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PubMed2005

The clinical and cost-effectiveness of implantable cardioverter defibrillators: a systematic review.

OBJECTIVES: To consider the clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators (ICDs) for arrhythmias. DATA SOURCES: Electronic databases. Manufacturer submissions. REVIEW METHODS: A systematic review of the literature on clinical and cost-effectiveness was undertaken. The quality of selected randomised controlled trials (RCTs) was assessed using the Jadad criteria, and of selected systematic reviews using criteria developed by the NHS Centre for Reviews and Dissemination. Economic evaluations were quality assessed by their internal validity (i.e. the methods used) using a series of relevant questions, and external validity (i.e. generalisability of the economic study to the population of interest) by modified standard criteria. The clinical effectiveness and cost-effectiveness of ICDs for arrhythmias were synthesised through a narrative review with full tabulation of results of all included studies. RESULTS: Eight RCTs, two systematic reviews and a meta-analysis met the inclusion criteria of the review. The RCTs were of variable quality, with most trials having a Jadad quality score of 1/5 or 2/5, owing to the nature of comparing a device with drug therapy and the impossibility of double-blinding. The outcome measure of interest was mortality, which was reported as all-cause mortality in most trials and sudden cardiac death in some trials. Eleven economic evaluations of ICDs for arrhythmias were identified. None were shown to have high internal and external validity. One unpublished study relevant to the UK was identified. The evidence suggests that ICDs reduce mortality in patients with previous ventricular arrest or symptomatic sustained ventricular arrhythmias, in patients who have not had a previous sudden cardiac episode or previous ventricular arrhythmia but have reduced left ventricular function due to coronary artery disease with asymptomatic non-sustained ventricular arrhythmia and sustained tachycardia that could be induced electrophysiologically, and in some patients with severe left ventricular dysfunction (ejection fraction 30%) after myocardial infarction. QoL data are inconsistent but suggest that there is impaired QoL in patients who received numerous shocks from implanted devices. Studies show that ICDs improve survival compared with drug treatment, but with considerably increased cost. Incremental cost per life-year gained ranges from 27,000 US dollars to 213,543 Can dollars and incremental cost per quality-adjusted life-year from 71,700 US dollars to 558,000 US dollars in the published literature. CONCLUSIONS: The use of ICDs in the UK is increasing, but the technology is still under-utilised compared with other developed countries. Extending the current indications to patients with prior myocardial infarction and depressed heart function would impact on costs and service provision. Further research is needed on the risk stratification of patients in whom ICDs are most likely to be clinically and cost-effective. An evaluation of shock frequency on QoL is also required.

Aged↗

PubMed2026

Tissue-based genomic instability markers for predicting malignant transformation in oral leukoplakia and proliferative verrucous leukoplakia: a systematic review.

OBJECTIVES: Although several biomarkers have been described for predicting malignant transformation in oral leukoplakias (OLs) and proliferative verrucous leukoplakias (PVLs), no systematic review has comprehensively evaluated tissue-based genomic instability markers. This review aimed to evaluate the evidence for these markers and their potential role in biomarker panel development. METHODS: A systematic review across PubMed, Embase and Cochrane Library was performed to identify studies evaluating the differences in tissue-based genomic markers between OL and PVL patients with and without malignant transformation. RESULTS: 34 observational studies comprising 3,237 patients were included, and genomic aberrations were categorised into DNA-level, chromosomal, and gene-specific alterations. For studies on OLs, DNA-level and chromosomal markers for which individual studies reported associations with malignant transformation included aneuploidy, impaired DNA repair capacity, loss of heterozygosity, chromosomal instability, and copy number alterations. Multiple gene-specific alterations also showed associations (e.g., TP53, MKI67, FGFR1), but findings varied across studies. The genomic markers of PVLs differed substantially, with fewer consistent predictors found. No meta-analysis was performed as all included studies were observational. CONCLUSIONS: Genomic instability across multiple levels contributes to malignant transformation, and represents a promising biological framework for predicting malignant transformation for OLs. While no single marker reliably demonstrates sufficient predictive performance, the integration of complementary genomic alterations with clinical and histopathological risk factors may provide a basis for the development of robust multi-marker panels. Future prospective studies using standardised detection methods and multivariable prediction models are required before clinical implementation. SYSTEMATIC REVIEW REGISTRATION: identifier CRD42024585830.

carcinoma↗

PubMedDate not supplied

Effectiveness of directional microphones and noise reduction schemes in hearing aids: a systematic review of the evidence.

A systematic review of the literature was undertaken to find evidence of real-world effectiveness of directional microphone and digital noise reduction features in current hearing aids. The evidence was drawn from randomized controlled trials, nonrandomized intervention studies, and descriptive studies. The quality of each study was evaluated for factors such as blinding, power of statistical analyses, and use of psychometrically strong outcome measures. Weaknesses in the identified studies included small sample size, resultant poor power to detect potentially worthwhile differences, and overlapping experimental conditions. Nine studies were identified for directional microphones, and the evidence (albeit weak) supports effectiveness. Two studies were identified for the noise reduction feature, and the evidence was equivocal. For the researcher, such a systematic review should encourage the careful consideration of appropriate methodologies for assessing feature effectiveness. For the clinician, the outcomes reported herein should encourage use of such a systematic review to drive clinical practice.

Amplifiers, Electronic↗

PubMed2007

The efficacy of subacromial corticosteroid injection in the treatment of rotator cuff disease: A systematic review.

To investigate whether subacromial corticosteroid injections are effective in the treatment of rotator cuff disease, an evidence-based systematic review was undertaken of nine randomized controlled trials that compared subacromial corticosteroid injection with placebo in patients with rotator cuff disease. Each study was systematically evaluated for biases, and outcome measures were scrutinized for statistical significance and clinical importance. One study demonstrated clinically important differences in pain relief. Two studies showed clinically important improvement in range of motion at final follow-up. This systematic review of the available literature indicates that there is little reproducible evidence to support the efficacy of subacromial corticosteroid injection in managing rotator cuff disease.

Adrenal Cortex Hormones↗

PubMed2000

Applying the results of a systematic review in general practice.

OBJECTIVE: To assess how general practitioners might interpret and apply the results of a systematic review relevant to general practice. DESIGN: Cross-sectional postal survey of general practitioners in August 1997. PARTICIPANTS: 51 general practitioners in the Southern Division of General Practice in Adelaide and 11 professors or heads of departments of general practice. MAIN OUTCOME MEASURES: Extent to which comments on the implications for practice and implications for research coincided with the evidence presented in a systematic review of antibiotics for the treatment of acute otitis media in children; and reported probability that respondents would prescribe antibiotics in three brief case scenarios. RESULTS: There was considerable variation in the comments made by general practitioners on the implications of the review for clinical practice. After reading the review, respondents with training in critical appraisal were more likely to state that children with acute otitis media would usually recover spontaneously and reported a lower probability of prescribing antibiotics in two of the three case scenarios. CONCLUSIONS: Providing systematic reviews is not sufficient for the results of such evidence to be translated into clinical practice. There is an association between critical appraisal skills and the application of evidence-based practice.

Adult↗

PubMed2006

Systematic review: impact of health information technology on quality, efficiency, and costs of medical care.

BACKGROUND: Experts consider health information technology key to improving efficiency and quality of health care. PURPOSE: To systematically review evidence on the effect of health information technology on quality, efficiency, and costs of health care. DATA SOURCES: The authors systematically searched the English-language literature indexed in MEDLINE (1995 to January 2004), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Abstracts of Reviews of Effects, and the Periodical Abstracts Database. We also added studies identified by experts up to April 2005. STUDY SELECTION: Descriptive and comparative studies and systematic reviews of health information technology. DATA EXTRACTION: Two reviewers independently extracted information on system capabilities, design, effects on quality, system acquisition, implementation context, and costs. DATA SYNTHESIS: 257 studies met the inclusion criteria. Most studies addressed decision support systems or electronic health records. Approximately 25% of the studies were from 4 academic institutions that implemented internally developed systems; only 9 studies evaluated multifunctional, commercially developed systems. Three major benefits on quality were demonstrated: increased adherence to guideline-based care, enhanced surveillance and monitoring, and decreased medication errors. The primary domain of improvement was preventive health. The major efficiency benefit shown was decreased utilization of care. Data on another efficiency measure, time utilization, were mixed. Empirical cost data were limited. LIMITATIONS: Available quantitative research was limited and was done by a small number of institutions. Systems were heterogeneous and sometimes incompletely described. Available financial and contextual data were limited. CONCLUSIONS: Four benchmark institutions have demonstrated the efficacy of health information technologies in improving quality and efficiency. Whether and how other institutions can achieve similar benefits, and at what costs, are unclear.

Biomedical Technology↗

PubMed2006

Systematic review: smoking cessation intervention strategies for adults and adults in special populations.

BACKGROUND: While smoking cessation interventions have been shown to work, questions remain about how to increase their efficacy. PURPOSE: To examine strategies for effective tobacco treatment in adults and special populations. DATA SOURCES: MEDLINE, Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane Library, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts (1 January 1980 to 10 June 2005). STUDY SELECTION: Systematic reviews; randomized, controlled trials; and observational studies. DATA EXTRACTION: Two reviewers independently abstracted data on study design, population, sample size, treatment, outcomes, and quality. DATA SYNTHESIS: Findings from systematic reviews were summarized and compared with findings from original research published beyond date ranges included in the reviews. Strength of evidence was used to assess the body of evidence. Our review included studies evaluating the efficacy of cessation strategies, such as self-help, counseling, single pharmaceutical agents, combined pharmacotherapies, and pharmacotherapies combined with psychological counseling. Research findings consistent with previous reviews show that self-help strategies alone are ineffective, but counseling and pharmacotherapy used either alone or in combination can improve rates of success with quit attempts. Two studies of self-help materials reported discrepancies across effects. Five studies provided mixed results for counseling interventions. Fourteen studies provided sufficient evidence of the efficacy of single pharmacotherapy, combined pharmacotherapy, and psychological interventions either with or without pharmacotherapy. Few studies focused on ways to reach or treat special populations. Three studies with hospitalized patients had findings consistent with a previous review showing no strong evidence that clinical diagnosis affected the likelihood of quitting. New evidence was insufficient to address the effectiveness of interventions for persons with coexisting psychiatric conditions and substance abuse problems. LIMITATIONS: Previous systematic reviews variably cover the range of issues we addressed. More recent studies do not fill all gaps, especially those for persons with coexisting disease. CONCLUSIONS: Although self-help strategies alone marginally affect quit rates, individual and combined pharmacotherapies and counseling either alone or in combination can significantly increase cessation. Using effective smoking treatments is strongly encouraged for all populations, especially those with high and heavy rates of smoking, such as psychiatric and substance abuse populations.

Adolescent↗

PubMed1998

Postoperative analgesia and vomiting, with special reference to day-case surgery: a systematic review.

BACKGROUND: Day-case surgery is of great value to patients and the health service. It enables many more patients to be treated properly, and faster than before. Newer, less invasive, operative techniques will allow many more procedures to be carried out. There are many elements to successful day-case surgery. Two key components are the effectiveness of the control of pain after the operation, and the effectiveness of measures to minimise postoperative nausea and vomiting. OBJECTIVES: To enable those caring for patients undergoing day-case surgery to make the best choices for their patients and the health service, this review sought the highest quality evidence on: (1) the effectiveness of the control of pain after an operation; (2) the effectiveness of measures to minimise postoperative nausea and vomiting. METHODS: Full details of the search strategy are presented in the report. RESULTS - ANALGESIA: The systematic reviews of the literature explored whether different interventions work and, if they do work, how well they work. A number of conclusions can be drawn. RESULTS-ANALGESIA, INEFFECTIVE INTERVENTIONS: There is good evidence that some interventions are ineffective. They include: (1) transcutaneous electrical nerve stimulation in acute postoperative pain; (2) the use of local injections of opioids at sites other than the knee joint; (3) the use of dihydrocodeine, 30 mg, in acute postoperative pain (it is no better than placebo). RESULTS-ANALGESIA, INTERVENTIONS OF DOUBTFUL VALUE: Some interventions may be effective but the size of the effect or the complication of undertaking them confers no measurable benefit over conventional methods. Such interventions include: (1) injecting morphine into the knee joint after surgery: there is a small analgesic benefit which may last for up to 24 hours but there is no clear evidence that the size of the benefit is of any clinical value; (2) manoeuvres to try and anticipate pain by using pre-emptive analgesia; these are no more effective than standard methods; (3) administering non-steroidal anti-inflammatory drugs (NSAIDs) by injection or per rectum in patients who can swallow; this appears to be no more effective than giving NSAIDs by mouth and, indeed, may do more harm than good; (4) administering codeine in single doses; this has poor analgesic efficacy. RESULTS-ANALGESIA, INTERVENTIONS OF PROVEN VALUE: These include a number of oral analgesics including (at standard doses): (1) dextropropoxyphene; (2) tramadol; (3) paracetamol; (4) ibuprofen; (5) diclofenac. Diclofenac and ibuprofen at standard doses give analgesia equivalent to that obtained with 10 mg of intramuscular morphine. Each will provide at least 50% pain relief from a single oral dose in patients with moderate or severe postoperative pain. Paracetamol and codeine combinations also appear to be highly effective, although there is little information on the standard doses used in the UK. The relative effectiveness of these analgesics is compared in an effectiveness 'ladder' which can inform prescribers making choices for individual patients, or planning day-case surgery. Dose-response relationships show that higher doses of ibuprofen may be particularly effective. Topical NSAIDs (applied to the skin) are effective in minor injuries and chronic pain but there is no obvious role for them in day-case surgery. RESULTS-POSTOPERATIVE NAUSEA AND VOMITING: The proportion of patients who may feel nauseated or vomit after surgery is very variable, despite similar operations and anaesthetic techniques. Systematic review can still lead to clear estimations of effectiveness of interventions. Whichever anti-emetic is used, the choice is often between prophylactic use (trying to prevent anyone vomiting) and treating those people who do feel nauseated or who may vomit. Systematic reviews of a number of different anti-emetics show clearly that none of the anti-emetics is sufficiently effective to be used for prophylaxis. (ABSTRACT TRUNCATE

Acetaminophen↗

PubMed1999

[A reproducibility and validity study of a systematic review on ischemic cardiopathy. The Study Group of the Quality of Care (GRECA)].

BACKGROUND: The systematic literature reviews have been proposed as a method of scientific evidence identification since they protect the final product from the subjectivity of each primary source reviewer. However, it is not known whether the different ways of evidence synthesis accomplish suitable criteria of objectivity, reliability and biases protection so as to be considered scientifically valid. An experiment of reliability and validity of a systematic literature review about coronary heart disease was carried out. MATERIAL AND METHODS: Study of blind concordance between two independent reviewers for the identification, selection, retrieval and quality evaluation of the articles by using the same protocol. The concordance was analysed by the kappa index for two observers in different categories. The validity was evaluated throughout the acceptability of the review users. RESULTS: The concordance for their identification capacity was poor although they used the same key words (869 versus 476). But the concordance improved when considering selection (26.6% versus 29.2%), retrieval (agreement = 76%) classification by kind of article (kappa = 0.60) and scoring by strength of the evidence (kappa = 0.87). The acceptability was high among review users. CONCLUSIONS: It would be assumed that, even under tight rules of performance, the systematic literature reviews are not completely protected against some biases which could damage their validity in a non easily controllable form. The implication of reviewers, experts in documentation and users of the literature, together with pilot studies performed previous to the review, seems to be the best way to yield better results.

Humans↗

PubMed2000

[The systematic review is the foundation of evidence based medicine. One of the most important contributions to clinical medicine of the past decade].

The traditional narrative review has been shown repeatedly to be biased, mostly towards exaggerated treatment size effects. In contrast, the systematic review follows a strict protocol regarding focused questions, explicit criteria for literature searches, inclusion and exclusion criteria, critical appraisal and a synthesis which is quantitative when appropriate. There is empirical evidence that bias is reduced and that the conclusions reached have greater validity for the construction of treatment guidelines. In this paper three sources of systematic reviews are identified: the Cochrane Library, reviews published in peer-reviewed journals, and assessments of health technology (HTA-reports). Editors are encouraged to publish systematic reviews after proper critical appraisal, and readers are advised to search for such reviews when in need of guidance on important clinical questions.

Bias↗

PubMed2000

Screening for hypercholesterolaemia versus case finding for familial hypercholesterolaemia: a systematic review and cost-effectiveness analysis.

BACKGROUND: In the majority of people with familial hypercholesterolaemia (FH) the disorder is caused by a mutation of the low-density lipoprotein receptor gene that impairs its proper function, resulting in very high levels of plasma cholesterol. Such levels result in early and severe atherosclerosis, and hence substantial excess mortality from coronary heart disease. Most people with FH are undiagnosed or only diagnosed after their first coronary event, but early detection and treatment with hydroxymethylglutaryl-coenzyme (HMG CoA) reductase inhibitors (statins) can reduce morbidity and mortality. The prevalence of FH in the UK population is estimated to be 1 in 500, which means that approximately 110,000 people are affected. OBJECTIVES: To evaluate whether screening for FH is appropriate. To determine which system of screening is most acceptable and cost-effective. To assess the deleterious psychosocial effects of genetic and clinical screening for an asymptomatic treatable inherited condition. To assess whether the risks of screening outweigh potential benefits. METHODS DATA SOURCES: Relevant papers were identified through a search of the electronic databases. Additional papers referenced in the search material were identified and collected. Known researchers in the field were contacted and asked to supply information on unpublished or ongoing studies. INCLUSION/EXCLUSION CRITERIA: SCREENING AND TREATMENT: The review included studies of the mortality and morbidity associated with FH, the effectiveness and cost of treatment (ignoring pre-statin therapies in adults), and of the effectiveness or cost of possible screening strategies for FH. PSYCHOSOCIAL EFFECTS OF SCREENING: The search for papers on the psychological and social effects of screening for a treatable inherited condition was limited to the last 5 years because recent developments in genetic testing have changed the nature and implications of such screening tests. Papers focusing on genetic testing for FH and breast cancer were included. Papers relating to the risk of coronary heart disease with similarly modifiable outcome (non-FH) were also included. DATA EXTRACTION AND ASSESSMENT OF VALIDITY: A data assessment tool was designed to assess the quality and validity of the papers which reported primary data for the social and psychological effects of screening. Available guidelines for systematically reviewing papers concentrated on quantitative methods, and were of limited relevance. An algorithm was developed which could be used for both the qualitative and quantitative literature. MODELLING METHODS: A model was constructed to investigate the relative cost and effectiveness of various forms of population screening (universal or opportunistic) and case-finding screening (screening relatives of known FH cases). All strategies involved a two-stage process: first, identifying those people with cholesterol levels sufficiently elevated to be compatible with a diagnosis of FH, and then either making the diagnosis based on clinical signs and a family history of coronary disease or carrying out genetic tests. Cost-effectiveness has been measured in terms of incremental cost per year of life gained. RESULTS: MODELLING COST-EFFECTIVENESS: FH is a life-threatening condition with a long presymptomatic state. Diagnostic tests are reasonably reliable and acceptable, and treatment with statins substantially improves prognosis. Therefore, it is appropriate to consider systematic screening for this condition. Case finding amongst relatives of FH cases was the most cost-effective strategy, and universal systematic screening the least cost-effective. However, when targeted at young people (16 year olds) universal screening was also cost-effective. Screening patients admitted to hospital with premature myocardial infarction was also relatively cost-effective. Screening is least cost-effective in men aged over 35 years, because the gains in life expectancy are small. (ABSTRACT TRUNCA

Adult↗

PubMed2002

International collaboration in conducting systematic reviews: the Cochrane Collaborative Review Group on HIV Infection and AIDS.

To make sound health care decisions, policy makers, providers and researchers need access to relevant research findings. The role of systematic reviews is increasingly acknowledged as an important contribution in evidence-based health care decision making, and several review efforts, including that of the international Cochrane Collaboration, are under way. The Cochrane Collaborative Review Group on HIV Infection and AIDS (CRG on HIV/AIDS), conducts systematic reviews on the prevention and the treatment of HIV infection and AIDS and is guided by the Cochrane Collaboration's principles, which include minimizing potential bias, ensuring quality in the review process, keeping reviews up to date, and enhancing collaboration. The CDC HIV/AIDS Prevention Research Synthesis (PRS) project is working closely with the CRG on HIV/AIDS to produce Cochrane reviews of behavioral prevention interventions and on development and maintenance of a centralized, cumulative electronic database of HIV/AIDS behavioral prevention studies. Systematic reviews can play an important role in advancing evidence-based policy and practice in HIV/AIDS prevention and care.

Acquired Immunodeficiency Syndrome↗

PubMed2002

A systematic review of the utility of electrodiagnostic testing in carpal tunnel syndrome.

Carpal tunnel syndrome (CTS) comprises a complex of symptoms in the hand, including pain and paresthesia and weakness of hand muscles thought to result from compression of the median nerve. Many clinicians either refer patients for electrodiagnostic studies to aid diagnosis or conduct electrodiagnostic studies, which may be useful as an aid to decisions on treatment. The aim of this systematic review is to evaluate the evidence base for the use of electrodiagnostic tests in the diagnosis and management of carpal tunnel syndrome. A systematic search was undertaken for studies that included patients with clinical diagnosis of CT5 who were undergoing electrodiagnostic tests and surgery together with reported outcomes of surgery. A published systematic review found that electrodiagnosis was not a useful diagnostic test in patients with clinical signs of CTS. Seven primary studies of prognosis reporting electrodiagnosis and surgery outcomes were found, however, one of them was subsequently retracted. The remaining six were retrospective case senes of poor quality. Four of these studies reported outcomes of surgery in patients with clinically identified CTS, comparing both positive or negative electrodiagnostic results. No study found any statistical difference in surgical outcome between those who were electrodiagnostic test positive and those who were negative. Despite the limited quality of the evidence, in cases of clear-cut clinical CTS, electrodiagnosis is not warranted either as a diagnostic test, where clinical symptoms are well defined, or as a predictive indicator of surgical outcome. It may still be useful in cases where the clinical diagnosis is not clear.

Carpal Tunnel Syndrome↗

PubMed2002

[Systematic reviews in practice. IX. Determining their place in treatment recommendations in practice guidelines].

In a systematic review (SR), the available evidence for a clinical problem is systematically and comprehensively collected from different studies, the likelihood of bias is assessed and the results are summarised in a reproducible manner. The results of an SR can be used in either individual patient care or the formulation of a practice guideline. Throughout the world, (national) organisations for guideline development use systems for classifying the validity of evidence according to the study design ('levels of evidence'), and this is also the case in the Netherlands. In formulating a treatment recommendation, consideration must be given to the various factors which determine the strength of the evidence: study design, consistency of the results (if more studies are available), quality of the individual studies, magnitude and precision of the reported effect and the clinical relevance of the outcome measures. If insufficient studies with the same outcome measure are available, problems can arise in an SR. In practice, problems can also arise with respect to estimating the cogency of an SR compared to another review or primary studies. For the same subject, there might be discordant reviews, differences between reviews and megatrials might exist or just one randomised clinical trial might be available. These problems can often be solved with the aid of a systematic analysis. This requires both methodological and clinical expertise.

Bias↗

PubMed2002

Expectant management versus labor induction for suspected fetal macrosomia: a systematic review.

OBJECTIVE: To systematically review and summarize the medical literature regarding the effects of expectant management and labor induction on mode of delivery and perinatal outcomes in patients with suspected fetal macrosomia. DATA SOURCES: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify studies assessing management of patients with suspected fetal macrosomia. METHODS OF STUDY SELECTION: We evaluated, abstracted data, and performed quantitative analyses in studies assessing the outcome of patients with suspected fetal macrosomia. Observational studies and randomized trials were included in this systematic review. TABULATION, INTEGRATION, AND RESULTS: Twenty-nine studies were identified, 11 of which met our criteria for systematic review and meta-analysis. These 11 studies included 3751 subjects. Of these, 2700 were managed expectantly, and 1051 underwent labor induction. We calculated an estimate of the odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous outcomes, using random- and fixed-effects models for outcomes. Summary statistics for the nine observational studies showed that, compared with those whose labor was induced, women who experienced spontaneous onset of labor had a lower incidence of cesarean delivery (OR 0.39, 95% CI 0.30, 0.50) and higher rates of spontaneous vaginal delivery (OR 2.07, 95% CI 1.34, 3,19); however, significant differences in these outcomes were not noted when the two randomized trials were assessed. No differences were noted in rates of operative vaginal deliveries, incidence of shoulder dystocia, or abnormal Apgar scores in the analyses of the observational or randomized studies. CONCLUSION: Based on data from observational studies, labor induction for suspected fetal macrosomia results in an increased cesarean delivery rate without improving perinatal outcomes. Although their statistical power is limited, randomized clinical trials have not confirmed these findings.

Cesarean Section↗

PubMed2003

Herbs for serum cholesterol reduction: a systematic view.

OBJECTIVES: To systematically review the clinical evidence for herbal medicinal products in the treatment of hypercholesterolemia. STUDY DESIGN: A systematic review of randomized clinical trials of herbal medicinal products used to lower serum cholesterol. Systematic literature searches were conducted in 6 electronic data-bases. The reference lists of all papers and our files were searched for more relevant publications. Experts in the field and manufacturers of identified herbal medicinal products were contacted for published and unpublished data. No language restrictions were imposed. OUTCOMES MEASURED: All randomized clinical trials of serum cholesterol reduction, in which mono-preparations of herbal medicinal products were administered as supplements to human subjects, were included. RESULTS: Twenty-five randomized clinical trials involving 11 herbal medicinal products were identified. Guggul (Commiphora mukul), fenugreek (Trigonella foenum-graecum), red yeast rice, and artichoke (Cynara scolymus) have been most extensively studied and have demonstrated reductions in total serum cholesterol levels of between10% and 33%. The methodological quality as assessed by the Jadad score was less than 3 (maximum, 5) for 13 of the 25 trials. CONCLUSIONS: Many herbal medicinal products have potential hypocholesterolemic activity and encouraging safety profiles. However, only a limited amount of clinical research exists to support their efficacy. Further research is warranted to establish the value of these extracts in the treatment of hypercholesterolemia.

Cholesterol↗

PubMed2003

Risk of venous thromboembolism in relatives of symptomatic probands with thrombophilia: a systematic review.

Clinical equipoise exists regarding whether relatives of individuals with venous thromboembolism (VTE) and thrombophilia should be screened for thrombophilia. There have been no systematic attempts to summarize studies that have assessed the incidence of VTE in relatives. The purpose of this review was to systematically identify and review observational studies with thrombophilic relatives and to summarize their findings with respect to their risk of VTE. We conducted a systematic literature review and included nine observational studies meeting a priori inclusion criteria. Potentially eligible studies evaluated VTE incidence in relatives of index patients (probands) with symptomatic thrombophilia. In the four prospective studies, the incidence of VTE for asymptomatic family members with factor V Leiden ranged from 0.58-0.67% per year, 1.0-2.5% for protein C deficiency, 0.7-2.2% for protein S deficiency, and 4% for antithrombin deficiency. About half of all VTEs occurred during well-known risk periods but incidence rates were decreased by use of prophylaxis. No deaths from pulmonary embolism or fatal hemorrhages from anticoagulants were reported. The incidence of VTE was generally lower in the retrospective studies. The pooled relative risk from four retrospective studies for factor V Leiden carriers was 3.69 (CI 2.27, 6.00) and from two studies the pooled relative risk for deficiencies of protein C, protein S, and antithrombin was 10.58 (CI 5.38, 20.81). In conclusion, the risk of VTE events in asymptomatic relatives is low, but this may be an underestimate. Anticoagulant prophylaxis during risk periods appears to be of benefit but further research in this area is required.

Adolescent↗

PubMed2003

[What is the systematic review?].

Systematic reviewing provides a major backbone for evidence-based laboratory medicine(EBLM). Compared with a usual review paper, a systematic review is characterized by pursuing both the most comprehensive search for available evidence and the highest level of scientific quality. The word of 'scientific' does not mean a scientific truth but means a reliable result proven by a scientific method. According to the best effort policy of EBM, a result including some statistical bias may be adopted as the current best evidence if better ones are not available. In addition, EBLM requires specialized approaches because of the following reasons. (1) Many factors, such as analytical errors or lack of standardization may cause various statistical biases in the laboratory data. (2) Unlike the effectiveness of therapeutic measures that can be evaluated by comparing only two groups, there are almost infinite combinations of diagnostic tests and phases of clinical courses, and it is hardly possible to statistically match the patient group with the control group at any of those combinations. (3) Unlike medication, which has direct effects on a patient's outcome, many steps must be taken to analyze the effects of laboratory tests. From now, more effort should be dedicated to promoting systematic reviewing in laboratory medicine.

Evidence-Based Medicine↗