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PubMed2005

Interactive Health Communication Applications for people with chronic disease.

BACKGROUND: Interactive Health Communication Applications (IHCAs) are computer-based, usually web-based, information packages for patients that combine health information with at least one of social support, decision support, or behaviour change support. These are innovations in health care and their effects on health are uncertain. OBJECTIVES: To assess the effects of IHCAs for people with chronic disease. SEARCH STRATEGY: We designed a four-part search strategy. First, we searched electronic bibliographic databases for published work; second, we searched the grey literature; and third, we searched for ongoing and recently completed clinical trials in the appropriate databases. Finally, researchers of included studies were contacted, and reference lists from relevant primary and review articles were followed up. As IHCAs require relatively new technology, the search time period commenced at 1990, where possible, and ran until 31 December 2003. SELECTION CRITERIA: Randomised controlled trials (RCTs) of IHCAs for adults and children with chronic disease. DATA COLLECTION AND ANALYSIS: One reviewer screened abstracts for relevance. Two reviewers screened all candidate studies to determine eligibility, apply quality criteria, and extract data from included studies. Authors of included RCTs were contacted for missing data. Results of RCTs were pooled using random-effects model with standardised mean differences (SMDs) for continuous outcomes and odds ratios for binary outcomes; heterogeneity was assessed using the I(2 )statistic. MAIN RESULTS: We identified 24 RCTs involving 3739 participants which were included in the review.IHCAs had a significant positive effect on knowledge (SMD 0.46; 95% confidence interval (CI) 0.22 to 0.69), social support (SMD 0.35; 95% CI 0.18 to 0.52) and clinical outcomes (SMD 0.18; 95% CI 0.01 to 0.35). Results suggest it is more likely than not that IHCAs have a positive effect on self-efficacy (a person's belief in their capacity to carry out a specific action) (SMD 0.24; 95% CI 0.00 to 0.48). IHCAs had a significant positive effect on continuous behavioural outcomes (SMD 0.20; 95% CI 0.01 to 0.40). Binary behavioural outcomes also showed a positive effect for IHCAs, although this result was not statistically significant (OR 1.66; 95% CI 0.71 to 3.87). It was not possible to determine the effects of IHCAs on emotional or economic outcomes. AUTHORS' CONCLUSIONS: IHCAs appear to have largely positive effects on users, in that users tend to become more knowledgeable, feel better socially supported, and may have improved behavioural and clinical outcomes compared to non-users. There is a need for more high quality studies with large sample sizes to confirm these preliminary findings, to determine the best type and best way to deliver IHCAs, and to establish how IHCAs have their effects for different groups of people with chronic illness.

Adaptation, Psychological↗

PubMed1997

[Transjugular intrahepatic portasystemic shunt (TIPS)--indications and outcome].

The use of the use of the transjugular intrahepatic portosystemic shunt (TIPS) and its indication for treatment of the various symptoms of portal hypertension is till under debate. This paper presents guidelines for its application based on randomized studies, case reports, and own experience. TIPS is indicated in acute variceal bleeding not responding to endoscopic treatment and medication. In this emergency situation TIPS has probably a lower early mortality rate than surgical shunts. The prophylactic treatment of first variceal bleeding is a domain for medical therapy. Due to its increased incidence of hepatic encephalopathy TIPS may only be indicated in very selected cases with a high risk of bleeding and associated severe complications. Five randomized trials including 402 patients exist comparing endoscopic treatment and TIPS. Except one study the results are conclusive demonstrating comparable survival of the groups. Despite these results, in view of the high rate of shunt-induced encephalopathy with its negative effect on life quality, TIPS may better be a secondary treatment as long as studies on life quality are lacking. However, im many patients additional complications, e.g., accompanying ascites or intolerance to bleedings, may justify the primary use of TIPS. TIPS is also effective in the treatment of refractory ascites. Conclusive randomized studies are not available, therefore, TIPS should be restricted to patients who are intolerant to or who fail paracentesis. In addition to the leading indications mentioned, rare indications for TIPS and the role of surgical shunts are discussed.

Esophageal and Gastric Varices↗

PubMed2002

A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women's Healthy Eating and Living (WHEL) Study.

The Women's Healthy Eating and Living (WHEL) Study is a multisite randomized controlled trial of the effectiveness of a high-vegetable, low-fat diet, aimed at markedly raising circulating carotenoid concentrations from food sources, in reducing additional breast cancer events and early death in women with early-stage invasive breast cancer (within 4 years of diagnosis). The study randomly assigned 3088 such women to an intensive diet intervention or to a comparison group between 1995 and 2000 and is expected to follow them through 2006. Two thirds of these women were under 55 years of age at randomization. This research study has a coordinating center and seven clinical sites. Randomization was stratified by age, stage of tumor and clinical site. A comprehensive intervention program that includes intensive telephone counseling, cooking classes and print materials helps shift the dietary pattern of women in the intervention. Through an innovative telephone counseling program, dietary counselors encourage women in the intervention group to meet the following daily behavioral targets: five vegetable servings, 16 ounces of vegetable juice, three fruit servings, 30 g of fiber and 15-20% energy from fat. Adherence assessments occur at baseline, 6, 12, 24 or 36, 48 and 72 months. These assessments can include dietary intake (repeated 24-hour dietary recalls and food frequency questionnaire), circulating carotenoid concentrations, physical measures and questionnaires about health symptoms, quality of life, personal habits and lifestyle patterns. Outcome assessments are completed by telephone interview every 6 months with medical record verification. We will assess evidence of effectiveness by the length of the breast cancer event-free interval, as well as by overall survival separately in all the women in the study as well as specifically in women under and over the age of 55 years.

Adult↗

PubMed1994

Strategies to slow the progression of renal disease.

Recent multicenter clinical trials have confirmed that it is indeed possible to slow the progression of chronic renal disease in patients with diabetic and nondiabetic nephropathy. Antihypertensive therapy is particularly protective in this regard, either due to the lowering of blood pressure or, as is sometimes the case with ACE inhibition, to mechanisms independent of a systemic hemodynamic effect. Similarly, strict glycemic control has now clearly been shown to ameliorate the progression of diabetic nephropathy, while dietary protein restriction appears to have some benefit, although further studies will be required to establish this definitively. Finally, preliminary data suggest that some of these therapies may also slow progression in patients with renal transplant nephropathy, which has unfortunately become an increasingly common cause of ESRD. These encouraging results will hopefully stimulate further efforts to elucidate the mechanisms by which progression occurs, so that even better therapies can be designed.

Antihypertensive Agents↗

PubMed1996

Placebos in clinical practice and research.

The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given.

Beneficence↗

PubMed2003

Effects of educational interventions for self management of asthma in children and adolescents: systematic review and meta-analysis.

OBJECTIVE: To determine the effectiveness of educational programmes for the self management of asthma in children and adolescents. DATA SOURCES: Databases of the Cochrane Airways Group, PsychINFO, reference lists of review papers, and eligible studies. REVIEW METHODS: Eligible studies were published randomised controlled trials or controlled clinical trials of educational programmes for the self management of asthma in children and adolescents that reported lung function, morbidity, self perception of asthma control, or utilisation of healthcare services. Eligible studies were abstracted, assessed for methodological quality, and pooled with fixed effects and random effects models. RESULTS: 32 of 45 identified trials were eligible, totalling 3706 patients aged 2 to 18 years. Education in asthma was associated with improved lung function (standardised mean difference 0.50, 95% confidence interval 0.25 to 0.75) and self efficacy (0.36, 0.15 to 0.57) and reduced absenteeism from school (-0.14, -0.23 to -0.04), number of days of restricted activity (-0.29, -0.33 to -0.09), and number of visits to an emergency department (-0.21, -0.33 to -0.09). When pooled by the fixed effects model but not by the random effects model, education was also associated with a reduced number of nights disturbed by asthma. The effect on morbidity was greatest among programmes with strategies based on peak flow, interventions targeted at the individual, and participants with severe asthma. CONCLUSIONS: Educational programmes for the self management of asthma in children and adolescents improve lung function and feelings of self control, reduce absenteeism from school, number of days with restricted activity, number of visits to an emergency department, and possibly number of disturbed nights. Educational programmes should be considered a part of the routine care of young people with asthma.

Adolescent↗

PubMed2005

An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently.

BACKGROUND: We aimed to determine if specialist journals implement specific Consolidated Standards for Reporting Trials (CONSORT) recommendations to the same extent as general medical journals. METHODS: Analysis of random controlled trials (RCTs) in five general medical journals (n=100) and 10 specialist journals (n=100), all endorsing CONSORT. We evaluated the likelihood of reporting important methodologic criteria. Analyses controlled for the nested effect of journal within each journal type. RESULTS: General medical journals published, on average, more CONSORT items per RCT than specialist journals (7.9 [SD 1.8] vs. 6.5 [SD 2.2] out of 11 possible items, P=.02). When compared with specialist journals, RCTs in general medical journals published a participant flow diagram more frequently (83 vs. 42%, odds ratio [OR] 6.7, 95% confidence interval [CI] 3.4-12.9) and more likely to report the method of randomization (78 vs. 55%, OR 2.9, 95% CI 1.5-5.3) and allocation concealment (48 vs. 26%, OR 2.6, 95% CI 1.4-4.7); they were less likely to publish RCTs reporting adverse events (58 vs. 78%, OR 0.3, 95% CI 0.2-0.7). Both page length and impact factor were weakly associated with number of CONSORT items reported. CONCLUSION: General medical and specialist journals that endorse CONSORT do not enforce reporting issues consistently, with specialty journals lagging behind general medical journals.

Clinical Medicine↗

PubMed2025

A Digital Tool for Clinical Evidence-Driven Guideline Development by Studying Properties of Trial Eligible and Ineligible Populations: Development and Usability Study.

BACKGROUND: Clinical guideline development preferentially relies on evidence from randomized controlled trials (RCTs). RCTs are gold-standard methods to evaluate the efficacy of treatments with the highest internal validity but limited external validity, in the sense that their findings may not always be applicable to or generalizable to clinical populations or population characteristics. The external validity of RCTs for the clinical population is constrained by the lack of tailored epidemiological data analysis designed for this purpose due to data governance, consistency of disease or condition definitions, and reduplicated effort in analysis code. OBJECTIVE: This study aims to develop a digital tool that characterizes the overall population and differences between clinical trial eligible and ineligible populations from the clinical populations of a disease or condition regarding demography (eg, age, gender, ethnicity), comorbidity, coprescription, hospitalization, and mortality. Currently, the process is complex, onerous, and time-consuming, whereas a real-time tool may be used to rapidly inform a guideline developer's judgment about the applicability of evidence. METHODS: The National Institute for Health and Care Excellence-particularly the gout guideline development group-and the Scottish Intercollegiate Guidelines Network guideline developers were consulted to gather their requirements and evidential data needs when developing guidelines. An R Shiny (R Foundation for Statistical Computing) tool was designed and developed using electronic primary health care data linked with hospitalization and mortality data built upon an optimized data architecture. Disclosure control mechanisms were built into the tool to ensure data confidentiality. The tool was deployed within a Trusted Research Environment, allowing only trusted preapproved researchers to conduct analysis. RESULTS: The tool supports 128 chronic health conditions as index conditions and 161 conditions as comorbidities (33 in addition to the 128 index conditions). It enables 2 types of analyses via the graphic interface: overall population and stratified by user-defined eligibility criteria. The analyses produce an overview of statistical tables (eg, age, gender) of the index condition population and, within the overview groupings, produce details on, for example, electronic frailty index, comorbidities, and coprescriptions. The disclosure control mechanism is integral to the tool, limiting tabular counts to meet local governance needs. An exemplary result for gout as an index condition is presented to demonstrate the tool's functionality. Guideline developers from the National Institute for Health and Care Excellence and the Scottish Intercollegiate Guidelines Network provided positive feedback on the tool. CONCLUSIONS: The tool is a proof-of-concept, and the user feedback has demonstrated that this is a step toward computer-interpretable guideline development. Using the digital tool can potentially improve evidence-driven guideline development through the availability of real-world data in real time.

Humans↗

PubMed2003

A comparison between traditional methods and multilevel regression for the analysis of multicenter intervention studies.

This article reviews three traditional methods for the analysis of multicenter trials with persons nested within clusters, i.e., centers, namely naïve regression (persons as units of analysis), fixed effects regression, and the use of summary measures (clusters as units of analysis), and compares these methods with multilevel regression. The comparison is made for continuous (quantitative) outcomes, and is based on the estimator of the treatment effect and its standard error, because these usually are of main interest in intervention studies. When the results of the experiment have to be valid for some larger population of centers, the centers in the intervention study have to present a random sample from this population and multilevel regression may be used. It is shown that the treatment effect and especially its standard error, are generally incorrectly estimated by the traditional methods, which should, therefore, not in general be used as an alternative to multilevel regression.

Adolescent↗

PubMed2006

Therapeutic potential of angiotensin receptor blockers in hypertension.

The renin-angiotensin-aldosterone system plays a key role in the regulation of fluid and electrolyte balance. Angiotensin II receptor blockers (ARBs) inhibit angiotensin II type 1 receptors and large clinical trials have shown that they are effective in many cardiovascular diseases including hypertension, heart failure, myocardial infarction and diabetic nephropathy. They lower blood pressure effectively, are very well tolerated and can be used as monotherapy or in combination with other drug classes for the treatment of hypertension. ARBs are particularly suitable for hypertensive patients with co-morbidities such as diabetes, microalbuminuria, proteinuria, left ventricular hypertrophy and heart failure. Unlike angiotensin-converting enzyme inhibitors, ARBs do not cause persistent dry cough. For patients in whom angiotensin-converting enzyme inhibitors are indicated but not tolerated, an ARB should be considered. Periodic monitoring of renal function and electrolytes is required in patients treated with an ARB.

Aged↗

PubMed2002

Rash in multicenter trials of lamotrigine in mood disorders: clinical relevance and management.

BACKGROUND: The rate of lamotrigine-associated rash in patients with mood disorders has not been well characterized. The objective of this report was to determine rash rates in clinical trials of lamotrigine in DSM-IV unipolar depression or bipolar disorder. METHOD: A retrospective analysis was conducted of rates of lamotrigine-related rash in 12 multicenter studies, including 1 open study, 7 randomized controlled acute trials, and 4 randomized controlled maintenance trials from 1996 to 2001. RESULTS: A total of 1955 patients were treated with lamotrigine in open-label settings (open-label phases preceding or following randomization and 1 stand-alone open-label study); 1198 patients received lamotrigine in controlled settings, and 1056 patients received placebo. In controlled settings, rates of benign rash were 8.3% and 6.4% in lamotrigine- and placebo-treated patients, respectively. Rates of serious rash were 0% with lamotrigine, 0.1% (N = 1) with placebo, and 0% with comparators. In the open-label setting, the overall rate of rash for lamotrigine was 13.1% (N = 257) and of serious rash, 0.1% (N = 2). One mild case of Stevens-Johnson syndrome not requiring hospitalization occurred in a patient treated with lamotrigine. There were no cases of toxic epidermal necrolysis in any setting. CONCLUSION: Serious drug eruptions associated with lamotrigine were rare. Although rash is a potentially life-threatening reaction, the risk of serious rash due to lamotrigine should be weighed against more common risks associated with untreated or undertreated bipolar depression.

Anticonvulsants↗

PubMed2006

Personalised risk communication for informed decision making about taking screening tests.

BACKGROUND: There is a trend towards greater patient involvement in healthcare decisions. Adequate discussion of the risks and benefits associated with different choices is often required if involvement is to be genuine and effective. Achieving both the adequate involvement of consumers and informed decision making are now seen as important goals for any screening programme. Personalised risk estimates have been shown to be effective methods of risk communication in general, but the effectiveness of different strategies has not previously been examined. OBJECTIVES: To assess the effects of different types of personalised risk communication for consumers making decisions about taking screening tests. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2004), MEDLINE (1985 to December 2005), EMBASE (1985 to December 2005), CINAHL (1985 to December 2005), and PsycINFO (1989 to December 2005). Follow-up searches involved hand searching Preventive Medicine, citation searches on seven authors, and searching reference lists of articles. For the original version of this review (Edwards 2003c) we also searched CancerLit (1985 to 2001) and Science Citation Index Expanded (searched March 2002). SELECTION CRITERIA: Randomised controlled trials addressing the decision by consumers of whether or not to undergo screening, incorporating an intervention with a 'personalised risk communication element' and reporting cognitive, affective, or behavioural outcomes. A 'personalised risk communication element' is based on the individual's own risk factors for a condition (such as age or family history). It may be calculated from an individual's risk factors using formulae derived from epidemiological data, and presented as an absolute or relative risk or as a risk score, or it may be categorised into, for example, high, medium or low risk groups. It may be less detailed still, involving a listing, for example, of a consumer's risk factors as a focus for discussion and intervention. DATA COLLECTION AND ANALYSIS: Two authors independently assessed each trial for quality and extracted data. We extracted data about the nature and setting of the intervention, and relevant outcome data, along with items relating to methodological quality. We then used standard statistical methods of the Consumers and Communication Review Group to combine data using MetaView, including analysis according to different levels of detail of personalised risk communication, different condition for screening, and studies based only on high risk participants rather than people at 'average' risk. MAIN RESULTS: Twenty-two studies were included, nine of which were added in the 2006 update of this review. There was weak evidence, consistent with a small effect, that personalised risk communication (whether written, spoken or visually presented) increases uptake of screening tests (odds ratio (OR) 1.31 (random effects, 95% confidence interval (CI) 0.98 to 1.77). In three studies the interventions showed a trend towards more accurate risk perception (OR 1.65 (95% CI 0.96 to 2.81), and three other trials with heterogenous outcome measures showed improvements in knowledge with personalised risk interventions. There was little other evidence from these studies that the interventions promoted or achieved informed decision making by consumers about participation in screening. More detailed personalised risk communication may be associated with a smaller increase in uptake of tests. That is, for personalised risk communication which used and presented numerical calculations of risk, the OR for test uptake was 0.82 (95% CI 0.65 to 1.03). For risk estimates or calculations which were categorised into high, medium or low strata of risk, the OR was 1.42 (95% CI 1.07 to 1.89). For risk communication that simply listed personal risk factors the OR was 1.42 (95% CI 0.95 to 2.12). Over half of the included studies assessed interventions in the context of mammography. These studies showed similar effects to the overall dataset. The five studies examining risk communication in high risk individuals (individuals at higher risk due to, for example, a family history of breast cancer or other conditions) showed larger odds ratios for uptake of tests than the other studies (random effects OR 1.74; 95% CI 1.05 to 2.88). There were insufficient data from the included studies to report odds ratios on other key outcomes such as: intention to take tests, anxiety, satisfaction with decisions, decisional conflict, knowledge and resource use. AUTHORS' CONCLUSIONS: Personalised risk communication (as currently implemented in the included studies) may have a small effect on increasing uptake of screening tests, and there is only limited evidence that the interventions have promoted or achieved informed decision making by consumers.

Communication↗

PubMed1997

Quantitative synthesis in systematic reviews.

The final common pathway for most systematic reviews is a statistical summary of the data, or meta-analysis. The complex methods used in meta-analyses should always be complemented by clinical acumen and common sense in designing the protocol of a systematic review, deciding which data can be combined, and determining whether data should be combined. Both continuous and binary data can be pooled. Most meta-analyses summarize data from randomized trials, but other applications, such as the evaluation of diagnostic test performance and observational studies, have also been developed. The statistical methods of meta-analysis aim at evaluating the diversity (heterogeneity) among the results of different studies, exploring and explaining observed heterogeneity, and estimating a common pooled effect with increased precision. Fixed-effects models assume that an intervention has a single true effect, whereas random-effects models assume that an effect may vary across studies. Meta-regression analyses, by using each study rather than each patient as a unit of observation, can help to evaluate the effect of individual variables on the magnitude of an observed effect and thus may sometimes explain why study results differ. It is also important to assess the robustness of conclusions through sensitivity analyses and a formal evaluation of potential sources of bias, including publication bias and the effect of the quality of the studies on the observed effect.

Bias↗

PubMed2006

Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial.

OBJECTIVES: The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study. BACKGROUND: The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS). METHODS: Patients with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years. RESULTS: Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups. CONCLUSIONS: Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis.

Coronary Angiography↗

PubMed2005

Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data. STUDY DESIGN: The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb > or =9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb > or =9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.

Anemia↗

PubMedDate not supplied

The effect of hemodiafiltration with on-line endogenous reinfusion (on-line HFR) on anemia: design of a European, open, randomised, multicentre trial. European Collaborative Study.

The lack of backfiltration reduces plasma levels of C-reactive protein and interleukin-6. Paired filtration dialysis is the hemodialfitration technique that abolishes backfiltration. By physically separating convection from diffusion, it allows pure ultrafiltrate to be available during the entire session, so the ultrafiltrate can be regenerated and used as infusion fluid. On these premises, we have developed a European, open, randomised, multicentre study aimed at evaluating the effect of hemodiafiltration with on-line endogenous reinfusion (on-line HFR) on anemia. At least 130 chronically uremic hemodialysed (bicarbonate hemodialysis) stable patients with mild anemia (Hb between 9 and 11 g/dL) will be enrolled and normalized for iron stores by concomitantly repleting iron deposits (if ferritin <300 microg/L) and reducing the dose of erythropoietin to maintain Hb values within the range at enrollment (9-11 g/dL). Patients will be included in the study, randomized to the two treatments (test treatment: on-line HFR; control treatment: hemodiafiltration or modified forms) and followed up for nine months. Iron stores will be maintained within normal levels and the dose of erythropoietin will be kept constant. The primary question and response variable will be the mean monthly changes in hemoglobin levels over the period of nine months. As secondary questions and response variables, we will measure the nutritional status using a subjective global assessment, protein catabolic rate, urea generation rate and the dietician's assessment, serum concentrations of vitamins A, C, E and serum C-reactive protein.

Anemia↗

PubMed2005

A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy.

BACKGROUND: There is a growing interest in extending the use of repetitive transcranial magnetic stimulation (rTMS) beyond research centres to the widespread clinical treatment of depression. Thus it is timely to critically review the evidence for the efficacy of rTMS as an antidepressant treatment. Factors relevant to the efficacy of rTMS are discussed along with the implications of these for the further optimization of rTMS. METHOD: Clinical trials of the efficacy of rTMS in depressed subjects are summarized and reviewed, focusing mainly on sham-controlled studies and meta-analyses published to date. RESULTS: There is a fairly consistent statistical evidence for the superiority of rTMS over a sham control, though the degree of clinical improvement is not large. However, this data is derived mainly from two-week comparisons of rTMS versus sham, and evidence suggests greater efficacy with longer treatment courses. Studies so far have also varied greatly in approaches to rTMS stimulation (with respect to stimulation site, stimulus parameters etc) with little empirical evidence to inform on the relative merits of these approaches. LIMITATIONS: Only studies published in English were reviewed. Many of the studies in the literature had small sample sizes and different methodologies, making comparisons between studies difficult. CONCLUSIONS: Current published studies and meta-analyses have evaluated the efficacy of rTMS as given in treatment paradigms that are almost certainly suboptimal (e.g of two weeks' duration). While the data nevertheless supports positive outcomes for rTMS, there is much scope for the further refinement and development of rTMS as an antidepressant treatment. Ongoing research is critical for optimizing the efficacy of rTMS.

Depressive Disorder↗

PubMed1994

Role of antibody and use of respiratory syncytial virus (RSV) immune globulin to prevent severe RSV disease in high-risk children.

Infants with cardiac disease or infants born prematurely with or without bronchopulmonary dysplasia are at increased risk of severe respiratory syncytial virus (RSV) disease. A recently developed RSV immune globulin (RSVIG) was studied in a 3-year multicenter trial to determine safety and efficacy in the prevention of severe RSV disease in children who are at high risk of severe RSV illness. Two hundred forty-nine children were studied; 102 had bronchopulmonary dysplasia, 87 had congenital heart disease, and 60 were born prematurely. RSVIG was given on a monthly basis to 81 children at a high dose of 750 mg/kg (15 ml/kg) and to 79 children at a low dose of 150 mg/kg (3 ml/kg). The 89 children in the control group did not receive RSVIG. There were 64 episodes of RSV infection: 19 in the high-dose group, 16 in the low-dose group, and 29 in the control group. High-dose recipients had significantly fewer RSV lower respiratory tract infections, hospitalizations, hospital days, intensive care unit days, and less use of ribavirin compared with control subjects. Only 19 adverse events were reported during the 580 infusions administered (3%). No death was attributed to RSV disease or RSVIG therapy. Treated children did not acquire exaggerated RSV illness in a subsequent year. Thus high-dose RSVIG reduced the incidence and severity of RSV lower respiratory tract infection. It is a safe and effective means of RSV prophylaxis in selected high-risk children.

Animals↗