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Interventions to improve adherence to lipid lowering medication.

BACKGROUND: Lipid lowering drugs are still widely underused, despite compelling evidence about their effectiveness in the treatment and prevention of cardiovascular disease. Poor patient adherence to medication regimen is a major factor in the lack of success in treating hyperlipidaemia. In this review we focus on interventions, which encourage patients at risk of heart disease or stroke to take lipid lowering medication regularly. OBJECTIVES: To assess the effect of interventions aiming at improved adherence to lipid lowering drugs, focusing on measures of adherence and clinical outcomes. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycInfo and CINAHL. Date of most recent search was in February 2003. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of adherence-enhancing interventions to lipid lowering medication in adults for both primary and secondary prevention of cardiovascular disease in an ambulatory setting. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data independently and assessed studies according to criteria outlined by the Cochrane Reviewers' Handbook. MAIN RESULTS: The eight studies found contained data on 5943 patients. Interventions could be stratified into four categories : 1. simplification of drug regimen, 2. patient information/education, 3. intensified patient care such as reminding and 4. complex behavioural interventions such as group sessions. Change in adherence ranged from -3% to 25% (decrease in adherence by 3% to increase in adherence by 25%). Three studies reported significantly improved adherence through simplification of drug regimen (category 1), improved patient information/education (category 2) and reminding (category 3). The fact that the successful interventions were evenly spread across the categories, does not suggest any advantage of one particular type of intervention. The methodological and analytical quality was generally low and results have to be considered with caution. Combining data was not appropriate due to the substantial heterogeneity between included randomised controlled trials (RCTs). REVIEWERS' CONCLUSIONS: At this stage, no specific intervention aimed at improving adherence to lipid lowering drugs can be recommended. The lack of a gold standard method of measuring adherence is one major barrier in adherence research. More reliable data might be achieved by newer methods of measurement, more consistency in adherence assessment and longer duration of follow-up. Increased patient-centredness with emphasis on the patient's perspective and shared-decision-making might lead to more conclusive answers when searching for tools to encourage patients to take lipid lowering medication.

Cardiovascular Diseases↗

Design of the BiRmingham Early Detection In untREated psyChosis Trial (REDIRECT): cluster randomised controlled trial of general practitioner education in detection of first episode psychosis [ISRCTN87898421].

BACKGROUND: Treatment delay in first episode psychosis is common. As general practitioners are the first point of contact for many individuals with first episode psychosis, they are well placed to detect the early symptoms and make urgent referrals to specialist secondary care services. However, early psychosis is often difficult to detect. The primary objective of the Redirect trial is to estimate whether an educational intervention targeted at general practitioners increases the general practitioner referral rate of young people with first episode psychosis to Early Intervention Services. METHODS/DESIGN: This paper describes the design of a stratified-cluster randomised controlled trial of an educational intervention on first episode psychosis in primary care. The primary outcome is the number of general practitioner referrals of young people with first episode psychosis to Early Intervention Services. Secondary outcomes are duration of untreated psychosis, time to recovery, use of the Mental Health Act, and general practitioner consultation rate. Young people with first episode psychosis referred to Early Intervention Services will be recruited over a two-year period from 1 March 2004. Seventy-eight out of 89 eligible general practices were recruited. The educational intervention has been implemented and evaluated by general practitioners. The education was well received and considered relevant to clinical practice by the general practitioners. DISCUSSION: The results suggest that the recruitment strategy and implementation of the educational intervention are feasible and acceptable in a primary care setting. The Redirect trial will provide robust information about the efficacy of an evidence-based complex educational intervention targeted at general practitioners on referral rates of young people with first episode psychosis to Early Intervention Services.

Adolescent↗

[Surgical alternatives in complex pancreatic injuries].

BACKGROUND: Objective of this study is to analyze the treatment outcomes of patients undergoing surgery for complex pancreatic injuries in our center over a 20-year period. METHODS: Between January 1980 and December 2001, medical records of 11 patients who underwent surgical intervention for complex pancreatic trauma were investigated retrospectively. RESULTS: The study group consisted of nine males and two female patients with a mean age of 36 years. Six patients had stab wounds, three had motor vehicle accidents and two had gunshot wounds. The mean value of Injury Severity Score (ISS) was 32. Among six patients with Grade III injury, five were managed by distal pancreatectomy and one by external drainage. In three patients with Grade IV injury each underwent distal pancreatectomy, subtotal pancreatectomy and pancreaticoduodenectomy. The remaining two patients with Grade V injury were managed by pancreaticoduodenectomy. In the postoperative course, pancreatic fistula was observed in two patients and peripancreatic abscess and pancreatitis in one patient each. Endocrine insufficiency occurred in one patient who underwent subtotal pancreatectomy. Operative mortality was 18.2%. CONCLUSION: Owing to the retroperitoneal location of the pancreas and its proximity to major vascular structures, associated organ injuries play a significant role in morbidity and mortality.

Adolescent↗

Combined endoscopic trephination and endoscopic frontal sinusotomy for management of complex frontal sinus pathology.

BACKGROUND: The advances in endoscopic sinus surgery have revolutionized the management of frontal sinus disease. Despite the successes, the purely endoscopic approach has its limitations, especially in patients with alterations in anatomy caused by previous surgical intervention or complex frontal sinus pneumatization patterns. The purpose of this study was to evaluate the efficacy of combined endoscopic trephination and endoscopic frontal sinusotomy (the above and below approach) in the management of these difficult cases. METHODS: Chart review was performed on patients undergoing the combined approach from October 1999 to June 2004. Demographic data, symptomatology, comorbidity, previous surgery, and primary pathology were determined. Outcome was assessed based on subjective symptom relief and objective endoscopic patency. RESULTS: Twenty-two patients with a mean age of 49.2 years underwent the combined approach. The primary pathology included mucoceles (15 patients), frontal sinusitis (2 patients), inverted papilloma (2 patients), osteoma (1 patient), fibrous dysplasia (1 patient), and pneumocephalus (1 patient). A total of 25 above and below procedures (22 primary and 3 revision procedures) were performed to manage the pathology. Postoperatively, headaches resolved in 47%, improved in 35%, and remained unchanged in 18% of the patients. Orbital symptoms resolved in 63%, improved in 25%, and remained unchanged in 12% of the patients. Endoscopic patency of the frontal sinusotomy was confirmed in 19 of 22 cases (86%) at a mean follow-up of 16.2 months. CONCLUSION: Management of complex frontal sinus pathology may require adjunct approaches in conjunction to the standard endoscopic techniques. In this series, the above and below approach was used successfully in 22 patients. The combined approach may serve as an important adjunct for management of complex frontal sinus disease.

Adult↗

Outpatient management of alcohol abuse.

Patients with alcohol problems come to their primary care physicians at different points along the spectrum of experiences with alcohol; therefore, physicians need to be able to respond with a variety of interventions. In addition, patients present in different stages of change, and physicians need to be aware of where the patient is in that continuum. Evidence shows that less intensive, outpatient treatment may be as beneficial as inpatient treatment for some patients and that primary care physicians can offer some of their patients relatively simple interventions that are effective. Medications such as disulfiram offer little in the treatment of alcoholism but may be of benefit in selected situations. Of greater benefit are more complex psychosocial interventions carried out by a team of health care professionals.

Alcohol Deterrents↗

The development of evidence-based nursing interventions: methodological considerations.

BACKGROUND: The call for evidence-based practice presents numerous challenges to nurses who are responsible for developing interventions and expanding the associated knowledge base. The challenge is compounded because there is limited literature concerning development of interventions and their evidence base. AIM: The purpose of this article is to present a model that has been successfully used to guide the process of developing and testing complex nursing interventions, especially those in which the experience of the client plays an important role. DISCUSSION: The model consists of four stages: problem definition, accumulation of building blocks for intervention design, intervention design and intervention validation. Each stage is described and examples from research studies are presented. Specific attention is given to the manner in which the model allows for the accumulation of empirical evidence and theory development during the development process. CONCLUSIONS: Use of the model could facilitate effective communication among nurses, researchers and educators when discussing the development and testing of nursing interventions.

Delivery of Health Care↗

The special injury pattern in terrorist bombings.

BACKGROUND: The destructive human consequences of terrorist bombing always challenge the medical system in diagnosis, decision making, and patient management. This injury is produced by multiple injury mechanisms, and departs from the conventional description of trauma complexity. Our objective was to characterize and compare terror-bombing victims with casualties of all other kinds of trauma, and to validate the existence of a different, more complex, injury pattern. STUDY DESIGN: A retrospective cohort study was conducted of patient records from October 2000 through June 2003 in the Israeli National Trauma Registry. All were categorized as victims of terrorist bombings or of nonterror-related trauma. Analysis included age, gender, Injury Severity Score, Glasgow Coma Scale, admission blood pressure, injury complexity, surgical interventions, intensive care and hospital lengths of stay, in-hospital mortality, and disposition. This analysis was extended to Injury Severity Score subgroups. RESULTS: Victims of terrorist bombings (n = 906) were compared with 55,033 casualties of nonterror-related trauma. Bombing resulted in significantly different injury complexity, increased severity, and with more body regions involved. Significantly enhanced use of intensive care, prolonged hospital stay, more surgical interventions, and increased hospital mortality are characteristic of these patients. CONCLUSIONS: Terrorist bombings inflict injury of a distinctly different pattern than other means of trauma. The simultaneous combination of different injury mechanisms in explosions results in a multidimensional injury pattern and a complicated clinical course. Hospital preparedness and medical team awareness to the unique nature of the injuries are mandatory for improving the outcomes of these patients.

Adolescent↗

Are the therapeutic effects of homeopathy attributed to the consultation, the homeopathic remedy, or both? A protocol for a future exploratory feasibility trial in patients with rheumatoid arthritis.

Systematic reviews suggest that homeopathy has a greater effect than placebo, however, the mechanisms of its action are unknown. The clinical effects of homeopathy could be attributed to the specific effects of the remedy and/or to the contextual effects of the consultation process; these factors have not been critically evaluated. We have developed a model that attempt to separate the consultation effects from the specific effects because of the remedy. We propose to investigate this design in a chronic condition, rheumatoid arthritis, for which previous research has evaluated both classical and complex homeopathic interventions. The following protocol describes the study design. The aims of this exploratory trial are to assess the feasibility of the study design, identify effect sizes of the consultation, the complex treatment, and the individualized remedy, as well as possibly efficacy, for the two types of homeopathic treatment and the homeopathic consultation. Data collection will take place in 2004.

Adolescent↗

Modeling pandemic preparedness scenarios: health economic implications of enhanced pandemic vaccine supply.

Influenza pandemic planning is a complex, multifactorial process, which involves public health authorities, regulatory authorities, academia and industry. It is further complicated by the unpredictability of the time of emergence and severity of the next pandemic and the effectiveness of influenza epidemic interventions. The complexity and uncertainties surrounding pandemic preparedness have so far kept the various stakeholders from joining forces and tackling the problem from its roots. We developed a mathematical model, which shows the tangible consequences of conceptual plans by linking possible pandemic scenarios to health economic outcomes of possible intervention strategies. This model helps to structure the discussion on pandemic preparedness and facilitates the translation of pandemic planning concepts to concrete plans. The case study for which the model has been used shows the current level of global pandemic preparedness in an assumed pandemic scenario, the health economic implications of enhanced pandemic vaccine supply and the importance of cell culture-based influenza vaccine manufacturing technologies as a tool for pandemic control.

Disease Outbreaks↗

Model driven therapy - the instance of computer assisted medical interventions.

OBJECTIVES: Taking into account a priori knowledge is a key issue to meet the medical, scientific and industrial challenges of the progresses of Minimally Invasive Surgery. We propose an overview of these challenges. METHODS: Models play a major role in representing the relevant knowledge to plan and realize complex medical and surgical interventions. We analyze the three basic steps of Perception, Decision and Action, and illustrate by some instances how models may be integrated in these steps. RESULTS: We propose a selection of the results obtained in Model Driven Therapy. These results illustrate the issues of Perception (models allow accurate reconstruction of 3D objects from a limited set of X-ray projections), Decision (models allow to take into account elastic and dynamic characteristics of muscles), and Action (models allow to design innovative navigational and robotics aids to the realization of complex interventions). Likewise, models play a major role in the process of surgeon's education, which leads to the concept of Virtual Orthopedic University. CONCLUSIONS: Model Driven Therapy emerges as the way to perform optimal medical and surgical interventions, providing physicians and surgeons with the possibility to augment their capacities of sensing multi-modal information, of combining them to define optimal strategies, and of performing accurate and safe actions.

Decision Support Systems, Clinical↗

Interventions to improve adherence to antiretroviral therapy.

Recent research has shown that very high levels of adherence are required to obtain the maximum benefit of highly active antiretroviral therapy (HAART). This situation justifies the importance of developing efficient strategies to improve adherence to drugs against HIV. A comprehensive range of factors are the targets of the most effective interventions to improve adherence, including cognitive, behavioral, emotional, and social aspects. The authors describe three theoretical models that can help identify barriers and guide interventions. Most of the interventions are complex and may include more convenient care, provision of information, counseling, reminders, reinforcement, self-monitoring, family therapy, or additional supervision or attention. The authors suggest aspects that should be included in interventions to promote adherence based on a review of the literature and clinical experience. Limited evidence suggests that interventions to enhance adherence to antiretroviral therapy in people with HIV are most likely to be successful when they are comprehensive, longitudinal, and tailored to the person.

Antiretroviral Therapy, Highly Active↗

The metabolic response to stress: a case of complex nutrition support management.

The ICU patient with burns, neurotrauma, sepsis, or major surgery typifies the classic hypermetabolic patient. These patients have increased energy and nutrient needs as a result of their injuries and require early nutrition support. Although these patients are likely to benefit from nutritional intervention, the complexity of the stress response to injury and subsequent changes in nutrient metabolism make the design and implementation of nutrition care challenging. This article reviews the pathophysiology of common hypermetabolic conditions and provides strategies to manage the complications associated with nutrition support.

Adult↗

The impact of intravascular ultrasound (IVUS) on endovascular interventions.

Intravascular ultrasound (IVUS) has undergone rapid evolution with the recent expansion of endovascular techniques and devices. This device can aid the surgeon, cardiologist, and interventional radiologist by increasing the accuracy of imaging and by adding important information to peripheral vascular and coronary interventions. Modern intravascular ultrasound provides a detailed view of the lumen, wall, and surrounding structures of blood vessels. Compared with other modalities, the diagnostic advantages of IVUS for examining arterial wall architecture and lesion morphology are evident. IVUS can determine lesion shape, length, and configuration, as well as identifying and examining the origins of branches and tributaries. Using this information, IVUS can guide the choice of appropriate angioplasty techniques, aid in the placement of endovascular devices, and assess and follow the efficacy of such interventions. IVUS helps reduce the use of radiation and contrast agents. Even though intravascular ultrasound requires additional equipment, personnel, and interpretative skills, it can be invaluable as a sensitive real-time imaging tool for complex endovascular interventions, therapeutic challenges, and diagnostic dilemmas.

Angioplasty, Balloon↗

Neonatal cardiac catheterization: A 10-year transition from diagnosis to therapy.

To assess the changing role of cardiac catheterization in the care of the neonate, a retrospective review of all catheterizations between January 1984 to December 1985 (group I) and January 1994 to December 1995 (group II) at C.S. Mott Children's Hospital was performed. Neonatal cardiac catheterization was performed more frequently (p = 0.02) in group I, comprising 14% (110 of 772) of all catheterizations versus 11% (93 of 880) in group II. Access was performed by cutdown in 15 patients (13 venous and 2 arterial), all in group I. In group I, 20 of 110 patients (18%) had balloon atrial septostomies; no other catheter interventions were performed. Interventions were more frequent (p = 0.003) and varied in group II, including 15 septostomies, 17 balloon valvuloplasties (13 pulmonary and 4 aortic), 2 coil embolizations of collaterals, and 1 cardiac biopsy. Despite the higher prevalence and complexity of interventions in group II, fluoroscopy times (median; range: 16 min; 2-55 vs 16 min; 1-107) were similar in both groups (p = not significant) as well as the prevalence of complications. Neonatal cardiac catheterizations are performed less frequently than they were a decade ago at our institution, and therapeutic interventions have become more common. Despite these changes, fluoroscopy time and the rate of complications have not increased.

Cardiac Catheterization↗

Interventional radiology in percutaneous management of bile duct obstruction: biliary drainage through a spontaneous common hepatic duct-duodenal fistula.

Bile duct injuries are a serious complication of biliary surgery. We report a case of benign obstruction of the common hepatic duct associated with common hepatic duct-duodenal spontaneous fistula following complex surgical intervention. We managed percutaneously the fistula with balloon dilatation and long-term stenting, as the fistula allowed biliary flow in the duodenum. We avoided reintervention preserving biliary flow, with good clinical results after a follow-up of a 3 years. We emphasize the role of a clinically focused approach to percutaneous management of complications following biliary surgery.

Bile Duct Diseases↗

Evidence-based public health: moving beyond randomized trials.

Randomized controlled trials (RCTs) are essential for evaluating the efficacy of clinical interventions, where the causal chain between the agent and the outcome is relatively short and simple and where results may be safely extrapolated to other settings. However, causal chains in public health interventions are complex, making RCT results subject to effect modification in different populations. Both the internal and external validity of RCT findings can be greatly enhanced by observational studies using adequacy or plausibility designs. For evaluating large-scale interventions, studies with plausibility designs are often the only feasible option and may provide valid evidence of impact. There is an urgent need to develop evaluation standards and protocols for use in circumstances where RCTs are not appropriate.

Causality↗

Successful emergency percutaneous cardiopulmonary support during coronary intervention in an 80-year old patient.

In an 80-year old patient with acute coronary syndrome emergency institution of stand-by percutaneous cardiopulmonary support (PCPS; Bio-Medicus; Medtronic Inc, Minneapolis MN) for hemodynamic collapse in the cardiac catheterization laboratory resulted in successful hemodynamic stabilization and enabled safe performance of a complex coronary intervention. Weaning from PCPS was effectuated after 4 hours total extracorporal circulation time. Despite development of a systemic inflammatory response syndrome and prolonged weaning from mechanical ventilation the patient could be discharged from the intensive care unit after 14 days and eventually from hospital another 28 days later with favorable outcome. Although an increased complication rate with prolonged rehabilitation has to be taken into account percutaneous cardiopulmonary support may constitute a live-saving option even in selected elderly patients.

Aged↗

Resectoscopic surgery in women with abnormal uterine bleeding and nonatypical endometrial hyperplasia.

STUDY OBJECTIVE: To evaluate the role of resectoscopic surgery in the diagnosis and treatment of women with abnormal uterine bleeding and endometrial hyperplasia without atypia. DESIGN: Retrospective analysis (Canadian Task Force classification II-2). SETTING: University-affiliated teaching hospital. PATIENTS: Twenty-five women with simple and seven with complex hyperplasia. INTERVENTION: Hysteroscopic endometrial ablation. MEASUREMENTS AND MAIN RESULTS: In patients with simple hyperplasia, average age, parity, body mass index, and mean arterial pressure were 53.2 years, 2.4 pregnancies, 30 kg/m2, and 99.5 mm Hg, respectively; in those with complex hyperplasia corresponding figures were 48 years, 2 pregnancies, 36 kg/m2, and 100 mm Hg. Nineteen of 32 women had postmenopausal bleeding, 9 of whom were taking combined hormone replacement therapy. Two had subsequent hysterectomies, one for pain and the other for incomplete resection due to an enlarged uterus. Resection could not be completed in one morbidly obese woman. One patient died from heart disease. During the follow-up of 1 to 8 years (mean 4 yrs) all patients remained amenorrheic with no evidence of recurrent disease or progression to cancer. CONCLUSION: Resectoscopic surgery by experienced hysteroscopists may be effective therapy for endometrial hyperplasia without atypia, especially in women at high risk for medical therapy or hysterectomy. Patient surveillance is mandatory for early detection and management of recurrent disease and progression to cancer.

Adult↗