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The Study on COgnition and Prognosis in the Elderly (SCOPE)--recent analyses.

Principal results of the Study on COgnition and Prognosis in the Elderly (SCOPE) were published in 2003. Blood pressure reduction was pronounced in both the candesartan and control groups, with little difference. With candesartan-based treatment, compared with control, the relative risk of non-fatal stroke was 0.72 (P = 0.04) and of major cardiovascular events 0.89 (P = 0.19). There were no significant differences in cognitive outcomes. We have reviewed recent subgroup analyses in SCOPE. Cardiovascular endpoints were analysed in patients who did not receive add-on treatment after random allocation to groups (post hoc) and in patients with certain characteristics at baseline, such as age, sex, diabetes, isolated systolic hypertension, or a history of stroke. Cognitive endpoints were analysed in patients with baseline Mini Mental State Examination (MMSE) score 24-28, and in those examined with more extensive investigations than the MMSE. In patients without add-on treatment, there were significant risk reductions in the candesartan group in major cardiovascular events [relative risk (RR) 0.68, 95% confidence interval (CI) 0.51 to 0.92] and mortality (RR 0.73, 95% CI 0.57 to 0.95). In other subgroups, the relative risks for major cardiovascular events and stroke were generally consistent with those in the entire study population. However, risk reductions in the candesartan group were particularly marked in patients with a history of stroke. In patients with MMSE score 24-28 at baseline, the score declined significantly less in the candesartan group (between-group difference 0.49, 95% CI 0.02 to 0.97). Cardiovascular outcome benefit of candesartan-based treatment was most evident in patients without add-on treatment and in those with a history of stroke. Results in other subgroups were generally consistent with those in the entire SCOPE study population. In patients with slightly low cognitive function at baseline, the MMSE score declined less in the candesartan group.

Aged↗

Nuclear medicine in the pediatric chest.

Nuclear medicine enables functional evaluation of organ systems not possible with standard anatomic imaging modalities. The pathophysiology necessitating scintigraphic examination of the pediatric patient is often different from that in the adult and therefore calls for new or modified applications of nuclear medicine. This article briefly reviews such application, with the scope limited to the evaluation of the pediatric chest and organ systems.

Bone and Bones↗

Is complementary and alternative medicine (CAM) cost-effective? A systematic review.

BACKGROUND: Out-of-pocket expenditures of over 34 billion dollars per year in the US are an apparent testament to a widely held belief that complementary and alternative medicine (CAM) therapies have benefits that outweigh their costs. However, regardless of public opinion, there is often little more than anecdotal evidence on the health and economic implications of CAM therapies. The objectives of this study are to present an overview of economic evaluation and to expand upon a previous review to examine the current scope and quality of CAM economic evaluations. METHODS: The data sources used were Medline, AMED, Alt-HealthWatch, and the Complementary and Alternative Medicine Citation Index; January 1999 to October 2004. Papers that reported original data on specific CAM therapies from any form of standard economic analysis were included. Full economic evaluations were subjected to two types of quality review. The first was a 35-item checklist for reporting quality, and the second was a set of four criteria for study quality (randomization, prospective collection of economic data, comparison to usual care, and no blinding). RESULTS: A total of 56 economic evaluations (39 full evaluations) of CAM were found covering a range of therapies applied to a variety of conditions. The reporting quality of the full evaluations was poor for certain items, but was comparable to the quality found by systematic reviews of economic evaluations in conventional medicine. Regarding study quality, 14 (36%) studies were found to meet all four criteria. These exemplary studies indicate CAM therapies that may be considered cost-effective compared to usual care for various conditions: acupuncture for migraine, manual therapy for neck pain, spa therapy for Parkinson's, self-administered stress management for cancer patients undergoing chemotherapy, pre- and post-operative oral nutritional supplementation for lower gastrointestinal tract surgery, biofeedback for patients with "functional" disorders (eg, irritable bowel syndrome), and guided imagery, relaxation therapy, and potassium-rich diet for cardiac patients. CONCLUSION: Whereas the number and quality of economic evaluations of CAM have increased in recent years and more CAM therapies have been shown to be of good value, the majority of CAM therapies still remain to be evaluated.

Complementary Therapies↗

Nurse-led acute care post-operative interventions in adult cardiac surgery: a systematic review.

AIMS: The primary aim of this systematic review was to identify nurse-led clinical interventions evaluated in randomized controlled trials (RCTs) for adults who had undergone cardiac surgery. The secondary aim was to assess the effectiveness of these interventions on post-operative clinical and patient-reported outcomes during the acute inpatient phase. METHODS AND RESULTS: A systematic review was undertaken according to an a priori protocol using Joanna Briggs Institute (JBI) methodology and PRISMA guideline for reporting. Eligible studies were RCTs of adult (≥18 years) cardiac surgery, nurse-led inpatient interventions implemented immediately post-surgery and prior to discharge. Six databases were searched from inception to June 2025. Of 2690 records, 19 RCTs were eligible, representing 13 countries, and 3142 participants. Risk of bias varied, with only two low-risk trials. Interventions were grouped into seven domains: behavioural support; temperature management and comfort strategies; pain and symptom management; wound care; infection prevention; respiratory and pulmonary function; and post-operative recovery, mobilization, and hydration. Across these domains, nurse-led interventions were generally feasible, safe, and positively affected patient comfort, physiological stability, symptom relief, and aspects of functional recovery. CONCLUSION: Nurse-led inpatient interventions contribute meaningfully to inpatient post-operative recovery in cardiac surgery, although the broader cardiac surgical nursing scope is underrepresented in RCTs. This review provides a foundation for developing further high-quality research, peer-reviewed interdisciplinary practice guidelines, and strengthening the scope and recognition of cardiac surgical nursing as a distinct specialty. REGISTRATION: PROSPERO-CRD420251063851.

Humans↗

United States Food and Drug Administration approach to risk evaluation and risk management for foods.

The Food and Drug Administration (FDA) is developing a comprehensive program on risk evaluation and risk management related to foods and food ingredients. Various groups view the FDA differently in terms of potential food hazards, but the regulatory agency is required to follow the laws that reflect a set of social judgments about permissible risks and benefits. The traditional agency approaches to risk management are reviewed and recent plans to consider structural changes in the basic food statute that could lead to greater administrative flexibility are presented. The proposed tentative suggestions discussed embody basic principles that the public health and trust remain the focus of food safety laws. Public confidence in the present system must be retained, it must be a credible system, embody valid scientific data, and the regulatory actions must be taken by FDA scientists who are recognized for their scientific competence. All the proposed actions need to be taken without placing unnecessary economic burdens on industry. The scope of this program is reviewed.

Food Additives↗

Issues surrounding tight glycemic control in people with type 2 diabetes mellitus.

OBJECTIVE: To review the prospective evidence surrounding the issue of tight glycemic control in people with type 2 diabetes mellitus and resultant long-term complications. DATA SOURCE: Conference proceedings and a MEDLINE search (1966-February 1998) identified pertinent English-language publications on type 2 diabetes in humans. Key search terms included insulin resistance, diabetes mellitus, non-insulin-dependent, macrovascular complications, microvascular complications, and intensive glycemic control. STUDY SELECTION: Selection of prospective epidemiologic and clinical studies were limited to those focusing on the management of type 2 diabetes. All articles with pertinent information relevant to the scope of this article were reviewed. DATA SYNTHESIS: The pathophysiology of type 1 and type 2 diabetes differ; however, both share chronic complications that significantly affect morbidity and mortality. People with type 1 diabetes have an absolute deficiency of insulin, whereas people with type 2 diabetes have varying degrees of insulin resistance and an inadequate compensatory insulin secretory response. The Diabetes Control and Complications Trial (DCCT) has clearly indicated that intense control of blood glucose in type 1 diabetes prevents and slows the progression of microvascular (i.e., retinopathy, nephropathy) and neuropathic complications. The Kumamoto study showed similar results in nonobese patients with type 2 diabetes. Intense insulin therapy in both populations has proven advantageous, thus supporting a common pathophysiologic process for the microvascular and neuropathic complications. Trends were seen toward fewer macrovascular (atherosclerotic disease) complications in the intensive insulin arm of the DCCT. Conversely, trends were seen toward an increase in macrovascular complications in the VA Cooperative study in people with type 2 diabetes using intensive insulin therapy. This may suggest a discordance in the pathophysiology of macrovascular disease between type 1 and type 2 diabetes. Additionally, it remains uncertain whether tight glycemic control prevents the onset or slows the progression of macrovascular disease. Two studies (the University Group Diabetes Program and the Veterans Affairs Cooperative Study on Glycemic Control and Complications in Type 2 Diabetes) to date have examined pharmacotherapy options for patients with type 2 diabetes and resultant macrovascular complications. It has yet to be determined whether any therapeutic intervention will decrease the morbidity and mortality of macrovascular disease in this population. CONCLUSIONS: In type 2 diabetes, limited prospective evidence does support tight glycemic control to help prevent or slow the progression of microvascular and neuropathic complications. It is uncertain whether tight glycemic control decreases macrovascular complications and which pharmacotherapeutic agent(s) is/are the best options. However, therapy that improves glucose control in combination with aggressive risk factor management should be initiated and enforced in patients with type 2 diabetes in an effort to reduce long-term complications.

Blood Glucose↗

Warfarin and its interactions with foods, herbs and other dietary supplements.

Despite its complex pharmacokinetic and pharmacodynamic profile, warfarin is still one of the most widely used oral anticoagulant agents. Attaining optimal anticoagulation with this agent is clinically challenging in view of its many food and drug interactions. Inappropriate anticoagulation control can expose patients to an increased risk of bleeding or thromboembolic complications, due to over and underanticoagulation, respectively. Fluctuations in dietary vitamin K intake can have a significant effect on the degree of anticoagulation in patients treated with warfarin. In addition, the explosion in use of various dietary supplements and herbal products can lead to undesired outcomes on anticoagulant levels. The aim of this review is to discuss the scope and the potential clinical impact of the most commonly reported food, dietary supplement and herbal interactions with warfarin therapy. Practical steps for patients and providers to minimise these interactions are highlighted.

Administration, Oral↗

Identification of differential gene expression by high throughput analysis.

High throughput analysis of differential gene expression is a powerful tool that can be applied to many areas in molecular cell biology, including differentiation, development, physiology, and pharmacology. In recent years, a variety of techniques have been developed to analyze differential gene expression, including comparative expressed sequence tag sequencing, differential display, representational difference analysis, cDNA or oligonucleotide arrays, and serial analysis of gene expression. This review explains the technologies, their scopes, impact on science, as well as their costs and possible limitations. The application of differential display is presented as a tool to identify genes induced by darkness or yellowing process in rice leaves.

Expressed Sequence Tags↗

Toward protecting the safety of participants in clinical trials.

It is a widely held belief that the current system of oversight of clinical research, particularly the means of assessing risks and minimizing harms to participants in clinical trials, could be improved. In particular, the system is inefficient with overemphasis on the monitoring ability of some groups such as research ethics review boards and investigators, underemphasis on others such as data monitoring committees (DMCs) and sponsors, confusion about responsibilities for safety and imperfect communication between these different groups. Research ethics review boards are not able to perform safety monitoring by review of individual adverse events and are often burdened by duplicative reviews of large multicenter studies. There are no standards for DMCs to ensure they can reliably identify safety issues. Sponsors may be overreliant on data audits and slow to disseminate safety data in a coherent summary. Investigators, their staffs and clinical sites may not fully appreciate all the nuances of good clinical practice or may be inattentive to the daily conduct of studies. Regulators, particularly those in the United States, have failed to completely harmonize their policies with each other or with international regulatory agencies. We recommend well-designed monitoring plans for all studies that are appropriate to their scope and risk, more centralized review of large multisite studies and closer local scrutiny of single-institution studies. In addition, sponsors should pay greater attention to monitoring adverse events and keeping up-to-date databases or investigator's brochures emphasizing safety issues. A minimal standard of education or expertise in good clinical practice should be established for investigators, their staffs and research ethics review board members. DMC composition and functions should be standardized and regulations should be harmonized nationally and internationally. Finally, there should be a concerted effort to study the efficacy of various components of the system.

Clinical Trials Data Monitoring Committees↗

Suicide and the media.

Evidence continues to amass on the significant impact of media coverage on suicide. The research literature on the impact of news reports of nonfictional suicides as well as fictional suicide stories is reviewed in order to determine the nature and scope of the influence of the mass media on suicide. The current review, building upon earlier reviews, is limited to English language publications or English translations of articles and/or abstracts. The interactive factors that may moderate the impact of media stories are also reviewed. Such interactive factors include characteristics of the stories (agent), individuals' attributes (host), and social context of the stories (environment). Recommendations are presented for the reporting of suicide stories, which may minimize the risk of imitative suicides. The media's positive role in educating the public about risks for suicide and shaping attitudes about suicide is emphasized. In summary, the existence of suicide contagion no longer needs to be questioned. We should refocus our research efforts on identifying which particular story components promote contagion under which circumstances and which components are useful for preventive programming.

Humans↗

Assessing the need to update prevention guidelines: a comparison of two methods.

BACKGROUND: An important concern for developers of clinical practice guidelines is how best to determine when guidelines require updating to ensure they remain current and evidence based. Because of the high costs associated with updating guidelines, recent attention has focused on approaches that can reliably assess the extent of updating required. Recently, Shekelle and colleagues proposed a model of limited literature searches with modest expert involvement as a way to reduce the cost and time requirements for assessing whether a guideline needs updating. METHODS: The main objective of this study was to compare the Shekelle et al. assessment model (review approach) and a conventional process using typical systematic review methods (traditional approach) in terms of comprehensiveness and effort. We modeled the review approach on that by Shekelle and colleagues but refined it iteratively over three phases to achieve greater efficiency. Using both methods independently, we assessed the need to update six topics from the 1996 Guide to Clinical Preventive Services from the US Preventive Services Task Force. Main outcomes included completeness of study identification, importance of missed studies and the effort involved. RESULTS: Although the review approach identified fewer eligible studies than the traditional approach, none of the studies missed was rated as important by task force members acting as liaisons to the project with respect to whether the topic required an update. On average, the review approach produced substantially fewer citations to review than the traditional approach. The effort involved and potential time saving depended largely on the scope of the topic. CONCLUSIONS: The revised review approach provides an efficient and acceptable method for judging whether a guideline requires updating.

Bacteriuria↗

How far should we lower blood pressure in the elderly.

In the last few years several large intervention trials have addressed the treatment of hypertension in the elderly and how far blood pressure should be lowered in such patients. The positive results of intervention against high blood pressure in the elderly has resulted in a positive attitude towards treatment and today this is an accepted and highly effective medical intervention. Both stroke and coronary morbidity have been shown to be positively affected as has total mortality. The specific issue, how far to lower blood pressure in the elderly was probably best addressed in the Hypertension Optimal Treatment (HOT) stduy in which about a third of the patients, i.e. >6,000 patients, were > or =65 years of age. In most of the early intervention studies of antihypertensive treatment in elderly patients diuretics or beta-blockers or the two in combination were used as the therapy by which blood pressure was lowered. However, novel therapies, in particular calcium antagonists, have shown benefits of the same magnitude as the older therapies, e.g. in the STONE trial, the Syst-Eur study, the Syst-China study and the STOP-Hypertension-2 study. In the latter study a regimen based on either of two ACE inhibitors was also shown to be equally effective as conventional treatment, based on diuretics and/or betablockers, in the elderly. These trials will be briefly reviewed here as will the SCOPE study which is an ogoing trial in which hypertensive patients aged 70-89 years are being treated with an angiotensin II receptor antagonist under double-blind and placebo-controlled conditions. It can be concluded that a wealth of information, based on large intervention trials, has been accumulated during the last decade. It is quite obvious that the elderly hypertensive patients benefit from antihypertensive treatment to at least the same extent as the young and middle-aged. It appears that blood pressure ought to be lowered down to normotensive values also in the elderly in order to minimize their risk if cardiovascular complications, although more studies would be welcome to address this issue specifically in the elderly.

Aged↗

An overview of the effects of annexin 1 on cells involved in the inflammatory process.

The concept of anti-inflammation is currently evolving with the definition of several endogenous inhibitory circuits that are important in the control of the host inflammatory response. Here we focus on one of these pathways, the annexin 1 (ANXA1) system. Originally identified as a 37 kDa glucocorticoid-inducible protein, ANXA1 has emerged over the last decade as an important endogenous modulator of inflammation. We review the pharmacological effects of ANXA1 on cell types involved in inflammation, from blood-borne leukocytes to resident cells. This review reveals that there is scope for more research, since most of the studies have so far focused on the effects of the protein and its peptido-mimetics on neutrophil recruitment and activation. However, many other cells central to inflammation, e.g. endothelial cells or mast cells, also express ANXA1: it is foreseen that a better definition of the role(s) of the endogenous protein in these cells will open the way to further pharmacological studies. We propose that a more systematic analysis of ANXA1 physio-pharmacology in cells involved in the host inflammatory reaction could aid in the design of novel anti-inflammatory therapeutics based on this endogenous mediator.

Annexin A1↗

Chemotherapy-induced peripheral neuropathy.

PURPOSE/OBJECTIVES: To review the literature documenting the scope, treatment, and prevention of chemotherapy-induced neuropathy. DATA SOURCES: Published abstracts, primary research literature, and textbook chapters. DATA SYNTHESIS: Recent improvements in the management of other treatment-related toxicities have led to peripheral neuropathy becoming a dose-limiting toxicity of commonly used chemotherapeutic groups such as platinols, vinca alkaloids, and taxanes. CONCLUSIONS: The nervous system has not been the focus of education or training for oncology nurses. Therefore, nurses' ability to educate patients regarding this aspect of their condition has been limited. IMPLICATIONS FOR NURSING: With its significant impact on quality of life, peripheral neuropathy treatment and prevention are important components in the care of patients with cancer.

Anticonvulsants↗

Pathophysiological tissue changes associated with repetitive movement: a review of the evidence.

Work-related musculoskeletal disorders (WMSDs) represent approximately one third of workers' compensation costs in US private industry, yet estimates of acceptable exposure levels for forceful and repetitive tasks are imprecise, in part, due to lack of measures of tissue injury in humans. In this review, the authors discuss the scope of upper-extremity WMSDs, the relationship between repetition rate and forcefulness of reaching tasks and WMSDs, cellular responses to injury in vivo and in vitro, and animal injury models of repetitive, forceful tasks. The authors describe a model using albino rats and present evidence related to tissue injury and inflammation due to a highly repetitive reaching task. A conceptual schematic for WMSD development and suggestions for further research are presented. Animal models can enhance our ability to predict risk and to manage WMSDs in humans because such models permit the direct observation of exposed tissues as well as motor behavior.

Animals↗

Scope and heterogeneous nature of MODY.

This review summarizes aspects of the phenotypic expression, natural history, recognition, pathogenesis, and heterogeneous nature of maturity-onset diabetes of the young (MODY), which is inherited in an autosomal-dominant pattern. There are differences in metabolic, hormonal, and vascular abnormalities in different ethnic groups and even among White pedigrees. In MODY patients with low insulin responses, there are delayed and decreased insulin and C-peptide secretory responses to glucose from childhood or adolescence even before glucose intolerance appears, which may represent the basic genetic defect. When followed for decades, nondiabetic siblings have normal insulin responses. The fasting hyperglycemia of some MODY patients has been treated successfully with sulfonylureas for up to 30 yr. In a few patients, after years or decades of diabetes, the insulin and C-peptide responses to glucose are so low that they resemble those of early insulin-dependent diabetes mellitus. The progression of the insulin secretory defect over time distinguishes between these two types of diabetes. In contrast are patients from families who have very high insulin responses to glucose, despite glucose intolerance and fasting hyperglycemia similar to that seen in patients with low insulin responses. In many of these patients, there is in vivo and in vitro evidence of insulin resistance. Whatever its mechanism, the compensatory insulin responses to nutrients must be insufficient to maintain normal carbohydrate tolerance. This suggests that diabetes occurs only in those patients who have an additional islet cell defect, i.e., insufficient beta-cell reserve and secretory capacity. In a few MODY pedigrees with high insulin responses to glucose and lack of evidence of insulin resistance, a structurally abnormal mutant insulin molecule that is biologically ineffective is secreted. No associations have been found between specific HLA antigens and MODY in White, Black, and Asian pedigrees. Linkage studies of the insulin gene, insulin-receptor gene, erythrocyte/HepG2 glucose-transporter locus, and apolipoprotein B locus have shown no association with MODY. Vascular disease may be as prevalent as in conventional non-insulin-dependent diabetes mellitus. Because of autosomal-dominant transmission and penetrance at a young age, MODY is a good model for further investigations of etiologic and pathogenetic factors in non-insulin-dependent diabetes mellitus, including the use of genetic linkage strategies to identify diabetogenic genes.

Adult↗