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PubMed2001

Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature.

BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) are common diseases of the airways and lungs that have a major impact on the health of the population. The mainstay of treatment is by inhalation of medication to the site of the disease process. This can be achieved by a number of different device types, which have wide variations in costs to the health service. A number of different inhalation devices are available. The pressurised metered-dose inhaler (pMDI) is the most commonly used and cheapest device, which may also be used in conjunction with a spacer device. Newer chlorofluorocarbons (CFC)-free inhaler devices using hydrofluoroalkanes (HFAs) have also been developed. The drug is dissolved or suspended in the propellant under pressure. When activated, a valve system releases a metered volume of drug and propellant. Other devices include breath-actuated pMDIs (BA-pMDI), such as Autohaler and Easi-Breathe. They incorporate a mechanism activated during inhalation that triggers the metered-dose inhaler. Dry powder inhalers (DPI), such as Turbohaler, Diskhaler, Accuhaler and Rotahaler, are activated by inspiration by the patient. The powdered drug is dispersed into particles by the inspiration. With nebulisers oxygen, compressed air, or ultrasonic power is used to break up solutions or suspensions of medication into droplets for inhalation. The aerosol is administered by mask or by a mouthpiece. There has been no previous systematic review of the evidence of clinical effectiveness and cost-effectiveness of these different inhaler devices. OBJECTIVES: To review systematically the clinical effectiveness and cost-effectiveness of inhaler devices in asthma and COPD. METHODS: The different aspects of inhaler devices were separated into the most clinically relevant comparisons. Methods involved systematic searching of electronic databases and bibliographies for randomised controlled trials (RCTs) and systematic reviews. Pharmaceutical companies and experts in the field were contacted for further information. Trials that met the inclusion criteria were appraised and data extraction was under-taken by one reviewer and checked by a second reviewer, with any discrepancies being resolved through agreement. RESULTS--IN VITRO CHARACTERISTICS VERSUS IN VIVO TESTING AND CLINICAL RESPONSE: There is evidence that when comparative testing is performed on inhaler devices using the same methods, there is some correlation between particle size measurements and clinical response. However, the measurements are dependent upon the methods used, and a single measure of a device in isolation is of limited value. Also, there is little data on comparing devices of different types. There is currently insufficient data to verify the ability of in vitro assessments to predict inhaler performance in vivo. RESULTS--EFFECTIVENESS OF METERED-DOSE INHALERS FOR THE DELIVERY OF CORTICOSTEROIDS IN ASTHMA: The review of three trials in children and 21 trials in adults demonstrated no evidence to suggest clinical benefits of any other inhaler device over a pMDI in corticosteroid delivery. RESULTS--EFFECTIVENESS OF METERED-DOSE INHALERS FOR THE DELIVERY OF BETA-AGONISTS IN STABLE ASTHMA: In children, 11 studies were reviewed, of which seven compared the Turbohaler with the pMDI. One study found a significant treatment difference in peak expiratory flow rate, although there were differences in the patients' baseline characteristics. In adults, a review of 70 studies found no demonstrable difference in the clinical bronchodilator effect of short-acting b2-agonists delivered by the standard pMDI compared with that produced by any other DPI, HFA-pMDI or the Autohaler device. The finding that HFA-pMDIs may reduce treatment failure and oral steroid requirement in beta-agonist delivery needs further confirmatory research in adequately randomised clinical trials. RESULTS--EFFECTIVENESS OF NEBULISERS VERSUS METERED-DOSE INHALERS FOR THE DELIVERY OF BRONCHODILATORS IN STABLE ASTHMA: In children, three included trials compared different devices with a nebuliser and demonstrated no evidence of clinical superiority of nebulisers over inhaler devices in bronchodilator delivery. A total of 23 studies in adults found no equivalence for the main pulmonary outcomes and no evidence of difference in other outcomes. RESULTS--EFFECTIVENESS OF METERED-DOSE INHALERS FOR THE DELIVERY OF BETA-AGONISTS IN COPD: Only two studies were included in this review. No evidence of clinical difference was found in beta-agonist delivery. RESULTS--EFFECTIVENESS OF NEBULISERS VERSUS METERED-DOSE INHALERS FOR THE DELIVERY OF BRONCHODILATORS IN COPD: Evidence from 14 trials demonstrated equivalence for the main outcomes of pulmonary function. For other outcomes there was no evidence of treatment difference in bronchodilator delivery. RESULTS--PATIENTS' ABILITY TO USE METERED-DOSE INHALERS: Differences among studies and the heterogeneity of the results make it difficult to draw conclusions about inhaler technique differences between device types. The review of technique after teaching the correct technique suggests that there is no difference in patients' ability to use DPI or pMDIs. RESULTS--ECONOMIC ANALYSIS: The total number of NHS prescriptions for inhaler therapy for asthma in 1998 was over 31 million, with a net ingredient cost in excess of 392 million GB pounds. This economic assessment uses decision analysis to estimate the relative cost-effectiveness of inhaler devices for the delivery of bronchodilator and corticosteroid inhaled therapy. Overall, there were no differences in patient outcomes among the devices. On the assumption that the devices were clinically equivalent, pMDIs were the most cost-effective devices for asthma treatment. CONCLUSIONS: This systematic review examined the evidence from clinical trials evaluating the clinical effectiveness of different inhaler devices in the delivery of inhaled corticosteroids and beta2-bronchodilators for patients with asthma and COPD. The evidence from the published clinical literature demonstrates no difference in clinical effectiveness between nebulisers and alternative inhaler devices compared to standard pMDI with or without a spacer device. The cost-effectiveness evidence therefore favours pMDIs (or the cheapest inhaler device) as first-line treatment in all patients with stable asthma unless other specific reasons are identified. Patients can use pMDIs as effectively as other inhaler devices as long as the correct inhalation technique is taught. CONCLUSIONS--RECOMMENDATIONS FOR RESEARCH: Further clinical trials are required to demonstrate any differences in the clinical effectiveness and cost-effectiveness of inhaler devices and nebulisers compared with pMDIs. These should be of sufficient statistical power and methodological rigour to demonstrate any clinical benefit. Trials should be undertaken in community settings to ensure the generalisability of results. Outcome measures should be more patient-centred and report adverse effects more completely. Reporting of data from trials should be improved.

Adolescent↗

PubMed2003

Systematic review and economic decision modelling for the prevention and treatment of influenza A and B.

OBJECTIVES: To establish the clinical and cost-effectiveness of amantadine, oseltamivir and zanamivir compared to standard care for the treatment and prevention of influenza. DATA SOURCES: Electronic databases. Reference lists of identified articles and key publications. Relevant trials. REVIEW METHODS: A systematic review and meta-analysis of the randomised evidence was undertaken to investigate the effectiveness of oseltamivir and zanamivir compared to standard care for treatment and prophylaxis use for influenza A and B. An additional systematic review of the effectiveness of amantadine for treatment and prophylaxis use for influenza A in children and the elderly was also undertaken. Economic decision models were constructed to examine the cost-effectiveness and cost-utility of the alternative strategies for treating and preventing influenza A and/or B. This was informed by the systematic reviews outlined above and additional sources of information where required. RESULTS: The systematic review of the treatment of influenza found that oseltamivir reduced the median duration of symptoms in the influenza positive group by 1.38 days for the otherwise healthy adult population, 0.5 day for the high-risk population, and 1.5 days for the children population. This compared to 1.26 days, 1.99 days, and 1.3 for the similar groups for inhaled zanamivir. The systematic review of the prevention of influenza found that the relative risk reduction for oseltamivir was between approximately 75 and 90% and approximately 70 and 90% for inhaled zanamivir depending on the strategy adopted and the population under consideration. For the economic model a base case was constructed that focussed primarily on the health benefits generated by shortening the period of influenza illness. This base case found that, compared to standard care, the estimated cost per quality-adjusted life year ranged from pound 6190 to pound 31,529 for healthy adults, from pound 4535 to pound 22,502 for the 'high-risk' group, from pound 6117 to pound 30,825 for children, and from pound 5057 to pound 21,781 for the residential care elderly population. The base case model included valuations of the health effects of pneumonia (and otitis media in the children's model) based on observed rates in the trials. However it does not include the cost of hospitalisations as only very limited data was available for the effects of antivirals on hospitalisation rates. As for mortality rates, deaths from influenza were rare in trials of neuraminidase inhibitors (NIs). Therefore, suitable data on mortality were not available from these sources. As avoided hospitalisation costs and avoided mortality are potentially important we also carried out sensitivity analysis that involved extrapolating the observed reductions in pneumonias in the NI trials to hospitalisations and deaths. In all four models the cost-effectiveness of NIs is substantially improved by this extrapolation. For prophylaxis, antiviral drugs were compared with vaccination as preventative strategies. In all cases the cost-effectiveness ratios for vaccination were either low or cost-saving. In the base case the cost-effectiveness of antivirals was relatively unfavourable, there were scenarios relating to the elderly residential care model where antivirals as an additional strategy could be cost-effective. CONCLUSIONS: The cost-effectiveness varies markedly between the intervention strategies and target populations. The estimate of cost effectiveness is also sensitive to variations in certain key parameters of the model, for example the proportion of all influenza-like illnesses that are influenza. The effectiveness literature that was used to inform the economic decision model spans many decades and hence great caution should be exercised when interpreting the results of indirect intervention comparisons from the model. Further randomised trials making direct comparisons would be valuable to verify the model's findings.

Antiviral Agents↗

PubMed2004

Systematic review of the long-term effects and economic consequences of treatments for obesity and implications for health improvement.

OBJECTIVES: To undertake a systematic review of the long-term effects of obesity treatments on body weight, risk factors for disease, and disease. METHODS: The study encompassed three systematic reviews that examined different aspects of obesity treatments. (1) A systematic review of obesity treatments in adults where the methods of the Cochrane Collaboration were applied and randomised controlled trials (RCTs) with a follow-up of at least 1 year were evaluated. (2) A systematic epidemiological review, where studies were sought on long-term effects of weight loss on morbidity and/or mortality, and examined through epidemiological modelling. (3) A systematic economic review that sought reports with both costs and outcomes of treatment, including recent reports that assessed the cost-effectiveness of pharmaceutical and surgical interventions. A Markov model was also adopted to examine the cost-effectiveness of a low-fat diet and exercise intervention in adults with obesity and impaired glucose tolerance. RESULTS: The addition of the drugs orlistat or sibutramine was associated with weight loss and generally improved risk factors, apart from diastolic blood pressure for sibutramine. Metformin was associated with decreased mortality after 10 years in obese people with type 2 diabetes. Low-fat diets were associated with continuing weight loss for 3 years and improvements in risk factors, as well as prevention of type 2 diabetes and improved control of hypertension. Insufficient evidence was available to demonstrate the benefits of low calorie or very low calorie diets. The addition of an exercise or behaviour programme to diet was associated with improved weight loss and risk factors for at least 1 year. Studies combining low-fat diets, exercise and behaviour therapy suggested improved hypertension and cardiovascular disease. Family therapy was associated with improved weight loss for 2 years compared to individual therapy. There was insufficient evidence to conclude that individual therapy was more beneficial than group therapy. Weight lost more quickly (within 1 year), from the epidemiology review, may be more beneficial with respect to the risk of mortality. The effects of intentional weight loss need further investigation. Weight loss from surgical and non-surgical interventions for people suffering from obesity was associated with decreased risk of development of diabetes, and a reduction in low-density lipoprotein cholesterol, total cholesterol and blood pressure, in the long term. Targeting high-risk individuals with drugs or surgery was likely to result in a cost per additional life-year or quality-adjusted life-year (QALY) of no more than 13,000 British pounds. There was also suggestive evidence of cost saving from treatment of people with type 2 diabetes with metformin. Targeting surgery on people with severe obesity and impaired glucose tolerance was likely to be more cost-effective at 2329 British pounds per additional life-year. Economic modelling over 6 years for diet and exercise for people with impaired glucose tolerance was associated with a high initial cost per additional QALY, but by the sixth year the cost per QALY was 13,389 British pounds. Results did not include cost savings from diseases other than diabetes, and therefore may be conservative. CONCLUSIONS: The drugs orlistat and sibutramine appear beneficial for the treatment of adults with obesity, and metformin for obese patients with type 2 diabetes. Exercise and/or behaviour therapy appear to improve weight loss when added to diet. Low-fat diets with exercise, or with exercise and behaviour therapy are associated with the prevention of type 2 diabetes and hypertension. Long-term weight loss in epidemiological studies was associated with reduced risk of type 2 diabetes, and may be beneficial for cardiovascular disease. Low-fat diets and exercise interventions in individuals at risk of obesity-related illness are of comparable cost to drug treatments. Long-term pragmatic RCTs of obesity treatments in populations with obesity-related illness or at high risk of developing such illness are needed (to include an evaluation of risk factors, morbidity, quality of life and economic evaluations). Drug trials that include dietary advice, plus exercise and/or behaviour therapy are also needed. Research exploring effective types of exercise, diet or behaviour and also interventions to prevent obesity in adults is required.

Anti-Obesity Agents↗

PubMed1999

Conflicting conclusions from two systematic reviews of epidural steroid injections for sciatica: which evidence should general practitioners heed?

Systematic reviews and meta-analyses are becoming increasingly important in informing clinical practice and commissioning. Two systematic reviews of a treatment for low back pain and sciatica using epidural steroid injections, published in the same year, arrived at conflicting conclusions. Only one was reported in a digest for evidence-based medicine. This paper aims to find the reasons for the discordance between the reviews, and draw conclusions for users of reviews. Using comparative analysis of two published systematic reviews and their source material, it was found that the two reviews had the same overall aims and met the criteria for review methods. They differed in their choice of methods, including the judgement of quality of studies for inclusion and for summing-up evidence. Estimation of summary odds ratios in one review led to stronger conclusions about effectiveness. In conclusion, the choice of methods for systematic review may alter views about the current state of evidence. Users should be aware that systematic reviews include an element of judgement, whatever method is used.

Adrenal Cortex Hormones↗

PubMed2004

[Primary prevention for alcohol misuse in young people: a Cochrane Systematic Review].

The Cochrane Collaboration is an international no-profit organization established in 1992 in UK. The aim of the Collaboration is the conduction, update and dissemination of systematic reviews about health care. Systematic reviews are electronic documents systematically updated which synthesise the results of randomized controlled studies about treatments. The Cochrane Group on Drugs and Alcohol has the editorial base in Rome (Department of Epidemiology ASL RME) where the Coordinator, the Coordinating Editor and the Trial Search Coordinator, coordinate the work of seven editors based in several countries. As of April 2003 we published 17 reviews and 11 protocols of review. The systematic reviews on primary prevention for alcohol misuse in young people, was conducted by David Foxcroft and published by the group in 2002. The objectives of the systematic review were the identification and synthesis of the studies on psychosocial and educational programs for prevention of alcohol abuse and the assessment of long term interventions (over three years).

Adolescent↗

PubMed2005

The librarian's roles in the systematic review process: a case study.

UNLABELLED: QUESTION/SETTING: Although the systematic review has become a research standard, little information addresses the actions of the librarian on a systematic review team. METHOD: This article is an observational case study that chronicles a librarian's required involvement, skills, and responsibilities in each stage of a real-life systematic review. MAIN RESULTS: Examining the review process reveals that the librarian's multiple roles as an expert searcher, organizer, and analyzer form an integral part of the Cochrane Collaboration's criteria for conducting systematic reviews. Moreover, the responsibilities of the expert searcher directly reflect the key skills and knowledge depicted in the "Definition of Expert Searching" section of the Medical Library Association's policy statement, "Role of Expert Searching in Health Sciences Libraries." CONCLUSION: Although the librarian's multiple roles are important in all forms of medical research, they are crucial in a systematic review. As an expert searcher, the librarian must interact with the investigators to develop the terms required for a comprehensive search strategy in multiple appropriate sources. As an organizer and analyzer, the librarian must effectively manage the articles and document the search, retrieval, and archival processes.

Humans↗

PubMed2026

Identifying and Prioritizing Core Components of Relationship Education Programs: a Case Study of an Artificial Intelligence (AI) Assisted Systematic Review.

The field of prevention science seeks to identify and implement effective strategies to address social, emotional, and health challenges. A critical aspect of this endeavor is determining the core components of prevention programs that drive positive outcomes. This article presents a case study utilizing artificial intelligence (AI)-assisted systematic review methods to identify key components of healthy marriage and relationship education programs. Given the growing body of research in this domain, AI tools offer a promising means to enhance the efficiency and accuracy of literature reviews. This study employed AI to screen, code, and validate research articles, demonstrating its effectiveness in expediting systematic reviews while maintaining high accuracy in inclusion screening. This case study involved a systematic review of 22,028 resources (identified from PsycINFO, Academic Search Ultimate, and Google) and a final data set of 268 relevant studies. AI screening was integral in effectively conducting multiple rounds of screening. However, findings also highlight challenges in AI-assisted qualitative data abstraction, underscoring the continued need for human expertise in complex coding tasks. The study contributes to the ongoing discourse on integrating AI into prevention science methodologies and offers insights for optimizing AI applications in systematic reviews.

Artificial Intelligence↗

PubMed1989

Systematic analysis of the total proteins of a mammalian organism: principles, problems and implications for sequencing the human genome.

High-resolution two-dimensional electrophoresis (2-DE) has reached a technological level that allows us to resolve most of the numerous unknown protein species of a mammalian organism if appropriate strategies are used. We will discuss the problems of classification and characterization of proteins and propose a systematic approach to the analysis of the total protein complex. Both a comprehensive as well as a pragmatic approach towards systematic analysis have been considered. A "complex protein database" is suggested and considered with regard to various uses. A systematic analysis of the mouse proteins has been started and some of the preliminary results are summarized here. In particular, genetic properties of the proteins were investigated and are presented in order to demonstrate the significance of a systematic analysis of proteins for research and practical application (e.g. mutagenicity testing). A concept is presented for sequencing the coding DNA of mouse and man, starting with a systematic analysis of mouse proteins and then using two recently developed methods - microsequencing of proteins from spots of 2-DE protein patterns, and utilization of the relatively short N-terminal sequences obtained - to produce the corresponding cDNA's of these proteins.

Animals↗

PubMed1987

Volume estimation of biological objects by systematic sections.

The absolute volume of biological objects is often estimated stereologically from an exhaustive set of systematic sections. The usual volume estimator V is the sum of the section contents times the distance between sections. For systematic sectioning with a random start, it has been recently shown that V is unbiased when m, the ratio between projected object length and section distance, is an integer number (Cruz-Orive 1985). As this quantity is no integer in the real world, we have explored the properties of V in the general and realistic situation m epsilon R. The unbiasedness of V under appropriate sampling conditions is demonstrated for the arbitrary compact set in 3 dimensions by a rigorous proof. Exploration of further properties of V for the general triaxial ellipsoid leads to a new class of non-elementary real functions with common formal structure which we denote as np-functions. The relative mean square error (CE2) of V in ellipsoids is an oscillating differentiable np-function, which reduces to the known result CE2 = 1/(5m4) for integer m. As a biological example the absolute volumes of 10 left cardiac ventricles and their internal cavities were estimated from systematic sections. Monte Carlo simulation of replicated systematic sectioning is shown to be improved by using m epsilon R instead of m epsilon N. In agreement with the geometric model of ellipsoids with some added shape irregularities, mean empirical CE was proportional to m-1.36 and m-1.73 in the cardiac ventricle and its cavity. The considerable variance reduction by systematic sectioning is shown to be a geometric realization of the principle of antithetic variates.

Animals↗

PubMed1976

[Significance of sibling constellations for the origin of systematic schizophrenias (author's transl)].

In previous examinations of twins the author found that, surprisingly, "systematic schizophrenias" did not occur in identical twins, whereas they did in binovular twins. Even though the term systematic schizophrenia may not be accepted, the results, in any case, remain valid because they are based on a classification that had been defined and described prior to the present investigation. From the findings in twins the question arised as to whether the constellation of siblings who are not twins might also be significant in preventing the outbreak of systematic schizophrenias. Therefore, in a sample of 500 patients examined earlier we stated how many siblings, older siblings, younger siblings, brothers, sisters were to be found in systematic schizophrenias and their special types. There were many findings, in part being statistically significant, in part suggesting, at least, that they be taken into consideration. As a result of the findings it seems clear that sibling constellations are important for the origin of systematic schizophrenias. Thus, whereas psychosocial factors proved prominent, we found the heredity rate especially low in these forms of schizophrenia.

Age Factors↗

PubMed1975

Systematic desensitization of erectile impotence: a controlled study.

Results of a study conducted to assess the therapeutic effectiveness of systematic desensitization of erectile impotence are described. Three groups of eight patients each were formed. They were treated with systematic desensitization or conventional medication and general advice, or put on a waiting list. Therapeutic effects were investigated on the behavioral, subjective, and physiological levels. There were no significant differences among the three groups except on the subjective level. On this level, after therapy the systematic desensitization group rated feelings in sexually arousing situations as associated with significantly less anxiety than the other two groups. Systematic desensitization used alone as a treatment for erectile impotence shows only limited therapeutic effect. The unimproved patients were later treated using a modification of the Masters and Johnson technique. Early results suggest that this technique may be superior to systematic desensitization alone.

Adult↗

PubMed2006

Symptom evaluation in palliative medicine: patient report vs systematic assessment.

PURPOSE: This study examined symptoms reported by patients after open-ended questioning vs those systematically assessed using a 48-question survey. MATERIALS AND METHODS: Consecutive patients referred to the palliative medicine program at the Cleveland Clinic Foundation were screened. Open-ended questions were asked initially followed by a 48-item investigator-developed symptom checklist. Each symptom was rated for severity as mild, moderate, or severe. Symptom distress was also evaluated. Data were collected using standardized pre-printed forms. RESULTS: Two hundred and sixty-five patients were examined and 200 were eligible for assessment. Of those assessed, the median age was 65 years (range 17-90), and median ECOG performance status was 2 (range 1-4). A total of 2,397 symptoms were identified, 322 volunteered and 2,075 by systematic assessment. The median number of volunteered symptoms was one (range zero to six). Eighty-three percent of volunteered symptoms were moderate or severe and 17% mild. Ninety-one percent were distressing. Fatigue was the most common symptom identified by systematic assessment but pain was volunteered most often. The median number of symptoms found using systematic assessment was ten (0-25). Fifty-two percent were rated moderate or severe and 48% mild. Fifty-three percent were distressing. In total, 69% of 522 severe symptoms and 79% of 1,393 distressing symptoms were not volunteered. Certain symptoms were more likely to be volunteered; this was unaffected by age, gender, or race. CONCLUSION: The median number of symptoms found using systematic assessment was tenfold higher (p<0.001) than those volunteered. Specific detailed symptom inquiry is essential for optimal palliation in advanced disease.

Adolescent↗

PubMed1994

Systematized delusions and neuropsychological function in paranoid and nonparanoid schizophrenia.

We extended research originating with the Tsuang-Winokur criteria for paranoid and nonparanoid schizophrenia. To partially resolve problems of subtype instability, 41 consecutive admissions meeting DSM-III-R criteria for schizophrenia were subdivided according to whether they ever experienced prominent systematized delusions. Neuropsychological profiles for paranoid patients and nonparanoids with a history of systematized delusions were extremely similar. When combined, this 'systematized' group had significantly better general verbal ability and verbal memory than patients who never manifested systematized delusions. There was also a significant neuropsychological function-by-group interaction. The neuropsychological data suggested that systematized patients had better premorbid cognitive functioning as well as a greater discrepancy between premorbid verbal ability and current attentional functioning. No between-group differences were found on a measure of prefrontal-executive function, nor were there any neuropsychological differences between traditionally defined (DSM-III-R) paranoid and nonparanoid subgroups. This study suggests a possible shift in the dividing line between paranoid and nonparanoid subtypes and illustrates the potential value of neuropsychological data for refining psychiatric nosologies.

Adult↗

PubMed2004

Availability of large-scale evidence on specific harms from systematic reviews of randomized trials.

PURPOSE: To assess how frequently systematic reviews of randomized controlled trials convey large-scale evidence on specific, well-defined adverse events. METHODS: We searched the Cochrane Database of Systematic Reviews for reviews containing quantitative data on specific, well-defined harms for at least 4000 randomized subjects, the minimum sample required for adequate power to detect an adverse event due to an intervention in 1% of subjects. Main outcome measures included the number of reviews with eligible large-scale data on adverse events, the number of ineligible reviews, and the magnitude of recorded harms (absolute risk, relative risk) based on large-scale evidence. RESULTS: Of 1727 reviews, 138 included evidence on > or =4000 subjects. Only 25 (18%) had eligible data on adverse events, while 77 had no harms data, and 36 had data on harms that were nonspecific or pertained to <4000 subjects. Of 66 specific adverse events for which there were adequate data in the 25 eligible reviews, 25 showed statistically significant differences between comparison arms; most pertained to serious or severe adverse events and absolute risk differences <4%. In 29% (9/31) of a sample of large trials in reviews with poor reporting of harms, specific harms were presented adequately in the trial reports but were not included in the systematic reviews. CONCLUSION: Systematic reviews can convey useful large-scale information on adverse events. Acknowledging the importance and difficulties of studying harms, reporting of adverse effects must be improved in both randomized trials and systematic reviews.

Humans↗

PubMed2005

An analysis of systematic reviews indicated low incorpororation of results from clinical trial quality assessment.

OBJECTIVE: We investigated the frequency of quality assessment of randomized controlled trials within systematic reviews and the incorporation of the quality assessment in the analysis. STUDY DESIGN AND SETTING: We included new systematic reviews of at least five trials of therapeutic or preventive interventions that appeared in issue 2, 2003, of the Cochrane Database of Systematic Reviews. All systematic reviews in the 2002 issues of the Annals of Internal Medicine, BMJ, JAMA, and Lancet were identified in Pubmed. All reviews were assessed under unblinded conditions using preprinted extraction forms. RESULTS: Trial quality was assessed in all Cochrane reviews and most (74%) of the paper reviews. When we excluded 11 paper reviews that were also published as Cochrane review, the percentage remained similar (67%). Fifty percent of all Cochrane reviews and 61% of all paper reviews incorporated the results of the quality assessment in the analysis. CONCLUSION: Half of the reviews did not incorporate the results of the quality assessment in the analysis. Authors, peer-reviewers, and editors should no longer focus exclusively on whether quality assessment has been performed but should also concentrate on incorporation of quality assessments in the analysis of the systematic review.

Databases, Bibliographic↗

PubMed2005

Systematic reviews involving complementary and alternative medicine interventions had higher quality of reporting than conventional medicine reviews.

OBJECTIVE: To compare the quality of systematic reviews reported in English and in languages other than English, and to determine whether there are differences between conventional medicine (CM) and complementary and alternative medicine (CAM) reports. STUDY DESIGN AND SETTING: We used the Oxman and Guyatt (OG) scale to assess the quality of reporting in 130 systematic reviews: 50 were language-restricted, 32 were language-inclusive but only English-language (EL) trials contained (inclusive-EL), and 48 were language-inclusive and included trials published in languages other than English (inclusive-LOE). Of the 130 reviews, 105 addressed CM interventions and 25 addressed CAM interventions. RESULTS: Comparison of the systematic reviews showed that the quality of reporting and reporting characteristics are not affected by inclusion or exclusion of LOE; however, the quality of reporting of systematic reviews involving CAM interventions is higher than that of reviews focusing on CM interventions. CONCLUSION: Informal comparison of the OG scale with the data collected on quality assessments showed that the OG scale performs well overall but may not identify important differences in comprehensiveness of the search strategy and avoidance of bias in study selection. Further research is required to determine the best methods for assessing quality of systematic reviews and whether the effect of language restrictions is dependent on the type of intervention (CM or CAM).

Bias↗

PubMed2006

Quality assessment of observational studies is not commonplace in systematic reviews.

BACKGROUND AND OBJECTIVE: To review current practice in the assessment of the quality of original observational studies included in systematic reviews. MATERIALS AND METHODS: Examination of all systematic reviews identified by a basic PubMed search for the years 1999-2000 (32 reviews) and 2003-2004 (98 reviews). English language systematic reviews published in peer-reviewed journals was the setting. Each review was evaluated for the use of quality assessment of original observational studies and if quality assessment occurred, what type of assessment was used. RESULTS: Quality assessment occurred in 22% of systematic reviews identified in 1999-2000 compared with 50% of reviews identified from 2003-2004. All earlier reviews devised their own quality assessment criteria, whereas in 2003-2004 10 different quality assessment techniques were identified. CONCLUSIONS: Quality assessment does not routinely occur in systematic reviews of observational studies. Where it does occur, there is no clear consensus in the method used.

Humans↗

PubMed1999

Aggressive systematic treatment for central retinal artery occlusion.

PURPOSE: To report the efficacy of an aggressive systematic regimen for the treatment of acute nonarteritic central retinal artery occlusion (CRAO). METHODS: Eleven patients who had unilateral CRAO with symptoms of fewer than 48 hours' duration were treated with an aggressive stepwise systematic regimen until retinal circulation improved or until all the treatment steps were performed. Five patients with unilateral CRAO and symptoms of fewer than 48 hours' duration were treated in the same institution in an arbitrary nonsystematic manner. The therapeutic steps of the aggressive treatment included ocular massage, sublingual isosorbide dinitrate, intravenous acetazolamide, intravenous mannitol or oral glycerol, anterior chamber paracentesis, intravenous methylprednisolone followed by streptokinase, and retrobulbar tolazoline. After each step, retinal flow was evaluated by three-mirror contact lens. The nonsystematic treatment was arbitrary and included one or several of the above. Visual acuity and complete eye examination data were recorded before and after treatment. RESULTS: Visual acuity and retinal arterial supply were improved in eight (73%) of the 11 patients treated in the stepwise systematic manner. All eight patients in whom visual acuity improved had symptoms for fewer than 12 hours, and the presumed cause was either platelet-derived or cholesterol embolus from atheroma or the patients had glaucoma. Patients in whom visual acuity did not improve had CRAO that was attributed to calcified emboli or primary antiphospholipid antibody syndrome and had symptoms more than 12 hours before treatment. Visual acuity did not improve in all five patients with the nonsystematic treatment regardless of the presumed cause or duration of the occlusion. The success of the treatment in the systematic treatment group was statistically significantly better compared with the outcome of the nonsystematic treated group (Fischer exact test, P = .01). CONCLUSIONS: In the treatment of CRAO, an aggressive systematic regimen including medical and mechanical means may reestablish retinal circulation and improve visual outcome. The cause of arterial occlusion, the nature of occlusive emboli, and the duration of retinal ischemia may determine the visual outcome, but a larger series is warranted to verify the effectiveness of the treatment and the prognostic factors.

Acetazolamide↗