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[Establishment of a uniform common data set for pediatric oncology. Applied Informatics Study Group of the GPOH (Society of Pediatric Oncology and Hematology)].

Large multicenter trials have made a major contribution to the improvement of treatment results in childhood malignancies. Coordination and central documentation ensure the quality of treatment and permit clinical and scientific investigations. This kind of cooperation requires a vast amount of documentation, which by itself has become a critical factor in answering important medical questions. The problems result from non-standardized documentation systems in different studies, from insufficient integration of clinical work and documentation and from a lack of application of modern computer based data management systems. The working group "Applied Informatics" of the German "Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)" has started a project to create an uniform basic data set for the German pediatric oncology group. Relevant initial diagnostic data, information about planned and realized treatment as well as data concerning negative event had to be standardized. A minimal common data set with a substantially reduced documentation, which is applicable for all patients and trials, would have failed to fulfil the clinical as well as the research needs. The data set presented here is a detailed information structure introduced as a basic tool for the improvement of data management in the German pediatric oncology group. This first version of the basic data set will need further development, since some of the problems still need to be resolved and the requirements for such data pools are changing. Based on this data set new computer software and clinical information systems have to be developed to enable documentation and processing of all clinical and study related data.

Child↗
PubMed2002

Massage for low-back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

BACKGROUND: Low back pain (LBP) is one of the most common and costly musculoskeletal problems in modern society. Proponents of massage therapy claim it can minimize pain and disability and speed return-to-normal function. OBJECTIVES: To assess the effects of massage therapy for nonspecific LBP. SEARCH STRATEGY: We searched MEDLINE, Embase, Cochrane Controlled Trials Register, HealthSTAR, CINAHL, and dissertation abstracts through May 2001 with no language restrictions. References in the included studies and in reviews of the literature were screened. Contact with content experts and massage associations was also made. SELECTION CRITERIA: The studies had to be randomized or quasirandomized trials investigating the use of any type of massage (using the hands or a mechanical device) as a treatment for nonspecific LBP. DATA COLLECTION AND ANALYSIS: Two reviewers blinded to authors, journals, and institutions selected the studies, assessed the methodologic quality using the criteria recommended by the Cochrane Collaboration Back Review Group, and extracted the data using standardized forms. The studies were analyzed in a qualitative way because of heterogeneity of population, massage technique, comparison groups, timing, and type of outcome measured. RESULTS: Nine publications reporting on eight randomized trials were included. Three had low and five had high methodologic quality scores. One study was published in German, and the rest, in English. Massage was compared with an inert treatment (sham laser) in one study that showed that massage was superior, especially if given in combination with exercises and education. In the other seven studies, massage was compared with different active treatments. They showed that massage was inferior to manipulation and transcutaneous electrical nerve stimulation; massage was equal to corsets and exercises; and massage was superior to relaxation therapy, acupuncture, and self-care education. The beneficial effects of massage in patients with chronic LBP lasted at least 1 year after the end of the treatment. One study comparing two different techniques of massage concluded in favor of acupuncture massage over classic (Swedish) massage. CONCLUSIONS: Massage might be beneficial for patients with subacute and chronic nonspecific LBP, especially when combined with exercises and education. The evidence suggests that acupuncture massage is more effective than classic massage, but this needs confirmation. More studies are needed to confirm these conclusions, to assess the effect of massage on return-to-work, and to measure longer term effects to determine cost-effectiveness of massage as an intervention for LBP.

Controlled Clinical Trials as Topic↗
PubMed1999

[Arterial hypertension and systolic left ventricular dysfunction: therapeutic approach].

Arterial hypertension is a cardinal precursor of congestive heart failure, and diastolic dysfunction is the most frequent mechanism for it. Systolic left ventricular dysfunction, although less frequent, has a worse prognosis. Most cases of systolic dysfunction in patients with hypertension is due to acute myocardial infarction, although other mechanisms can be involved. In some studies, non-ischemic hypertensive systolic dysfunction is the etiology of chronic heart failure in up to 10% of patients with dilated cardiomyopathy. Diastolic dysfunction and left ventricular hypertrophy are also associated with a higher risk of heart failure and systolic dysfunction. Given the poor prognosis of patients with congestive heart failure and dilated cardiomyopathy, it is fundamental to try to prevent the development of left ventricular dysfunction by means of a correct control of blood pressure, regression of left ventricular hypertrophy and prevention of coronary artery disease. When systolic dysfunction is established, angiotensin converting enzyme inhibitors are the treatment of choice; diuretics and digoxin can be added in patients with overt congestive heart failure. Recent studies suggest that other drugs, such as carvedilol and losartan, can be beneficial, but current evidence is still scarce.

Amlodipine↗
PubMed2005

Combination of chemotherapy without platinum compounds in the treatment of advanced non-small cell lung cancer: a systematic review of phase III trials.

Hitherto, platinum-based combinations are world-wide accepted regimens in the treatment of advanced non-small cell lung cancer (NSCLC) due to a clear survival improvement using various platinum-based doublets in comparison with best supportive care only. However, treatment-allocated time and period with high grade toxicity could be considered as wasted from the patient point of view and the high toxicity induced by platinum-based doublets urges the research of alternate treatments. Newest cytotoxic compounds as so-called third generation drugs (i.e. vinorelbine, docetaxel, paclitaxel and gemcitabine) yield a better efficacy/toxicity ratio. Platinum-free doublet regimens based on these new drugs are expected to offer the patients an improved survival without decreasing his quality of life. Recent update of ASCO guidelines recommended that "for stage IV NSCLC, [...] non-platinum-containing chemotherapy regimens may be used as alternatives to platinum-based regimens in the first line." In spite of this recommendation, the case of non-platinum containing regimen is still debatable and this review deals with methodological statements highlighted by the reports of 14 recently reported randomised studies comparing non-platinum with platinum-based doublets (174 words).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2000

Human immunodeficiency virus on the web: a guided tour.

Through the efforts of thousands of individuals, the World Wide Web has become a gold mine of information about HIV. In this article, we describe approximately 90 Web sites that are among the most useful to clinicians and researchers with regard to HIV. Web sites were classified according to their content and target audience and were judged according to their adherence to accepted standards of medical Internet publishing. Selected Web sites were categorized into the following groups: (1) sites with comprehensive coverage of HIV treatment and its management, (2) on-line peer-reviewed journals, (3) proceedings of scientific meetings, (4) sites with HIV-related textbooks, manuals, and guidelines, (5) government publications, (6) research databases, (7) information on clinical trials, (8) sites with comprehensive information for laypersons, and (9) sites with information related to specific medical complications of HIV infection.

Clinical Trials as Topic↗
PubMed2006

Adolescents with acute lymphoblastic leukaemia: emerging from the shadow of paediatric and adult treatment protocols.

Adolescents and young adults (AYA) with acute lymphoblastic leukaemia (ALL) constitute a distinct population from children and older adults. Based on patterns of referral, they may be treated by either paediatric or adult oncologists. As a group, AYA with ALL have a worse survival and event-free survival (EFS) compared to that achieved by younger children. A systematic review of all published clinical trials, which provide data on treatment and outcome of adolescents with ALL, has been summarised in an effort to determine whether they should be treated on paediatric or adult type protocols. Adolescents appear to have a consistent survival advantage when treated on paediatric regimens.

Adolescent↗
PubMed2005

The Cochrane Collaboration.

The Cochrane Collaboration is an international, not-for-profit organisation that aims to help people make well-informed decisions about health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of health-care interventions. Cochrane systematic reviews are prepared according to predefined, explicit methodology, and published in The Cochrane Library. The abstracts and plain English summaries of the reviews are freely available on the Internet. All reviews are prepared and maintained under the editorial control of 50 Cochrane Collaborative Review Groups that focus on (groups of) health problems. The work of Collaborative Review Groups is supported, among others, by people working in Cochrane Fields. Cochrane Fields focus on dimensions of health care other than health problems. To date, the issue of nutrition has not been addressed sufficiently in The Cochrane Collaboration. Nutrition issues are very important for day-to-day health care and the initiatives to establish a new Cochrane Diet and Nutrition (Sub)Field will help to promote the preparation of systematic reviews of nutritional interventions by the variety of Collaborative Review Groups to whom such interventions are relevant. Many issues regarding nutritional interventions, however, are complex, and methodological challenges will have to be overcome. A Cochrane Diet and Nutrition (Sub)Field with experts on nutritional research can help fill this gap and make those reviews more possible.

Clinical Trials as Topic↗
PubMed2000

Fish oil supplementation in type 2 diabetes: a quantitative systematic review.

OBJECTIVE: To determine the effects of fish oil supplementation on lipid levels and glycemic control in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A comprehensive search of Medline, Embase, Lilacs, the Cochrane Clinical Trials Registry bibliographies of relevant papers, and expert input updated through September 1998 was undertaken. All randomized placebo-controlled trials were included in which fish oil supplementation was the only intervention in subjects with type 2 diabetes. Three investigators performed data extraction and quality scoring independently with discrepancies resolved by consensus. Eighteen trials including 823 subjects followed for a mean of 12 weeks were included. Doses of fish oil used ranged from 3 to 18 g/day The outcomes studied were glycemic control and lipid levels. RESULTS: Meta-analysis of pooled data demonstrated a statistically significant effect of fish oil on lowering triglycerides (-0.56 mmol/l [95% CI -0.71 to -0.41]) and raising LDL cholesterol (0.21 mmol/l [0.02 to 0.41]). No statistically significant effect was observed for fasting glucose. HbA1c total cholesterol, or HDL cholesterol. The triglyceride-lowering effect and the elevation in LDL cholesterol were most marked in those trials that recruited hypertriglyceridemic subjects and used higher doses of fish oil. Heterogeneity was observed and explained by the recruitment of subjects with baseline hypertriglyceridemia in some studies. CONCLUSIONS: Fish oil supplementation in type 2 diabetes lowers triglycerides, raises LDL cholesterol, and has no statistically significant effect on glycemic control. Trials with hard clinical end points are needed.

Blood Glucose↗
PubMed1997

Formulating questions and locating primary studies for inclusion in systematic reviews.

Much time and effort are spent on designing primary research studies. Similar care must be given to planning systematic reviews. The review should be based on an important, well-focused question that is relevant to patient care. By formulating the question properly, the criteria that primary studies must meet to be included in the review become clear. These criteria, which comprise the types of persons involved, exposure, control group, outcomes, and study designs of interest, can then be refined so that they are clinically relevant, sensible, and workable. Inclusion criteria that are too narrow will limit the amount of data in the review, thereby increasing the risk for chance results and making the review less useful for the reader. Reviews should include studies whose designs offer the least biased answer to the question being asked. To maximize available data and reduce the risk for bias, as many relevant studies as possible need to be identified, regardless of publication status or language. Multiple overlapping search strategies should therefore be used and must be carefully planned. Strategies include searching the many electronic databases available (after careful consideration of which terms to enter), manually searching journals and conference proceedings, searching bibliographies of articles, searching existing registers of studies, and contacting companies or researchers. The time taken to formulate the question adequately and develop appropriate searches will increase the chance of producing a high-quality, meaningful review.

Clinical Trials as Topic↗