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PubMed2003

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials.

OBJECTIVES: To determine whether parachutes are effective in preventing major trauma related to gravitational challenge. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists. STUDY SELECTION: Studies showing the effects of using a parachute during free fall. MAIN OUTCOME MEASURE: Death or major trauma, defined as an injury severity score > 15. RESULTS: We were unable to identify any randomised controlled trials of parachute intervention. CONCLUSIONS: As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.

Accidents, Aviation↗
PubMed2006

Decision support, knowledge representation and management: A broad methodological spectrum. Findings from the Decision Support, Knowledge Representation and Management.

OBJECTIVES: To summarize current excellent research in the field of decision support, knowledge management and representation. METHODS: Synopsis of the articles selected for the IMIA Yearbook 2006. RESULTS: Decision Support, Knowledge Representation and Management covers a broad spectrum of methods applied to a variety of medical problems and domains. Some particularly interesting and current topics were picked for the IMIA Yearbook 2006: the importance of ontologies for systematic system engineering of decision support systems, syndromic surveillance based on natural language processing, the evaluation of large semantic networks, and a comprehensive ontology for a randomised controlled trial database to support evidence-based practise. CONCLUSIONS: The best paper selection shows that methods for decision support, knowledge representation and management can decisively contribute to the solution of many different medical problems, but also that there is still a lot of exiting research to be done.

Awards and Prizes↗
PubMed1995

Blood pressure lowering for the primary and secondary prevention of coronary and cerebrovascular disease.

An overview of the 17 completed randomised trials of antihypertensive treatment demonstrates that a 5-6 mm Hg reduction in DBP reduced stroke risk by 38% (SD 4) and CHD risk by 16% (SD 4). These results indicate that a few years' treatment with diuretic- or beta-blocker-based therapy produces most or all of the long-term stroke avoidance and much of the long-term CHD avoidance that would be predicted from observational epidemiological studies, given the blood pressure reductions that were achieved in the trials. The relative risk reductions were similar in trials of older and younger patients, although the absolute reduction in events was more than twice as great in the trials in older patients. From these results it can be estimated that in fully compliant patients at similar risk of vascular disease to those included in the trials, antihypertensive treatment for 5 years would prevent one major vascular event among every 20 older patients and one major vascular event among every 60 younger patients. Obviously the benefits of treatment will be greater among those at higher risk than the patients included in the previous trials. The greatest benefits are likely to be achieved in those with a history of vascular disease since their risk of future events is particularly high. Among such patients it is possible that blood pressure reduction will confer worthwhile benefits in those without hypertension, as well as those with hypertension. It is also possible that the benefits of treatment will be determined by the size of the blood pressure reduction and by the choice of the anti-hypertensive agent. However, each of these possibilities requires confirmation in large scale randomised controlled trials.

Adult↗
PubMed2004

Radiography as primary outcome in rheumatoid arthritis: acceptable sample sizes for trials with 3 months' follow up.

OBJECTIVES: To investigate whether plain radiographs can show changes in joint damage due to rheumatoid arthritis (RA) within 3 months. METHODS: 188 film pairs taken with a 3 month interval were evaluated. They were scored with (chronological) and without (paired) knowledge of the sequence of the films according to the Sharp/van der Heijde method. Changes in joint damage were analysed on a group and an individual level for different subsets of patients. Sample sizes required to detect statistically and clinically significant differences were estimated based on the percentages of patients with progression larger than the smallest detectable change (SDC). RESULTS: Changes in joint damage were seen by both the chronological and the paired scoring method. The percentage of patients with progression of joint damage larger than the corresponding SDCs (1.7 and 2.4) varied in the subsets from 18% to 64% if based on the chronological change-scores and from 9% to 36% using paired change-scores. Acceptable sample size estimates were seen in several subsets, depending on (a) how the investigated drug would reduce the individual risk of progression of joint damage (by an absolute or a relative risk reduction model); (b) how damage was scored (chronological or paired); (c) the baseline risk; and (d) whether a two sided or one sided test would be used. CONCLUSIONS: Changes in joint damage due to RA can be detected reliably already within 3 months. This finding can be used to plan short term, randomised controlled trials with radiographic progression as primary outcome.

Adult↗
PubMed2005

The use of positive end-expiratory pressure in the management of the acute respiratory distress syndrome.

Clinical and experimental research on the effects of positive end-expiratory pressure (PEEP) has produced a plethora of information during the last two decades. The application of PEEP is expected to increase PaO2; however, it is generally agreed that simply using increased PaO2 as the end point is inappropriate. Four mechanisms have been proposed to explain the improved pulmonary function and gas exchange with PEEP: 1) increased functional residual capacity; 2) alveolar recruitment; 3) redistribution of extravascular lung water; and 4) improved ventilation-perfusion matching. The optimal method of applying PEEP is still controversial. The main effect of augmenting PEEP is maintain recruitment of alveolar units that were previously collapsed. Thus, since tidal volume is distributed to more alveoli, peak airway pressure is reduced and compliance is increased. During acute lung injury, and depending on the severity of lung disease, PEEP can markedly alter the compliance of the lung by alveolar recruitment. The greater the alveolar collapse and pulmonary edema, the more the compliance curve of the respiratory system shifts downward and to the right. As PEEP is applied and alveoli recruited, the pressure-volume curve shifts upward and to the left. Despite its intuitive benefit, there were very few controlled studies of the effects of PEEP on ARDS outcome and no prospective randomised controlled trial of PEEP has been ever carried out in patients with acute lung injury and/ or ARDS to evaluate its efficacy until recently.

Adult↗
PubMed1976

Comparison of desoximetasone and hydrocortisone butyrate in psoriasis.

Thirty psoriatics were treated for 2 weeks on a double-blind controlled basis with desoximetasone (0.25%) and with hydrocortisone butyrate (0.1%). It was a randomised left-right comparative trial. Thirteen out of 27 patients preferred desoximetasone, 3 patients preferred hydrocortisone butyrate. There was also a significantly better effect of desoximetasone as judged by the observer after the second week of treatment.

Administration, Topical↗
PubMed2005

Labeling of adult stem cells for in vivo-application in the human heart.

Tissue regeneration with human hematopoietic or mesenchymal stem cells has become a fashionable research topic. In cardiology, intracoronary injection of adult stem cells has already been used for the treatment of human myocardial infarction and ischemic cardiomyopathy. The experimental background of such therapies, however, i.e. the potential of adult stem cells to regenerate myocardium through "transdifferentiation" of hematopoietic or mesenchymal stem cells into cardiomyocytes described in animal models, has recently been challenged by other experimental data. Nonetheless, clinical trials are continuing. This may be due to the fact that, in open-labeled pilot trials, a benefit of intracoronary injection of adult stem cells for the treatment of myocardial infarction has been described. As pilot trials may overemphasize the beneficial effects of intracoronary injection of bone marrow stem cells, controlled double-blinded randomised multicenter studies are warranted. Furthermore, a careful characterization of the cells involved in the proposed cardiac repair as well as in vivo-monitoring of such cells following intracoronary injection in humans might help to answer many essential questions linked to this important research topic. The latter requires biocompatible labeling. This review focuses on the technologies available for stem cell labeling and summarizes the arguments and contra-arguments to use these labeling technologies for application in humans.

Adult↗
PubMed2004

Percutaneous transluminal angioplasty and stenting for carotid artery stenosis.

BACKGROUND: Carotid artery stenosis may be treated endovascularly by percutaneous transluminal balloon angioplasty with or without stent insertion or by primary stenting. Endovascular treatment may be a useful alternative to carotid endarterectomy (CEA), particularly for lesions not suitable for surgery. OBJECTIVES: The objective of this review was to assess the benefits and risks of endovascular treatments compared with carotid endarterectomy (in patients suitable for surgery) or medical therapy (in patients not suitable for surgery). SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched 1 September 2003). In addition we searched the following bibliographic databases: Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 to June 2003), EMBASE (1980 to June 2003) and Science Citation Index (1981 to June 2003). We also contacted researchers in the field and balloon catheter and stent manufacturers. SELECTION CRITERIA: We selected randomised trials of carotid endovascular treatment compared with carotid endarterectomy, or endovascular treatment plus best medical therapy compared with best medical therapy alone, in patients with symptomatic or asymptomatic carotid artery stenosis. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion criteria, extracted data and assessed trial quality. MAIN RESULTS: Two completed trials comparing endovascular treatment with carotid endarterectomy involving 608 patients were found. In addition there were two trials which fulfilled the inclusion criteria and which were stopped early (242 patients), and a third trial which has completed randomisation and 30 day follow up of 307 patients. Four trials are ongoing. Meta analysis of the data from the included studies found no significant difference between the odds of death or any stroke at 30 days post procedure (Odds Ratio [OR] endovascular:surgery 1.26, 95% Confidence Interval [CI] 0.82 to 1.94). The odds of death or disabling stroke at 30 days were similar in the endovascular and surgical group (OR 1.22, CI 0.61 to 2.41). At one year following procedure, there was no significant difference between the two groups in preventing any stroke or death (OR 1.36,CI 0.87 to 2.13). Endovascular treatment significantly reduced the risk of cranial neuropathy (OR 0.12, CI 0.06 to 0.25). There was no significant difference between the two groups when the risk of death, any stroke or myocardial infarction was considered (OR 0.99, CI 0.66 to 1.48). There was substantial heterogeneity between the trials for four of the five outcomes. REVIEWERS' CONCLUSIONS: Data from randomised trials comparing endovascular treatment for carotid artery stenosis with carotid endarterectomy suggest that the two treatments have similar early risks of death or stroke and similar long term benefits. However, the substantial heterogeneity renders the overall estimates of effect somewhat unreliable. Furthermore, two trials were stopped early because of safety concerns, so perhaps leading to an over-estimate of the risks of endovascular treatment. On the other hand, endovascular treatment appears to avoid completely the risk of cranial neuropathy. There is also uncertainty about the potential for restenosis to develop and cause recurrent stroke after endovascular treatment. The current evidence does not support a widespread change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis. There is a strong case to continue recruitment in the current randomised trials comparing carotid stenting with endarterectomy.

Angioplasty, Balloon↗
PubMed2004

Interventions for isolated diaphyseal fractures of the ulna in adults.

BACKGROUND: Isolated fractures of the shaft of the ulna, which are often sustained when the forearm is raised to shield against a blow, are generally treated on an out-patient basis. OBJECTIVES: To assess the effects of various forms of treatment for isolated fractures of the ulnar shaft in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (November 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2003), MEDLINE (1966 to November week 2 2003), EMBASE (1981 to 2003 week 51) and CINAHL (1982 to December week 2 2003), Current Controlled Trials (accessed November 2003), the UK National Research Register (up to Issue 4, 2003 ), various conference proceedings and bibliographies of relevant articles. Date of the most recent search: December 2003. SELECTION CRITERIA: Randomised or quasi-randomised trials of conservative and surgical treatment of isolated fractures of the ulnar shaft in adults. Excluded were fractures of the proximal ulna and Monteggia fracture dislocations. DATA COLLECTION AND ANALYSIS: Independent quality assessment and data extraction were performed by the reviewers. Requests for more information were sent to trialists. Given the limited and generally poor quality evidence available, quantitative analysis was kept to a minimum. MAIN RESULTS: One new trial comparing two types of plates used for the surgical fixation of these fractures was included in the fifth update of this review. Thus there are now three trials, involving a total of 135 patients. All three trials were methodologically flawed, particularly the two trials of conservative treatment. One of these compared short arm pre-fabricated functional braces with long arm plaster casts. There was no statistically significant difference in the time it took for fracture union. Patient satisfaction and return to work were better in the brace group. The other, a quasi-randomised trial, compared Ace Wrap elastic bandage, short arm plaster cast and long arm plaster cast. The large loss to follow-up in this trial makes any data analysis tentative. However the need for replacement of the Ace wrap by other methods due to pain does indicate the potential for a serious problem with this intervention. There were no statistically significant differences in anatomical or functional outcomes nor complications between the two plate groups in the surgical trial. REVIEWERS' CONCLUSIONS: There is insufficient evidence from randomised trials to determine which method of treatment is the most appropriate for isolated fractures of the ulnar shaft in adults. There is a need to establish the incidence of this injury and the outcome and associated costs of the various forms of treatment. Well designed randomised trials of current forms of conservative treatment are recommended.

Adult↗
PubMed2005

Screening and case finding instruments for depression.

BACKGROUND: Screening or case finding instruments have been advocated as a simple, quick and inexpensive method to improve detection and management of depression in non-specialist settings, such as primary care and the general hospital. However, screening/case finding is just one of a number of strategies that have been advocated to improve the quality of care for depression. The adoption of this seemingly simple and effective strategy should be underpinned by evidence of clinical and cost effectiveness. OBJECTIVES: To determine the clinical and cost effectiveness of screening and case finding instruments in: (1) improving the recognition of depression; (2) improving the management of depression, and (3) improving the outcome of depression. SEARCH STRATEGY: The researchers undertook electronic searches of The Cochrane Library (Issue 4, 2004); The Cochrane Depression, Anxiety and Neurosis Group's Register [2004); EMBASE (1980-2004); MEDLINE (1966-2004); CINAHL (to 2004) and PsycLIT (1974-2004). References of all identified studies were searched for further trials, and the researchers contacted authors of trials. SELECTION CRITERIA: Randomised controlled trials of the administration of case finding/screening instruments for depression and the feedback of the results of these instruments to clinicians, compared with no clinician feedback. Trials had to be conducted in non-mental health settings, such as primary care or the general hospital. Studies that used screening strategies in addition to enhanced care, such as case management and structured follow up, were specifically excluded. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by researchers, papers ordered, re-inspected and quality assessed. Data were also independently extracted. Data relating to: (1) the recognition of depression; (2) the management of depression and (3) the outcome of depression over time were sought. For dichotomous data the Relative Risk (RR), 95% confidence interval (CI) were calculated on an intention-to-treat basis. For continuous data, weighted and standardised mean difference were calculated. A series of a priori sensitivity analyses relating to the method of administration of questionnaires and population under study were used to examine plausible causes of heterogeneity. MAIN RESULTS: Twelve studies (including 5693 patients) met our inclusion criteria. Synthesis of these data gave the following results:(1) the recognition of depression: according to case note entries of depression, screening/case finding instruments had borderline impact on the overall recognition of depression by clinicians (relative risk 1.38; 95% confidence interval 1.04 to 1.83). However, substantial heterogeneity was found for this outcome. Screening and feedback, irrespective of baseline score of depression has no impact on the detection of depression (relative risk 1.00; 95% confidence interval 0.89 to 1.13). In contrast, three small positive studies using a two stage selective procedure, whereby patients were screened and only patients scoring above a certain threshold were entered into the trial, did suggest that this approach might be effective (relative risk 2.66; 95% confidence interval 1.78 to 3.96). Separate pooling according to this variable reduced the overall level of heterogeneity. Publication bias was also found for this outcome.(2) the management of depression: according to case note entries for active interventions and prescription data, a selected subsample of all studies reported this outcome and found that there was there was an overall trend to showing a borderline higher intervention rate amongst those who received feedback of screening/case finding instruments (relative risk 1.35; 95% confidence interval 0.98 to 1.85), although substantial heterogeneity between studies existed for this outcome. This result was dependant upon the presence of one highly positive study.(3) the outcome of depression: few studies reported the impact of case finding/screening instruments on the actual outcome of depression, and no statistical pooling was possible. However, three out of four studies reported no clinical effect (p<0.05) at either six months or twelve months. No studies examined the cost effectiveness of screening/case finding as a strategy. AUTHORS' CONCLUSIONS: There is substantial evidence that routinely administered case finding/screening questionnaires for depression have minimal impact on the detection, management or outcome of depression by clinicians. Practice guidelines and recommendations to adopt this strategy, in isolation, in order to improve the quality of healthcare should be resisted. The longer term benefits and costs of routine screening/case finding for depression have not been evaluated. A two stage procedure for screening/case finding may be effective, but this needs to be evaluated in a large scale cluster randomised trial, with a prospective economic evaluation.

Depression↗
PubMed2005

Base administration or fluid bolus for preventing morbidity and mortality in preterm infants with metabolic acidosis.

BACKGROUND: Metabolic acidosis in the early newborn period is associated with adverse outcomes in preterm infants. The most commonly used strategies to correct metabolic acidosis are intravascular infusion of base, for example sodium bicarbonate, and intravascular infusion of a fluid bolus, usually a crystalloid or colloid solution. OBJECTIVES: To evaluate the available evidence from randomised controlled trials that either infusion of base, or of a fluid bolus, reduces mortality and adverse neurodevelopmental outcomes in preterm infants with metabolic acidosis. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE (1966 - January 2005), EMBASE (1980 - January 2005), CINAHL (1982 - January 2005). SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that evaluated the following treatments for preterm infants with metabolic acidosis:1. Infusion of base versus no treatment.2. Infusion of fluid bolus versus no treatment.3. Infusion of base versus fluid bolus. DATA COLLECTION AND ANALYSIS: We extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two authors, and synthesis of data using relative risk and risk difference. MAIN RESULTS: We found two small randomised controlled trails that fulfilled the eligibility criteria (Corbet 1977; Dixon 1999). Corbet 1977 compared treating infants with sodium bicarbonate infusion (N = 30) versus no treatment (N = 32) and did not find evidence of an effect on mortality [Relative risk 1.39 (95% confidence interval 0.72 to 2.67), risk difference 0.12 (95% confidence interval -0.12 to 0.36)], or in the incidence of intra/peri-ventricular haemorrhage [Relative risk 1.24 (95% confidence interval 0.47 to 3.28), risk difference 0.05 (95% confidence interval -0.16 to 0.25)]. Dixon 1999 compared treatment with sodium bicarbonate (N = 16) versus fluid bolus (N = 20). The primary outcome assessed was arterial blood pH/base excess two hours after the intervention. Other clinical outcomes were not reported. Neither trial assessed longer term neurodevelopmental outcomes. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to determine whether infusion of base or fluid bolus reduces morbidity and mortality in preterm infants with metabolic acidosis. Further large randomised trials are needed.

Acidosis↗