergoing complex cardiac intervention. We reviewed data from 62 articles on cardiac surgery in octogenarians. The medical and ethical issues involved in making the decision are complex. Long-term results of cardiac surgery in octogenarians show that these patients can withstand heart surgery with improved functional benefit and quality of life. Surgery is beneficial especially for patients undergoing coronary artery revascularization or isolated aortic valve surgery. The operative course in octogenarians is more complicated, which is reflected in longer postoperative hospitalization. In refutation of the assumption that mortality in octogenarians is related to multisystem failure, most deaths are cardiac in nature. Highly selective criteria (identifying risks and benefits individually) should be applied to octogenarians undergoing cardiac surgery to achieve a satisfactory result.

Age Factors↗

Skin sparing in interventional radiology: the effect of copper filtration.

Complex and lengthy interventional radiological techniques have resulted in a number of patients developing skin reactions in recent years. To safeguard against these side effects, we have investigated the degree to which entrance skin dose can be reduced by inserting 0.18 mm and 0.35 mm copper filtration in the incident beam. The potential reduction was measured on a 22 cm water phantom for each of eight models of a fluoroscopy unit. Using the catheter laboratory fluoroscopy unit on which radiofrequency ablations are routinely performed, we assessed the relative effectiveness of adding filtration and increasing the kV:mA ratio. Image quality was subjectively assessed for diagnostic and therapeutic acceptability in two groups of 10 patients undergoing radiofrequency ablations, pacemaker insertions or electrophysiology studies. One of the groups was screened with 0.35 mm copper filtration in place and the other group acted as the control. Maximum patient skin dose proved difficult to measure directly because of the unpredictable dose pattern. This pattern was studied in four patients using a film method in conjunction with thermoluminescent dosemeters. Copper filtration 0.35 mm thick inserted in the beams of the eight fluoroscopy units produced a mean reduction in entrance dose to the phantom of 58% with a mean increase in tube loading of 29%. At 100 kV the increased loading on the X-ray tube was equivalent to increasing the anteroposterior separation of the patient by 2 cm. Measurements on the catheter laboratory unit showed that the tube voltage would need to be raised above the normal diagnostic range to obtain an equivalent entrance dose reduction without the filter. The blackening of films under the patients showed complex patterns, but the estimated skin doses were consistent with those predicted by the phantom experiments. All six cardiologists considered there to be insignificant detriment to image quality in the procedures investigated.

Copper↗

Pharmacological intervention at ionotropic glutamate receptor complexes.

L-glutamate is considered the main excitatory neurotransmitter in the mammalian brain. Paradoxically, L-glutamate is also the most important excitotoxin pivotally involved in the aetiology of several neurodegenerative diseases such as stroke, Alzheimer, Parkinson, amyotropic lateral sclerosis, Huntington and neuropathic pain. L-glutamate signalling is transduced both presynaptically and postsynaptically by metabotropic and ionotropic receptors. Three types of glutamate-gated channels integrate the synaptic signal, namely AMPA, kainate and NMDA receptors. Sustained activation of these receptors, and especially of the NMDA receptor, is a casuistic phenomenon that leads to the neuronal death underlying neurodegeneration. Thus, pharmacological intervention at these neuronal receptors and their synaptic protein complexes is a valuable therapeutic strategy. The approval of memantine, a safe, well-tolerated uncompetitive NMDA antagonist for the treatment of moderate to severe Alzheimer dementia validates ionotropic glutamate receptors as key therapeutic targets of neurodegenerative diseases in humans. As a consequence, an enormous effort is being carried out to identify and develop safe and potent antagonists for the clinics. In this review, we will describe progress in this important arena of human health.

Excitatory Amino Acid Antagonists↗

Termination of nutrition and hydration in a child with vegetative state.

A child in a vegetative state may present difficult decisions for physicians and families regarding the course of treatment. We report a case of a child who entered a prolonged vegetative state following status epilepticus. The child's parents requested termination of artificial means of nutrition and hydration. That request culminated in a complex legal intervention by multiple state agencies and attracted local media attention. This article presents the details of the case and discusses the medical and legal complexities encountered. The diagnosis and prognosis of the persistent vegetative state in children have recently been defined. Decision making in these circumstances should be based on adequate, careful clinical evaluation of the medical facts. Hospital ethics committees can provide an independent forum in which the diverse viewpoints in a case may be examined. Decision making should optimally be accomplished between families and caretakers.

Brain Diseases↗