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Showing papers by "Cochrane Collaboration published in 2001"


Journal ArticleDOI
TL;DR: Concomitant chemotherapy and radiotherapy improves overall and progression-free survival and reduces local and distant recurrence in selected patients with cervical cancer, which may give a cytotoxic and sensitisation effect.

957 citations


Journal ArticleDOI
TL;DR: A Cochrane review has confirmed and strengthened previous findings that there is no reliable evidence that screening for breast cancer reduces mortality and shows that breast-cancer mortality is a misleading outcome measure.

722 citations


Journal ArticleDOI
TL;DR: Bilateral IMA grafts seem to give better survival rates than single grafts in CABG, although the results are more uncertain than is indicated by the 95% CI.

705 citations


Journal ArticleDOI
TL;DR: This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing guidelines that incorporates clinicians' feedback and is widely acceptable to practicing clinicians.
Abstract: Introduction. A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back pain. Methods. Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analysis was conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies. Developing Recommendations. An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required, but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established. Validating the Recommendations. A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%. Results. Four positive recommendations of clinical benefit were developed. Therapeutic exercises were found to be beneficial for chronic, subacute, and postsurgery low back pain. Continuation of normal activities was the only intervention with beneficial effects for acute low back pain. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 85%). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation), there was a lack of evidence regarding efficacy. Conclusions. This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing guidelines that incorporates clinicians' feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions for patients with low back pain where evidence was insufficient to make recommendations.

524 citations


Journal ArticleDOI
TL;DR: In this paper, a long-acting depot antipsychotic medication is a widely used treatment for schizophrenia, and the results showed no convincing advantages for one depot over another in terms of long-term adverse effects.
Abstract: Background Long-acting depot antipsychotic medication is a widely used treatment for schizophrenia. Aims To synthesise relevant systematic Cochrane reviews. Method The Cochrane Database was searched and summary data were extracted from randomised controlled clinical trials of depots. Results Standard dose depot v . placebo resulted in significantly less relapse but more movement disorders. Those on depots ( v . oral drugs) showed more global change on one outcome measure; relapse and adverse effects showed no difference. Comparisons showed no convincing advantages for one depot over another. Conclusions Depot antipsychotics are safe and effective. They may confer a small benefit over oral drugs on global outcome. Those for whom depots are most indicated may not be represented. Large studies are required to discern differences in relapse rates and long-term adverse effects, and data on satisfaction, quality of life and economics.

298 citations


Journal ArticleDOI
TL;DR: A systematic review aims to circumvent this weakness by the use of a predefined, explicit methodology that includes steps to minimise bias in the identification of relevant studies, in the selection criteria for inclusion, and in the collection of data.

255 citations


Journal ArticleDOI
TL;DR: Most active recruitment strategies for breast cancer screening programs examined in this review were more effective than no intervention, although some costly strategies, as a home visit and a letter of invitation to multiple screening examinations plus educational material, were not effective.
Abstract: Background Strategies for reducing breast cancer mortality in western countries have focused on screening, at least for women aged 50 to 69 years. One of the requirements of any community screening program is to achieve a high participation rate, which is related to methods of invitation. Therefore, it was decided to systematically review the scientific evidence on the different strategies aimed at improving women's participation in breast cancer screening programs and activities. Objectives To assess the effectiveness of different strategies for increasing the participation rate of women invited to community (population-based) breast cancer screening activities or mammography programs. Search methods MEDLINE (1966-2000), CENTRAL (2000), and EMBASE (1998-1999) searches for 1966 to 1999 were supplemented by reports and letters to the European Screening Breast Cancer Programs (Euref Network). Selection criteria Both published and unpublished trials were eligible for inclusion, provided the women had been invited to a community breast screening activity or program and had been randomised to an intervention group or a control group with no active intervention. Data collection and analysis We identified 151 articles, which were reviewed independently by two people. The discrepancies were resolved by a third reviewer in order to reach consensus. Thirty-four studies were excluded because they lacked a control group; 58 of the other 117 articles were considered as opportunistic and not community-based; 59 articles, which reported 70 community-based randomised controlled trials or clinical controlled trials, were accepted. In 24 of these, the control group had not been exposed to any active intervention, but 8 of the 24 had to be excluded because the denominator for estimating attendance was unknown. At the end, 16 studies constituted the material for this review, although two studies were further excluded because their groups were not comparable at baseline. Data from all but one study were based on or converted to an intention-to-treat analysis. Attendance in response to the mammogram invitation was the main outcome measure. Main results The evidence favoured five active strategies for inviting women into community breast cancer screening services: letter of invitation (OR 1.66, 95% CI 1.43 to 1.92), mailed educational material (Odds Ratio(OR) 2.81, 95% Confidence Interval (CI) 1.96 to 4.02), letter of invitation plus phone call (OR 2.53, 95% CI 2.02 to 3.18), phone call (OR 1.94, 95% CI 1.70 to 2.23), and training activities plus direct reminders for the women (OR 2.46, 95% CI 1.72 to 3.50). Home visits did not prove to be effective (OR 1.06, 95 % CI 0.80 to 1.40) and letters of invitation to multiple examinations plus educational material favoured the control group (OR 0.62, 95 % CI 0.32 to 1.20). Authors' conclusions Most active recruitment strategies for breast cancer screening programs examined in this review were more effective than no intervention. Combinations of effective interventions can have an important effect. Some costly strategies, as a home visit and a letter of invitation to multiple screening examinations plus educational material, were not effective. Further reviews comparing the effective interventions and studies that include cost-effectiveness, women's satisfaction and equity issues are needed.

165 citations


Journal ArticleDOI
13 Oct 2001-BMJ
TL;DR: Too often, reviewers' conclusions over-rated the benefits of new interventions and readers of Cochrane reviews should remain cautious, especially regarding conclusions that favour new interventions.
Abstract: Objective: To assess the quality of Cochrane reviews. Design: Ten methodologists affiliated with the Cochrane Collaboration independently examined, in a semistructured way, the quality of reviews first published in 1998. Each review was assessed by two people; if one of them noted any major problems, they agreed on a common assessment. Predominant types of problem were categorised. Setting: Cyberspace collaboration coordinated from the Nordic Cochrane Centre. Studies: All 53 reviews first published in issue 4 of the Cochrane Library in 1998. Main outcome measure: Proportion of reviews with various types of major problem. Results: No problems or only minor ones were found in most reviews. Major problems were identified in 15 reviews (29%). The evidence did not fully support the conclusion in nine reviews (17%), the conduct or reporting was unsatisfactory in 12 reviews (23%), and stylistic problems were identified in 12 reviews (23%). The problematic conclusions all gave too favourable a picture of the experimental intervention. Conclusions: Cochrane reviews have previously been shown to be of higher quality and less biased on average than other systematic reviews, but improvement is always possible. The Cochrane Collaboration has taken steps to improve editorial processes and the quality of its reviews. Meanwhile, the Cochrane Library remains a key source of evidence about the effects of healthcare interventions. Its users should interpret reviews cautiously, particularly those with conclusions favouring experimental interventions and those with many typographical errors. What is already known on this topic Cochrane reviews are, on average, more systematic and less biased than systematic reviews published in paper journals Errors and biases also occur in Cochrane reviews What this study adds Too often, reviewers9 conclusions over-rated the benefits of new interventions Readers of Cochrane reviews should remain cautious, especially regarding conclusions that favour new interventions The Cochrane Collaboration has taken steps to improve the quality of reviews

157 citations


Journal ArticleDOI
TL;DR: Medical anti-shock trousers (MAST) provides external pneumatic compression of the legs and was first used in the Vietnam war to stabilise patients with haemorrhagic shock during transportation.

152 citations


Journal ArticleDOI
TL;DR: The newly formed Campbell Collaboration will prepare, maintain, and make accessible systematic reviews of research on the effects of social and educational interventions through mechanisms such as rigorous quality control, electronic publication, and worldwide coverage of the literature.
Abstract: Evidence-based policy has much to recommend it, but it also faces significant challenges. These challenges reside not only in the dilemmas faced by policy makers but also in the quality of the evaluation evidence. Some of these problems are most effectively ad- dressed by rigorous syntheses of the literature known as systematic reviews. Other problems remain, including the range of quality in systematic reviews and their general failure to be updated in light of new evidence or disseminated beyond the research community. Based on the precedent established in health care by the international Cochrane Collaboration, the newly formed Campbell Collaboration will prepare, maintain, and make accessible systematic reviews of re- search on the effects of social and educational interventions. Through mechanisms such as rigorous quality control, electronic publication, and worldwide coverage of the literature, the Campbell Collaboration seeks to meet challenges posed by evidence-based policy.

142 citations


Journal ArticleDOI
TL;DR: This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing E BCPGs that incorporates clinicians' feedback and is widely acceptable to practicing clinicians.
Abstract: Introduction. A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back, neck, knee, and shoulder pain. Methods. Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analyses were conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies. Developing Recommendations. An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established. Validating the Recommendations. A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%. Results. Eight positive recommendations of clinical benefit were developed. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 75% agreement). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation, mechanical traction), there was a lack of evidence regarding efficacy. Conclusions. This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing EBCPGs that incorporates clinicians' feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions where evidence was insufficient to make recommendations.

Journal ArticleDOI
25 Dec 2001-BJUI
TL;DR: To conduct a systematic review of the evidence for the efficacy of β‐sitosterolin in men with symptomatic benign prostatic hyperplasia (BPH).
Abstract: Objectives To conduct a systematic review of the evidence for the efficacy of beta-sitosterol in men with symptomatic benign prostatic hyperplasia (BPH). Methods Studies were identified through Medlinetrade mark (1966-98), EMBASEtrade mark, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with study authors and pharmaceutical companies. Randomized trials were included if: men had symptomatic BPH; plant extract preparations contained beta-sitosterols; a control group received placebo or a pharmacological therapy; and treatment duration was >/=30 days. Study characteristics, demographic information, enrolment criteria and outcomes were extracted. Results Four trials comprising a total of 519 men met the inclusion criteria. All were double-blind and lasted 4-26 weeks. Three studies used nonglucosidic beta-sitosterols and one used a preparation that contained only beta-sitosterol-beta-d-glucoside. Compared with placebo, beta-sitosterol improved urinary symptom scores and flow measures. For the two studies reporting the International Prostate Symptom Score (IPSS), the weighted mean difference (WMD) against placebo was -4.9 IPSS points (95% confidence interval, CI,-6.3 to-3.5). The WMD for peak urinary flow rate was 3.91 mL/s (95% CI 0.91 to 6.90, four studies) and for residual volume the WMD was -28.62 mL (95% CI-41.42 to-15.83, four studies). beta-sitosterol did not reduce prostate size. The trial using pure beta-sitosterol-beta-d-glucoside (WA184) showed no improvement in urinary flow measures. Withdrawal rates for men assigned to beta-sitosterol and placebo were 7.8% and 8.0% (not significant), respectively. Conclusion beta-sitosterol improves urological symptoms and flow measures. However, the existing studies are limited by short treatment duration and lack of standardized beta-sitosterol preparations. Their long-term effectiveness, safety and ability to prevent the complications of BPH are unknown.

Journal ArticleDOI
TL;DR: This complementary paper introduces and discusses some milestones between 1662 and 1948 in the development of methods to control selection biases when assembling therapeutic comparison groups, to ensure, as far as possible, that 'like is compared with like'.
Abstract: Histories of clinical trials have recorded and analysed the development of quantification in therapeutic evaluation, the emergence of probabilistic thinking, the application of statistical methods and theory, and the sociology, ethics and politics of clinical trials; but it is surprising that they only rarely identify as a distinct theme the development of efforts to control biases. An exception is Kaptchuk's recent account of the history of blinding and placebos for reducing observer biases. In this complementary paper I introduce and discuss some milestones between 1662 and 1948 in the development of methods to control selection biases when assembling therapeutic comparison groups, to ensure, as far as possible, that 'like is compared with like'. In the paper I note (i) that treatment allocation based on strict alternation abolishes selection bias as effectively as treatment allocation based on strict random allocation; (ii) that use of schedules based on random numbers is more likely to prevent foreknowledge of allocation schedules, and thus the risk of introducing selection bias at the point of recruitment to trials; (iii) that a concern to conceal allocation schedules was the rationale for using schedules based on random numbers in the Medical Research Council trials of vaccination for whooping cough and streptomycin for pulmonary tuberculosis; and (iv) that the introduction of allocation concealment more than half a century ago remains the most recent substantive milestone in the history of efforts to control selection biases in therapeutic experiments.

Journal ArticleDOI
17 Nov 2001-BMJ
TL;DR: Treatment with interferon alfa plus ribavirin has a significant beneficial effect on the virological and histological responses of patients with chronic hepatitis C, irrespective of previous treatment.
Abstract: Objective: To assess the efficacy and safety of interferon alfa with or without ribavirin for treatment of chronic hepatitis C. Design: Systematic review of randomised trials on interferon alfa plus ribavirin combination therapy versus interferon alfa. Patients were naive (not previously treated with interferon), relapsers (transient response to previous interferon therapy), or non-responders (no response to previous interferon therapy). Studies reviewed: Of 1155 references identified, 48 trials with 6585 patients met the inclusion criteria. Patients were followed to the end of treatment in 20 trials and in 28 trials for 12–96 weeks after treatment. Main outcome measures: Virological response and morbidity plus mortality. Results: Compared with interferon, combination therapy reduced the risk of not having a sustained virological response for 6 months by 26% in naive patients (relative risk 0.74, 95% confidence interval 0.70 to 0.78), 33% in relapsers (0.67, 0.57 to 0.78), and 11% in non-responders (0.89, 0.83 to 0.96). Morbidity and mortality showed a non-significant trend in favour of combination therapy (Peto odds ratio 0.45, 0.19 to 1.06). Combination therapy significantly reduced the risk of not having improvement in results of histology by 17% in naive patients (0.83, 0.74 to 0.93) and by 27% in relapsers and non-responders (0.73, 0.66 to 0.82). The risk of treatment discontinuations was significantly higher after combination therapy (1.28, 1.07 to 1.52). Conclusion: Treatment with interferon alfa plus ribavirin has a significant beneficial effect on the virological and histological responses of patients with chronic hepatitis C, irrespective of previous treatment. Combination therapy may therefore also be considered appropriate for relapsers and non-responders. What is already known on this subject Interferon alfa was the recommended treatment for chronic hepatitis C until the late 1990s Combination therapy is recommended for previously untreated patients with chronic hepatitis C, but the benefit of treating relapsers and non-responders to previous treatment with interferon remains controversial The effect of treatment on liver related morbidity and mortality has not been established What this study adds Combination therapy is more effective in treating hepatitis C than interferon alfa alone in naive patients, relapsers, and non-responders Combination therapy significantly reduced the risk of not having a sustained virological or histological response irrespective of previous treatment and may therefore also be considered in relapsers and non-responders to previous treatment The data indicate a non-significant trend towards a beneficial effect on morbidity plus mortality rates

Journal Article
TL;DR: The methodologic quality of studies addressing the diagnostic accuracy of meniscal tests was poor, and the results were highly heterogeneous, indicating that these tests are of little value for clinical practice.
Abstract: OBJECTIVE. Our systematic review summarizes the evidence about the accuracy of physical diagnostic tests for assessing meniscal lesions of the knee. SEARCH STRATEGY. We performed a literature search of MEDLINE (1966-1999) and EMBASE 1988- 1999) with additional reference tracking. SELECTION CRITERIA. Articles written in English, French, German, or Dutch that addressed the accuracy of at least one physical diagnostic test for meniscus injury with arthrotomy, arthroscopy, or magnetic resonance imaging as the gold standard were included. DATA COLLECTION AND ANALYSIS. Two reviewers independently selected studies, assessed the rnethodologic quality, and abstracted data using a standardized protocol. MAIN RESULTS. Thirteen studies (of 402) met the inclusion criteria. The results of the index and reference tests were assessed independently (blindly) of each other in only 2 studies, and in all studies verification bias seemed to be present. The study results were highly heterogeneous. The summary receiver operating characteristic curves of the assessment of joint effusion, the McMurray test, and joint line tenderness indicated little discriminative power for these tests. Only the predictive value of a positive McMurray test was favorable. CONCLUSIONS. The methodologic quality )f studies addressing the diagnostic accuracy of meniscal tests was poor, and the results were highly heterogeneous. The poor characteristics indicate that these tests are of little value for clinical practice.

Journal ArticleDOI
24 Dec 2001-BJUI
TL;DR: The evidence for the clinical effects and safety of the rye‐grass pollen extract (Cernilton) in men with symptomatic benign prostatic hyperplasia (BPH) is reviewed.
Abstract: Objective To systematically review the evidence for the clinical effects and safety of the rye-grass pollen extract (Cernilton) in men with symptomatic benign prostatic hyperplasia (BPH) Methods Trials were identified by searching Medline, specialized databases (EMBASE, Cochrane Library, Phytodok), bibliographies, and contacting relevant trialists and manufacturers Randomized or controlled clinical trials were included if: men with symptomatic BPH were treated with Cernilton; a control group received either placebo or pharmacological therapy; the treatment duration was 30 days; and clinical outcomes were reported Results In all, 444 men were enrolled in two placebo-controlled and two comparative trials lasting 12–24 weeks Three studies used a double-blind method although the concealment of treatment allocation was unclear in all Cernilton improved ‘self-rated urinary symptoms’ (the proportion reporting satisfactory or improving symptoms) vs placebo and another plant product, Tadenan The weighted mean (95% confidence interval) risk ratio (RR) for self-rated improvement vs placebo was 240 (121–475) and the weighted RR vs Tadenan was 142 (121–475) Cernilton reduced nocturia compared with placebo or Paraprost (a mixture of amino acids); against placebo, the weighted RR was 205 (141–300), and against Paraprost the weighted mean difference for nocturia was – 040 times per evening (– 073 to 007) Cernilton did not improve urinary flow rates, residual volume or prostate size compared with placebo or the comparative study agents Adverse events were rare and mild; the withdrawal rate for Cernilton was 48%, compared with 27% for placebo and 52% for Paraprost Conclusions The Cernilton trials analysed were limited by their short duration, limited number of enrolees, omissions in reported outcomes, and the unknown quality of the preparations used The comparative trials had no confirmed active control The available evidence suggests that Cernilton is well tolerated and modestly improves overall urological symptoms, including nocturia Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton

Patent
17 May 2001
TL;DR: In this paper, a method and apparatus for deploying data using a website development software application and executing scripts related to such deployment is described, where scripts may be deployed using the same menans as the deployed data, or may preexist within devices along the deployment path.
Abstract: A method and apparatus is provided for deploying data using a website development software application (116) and executing scripts (144) related to such deployment. A system that utilizes the invention may work in synchronicity with the application to deploy these scripts so that they can be executed in order to improve the delivery and maintenance of web content and related data. The scripts (144) may be deployed using the same menans as the deployed data, or may preexist within devices along the deployment path. Unlike other solutions, the unique use of scripts in such an application allows for further control and monitoring of locations along the deployment path, such as website production servers (120) and other possibly disparate devices and systems. Another aspect provides security to deployment destinations by, requiring screening of incoming data deployments.

Reference EntryDOI
TL;DR: Flumazenil had a significant effect on short-term improvement of hepatic encephalopathy in some patients with chronic liver disease and a highly favourable prognosis, but cannot be recommended for routine clinical use.
Abstract: BACKGROUND The pathogenesis of hepatic encephalopathy is unknown. It has been suggested that liver failure leads to the accumulation of substances that bind to a receptor-complex in the brain resulting in neural inhibition which may progress to coma. Several trials have assessed benzodiazepine receptor antagonists for hepatic encephalopathy, but the results are conflicting. OBJECTIVES To evaluate the efficacy and safety of benzodiazepine receptor antagonists for patients with acute or chronic hepatic encephalopathy. SEARCH STRATEGY Eligible trials were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register, MEDLINE, EMBASE, reference lists of relevant articles, authors of trials, and the pharmaceutical company known to produce benzodiazepine receptor antagonists. SELECTION CRITERIA Randomised trials comparing any benzodiazepine receptor antagonist versus placebo or no intervention for hepatic encephalopathy were included, regardless of language or publication status. DATA COLLECTION AND ANALYSIS Trial inclusion and data extraction were made independently by two contributors. Depending on the presence or absence of significant heterogeneity (P<0.1) a random or fixed effect model was used. Potential causes for heterogeneity were explored by sensitivity analyses. MAIN RESULTS Twelve randomised trials with 765 patients were included. Eight trials used a crossover design. All trials were double-blind and assessed flumazenil versus placebo. Data on all outcomes could not be extracted from all trials. The included patients had a favourable prognosis (341/370 (92%) survived in the flumazenil group versus 325/356 (91%) in the placebo group). Flumazenil had no significant effect on full recovery (two trials), survival (nine trials), or on the occurrence of adverse events (five trials). However, flumazenil was associated with a significant effect on improvement of hepatic encephalopathy compared to placebo at the end of treatment (103/346 (30%) versus 23/332 (7 %), risk difference 0.23, 95% confidence interval 0.18 to 0.28, five trials). REVIEWER'S CONCLUSIONS Flumazenil had no significant effect on recovery or survival from hepatic encephalopathy. However, flumazenil had a significant effect on short-term improvement of hepatic encephalopathy in some patients with chronic liver disease and a highly favourable prognosis. Considering the fluctuating nature of hepatic encephalopathy, future trials should use a parallel design and assess if treatment with flumazenil leads to a sustained improvement or increased recovery and survival. Until this has been demonstrated, flumazenil may be considered for patients with chronic liver disease and hepatic encephalopathy, but cannot be recommended for routine clinical use.

Journal ArticleDOI
TL;DR: Research into the outcomes of peer review, the establishment of sound methods for measuring the quality of the process and its outcomes, and comparisons with alternative methods are needed are needed.
Abstract: Peer review is well established across most academic disciplines, and publishers, editors, and researchers devote considerable resources to it. This paper uses examples from biomedical journals to examine its shortcomings. Although mainly anecdotal, the evidence suggests that peer review is sometimes ineffective at identifying important research and even less effective at detecting fraud. Most reviewers identify only the minority of a paper's defects and they may be biased. Peer review plus other editorial processes are associated with improvements in papers between submission and publication, but published papers remain hard to read and a significant proportion contain errors or omissions. While it is hard to quantify the costs, peer review does not seem an efficient use of resources. Research into the outcomes of peer review, the establishment of sound methods for measuring the quality of the process and its outcomes, and comparisons with alternative methods are needed.

Journal ArticleDOI
TL;DR: No formal recommendations can be made about the use of anticholinergic therapy in acute or stable bronchiectasis based on the literature currently available.
Abstract: Background Anticholinergic agents block bronchoconstriction mediated by the vagus nerve and may also dry up bronchial secretions. They are effective in obstructive airways disease and may be beneficial in bronchiectasis Objectives To determine the effect of anticholinergic therapy in acute exacerbations and stable bronchiectasis. Search methods The Cochrane Airways Group Specialised Register was searched and bibliographies of retrieved papers were checked. Searches are current as of May 2011. Selection criteria Only randomised controlled trials were considered. Data collection and analysis Two reviewers assessed the retrieved studies working independently. Main results Twelve studies were identified, of which six were obtained for further scrutiny. One was translated from Italian. None met the inclusion criteria. An update search conducted in May 2011 did not yield any new studies. Authors' conclusions No formal recommendations can be made about the use of anticholinergic therapy in acute or stable bronchiectasis based on the literature currently available. Plain language summary The effects of anticholinergic drugs in the treatment of bronchiectasis Bronchiectasis is a chronic respiratory disease. People with the condition experience difficulty in clearing mucus from their lungs, leaving them prone to infections. Atrovent and other anticholinergic agents are bronchodilators which could help with opening up the airways in people with bronchiectasis. We looked for randomised studies addressing this question but we could not identify any evidence for or against the use of anticholinergic drugs in the treatment of bronchiectasis.

Journal ArticleDOI
TL;DR: Overall, the study provides a comprehensive baseline profile of drinking behaviour in this community, but did not show the CAGE questionnaire or CDT profile to be useful in in this population.
Abstract: This paper aims to: (1) profile the drinking behaviour of a rural Lesotho community facing relocation; (2) compare the following measures of hazardous drinking in this community: quantity/frequency self-report, the CAGE questionnaire and carbohyd rate- deficient transferrin (CDT) levels; (3) describe community awareness of, and attitude towards, treatment services. As part of a larger baseline survey of community health status, households in 29 villages in Lesotho were randomly sampled. Consenting adults ( n = 348) participated in a face-to-face interview about alcohol use, which included the CAGE. Blood was taken from participants for CDT deter- mination. Fifty-three per cent of men (37/69) and 19% of women (53/279) reported drinking alcohol. Thirty-six per cent of men ( 25/69) and 9% of women (25/279) were classified as hazardous drinkers defined as drinking 350 g (males) or 225 g (females) of alcohol/ week, or 'engaged in bouts of heavy drinking 1 to 2 days a month or more during the past 12 months'. Hazardous drinkers were signific antly more likely to be male and older, but did not differ from the rest of the sample on marital status. Using hazardous drinking as the standard, CAGE (score ♢2) had a positive predictive value (PPV) of 75% for men and 62% for women. The parameters for CDT must be interpreted with caution as the cut-offs for hazardous drinking, especially for women's drinking, were lower than the usual cut-offs in published CDT studies. However, the high specificities for CDT in men (100%; 19/19) and in women (77%; 110/142) are consiste nt with other studies, but the low PPV of 14% (5/37) for men and women combined suggests that CDT is not effective as a predictor of hazardous drinking in this population. There was high awareness of available treatment services among participants, and most be lieved treatment to be beneficial. Overall, the study provides a comprehensive baseline profile of drinking behaviour in this communit y, but did not show the CAGE questionnaire or CDT profile to be useful in in this community.

Reference EntryDOI
TL;DR: Interferons, interferon-inducers and other antivirals appear to have important antiviral properties and are well-tolerated, and future research efforts should focus on non virus-specific compounds.
Abstract: Despite a 60-year history of discovery, trial and evaluation of scores of different compounds, there are no currently licensed effective antivirals for the common cold. The history of the development and abandonment of all potential compounds so far teaches us some important lessons for the continuation of our fight against colds. First, the common cold is a benign self-limiting condition, making the consumption of ‘harmless’ antivirals a requisite of prime importance for regulators. Second, the common cold is a syndrome caused by a myriad of known and unknown agents, which reduces the effectiveness of compounds that interfere with single specific agents or types of agents. The multifactorial nature of the genesis of colds makes it difficult for compounds showing in vitro efficacy to ‘make the jump’ to field effectiveness. Last, despite the heavy burden that the cold imposes on society, the vagueness and shortness of symptoms make it difficult for sufferers to present in time for physicians to prescribe antivirals, which are only effective if taken within a short time frame. Attention should be paid to the development of compounds with a non-virus-specific action.

Patent
09 Oct 2001
TL;DR: A male urinary incontinence control device including a first element for applying preferential pressure to the penis shaft between the lateral superficial veins and the central dorsal vascular group was proposed by as discussed by the authors.
Abstract: A male urinary incontinence control device including a first element for applying preferential pressure to the penis shaft between the lateral superficial veins and the central dorsal vascular group, and a second element for applying pressure ventrally to the penis shaft at the urethra and the corpus spongiosum thereby substantially or completely closing the urethra and preventing or limiting the flow of urine through the urethra.

Journal ArticleDOI
TL;DR: There are no randomised trials upon which to base recommendations about the use of oral corticosteroids in acute or stable bronchiectasis, and there is no evidence for or against theUse of oral steroids for this condition.
Abstract: Background Inflammation plays a significant role in the pathophysiology of bronchiectasis. Two small studies have shown small benefits from inhaled corticosteroids and oral corticosteroids may be of benefit in bronchiectasis Objectives To determine the efficacy of oral corticosteroids in acute and stable bronchiectasis Search methods The Cochrane Airways Group Specialised Register was searched and bibliographies of retrieved papers were checked. Searches are current as of May 2011. Selection criteria Only randomised controlled trials were considered Data collection and analysis No trials met the inclusion criteria for the review. Main results No randomised controlled trials were identified Authors' conclusions There are no randomised trials upon which to base recommendations about the use of oral corticosteroids in acute or stable bronchiectasis. Plain language summary Oral corticosteroids for bronchiectasis (stable and acute exacerbations) Bronchiectasis is a chronic respiratory disease. People with the condition experience difficulty in clearing mucus from their lungs, leaving them prone to infections. Oral steroids have a place in the management of acute and severe asthma. In bronchiectasis, inhaled steroids have small benefits but there is no evidence for or against the use of oral steroids for this condition.

Reference EntryDOI
TL;DR: There is no evidence of a consistent difference between zuclopenthixol acetate and other 'standard drugs' for either the pattern of side effects or the wish to leave the study early, and well conducted randomized controlled trials are needed to confirm claims related to the use of zuclanalyst acetate in emergency psychiatry.
Abstract: Background People with schizophrenia or other psychotic illnesses may have delusions or hallucinations that may lead them to be aggressive or violent to themselves or others. Medication that is used in this context requires the properties of rapid onset of effect (tranquillisation or at least initial sedation in order to quell aggressive or disorganised behaviour, but also antipsychotic effect), low frequency of administration and low levels of side effects, such as cardiological or neurological side effects, or pain at the injection site. Zuclopenthixol is the cis(Z)-isomer of clopenthixol, a neuroleptic of the thioxanthene group, used for treating people with psychotic symptoms. There is one oral preparation and two depot forms: zuclopenthixol acetate and zuclopenthixol decanoate. The acetate version does not stay in the body for very long (a single dose persists for only 72 hours) and is said to have these properties. Objectives To estimate the effectiveness of zuclopenthixol acetate for the acute treatment of serious mental illnesses in comparison to other neuroleptic drugs. Search strategy Searches of Current Controlled Trials (http://www.controlled-trials.com - accessed 5.10.2000), Cochrane Schizophrenia Group's Register of Trials (January 2001), the Cochrane Library (1997, CD-ROM, issue 2), MEDLINE (1966-1997) were supplemented by appeals for unpublished data to the research community and to the Medical Information Department of Lundbeck Limited. Attempts were made to contact relevant authors. Selection criteria Two reviewers independently assessed citations or papers and selected all randomised trials that included people with serious mental illnesses and compared zuclopenthixol acetate with other drug regimes. Data collection and analysis Two reviewers extracted data independently. Attempts were made to contact authors for additional or missing information. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for binary data. Where possible, OR were pooled using Peto method and intention-to-treat analysis undertaken. Mean differences were used for continuous variables. Main results Pooled data show no difference for the outcome 'no important improvement' in psychotic symptoms at the end of the follow-up period (OR 0.84 CI 0.34-2.05). Sedation was evaluated using different instruments. Only one study presented data which suggested an earlier and more intense sedation in zuclopenthixol acetate users at four hours (OR 0.18 CI 0.04-0.93). Use of additional antipsychotic medication was not avoided in the zuclopenthixol acetate group (OR 2.18, CI 0.64-7.42) and data on total number of administrations were not obtainable. Side effect data were poorly reported but there is no evidence of a consistent difference between zuclopenthixol acetate and other 'standard drugs' for either the pattern of side effects or the wish to leave the study early. Hospital and service outcomes, number of aggressive incidents, satisfaction with care and economic outcomes were not addressed by any study. Reviewer's conclusions Recommendations on the use of zuclopenthixol acetate for the management of psychiatric emergencies in preference to 'standard' treatment have to be viewed with caution. Most trials present important methodological flaws and findings are poorly reported. This review did not find any suggestion that zuclopenthixol acetate is more effective in controlling aggressive/disorganised behaviour, acute psychotic symptoms, or preventing side effects. There were no data directly related to tranquillisation, but it may produce more earlier and intense sedation than oral haloperidol. Well-conducted randomised controlled trials are needed to confirm claims related to the use of zuclopenthixol acetate in emergency psychiatry.

Journal ArticleDOI
TL;DR: After 3 months of therapy with a HAART regimen, including two nucleoside analogues plus indinavir, naive patients presented a greater virological response but no significant differences in changes in HR-QOL when compared to pretreated patients.
Abstract: Purpose: To compare changes in health-related quality of life (HR-QOL) over 3 months in a cohort of patients who were initiating their first antiretroviral therapy (naive patients) and patients who had been previously treated with two nucleoside analogues and who switched to HAART (pretreated patients). Method: One hundred thirty-eight patients initiating or changing to HAART (indinavir plus two nucleoside analogues) were recruited from 23 Spanish hospitals. Patients’ HR-QOL was evaluated by administering the Medical Outcome Study HIV Health Survey (MOS-HIV) questionnaire at baseline and after 3 months of treatment. Clinical changes and changes in HR-QOL were measured after 3 months of treatment. The size of changes in HR-QOL scores was calculated at 3 months using the effect size (ES). Results: On entering the study, both groups showed similar characteristics except in viral load and number of symptoms. The naive group presented an average viral load 2.5 times greater than the pretreated group an...

Journal ArticleDOI
TL;DR: Findings suggest that available evidence does not support a causal link or is equivocal but the accuracy of current methods of vaccine surveillance should be urgently improved.
Abstract: The recent decision by the French government to compensate 3 recipients of hepatitis B vaccine preceding the onset of multiple sclerosis presumes a possible causal link and brings into question the use of current rules of causality assessment. Available evidence does not support a causal link or is equivocal but the accuracy of current methods of vaccine surveillance should be urgently improved. Larger and longer randomised trials, updated summaries of evidence, linked databases, prospective vaccination registers, bar-coding of vaccines and standardisation of adverse event definitions are possible measures to address current problems.

Journal ArticleDOI
TL;DR: The rate of full publication of abstracts related to the methodology of systematic reviews seems similar to that for randomized trials.
Abstract: To assess the extent to which abstracts of methodological research, initially presented at meetings on systematic reviews, have gone on to be published as full articles.Full publication was assessed in three ways: a search was carried out of The Cochrane Library; a search was conducted using MEDLINE; and a questionnaire was sent to the contact author of each abstract.Approximately half of the abstracts had not been, or were unlikely ever to be, published in full.The rate of full publication of abstracts related to the methodology of systematic reviews seems similar to that for randomized trials.

Journal ArticleDOI
TL;DR: The study showed that many women, perhaps most, who have previously had a UTI can learn to diagnose and manage a subsequent episode themselves, and it is likely that self-management of recurrent UTI saves time and money.
Abstract: Gupta and colleagues' article in this issue shows that many women with a previous urinary tract infection can learn to diagnose and manage a subsequent episode themselves. This promising finding pr...

Journal ArticleDOI
TL;DR: Arthritis trials have been reported inadequately in relation to meta-analysis and the deficit therefore needs urgent improvement, as most trials are underpowered.
Abstract: OBJECTIVES—To study whether the reporting of clinical outcomes in arthritis trials measured on ordinal and interval scales is adequate in relation to meta-analysis. METHODS—Systematic review of randomised trials of non-steroidal anti-inflammatory drugs in patients with rheumatoid arthritis. Optimal reporting was defined as data in the original ordered categories for global evaluation and pain, and as mean and SD for number of tender joints and grip strength, and if a visual analogue scale had been used to measure pain. RESULTS—A total of 144 trials were included. The median sample size was 60 patients. The quality of the reporting increased over time for three of the four variables. Global evaluation was optimally reported in 52 of the 127 trials (41%) in which it was recorded. Pain was optimally reported in 27 of 98 trials (28%), number of tender joints in 41 of 123 trials (33%), and grip strength in 34 of 124 trials (27%). Even if rather broad criteria are adopted, only about half of the data were reported in a potentially useful way for a meta-analysis. CONCLUSIONS—Arthritis trials have been reported inadequately in relation to meta-analysis. As most trials are underpowered, meta-analysis is indispensable and the deficit therefore needs urgent improvement. Investigators should specify a priori what constitutes an important treatment effect and report numbers of patients improved.